Heart valve prosthesis and separate support flange for attachment thereto

• US 10,575,946 B2
• Filed: 09/01/2016
• Issued: 03/03/2020
• Est. Priority Date: 09/01/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Costello, Declan, Curley, Donna
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US15/253,933
• Publication Number:
  US 20180055633A1
• Time in Patent Office: 1,279 Days
• 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 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00071 Nickel or Ni-based alloys

Abstract

A valve prosthesis assembly for implantation into a native valve site includes a valve prosthesis with a prosthetic valve component and a frame. The frame of the valve prosthesis includes a central portion supporting the prosthetic valve component, the central portion being configured to fit within an annulus of the native valve site, and an inflow portion configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site. The valve prosthesis assembly also includes a separate support flange configured to be attached to the frame after the valve prosthesis has been deployed in situ and a plurality of anchors configured to attach the support flange to the frame and configured to embed into the annulus to anchor the frame of the valve prosthesis to the native valve.

Claims

1. A valve prosthesis assembly configured for transcatheter implantation into a native valve site, the valve prosthesis assembly comprising:

a valve prosthesis having a compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within an annulus of the native valve site, the valve prosthesis including,

a prosthetic valve component, and

a frame including

a central portion supporting the prosthetic valve component, the central portion configured to fit within an annulus of the native valve site, and

an inflow portion configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site;

a separate support flange configured to be attached to the frame after the valve prosthesis has been deployed in situ, wherein the support flange is configured to be located upstream of the inflow portion of the frame; and

a plurality of anchors configured to attach the support flange to the frame and configured to embed into the annulus to anchor the frame of the valve prosthesis to the native valve.

2. The valve prosthesis assembly of claim 1, wherein the inflow portion further includes receiving holes configured to receive the anchors.

3. The valve prosthesis assembly of claim 2, wherein the anchors are attached to the support flange and extend in a downstream direction from the support flange, wherein the anchors are configured to extend through the receiving holes and into the annulus of the native valve site.

4. The valve prosthesis assembly of claim 2, wherein the support flange includes guide holes, wherein the anchors are separate from the support flange and are configured to extend into the guide holes, the receiving holes, and into the annulus in situ.

5. The valve prosthesis assembly of claim 1, wherein the central portion of the frame includes receiving arms extending radially outward therefrom, wherein each of the receiving arms includes a respective receiving hole,

wherein each of the anchors are configured to engage a respective receiving hole.

6. The valve prosthesis assembly of claim 5, wherein the anchors are attached to the support flange and extend downstream to engage the receiving holes.

7. The valve prosthesis assembly of claim 1, wherein the support flange has a compressed configuration for delivery within a vasculature and a radially expanded configuration for attachment to the frame.

8. The valve prosthesis assembly of claim 7, wherein the support flange in the radially expanded configuration is an annular component having an outer diameter and an inner diameter that defines a central opening therethrough, the annular component being substantially planar.

9. The valve prosthesis assembly of claim 8, wherein the annular component has a mesh configuration with a plurality of openings defined by a framework of the mesh configuration, and the central opening and the plurality of openings are oriented transverse to blood flow when the support flange is in the radially expanded configuration in situ.

10. A valve prosthesis assembly configured for transcatheter implantation into a native valve site, the valve prosthesis assembly comprising:

a valve prosthesis having a compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within an annulus of the native valve site, the valve prosthesis including

a prosthetic valve component, and

a frame including

a central portion supporting the prosthetic valve component, the central portion configured to fit within the annulus when the valve prosthesis is in the radially expanded configuration, and

an inflow portion having a larger diameter than the central portion when the valve prosthesis is in the radially expanded configuration to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site;

a separate support flange configured to be attached to the frame after the valve prosthesis has been deployed in situ, the support flange having a compressed configuration for delivery within a vasculature and a radially expanded configuration for attachment to the frame, wherein the support flange in the radially expanded configuration is a ring defining an opening therethrough and wherein the support flange is formed from a shape memory material and wherein the support flange is configured to be located upstream of the inflow portion of the frame; and

a plurality of anchors configured to attach the support flange to the frame and configured to embed into the annulus to anchor the frame of the valve prosthesis to the native valve.

11. The valve prosthesis assembly of claim 10, wherein the valve prosthesis further includes receiving holes configured to receive the anchors.

12. The valve prosthesis assembly of claim 11, wherein the anchors are attached to the support flange and are configured to extend through the receiving holes.

13. The valve prosthesis assembly of claim 12, wherein the support flange includes guide holes, and wherein the anchors are separate from the support flange and are configured to extend through the guide holes and the receiving holes.

14. The valve prosthesis assembly of claim 10, wherein the ring is substantially planar.

15. The valve prosthesis assembly of claim 14, wherein the opening is a central opening and the ring has a mesh configuration with a plurality of openings defined by a framework of the mesh configuration, and the central opening and the plurality of openings are oriented transverse to blood flow when the support flange is in the radially expanded configuration in situ.

16. A method of delivering and deploying a valve prosthesis assembly within a native valve via transcatheter implantation, the method comprising the steps of:

advancing a valve prosthesis within a vasculature to the native valve, wherein the valve prosthesis includes a prosthetic valve component coupled to a central portion of a frame and wherein the valve prosthesis is in a compressed configuration for delivery;

deploying the valve prosthesis to a radially expanded configuration such that the central portion is disposed in the annulus of the native valve and an inflow portion having a larger diameter than the central portion engages an upstream side of the annulus to restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve;

after the valve prosthesis has been deployed, delivering a support flange to the native valve;

deploying the support flange upstream of the inflow portion of the frame; and

attaching the support flange to the frame of the valve prosthesis with a plurality of anchors, wherein the anchors are configured to embed into the annulus in order to anchor the frame of the valve prosthesis to the native valve.

17. The method of claim 16,

wherein the anchors extend from a downstream surface of the support flange,

wherein the inflow portion further includes receiving holes configured to receive the anchors,

wherein the step of deploying the support flange includes aligning the anchors with the receiving holes, and

wherein the step of anchoring the support flange to the frame includes advancing the support flange downstream such that the anchors extend through the receiving holes and into the annulus.

18. The method of claim 16,

wherein the support flange includes guide holes therethrough,

wherein the inflow portion includes receiving holes configured to receive anchors,

wherein the step of deploying the support flange includes aligning the guide holes with the receiving holes, and

wherein the anchors are separate from the support flange and the step of anchoring the support flange to the frame includes advancing the anchors through the guide holes of the support flange, through the receiving holes of the inflow portion, and into the annulus in situ.

19. The method of claim 18, wherein advancing the anchors through the guide holes of the support flange includes advancing a respective push wire in order to individually advance each anchor, each push wire individually associated with a respective anchor and each push wire having a shape memory shape with a radially expanded step therein.

20. The method of claim 16,

wherein the anchors extend from a downstream surface of the support flange,

wherein the central portion of the frame includes receiving arms extending radially outward therefrom, wherein each of the receiving arms includes a respective receiving hole configured to receive a respective anchor,

wherein the step of deploying the support flange includes aligning the anchors with the receiving holes, and

wherein the step of anchoring the support flange to the frame includes advancing the support flange downstream such that the anchors extend through the receiving holes.