PROSTHESES

• US 20140358223A1
• Filed: 08/18/2014
• Published: 12/04/2014
• Est. Priority Date: 09/22/2011
• Status: Abandoned Application

• Current Assignee: MEHR Medical LLC
• Original Assignee: MEHR Medical LLC
• Inventors: Rafiee, Nasser, Groothuis, Adam, Green, G. Randall
• Application Number:
  US14/461,732
• Publication Number:
  US 20140358223A1
• Time in Patent Office: Days
• US Class Current: 623/2.13
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular

Abstract

The disclosure provides valve prostheses and methods of installation. One embodiment of the prosthesis has a generally tubular body adapted for placement proximate a mitral annulus. The tubular body has a generally tubular upper portion adapted to substantially reside in the left atrium above the mitral annulus. The generally tubular upper portion has a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium. The tubular body also includes a lower portion extending downwardly from the generally tubular upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus. The lower portion of this embodiment can be defined by an generally circumferential wall that extends downwardly from the generally tubular upper portion. The generally circumferential wall has a first circumferential end and a second circumferential end, and defines a circumferential extent therebetween.

Claims

1. A valve prosthesis, comprising a generally tubular body adapted for placement proximate a mitral annulus, the tubular body having:

a) a generally tubular upper portion adapted to substantially reside in the left atrium above the mitral annulus, the generally tubular upper portion having a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium;

b) a lower portion extending downwardly from the generally tubular upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus, the lower portion being defined by an generally circumferential wall that extends downwardly from the generally tubular upper portion, the generally circumferential wall having a first circumferential end and a second circumferential end defining a circumferential extent therebetween, the generally circumferential wall extending along a posterior portion of the left ventricle, the first and second circumferential ends of the generally circumferential wall defining a circumferential gap therebetween, the circumferential gap being of sufficient circumferential extent to substantially prevent the prosthesis from interfering with the opening and closing of a native anterior mitral valve leaflet; and

c) at least one prosthetic valve leaflet disposed within the tubular body, the at least one prosthetic valve leaflet being configured to occupy at least a portion of an opening defined by the generally tubular upper portion and the lower portion.

2. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet includes at least one posterior prosthetic valve leaflet disposed proximate a posterior region of the prosthesis, the at least one posterior prosthetic valve leaflet being configured to coapt with the native anterior mitral valve leaflet to close the mitral valve opening.

3. The valve prosthesis of claim 2, wherein the at least one posterior prosthetic valve leaflet includes a plurality of prosthetic leaflets.

4. The valve prosthesis of claim 3, wherein the plurality of prosthetic leaflets are joined to each other to form a row of leaflets along a posterior portion of the valve prosthesis.

5. The valve prosthesis of claim 2, wherein the at least one posterior prosthetic valve leaflet is substantially fixed.

6. The valve prosthesis of claim 2, wherein the at least one posterior prosthetic valve leaflet is substantially movable.

7. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet includes biological cells residing on the prosthetic material.

8. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet includes fabric.

9. The valve prosthesis of claim 1, wherein the fabric includes at least one of expanded PTFE, Dacron(R) polyester, and pericardium tissue.

10. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet is substantially formed from living tissue.

11. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is between about 90 degrees and about 270 degrees.

12. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is between about 120 degrees and about 240 degrees.

13. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is between about 150 degrees and about 210 degrees.

14. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is about 180 degrees.

15. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is configured to reside substantially between the commissures of the mitral valve along a posterior extent of the left ventricle.

16. The valve prosthesis of claim 1, wherein the prosthesis forms an open channel in the mitral annulus, and further wherein the at least one prosthetic valve leaflet is provided in a separate mechanism.

17. The valve prosthesis of claim 1, further comprising at least one transverse support extending from a first lateral portion of the prosthesis to an opposing, second lateral portion of the prosthesis to prevent prolapse of an anterior native leaflet during systole.

18. The valve prosthesis of claim 17, wherein the at least transverse support includes at least one of Dacron®

polyester material, expanded PTFE and pericardium tissue.

19. The valve prosthesis of claim 1, further comprising at least one circumferential inflatable bladder disposed along a portion of the generally circumferential wall of the lower portion, the bladder being configured to inflate outwardly from the generally circumferential wall of the lower portion and against a surface of the left ventricle to prevent flow around the outside of the valve prosthesis.

20. The valve prosthesis of claim 1, further comprising at least one circumferential inflatable bladder disposed within a portion of the generally circumferential wall of the lower portion, the inflatable bladder being configured to inflate outwardly to cause the generally circumferential wall of the lower portion to urge against an inner surface of the left ventricle to prevent flow around an outer portion of the valve prosthesis.