Method for implanting prosthetic valve

• US 9,326,852 B2
• Filed: 02/28/2013
• Issued: 05/03/2016
• Est. Priority Date: 07/08/2010
• Status: Active Grant

• Current Assignee: TrueLeaf, Ltd., Truleaf Medical Ltd.
• Original Assignee: Benjamin Spenser
• Inventors: Spenser, Benjamin
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US13/779,913
• Publication Number:
  US 20130211509A1
• Time in Patent Office: 1,160 Days
• Field of Search: 623 21- 219, 623/904, 128/898
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A method for implanting a prosthetic valve apparatus in a novel location which replaces the function of a native diseased valve after an Alfieri procedure. The prosthetic valve apparatus includes a one way valve and an expandable valve seating. anchoring and securing apparatus in a newly created orifice near or at the center of the anterior valve leaflet. The prosthetic valve apparatus also causes the sealing of the native valve and thus results in a solution for paravalvular leakage and regurgitation.

Claims

1. A method of treating a patient with a dysfunctional or diseased heart valve comprising the steps of:

(A) performing a preliminary edge to edge procedure to couple leaflets of the heart valve together edge-to-edge;

(B) piercing an aperture through a first leaflet of the valve;

(C) advancing and positioning a collapsed prosthetic valve apparatus comprising a one-way valve mounted on an expandable seating, into the aperture;

(D) expanding the expandable seating and forcing an outer edge of the first leaflet against an outer edge of a second leaflet;

the prosthetic valve providing an alternative passageway for blood flow therethrough, whilst inhibiting back-flow in systole.

2. The method of claim 1, wherein said preliminary edge to edge procedure is performed during an earlier procedure, and the present method is a further procedure to further treat the patient.

3. The method of claim 2, wherein said preliminary edge to edge procedure is selected from the group consisting of double orifice repair and paracommissural repair.

4. The method of claim 1, wherein said preliminary edge to edge procedure is selected from the group consisting of suturing, clipping and stapling leaflet edges together.

5. The method of claim 1, wherein said preliminary edge to edge procedure is an Alfieri procedure.

6. The method of claim 1, wherein the valve is a mitral valve.

7. The method of claim 1 wherein said piercing is by a technique selected from the group comprising mechanical tools, laser tools and hot wires.

8. The method of claim 1 wherein said first leaflet is an anterior leaflet.

9. The method of claim 1 further comprising at least one limitation selected from the group comprising:

(i) the first leaflet of the mitral valve is accessed via the left ventricle;

(ii) access is by a transvascular approach route;

(iii) access uses transcatheterization;

(iv) the left ventricle is accessed transapically;

(v) the left ventricle is accessed via the aortic valve.

10. The method of claim 1 wherein the first leaflet of the mitral valve is accessed via right atrium by a transvascular approach.

11. The method of claim 10, using transcatheterization or wherein the right atrium is accessed via vena cava and the left atrium is accessed by piercing septum interatrial.

12. The method of claim 1, wherein the expandable seating has at least one of the following limitations:

(i) said expandable seating is an annular member and the step of expanding the expandable seating comprises inflating a balloon within the annular member;

(ii) the expandable seating comprises a shape memory alloy that expands as it approaches body temperature;

(iii) the expandable seating comprises a super elastic alloy that expands as it released from a constraining tube (over tube);

(iv) the expandable seating is coated with a material which aids tissue growth;

(v) the expandable seating has a textured surface which engages surrounding tissue to secure valve apparatus in place;

(vi) the expandable seating comprises self-expanding shoulders which assist in securing the valve in its proper position.

13. The method of claim 1 comprising a preliminary step selected from the group consisting of:

(a) obtaining regulatory approval for the prosthetic valve for insertion into an aperture made within the first leaflet of the valve;

(b) packaging the prosthetic valve in a package labeled as appropriate for insertion into an aperture made within the first leaflet of the valve;

(c) packaging the prosthetic valve with instructions describing its suitability for insertion into an aperture made within the first leaflet of the valve;

(d) marketing the prosthetic for insertion into an aperture made within the first leaflet of the valve.

14. A method of correcting a heart valve that has been repaired by an edge to edge procedure, comprising the steps of:

(B) piercing an aperture through a first leaflet of the valve;

(C) advancing and positioning a collapsed prosthetic valve apparatus comprising a one-way valve mounted on an expandable seating, into the aperture;

(D) expanding the expandable seating and forcing an outer edge of the first leaflet against an outer edge of a second leaflet;

the prosthetic valve providing an alternative passageway for blood flow therethrough, whilst inhibiting back-flow in systole.

15. The method of claim 14, wherein the edge to edge procedure comprises suturing an anterior leaflet to a posterior leaflet to reduce mitral regurgitation.

16. The method of claim 14, wherein the edge to edge procedure comprises clipping an anterior leaflet to a posterior leaflet to reduce mitral regurgitation.

17. The method of claim 14, wherein the edge to edge procedure comprises a paracommissural repair to reduce mitral regurgitation.

18. The method of claim 14 comprising a preliminary step selected from the group consisting of:

(a) obtaining regulatory approval for the prosthetic valve for insertion into an aperture made within the first leaflet of the valve;

(b) packaging the prosthetic valve in a package labeled as appropriate for insertion into an aperture made within the first leaflet of the valve;

(c) packaging the prosthetic valve with instructions describing its suitability for insertion into an aperture made within the first leaflet of the valve;

(d) marketing the prosthetic for insertion into an aperture made within the first leaflet of the valve.

19. A method of repairing a dysfunctional or diseased heart valve comprising the steps of:

(B) piercing an aperture through a first leaflet of the valve;

(C) advancing and positioning a collapsed prosthetic valve apparatus comprising a one-way valve mounted on an expandable seating, into the aperture;

(D) expanding the expandable seating and forcing an outer edge of the first leaflet against an outer edge of a second leaflet;

the prosthetic valve providing an alternative passageway for blood flow therethrough, whilst inhibiting back-flow in systole, and

(E) joining edges of a first leaflet to a second leaflet.

20. The method of claim 19 wherein said joining is selected from the group consisting of suturing, clipping and stapling.