DEVICES AND METHODS FOR DELIVERY OF AORTIC AND MITRAL VALVE PROSTHESES

• US 20100249918A1
• 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 8,540,767 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 and implantation device, and methods for use are provided. The devices described herein may be used for transcatheter delivery of an aortic valve prosthesis or transapical delivery of a mitral valve prosthesis. The implantation device utilizes movable claspers for both positioning and anchoring the valve prosthesis, reducing the extent of imaging needed during the implantation procedure.

Claims

1. A method for deploying a cardiac valve prosthesis, comprising:

providing an implantation device, wherein the implantation device comprises,

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 the at least one valve clasper is comprised of a u-shaped member; and

a control unit;

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 the at least one valve clasper;

a first sheath, wherein the first sheath encases at last a portion of the at least one valve clasper; and

a second sheath, wherein the second sheath encases at least a portion of the support frame in a compact condition and wherein the second sheath is positioned serially to and distally from the first sheath;

inserting the implantation device into a patient for deploying the valve prosthesis within a native cardiac valve; and

removing the implantation device without the valve prosthesis from the patient.

2. The method of claim 1, wherein the native cardiac valve is an aortic valve and the inserting the implantation device comprises inserting the implantation device into the femoral artery and advancing the distal end of the second sheath of the implantation device to the aortic valve.

3. The method of claim 1, wherein the native cardiac valve is a mitral valve and the inserting the second sheath of the implantation device into a heart chamber comprises inserting the second sheath of the implantation device into the left ventricle.

4. The method of claim 3, further comprising advancing the second sheath to the mitral valve.

5. The method of claim 1, further comprising manipulating the implantation device to expose the at least one valve clasper.

6. The method of claim 5, further comprising manipulating the implantation device to advance that at least one valve clasper to anchor the at least one valve clasper in a sinus of the native cardiac valve.

7. The method of claim 6, further comprising sliding the second sheath in a distal direction to release the entire support frame from the first sheath, whereby the entire support frame expands to its expanded position.

8. The method of claim 6, further comprising sliding the second sheath in a distal direction to release at least a portion of the valve prosthesis from the second sheath, whereby the portion of the valve prosthesis expands to its expanded condition, prior to sliding the second sheath in a distal direction to release the entire support frame.

9. The method of claim 6, wherein the manipulating the implantation device to advance the at least one valve clasper to anchor the at least one valve clasper in a sinus of the cardiac valve comprises moving the at least one track wire in a distal direction.

10. The method of claim 1, wherein the implantation device further comprises a second sheath control cable having a distal end attached to the second sheath and having a proximal end attached to a second sheath controller.

11. The method of claim 7, wherein the implantation device further comprises a second sheath control cable having a distal end attached to the second sheath and having a proximal end attached to a second sheath controller, and wherein the sliding the second sheath in a distal direction to release the entire valve prosthesis from the first sheath comprises pushing the second sheath control cable in a distal direction.