Implant device and implantation kit

• US 10,245,141 B2
• Filed: 05/14/2014
• Issued: 04/02/2019
• Est. Priority Date: 05/14/2014
• Status: Expired

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Ghione, Laura, Gaschino, Paolo, Achiluzzi, Monica Francesca
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/310,701
• Publication Number:
  US 20170071733A1
• Time in Patent Office: 1,784 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

An implant device (V), such as a heart valve, for implantation in an animal body includes an annular structure and one or more elongated anchoring members deployable to a deployed condition for insertion into an animal body. The anchoring members are retractable from the deployed condition to a rolled up condition wherein the anchoring members protrude radially out from the annular structure of the device (V) to provide anchoring to a body structure (AS) of an animal. In the rolled up condition the anchoring members at least partly protrude axially of the annular structure of the device (V).

Claims

1. An implant device for implantation in an animal body, the device including an annular structure extending axially between opposed ends and at least one elongated anchoring member deployable to a deployed condition for insertion into an animal body and retractable from said deployed condition to a rolled up condition wherein the anchoring member protrudes radially outwardly of the annular structure of the device to provide anchoring of the implant device to a body structure of an animal, wherein in said rolled up condition the anchoring member at least partly protrudes axially outwardly of the annular structure of the device, and wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory having an angular extent between 180°

and 900°

.

2. The implant device of claim 1, wherein the at least one elongated anchoring member includes a proximal portion which retains the deployed condition and a distal portion subject to winding from the deployed condition to the rolled up condition.

3. The implant device of claim 1, wherein the anchoring member is located at one end of the annular structure of the device and includes a distal portion, which, in said rolled up condition, extends in a trajectory centered around a point coplanar with said one end of the annular structure of the device.

4. The implant device of claim 1, wherein the anchoring member includes a proximal portion coextensive with the annular structure of the device and a distal portion extending away from the annular structure of the device, wherein in said rolled up condition, the region of the said distal portion adjacent to said proximal portion has an axial orientation with respect to the annular structure of the device.

5. The implant device of claim 1, wherein the at least one elongated anchoring member includes elastic material, whereby the anchoring member is deployable to the deployed condition and elastically returns to the rolled up condition from the deployed condition.

6. The implant device of claim 1, wherein the at least one elongated anchoring member includes shape memory material, whereby the anchoring member returns to the rolled up condition from the deployed condition by shape memory effect.

7. The implant device of claim 1, wherein the at least one elongated anchoring member includes material selected out of one or combinations of flexibly resilient materials, medical grade materials, metal materials, plastics materials, shape memory materials, Nitinol, and stainless steel.

8. The implant device of claim 1, wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory which is spiral-shaped or helix-shaped.

9. The implant device of claim 1, wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory having an angular extent in excess of 360°

.

10. The implant device of claim 1, wherein the at least one elongated member is blade-like or wire-like.

11. The implant device of claim 1, wherein the at least one elongated member is of solid cross-section or tubular.

12. The implant device of claim 1, wherein the device includes a prosthetic heart valve.

13. An implantation kit for an implant device including:

an implant device according to claim 1,

at least one constraint member to cooperate with the at least one anchoring member to constrain the at least one anchoring member to the deployed condition during insertion into an animal body and to permit winding of the at least one anchoring member to a rolled up condition to provide anchoring of the implant device to a body structure of an animal.

14. The kit of claim 13, wherein the at least one constraint member includes a tubular sheath extending along an axis, the tubular sheath maintaining the at least one anchoring member in the deployed condition by confining the at least one anchoring member radially of said axis, the tubular sheath withdrawable along said axis to at least partly uncover the at least one anchoring member to permit winding thereof to the rolled up condition.

15. The kit of claim 13, wherein the at least one anchoring member is tubular with a longitudinal cavity and the at least one constraint member includes a wire member for insertion into the longitudinal cavity of the at least one anchoring member to maintain the at least one anchoring member in the deployed condition, the wire member extractable from the longitudinal cavity of the at least one anchoring member to permit winding thereof to the rolled up condition.

16. The kit of claim 13, wherein the at least one constraint member includes an inflatable balloon element vested onto the at least one anchoring member to form a tubular tunic therearound, the inflated balloon to maintain the at least one anchoring member to the deployed condition and de-inflatable to permit winding of the at least one anchoring member to the rolled up condition.

17. An implant device for implantation in an animal body, the device including an annular structure extending axially between opposed ends and at least one elongated anchoring member deployable to a deployed condition for insertion into an animal body and retractable from said deployed condition to a rolled up condition wherein the anchoring member protrudes radially outwardly of the annular structure of the device to provide anchoring of the implant device to a body structure of an animal, wherein in said rolled up condition the anchoring member at least partly protrudes axially outwardly of the annular structure of the device, and wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory having an angular extent in excess of 360°

.

18. The implant device of claim 17, wherein the at least one elongated anchoring member includes a proximal portion which retains the deployed condition and a distal portion subject to winding from the deployed condition to the rolled up condition.

19. The implant device of claim 17, wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory which is spiral-shaped or helix-shaped.

20. An implantation kit for an implant device including:

an implant device for implantation in an animal body, the device including an annular structure extending axially between opposed ends and at least one elongated anchoring member deployable to a deployed condition for insertion into an animal body and retractable from said deployed condition to a rolled up condition wherein the anchoring member protrudes radially outwardly of the annular structure of the device to provide anchoring of the implant device to a body structure of an animal, wherein in said rolled up condition the anchoring member at least partly protrudes axially outwardly of the annular structure of the device; and

at least one constraint member to cooperate with the at least one anchoring member to constrain the at least one anchoring member to the deployed condition during insertion into an animal body and to permit winding of the at least one anchoring member to a rolled up condition to provide anchoring of the implant device to a body structure of an animal,

wherein the at least one anchoring member is tubular with a longitudinal cavity and the at least one constraint member includes a wire member for insertion into the longitudinal cavity of the at least one anchoring member to maintain the at least one anchoring member in the deployed condition, the wire member extractable from the longitudinal cavity of the at least one anchoring member to permit winding thereof to the rolled up condition.