AU751430B2 - Devices and methods for performing a vascular anastomosis - Google Patents

Description

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AUSTRALIA

Patents Act 1990

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Heartport, Inc.

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Devices and methods for performing a vascular anastomosis The following statement is a full description of this invention including the best method of performing it known to us:- DEVICES AND METHODS FOR PERFORMING A VASCULAR

ANASTOMOSIS

ildof inventon Thne Present invention relates generally to devices and met-hods for surgical lv performing an end-to-side =raszormosis of hollow oroans. More oatclalit relates :o vascar- an.astomosis devi ces ror ]o n ing Che end o f a ar a vessel, such as a co-ronary ,vrass cra:: tothsie al 7tarz: vessel, such as th-e aorta or a coron-ary artery.

BACKGROUNTD OF TEINVENTION Ana-1stomosis is the surgical joining of biological ssueS, es:Deciallv the 'o~ng o= :ubular c=ans to create an :ei~mncat:ion between :hem. Vascuiar su,-raerv o::en iz;7ves crea::ncr an anaszoomosis bet-ween blood vessels or e bten a blo oda v eSsse i ad a v a sculIa r g r a z to c re at e o r r-eS-t~ore a blood flow oath* t~o -esse~' tssues. Coronary., a~tr ovoass:. ora:: s urgerv u- )i suzc-4a! o roced-ure toc re*:Srestore oo f low t~o iJs che-ic he ar: msc e .,no1se 11ood suooiv has been compromised by occlusion or st-enosis of one or more or: tne cor-onary ar----ies. One me o rr performing CC3 surcrerv involves harvestina a sazchen.-ous v/ein or other "enous or arterial conduit- from elsewhere in. :he body, or usinoa an arto4,f-Icia condu-it, such as one made o:Dacron or Goret-ex u .bng, an"- connec:ina tnis ui as a oyo,-ass ara::- fromL v~a~eartery, such as th-oraht.:e coronary artery co1-wn.s--ream or" the bock- or narwn. acraft with' bot "fre Z C 7A seoA eno nv ~es rerouti-na a less 33 es-e a- such as tnhe Int~erna- mammary artery, o-ror -zs natov,-e location so znat i may oDe connected- t.oth coro-ary a-rtery downst:ream. of heboag. The oroxm,-a, eno, o0e =raf: ve-ssel- remain-s atahci is natove coso-toon.

2 This type of graft is known as a "pedicled graft". In the first case, the bypass graft must be attached to the native arteries by an end-to-side anastomosis at both the proximal and distal ends of the graft. In the second technique at least one end-to-side anastomosis must be made at the distal end of the artery used for the bypass. In the description below we will refer to the anastomoses on a free graft as the proximal anastomosis and the distal anastomosis. A proximal anastomosis is an anastomosis on the end of the graft vessel connected to a source of blood the aorta) and a distal anastomosis is an anastomosis on the end of the graft vessel ***connected to the. destination of the blood flowing through it a coronary artery). The anastomoses will also sometimes be called the first anastomosis or second anastomosis, which e 3 rerers to the order in which the anastomoses are performed regardless of whether the anastomosis is on the proximal or distal end of the graft.

A present, essentially all vascular anastomoses are performed by conventional hand suturing. Suturing the anastomoses is a time-consuming and difficult task, recuirina much skill and practice on the part of the surgeon. It is impcrtant that each anastomosis provide a smooth, open flow path for the blood and that the attachment be completely free of leaks. A completely leak-free seal is not always achieved 25 on the very firs: try. Consequently, there is a frequent need for resuturing of the anastomosis to close any leaks that are detected.

The time consuming nature of hand sutured anastomoses is of special concern in CABG surgery for several reasons. irstly, the patient is required to be supported on cardiopulmonary bypass (CPB) for most of the surgical procedure, the heart must be isolated from the systemic circulation "cross-clamped"), and the heart must usuallv be. soopped, typically by infusion of cold cardioplegia soluion, so that the anastomosis site on the heart is still and blood-free during the suturing of the anastomosis.

CPB,

circulatory isolation and cardiac arrest are inherently very traumatic, and it has been found that the frequency of certain

S-A

3 post-surgical complications varies directly with the duration for which the heart is under cardioplegic arrest (frequently referred to as the "crossclamp time"). Secondly, because of the high cost of cardiac operating room time, any prolongation of the surgical procedure can significantly increase the cost of the bypass operation to the hospital and to the patient.

Thus, it is desirable to reduce the duration of the crossclamD time and of the entire surgery by expediting the anastomosis procedure without reducing the quality or effectiveness of the anastomoses.

The already high degree of manual skill required for conventional manually sutured anastomoses is even more elevated for closed-chest or port-access thoracoscopic bvyass surgery, a newly developed surgical procedure desained to 15 reduce the morbidity of CA3G surgery as compared to the standard open-chest CA3CG procedure. This procedure is more -ully described in commonly-assigned, co-pendinc patent 'applications 08/023,778, filed February 22, 1993, and 08/231,981. filed July 28, 1994, the complete disclosures of which are hereby incororated by reference. in th closed-chest procedure, surgical access to the hear: is made through narrow access ports made in :he incercostal spaces of the paient's chest, and the procedure is performed under thoracoscopic observation. Because :he pacient's ches is not 25 opened, the suturing of the anastomoses must be performed at some distance, using elongated instruments positioned through the access porcs for approximacing the tissues and for holding and manipulating the needles and sutures used to make the anastomoses. This requires even greater manual skill than .he already difficult procedure of suturing anastomoses during open-chest CABG surgery.

In order to reduce the difficulty of creacing the vascular anastomoses during either open or closed-chest

CABG

surgery, it would be desirable to provide a rapid means for making a reliable end-to-side anascomosis between-a bypass graft or artery and the aorta or the native vessels of the heart. A first approach to expediting and improvina anastomosis procedures has been through stapling technology.

4 Stapling technology has been successfully employed in many different areas of surgery for making tissue attachments faster and more reliably. The greatest progress in stapling technology has been in the area of gastrointestinal surgery.

Various surgical stapling instruments have been developed for end-to-end, side-to-side, and end-to-side anastomoses of hollow or tubular organs, such as the bowel. These instruments, unfortunately, are not easily adaptable for use in creating vascular anastomoses. This is partially due to the difficulty in miniaturizing the instruments to make them suitable for smaller organs such as blood vessels. Possibly even more important is the necessity of providing a smooth, open flow path for the blood. Known castroines-inal saoline insrumens for end-to-side or end-to-end anastcmosis of s cubular organs are designed to create an inverted anastomosis, that is, one where the tissue folds inward into the lumen of the organ that is being attached. This is acceotable in gastroincescinal surgery, where it is most imoortant co approximaze the outer layers of the intestinal trac (the serosa) This is the tissue which grows together to form a strong, permanent connection. However, in vascular surgery t. zhis geo-metry is unacceotable for several reasons. !irstlv, tne inverted vessel walls would cause a disruption in te bocod flo;. This could cause decreased flow and 4 sc--m downstream of the disruption, or, worse vet, the flow disruption or eddies created could become a locus for tnrombosis which could shed emboli or occlude the vessel at the anastomosis site. Secondly, unlike the intestinal tract, the outer surfaces of the blood vessels (the adventitia) will not crow tocether when approximated. The sutures, staples, or otner jo.iin device may therefore be needed oermanently to maLntain ze structural integrity of the vascular anastomosis.

Thirdly, to establish a permanent, nonhrombocenic vessel, the innermost laver (the endothelium) should grow together for a con-inuous, un-terrupted lining of the entire vessel. Thus, it would be preferable to have a stapling instrument that would create vascular anastomoses that are everted, that is folded outward, or which create direct edge-to-ecac coapta tion without inversion.

At I-east one stazling instrument has been appli-,j to performing vascular anastomoses during CABG surgerv. Thi s s device, first adaoted for use in CA3G surgery by Dr. Vasilli I. Kolesov and later refined by Dr. Evgeni4i V. Kolesov (U.S.

patent 41,350,160), was used to create an end-to-end anastomosis between the internal mammary artery or a vein graft and one of the coronary arte ries, zrimarily the left anterior descending coronary artery (LAD) ecause the device could only perform end-to-endi anastomoses, tne coronary artery -first nad to be severed and dissected from t-h surroundna myocardium, exzosed end evertec. -for attacnment. T-his tech'nique lte-a zne Ind-1ations o: the device to cases where the coronary artery wastoal *occlude--'-, and therefLore there was no loss o f blood f low by ccmplet.ely- sever-ing t*-e coronary artzery dcwnst_-raM 0- tne blockace to make the anastcrnosils. Cons ecruentlIv, th'-is devrice is not azoolicable where the crn-:art-ery :s on_-v nar-- _a 1 lv occluded and is not at- all aozic= makin- z the orox-:ma7 s-'de-tzc-end anastcmosls cetween a cvzass nraf: an-d the aorta.

O ne a::r-e mt t _o p r de a 7a sc u',a r stza p I I nde,,71'ce or end-zo-s_,n-e vascular anast-omoses Is cescr'moed n- U.S.

cazent ,3,4,a-ranted to Kaster et- a1.o S.d-:-n Vas c uIar Ana stzomoc Stcanl _Zznara s Ka st--er- et a p or ov d a ring-shaped stzaole stap.e lezs ext-ending from the 7crox~mal_ and di;.stal ends of th-e ri= zto join1 two Iblood v,,essels tcgrether__ in an end-to-side anastom,,,-s_4s. H-owever, 7-i device als short: of -fulfilling th-e desired objectives of- the resent invention. Specifically K7ast~er does not- provide a comrleze svs!--m fcor auicklv ann_ a -cmazicalv oerformina an an-astomrosis. The metnod 0:f apolyving the anaszomoSis st~anle disclosed by Kast~er involves a gr- de_= off manual maniu~at of 0: te szaole, using ha-nd operatea tzccs to 4 -d iv4 dn1a! ly deform the dis--a t:_Jes of the st-atic after the grafrt n-as been atz:acnen and before is insert-ennt the ooen-ina made in the aort~ic wall. One of the more difficult maneuvers in applying the Kast-er stanle involves caref-i 1 ly 6 everting the graft vessel over the sharpened ends of the staple legs, then piercing the everted edge of the vessel with the staple legs. Experimental attempts to apply this technique have proven to be very problematic because of difficulty in manipulating the graft vessel and the potential for damage to the graft vessel wall. For speed, reliability and convenience, it is preferable to avoid the need for complex maneuvers while performing the anastomosis. Further bending operations must then be performed on the staple legs.

Once the distal tines of the staple have been deformed, it may be difficult to insert the staple through the aortotomy opening. Another disadvantage of the Kaster device is that :the distal tines of the staple pierce the wall of the graft vessel at the point where it is everted over the staole.

1 5 Piercing the wall of the graft vessel potentially invites leaking of the anastomosis and may compromise the structural integrity of the graft vessel wall, serving as a locus for a Sdissection or even a tear which could lead to catastrohic fail ur. Because the Kaster staple legs only apply pressure to the anastomosis at selected points, there is a potential zor leaks between the staple legs. The distal tines of the staple are also exposed to the blood flow oath at the anastomotic site where it is most critical to avoid the potential for thrombosis. There is also the cotencial that 5 exposure of the medial layers of the graft vessel where the staple pierces the wall could be a site for the onset of intimal hyperplasia, which would compromise the long-term patency of the graft. Because of these potential drawbacks, it is desirable to make the attachment to the graft vessel as atraumatic to the vessel wall as possible and to eliminate as much as possible the exposure of any foreian materials or any vessel layers ocher than a smooth uninterrupted intimal laver witin the anastomosis site or within the graft vessel lumen.

A second approach to expediting and improving anastomosis procedures is through the use of anastomotic rittings for joining blood vessels together. One attempt to provide a vascular anastomotic fitting device for end-to-side vascular anastomoses is described in U.S. patent 4,366,819, 7 granted to Kaster for an Aastomocic Fitting. This device is a four-oart anastomotic fitting having a tubular member over which the graft vessel is everted, a ring flange which engages t'ne aortic wall from within the aorzic lumen, and a fixazicn ring and a locking ring which engage the exterior of the aortic wall. Another similar Anastomotic Fitting is describec_ in U.S. patent 4,368,736, also granted to Kaster. This device is a tubular fitting with a flanged distal end that fastens to the aortic wall with an attachment ring, and a proximal end with a graft fixation collar for attaching to the graft vessel. These devices have a number of drawbacks that the oresenrt ;invention seeks to overcome. Firstly, the anastomot'- ':_ittincs descr_;;bed exroose the f-'orejo(n material of the ana=stomotic device to the blood flow oath withnin the ar es.

-s is undesirable because foreonmtraswhiteboc flow oath can have a tenoenc to cuehMolysi s,paee denosition and thr-ombosis. Immune resonses to foreian material, such as reject-ion of the focreign material or ao-:i m -mune responses triggered by tn e presence of f ore I an Matril tend to be stroncer when temar-ri= -xzose-o to th-e bloodst-ream. As such', is ore -erazle that: as muon as o ossi ble of the.- interior surfaces of, an anastomocic :tz~nc tnat will be exzosed to t~he blood lo ahbe odvered w vascular tissue, either from the t-aroet_ vessel or- from t-e Z! raz7t vessel, so toat a smooth, corzinuous, h-emocomoarczbe endot:helial layer will be presenteo_ to the bloods--rar.Th anastomot ic fi'_t:_na describoed by Kast~er in the 18-19 patent a Iso has the =o:ten tZ al orawoack that- the sz ikes that hono toen gra; t vessel onto the an-aszomotic -Eittina are very close toc blood fElow zat-h. pocent~ially causing trauma to the b~co vessel that could lead toc leaks in thne anastomosis or ccmoromise o: the mechnical integ-rty of the vessels.

Consecuently, it is desi'rable to provide an anastomos-is A:rO :a Js as atraumatiic to the graft_ vessel as Oossihle.

nysh-ar-. featZures sucn as attachment- soikes should be placed as far away from toe b 1 ood flow path and the anastomos-is size as possible so that there is no compromise of the anastomosis seal or toe st-ruct~ural integrity of to.e vessels.

Another device, the 3M-Unilink device for end-to-end anastomosis (U.S.

patent numbers 4,624,257; 4,917,090; 4,917,091) is designed for use in microsurgery, such as for reattaching vessels severed in accidents. This device provides an anastomosis clamp that has two eversion rings which are locked together by a series of impaling spikes on their opposing faces. However, this device is awkward for use in end-to-side anastomosis and tends to deform the target vessel; therefore it is not currently used in CABG surgery. Due to the delicate process needed to insert the vessels into the device, it would also be unsuitable for port-access surgery.

In order to solve these and other problems, it is desirable to provide an anastomosis device which performs an end-to-side anastomosis between blood vessels or other hollow organs and vessels. It is also desirable to provide an anastomosis device which minimizes the trauma to the blood vessels while performing the anastomosis, which minimizes the amount of foreign materials exposed to the blood flow path within the blood vessels and which avoids leakage problems, and which is promotes rapid endothelialization and healing. Further, it would be desirable to

O**

provide such a device which could be used in port-access CABG surgery. Whether it is used with open-chest or closed-chest surgical techniques, it is also desirable that the invention provide a complete system for quickly and automatically performing an anastomosis with a minimal amount of manual manipulation.

SUMMARY OF THE INVENTION This invention in one broad form provides an anastomosis staple device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis staple device comprising: a tubular member having an internal lumen of sufficient size to accommodate an external diameter of said graft vessel, said tubular member being configured to attach said free end of said graft vessel to said tubular member, and a plurality of attachment legs extending from said tubular member, said plurality of attachment legs being configured to at least partially penetrate said wall of said target vessel.

This invention in a further-broad form provides a method of performing an anastomosis to connect a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the method comprising: attaching said free end of said graft vessel to an anastomosis staple by passing the end of said graft vessel through an internal lumen in said anastomosis staple and everting said free end of said graft vessel over a distal end of said anastomosis staple; inserting said distal end of said anastomosis staple with the everted end of said graft vessel attached through said opening in said wall of said target vessel; and penetrating said wall of said target vessel with a plurality of attachment legs connected to said anastomosis staple to hold said anastomosis staple within said opening in said wall of said target vessel such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

In a further aspect, the present invention comprises an anastomosis staple device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a ***lumen in the target vessel through an opening in the wall of the target vessel, 15 the anastomosis staple device comprising: an anchor member, said anchor member having means for attaching said anchor member to said wall of said target vessel, :a coupling member, said coupling member being configured to attach said free end of said graft vessel to said coupling member, and a coupling means for attaching said coupling member to said anchor member such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

In a still further aspect, the present invention comprises a method of performing an anastomosis to connect a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the method comprising: attaching an anchor member to an exterior surface of said target vessel; creating an opening in said wall of said target vessel; attaching a coupling member to said free end of said graft vessel; and connecting said coupling member to said anchor member so as to hold said coupling member proximate said wall of said target vessel such that said end of said graft vessel is sealingly connected to said wall of said target 9A vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

In yet a further aspect, the present invention comprises a device for applying an anastomosis staple, said device comprising: a stapling mechanism for applying an anastomosis staple, said stapling mechanism having an internal lumen therethrough, a punch means for creating an opening in wall of a hollow organ, said punch means being removably receivable within said internal lumen of said stapling mechanism, whereby said device is coupled to said punch means for applying said anastomosis staple to said wall of said target vessel in alignment with said opening.

0: In still yet a further aspect, the present invention comprises an 15 anastomosis fitting for connecting a free end of a graft vessel to a wall of a .target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis fitting comprising: an inner flange, said inner flange having a proximal surface and a distal surface and a central orifice of sufficient size to accommodate an external diameter of said graft vessel, said inner flange providing an atraumatic attachment for said end of said graft vessel when said end of said graft vessel is passed through said central orifice and everted over said inner o a o flange, said inner flange being insertable through said opening in said wall of 25 said target vessel, an outer flange, said outer flange having a proximal surface and a distal surface and a central orifice of sufficient size to accommodate the external diameter of said graft vessel, said distal surface of said outer flange being configured to contact an exterior surface of said wall of said target vessel proximate said opening, and means for maintaining said outer flange in a selected position with respect to said inner flange such that said everted end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

In still yet a further aspect, the present invention comprises a method of performing an anastomosis to connect a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the method comprising: attaching said free end of said graft vessel to an inner flange of an anastomotic fitting; inserting said inner flange with said free end of said graft vessel attached through said opening in said wall of said target vessel and engaging an inner surface of said target vessel with said inner flange; positioning an outer flange of said anastomotic fitting in contact with an exterior surface of said wall of said target vessel proximate said opening; and coupling said inner flange and said outer flange such that said graft 15 vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

In a further aspect, the present invention comprises an anastomosis device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis fitting comprising: a fastening flange, said fastening flange having a distal surface and a central orifice of sufficient size to accommodate an external diameter or said 25 graft vessel, said fastening flange providing an attachment for said end of said graft vessel by passing said end of said graft vessel through said central orifice and everting said end of said graft vessel over said fastening flange, and a plurality of staple members movable with respect to said fastening flange, said staple members being configured to pierce the everted end of said graft vessel and to penetrate the wall of said target vessel thereby attaching said fastening flange and the everted end of said graft vessel to the wall of said target vessel.

In yet a further aspect, the present invention comprises an improved tissue punch of the type having an anvil axially movable with respect to a tubular cutter, said anvil being configured to be slidably received within an internal lumen of said tubular cutter to punch a hole through tissue interposed between said anvil and said tubular cutter, wherein the improvement comprises: a clamping means coupled to said tissue punch for clamping the tissue to be cut by said tissue punch.

In yet a further aspect, the present invention comprises an anastomosis fitting for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis fitting comprising: a tubular member having an internal lumen of sufficient size to accommodate an external diameter of said graft vessel, said tubular member having a distal end with a plurality of attachment legs extending therefrom, said plurality of attachment legs being configured to penetrate at least said wall of said graft vessel from within the lumen of said target vessel, S 15 an outer flange, said outer flange having a distal surface and a central orifice of sufficient size to accommodate the external diameter of said graft vessel, said distal surface of said outer flange being configured to contact an S'exterior surface of said wall of said target vessel proximate said opening, and S'means for maintaining said outer flange in a selected position with respect to said tubular member.

:In yet a further aspect, the present invention comprises a method of performing an anastomosis to connect a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target S 25 vessel, the method comprising: passing said graft vessel through an internal lumen of a tubular member; everting said free end of said graft vessel; penetrating the everted end of said graft vessel with a plurality of attachment legs extending from a distal end of said tubular member; inserting said plurality of attachment legs through said opening in said wall of said target vessel; penetrating an interior surface of said wall of said target vessel with said plurality of attachment legs; positioning a distal surface of an outer flange in contact with an exterior surface of said wall of said target vessel proximate said opening; and locking said outer flange in a selected position with respect to said tubular member.

In still yet a further aspect, the present invention comprises an anastomosis device comprising: an anastomosis means for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, and a flexible tubular extension extending from said anastomosis means, said flexible tubular extension encircling and supporting at least a portion of said graft vessel.

In yet a further aspect, the present invention comprises an anastomosis device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen 15 in the target vessel through an opening in the wall of the target vessel, the :anastomosis fitting comprising: a first ring having a distal end with a plurality of staple members depending therefrom, and S"a second ring concentrically positionable with respect to said first ring, said second ring having a distal end with a plurality of staple members depending therefrom.

In yet a further aspect, the present invention comprises a catheter apparatus for nonocclusively isolating a section of a tubular organ from fluid flow within said tubular organ, said catheter apparatus comprising: 25 a distal balloon and means for inflating said distal balloon, a proximal balloon and means for inflating said proximal balloon, a perfusion tube to which said proximal and distal balloons are attached in spaced apart positions, said perfusion tube having a proximal opening proximal to said proximal balloon, a distal opening distal to said distal balloon and a perfusion lumen therebetween, and an elongated catheter shaft connected to said perfusion tube between said proximal balloon and said distal balloon in a T configuration.

In a further aspect, the present invention comprises an improved method for performing a vascular anastomosis of the type in which an end of a graft vessel is anastomosed to a wall of a target vessel at a selected anastomosis site, wherein the improvement comprises performing the step of: 9E isolating said anastomosis site within said target vessel from blood flow by inserting a catheter into a lumen of said target vessel, inflating a first balloon on said catheter upstream of said anastomosis site and inflating a second balloon on said catheter downstream of said anastomosis site; perfusing said target vessel downstream of said second balloon with blood delivered through a perfusion lumen of said catheter; and performing the anastomosis at said anastomosis site between said first balloon and said second balloon.

In a final aspect, the present invention comprises an anastomosis system comprising: an anastomosis staple means for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, and 15 a staple applying means for applying said anastomosis staple means such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

Brief Description of the Drawings Fig. 1 is a perspective view of the anchor member and the coupling member of a two-piece embodiment of the anastomosis staple device of the present invention.

Fig. 2 is a perspective view of a staple applier system for applying the 25 anastomosis staple device of Fig. 1.

Fig. 3. is a perspective view of the distal end of the staple applier system of Fig. 2 showing the stapling mechanism and the vessel punch mechanism along with the anchor member of the two-piece anastomosis staple device of Fig. 1.

Fig. 4 is a cross-sectional view of the distal ends of the stapling mechanism and the vessel punch mechanism of the staple applier system of Fig. 2 along with the anchor member of the two-piece anastomosis staple device of Fig. 1.

Figs. 5A-5G are side cross-sectional views showing the sequence of operations for creating an end-to-side anastomosis with the two-piece anastomosis staple device of Fig. 1.

Fig. 6A is a perspective view of the graft insertion tool of the anastomosis staple applier system of Fig. 2 prepared for insertion of the bypass graft with the coupling member of the two-piece anastomosis staple device.

Figs. 6B-6C are side cross-sectional and perspective views, respectively, of the distal end of the graft insertion tool of Fig. 6A.

Figs. 7A-7C are perspective, bottom end, and side cross-sectional views, respectively, showing a variation of the graft insertion tool prepared for creating a second anastomosis of the bypass graft using the two-piece anastomosis staple device of Fig. 1.

Figs 8A-8G are side views of various configurations of the attachment 15 legs of the anchor member of Fig. 1 which allow for tailored amounts of tissue compression at the anastomosis site.

Fig. 9 is a perspective view of a one-piece embodiment of the anastomosis staple device of the present invention.

Fig. 10 is a cross-sectional view of the one-piece anastomosis staple device of Fig. 9 being actuated to form an end-to-side anastomosis.

Fig. 11 is a cross-sectional view of a one-piece anastomosis staple device with extended first segments on the staple legs.

Fig. 12 is a cross-sectional view of a one-piece anastomosis staple device with secondary pivot points on the staple legs to create radial tissue 25 compression.

Fig. 13 is a side-cross sectional view of a staple applying tool for creating an end-to-side anastomosis using the one-piece anastomosis staple device of Fig. 9.

Fig. 14 is a cross-sectional view of the distal end of the staple applying tool of Fig. 13 holding the one-piece anastomosis staple device of Fig. 9 with a graft vessel attached thereto.

Figs. 15A is a detail drawing of the female bayonet connector on the distal end of the anastomosis staple applying tool of Fig. 13.

Fig. 15B is an end view of the male bayonet connector on the proximal end of the one-piece anastomosis staple device of Fig. 9.

Fig. 16 is a cross sectional schematic of another alternate embodiment of the one-pDiece anastomosis staple device being actuated to form an end--o-side anastomdsis.

Fig. 17A-17B are a perspective views of a first alternate construction of the two-piece anastomosis staple device of Fig. 1. Fig. 17C is a cross section view of the anchor member of the anastomosis staple device of Fig. 17A attached to the wall of a target vessel. Fig. 17D is a cross section view of a completed anastomosis using the device of Fig. 17A-17B.

Figs. 18A-18F show a second alternate construction of the two-piece anastomosis staple device of Fig.:1.

Fig. 19A-19B shows a third alternate construction of the two-piece anastomosis staple device of Fia. 1.

Fig. 20 is a side cross secion view of a fourth alternate construction of the two-piece anastomosis staple device of Fig. 1.

SFigs. 21A-21C are side partial cross section views or a first embodiment of an anastomotic fitting according to *C0 the invention.

Figs. 22A-22C are side cross section views of an anastomosis fitting which is a variation of the embodiment of Figs. 21A-21C. Fig. 22D is a proximal end view of the anascomosis fitting of Fig. 22C.

Figs. 23A-23D are side cross section views of another variant of the embodiment of :he anastomosis fittina o 21A-21C and Figs. 22A-22C.

Figs. 24A-24B are side cross section views of a second embodiment of tie anastomotic fitting of the invention having an expanding inner flance. Fics. 24C and 24D are distal en views of th expandicg inner flange in the collapsed position and the expanded ncsltion, resoectively.

zigs. 25A-251H show a second *ariant of the anas:omotic fitting with an exaandina _nner flance is shown in Figs. 24A-24D.

Figs. 26A-2f show a :hird embodiment which is a one-piece anascomocic fitting ;:tc a zeformabe outer flange.

11 Figs. 27A-27D show a second variant of the anastomotic fitting with a deformable outer flange.

Figs. 28A-28Ishow a third variant of the anastomotic fitting with a deformable outer flange.

Figs. 29A-29C show an embodiment of the anastomotic fitting having a secondary flange washer which attaches to the inner flange.

Figs. 30A-30K show an embodiment of the anastomotic fitting combining deformable inner staple members and an outer flange.

S

S.

OOS

~0 *55* 0 S .5 Figs. 31A-31F show a first embodiment of an anastomotic device combining a fastening flange with a plurality of staple members.

Figs. 32A-32F show an anastomosis device using preformed spring-like fastening staple members.

Figs. 33A-33D show an anastomosis device using s-shaped staple members target vessel.

Figs. 34A-34D S-shaped staple members of the target vessel.

Figs. 35A-35F U-shaped staple members Figs. 36A-36C U-shaped staple members Figs. 37A-37C U-shaped staple members Figs. 38A-38C that pierce the interior wall of the show an anastomosis device using that do not pierce the interior wall show an anastomosis device using with barbed points.

show an anastomosis device using and a locking collar.

show a second anastomosis device using and a locking collar.

show a one-piece anaszomosis device with integral staple members.

Figs. 39A-39C show a seccnd one-piece anastomosis device with integral staple members.

Figs. 40A-40D show a two-piece anastomosis device having two concentric ring flanges ith integral staole members.

Figs. 41A-41E show an anastomosis device having a fastening flange and a plurality of individual staple members.

Figs. 42A-42D illustrate a one-piece embodiment of the anastomosis device with a fastening flange and attached staple members.

Figs. 43A-43B show the fastening flange of an anastomosis device using preformed superelastic alloy staple members in a top view and a side view, respectively.

