Method and apparatus for performing end-to-end and end-to-side anastomosis with eversion of tissue edges

• US 20040002721A1
• Filed: 02/25/2003
• Published: 01/01/2004
• Est. Priority Date: 09/01/1999
• Status: Abandoned Application

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Willis, Geoffrey H., McFann, Timothy B., Spence, Paul A., Podmore, Jonathan L., McCoy, Timothy J., Callas, Peter, Wei, Michael Francis
• Application Number:
  US10/374,350
• Publication Number:
  US 20040002721A1
• Time in Patent Office: Days
• US Class Current: 606/155
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

An element for use in anastomosis and a method and apparatus for installing the element (having tines that extend from a central portion) at the open end of a blood vessel (or other tubular body structure). To install an embodiment of the element; a carriage holds the element and shields the tines, the vessel'"'"'s open end is passed through the shielded element and fitted over an anvil, the tines are exposed, and the carriage is actuated to fire the element against the anvil so that the tines pierce the vessel and curl against the anvil (everting the tissue around the vessel'"'"'s open end). The anvil preferably forms the vessel end portion into a hooded shape suitable for creating an anastomotic junction. Or, the element is installed by inserting an intraluminal anvil through an incision in the vessel'"'"'s upper wall, advancing an extracorporeal anvil against the vessel'"'"'s lower wall (pinching the vessel closed at a location between the incision and the vessel'"'"'s open end), and firing the element against the anvils so that tines at the incision'"'"'s heel pierce the upper wall, tines at the incision'"'"'s toe pierce both upper and lower wall, and all tines curl against the anvils. Preferably, the element is formed from sheet metal with the tines extending out from the central portion'"'"'s inner edge and the tines are then bent relative to the central portion. Alternatively, the element is installed by sliding it onto (and inserting an anvil in) the vessel and folding it to cause the tines to pierce the vessel and curl against the anvil, or the element is C-shaped and is installed by sliding it onto the vessel, squeezing it to make it O-shaped, and firing it against an anvil that has been inserted in the vessel.

Claims

1. An anastomosis element, comprising:

a central portion that extends at least partially around a central orifice, the central portion having an inner edge that faces the central orifice; and

deformable tines extending from the inner edge of the central portion.

2. The element of claim 1, wherein the element is integrally formed from metal.

3. The element of claim 1, wherein the central portion has a heel end and a toe end, the tines include a first set of tines at the heel end and a second set of tines at the toe end, and each of the tines in the second set is longer than each of the tines in the first set.

4. The element of claim 1, wherein the central portion is a ring portion that extends completely around the central orifice.

5. An anastomosis element, comprising:

a central portion extending at least partially around a central orifice and having a first end and a second end; and

deformable tines extending from the central portion,

wherein the central portion has a central hinge portion along which the central portion folds in response to torque, exerted on the central portion, tending to move the first end and the second end closer together.

6. The element of claim 5, wherein the central portion also has a side hinge portion between the central hinge portion and the first end, and a second side hinge portion between the central hinge portion and the second end.

7. The element of claim 6, wherein the side hinge portion and the second side hinge portion are configured so that when the central portion has been folded about the central hinge portion and the tines installed in the side wall of a tubular body structure, the central portion folds along the side hinge portion and the second side hinge in response to pinching together of a first part of the central portion between the central hinge portion and the side hinge portion and a second part of the central portion between the central hinge portion and the second side hinge portion.

8. The element of claim 5, wherein the element is integrally formed from metal.

9. An anastomosis element, comprising:

a C-shaped, deformable central portion; and

deformable tines extending from the central portion.

10. The element of claim 9, wherein the element is integrally formed from metal.

11. A method for installing an anastomosis element in a body structure having a tubular end portion defining an open end, wherein the element has a central portion and deformable tines extending from the central portion, said method including the steps of:

(a) removably mounting the element to a carriage assembly such that the tines are shielded from the body structure;

(b) passing the end portion of the body structure through the central portion and positioning the open end of the body structure against an anvil;

(c) exposing the tines to the end portion of the body structure and actuating the carriage assembly to drive the tines against the anvil, thereby causing the tines to pierce the body structure and curl radially outward from the central portion to evert tissue of the body structure around the open end.

12. The method of claim 11, wherein the body structure is a blood vessel having an intima, and step (c) leaves the element installed in the vessel with the tines everting said tissue so as to expose the intima around the open end.

13. The method of claim 12, wherein the anvil has a convex shaping surface, step (b) includes the step of positioning the body structure'"'"'s end portion over the shaping surface, and during step (c) the vessel'"'"'s end portion is formed into a hooded shape in response to force exerted thereon by the element and the anvil'"'"'s shaping surface.

14. The method of claim 11, wherein the anvil has a protruding guide portion and wherein step (b) includes the step of positioning the body structure so that the guide portion of the anvil extends inside the body structure'"'"'s end portion.

