Implantable flow connector

• US 8,690,816 B2
• Filed: 08/04/2008
• Issued: 04/08/2014
• Est. Priority Date: 08/02/2007
• Status: Active Grant

• Current Assignee: Bioconnect Systems, Inc.
• Original Assignee: Bioconnect Systems, Inc.
• Inventors: Dakin, Adam, Dugery, Michael, Polk, Todd, Briganti, Richard, Paris, Michael, Gately, Nicholas, Win, Zaw N.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/185,810
• Publication Number:
  US 20090036820A1
• Time in Patent Office: 2,073 Days
• Field of Search: 604/8, 604/9, 604/264, 623/1.3, 623/1.31, 623/1.36, 623/23.64, 606/153
• US Class Current: 604/8
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• 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: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014

Abstract

An implantable flow connector for fluidically coupling a source tissue-enclosed body space with a destination element, comprising: a conduit having a lumen terminating at an orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit implantable in the destination element through an opening in a surface of the destination element; and a circumferential flange, radially extending from the conduit proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening, the flange comprising one or more circumferentially adjacent sections at least one of which has a rigidity that decreases in a radially-increasing direction.

Claims

1. An implantable flow connector for fluidically coupling a tissue-enclosed source body space with a destination element, comprising:

a conduit having a lumen terminating at an orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit implantable in the destination element through an opening in a surface of the destination element; and

a circumferential flexible flange, radially extending from the conduit proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening, the flange comprising first and second longitudinal sections extending on first and second opposing sides of the conduit and first and second lateral sections extending on third and fourth opposing sides of the conduit, the longitudinal and lateral sections each having an inner section closer to the conduit and an outer section positioned radially outward of the inner section and further from the conduit than the inner section, wherein adjacent lateral and longitudinal sections are joined at the outer sections to form a continuous flange with a continuous outer edge, the lateral sections configured to extend around a longitudinal axis of the source body space and configured to cooperate with the walls of the body space such that the flange sealingly conforms to an inner surface of the tissue wall adjacent the opening in the body space.

2. The flow connector of claim 1, wherein said destination element is a destination tissue-enclosed body space.

3. The flow connector of claim 2, wherein the opening in the destination is an artificial opening in a tissue wall of the destination body space.

4. The flow connector of claim 2, wherein the artificial opening is an orifice at a severed end of the destination.

5. The flow connector of claim 2, wherein said flow connector conduit has an outside diameter that is substantially the same as an inside diameter of a region of said destination element into which the flow connector conduit is implanted.

6. The flow connector of claim 1, wherein said destination element is a medical device.

7. The flow connector of claim 1, wherein said lumen is non-cylindrical.

8. The flow connector of claim 1, wherein said conduit and said flange are formed as separate parts and joined together.

9. The flow connector of claim 1, further comprising one or more cutout regions disposed on said flange and configured to promote folding of said flange to facilitate insertion through the opening.

10. The flow connector of claim 1, wherein outer edges of said flange are chamfered.

11. The flow connector of claim 1, wherein a longitudinal axis of said lumen in said conduit is disposed at an angle of approximately 10°

to 90°

with respect to a longitudinal axis of said flange.

12. The flow connector of claim 11, wherein the longitudinal axis of said lumen in said conduit is disposed at an angle of approximately 60°

with respect to the longitudinal axis of said flange.

13. The flow connector of claim 1, wherein said lateral sections taper from an imaginary plane flush with the conduit orifice, by a taper angle greater than 0°

from said plane.

14. The flow connector of claim 13, wherein said taper angle of said longitudinal sections from said imaginary plane is approximately 10°

.

15. The flow connector of claim 1, wherein the lateral sections are memory material and have a radius of curvature greater that the radius of curvature of the source body space.

16. The flow connector of claim 1, wherein the flow connector is configured such that it is urged out of the opening of the source body space by forces generated by said lateral sections being disposed against the tissue wall.

17. The flow connector of claim 1, wherein the flange comprises one or more circumferentially adjacent sections at least one of which has a rigidity that decreases as the radial distance of the flange from the conduit increases.

18. The implantable flow connector of claim 17, wherein said one or more circumferentially adjacent sections comprise:

a first section having a first rigidity; and

a second section having a second rigidity,

wherein the rigidity of said first section is greater than the rigidity of said second section.

19. The implantable flow connector of claim 18, wherein a composition of said first and second sections are substantially similar and further wherein a thickness of said first and second sections are different.

20. The implantable flow connector of claim 17, wherein a composition of said first and second sections are different and further wherein a thickness of said first and second sections are substantially similar.

