Prosthetic valve system having a docking component and a prosthetic valve component

• US 10,034,747 B2
• Filed: 08/27/2015
• Issued: 07/31/2018
• Est. Priority Date: 08/27/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Harewood, Frank
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US14/837,194
• Publication Number:
  US 20170056162A1
• Time in Patent Office: 1,069 Days
• Field of Search: None
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A two-component valve prosthesis system includes a docking component and a prosthetic valve component that is configured to be delivered separately from the docking component. The docking component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The docking component includes a tubular skirt, a first annular scaffold attached to a first end of the tubular skirt and a second annular scaffold attached to a second end of the tubular skirt. The first and second annular scaffolds are independent from each other. An intermediate portion of the tubular skirt is unsupported such that neither of the first or second annular scaffolds surrounds the intermediate portion of the tubular skirt. The prosthetic valve component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion of the docking component.

Claims

1. A valve prosthesis system comprising:

a docking component having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the docking component comprising,

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

a first annular scaffold attached to the tubular body along the first end portion thereof, and

a second annular scaffold attached to the tubular body along the second end portion thereof, wherein the first and second annular scaffolds are independent from each other, wherein the intermediate portion of the tubular body is unsupported such that neither of the first or second annular scaffolds surround the intermediate portion of the tubular body; and

a prosthetic valve component having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion of the docking component, wherein the prosthetic valve component is configured to be delivered separately from the docking component and includes barbs that are configured to embed into the intermediate portion of the tubular body of the docking component to couple the prosthetic valve component to the intermediate portion in situ without contacting the first and second annular scaffolds of the docking component.

2. The valve prosthesis system of claim 1, wherein the first and second annular scaffolds are sized to anchor the valve prosthesis system against native valve tissue when the docking component is in the expanded configuration.

3. The valve prosthesis system of claim 1, wherein the prosthetic valve component includes a scaffold and at least two leaflets.

4. The valve prosthesis system of claim 3, wherein the prosthetic valve component includes three leaflets and the scaffold is an annular ring that defines three posts aligned with commissures of the three leaflets of the prosthetic valve component.

5. The valve prosthesis system of claim 4, wherein the annular ring includes the barbs on an outside surface thereof.

6. The valve prosthesis system of claim 1, wherein the first and second annular scaffolds extend beyond the first and second end portions of the tubular body.

7. The valve prosthesis system of claim 1, wherein the impermeable material is selected from a group consisting of a polymer material, a fabric material, or a pericardium.

16. The valve prosthesis system of claim 1, wherein each of the first annular scaffold and the second annular scaffold is a sinusoidal patterned ring.

17. The valve prosthesis system of claim 1, wherein the intermediate portion of the tubular body has a longitudinal length at least as long as the prosthetic valve component.

8. A valve prosthesis system, the system comprising:

an exterior docking component including a tubular skirt, a first annular scaffold attached to a first end of the tubular skirt, and a second annular scaffold attached to a second end of the tubular skirt, the exterior docking component having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve, wherein the first and second annular scaffolds are independent from each other and an intermediate portion of the tubular skirt that longitudinally extends between the first and second annular scaffolds is unsupported such that neither of the first or second annular scaffolds surround the intermediate portion of the tubular skirt; and

an interior dockable component including a scaffold and at least two valve leaflets disposed within and secured to the scaffold, the interior dockable component having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the tubular skirt of the exterior docking component, wherein the interior dockable component includes three valve leaflets and wherein the scaffold of the interior dockable component is an annular ring that defines three posts aligned with commissures of the three valve leaflets, and

wherein the interior dockable component is configured to be delivered separately from the exterior docking component and the interior dockable component is configured to couple to the intermediate portion of the tubular skirt of the exterior docking component without contacting the first and second annular scaffolds of the exterior docking component in situ such that the tubular skirt is radially disposed around and contacts the interior dockable component.

9. The valve prosthesis system of claim 8, wherein the first and second annular scaffolds are sized to anchor the valve prosthesis system against native valve tissue when the exterior docking component is in the expanded configuration.

10. The valve prosthesis system of claim 8, wherein the annular ring includes barbs on an outside surface thereof, the barbs being configured to embed into the intermediate portion of the tubular skirt of the exterior docking component in order to couple the interior dockable component to the exterior docking component in situ.

11. The valve prosthesis system of claim 8, wherein the tubular skirt is formed from an impermeable material and the impermeable material is selected from a group consisting of a polymer material, a fabric material, or a pericardium.

18. The valve prosthesis system of claim 8, wherein each of the first annular scaffold and the second annular scaffold is a sinusoidal patterned ring.

19. The valve prosthesis system of claim 8, wherein the intermediate portion of the tubular skirt has a longitudinal length at least as long as the interior dockable component.

12. A valve prosthesis system, the system comprising:

an exterior docking component including a tubular skirt, a first annular scaffold attached to a first end of the tubular skirt, and a second annular scaffold attached to a second end of the tubular skirt, the exterior docking component having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve, wherein the first and second annular scaffolds are independent from each other and an intermediate portion of the tubular skirt that longitudinally extends between the first and second annular scaffolds is unsupported such that neither of the first or second annular scaffolds surround the intermediate portion of the tubular skirt; and

an interior dockable component including a scaffold, at least two valve leaflets disposed within and secured to the scaffold, and barbs on an outside surface thereof, the interior dockable component having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the skirt of the exterior docking component,

wherein the interior dockable component is configured to be delivered separately from the exterior docking component and the barbs of the interior dockable component are configured to embed into the tubular skirt of the exterior docking component in order to couple the interior dockable component to the intermediate portion of the tubular skirt of the exterior docking component in situ such that the tubular skirt is radially disposed around and contacts the interior dockable component.

13. The valve prosthesis system of claim 12, wherein the interior dockable component includes three valve leaflets and wherein the scaffold of the interior dockable component is an annular ring that defines three posts aligned with commissures of the three valve leaflets.

14. The valve prosthesis system of claim 12, wherein the first and second annular scaffolds each include a sinusoidal patterned ring sized to anchor the valve prosthesis system against native valve tissue when the exterior docking component is in the expanded configuration.

15. The valve prosthesis system of claim 12, wherein the intermediate portion of the tubular skirt has a longitudinal length at least as long as the interior dockable component.