SHOCKWAVE VALVULOPLASTY DEVICE WITH GUIDEWIRE AND DEBRIS BASKET

• US 20120116289A1
• Filed: 09/14/2011
• Published: 05/10/2012
• Est. Priority Date: 11/09/2010
• Status: Abandoned Application

• Current Assignee: Shockwave Medical, Incorporated
• Original Assignee: Shockwave Medical, Incorporated
• Inventors: HAWKINS, DANIEL, ADAMS, JOHN M., GOFF, TOM
• Application Number:
  US13/232,730
• Publication Number:
  US 20120116289A1
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material

Abstract

A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve. The balloon is carried on a catheter that includes a guidewire lumen. The system further includes a debris collecting basket carried on the catheter proximal to the balloon.

Claims

1. A valvuloplasty system, comprising:

a balloon adapted to be placed adjacent leaflets of a valve, the balloon being inflatable with a liquid;

an embolic protection basket; and

a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the valve, the embolic protection basket being arranged for collecting debris resulting from the shock waves impinging upon the valve.

2. The system of claim 1, wherein the embolic protection basket is self-deployable.

3. The system of claim 1, further comprising an elongated tube, wherein the balloon is carried by the elongated tube, and wherein the embolic protection basket is carried on the elongated tube.

4. The system of claim 3, wherein the balloon is at a distal end of the elongate tube and wherein the embolic protection basket is carried on the elongated tube proximal to the balloon.

5. The system of claim 4, wherein the embolic protection basket includes a tubular extension extending proximally from the embolic protection basket.

6. The system of claim 5, wherein the embolic protection basket and the tubular extension are carried on the elongated tube.

7. The system of claim 1, wherein the shock wave generator comprises a first electrical arc generator and a second electrical arc generator.

8. The system of claim 7, wherein each of the electrical arc generators comprises at least one electrode adapted for connection to a voltage pulse generator.

9. The system of claim 7, wherein each of the electrical arc generators comprises an electrode pair adapted for connection to a voltage pulse generator.

10. The system of claim 1, further comprising an elongated tube having a lumen, wherein the balloon is carried by and about the elongated tube, and wherein the system further includes a guidewire adapted to slidingly receive the lumen of the elongated tube.

11. The system of claim 10, wherein the embolic protection basket is carried on the elongated tube.

12. The system of claim 11, wherein the balloon and the embolic protection basket are arranged on the elongated tube such that when the balloon is within the leaflets of an aortic valve, the embolic protection basket is distal to a brachiocephalic trunk.

13. The system of claim 11, further comprising an elongated over tube arranged to be received over the elongated tube, the balloon, and the embolic protection basket.

14. The system of claim 13, wherein the embolic protection basket and the balloon are arranged to be in a collapsed state while being in the over tube.

15. The system of claim 13, wherein the embolic protection basket is further arranged to expand into a deployed state when exiting the over tube.

16. A valvuloplasty system, comprising:

an elongated tube, the elongated tube having a proximal end, a distal end, and a longitudinal lumen extending there through;

a balloon carried on the distal end of the elongated tube and adapted to be placed adjacent leaflets of a valve, the balloon being inflatable with a liquid;

a guidewire slidingly received by the longitudinal lumen of the elongated tube for guiding the elongated tube and the balloon along a desired path; and

a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the valve.

17. The system of claim 16, further comprising an embolic protection basket carried on the elongated tube proximal to the balloon.

18. The system of claim 17, wherein the shock wave generator comprises an electrical arc generator.

19. The system of claim 18, wherein the electrical arc generator comprises at least one electrode adapted for connection to a voltage pulse generator.

20. A valvuloplasty method of treating a valve having leaflets and an annulus, comprising the steps of:

placing a balloon adjacent to the leaflets of the valve;

placing an embolic protection basket proximal to the balloon;

inflating the balloon with a liquid;

producing shockwaves within the balloon that propagate through the liquid for impinging upon the valve leaflets and the valve annulus; and

capturing debris resulting from the shockwaves impinging upon the valve annulus and leaflets within the embolic protection basket.

21. The method of claim 20, wherein the placing step is performed by placing the balloon on opposite sides of the valve leaflets.

22. The method of claim 20, wherein placing step is performed by placing the balloon within the valve annulus.

23. A valvuloplasty method for treating a valve having leaflets and an annulus, comprising:

providing an elongated tube having a proximal end, a distal end, and a longitudinal lumen extending there through, a balloon, inflatable with a liquid, carried on the distal end of the elongated tube and adapted to be placed adjacent leaflets of a valve, a guide wire, and a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the valve;

advancing the guide wire along a desired path through the valve annulus;

sliding the elongated tube onto the guide wire and advancing the elongated tube on the guide wire until the balloon is adjacent the valve leaflets;

inflating the balloon with the liquid; and

producing shockwaves within the balloon with the shock wave generator.

24. The method of claim 23, comprising the further steps of providing the elongated tube with an embolic protection basket proximal to the balloon;

and capturing debris resulting from the shockwaves impinging upon the valve annulus and leaflets within the embolic protection basket.