Apparatus and methods for alignment and deployment of intracardiac devices

• US 10,555,718 B2
• Filed: 03/30/2016
• Issued: 02/11/2020
• Est. Priority Date: 10/17/2013
• Status: Expired due to Fees

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: Vidlund, Robert M., Ekvall, Craig A.
• Primary Examiner(s): Remaly, Mark D
• Application Number:
  US15/085,229
• Publication Number:
  US 20160206280A1
• Time in Patent Office: 1,413 Days
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

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.

Claims

1. An apparatus, comprising:

a handle assembly;

a tube assembly including an outer tube member defining a lumen and a coupling member coupled to a distal end portion of the outer tube member;

a needle assembly configured to be received through the lumen of the outer tube member, the needle assembly including an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart and extend within the left ventricle of the heart; and

an imaging probe coupled to the coupling member, the imaging probe including a cable and an imaging element disposed at, and directly coupled to, a distal end portion of the cable, the imaging probe 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 deployed and positioned within the heart based at least in part on the C-C plane and the A-P plane,

wherein the cable includes a proximal end portion coupled to the handle assembly and an intermediate portion extending between the proximal end portion and the distal end portion, the intermediate portion of the cable being positioned within the outer tube member, the distal end portion of the cable exiting a distal end of the outer tube member so that the distal end portion of the cable of the imaging probe forms a targeting loop configured to contact a portion of the epicardial surface to help stabilize the needle assembly when inserted into the heart, the targeting loop configured to define an aperture through which the elongate needle is configured to travel.

2. The apparatus of claim 1, wherein the imaging element of the imaging probe includes at least one ultrasound transducer.

3. The apparatus of claim 1, wherein the imaging element of the imaging probe includes a side-looking multi-element phased array transducer.

4. The apparatus of claim 3, wherein the phased-array transducer is configured to operate at a frequency ranging from about 5.0 to about 8.5 MHz.

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

6. The apparatus of claim 1, wherein the imaging probe is configured to provide multi-direction steerability.

7. The apparatus of claim 1, further comprising:

a prosthetic valve delivery device configured to deploy and align the prosthetic mitral valve within the heart, the alignment of the prosthetic mitral valve being based at least in part on the C-C plane and the A-P plane determined by the image data.

8. The apparatus of claim 7, further comprising:

a self-expanding prosthetic mitral valve disposable within a lumen of the delivery device.

9. The apparatus of claim 7, further comprising:

an epicardial pad, the epicardial pad configured to be secured to a tether coupled to the prosthetic mitral valve extending outside the epicardial surface of the heart when the prosthetic mitral valve has been deployed within the heart.

10. The apparatus of claim 7, wherein the needle assembly includes a needle tube defining a lumen, the apparatus further comprising:

a guidewire configured to be received through the lumen of the needle tube and advanced into the left ventricle of the heart; and

a dilator configured to be disposed over the guide wire and inserted into the left ventricle of the heart.