Figs. 44A-44B show the superelastic alloy staple members of the anastomosis device in a front view and a side view, respectively.

Figs. 45A-45E show the sequence of operations of an application instrument for the anastomosis device of Figs.

43A-43B and Figs. 44A-44B.

,Figs. 46A-46D illustrate a second embodiment of the anastomosis system using an anastomosis device with an inner fastening flange, an outer flange and staple members made of a superelastic alloy.

Figs. 47A-47B show an anastcmosis staple device combining a fastening flange with precurved inner staple members of a highly resilient material and deformable outer 20 attachment legs in an undeployed state.

Figs. 48A-48B show the anastomosis staple device of Figs. 47A-47B in a deployed state.

Figs. 49A-49C show the sequence of operations for deploying the anastomosis staple device of Figs. 47A-47B.

Figs. 50A-50B show a staple application instrument for applying the anastomosis staple devices of Figs. 47A-47B.

Fig. 51 shows a combination s.rain relief and compliance mismatch transition sleeve for use with any of the Sanastomosis devices of the present in-.ention.

.:30 Fig. 52 shows a dual-balloon perfusion endoaortic clamp catheter for isolating a portion of the aortic wall while performing a proximal anastomosis in CABG surgery.

Fig. 53 shows a dual-balloon coronary isolation and perfusion catheter for use in performn-- a distal anastomosis in CABG surgery.

Fig. 54 shows a T-shaped dual-balloon coronary isolation and perfusion catheter for use in performing a distal anastomosis in CABG surgerv.

13 Figs. 55, 56, 57 show the sequence of operations for creating an end-to-side anastomosis during port-access

CABG

surgery using the anastomosis stapling system of the present invention.

DESCRIPTION OF THE PREFERRED

EMBODIMENT

The invention will be now be described in detail with reference to the accompanying drawings. The detailed description describes the invention in relation to a proximal anastomosis during CABG surgery for joining the proximal end of the bypass graft to the aortic wall. This example is given by way of illustration only and is in no way meant to be limiting. Those skilled in-the art will recognize that the anastomosis staple device and anastomosis stapling system of the present invention are readily adaptable for end-to-side connections of distal anastomoses graft to coronary artery anastomoses) during CABG surgery, as well as for use on other blood vessels and other tubular organs within the body.

For consistency and convenience, throughout the description the two ends of the anastomosis staple are referred to as the proximal and distal ends of the staple, the distal end of the staple being the end which is closest to the inner lumen of the target vessel and the proximal end being the free end S which is farthest from the inner lumen of the target vessel.

Fig. 1 is a perspective drawing of a first embodiment of the anastomosis staple device of a first asDect of the present invention. The anastomosis staple device 100 consists of two parts: an anchor member 101, and a coupling member 102. The anchor member 101 forms the attachment to the exterior surface of the wall of a target vessel such as the aorta. The coupling member 102 forms the attachment to the bypass graft vessel. When the coupling member is joined to the anchor member, as shown by the dotted lines 103, it forms a complete anastomosis.

The anchor member 101 has a ring-shaped frame 104 which is configured to encircle an opening in the wall of a target vessel, such as the aorta. The ring-shaped frame 104 has a plurality of attachment legs 105, preferably six to 14 twelve, circumferentially spaced around the frame 104 and Projecting from the distal end 106 of the ring. The anchor member 101 is preferably made of stainless steel or a titanium alloy for strength, biocompatibility and absence of MRI interference. The ring-shaped frame 104 and the attachment legs 105 preferably have a wall thickness of approximately 0.2 to 0.6 mm. The width of each of the attachment legs 105 is preferably between 0.5 and 2.0 mm. The attachment legs 105 could also be made with a round cross section to eliminate sharp edges which might propagate tears. The precise dimensions of the attachment legs 105 would be a compromise between making the legs rigid enough to pierce.the: wall of the target vessel without undue deformation, yet flexible enough to permit the stapling mechanism to deform the attachment legs after they have pierced the target vessel wall to hold the anchor member in place. These dimensions may vary depending on which vessel is chosen as the target vessel for the anastomosis.

The attachment legs 105 extend first radially 20 outward from the ring 104, then there is a transition curve 107, after which the legs 105 extend axially away from the ring 104 in the distal direction. The transition curve 107 in each attachment leg 105 is shaped so that the anchor member 101 can be placed precisely on the target vessel wall, then 5 affixed firmly in place with minimal displacement of the anchor member 101 or distortion of the target vessel wall.

This attachment process will be described more fully in the operational description below.

The points of attachment between the attachment legs 105 and the ring-shaped frame 104 in this illustrative embodiment are all shown as being coplanar with one another.

In other preferred embodiments, the distal extremity 106 of the anchor member 101 may be contoured to match the curvature of the exterior surface of the target vessel. Thus, the points of attachment between the attachment legs 105 and the ring shaped frame 104 will be arranged on a cylindrically curved surface which intersects the ring 104 of the anchor member 101 rather than a plane. This would be esoecially important when there is closer parity between the diameter of the graft vessel and the diame.er of the target vessel, such as when performing a distal anastomosis between a venous or arterial graft and a coronary artery, because a planar arrangement of the attachment legs 105 would not approximate the curvature of the target vessel wall as well as for a larger target vessel such as the aorta. In other alternate embodiments, the distal end of the anchor member 106 and the attachment legs 105 may be angled with respect to the ring-shaped frame 104 to permit an angled takeoff of the graft vessel from the target vessel.

One preferred configuration for the transition curve 107 in the attachment legs 105 is illustrated in Fig. 1. The first segment 108 of each attachment leg extends radially from the ring-shaped frame for a short distance. The second segment 109 of each leg angles proximally from the first segment at approximately 60" for a short distance. Then, the third segment 110 angles approximately 60" in the distal direction from the second segment 109. The fourth segment iii extends in the distal direction from the third segment 110 so that the fourth segment 111 extends axially away from the ring-shaped frame 104 parallel to the central axis of the ring 104. The second 109 and the third 110 segments should be approximately equal in length to one another. The actual length of the second 109 and third 110 segments will be determined by the wall thickness of the target vessel.

A

typical length of 1.5-5 mm would be used for attachment to the wall of the aorta. The distal ends 112 of the attachment legs 105 are sharpened to easily penetrate the aortic wall.

This illustrates just one preferred transition curve 107 for the attachment legs 105. Alternate transition curves 107 for the attachment legs 105 may include arc-shaped segments in place of some of the straight segments or may include a greater number of straight segments to approximate a smoother curve. When choosing alternate curves, it is important to preserve the axially extending final segment 111 of the attachment legs in order to penetrate the target vessel wall. In addition, it is important to control the amount of distortion of the target vessel wall when the anchor member 101 is attached. This is in contrast to many standard wound closure staples which deliberately bunch up the tissue when they are applied to create a closer approximation of the tissues being joined. This type of distortion may be counterproductive in attaching a graft vessel to the aortic wall because the wall may be too stiff to distort in this manner and the distortion might cause problems in creating a leak proof seal at the anastomosis. The anvil geometry of the stapling mechanism will also be important in determining the optimum geometry of the attachment legs.

The amount of radial compression of the target vessel wall around the anastomosis can be.tailored by the choice of the transition curve 107 in the attachment-legs 105 of the anchor member 101. Radial compression of the target vessel wall around the anastomosis helps to create and maintain an anastomotic seal between the target vessel and the graft vessel in the completed anastomosis. This is especially important when blood pressure is restored in the target vessel which will tend to stretch the target vessel wall and pull it away from the anastomosis. The radial compression by the attachment legs counteracts this expansion and maintains the anastomotic seal under pressure. Fig. 8A-8G show various other possible geometries for the attachment legs 105 of the anchor member 101 arranged according to the degree of tissue compression applied to the target vessel wall. Fig. 8A shows a staple attachment leg 105 where the transition curve 107 consists of a straight second segment which extends upward at ninety degrees from the first radially extending segment. The 3*0 third segment 110 describes a 90" arc with a center of rotation at the transition point between the first 108 and second 109 segments. The fourth segment 111 extends straight in an axial direction from the third segment 110. This embodiment of the attachment legs 105 creates very little tissue compression when applied. The amount of tissue compression is indicated by the shaded region between the straight insertion path of the fourth segment 111 and the final position of the actuated scaple shown in phantom lines 17 105. Fig. 8B shows a transition curve 107 with an elliptically shaped second segment 109 which smoothly evolves into an arc-shaped third segment 110 with a center of rotation at the transition point between the first 108 and second 109 segments. This embodiment creates a slightly greater degree of tissue compression. Fig. 8C shows an attachment leg geometry which is formed entirely of smooth curves so as to avoid any sharp bends in the attachment legs 105, but which produces approximately the same tissue compression as the attachment leg of Fig. 8B. Fig. 8D shows a transition curve 107 with a 30' arc-shaped second segment 109 connecting to a arc-shaped third segment 110 with a center of rotation at the transition point between the first 108 and second 109 segments. Fig. 8E shows a side view of the embodiment illustrated and described above in Fig. 1. The second segment 109 angles 60" upward from the first segment 108, and.the third segment 110 angles downward at 60' from the second segment 109. This produces a selected degree of tissue compression when the attachment legs 105 are actuated. Fig.

20 8F shows an attachment leg geometry which produces slightly greater tissue compression in the target vessel. The second 109 and third 110 segments of the transition 107 are smoothly blended together in a continuous semicircular arc. Fig. 8G shows an attachment leg geometry which produces even more tissue compression. The second segment 109 angles upward at from the first segment 108 and the third segment 110 angles downward from the second 109 at a 90' angle. Many other attachment leg geometries may be tailored to produce the desired degree of tissue compression in the target vessel.

The coupling member 102, as seen in Fig. 1, has a tubular body 113 with a passage 114 through it. The distal end of the coupling 102 has an atraumatic edge 115 over which the graft vessel will be everted in forming the anastomosis.

The atraumatic edge 115 is important co avoid piercing or damaging the vessel wall in the vicinity of the anastomosis which occurs with some prior art devices. Atraumatic attachment of the graft vessel to the coupling member helps to assure a reliable anastomotic seal between the graft vessel and the target vessel and reduces the likelihood of mechanical failure of the graft vessel wall due to punctures or tears in the wall. The exterior of the coupling member 102 is preferably sized to fit into the interior of the ringshaped frame 104 of the anchor member with enough space between them to accommodate one wall thickness of the bypass graft. The coupling member 102 is preferably made of stainless steel, a titanium alloy or plastic with a wall thickness of approximately 0.1 to 0.6 mm. In a preferred embodiment, the exterior of the coupling member 102 has exterior surface features 116 which serve a dual purpose. The exterior surface features 116 serve to hold an everted end of the bypass graft onto the coupling member 102, as well as to interlock the coupling member 102 with the anchor member 101 to complete the anastomosis. Likewise, the interior of the anchor member 101 is made with interior surface features 117 which interact with the exterior surface features 116 to create the interlock. The exterior surface features 116 15 of the coupling member 102 could be in the form of bumps, pins, points, barbs, ridges, threads, holes or a combination of these features. The interior surface features 117 of the anchor member 101 would then be in the form of corresponding bumps. pins, points, barbs, ridges, threads or holes to lock the two parts together. It should be noted that, if pins, points, barbs or other piercing members are used as the interior 117 or exterior 116 surface features of the anastomosis staple device 100, these potentially traumatic features are located away from the everted edge of the graft vessel and outside of the lumens of the graft vessel and target vessel that will serve as the conduit of ~the bypass so as not to compromise the integrity of the anastomosis In the embodiment illustrated, the coupling member 102 is shown with bump-shaped exterior surface features 117 that hold the everted graft vessel 0onto the coupling member 102 and interlock with a series of circumferential .*ridges 116 within the anchor member 101. The interior ridges 116 of the anchor member 101 permit a variable degree of engagement between the coupling member 102 and the anchor member 101 to allow for different wall thicknesses of the target vessel and 19 the graft vessel used in the anastomosis. The axial position of the coupling member 102 with respect to the anchor member 101 can be varied to create the desired degree of axial tissue compression to assure an anastomotic seal despite variations in the vessel wall thicknesses.

The complete anastomosis staplingsystem includes the anastomosis staple device 100 and an instrument 118 for applying the anastomosis staple 100. The instrument 118 for applying the two-part anastomosis staple 100 consists of three separate, but interacting, mechanisms: a stapling mechanism 119, a vessel punch mechanism 120, and a graft insertion tool 121, 122. Together with the anchor member 101 and the coupling member 102, they comprise a complete system for performing an anastomosis. In Fig. 2, we can see two of these mechanisms, the stapling mechanism 119 and the vessel punch mechanism 120, assembled together with the anchor member 10.1 of the anastomosis staple 100, prepared for the first stage of the anastomosis procedure. The third mechanism, the graft insertion tool, is shown in two different embodiments 121, 122 .4 in Figs. 6A-6C and Figs. 7A-7C, respectively.

The stapling mechanism 119 and the vessel punch 120 are shown assembled together in a perspective view in Fig. 2.

The anchor member 101 of the anastomosis staple 100 is held by the staple retainer 123 on the distal end of the stapling mechanism. This same assembly can be seen in cross section in the operational drawings 5A-5C. The distal end of this assembly is shown in greater detail in cross section in Fig.

4. The stapling mechanism 119 has an inner tube 124 and an outer tube 125 which are threaded together at their distal ends. The outer tube 125 has a handle 126 at the proximal end and an annular staple driver 127 at the distal end of the tube. The inner tube 124 has a staple retainer 123 for holding the anchor member 101 of the anastomosis staple 100 on the distal end of the tube. The inner tube 124 has an internal lumen 128 of sufficient size to accommodate the vessel punch mechanism 120 and the graft insertion tool 121, alternately. The proximal end of the inner tube 124 has a pair of opposing slots 129 on che inner surface that act as splines for engagement with a corresponding pair of lugs 134 on the exterior of the vessel punch mechanism 120 and on the graft insertion tool 121.

The vessel punch mechanism 120 is sized to fit through the internal lumen 128 of the inner tube 124 of the stapling mechanism 119. The vessel punch mechanism 120 has an outer tube 131 and an inner drive member 132 slidably received within the outer tube. The proximal end of the outer tube 131 is attached to a T-shaped handle 133. The outer tube 131 has a pair of lugs 130 near the proximal end which extend radially from the exterior of the tube 131 to engage the opposing slots 129 in the inner tube 124 of the stapling mechanism 119. The distal end of the outer tube 131 tapers to form a neck 135 which attaches to a cutter anvil 136. The vessel punch cutter S 137 is a tubular member which slides telescopically on the distal end of the outer tube 131 of the vessel punch 120. The distal edge 138 of the tubular cutter 137 is sharpened with an approximately conical bevel 138. The cuter tube 131 of the S* vessel punch mechanism 120 may include a step 139 against which the cutter is located in the retracted position as in Figs. 5A and 5B. The tubular cutter 137 is attached to the S drive member by a transverse pin 140 which extends through a pair of opposing slots 141 in the distal end of the outer tube 131. The proximal end of the drive merber 132 is attached to an actuating plunger 142 which extends proximally of the T-shaped handle 133.

The vessel punch mechanism 12: is actuated by pressing on the actuating plunger 142 tc move it with resoect to the T-shaped handle 133. This linear motion is transferred to the inner drive member 132 and then, in turn, to the tubular cutter 137 by way of the transverse Din 140. The tubular cutter 137 slides -forward until the inner lumen of rhe cutter 137 slides over the anvil 136 ir. a shearing action.

There is.a very tight clearance betweern he inner lumen of -he cutter 137 and the outer diameter of the anvil 136. This eight clearance assures a cleanly cut hrle through the vessel wall without ragged or torn edges. In Fig. 5C, the vessel 21 punch mechanism 120 is shown-actuated to cut a hole through the aortic wall tissue.

Fig. 3 is a large scale perspective detail drawing of the distal end of the vessel punch mechanism 120 assembled with the stapling mechanism 119. The anchor member 101 of the anastomosis staple 100 is held by the staple retainer 123 on the distal end of the inner tube 124 of the stapling mechanism 119. The ring-shaped frame 104 of the anchor member 101 fits inside of a counterbore 143 on the distal end of the inner tube, as can be seen in Figs. 4 and 5A-5E. The attachment legs 105 of the anchor member 101 are captured and held by the L--shaped gripping fingers 144 which extend from the distal end of the inner tube 124. There are an equal number of gripping fingers 144 on the inner tube 124 as there are attachment legs 1s 105 on the anchor member 101. Each gripping finger 144 has an axial slot 145 alongside of it which is at least as wide as the attachment legs 105. The axial slot 145 connects with a transverse slot 146 in the side of each gripping finger 144.

The anchor member 101 of the anastomosis staple 100 is loaded 0 onto the staple retainer 123 by aligning the attachment legs.

105 with the ends of the axial slots 145, mushing the attachment legs 105 to the bottom of the axial slots 145, then *turning the anchor member io1'counterclockwise until the attachment legs 105 enter the transverse slots 146 in the side of the gripping fingers 144. The anchor member 101 can be secured in this position by rotating the outer tube 124 of the stapling mechanism to advance it distally until the staple driver 127 contacts the attachment legs 105 with enough force to hold the anchor member 101 in place without deforming the legs. Alternatively, the inner tube 124 of the stapling mechanism 119 could be adapted to grip the ring-shaped element 104 of the anchor member 101 directly.

The T-shaped handle 133 of the vessel punch mechanism 120 also serves as the handle for the inner tube 124 of the stapling mechanism 119 at this stage of the procedure because the lugs 130 on the exzerior of the vessel punch outer tube 131 engage the slots 129 i n the interior of the stapler inner tube 124. Likewise, in zhe latter stages of the 22 procedure, the T-shaped handle 133 of the graft insertion tool 121 can also serve as a handle for the inner tube 124 of the stapling mechanism 119 because the lugs 134 of the graft insertion tool 121 engage the inner slots 129 of the stapler inner tube 124 in a similar fashion. Alternatively, the inner tube 124 of the stapling mechanism may be supplied with a separate handle or knob of its own so the inner 124 and outer 125 tubes of the stapling mechanism can be rotated with respect to one another to operate the stapling mechanism when neither the aortic punch mechanism 120 nor the graft insertion tool 121 is inserted into the stapling mechanism 119.

A first embodiment of the graft insertion tool 121 and its relationship to the coupling member 102 of the anastomosis staple 100 are shown in detail in Figs. GA-6C.

5 This embodiment of the graft insertion tool 121 may be used when the anastomosis staple 100 is used to form the first *o anastomosis of the bypass procedure no matter whether the first anastomosis is the proximal or the distal anastomosis of the graft. To prepare the bypass graft for creating the anastomosis, the coupling member 102 is first loaded onto the distal end of the graft insertion tool 121. A shoulder 147 on the graft insertion tool 121 holds the coupling member 102 in the correct position, and a tight interference fit or a spring action prevents it from inadvertently falling off. The graft vessel 148 is then loaded into the internal lumen 149 of the graft insertion tool 121. This can be done by tying a suture around the graft vessel on the end opposite to the end that will be anastomosed, passing the suture through the internal lumen 149 of the graft insertion tool 121, then drawing the graft vessel 148 into the lumen until the end 192 of the graft vessel 148 to be anastomosed extends a short distance from the distal end of the graft insertion tool 121. Alternatively, a special tool, such as a narrow pair of endoscopic forceps or a nerve hook, may be used for grasping the graft vessel 148 and drawing it through the graft insertion tool 121. At this point, the end 192 of the graft vessel 148 to be anastomosed is everted over the end of the araft insertion tool 121 and the coupling member 102, as shown in Figs. 6A-GC. The external surface features 116 of the coupling member 102 serve to hold the graft vessel onto the exterior of the coupling member 102 in the everted position. The external surface features 116 of the coupling member may at least partially penetrate the wall of the graft vessel 148 to provide greater holding force.

With the anchor member 101 loaded onto the stapling mechanism 119 and the graft vessel 148 prepared by everting and attaching it to the coupling member 102 as described above, the device is ready to perform the end-to-side anastomosis, as illustrated in Figs. SA-5G. Referring now to Fig. 5A, the stapling mechanism 119 and the vessel- punch mechanism 120 are shown assembled together. A slit 150 is made in the target vessel wall 150 with a scalpel or other **is sharp instrument, and the anvil 136 of the vessel punch 120 is inserted through the slit 151 into the lumen of the target vessel 150. The anvil 136 serves to center the stapling mechanism 119 and the anchor member 101. around the chosen attachment point on the target vessel 150 where the slit 151 0 is made. The stapling mechanism 119 is advanced over the vessel punch mechanism 120 toward the wall of the target vessel 150, as shown in Fig. 5B. A slight tension is maintained on the T-handle 133 of the vessel punch mechanism 120 so that the anvil 136 supports the wall of the target vessel 1SO as the attachment legs 105 o-ff the anchor member 101 contact and penetrate the target vessel wall 150. The fourth segments ill of the attachment legs 105 penetrate the target vessel wall 150 in a linear path. Once the fourth segments 111 of the attachment legs 105 have traversed the target vessel wall 150, the attachment legs 105 are actuated, as shown in Fig. SC. The outer tube 125 of the stapli'ng mechanism 119 is advanced over the inner tube 124 by rotating the handle 126 of the outer tube 125 with respect to the T-handle 133 of the vessel punch mechanr.ism 120. This advances the staple driver 127 against the attachment legs deforming them into the position- show-. in Fig. 50C. After the attachment legs 105 have been actuated, the tubular cutter 137 of the vessel ounch mechanism 120 is advanced with respect to the anvil 136, as shown in 5SD by pressing on the actuating plunger 142 at the proximal end of the drive member 132. The punch mechanism 12C creates an opening 152 through the target vessel wall 150. -he vessel punch with the tissue 153 that was excised by the punch can now be withdrawn from the inner lumen 128 of the stapling mechanism 119, as shown in Fig. 5E, leaving the anchor member 101 attached to the target vessel wall 150 in alignment with the opening 152 punched therein.

The graft vessel insertion tool 121 with the prepared graft vessel 148 and coupling member 102 in place is inserted into the inner lumen 128 of the stapling mechanism 119 as shown in Fig. 5F. The coupling member 102 is pressed into the ring-shaped frame 104 of the anchor member 101 and the exterior features 116 on the coupling member 102 engage the interior features 117 of the ring-shaped frame 104 to hold the coupling member 102 and the anchor member 101 together.

The staple retainer 123 of the stapling mechanism 119 still has a firm grasp on the anchor member 101 to provide support as the coupling member 102 is pressed into the ring-shaped Sframe 101. The coupling member 102 should be pressed into the S ring-shaped frame 104 until the everted end of the graft vessel 148 bears against the exterior surface of the target vessel wall 150, creating a fluid tight seal at the anastomosis site. Alternatively, the coupling member 102 with the everted end of the graft vessel 148 attached, can be made to extend into the opening 152 in the target vessel wall 150 with the target vessel wall 150 creating a radial compression around the graft vessel 148 and the coupling member 102. The stapling mechanism 119 can now be disengaged from the from the anchor member 101 by turning the handle 126 of the outer tube 125 with- respect to the T-handle 133 of the graft insertion tool 121 until the staple driver is withdrawn from the attachment legs 105. Then the inner tube 124 of the stapling device can be turned counterclockwise by turning the T-shaped handle 133 of the graf: insertion tool 121 to disengage the gripping fingers 144 of che staple retainer 123 from the attachment legs 105 c: the anchor member 101.

A

complete end-to-side anastomosis, as shown in Fig. 5G, is left at the anastomosis site.

It should be noted that the order of the steps of the anastomosis procedure 127 could be altered. For instance, the opening could be first punched in the target vessel with an aortic punch or similar instrument, and then the anchor member of the staple could be attached. In this instance, the graft vessel could be attached to the anchor member either before or after the anchor member is attached to the target vessel. Other variations in the order of the steps are also possible.

Fig. 7A shows a perspective drawing of a second embodiment of the graft insertion tool 122 for use in performing the second anastomosis on a graft vessel, one end of which has already been anastomosed, or for other situations when both ends of the graft vessel are not available, such as when making the distal anastomosis on an internal mammary S artery bypass graft. This embodiment of the graft insertion tool 122 is made with a two-part, hinged holder 154 for the 20 coupling member of the anastomosis staple device so that the holder 154 can be removed from around the graft vessel 148 after both ends of the graft have been anastomosed. The holder 154 is attached to the'distal end of a tubular member 155 which is attached on its proximal end to a handle grip 156. A shaft 157 is slidably received within the. tubular member 15/5 The distal end of the shaft 157 is attached to a U-shaped yoke 158 which is configured to grip a flange 159 or a pair of lugs on the proximal end of the anchor member 101.

The handle grip 156 has a coacting trigger member 160 which is attached to the proximal end of the shaft 157 through a slot 161 in the side of the tubular member 155. The holder 154 is spring biased toward the open positicn 154'. The force of the spring action helps the holder 154 tc grip the coupling member 102 so that it does not slip of.f of the holder 154 prematurely. A distal end view of the holder 154 is shown in Fig. 7B, with the holder 154 shown in both the closed position and the open position (phantom lines 154') \r To prepare the graft vessel 148 for the anastomosis, the coupling member 102 is firs" placed onto the holder 154 and the end of the graft vessel 148 to be anastomosed is passed through the lumen 162 of the holder 154 and the coupling member 102 from the proximal to the distal- end. The end of the graft vessel 148 is then everted back over the coupling member 102, as shown in Fig. 7C. The external surface features 116 on the coupling member 102 will hold the .everted vessel in place on the coupling member. In figure 7C, the anchor member i01 of the anastomosis staple device I00 has been fastened to the target vessel 150, as described above in relation to Figs. 5A-5E, and the stapling mechanism 119 has been removed by turning the handle 126 of the stapling mechanism 119 counterclockwise relative to the handle 126 on the vessel punch mechanism 120 until the anchor member I01 is released. The graft insertion tool 122 with the prepared graft vessel 148 is now positioned at the anastomosis site and the U-shaped yoke 158 is used to grip the anchor- member 101, retained by the flange 159 on its proximal end. With the graft vessel 148 and the coupling member 102 aligned with the anchor member 101 as shown, the handle grip 156 and the trigger 160 are squeezed together to press the coupling member 102 into the anchor member 10i until the everted end of the graft vessel 148 is pressed against the outer surface of the se. target vessel 1SO creating a leak-proof anastomosis. The holder 154 is then retracted from the coupling member 102 by moving the trigger 160 away from the handle grip 154. The hinged holder 154 opens when it is withdrawn from the coupling member 102, releasing the graft vessel 148 from the lumen 162 of the holder 154. The U-shaped yoke 158 can now be slid sideways off of the anchor member and the anastomosis is complete.

A one-piece version of the anastomosis staple device of the present invention along with a specially adapted staple applying tool will now be described in detail.. In the one-piece embodiments which follow, a tubular member, analocous to the coupling member of the previously described embodiment, is permanently attached to a circular staple member, which is analogous to the anchor member 101 of the previously described embodiment.

Fig. 9 shows a perspective view of-a first embodiment of the one-piece anastomosis staple device 163 of the present invention. This same embodiment is shown in cross section in Figs. 11 and 13. The anastomosis staple 163 has a tubular body member 164 which has an inner lumen 165 sized to accommodate the exterior diameter of the graft vessel 148.

Means for attaching the graft vessel 148 are provided at the distal end of the tubular body member 164 or on the outside of the tubular member 164. In the preferred embodiment, the means for attaching the graft vessel 148 to the anastomosis staple 163 is a tubular distal extension 166 of the tubular body over which the graft vessel 148 is everted. The tubular extension 166 may include a flange 167 to secure the attachment of the everted graft vessel 148 to the tubular extension 166. This flange 167 may also engage the inner surface of the target vessel 150 to help retain the graft 148 in place.

The anastomosis staple device 163 has a multiplicity S of staple legs 168 extending from the tubular body member 164 proximal to the tubular distal extension 166. Optionally, the tubular body member 164 may extend proximally 169 from the staple legs 168 as shown, or the tubular body member can be truncated at or near the level of the staple legs to decrease the overall profile of the staple. The optional proximal extension 169 of the tubular body member 164 may include lugs or tabs 170 or a flange or other features that can be used for gripping the staple 163 by a staple applying tool.

