Methods for delivery of a sutureless pulmonary or mitral valve

• US 8,366,768 B2
• Filed: 03/26/2010
• Issued: 02/05/2013
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: JC Medical, Inc.
• Original Assignee: Causper Medical, Inc.
• Inventors: Zhang, Ji
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US12/732,980
• Publication Number:
  US 20100249917A1
• Time in Patent Office: 1,047 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.1, 623/2.11, 623/2.17, 623/2.18
• US Class Current: 623/2.11
• 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

Methods for delivering a sutureless pulmonary or mitral valve prosthesis using a transcatheter approach are provided. The implantation devices utilize movable claspers for both positioning and anchoring the valve prostheses within the native cardiac valve, minimizing the extent of imaging necessary.

Claims

1. A method for implanting a cardiac valve prosthesis in a patient, comprising:

providing an implantation device, comprising;

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 a longitudinal axis and defining a central orifice about an axis along an inflow-outflow direction, a plurality of flexible leaflets attached to the support frame, and at least one valve clasper movably attached to said support frame such that the at least one valve clasper is movable relative to the support frame along the longitudinal axis between a nesting position with the outer surface and an engagement position with the valve annulus, and wherein said clasper comprises a u-shaped member and two leg members; and

a delivery device comprising a control unit, 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, a first sheath, wherein the first sheath encases at least a portion of the valve prosthesis in its compact condition, and a second sheath, wherein the second sheath encases the at least one valve clasper; and

advancing the implantation device toward the heart through the vena cava to implant the valve prosthesis.

2. The method of claim 1, wherein the delivery device is advanced along a guidewire.

3. The method of claim 1, wherein the support frame is at least partially covered by a covering.

4. The method of claim 3, wherein each of the two leg members is at least partially disposed between the support frame and the covering.

5. The method of claim 1, wherein the implantation device is inserted into the femoral vein of the patient and advanced to the inferior vena cava.

6. The method of claim 1, wherein the implantation device is advanced through the superior vena cava.

7. The method of claim 1, wherein the cardiac valve is a pulmonary valve.

8. The method of claim 7, further comprising,

advancing the distal end of the implantation device through the right atrium, then through the tricuspid valve into the right ventricle, and then advancing at least the distal end of the second sheath into the pulmonary artery;

guiding the implantation device to a position such that the at least one valve clasper passes through and extends beyond the native pulmonary valve annulus;

manipulating the implantation device to expose the at least one valve clasper and to anchor the at least one valve clasper in a sinus of the native pulmonary valve;

adjusting by means of the control unit the position of the valve prosthesis such that a distal edge of the valve prosthesis is disposed approximately adjacent the two apex members of the at least one valve clasper;

sliding the first sheath in a proximal direction to release the valve prosthesis from the first sheath, whereby the valve prosthesis expands to its expanded condition;

unattaching the at least one track wire from the at least one valve clasper; and

removing the implantation device from the patient.

9. The method of claim 1, wherein the cardiac valve is a mitral valve.

10. The method of claim 9, further comprising, advancing the distal end of the implantation device through the right atrium, performing a transeptal puncture, then advancing the distal end of the implantation device into the left atrium, and then advancing at least the distal end of the second sheath through the native mitral valve and into the left ventricle;

guiding the implantation device to a position such that the at least one valve clasper passes through and extends beyond the native mitral valve annulus;

manipulating the implantation device to expose the at least one valve clasper and to anchor the at least one valve clasper in a sinus of the native mitral valve;

adjusting by means of the control unit the position of the valve prosthesis such that a distal edge of the valve prosthesis is disposed approximately adjacent the two apex members of the at least one valve clasper;

sliding the first sheath in a proximal direction to release the valve prosthesis from the first sheath, whereby the valve prosthesis expands to its expanded condition;

unattaching the at least one track wire from the at least one valve clasper; and

removing the implantation device from the patient.