Devices and methods for performing a vascular anastomosis
First Claim
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, anda 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 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.
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Accused Products
Abstract
A system for performing an end-to-side vascular anastomosis, including an anastomosis device, an application instrument and methods for performing a vascular anastomosis. The system is applicable for performing an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly in port-access CABG surgery. A first aspect of the invention includes a vascular anastomosis staple. A first configuration has two parts: an anchor member, forming the attachment with the target vessel wall and a coupling member, forming the attachment with the bypass graft vessel. The anastomosis is completed by inserting the coupling member, with the graft vessel attached, into the anchor member. A second configuration combines the functions of the anchor member and the coupling member into a one-piece anastomosis staple. A second aspect of the invention includes an anastomotic fitting, having an inner flange over which the graft vessel is everted and an outer flange which contacts the exterior surface of the target vessel. A tailored amount of compression applied by the inner and outer flanges grips the target vessel wall and creates a leak-proof seal between the graft vessel and the target vessel. A third aspect of the invention has a flange to which the graft vessel attaches, by everting the graft vessel over the flange, and a plurality of staple-like members which attach the flange and the everted end of the graft vessel to the wall of the target vessel to form the anastomosis.
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Citations
56 Claims
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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:
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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 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.
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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:
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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, 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. - View Dependent Claims (3, 4, 5, 6, 7, 8)
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9. 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:
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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 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, 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.
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10. 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:
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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, 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, and wherein, in said deployed configuration, said plurality of attachment legs is configured to axially compress said graft vessel against said wall of said target vessel.
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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 though an opening in the wall of the target vessel, the anastomosis staple device comprising:
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an anchor member, said anchor member having a plurality of attachment 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 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 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.
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12. 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:
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an anchor member, said anchor member having a plurality of attachment 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 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; said anchor member comprises a ring-shaped body configured to receive said coupling member within a central opening within said ring-shaped body, said plurality of attachment legs extending 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, and wherein said coupling member is initially separable from said anchor member and said coupling means 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. - View Dependent Claims (13)
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14. 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:
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an anchor member, said anchor member having a plurality of attachment 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 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; said anchor member comprises a tubular extension configured to receive said coupling member within a central opening within said tubular extension, a flange extending from a distal end of said tubular extension, said plurality of attachment legs being connected to said flange, said plurality of attachment legs being configured to penetrate said wall of said target vessel, and to attach said flange and said tubular extension to an exterior surface of said wall of said target vessel at a position external to said lumen of said target vessel, and wherein said coupling member is initially separable from said anchor member and said coupling means 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.
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15. 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:
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an anchor member, said anchor member having a plurality of attachment 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 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 said anchor member has a central opening for receiving the coupling member, and said coupling 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 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.
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16. An anastomosis staple device for connecting 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 staple device comprising:
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a graft vessel selected from the group consisting of allografts, xenografts and artificial grafts, said graft vessel having a free end and a graft vessel lumen therethrough; an anchor member, said anchor member having a plurality of attachment 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 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 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, 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.
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17. 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:
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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, wherein said plurality of attachment legs is configured to compress said wall of said target vessel toward said tubular member. - View Dependent Claims (18, 19, 20)
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21. 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:
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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, 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; and a flange connected to a distal end of said tubular member, said flange being configured to attach said free end of said graft vessel to said coupling member by everting said free end of said graft vessel over said flange, wherein said tubular member is configured to extend into said opening in said wall of said target vessel and said flange is configured to hold the everted end of said graft vessel in contact with an interior surface of said wall of said target vessel, wherein said plurality of attachment legs is configured to compress said wall of said target vessel radially toward said tubular member.
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22. 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:
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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, 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; and a flange connected to a distal end of said tubular member, said flange being configured to attach said free end of said graft vessel to said coupling member by everting said free end of said graft vessel over said flange, wherein said tubular member is configured to extend into said opening in said wall of said target vessel and said flange is configured to hold the everted end of said graft vessel in contact with an interior surface of said wall of said target vessel, wherein said plurality of attachment legs is configured to axially compress said graft vessel against said wall of said target vessel.
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23. 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:
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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, wherein each of said plurality of attachment legs has a first segment which is attached to said tubular member at an attachment point, and a second segment connected to said first segment, said second segment describing an arc having a radius of curvature with a center of rotation proximate said attachment point, said second segment having a tip configured to penetrate said wall of said target vessel, whereby as the first segment is rotated about said attachment point, said tip of said second segment penetrates said wall of said target vessel and said second segment traverses said wall in an arcuate path.
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24. 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:
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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, wherein each of said plurality of attachment legs has a first segment which is attached to said tubular member at an attachment point, and a second segment which describes an arc having a radius of curvature with a center of rotation proximate said attachment point, and a transition segment connecting said first segment to said second segment, said transition segment describing an arc having a radius of curvature less than the radius of curvature of said second segment, said second segment having a tip configured to penetrate said wall of said target vessel, whereby as the first segment is rotated about said attachment point, said tip of said second segment penetrates said wall of said target vessel and said second segment traverses said wall in an arcuate path, and subsequently said transition segment traverses said wall of said target vessel compressing said wall of said target vessel radially toward said tubular member.
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25. 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:
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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, wherein each of said plurality of attachment legs has a first segment which is attached to said tubular member at an attachment point, said attachment point defining a primary center of rotation, and a second segment connected to said first segment, said second segment describing an arc having a radius of curvature with a center of rotation proximate said attachment point, said first segment having a bending point defining a secondary center of rotation on said first segment intermediate said tubular member and said second segment, said second segment having a tip configured to penetrate said wall of said target vessel, whereby as the first segment is rotated about said primary center of rotation, said tip of said second segment penetrates said wall of said target vessel and said second segment traverses said wall in an arcuate path, and subsequently said first segment bends about said secondary center of rotation, thereby compressing said wall of said target vessel radially toward said tubular member. - View Dependent Claims (26)
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27. 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:
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a graft vessel selected from the group consisting of allografts, xenografts and artificial grafts, said graft vessel having a free end and a graft vessel lumen therethrough; a tubular member having an internal lumen of sufficient size to accommodate an external diameter of said graft vessel, said tubular member being attached to said free end of said graft vessel, 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, wherein said plurality of attachment legs is configured to compress said wall of said target vessel toward said tubular member.
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28. 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:
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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, 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. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. 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:
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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, 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.
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44. 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:
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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, further comprising the step of compressing said wall of said target vessel radially toward said distal end of said anastomosis staple within said opening in said wall of said target vessel. - View Dependent Claims (45, 46, 47, 48, 49, 50, 51, 52)
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53. 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:
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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, wherein the step of penetrating said wall of said target vessel with a plurality of attachment legs comprises applying a force in a distal direction to said plurality of attachment legs to deform said plurality of attachment legs such that a distal portion of said plurality of attachment legs penetrates said wall of said target vessel. - View Dependent Claims (54, 55, 56)
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Specification