Prosthetic valve with leaflet connectors

• US 10,098,732 B1
• Filed: 06/01/2018
• Issued: 10/16/2018
• Est. Priority Date: 08/10/2016
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz, Iamberger, Meni, Baum, Aviram
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US15/995,597
• Publication Number:
  US 20180280136A1
• Time in Patent Office: 137 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

A unitary flexible sheet is folded to define: (i) a panel, defining a plane, and having a first side facing in a first direction away from the plane, (ii) a first tab, disposed on the first side of the panel, and protruding in the first direction away from the panel, and (iii) a second tab, disposed on the first side of the panel, and protruding in the first direction away from the panel. Between the first tab and the second tab are secured (i) a first-leaflet commissural portion of a first prosthetic leaflet, and (ii) a second-leaflet commissural portion of a second prosthetic leaflet. At the first tab, the sheet is folded to define a first cushion at a downstream edge of the first tab. At the second tab, the sheet is folded to define a second cushion at a downstream edge of the second tab.

Claims

1. Apparatus, comprising:

a unitary flexible sheet, folded to define;

a panel, defining a plane, and having a first side facing in a first direction away from the plane, and a second side that is opposite the first side;

a first tab, disposed on the first side of the panel, and protruding in the first direction away from the panel; and

a second tab, disposed on the first side of the panel, and protruding in the first direction away from the panel;

a first prosthetic leaflet having a first-leaflet commissural portion disposed between the first tab and the second tab;

a second prosthetic leaflet having a second-leaflet commissural portion disposed between the first tab and the second tab;

wherein;

at the first tab, the sheet is folded to define a first cushion at a downstream edge of the first tab, the first cushion being configured and positioned to inhibit deflection of a downstream portion of the first prosthetic leaflet away from the second prosthetic leaflet and toward the plane, and

at the second tab, the sheet is folded to define a second cushion at a downstream edge of the second tab, the second cushion being configured and positioned to inhibit deflection of a downstream portion of the second prosthetic leaflet away from the first prosthetic leaflet and toward the plane.

2. The apparatus according to claim 1, further comprising a separate flexible sheet, sandwiched between the first-leaflet commissural portion and the second-leaflet commissural portion.

3. The apparatus according to claim 1, wherein the first cushion and the second cushion are disposed downstream of the first prosthetic leaflet and the second prosthetic leaflet.

4. The apparatus according to claim 1, wherein:

the sheet is folded such that the first tab has a first-tab outer layer and a first-tab inner layer, and the second tab has a second-tab outer layer and a second-tab inner layer,

the first-leaflet commissural portion is disposed between the first-tab inner layer and the second-tab inner layer, and

the second-leaflet commissural portion is disposed between the first-tab inner layer and the second-tab inner layer.

5. The apparatus according to claim 4, wherein the first tab defines a downstream opening between the first-tab inner layer and the first-tab outer layer, and the second tab defines a downstream opening between the second-tab inner layer and the second-tab outer layer.

6. The apparatus according to claim 4, wherein:

the sheet defines a first-tab fold and a second-tab fold,

the first cushion comprises the first-tab fold, folded between the first-tab inner layer and the first-tab outer layer, and

the second cushion comprises the second-tab fold, folded between the second-tab inner layer and the second-tab outer layer.

7. The apparatus according to claim 6, wherein the first-tab fold is secured by stitching, and the second-tab fold is secured by stitching.

8. The apparatus according to claim 6, wherein:

the first-tab fold is a first-tab outer fold, continuous with the first-tab outer layer,

the second-tab fold is a second-tab outer fold, continuous with the second-tab outer layer,

the sheet further defines;

a first-tab inner fold, continuous with the first-tab inner layer, and

a second-tab inner fold, continuous with the second-tab inner layer, the first cushion comprises;

the first-tab outer fold, folded between the first-tab outer layer and the first-tab inner fold, and

the first-tab inner fold, folded between the first-tab inner layer and the first-tab outer fold, and

the second cushion comprises;

the second-tab outer fold, folded between the second-tab outer layer and the second-tab inner fold, and

the second-tab inner fold, folded between the second-tab inner layer and the second-tab outer fold.