The anastomosis staple 163 typically has five to twelve staple legs 168 for attaching to the target vessel wall 150. The presently preferred embodiment of the scaple 163 has six staple legs 168 as illustrated in Fig. 9. The staple legs 168 are distributed circumferentialiv around the exterior of the tubular body member 164. The staple legs 168 can be formed integrally with the tubular body member 164, or they can be manufactured separately and attached to the tubular body member 164. Optionally, ex-erior of the tubular body member 164 may include a circumferential ledge 171 to which the staple legs 168 are attached. In the pre-actuated position, the legs 168 angle proximally from where they attach to the tubular body member 164 so that the sharpened tips 172 of the staple legs are proximal to the point of attachment with the body. The staple legs 168 have a first segment 173 which extends approximately straight from the tubular body member; then there is a transitional segment 174 and a curved end segment 175. The curved end segment 175 of each staple leg has a sharpened tip 172 for easily piercing the wall of the target vessel 150. The curve of the end segment 175 is a circular arc whose center of rotation coincides approximately with the point of attachment 176 between the staple leg and the tubular body member. The point of attachment 176 serves 15 as a pivot point for the staple leg 168 when it is actuated, so that the end segment 175 of the staple legs 168 describes an arc-shaped path through the tissue of.the target vessel wall that follows the curvature of the arc-shaped end segment 175.

The transition segment 174 of the staple legs 168 S can take on one of several forms depending on the effect desired in the actuated staple. If the transition segment 174 is largely a right-angle bend, so that only the end segment 175 penetrates the tissue, then the staple legs 168 will cause very little radial compression of the target vessel wall tissue 150 as the staple 163 is actuated. If, on the other hand, the transition segment 174 has a curve of smaller radius than that of the curved end segment 175, the tissue will be compressed and pulled toward the tubular body member 164 as the transition segment 174 enters and travels through the target vessel wall 150, as illustrated in Fig. 10. The degree of radial tissue compression can be regulated to the appropriate amount by proper design of the curve in the transition segment 174 of the staple legs 168. In addition, the shape of the first segment 173 may help to define the surface shape of the target vessel 150 after the staple 163 is applied. It may be desirable to keep it as flat as possible, or it may be desirable to "tent up" the target vessel somewhat *in the area of the anastomosis. Optionally, the first segment may be given greater effect on the target vessel surface shape by extending the first segment-- 173 beyond the transition poinwith the second segment 174, as shown in Fig. 11. The straight extension 177 of the first segment 173 beyond the attachment point of the transition curve 174 will tend to flatten out the tissue of the target vessel wall 150 at the anastomosis site so that undue deformation of the vessel wall does not compromise the integrity of the anastomosis.

Fig. 12 shows another means for accomplishing the tissue compression performed by the transition segment 174 of the staple legs 168 in the embodiment of Figs. 9 and 10. In this embodiment, the transition segment 174 of the staple legs 168 is essentially a -right angle bend with very little' radiusing, so the staple legs 168 cause very little tissue S. compression as they pierce the target vessel wall 150 and travel through the tissue. However, before the staple legs 168 have reached the end of their travel, the first segment 173 comes into contact with a circumferential ledge 178 that Zo ext ends outward from the tubular body member 164 just below 0 .00 the attachment point 176 of the staple legs 168. When the staple legs 168 contact the ledge 178, the first segments 173 of the legs bend where they contact the outer edge of the ledge 178. This moves the center of rotation outward and shortens the radius of rotation of the curved end segment 175 so that the staple legs will pull the tissue of the target vessel wall 150 toward the tubular body member 164, compressing the tissue.

The staple legs 168 are preferably dimensioned so that the staple legs travel all the way through the target vessel wall 150 when the stanle is actuated. In the embodiment of Fig. 10, after act.uation, the ends 172 of the staple legs 168 rest just distal, to the flange 167 on the distal end 166 of the tubular body member 164. In the embodiment of Fic. 12, the staple leas 168 are configured to pierce the wall o-f the grafZ vessel 148 just proximal to the flange 167 on the distal end 19-6 of the- tubular body member 164, adding to the securitv of-, :he at -achnent In" both embodiments the flange 1G7 supports the tissue of the target vessel wall 150 as the ends 172 of the staple legs 168 emerge, helping to insure that the staple legs 1G8 will pierce Cl -eanlythrough the target vessel wall 150 without separating the lamina, which could lead to dissection. In both cases, the staple legs 168 are configured so that the curved end segments 175 of the staple -legs 168 are driven all the way through the target vessel wall 150 before there is significant compression of the tissues. The tubular body member 164 isolates the cut edge at the opening 152 -in the target vessel wall 150 from the blood flow path so that blood pressure will not cause delamination of the target vessel wall 150. The -staple 'legs 168, the tubular body member 164 andi the flange 167 form a c.losed loop, similar to a sutured attachment. These factors also help to minimize the danger of dissection of the target vessel wall 150.

Fig. 13: shows one preferred embodiment of the one-piece anastomosis staple 163. mounted on the itledo a specially adapted staple applying tool 179. The staple applying tool 179 has an outer tube 180 and an inner tube 181 slidably received within the outer tube 180. The inner tube' 181 has an inner lumen 182 of sufficient diameter to accommodate the outer diameter- of the graft vessel 148 that wil b e us d f r te.a t m s T e s a l p l i g t o wl eue o h nsooi: Tesal pligto 0025 179 has a main body 183 which is shaped in the for-m of a pistol grip. The proximal end of the inner tube 182. is 0 anchored with respect to the main body 183 by a flange 184 or 0 00* other attachment on the proximal end. The outer tube 180 is slidable with respect to the inner tube 181 by actuating the levrer 185 of the staple applying tool 179 which engages a palir of pins 186 attached to the exterior o"L the outer tube.

Pulling the lever 185 advances the outer tube 180 distally over the inner tube 181. A return spring 187 attached to the lever 185 returns the lever 185 and the outer tube 180 to their unactuated positions.

A close-up view of the anastomosis staple 163 and the distal end of" the staple applying tool 178 is shown in Fig. 14. The anastomosis s taole 163 in this embodiment has a tubular body 164 which is permanently attached to a plurality of circumferentially distributed attachment legs 168. The tubular body 164 has a distal tubular extension 166 with a flange 167 for eversion and attachment of the graft vessel 148. There is also a proximal tubular extension 169 which has a pair of tabs 170 for grasping the staple with a staple retainer 188 on the distal end of the inner tube 181 of the staple applying tool 179. An end view of the tabs 170 is .shown in Fig. 15A. The staple retainer 188 at the distal end of the inner tube 181 shown in detail in Fig. 15B, has a pair of longitudinal slots 189 corresponding to the two tabs 170 of the anastomosis staple. Connected to the longitudinal slots 189 is a circumferential groove 190 within the inner tube 188.

The staple 163 is attached to the staple retainer 188 by aligning the tabs 170 with the longitudinal slots 189 and sliding the tabs into the slots 189. When the tabs 170 reach the bottom of the longitudinal slots 189, the staple 163 is S rotated with respect to the inner tube 181 so that the tabs 170 enter the circumferential groove 190. A ridge 191 on the 20 distal side of the groove 190 holds the tabs 170 within groove 190 to retain the staple 163 on the end of the inner tube 181.

It should be noted that a number of methods of attaching the tubular member 164 to the stapling mechanism 179 are possible besides the bayonet attachment illustrated. The end of the stapling mechanism 179 may be configured to grasp the tubular member 164 on the inner diameter or the outer diameter distal to the point of attachment 176 of the staple legs 168, allowing the proximal tubular extension 169 of the anastomosis staple 163 to be eliminated. This modification would allow a lower profile anastomosis attachment to be created.

To prepare the graft vessel 148 for anastomosis, an anastomosis staple 163 is attached to :he distal end of the staple applying tool 179 as jus: described, then, using a suture or an elongated grasping :ool, :he graft vessel 148 is drawn into the inner lumen 182 c the zool until the end 192 of the graft vessel 148 to be anastomcsed extends a short distance from the distal end of :he tcool. At this point, the end 192 of the graft vessel 148 to be anastomosed is everted over the distal tubular extension 166 and the flange 167 as shown in Fig. 14. A suture can be tied around the everted end 192 of the graft vessel 148 proximal to the flange 167 to retain the graft vessel 148 on the staple 163, if desired.

Thus prepared, the staple 163 is advanced toward an opening 152 that has been previously made in the target vessel wall 150 with an aortic punch or other appropriate tool.

Preferably, the opening 152 is made with a diameter approximately equal to the outer diameter of the distal tubular extension 166 of the staple 163 just proximal to the flange 167. The flange 167 with the everted end 192 of the graft vessel 148 is passed through the opening 152 in the target vessel 150, as shown in Fig. 10. The target vessel wall 150 may need. to be stretched slightly to allow the flange o 167 to pass through the opening 152. The elastic recovery of the target vessel wall 150 creates a compressive force where the target vessel wall 150 surrounds the distal tubular S extension 166 with the everted end 192 of the graft vessel 148 which contributes to the fluid-tight seal of the anastomosis.

Once the flange 167 has been passed through the opening 152 in the wall of the target vessel 150, the anastomosis staple 163 is pulled back slightly so that the flange 167, covered by the everted graft vessel wall 192, is against the inner surface of the target vessel wall 150.

Then, the staple 167 is actuated by pulling on the lever 185, which moves the outer tube 180 distally until the staple driver 193 at the distal end of the outer tube 180 bears on the attachment legs 168. As the staple driver 193 advances, the attachment legs 168 bend at the fulcrum 176 where they attach to the tubular member 164. The arc-shaped third segments 175 of the attachment legs 168 penetrate and traverse the wall of the target vessel 150. Once the third segments 175 of the attachment legs 168 have traversed the wall, the staple 163 begins to compress the tissue of the target vessel wall 150 radially against the discal tubular extension 166 of the anastomosis staple 163 by any of the mechanisms previously discussed. After the attachment legs 16! of the anastomosis staple 163 have been fully actuated, the lever 185 is released and the staple applying tool 179 is rotated to disengage the staple retainer 188 from the tabs 170 on the proximal tubular extension 169 of the staple 163. The staple applying tool 179 is withdrawn and the anastomosis is complete.

Fig. 16 shows another potential configuration for the staple legs 194 of the one-piece anastomosis staple 195.

In this embodiment, the staple legs 194 have a compound curved transition segment 197 which provides two different axes of rotation for the staple legs 194 as they are actuated. The staple legs 194 attach to the proximal end of the tubular body member 198. A first segment 199 of the staple leg 194 extends approximately radially from the point of attachment 206.

There is a U-shaped bend 200 at the end of the first segment 199 that connects it to a second segment 201 which lies roughly parallel to the first segment 199. A third segment 202 attaches the second segment 201 to the fourth, and most distal, segment 203 of the staple leg. The fourth segment 203 has an arc-shaped curve whose center of rotation is approximately at the center of the U-shaped curve 200 between the first 199 and second 201 segments. The distal tip 204 of the fourth segment 203 is sharpened so that it easily S penetrates the target vessel wall 150.

In the operation of this embodiment of the anastomosis staple, the staple legs 194 are initially in the position shown by solid lines 194 in Fig. 16. In this position the staple legs 194 are held well above the flange 205 on the distal end of the tubular body member, making it easier to insert the flange 205, with the everted graft vessel 192 attached, into the opening in the target vessel 150 and to seat the flange 205 against the inner surface of the tarcet vessel 150. When the staple driver is advanced, the staDle legs 194 initially rotate about attachment point 206 between the first segment and the tubular body member. After the staple leg 194 has rotated approximately 90 degrees, to the position shown by phantom lines 194', the first segment 199 comes into contact with the exterior of the tubular body member 193 and it stops rotating. Advancing the staple driver further causes the second 201, third 202 and fourth 203 segments of the staple leg 194 to rotate around the U-shaped curve 200 connecting the first 199-and second 201 segments.

The U-shaped curve 200 opens up to about 90 degrees as the curved fourth segment 203 of the staple leg 194" penetrates the target vessel wall 150, attaching the graft vessel 148 to the target vessel 150 to complete the anastomosis.

Another embodiment of the two-piece anastomosis .staple is shown in Figs. 17A-17D. This embodiment differs somewhat in its construction from the embodiment of Fig. 1 although the operational principles are basically the same.

The anastomosis staple 207 again includes an anchor member 208 and a coupling member 209 which interconnect. The anchor member 208 is made with a ring-shaped frame 210 which is pierced by two parallel rows of slots 211, 212. The metal 213 between the slots 211, 212 is deformed outward slightly to allow insertion of wire attachment legs 214. After the attachment legs 214 are inserted, the metal 213 is pressed inward to firmly attach the wire attachment legs 214 to the frame 210. Either before or after attachment to the S ring-shaped frame 210, the wire attachment legs 214 can be formed with a desired curve, such as one of the curves described in Figs. 8A-8G. The distal tips 215 of the wire attachment legs are sharpened so that they easily penetrate.

the target vessel wall 150. The use of round wire attachment legs 214 with conically sharpened points 215, as opposed to the flat attachment legs 105 with chisel-shaped points 212 of Fig. 1, has shown some advantage in preliminary testing, in that the round wire legs 214 cause less trauma to the tissue of the target vessel wall 150 as they penetrate it. This may be due to the tendency of the conically sharpened tips 215 of the attachment legs 214 to dilate the tissue as they pass through the target vessel wall 150 more than to cut it. The tissue of the target vessel wall 150 is thus left more intact and may be less prone to dissections or other structural failure.

A plurality of retaining clips 216 are integrally formed on the proximal edge of -he rin -shaped frame 210. The retaining clips 216 perform the function of coupling the anchor member to the coupling member, similar to the interior surface features 117 of the anchor member 101 of Fig. i. The coupling member 209, shown in Fig. 17B, has a tubular body 217 with a plurality of graft holding points 218 extending from its distal edge. If desired, the graft holding points 218 could be relocated, replaced with other'gripping features, or eliminated entirely to avoid piercing the graft vessel 148 at the point of eversion. The graft holding points 218 perform one of the functions of the exterior surface features 116 of the coupling device 102 shown in Fig. 1 in that they attach the graft vessel 148 to the coupling member 209.

This embodiment of the two-piece anastomosis staple 207 can be applied with a slightly modified version of the 1 5 anastomosis stapling tool 118 of Figs. 2, 6 and 7, following the sequence of steps of Figs. 5A-5G. The inner tube 124 of S the stapling mechanism 119 grasps the anchor member 208 by either the ring-shaped frame 210 or the first segment of the attachment legs with the L-shaped legs of the staple retainer.

After a small incision 151 has been made in the target vessel wall 150 at the desired anastomosis site, the stapling mechanism 119, with the vessel punch mechanism 120 inserted into the inner lumen 128, is positioned at the anastomosis to.. site. The anvil 136 of the vessel punch 120 is inserted through the incision 151 and drawn back slightly to support the target vessel wall 150 so that the wire attachment legs 214 can be driven into the wall 150. The wire attachment legs 214 are then deformed by the stapling mechanism 119 to attach the anchor member 208 to the target vessel wall 150. The vessel punch 120 is then actuated to form a hole 152 through the target vessel wall 150 centered within the ring-shaped frame 210, as described in relation to Fig. 5D. The anchor member 208 is now attached to the target vessel wall 150 with the ring shaped frame 210 centered around the opening in the vessel wall 152, as shown in Fig. 17B. In this illustrative embodiment, the wire attachment legs 214 are configured so as to only partially penetrate the target vessel wall 150 so that they are embedded within the target vessel wall 150 in their final, deployed configuration. This variation of the method may be preferred for attachment co some types of body tissues as the target vessel 150. The wire attachment legs 214 may also be pierced through the entire target vessel wall 150 before they are deformed so that they reside against the interior of the target vessel wall 150, as shown in Fig. Once the anchor member 208 is attached to the target vessel 150, the vessel punch mechanism 120 is withdrawn and the graft insertion tool 121 with the graft vessel 192 everted over the distal end of the coupling member 209 is inserted into the inner lumen 128 of the stapling mechanism 119. The graft insertion tool 121 is used to press the coupling member 209 into the ring-shaped frame 210 of the anchor member 208 until the everted end 192 of the graft vessel 148 is firmly sealed against the outer surface of the target vessel wall 150 and the retaining clips 216 have seated over the proximal end of the coupling member 209. The coupling member 209 is held in the ring-shaped frame 210 by the retaining clips 216. The 0. graft holding points 218 may be made so that they penetrate through the graft vessel wall 192 and into the target vessel S wall 150, as shown in Fig. 17C, to increase the security or the anastomosis attachment. It should be noted that other sequences of operations are also possible for this embodiment, S such as punching the opening in the target vessel wall prior to attachment of the anchor member. J Another embodiment of the two-piece anastomosis Sstaple device 219 is shown in Figs. 18A-18F. This embodiment of the device lends itself to differenz manufacturing methods than the previously described embodimen.s. The anchor member 220 shown in perspective in Fig. 18A ca- be formed from a single piece of sheet metal by a combinraion of punching and drawing steps. The anchor member 220 .as a plate 221 which is curved to fit the contours of the exterior surface of the target vessel wall 150, as seen in the end view Fig. 18B. For performing an aortic anastomosis, the radius of curvature of the plate 221 would typically be betwee. 10 and 20 mm in an adult human. The plate 221 would be ar.roximately 10 to 20 mm in width and 10 co 25 m. in leng:h. The plate 221 is punched so as to form integral attachment legs 222. This illustrative embodiment is shown with four integrally formed attachment legs 222, as best seen in top view Fig.- 18C. A tubular proximal extension 223 is formed on the curved plate 221 by drawing the sheet metal plate 221 to form a cylindrical extension 223, then piercing or drilling it to open the proximal end of the cylinder. A final forming or stamping operation forms a radiused flange 224 at the proximal end of the tubular extension 223 that serves as a strain relief to prevent sharp bends or kinking of the graft vessel 148 close to the anastomosis site.

This embodiment of the anchor member can be attached to the target vessel wall by a sequence of operations similar to that described in relation to Figs. 5A-5G. Alternatively, the sequence of operations can be re-ordered so that the target vessel is punched before placement of the anchor member similar to that described for the one-piece embodiment of Fig.

9. Thus, either of the anastomosis stapling mechanisms 118, 179 previously described could easily be adapted to hold the S anchor member 208 of Fig. 18 and to-drive the attachment legs 222 into the target vessel wall 150.

The coupling member 225 in this embodiment is a toroidal ring 225 made of a resilient biocompatible material such as plastic, rubber or a springy metal having an outside diameter slightly smaller than the inside diameter of the cylindrical extension 223. The coupling member 225 is shown in Fig. 18D. The graft vessel 148 is prepared for anastomosis by passing the end of the vessel through the central opening of the toroidal ring 225 and everting it back 192 over the ring, as shown in the Fig. 18E. The ring 225, with the graft vessel 192 everted over it, is then collapsed or folded enough so that it can be inserted into the proximal tubular extension 223 of the anchor member 220. Once through the cylindrical extension 223, the toroidal ring 225 recoils to its expanded size, sealing the graft vessel wall 192 against the wall of the target vessel 150 and preventing the end of the graft vessel 192 from pulling out of the tubular extension 223.

Alternatively, a cylindrical ring-shaped coupling member with locking features, similar to those shown in Figs. 1 and 173 can be used in conjunction with the anchor member of Fig. 18A.

Figs. 19A and 19B show an alternate construction 226 of the two-piece anastomosis staple 219 device of Figs.

18A-18E. In this variation of the device, the anchor member 227 may be made from a flat piece of sheet metal that is punched to form a flange 238 with a central aperture 228 and integrally formed attachment legs 229. The anchor member 227 is attached to the target vessel 150 with the central aperture aligned 228 with a preformed hole 152 in the wall of the target vessel 150. Alternatively, the anchor member 227 can be placed before the hole 152 is punched. The attachment legs 229 are shaped with straight distal segments, as shown by the phantom lines 231', that penetrate the target vessel wall 150 1 5 in a linear fashion. A stapling device with a staple deforming anvil is passed through the hole 152 in the target vessel wall 150 to deform the attachment legs 229 so that they grip the target vessel wall 150, as shown by the solid lines 231. The attachment legs 229 can be deformed one at a time or some or all of the attachment legs 229 can be deformed at once depending on the design of the stapling device.

Alternatively, the attachment legs 229 can be precurved and driven into the target vessel'wall 150 from the outside.

The central aperture 228 in the flange 230 of the anchor member 227 has attachmen features that interlock with matching attachment features on a first tubular coupling member 232. As an illustration of one possible configuration, the first coupling member is shown with two pairs of tabs 233, 234 extending radially from the distal edge of the first tubular coupling member 232. One pair of tabs 234 is slightly more distal than the other pair 233. The central aperture 228 of the anchor member 227 has a matching pair of slots 235 extending from the aperture 228. The first coupling member 232 is joined to the anchor membrer 227 by aligning the more distal pair of tabs 234 with the slots 235, pushing the tabs 234 through the slots 235, then curning the coupling member 232 until the tabs 234 are locked onto the edges of the aperture 228. The first tubular coupling member 232 may be made with integrally formed craft holding points 236 which are cut and bent inward from the wall of the first tubular coupling member 232 to hold the everted graft in place. The graft may be everted over a second tubular coupling member 196, which is inserted into the first tubular coupling member 232 and is attachable to the first tubular coupling member at the proximal ends of the tubular coupling members, as shown in Fig. 19B.

Fig. 20 shows a fourth alternate construction 237 of the two-piece embodiment of the anastomosis staple device 100 of Fig. 1. The anchor member 238 of the anastomosis staple device 237 may be formed from a piece of sheet metal, similarly to the other alternate embodiments previously described. The anchor member 238 has a distal plate 239 which 15 may be flat or curved to match the exterior curvature of the target vessel 150. Multiple attachment legs 240 are cut from the plate material 239, sharpened at the ends 241, and bent with a ifirst section 242 that angles upwardly from the plate 239 and a second section 243 that is angled downward to pierce 20 the target artery wall, as shown in phantom lines 243' in Fig.

Preferably, the second section 243 is curved with a radius of curvature approximately equal to the length of the first section 242. A tubular proximal extension 244 with a slight hourglass shape extends from the distal plate 239 of 25 the anchor member 238.

The coupling member 245 of the anastomosis staple device 237, shown in Fig. 20, is made in a tubular shape of a biocompatible resilient material such as plastic, rubber or a springy metal, such as a nickel-titanium alloy.* The tubular coupling member 245 has a slight hourglass shape in axial cross section, matching the in-erior shape of the tubular proximal extension 244 of the anchor member 238. If desired, the tubular coupling member 2-5 can be made with slightly thickened proximal 246 and distal 247 extremities which act as O-rings molded integrally with the wall of the tube. The tubular coupling member 245 can be made with a continuous tubular wall or with a longitudinal slot in the wall of the tube to increase the resilien:-/ of t-e coupling member.

Alternatively, the tubular coupling member 245 can be made of a coiled spring with an hourglass shape in axial cross section.

As with the previously described embodiments, the anchor member 238 can be applied to the exterior of the target vessel 150 either before or after an opening 152 has been created with a vessel punch. To place the anchor member 238, the plate 239 of the anchor member 238 is pressed against the exterior surface of the target vessel 150 at the anastomosis site and the attachment legs .240 are pressed to drive the sharpened tips 241 through the target vessel wall 150. If an opening 152 has not yet been made in the target vessel wall 150, a vessel punch is inserted through the lumen 244 of the proximal tubular extension 244 to create an opening 152 in the 15 wall 150 concentric with the tubular extension 244.

Meanwhile, the graft vessel 148 is prepared by placing it through the lumen of the tubular coupling member and everting the end 192 of the graft vessel 148 over the outside of the coupling member 245. To complete the 20 anastomosis, the coupling member 245 with the end 192 of the graft vessel 148 attached is collapsed or folded and inserted into the proximal tubular extension 244 of the anchor member 238. The resilience of the coupling member 245, combined with the matching hourglass shapes cf the two parts of the staple device, locks the parts together to ftrm a leak-proof anastomosis.

The coupling member 245 can be dimensioned so that the distal end of the coupling member 245 extends through the opening 152 in the target vessel wall and the everted edge 192 of the graft vessel 148 seals within -he opening 152, as illustrated, or against the interior surface of the target vessel 150 similarly to the one-piece embodiment of the anastomosis staple device illus:rated in Fig. 9.

Alternatively, the coucling member 245 can be shaped so that it presses the everced edge 1!2 of the graft vessel 148 againsz the exterior surface of the target vessel 150 to create a leak-proof seal similar to the embodiment of Fig. 1.

41 In a further aspect of the invention, an anastomosis fitting is provided for rapidly and reliably creating an end-to-side anastomosis between a graft vessel and a target vessel. A first representative embodiment of an anastomotic fitting 250 according to this second aspect of the present invention is shown in Figs. 21A-21C. The anastomotic fitting 250 is made up of two coacting parts: a) a tubular inner sleeve 251 which has an internal lumen 252 of sufficient size to accommodate the external diameter of the graft vessel 254 and an inner flange 253 which is attached or formed at the distal end of the sleeve 251 so as to be positioned within the lumen 256 of the target vessel 255, and b) an outer flange 260 which has a central orifice 261 that is sized to fit over the exterior of the inner sleeve 251 to be positioned against the 5 exterior surface 258 of the target vessel wall 255. The anastomotic fitting 250 is thus held in place by compressing the target vessel wall 255 between the inner 253 and outer 260 flanges. An adjustable locking mechanism 262 holds the outer flange 260 on the inner sleeve 251 at a selected position to 0 create a tailored degree of tissue compression at the anastomotic site. The anastomosis fitting 250 can be made of various biocompatible materials, such as stainless steel, titanium alloys, plastic, pyrolytic carbon, etc.

Additionally, biocompatible coatings could be applied to the S. inner and/or outer surfaces of the fitting 250 to increase its acceptance by the body tissues or to reduce thrombosis.

The inner sleeve 251 is a tubular member with an internal lumen252 large enough to accommodate the external diameter of the graft vessel 254, either a natural graft vessel or an artificial graft vessel. Natural saphenous vein autografts typically have an internal diameter between 3 mm and 10 mm and an external diameter between 4 mm and 11 mm.

Pedicled arterial grafts, such as the internal mammary artery or the gastroepiploic artery typically have an internal diameter between 2 mm and 7 mm and an external diameter between 3 mm and 8 mm, with thicker, -ore muscular walls.

Artificial prosthetic graft vessels, made of materials such as Dacron or Goretex, -typically have a d-amezer of 3 mm t- 30 mm.

The tubular inner sleeve 251 should be made of a rigid biocompatible material, such as stainless steel, titanium alloys or a rigid biocompatible plastic. The wall thickness of the sleeve is preferably about 0.2 mm to 2.0 mm.

The distal end of the inner sleeve is flared at an angle of approximately 45 to 75 degrees to form a conical inner flange 253. The inner flange 253 has an outer diameter of approximately 1.3 to 2.5 times the inner diameter of the inner sleeve 251. The use of a conical or rounded inner flange 253 helps to improve the hemodynamic efficiency of the anastomosis connection by improving the orifice coefficient at the entrance to the graft vessel 254. It also assures that the finished anastomosis will not protrude into the lumen 246 of the target vessel 255 or upset the hemodynamic flow in that vessel. The exterior of the tubular inner sleeve 251 has a series of circumferential ridges 263 or threads which may be sawtooth in shape.

eeo. The outer flange 260 as a central orifice 261 which is sized to fit over the exterior of the tubular inner sleeve 251. The outer flange 260 has an outer diameter of approximately 1.3 to 3.0 times the inner diameter of the inner sleeve 251. A ratchet mechanism 264 within or adjacent to the central orifice 261 of the outer flange 260 engages the circumferential ridges 263 on the exterior of the tubular S inner sleeve 251. The ratchet 264 can be strictly a one-way mechanism so that the outer flange 260 can only move in the direction of the inner flange 253 or a release mechanism can be incorporated so that the outer flange 260 can be moved away from the inner flange 253 in case of premature activation of the ratchet mechanism 264. Alternatively, the outer flange 260 could be threaded to the exterior of the tubular inner sleeve 251. The distal edge 265 of the outer flange 260 may incorporate a plurality of attachment spikes 266 that engage and hold the wall of the target vessel 255 and/or the everted wall 259 of the graft vessel 254 when che outer flange 260 is applied. In the preferred embodiment which is intended for creating an anastomosis becween a coronary artery bypass graft and the ascending aorta, the outer flance 260 has 4 to 12 43 spikes of 1 to 3 mm length and 0.2 to 0.5 mm diameter.

Variations of this configuration may be made where appropriate for different graft vessels and target vessels.

