Method for implanting prosthetic valve

• US 20120010700A1
• Filed: 07/08/2010
• Published: 01/12/2012
• Est. Priority Date: 07/08/2010
• Status: Active Grant

• Current Assignee: TrueLeaf, Ltd., Truleaf Medical Ltd.
• Original Assignee: Benjamin Spenser
• Inventors: Spenser, Benjamin
• Granted Patent: US 8,408,214 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A method for implanting a prosthetic valve apparatus in a novel location which replaces the function of a native diseased valve. 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 valve comprising the steps of:

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

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

(C) expanding the expandable seating and forcing an outer edge of the first leaflet against an outer edge of a second leaflet, thereby inhibiting the natural separating of the first and second leaflets in systole by forcing the outer edges of the leaflets together and preventing their separation;

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 valve is a mitral valve.

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

4. The method of claim 2 wherein said first leaflet is an anterior leaflet.

5. The method of claim 2 wherein the first leaflet of the mitral valve is accessed via the left ventricle.

6. The method of claim 5 wherein said access is by a transvascular approach route.

7. The method of claim 5 wherein said access uses transcatheterization.

8. The method of claim 5 wherein the left ventricle is accessed transapically.

9. The method of claim 8 wherein said piercing is performed when the heart is in systole causing the anterior mitral valve leaflet to coapt with the posterior mitral leaflet.

10. The method of claim 5 wherein the left ventricle is accessed via the aortic valve.

11. The method of claim 10, wherein said piercing is performed when the heart is in systole causing the anterior mitral valve leaflet to coapt with the posterior mitral leaflet.

12. The method of claim 2 wherein the first leaflet of the mitral valve is accessed via right atrium by a transvascular approach.

13. The method of claim 12, using transcatheterization.

14. The method of claim 12 wherein the right atrium is accessed via vena cava and the left atrium is accessed by piercing septum interatrial.

15. 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.

16. The method of claim 1 comprising a preliminary step of obtaining regulatory approval for the prosthetic valve for insertion into an aperture made within the first leaflet of the valve.

17. The method of claim 1 comprising a preliminary step of packaging the prosthetic valve in a package labeled as appropriate for insertion into an aperture made within the first leaflet of the valve.

18. The method of claim 1 comprising a preliminary step of packaging the prosthetic valve with instructions describing its suitability for insertion into an aperture made within the first leaflet of the valve.

19. The method of claim 1 comprising a preliminary step of marketing the prosthetic for insertion into an aperture made within the first leaflet of the valve.

21. The method of claim 1 comprising a preliminary step of inflating a balloon in the aortic valve.

20. A prosthetic valve apparatus comprising an expandable valve seating and a one-way valve coupled to the seating for engageable insertion into an aperture through a mitral valve leaflet to provide a route for unidirectional blood through from a left atrium into a left ventricle of a heart in lieu of natural mitral valve.