Apparatus and methods for alignment and deployment of intracardiac devices

Patent metadata

Field	Value
Publication number	US-11246562-B2
Application number	US-201916680620-A
Country	US
Kind code	B2
Filing date	Nov 12, 2019
Priority date	Oct 17, 2013
Publication date	Feb 15, 2022
Grant date	Feb 15, 2022

Abstract

Apparatus and methods are described herein for use in the alignment and deployment of a prosthetic heart valve, such as a mitral valve. In some embodiments, an apparatus includes a tube assembly and a needle assembly configured to be received through a lumen of an outer tube member of the tube assembly. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart. An imaging probe is coupled to a coupling member and includes an imaging element. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane.

First claim

What is claimed is:

1. A method, comprising:
positioning an alignment device near an epicardial surface of a heart of a patient such that an imaging element mounting member of the alignment device is disposed in contact with the epicardial surface of the heart, the alignment device including a tube assembly including an outer tube member and a coupling member, and a needle assembly movably disposed at least partially within a lumen of the outer tube member, the needle assembly including a needle tube and an elongate needle movably disposed within the needle tube;
actuating the alignment device to image the heart with an imaging element coupled to the imaging element mounting member, the imaging producing image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of a mitral valve and an annular region of the heart;
determining an insertion point on the epicardial surface for the needle assembly;
inserting a distal end portion of the needle assembly through the epicardial surface at the insertion point and into a left ventricle of the heart;
removing the elongate needle of the needle assembly leaving the needle tube in position within the heart;
inserting a prosthetic valve delivery device through an opening in the epicardial surface and deploying a prosthetic mitral valve within the heart, the prosthetic mitral valve having a tether coupled to the prosthetic mitral valve that extends outside the epicardial surface after being deployed;
positioning the prosthetic mitral valve within the heart based at least in part on the C-C plane and the A-P plane determined by the imaging data produced by the alignment device; and
securing an epicardial pad to the tether at a location on the epicardial surface.

2. The method of claim 1 , further comprising:
after the removing the elongate needle, inserting a guidewire through the needle tube and into a left atrium of the heart; and
removing the needle tube.

3. The method of claim 2 , further comprising:
prior to inserting the prosthetic valve delivery device, inserting a dilator over the guidewire and into the left ventricle, the dilator configured to provide a lead-in for the prosthetic mitral valve delivery device.

4. The method of claim 1 , further comprising:
after the removing the elongate needle, inserting a guidewire through the needle tube and into a left atrium of the heart;
anchoring the guidewire to a vessel within the heart;
removing the needle tube from the heart; and
removing the alignment device from the patient.

5. The method of claim 1 , wherein the imaging the heart includes positioning the imaging element in a first orientation such that image data associated with the location of the C-C plane is produced, and rotating the imaging element about 90 degrees to position the imaging element in a second orientation such that image data associated with the location of the A-P plane is produced.

6. The method of claim 1 , further comprising:
determining based at least in part on the image data, an alignment path for inserting the needle assembly into the heart.

7. The method of claim 1 , further comprising:
prior to inserting the prosthetic valve delivery device, attaching purse string sutures at the epicardial surface;
removing the prosthetic delivery device from the heart; and
after the removing the prosthetic delivery device, tightening the purse string sutures to close the opening at the epicardial surface of the heart.

8. The method of claim 1 , wherein the imaging element includes at least one ultrasound transducer.

9. The method of claim 1 , wherein the imaging element includes a side-looking multi-element phased array transducer.

10. The method of claim 9 , wherein the phased-array transducer is configured to operate at a frequency ranging from about 5.0 to about 8.5 MHz.

11. The method of claim 9 , wherein the phased-array transducer is configured to provide at least one of greyscale imaging, color doppler imaging, tissue imaging, or 3D localization.

12. The method of claim 1 , wherein the alignment device is configured to provide multi-direction steerability.

13. The method of claim 1 , further comprising forming a targeting loop with a cable of the alignment device, and contacting a portion of the epicardial surface with the targeting loop to help stabilize the needle assembly when inserted into the heart.

Assignees

• Tendyne Holdings Inc

Inventors

• Vidlund Robert M
• Ekvall Craig A

Classifications

• A61B17/3403 Primary

  Needle locating or guiding means · CPC title

• A61B8/0883

  for diagnosis of the heart · CPC title

• A61B2017/00247

  Making holes in the wall of the heart, e.g. laser Myocardial revascularization · CPC title

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title