Prosthetic valve with leaflet connectors

• US 9,987,132 B1
• Filed: 01/23/2018
• Issued: 06/05/2018
• Est. Priority Date: 08/10/2016
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz, Iamberger, Meni, Baum, Aviram
• Primary Examiner(s): Wilensky, Moshe
• Application Number:
  US15/878,206
• Publication Number:
  US 20180153687A1
• Time in Patent Office: 133 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 2/2415 Manufacturing methods
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: B23P 15/001 valves or valve housings welding B23K; valve housings per se F16K

Abstract

In an unfolded state, a sheet defines a panel at a medial region, and tab portions disposed peripherally to the panel. A method comprises (A) sandwiching, between a first tab portion and a second tab portion, (i) a first commissural portion of a first leaflet, and (ii) a second commissural portion of a second leaflet; (B) attaching the first tab portion and the second tab portion to the sheet by stitching a first stitching through the tab portions and the commissural portions; (C) subsequently, covering the first stitching by: (i) forming the first tab portion into a first tab having an outer layer and an inner layer, and (ii) forming the second tab portion into a second tab having an outer layer and an inner layer; and (D) subsequently, stitching a second stitching through the outer and inner layers, and the commissural portions. Other embodiments are also described.

Claims

1. A method for use with a flexible sheet that, in an unfolded state of the sheet, defines a panel at a medial region of the sheet, a first tab portion disposed peripherally to the panel, and a second tab portion disposed peripherally to the panel opposite the first tab portion, the method comprising:

sandwiching, between the first tab portion and the second tab portion, (i) a first commissural portion of a first prosthetic leaflet, and (ii) a second commissural portion of a second prosthetic leaflet;

attaching the first tab portion and the second tab portion to the flexible sheet by stitching a first stitching through the first tab-portion, the first commissural portion, the second commissural portion, and the second tab-portion;

subsequently, covering the first stitching by;

folding the first tab portion back against itself to form the first tab portion into a first tab having first-tab outer layer and a first-tab inner layer, such that the first-tab inner layer is sandwiched between the first-tab outer layer and the first commissural portion, and

folding the second tab portion back against itself to form the second tab portion into a second tab having a second-tab outer layer and a second-tab inner layer, such that the second-tab inner layer is sandwiched between the second-tab outer layer and the second commissural portion; and

subsequently, stitching a second stitching through the first-tab outer layer, the first-tab inner layer, the first commissural portion, the second commissural portion, the second-tab inner layer, and the second-tab outer layer.

2. The method according to claim 1, wherein the step of sandwiching comprises sandwiching a separate flexible sheet between the first commissural portion and the second commissural portion.

3. The method according to claim 1, wherein stitching the first stitching comprises stitching the first stitching through (i) the first tab-portion, (ii) the first commissural portion, (iii) a separate flexible sheet disposed between the first commissural portion and the second commissural portion, (iv) the second commissural portion, and (v) the second tab-portion.

4. The method according to claim 1, wherein the step of sandwiching comprises sandwiching a fabric divider between the first tab portion and the second tab portion.

5. The method according to claim 1, wherein the step of sandwiching comprises sandwiching a separate flexible sheet between the first commissural portion and the second commissural portion, and wherein stitching the first stitching comprises stitching the first stitching through the separate flexible sheet.

6. The method according to claim 5, wherein stitching the second stitching comprises stitching the second stitching through the separate flexible sheet.

