IP Library Granted Patent US 10,232,098
Granted Patent B2
US 10,232,098 · App. 14/587,314 · Granted Mar 19, 2019

Device and method for establishing an artificial arterio-venous fistula

Inventors: Rodney A. Brenneman (San Juan Capistrano, CA); J. Christopher Flaherty (Auburndale, FL); Brad Kellerman (Escondido, CA)
Assignee: ROX Medical, Inc.
A61M1/0094A61B17/083A61B17/10A61B17/11A61B2017/00004A61B2017/00867A61B2017/1107A61B2017/1139
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Quick Facts
Patent No.
US 10,232,098
App. No.
14/587,314
Granted
Mar 19, 2019
Kind
B2
Abstract

A shunt rivet for implantation between a first body space and a second body space in a patient, such as to treat chronic obstructive pulmonary disease.

Claims (72)

1. A coupler for placement between a first body space and a second body space in a patient, the coupler comprising:

a first clinch member; and

a second clinch member,

wherein the coupler is completely bioabsorbed over a time period of less than 6 months,

wherein the coupler is configured to have a first configuration at a first time after placement and a second configuration at a second time after placement,

wherein more of the first and second clinch members are bioabsorbed in the second configuration than in the first configuration, and

wherein the coupler maintains a fluid flow path between the first body space and the second body space.

2. The coupler of claim 1 , further comprising a channel portion having a first and second end, wherein the first clinch member is coupled to the first end of the channel portion, wherein the second clinch member is coupled to the second end of the channel portion, and wherein the first and second clinch members each extend at least one of radially away and longitudinally away from the channel portion.

3. The coupler of claim 2 , wherein the channel portion is configured to bioabsorb, and wherein more of the channel portion is bioabsorbed in the second configuration than in the first configuration.

4. The coupler of claim 2 , wherein the channel portion comprises a wire.

5. The coupler of claim 2 , wherein the channel portion has a cross section approximating a circle or ellipse.

6. The coupler of claim 2 , wherein the channel portion defines an opening having a tapered cross section.

7. The coupler of claim 3 , wherein the channel portion is configured to bioabsorb slower than the first clinch member.

8. The coupler of claim 3 , wherein the channel portion is configured to bioabsorb at a different rate than the first clinch member.

9. The coupler of claim 1 , wherein the fluid flow path has a cross section approximating a circle or ellipse.

10. The coupler of claim 1 , wherein the fluid flow path has a non-constant cross section.

11. The coupler of claim 1 , wherein the first clinch member comprises a stabilizing arm.

12. The coupler of claim 1 , wherein at least a portion of the coupler is self-expanding.

13. The coupler of claim 1 , wherein the coupler is configured to modify the flow of an existing fluid flow path.

14. The coupler of claim 1 , wherein the coupler includes a mesh surface comprising woven material.

15. The coupler of claim 1 , wherein the first body space is the lumen of a blood vessel and the second body space is the lumen of a blood vessel.

16. The coupler of claim 1 , wherein the coupler has a user adjustable geometry.

17. The coupler of claim 1 , wherein the coupler is configured to be enlarged after implantation.

18. The coupler of claim 1 , further comprising a radioactive portion.

19. A coupler for placement between a first body space and a second body space in a patient, the coupler comprising:

a channel portion having a first end and a second end;

a first clinch member coupled to the first end of the channel portion; and

a second clinch member coupled to the second end of the channel portion,

wherein the coupler is completely bioabsorbed over a time period of less than 6 months,

wherein the coupler is configured to have a first configuration at a first time after placement and a second configuration at a second time after placement,

wherein less of the first clinch member is bioabsorbed in the first configuration than in the second configuration, and

wherein the coupler maintains a fluid flow path between the first body space and the second body space.

20. A method of treating a patient comprising:

inserting a coupler between a first body space and a second body space, wherein the coupler comprises a channel portion, a first clinch member, and a second clinch member,

wherein the coupler is completely bioabsorbed over a time period of less than 6 months,

wherein the coupler is configured to have a first configuration at a first time after insertion and a second configuration at a second time after insertion, and

wherein more of the first clinch member is bioabsorbed in the second configuration than in the first configuration.

21. The method of claim 20 , wherein the channel portion is configured to be bioabsorbable, and wherein more of the channel portion is bioabsorbed in the second configuration than in the first configuration.

22. The method of claim 20 , wherein the channel portion has a cross section approximating a circle or ellipse.

23. The method of claim 20 , wherein the coupler is configured to modify the flow of an existing fluid flow path.

24. The method of claim 20 , wherein the first body space is the lumen of a blood vessel and the second body space is the lumen of a blood vessel.

25. The method of claim 20 , wherein the channel portion defines an opening having a tapered cross section.

26. The method of claim 20 , wherein the channel portion is configured to bioabsorb at a different rate than the first clinch member.

27. The method of claim 20 , wherein the coupler comprises a bioactive agent.

28. The coupler of claim 1 , wherein none of the first clinch member is bioabsorbed in the first configuration, and wherein some of the first clinch member is configured to be bioabsorbed in the second configuration.

