Devices, systems and methods for accurate positioning of a prosthetic valve

• US 9,999,503 B2
• Filed: 06/29/2016
• Issued: 06/19/2018
• Est. Priority Date: 04/22/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Duhay, Francis G., Zollinger, David L.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US15/197,559
• Publication Number:
  US 20160302923A1
• Time in Patent Office: 720 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements lie against the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.

Claims

1. A method of delivering a prosthetic valve to a position within the heart of a patient, comprising:

advancing a catheter to a native valve annulus position within the heart of the patient;

deploying at least one extendable positioner positioned at the distal end of the catheter from a first position to a second position, wherein the at least one extendable positioner extends radially away from the catheter to the second position;

confirming that the prosthetic valve is properly positioned in alignment with or adjacent to the native valve annulus by using tactile feedback from the catheter created by contact of a free end of the at least one extendable positioner with native valve tissue; and

deploying the prosthetic valve into a desired position within the native valve annulus;

wherein at least one extendable positioner is spring-loaded or biased toward the second position.

2. The method of claim 1, further comprising:

retracting the at least one extendable positioner back to the first position; and

withdrawing the catheter from the heart.

3. The method of claim 1, further comprising:

directing the catheter percutaneously through an intercostal opening in the body of the patient; and

puncturing an opening into the left ventricular apex of the heart of the patient.

4. The method of claim 3, further comprising closing the apical and intercostal openings.

5. The method of claim 1, further comprising directing the catheter into the heart of the patient via the femoral artery.

6. The method of claim 1, wherein the prosthetic valve is self-expanding and restrained by a retractable sheath, and the method further comprises:

sliding the retractable sheath to deploy the prosthetic valve.

7. The method of claim 1, further comprising:

expanding a balloon to deploy the prosthetic valve into the desired position.

8. The method of claim 7, further comprising:

controlling the catheter and balloon using one or more controls on a catheter handle located on a proximal portion of the catheter.

9. The method of claim 1, further comprising:

controlling at least one of extension and retraction of the at least one positioner member with a control outside the patient'"'"'s body.

10. A method of delivering a medical implant to a desired position within a patient, comprising:

advancing a distal portion of a device into the patient from outside a patient'"'"'s body, wherein the distal portion of the device is configured to hold a medical implant;

deploying a plurality of positioner members, wherein the plurality of positioner members are configured such that a fixed end is secured to the distal portion of the device and a free end extends away from the device;

retracting the device until the free end of a plurality of positioner members makes abutting contact with the patient'"'"'s native tissue at a desired implant location; and

implanting the medical implant into the desired position;

wherein the positioner members are spring-loaded or biased toward an extended position and restrained by a cuff, the method further comprising;

sliding the cuff along the device, thereby releasing the positioner members to a deployed configuration.

11. The method of claim 10, further comprising

retracting the positioner members such that the free end is generally parallel to the distal portion of the device;

and

removing the device from the body of the patient.

12. The method of claim 10, wherein the medical implant is a transcatheter heart valve.

13. The method of claim 12, wherein the advancing comprises:

creating an intercostal incision in the patient;

puncturing an apex of the heart; and

advancing the device through a native valve annulus and into an aorta.

14. The method of claim 12, wherein the advancing comprises:

advancing the device into the patient through a femoral artery, an aorta and through a native valve annulus, and into a left ventricle, respectively.

15. The method of claim 10, wherein the fixed end of the plurality of positioner members are attached to a telescopically slidingly-movable portion of the device, the method further comprising:

holding the device stationary at the desired location;

extending the telescopically slidingly-movable portion of the device via an extendable support rod in a direction away from an implant-holding section of the device until a majority of the plurality of positioner members are clear of the implant-holding section of the device.

16. The method of claim 10, further comprising:

controlling at least one of extension and retraction of the positioner members with a control outside the patient'"'"'s body.

17. A method of replacing a deficient heart valve within the heart of a patient, comprising:

advancing a distal portion of a device into the heart of the patient from outside a patient'"'"'s body, wherein the distal portion of the device is configured to hold a medical implant;

deploying a plurality of positioner members, wherein the plurality of positioner members are configured such that a fixed end of the positioner members is secured to an attachment point located on a proximal end of an implant holding section located on the distal portion of the device;

using tactile feedback from the device to confirm proper positioning of the medical implant; and

deploying the medical implant in the desired position within the heart;

wherein the positioner members form a ring upon deployment, and wherein the deploying of the plurality of positioning members comprises;

contacting the ring with native tissue to confirm proper positioning of the medical implant.

18. The method of claim 17, further comprising:

retracting the positioner members such that the free end is generally parallel to and overlies the implant holding section of the device;

and

removing the device from the body of the patient.

19. The method of claim 17, wherein the deploying the medical implant comprises:

expanding a balloon from a first diameter to a second diameter to deploy the medical implant within the desired position within the heart.

20. The method of claim 17, wherein the deploying the medical implant comprises:

removing a restraining sheath from the implant holding section of the device to deploy the medical implant into the desired position within the heart.

21. The method of claim 17, wherein the plurality of positioner members are tethered to form the ring upon deployment, and wherein the deploying of the plurality of positioning members comprises:

contacting the ring with a native tissue to confirm proper positioning of the medical implant.

22. The method of claim 17, wherein the ring is a full ring.

23. The method of claim 17, further comprising:

controlling at least one of extension and retraction of the positioner members with a control outside the patient'"'"'s body.