SEGMENTED TRANSCATHETER VALVE PROSTHESIS HAVING AN UNSUPPORTED VALVE SEGMENT

• US 20160151153A1
• Filed: 12/01/2014
• Published: 06/02/2016
• Est. Priority Date: 12/01/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sandstrom, Jeffrey, Maiorano, Alaena, Racchini, Joel
• Granted Patent: US 9,693,860 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Embodiments hereof relate to a transcatheter valve prosthesis including a tubular fabric body, a first or inflow tubular scaffold attached to a first end portion of the tubular fabric body, and a second or outflow tubular scaffold attached to a second end portion of the tubular fabric body. A prosthetic valve component is disposed within and secured to an intermediate portion of the tubular fabric body that longitudinally extends between the first and second end portions of the tubular fabric body. The intermediate portion is unsupported such that neither of the first and second tubular scaffolds surrounds the intermediate portion of the tubular fabric body. The intermediate portion may include one or more windows for coronary access and may include one or more commissure reinforcement members coupled thereto to provide support for the prosthetic valve component.

Claims

1. A transcatheter valve prosthesis, the prosthesis comprising:

a tubular fabric body formed from a synthetic material, the tubular fabric body having opposing first and second end portions and an intermediate portion extending between the first and second end portions;

a first tubular scaffold attached to the tubular fabric body along the first end portion thereof;

a second tubular scaffold attached to the tubular fabric body along the second end portion thereof, wherein the first and second tubular scaffolds are independent from each other; and

a prosthetic valve component disposed within and secured to the intermediate portion of the tubular fabric body, wherein the intermediate portion of the tubular fabric body is unsupported such that neither of the first or second tubular scaffolds surround the intermediate portion of the tubular fabric body, and

wherein the prosthesis has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native valve.

2. The prosthesis of claim 1, wherein the first and second tubular scaffolds are configured to be self-expanding and are sized to anchor the prosthesis against native valve tissue when the prosthesis is in the expanded configuration.

3. The prosthesis of claim 1, wherein at least one window is formed through the intermediate portion of the tubular fabric body.

4. The prosthesis of claim 1, wherein the prosthetic valve component includes at least two leaflets and the prosthesis further includes at least two reinforcement members that are attached to the intermediate portion of the tubular fabric body, the at least two reinforcement members being aligned with commissures of the at least two leaflets of the prosthetic valve component.

5. The prosthesis of claim 4, wherein the reinforcement members extend from the first tubular scaffold.

6. The prosthesis of claim 1, wherein second tubular scaffold extends beyond the second end of the tubular fabric body.

7. The prosthesis of claim 1, wherein the second tubular scaffold is configured to have a higher radial force than the first tubular scaffold.

8. The prosthesis of claim 1, wherein the second tubular scaffold includes barbs on an outer surface thereof.

9. The prosthesis of claim 1, wherein the first tubular scaffold is flared such that a first end of the first tubular scaffold has a smaller diameter than a second, opposing end of the first tubular scaffold.

10. The prosthesis of claim 9, wherein the first tubular scaffold includes sealing material coupled thereto.

11. The prosthesis of claim 1, wherein when the prosthesis is in the expanded configuration each of the first tubular scaffold, the intermediate portion of the tubular fabric body and the second tubular scaffold comprises a respective third of a total length of the prosthesis.

12. A transcatheter valve prosthesis for implantation within a native valve, the prosthesis comprising:

a tubular fabric body having a first end portion, a second end portion, and an intermediate portion that longitudinally extends between the first and second end portions;

a first tubular scaffold attached to the tubular fabric body along the first end portion thereof;

a second tubular scaffold attached to the tubular fabric body along the second end portion thereof, wherein the first and second tubular scaffolds are configured to be self-expanding and are sized to deploy against native valve tissue, the first and second tubular scaffolds being independent from each other; and

a prosthetic valve component disposed within and secured to the intermediate portion of the tubular fabric body, wherein the prosthetic valve component includes three leaflets; and

three reinforcement members that are attached to the intermediate portion of the tubular fabric body, the three reinforcement members being aligned with commissures of the three leaflets of the prosthetic valve component,

wherein the intermediate portion of the tubular fabric body is unsupported such that neither of the first or second tubular scaffolds surround the intermediate portion of the tubular fabric body and only the three reinforcement members are coupled to the intermediate portion, and

wherein the prosthesis has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native valve.

13. The prosthesis of claim 12, wherein at least one window is formed through the intermediate portion of the tubular fabric body.

14. The prosthesis of claim 12, wherein the three reinforcement members extend from the first tubular scaffold.

15. The prosthesis of claim 12, wherein the second tubular scaffold is configured to have a higher radial force than the first tubular scaffold.

16. The prosthesis of claim 12, wherein the second tubular scaffold includes barbs coupled to an outer surface thereof.

17. The prosthesis of claim 12, wherein the first tubular scaffold is flared such that a first end of the first tubular scaffold has a smaller diameter than a second, opposing end of the first tubular scaffold.

18. The prosthesis of claim 17, wherein the first tubular scaffold includes sealing material coupled thereto.

19. A segmented transcatheter valve prosthesis, the prosthesis comprising:

a tubular fabric body formed from a synthetic material;

a first tubular scaffold attached to the tubular fabric body along a first end portion thereof such that the first tubular scaffold and the first end portion form a first anchoring segment at an inflow end of the prosthesis;

a second tubular scaffold attached to the tubular fabric body along a second end portion thereof such that the second tubular scaffold and the second end portion form a second anchoring segment at an outflow end of the prosthesis, wherein the first and second tubular scaffolds are independent from each other; and

a prosthetic valve component disposed within and secured to an intermediate portion of the tubular fabric body that extends between the first and second end portions of the tubular fabric body, the prosthetic valve component and intermediate portion forming a central valve segment of the prosthesis, wherein the central valve segment longitudinally extends between the first and second anchoring segments of the prosthesis and is unsupported such that neither of the first or second tubular scaffolds surround the intermediate portion of the tubular fabric body, and

wherein the prosthesis has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native valve.

20. The prosthesis of claim 19, wherein the prosthetic valve component includes at least two leaflets and the prosthesis further includes at least two reinforcement members that are attached to the intermediate portion of the tubular fabric body, the at least two reinforcement members being aligned with commissures of the at least two leaflets of the prosthetic valve component.