29. The coupler of claim 1 , wherein more of the second clinch member is configured to be embedded in tissue in the second configuration than in the first configuration.

30. The coupler of claim 1 , wherein the coupler is configured to have a first shape in the first configuration and a second shape in the second configuration, and wherein the first and second shapes are different from one another at least because more of the first clinch member is bioabsorbed in the second configuration than in the first configuration.

31. The coupler of claim 1 , wherein the first clinch member is configured to stabilize the coupler in the first body space in the first configuration, and wherein the second clinch member is configured to stabilize the coupler in the second body space in the second configuration.

32. The coupler of claim 1 , wherein the first clinch member is configured to contact a luminal wall of the first body space to stabilize the coupler in the first body space, and wherein the second clinch member is configured to contact a luminal wall of the second body space to stabilize the coupler in the second body space.

33. The coupler of claim 1 , wherein the first clinch member is configured to temporarily stabilize the coupler between the first and second body spaces before the first clinch member bioabsorbs.

34. The coupler of claim 19 , wherein the channel portion is configured to bioabsorb, wherein less of the channel portion is bioabsorbed in the first configuration than in the second configuration, and wherein the first clinch member and the second clinch member each extend at least one of radially away and longitudinally away from the channel portion.

35. The coupler of claim 34 , wherein the first clinch member is configured to bioabsorb faster than the channel portion.

36. The coupler of claim 19 , wherein none of the first clinch member is bioabsorbed in the first configuration, and wherein a portion of the first clinch member is configured to be bioabsorbed in the second configuration.

37. The coupler of claim 19 , wherein less of the second clinch member is configured to be embedded in tissue in the first configuration than in the second configuration.

38. The coupler of claim 19 , wherein the coupler is configured to have a first shape in the first configuration and a second shape in the second configuration, and wherein the first and second shapes are different from one another at least because less of the first clinch member is bioabsorbed in the first configuration than in the second configuration.

39. The coupler of claim 19 , wherein the first clinch member is configured to contact a luminal wall of the first body space to stabilize the coupler in the first body space, and wherein the second clinch member is configured to contact a luminal wall of the second body space to stabilize the coupler in the second body space.

40. The method of claim 20 , wherein less of the second clinch member is configured to be embedded in tissue in the first configuration than in the second configuration.

41. The method of claim 20 , wherein the coupler is configured to have a first shape in the first configuration and a second shape in the second configuration, and wherein the first and second shapes are different from one another at least because less of the first clinch member is bioabsorbed in the first configuration than in the second configuration.

42. The method of claim 20 , wherein the first clinch member is configured to stabilize the coupler in the first body space in the first configuration, and wherein the second clinch member is configured to stabilize the coupler in the second body space in the second configuration.

43. The method of claim 20 , further comprising deploying the first clinch member and the second clinch member in a predetermined sequence.

44. The method of claim 43 , wherein the predetermined sequence comprises first deploying the first clinch member or the second clinch member and then deploying the other of the first clinch member or the second clinch member.

45. The coupler of claim 1 , wherein more of a terminal end of the first clinch member is bioabsorbed in the second configuration than in the first configuration.

46. The coupler of claim 19 , wherein the coupler comprises a bioabsorbable coating that has at least one of an anti-stenotic agent and an anti-infective agent.

47. The method of claim 19 , wherein more of a terminal end of the first clinch member is bioabsorbed in the second configuration than in the first configuration.

48. The coupler of claim 1 , wherein the first clinch member is partially bioabsorbed in the second configuration.

49. The coupler of claim 19 , wherein the first clinch member is partially bioabsorbed in the second configuration.

50. The coupler of claim 49 , wherein the entire first clinch member is bioabsorbed in the second configuration.

51. The coupler of claim 19 , wherein the first clinch member has a first clinch member length, wherein the second clinch member has a second clinch member length, and wherein the first clinch member length is less than half the second clinch member length when the coupler is in the second configuration.

52. The method of claim 20 , wherein the coupler has coating separate from the first clinch member and wherein the coating is partially bioabsorbed in the first configuration.

53. The coupler of claim 1 , wherein the time period is at least 24 hours.

54. The coupler of claim 19 , wherein the time period is at least 24 hours.

55. The method of claim 20 , wherein the time period is at least 24 hours.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2019
From: ROX MEDICAL, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 051396/0927 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 31, 2014
From: BRENNEMAN, RODNEY A.; FLAHERTY, J. CHRISTOPHER; KELLERMAN, BRAD
To: ROX MEDICAL, INC.
Reel/Frame 034715/0913 →
Continuity (6)
Continuation 12752397 · Apr 1, 2010
Continuation In Part 11696635 · Apr 4, 2007
Continuation In Part 11356876 · Feb 17, 2006
Continuation In Part 10927704 · Aug 27, 2004
Provisional Application 61170774 · Apr 20, 2009
Related Publication 20150141899A1 · May 21, 2015
Cited By (5)
US 12,285,576 US 12,310,837 US 12,318,563 US 12,527,942 US 12,691,266