The anastomosis is performed by passing the end 259 of the graft vessel 254 through the inner lumen 252 of the tubular inner sleeve 252 until the end of the vessel extends a short distance from the distal end of the sleeve, as shown by phantom lines 259' in Fig. 21A. The end 259 of the graft vessel 254 is then everted over the conical inner flange 253 of the fitting 250 to form an atraumatic attachment, as shown in Fig. 23A. If desired, a loop of suture can be tied around the everted end 259 of the graft vessel 254 to hold it in place on the inner flange 253 and/or the tubular inner sleeve 251. The conical inner flange 253 and the everted end 259 of 5 the graft vessel 254 are then passed through an opening 267 that has previously been made in the wall of the target -vessel 255 with an instrument such as a vessel punch, as shown in Fig. 21B. The diameter of the opening 267 in the target vessel wall is preferably about the same as the external diameter of the tubular inner sleeve 251. The opening 267 may need to stretch slightly to allow the conical inner flange 253 to pass through. The elastic recovery of the target vessel wall 255 around the opening 267 helps to create an anastomotic seal by contracting around the inner sleeve 251 and the everted graft vessel wall 259. The outer flange 260 is then slid onto the proximal end of the inner sleeve 251. If the anastomosis being performed is the first anastomosis of a free graft, such as a saphenous vein graft, with the other end of the graft unattached, then the outer flange 260 can be slid over the graft vessel 254 from the free end. If the other end of the graft vessel 254 is not free, such as when performing a second anastomosis or a distal anasto-osis on a pedicled graft like the IMA, then the outer flange 2-_0 should be back loaded onto the graft vessel 254 or preloaded onto the proximal end of the inner sleeve 251 before the end 259 of the graft vessel 254 is attached to the inner flange 253 of the fitting 250.

The outer flange 260 is slid down the inner sleeve 251 until it contacts the exterior wall 258 of :he target vessel 255 and 44 a desired degree of compression of the target vessel wall 255 is applied between the inner 253 and cuter 260 flanges. The ratchet mechanism 264 of the outer flange 260 locks the flange 260 in place on the tubular inner sleeve 251 to complete the anastomosis, as shown in Fig. 21C.

Figs. 22A-22D show an anastomosis fitting 268 which is a variation of the embodiment of Figs. 21A-21C. In this variant the inner flange 269 has a flat annular configuration rather than a conical shape as in the previously described embodiment. To insure that the completed anastomosis does not protrude into the blood flow lumen 256 of the target vessel 255, the outer flange 270 of the fitting is concave on its distal surface 271. The central orifice 272 of the outer flange 270 tapers proximally to a locking ring 273 within the "15 central orifice 272 that slips over and locks with a collar S 274 on the proximal end of the tubular inner sleeve 275.: As shown in Fig. 22C, when the outer fla-ge 270 is applied to the exterior surface 258 of the target vessel 255 and locked onto the collar 274 of the tubular inner sleeve 275, the inner flange 269 is drawn into the concave c-:er flange 270, so that Sthe anastomosis is flush with or recessed into the inner wall 257 of the target vessel 255. This helps to assure a S hemodynamically correct inflow at the entrance to the graft vessel 254. Two or more collars 274 -yv be provided on the 5 tubular inner sleeve 275 to allow adjus able compression by S the anastomotic fitting 268.

Figs. 23A-23D show another variant 276 of the embodiment of the anastomosis fitting =f Figs. 21A-21C and Figs. 22A-22D. In this variant the czncave outer flange 277 has a simple central orifice 275 withe-- a locking ring. The locking mechanism is provided by multiple downwardly oriented tangs 279 or tapered ridges, which have been formed in the sidewall of the tubular inner sleeve 2:3 by cutting, punching or molding. The outer flange 277 is slid over the proximal end of the inner sleeve 280 and over -he tangs 279, which engage the proximal end of the outer flange 277 to lock the outer flange 277 inzo place on :he inner sleeve 280, as illustrate in Fig. 23C. If desired, i-iple Darallel rows of tangs 279 can be provided at different axial locations on the inner sleeve 280 to accommodate different thicknesses of the target vessel wall 255 and to provide a tailored degree of tissue compression at the anastomosis site. Optionally, the underside of the outer flange 277 may have a plurality of attachment points which engage and hold the target vessel wall 255 near the opening 267 in it, adding security to the anastomosis attachment without piercing the target vessel wall 255.

Figs. 23A-23D also illustrate a variation of the method for applying the anastomosis fitting. In this embodiment, the method includes applying a suture 281 to the everted end 259 of the graft vessel 254 to secure it to the inner flange 282. As best seen in the top view Fig. 23D, the everted end 259 of the graft vessel 254 has been secured to the inner flange 282 of the fitting by making a running stitch i; around the end of the graft vessel with a suture 281 on the back of the inner flange 282 and tyinc it to create a purse string that holds the end 259 of the graft vessel 254 in :0 place.

A second representative embcdiment of an anastomotic fitting 283 employing inner 284 and outer 285 flanges has an expanding inner flange 284 which facilitates the atraumatic attachment of the graft vessel 254 to :he fitting 283 and makes it easier to pass the inner flane 284 and the everted graft vessel 259 through the opening 2-7 in the target vessel wall 255. Two variations of such an expanding inner flange are shown in Figs. 24A-24D and Figs. 25A-25H. The graft vessel 254 is passed through an interral lumen 287 of an inner sleeve 286 which has the expandable inner flange 284 attached at its distal end. The end 259 of the graft vessel 254 is everted over the unexpanded inner flanze 284'. The inner flange 284' and the everted end 259 of :he graft vessel 254 are passed through the openin= 267 in :he target vessel wall 255. Once the inner flange 274' of the fitting 283 is in the lumen 256 of the target vessel 255, it is expanded to a diameter 284 which is sicnificantly larger than the opening 267 in the target vessel wall 255. Then an outer flange 285 is applied and locked into a selected position on the inner sleeve 286 as described above to complete the anastomosis.

In the first variant of the expanding inner flange 284, shown in Figs. 24A-24D, the flange 284 and a portion of the inner sleeve 286 are slotted to create multiple fingers 288 which are initially collapsed inward toward the center of the inner sleeve 286. The ends of the fingers form sector-shaped sections 289 of the flange 284, as seen in the distal end view of Fig. 24D. When the flange 284 is collapsed inward 284', as in Fig. 24C, the sectors 289 fit together to form a smaller diameter flange 284' with a passage 287' through the center large enough for a collapsed graft vessel 254 to fit through. A tubular former 290 is slidably received within the slotted inner sleeve 286 and has an axial lumen 291 large enough to receive the graft vessel 254. The tubular former 290 initially resides in a proximal position, as shown in Fig. 24A. The tubular former 290 has a ridge 292 at its proximal end that positions the tubular former 290 in the correct location with respect to the inner sleeve 286 when the 20 tubular former 290 is in its distal, deployed position. An outer flange 285, with a concave distal surface 293 may be permanently attached to the inner sleeve 286 proximal to the S. expanding inner flange 284. Alternatively, the outer flange 285 can be provided as a separate component which is attached to n te inner sleeve 286 after the graft vessel 254 has been attached or at the end of the anastomosis procedure.

In operation, the graft vessel 254 is inserted through the axial lumen 291 of the tubular former 290 and through the internal lumen 287 of the slotted inner sleeve 286 and through the central opening 287' between the collapsed sectors 289' of the inner flange 284' The end 259 of the graft vessel 254 is everted over the collapsed sectors 289' of the flange 284'. The collapsed flange 282' and the everted end 259 of the graft vessel 254 are inserted through the opening 267 in the target vessel 255. Then, the tubular rormer 290 is slid distally within the slotted inner sleeve 286. The tubular former 290 forces the fingers 288 outward, expanding the flange 284 within the target vessel 255. If the outer flange 285 is already ar-ached -o the inner sleeve 286 at this point, the distal surface 283 of the outer flange 285 is pressed against the extericr surface 258 of the target vessel 255 as the expandable inner flange 284 is being deployed to complete the anastomosis. If, on the other hand, the outer flange 285 has been supplied as a separate component, the outer flange 285 is slipped over the proximal end of the inner sleeve 286 after the expandable inner flange 284 has been deployed and a desired degree of tissue compression is applied between the inner 284 and outer 285 flanges of the fitting 283 to complete the anastomosis, as shown in Fig. 24B.

A second variant of the anastomotic fitting 294 with an expanding inner flange 298 is shown in Figs. 25A-25H. The 5 inner sleeve 295 of the fitting 294 is slotted along its entire length to form multiple fingers 296 that are oriented S essentially longitudinally to the inner sleeve 295. A collar 297 on the proximal end of the slotted inner sleeve 295 joins the multiple fingers 296 together in a tubular configuration.

*0 A concave outer flange 299 is captured on the slotted inner sleeve 295 by the proximal collar 297. As seen in the end view in Fig. 25E, the inside diameter of the collar 297 has notches 301 which are extensions of the slots 300 between the fingers 296 of the inner sleeve 295. Each of the fingers 296 has a bend 302 in it to predispose it to bend outward at the middle when contracted longitudinally. A tubular forming tool 303 for expanding the inner flange 298 is slidably received within the slotted inner sleeve 295. The distal end of the tubular forming tool 303 is crenellated with multiple radially extending tabs 304. The multiple radially extending tabs 304, as seen in the end view in Fig. 25F, are configured to fit through the notches 301 in the collar 297 and into the slots 301 of the inner sleeve. The -tuular forming tool 303 is inserted into the slotted inner sleeve 295 by aligning the radially extending tabs 304 wit: the notches 301 in the collar 297 and sliding ic distally aicng the slots 300 until the tabs 304 pass the distal ends 305 of -he fingers 296. Then, the tubular forming tool 303 is roca.ed s-lgh-Cl so that the ~o s -ighzy so that the 48 radially extending tabs 304 engage the discal ends 305 of the fingers 296 of the slotted inner sleeve 295, as shown in Fig The anastomosis is performed by passing the graft vessel 254 through the internal lumen of the forming tool 303 within the slotted inner sleeve 295 and everting it 259 over the distal ends 305 of the fingers 296. A loop of suture 306 can be used to hold the everted vessel 259 in place. The fingers 296 of the fitting 294 and the everted end 259 of the graft vessel 254 are inserted through an opening 267 in the target vessel wall 255. When the tubular forming tool 303 is slid proximally with respect to the slotted inner sleeve 295, the radially extending tabs 304 of the tubular forming tool 303 bear against the distal ends 305 of the fingers 296 compressing them longitudinally. The fingers 296 bow outward, folding at the bend 302 to expand and create an inner flange 298 which engages the inner surface 257 of the target vessel wall 255. The tubular forming tool 302 is pulled further proximally until the newly formed inner flange is drawn into .:29 the concave outer flange 299, compressing the target vessel wall 255 and recessing the inner flange 298 and the anastomotic connection into the target vessel wall 255, as shown in Fig. 25D. The tubular forming tool 303 can now be removed by rotating it with respect to :he slotted inner sleeve 295 so that the tabs align with hne slots 300 and withdrawing it from the fitting 294. The mass of foreign material that is left as an implant at :he anastomotic site is thus reduced.

Alternatively, the inner sleeves 295 and the tubular forming tool 303 can be formed inzegral-y or welded together as one piece, in which case both -he inner sleeve 295 and the tubular forming tool 303 would remain i- the finished anastomosis. As a further alternative, The tubular forming tool 303 could be made to break a.;ay fr:- che inner sleeve 295 when a certain force is applied.

In a further aspect of -he i-.-enion, the anastomotic fitting has a sincle-ciece z:nscruction with an inner sleeve that is integrally a:ached tc a fixed inner flange and to a deformable outer flange. Three variants of the anastomotic fitting with a deformable outer flange and their forming tools are shown in Figs. 26A-26I, 27A-27D and 28A-28I.

The first variant of the anastomotic fitting 306 with a deformable outer flange is shown in Figs. 26A-26I. The anastomotic fitting 306 has a tubular main body 307 having an internal lumen 303 sized to accommodate the external diameter of the graft vessel 254. A fixed inner flange 309 is attached to the distal end of the tubular body 307. On the proximal end of the tubular body 307 are a plurality of hingedly attached outer flange segments 310. In this illustrative embodiment, there are four such flange segments 310 which are enlarged at their outer edges to form sector-shaped segments 310 of the outer flange 311. The hinge portion 312 of each flange segment 310 is. a deformable strip of metal 312 connecting the flange segment 310 to the main tubular body 307. Preferably, the tubular body 307, the inner flange 309 and the flange segments 310 of the outer flange 311, including the deformable hinge portion 312, are integrally formed of a single piece of biocompatible metal, such as stainless steel, a titanium alloy or a cobalt alloy Carpenter The distal end of a device 313 for applying the anastomosis fitting is shown in Fig. 263. The device has an .5 inner tubular member known as the anvil 314 and an outer tubular member called the driver 315. The distal end of the anvil 314 has a gripper 316 for holding onto the anastomosis fitting 306. The gripper 316 in the preferred embodiment has a bayonet-type fitting with four L-shaped gripping fingers 317 which hold the fitting 306 by hooking onto each of the flange segments 310 at the deformable hinge portion 312. The driver slides 315 telescopically over the outside of the anvil 314 and has an annular driving surface 318 on its distal end configured to engage the outer ends of each flange segment 310. The anvil 314 and the driver 315 can be made in a long version, approximately 15 c.o 30 cm in length, for performing port-access CA.G surgery or a short version, approximately to 20 cm in length, for performing standard open-chest

CABG

surgery.

The fitting 306 is prepared for performing the anastomosis by attaching the fitting 306 to the gripper 316 on the distal end of the anvil 314. Then, the graft vessel 254 is passed through the inner lumen 319 of the anvil 314 until the end 259 to be anastomosed extends a short distance from the distal end of the fitting 306. The end of the graft vessel 259 is everted over the inner flange 309 of the fitting to form an atraumatic attachment between the two. If the anastomosis being performed is part of a port-access

CABG

surgery procedure, the fitting on the end of the application tool is inserted into the patient's chest through an access port made through one of the intercostal spaces. The inner flange 309 and the everted end 259 of the graft vessel 254 are inserted through an opening 267 that has been made in the wall of the target vessel 255. The fitting 306 is pulled back slightly so that the inner flange 309 is flush against the interior surface 257 of the target vessel. Then, the driver :2 315 is pushed distally with respect to the anvil 314 until the driving surface 318 deforms the outer flange segments 310 against the exterior surface 258 of the target vessel wall 255 and the desired degree of compression of the vessel wall 255 is obtained. The anvil 314 is rotated slightly to release the gripper 316 from the flange segments 310 of the fitting 306 and the application device 313 is withdrawn from the patient's body.

The second variant of the anastomotic fitting 320 with a deformable outer flange 321 is shown in Figs. 27A-27D.

This variant is largely the same as the first variant just described in connection with Figs. 26A-26I with the exception of the inner flange 322 construction. In this embodiment, the inner flange 322 is slightly conical in order to orovide a more hemodynamically efficient inlet to the graft vessel 254 at the anastomosis. In addition, a plurality of attachment spikes 323 preferably 6 to 8 spikes, have been provided along the periphery of the inner flance 322. In a preferred configuration, the anastomotic fitting 320 is fully deployed, the spikes 323 penetrate through the everted wall 259 of the graft vessel 254 and into the wall of the target vessel 255 to create a-more secure attachment for the anastomosis. When the outer flange segments 324 are deformed against the exterior surface 258 of the target vessel 255 and compress the vessel wall 255 such that they engage the spikes 323 on the inner flange 322 for a very secure attachment.

The third variant of the anastomotic fitting 325 with a deformable outer flange 326 is shown in Figs. 28A-28I.

The anastomotic fitting 325 has a tubular main body 327 with an internal lumen 328 sized to accommodate the external diameter of the graft vessel 254. The walls of the tubular body 327 have a pair of L-shaped slots 329 that are open at the top of the tubular body 327 to form a bayonet fitting. An inner flange 330, which may be slightly conical in shape, is attached to the distal end of the tubular body 327. Attached to the proximal end of the tubular body 327 is a deformable outer flange 326, comprising a multiplicity of axially-oriented bars 331 separated by axial slots. 332 The 20 axially-oriented bars 331 are attached at their distal ends to the tubular main body 327, and are joined at their proximal S. ends by a ring 333 forming the proximal end of the fitting 325 The bars 331 are bent outwardly near their centers 334 so that the bars 331 preferentially bend outwardly when compressed. The tubular body 327, the inner flange 330 and the deformable outer flange 326 are preferably machined of a single piece of biocompatible metal, such as stainless steel, a titanium alloy or a cobalt alloy. The geometry of this device could also be configured so that the bars 331 of the outer flange 326 start off almost straight, and are deformed further to reach their final geometry.

A device 335 or applying the anastomotic fitting is shown in Fig. 28D-F. The device 335 has an inner tubular member 336 which has a pair of radially extending tabs 337 on its distal end that interlock within the L-shaped slots 329 in the tubular body 327 of the fitting 325. An outer tubular member 338, the pusher 338, slides telescopically over the oucside of the inner tubular member 336 and has an annular.

52 driving surface 339 on its distal end. This anastomosis fitting application device 335 can be made in a long version for port-access CABG surgery or a short version for standard open-chest CABG surgery.

The fitting 325 is prepared for performing the anastomosis by attaching the anastomotic fitting 325 to the inner tubular member 336. Then, the graft vessel 154 is passed through the inner lumen 340 of the inner tubular member 336 until the end 159 to be anastomosed extends a short distance from the distal end of the fitting 325. The end 159 of the graft vessel 154 is everted over the inner flange 330 of the fitting 325 to form an atraumatic attachment, as shown in Fig. 28D. If the anastomosis being performed is part of a port-access CABG surgery procedure, the fitting 325 on the end J5 of the application tool 335 is inserted into the patient's chest through an access port made through one of the intercostal spaces. The inner flange 330 and the everted end 159 of the graft vessel 154 are inserted through an opening 267 that has been made in the wall of the target vessel 225, as shown in Fig. 28E. The fitting 325 is pulled back slightly so that the inner flange 330 is flush against the interior surface 257 of the target vessel 255. Then, the pusher 338 is moved distally with respect to the inner tubular member 336 until the driving surface 339 contacts the proximal surface of S the deformable outer flange 326. The pusher 338 deforms che outer flange 326 by compressing the bars 331, which bend outwardly and fold into a flattened configuration, as shown in Fig. 28F, to form a radially spoked outer flange 326'. The pusher 338 further deforms the bars 331 to press the outer flange 326' against the exterior surface 258 of the target vessel wall 255 and obtain the desired degree of compression between the inner 33C and-outer 326' flanges. The inner tubular member 336 is removed by rotating it with respect -o the fitting 325 and withdrawing the cabs from the L-shaped slots 329.

A furcher embodiment of an anastomosis fitting 340 according to the invention is illustrated in Fig. 29A-C. The anastomosis fizzing of Fig. 29A-C may be particularly advantageous with older patients, diabetic patients and other patients whose veins are no longer as resilient as they once -were, where it may be difficult to stretch the saphenous vein graft enough to evert it over a large inner flange. This is also true of many artificial graft materials that will not stretch at all to evert them over a large flange. The anastomosis fitting 340 of Fig. 29 A-C has a tubular body member 341 with a small primary inner flange 342 attached to the distal end. Threads 343 or similar features on the inner surface the proximal end of the tubular body member 341 facilitate grasping the tubular body member 341 with an application instrument. A secondary inner flange washer 344 has a central orifice 345 with inwardly facing tabs 346 configured to engage the primary inner flange 342, as seen in 15 distal end view 29C. An outer flange 347 is configured to slide over the proximal end of the tubular body 341 and is locked in place by a self-locking retaining washer 348 with upwardly inclined tabs 349 that frictionally engage the outer surface of the tubular body 341, allowing the outer flange 347 to slide in the distal direction with respect to the tubular outer body 341, but not in the proximal direction. The outer flange 341 may have a plurality of attachment spikes 350 on its distal surface to penetrate the outer wall 258 of the target vessel 255.

In operation, first the outer flange 347 with its retaining washer 348 and then the secondary inner flange washer 344 are back loaded onto the holder 352 of the application device 351. Next, the tubular body 341 is threaded onto the distal end of the holder 352. The graft vessel 254 is passed through the internal lumen 353 of the application instrument 351 and the disal1 end 259 of the graft vessel 254 is everced over the small primary inner flange 342 of the anastomosis fitting 340. The secondary inner flange washer 344 is then slid distally so thea it bears against the proximal face of the inner flange 342, as shown in Fig. 29A.

The primary inner flange 342, with the everted graft vessel 259 attached, and the secondary inner flange washer 344 are inserted through an opening 267 chat has been made in the target vessel wall 255 as shown in Fig. 29A. .A slight tension is exerted on the application instrument 351 to seat the primary inner flange 342 and the secondary inner flange washer 344 against the interior surface 257 of the target vessel wall 255 and the driver 354 is advanced distally to press the outer flange 347, with its self-locking retaining washer 348, onto the exterior of the tubular body member 341 until the desired degree of compression between the inner 242, 344 and outer flanges is obtained. The holder 352 is disengaged from the tubular body member 341 and the entire application instrument 351 is withdrawn from the body.

A distal end view of the completed anastomosis is shown in Fig. 29C. The larger diameter of the secondary inner flange washer 344 adds to the security of the anastomosis attachment, while it does not require the graft vessel 254 to be stretched to fit over a large inner flange. Only a very small amount of foreign material is exposed within the target vessel lumen and it is spaced a short distance from the actual anastomosis site which may reduce the likelihood of :%20 complications. Because the secondary inner flange 344 washer only contacts the primary inner flange 342 and the everted graft vessel wall 259 at four small points, it will not 0 0000 interfere with the intima-to-intima approximation of the graft vessel 259 and the target vessel 255 which is preferred in 5 order to promote endothelialization of the anastomosis site.

d o S" Figs. 30A-30F illustrate an embodiment of the anastomosis fitting 355 of the present invention which combines an inner tubular member 356 having deformable attachment legs 357 at its distal end, with an outer flange 358. The deformable attachment legs 357 have an initial position 357 allowing the graf: vessel 254 to be easily everted over and penetrated by the attachment legs 357. The attachment legs 357 are subsequently deformed to a deployed position 357' wherein the attachment legs 357' perform the function of the inner flange in many of the above-described embodiments by engaging the interior surface 257 of the target vessel 255 and compressing the tissue between the attachment legs 357' and the outer flange. 358 The inner tubular member 356 is shown in Fig. 30A. The tubular member 356 is preferably made from a biocompatible metal, such as an alloy of stainless steel, titanium or cobalt. The tubular member 356 has an internal lumen 359 of sufficient size to S accommodate the external diameter of the graft vessel 254.

The tubular member 356 is made with a plurality of attachment legs 357 extending axially from its distal end 360. This illustrative embodiment is shown with four attachment legs 357. Other exemplary embodiments may have from three to twelve attachment legs 357 depending on the sizes of the graft 'vessel 254 and target vessel 255 to be joined. The attachment legs 357 preferably 'have a width of approximately' 0.5-2.0 mm, more preferably about 1.0 mm, and a thickness of approximately 0.1-0.5 mm, more preferably about 0.25 mm. The width and thickness of the attachment legs 357 is chosen so that the legs 357 will be relatively rigid when they are in their deployed position 357' yet they are still easily deformed :using the special forming dies 369, 370, 371 provided with the anastomosis system. The di4stal ends 361 of the attachment legs 357 are sharpened to easily pen~etrate the walls of the graft vessel 254 and target vessel 255. The exterior surface of the tubular member 256 may be made with a groove or slot 362 around its circumference "as a detent for the outer flange 358 spaced a calculated distance from the distal end 360 of the tubular member 356 to provide a desired degree of compression on the anastomosis when the outer flange 353 locks into the groove. 362 A plurality of holes 363 through the wall of the tubular member 356 (three holes 363 in this illustrative embodiment) are located near the proximal end of the tubular member 356 to facilitate grasping the device 355 with an application instrument 372 The outer flange 358, illust:rated in Fig. 302, nas a central orifice 364 which is sized to -fit over the exterior o: the tubular member 356. The outer flange 358 has a locking mechanism, which includes a self-locking reta ining washer 365 with upwardl4-y inclined locking tabs 3696 integrally forme-d wit'.

the outer flange, 358 to slidably position the outer flange 358 on the exterior surface off the tubular membe- 356.

56 Alternatively, the self-locking retaining washer 365 can be manufactured separately and attached to the outer flange 358 The upwardly inclined locking tabs 366 allow the retaining washer 365 to slide in the distal direction over the exterior of the tubular member 356, but resist sliding in the proximal direction. When the upwardly inclined locking tabs 366 lock into the groove 362 in the exterior surface of the tubular body 356 it forms a more permanent attachment, strongly resisting movement in the proximal direction. Other locking mechanisms can also be used for positioning the outer flange 358 with respect to the tubular member 356, such as ratchet mechanisms, detents, or releasable locking devices. The distal surface 367 of the outer flange 358 is configured to contact the exterior surface 258 of the target vessel 255.

15 Preferably, the distal surface 367 of the outer flange 358 is S slightly concave, as illustrated. If desired, the outer flange 358 may be made with short spikes extending from its distal surface. The outer periphery of the outer flange 358 is perforated with a series of holes 368, which are positioned to be aligned with the distal ends 361' of the attachment legs 357' of the tubular member 356 when the fitting 355 is fully deployed. Making the holes 368 in a multiple of the number of attachment legs 357, as in the present example which has eight holes 368, corresponding with four attachment legs 357, facilitates aligning the holes 368 with the distal ends 361' of the attachment legs 357'. The outer flange 358 is preferably made from a biocompatible metal, such as an alloy of stainless steel, titanium or cobalt or a biocompatible polymer. Alternatively, a separate lccking washer 365 made from a biocompatible metal can be joined to an outer flange 358 made of a polymer or other biocompatible material.

The anastomosis-fitting 355 is part of a complete anastomosis system for forming and applying the anastomosis fitting 355 to create an end-to-side anastomosis. A set of three forming dies 369, 370, 371 are configured to deform the attachment legs 357 of the anastomosis fitting 355 from their initial position 357 co a deployed posiion 357' and a specialized grasping tool 372 is used :o insert he deploved inner tubular member 356 through an opening 267 in the side wall of the target vessel 355. These tools, which will be described in more detail in the operational description below facilitate the rapid and repeatable deployment of the anastomosis fitting 355 with a minimum of manual manipulation required.

In operation, the end-to-side anastomosis procedure is performed using the anastomosis fitting 355 by first -preparing the free end 259 of the graft vessel 254 for attachment. If the anastomosis being performed is a second anastomosis or is being performed on the free end of a pedicled graft, the outer flange 358 must first be backloaded onto the graft vessel 254 with the distal surface 367 facing the end 259 of the vessel to be attached. If the anastomosis is being performed as the first anastomosis on a free graft, the outer flange 358 can be backloaded onto the graft vessel 254 at this time or it can be passed over graft vessel 254 from ihe far end at a later point in the procedure, whichever is preferable. Next, the free end 259 of the graft vessel 254 is passed through the internal lumen 359 of the inner tubular member 356 so that it extends a short distance from the distal end 360 of the tubular member 356, as shown in Fig. 30C. The free end 259 of the graft vessel 254 is everted and the attachment legs 357 are pierced through the everted wall 259 of the graft vessel 254 to prepare the graft vessel 254 as shown in Fig. 30D. If desired, a loop of suture can be tied around the everted end 259 of the graf: vessel 254 to help secure the graft vessel 254 in its everted position over the exterior surface of the tubular member 356.

After piercing the graft vessel wall 259, the attachment legs 357 of the tubular member 356 are deformed from their axially extending position 357 by first bending them outward so that they extend radially from the distal end 360 of the tubular member 356, then bending the distal ends 361' of each of the attachment legs 357' so that they are directed proximally with respect to the cubular member 356, as shown in Fig. 30E. For a typical application of che anastomosis fitting 355 in making an end-to-side anascomosis between a saphenous vein grafz and the ascending aorta, the radially extending portion 373 of each deployed attachment leg 37 is about 3-4 mm long, and the proximally directed distal portion 374 of each deployed attachment leg 357' is about mm long. These dimensions will vary somewhat depending on the size and the wall thickness of the graft vessel and the target vessel to be joined.

