LEAFLET CONTACTING APPARATUS AND METHOD

• US 20110077733A1
• Filed: 09/25/2009
• Published: 03/31/2011
• Est. Priority Date: 09/25/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Solem, Jan Otto
• Application Number:
  US12/567,047
• Publication Number:
  US 20110077733A1
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A prosthesis can include a leaflet contacting member and an anchoring member. The leaflet contacting member can have an outer surface and an aperture that extends through at least a portion of the leaflet contacting member. The outer surface of the leaflet contacting member can be configured to contact one or more leaflets of the heart valve during coaptation of the leaflets, and the contact of the leaflets with the outer surface can prevent the leaflets from contacting one or more wires that extend through the aperture of the leaflet contacting member.

Claims

1. A prosthesis for positioning within an annulus of a heart valve, the prosthesis comprising:

a leaflet contacting member having an outer surface, an inflow side, an outflow side, and an aperture that extends through at least a portion of the leaflet contacting member, the aperture being sized to allow one or more wires to extend through the leaflet contacting member from the inflow side to the outflow side; and

an anchoring member coupled to the leaflet contacting member, the anchoring member configured to anchor the leaflet contacting member within the annulus of a heart valve,

wherein the outer surface is configured to contact one or more leaflets of the heart valve during coaptation of the leaflets, and the contact of the leaflets with the outer surface prevents the leaflets from contacting the one or more wires when positioned to extend through the aperture of the leaflet contacting member.

2. The prosthesis of claim 1, wherein the aperture has a width that is substantially the same as the width of the one or more wires that extend through the aperture, thereby substantially restricting blood flow through the aperture when the one or more wires extend through the aperture.

3. The prosthesis of claim 1, further comprising:

a plug member configured to restrict blood flow through the aperture when the one or more wires extend through the aperture.

4. The prosthesis of claim 1, wherein the anchoring member has a compressed state sized to fit within a delivery catheter and an expanded state sized for fixation on at least a portion of a wall of a left atrium.

5. The prosthesis of claim 4, wherein the anchoring member comprises a plurality of loops formed of a shape memory material.

6. The prosthesis of claim 1, wherein the anchoring structure extends into the right ventricle and is secured to a wall of the right ventricle.

7. The prosthesis of claim 1, wherein the anchoring structure comprises an electrode tip coupled to a distal end of the one or more wires.

8. The prosthesis of claim 1, wherein the leaflet contacting member comprises an expandable member, the expandable member having an expanded state that restricts blood flow between the leaflets and the leaflet contacting member and a contracted state that allows blood to flow between the leaflets and the leaflet contacting member.

9. The prosthesis of claim 1, wherein the leaflet contacting member has a length that is substantially equal to a length of a commissure of the leaflets.

10. The prosthesis of claim 9, wherein the aperture is positioned at a substantially central location along the length of the leaflet contacting member.

11. The prosthesis of claim 9, wherein the aperture is positioned off center relative to the length of the leaflet contacting member.

12. A system for preventing contact between a wire and one or more valve leaflets, the system comprising:

a prosthetic device comprising a main body that is sized for placement at least partially between two valve leaflets that are movable between an open state and a closed state, the main body comprising an opening that extends from a first side of the main body to a second side of the main body; and

at least one wire configured to extend through the opening of the main body from the first side to the second side,

wherein the opening is spaced apart from an outer perimeter of the main body so that, when the prosthetic device is placed between the two valve leaflets, the wire does not contact either of the two valve leaflets when the valve leaflets are in the open or closed states.

13. The system of claim 12, wherein the prosthetic device further comprises an anchoring member, the anchoring member being configured to securely hold the main body at least partially between the two valve leaflets.

14. The system of claim 13, wherein the anchoring member has a compressed state sized to fit within a delivery catheter and an expanded state sized for fixation on at least a portion of a wall of a left atrium.

15. The system of claim 14, wherein the anchoring member comprises a plurality of loops formed of a shape memory material.

16. The system of claim 12, wherein the opening is substantially the same size as the one or more wires that extend through the opening, thereby substantially restricting blood flow through the opening when the one or more wires extend through the opening.

17. The system of claim 12, wherein the main body further comprises an expandable member having an outer surface that surrounds the aperture, the expandable member having an expanded state that restricts blood flow between the leaflets and the outer surface of the expandable member and a contracted state that allows blood to flow between the leaflets and the outer surface of the leaflet contacting member.

18. The system of claim 12, wherein the main body has a length that is substantially equal to a length of a commissure of the leaflets.

19. A method for delivering a wire through a valve of the heart, the method comprising:

providing a leaflet contacting member having an outer surface and an aperture passing through the leaflet contacting member;

positioning the leaflet contacting member at least partially between two leaflets of a valve so that the outer surface of the leaflet contacting member contacts the leaflets when the leaflets undergo coaptation; and

passing one or more wires through the aperture of the leaflet contact member, the aperture being positioned such that the one or more wires do not contact the leaflets.

20. The method of claim 19, further comprising:

providing an anchoring member coupled to the prosthetic device; and

anchoring the leaflet contacting member at least partially between the two leaflets.

21. The method of claim 19, further comprising:

providing a plug member; and

positioning the plug member at or around the aperture to restrict blood flow through the aperture.

22. A diagnostic tool comprising:

an elongate member having a proximal portion, a distal portion, and a distal opening, the elongate member having a lumen that extends from the proximal portion to the distal portion;

a temporary coaptation member coupled to the distal portion of the elongate member at an attachment portion, the temporary coaptation member being configured to be positioned between two leaflets,

wherein the attachment portion is located proximally to the distal opening in the elongate member, the distal opening being in fluid connection with the lumen.

23. The tool of claim 22, further comprising a fluid delivery device coupled to the proximal portion of the diagnostic tool and configured to pump fluid from the proximal portion to the distal portion.

24. The tool of claim 22, wherein the temporary coaptation member comprises an expandable member that has an expanded state that restricts blood flow between the leaflets and the expandable member and a contracted state that allows blood to flow between the leaflets and the expandable member.

25. A method of using a diagnostic tool for determining an effectiveness of an temporary coaptation member to minimize regurgitation in a heart valve in a body of a patient;

the method comprising;

providing an elongate member having a proximal portion and a distal portion;

providing an temporary coaptation member coupled to the distal portion of the elongate member;

positioning the temporary coaptation member at least partially between two leaflets of heart valve, the leaflets being movable between an open state and a closed state;

monitoring the effectiveness of the temporary coaptation member in restricting blood flow between the leaflets and the temporary coaptation member when the leaflets are in the closed state; and

removing the expandable member from the patient'"'"'s body.

26. The method of claim 25, further comprising:

providing a lumen that extends through the elongate member from the proximal portion to the distal portion, the lumen being in fluid connection with a distal opening in the elongate member;

positioning the distal opening of the elongate member in the left ventricle; and

delivering fluid through the lumen into the left ventricle to increase a fluid pressure in the left ventricle.

27. The method of claim 25, further comprising:

moving the temporary coaptation member to a different position at least partially between the leaflets; and

monitoring the effectiveness of the temporary coaptation member in restricting blood flow between the leaflets and the temporary coaptation member when the leaflets are in the closed state.

28. The method of claim 25, wherein the temporary coaptation member comprises an expandable member that has an expanded state that restricts blood flow between the leaflets and the expandable member and a contracted state that allows blood to flow between the leaflets and the expandable member.