Prosthetic heart valve system with positioning markers

• US 9,980,818 B2
• Filed: 03/02/2010
• Issued: 05/29/2018
• Est. Priority Date: 03/31/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Zeng, Qinggang
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/716,062
• Publication Number:
  US 20100249908A1
• Time in Patent Office: 3,010 Days
• Field of Search: 623 134, 623 218
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An exemplary two-stage prosthetic heart valve system has a radially expandable base stent implanted within a native valve annulus. The base stent desirably has three position markers projecting in the axial direction from the outflow end of the base stent to assist in aligning the stent with respect to the commissures of the native valve. The two-stage heart valve system also has a valve component that is delivered to and mounted within the base stent in a separate or sequential operation after the base stent has been anchored within the annulus. The valve component in certain embodiments comprises a hybrid valve component that includes a conventional, non-expandable surgical valve that is modified to include an expandable coupling stent that can be expanded to engage the inner surface of the base stent, thereby anchoring the valve component to the base stent.

Claims

1. A two-stage prosthetic heart valve system comprising:

a base stent comprising a radially expandable and compressible stent body adapted to anchor against a heart valve annulus having three native commissures, the stent body having a first end, a second end, and a lumen extending therebetween, the stent further comprising three evenly circumferentially spaced visual position marker posts visual to the naked eye projecting axially from a first end of the stent body, one marker post to correspond to each of the three native commissures and each being spaced 120°

apart from the other two; and

a valve component adapted to be anchored within the base stent without sutures, the valve component comprising a prosthetic valve with a non-expandable, non-collapsible support frame including three commissures posts projecting in an outflow direction and three leaflets intermediate the three commissures posts and supported by the support frame and a radially expandable coupling stent attached to and projecting from an inflow end thereof and adapted to extend within the lumen of the base stent such that at least a majority of the coupling stent is located within the base stent in a contracted state and anchor against the base stent in an expanded state, wherein the commissure posts of the valve component are configured to be aligned with the position marker posts when the valve component anchors within the base stent.

2. The heart valve system of claim 1, wherein the position marker posts also extend radially outward from the first end of the stent body.

3. The heart valve system of claim 1, wherein the position marker posts are colored differently than the remainder of the stent.

4. The heart valve system of claim 1, wherein the position marker posts have radiopaque indicators.

5. The heart valve system of claim 1, wherein in an expanded state the base stent has a tri-lobular shape with three outward sinus-shaped sections defined intermediate the three position marker posts, and wherein the prosthetic valve further includes a sewing ring on an inflow end with a tri-lobular shape defining three sinus-shaped sections which generally conform to the tri-lobular shape of the base stent to form a tight seal with the sinus-shaped sections, thereby minimizing paravalvular leakage therebetween.

6. The heart valve system of claim 1, wherein the coupling stent further has an undulating upper end secured to an inflow end of the prosthetic valve, the upper end defining three peaks between three valleys equally spaced around the upper end, and wherein the three peaks align rotationally with the position marker posts when the valve component anchors within the base stent.

15. The heart valve system of claim 1, wherein each position marker post has an axially extending lower portion and a radially extending upper portion that projects radially outward beyond the outer diameter of the first end of the stent body.

7. A two-stage prosthetic heart valve system comprising:

a base stent comprising a radially expandable and compressible stent body adapted to anchor against a heart valve annulus having three native commissures, the stent body having a first end, a second end, and a lumen extending therebetween, the stent further comprising three visual position marker posts visual to the naked eye equally spaced around and projecting axially from a first end of the stent body, one position marker post to correspond to each of the three native commissures to enable alignment therewith; and

a valve component adapted to be anchored within the base stent without sutures, the valve component comprising a prosthetic valve with a non-expandable, non-collapsible support frame and leaflets supported by the support frame, and a radially expandable coupling stent attached to and projecting from an inflow end thereof and adapted to extend within the lumen of the stent body such that at least a majority of the coupling stent is located within the base stent in a contracted state and anchor against the stent body in an expanded state, the coupling stent having an undulating upper end secured to an inflow end of the prosthetic valve, the upper end defining three peaks between three valleys equally spaced around the upper end, and wherein the three peaks are configured to be aligned rotationally with the position marker posts when the valve component anchors within the base stent.

8. The heart valve system of claim 7, wherein in an expanded state the base stent has a tri-lobular shape with three outward sinus-shaped sections defined intermediate the three position marker posts, and wherein the prosthetic valve further includes a sewing ring on an inflow end with a tri-lobular shape defining three sinus-shaped sections which generally conform to the tri-lobular shape of the base stent to form a tight seal with the sinus-shaped sections, thereby minimizing paravalvular leakage therebetween.

9. The heart valve system of claim 7, wherein the coupling stent includes a plurality of axially-extending struts that are in-phase with the peaks of the upper end of the stent.

10. The heart valve system of claim 7, wherein the coupling stent includes a plurality of axially-extending struts that are out-of-phase with the peaks of the upper end of the stent.

11. The heart valve system of claim 7, wherein the position marker posts also extend radially outward from the first end of the stent body.

12. The heart valve system of claim 7, wherein the position marker posts are colored differently than the remainder of the stent.

13. The heart valve system of claim 7, wherein the position marker posts have radiopaque indicators.

14. The heart valve system of claim 7, wherein each position marker post has an axially extending lower portion and a radially extending upper portion that projects radially outward beyond the outer diameter of the first end of the stent body.