7. The method according to claim 1, wherein the flexible sheet is a first flexible sheet, and the steps of sandwiching, attaching, covering, and stitching the second stitching, are steps in assembling the first flexible sheet into a first commissure at which the first prosthetic leaflet and the second prosthetic leaflet meet, and wherein the method further comprises:

assembling a valvular assembly that includes the first commissure, a second commissure, a third commissure, the first prosthetic leaflet, the second prosthetic leaflet, and a third prosthetic leaflet, by;

assembling a second flexible sheet into a second commissure at which the second prosthetic leaflet and a third prosthetic leaflet meet; and

assembling a third flexible sheet into a third commissure at which the third prosthetic leaflet and the first prosthetic leaflet meet; and

subsequently to assembling the valvular assembly, securing the valvular assembly within a lumen defined by a tubular frame, such that;

the first, second, and third prosthetic leaflets are arranged within the lumen to facilitate upstream-to-downstream fluid flow through the lumen by the first, second, and third prosthetic leaflets opening, and to inhibit downstream-to-upstream fluid flow through the lumen by the first, second, and third prosthetic leaflets closing, and

for each of the commissures;

the panel is disposed against an inner surface of the tubular frame, and

the first tab and the second tab extend away from the panel into the lumen.

8. The method according to claim 7, wherein for each of the commissures, assembling the flexible sheet into the commissure comprises assembling the flexible sheet into the commissure such that the first tab and the second tab each define a loose region, radially inward from the first stitching and the second stitching, that is loose with respect to the prosthetic leaflets that meet at the commissure.

9. The method according to claim 7, wherein securing the valvular assembly within the lumen comprises securing the valvular assembly within the lumen such that, for each of the commissures, in response to the first, second, and third prosthetic leaflets opening, at least part of the first tab and at least part of the second tab move away from each other, and in response to the first, second, and third prosthetic leaflets closing, at least part of the first tab and at least part of the second tab move toward each other.

10. The method according to claim 1, further comprising, subsequently to stitching the second stitching, securing the panel against an inner surface of a tubular frame, such that (i) the first tab, the second tab, the first prosthetic leaflet, and the second prosthetic leaflet extend away from the panel into a lumen defined by the tubular frame, and (ii) the first and second leaflets are arranged to facilitate upstream-to-downstream fluid flow through the lumen, and to inhibit downstream-to-upstream fluid flow through the lumen.

11. The method according to claim 10, wherein the sheet, in its unfolded state, further defines a plurality of flaps disposed peripherally to the panel, and wherein securing the panel against the inner surface of the tubular frame comprises folding each flap of the plurality of flaps around a respective component of the tubular frame.

12. The method according to claim 11, wherein securing the panel against the inner surface of the tubular frame further comprises stitching each flap of the plurality of flaps to the respective component of the tubular frame.

13. The method according to claim 10, further comprising (i) forming a first cushion by folding a first-tab fold in a downstream edge of the first tab portion, and (ii) forming a second cushion by folding a second-tab fold in a downstream edge of the second tab portion.

14. The method according to claim 13, wherein forming the first cushion and forming the second cushion comprise forming the first cushion and forming the second cushion such that, after the panel has been secured against the inner surface of the inner frame, the first cushion and the second cushion are disposed downstream of the first prosthetic leaflet and the second prosthetic leaflet.

15. The method according to claim 13, wherein forming the first cushion and forming the second cushion comprise forming the first cushion and forming the second cushion such that, after the panel has been secured against the inner surface of the inner frame, neither the first cushion nor the second cushion are in contact with the first prosthetic leaflet or the second prosthetic leaflet.

16. The method according to claim 13, wherein forming the first cushion comprises forming the first cushion such that, after the panel has been secured against the inner surface of the inner frame, the first tab defines a downstream opening between the first-tab inner layer and the first-tab outer layer, and forming the second cushion comprises forming the second cushion such that, after the panel has been secured against the inner surface of the inner frame, the second tab portion defines a downstream opening between the second-tab inner layer and the second-tab outer layer.

17. The method according to claim 13, wherein:

forming the first cushion comprises folding the first-tab fold such that, after the panel has been secured against the inner surface of the inner frame, the first-tab fold is disposed between the first-tab inner layer and the first-tab outer layer, and

forming the second cushion comprises folding the second-tab fold such that, after the panel has been secured against the inner surface of the inner frame, the second-tab fold is disposed between the second-tab inner layer and the second-tab outer layer.

