Devices and methods for interconnecting body conduits

• US 20040087984A1
• Filed: 09/04/2002
• Published: 05/06/2004
• Est. Priority Date: 09/04/2002
• Status: Active Grant

• Current Assignee: Bioconnect Systems, Inc.
• Original Assignee: Bioconnect Systems, Inc.
• Inventors: Conston, Stanley R., Miller, Aaron, Kupiecki, David, Pinson, Candice Danielle, Moshe, Meir, Yamamoto, Ron K.
• Granted Patent: US 7,351,247 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

The present invention provides devices and associated methods for delivering side-to-side and end-to-side anastomotic connectors to join any two (or more) vessels together such that fluid communication is established between the lumens of the two or more joined vessels. The systems of the present invention employ one or more deployment mechanisms over which the anastomotic connector is positioned for delivery and subsequently deployment within a vessel. The deployment mechanisms may be inflatable balloons or expandable baskets or a combination thereof or the like, which, when inflated and/or expanded, cause one or more portions of the anastomotic connector to deploy.

Claims

1. A system for delivering an anastomotic connector to interconnect vessels, comprising:

an elongated connector engagement member having a connector deployment mechanism at a distal end thereof; and

a connector retaining member configured to axially receive said elongated connector engagement member therein and comprising a slit at a distal end thereof to hold at least a portion of the anastomotic connector therein.

2. The system of claim 1, further comprising a sheath for accessing a vessel to be interconnected and configured to axially receive said retaining member wherein said sheath and said retaining member are axially translatable relative to each other to selectively maintain said anastomotic connector in a deployable configuration.

3. The system of claim 2, further comprising a cuff for configuring the anastomotic connector into a deployable condition and for loading the deployable anastomotic connector into said sheath.

4. The system of claim 3, wherein said cuff comprises a split sleeve configuration.

5. The system of claim 4, wherein said split sleeve configuration comprises a split along at least a portion of the length of said cuff.

6. The system of claim 5, wherein said split is along the entire length of said cuff.

7. The system of claim 3, wherein said cuff further comprises an opening for accommodating a portion of the anastomotic connector therein.

8. The system of claim 1 wherein said connector deployment mechanism comprises at least one inflatable member.

9. The system of claim 8 wherein said at least one inflatable member has a shape selected from the group consisting of cylindrical, round, oval, bean-shaped, conical-tipped, square-tipped and barbell.

10. The system of claim 8 wherein said at least one inflatable member has a kidney-bean shaped cross-section.

11. The system of claim 8 wherein said at least one inflatable member is selectively inflatable and deflatable.

12. The system of claim 8 wherein said connector deployment mechanism comprises two inflatable members.

13. The system of claim 12 wherein said two inflatable members are positioned substantially side-to-side.

14. The system of claim 12 wherein said inflatable members are positioned substantially end-to-end.

15. The system of claim 12 wherein said inflatable members have substantially similar volume capacities.

16. The system of claim 12 wherein said inflatable members have different volume capacities.

17. The system of claim 12 wherein said inflatable members have substantially equal shapes.

18. The system of claim 12 wherein said inflatable members have different shapes.

32. A method of delivering an anastomosis connector comprising at least one flexible member and a tubular flow channel, said method comprising:

providing the system of claim 3;

inserting said inflatable deployment mechanism into said tubular flow channel;

inserting at least a portion of said anastomotic connector into said retaining member slit;

compressing said anastomotic connector with said cuff;

inserting said engagement member and said retaining member along with said compressed anastomotic connector into said sheath;

positioning said at least one member within an opening in a first vessel;

inflating said deployment mechanism wherein said at least one member is deployed within said first vessel;

appositioning an opening in a second vessel with said opening in said first vessel;

flexing the portion of said retaining member proximate said slit; and

expanding said tubular flow channel.

33. The method of claim 32 further wherein said anastomotic connector comprises two flexible members one on each side of said tubular flow channel:

inflating said deployment mechanism wherein said second member is deployed within said second vessel.

34. The method according to claim 32 wherein said cuff includes a cut-out at the distal end thereof and wherein, prior to said compressing step, said method comprises positioning said at least a portion of said anastomotic connector within said cut-out.

19. A system for creating an anastomotic connection between a target vessel and a graft vessel, comprising:

an elongated connector engagement member having a connector deployment mechanism at a distal end thereof;

a connector retaining member configured to axially receive said elongated connector engagement member therein and comprising a slit at a distal end thereof to hold at least a portion of the anastomotic connector therein; and

an anastomotic connector comprising at least one flexible member adapted to fit within said slit and a tubular flow channel portion adapted to be disposed about said connector deployment mechanism.

20. A system for creating an anastomotic connection between a target vessel and a graft vessel, comprising:

an anastomotic connector comprising at least one flexible member and a tubular flow channel; and

two or more deployment members configured to be axially positioned within said tubular flow channel.

21. The system of claim 20 wherein at least one of said two or more deployment members or a portion thereof is positioned to deploy said at least one flexible member within a target vessel.

