SHOCK WAVE VALVULOPLASTY DEVICE WITH MOVEABLE SHOCK WAVE GENERATOR

• US 20130116714A1
• Filed: 11/08/2011
• Published: 05/09/2013
• Est. Priority Date: 11/08/2011
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated
• Original Assignee: Shockwave Medical, Incorporated
• Inventors: Adams, John M., Goff, Thomas G.
• Granted Patent: US 8,574,247 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 17/22022 using electric discharge
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22025 applying a shock wave A61B2017/22091 takes precedence
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22098 Decalcification of valves

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 that propagate through the liquid for impinging upon the valve. The shock wave generator is moveable within the balloon to vary shock wave impingement on the valve.

Claims

1. A valvuloplasty system, comprising:

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

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

wherein the shock wave generator is moveable within the balloon.

2. The system of claim 1, wherein the shock wave generator is moveable within the balloon to subscribe a circular area.

3. The system of claim 2, wherein the shock wave generator is further moveable within the balloon to subscribe a cylindrical space.

4. The system of claim 1, wherein the shock wave generator includes at least one electrode.

5. The system of claim 4, wherein the system further comprises an elongated element that carries the at least one electrode to extend into the balloon and an elongated sheath through which the elongated element extends and wherein the at least one electrode is moveable within the balloon by displacement of the elongated element and/or the sheath.

6. The system of claim 5, wherein the at least one electrode is moveable within the balloon to subscribe a circular area.

7. The system of claim 6, wherein the at least one electrode is further moveable within the balloon to subscribe a cylindrical space.

8. The system of claim 4, further comprising an elongated carrier, wherein the balloon is at one end of the carrier in sealed relation thereto, wherein the system further comprises an elongated element that carries the at least one electrode to extend through the carrier into the balloon, and wherein the at least one electrode is moveable within the balloon to subscribe a circular area by rotational displacement of the elongated element.

9. The system of claim 8, wherein the at least one electrode is further moveable within the balloon to subscribe a cylindrical space by rotational and axial displacement of the elongated element.

10. The system of claim 9, wherein the carrier has a distal end and a proximal end, wherein the elongated element has a distal end and a proximal end, wherein the balloon is at the distal end of the carrier, wherein the at least one electrode is at the distal end of the elongated element, wherein the elongated element extends through the carrier from the balloon to the proximal end of the carrier, and wherein the elongated element is displaceable at the proximal end of the carrier.

11. The system of claim 10, further including an elongated sheath through which the elongated element and at least one electrode extend, and wherein the size of the circular area subscribed by the at least one electrode within the balloon is adjustable by axial displacement of the elongated element with respect to the sheath.

12. The system of claim 11, wherein the at least one electrode extends from the elongated element at an angle.

13. The system of claim 12, wherein the at least one electrode and the elongated element are formed from a common conductor.

14. The system of claim 4, further comprising a cage enclosing the at least one electrode that prevents the at least one electrode from contacting the balloon.

15. The system of claim 14, wherein the cage is formed of electrically insulative material.

16. The system of claim 14 wherein the cage is formed of conductive material and includes an insulation covering at least a portion of the cage.

17. The system of claim 16, wherein the shock wave generator further comprises a second electrode within the balloon and wherein the cage forms the second electrode.

18. The system of claim 4, wherein the shock wave generator further includes a reflector that directs the shock waves generated by the at least one electrode in a desired direction.

19. The system of claim 18, wherein the reflector is arranged to move with the at least one electrode.

20. The system of claim 4, wherein the at least one electrode comprises an electrode pair.

21. The system of claim 20, wherein the electrode pair are formed by coaxially disposed electrodes including a center electrode and an outer electrode circumscribing the center electrode.

22. The system of claim 21, wherein the shock wave generator further includes a reflector carried by the electrode pair that directs the shockwaves in a desired direction.

23. The system of claim 22, wherein the reflector is coupled to the outer electrode.

24. The system of claim 4, wherein the shock wave generator further includes a pulsating voltage source and wherein the pulsating voltage source is arranged to provide the at least one electrode with a negative polarity.

25. The system of claim 4, wherein the balloon comprises first and second chambers, wherein the shock wave generator comprises the at least one electrode within the first chamber and a second electrode within the second chamber, wherein the at least one electrode is moveable within the first chamber and wherein the second electrode is moveable within the second chamber.

