Method for heart valve implantation
First Claim
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.
1 Assignment
0 Petitions
Accused Products
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.
314 Citations
34 Claims
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1. A method of implanting a bistable percutaneous heart valve, comprising the steps of:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of implanting a heart valve, comprising the steps of:
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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. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of implanting a heart valve, comprising the steps of:
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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. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of implanting a heart valve, comprising the steps of:
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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.
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Specification