Prosthetic valve with sealing members and methods of use thereof

• US 10,441,413 B2
• Filed: 12/05/2016
• Issued: 10/15/2019
• Est. Priority Date: 04/21/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tabor, Charles
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/368,842
• Publication Number:
  US 20170079779A1
• Time in Patent Office: 1,044 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2250/0069 Sealing means

Abstract

Embodiments of the present invention provide prosthetic valves having sealing members on the external surface thereof. The prosthetic heart valves of the present invention are preferably delivered by catheter directly through the apex of the heart or by other close range transcatheter delivery methods. Because these methods of implantation require a shorter length of catheter, a prosthetic valve can be more accurately oriented in the desired implantation location. Fluoroscopy can be used to further assist in orientation of the valve. The sealing members of the present invention can be positioned on the prosthetic valve such that, when the prosthetic valve is implanted in a native annulus, each provided sealing member is located adjacent to a commissural point of the native valve leaflets. Because the sealing members are precisely oriented on the prosthetic valve, a physician can ensure that the sealing members are aligned with the commissural points of the native valve leaflets. In embodiments of the present invention, the prosthetic valve can have a waisted middle section, and the sealing members can be located in the waisted middle section such that the crimped diameter of the prosthetic valve is not negatively impacted by the sealing, members.

Claims

1. A prosthetic valve comprising:

a radially expandable circumferential frame having an inner area and an outer surface;

a valve structure attached to the inner area; and

sealing members positioned around the frame and extending radially outward from the outer surface, each sealing member being a structure that is independent of and unconnected to a structure of any other sealing member, wherein each of the sealing members, upon implantation of the prosthetic valve, is rotationally aligned with a respective commissure of a valve in a patient, wherein each sealing member is configured to occlude a gap created between the outer surface and a respective commissure to prevent paravalvular leakage, wherein the number of sealing members matches the number of commissures.

2. The prosthetic valve of claim 1, wherein each sealing member has a size and shape corresponding to a gap to occlude.

3. The prosthetic valve of claim 1, wherein the number of sealing members is three.

4. The prosthetic valve of claim 1, wherein the number of sealing members is two.

5. The prosthetic valve of claim 1, wherein the frame comprises commissural members, wherein each sealing member is longitudinally aligned with a corresponding commissural member of the frame, and wherein the number of sealing members matches the number of commissural members.

6. The prosthetic valve of claim 1, wherein at least one sealing member comprises biological tissue.

7. The prosthetic valve of claim 1, wherein at least one sealing member comprises polyethylene terephthalate.

8. The prosthetic valve of claim 1, wherein each sealing member comprises at least one pad.

9. The prosthetic valve of claim 1, wherein the frame comprises an inflow section, an outflow section, and a waisted middle section having an expanded diameter less than respective expanded diameters of the inflow section and the outflow section, and wherein the sealing members are positioned in the waisted middle section of the frame.

10. The prosthetic valve of claim 1, wherein the frame is self-expanding.

11. The prosthetic valve of claim 1, wherein the frame is balloon expandable.

12. A prosthetic valve comprising:

a radially expandable circumferential frame having commissural members, an inner area and an outer surface;

a valve structure attached to the inner area; and

sealing members positioned around the frame and extending radially outward from the outer surface, each sealing member being a structure that is independent of and unconnected to a structure of any other sealing member, wherein each sealing member is longitudinally aligned with a corresponding commissural member of the frame, wherein each of the sealing members, upon implantation of the prosthetic valve, is rotationally aligned with a respective commissure of a valve in a patient, wherein each sealing member is configured to occlude a gap created between the outer surface and a respective commissure to prevent paravalvular leakage, wherein the number of sealing members matches the number of commissural members of the frame and the number of commissures of a valve in a patient.

13. The prosthetic valve of claim 12, wherein each sealing member has a size and shape corresponding to a gap to occlude.

14. The prosthetic valve of claim 12, wherein the number of sealing members is three.

15. The prosthetic valve of claim 12, wherein the number of sealing members is two.

16. The prosthetic valve of claim 12, wherein at least one sealing member comprises biological tissue.

17. The prosthetic valve of claim 12, wherein at least one sealing member comprises polyethylene terephthalate.

18. The prosthetic valve of claim 12, wherein each sealing member comprises at least one pad.

19. The prosthetic valve of claim 12, wherein the frame comprises an inflow section, an outflow section, and a waisted middle section having an expanded diameter less than respective expanded diameters of the inflow section and the outflow section, and wherein the sealing members are positioned in the waisted middle section of the frame.

20. The prosthetic valve of claim 12, wherein the frame is one of self-expanding and balloon expandable.