9. A method, comprising:

folding a unitary flexible sheet to define;

a panel, defining a plane, and having a first side facing in a first direction away from the plane, and a second side that is opposite the first side,

a first tab, disposed on the first side of the panel, and protruding in the first direction away from the panel, and

a second tab, disposed on the first side of the panel, and protruding in the first direction away from the panel;

securing, between the first tab and the second tab;

a first-leaflet commissural portion of a first prosthetic leaflet, and

a second-leaflet commissural portion of a second prosthetic leaflet;

at the first tab, folding the sheet to define a first cushion at a downstream edge of the first tab, the first cushion being configured and positioned to inhibit deflection of a downstream portion of the first prosthetic leaflet away from the second prosthetic leaflet and toward the plane; and

at the second tab, folding the sheet to define a second cushion at a downstream edge of the second tab, the second cushion being configured and positioned to inhibit deflection of a downstream portion of the second prosthetic leaflet away from the first prosthetic leaflet and toward the plane.

10. The method according to claim 9, further comprising sandwiching a separate flexible sheet between the first-leaflet commissural portion and the second-leaflet commissural portion.

11. The method according to claim 9, wherein:

folding the sheet to define the first cushion comprises folding the sheet to define the first cushion such that the first cushion is disposed downstream of the first prosthetic leaflet and the second prosthetic leaflet, and

folding the sheet to define the second cushion comprises folding the sheet to define the second cushion such that the second cushion is disposed downstream of the first prosthetic leaflet and the second prosthetic leaflet.

12. The method according to claim 9, wherein:

folding the sheet to define the first tab comprises folding the sheet such that the first tab has a first-tab outer layer and a first-tab inner layer,

folding the sheet to define the second tab comprises folding the sheet such that the second tab has a second-tab outer layer and a second-tab inner layer,

securing the first-leaflet commissural portion and the second-leaflet commissural portion between the first tab and the second tab comprises securing the first-leaflet commissural portion and the second-leaflet commissural portion between the first-tab inner layer and the second-tab inner layer.

13. The method according to claim 12, wherein:

folding the sheet such that the first tab has a first-tab outer layer and a first-tab inner layer comprises folding the sheet such that the first tab defines a downstream opening between the first-tab inner layer and the first-tab outer layer, and

folding the sheet such that the second tab has a second-tab outer layer and a second-tab inner layer comprises folding the sheet such that the second tab defines a downstream opening between the second-tab inner layer and the second-tab outer layer.

14. The method according to claim 12, wherein:

folding the sheet to define the first cushion comprises folding a first-tab fold of the sheet between the first-tab inner layer and the first-tab outer layer, and

folding the sheet to define the second cushion comprises folding a second-tab fold of the sheet between the second-tab inner layer and the second-tab outer layer.

15. The method according to claim 14, further comprising securing the first-tab fold by stitching, and folding the second-tab fold by stitching.

16. The method according to claim 14, wherein:

the first-tab fold is a first-tab outer fold, continuous with the first-tab outer layer,

the second-tab fold is a second-tab outer fold, continuous with the second-tab outer layer,

the sheet further defines;

a first-tab inner fold, continuous with the first-tab inner layer, and

a second-tab inner fold, continuous with the second-tab inner layer, folding the sheet to define the first cushion comprises;

folding the first-tab outer fold between the first-tab outer layer and the first-tab inner fold, and

folding the first-tab inner fold between the first-tab inner layer and the first-tab outer fold, and

folding the sheet to define the second cushion comprises;

folding the second-tab outer fold between the second-tab outer layer and the second-tab inner fold, and

folding the second-tab inner fold between the second-tab inner layer and the second-tab outer fold.