REPOSITIONING OF PROSTHETIC HEART VALVE AND DEPLOYMENT
First Claim
11. A prosthetic heart valve, comprising:
- a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, and a transition section between the aortic section and the annulus section, the annulus section having a first expanded cross-section, the aortic section having a second expanded cross-section larger than the first expanded cross-section, and the transition section having an expanded cross-section which transitions from the first expanded cross-section to the second expanded cross-section;
a plurality of commissure points disposed at a juncture between the annulus section and the transition section; and
a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points;
the plurality of commissure points being spaced from the distal end of the stent by a selected distance such that the prosthetic valve can be partially deployed from a delivery device at a target site by withdrawing a portion of the sheath of the delivery device from around the prosthetic valve, and the valve assembly can function as intended while the distal end of the stent is held within the sheath of the delivery device in a manner that enables resheathing.
1 Assignment
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Accused Products
Abstract
A collapsible prosthetic heart valve includes a stent and a valve assembly. The stent has an annulus section with a relatively small cross-section, and an aortic section with a relatively large cross-section. The valve assembly, including a cuff and a plurality of leaflets, is secured to the stent in the annulus section such that the valve assembly can be entirely deployed in the native valve annulus and function as intended while at least a portion of the aortic section is held by the delivery device in a manner that allows for resheathing. The configuration of the prosthetic valve is such that the valve leaflets can fully coapt and the valve can function properly even when the stent and/or valve assembly become distorted upon deployment or use.
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Citations
28 Claims
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11. A prosthetic heart valve, comprising:
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a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, and a transition section between the aortic section and the annulus section, the annulus section having a first expanded cross-section, the aortic section having a second expanded cross-section larger than the first expanded cross-section, and the transition section having an expanded cross-section which transitions from the first expanded cross-section to the second expanded cross-section; a plurality of commissure points disposed at a juncture between the annulus section and the transition section; and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points; the plurality of commissure points being spaced from the distal end of the stent by a selected distance such that the prosthetic valve can be partially deployed from a delivery device at a target site by withdrawing a portion of the sheath of the delivery device from around the prosthetic valve, and the valve assembly can function as intended while the distal end of the stent is held within the sheath of the delivery device in a manner that enables resheathing.
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12. A prosthetic heart valve, comprising:
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a collapsible and expandable stent and having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the annulus section having a first expanded cross-section and an unconstrained shape and the aortic section having a second expanded cross-section larger than the first expanded cross-section; a plurality of commissure points disposed in the annulus section; and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points, the plurality of leaflets having an open condition in which the leaflets are spread apart from one another to define a flow passageway through the stent, and a closed condition in which the leaflets form coaptation sections to occlude the flow passageway, the coaptation sections occluding the flow passageway both when the annulus section has the unconstrained shape and when the annulus section is distorted from the unconstrained shape. - View Dependent Claims (13, 14, 15, 16)
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17. A method of deploying a prosthetic heart valve at a target site, the method comprising:
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introducing a delivery device to the target site, the delivery device housing a prosthetic heart valve in a collapsed condition and having an outer sheath surrounding the prosthetic heart valve, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, a plurality of commissure points disposed in the annulus section, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points; withdrawing the sheath a first distance to partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device; and further withdrawing the sheath so as to fully deploy the prosthetic heart valve. - View Dependent Claims (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 19, 20, 21, 22)
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18. A method of deploying a prosthetic heart valve at a target site, the method comprising:
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introducing a delivery device to the target site, the delivery device housing a prosthetic heart valve in a collapsed condition and having an outer sheath surrounding the prosthetic heart valve, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, a plurality of commissure points disposed in the annulus section, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points; withdrawing the sheath a first distance to partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device; resheathing the prosthetic heart valve; and withdrawing the sheath a first distance to partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device.
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19-1. The method of claim 17, wherein the valve assembly includes a plurality of leaflets connected to the plurality of commissure points, the plurality of leaflets having an open condition in which the leaflets are spaced apart from one another to define a flow passageway through the stent, and a closed condition in which the leaflets coapt to occlude the flow passageway and the valve assembly functions as intended by providing adequate coaptation by the leaflets in the closed condition.
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23. A method of testing the operability of a prosthetic heart valve at a target site, the method comprising:
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introducing a delivery device to the target site, the delivery device housing a prosthetic heart valve in a collapsed condition and having an outer sheath surrounding the prosthetic heart valve, the prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, a plurality of commissure points disposed in the annulus section, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points; withdrawing the sheath a first distance to partially deploy the prosthetic heart valve at the target site, the prosthetic heart valve being deployed from the proximal end of the stent toward the distal end of the stent such that the valve assembly is fully deployed at the first distance and can function as intended while the distal end of the stent is held within the sheath of the delivery device; and assessing valve function when the prosthetic heart valve is partially deployed and resheathing the prosthetic heart valve. - View Dependent Claims (24, 25, 26)
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27. A system comprising:
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a prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the annulus section having a first expanded cross-section and the aortic section having a second expanded cross-section larger than the first expanded cross-section, a plurality of commissure points disposed in the annulus section, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points, the plurality of commissure points being spaced from the distal end of the stent by a selected distance such that the prosthetic valve can be partially deployed from a delivery device at a target site by withdrawing a sheath of the delivery device from around the prosthetic valve; and a delivery device comprising a sheath partially covering the stent and releasably retaining same wherein the valve assembly is free to operate in a portion of the stent not retained by the sheath.
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28. A system comprising:
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a prosthetic heart valve including a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the annulus section having a first expanded cross-section and the aortic section having a second expanded cross-section larger than the first expanded cross-section, a plurality of commissure points disposed in the annulus section, and a collapsible and expandable valve assembly disposed entirely within the annulus section between the proximal end of the stent and the plurality of commissure points, the valve assembly including a plurality of leaflets connected to the plurality of commissure points, the plurality of commissure points being spaced from the distal end of the stent by a selected distance such that the prosthetic valve can be partially deployed from a delivery device at a target site by withdrawing a sheath of the delivery device from around the prosthetic valve; and a delivery device comprising a sheath capable of being moved from a first configuration wherein the sheath partially covers the stent and releasably retains same wherein the valve assembly is free to operate in a portion of the stent not retained by the sheath, and a second configuration wherein the sheath substantially completely covers the stent and the valve assembly is incapable of normal function.
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Specification