Prosthetic heart valve device and associated systems and methods

• US 10,702,378 B2
• Filed: 04/18/2017
• Issued: 07/07/2020
• Est. Priority Date: 04/18/2017
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Miyashiro, Katherine
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US15/490,047
• Publication Number:
  US 20180296335A1
• Time in Patent Office: 1,176 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support having an inflow region and an outflow region, and a prosthetic valve assembly within the valve support. The device further includes an anchoring member having a base attached to the outflow region of the valve support, a plurality of arms projecting laterally outward from the base and inclined in an upstream direction in a deployed state, and a fixation structure extending upstream from the arms. The fixation structure has a plurality of struts that define an annular engagement surface configured to press outwardly against the native annulus and a plurality of fixation elements projecting from the struts. The downstream-most portion of the fixation structure extends from the arms at a smooth bend, and fixation elements at the downstream-most portion of the fixation structure extend in an upstream direction.

Claims

1. A prosthetic heart valve device for treating a native valve of a human heart having a native annulus and native leaflets, comprising:

a valve support having an inflow region and an outflow region;

a prosthetic valve assembly within the valve support; and

an anchoring member having a base attached to the outflow region of the valve support, a plurality of arms projecting laterally outward from the base and inclined in an upstream direction in a deployed state, and a fixation structure extending upstream from the arms, the fixation structure having a plurality of struts that define an annular engagement surface configured to press outwardly against the native annulus and a plurality of fixation elements projecting from the struts, wherein a downstream-most portion of the fixation structure extends from the arms at a smooth bend, and all of the fixation elements projecting from the fixation structure extend in an upstream direction, and wherein the plurality of arms, the plurality of struts, and the plurality of fixation elements are configured to be partially deployed from a capsule and then at least substantially recaptured within the capsule by moving at least one of the capsule and/or the device relative to the other such the plurality of arms, the plurality of struts, and the plurality of fixation elements slide into the capsule.

2. The prosthetic heart valve device of claim 1 wherein the arms are spaced apart from each other throughout their length.

3. The prosthetic heart valve device of claim 1 wherein the struts of the fixation structure are arranged in cells having sides, and the arms have a first length and each side of the cells has a second length less than the first length.

4. The prosthetic heart valve device of claim 1 wherein each arm and the struts of the fixation structure extending from each arm form a Y-shaped portion of the anchoring member, and a right-hand strut of each Y-shaped portion is coupled directly to a left-hand strut of an immediately adjacent Y-shaped portion.

5. The prosthetic heart valve device of claim 1, further comprising connector extensions projecting from a downstream end of the valve support and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the valve support and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.

6. The prosthetic heart valve device of claim 1 wherein the valve support comprises:

a first row of first hexagonal cells at the outflow region of the valve support, and the first hexagonal cells having first longitudinal supports;

a second row of second hexagonal cells at the inflow region of the valve support, the second hexagonal cells having second longitudinal supports, wherein the first and second hexagonal cells are directly adjacent to each other such that the first longitudinal supports extend directly from downstream apexes of the second hexagonal cells and the second longitudinal supports extend directly from upstream apexes of the first hexagonal cells; and

wherein the prosthetic valve assembly is attached to at least one of the first longitudinal supports and/or at least one of the second longitudinal supports.

7. The prosthetic heart valve device of claim 6 wherein the valve support further comprises a first row of diamond-shaped cells at a downstream end of the first row of hexagonal cells and a second row of diamond-shaped cells at an upstream end of the second row of hexagonal cells.

8. The prosthetic heart valve device of claim 6 wherein the first row of hexagonal cells flares outward in the downstream direction and the second row of hexagonal cells flares outward in the upstream direction.

9. The prosthetic heart valve device of claim 6, further comprising connector extensions projecting from a downstream end of the valve support and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the valve support and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.

10. The prosthetic heart valve device of claim 1 wherein the valve support comprises:

a first row of first hexagonal cells at the outflow region of the valve support, wherein the first hexagonal cells have first longitudinal supports, first upstream V-struts extending upstream from the first longitudinal supports, and first downstream V-struts extending downstream from the first longitudinal supports;

a second row of second hexagonal cells at the inflow region of the valve support, wherein the second hexagonal cells have second longitudinal supports, second upstream V-struts extending upstream from the second longitudinal supports, and second downstream V-struts extending downstream from the second longitudinal supports; and

wherein the first upstream V-struts of the first hexagonal cells and the second downstream inverted V-struts of the second hexagonal cells are the same struts.

