Methods for delivery of heart valve devices using intravascular ultrasound imaging

• US 10,335,275 B2
• Filed: 09/29/2016
• Issued: 07/02/2019
• Est. Priority Date: 09/29/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Millipede, Inc. (Boston Scientific Corporation)
• Inventors: Lashinski, Randall, Kristoffersen, Kristian, Rust, Matthew, Glenn, Richard, Lee, Michael, Macaulay, Patrick
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/280,004
• Publication Number:
  US 20170086974A1
• Time in Patent Office: 1,006 Days
• Field of Search: 623 211
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• 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: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

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.

Claims

1. A method of anchoring an implant having a replacement mitral valve in the heart, comprising:

advancing a deployment catheter to a deployment site in a heart, the deployment catheter releasably carrying the implant having at least one tissue anchor;

positioning an imaging element in the heart adjacent the implant;

visualizing a relationship between the tissue anchor and a mitral valve annulus; and

attaching the replacement mitral valve by driving the tissue anchor into tissue in the heart wherein the imaging element is carried by an imaging catheter, and the positioning step comprises centering the imaging catheter within the implant.

2. The method of claim 1, wherein the positioning an imaging element step comprises advancing the imaging element transvascularly along a same access path followed by the deployment catheter.

3. The method of claim 1, wherein the positioning an imaging element step comprises advancing the imaging element transvascularly along an access path that is different from an access path followed by the deployment catheter.

4. The method of claim 1, wherein the positioning an imaging element step comprises directing the imaging element to a predetermined relationship with the deployment catheter using an alignment structure.

5. The method of claim 4, wherein the positioning step comprises centering the imaging catheter within the implant using the alignment structure.

6. The method of claim 5, wherein the centering step comprises inclining at least one alignment arm with respect to a longitudinal axis of the deployment catheter.

7. The method of claim 1, wherein the visualizing step comprises capturing at least one radial image.

8. The method of claim 1, wherein the visualizing step comprises capturing at least one circumferential image.

9. The method of claim 1, wherein the attaching the replacement mitral valve step comprises driving at least two anchors into tissue in the heart.

10. The method of claim 9, further comprising the step of capturing a circumferential image following the attaching step.

11. The method of claim 10, further comprising the step of releasing the implant from the deployment catheter following the capturing a circumferential image step.

12. The method of claim 10, further comprising the step of manipulating at least one anchor following the capturing a circumferential image step.

13. The method of claim 9, comprising capturing a first image of a first anchor, repositioning the imaging element, and capturing a second image of a second anchor.

14. The method of claim 1, wherein the attaching step comprises rotating the anchor.

15. The method of claim 1, wherein the deployment catheter has a central longitudinal axis and further comprising the step of deflecting the imaging element away from the central longitudinal axis.

16. A method of delivering an implant proximate a cardiac valve annulus, the method comprising:

advancing a distal end of a delivery catheter proximate the cardiac valve annulus;

advancing the implant through the distal end of the delivery catheter proximate the cardiac valve annulus;

advancing a distal end of an ultrasound catheter proximate the cardiac valve annulus, the distal end of the ultrasound catheter including one or more ultrasonic transducers;

capturing an ultrasound image of the implant and the cardiac valve annulus with the one or more ultrasonic transducers; and

anchoring the implant to the cardiac valve annulus,

wherein the implant comprises;

a series of struts defining a tubular frame and an axis and forming a plurality of upper and lower crowns;

a plurality of anchors coupled with the lower crowns of the frame and configured to translate axially relative to the frame to engage cardiac tissue proximate the cardiac valve annulus; and

a plurality of collars at least partially surrounding the upper crowns and configured to translate axially relative to the frame to adjust a width of the implant.

17. The method of claim 16, further comprising:

rotating the distal end of the ultrasound catheter proximate the cardiac valve annulus to a plurality of rotational positions; and

capturing a series of ultrasound images of the implant and the cardiac valve annulus with the one or more ultrasonic transducers at the plurality of rotational positions.

18. The method of claim 16, wherein the one or more ultrasonic transducers includes a radial ultrasonic transducer, and wherein capturing the series of ultrasound images comprises capturing one or more radial images of the implant and the cardiac valve annulus to properly position anchors of the implant for insertion into the cardiac valve annulus.

19. The method of claim 18, wherein the one or more ultrasonic transducers includes a circumferential ultrasonic transducer, and wherein capturing the series of ultrasound images further comprises capturing one or more circumferential images of the implant and the cardiac valve annulus.

20. The method of claim 16, comprising advancing the distal end of the ultrasound catheter proximate the cardiac valve annulus separately from the delivery catheter.

21. The method of claim 20, comprising advancing the distal end of the ultrasound catheter proximate the cardiac valve annulus through the aortic valve.

22. The method of claim 20, wherein the ultrasound catheter comprises:

a proximal end having a guidewire entry port;

a distal end having a guidewire exit port; and

a guidewire extending through the entry and exit ports.

23. The method of claim 16, further comprising centering the ultrasound catheter relative to the implant before capturing the ultrasound image and anchoring the implant.

24. A method of delivering an implant proximate a cardiac valve annulus, the method comprising:

advancing a distal end of a delivery catheter proximate the cardiac valve annulus;

advancing the implant through the distal end of the delivery catheter proximate the cardiac valve annulus;

advancing a distal end of an ultrasound catheter proximate the cardiac valve annulus, the distal end of the ultrasound catheter including one or more ultrasonic transducers;

capturing an ultrasound image of the implant and the cardiac valve annulus with the one or more ultrasonic transducers; and

anchoring the implant to the cardiac valve annulus,

wherein the implant is a cardiac valve replacement and comprises;

a series of struts defining a tubular frame and an axis and forming a plurality of lower crowns;

a plurality of anchors coupled with the lower crowns of the frame and configured to translate axially relative to the frame to engage cardiac tissue proximate the cardiac valve annulus; and

a plurality of valve leaflets coupled with the frame.

25. The method of claim 24, further comprising:

rotating the distal end of the ultrasound catheter proximate the cardiac valve annulus to a plurality of rotational positions; and

capturing a series of ultrasound images of the implant and the cardiac valve annulus with the one or more ultrasonic transducers at the plurality of rotational positions.

26. The method of claim 24, wherein the one or more ultrasonic transducers includes a radial ultrasonic transducer, and wherein capturing the series of ultrasound images comprises capturing one or more radial images of the implant and the cardiac valve annulus to properly position anchors of the implant for insertion into the cardiac valve annulus.

27. The method of claim 26, wherein the one or more ultrasonic transducers includes a circumferential ultrasonic transducer, and wherein capturing the series of ultrasound images further comprises capturing one or more circumferential images of the implant and the cardiac valve annulus.

28. The method of claim 24, comprising advancing the distal end of the ultrasound catheter proximate the cardiac valve annulus separately from the delivery catheter.

29. The method of claim 28, comprising advancing the distal end of the ultrasound catheter proximate the cardiac valve annulus through the aortic valve.

30. The method of claim 28, wherein the ultrasound catheter comprises:

a proximal end having a guidewire entry port;

a distal end having a guidewire exit port; and

a guidewire extending through the entry and exit ports.

31. The method of claim 24, further comprising centering the ultrasound catheter relative to the implant before capturing the ultrasound image and anchoring the implant.