Multi-portion replacement heart valve prosthesis

• US 10,639,143 B2
• Filed: 08/25/2017
• Issued: 05/05/2020
• Est. Priority Date: 08/26/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Oba, Travis Zenyo, Peterson, Matthew A., Rabito, Glen T., Cooper, Alexander H., Landon, David Robert, Ratz, J. Brent, Yi, Seung-Beom
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/687,184
• Publication Number:
  US 20180055629A1
• Time in Patent Office: 984 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors are coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Claims

1. A replacement heart valve prosthesis, the prosthesis comprising:

an expandable frame configured to radially expand and contract for deployment within a native heart valve, the expandable frame having a longitudinal axis between upper and lower ends, the expandable frame comprising;

a first frame portion comprising a first frame body having a plurality of body struts forming a plurality of rows of closed cells, a first anchoring feature comprising a plurality of anchoring struts each of which ends in a flared tip, and a plurality of cushions covering at least some of the flared tips, the first frame body comprising a generally cylindrical first upper region, a generally cylindrical first intermediate region, and a first lower region, wherein the first upper region includes a plurality of locking tabs each having an enlarged head attached to a strut, and wherein, when the prosthesis is in an expanded configuration;

the first anchoring feature extends radially outwardly from the first lower region; and

at least a portion of the first anchoring feature extends towards the first upper region;

a second frame portion positioned radially outward of the first frame body, the second frame portion comprising a second frame body having a plurality of struts forming a zig-zag configuration and having a second upper region ending in a plurality of struts containing apertures, a second intermediate region, and a second lower region, wherein, when the prosthesis is in an expanded configuration;

at least a portion of the second upper region extends radially outwardly from the first upper region;

the second lower region is positioned radially between the first anchoring feature and the first frame body;

the second intermediate portion is configured such that, when the prosthesis is deployed within the native heart valve, the second intermediate portion is positioned within a native valve annulus; and

the second upper region is sutured to the first upper region;

a valve body positioned within an interior of the first frame portion, the valve body comprising a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction; and

a skirt, wherein at least a portion of the skirt extends along an exterior of the second frame portion and at least a portion of the skirt extends between the first frame portion and the second frame portion.

2. The replacement heart valve prosthesis of claim 1, wherein, when the prosthesis is in an expanded configuration, the second intermediate region is generally non-cylindrical.

3. The replacement heart valve prosthesis of claim 1, wherein the second frame portion and the first anchoring feature are sized such that, when the prosthesis is deployed and expanded within the native heart valve, at least one of native valve leaflets and the native valve annulus are pinched between the second frame portion and the first anchoring feature.

4. The replacement heart valve prosthesis of claim 1, wherein the first anchoring feature is sized such that, when the prosthesis is deployed and expanded within a native mitral valve, at least a portion of the first anchoring feature contacts a native mitral valve annulus on a ventricular side.

5. The replacement heart valve prosthesis of claim 1, wherein the second frame portion comprises a second anchoring feature.

6. The replacement heart valve prosthesis of claim 1, wherein the portion extending between the first frame portion and the second frame portion is attached to the valve body.

7. The replacement heart valve prosthesis of claim 1, wherein the valve body comprises one or more intermediate components, the one or more intermediate components positioned between the first frame body and the valve leaflets.

8. The replacement heart valve prosthesis of claim 1, wherein the first frame body forms a bulbous shape.

9. A replacement mitral valve prosthesis, comprising:

a valve body including three flexible leaflets made from pericardium; and

a self-expanding, metallic support structure surrounding and supporting the valve body, the support structure sized for deployment in a native mitral valve, the support structure comprising;

a cylindrical valve frame having an upper portion including tabs with enlarged heads, an intermediate portion, and a lower portion, the valve frame having at least two circumferential rows of closed cells;

a plurality of anchors coupled to the lower portion, each of the anchors extending radially outwardly and upwardly and ending in a flared tip, at least some of the flared tips having cushions; and

a sealing frame separate from, coupled to by sutures, and disposed radially outwardly of the valve frame, the sealing frame having an upper portion including a plurality of struts having apertures, an intermediate portion and a lower portion, wherein a clearance is provided between the sealing frame and the valve frame and wherein the plurality of anchors have ends disposed radially outwardly of the sealing frame.

10. The prosthesis of claim 9, wherein the upper portion of the sealing frame is coupled to the upper portion of the valve frame via the sutures.

11. The prosthesis of claim 9, wherein the sealing frame is more flexible than the valve frame for conforming to a mitral valve annulus.

12. The prosthesis of claim 9, wherein the support structure is adapted to capture native mitral valve leaflets between the sealing frame and the anchors.

13. The prosthesis of claim 9, wherein the intermediate portion of the sealing frame has a diameter in the range of about 35 mm to 55 mm.

14. The prosthesis of claim 9, wherein at least a portion of the sealing frame is covered by fabric.

15. The prosthesis of claim 9, wherein the lower portion of the sealing frame has a larger diameter than the upper portion of the sealing frame.

16. The prosthesis of claim 15, wherein the intermediate portion of the sealing frame has a larger diameter than the lower portion of the sealing frame.

17. The prosthesis of claim 9, wherein the valve frame is bulbous.

18. A replacement heart valve prosthesis, the prosthesis comprising:

an expandable frame configured to radially expand and contract for deployment within a native mitral heart valve, the expandable frame having a longitudinal axis between inlet and outlet ends, the expandable frame comprising;

a generally cylindrical inner frame comprising;

an inner frame inlet end including a plurality of locking tabs each having an enlarged head;

an intermediate section having a plurality of rows of closed cells;

an inner frame outlet end having a plurality of anchoring struts, the anchoring struts extending radially outwards and towards the inlet end; and

at least one cushion located on a flared tip of at least one of the plurality of anchoring struts;

an outer frame sutured to the inner frame, the outer frame comprising;

an outer frame inlet end extending generally parallel with the longitudinal axis and having a plurality of apertures configured for suturing to the inner frame; and

a bulbous section which first extends radially away from the longitudinal axis and then extends radially towards the longitudinal axis;

a skirt covering an exterior surface of the inner frame and an exterior surface of the outer frame, wherein the skirt creates separation between the inner frame and the outer frame; and

a valve body positioned within an interior of the inner frame, the valve body comprising a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction.