Heart valve and apparatus for replacement thereof

• US 6,309,417 B1
• Filed: 05/12/1999
• Issued: 10/30/2001
• Est. Priority Date: 05/12/1999
• Status: Expired due to Fees

• Current Assignee: Paul A. Spence
• Original Assignee: Paul A. Spence
• Inventors: Ortiz, Mark, Spence, Paul A.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US09/310,891
• Time in Patent Office: 902 Days
• Field of Search: 623/2.1, 623/2.13, 623/2.12, 623/2.11
• US Class Current: 623/2.11
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

Apparatus and methods for replacing a heart valve within a vessel. The apparatus includes a replacement heart valve and a plurality of commisure stabilizers connected to the commisures of the heart valve in a removable manner. The commisure stabilizers position and stabilize the commisures in the proper positions as the replacement heart valve is secured within the vessel. The commisure stabilizers may be removed following securement of the replacement heart valve within the vessel. An expansion or retraction device of the invention assists in properly positioning the valve within the vessel.

Claims

1. A prosthesis system for replacing a heart valve within a vessel, the apparatus comprising:

a replacement heart valve having an annular base and a plurality of commisures extending from the annular base at spaced apart positions, each commisure having a proximal end connected with the annular base and an opposite distal end, and

a plurality of commisure stabilizers connected to the replacement heart valve in a removable manner, wherein the commisure stabilizers include elongate members configured to extend lengthwise alone the respective commisures between the proximal and distal ends, said elongate members leaving a central opening between the distal ends of the commisures through which a suturing implement may be introduced to apply a suture along each commisure, the elongate members being removable from the replacement heart valve after the replacement heart valve has been sutured within the vessel.

2. The system of claim 1, further comprising a generally annular member and wherein each commisure stabilizer further comprises at least one elongate member coupled at one end thereof to the generally annular member.

3. The system of claim 2, wherein the three elongate members each curve outwardly in a lengthwise direction to urge the commisures of the replacement heart valve against an interior wall of the vessel.

4. The system of claim 2, wherein the replacement heart valve includes respective receiving elements to removably receive the respective commisure stabilizers.

5. The system of claim 4, wherein the receiving elements further comprise pockets.

6. The system of claim 4, wherein the receiving elements further comprise loops affixed to said commisures.

7. The system of claim 2, wherein the commisure stabilizers are removably affixed to the generally annular member.

8. The system of claim 2, wherein each commisure stabilizer further comprises at least two spaced apart elongate members.

9. The system of claim 1, wherein each commisure stabilizer further comprises an elongate central member and a pair of elongate side members angled away from the elongate central member and extending along opposite edge portions of the respective commisure.

10. The system of claim 1, wherein the positioning and stabilizing device is formed in a collapsible manner allowing insertion into the vessel in a collapsed state and subsequent expansion for positioning and stabilizing the valve commisures during securement of the valve within the vessel.

11. The system of claim 10, wherein the positioning and stabilizing device is at least partially formed of a shape memory material allowing the positioning device to be selectively collapsed and expanded.

12. The system of claim 1 further comprising a flexible material connecting the distal ends of the three commisures.

13. The system of claim 1, wherein said replacement heart valve is formed from animal or human tissue.

14. The system of claim 1, wherein said replacement heart valve is formed from a synthetic biologically compatible material.