Valve assembly for medical procedures

• US 20090306598A1
• Filed: 06/03/2009
• Published: 12/10/2009
• Est. Priority Date: 06/04/2008
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Arcaro, David J., Wilkie, William
• Granted Patent: US 9,314,605 B2
• Time in Patent Office: Days
• US Class Current: 604/167.30
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/228 with a tubular diaphragm constrictable by radial fluid force
• CPC Class Codes: B29C 64/135 the energy source being concentrated, e.g. scanning lasers or focused light sources
• CPC Class Codes: B29L 2031/7546 Surgical equipment
• CPC Class Codes: B33Y 10/00 Processes of additive manufacturing
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: Y10T 29/49764 with testing or indicating
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49904 Assembling a subassembly, then assembling with a second subassembly
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall

Abstract

The invention relates to a valve used in medical procedures. More specifically the invention relates to an introducer sheath valve used in minimally invasive and conventional surgical procedures. The valve may accommodate a wide range of surgical implement diameters, shapes, and multiple implements without imposing the high frictional forces of known valves.

Claims

1. An introducer sheath valve comprising:

an outer tube;

an inner tube comprised of porous substrate; and

a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube.

2. The introducer sheath valve of claim 1, wherein the porous substrate comprises a polymer.

3. The introducer sheath valve of claim 1, further comprising at least one polymer filling at least a portion of the porous substrate.

4. The introducer sheath valve of claim 2, further comprising at least one polymer filling at least a portion of the porous substrate.

5. The introducer sheath valve of claim 1, wherein the pressurizable space is pressurized with at least one substance to a sufficient pressure to cause the inner tube to collapse.

6. The introducer sheath valve of claim 5, wherein the pressure is sufficient to prevent back bleeding.

7. The introducer sheath valve of claim 5, wherein at least one interventional device can be advanced through the inner tube.

8. The introducer sheath valve of claim 1, wherein the inner tube comprises a lubricious material.

9. The introducer sheath valve of claim 1, wherein the inner tube comprises a material selected from the group consisting of ePTFE (expanded polytetrafluoroethylene), fabrics, silk, and Kevlar®

.

10. The introducer sheath valve of claim 9, wherein the inner tube comprises ePTFE.

11. The introducer sheath valve of claim 5, wherein the at least one substance comprises a material selected from the group consisting of air, silicone, water, saline solution, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, elastomeric spheres, and crosslinked silicone gels.

12. The introducer sheath valve of claim 1, wherein the pressurizable space is formed by sealing a first end of the outer tube to a first end of the inner tube and sealing a second end of the outer tube to a second end of the inner tube.

13. The introducer sheath valve of claim 12, wherein the sealing is accomplished by at least one of the following:

interference fit, adhesion, thermal bond, and insert molding.

14. The introducer sheath valve of claim 13, wherein the interference fit is formed using at least one o-ring.

15. The introducer sheath valve of claim 1, wherein the pressurizable space maintains a pressure wherein the pressure is attained by an external source.

16. The introducer sheath of claim 15, where in the pressure is attained by at least one of the following:

finger pressure, a leaf spring, and filled syringe.

17. An introducer sheath valve comprising:

an outer tube;

an inner tube having a thickness of about 0.0025 mm to about 1 mm; and

a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube.

18. The introducer sheath valve of claim 17, wherein the porous substrate comprises a polymer.

19. The introducer sheath valve of claim 17, further comprising at least one polymer filling at least a portion of the porous substrate.

20. The introducer sheath valve of claim 18, further comprising at least one polymer filling at least a portion of the porous substrate.

21. The introducer sheath valve of claim 17, wherein the pressurizable space is pressurized with at least one substance to a sufficient pressure to cause the inner tube to collapse.

22. The introducer sheath valve of claim 21, wherein the pressure is sufficient to prevent back bleeding.

23. The introducer sheath valve of claim 21, wherein at least one interventional device can be advanced through the inner tube.

24. The introducer sheath valve of claim 17, wherein the inner tube comprises a lubricious material.

25. The introducer sheath valve of claim 17, wherein the inner tube comprises a material selected from the group consisting of ePTFE, fabrics, silk, and Kevlar®

.

26. The introducer sheath valve of claim 25, wherein the inner tube comprises ePTFE.

27. The introducer sheath valve of claim 21, wherein the at least one substance comprises a material selected from the group consisting of air, silicone, water, saline solution, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, and crosslinked silicone gels.

28. The introducer sheath valve of claim 17, wherein the pressurizable space is formed by sealing a first end of the outer tube to a first end of the inner tube and sealing a second end of the outer tube to a second end of the inner tube.