A set of three forming dies 369, 370, 371 are provided for rapidly and repeatably forming the anastomosis fitting 355 into. the deployed position shown in Fig. 30E. The first die 369 is cylindrical in shape with a counterbored recess 375 on one end which is sized to hold the proximal end of the tubular member 356 of the anastomosis fitting. An annular forming surface 376 on the end of the die 369 surrounds the counterbored recess 375 An annular space 377 b A annular space 377 S between the counterbored recess 375 and the annular forming surface 376 provides sufficient clearance for the everted end 259 of the graft vessel 254 when the inner tubular member 356 of the anastomosis fitting 355 is inserted into the 20 counterbored recess 375. The proximal end of the graft vessel 354 extends through a central lumen 378 in the first die 369 and exits the die through a notch 379 in the ar end of the ie 369 which communicates with the lumen 378 The second die 370 has a conically tapered end 380 which is used to initiate the outward bend of the attachment legs 357 by pressing the tapered end 380 between the attachment legs 357, as shown in Fig. 30G. The third die 371 is cylindrical in shape with a counterbore 381 on one end that is sized to fit over the outside of the first die 369 wih a radi-a clearance sufficient for the thickness o the attachment legs 357' There is a forming shoulder 382 within -ne counterbore 381 of the third die 371, and there is a tapered edge 383 leading into the counterbore 381. The :-ird die 371 is placed over the distal end of the inner tubular merm- 356 aftr the attachment legs 357 have been be-t outward bv the second die 370. As the counterbore 381 of -he third de 371 slides over the exterior of the first die, 3-9 the etending portion 373 of the a:achmen ies 373 ae c d betweending portion 373 of the artachmen j73 S-e a'e o-med between- the forming shoulder 382 of the third die 371 and the annular forming surface 376 of the first die 369 and the proximally extending portion 374 of the attachment legs 357' is formed between the exterior of the first die 369 and the counterbore 381 of the third die 371, as shown in Fig. The tubular member 356 of the anastomosis fitting 355, which has been formed to its deployed position, is withdrawn from the first die 369 and is grasped with the special grasping tool 372. The grasping tool 372 has expandable jaws 384, 385 which fit between the graft vessel 354 and the inner lumen 359 of the tubular member 356. The jaws 384, 385 are shaped like sectors of a cylinder with an exterior diameter approximately equal to the inner diameter of S the tubular member 356. Each of the sectors is somewhat smaller than a semi-cylinder so that the jaws 384, 385 can be collapsed small. enough to easily fit within the internal lumen S 359 of tubular member 357. A thumbscrew, or other suitable S mechanism, on the grasping tool 372 expands the jaws 384, 385 so that they bear against the interior surface of the tubular '0 member 356. Lugs 386 corresponding-to the three holes 363 in S the proximal end of the tubular member 356 engage the three holes 363 to enhance the grasping tool's grip on the tubular member 356.

Using the grasping tool 382, the bent attachment S.legs 357' and the distal end 360 of the tubular member, with the everted end 259 of the graft vessel 254 attached, are inserted through an opening 267 in the target vessel wall 255 that has previously been made with an aortic punch or similar instrument, as shown in Fig. 301. The opening 367 is preferably made so that it is approximately the size of the external diameter of the tubular member 356 to provide compression around the everted end 259 of the graft vessel 254 to help create an anastomotic seal. Since the opening 267 is slightly smaller than the diameter of -he bent attachment legs 357', the opening 267 must be s-retched slightly to allow the attachment legs 357' to pass through e openinc 267.

Insertion can be effectively accomplised by passing two of the attachment legs 357' throuc-. te czening 267 the ar u he en ng 207 in the farce vessel wall 255, then genly stretching the opening 267 with forceps to insert the remaining attachment legs 357' Once the attachment legs 357' have been passed through the opening 267 in the target vessel wall 255, the inner tubular member 356 is pulled back with enough force to cause the sharpened distal ends 361' of the attachment legs 357' to pierce the interior surface 257 of the target vessel wall 255. This action also serves to approximate the everted end 259 of the graft vessel 254 with the interior surface 257 of the target vessel 255 to effect the desired intimal surface-to-intimal surface approximation between the two vessels. The sharpened distal ends 361' of the attachment legs 357' can be assisted in piercing the target vessel wall 255 by pressing on the exterior 258 of the target vessel wall 5 255 with an elastomeric-tipped probe while maintaining some tension on the tubular body 356 of the fitting using the grasping tool 372. The anastomosis is completed by sliding the central orifice 364 of the outer flange 358 over the exterior surface of the. tubular member 356 and moving the outer flange 358 distally while keeping some tension on the tubular member 356 to create tissue compression at the S anastomosis site to assure an anastomotic seal. A probe 387 with a distal pushing surface 388 can be used to press the outer flange 358 onco the tubular member 356. The distal pushing surface 388 of the probe 387 is slotted and angled so that it can be used from the side of the grasping tool 372 The proximally directed distal ends 361' of the attachment legs 357' pass through the holes 363 around the periphery of the outer flange 358, as shown in Fig. 30J. f desired, the distal surface 367 of the outer flange 353 can be made somewhat concave to help create a hemodynamically efficient transition between the target vessel lumen 256 and the graft vessel lumen 249. The self-locking retaining washer 365 or the outer flange 358 locks inco the circumerential groove 362 on the exterior of the tubular member 35 to permanently hold the outer flange 358 in a fixe position relative to the tubular member 356.

Fig. 31A shows a further embodiment of an anastomosis device 390 according to the nvention that combines a fastening flange 391 with a plurality of staple members 392. The device 390 includes a rastening flange 391 which has a central orifice 393 of sufficient size to accommodate the external diameter of the graft vessel 254.

The external diameter of a saphenous vein graft used in CBG surgery can range from 3 to 10 mm. The fastening flange 391 and the central orifice 393 can be made circular, as shown in Fig. 318, for making a typical right angle anastomosis.

Alternatively, the fastening flange 391 and/or the central orifice 393 can be made elliptical, oval, egg-shaped or tear drop shaped, as shown in Figs. 31C and 31D, for making a more S hemodynamically efficient angled Anastomosis. Many of the anastomotic fittings and staples described herein lend themselves to noncircular configuration such as ellitical r teardrop shapes. Each of the detailed descriptions of the various embodiments should be assumed to include noncircular flanges as an optional configuration The fastening flange 391 is made with a distal surface 394- over which the free end 259 of the graft vessel 254 is everted, as shown in Fig. 31A.

The fastening flange 391 can be made with an annular ridge 395 or with other features on its outer surface to help attach the everted end 259 of the graft vessel 254 to t- fange 391.

The distal surface 394 of the fasteninz flange 391 may be contoured to provide a close fit between the everted edge 259 of the graft vessel 254 and the exterior wall 258 of the target vessel 255. If the target vessel 254 diameter is very large compared to the diameter of the craft vessel 254 as in a coronary artery bypass graf- to asce ng aorta anastomosis, then a planar distal surface 394 on the fast c anaso 3os may sufficiently approximate -he ex-eror surace 258 of the target vessel 255. However -f the graft vessel 254 diameter is closer to the diameter of the target vessel 255, as ina 3 bypass graft to coronary artery anas-o, os, hen the fastening flange 391 should be made with a c indrica or saddle-shaped contour on the distal surface 394 that closely approximates the excerior con-our t- c l o s e l 'essel 255 62 The fastening flange 391 should be made of a biocompatible material such as stainless steel, titanium alloys, or a biocompatible polymer. The fastening flange 391 acts as an external stent which holds the anastomosis site open and patent, so the flange material is preferably rigid or at least sufficiently resilient to hold its intended shape.

The fastening flange 391 with the everted end 259 of the graft vessel 254 attached to it is fastened to the exterior wall 258 of the target vessel 255 with the central orifice 393 aligned with an opening 267 in the target vessel wall 255 that has been previously made using a vessel punch or similar instrument. The fastening flange 391 is held in place by a plurality of fastening members 292, which in this embodiment take the form of metallic surgical staples 292 5 which are shown in Fig. 31E. The surgical staples 292, preferably 4-12. of them arranged around the periphery of the fastening flange 391, traverse from the proximal side 396 to the distal side 394 of the flange 391, then pierce the everted S graft vessel wall 259 and the wall of the target vessel 255.

It is preferable that the staples 292 pass through premade t holes 397 in the fastening flange 391, however, if the fastening flange 391 is made of a resilient material, the staples 392 may pierce the flange 391 as they pass through it.

The distal ends 398 of the staples 392 are deformed by a forming device or anvil against the interior surface 257 of the target vessel wall 255 to hold the device in place to Scomplete the anastomosis.

The staples 392 can be specially constructed so that they will deform at the appropriate point on the attachment legs 399. One way to achieve this desired result is to make the core 400 of the staple 392, including the crossbar 401 and the two attachment legs 3-99, of a soft deformable metal such as annealed stainless steel. A proximal portion of each of the attachment legs 399 is surrounded by a stiffening sleeve 3 02 that is made of a more rigid material, su as hard stainless steel hypodermic tubing. The slffeni sleeves 402 Prevent the proximal portion of the atrachmenc leas 392 from aerorming. The stiffening sleeves 402 should be sized so thac their length corresponds to slightly less than the combined thickness of the flange 391, the graft vessel wall 259 and the target vessel wall 255 so that, when the attachment legs 399 are bent at the distal edge of the stiffening sleeves 402, a tailored amount of compression is applied at the anastomotic site to ensure a leak proof attachment without excessive crushing of the tissue which could lead to necrosis.

Alternatively, the staples could be manufactured with attachment legs 399 having a thicker cross section proximal portion and a thinner cross section distal portion so that the attachment legs 399 will deform at the appropriate point The anastomosis device 390 is part of a complete anastomosis system that includes a specially adapted application device 403 for creating the anastomosis. The 1 distal end of the application device 403 can be seen in Fig 31A. A staple driver 404 pushes the staples 392 from the proximal end, while a specially constructed anvil 405 reaches into the lumen 256 of the target vessel 255 to deform the distal ends 398 of the attachment legs 399. The staple driver *2 404 has an annular distal surface 406 which presses against the crossbars 401 of the staples 392. In one embodiment, the staple driver 404 can be tubular with an internal lumen 407 large enough to accommodate the graft vessel 254, allowing the graft vessel 254 to be passed through the staple driver 404 from the proximal end to the distal end. Alternatively, the staple driver 404 can be made with a C-shaped cross section S with a side opening that is large enough to pass the graft vessel through from the side. The anvil 405 is articulated on the distal end of an elongated shaft 408. The shaft 408 is 3 long and narrow enough to pass through the lumen 249 of the graft vessel 254 from the free end of the graft. The anvil 405 is passed through the graft vessel lumen 249 in an orientation axially aligned with of the shaft 408 and, once it is in the lumen 256 of the target vessel 255, it is articulated at 90', as shown in Fig. 31A. A cylindrica or olive-shaped centering element 409, such as an inflatable centering balloon on the shaft 408, can be used to center the shaf: 408 of the anvil 405 within the lumen 249 of the cra'ft vessel 254 and within the central orice 393 of the lange 291. The anvil 305 can now be rotate= about the shaft 308 t deform the distal ends 398 of the at-achment legs 399.

The application device 403 can operate by two different mechanisms. It can operate in a manner similar t other surgical staplers by aligning he staple driver 404 and the anvil 405 on opposite ends of a s-aple 292, then moving them axially toward one another, by rcving either the staple driver 404 distally, or the anvil 405 proximally, or a combination of the two motions. This relative movement compresses the staple leg 399 in between the anvil 405 and the staple driver 404 and deforms it to hold the anastomosis together. An alternative mechanism involves rotating the anvil 405 with respect to the staple driver 404 and the S anastomosis device 390 like a wiper tc sequentially bend over the distal ends 398 of the staples 39-, as shown in Fig. 31F.

as shown n Fig 3 !F The staple driver 404 may be equipped with a gripping means for holding the fastening flange 391 :o prevent any resultant torque on the flange 391 from being transferred to the delicate vascular tissues. Alternati--ely, the olive-shaped centering element 409 or balloon coul have sufficient bearing S surface that the delicate vascular tissues do not suffer any significant damage. An alternative embodiment would have two or more wiper anvil elements 405 spac= symmetrically about the axis of the shaf -08, so c.at opsing staples 392 are bent simultaneously, reducinc the net :orque applied to the centering element 409 and the tissues.

Fig. 32A shows another. varia:ion of the anascomosis device of Fig. 31A. This variation of the anastomosis device 410 uses preformed spring-like fasten-. staples 411. As n the previously described device, the a.astomosis device 410 includes a fastening flange 412 with a central orifice 413 csufficient size to accommodate :ce ex-erior diameter f the graft vessel 254. A oiurali_ o c- re- ed fa c p----rted Zasceninc scaDple 411 are arranged around the periheryv the as enin flance 412. Preferably, the s-aples 41 are :reloaded inco premade axial holes zro-uch e tning :lange 412. The scaoles 41 should be made cf a highl resi e- biocompaible scrimaterial, such as spring-tempered stainess steel or titanium alloys. Superelastic materials, such as nickel-titanium alloys, can also be used for forming the spring-like staples Information about the comDosition and treatment of superelastic metal alloys useful in the manufacture of the spring like staples can be found in U.S. patent 4,665,906 entitled Medical Devices Incorporating SIM Alloy Elements the entire disclosure of which is hereby incorporated by reference. Two alternate forms for the spring-like staples 411, 420 are shown in Figs. 32B and 32C. Fig. 32B shows a single staple 411 which has one attachment leg 415. The distal end 416 of the attachment leg 415 is sharpened to easily pierce the blood vessel walls. A distal portion 417 of S the attachment leg 415 is bent at an acute angle with respect *5 to a central portion 418 of the leg 415. Similarly a proximal portion 419 of the leg 415 is bent at an acute angle with respect to the central portion 418. The proximal portion 419 and the distal portion 417 of the staple 411 can be angled *2 in the same direction with respect to the central portion 418 to make a C-shaped staple, as shown in Fig. 32B, or the S proximal 419 and distal 417 portions can be angled in opposite directions to create a Z-shaped staple. Fig. 32C shows a double staple 420 which has two parallel attachment legs 415.

The distal end 415 of each attachment lea 415 is sharpened to easily pierce the blood vessel walls. The distal portions 417 of the attachment legs 415 are bent at an acute angle with respect to the central portions 418 of the legs 415. The proximal portions 419 of the legs 415 are also bent at an acute angle with respect to the central portions 418. The proximal portions 419 of the attachment legs 415 are linked together by a crossbar 421. The double staple 420 has an advantage in that the crossbar 421 linki-n the two attachment legs 415 keeps the staple 420 aligned wi-.in the fastening flange 412. When using double staples 420 with the fastening 3 flange 412, the axial holes 414 through flange 412 should be made as pairs of holes 414 spaced apar: by approximately the length of the crossbar 421 of the scaple 420. Similar to the single staple 411 of Fig. 323, -he dcole szaole 420 ca 66 be made with the proximal portions 419 and the distal ortion 417 of the attachment legs 415 angled in the same direction with respect to the central portions 418 to make a C-shaped staple, when viewed from the side, or the proximal 419 and distal 417 portions can be angled in opposite directions to create a Z-shaped staple as shown in Fig. 32C.

The operation of either staple version can be understood from the sequence of drawings in Figs. 32D, 32E, and 32F. The following operational description using the single staple 411 of Fig. 32B is, therefore equally applicable to the double staple 420 of Fig. 32C. The staples 411 are preferably preloaded into the fastening flange 412 so that the distal bend 427 of the staple legs 415 is captured within and s. traightened by the hole 414 through the flange 412. The resilience of the spring material prevents the staple legs 415 from taking a permanent set when they are straightened out to load them into the holes 414 in the flange 412.

If a superelastic nickel-titanium alloy is used for the spring-like staples 411, then the shape-memory property of .ng e the ape-memory property of 0 the alloy can be used to facilitate loading the staples 411 Sinto the flange 412. To do this, the staple 411 would first be annealed in the desired shape for the final staple. Then the staple 411 would be plastically deformed below its transition temperature to straighten out the distal bend 427.

The Straichtened staples 411 are easily inserted into the holes 414 in the flange 412. Finally, the staples 411 are heated above their shape-memory transition temperature to make them resume their annealed shape. Preferably, the transition temperature is below body temperature so that the alloy of the staple 411 is in its martensitic or superelastic phase when the staple 411 is deployed within the body. Since the distal bend 427 is captured withi-n the hole 1- in the flange 412, it is held straight until the stapie 411i deployed in the following steDs.

The Tree end 259 of the graft vessel 254 is everted over the distal surface 422 of the fasc-eing flange 412, as shown in Fig. 32D, and the device 410 is aicgned with an opening 267 thac has been. pr-evi0usy made in -he target vessel 67 wall 255. To help align the central orifice 413 of the flange 412 with the opening 267 in the target vessel 255, an alignment device 423 can be inserted through the lumen 249 of the graft vessel 254 from the opposite end of the graft. The S alignment device 423 has a narrow, elongated shaft 424 which fits through the lumen 249 of the graft vessel 254 and an atraumatic centering element 425, such as an inflatable centering balloon on the distal end of the shaft 424. The ,centering element 425 serves to align the central orifice 413 of the flange 412 and the graft vessel lumen 249 with the opening 267 in the wall of the graft vessel 255. The alignment device 425 can also be used to apply a mild amount of traction on the target vessel wall 255 to better approximate the everted end 259 of the graft vessel 254 and the target vessel 255 when making the anastomosis.

Alternatively, the centering element 425 could be replaced with a vessel punch introduced through the graft vessel lumen 249, as in the embodiments described in connection with Figs.

S 2-5.

Once the everted end 259 of the graft vessel 254 and the target vessel 255 have been properly approximated, the staple driver 426 is advanced distally, as shown in Fig. 32E.

The distal ends 416 of the staples 411 pierce the everted graft vessel wall 259 and the target vessel wall 255 and the distal portion 417 of the attachment legs 415 traverses the vessel walls in a linear path. As the distal bend 427 of the attachment legs 415 exit the hole 414 in the fastening flange 412, the distal portions 417 begin to resume their acute angle bend. By the time the staple driver 426 reaches its most distal position, the distal bend 427 of the attachment legs 415 is fully reconstituted within the lumen 256 of the target vessel 255. When the staple driver 426 is withdrawn, the spring action of the proximal bend 428 in the attachment legs 415 pulls the staple 411 back slightlv to embed the distal portions 417 of the attachment legs 415 into the interior surface 257 of the target vessel wall 255, as shown in Fig.

32F. The spring action of the staples 411 also serves to exert compressive force between the fasteninz flance 412 and 68 the target vessel wall 255 to assure a leak proof and secure attachment.

During the manufacture of the staples 411, the distal bends 427 on the staple attachment legs 415 can be made with almost any desired orientation. The distal bends 427 can be oriented to turn the distal portion 417 of the attachment legs 415 toward the opening 267 in the target vessel wall 255, as shown in Fig. 32F, or the distal portions 417 can be oriented pointing away from the opening 267. Alternatively, the distal portions 417 can be aligned so that they bend tangentially to the opening 267. The tangential distal portions can be oriented so that they cross one another.

erhaps more advantageously, the tangential distal portions 417 can be oriented so that they all bend in the same direction, as shown in Fig. 32G, so that a more comolete gap-free seal is made all around the periphery of the anastomosis.

Figs. 33A-33D and 34A-34D show two variations of .an anastomosis device 430 having a fastening flange 431 and a O0 plurality of S-shaped staple members 432 formed from a superelastic metal alloy such as a nickel-titanium alloy. The fastening flange 431 has a central orifice 433 which is sized to accommodate the exterior diameter of the graft vessel 254.

The fastening flange 431 has an annular distal ridge 434 and "2 an annular proximal ridge 435 around its outer surface. There S" are a plurality of holes 436 arranged in a circle around the periphery of the central orifice 433 of the flange 431 passing through the flange 431 from the proximal surface to the distal surface 438. Each of the holes 436 is sized to S slidably receive one of the S-shaped staple members 432.

There are a plurality of cylindrical lugs 439 extending from the proximal surface 437 of the flange 431. Preferably, the lugs 439 are arranged in a circle concentric with the central orifice 433 and there are an eaual number of lugs 439 to the S number of holes 436 in the flange 431 with the lucs 439 soaced equidistant from adjacent holes 436.

The S-shaped superelascic alloy staple members 432 are shown in perspecrive Fic. :3D. The staple me ier 432 is formed with a straight central segment 440 that is attached to a hook-shaped distal segment 441 and a proximal segment 442 which bends at an angle just under 90 degrees from the central segment 440 in a plane that is approximately at a right angle to the plane defined by the hook-shaped distal segment 441.

The distal tip 443 of the hook-shaped distal segment 441 is sharpened to easily penetrate the graft vessel wall 254 and the target vessel wall 255. Fig. 34D shows a slight variation .of the staple member 432 of Fig. 33D. This variation differs from the previous one in that the distal segment 444 is bent at an acute angle to the central segment rather than being a fully formed hook. The S-shaped staples 432 are annealed in the desired configuration so that they will retain the annealed shape. The extremely resilient nature of the superelastic alloy allows the staple members 432 to be S. completely straightened without causing plastic deformation of the staples so that they will return to their annealed shape.

The anastomosis device 430 is prepared for use by Sassing the graft vessel 254 through the central orifice 433 of the fastening flange 431 then everting the distal end 259 of the graft vessel 254 over the distal surface 437 of the -flange 431. A suture 445 can be tied around the everted end 259 of the graft vessel 254 to secure it to the flange 431.

The distal ridge 434 of the flange 431 prevents the tied grafz vessel 259 from slipping off of the flange 431. Next, the staple members 432 are straightened and passed through the holes 436 in the flange 431 from the proximal surface 437 to the distal surface 438. The distal curve 441 of the staples 432 is restrained in the straightened position by the sliding fit with the holes 436 in the flange 431. When the staples 432 emerge from the distal surface 438 of the flange 431, they Pierce the everted wall 259 of the graft vessel 254 At this Point the fastening flange 431 with the everted end 259 of graft vessel 254 attached to it is approximated to the exterior surface 258 of the target vessel 255 with the central on-ice 433 and the lumen 249 of the graft vessel 254 centered on an opening 257 that has been -ade in the wall of the tarcet vessel 255. The discal ends 443 of the staple members 432 pass through the opening 267 in the target vessel wall 255 Once the graft vessel 254 and the target vessel 255 are properly approximated, an annular staple driver 446 is used to push the staple members 432 distally through the holes 436 in the flange 431 so that they emerge into the lumen 256 of the target vessel 255. As the distal ends 443 of the staple members 431 emerge from the distal surface 438 of the flange 431 the distal segments 441 resume their annealed shape. The hook-shaped distal segments 441 of the staple members 431 in Fig. 33D curve back toward the interior surface 257 of the target vessel and penetrate the target vessel wall 55. The proximal segments 442 of the staple members 432 are positioned between the lugs 439 on the proximal surface 437 of the flange 431 to lock the staples 432 from rotating with respect to the flange 431. Fig. 33C shows a proximal view of the anastomosis device 430 with the staple members 432 deployed. This view is shown without the graft vessel or the target vessel present for the sake of clarity. As best seen in Fig. 33B, the acute angle of the proximal segment 442 acts like a spring to pull back on the staple member 432 to help the distal segment 441 to pierce the target vessel wall 255 and to help create compression between the flange 431 and the target vessel wall 255 to create a leak proof anastomotic seal between the graft vessel 254 and the. target vessel 255.

The deployment of the anastomosis device in Figs 34A-34D is essentially the same as just described up until the point when the distal ends 444 of the staple members 432 begin to emerge into the target vessel lumen 256. As the distal ends 443 of the staple members 432 emerge from the distal surface 438 of the fastening flange 431, they resume their acute angle bend. Rather than penetrating the target vessel wall 255, the distal segments 444 of the staple member 432 align themselves flat against the interior surface 257 of the target vessel 255 and press against the vessel wall 255, compressively clamping the fastening flange 431 and the everted end 259 of the graft vessel 254 :o the target vessel wall 255 The acute angle of the proximal segment 442 acts like a spring to ull back on :he salmember 42 to k the distal segment 444 snug against the iterior 4 suace e e of the target vessel wall 255. in r 27 Figs. 35A-35F show another variation of an anastomosis device 447 using a fastening flange 448 and attachment staple 449 combination. The fastening flange 448 is a cylindrical member with an internal lumen 450 large enough to accommodate the external diameter of the graft vessel 254. The flange 448 has a distal surface 451 over which the free end 254 of the graft vessel 259 may be everted.

An annular ridge 452 around the outer surface of the flange 448 at the distal end helps to hold the everted graft vessel 259 in place and serves as part of a locking mechanism for the attachment staples 449, as will be described below. The attachment staples 449 are in the form of U-shaped hooks with barbed points 453 on their distal tips. Each staple 49 has a proximal portion 454 which is slidably received within an axial hole 456 through the cylindrical wall 457 of the Lastening flange 448. The proximal end 455 of the proximal C portion 454 is sharpened for easily piering the tissue of the graft vessel wall 254. A U-shaped bend 458 connects the roximal portion 454 of the staple 449 to the barbed, pointed distal portion 453.

The anastomosis device 447 is aDnlied by removina the U-shaped staples 449 from the flance 448. The end 259 of the graft vessel 254 is passed through the internal lumen 450 of the flange 448 until the graft vesse 254 extends a short distance from the distal end 459 of the flange 448. Then, the end 259 of the graft vessel 254 is evered back over the distal end 259 of the flange 448. Once the grat vessel 254 is everted over the flange 448, the sta-les 449 are rinserte into he holes 456 in the flange 458 by piercing the proxima end 445 through the everted wall 259 -of he graft vesse 254.

Marks or other visual indications can be provided on the side o- te cylindrical flange 448 to aid in aligning the proximal ends 455 of the staples 449 with the hcles 456 The oroximal portions 454 of the staples 449 are par--allv advanced into nhe i-ange 448 as snownn ic c. U-sha ends 45 hana ed ends 458 -o the staples 449 are inserted through an opening 267 in the wall of the target vessel 255 which has previously been made using a vessel punch or similar instrument. Two-alternate methods can be used for inserting the staples 449 through the opening 267 in the target vessel wall 255. In the first method, shown in Fig. 35C, the U-shaped ends 458 of the staples are extended from the cylindrical flange 448 far enough that they easily deflect inward toward the center of the opening 267 in the target vessel wall 255 when they contact the edge of the opening 267 so that they can be simultaneously inserted through the opening 267. In the second method, the U-shaped ends 458 of the staples 449 are rotated, as shown in Fig. 35D, so that the U-shaped ends 458 all fit within a circle that will pass through the opening 267 5 in the target vessel wall 255. Once the U-shaped ends 458 of the staples 449 are within the lumen 2.56 of the target vessel 255, the staples 449 can be rotated so that the U-shaped ends 458 extend radially outward from the fastening flange 448.

S The distal surface 459 of the cylindrical flange 448 with the everted graft vessel 259 attached to it is approximated to the exterior surface 258 of the target vessel 255, then the staples 449 are withdrawn in the proximal direction so that the barbed, pointed distal ends 453 pierce the target vessel wall 255. The distal portion 460 of the scaole 449 oasses through the target vessel 255 wall in a inear path, then pierces the everted edge 259 of the graft vessel wall 254 a second time. When the barbed end 453 of staples 449 pass the annular ridge 452 on the distal end 459 of the flange 448 the barbs 453 engage the proximal surface of the ridge 452, locking the staples 448 in position to permanently attach the anastomotic device 447 in place. The excess lengch on the proximal portion 454 of the U-shaped sraples 449 may be cut off flush with the proximal end 461 of :he cylindrical flange 448. Alternatively, the proximal port:in 454 of the scaole 449 can be bent over at the proximal end 461 of the cylindrical flange 448 for a second means of attachment, then tne excess length cui off.

73 Two alternative versions of the anastomosis device of Fig. 35A, using different locking means for the U-shaped staples, are shown in Figs. 36A-36C and 37A-37C. Fig. 36A shows an anastomosis device 462 with a fastening flange 463 and a plurality of non-barbed U-shaped staples 464 and a locking collar 465 for locking the U-shaped staples 464 onto the fastening flange 463. The flange 463 and the staples 464 are applied in much the same way as described above for the previous embodiment, by inserting the staples 464 through the opening 267 in the target vessel 255 and withdrawing them in the proximal direction so that the distal ends 466 of the staples 464 pierce the target vessel wall 255 and emerge alongside the outer surface of the fastening flange 463.

A

locking collar 465 is then ressed onto the proximal end 467 5 proximal end 67 S of the fastening flange 463, as shown in Fig. 36, crimping the distal ends 466 of the staples 464 and locking them to the flange 463 in the process. The excess length of the proximal portion 468 of the staples 464 is cut off flush with the proximal end 467 of the fastening flange 463 to complete the h anastomosis, as shown in Fig. 36C.

non-Fig. 37A shows a second anastomosis fitting 469 with non-barbed U-shaped staples 470 and a locking collar 471 for locking the U-shaped staples onto the fastening flange 472 of S the fitting 469. The fastenina flange 472 in this embodiment 2. has a conical surface 473 on the outer surface of the flance 472 proximal to the distal rim 474 of the flange 472. The roximal end 475 of the fastening flange 472 has a series of parallel annular locking ridges 476 around its exterior surface. A locking collar 471 has an interior taper 477 which matches the conical taper 473 of the fastening flange 472 and a series of parallel locking ridges 478 on the proximal end.