21. The implantable flow connector of claim 17, wherein said first section is proximal the conduit and said second section is distal the conduit with respect to said first section.

22. The implantable flow connector of claim 17, wherein said one or more circumferentially adjacent sections form a continuous surface around said conduit.

23. The implantable flow connector of claim 1, wherein the flange comprises one or more circumferentially adjacent sections constructed and arranged to reinforce the conduit.

24. The implantable flow connector of claim 23, wherein said one or more circumferentially adjacent sections comprise:

a first section having a first rigidity; and

a second section having a second rigidity,

wherein the rigidity of said first section is greater than the rigidity of said second section and is sufficient to reinforce said conduit.

25. The implantable flow connector of claim 1, further wherein the cooperation of the lateral sections and the tissue wall urge the flow connector toward the opening thereby causing the flow connector to be supported by the flange sections.

26. The implantable flow connector of claim 25, wherein said lateral sections are configured to collectively extend into the body space at least up to a point along the tissue wall having a largest diameter in the body space when said flange is implanted in the source body space to its operative position.

27. The implantable flow connector of claim 25, wherein said lateral sections are configured to collectively extend into the body space to approximately 180°

of the circumference of the body space when said flange is implanted in the source body space to its operative position.

28. The implantable flow connector of claim 1, wherein the flange comprises one or more circumferentially adjacent sections constructed and arranged to substantially retain the flow connector in a substantially stationary operable position within the source body space.

29. The implantable flow connector of claim 1, wherein the flange comprises one or more circumferentially adjacent sections each having a combination of one or more of composition and dimensions that prevents the lateral sections from substantially deflecting in response to explant forces exerted on the flow connector.

30. The implantable flow connector of claim 29, wherein one of said one or more circumferentially adjacent sections has a maximum length from said conduit of approximately 25% to 100% of an outside diameter of said conduit, wherein said length is along a longitudinal axis of a region the body space in which said flange is to be implanted.

31. The implantable flow connector of claim 29, wherein one of said one or more circumferentially adjacent sections has a maximum length from said conduit of approximately 35% to 85% of an outside diameter of said conduit, wherein said length is along a longitudinal axis of a region the body space in which said flange is to be implanted.

32. The implantable flow connector of claim 29, wherein one of said one or more circumferentially adjacent sections has a maximum length from said conduit of approximately 50% of an outside diameter of said conduit, wherein said length is along a longitudinal axis of a region the body space in which said flange is to be implanted.

33. The implantable flow connector of claim 29, wherein the one or more circumferentially adjacent sections of said flange comprise:

a first section having a first thickness; and

a second section having a second thickness,

wherein the first thickness is different from the second thickness.

34. The implantable flow connector of claim 33, wherein one of at least said first and second thicknesses is substantially equal to a thickness of the wall tissue of the source body conduit.

35. The implantable flow connector of claim 34, wherein one of at least said first and second thicknesses is approximately 0.2 mm to approximately 1.0 mm.

36. The implantable flow connector of claim 35, wherein one of at least said first and second thicknesses is approximately 0.5 mm.

37. The implantable flow connector of claim 36, wherein the thickness of said first section is approximately 50% to approximately 100% of the thickness of said second section.

38. The implantable flow connector of claim 29, wherein the one or more circumferentially adjacent sections of said flange comprise:

a first section having a first composition; and

a second section having a second composition,

wherein the first composition is different from the second composition.

39. The implantable flow connector of claim 38, wherein one of at least said first and second compositions has a shore value of 80A.

40. The implantable flow connector of claim 39, wherein the other of at least said first and second compositions has a shore value of 55D.

41. The implantable flow connector of claim 38, wherein said first and second compositions each have a softness corresponding to a shore value between 80A and 55D.

42. The implantable flow connector of claim 1, wherein the lateral sections cooperate with the tissue wall to urge the flow connector out of the opening thereby causing the flange to sealingly abut the inner surface of the source body conduit.

43. An implantable flow connector configured to fluidically couple a tissue-enclosed source body space with a destination element, comprising:

an elongate body including a fluid channel extending therethrough and implantable in the destination element; and

a flexible flange extending from the elongate body proximate an end of the elongate body, the flange being configured to be implanted in the source body space adjacent an opening formed in a tissue wall such that the fluid channel fluidically couples fluid in the source tissue-enclosed body space with the destination element, wherein

the flange includes first and second lateral sections and a contact surface configured to interface with an interior of the tissue wall of the source body space, and

wherein the flange is configured upon implantation to exert an outward force on the interior of the tissue wall so as to cause the wall of the source body to resist the outward force to thereby provide a compression force to the lateral sections to urge the contact surface of the flange toward the opening so as to provide a seal between the contact surface and the tissue wall without a force applied by an external device against an exterior of the tissue wall such that fluid within the source body space will not leak out the opening formed between the tissue wall of the source body space and an exterior of the implantable flow connector.