22. The system of claim 20 wherein at least one of said two or more deployment members or a portion thereof is positioned to expand said tubular flow channel.

23. The system of claim 20 wherein at least one of said two or more deployment members is an inflatable balloon.

24. The system of claim 20 wherein at least one of said two or more deployment members is an expandable basket.

25. A method of forming an anastomotic connection between two vessels, said method comprising:

providing an anastomotic connector comprising at least one flexible member and a tubular flow channel wherein said flexible member is in an original configuration;

inserting at least one balloon into said flow channel;

compressing at least one of said at least one flexible member and said tubular flow channel;

positioning said compressed at least one flexible member within a vessel; and

inflating said at least one balloon wherein said at least one flexible member substantially returns to said original configuration.

26. The method of claim 25 further comprising inflating said at least one balloon at least one more time to completely form said anastomotic connection.

27. The method of claim 25 wherein said anastomotic connector comprises two flexible members and wherein said second flexible member remains at least partially compressed during said inflating.

28. The method of claim 25 wherein said anastomotic connector further comprises two flexible members and said method further comprises:

positioning said second flexible member within a second vessel; and

inflating said at least one balloon wherein said second flexible member substantially returns to said original configuration within the second vessel.

29. The method of claim 25 further comprising deflating said at least one balloon after said first inflating step.

30. The method of claim 25 further comprising expanding said tubular flow channel.

31. The method according to claim 30 wherein said tubular flow channel expansion causes said at least one flexible member to substantially return to said original configuration.

35. A system for delivering an anastomotic connector to interconnect vessels comprising at least one expandable basket for deploying said anastomotic connector.

36. A system for delivering an anastomotic connector to interconnect vessels, comprising:

a tubular anastomotic connector engagement member comprising at least one expandable member at a distal end thereof and a lumen therethrough, wherein said at least one expandable member comprises at least one slit disposed through a wall thereof; and

an actuator disposed within said lumen of said first tubular engagement member, and connected to said at least one expandable member, wherein a force applied to said proximal end of said actuator causes said at least one slit to open, thereby forming a raised diameter portion of said at least one expandable member.

38. The system according to claim 36, further comprising a tubular retaining member having a lumen therethrough and configured to be slidably disposed over said expandable member, therein defining a space between said expandable member and said retaining member to accommodate an anastomotic connector disposed radially about said expandable member.

37. The system 36 further comprising:

a second tubular anastomotic connector engagement member comprising a second expandable member and having a lumen therethrough, wherein said second expandable member comprises at least one slit disposed through a wall thereof; and

a second actuator disposed within said lumen of said second tubular engagement member, and connected to said second expandable member, wherein a force applied to said proximal end of said second actuator causes said at least one slit to open, thereby forming a raised diameter portion of said second expandable member, wherein said second tubular engagement member being further configured to slidably receive said first tubular engagement member.

39. A system for delivering an anastomotic connector having an original state and a constrained state, comprising:

a first tubular engagement member comprising at least one expandable member and a lumen therethrough;

a first actuator disposed within said lumen of said first tubular engagement member, and associated with said first expandable member;

a second engagement member including at least one expandable member and a lumen therethrough;

a second actuator disposed within the lumen of said second tubular engagement member and connected to said second expandable member, said second actuator further configured to slidably receive said first expandable member and said first actuator;

a retaining member comprising a lumen therethrough and configured to be slidably disposed over said first and second expandable members, therein defining a space between said first and second expandable members and said retaining member; and

an anstomotic connector disposed radially about at least said first expandable member and within said space defined by said retaining member.

40. The system of claim 39 wherein said anastomotic connector is disposed adjacent to said second expandable member.

41. The system of claim 40 wherein said anastomotic connector includes first and second flexible members connected by a generally cylindrical member, said first and second flexible members being generally pliable and configured to be received within said space defined by said retaining member.

42. A method for interconnecting a first conduit to a second conduit, comprising the steps of:

providing an anastomotic connector;

providing the system of claim 39;

operatively constraining said anastomotic connector within said space;

operatively engaging said first conduit with said system;

positioning a distal end portion of said system within said second conduit;

deploying a first portion of said anastomotic connector within said second conduit;

deploying a second portion of said anastomotic connector within said first conduit; and

removing said system from said first and second conduit.

43. The method of claim 42 wherein said step of operatively engaging said first conduit with said system comprises inserting said distal end portion into a transected end of said first conduit and through a side wall of said first conduit.

44. The method of claim 43 wherein said step of deploying a first portion of said anastomotic connector comprises the step of moving said retaining member proximally and expanding said first expandable member by moving said first actuator proximally.

45. The method of claim 44 wherein said step of deploying a second portion of said anastomotic connector comprises said step of moving said retaining member proximally to expose said second expandable member and expanding said second expandable member by moving said second actuator proximally.

46. The method of claim 42 wherein said step of operatively engaging said first conduit with said system comprises inserting said distal end portion of said system into a transected end of said first conduit and operatively positioning said first conduit about said proximal shaft portion of said system.