Method for heart valve implantation

• US 8,118,866 B2
• Filed: 10/21/2009
• Issued: 02/21/2012
• Est. Priority Date: 07/21/2003
• Status: Active Grant

• Current Assignee: Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Herrmann, Howard C., Mankame, Nilesh, Ananthasuresh, Suresh G. K.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/582,986
• Publication Number:
  US 20100042208A1
• Time in Patent Office: 853 Days
• Field of Search: 623 21- 235, 623/904
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A percutaneously inserted bistable heart valve prosthesis is folded inside a catheter for transseptal delivery to the patient'"'"'s heart for implantation. The heart valve has an annular ring, a body member having a plurality of legs, each leg connecting at one end to the annular ring, claws that are adjustable from a first position to a second position by application of external force so as to allow ingress of surrounding heart tissue into the claws in the second position, and leaflet membranes connected to the annular ring, the body member and/or the legs, the leaflet membranes having a first position for blocking blood flow therethrough and a second position for allowing blood flow therethrough. The heart valve is designed such that upon removal of the external force the claws elastically revert to the first position so as to grip the heart tissue positioned within the claws, thereby holding the heart valve in place. The body member and claws may be integrated into a one-piece design. The heart valve may be used as a prosthesis for the mitral valve, aortic valve, pulmonary valve, or tricuspid valve by adapting the annular ring to fit in a respective mitral, aortic, pulmonary, or tricuspid valve opening of the heart.

Claims

1. A method of implanting a bistable percutaneous heart valve, comprising the steps of:

a. providing a bistable percutaneous heart valve that includes (i) a continuous annular ring defining an undeformed configuration having a first diameter, (ii) at least two circumferentially spaced jaws mounted with respect to the continuous annular ring, and (iii) a plurality of leaflet membranes mounted with respect to the continuous annular ring;

b. folding said bistable percutaneous heart valve into a collapsed position such that (i) said continuous annular ring collapses from said undeformed configuration to a deformed configuration of reduced diameter relative to said first diameter, and (ii) said at least two jaws are positioned in a non-tissue engaging orientation relative to the continuous annular ring;

c. inserting a catheter into a patient and guiding a distal end of said catheter to a position adjacent an implantation position in a patient'"'"'s heart;

d. inserting said folded heart valve into said catheter and steering said folded heart valve to said distal end of said catheter using a guiding device;

e. guiding said folded heart valve beyond said distal end of said catheter so as to cause said heart valve to elastically unfold to a stable unfolded position, whereby (i) said continuous annular ring automatically and elastically returns to said undeformed configuration, and (ii) said at least two jaws assume a tissue engaging orientation relative to the continuous annular ring;

f. forcing the unfolded heart valve into a second stable position;

g. guiding the heart valve to the implantation position;

h. adjusting said at least two claws of said heart valve by the application of an external force so as to allow ingress of surrounding heart tissue into said claws, whereupon removal of the external force the claws elastically revert to an initial position so as to grip the heart tissue positioned within the claws, thereby holding said heart valve in place; and

i. removing the guiding device and the catheter.

2. A method as in claim 1, comprising the further step of repeating the steps of guiding the unfolded heart valve to the implantation position and adjusting the claws to hold the heart valve in place until the position, stability and functioning of the heart valve are satisfactory.

3. A method as in claim 1, wherein said implantation position is a mitral valve opening of the heart.

4. A method as in claim 1, wherein said implantation position is an aortic valve opening of the heart.

5. A method as in claim 1, wherein said implantation position is a pulmonary valve opening of the heart.

6. A method as in claim 1, wherein said implantation position is a tricuspid valve opening of the heart.

7. A method as in claim 1, wherein said continuous annular ring of the heart valve pushes outward on heart tissue in the stable unfolded position so as to assist anchoring said heart valve in said heart tissue.

8. A method as in claim 1, wherein said external force is applied in said claws adjusting step by manipulating at a proximal end of said catheter at least one filament that passes through said catheter and connects at a distal end to said claws so as to cause said claws to move to a position permitting said ingress of surrounding heart tissue into said claws.

9. A method as in claim 8, wherein said at least one filament is further used to switch the heart valve from the stable unfolded position to the second stable position prior to implantation.

10. A method of implanting a heart valve, comprising the steps of:

a. providing a heart valve that includes (i) a continuous annular ring defining an undeformed configuration having a first diameter, (ii) a plurality of circumferentially spaced tissue engaging members mounted with respect to the continuous annular ring, and (iii) a plurality of leaflet membranes mounted with respect to the continuous annular ring;

b. folding said heart valve into a collapsed position such that (i) said continuous annular ring collapses from said undeformed configuration to a deformed configuration of reduced diameter relative to said first diameter, and (ii) said plurality of tissue engaging members are positioned in a non-tissue engaging orientation relative to the continuous annular ring;

c. inserting said folded heart valve into a catheter;

d. positioning a distal end of said catheter adjacent an implantation site in a patient'"'"'s heart;

e. advancing said folded heart valve beyond said distal end of said catheter so as to permit said heart valve to elastically unfold to an unfolded position, whereby (i) said continuous annular ring automatically and elastically returns to said undeformed configuration, and (ii) said plurality of tissue engaging members assume a tissue engaging orientation relative to the continuous annular ring; and

f. anchoring said plurality of tissue engaging members in heart tissue, thereby holding said heart valve in place relative to said implantation site.

