Implantable transcatheter intracardiac devices and methods for treating incompetent atrioventricular valves

• US 10,383,726 B2
• Filed: 01/13/2016
• Issued: 08/20/2019
• Est. Priority Date: 01/13/2015
• Status: Active Grant

• Current Assignee: George Kramer
• Original Assignee: George Kramer
• Inventors: Kramer, George
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/994,881
• Publication Number:
  US 20160199181A1
• Time in Patent Office: 1,315 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Heart valve implants and methods utilizing those valves designed to reduce or eliminate the regurgitant jet associated with an incompetent atrioventricular valve. The heart valve implants, which are deployed via a transcatheter venous approach, comprise a collapsible framework connected to an anchored guide shaft, a valve portion and an apron which permits ingrowth of native heart tissue into the apron.

Claims

1. A heart valve implant comprising:

a guide shaft comprising a distal end and a proximal end;

an anchor coupled to said guide shaft proximate said distal end;

a valve connector connected to said guide shaft;

a framework connected to valve connector and extending radially outwardly from said valve connector;

said framework comprising a first portion extending radially outwardly from said valve connector and a second portion extending further radially outwardly from said first portion of said framework;

a valve portion connected to said framework and disposed proximate to and distally of said first portion of said framework, at least a portion of said valve portion is movable away from said framework during diastole and into contact with said framework during systole; and

an apron connected to said framework and disposed proximate to and distally of said second portion of said framework, said apron comprising material which permits ingrowth of native heart tissue.

2. A heart valve implant according to claim 1 wherein said valve connector is selectively positionable at different locations on said guide shaft.

3. A heart valve implant according to claim 2 wherein said valve connector comprises a substantially hollow tube.

4. A heart valve implant according to claim 1 wherein said valve connector comprises a substantially hollow tube.

5. A heart valve implant according to claim 4 wherein said valve connector comprises a substantially hollow tube formed of nitinol.

6. A heart valve implant according to claim 4 wherein said valve connector comprises a substantially hollow tube formed of braided nitinol wire.

7. A heart valve implant according to claim 6 wherein said framework is integrally formed of nitinol wires which form said tube.

8. A heart valve implant according to claim 1 wherein said valve connector comprises a substantially hollow tube having a diameter of less than 8 Fr.

9. A heart valve implant according to claim 1 wherein said valve connector comprises a substantially hollow tube having a diameter of less than 6 Fr.

10. A heart valve implant according to claim 1 wherein said framework comprises at least eight collapsible fingers.

11. A heart valve implant according to claim 1 wherein said first portion of said framework comprises fingers disposed at an angle of about 90°

to about 170°

to a longitudinal axis passing through the center of said valve connector.

12. A heart valve implant according to claim 1 wherein said first portion of said framework comprises fingers disposed at an angle of about 100°

to about 140°

with a longitudinal axis passing through the center of said valve connector.

13. A heart valve implant according to claim 12 wherein said second portion of said framework is disposed at an angle of about 120°

to about 170°

to said first portion of said framework.

14. A heart valve implant according to claim 12 wherein said second portion of said framework is disposed at an angle of about 135°

to about 170°

to said first portion of said framework.

15. A heart valve implant according to claim 1 wherein said framework comprises collapsible fingers, said first portion and said second portion of said framework comprising sections of said fingers such that each of said fingers comprises an inner portion and an outer portion, said fingers further comprise tips which are angled proximally relative to said second portion.

16. A heart valve implant according to claim 1 wherein said framework comprises collapsible fingers, said first portion and said second portion of said framework comprising sections of said fingers such that each of said fingers comprises a center portion and an outer portion, said fingers further comprise tips which are curved proximally relative to said second portion.

17. A heart valve implant according to claim 1 wherein said framework comprises collapsible fingers, said first portion and said second portion of said framework comprising sections of said fingers such that each of said fingers comprises an inner portion and an outer portion, said fingers further comprise tips which are coiled proximally relative to said second portion.

18. A heart valve implant according to claim 1 wherein said framework comprises at least eight collapsible fingers, said first portion and said second portion of said framework comprising sections of said fingers such that each of said fingers comprises an inner portion and an outer portion, wherein said outer portion is disposed at an angle of about 80°

to about 100°

with a longitudinal axis passing through the center of said valve connector.

19. A heart valve implant according to claim 1 wherein said framework comprises at least eight collapsible fingers, said first portion and said second portion of said framework comprising sections of said fingers such that each of said fingers comprises an inner portion and an outer portion, wherein said outer portion is disposed at an angle of less than 90°

with a longitudinal axis passing through the center of said valve connector.

20. A heart valve implant according to claim 1 wherein said guide shaft comprises flexible polyurethane.

21. A heart valve implant according to claim 1 wherein said guide shaft comprises a silicone.

22. A heart valve implant according to claim 1 wherein said guide shaft comprises a polyether-polyurethane co-polymer.

23. A heart valve implant according to claim 1 wherein said anchor is generally helically-shaped.

24. A heart valve implant according to claim 1 wherein said apron comprises a material selected from the group consisting of expanded PTFE, porcine tissue, bovine tissue and canine tissue.

25. A heart valve implant according to claim 24 wherein said tissue comprises processed small intestine submucosa or processed pericardium.

26. A heart valve implant according to claim 1 wherein said apron comprises a center opening and said valve portion is dimensioned to prevent the flow of blood through said center opening during systole.

27. A heart valve implant according to claim 1 wherein said valve portion comprises a ring portion and a plurality of leaflets.

28. A heart valve implant according to claim 27 wherein said leaflets are integrally formed with said ring portion.

29. A heart valve implant according to claim 1 wherein said valve portion comprises a generally tubular shape.

30. A heart valve implant according to claim 1 wherein said valve portion comprises a material selected from the group consisting of expanded PTFE, porcine tissue, bovine tissue and canine tissue.

31. A heart valve implant according to claim 30 wherein said tissue comprises processed small intestine submucosa or processed pericardium.

32. A heart valve implant according to claim 1 wherein said valve portion comprises discernible markers which can be detected radiographically during surgery.