After the flange 472 and the staples 470 have been applied as described above, the locking collar 471 is pressed onto the flange 472, as in Fig. 37B. The distal portion 479 of the U-shaped staple 470 is wedged between the mating conical tapers 473, 477. The locking ri-ges 473 of the locking collar 471 engage the locking ridges 47; of the flange 472 to permanent-' iock t.-e a.mastomsis aevice 469 in oace and s 9 in Place and the 74 anastomosis is completed by cuttina off the proximal portions 480 of the staples 470 flush with the proximal end of the flange 475, as shown in Fig. 37C.

The anastomosis fittings of Figs. 33-37 may lso be manufactured using staple elements made of a highly elastic material, such as a superelastic nickel-titanium alloy, so that the staples may be preformed with U-shaped ends which can be straightened and loaded into the holes in the fastening flange. The staples would be deployed by pushing them out the distal end of the flange so that they pass through the wall of the graft vessel into the target vessel, after which, they resume their U shape within the lumen of the target vessel.

The highly elastic staple elements could be locked onto the fastening flange using any of the methods described in connection with Figs. 33-37.

Figs. 38A-38C and 39A-39C show one-piece versions of an anastomosis device using a fastening flange and attachment staple combination. Fig. 38A shows an anastomosis device 481 S that has a fastening flange 482 and integrally formed staple members 483. The fastening flange 482 is a flat annular ring which may be formed from a flat sheet of a biocompatible metal. The staple members 483, which may be formed from the .:same sheet of metal, attach to the inner diameter 484 of the ring 482 and are initially bent 90' from the flange 482 so that they extend in the distal direction, as shown in Fig.

38B. The inner diameter 484 of the flange fits over a tubular nner member 485 of an application tool 486. The graft vessel 254 is passed through an inner lumen 487 within the tubular member 485 and then the end 259 of the graft vessel 254 is everted over the distal end 488 of the tubular member 485.

The application tool 486 is used to approximate the end 259 of the graft vessel 254 to an-openinc 267 that has previously been made in the wall of the targer vessel 255. A tubular staple driver 489 slides telescopicallv over the exterior of S the tubular inner member 485. The fastening flange 482 is moved distally by sliding the scalIe driver 489 axially with respect to the inner tubular merber 435, ;ihich forces the sharcened distal ends 4 90 of h eCra staple legs 483 ra c aple legs 483 through the everted wall 259 of the raft vessel 254 and he wall of the target vessel 255. Once the staple legs 483 have traversed the graft vessel 25' and target vesse walls the distal ends 490 of the saple lees 483 are deformed to lock the anastomosis device 481 in place as shown in Fig 38C.

Different methods can be used for deforming the distal ends 490 of the staple legs 483 to attach the anastomosis device 481. An articulating anvil, similar to the one described in Fig. 31A can be inserted through the lumen 249 of the graft vessel 254 to work cooperatively with the staple driver 489 to deform the distal ends 490 of the staple legs 483. Alternatively, the fastening flange 482 and the staple legs 483 can be made of a spring-like elastic or S superelastic alloy and preformed into their final desired shade. The inner tubular member 485 of the staple aplicaion device 486 seen. in Fig. 38B holds the preformed distal bend 491 in the staple legs 483 straight until the anastomosis device 481 is deployed by the staple driver 489. Anothealeratd h s ps s d alternative is to make the anastomosis device 481 and the stapele legs 483 from a shape-memory alloy, such as a "nicke-titanium. The staple legs 483 are annealed in their final shape. Then, the staple legs 483 are plastically deformed below the material's transition temperature to straighten out the distal bends 491. The straiahtened staple legs 483 are driven chrough the walls of the graft vessel 254 and the target vessel 255 and the staple legs 483 are heated above their shape-memory transiion temperature to make them resume their annealed shape. The material is referably chosen so that the transition temperature is at or near body temperature so that heating the staple above the transition temperature does not cause damace to the delicate vascular tissues.

Fig. 39A shows an addicional anastomosis device 42 that has a fastening =fange 493 and inPearally formed staD members 4_4. The fastening fla-.e 493 in h case is a cylindrical ring formed from a be of biocomoaible meta.

The staple members 494 are attahed co the distal edge o cV 1 'dricaL fastenin- flange 49 OCo-inally, there are also proximal fastening members a--ached to the proximal edge of the cylindrical fastening flange 493. This variation of the anastomosis device can be applied with any of the methods just described in connection with Figs. 37A-37C. If the anastomosis device 492 has been made of an elastic or superelastic alloy, the optional proximal fastening members 495 can serve as spring members to compress the anastomotic attachment, similar to the proximal portions of the spring-like staples 411, 420 described in connection with Figs. 32A-32F.

Figs. 40A-40D show a two-piece version of an anastomosis device 496 having a fastening flange and integrally formed staple members. In this case, the fastening flange of the device is formed of two concentric cylindrical flange rings 497, 498. A plurality of interlocking staple members 499, 500 extend from the distal edges of both cylindrical flange rings 497, 498. Preferably, the staple members 499, 500 are integrally formed with the cylindrical flange rings 497, 498. The staple members 499 of the inner 20 flange ring 497 are angled so that they spiral downward from the ring 497 in a clockwise direction. The staple members 500 of the outer flange ring 498 are oppositely angled so that they spiral downward from the ring 497 in a counterclockwise direction. Corresponding locking features 501, 502 on the s5 inner surface of the outer flange ring 498 and on the outer surface of the inner flange ring 497 are capable of locking the two flange rings 498, 497 tocether in a fixed position.

Indentations on one flange ring, with corresponding detents on the other flange ring are one of the many possibilities for 0 the locking features 501, 502.

The anastomosis device 496 is applied by separately placing first the outer flancg ring 498, then the inner f-ance ring 497 around the distal en. 259 of the graft vessel 254.

The end 259 of the graft vessel 254 is then everced and approximated to the exterior 258 of the tarce- vessel 255 surrounding an opening 237 wr-. .s bee- previous 1 v mad tne wall, as shown in Fic. 40- n. ng 97 is moved cistall-y along the graf: vesse l 4-7 until the pi-s of staple members 499 contact t-e ever:d vessel wall 259. The inner ring 497 is pressed in:D the everted graft vessel wal 259 and simultaneously rotate- in a clockwise direction, thereby driving the staple me~bers 497 through the graft vessel wall 259 and the targe- vessel wall 255. Next, the outer ring 498 is moved distally along the graft vessel 254 until it is concentric with the inner ring 497. Then the outer ring 498 is pressed into the everted graft vessel wall .259 and simultaneously rotated in a cunterclockwi e se direction, driving the staple members 500 through the graft vessel wall 259 and the target vessel wall 255. When the locking features 501 of the outer ring 498 coincide with the locking features 502 of the inner ring 497, the outer 498 and 5 inner 497 rings become locked together. As the flange rings *5 497, 498 are rotated in opposite directions, he s the staple members 499, 500 of the inner 497 and outer rings 498 penetrate the vessel walls in opposite directions as shown in Fig. 40C, effectively locking the anastomosis device 49 to the exterior 258 of he e nastomosis device 496 to the exterior 258 of the target vessel 255.

Alternatively, the inner 497 and outer rings 498 of the flange can be applied simultaneously to the everted end 259 of the graft vessel 254 by arranging the rings 497, 498 concentrically, then pressing te staple members 499, 500 into the graft vessel wall 259 whil- counterrotatng the inner 97 and outer 498 g Le inn 497 and ouer 8 rngs. This could best be done with an nstrument that holds and rotaes the inner 497 and outer 498 rings mechanically.

Figs. 41A-41E show another azroach to making an anastomosis device 503 having a faste flange 504 an 3 C ngu aty fasef ni: 0 4 a n d plurality of individual staple members 505. The method oa deployment used in this embodiment allo.s th slea membrs 505 to be made of a normally elastic mI alloy, such as spring-tempered stainless steel. as g 54 -e -=sceinc flange 50 i this embodiment is a tubular eleen a central ori g fice 506 which is surrounded by an iner wa" 507, a distal su r f ce 508, and an oucer wall 509 defiing a nnla s u pace 50 between the inner 507 and outer wails 509 The annular dista surface in erconnects he inner 507 h-ee 5Inl d isa l l O2r 509 -walls.

78 annular space 510 is sized to fit the staple members S05 prior to deployment, as shown in Fig. 41A. A staple application tool 511 has an annular staple driver 512 which fits into the annular space 510 within the flange 504. The distal surface 508 and the inner wall 507 of the flange 504 is slotted with pairs of L-shaped slots 513 to allow penetration of the staple members 505 through the distal surface 508.

Alternatively, the flange 504 may have a solid body and the annular space 510 can be replaced by a series of individual staple slots formed in the body of the flange by a process like electrical discharge machining. The individual staple slots can each be sized to fit a single staple member 505. Each individual staple slot should communicate with a S single slot or a pair of slots in the distal surface 508 of the fastening flange 504 for proper deployment of the staple members 505, depending on whether.the staple members are single or double-leg staples. In this case, the annular staple driver 512 of the application tool 511 must be replaced with an array of individual staple drivers sized to fit into :20 the individual staple slots.

The staple members 505 for this embodiment can be made as J-shaped, single-leg staples 505' or as U-shaped, double-leg staples 505. When viewed from the side, the single 05' and double-leg staples 505 are both roughly the shaDe of an inverted J, as seen in Fig. 41A. The double-leg scaples 505 combine two such J-shaped staple leas 514 with a crossbar 515 that connects the proximal ends of the staple legs 514 to form staples 505 that are roughly U-shaped when viewed from the front or from the top, as in Fig. -4E. The staple legs 3- 514 are formed with a central segment 516 that is attached at an acute angle to a proximal segment 517. A short intermediate segmenz 518 may be used to connect the proximal segment 517 to the central segment 516 of the staole member 505. The croxima nd ac o he roxmal sements 57 3Z joined to the crossbar 515 of The staple member 505. A distal segment 519 is attached to the central segmen 516 at an obtuse angle so thna t is approximately paralle to the proximal segment 517. The dis end 520 of .he distal segment 519 is sharpened to easily p"netrate the graf esse wall 259.he gra vessel The anastomosis device 503 is prepared by passin the graft vessel 254 through the central orifice 506 of the fastening flange 504 and everting it over the distal surface 508 of the flange 504. As an alternative to the loop of suture described in previous embodiments of the device, a vessel cap 521 may be used to secure the everted graft vessel 259 to the fastening flange 509. The vessel cad 521 is a toroidal ring with an L-shaped cross section that fits around the outer diameter of the distal surface 508 of the fastening flange 504 and holds the everted end 259 of the graft vessel 254 in place.

Next, the fastening flange 504 with the everted end S 259 of the graft vessel 254 attached is approximated to the eeio28oth approximated to the Sexterior 258 of the target vessel 255 with the central orifice 506 al d nrif 5 igne with an opening 267 hrouh the target vessel wall 255, as shown in F 41A. The stale driver 512 is then advanced in the distal direction to press against the attachment legs 514 of the saple memers 505 and force the ta ends 520 thstataple members 505 through the slots 513 in the distal end 508 of the fastening lange 504 to 3. pierce the graft vessel wall 259 and er the target vesse lumen 256 through he opening 267 in teo target vesse wall 25g5, as shown in 41B. As the staie driver 512 is advanced further te crossbar 515 of te taole member 505 .a g 5 2 3 a nd a -i stsale members 502 P t contacts the distal wall 508 of the fastening flange 504 and the staple member 505 begins to rotate about the point of contact, as shown in Fig. 41C. The distal segments 519 of the staple members 505 capture the target vessel wall 255 and pull it tight against "the distal surface 50 o the astenn flange 504, as show in Fig. 41D, to form a leak Droof anastomo veseal between the everted graft vessel wall 259 and the target vessel 255 Figs. 42A-42D illustrate ano-her one-piece embodimen- of the anastomosis device 522 witha fase nng flange 523 and atrached staple members 524. preerab tn e anastomosis device 's made fr- m a- Cermble icca -v _s mace rrom a deform.able bICCOE*- s i= metal, such as a scainless szeel allv, tianium alloy or a cobalt alloy. I desired a surface c n can be appid t the anastomosis device to im=rove the bicomoat biity or other material characteristics.

In contrast to some of the reviously described embodiments, in this version of the anastomosis device 522, the fastening flange 523 resides on the interior surface 258, of the target vessel wall 255 when the anastomosis is completed. To avoid any problems with hemolysis thrombogenesis or foreign body reactions, the total mass of the fastening flange 523 has been reduced to an absolute minimum to reduce the amount of foreicn material within the target vessel lumen 256.

The fastening flange 523 is in the form of a wire 5 ring 523 with an internal diameter which when fully extended s just slightl-y larger than the diameter of the graft vessel *254 and of the opening 267 made in the target vessel wall 255.

Initially, the wire ring 523 has a rihled wave--ike shape to reduce the diameter of the ring 523 so that it will easily fit through the opening 267 in the target vessel wall 255.

A

plurality of staple members 524 extend from the wire ring 523 in the proximal direction. In the ill'strative embodiment shown in Fig. 42A, there are nine stacse members attached to the wire ring fastening flange 523. COter variatons 0: tne S anastomosis device 522 might tyically ave frrom four to twelve staple members 524 deDedin o he size o th vessels ,i to be joined and the securiy reauatM rh e ie of h in v -e j o i n e dr e q u r e d i n h e articular application. The s-aple me.rs 524 can be formed integrally with the wire ring fastenic flange 523 or the staple members 524 could be attached c the ring 523 by welding or- brazing metchods. The roxia eds 525 of the staple members 524 are sha-rpen o SL ierc e taret vesse nez o easiLy pierce rhe target vessel wall 255 and the graf: -ess i 29. D- av the proxi-=l ends 525 of then szaole mr-e-ers 52- he barys 52 S to imrove the secuitv of ee Cc'r '02e he baZ 5Ce 2 dePlo oed.

-he anastomosis devic: 522 zr=arder mcun inc C device onoC te disc E sp ll adc-d 81 application instrument 527, as shown 4- T h fastening flange 523 is mounted onto a anv 528 attached to the distal end of the elongated shaf 531 of the a ication instrument 527. The staple members 524 are compressed inward against a conical holder 529 attached to the instrument 527 just proximal to the anvil 528 The staple members 524 are held in this compressed position by a cap 530 which is slidably mounted on the elongated shaft 531. The cad 530 moves distally to cover the sharpened, barbed ends 525 of the 0 staple members 524 and to hold them against the conical holder 529. The application instrument 527 is then inserted through the lumen 249 of the graft vessel 254. This can be done by h r inserting the instrument through the graft vessel lumen 249 from the proximal to the distal end of the graft vessel 254, S or it can be done by backloading the elongated shaft 531 of theoo ihe grat sat 531 of the instrument into the graft vessel lumen 249 from the distal end to the proximal end, whichever is st convenent n the case. The anvil 528 and holder 529 on the distal end of the application instrument 527 with the anastomosis device 22 20 at e anastomosis device 522 0 attached is extended through the openiin 267 into the lumen 256 of the target vessel 255.

Next, the distal end 259 of the graft vessel wall 5 e grate vessel wall .4 is everted against the exterior surface 258 of the target vessel wall 255 with the graft vessel lm.en 2- 9 cen- red on the opening 267 in the target vessel wall 255. The ca 530 is withdrawn from the proximal ends 525 of the staple members 524, allowing the staple members 524 to spring outward to their uncompressed position shown by the phantom lines 524' Fig. 42B. The application instrument 527 is then drawn in the proximal direction so that the scaple members 524' pierce the target vessel wall 255 surrounding the open-in 267 and the everted end 259 of the graft vessel 254.

The application instrument 527 has an annular staole former 532 which surrounds the outside f t graft vesse 254 Some slight pressure on :ne everz-e cr-af: ve wall 259 from the annular scaple former 532 rin e -he piercing step assists in piercing the scaole memcers 524' trou the graft vessel walls 259. Care should be ake no C aolC z e .^oui o no- apply c^ much pressure with the staple former 532 at this oint becaus the staple members 524' could be prematurel deformed before they have fully traversed the vessel walls. If desired, an annular surface made of a softer material such as an elastomer, can be provided on the application instrument 527 to back up the vessel walls as the staple members 524' pierce through them.

Once the staple members 524' have fully traversed the target vessel wall 255 and the graft vessel wall 259, as shown in Fig. 42C, the staple former 532 is brought down with greater force while supporting the fastening flange 523 with the anvil 528. The staple members 524' are deformed outward, as shown by the phantom lines 524", so that the sharpened barbed ends 525 pierce back through the everted graft vessel wall 259 and into the target vessel wall 255 to form a

D

ermanent attachment. To complete the anastomosis, the anvil 28 is withdrawn through the graft vessel lumen 249. As the anvil 528 passes through the wire ring fastening flange 523, -t straightens out the wave-like ripples so that the wire ring 20 523 assumes its full uncompressed diameter, as shown in figure 42D. Alternatively, the wire ring fastening flange 523 can be made or a resilient material so that the flange 523 can be Scc: cmpressed and held in a rippled or folded position until it is.. released within the target vessel lumen 256, whereupon it S will resume its full, expanded diameer. Another alternative construction would be to make the anastomosis device of a shape-memory alloy so that the wire rinc fastening flange 523 can be compressed and inserted through the opening in the target vessel 267, whereupon it would be returned to its full expanded diameter by heating the device 522 to a temperacure aoove the shape-memory transition temperature.

Figs. 43A-43B, 44A-44B, and 45A-45E show a complete system for creating an end-to-side vascular anastomosis using an anastomosis device 533 with a fasceninc flange 534 and a Plurality of staple members 535 made of a highly resiliet or su erelastic metal. The system i.-cludes a specially adap-ed ap ication instrumen: 536 for ac-lving -e anastomosis device 33. F-i. 43A shows a top view cf he fas=eninc flance 534 o the anastomosis device 533. i 43 shows the fasten flange 534 of Fig. 43A in cross section from the side. The fastening flange 534 is gen-erally cylindrical in shape with central orifice 537 of sufficient diameter to accommodate th S external diameter of the graft vessel 254. The wall 538 of the fastening flange has a plurality of holes 539 extending from the proximal surface 540 of the flange to the distal surface 541 of the flange. Preferably there are an even number of holes 539, two for each of the staple members 535, which may number from four to twelve depending on the size of the vessels to be anastomosed. The illustrated embodiment has twelve holes 539 to accommodate six staple members 535. The holes 539 are preferably angled toward the central orifice 537 from the proximal end 540 to the distal end 541 so that they exit the wall 538 of the flange 534 at the juncture of the distal surface 541 of the flange and the internal surface of the central orifice 537. In the illustrative embodiment shown in Figs. 43A and 43B the holes 539 are angled at approximately degrees to the longitudin axis of the flange 534. Other angles are also possible, from -10 to +20 degrees from the longitudinal axis of the flange 534 The fastening flange 534 has a circumferential notch 542 on the exterior of the flange 534 close to the distal end 541 of the flange to aid in attachment of the graft vessel wall 25 There is also a circumferencial ridge 543 around the eerior of the fastening flange 534 proximal to the notch 542 to assist in gripping the S flange 534 for the operation of the application tool 536.

Figs. 44A and 44B show the staple member 535 of the anastomosis device 533 in a front view and a side view. The staple members 535 are referabl formed from wire made o a highly resilient biocompatibie metal such as a spring-temered alloy of stainless steel, titaniu, or cobalt, or more preferably of a superelastic metal allcy, such as a nickel-titanium alloy. The wire preferably has a diameter between 0.006 and 0.025 inches, ependinc on the stiffness of the metal alloy c-osen. Nickel--ani wire with a diame of 0.010 to 0.01 inches has been ound to be very suitable -or this applica-C. he stapl mbers 55 are rough tabl aom. icapee-33 are roughly an 84 inverted shace O8 ttchend U s h a p e w hen viewed from the front with two aegs 544 joined togeher a their proxima ends by a crossbar 545, as shown in Fic. 44A When viewed from the side as in Fig. 44, the staple members 535 are roughly J-shaped with the distal ends 546 of the attachment legs 544 curving back toward the proximal end of the stale member 535.

Each of the J-shaped hooks 547 ends in a short straight section 548 with a sharpened distal end 546 to easily penetrate the graft vessel 259 and target vessel 255 walls.

The staple members 535 should be annealed or cold worked in the illustrated configuration, whichever treatment isrmost appropriate for the metal alloy chosen, so that the staple member has a permanent elastic memory which makes it return to the treated shade.s i n to 5The holes 539 through the fastening flange 534 are sized so that there is a close sliding fit between the S attachment legs 544 of the staple members 535 and the interior of the holes 539. The anastomosis device 533 is prepared for use by inserting the two attachment legs 544 of each staple member 535 into two adjacent holes 539 in the fastening flange 534, until the curved distal portion 547 of the attachment legs 544 are entirely within the holes 539. When inerting the taple members 535, they should be oriented so that the curve of the disal ends 547 of the at-achment legs 544 will be biased cutward from the central orifice 537 of the rastening flange 534 when extend- d S* ai enig f e 54 extende distally from the holes 539 in the flange 534. Because of the close sliding fit, the interior walls of the holes 539 constrain the curved distal ends 5=7 of the attachment legs 4 in a straightosition, as 3 0 sho In a straight position, as shown in Fic 43. The straight proxir al portion 549 of the staple members 535 ex-end proxima-ly from the proximal end 540 of the fascening flange 534 as s.own.

The preparation of the aastc-osis device 533 can also be accomplished using the saDe-memory property of a nicke!-:icanium allov The s' a p l o members 535 would be formed as sho.wn in Figs. 44A and 44B and annealed to create a shape--emor. The a:cachment: e-s 544 the stale members 53 are the- s:rai ned by cle ork the c be e thbe ae ene- s-raignened by col working tnem below the transition temperature of the shape-memory alloy. t straightened condition, the distal ends 547 of the aitachmen legs 544 are easily inserted into the holes 539 in the fastening flange 534. Care must be taken to orient the taple members 535 so that the curve of the distal ends 547 of the attachment legs 544 will be biased outward from the centra orifice 537 of the fastening flange 534. Once all of the staple members 535 have been inserted into the holes 539 of the fastening flange 534, the entire anastomosis device 533 can be warmed above the transition temperature of the shape-memory alloy so that the distal ends 547 of the attachment legs 544 will try to return to their curved shape.

Being constrained by the interior walls of the holes 539, the attachment legs 544 will remain straight, but they will have S* an elastic memory that will cause them to resume their curved a n e l a s t i c shape when they .are released from the confinement of the holes S 539.

5 With the anastomosis device 533 thus preared, it is ready to be inserted into the application instrument 536 which is shown in Figs. 45A-45E. The application instrument 536 consists of two separate, but interactin, mechanisms a stapling mechanism 550 and a punching mechanism 551. Th punching mechanism 551 is sized to be slidingly received within an internal lumen 552 of the stapling mechanism Most of the parts of the application instrument 536, unless otherwise specified, are preferably made of a high-strength dimensionally stable polymer material, such as acetal,

AS,

HDPE, PTFE, etc. Alternatively, the application instrument 536 could be made from stainless, steel, titanium or other metals, if desired.

The staplin g mechanism 550 has a generally cylindrical holder 553 which has a proximal end 554 and a distal end 555. An internal lumen 556 ex:ends from the proximal end 554 to the distal end 555. The distal end 5 c the holder 553 is adapted to hold the fas ening flange 53- o: the anastomosis device 533. A through hcle 557 in the distl_ end of the holder 553 is sized to be a lizht Dress fit arouni the proximal end 540 of te= fas tesinc flae 53 -a c n 534 councerbore 558 on the distal end of the through hole 557 fits the circumferential ridae 543 of the fasening lange 53 7 to axially locate the fastening flange 534 with respect to the holder 553. A staple driver 559, whic is generally tubular in shape, is slidably received within the internal lumen in the holder 553. The staple driver 559 has a T-shaped handle 560 attached to its proximal end for operating the stapling mechanism 550. The proximal end of the staple driver 559 has a short tubular extension 561 with a circumferential groove 562 around the exterior of the tubular extension 561.

The distal end has an annular staple driving surface 563.

To insert the anastomosis device 533 into the distal end of the stapling mechanism 550, the proximal ends 549 of the scaple members 535 must be flexed slightly toward the central axis of the fastening flange 534 so that they will all fit through the through hole 557 on the distal end of the holder 553. Once the proximal ends 549 of the staple members 535 have been inserted, the proximal end of the fastening flange 540 is inserted into the through hole 557 with the circumferential ridge 543 seated into te- counterbore 558.

The stapling mechanism 550 is now ready for attachment of the graft vessel 254 to the fastening flange 53nt -fastening flange 534 To begin, the graft vessel 254 is oassed through the Sinernal lumen 552 of the holder 553 and the staple driver 559. This can be done by tying a suture around one end of the graft vessel 254, passing the suture through the stapling mechanism 550 and drawing the graft vessel 254 through Alternatively, an elongated hook or grasping instrument can be inserted through c he lumen 552 of the s-apling mechanism 550 to draw the graft vessel 254 through. -e distal end 259 o the graft vessel 254 is then ever-ed over the distal end 54 of the fastening flange 534. f desired, a loop Cf suctu can be tied around the everted en- 259 he raf vessel 254 at the location of the circumferen-ial -h or groove 542 to secure the graft 259 to the fasning flnge 534. The proximal end 565 of the graft vessel 254 can also b evere and temporarily ac:acned wiah a icoo of su-ure to -h -rox o Dr,_oxira extension 561 of the staple dr--er 55 to make the graf vessel 254 easier to handle.

At this-point, the vessel pu-nh mechanism 551 should be inserted into the staplin m^echanism 550 through the lumen 249 of the graft vessel 254. The vessel punch mechanism 551 consists of a housing 566, a cutter 567, an anvil 568, a clamp 569, a clamp knob 570 and a punch knob 571. The housing 566 is generally cylindrical in shape There are two inner chambers 572, 573 in the housing which are separated by an internal wall 574. The distal chamber 572 is sized to have a light press fit over the holder 553 of the stapling mechanism 550. A pair of set screws 575 in the side wall 576 of the distal chamber 572 are to ecue stachamber 572 are provided to secure the housing 566 to the holder 553. The side wall 576 of the distal chamber 572 has pair of opposing open-ended slots 577 that are sized to fit over the T-shaped handle 560 of the staple driver 559 and allow the handle 560 to move axialy witin the slots 577.

a The proximal chamber 573 has an interna: thread 579 that matches an external thread 579 on the clam knob 570. A *2 counterbored hole 580 through the internal wall 574 connects the proximal 573 and distal 522 chambers The cutter 567 of the vessel punch mechanism 551 is a long slender tubular member which is preferably made of a nhardenable alloy of stainless stee. The distal end 581 of the cutter 567 is slightly enlarced w respect to the shaft 582 of the cutter 567, and there Is a co-nterbore 53 within the enlarged distal end 581. he istal ede of the cutter 567 has a sharp, beveled cutting ge 584. Preferably, at least the cutting edge 584 of the :ubular cutter 567 is 0 hardened. The proximal end of cutte shaft 582 has a snua press fit into the counter hole 5- thro-h the internal wall 574 of the housing 566. The punch mechan-sm 551 also includes a clamp 569. The clam 569 has anc t-'ua- shaf 585 which is sized to be slidablv received '-:hin :e inernal 5 u 5 w c 86 S of the cutter shaft 582. An e ar-ed ihea 537 on the dista end of the shaft 585 is sized tc ithn CO Un terbore 583 in the distal end of the cutter- 67. The end o the enlarged head 57 has an ann- i c a e n d 588.

The proximal end of the clam shat is inserted into the cutter 557 and glued or otherwise fastened to the clamp knob 570 which is threaded into the proxima chamber 573 of the houing 566. The anvil 568 of the punch mechanism 551 is preferably made of stainless steel. The anvil 568 has an elongated shaft 589 that has a sliding fit with the internal lumen 590 of the clamp 569. An enlarged head 591 on the distal end of the shaft 589 is sized to fit within the counterbored distal end 583 of the cutter with a very close clearance between the head of the anvil 591 and the cutter 567. The proximal end of the shaft. 589 is threaded to attach it to the punch knob 571. The punch kncb 571 has a distal extension 592 which is threaded to fit to a threaded hole 593 on the proximal end of the clamp kncb 570.