15. A method for installing an anastomosis element in a body structure having a tubular end portion defining an open end, wherein the element has a central portion and deformable tines extending from the central portion, said method including the steps of:

(a) inserting an anvil having a tine-curling surface into the open end of the body structure, so that tissue of the body structure'"'"'s end portion covers the tine-curling surface;

(b) after step (a), driving the element against the tissue covering the tine-curling surface, thereby causing the tines to pierce said tissue and engage the anvil, and causing the tines to curl radially outward from the central portion against the anvil thereby everting said tissue; and

(c) after step (b), retracting the anvil from the body structure so that the element remains installed at the open end of the body structure.

16. The method of claim 15, wherein the body structure is a blood vessel.

17. A method for installing an anastomosis element in a body structure using a composite anvil comprising an intraluminal anvil having a first tine-forming surface and an extracorporeal anvil having a second tine-forming surface, wherein the body structure has a tubular end portion surrounding a lumen and defining an open end, and the element has a central portion with a heel end and a toe end and deformable tines extending from the central portion including the heel end and the toe end, said method including the steps of:

(a) inserting the intraluminal anvil into the lumen through an incision in the end portion, wherein the incision is spaced from the open end;

(b) advancing the extracorporeal anvil into engagement with an outer surface of the end portion without entering the lumen, until the first tine-forming surface is aligned with the second tine-forming surface, thereby forming an aligned anvil pair which pinches the body structure closed at a location between the incision and the open end; and

(c) after step (b), orienting the element with the toe end facing the open end and the heel end facing away from the open end, and advancing the element toward the aligned anvil pairs until the tines at the heel end pierce a first side of the end portion of the body structure, the tines at the toe end pierce both the first side of the end portion and a second side of the end portion opposite to the first side, and all the tines curl radially outward in response to being forced against the first tine-forming surface and the second tine-forming surface.

18. The method of claim 17, also including the step of:

(d) after step (c), removing the intraluminal anvil from the lumen through the incision, leaving the element installed in the body structure with the tines piercing and everting tissue of the body structure surrounding the incision, and sealing together the first side and the second side of the end portion at said location between the incision and the open end.

19. The method of claim 17, wherein the body structure is a blood vessel having an intima, and step (d) includes the step of leaving the element installed in the body structure with said tines everting said tissue so as to expose the intima around the incision.

20. A method for installing an anastomosis element in a body structure having a tubular portion surrounding a lumen and defining an open end, the element having a central portion with a first end and a second end and deformable tines extending from the central portion, said method including the steps of:

(a) inserting an anvil through the open end into the lumen;

(b) folding the central portion about a first axis between the first end and the second end, thus causing the tines to pierce the body structure and curl against the anvil;

(c) removing the anvil from the lumen through the open end; and

(d) after steps (b) and (c), folding the central portion along a second axis and a third axis by pinching together a first part of the central portion between the first axis and the second axis and a second part of the central portion between the first axis and the third axis.

21. The method of claim 20, also including the step of:

(e) cutting off an end portion of the tubular portion to expose a surface of the body structure as a new open end of the tubular portion, leaving the element installed in the body structure with the tines piercing and everting tissue of the body structure around the new open end.

22. The method of claim 20, wherein the body structure is a blood vessel having an intima, and step (e) includes the step of leaving the element installed in the body structure with said tines everting said tissue so as to expose the intima around the new open end.

23. A method for installing an anastomosis element in a body structure having a tubular portion surrounding a lumen and defining an open end, the element having a C-shaped, deformable central portion and deformable tines extending from the central portion, the central portion having a first open end and a second open end, said method including the steps of:

(a) sliding the element onto the tubular portion of the body structure;

(b) squeezing together the first open end of the element and the second open end of the element, to change the C-shaped, deformable central portion to an O-shaped central portion;

(c) inserting an anvil into the lumen through the open end of the body structure, thereby flaring the tubular portion of the body structure;

(d) after steps (b) and (c), advancing the element toward the open end to cause the tines to pierce the tubular portion of the body structure and curl against the anvil, so that the tines evert tissue of the body structure at the open end as a result of curling against the anvil.

24. The method of claim 23, wherein the body structure is a blood vessel having an intima, and also including the step of:

(e) after step (d), removing the anvil from the lumen through the open end, leaving the element installed in the blood vessel with the tines everting said tissue at the open end so as to expose the intima around the open end.

25. An apparatus for installing an anastomosis in a body structure having a tubular end portion defining an open end, wherein the element has a central portion and deformable tines extending from the central portion, said apparatus comprising:

an anvil assembly; and

a carriage assembly translatably mounted to the anvil assembly for translation toward the anvil assembly, wherein the carriage assembly is configured to support the element and to drive the element toward the anvil assembly when the carriage assembly is translated toward the anvil assembly, the carriage assembly defines an opening that is sized and shaped for guiding the tubular end portion of the body structure through the central portion into engagement with the anvil assembly, the carriage assembly includes a tine shield assembly having a first state and a second state, the tine shield assembly in the first state shields the tines of the element when said element is supported by the carriage assembly, and the tine shield assembly in the second state exposes the tines of the element when said element is supported by the carriage assembly.