11. A prosthetic heart valve device for treating a native valve of a human heart having a native annulus and native leaflets, comprising:

an annular inner support frame having an inflow region and an outflow region;

a prosthetic valve assembly within the inner support frame; and

an anchoring member having a base attached to the outflow region of the inner support frame, a plurality of arms projecting laterally outward from the base at an angle inclined in an upstream direction, an outer fixation frame extending upstream from the arms, and fixation elements projecting from the outer fixation frame, and wherein all of the fixation elements project from the outer fixation frame extend in an upstream direction, the outer fixation frame having a plurality of struts that define an annular engagement surface spaced radially outward from the inflow region of the inner support frame in the deployed state, wherein the arms and the struts are configured to be partially deployed from a capsule and then at least substantially recaptured within the capsule by moving at least one of the capsule and/or the device relative to the other such the arms and struts slide into the capsule.

12. The prosthetic heart valve device of claim 11 wherein the arms are spaced apart from each other throughout their length.

13. The prosthetic heart valve device of claim 11 wherein the struts of the outer fixation frame are arranged in cells having sides, and the arms have a first length and each side of the cells has a second length less than the first length.

14. The prosthetic heart valve device of claim 11 wherein each arm and the struts of the outer fixation frame extending from each arm form a Y-shaped portion of the anchoring member, and a right-hand strut of each Y-shaped portion is coupled directly to a left-hand strut of an immediately adjacent Y-shaped portion.

15. The prosthetic heart valve device of claim 11, further comprising connector extensions projecting from a downstream end of the inner annular support frame and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the inner annular support frame and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.

16. The prosthetic heart valve device of claim 11 wherein the inner annular support frame comprises:

a first row of first hexagonal cells at the outflow region of the inner annular support frame, and the first hexagonal cells having first longitudinal supports;

a second row of second hexagonal cells at the inflow region of the inner annular support frame, the second hexagonal cells having second longitudinal supports, wherein the first and second hexagonal cells are directly adjacent to each other such that the first longitudinal supports extend directly from downstream apexes of the second hexagonal cells and the second longitudinal supports extend directly from upstream apexes of the first hexagonal cells; and

wherein the prosthetic valve assembly is attached to at least one of the first longitudinal supports and/or at least one of the second longitudinal supports.

17. The prosthetic heart valve device of claim 16 wherein the inner annular support frame further comprises a first row of diamond-shaped cells at a downstream end of the first row of hexagonal cells and a second row of diamond-shaped cells at an upstream end of the second row of hexagonal cells.

18. The prosthetic heart valve device of claim 16 wherein the first row of hexagonal cells flares outward in the downstream direction and the second row of hexagonal cells flares outward in the upstream direction.

19. The prosthetic heart valve device of claim 16, further comprising connector extensions projecting from a downstream end of the inner annular support frame and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the inner annular support frame and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.

20. A valve support for a prosthetic heart valve, comprising:

a first row of first hexagonal cells at an outflow region of the valve support, wherein the first hexagonal cells have first longitudinal supports, first and second upstream struts extending upstream from the first longitudinal supports, and first and second downstream struts extending downstream from the first longitudinal supports;

a second row of second hexagonal cells at an inflow region of the valve support, wherein the second hexagonal cells have second longitudinal supports, first and second upstream struts extending upstream from the second longitudinal supports, and first and second downstream struts extending downstream from the second longitudinal supports; and

wherein the first and second upstream struts of the first hexagonal cells and the first and second downstream struts of the second hexagonal cells are the same struts.

21. The valve support of claim 20 wherein the first and second longitudinal supports have a first width and the first and second upstream struts and the first and second downstream struts have a second width less than the first width.

22. The valve support of claim 20 wherein:

the first and second hexagonal cells are directly adjacent to each other such that the first longitudinal supports extend directly from downstream apexes of the second hexagonal cells and the second longitudinal supports extend directly from upstream apexes of the first hexagonal cells; and

wherein the prosthetic valve assembly is attached to at least one of the first longitudinal supports and/or at least one of the second longitudinal supports.

23. The valve support of claim 20 further comprising a first row of diamond-shaped cells at a downstream end of the first row of hexagonal cells and a second row of diamond-shaped cells at an upstream end of the second row of hexagonal cells.

24. The valve support of claim 23 wherein the first row of hexagonal cells flares outward in the downstream direction and the second row of hexagonal cells flares outward in the upstream direction.

25. The valve support of claim 20, further comprising connector extensions projecting from a downstream end of the first hexagonal cells, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the first hexagonal cells, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.