SUTURELESS VALVE PROTHESIS DELIVERY DEVICE AND METHODS OF USE THEREOF

• US 20160015512A1
• Filed: 03/14/2014
• Published: 01/21/2016
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: JC Medical, Inc.
• Original Assignee: Cardiovantage Medical, Inc.
• Inventors: Zhang, Ji, Walsh, Brandon G.
• Granted Patent: US 10,507,104 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

Abstract

Devices and methods for delivering a sutureless valve (5) to repair a defective native valve are described herein. The devices and methods are particularly useful in minimally invasive procedures.

Claims

1. A valve prosthesis delivery device comprising:

a first sheath which encases a valve clasper;

a second sheath which encases an expandable support frame; and

a control unit;

wherein the valve clasper and the support frame are movably attached; and

wherein along a longitudinal axis, the first sheath is distal to the second sheath and the second sheath is distal to the control unit.

2. The delivery device of claim 1, further comprising a valve carrier which is encased by the first sheath.

3. The delivery device of claim 1, wherein the valve prosthesis is for treating a defective aortic valve.

4. A method for deploying a prosthetic heart valve to an implantation site of a patient, the method comprising:

introducing the distal end of a valve delivery device, wherein the delivery device comprises

a first sheath which encases an expandable support frame to which a valve structure is attached,

a second sheath which encases a valve clasper which comprises three u-shaped members and three leg members, wherein the support frame and the valve clasper are movably attached, and wherein the first sheath is distal to the second sheath along a longitudinal axis,

and three track wires, wherein each of the three track wires is reversibly attached to each of the three leg members,

advancing to distal end of the delivery device to a defective cardiac valve in the direction of blood flow until the three u-shaped members are located distal to the defective cardiac valve annulus,

pulling the second sheath in a proximal directed to uncover the three u-shaped members,

pulling the first sheath in a proximal direction to align the proximal end of the support frame with the proximal ends of the three u-shaped members,

advancing the first sheath forward independent of the support frame to uncover the support frame,

unattaching each of the three track wires from the three leg members,

and removing the delivery device from the patient.

5. The method of claim 4, wherein the first sheath encases a valve carrier which holds the support frame stationary within the first sheath prior to deployment of the support frame.

6. A valve prosthesis delivery device comprising:

a first sheath which encases at least one u-shaped member of a valve clasper and an expandable support frame;

a second sheath which encases a locking member and a distal portion of a leg member of the valve clasper;

and a control unit;

wherein the valve clasper and support frame are movably attached, and wherein along a longitudinal axis, the first sheath is distal to the second sheath and the second sheath is distal to the control unit.

7. The delivery device of claim 6, further comprising a stabilizing member which is encased in the second sheath at a position proximal to the support frame.

8. A method for deploying a prosthetic valve to an implantation site of a patient, the method comprising:

introducing the distal end of a valve delivery device into a vessel of a patient,

wherein the delivery device comprises a first sheath which encases an expandable support frame and at least one u-shaped member of a valve clasper and a second sheath with encases a locking member and a distal portion of a leg member of the valve clasper, and wherein the valve clasper and the support frame are movably attached;

advancing the valve delivery device through the vessel toward a defective native valve until the first sheath is approximately within the defective native valve annulus;

pulling the second sheath in a proximal direction while holding the valve clasper stationary along the longitudinal axis until the at least one u-shaped member expands radially;

moving the second sheath in a distal direction while the valve clasper is held stationary along the longitudinal axis until the support frame is aligned with the valve clasper;

moving the delivery device in a distal direction until the at least one u-shaped member is in contact with the native valve sinus;

and moving the second sheath in a proximal direction while holding the support frame and valve clasper stationary along the longitudinal axis until the support frame deploys.

9. The method of claim 8, wherein the vessel is the aorta, superior vena cava or a pulmonary vein or artery.