HEART VALVE ANCHORING DEVICE

• US 20160331529A1
• Filed: 01/20/2015
• Published: 11/17/2016
• Est. Priority Date: 01/20/2014
• Status: Active Grant

• Current Assignee: Tricare
• Original Assignee: Tricare
• Inventors: MARCHAND, Coralie, RIOU, Cecile
• Granted Patent: US 10,039,639 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• 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

1-17. -17. (canceled)

18. 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, 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 the 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.

19. The anchoring device according to claim 18, wherein the outer wall and the inner wall are connected at a folded end.

20. The anchoring device according to claim 18, wherein the extraventricular part comprises at least one extraventricular flange extending from the outer wall or the inner wall.

21. The anchoring device according to claim 18, wherein the ventricular part comprises a cylindrical inner wall and a substantially conical outer wall having its smaller diameter directed in the direction of the extraventricular part and its larger diameter connected to the cylindrical inner wall at the folded end.

22. The anchoring device according to claim 18, 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°

.

23. The anchoring device according to claim 18, wherein the V-shaped groove exhibits an acute angle ranging from 5°

to 50°

.

24. The anchoring device according to claim 18, wherein said extraventricular part comprises at least one extraventricular flange extending from the outer wall or the inner wall and wherein the extraventricular side of the V-shaped groove comprises the at least one extraventricular flange and the ventricular side of the V-shaped groove comprises the outer wall of the ventricular part.

25. The anchoring device according to claim 18, wherein:

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,

the ventricular part comprises a cylindrical inner wall and a substantially conical outer wall having its smaller diameter directed in the direction of the extraventricular part and its larger diameter connected to the cylindrical inner wall at the folded end, and

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

26. The anchoring device according to claim 18, further comprising a cover covering totally or partially the anchoring device.

27. The anchoring device according to claim 18, further comprising a cover covering totally or partially the anchoring device, said cover being made of biological tissue, silicone, polytetrafluoroethylene, polyurethane, polyamide, polyester or mixture thereof.

28. The anchoring device according to claim 18, wherein the anchoring device is made of a biocompatible alloy.

29. The anchoring device according to claim 18, further comprising a plurality of arms extending outwardly from the ventricular part in the direction of the extraventricular part for securing the native leaflets.

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

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, a ventricular part designed to be positioned inside a ventricle, said ventricular part comprises a double wall composed of an outer wall and an inner wall spaced apart at the level where the prosthetic heart valve is intended to be inserted, the anchoring device also comprises a predefined V-shaped groove formed between the extraventricular part and the ventricular part,

a prosthetic heart valve support, and

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

31. The anchoring system according to claim 30, 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 the longitudinal axis of the anchoring device, and then

upon release of the extraventricular part out of the catheter, the ventricular part returns to its original shape defining a V-shaped groove with the extraventricular part.

32. The anchoring system according to claim 30, 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 the longitudinal axis of the anchoring device, and then

upon release of the ventricular part out of the catheter, the extraventricular part returns to its original shape defining a V-shaped groove with the ventricular part.

33. The anchoring system according to claim 30, 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.

34. The anchoring system according to claim 30, further comprising a cover covering totally or partially the prosthetic heart valve support.

35. The anchoring system according to claim 30, further comprising a cover covering totally or partially the prosthetic heart valve support, said cover being made of biological tissue, silicone, polytetrafluoroethylene, polyurethane, polyamide, polyester or mixture thereof.

36. The anchoring system according to claim 30, further comprising a plurality of arms extending outwardly from the prosthetic heart valve support for securing the native leaflets.

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

the 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, a ventricular part designed to be positioned inside a ventricle, where said ventricular part comprises a double wall composed of an outer wall and an inner wall spaced apart at the level where the prosthetic heart valve is intended to be inserted, the anchoring device also comprises a predefined V-shaped groove formed between the extraventricular part and the ventricular part,

a prosthetic heart valve support,

a prosthetic heart valve, and

a catheter.