Devices and methods for interconnecting conduits and closing openings in tissue

• US 7,892,246 B2
• Filed: 09/04/2002
• Issued: 02/22/2011
• Est. Priority Date: 07/28/1999
• Status: Active Grant

• Current Assignee: Bioconnect Systems, Inc.
• Original Assignee: Bioconnect Systems, Inc.
• Inventors: Ramee, Stephen R., Akin, Jodi J.
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US10/235,948
• Publication Number:
  US 20030100920A1
• Time in Patent Office: 3,093 Days
• Field of Search: 606/213, 606/151, 606/153, 606/154, 606/155, 606/191, 606/194, 623/1.15
• US Class Current: 606/155
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00867 shape memory effect
• 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
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

The subject invention provides devices and methods for closing and sealing an opening in a conduit. The subject devices consist of an implantable flexible member adapted to conform to and seal with an inner surface of a conduit and further adapted to utilize the internal conduit pressure exerted thereon to form a substantially fluid-tight seal with the inner surface of the conduit whereby substances are prevented from leaking from the opening under normal physiological conditions. In the subject methods, a subject device is provided and positioned inside a conduit, operatively aligned over an opening to be sealed. The device is conformed to and sealed with an inner surface of the conduit and a substantially fluid-tight seal is formed between the device and the inner surface of the conduit utilizing the internal conduit pressure whereby substances within the conduit are prevented from leaking from the opening under normal physiological conditions.

Claims

1. A device for connecting first and second tissue structures comprising:

first and second substantially parallel and elongate flexible segments each having proximal and distal ends, wherein the first and second segments each comprise a compliant material configured to be constricted for implantation within the first and second tissue structures, respectively, and wherein the material has a natural tendency to return to an unconstricted state such that, when implanted in the tissue structures, the material utilizes an internal fluid pressure within the respective tissue structure to conform to a shape of an inner surface of the tissue structure to provide a sealing contact with the inner surface; and

a flow opening extending between the first and second segments at a point along the elongate length of the segments at least a distance from each of the proximal and distal ends to fluidically couple the first and second tissue structures.

2. The device according to claim 1, wherein the first and second flexible segments are formed of a material that is one or more of biodegradable and bioresorbable.

3. The device according to claim 1, wherein the first and second flexible segments do not substantially compress, tension, or puncture the tissue structure when implanted therein.

4. The device according to claim 1, further comprises a thrombogenic substance.

5. The device according to claim 1, wherein at least a portion of the device is coated with a therapeutic substance.

6. The device according to claim 1, wherein the first tissue structure is one of a blood vessel and a portion of a heart.

7. The device according claim 1, wherein the first and second segments are configured to cooperatively provide a passive sealing force to the respective first and second tissue structures in which each are operationally disposed that pulls the first and second tissue structures together.

8. The device according to claim 1, further comprising:

a separation thread disposed at least partially within the first flexible segment and configured to tear at least a portion of the first flexible segment in response to receiving a pulling force on the separation thread.

9. The device according to claim 1, wherein one or more of the first and second segments have a cylindrical shape.

10. The device according to claim 1, wherein the flow opening comprises an elongate member having a cylindrical shape.

11. The device according to claim 10, wherein the elongate member extends substantially perpendicularly between the first and second segments.

12. The device according to claim 10, wherein the elongate member extends between an aperture in the first segment to an aperture in the second segment, and wherein the apertures in the first and second segments are offset from one another.

13. The device according to claim 1, wherein at least the portions of the first and second segments adjacent the ends of the flow opening are positioned in substantially parallel planes.

14. The device according to claim 1, wherein the first and second segments have substantially the same size and shape.

15. The device according to claim 1, wherein the second segment has at least one of a different size and shape than the first segment.

