VALVE PROSTHESIS WITH MOVABLY ATTACHED CLASPERS WITH APEX

• US 20100249915A1
• Filed: 03/26/2010
• Published: 09/30/2010
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: JC Medical, Inc.
• Original Assignee: Causper Medical, Inc.
• Inventors: Zhang, Ji
• Granted Patent: US 8,444,689 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/006 modular

Abstract

A valve prosthesis, implantation device, and methods for use are provided. The implantation device utilizes movable claspers for both positioning and anchoring the valve prosthesis. Alternative designs of the devices allow different methods for minimally invasive implantation of a sutureless valve prosthesis, including transapical and transcatheter approaches. Also provided is a delivery device for delivery of a medical prosthesis though minimally invasive means.

Claims

1. A valve prosthesis, comprising:

a support frame radially expandable between a compact condition and an expanded condition, said support frame having an outer surface and defining a central orifice about an axis along an inflow-outflow direction;

a plurality of flexible leaflets attached to the support frame to provide a one-way valve in the orifice when the support frame is in its expanded condition; and

at least one valve clasper movably attached to said support frame such that said at least one valve clasper is movable along said axis between a nesting position with the outer surface of the support frame and an engagement position wherein said at least one valve clasper is physically separated from said support frame.

2. The valve prosthesis of claim 1, wherein said support frame is comprised of a shape-memory material.

3. The valve prosthesis of claim 1, wherein said support frame in its expanded condition has a radius r, and said at least one valve clasper is dimensioned to concentrically nest with the support frame when the support frame is in its expanded condition.

4. The valve prosthesis of claim 1, wherein said at least one valve clasper is comprised of a first leg member, a second leg member and a u-shaped member, wherein each of said first leg member and said second leg member has a first end and a second end, and said first leg member and said second leg member are joined to the u-shaped member.

5. The valve prosthesis of claim 4, wherein said second ends of the first and second leg members terminate in a detent.

6. The valve prosthesis of claim 4, wherein said support frame is at least partially covered by a covering.

7. The valve prosthesis of claim 6, wherein at least a portion of the first and second legs are disposed between the support frame and the covering.

8. The valve prosthesis of claim 1, wherein said at least one valve clasper is comprised of a u-shaped member.

9. The valve prosthesis of claim 8, wherein each of the free ends of the u-shaped member terminates in a detent.

10. The valve prosthesis of claim 8, wherein said support frame is at least partially covered by a covering.

11. The valve prosthesis of claim 10, wherein at least a portion of the u-shaped member is disposed between the support frame and the covering.

12. An implantation device, comprising:

the valve prosthesis according to claim 1;

a delivery device comprising

a control unit; and

at least one track wire, said at least one track wire having a proximal end attached to the control unit and a distal end for contact with said at least one valve clasper.

13. The implantation device of claim 12, further comprising a first sheath.

14. The implantation device of claim 13, further comprising a second sheath.

15. The implantation device of claim 14, wherein the second sheath is positioned serially with and distally to the first sheath.

16. The implantation device of claim 14, wherein the first sheath at least partially encases the support frame and the second sheath at least partially encases the at least one valve clasper.

17. The implantation device of claim 14, wherein the first sheath at least partially encases the at least one valve clasper and the second sheath at least partially encases the support frame.

18. The implantation device of claim 12, wherein said at least one track wire is a hollow track wire, and a locking wire is disposed within said hollow track wire, said locking wire at its proximal end having a locking member to releasably secure said at least one valve clasper to said at least one track wire.

19. The implantation device of claim 12, wherein the control unit comprises a track wire controller.

20. The implantation device of claim 12, further comprising a valve prosthesis pusher wire having a proximal end fixed to said control unit and a distal end for contact with said valve prosthesis.