PROSTHETIC DEVICE FOR A HEART VALVE

• US 20160346080A1
• Filed: 02/04/2015
• Published: 12/01/2016
• Est. Priority Date: 02/04/2014
• Status: Active Grant

• Current Assignee: InnovHeart s.r.l.
• Original Assignee: Innovheart Sri
• Inventors: RIGHINI, Giovanni, ZANON, Sarah
• Granted Patent: US 11,123,179 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A prosthetic device for a heart valve, comprising a valve portion with prosthetic leaflets capable of reproducing the function of the valve leaflets of a native heart valve, selectively expandable from a collapsed configuration for implantation to a working expanded configuration. The prosthetic device also comprises a containment portion which surrounds the valve portion to contain its expansion in the working expanded configuration. The prosthetic device also comprises a connecting portion which stably connects the valve portion to the containment portion by means of connecting elements. The invention allows for both the use of minimally invasive surgical implantation procedures and implantation procedures based completely on transcatheteral techniques.

Claims

1. Prosthetic device for a heart valve, comprising:

a valve portion with prosthetic leaflets capable of reproducing a function of valve leaflets of a native heart valve, expandable from a collapsed configuration for implantation to a working expanded configuration;

a containment portion which surrounds the valve portion to contain expansion of the valve portion in the working expanded configuration; and

a connecting portion which stably connects the valve portion to the containment portion through connecting elements.

2. The prosthetic device according to claim 1, wherein the valve portion comprises a central support element intended to support all the prosthetic leaflets, the connecting elements of the connecting portion comprising flexible elements for physical connection and structural unity between the central support element and the containment portion.

3. The prosthetic device according to claim 1, wherein the containment portion is a structure with a two-dimensional or three-dimensional geometry which is substantially annular when seen from above.

4. The prosthetic device according to claim 3, wherein the containment portion is substantially non-extendable longitudinally.

5. The prosthetic device according to claim 3, wherein the containment portion is selectively assemblable from an open configuration, suitable for making possible for insertion of the containment portion on a back of the native valve leaflets, to a substantially annular closed configuration.

6. The prosthetic device according to claim 5, wherein the containment portion comprises a plurality of segments each comprising a connector for assembled reconstruction of an annular continuity of the containment portion.

7. The prosthetic device according to claim 6, wherein the connector comprises at least one connecting element of the connecting portion.

8. The prosthetic device according to claim 6, wherein at least one of the segments is temporarily separable from the valve portion.

9. The prosthetic device according to claim 1, wherein the containment portion is flexible with respect to deformations which occur in a plane identified by the containment portion, and substantially rigid with respect to direct deformation outside the plane.

10. The prosthetic device according to claim 1, wherein at least part of the containment portion is covered by tissue of a biological or artificial nature or with polymer material, or a combination thereof.

11. The prosthetic device according to claim 1, comprising a locking mechanism compatible with transcatheteral technologies, in which the containment portion is subdivided into sub-components to allow the containment portion to be positioned on a back of the valve leaflets of the native heart valve, the locking mechanism comprising at least one structure of the containment portion which can be aligned and coupled in a stable manner to at least one structure of the valve portion using a guidewire.

12. The prosthetic device according to claim 11, in which each guidewire is connected to one of the at least one structure of the containment portion and to one of the at least one structure of the valve portion.

13. The prosthetic device according to claim 12, in which the at least one structure of the containment portion and the at least one structure of the valve portion comprise hollow organs suitable for allowing the guidewire to pass through.

14. The prosthetic device according to claim 11, in which the valve portion has, on a periphery thereof, hollow structures suitable for passage of the guidewire suitable for carrying out stable mechanical coupling with corresponding hollow structures present on the containment portion.

15. The prosthetic device according to claim 11, in which each sub-component of the containment portion has joint mechanisms which allow each sub-component to be deformed elastically until each sub-component assumes a configuration taking up reduced radial space with respect to the working expanded configuration.

16. A method for assembling a prosthetic device for a heart valve, comprising the steps of:

providing a valve portion in a collapsed configuration, the valve portion having prosthetic leaflets capable of reproducing the function of valve leaflets of a native heart valve, the valve portion being expandable from a collapsed configuration for implantation to a working expanded configuration;

providing a containment portion which surrounds the valve portion to contain expansion of the valve portion in the working expanded configuration; and

stably connecting the valve portion to the containment portion by a connecting portion through connecting elements.

17. The method for assembling the prosthetic device according to claim 16, where the containment portion is selectively assemblable from an open configuration to a substantially annular closed configuration.

18. The method for assembling the prosthetic device according to claim 17, wherein the containment portion comprises a plurality of segments each comprising a connector for assembled reconstruction of annular continuity of the containment portion.