Valve holder with leaflet protection

• US 9,480,563 B2
• Filed: 03/06/2014
• Issued: 11/01/2016
• 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
• Application Number:
  US14/198,846
• Publication Number:
  US 20140257468A1
• Time in Patent Office: 971 Days
• Field of Search: 623/2.11
• US Class Current: 1/1
• 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

at least one protective sheet having at least one eyelet for receiving a suture therethrough, the at least one protective sheet being configured to be coupled at a first end to the valve holder and at a second end to a portion of the prosthetic heart valve via the at least one eyelet, and extending from a first commissure portion to a second commissure portion of the prosthetic heart valve to cover a leaflet of the heart valve during implantation.

2. The implantation device of claim 1, wherein the at least one protective sheet includes three protective sheets.

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

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

5. The implantation device of claim 1, wherein the at least one protective sheet includes multiple sheets, each of the multiple sheets including a leg coupleable to a ring of a 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 to be removed with the handle after implantation of the prosthetic heart valve.

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

a valve holder for maintaining the prosthetic heart valve in a closed configuration when coupled to the prosthetic heart valve;

a chimney coupled to the valve holder, the chimney defining a lumen; and

at least one protective sheet configured to be coupled at a first end to the valve holder, extend through the lumen of the chimney, wrap around the prosthetic heart valve and couple to the valve holder at a second end to form a tent that encloses the prosthetic heart valve.

8. The implantation device of claim 7, wherein the prosthetic heart valve is a prosthetic mitral valve.

9. The implantation device of claim 7, wherein the at least one protective sheet includes three protective sheets.

10. The implantation device of claim 7, wherein the at least one protective sheet includes a protective sheet for each leaflet of the prosthetic heart valve.

11. The implantation device of claim 7, wherein the at least one protective sheet is comprised of at least one of Ultra-high-molecular-weight polyethylene (UHMWPE), PTFE, polyurethane.

12. The implantation device of claim 7, wherein the valve holder includes a slot for receiving a handle.

13. The implantation device of claim 7, further comprising a sheet clamp coupled to the valve holder for clamping a portion of the at least one sheet protector.

14. The implantation device of claim 13, wherein the sheet clamp includes complementary upper and lower portions configured to retain a protective sheet between the upper and lower portions.

15. The implantation device of claim 14, wherein the upper and lower portions include complementary suture holes for coupling the upper portion to the lower portion via sutures.

16. The implantation device of claim 7, wherein the valve holder includes three legs, and each of the at least one protective sheet is attached to a first leg on one end and to a second leg at another end.

17. The implantation device of claim 9, wherein each of the three protective sheets is joined to another two of the protective sheets at edges thereof.