Controlled porosity devices for tissue treatments, methods of use, and methods of manufacture

Patent metadata

Field	Value
Publication number	US-11007351-B2
Application number	US-201615229808-A
Country	US
Kind code	B2
Filing date	Aug 5, 2016
Priority date	Oct 6, 2011
Publication date	May 18, 2021
Grant date	May 18, 2021

Abstract

In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

First claim

The invention claimed is:

1. A balloon comprising a porous membrane consisting essentially of fibrils so that the porous membrane is substantially node-free and configured to inflate to a nominal diameter in response to introduction of a fluid at a first pressure, wherein the porous membrane defines a weeping control layer that is operable to allow fluid perfusion and the porous membrane is not imbibed or coated with a material at the weeping control layer, wherein the fluid begins to perfuse through the balloon at a second pressure, the second pressure being at least equal to or greater than the first pressure, wherein the second pressure is at least 1 atm, and wherein the porous membrane is configured to cease perfusing when the second pressure is reduced, and wherein the weeping control layer maintains a substantially stable mean flow pore size throughout the inflation, the perfusion, and the reduction of the second pressure.

2. The balloon of claim 1 , wherein the porous membrane has a bubble point of greater than 4 KPa.

3. The balloon of claim 1 , wherein the porous membrane has a bubble point of greater than 50 KPa.

4. The balloon of claim 1 , wherein the porous membrane has a bubble point of greater than 100 KPa.

5. The balloon of claim 1 , wherein the porous membrane has a bubble point of greater than 200 KPa.

6. The balloon of claim 1 , wherein the porous membrane has a bubble point of greater than 400 KPa.

7. The balloon of claim 1 , wherein the weeping control layer allows the fluid perfusion to occur at only a desired portion of the balloon.

8. The balloon of claim 1 , wherein the weeping control layer allows the fluid perfusion to occur at one or more portions of the balloon.

9. The balloon of claim 1 , wherein the weeping control layer allows the fluid perfusion across an entire surface of the porous membrane.

10. The balloon of claim 1 , wherein the weeping control layer is operable to allow the fluid perfusion and has perfusion properties that are a function of location on a weeping surface.

11. The balloon of claim 1 , wherein the porous membrane is compliant so as to conform to a surface of a blood vessel, vessel, body lumen or body cavity.

12. The balloon of claim 1 , wherein the porous membrane is compliant.

13. The balloon of claim 1 , wherein the porous membrane is longitudinally compliant.

14. The balloon of claim 1 , further comprising a wetting agent that coats the porous membrane.

15. The balloon of claim 1 , wherein the balloon is evertable.

16. The balloon of claim 1 , wherein the fluid is a gas.

17. The balloon of claim 1 , wherein the fluid is a liquid.

18. The balloon of claim 1 , wherein the fluid comprises water.

19. The balloon of claim 1 , wherein the fluid comprises a therapeutic agent.

20. The balloon of claim 19 , wherein the therapeutic agent is saline.

21. The balloon of claim 1 , wherein the fluid comprises a therapeutic agent and saline.

22. The balloon of claim 1 , wherein the fluid comprises a therapeutic agent and water.

23. The balloon of claim 1 , wherein the fluid inflates the balloon.

24. The balloon of claim 1 , wherein the porous membrane is tubular.

25. The balloon of claim 1 , wherein the porous membrane comprises a tubular structure.

26. The balloon of claim 1 , wherein the second pressure is at least 2 atm.

27. The balloon of claim 1 , wherein the second pressure is at least 6 atm.

28. The balloon of claim 1 , further comprising a textured network disposed on at least a portion of an outer surface of the porous membrane.

29. The balloon of claim 28 , wherein the textured network is a coherent irregular network contiguous with the porous membrane.

30. The balloon of claim 28 , wherein the textured network is a coherent irregular network of thermoplastic elements.

31. The balloon of claim 1 , wherein the balloon is configured to cool a blood vessel, vessel, body lumen or body cavity.

32. The balloon of claim 1 , wherein the balloon is configured to deliver cold or hot fluid during a medical procedure to control damage to a blood vessel or alter elastic or mechanical properties of the blood vessel.

33. The balloon of claim 1 , wherein the balloon is configured to impart dilation and thermal therapy to a blood vessel, vessel, body lumen or body cavity, wherein the balloon exerts a dilation force to the blood vessel, vessel, body lumen or body cavity and providing concurrent fluid perfusion through the porous membrane.

34. The balloon of claim 1 , wherein a perfusion rate of the porous membrane is about equal to or greater than an inflation rate of the balloon, wherein the perfusion rate is volume of the fluid flowing through pores of the balloon per unit time and the inflation rate is volume of influx fluid introduced into the balloon per unit time.

35. The balloon of claim 1 , wherein a perfusion rate of the fluid at a first area of the balloon is substantially equal to a perfusion rate of the fluid at a second area of the balloon that is adjacent to the first area, wherein the perfusion rate is volume of the fluid flowing through pores of the balloon per unit time.

36. A balloon comprising a porous membrane configured to inflate to a nominal diameter in response to introduction of a fluid at a first pressure, wherein the fluid begins to substantially perfuse through the balloon at a second pressure, the second pressure being at least equal to or greater than the first pressure, wherein the second pressure is at least 1 atm, wherein the porous membrane defines a weeping control layer that is operable to allow fluid perfusion and the porous membrane is not imbibed or coated with a material at the weeping control layer, wherein the porous membrane is configured to cease perfusing when the second pressure is reduced, and wherein the weeping control layer maintains a substantially stable mean flow pore size throughout the inflation, the perfusion, and the reduction of the second pressure.

37. The balloon of claim 36 , wherein the porous membrane comprises a porous microstructure consisting essentially of fibrils.

38. The balloon of claim 36 , wherein the porous membrane has a bubble point of greater than 4 KPa.

39. The balloon of claim 36 , wherein the porous membrane has a bubble point of greater than 50 KPa.

40. The balloon of claim 36 , wherein the porous membrane has a bubble point of greater than 100 KPa.

41. The balloon of claim 36 , wherein the porous membrane has a bubble point of greater than 200 KPa.

42. The balloon of claim 36 , wherein the porous membrane has a bubble point of greater than 400 KPa.

43. The balloon of claim 36 , wherein the weeping control layer allows the fluid perfusion to occur at only a desired portion of the balloon.

44. The balloon of claim 36 , wherein the weeping control layer allows the fluid perfusion to occur at one or more portions of the balloon.

45. The balloon of claim 36 , wherein the weeping control layer allows the fluid perfusion across an entire surface of the porous membrane.

46. The balloon of claim 36 , wherein

Assignees

• Gore & Ass

Inventors

• Bacino John E
• Campbell Carey V
• Cully Edward H
• Trapp Benjamin M
• Vonesh Michael J

Classifications

• A61L29/146 Primary

  Porous materials, e.g. foams or sponges · CPC title

• A61M2025/1075

  having a balloon composed of several layers, e.g. by coating or embedding · CPC title

• A61L29/16

  Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} · CPC title

• A61M2205/36

  related to heating or cooling · CPC title

• A61M25/1034

  Joining of shaft and balloon · CPC title