Low-profile heart valve and delivery system

• US 8,795,354 B2
• Filed: 03/04/2011
• Issued: 08/05/2014
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel, Rowe, Stanton J., Chow, Sean
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US13/040,896
• Publication Number:
  US 20110218619A1
• Time in Patent Office: 1,250 Days
• Field of Search: 623/2.11, 623/2.14, 623/2.17, 623/2.18, 623/1.24, 623/1.26, 623/1.11, 623/1.12, 606/108
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0059 temporary

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.

Claims

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.

2. The method according to claim 1, further comprising removing the delivery system from the replacement valve, wherein transitioning the replacement valve from the delivery configuration to the operating configuration occurs prior to removing the delivery system from the replacement valve.

3. The method of claim 1, wherein, in the delivery configuration, the entire valve portion is positioned outside of the lumen defined by the stent portion.

4. The method of claim 1, wherein the act of transitioning the replacement valve from the delivery configuration to the operating configuration occurs after advancing the replacement heart valve to the implant position.

5. The method according to claim 1, wherein the plurality of rails comprises upper rails coupled to the valve portion and lower rails coupled to the stent portion and wherein the upper and lower rails move relative to each other when sliding the valve portion into the lumen of the stent portion.

6. The method of claim 5, wherein the upper and lower rails move relative to each other by sliding by each other axially when sliding the valve portion into the lumen of the stent portion.

7. The method according to claim 1, 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.

8. The method according to claim 7, wherein at least the stent portion of the replacement heart valve is crimped onto the delivery system at a location separated axially from the balloon during advancement toward the heart valve annulus.

9. 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 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.

10. The method of claim 9, comprising deflating the balloon after pulling the valve portion toward the stent portion.

11. The method of claim 9, comprising deflating the balloon after both pulling the valve portion toward the stent portion and positioning at least a portion of the leaflets inside of the lumen defined by the stent portion.

12. The method of claim 9, further comprising inflating the balloon for radially expanding the replacement heart valve to cause the stent portion to engage the heart valve annulus.

13. The method of claim 12, wherein the act of inflating the balloon for radially expanding the replacement heart valve occurs after positioning at least a portion of the leaflets inside the lumen defined by the stent portion.

14. The method of claim 12, wherein the act of inflating the balloon for radially expanding the replacement heart valve occurs after positioning the valve portion inside the lumen defined by the stent portion.