26. The system of claim 25, wherein each of the at least one electrode and the second electrode is arranged for movement to subscribe a cylindrical space.

27. The system of claim 25, wherein each of the at least one electrode and the second electrode comprises a first electrode pair and a second electrode pair, respectively.

28. The system of claim 27, wherein the first and second electrode pair are each formed by coaxially disposed electrodes including a center electrode and an outer electrode circumscribing the center electrode.

29. The system of claim 25 wherein one of the at least one electrode and the second electrode is a distal electrode with respect to the other one of the at least one electrode and second electrode and wherein the distal electrode is moveable axially so as to be proximal to the other one of the at least one electrode and second electrode.

30. The system of claim 25 wherein one of the at least one electrode and the second electrode is a distal electrode with respect to the other one of the at least one electrode and second electrode, and wherein the distal electrode is reflexed in a proximal direction.

31. A valvuloplasty system for treating a calcified valve, comprising:

an elongated carrier;

a balloon at one end of the carrier in sealed relation thereto, the balloon being inflatable with a liquid and including a first chamber and a second chamber; and

a shock wave generator including a first electrode within the balloon first chamber and a second electrode within the balloon second chamber, the electrodes being arranged to produce shock waves within their respective balloon chambers that propagate through the liquid and impinge upon the valve being treated adjacent the balloon chambers,

wherein the first electrode is moveable within the first balloon chamber and the second electrode is moveable within the second balloon chamber.

32. The system of claim 31, wherein the shock wave generator further includes a pulsating voltage source and wherein the pulsating voltage source is arranged to provide the first and second electrodes with a negative polarity.

33. The system of claim 31, wherein each of the first and second electrodes is moveable within its respective balloon chamber to subscribe a cylindrical space.

34. The system of claim 31, further comprising a first drive element coupled to the first electrode and a second drive element coupled to the second electrode, and wherein the first and second electrodes are each arranged to subscribe a cylindrical space by rotational and longitudinal displacement of their respective drive element.

35. The system of claim 31, wherein each of the first electrode and the second electrode comprises a first electrode pair and a second electrode pair, respectively.

36. The system of claim 31, wherein the first and second electrode pair are each formed by coaxially disposed electrodes including a center electrode and an outer electrode circumscribing the center electrode.

37. The system of claim 31 wherein one of the at least one electrode and the second electrode is a distal electrode with respect to the other one of the at least one electrode and second electrode and wherein the distal electrode is moveable axially so as to be proximal to the other one of the at least one electrode and second electrode.

38. The system of claim 31 wherein one of the at least one electrode and the second electrode is a distal electrode with respect to the other one of the at least one electrode and second electrode, and wherein the distal electrode is reflexed in a proximal direction.

39. A valvuloplasty method for treating a cardiac valve, comprising:

placing a balloon adjacent to the valve;

inflating the balloon with a liquid;

introducing a shock wave generator into the balloon arranged to produce shock waves within the balloon to propagate through the liquid for impinging upon the valve,

producing shock waves within the balloon; and

changing the position of the shock wave generator within the balloon to vary the shock wave impingement upon the valve.

40. The method of claim 39, wherein the shock wave generator includes at least one electrode, and wherein the producing step includes applying pulsating electrical energy to the at least one electrode.

41. The method of claim 40, wherein the step of changing the position of the shock wave generator within the balloon includes moving the at least one electrode along an arcuate path.

42. The method of claim 41, wherein the arcuate path has a radius of curvature, and wherein the step of changing the position of the shock wave generator within the balloon further includes varying the radius of curvature.

43. The method of claim 40, wherein the step of changing the position of the shock wave generator within the balloon includes moving the at least one electrode longitudinally within the balloon.

44. The method of claim 40, wherein the step of changing the position of the shock wave generator within the balloon includes moving the at least one electrode within a subscribed cylindrical space.

45. The method of claim 39, including the further steps of introducing a second shock wave generator into the balloon arranged to produce shock waves within the balloon to propagate through the liquid for impinging upon the valve, producing shock waves within the balloon with the second shock wave generator, and changing the position of the second shock wave generator within the balloon to vary the shock wave impingement upon the valve.