11. The implantation method of claim 10, further comprising introducing said heart valve to a proximal end of said catheter and steering said heart valve to said distal end of said catheter using a guiding device.

12. The implantation method of claim 10, wherein said heart valve further includes a body member centrally located relative to said continuous annular ring.

13. The implantation method of claim 12, wherein said heart valve further includes a plurality of legs that extend between said body member and said continuous annular ring.

14. The implantation method of claim 13, wherein each of said plurality of legs aligns with a corresponding one of said plurality of tissue engaging members.

15. The implantation method of claim 10, wherein in elastically unfolding from said folded position to said unfolded position, said plurality of tissue engaging members rotate relative to said continuous annular ring.

16. The implantation method of claim 10, wherein said heart valve further includes a plurality of filaments that cooperate with said plurality of tissue engaging members.

17. The implantation method of claim 16, wherein said heart valve further includes a body member centrally located relative to said continuous annular ring and wherein said plurality of filaments pass through an opening defined by said body member.

18. The implantation method of claim 16, further comprising the step of manipulating said plurality of filaments in connection with said anchoring of said plurality of tissue engaging members in said heart tissue.

19. The implantation method of claim 18, wherein said plurality of filaments are individually manipulable so as to independently effect the positioning of said plurality of tissue engaging members relative to said heart tissue.

20. The implantation method of claim 10, wherein said implantation site is a mitral valve opening of the heart.

21. The implantation method of claim 10, wherein said implantation site is an aortic valve opening of the heart.

22. The implantation method of claim 10, wherein said implantation site is a pulmonary valve opening of the heart.

23. The implantation method of claim 10, wherein said implantation site is a tricuspid valve opening of the heart.

24. A method of implanting a heart valve, comprising the steps of:

a. providing a heart valve that includes (i) a continuous annular ring defining an undeformed configuration having a first diameter, (ii) a plurality of circumferentially spaced tissue engaging members mounted with respect to the continuous annular ring, and (iii) a plurality of leaflet membranes mounted with respect to the continuous annular ring;

b. collapsing said heart valve into a collapsed position wherein (i) said continuous annular ring is elastically deformed from said undeformed configuration to a deformed configuration of reduced diameter relative to said first diameter, and (ii) said plurality of tissue engaging members are positioned in a non-tissue engaging orientation relative to the deformed continuous annular ring;

c. advancing said heart valve in said collapsed position to an implantation site;

d. permitting said annular ring of said heart valve to elastically return to a non-deformed configuration, whereby (i) said continuous annular ring automatically and elastically returns to said undeformed configuration, and (ii) said plurality of tissue engaging members assume a tissue engaging orientation relative to the continuous annular ring; and

e. anchoring said plurality of tissue engaging members with respect to heart tissue, thereby holding said heart valve in place relative to said implantation site.

25. The implantation method of claim 24, wherein said heart valve is positioned in a catheter in said collapsed position prior to advancement to said implantation site.

26. The implantation method of claim 24, wherein said heart valve further includes a body member centrally located relative to said continuous annular ring.

27. The implantation method of claim 26, wherein said heart valve further includes a plurality of legs that extend between said body member and said continuous annular ring.

28. The implantation method of claim 24, wherein said heart valve further includes a plurality of filaments that cooperate with said plurality of tissue engaging members.

29. The implantation method of claim 28, further comprising the step of manipulating at least one of said plurality of filaments in connection with said anchoring of said plurality of tissue engaging members with respect to said heart tissue.

30. The implantation method of claim 29, wherein said plurality of filaments are individually manipulable so as to independently effect the positioning of said plurality of tissue engaging members relative to said heart tissue.

31. The implantation method of claim 30, further comprising removing said plurality of filaments from interaction with said plurality of tissue engaging members after said heart valve is anchored relative to said heart tissue.

32. The implantation method of claim 24, further comprising repositioning of the heart valve relative to the implantation site at least in part based on manipulation of filaments associated with the plurality of tissue engaging members.

33. The implantation method of claim 24, wherein said implantation site is a mitral valve opening of the heart.

34. A method of implanting a heart valve, comprising the steps of:

a. providing a heart valve that includes (i) a continuous annular ring defining an undeformed configuration having a first diameter, (ii) a plurality of circumferentially spaced legs that define tissue engaging surfaces at distal ends thereof, the plurality of circumferentially spaced legs being mounted with respect to the continuous annular ring, and (iii) a plurality of leaflet membranes mounted with respect to the continuous annular ring;

b. collapsing said heart valve into a collapsed position wherein (i) said continuous annular ring is elastically deformed from said undeformed configuration to a deformed configuration of reduced diameter relative to said first diameter, and (ii) said plurality of legs are positioned with the tissue engaging surfaces in a non-tissue engaging orientation relative to the deformed continuous annular ring;

c. advancing said heart valve in said collapsed position to an implantation site;

d. permitting said heart valve to elastically return to a non-deformed configuration, whereby (i) said continuous annular ring automatically and elastically returns to said undeformed configuration, and (ii) said plurality of legs assume a tissue engaging orientation relative to the continuous annular ring with said tissue engaging surfaces in tissue engagement; and

e. anchoring said heart valve with respect to heart tissue, thereby holding said heart valve in place relative to said implantation site.