44. The implantable flow connector of claim 43, wherein:

the seal is a hydrophobic seal.

45. The implantable flow connector of claim 43, further comprising longitudinal sections contiguous with the lateral sections.

46. The implantable flow connector of claim 45, wherein:

elongate body and the flange are a monolithic structure.

47. The implantable flow connector of claim 45, further comprising:

a securing element configured to extend around the elongate body configured to secure the destination element thereto.

48. The implantable flow connector of claim 47, wherein the conduit includes a plurality of radial protrusions and the securing element engages the protrusions on an external surface of the conduit.

49. The implantable flow connector of claim 43, wherein the flange comprises one or more circumferentially adjacent sections constructed and arranged to reinforce the conduit.

50. The implantable flow connector of claim 43, further comprising first and second longitudinal sections contiguous with the lateral sections.

51. The implantable flow connector of claim 50, wherein the first and second longitudinal sections have different lengths.

52. A method of fluidically coupling a source tissue-enclosed body space with a destination element, comprising:

obtaining access to an opening in a tissue wall of the source body space;

inserting a flange portion of an implantable flow connector through the opening and into the source body space such that a conduit within the flow connector is implanted in the destination element for fluid communication with an interior of the source body space;

establishing a seal between the implantable flow connector and the tissue wall such that fluid within the source body space will not leak out an area between the opening in the tissue wall of the source body space and an exterior of the implantable flow connector by enabling a portion of the implantable flow connector located within the source body space to exert a force against the tissue wall, said force being substantially primarily generated by the portion of the implantable flow connector in the source body space without a reacting force generated on an outside of the tissue wall.

53. The method of claim 52, wherein:

said force consists of force generated by the portion of the implantable flow connector in the source body space.

54. The method of claim 52, wherein:

the seal is established without an additional component that interfaces with the tissue wall.

55. The method of claim 52, wherein:

the implantable flow connector is a monolithic device; and

the seal is established with only the implantable flow connector interfacing with the tissue wall.

56. The method of claim 52, wherein:

the force is generated solely by a flange of the implantable flow connector implanted within the source body space.

57. The method of claim 52, wherein the force is generated by a flange of the implantable flow connector, the flange having a radius of curvature lying on a plane, the method further comprising:

selecting the implantable flow connector such that the radius of curvature of the flange is greater than a radius of curvature of the interior wall of the source body space lying on the plane when the implantable flow connector is located therein.

58. The method of claim 52, wherein:

after the flow connector is inserted through the opening into the source body space, the flow connector is urged out of the opening of the source body space by the exerted force.

59. An implantable flow connector for fluidically coupling a tissue-enclosed source body space with a destination element, comprising:

a conduit having a lumen terminating at an orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit implantable in the destination element through an opening in a surface of the destination element; and

a circumferential flexible flange, radially extending from the conduit proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening, the flange comprising first and second lateral sections configured to extend around the longitudinal axis of the source body space and configured to cooperate with the walls of the body space such that the flange sealingly conforms to the inner surface of the tissue wall adjacent the opening in the body space to provide a sealing region, and a reinforcement region adjacent the sealing region to reinforce the flow connector.

60. The implantable flow connector of claim 59, wherein the reinforcement region has a rigidity to aid in opposition of deflection forces.

61. The implantable flow connector of claim 60, wherein the rigidity of the reinforcement region decreases in a radially increasing direction with respect to the conduit.

62. The implantable flow connector of claim 59, wherein the reinforcement region is composed of a material of a greater durometer than the sealing region.

63. The implantable flow connector of claim 59, wherein the reinforcement region has a thickness greater than adjacent regions of the flange.

64. The implantable flow connector of claim 59, wherein the reinforcement region is proximal to the conduit to provide structural integrity to the conduit.

65. The implantable flow connector of claim 59, wherein the reinforcement region comprises multiple regions extending circumferentially around the conduit.

66. The implantable flow connector of claim 59, wherein the reinforcement region is contiguous.

67. The implantable flow connector of claim 59, wherein the reinforcement region has a perimeter similar to a perimeter of the flange.

68. The implantable flow connector of claim 59, wherein the lateral sections when implanted in the source body space form an angle to an imaginary plane flush with the conduit orifice.

69. The implantable flow connector of claim 59, wherein the reinforcement region extends around the conduit.