Heart valve annulus device and method of using same

• US 9,770,328 B2
• Filed: 10/29/2015
• Issued: 09/26/2017
• Est. Priority Date: 09/20/2000
• Status: Expired due to Fees

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Macoviak, John A.
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US14/926,242
• Publication Number:
  US 20160045308A1
• Time in Patent Office: 698 Days
• Field of Search: 623 214, 623 218, 623 22, 623 232, 623 234, 623 235, 623 238, 623 24, 623 241
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A heart valve implant has a body sized and configured to rest near or within a heart valve annulus. A plurality of spaced-apart retainers extend outwardly from the body to contact tissue near or within the heart valve annulus. The retainers are sized and configured to secure the body to the heart valve annulus. The implant can be secured, e.g., without the use of sutures.

Claims

1. A heart valve implant comprising

a body sized and configured to rest near or within a heart valve annulus, the body further comprising an inner ring and an outer ring having a top and bottom end, each of the inner ring and the outer ring having an outer circumference and an inner circumference, the majority of the outer circumference of the inner ring being contained within the inner circumference of the outer ring, each of the rings forming a flare, wherein the an abutment of the flares limits proximal travel of the exterior ring relative to the interior ring, the inner ring removably mechanically coupled to the outer ring by an anchor mechanism, without the use of sutures,

a plurality of spaced-apart conformable retainers extending radially outwardly from the body to contact tissue near or within the heart valve annulus, the retainers mounted to the bottom end of the inner ring, the retainers being sized and configured to secure the body to the heart valve annulus without the use of sutures;

a prosthetic valve member having a frame sized and configured to be removably received within the body.

2. The heart valve implant according to claim 1 where the anchor mechanism comprises a screw type anchor mechanism, a rail fastener anchor mechanism, or a bayonet style anchor mechanism, the anchor mechanism permitting removal of the first prosthetic valve member without removal of the body.

3. The heart valve implant according to claim 2 further comprising a replacement prosthetic valve member having a frame sized and configured to be received within the body and mechanically coupled to the body within the mounting socket by an anchor mechanism.

4. A heart valve implant comprising:

an annular body sized and configured to rest near or within a heart valve annulus, the annular body further comprising an upper portion and a lower portion, the annular body being configured such that, when deployed, the lower portion engages tissue within a heart chamber downstream of the heart valve annulus and the upper portion is disposed in a heart chamber upstream the heart valve annulus, wherein the upper portion and the lower portion are separate components that are interfaced together and mechanically coupled together by a separate anchor member when the heart valve implant is deployed;

a plurality of spaced-apart retainers extending radially outwardly from the annular body and coupled to the lower portion of the annular body, the retainers being sized and configured to secure the body within the heart valve annulus; and

a prosthetic valve member configured for one-way blood flow therethrough, wherein the prosthetic valve member is supported within the upper portion of the annular body when deployed.

5. The heart valve implant of claim 4, wherein the plurality of spaced-apart retainers are movable relative the lower portion such that when the annular body is deployed the plurality of spaced-apart retainers project radially outward from the annular body so as to engage tissue downstream of the heart valve annulus and/or within the heart valve annulus.

6. The heart valve implant of claim 5, wherein the plurality of spaced-apart retainers comprise wire loops or fingers.

7. The heart valve implant of claim 6, wherein each of the plurality of retainers include a bent portion having a curved outer radius to enhance a surface area of the retainers that contacts heart tissues.

8. The heart valve implant of claim 5, wherein the plurality of spaced-apart retainers are pivotally coupled to the lower portion of the annular body.

9. The heart valve implant of claim 5, wherein the plurality of spaced-apart retainers are biased toward an outwardly extended position and delivered in a constrained condition such that, when deployed, the plurality of retainers spring radially outward to facilitate anchoring of the implant within the heart valve annulus.

10. The heart valve implant of claim 5, wherein at least one of the plurality of retainers is collapsible onto the annular body and is deployable from a collapsed condition to a deployed condition.

11. The heart valve implant of claim 4, wherein the lower portion of the annular body is compressible and the plurality of retainers are formed integrally with the lower portion.

12. The heart valve implant of claim 4, wherein the annular body is configured to anchor within the heart valve annulus without penetration of heart tissues.

13. The heart valve implant of claim 4, wherein the lower portion and the upper portion are mechanically coupled together yet movable relative each other at least during deployment.

14. The heart valve implant of claim 13, wherein the anchor member coupling the lower portion and the upper portion together comprises any of:

a screw, a rail fastener, and a bayonet style engagement.

15. The heart valve implant of claim 4, wherein engagement of the lower portion and the upper portion moves the plurality of retainers to a deployed position to facilitate anchoring of the implant within the heart valve annulus.

16. The heart valve implant of claim 4, wherein the body is sized and configured for deployment within the mitral valve annulus such that, when deployed, the upper portion is disposed within a left atrial chamber and the lower portion engages tissues within the left ventricle.

17. The heart valve implant of claim 4, wherein the upper portion and the lower portion are separable.

18. The heart valve implant of claim 4, wherein implant is operably interfaced with a pull-wire extending outside of the patient during delivery and configured such that proximal retraction of the pull wire moves the lower portion of the body relative the upper portion of the body so as to force the plurality of retainers radially outward to facilitate anchoring of the implant within the heart valve annulus.

19. The heart valve implant of claim 4, wherein one or both of the lower portion and the upper portion is formed of a material having a spring memory.

20. The heart valve implant of claim 4, wherein the lower portion is axially compressible and comprises a band with diamond shaped openings that are adapted to expand radially outward to assume a diameter larger than that of the respective heart valve annulus, wherein the plurality of retainers are integral with the band.

21. The heart valve implant of claim 4, wherein the heart valve implant is configured for minimally invasive delivery and implantation.

22. The heart valve implant of claim 4, wherein the heart valve implant is configured for implantation without sutures.

23. A heart valve implant comprising:

an annular body sized and configured to rest near or within a heart valve annulus, the annular body defined by a first portion and a second portion, each of the first portion and the second portion circumscribing the annular body, wherein the first portion and the second portion are separate components that are interfaced together and mechanically coupled together when the heart valve implant is deployed;

a plurality of spaced-apart retainers coupled to the annular body and extending radially outwardly from a bottom edge of the annular body, the retainers being sized and configured to secure the annular body within the heart valve annulus,

wherein the first and second portion are interfaced such that movement of the first portion relative the second portion deploys the plurality of spaced-apart retainers radially outward thereby securing the annular body within the heart valve annulus; and

a prosthetic valve member configured for one-way blood flow therethrough, wherein the prosthetic valve member is supported within the first portion of the annular body when deployed.