Prosthetic heart valve frame with flexible commissures
First Claim
1. A prosthetic heart valve that is radially expandable from a compressed configuration to an expanded configuration, comprising:
- a balloon-expandable stent portion configured to anchor the prosthetic valve against a heart valve annulus, the stent portion defining a lumen therethrough, wherein the stent portion is radially expandable from a collapsed state to an expanded state, wherein the stent portion has a circumferential strut at an outflow end thereof having an expanded diameter in the expanded state of the stent portion, the stent portion further including an inflow end opposite the outflow end that flares outward from the outflow end in the expanded state of the stent portion;
a plurality of valve leaflets;
a self-expandable wireform portion that is separate from the stent portion, the wireform portion comprising a plurality of commissure supports extending in an outflow direction and the same number of cusps defining an inflow end of the wireform portion, each cusp adapted to support one of the valve leaflets, wherein the wireform portion is radially expandable from a constrained configuration to an expanded configuration where the cusps define an inflow diameter of the wireform portion, the wireform portion having a cloth covering;
a cloth-covered flexible leaflet support stent arranged around the wireform portion and being radially collapsible and expandable along with the wireform portion, the cloth-covered leaflet support stent being attached with sutures to the cloth covering of the wireform portion;
connecting sutures coupling the circumferential strut at the outflow end of the stent portion adjacent to an inflow end of the leaflet support stent such that the expanded diameter of the stent portion is equal to the cusp diameter;
a sealing ring circumscribing and extending outward from the cloth-covered leaflet support stent and from the outflow end of the stent portion, andwherein the stiffness of the circumferential strut of the stent portion in its collapsed state is sufficient to prevent the inflow end of the wireform portion from expanding toward its expanded configuration by virtue of the outflow end of the stent portion being sutured thereto.
1 Assignment
0 Petitions
Accused Products
Abstract
A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient'"'"'s native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.
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Citations
17 Claims
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1. A prosthetic heart valve that is radially expandable from a compressed configuration to an expanded configuration, comprising:
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a balloon-expandable stent portion configured to anchor the prosthetic valve against a heart valve annulus, the stent portion defining a lumen therethrough, wherein the stent portion is radially expandable from a collapsed state to an expanded state, wherein the stent portion has a circumferential strut at an outflow end thereof having an expanded diameter in the expanded state of the stent portion, the stent portion further including an inflow end opposite the outflow end that flares outward from the outflow end in the expanded state of the stent portion; a plurality of valve leaflets; a self-expandable wireform portion that is separate from the stent portion, the wireform portion comprising a plurality of commissure supports extending in an outflow direction and the same number of cusps defining an inflow end of the wireform portion, each cusp adapted to support one of the valve leaflets, wherein the wireform portion is radially expandable from a constrained configuration to an expanded configuration where the cusps define an inflow diameter of the wireform portion, the wireform portion having a cloth covering; a cloth-covered flexible leaflet support stent arranged around the wireform portion and being radially collapsible and expandable along with the wireform portion, the cloth-covered leaflet support stent being attached with sutures to the cloth covering of the wireform portion; connecting sutures coupling the circumferential strut at the outflow end of the stent portion adjacent to an inflow end of the leaflet support stent such that the expanded diameter of the stent portion is equal to the cusp diameter; a sealing ring circumscribing and extending outward from the cloth-covered leaflet support stent and from the outflow end of the stent portion, and wherein the stiffness of the circumferential strut of the stent portion in its collapsed state is sufficient to prevent the inflow end of the wireform portion from expanding toward its expanded configuration by virtue of the outflow end of the stent portion being sutured thereto. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A fully collapsible prosthetic heart valve that is radially expandable from a compressed configuration to an expanded configuration, comprising:
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a valve portion comprising a self-expandable wireform portion and a plurality of valve leaflets supported thereby, wherein the valve portion is radially expandable from a constrained state toward an expanded state, the valve portion including a suture-permeable sealing ring disposed around an inflow end of the wireform portion, the inflow end defining an expanded diameter in the expanded state; and a pre-crimped balloon-expandable stent portion configured to anchor the prosthetic valve against a heart valve annulus, wherein the stent portion is coupled to the valve portion via sutures connected between an outflow end of the stent portion and the inflow end of the wireform portion such that the wireform portion is in its constrained state when the stent portion is in a pre-crimped state and wherein balloon expansion of the stent portion permits expansion of the inflow end of the wireform portion to the same diameter as the stent portion outflow end. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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Specification