Heart valve anchoring device

• US 10,039,639 B2
• Filed: 01/20/2015
• Issued: 08/07/2018
• Est. Priority Date: 01/20/2014
• Status: Active Grant

• Current Assignee: Tricare
• Original Assignee: Tricare
• Inventors: Marchand, Coralie, Riou, Cecile
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US15/112,311
• Publication Number:
  US 20160331529A1
• Time in Patent Office: 1,295 Days
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An anchoring device (1) designed for anchoring a prosthetic heart valve inside a heart, includes an extraventricular part (2) designed to be positioned inside an atrium or an artery and a ventricular part (3) designed to be positioned inside a ventricle, wherein the ventricular part includes a double wall composed of an outer wall (4) and an inner wall (5) spaced apart at the level where the prosthetic heart valve is intended to be inserted, and wherein the anchoring device further includes a predefined V-shaped groove (8) formed between the extraventricular part (2) and the ventricular part (3). The present invention also relates to an anchoring system (11) for anchoring a prosthetic heart valve inside a heart, including the anchoring device (1), a prosthetic heart valve support (12) and a prosthetic heart valve (13) connected to the prosthetic heart valve support (12).

Claims

1. An anchoring device for anchoring a prosthetic heart valve support supporting a prosthetic heart valve inside a heart, said anchoring device comprising an extraventricular part designed to be positioned inside an atrium or an artery and a ventricular part designed to be positioned inside a ventricle, wherein said ventricular part comprises a double wall composed of an outer wall and an inner wall spaced apart at a level where the prosthetic heart valve is intended to be inserted, and

wherein the anchoring device comprises a predefined V-shaped groove formed between the extraventricular part and the ventricular part;

the outer wall and the inner wall are connected at a folded end;

the extraventricular part comprises at least one extraventricular flange extending from the outer wall or the inner wall;

an extraventricular side of the V-shaped groove comprises the at least one extraventricular flange and a ventricular side of the V-shaped groove comprises the outer wall of the ventricular part;

the ventricular part comprises a cylindrical inner wall;

the outer wall is characterized by a decreasing diameter and has a smaller diameter directed in a direction of the extraventricular part and a lamer diameter connected to the cylindrical inner wall at the folded end; and

the extraventricular part comprises at least one cylindrical portion extending from the at least one extraventricular flange in a direction opposite to the ventricular part.

2. The anchoring device according to claim 1, wherein the outer wall of the ventricular part is conical.

3. The anchoring device according to claim 1, wherein the inner wall of the ventricular part defines a longitudinal axis and wherein the ventricular side of the groove presents an angle, with regard to the longitudinal axis and in the direction of the ventricular part, ranging from 20°

to 80°

, and the extraventricular side of the groove presents an angle, with regard to the longitudinal axis and in the direction of the ventricular part, ranging from 65°

to 110°

.

4. The anchoring device according to claim 1, wherein the V-shaped groove exhibits an acute angle ranging from 5°

to 50°

.

5. The anchoring device according to claim 3, wherein the V-shaped groove exhibits an acute angle ranging from 5°

to 50°

.

6. The anchoring device according to claim 5, wherein the outer wall of the ventricular part is conical.

7. The anchoring device according to claim 1, further comprising a cover covering totally or partially the inner wall or the outer wall of the ventricular part.

8. The anchoring device according to claim 1, further comprising a cover covering totally or partially the inner wall or the outer wall of the ventricular part, said cover being made of biological tissue, silicone, polytetrafluoroethylene, polyurethane, polyamide, polyester or mixture thereof.

9. The anchoring device according to claim 1, wherein the anchoring device is made of a biocompatible alloy.

10. The anchoring device according to claim 1, further comprising a plurality of arms extending outwardly from the ventricular part in the direction of the extraventricular part for securing a plurality of native leaflets.

11. An anchoring system for anchoring a prosthetic heart valve inside a heart, comprising:

i) the anchoring device of claim 1;

ii) prosthetic heart valve support, and

iii) a prosthetic heart valve connected to the prosthetic heart valve support.

12. The anchoring system according to claim 11, wherein the anchoring system may be crimped in the lumen of a catheter with the ventricular part located distally in the catheter, wherein the ventricular part and the extraventricular part, may be released out of the catheter sequentially, and wherein:

upon release of the ventricular part out of the catheter, the ventricular part expands and provides a mechanical stop which protrudes radially with respect to the catheter and presents an angle of about 90°

, with respect to a longitudinal axis of the anchoring device, and then upon release of the extraventricular part out of the catheter, the ventricular part returns to an original shape defining a V-shaped groove with the extraventricular part.

13. The anchoring system according to claim 11, wherein the anchoring system may be crimped in the lumen of a catheter with the extraventricular part located distally in the catheter, wherein the wherein the ventricular part and the extraventricular part, may be released out of the catheter sequentially, and wherein:

upon release of the extraventricular part out of the catheter, the extraventricular part expands and provides a mechanical stop which protrudes radially with respect to the catheter and presents an angle of about 90°

, with respect to a longitudinal axis of the anchoring device, and then upon release of the ventricular part out of the catheter, the extraventricular part returns to an original shape defining a V-shaped groove with the ventricular part.

14. The anchoring system according to claim 11, further comprising a tie which passes through the mesh of the anchoring device enabling the re-introduction of the anchoring system inside a catheter by turning inversely the outer wall once the anchoring system has been totally deployed out of said catheter.

15. The anchoring system according to claim 11, further comprising a cover covering totally or partially the prosthetic heart valve support.

16. The anchoring system according to claim 11, further comprising a cover covering totally or partially the prosthetic heart valve support, said cover being made of a biological tissue, a silicone, a polytetrafluoroethylene, a polyurethane, a polyimide, a polyester or a mixture thereof.

17. The anchoring system according to claim 11, further comprising a plurality of arms extending outwardly from the prosthetic heart valve support for securing a plurality of native leaflets.

18. A kit of parts for performing heart valve replacement comprising:

i) the anchoring device of claim 1;

ii) a prosthetic heart valve support,

iii) a prosthetic heart valve, and

iv) a catheter.

19. The anchoring device of claim 9, wherein the biocompatible alloy is stainless steel, nitinol, or cobalt-chromium alloy.

20. The anchoring device of claim 6, wherein the inner wall or the outer wall of the ventricular part is at least partially covered internally or externally by a cover;

wherein the cover is made of a biological tissue, a silicone, a polytetrafluoroethylene, a polyurethane, a polyamide, a polyester or a mixture thereof.