Methods for delivery of heart valve devices using intravascular ultrasound imaging

Patent metadata

Field	Value
Publication number	US-11241309-B2
Application number	US-201916431806-A
Country	US
Kind code	B2
Filing date	Jun 5, 2019
Priority date	Sep 29, 2015
Publication date	Feb 8, 2022
Grant date	Feb 8, 2022

Abstract

Methods related to delivery of various heart valve implants are described. The implant may be delivered using an ultrasound imaging delivery system. The ultrasound imaging delivery system may be used to deliver a variety of different devices, including mitral valve reshaping devices, mitral valve replacement valves, and others. A deployment catheter carrying an implant having a tissue anchor is advanced to a deployment site in a heart. An imaging element is positioned adjacent the implant and a relationship between the tissue anchor and an anatomical landmark in the heart is visualized. The implant is then attached by driving the tissue anchor into tissue in the heart.

First claim

What is claimed is:

1. An implant delivery system comprising:
a delivery catheter comprising a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the delivery catheter configured to transluminally position the distal end of the delivery catheter proximate to a valve annulus;
an implant releasably coupled to the distal end of the delivery catheter, the implant comprising a tubular frame defining an opening, and at least one tissue anchor proximate to said opening;
an imaging catheter comprising an imaging element at its distal end; and
an alignment mechanism coupled to the implant and to the imaging catheter and configured to position the imaging catheter relative to the implant for visualization during deployment.

2. The implant delivery system of claim 1 , wherein the alignment mechanism further comprises an alignment frame coupled to the frame of the implant.

3. The implant delivery system of claim 1 , wherein the alignment mechanism mechanically docks the imaging catheter to the delivery catheter.

4. The implant delivery system of claim 3 , wherein the lumen of the delivery catheter extends along a longitudinal axis and the imaging element is aligned with the longitudinal axis of the delivery catheter.

5. The implant delivery system of claim 3 , wherein the lumen lies along a longitudinal axis of the delivery catheter and the imaging element diverges from the longitudinal axis of the delivery catheter.

6. The implant delivery system of claim 5 , wherein the alignment mechanism diverts the imaging element towards the at least one tissue anchor.

7. The implant delivery system of claim 1 , wherein the alignment mechanism comprises the lumen of the delivery catheter.

8. The implant delivery system of claim 1 , wherein the imaging catheter is configured for advancement of the imaging element through the distal end of the lumen of the delivery catheter into the opening of the tubular frame.

9. The implant delivery system of claim 1 , wherein the imaging element comprises one or more ultrasonic transducers.

10. The implant delivery system of claim 9 , wherein the one or more ultrasonic transducers includes a radial ultrasonic transducer.

11. The implant delivery system of claim 1 , wherein the imaging catheter comprises an intravascular cardiac echography (ICE) catheter.

12. The implant delivery system of claim 1 , wherein the alignment mechanism centers the imaging catheter within the implant.

13. The implant delivery system of claim 1 , wherein the delivery catheter is configured to transluminally position the distal end of the delivery catheter proximate to one of a mitral valve annulus and a tricuspid valve annulus, and the tubular frame is configured to be anchored to the one of a mitral valve annulus and a tricuspid valve by the at least one tissue anchor extending from a distal end of the tubular frame.

14. An implant comprising:
a series of struts defining a tubular frame and an axis and forming a plurality of upper crowns and lower crowns;
a plurality of anchors coupled with at least some of the plurality of lower crowns of the tubular frame and configured to translate axially relative to the tubular frame to engage cardiac tissue proximate the cardiac valve annulus; and
an alignment mechanism for an imaging catheter, the alignment mechanism being coupled to the tubular frame and configured to position an imaging element of the imaging catheter at a predetermined location relative to the tubular frame.

15. The implant of claim 14 , further comprising a plurality of collars at least partially surrounding the upper crowns and configured to translate axially relative to the tubular frame to adjust a width of the implant.

16. The implant of claim 14 , wherein the alignment mechanism is configured to enable rotation of the imaging catheter within the tubular frame.

17. The implant of claim 14 , wherein the alignment mechanism includes at least one strut coupled to the tubular frame configured to center the imaging catheter within the tubular frame when the tubular frame is in an expanded state.

18. The implant of claim 14 , wherein the tubular frame is sized to surround at least a portion of a mitral valve annulus.

19. The implant of claim 14 , wherein the tubular frame is sized to surround at least a portion of a tricuspid valve annulus.

20. A cardiac valve implant delivery system comprising:
a delivery catheter comprising a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the delivery catheter configured to transluminally position the distal end of the delivery catheter proximate to a cardiac valve annulus;
an implant releasably coupled to the distal end of the delivery catheter, the implant comprising a tubular frame comprised of a series of struts joined to form a plurality of upper and lower crowns;
a plurality of anchors coupled with the lower crowns of the tubular frame and configured to translate axially relative to the tubular frame to engage cardiac tissue proximate the cardiac valve;
an imaging catheter comprising at least one imaging element rotatably disposed within the tubular frame; and
an alignment mechanism coupled to the tubular frame and the imaging catheter and configured to position the imaging elements of the imaging catheter within the tubular frame to enable visualization of the plurality of anchors during deployment of a cardiac valve implant.

Assignees

• Boston Scient Scimed Inc

Inventors

• Lashinski Randall
• Kristoffersen Kristian
• Rust Matthew
• Glenn Richard
• Lee Michael
• Macaulay Patrick

Classifications

• A61B8/085

  for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules · CPC title

• A61B2017/00309

  Cut-outs or slits · CPC title

• A61B2017/00327

  with actuating members moving in opposite directions · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61B2017/00314

  Separate linked members · CPC title