IP Library › Granted Patent US 12,447,013
Granted Patent B2
US 12,447,013 · App. 17/556,830 · Granted Oct 21, 2025

Apparatus and method for replacing a diseased cardiac valve

Inventors: Jose Luis Navia (Shaker Heights, OH); Ji-Feng Chen (Lakewood, OH); Qun Zhou (Lakewood, OH)
Assignees: The Cleveland Clinic Foundation; EDWARDS LIFESCIENCES CORPORATION
A61F2/2418A61F2/2412A61F2/2436A61F2210/0004A61F2210/0014A61F2220/0008A61F2220/005A61F2220/0066A61F2220/0075A61F2230/0054A61F2230/0069A61F2230/0078A61F2250/006A61F2250/0098A61F2310/00023
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Quick Facts
Patent No.
US 12,447,013
App. No.
17/556,830
Granted
Oct 21, 2025
Kind
B2
Abstract

A method for replacing a native atrioventricular heart valve includes inserting a delivery catheter into the heart with a prosthetic apparatus retained in a compressed state inside of the delivery catheter. The prosthetic apparatus includes an annular anchoring member having a mesh structure made of Nitinol and defining a plurality of circumferentially extending rows of cells. A fabric layer is attached to an inner surface of the anchoring member. An annular support member made of Nitinol is disposed within the anchoring member. The support member is attached to the anchoring member with sutures. A prosthetic valve made of biological tissue is disposed within and secured to the support member. The method further includes allowing the prosthetic apparatus to self-expand to a radially expanded state in which the anchoring member contacts tissue of the native atrioventricular valve.

Claims (26)

1. A method for replacing a native atrioventricular valve of a heart, the method comprising:

inserting a delivery catheter into the heart with a prosthetic apparatus retained in a radially compressed state inside of the delivery catheter, wherein the prosthetic apparatus comprises an annular anchoring member comprising a mesh structure made of Nitinol and defining a plurality of circumferentially extending rows of cells that extend continuously around the anchoring member, a fabric layer attached to and covering an inner surface of the anchoring member, an annular support member made of Nitinol and disposed within the anchoring member, wherein the support member is pre-attached to the anchoring member with sutures before placing the prosthetic apparatus within the delivery catheter, and a prosthetic valve made of biological tissue disposed within and secured to the support member; and

deploying the prosthetic apparatus from a distal end of the delivery catheter, thereby allowing the prosthetic apparatus to self-expand to a radially expanded state in which the anchoring member contacts tissue of the native atrioventricular valve.

2. The method of claim 1 , wherein the fabric layer also extends over a portion of an outer surface of the anchoring member.

3. The method of claim 1 , wherein the anchoring member comprises an inlet end portion, an outlet end portion, and a main body portion extending between the inlet end portion and the outlet end portion, and wherein after the apparatus self-expands to the radially expanded state, the inlet end portion of the anchoring member extends radially outwardly from the main body portion and contacts a superior aspect of the native atrioventricular valve.

4. The method of claim 1 , wherein the anchoring member contacts and conforms to the annulus of the native atrioventricular valve when the prosthetic apparatus is deployed from the delivery catheter and expands to the radially expanded state.

5. The method of claim 1 , wherein the support member has an inlet end that is spaced downstream from an inlet end of the anchoring member.

6. The method of claim 1 , wherein the native atrioventricular valve is a native tricuspid valve.

7. The method of claim 1 , wherein the native atrioventricular valve is a native mitral valve.

8. The method of claim 1 , wherein support member has a first length extending from an inlet end to an outlet end of the support member, the anchoring member has a second length extending from an inlet end to an outlet end of the anchoring member, wherein the second length is greater than the first length.

9. The method of claim 1 , wherein the support member is cylindrical.

10. A method for replacing a native atrioventricular valve of a heart, the method comprising:

inserting a delivery catheter into the heart with a prosthetic apparatus retained in a radially compressed state inside of the delivery catheter, wherein the prosthetic apparatus comprises an annular anchoring member made of Nitinol, annular support member made of Nitinol and disposed within and pre-attached to the anchoring member before placing the prosthetic apparatus in the delivery catheter, and a prosthetic valve disposed within and secured to the support member, wherein the anchoring member comprises a first end portion, a second end portion, and a main body portion extending between the first and second portions; and

deploying the prosthetic apparatus from a distal end of the delivery catheter, thereby allowing the prosthetic apparatus to self-expand to a radially expanded state in which the main body portion of the anchor member contacts and conforms to the annulus of the native atrioventricular valve.

11. The method of claim 10 , wherein the main body portion of the anchoring member has an inner surface defining a channel and wherein the support member and the prosthetic valve are disposed within the channel.

12. The method of claim 10 , further comprising a fabric layer attached to an outer surface of the anchoring member.

13. The method of claim 10 , further comprising a fabric layer attached to an inner surface of the anchoring member.

14. The method of claim 10 , further comprising a fabric layer attached to an inner surface of the anchoring member and to an outer surface of the anchoring member.

15. The method of claim 10 , wherein after the prosthetic apparatus self-expands to the radially expanded state, the first end portion of the anchoring member extends radially outwardly from the main body portion and contacts a superior aspect of the native atrioventricular valve.

16. The method of claim 10 , wherein the prosthetic valve has an inlet end and an outlet end, wherein the inlet end of the prosthetic valve is spaced downstream from an inlet end of the anchoring member and the outlet end of the prosthetic valve is spaced upstream from an outlet end of the anchoring member.

17. The method of claim 10 , wherein the anchoring member includes radiopaque markers to facilitate fluoroscopic visualization.

18. The method of claim 10 , wherein the prosthetic apparatus includes a therapeutic agent that is eluded into cardiac tissue or blood after the prosthetic apparatus is deployed within the heart.

19. A method for replacing a native atrioventricular valve of a heart, the method comprising:

inserting a delivery catheter into the heart with a prosthetic apparatus retained in a radially compressed state inside of the delivery catheter, wherein the prosthetic apparatus comprises an annular anchoring member made of Nitinol, a fabric layer attached to and covering an inner surface of the anchoring member, an annular support member made of Nitinol and disposed within and pre-attached to the anchoring member before placing the prosthetic apparatus in the delivery catheter, a prosthetic valve made of biological tissue and disposed within and secured to the support member, wherein the anchoring member comprises an inlet end portion, an outlet end portion, and a main body portion extending between the inlet end portion and the outlet end portion, wherein the anchoring member further comprises a mesh structure defining a plurality of circumferentially extending rows of cells that extend continuously around the anchoring member; and

deploying the prosthetic apparatus from a distal end of the delivery catheter, thereby allowing the prosthetic apparatus to self-expand to a radially expanded state in which the main body portion of the anchor member contacts and conforms to the annulus of the native atrioventricular valve.

20. The method of claim 19 , wherein after the prosthetic apparatus self-expands to the radially expanded state, the inlet first end portion of the anchoring member extends radially outwardly from the main body portion and contacts a superior aspect of the native atrioventricular valve.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2023
From: NAVIA, JOSE LUIS; CHEN, JI-FENG; ZHOU, QUN
To: THE CLEVELAND CLINIC FOUNDATION
Reel/Frame 062638/0643 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2022
From: THE CLEVELAND CLINIC FOUNDATION
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 059833/0455 →
Continuity (4)
Continuation 17067580 · Oct 9, 2020
Continuation 12769593 · Apr 28, 2010
Provisional Application 61173782 · Apr 29, 2009
Related Publication 20220110748A1 · Apr 14, 2022
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