29. The introducer sheath valve of claim 28, wherein the sealing is accomplished by at least one of the following:

interference fit, adhesion, thermal bond, and insert molding.

30. The introducer sheath valve of claim 29, wherein the interference fit is formed using at least one o-ring.

31. The introducer sheath valve of claim 17, wherein the pressurizable space maintains a pressure wherein the pressure is attained by an external source.

32. The introducer sheath of claim 31, wherein the pressure is attained by at least one of the following:

finger pressure, a leaf spring, and filled syringe.

33. An introducer sheath valve comprising:

an outer tube;

an inner tube comprising ePTFE; and

a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube.

34. The introducer sheath valve of claim 33, wherein the porous substrate comprises a polymer.

35. The introducer sheath valve of claim 33, further comprising at least one polymer filling at least a portion of the porous substrate.

36. The introducer sheath valve of claim 34, further comprising at least one polymer filling at least a portion of the porous substrate.

37. The introducer sheath valve of claim 33, wherein the pressurizable space is pressurized with at least one substance to a sufficient pressure to cause the inner tube to collapse.

38. The introducer sheath valve of claim 37, wherein the pressure is sufficient to prevent back bleeding.

39. The introducer sheath valve of claim 37, wherein at least one interventional device can be advanced through the inner tube.

40. The introducer sheath valve of claim 37, wherein the at least one substance comprises a material selected from the group consisting of air, silicone, water, saline solution, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, and crosslinked silicone gels.

41. The introducer sheath valve of claim 33, wherein the pressurizable space is formed by sealing a first end of the outer tube to a first end of the inner tube and sealing a second end of the outer tube to a second end of the inner tube.

42. The introducer sheath valve of claim 41, wherein the sealing is accomplished by at least one of the following:

interference fit, adhesion, thermal bond, and insert molding.

43. The introducer sheath valve of claim 42, wherein the interference fit is formed using at least one o-ring.

44. The introducer sheath valve of claim 33, wherein the pressurizable space maintains a pressure wherein the pressure is attained by an external source.

45. The introducer sheath of claim 44, wherein the pressure is attained by at least one of the following:

finger pressure, a leaf spring, and filled syringe.

46. A method of assembling an introducer sheath valve comprising:

(a) providing an outer tube;

(b) attaching a snap ring one end of the outer tube and attaching a snap ring will fill port to another end of the outer tube forming an outer tube assembly;

(c) attaching a ring to each end of an inner tube forming an inner tube assembly;

(d) threading the inner tube assembly through the outer tube assembly;

(e) attaching the inner tube assembly to a front fitting;

(f) snapping the outer tube assembly onto the surface of the front fitting;

(g) attaching the inner tube assembly to a rear fitting;

(h) snapping the snap ring with a fill port on the outer tube assembly and the rear fitting closed;

(i) filling a pressurizable space through the fill port prior to use.

47. A method of assembling an introducer sheath valve comprising:

(a) providing an outer tube;

(b) attaching a snap ring one end of the outer tube and attaching a snap ring will fill port to another end of the outer tube forming an outer tube assembly;

(c) attaching an inner tube to a front fitting;

(d) threading the inner tube through the outer tube assembly;

(e) snapping the outer tube assembly onto the surface of the front fitting;

(f) attaching the inner tube to a rear fitting;

(g) snapping the snap ring with fill port on the outer tube assembly and the rear fitting closed;

(h) filling a pressurizable space through the fill port prior to use.

48. A method of assembling an introducer sheath valve comprising:

(a) providing an outer tube;

(b) attaching a snap ring to both ends of the outer tube forming an outer tube assembly;

(c) attaching a ring to each end of an inner tube forming an inner tube assembly;

(d) threading the inner tube assembly through the outer tube assembly;

(e) attaching the inner tube assembly to a front fitting;

(f) snapping the outer tube assembly onto the surface of the front fitting;

(g) attaching the inner tube assembly to a rear fitting;

(h) filling with a substance a space formed between the inner tube and the outer tube assembly;

(i) snapping the snap ring on the outer tube assembly and the rear fitting closed;

(j) removing all excess fluid from the outer tube housing unit.

49. A method of assembling an introducer sheath valve comprising:

(a) providing an outer tube;

(b) attaching a snap ring to both ends the outer tube forming an outer tube assembly;

(c) attaching an inner tube to a threaded adapter;

(d) threading the inner tube through the outer tube assembly;

(e) snapping the outer tube assembly onto the surface of the threaded adaptor;

(f) attaching the inner tube to a rear fitting;

(g) filling with a substance a space formed between the inner tube and the outer tube housing;

(h) snapping the inner tube and the rear fitting closed;

(i) removing all excess fluid from the outer tube housing unit.