26. The apparatus of claim 25, wherein the anvil assembly includes:

an anvil having a convex, body structure-shaping surface shaped to form the tubular end portion of the body structure into a hooded shape in response to actuation of the carriage assembly to drive the element against the tubular end portion and the anvil to press the tubular end portion against the body structure-shaping surface, when the tubular end portion has been inserted through the central portion and positioned in engagement with the anvil.

27. The apparatus of claim 26, wherein the anvil also has a concave, tine-curling surface around the body structure-shaping surface.

28. The apparatus of claim 27, wherein the anvil defines a channel, and at least one of the tine-curling surface and the body structure-shaping surface defines suction holes in fluid communication with the channel.

29. The apparatus of claim 27, wherein the base defines an anvil-mounting opening, and the anvil includes:

a central part defining the body structure-shaping surface and a radially inner portion of the tine-curling surface; and

an outer part defining a radially outer portion of the tine-curling surface and a mounting surface, wherein the outer part abuts a first side of the base and the central part extends through the anvil-mounting opening from a second side of the base into engagement with the mounting surface of the outer part.

30. The apparatus of claim 29, wherein the mounting surface of the outer part defines linear features, the central part has a side wall defining additional linear features, and the additional linear features are shaped to lock with the linear features of the outer part'"'"'s mounting surface.

31. The apparatus of claim 25, wherein the anvil assembly includes a base and an anvil, the base defines an anvil-mounting opening, and the anvil has a concave, tine-curling surface, said anvil comprising:

a central part defining a radially inner portion of the tine-curling surface; and

an outer part defining a radially outer portion of the tine-curling surface and a mounting surface, wherein the outer part abuts a first side of the base and the central part extends through the anvil-mounting opening from a second side of the base into engagement with the mounting surface of the outer part.

32. The apparatus of claim 31, wherein the anvil mounting surface of the outer part defines linear features, the central part has a side wall defining additional linear features, and the additional linear features are shaped to lock with the linear features of the outer part'"'"'s mounting surface.

33. The apparatus of claim 25, wherein the carriage assembly defines anvil receiving openings, and the anvil assembly includes:

a base;

carriage guide members extending from the base and configured to extend through the anvil receiving openings;

an anvil mounted to the base and having a convex, body structure-shaping surface shaped to form the tubular end portion of the body structure into a hooded shape in response to actuation of the carriage assembly to drive the element against the tubular end portion and the anvil to press the tubular end portion against the body structure-shaping surface, when the tubular end portion has been inserted through the central portion and positioned in engagement with the anvil.

34. The apparatus of claim 33, wherein the base defines an anvil-mounting opening, the anvil has a concave, tine-curling surface, and the anvil comprises:

a central part defining the body structure-shaping surface and a radially inner portion of the tine-curling surface; and

an outer part defining a radially outer portion of the tine-curling surface and a mounting surface, wherein the outer part abuts a first side of the base and the central part extends through the anvil-mounting opening from a second side of the base into engagement with the mounting surface of the outer part.

35. The apparatus of claim 25, wherein the anvil assembly includes an anvil, and wherein said apparatus also includes:

a body structure-pulling assembly translatably mounted to the anvil assembly, the body structure-pulling assembly being translatable between a first state and a second state, wherein the body structure-pulling assembly is configured to engage the tubular end portion of the body structure in the first state after the tubular end portion has been inserted through the central portion, and the body structure-pulling assembly is configured to pull the tubular end portion into engagement with the anvil as said body structure-pulling assembly translates from the first state to the second state.

36. The apparatus of claim 35, wherein the body structure-pulling assembly includes a set of hooks, each of the hooks having a straight portion which engages the anvil assembly and is translatable linearly relative to the anvil assembly.

37. The apparatus of claim 25, wherein the anvil assembly includes an anvil defining concave, tine-curling surface and convex, body structure-shaping surface, wherein the anvil defines a channel, and wherein at least one of the tine-curling surface and the body structure-shaping surface defines suction holes in fluid communication with the channel.

38. An apparatus for installing an anastomosis element in a body structure having a tubular end portion surrounding a lumen and defining an open end, wherein the element has a central portion and deformable tines extending from the central portion, said apparatus comprising:

a first part comprising a stem and an intraluminal anvil mounted to the stem, wherein the intraluminal anvil has a generally flat, intraluminal tine-forming surface, and the intraluminal anvil is sized and shaped for insertion into the lumen through an incision in the tubular end portion; and

a second part defining a generally flat, extracorporeal anvil surface, configured to be aligned with the intraluminal tine-forming surface.

39. The apparatus of claim 38, wherein each of the intraluminal tine-forming surface and the extracorporeal anvil surface defines tine-forming pockets.

40. The apparatus of claim 38, wherein the intraluminal anvil has a convex, body structure-engaging surface and the extracorporeal anvil has a concave, body structure-L.,gaging surface shaped to mate with the convex, body structure-engaging surface of the intraluminal anvil with body structure tissue pinched between said concave, body structure-engaging surface of the extracorporeal anvil and said convex, body structure-engaging surface of the intraluminal anvil.