Endoluminal cardiac and venous valve prostheses and methods of manufacture and delivery thereof

• US 20030023300A1
• Filed: 09/30/2002
• Published: 01/30/2003
• Est. Priority Date: 12/31/1999
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: ABPS Venture One, Ltd. (Palmaz Scientific, Inc.)
• Inventors: Bailey, Steven R., Boyle, Christopher T.
• Granted Patent: US 7,338,520 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

This invention relates to prosthetic cardiac and venous valves and a single catheter device and minimally invasive techniques for percutaneous and transluminal valvuloplasty and prosthetic valve implantation.

Claims

1. An implantable valvular prosthesis, comprising:

a. a stent body member having lumenal and ablumenal surfaces thereof and a central annular opening along a central longitudinal axis of the stent body member;

b. a graft member covering at least a portion of at least one of the lumenal and ablumenal surfaces of the stent body member;

c. at least one biasing arm projecting from the stent body member and into the central annular opening of the stent body member; and

d. at least one valve flap member coupled to the at least one biasing arm and to at least a portion of the graft member, the at least one valve flap member assuming a position, under zero pressure differential across the prosthesis, which occludes the central annular opening of the stent body member.

2. The implantable valvular prosthesis according to claim 1, wherein the stent body member further comprises a proximal anchoring section.

3. The implantable valvular prosthesis according to claim 1, wherein the stent body member further comprises a distal anchoring section.

4. The implantable valvular prosthesis according to claim 2, wherein the stent body further comprises a distal anchoring section.

5. The implantable valvular prosthesis according to claim 2, wherein the proximal anchoring section further comprises a plurality of stent struts which project radially outward away from the central longitudinal axis of the stent body member.

6. The implantable valvular prosthesis according to claim 3, wherein the distal anchoring section further comprises a radially enlarged section of the stent body member which communicates with the central annular opening of the stent body member.

7. The implantable valvular prosthesis according to claim 1, wherein the graft member further comprises an outer graft member coupled to the ablumenal surface of the stent body member.

8. The implantable valvular prosthesis according to claim 1, wherein the graft member further comprises an inner graft member coupled to the lumenal surface of the stent body member.

9. The implantable valvular prosthesis according to claim 7, wherein the graft member further comprises an inner graft member coupled to the lumenal surface of the stent body member.

10. The implantable valvular prosthesis according to claim 4, wherein the distal anchor section further comprises a diametrically enlarged section of the stent body member.

11. The implantable valvular prosthesis according to claim 10, wherein the proximal anchor section further comprises a flange which projects radially outward and away from the central longitudinal axis of the stent body member.

12. The implantable valvular prosthesis according to claim 11, wherein the flange projects substantially perpendicular to the central longitudinal axis of the stent body member.

13. The implantable valvular prosthesis according to claim 10, wherein the proximal anchor section further comprises a diametrically enlarged section of the stent body member.

14. The implantable valvular prosthesis according to claim 4, wherein proximal and the distal anchor sections of the stent body member each further comprise a flange which projects radially outward and away from the central longitudinal axis of the stent body member.

15. The implantable valvular prosthesis according to claim 14, wherein the flanges of each of the proximal and distal anchor section of the stent body member project substantially perpendicular to the central longitudinal axis of the stent body member.

16. The implantable valvular prosthesis according to claim 4, wherein the each of the proximal and the distal anchor sections further comprise diametrically enlarged sections of the stent body member.

17. The implantable valvular prosthesis according to claim 10, wherein the at least one biasing arm has a length which is greater than a length of a radius of the central annular opening of the stent body member.

25. The implantable septal prosthesis according to claim 27, wherein proximal and the distal anchor sections of the stent body member each further comprise a flange which projects radially outward and away from the central longitudinal axis of the stent body member.

26. The implantable valvular prosthesis according to claim 4, wherein proximal and the distal anchor sections of the stent body member each further comprise a flange which projects radially outward and away from the central longitudinal axis of the stent body member.

27. The implantable valvular prosthesis according to claim 14, wherein the flanges of each of the proximal and distal anchor section of the stent body member project substantially perpendicular to the central longitudinal axis of the stent body member.

28. The implantable valvular prosthesis according to claim 26, wherein the flange further comprises an oriented opening in the flange.

18. An implantable valvular prosthesis, comprising:

a. a tubular stent body member comprising a plurality of spaced struts with interstices intermediate adjacent pairs of struts, the tubular stent body having lumenal and ablumenal surfaces thereof, a central annular opening along a central longitudinal axis of the stent body member, a proximal anchor section, a distal anchor section and an intermediate annular section;

b. a graft member covering at least a portion of at least one of the lumenal and ablumenal surfaces of the stent body member;

c. biasing arms projecting from the stent body member at a proximal end of the intermediate annular section and into the central annular opening of the stent body member; and

d. valve flap members coupled to the biasing arms and to at least a portion of the graft member, the valve flap members assuming a closed position under zero strain load conditions.

19. The implantable valvular prosthesis according to claim 18, wherein proximal and the distal anchor sections of the stent body member each further comprise a flange which projects radially outward and away from the central longitudinal axis of the stent body member.

20. The implantable valvular prosthesis according to claim 19, wherein the flanges of each of the proximal and distal anchor section of the stent body member project substantially perpendicular to the central longitudinal axis of the stent body member.

21. The implantable valvular prosthesis according to claim 18, wherein the each of the proximal and the distal anchor sections further comprise diametrically enlarged sections of the stent body member.

22. The implantable valvular prosthesis according to claim 18, wherein the proximal anchor section further comprises a flange section which projects radially outward from the stent body member away from the central longitudinal axis of the stent body member, and distal anchor section further comprises a diametrically enlarged section of the stent body member.

23. The implantable valvular prosthesis according to claim 22, wherein the flange section projects substantially perpendicular away from the central longitudinal axis of the stent body member.

24. An implantable septal prosthesis, comprising:

a. a tubular stent body member comprising a plurality of spaced struts with interstices intermediate adjacent pairs of struts, the tubular stent body having lumenal and ablumenal surfaces thereof, a central annular opening along a central longitudinal axis of the stent body member, a proximal anchor section, a distal anchor section and an intermediate annular section;

b. a graft member covering at least a portion of at least one of the lumenal and ablumenal surfaces of the stent body member and subtending the central annular opening of the tubular stent body member.