Valve holder with leaflet protection

• US 10,028,829 B2
• Filed: 09/29/2016
• Issued: 07/24/2018
• Est. Priority Date: 03/08/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Li, Xue Mei
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US15/279,692
• Publication Number:
  US 20170014231A1
• Time in Patent Office: 663 Days
• 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

Abstract

An implantation device for a prosthetic heart valve includes a valve holder for maintaining the prosthetic heart valve in a closed configuration and at least one protective sheet coupled to the valve holder, the at least one protective sheet being configured to cover a leaflet of the heart valve during implantation.

Claims

1. An implantation device for a prosthetic heart valve having a plurality of leaflets, comprising:

a valve holder for maintaining the plurality of leaflets of the prosthetic heart valve in a closed configuration when coupled to the prosthetic heart valve; and

a plurality of protective sheets each of the plurality of protective sheets extending between a first end coupled to the valve holder, and a second end for coupling to a portion of the prosthetic heart valve via an aperture for receiving a suture therethrough, and extending from a first commissure portion to a second commissure portion of the prosthetic heart valve, the plurality of protective sheets collectively covering the leaflets of the prosthetic heart valve during implantation.

2. The implantation device of claim 1, wherein the plurality of protective sheets includes three protective sheets.

3. The implantation device of claim 1, wherein the plurality of protective sheets includes a protective sheet for each leaflet of the prosthetic heart valve.

4. The implantation device of claim 1, wherein the plurality of protective sheets is comprised of at least one of Ultem, Delrin, Udel, and PEEK.

5. The implantation device of claim 1, wherein each of the plurality of protective sheets includes a leg coupleable to a portion of a prosthetic heart valve.

6. The implantation device of claim 1, wherein the valve holder includes a slot for receiving a handle, and the valve holder is configured and arranged to be removed with the handle after implantation of the prosthetic heart valve.

7. The implantation device of claim 1, wherein each of the plurality of protective sheets are sutured to the valve holder.

8. The implantation device of claim 1, wherein each of the plurality of protective sheets are sutured to the prosthetic heart valve.

9. The implantation device of claim 1, wherein at least one of the plurality of protective sheets covers a majority of a surface of one of the plurality of leaflets.

10. The implantation device of claim 1, wherein at least one of the plurality of protective sheets covers an entire surface of one of the plurality of leaflets.

11. A method of implanting a prosthetic heart valve having a plurality of leaflets in a patient'"'"'s body, the method comprising:

providing a valve holder for maintaining the plurality of leaflets of the prosthetic heart valve in a closed configuration when coupled to the prosthetic heart valve; and

covering the plurality of leaflets with a plurality of protective sheets to protect the prosthetic heart valve, each of the plurality of protective sheets extending between a first end coupled to the valve holder, and a second end for coupling to a portion of the prosthetic heart valve via an aperture for receiving a suture therethrough, and extending from a first commissure portion to a second commissure portion of the prosthetic heart valve, the plurality of protective sheets collectively covering the leaflets of the prosthetic heart valve during implantation; and

introducing the protected prosthetic heart valve to a site of implantation.

12. The method of claim 11, further comprising coupling the plurality of protective sheets to the prosthetic heart valve.

13. The method of claim 12, wherein coupling the plurality of protective sheets to the prosthetic heart valve including suturing each of the plurality of sheets to the prosthetic heart valve.

14. The method of claim 11, wherein covering the plurality of leaflets includes suturing the plurality of protective sheets to the valve holder.

15. The method of claim 11, wherein the valve holder includes a slot, the slot being capable of accepting a handle.

16. The method of claim 15, further comprising coupling the handle to the slot and maneuvering the handle to position the prosthetic heart valve.

17. The method of claim 11, further comprising uncovering the plurality of leaflets by removing the plurality of protective sheets.

18. The method of claim 12, further comprising decoupling the plurality of protective sheets from the valve holder and removing the protective sheets from the patient'"'"'s body.

19. The method of claim 11, further comprising removing the valve holder from the patient'"'"'s body.