18. The method according to claim 17, wherein:

the first-tab fold is a first-tab outer fold,

the second-tab fold is a second-tab outer fold,

forming the first cushion further comprises folding a first-tab inner fold in the downstream edge of the first tab portion, such that after the panel has been secured against the inner surface of the inner frame;

the first-tab outer fold is continuous with the first-tab outer layer, and is disposed between the first-tab outer layer and the first-tab inner fold, and

the first-tab inner fold is continuous with the first-tab inner layer, and is disposed between the first-tab inner layer and the first-tab outer fold, and

forming the second cushion further comprises folding a second-tab inner fold in the downstream edge of the second tab portion, such that after the panel has been secured against the inner surface of the inner frame;

the second-tab outer fold is continuous with the second-tab outer layer, and is disposed between the second-tab outer layer and the second-tab inner fold, and

the second-tab inner fold is continuous with the second-tab inner layer, and is disposed between the second-tab inner layer and the second-tab outer fold.

19. The method according to claim 13, wherein forming the first-tab cushion comprises forming the first-tab cushion prior to folding the first tab-portion back against itself, and forming the second-tab cushion comprises forming the second-tab cushion prior to folding the second tab-portion back against itself.

20. The method according to claim 19, wherein forming the first-tab cushion and forming the second-tab cushion comprises forming the first-tab cushion and forming the second-tab cushion subsequently to stitching the first stitching.

21. The method according to claim 1, wherein:

the first tab portion defines a plurality of first-tab portion suture holes arranged in;

a first row,

a second row, and

a third row, and

the second tab portion defines a plurality of second-tab portion suture holes arranged in;

a fourth row,

a fifth row, and

a sixth row, and

stitching the first stitching through the first tab-portion, the first commissural portion, the second commissural portion, and the second tab-portion comprises stitching the first stitching through the second row, the first commissural portion, the second commissural portion, and the fifth row.

22. The method according to claim 21, wherein, in the unfolded state of the sheet, the first row and the third row diverge at a diverging angle, and wherein folding the first tab portion back against itself comprises folding the first tab portion along a fold line such that an angle between the fold line and the first row is substantially equal to an angle between the fold line and the third row.

23. The method according to claim 22, wherein folding the first tab portion back against itself comprises folding the first tab portion such that an angle between the fold line and the second row is smaller than both (i) the angle between the fold line and the first row, and (ii) the angle between the fold line and the third row.

24. The method according to claim 21, wherein:

folding the first tab portion back against itself comprises folding the first tab portion back against itself such that the first-tab outer layer covers the second row, and the third row is aligned with the first row, and

folding the second tab portion back against itself comprises folding the second tab portion back against itself such that the second-tab outer layer covers the fifth row, and the sixth row is aligned with the fourth row.

25. The method according to claim 21, wherein stitching the second stitching through the first-tab outer layer, the first-tab inner layer, the first commissural portion, the second commissural portion, the second-tab inner layer, and the second-tab outer layer comprises stitching the second stitching through the third row, the first row, the first commissural portion, the second commissural portion, the fourth row, and the sixth row.

26. The method according to claim 1, further comprising, subsequently to stitching the second stitching, bringing the panel closer to the first prosthetic leaflet and the second prosthetic leaflet.

27. The method according to claim 26, wherein bringing the panel closer comprises moving an unstitched part of the first commissural portion away from an unstitched part of the second commissural portion.

28. The method according to claim 26, wherein bringing the panel closer comprises sandwiching unstitched parts of the first commissural portion and unstitched parts of the second commissural portion between the panel and another region of the sheet.

29. The method according to claim 26, wherein bringing the panel closer to the first prosthetic leaflet and the second prosthetic leaflet comprises flattening the panel.

30. The method according to claim 29, wherein the step of sandwiching comprises bending the panel.