AORTIC VALVE REPLACEMENT

• US 20100049312A1
• Filed: 03/23/2007
• Published: 02/25/2010
• Est. Priority Date: 03/23/2006
• Status: Active Grant

• Current Assignee: Edrich Health Technologies, Inc.
• Original Assignee: Edrich Health Technologies, Inc.
• Inventors: Richard, Thierry, Edoga, John K.
• Granted Patent: US 8,496,700 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/2436 Deployment by retracting a sheath

Abstract

A device for replacement of a bioprosthetic valve having an annulus (104) and one or more leaflets (105), the device having an outer housing (106) and an inner shaft (108) with a distal end (110). The outer housing (106) is slideable relative to the inner shaft (108) such that a portion of the inner shaft (108) may be revealed. A cap (112) is associated with the distal end (110) of the inner shaft (108), the cap (112) movable between a first position adjacent the inner shaft (108) and a second position displaced from the inner shaft (108). The cap (112) is adapted to trap a skirted valve frame (102) between said cap (112) and the inner shaft (108) when in the first position. The skirted valve frame (102) may be released by the cap (112) upon sliding of the outer housing (106) relative to the inner shaft (108) to reveal the inner shaft (108) and upon movement of the cap (112) to the second position. Also disclosed are associated methods.

Claims

1. A device for replacement of a bioprosthetic valve having an annulus and one or more leaflets, said device comprising:

an outer housing;

an inner shaft having a distal end, said outer housing slideable relative to said inner shaft such that a portion of said inner shaft may be revealed;

a cap associated with said distal end of said inner shaft, said cap movable between a first position adjacent said inner shaft and a second position displaced from said inner shaft, said cap adapted to trap a skirted valve frame between said cap and said inner shaft when in said first position;

wherein the skirted valve frame may be released by said cap upon sliding of said outer housing relative to said inner shaft to reveal said inner shaft and upon movement of said cap to said second position.

2. The device of claim 1, wherein the trapped skirted valve frame comprises a shape memory alloy.

3. The device of claim 1, wherein said cap comprises hooks retaining the trapped skirted valve when in said first position.

4. The device of claim 1, wherein said trapped skirted valve is partially released when said outer housing is slid to reveal said inner shaft and said cap is in said first position.

5. The device of claim 1, wherein said inner shaft may be completely removed from within said outer housing.

6. A bioprosthetic replacement valve comprising:

a valve frame formed from memory metal;

a skirt operatively engaged with said valve frame;

securing members attached to said valve frame and formed from memory metal;

wherein said valve may be introduced into the annulus of a previously installed bioprosthetic valve and secured thereto with said securing members.

7. The bioprosthetic valve of claim 6, wherein said valve further comprises a plurality of leaflets.

8. A delivery system for attachment of a bioprosthetic aortic valve to the annulus of a previously installed bioprosthetic aortic valve, said delivery systems compring:

a valve replacement instrument, said instrument having an outer housing adapted to be inserted within an aortic root toward the previously installed bioprosthetic valve and an inner shaft, said outer housing having a first position concealing said inner shaft and a second position revealing at least a portion of said inner shaft;

a bioprosthetic replacement valve having a valve frame and a skirt operatively engaged to said valve frame, said bioprosthetic replacement valve trapped between said inner shaft and said outer housing in said first position of said outer housing.

9. The delivery system of claim 8, wherein said bioprosthetic replacement valve is released from between said inner shaft and said outer housing in said second position of said outer housing.

10. The delivery system of claim 9, wherein said bioprosthetic replacement valve further comprises a plurality of securing members for association with the annulus of a previously installed bioprosthetic aortic valve upon positioning of said outer housing in said second position.

11. The delivery system of claim 10, wherein said securing members are hooks.

12. The delivery system of claim 8, wherein said frame of said bioprosthetic replacement valve is formed from a memory metal.

13. The delivery system of claim 8, wherein said inner shaft may be removed from said outer housing.

14. The delivery system of claim 13, further comprising a stapler adapted to be inserted within said outer shaft, said stapler adapted to attach said bioprosthetic replacement valve to the annulus.

15. The delivery system of claim 8, wherein said valve replacement instrument further comprises a cap associated with said inner shaft, said cap further trapping said folded valve in said first position of said outer housing.

21. The method of claim 15, wherein the folded replacement valve includes a skirt attached to the frame, said step of stapling the valve involving stapling the skirt of the valve to the annulus.

22. The method of claim 21, wherein the step of releasing the folded valve opens the skirt and applies it against the annulus.

16. A method of replacing a previously installed bioprosthetic aortic valve having leaflets and an annulus, said method comprising:

preparing said leaflets for replacement;

inserting a valve delivery instrument into the aortic root, the valve delivery instrument including a folded replacement valve having securing members formed from a memory metal;

positioning the valve delivery instrument such that the folded replacement valve is adjacent to the annulus of the previously installed bioprosthetic valve;

releasing the folded valve from the valve delivery instrument such that the securing members return to their natural condition and connect to the annulus;

removing an inner portion of the valve delivery instrument;

inserting a stapler into the remaining portion of the valve delivery instrument;

positioning the stapler adjacent to the annulus;

stapling the valve to the annulus.

17. The method of claim 16, wherein said step of preparing said leaflets for replacement involves destroying said leaflets.

18. The method of claim 16, wherein said step of stapling the valve to the annulus involves multiple staples.

19. The method of claim 16, wherein the stapler further comprises at least one balloon, said method further comprising the step of inflating the at least one balloon.

20. The method of claim 16, wherein the folded replacement valve includes a frame formed from a memory metal.