16. The device according to claim 1, wherein the device comprises a unitary component.

17. The device according to claim 1, wherein the device comprises two or more connectable components.

18. A device for fluidically coupling an artificial opening in a first vascular tissue structure with a second tissue structure comprising:

a first elongate flexible segment having a proximal and a distal end and comprising a compliant material configured to be constricted for implantation in the first tissue structure via the artificial opening, wherein the material has a natural tendency to return to an unconstricted state such that, when implanted in the tissue structure, the material utilizes an internal fluid pressure within the first tissue structure to conform to a shape of an inner surface of the first tissue structure to provide sealing contact with the inner surface of the first tissue structure around the artificial opening;

a second elongate flexible segment disposed substantially parallel to the first segment having a proximal and a distal end and implantable within the second tissue structure; and

a flow opening extending through the artificial opening between the first and second segments at a point along the elongate length of the segments at least a distance from each of the proximal and distal ends of the first and second segments to fluidically couple the first and second tissue structures.

19. The device according to claim 18, wherein the first segment further comprises a non-tissue facing surface and a tissue-contacting surface configured to conformingly contact the inner surface of the first tissue structure.

20. The device according to claim 19, wherein the non tissue-facing surface is configured to receive and to transmit fluid pressure exerted thereon to the tissue contacting surface such that a substantially fluid tight contact between the tissue-contacting surface and the inner surface of the first tissue structure is formed.

21. The device according to claim 18, wherein the first segment comprises an elastomer.

22. The device according to claim 18, wherein the first segment comprises a biocompatible material.

23. The device according to claim 18, wherein the first segment comprises one of a biodegradable and a bioresorbable material.

24. The device according to claim 18, wherein the first segment comprises a polymer material.

25. The device according to claim 24, wherein said polymer is an elastomer.

26. The device according to claim 25, wherein said elastomer comprises polysiloxane or polyurethane.

27. The device according to claim 25, wherein said elastomer has a durometer ranging from about 80 Shore A to 55 Shore D.

28. The device according to claim 18, further comprising:

a valve controlling flow through said aperture.

29. The device according to claim 18, wherein the first and second segments are configured to cooperatively provide a passive sealing force to the respective first and second tissue structures in which each are operationally disposed that pulls the first and second tissue structures together.

30. The device according to claim 18, further comprising:

a separation thread disposed at least partially within the first flexible segment and configured to tear at least a portion of the first flexible segment in response to receiving a pulling force on the separation thread.

31. The device according to claim 18, wherein one or more of the first and second segments have a cylindrical shape.

32. The device according to claim 18, wherein the flow opening comprises an elongate member having a cylindrical shape.

33. The device according to claim 32, wherein the elongate member extends between an aperture in the first segment to an aperture in the second segment, and wherein the apertures in the first and second segments are offset from one another.

34. The device according to claim 32, wherein the elongate member extends substantially perpendicularly between the first and second segments.

35. The device according to claim 18, wherein at least the portions of the first and second segments adjacent the ends of the flow opening are positioned in substantially parallel planes.

36. The device according to claim 18, wherein the first and second segments have substantially the same size and shape.

37. The device according to claim 18, wherein the second segment has at least one of a different size and shape than the first segment.

38. The device according to claim 18, wherein the device comprises a unitary component.

39. The device according to claim 18, wherein the device comprises two or more connectable components.

40. A kit for connecting first and second tissue structures comprising:

an implantable device comprising;

first and second substantially parallel and elongate flexible segments each having proximal and distal ends, wherein the first and second segments comprise a compliant material configured to be constricted for implantation within first and second tissue structures, respectively, the and wherein the material has a natural tendency to return to an unconstricted state such that, when implanted in the tissue structures, the material utilizes an internal fluid pressure within the respective tissue structure to conform to a shape of an inner surface of the tissue structure to provide a sealing contact with the inner surface,

a flow opening extending between the first and second segments along the elongate length of the segments at least a distance from each of the proximal and distal ends to fluidically couple the first and second tissue structures,

wherein the first and second segments are removably connectable to one another; and

a third elongate flexible segment having at least one of a different size and shape than the second segment and configured to be connected to the first segment in place of the second segment.

41. The kit of claim 40, further comprising:

a tool for implanting at least one of the first and second segments in the respective first or second tissue structure.