When the clamp knob 570 is rotated with respect to the housing 566, the clamp 569 is advanced proximally or distally with respect to the cutter 567. In its farthest distal position, the clamping surface SE5 of the clamp 569 is just distal to the cutting edge 584 of e tubular cutter 567 When the punch knob 571 i s rotated with respect to the clamp knob 570, the anvil 568 is advanced proximally or distally with respect to the clamp 569. By movinz the anvil 568 S proximally with respect to the clamp 569 when the clamp is in its farthest distal position, the tissue of the target vessel wall can be clamped between the clamp and the anvil When the S. clamp knob 255 and the punch knob 571 are rotated in unison, the anvil 568 and the clamD 569 can be w--hdrawn into the tubular cutter 567 to effect the cuttinc action of the punch mechanism 551. Preferably, the clamp 569, the anvil 568 and 0 the tubular cutter 567 are keyed 7o one another or otherwise rotationally fixed so that they cve ax with resect to one another wizhout relative roa:ion.

The punch mechanism 551, as it -as just been described, is insered into the s:aoPinc -echanism 550 throuch the lumen 249 of the graft vessel 254. Te clamp 559 of the puncn mechanism 551 should be advanced t: its farthest distal pos iion befcre insertano the punc- 551 -hrough the araft vessel 254 tc avoid damaging -he i:cericr wall o-f he craf: vessel 254 with the cutter 567 as it sses hrough. The screws 575 in the housing 566 of the nch mechanism 55 a se t he richsi 6 5S1 ar e screwed into corresponding holes- 594 nthe holde 55 o te stapling mechanism 550 to secure the o interacting 5 5 3 t h e mechanisms together. The graft vessel 254 occupies an annular space 595 between the punch mechanism 551 and the interior surface of the stapling mechanism 550. Thus assembled, the anastomosis system, which includes the anastomosis device 53 attached to the graft vessel 254 and the application instrument 536, is prepared to perform an end-to-side anastomosis between the graft vessel 254 and a target vessel 255.

The operation of the application instrument 536 is illustrated in Figs. 45A-45E. A slit 596 is made in the wall of the target vessel 255 with a scalpel or other sharp S instrument. If .it has not been done already, the clamp 569 o the punch mechanism 551 is advanced disally by turning the clamp knob 570 until the clamp surface 588 extends slightly beyond the cutting edge 584 of the cutter 567, and the anvil 568 of the punch mechanism 551 is advanced distally by turning the punch knob 571 until the anvil head 591 extends distally from the application instrument 536. The anvi head 591 of the Punch mechanism 551 is inse- ed thr-uh the slit 596 into the lumen 256 of the target vessel 255, and the distal edge 541 of the fastening flange 534 with th everted end 259 of the graft vessel 254 attached is approxiated to the exterior surface 258 of the target vessel 255, as shown in Fig. The target vessel wall 255 is then clamped by the punch mechanism 551 by turning the punch knob 571 to move the anvil head 591 proximally until the target vessel wall 255 is firm!, gripped between the anvil hea- and te clam surface 588, f as shown in Fig. 45B. The clam feature of the punch mechanism 551 prevents the cu-zr 567 rematel cutn through the wall the tarc ve: pr e ma t c r e l y c u tin through the wall of the target vessel 255 and it provides a firm suppor- to the target vesse wall 2 or the stalina step which follows.

If the anastomosis is e used to create a pro-xim-al anastomosis be-ween a vessel and the aorta an the aorza uring a CABG procedure, the clampinc feature provides an additional benefit at this point in the procedure. In rder to reduce the crossclamp time that the patient is Subjec-ed to, many cardiac surgeons prefer to perform the proximal S anastomosis while the patient's heart is stil beating. This requires isolating a portion of the aortic wall with a nonoccluding side-biting clamp to prevent excessive bleeding from the opening formed in the aorta. This has a number of disadvantages: 1) even a nonoccluding side-biting clamp presents additional resistance to aortic blood f ow, possibly reducing cardiac output which. may already be low, 2) the side-biting clamp tends to distort the aortic wall, making i harder to create a neat anastomosis, 3) conventional side-biting clamps are difficult to aly in a closedchest or i Port-access thoracoscopic CABG procedure, and 4) side-biting clamps may break atherosclerotic tissue loose from the inner wal of the aorta, possibly causing strokes or other complications. The clamping feature reduces the need for the side-biting clamp by clamping directly to the aortic wall around the slit made by the scalpel for insertin the anvil This creates a fluid-tight seal preventing bleeding through the aortotomy opening, so that the side-biting clamp can be released and removed from the site It is also cossible to avoid the need for the side-bitinz clamp entirely by uic:v inserting the anvil head 591 of the punch mechanism 551 and tightening the clamp 569 immediately after creating the aortotomy slit before significant blood oss can occur.

the head of the anvil 591 were made with a blade or trocar extending from its distal surface, the device 536 could oierce L nd ds-i 'e t e cevice 536 could DPierce and dilate an opening n the aorta wall in the same motion as inserting the anvil 591 throuc:h the opening, otential saving time and blood loss.

In the scapling step, t- stale driver 559 is advanced discally by pressing on the T-shaped handle 560, as shown by arrows 597 in i 4C. This causes the disa n 63 -he s- T is c a u s e s c h e d i s c a l e n d 53f he staple driver 559 o ress against the crossbars o -he scaple members 535 and forces the attachmen- s -544 to ex through the holes 5= i-n che -dstal en 541 fhe 41 o fastening flange 534. As the attachment legs 544 emerge from the holes 539, the sharpened distal ends 546 of the attachmen legs 544 pierce the graft vessel wall 259 and the short traight section 548 traverses the graft essel wall 259 in a linear path. Optionally, the staples 535 can be advanced through the graft vessel wall 259 before the graft vessel 259 is approximated to the target vessel 255 so that the surgeon can verify that all of the staple attachment legs 544 have properly pierced the everted graft vessel wall 259. The sharpened distal ends 546 of the attachment legs 544 then pierce the target vessel wall 255. The clamping feature 569 of the punch mechanism 551 supports the target vessel wall 255 and keeps it closely approximated to the everted end 259 of the graft vessel 254 as the staple members 535 penetrate t 5 As the attachment legs 544 penetrate the target vessel wall 255, the curved.sections 547 of the attachment legs 54 emerge from the confinement of the holes 539 in the fastening flange 534 and the elastic memory of the unrestrained curve causes the attachment legs 544 to take a curved path outwardly from the central orifice 537 through the target vessel wall 255.

The distal ends 547 of the attachment legs 544 resume their j Sshape, as shown in Fia. 45C, firmly attaching the fastening flange 534 and the everted graft vessel 259 to the exterior surface 258 of the targec vessel 255.

""Once the fastening flange 534 and the graft vessel 254 are attached, an opening 267 is made in the target vessel wall 255 by turnin the lam knob 570 and punch knob 571 in unison to withdraw the anvil 568 and the clam 569, with the target vessel wall 255 gripped between them, into the tubular cutter 567, as shown in Fig. 45D. This action shrs off a Small, circular portion of the target vessel wall 255 to form a -luid communication between the lumen 256 of the arget vessel 255 and the lumen 249 of the graft vessel 254 To complete the anastomosis, the astening flange 53 is released from the holder 553 and the punch mechanism 551 a- rt entire ap plcation inscrumen: 536 are withdraw-, as show: tn Fig as sow in Figs. 46A-46D illustrate a second embodiment o0 the anastomosis system using an anastomosis device 600 with an inner fastening flange 601, an outer flange 602 and staple members 603 made of a superelastic nickel-titanium alloy. The S system includes a stapling mechanism 604 for attaching the anastomosis device 600 to the wall of the target vessel 255 through a previously made opening 267. The anastomosis device 600 has a fastening flange 605, which is shown in top view in Fig. 46C and in side cross section views in Figs. 46A and 46B.

The fastening flange 605 includes a tubular body 606 which has an internal lumen 607 of sufficient diameter to accommodate the external diameter of the graft vessel 254. Attached to S the distal end of the tubular body 606 is an inner flange 601 o:ver which the free end 259 of the craft vessel 254 will be everted. On the proximal end 610 of the tubular body 606 are three radially extending lugs 608, which facilitate grasping the anastomosis device 600 while performing the anastomosis The exterior of the tubular body 606 has an external step 609 0so that it is slightly larger in dia-eter at its proximal end 610 than at its distal end 611. Th interior of the tubular body 606 has an internal step 612 so that the internal diameter of the tubular body is slicghly smaller at the distal end 610 than at the proximal end 611. A plurality of holes 613 pass through the fastening flance 605 from the internal S step 612 to the distal surface 611 o the inner flange 601 The holes 613 are arranged in pairs, six pairs in this illustrative example, to accommodat= a like number of staple members 603.

An outer flange 602 is concentrically located o- the tubular body 606. The outer flange 62 is attached to the tubular body 606 by a self-loc-inc ri-g washer 614 which as inclined lugs 615 which allow r-g- washer 614 to slide distally with respect to the ztbular sody 606, but which prevent it from sliding proximllyv -e ring washer 614 can be made integrally with the ou-er flazne 602 or a seDarate sheet metal ring washer 614 ca be aach o the outer flange 602, as illustrated T- i-era ie 66 of rg washer 614 and the out 2 is mde 1th three 7 washer 614 and r ou-- -=nge is made with three wide slots 617 between the inclined lugs 615 to allow them to be placed onto the tubular body 606 over the lugs 615 which extend from the proximal end 610 of the tubular body 606. The outer flange 602 has a distal surface 618 which is slightly concave. The peripheral edge 619 of the outer flange 602 has six notches 620 cut into it which coincide with the location of the distal ends 621 of the staple members 603 after they are deployed, as shown in Fig. 46C.

1The staple members 603 are generally an inverted

U

0 shape when viewed from the front as in Fig. 46D. Two attachment legs 622 are joined together at their proximal ends by a crossbar 623. Viewed from the side as in Fig. 46B, the staple members are somewhat J-shaped with the sharpened distal ends 624 curving back in the proximal direction. The stale members 603 are preferably formed from wire made of a highly resilient biocompatible metal such as a spring-tempered alloy of stainless steel, titanium, or coblt, or more preferably of a superelastic metal alloy, such as a nickel-titanium alloy.

For clarity only the distal end of the stapling :20 mechanism 604 has been shown in Fig. 46A. Suitable handle means are provided at the proximal end for actuating the S* stapling mechanism 604. The staplinr. mechanism 604 has an outer sleeve 625, which is a tubular member having three L-shaped fingers 626 extending from distal end that craso the radially extending lugs 615 on z:e proximal end of the tubular body 606 like a bayonet connetor. The clamp sleeve 627 is a tubular member which slides -elescopically over the exterior of the outer sleeve 625. A staple guide 628 resides within the outer sleeve 625. The sztple guide 628 is a tubular member having a plurality of slots 629, equal to the number of staple members 603 in the =-astomosis device, extending through the wall from the :-oxial end to the distal end of the guide 628. The slots 62 he guide 628 are sized to fit the staple members 603 erein and to constrain the J-shaped attachment legs 622 stale members 603 in a straight position prior to deplovy-.F. as shown in Fig. 46A The staple guide 628 can be made by t a plurality of slots 629 through rhe wall of the u ar m er with lectrical discharge machining, or staple uide 628 can be made from two closely fitting concentric tubes by cuttn slots like splines in the external surface of the inner tube and sliding the outer tube over it to close the slots. The S staple driver 630 is a tubular member which is slidably received within the outer sleeve 625. A plurality of fingers 631 extend from the distal end of the staple driver 630. The fingers 631 of the staple driver 630 are sized to be slidably received within the slots 629 of the staple guide 628.

The anastomosis device 600 is prepared by inserting the staple members 603 into the slots 629 in the staple guide 628 in the stapling mechanism 604. The staple guide 628 holds S the staple members 603 in a straightened position within the tapling mechanism 604. The fastening flange 605 is inserted 5 into the stapling mechanism 604 and the radially extending S. lugs 608 are grasped by the L-shaped fingers 626 of the outer sleeve 625. The staple holes 613 through the tubular body 606 are carefully aligned with the distal ends 621 of the staple rr members 603 and the staple driver 630 is advanced slightly to start the staple members 603 into the holes 613. The anastomosis device 600 is now prepared to perform an end-to-side anastomosis between a graft vessel 254 and the wall of a target vessel 255 as follows.

To begin, the graft vessel 254 s inserted through t-e central lumen 607 of the fascening flange 605 and the internal lumen 632 of the stapling mechanism 604 by drawing it through with a suture or an elongated grasping instrument The distal end 259 of the graft vessel 254 is then everted ove the inner flange 601 on the distal end 611 of the asenin flange 605. The inner flange 6 0 1 with the everted enc 259 of the graft vessel 254 attached is inserted throuah an opening 267 in the target vessel wall 255 chat has previously been made using an aortic punch or similar Instrument The s aple driver 630 is advanced distally, causing he sharened ends 621 of the staple members 603 to P-lrce :he evered wall 259 of the graft vesse 254 and ener the lumen 256 of the arget vessel 256. As te scaple nembers 603 emer=e from -he distal -d Cf te fas enin flance 605, the attachment legs 622 resume their J-shaped curve and penetrate the interior surface 257 of the target vessel wal! 255, as shown in Fig. 46D. Once the staple members 603 are completely deployed, the clamp sleeve 627 is advanced distally with respect to the outer sleeve 625, which forces the uter flange 602 to move in the distal direction with respect to the tubular body 606. As the outer flange 602 moves distally, the inner flange 601 and the target vessel wall 255 are pulled into the concave distal surface 618 of the outer flange 602 to form a smooth, hemodynamically efficient connection beteen the lumen 256 of the target vessel 255 and the lumen 249 of the graft vessel 254. The stapling mechanism 604 is now S removed by rotating the outer sleeve 625 to release its grasp on the tubular body 606 and withdrawing the entire stapling mechanism 604. It should be noted that the embodiment of Fig. 6, like the embodiment off Fii 3 46, like the embodiment of Fig. 43, could optionally be manufactured without an inner flange 601, whereby the inner wall .257 of the target vessel 255 is supported by the staple members 603 themselves.

Figs. 47A-47B, 48A-48B, and 49A-49C show an anastomosis staple device 635 which combines a plurality of precurved inner staple members 636 of a highly resilient material with a plurality of deformable outer attachment legs 637. Figs. 47A-47B show a top view and a side cross section view of the anastomosis staple in an undeployed state. Figs.

S 47A-47B show a top view and a side cross section view of the anastomosis staple in a deployed state. Figs. 49A-49C show the sequence of operations for deploying the anastomosis staple device. As shown in Figs. 47A-47C, the device 635 has a ring-shaped bushing 638 with an internal diameter 639 of sufficient size to accommodate the exterior diameter of the graft vessel 254. A plurality of deformable attachment legs 637, six in this exemplary embodiment, are attached to the proximal end of the ring-shaped bushing 638. The deformable attachment legs 637 are preferablv made of a metal which can be plastically deformed and which will maintain its final deformed shape, such as stainless steel or a titanium allov.

The acachment legs 637 can be ma:ninec intecrallv wich the ring-shaped bushing 638 as shown, or the attachment legs 637 can be made searately, for instance by stamping, electcal discharge machining or die cutting a ring of attachment legs 637 from sheet metal, and fastening the attachment legs 637 to the ring-shaped bushing 638. The attachment legs 637 are typically 0.012 inches thick, 0.040 inches wide and 0.230 inches long. The thickness and width of the attachment legs can vary somewhat depending on the stiffness of the material chosen for the attachment legs 637. It may be desirable to radius the edges of the attachment legs 637 or to make the attachment legs 637 round in cross section in order to reduce the potential for initiating cracks or tears in the target vessel wall 255. The length of the attachment legs 637 can be varied to accommodate different wall thicknesses of the graft vessels 254 and target vessels 255 to be attached.

S* The attachment legs 637 are typically formed flat, then bent or stamped into a curved configuration as shown in Figs. 47B. The distal portion 640 of ,each attachment leg 637 is curved in a circular arc whose center coincides approximately with the point of attachment 641 between the attachment leg 637 and the ring-shaped bushing 638. The attachment point 641 serves as the bending fulcrum for the attachment legs 637 when they are deformed during the anastomosis procedure. The intermediate portion 642 of the attachment legs 637 can be left relatively straight, or an intermediate curve 642 can be formed in the attachment legs 637, as shown in Fig. 47B. The distal ends 643 of the attachment legs 637are sharpened so that they will easily penetrate the target vessel walls 255.

The ring-shaped bushing 638 has a distal surface 644 over which the end 259 of the craft vessel 254 will be everted. The distal end 644 of the ring-shaped bushing 638 is flared out slightly to provide a more secure attachment of the everted end 259 of the graft vessel 254 to the bushinc 638.

There are a pluralitv of axial holes 645 in the wall of -he ring-shazed bushing 633 which communicate wich the distal surface 644 of zhe bushinc 638. The holes 645 are szed to nave a close sliding clearance wi- the lecs 646 C -h 6-6 of -he inn.er staple members 636. Preferably, the axial holes 645 are arranged in pairs to accommodate both legs of U-shaped inner staple members 636. As shown in Fig. 47A, the Currently preferred embodiment has six pairs of axial holes 645 for six U-shaped inner staple members 636. The axial holes 64 are angled outward slightly, typically by about 10 degrees from the central axis of the ring-shaped bushing 638. Angling the axial holes 645 outward tends to reduce the distance from the distal surface 644 of the bushing 638 to the bottom of the curve of the staple members 636 once the staple members 636 have been deployed. There are also a plurality of transverse holes 647 through the wall of the ringshaped bushing 38 to acilitate gripping the bushing 638 with the stale 6 3 8 t o application instrument 648.

The staple members 636 are generally an inverted U shape when viewed from the front as in Fig. 47A. Two stale legs 646 are joined together at their proximal ends by a crossbar 649. Viewed from the side as in Fig.. 48B, the deployed staple members 636 are somewhat J-shaped with the sharpened distal ends 650 curving back approximately 180 degrees in the proximal direction. The staple members 636 are preferably formed from wire made of a S highly resilient biocompatible metal such as a sprin-temered alloy of stainless steel, itanium, or cobalt, or more preferably of a superelastic metal alloy, such as a ickel-tianium alloy. The nastomosis staple device 635 is Srepared for use by inserting the curved distal ends 651 of the J-shaped staples into the axial holes 645 in the ring-shaped bushing 638. The internal walls of the axial holes 645 hold the curved ends 651 of the staple members 636 in a straightened position within the ring-shaped bushing 638 The anastomosis staple of Figs. 47A-47B and 48A-48 is part of a complete anastomosis system which includes a specialized staple application instrument 648 for performina the anastomosis procedure he staple application instrument 648 s shown in Fics. 50A-50E. As seen in Fig. 50B, the instrument 648 has a gripper 652 which is adapted to hold the ring-shaped bushinc 638 f he sacle device. The grioer:652 The gripper-652 s a generally tubular member that has a plurality o griDD ringers 653 extending axially from its distal end. Each of the gripping fingers 653 has an inwardly turned distal ti which is sized to fit into one of the transverse holes 647 in the ring-shaped bushing 638. The gripping fingers 653 are spring-biased outward. A combination gripper actuator and outer attachment leg driver 655 is slidably received on the exterior of the gripper shaft 656. The actuator/driver 655 is generally tubular in shape, having a lumen 657 with a close sliding fit over the exterior of the gripper 652 and a radiused annular staple driving surface 658 on its distal end.

When the actuator/driver 655 is slid distally over the exterior of the gripping fingers 653, the outwardly biased fingers 653 are pressed inward so that they grip the i ring-shaped bushing 638 by engaging the transverse holes 647.

,An inner staple driver 659 is slidably received within the inner lumen 661 of the tubular shaft 656 of the gripper 652. The inner staple driver 659 has an annular staple driving surface 660 on its distal end. The inner staple driver 659 has an internal lumen 662 that can accommodate the graft vessel 254 during the anastomosis rocedure. The gripper 652, the actuator/driver 655 and the inner staple driver 659 are held together by a pair of alignment pins 663 which are threaded into the wall of the 25 actuacor/driver 655. The grioer shaft 656 has a pair of oposing axial slots 664 that allow it to slide axially with respect the actuator/driver 655. The inner staple driver 659 has a pair of opposing L-shaped slots 665 oriented to allow the inner staple driver 659 to slide axially with respec t the cripper 652 and the actuacor/driver 655. The inner staple driver 659 can be moved to a locked position to Prevent premature activation of the inner staples 636 by withdraw ic it distally and ro-ating i so that the alignment pins 663 enter the L-shaped portion 666 of the slots 665.

in preparation for the anastomosis procedure, the ximal en or the ng-shaed bushine wt h -he ri a hinc G38, with the proximai en.s of t-e inner szaples 636 e:,r:endin from it, is inserted -no -e .ripper 552 with t :ransverse holes 647 alianed with the ends 654 of the gripping fingers 653. The inner staple driver 659 should be withdrawn to the locked position before the staple device 648 is inserted. The actuator/driver is advanced distally, causing the ends 654 of the gripping fingers 653to flex inward and engage the transverse holes 647 in the ring-shaped bushing 638. The actuator driver 655 can be advanced distally until it rests against but does not deform, the attachment leg 637 of the staple device 635.

At this point the graft vessel 254 is passed through the internal lumen 662 of the staple applying instrument 648 until a short length of the graft 254 extends from the dista end of the instrument 635. The end 259 of the graft 25is a l then everted over the distal surface 644 of the ringhape bushing 638. If desired, a loop of sutur e i ed a nd the everted end 259 of the graft vessel 254 to secure it to S the bushing 638. The staple instrument 635, with the everted end 259 of the graft vessel 254 attached, is approximated to the exterior surface 258 of th s a p p r o x i mat e d to the exterior surface 258 of the target vessel 255 where an opening 267 in the target vessel wall 255 has reviously been •o made with a vessel punch or similar instrument. If the anastomosis is part of a port-access CABG procedure, the instrument 635 is inserted into the chest of the atient through an access port made in one of the intercostal spaces.

The ring-shaped bushing 638 is inserted into the Spening 267 in the target vessel wall 255 to approximate the inimal surface on the everted end 259 of the graft vessel 254 with the intimal surface 257 of the target vessel 255, as shown in F e ta r g e t v e s s e l 2 5 5, a s shown in Fig 49A. Prefrably, the opening 267 in the wall of the taret vessel 255 is made slightly smaller than the outer diameter of the ring-shaped bushing 638 so that there is some compression around the bushing 638 which helps to seal the anastomosis against leakage The inner staple driver 659 is rotated to release It from the locked position and advanced distallv o drive the inner staple members 636 throuch the everted wall 259 of the graft vessel 254 As the staple members 636 exit the axial holes 645 in the bushing 638, thev resume their J-shaped curve 651 so that th e curve back dis-a:- and penetrate the interr s e 2 e i- saor surface 257 or hs 100 vessel wall 255, as shown in Fig. 49- After the inner members 636 have been deployed, a lizht tension is exerted on the staple applying instrument 648 to make sure that he o ner staple members 636 are well seated and the actuator/driver is advanced distally to deform the outer attachment legs 637.

The sharpened distal ends 643 of the attachment legs 637 penetrate the exterior 258 of the target vessel wall 255 in a circular arc, gathering the tissue and compressing it against the exterior of the ring-shaped bushing 638 and the everted edge 259 of the graft vessel 254 to form a leak-proof anastomotic seal, as shown in Fig. 49C. The actuator/driver 655 is withdrawn in the proximal direction, thereby releasina the ring-shaped bushing 638 from the gripper 652, and the S entire staple applying instrument 648 is withdrawn from the anastomosis site.

Fig..51 shows an additional feature which can be used with any of the anastomosis devices described above This feature is a combination strain relief and compliance mismatch transition sleeve 667. One of the current theories about long-term patency and the causes of rescenosis in bypass grafts proposes that the mismatch in vessel compliance between S the target vessels, which include the aorta and the coronary .arteries, and the graft vessel, typically a saphenous vein, can contribute to the developmen- of i.nimal hvperplasia, stenosis and occlusion in the graft vese especially at h anastomosis where the compliance misma-ch is most apparent Joining a highly compliant vessel, such as a saphenous vein, to a relatively noncompliant vessel, like the aortic wall, places extra strain on the vessels and on the anastomosis.

Another cause for mismatched comzliance at an anastomosis site is the joining of a compliant blood vessel with a highly noncompliant artificial graft vessel. Additionally turbulence in the blood flow at :ne anastomosis site may exacerbate the problem, acceleraing t-e Stensis process 3 is preferable that all of the vessels he equally comoliant 0o at least that there is a gradual :ransL:ion in comoliance from one vessel to another. As suc-, t wobLd be desirable to provide the anastomosis devices w.ith a -eans -o c-ate a gradual transition in compliance be-ween the vessels t the anastomosis site.he Another concern in anasto-sis procedures is to create a gradual curve in the graft vessel leading away from the anastomosis site. This is sometimes necessary because the most convenient angle for attaching the graft vessel to the target vessel does not match the desired path for the graft vessel away from the anastomosis. For instance, in CABG .surgery the desired path for the graft vessel is often parallel to the ascending aorta, however the graft vessel must be joined to the ascending aorta at some angle in order to create the anastomosis. Creating a gradual curve leading away from the anastomosis site to avoid kinking -or narrowing of the graft vessel lumen is sometimes problematic This is 3 especially true when the graft vessel is joined at right angles to the ascending aorta It would be desirable therefore to provide the anastomosis devices with a reliable means to create a gradual curve in the graft vessel leading away from the anastomosis site.

2 0 The combination strain relief and comoliance mismatch transition sleeve 667 is a lexible tubular member 668 which can be appended to the proximal end of the anastomosis device 669 to support the graft vessel 254 leading away from the anastomosis site. The flexible tubular membe 668 may have any or all of gradually decreasing stiffness, i* ncreasing compliance and increasing cdameter as it extends proximally from the anastomosis device 669. This will give the graft vessel 254 a gradual curve, a gradual change in its radial compliance, and a gradual chane in diameter from the c^ in diameter from the 3 constrained diameter within the anastc-osis device 669 to an unconstrained diameter some distance from the device 669 The strain relief sleeve 667 can be made in any one of several possible constructions, in-cdinc raidd wire cr monofilament, a wire or lastic coil, solid polmer tube or a composite construction, such as a wire coil embedded a Polymer wall. The strain relief sle 67 also be ma 0 :y also be made of a soft, scretchy, biocompatible occ er, such as polyuretnane, silicone, or Gorex (ex:z ded =T7E) 102 Fig. 52 shows a device 670 for isolating a orton of the target vessel lumen 256 to facilitate Performng an anastomosis using any of the devices and-techniques described herein. The isolation device 70 may be used as an e s e d S alternative to the side-biting clamp described above for use in the proximal anastomosis procedure during CABG surgery.

The side-biting clamp is used in CABG surgery to isolate a portion of the aortic wall so that the proximal anastomosis can be performed while the heart is still beating without excessive bleeding at the anastomosis site. Placing a side-biting clamp thoracoscopically during port-access

CABG

surgery may prove problematic. A perfusion endoaortic clamp catheter 670, as shown in Fig. 52, performs the same functions as the side-biting clamp with a percutaneouslv placed catheter. The catheter 670 has a first doughnut-shaned balloon 671 and a second doughnut-shaped balloon 672 which are interconnected by a large-bore perfusion tube 673. The balloons 671 672 and the perfusion tube 673 are mounted on the distal end of an elongated catheter shaft 674. The balloons :0 671, 672 and the perfusion tube 673 are preferably made of a semi-elastic polyurethane material so that it can be collaosed or percutaneous entry and so it will resume the appropriate Ss. shape when they are deployed. The catheter shaft 674 may have a single inflation lumen 675 which connects to both balloons 671, 672 or separate inflation iumens connected to each balloon If desired, the catheter 670 may also be provided with a flushing lumen which connects to a flushing port located on the exterior of the perfusion tube 673 between the balloons 671, 672 for flushing the anastomosis site 678 with clear saline to improve visibiiiv.

In operation, the balloons 671, 672 and the perrusion tube 673 are introduced percutaneously into a peripheral artery, such as the feoral artery and advance into the ascendinc aora 676, preferably under fluoroscooi c visualization. When the surgec: is prepared to make -he aortotomy incision zo start the proximal anascomosis procedure, the first and second balloons 671, 672 are InZated, isolating the oortionc o the otic .77 -i ic wa__ 577 103 between the two balloons 671, 572 from the blood flow n the aorta lod continues to flow through the large-bore perfusion tube 673, supplying the rest of the body wi blood With the aortic wal 677 isolaed, the aortotomy incision can be made at the anastomosis site 678 and the anastomosis completed by any of the methods described in the specification. After the anastomosis is complete, the balloons 671, 672 are deflated and the catheter is withdrawn from the aorta 676.

