Low-profile heart valve and delivery system
First Claim
1. A method of implanting a replacement heart valve, comprising:
- mounting the replacement heart valve onto a delivery system in a delivery configuration, the replacement heart valve comprising a radially-expandable metallic stent portion, a valve portion, and a plurality of metallic longitudinal rails connecting the valve portion to the stent portion, wherein the stent portion comprises an outer surface and an inner surface defining a lumen, wherein the valve portion comprises a plurality of leaflets formed of pericardial tissue, and wherein, in the delivery configuration, at least a portion of the leaflets are positioned outside of the lumen defined by the stent portion;
advancing the replacement heart valve to an implant position adjacent a heart valve annulus;
transitioning the replacement valve from the delivery configuration to an operating configuration by sliding the valve portion along the plurality of longitudinal rails for advancing the valve portion relative to the stent portion and positioning the valve portion within the lumen of the stent portion;
radially expanding the stent portion and the valve portion together to cause the stent portion to engage the heart valve annulus, thereby anchoring the replacement heart valve in position within the heart valve annulus; and
partially inflating a balloon for engaging the valve portion and pulling the valve portion along the plurality of rails toward the stent portion with the balloon partially inflated.
1 Assignment
0 Petitions
Accused Products
Abstract
Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed.
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Citations
14 Claims
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1. A method of implanting a replacement heart valve, comprising:
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mounting the replacement heart valve onto a delivery system in a delivery configuration, the replacement heart valve comprising a radially-expandable metallic stent portion, a valve portion, and a plurality of metallic longitudinal rails connecting the valve portion to the stent portion, wherein the stent portion comprises an outer surface and an inner surface defining a lumen, wherein the valve portion comprises a plurality of leaflets formed of pericardial tissue, and wherein, in the delivery configuration, at least a portion of the leaflets are positioned outside of the lumen defined by the stent portion; advancing the replacement heart valve to an implant position adjacent a heart valve annulus; transitioning the replacement valve from the delivery configuration to an operating configuration by sliding the valve portion along the plurality of longitudinal rails for advancing the valve portion relative to the stent portion and positioning the valve portion within the lumen of the stent portion; radially expanding the stent portion and the valve portion together to cause the stent portion to engage the heart valve annulus, thereby anchoring the replacement heart valve in position within the heart valve annulus; and
partially inflating a balloon for engaging the valve portion and pulling the valve portion along the plurality of rails toward the stent portion with the balloon partially inflated. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of implanting a replacement heart valve, comprising:
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mounting the replacement heart valve onto a delivery system in a delivery configuration, the replacement heart valve comprising a radially-expandable metallic stent portion, a valve portion, and a plurality of metallic longitudinal rails connecting the valve portion to the stent portion, wherein the stent portion comprises an outer surface and an inner surface defining a lumen, wherein the valve portion comprises a plurality of leaflets formed of pericardial tissue, and wherein, in the delivery configuration, at least a portion of the leaflets are positioned outside of the lumen defined by the stent portion; advancing the replacement heart valve to an implant position adjacent a heart valve annulus; transitioning the replacement valve from the delivery configuration to an operating configuration by sliding the valve portion along the plurality of longitudinal rails for advancing the valve portion relative to the stent portion and positioning the valve portion within the lumen of the stent portion; radially expanding the replacement heart valve to cause the stent portion to engage the heart valve annulus, thereby anchoring the replacement heart valve in position within the heart valve annulus; wherein the valve portion and stent portion are coupled together by the plurality of rails while the replacement heart valve is advanced toward the heart valve annulus; wherein at least the stent portion of the replacement heart valve is crimped onto the delivery system at a location separated axially from a balloon during advancement toward the heart valve annulus; partially inflating the balloon for engaging the valve portion and pulling the valve portion along the plurality of rails toward the stent portion with the balloon partially inflated; and deflating the balloon and then advancing the replacement heart valve relative to the balloon such that both the stent portion and the valve portion are positioned on the balloon before the step of radially expanding the replacement heart valve. - View Dependent Claims (10, 11, 12, 13, 14)
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Specification