IP Library Granted Patent US 11,766,271
Granted Patent B2
US 11,766,271 · App. 16/942,605 · Granted Sep 26, 2023

Shock wave valvuloplasty with multiple balloons

Inventor: John M. Adams (Snohomish, WA)
Assignee: SHOCKWAVE MEDICAL, INC.
A61B17/2202A61B17/22004A61B17/22012A61B17/22022A61B2017/22025A61B2017/22055A61B2017/22062A61B2017/22098A61M25/1011A61M29/00
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Quick Facts
Patent No.
US 11,766,271
App. No.
16/942,605
Granted
Sep 26, 2023
Kind
B2
Abstract

Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.

Claims (30)

1. A device for treatment of an aortic valve having at least one cusp, the device comprising:

a catheter;

an elongate member translatable within the catheter and having a bent distal end, the bent distal end of the elongate member including a shock wave source having first and second electrode pairs located along a side of the elongate member, wherein the first electrode pair and the second electrode pair are located at the same longitudinal location on the elongate member with the first electrode pair being circumferentially offset from the second electrode pair; and

a flexible member surrounding the shock wave source and being fillable with conductive fluid, wherein the shock wave source is movable within the flexible member, and wherein moving the shock wave source within the flexible member causes the bent distal end of the elongate member to move closer to calcified tissue within the aortic valve.

2. The device of claim 1 , wherein the flexible member is an inflatable balloon.

3. The device of claim 2 , wherein the inflatable balloon comprises one or more stand-off structures on an external surface of the inflatable balloon.

4. The device of claim 3 , wherein the one or more stand-off structures are configured to maintain a space between the inflatable balloon and a wall of the aortic valve when the inflatable balloon is inflated.

5. The device of claim 1 , further including a high voltage pulsed power supply connected to the shockwave source.

6. The device of claim 1 , wherein the circumferential offset is 180 degrees.

7. The device of claim 1 , wherein the shock wave source is movable along a longitudinal axis of the elongate member.

8. The device of claim 1 , wherein the shock wave source is rotatable around a longitudinal axis of the elongate member.

9. The device of claim 1 , wherein the bent distal end is configured for positioning within a concave portion of the at least one cusp when the catheter is positioned centrally within an aortic valve and the bent distal end is translated beyond a distal end of the catheter.

10. The device of claim 9 , wherein the bent distal end at least partially unbends when constrained within the catheter.

11. The device of claim 9 , wherein the bent distal end has shape memory to resume a bent configuration when unconstrained.

12. The device as recited in claim 1 , wherein the bent distal end of the elongate member is configured to fit within a concave portion of the cusp facing the aorta.

13. The device as recited in claim 1 , wherein the shock wave source is immersed in a fluid.

14. A device for treatment of an aortic valve having at least one cusp, the device comprising:

a catheter;

an elongate member translatable within the catheter and having a bent distal end, the bent distal end of the elongate member including a shock wave source having first and second electrode pairs located along a side of the elongate member, wherein the first electrode pair and the second electrode pair are located at the same longitudinal location on the elongate member, with the first electrode pair being circumferentially offset from the second electrode pair, wherein the bent distal end has shape memory to resume a bent configuration when unconstrained, and wherein the bent distal end is configured for positioning within a concave portion of the at least one cusp when the catheter is positioned centrally within the aortic valve and the bent distal end is translated beyond a distal end of the catheter; and

a flexible member surrounding the shock wave source and being fillable with conductive fluid, wherein the shock wave source is movable within the flexible member.

15. The device of claim 14 , wherein the flexible member is an inflatable balloon.

16. The device of claim 15 , wherein the inflatable balloon comprises one or more stand-off structures on an external surface of the inflatable balloon.

17. The device of claim 16 , wherein the one or more stand-off structures are configured to maintain a space between the inflatable balloon and a wall of the aortic valve when the inflatable balloon is inflated.

18. The device as recited in claim 14 , further including a high voltage pulsed power supply connected to the shockwave source.

19. The device of claim 14 , wherein the circumferential offset is 180 degrees.

20. The device of claim 14 , wherein the shock wave source is movable along a longitudinal axis of the elongate member.

21. The device of claim 14 , wherein the shock wave source is rotatable around a longitudinal axis of the elongate member.

22. The device of claim 14 , wherein the device is configured such that moving the shock wave source within the flexible member causes the bent distal end of the elongate member to move closer to calcified tissue within the aortic valve.

23. The device of claim 14 , wherein the bent distal end of the elongate member is configured to fit within a concave portion of the cusp facing the aorta.

24. The device of claim 14 , wherein the shock wave source is immersed in a fluid.

Assignments (3)
TERMINATION OF PATENT SECURITY AGREEMENT Recorded Jun 3, 2024
From: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
To: SHOCKWAVE MEDICAL, INC.
Reel/Frame 067605/0799 →
SECURITY AGREEMENT Recorded Oct 20, 2022
From: SHOCKWAVE MEDICAL, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 061728/0132 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 21, 2021
From: ADAMS, JOHN M.
To: SHOCKWAVE MEDICAL, INC.
Reel/Frame 054990/0432 →
Continuity (4)
Continuation 15377090 · Dec 13, 2016
Continuation 13962315 · Aug 8, 2013
Provisional Application 61681068 · Aug 8, 2012
Related Publication 20210038237A1 · Feb 11, 2021
Cited By (2)
US 12,310,605 US 12,318,294