This catheter approach has certain advantages over the use of a side-biting clamp. First, it isolates a larger portion of the aortic wall so that the surgeon has more choice n the placement of the anastomotic sites. Second, because it solates a larger portion of the aortic wall it also allows multiple anastomoses to be made to the aorta without having to move the clamp. Third, it does not distort the wall of the aorta as the side-biting clamp does. This may allow more accurate placement of the anastomotic sites and more effective' S attachment of the anastomosis devices and therefore reduced leakage of the anastomoses.

A second, smaller scale version of a similar catheter device 679 is shown in Fig. 53 for isolating a Ssection of a coronary artery 682 while performing a distal anastomosis This evice would allow the section of the coronary artery 682 close to the anastomosis to be isolated :from the blood flow without blocking blood flow to vital myocardium downstream of the anastomosis site The availability of rapid and reliable aasomosis devices, such as those described herein, could open the door to performing CABG surgery on patients whose hearts re still beating, with no need at all for cardioplegic arrest The raoidity of the anastomosis procedure using these devices will minimize the interference from the wall motic. of the beating hear that makes hand sutured anastomoses problema-c owever two Other obstacles remain: 1) excessive b eedin at the anastomotic site when the coronarV artery s incised, and 2) temporary ischemia of the myocardial tissue downs-,eam of the anastomosis site The catheetr 79 in 53 solves bo-th these potential problems. The dista end o th catheter has a distal balloon 680 and a proximal balloon 681 separated by a few centimeters distance alon the catheter shaf 683. The balloons 680, 681 may be elastic balloons made cf latex, polyurethane or silicone, or they ay be inelastc balloons made of polyethylene, polyester or polyamide. The catheter shaft 683 may have a single inflation lumen 648 which connects to both balloons 680, 681 or separate inflation lumens connected to each balloon If desired, the catheter 679 may also be provided with a flushing lumen which connects to a flushing port located on the catheter shaft 683 between the balloons 680, 681 for flushing the anastomosis site 690 with clear saline to improve visibility. In addition, the catheter shaft 683 has a perfusion lumen 685 for blood flow through the catheter 679. The perfusion lumen 685 has one or more inflow ports 686 on the catheter shaft 683 proximal to both of the balloons 680, 681 and at least one outflow port 687 at the of the catheter 679, distal to both of the balloons 680, 681.

n operation, the catheter 679 is introduced into 0 the coronary artery 682 through a coronary guiding catheter 688 which is preferably introduced percutaneously from the femoral or brachial artery. The distal balloon 680 is advanced past the stenosis 689 in the artery 682, preferably under fluoroscopic visualization, and place distal to the red anastomosis site 690 desired anastomosis site 690. The proximal balloon 681 is placed proximal to the desired anastomosis site 690 at a point which may be proximal or distal to the stenosis 69. The inflow ports 686 of the perfusion lumen 685, however, should be locate proxima to the stenoss 689 The proximal 681 and distal 680 balloons are inflated to isolate the area between them from the blood flow throuh the coronary artery 682.

Blood conZinues to flow into th arter isl to he catheter 679 through the perfusion lumen a85. Te distal anastomosis Procedure can now be performed on the isolated section o the corary a rtery IWThen the anastomosis is complete, the alloons 5 3 0 681 are deflated and the catheter 67 -s withdrawn A third catheter device 691 is shown in Fig. 4.

This catheter device 691 is ccnigure to be delivered to he anastomosis site through the lumen 249 of the grat vessel 254 which has a number of potential advantages First the device 691 can be used without the need for a femoral or brachial artery puncture or a coronary guiding catheter to deliver the catheter 691 into the coronary arteries 682. Second, the catheter 691 can be deployed under direct or endoscopic visualization by the surgeon without the need for fluoroscopic 1 0 imaging. Third, the T-shaped configuration of the catheter 691 can help to facilitate approximation of the graft vessel 254 and the target vessel 255 during the anastomosis procedure The catheter 691 has a proximal catheter body 692 connected to a T-shaped distal portion 93 c The r d distal portion 693 has two distal ends 694, 695, each having n inflatable balloon 696, 697 at its distal extremity The balloons 696, 697 extre eity.. The balloons 696, 697 are each connected to one or more inflation lumens 698 that terminate in a luer fit tng at the proximal extremity of the proximal catheter body 692. A perfusion lumen 699 connects a separate luer fittg the proximal extremicv of t *ing at the proximal extremity of the proximal catheter body -92 to the extremities of both distal ends 694, 695 of the catheter 691, distal to the inflatable balloons 696, 697.

In operation, the T-shaped dis-l end 93 of the S catheter is passed through the lumen 24- of the graft vessel 254 with the balloons 696, 697 deflated. An incision 700 is made in the wall of the corona-y artery -32 or other vessel at the desired anascomosis site and both dis al ends 694, 695 of catheter 691 are introduced inzo the cornarv artery 682 through the incision 700. One dis e 695 of the catheter 691 is directed upstream of the -aastomcsis site and the other distal end 694 is directed downs:ream o- :he anastomosis site.

Both of the balloons 696, 697 are inflate to isolate the portion of the coronary artery 62 betwe the balloons 696, 697 from the blood lo o ow in the arer o odes of o erfusion are possible with the ca:heter s of the scal o upstream end 695 S t ista or o 63 o t receives enouc- 106 blood flow, the blood will pass throuah the perfusion lume 699 from the upstream side 695 to the downstream side 694 o perfuse the coronary artery 682 distal to the anastomosis site 700. If the blood flow is insufficient because of a severe stenosis or total occlusion upstream of the anastomosis site 700, blood and/or cardioplegic fluid can be injected into the catheter 691 through the luer fitting connected to the perfusion lumen 699 at the proximal end of the catheter 691.

With the anastomosis site 700 isolated from the blood flow, the graft vessel 254 can be approximated to the target vessel with the T-shaped catheter body 693 providing a guide for the approximation. The anastomosis can be performed in a blood-free environment using any one of the devices and methods described above. When the anastomosis is complete, the balloons 696, 697 can be deflated and the catheter S withdrawn through the lumen 249 of the graft vessel 254.

The catheter devices described above are not limited in their use to CABG surgery. Either of the catheter devices could easily be modified to be the appropriate size for use during other bypass operations such as aorto-femoral bypass or femoral-femoral bypass.

Port-Access CABG Procedure *nd m oA vascul a r anascomosis procedure usinc che devices and methods of the present invention will now be described in relation to performing a proximal anastomosis on a free graft during a closed-chest or port-access coronary artery bypass graft surgical procedure. Closed-chest or port-access coronary artery b-v ass graft (CABG) surcery is a newly developed procedure designed to reduce the morbidity of C.AG surgery as comoare- to th= standard oe-es CA rocedr saard open-cnest CABG procedure.

The morbidity is reduced in the port-access CABG procedure by gaining access to h e h e art and the coronry arteies throuc.

one or more access ports which are made -i the ntercostal S spaces of c he patit's chest therebv =iintina th neec for a median scer-noomv or other gross 'c acotomy as s -rulred i ooen-ces C surcery. orc-access coronary arCery b-opass craf- surical c-rcedure Sn- S ur 107 anastomosis techniques is more fully described in c-pendin patent applications, serial numbers 08/023,778 and 08/281,89, which have been inccrporated herein by reference.

To prepare the patient for the port-access CABG procedure, the patient is placed under general anesthesia and cardiopulmonary bypass (CPB) is established to support the patient's circulatory system during the surgical procedure.

Preferably, a femoral-to-femoral CPB system is used to reduce the invasive nature of the procedure. One or more access 0 ports 702 are made through the intercostal spaces 703 of the patient's chest by making an incision between the ribs 705 and placing a trocar with a cannula 704 through the wall of the chest. The trocar is then withdrawn, leaving the cannula 704 as an access port into the chest cavity. Typically, an endoscope, preferably a thoracoscopic surgical microsco is placed through one of the access ports to allow direct visualization of the heart, the ascending aorta and the coronary arteries.

SMeanwhile a graft vessel is prepared for creating the bypass graft which will redirect blcod flow from the ascending aorta to one or more of the cronary arteries downstream of any blockage caused by at oscleroic disease.

Vessels which can be used as tree grafts in C :AB surgery S include veins, such as the saphenous vein, arteres, such as one oF the internal mammary arteries or :he gastro-epiloic artery, and artificial grafts, such as Dacron or Goretex (expanded PTFE) grafts. If an autologous graft, such as a vein or an artery, is to be used, the vessel is generally S harvested from the patient at this time.

Depending on the preference of he surge, the proximal anastomosis, which joins the grart vessel to the aorta, can be performed before or after :ne distal anascomosis, which joins the graf: vessel t one more of the coronary arteries. The distal anastmosi 5 s generally performed while the patient's ea is sto i s ped, era l he proximal anastomosis may be perf- med wi:h the heat s toped or while the heart is still bea:-i., acccrdina to he references of the surgeon. TO soo the s-ec a soecial 108 endo-aortic clamning catheter, which is described n aforementioe patent aoprlica-zons, s inserted into the ascending aorta via a percutaneous entrv or a surgicai cudw i~to the femoral artery. An- endo-aor:,ic clamping balloon on- S the distal end of the catheter iJs inflated in the patientis ascending aorta to block blood flow in the patient's aorta downstream of the coronary arteries. Cardiopjlegic solution- is immediately infused into the patient's coronary arteries tilrough a lumen in the catheter to temporarily stop the Patient's heart from beating. Alternatively, the proximal anastomosis can be performed while the heart is still beating by using a side-biting clamp or other device to isolate a portion of the aortic wall from the aortic blood cir culation.

Wiha portion of the aortic wall isolated from the systemic c.Irculation by either of these methods, the proximal anastomosis can -be performed using any of the devices an~d mrethods previously described herein.

The rapidity and reliability of pefomnth -anastomoses using the devices and methods of the present O 'uvention may, in some instances, allow the entire coronary a-rterv bypass procedure, including the Droximladisa 0.a-nastomoses to be performed without the need for cardio~pulmonary by-pass support or cardio-Igcaretoth neart. This would be of even great-er benefit to0 he Pat_-ie urther decreasing the morbi,:v from the_ procedure and reducing the likelihood of side effects associated with CPS and cardiopl egia. It would also be beneficial to the surgeon and the hospital by rediucing the cost and complexitv of the C-AB-G mrocedure.

By way o: example, the proximal anastomosis przocedure will now., oe described -u-s.g the zwo-part_ anastomosis sizapi e device 100 of Fig. i. A I incision 151 is made In teascending aorta 707 at the =nsomosis site 70G under _ztdsccnic visualization. Thenl Vesgzi_ Punch mechanism -20 and the staop!.i mechanism the anchor mrember 101 of" the anastomosis st-aple, whic. ore--lou sly been- ooep--* as shown in Fig 2, are inrdc~ :qcua- one of': 4 2 -=rosza1 access PDorts 702 an z lne a: the2 anaso--os- 109 site, as in Fig. 55. The anchor member 101 is attached to the ascending aorta 707 at the anastomosis site 706 according to the procedure in Figs. 5A-5D, as follows. The anvil 136 of the vessel punch 120 is inserted though the incision 151 in the aortic wall 707, and the anchor member i01 is advanced distally so that the attachment legs 105 penetrate the aortic wall 707. Then, staple driver 127 is advanced to deform the attachment legs 105 and fasten the anchor member o01 to the exterior wall of the aorta 707. An opening 152 is then 0 punched in the aortic wall '707 with the vessel punch 120 and the punch 120 is removed along with the tissue 153 excised by the punch The e 1 5 3 ecsed by ch The graft insertion tool 121 and the graft vessel 148, which has previously been prepared with the coupling member 102 as shown in Fig. 6 by evering the distal end o the graft vessel 148 over the coupling member 102, are then inserted though.the access port 702, as shown in Fig 5, and the craft vessel 148 is attached to the ascending aorta 707 at the anastomosis site 706 by inserting the coupling member 102 S intothe anchor member 01 as shown in Figs. The bypass operation is then completed by S anastomosing the distal end 708 of the graft vessel to the coronary artery 709 below the stenosis or occlusion, as shown in Fig. 57. The distal anastomosis can be performed usino suturing technicues or the graft vesse 8 can b e in anbe joined t the coronary artery 709 usin a secon anasomos stale following the steps shown in Fics. 5A-C and Fig. 7C, usin the embodiment of the graft insertion ool 122 illustrated in Figs. 7A-7C.

Alternatively, the proximal and distal anastomoses can be Performed in the reverse order, as is preferred by some cardiac surgeons. :n this case he adi-s:,a astomosis would be performed first, using the graft insertion too si21 ou Fgs 6A-6Cr r t1 121 of Figs. A-6C, followed by the proximal anastomosis performed using the. graft insertion tool 122 of -igs t 7A-7C. When 3 erforming the proximal anasomosis as -he second anastomosis on a free graft, both ends of th raf v an be ara vess-I can be preparec for anastomosis by a:cning a colin member 102 to the proximal and the discal end cf t:e graf: vesseI a and 110 inserting the graft vessel into he chest cavity patient through one of the access ports 702 at v er attac h anchor members 101 to both the aorta 707 and th e coronary artery 709. Each of the coupling 7 membes 102 can then be inserted into its respective anchor member 101 Using the appropriate insertion tool 121, 122. An alternat technique is to first attach the distal end of the graft essel 148 to a coronary artery 709 using an anastomosis staple or sutures, according to the preference of the surgeon, then, after verifying the correct length of the graft vesse drawing the proximal end 710 of the graft sevessel d r a 148 ut i n the chest cavity through one of the access ports 702. The free roxima end 710 of the graft vessel 148 can be r e e p r o x i mr a l vision by the sure b ahbe repared under direct S vision by the surgeon by passing the free end of the graft 5 vessel through the lumen of the coupling member 102 and S everting it over the distal end 115 of the coupling member 102. The coupling member 102 with the proximal end 710 of the graft vessel attached can be reinserted into the chest cavity through the access port 702 an into t h e c h e s c y the702 and inserted into an anchor member 2 0 101 attached to the aortic wall 707 using the graft insertion tool 122 of Figs. 7A-7C This g r a iertion tool 122f Figs. 7A-7C. This same techniue can be used with the two-piece anastomosis staple for p nin b e u s e d ait anastomosis on a pedicled graft vessel or for performing distal anastomosis on a -ree raft T p ex rm xi g anastomosis has already been ma er de The operation of the one-iec asom stles r Figs. 9, 10 11 o 1 ec nastomosis staples of Figs. 59, 0, 11 or 12 can also be unerstood in relation to Figs. 55-57. The graft vessel 148 and O ne-piece anastomosis staple 163 are prepared as described above in r0 relation to Figs. 13 and 1. small sion 15 is mae in the ascending aorta 707 with a shar blade a 1 5 int s de n enaZDhe inended anastomosis site 706, which has been isate ro thded circulation with a side-bitinc am or he sol the device. An elongated punch, which may be simila the S vessel punch 120 described in relation t s 2 and D above, is inserced th ouh on f t e s 2 and neough one the crO s 702 in patien:-s chest .A ce n2 s pace the wall in o he eIs -w -n ascending aorza 707 =v c c e w al o f ^h -s.unch,^ 111 through the incision, then pressing :he actuating plunger to advance the tubular cutter over the anvil. The staple applying tool of Fig. 13 with the graft vessel 148 everted over the distal tubular extension 16 of the anastomosis S staple 163, as shown in Fig. 14, is ntroduced through an access port 702 and positioned near the punched hole 152 in the ascending aorta 707 as illustrated in Fig. 55. The flanged end 167 of the distal tubular extension 166 is passed through the hole 152 so that it is in the position shown in Fig. 10. The wall of the ascending aorta 707 stretches Slightly to allow the flange 167 to pass through the hole 152.

The staple applying tool 179 is pulled back slightly to make ure the flange 167 of the staple 163 engages the interior wall of the aorta 707, then the lever 185 of the staple applying tool 179 is pulled to deform the attachment legs 168 of the staple 163 and drive them thrcugh the aortic wall 707, as shown in Fig. 10. The lever 185 is released and the staple applying tool 179 is rotated to dise age t he staple retainer 188 from the tabs 170 on the proximal tubular extension 169 of the staple 163. The staple applying ool 179 is withdrawn and he anastomosis is complete.

As with the two-piece embodment of the anastomosis staple, the one-piece anastomosis stale of Fig. 9 can also be used for creating the proximal and/or distal anastomoses on a graft vessel in either order, accord-- to the preference of the surgeon. When performin second anastomosis on a fee graft or the distal anastomosis on a cedicled graft, the free end of the graft vessel can be drawn :ct of the chest cavity through one of the access ports to pre are the end of the graft vessel under direct visic-n by t surgeon. The raft vessel is prepared by passing fe d of the rat vess through the lumen of the anastoc-sis s:aple and everting it over the distal flange. The anastomosis staple with the free end of the graft vessel attache- can reinsered into the chest cav-can c reinserced into the 3 chest cavity through the access ort a: attached to the wall of the target vessel, which -ma be th=e scending aorta or one of the coronary arteries.

Althou:n the forego -I desCription focuses or, use of the anastomosis system clcs -chest CAuG surg ery the system is equally aPplicable to -er situations that require vessel anastomosis, inludin, but not limited to S renal artery bypass grafting, acorto-femoral bypass, femoral-femoral bypass and arterio-veus shuntina such as is commonly used for dialysis. Surgical anastomoses are also performed for various reasons on many different tubular oraans of te bdy oherchanb~s on c 07 different tubular orans of the body other than blood vessels, including the bowel, intestines, stomach and esophacgs Wnile the devices and methods of the present invention are tended primarily for vascular anastomoses, some or all o Lce embodiments could als bemdiid e embodiments could also be modified for performing end-tc-side anastomoses on oher tubular organs. Any one of the one or two-piece embodiments of the anastomosis sca le -vice can be suplied preattached to a prosthetic grvaf vesse For instance, the two-piece anastomosis staple device co=d be supplied in a kit, including a natural or artificia =raft that is prenared with a coupling member attached to one or both ends and one or 0 two anchor members for attachmen rto t- target vessel(s) Likewise, the one-piece anastomosis s- device can be S supplied in a procedural kit prea tac t prosthetic grat vessel This is equally applicable tec artificial graft materials, such PTFE or Dacron as, t to natural biological graft maerials, Inc--ding allografts of human graft vessels, or xenografts such as b-.--ine or porcine gra vessels, either freshly harvest glu: -raldehyd treated or cryogenically preserved An anaztomot-: device aoclicateon instrument, such as those descr d cl also s ec could also be supplied in the procedural kit h on f the anasomotic devices alre-ady atached to he aisal nd of the instrument ;hile che above is a cmple t sescriptin of the prererre ear cIto or the re red embodimencs of the invntJon .arious alternatives, modifications and ecuivalents be uCa u Thereaore, the above descritio n should not be -a .s Ther re, t the en limiting the scoe of the inventon wich iS defined t he a-zended claims.

Claims (29)

1. An anastomosis device for connection to a wall of a target vessel in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis device comprising: a graft vessel having a free end, a conduit portion adjacent said free end, and a graft vessel lumen extending therethrough; an anchor member, said anchor member having a body with a central opening and a plurality of attachment legs extending from said body adjacent said central opening configured to penetrate said wall of said target vessel for attaching said anchor member to said wall of said target vessel, a coupling member, said coupling member having a tubular body with an internal lumen of sufficient size to accommodate an external diameter of the conduit portion of the graft vessel, a proximal end, and a distal end configured to allow eversion of said free end of said graft vessel thereover to attach said free end of said graft vessel to said coupling member, and a coupling mechanism operative on the coupling member and the anchor member for attaching said coupling member to said anchor member such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said graft vessel lumen is in fluid communication with 20 said lumen of said target vessel through said opening in said wall of said target vessel; *wherein each of said plurality of attachment legs is deformable from an initial configuration to a deployed configuration, wherein, in said deployed configuration, said plurality of attachment legs is configured to compress said wall of said target vessel inwardly toward said body of said anchor member and wherein said coupling member is atraumatic to at least said conduit portion of said graft vessel between said proximal and distal ends of said coupling member.

2. An anastomosis staple device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis staple device comprising: an anchor member, said anchor member having a central opening and a plurality of attachment legs adjacent said central opening configured to penetrate said wall of said target vessel for attaching said anchor member to said wall of said target vessel, 114 a coupling member, said coupling member having a tubular body with an internal lumen of sufficient size to accommodate an external diameter of the graft vessel and a distal end configured to allow eversion of said free end of said graft vessel thereover to attach said free end of said graft vessel to said coupling member, and a coupling mechanism operative on the coupling member and the anchor member for attaching said coupling member to said anchor member such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel: wherein each of said plurality of attachment legs is deformable from an initial configuration to a deployed configuration, the initial configuration comprising a first segment extending generally laterally away from said central opening, a transition segment connecting said first segment to a distal segment extending generally axially with respect to said anchor member, and a distal end configured to penetrate said wall of said target vessel.

3. The anastomosis staple device of claim 2 wherein said attachment legs are configured to attach said anchor member to an exterior surface of said 20 wall of said target vessel at a position external to said lumen of said target vessel.

4. The anastomosis staple device of claim 2 wherein in said deployed configuration, each of said plurality of attachment legs penetrates said wall of said target vessel with said distal segment contacting an interior surface of said wall of said target vessel. The anastomosis staple device of claim 2 wherein in said deployed configuration, said distal segment of each of said plurality of attachment legs is approximately parallel to said first segment.

6. The anastomosis staple device of claim 2 wherein said anchor member comprises a ring-shaped body configured to receive said coupling member within a central opening within said ring-shaped body.

7. The anastomosis staple device of claim 2 wherein said coupling member is initially separable from said anchor member and said coupling mechanism is configured to allow said coupling member to be connected to said anchor member after said anchor member has been attached to said wall Sof said target vessel.

8. The anastomosis staple device of claim 2, wherein said coupling member is configured to extend into said opening in said wall of said target vessel and to hold the everted end of said graft vessel within said opening in contact with an interior surface within said opening when said coupling member is connected to said anchor member.

9. The anastomosis staple device of claim 2 wherein the anchor member has a body with a central opening and wherein the plurality of attachment legs extend from said body adjacent said central opening and wherein, in said deployed configuration, said plurality of attachment legs is configured to compress said wall of said target vessel inwardly toward said body of said anchor member. The anastomosis staple device of claim 9 wherein, in said deployed configuration, said plurality of attachment legs is configured to axially compress said target vessel.

11. An anastomosis staple device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis staple device comprising: an anchor member, said anchor member having a plurality of attachment 20 legs configured to penetrate said wall of said target vessel for attaching said anchor member to said wall of said target vessel, a coupling member, said coupling member having a tubular body with an internal lumen of sufficient size to accommodate an external diameter of the graft vessel, a proximal end, and a distal end configured to allow eversion of said free end of said graft vessel thereover to attach said free end of said graft vessel to said coupling member, and I:ii a coupling mechanism operative on the coupling member and the anchor member for attaching said coupling member to said anchor member such that the said end of said graft vessel is sealingly connected to said wall of said target 30 vessel and said lumen of said graft vessel is in a fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel, wherein said coupling member is configured to hold the everted end of said graft vessel in contact with an exterior surface of said wall of said target vessel when said coupling member is connected to said anchor member.

12. The anastomosis staple device of claim 11 wherein said anchor member comprises a ring-shaped body configured to receive said coupling member within a central opening within said ring-shaped body.

13. The anastomosis staple device of claim 12 wherein the plurality of attachment legs extend from said ring-shaped body, said plurality of attachment legs being configured to penetrate said wall of said target vessel, and to attach said ring-shaped body to an exterior surface of said wall of said target vessel at a position external to said lumen of said target vessel.

14. The anastomosis staple device of any one of claims 11 to 13 wherein the coupling member is initially separable from said anchor member and said coupling mechanism is configured to allow said coupling member to be connected to said anchor member after said anchor member has been attached to said wall of said target vessel. The anastomosis staple device of claim 14, wherein said coupling mechanism comprises at least one retaining clip connected to said ring-shaped body of said anchor member, said retaining clip being configured to engage said proximal end of said tubular body of said coupling member.

16. The anastomosis staple device of claim 11 wherein the anchor member comprises a tubular extension configured to receive said coupling member 20 within a central opening within said tubular extension.

17. The anastomosis staple device of claim 16 wherein a flange extends from a distal end of said tubular extension and wherein said plurality of attachment legs are connected to said flange, the plurality of attachment legs being configured to penetrate said wall of said target vessel and to attach said flange S 25 and said tubular extension to an exterior surface of said wall of said target vessel.

18. The anastomosis staple device of claim 12 wherein said coupling I:ii mechanism comprises an hourglass-shaped internal contour within said central opening of said anchor member and a corresponding hourglass-shaped external contour on said tubular body of said coupling member, whereby said coupling 30 member is coupled to said anchor member by insertion of the hourglass-shaped external contour of said tubular body into the hourglass-shaped internal contour within said central opening of said anchor member.

19. The anastomosis staple device of claim 1 further comprising a graft vessel attached to said coupling member, said graft vessel being selected from the group consisting of allografts, xenografts and artificial grafts. 117 A method of performing an anastomosis to connect a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the method comprising: attaching an anchor member to an exterior surface of said target vessel; creating an opening in said wall of said target vessel; attaching a coupling member to said free end of said graft vessel; and connecting said coupling member to said anchor member so as to hold said coupling member proximate said wall of said target vessel such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

21. The method of claim 20 wherein said anchor member is attached to said exterior surface of said target vessel by penetrating said wall of said target vessel with a plurality of attachment legs connected to said anchor member.

22. The method of claim 20 wherein said anchor member is attached to said exterior surface of said target vessel by penetrating said wall of said target vessel with a plurality of attachment legs connected to said anchor member, and subsequently deforming said attachment legs to affix said anchor member to said exterior surface of said target vessel.

23. The method of claim 20, wherein said coupling member is attached to said free end of said graft vessel with an attachment that is a traumatic to said graft vessel. S 25 24. The method of claim 20 wherein the step of attaching said coupling member to said free end of said graft vessel includes the substeps of passing said free end of said graft vessel through an internal lumen of said coupling member and everting said end of said graft vessel over a distal surface of said coupling member.

25. The method of claim 24 further comprising the step of axially compressing the everted end of said graft vessel against said wall of said target vessel to create an anastomotic seal.

26. The method of claim 20 wherein said anchor member has a ring- shaped body having an orifice therethrough and the step of connecting said coupling member to said anchor member comprises the substep of inserting S said coupling member into said orifice in said anchor member.

27. The method of claim 20 wherein said anchor member has a tubular extension connected thereto and the step of connecting said coupling member to said anchor member comprises the substep of inserting said coupling member into said tubular extension connected to said anchor member.

28. The method of claim 20 wherein said anchor member is attached to said exterior surface of said target vessel prior to creating said opening in said wall of said target vessel, and wherein said opening in said wall of said target vessel is created by inserting a vessel punch through an orifice within said anchor member and cutting an opening in said wall of said target vessel in alignment with said orifice within said anchor member.

29. The method of claim 20 wherein the step of attaching an anchor member to an exterior surface of a target vessel comprises attaching said anchor member to an exterior surface of an aorta of a patient.

30. The method of claim 20 wherein the step of attaching a coupling member to a free end of a graft vessel comprises attaching said coupling member to a free end of a coronary artery bypass graft.

31. The method of claim 20 further comprising the steps of creating at least one access port into a chest cavity of a patient through 20 an intercostal space of the patient without cutting or substantially displacing any ribs or sternum of said patient; *inserting said anchor member into said chest cavity through said access port; and inserting said coupling member into said chest cavity through said S 25 access port.

32. The method of claim 31 further comprising the step of: imaging said target vessel with an endoscopic imaging instrument inserted through an access port into said chest cavity of said patient through an intercostal space of the patient. 30 33. The method of claim 31 wherein the step of attaching a coupling *member to said free end of said graft vessel includes the substeps of passing said free end of a said graft vessel out of the chest of the patient through said at least one access port, attaching said coupling member to said free end of said graft vessel outside of the chest of the patient, and reinserting the free end of said graft vessel with the coupling member attached into the chest of the patient through said at least one access port. 119

34. The method of claim 24 wherein the step of connecting said coupling member to said anchor member includes the substep of approximating the everted end of said graft vessel to said exterior surface of said target vessel. The method of claim 24 wherein the step of connecting said coupling member to said anchor member includes the substep of inserting said coupling member with said graft vessel attached into said opening in said wall of said target vessel thereby approximating the everted end of said graft vessel to an interior surface of said target vessel.

36. The method of claim 35 further comprising the step of radially compressing said wall of said target vessel around said coupling member to create an anastomotic seal between the everted end of said graft vessel and said wall of said target vessel. Dated this twenty seventh day of June 2002 Heartport Inc Patent Attorneys for the Applicant: F B RICE CO i o