Sinus-engaging valve fixation member

• US 10,543,077 B2
• Filed: 01/29/2018
• Issued: 01/28/2020
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuval, Yossi, Benary, Raphael, Kilemnik, Ido
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/881,853
• Publication Number:
  US 20180147053A1
• Time in Patent Office: 729 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Claims

1. A prosthetic valve comprising:

an expandable annular inner support structure;

a valve member positioned inside and coupled to the inner support structure; and

an expandable annular outer support structure, the outer support structure positioned around the inner support structure, a downstream end portion of the outer support structure coupled to a downstream end portion of the inner support structure prior to delivery to a native valve, the outer support structure extending radially outward in an upstream direction from the inner support structure such that, in an expanded state, a space exists between the outer support structure and the inner support structure, at least a portion of the outer support structure being configured to engage the native valve from within leaflets of the native valve, wherein an upstream end of the outer support structure is not coupled to the inner support structure.

2. The prosthetic valve of claim 1, wherein the native valve is a mitral valve.

3. The prosthetic valve of claim 1, wherein the native valve is an aortic valve.

4. The prosthetic valve of claim 1, wherein the inner support structure is self-expanding.

5. The prosthetic valve of claim 1, wherein the outer support structure is self-expanding.

6. The prosthetic valve of claim 1, wherein the outer support structure comprises one or more fixation elements.

7. The prosthetic valve of claim 6, wherein the one or more fixation elements comprise one or more barbs.

8. The prosthetic valve of claim 1, wherein at least a portion of the outer support structure comprises a covering.

9. The prosthetic valve of claim 1, wherein at least a portion of the inner support structure comprises a covering.

10. The prosthetic valve of claim 1, wherein the inner support structure further comprises an upstream portion and a downstream portion, the upstream portion extending radially outward from the downstream portion.

11. The prosthetic valve of claim 10, wherein the upstream portion is configured to reduce leakage around the prosthetic valve.

12. The prosthetic valve of claim 1, wherein the outer support structure further comprises an upstream tissue engagement portion and a downstream tissue engagement portion, wherein the upstream tissue engagement portion is configured to engage an upstream surface of the native valve, and wherein the downstream tissue engagement portion is configured to engage a downstream surface of the native valve.

13. The prosthetic valve of claim 12, wherein the downstream tissue engagement portion is configured to engage the downstream surface of the native valve at a location opposite the upstream tissue engagement portion.