SHOCK WAVE BALLOON CATHETER WITH MULTIPLE SHOCK WAVE SOURCES

• US 20140005576A1
• Filed: 06/27/2012
• Published: 01/02/2014
• Est. Priority Date: 06/27/2012
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Original Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Inventors: Goff, Thomas G., Adams, John, Hakala, Doug
• Granted Patent: US 9,642,673 B2
• Time in Patent Office: Days
• US Class Current: 601/4
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/22022 using electric discharge
• CPC Class Codes: A61B 17/22029 Means for measuring shock waves
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22058 reflective
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22098 Decalcification of valves

Abstract

An apparatus includes a balloon adapted to be placed adjacent a calcified region of a body. The balloon is inflatable with a liquid. The apparatus further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the calcified region adjacent the balloon. The shock wave generator includes a plurality of shock wave sources distributed within the balloon.

Claims

1. An apparatus, comprising:

a balloon adapted to be placed adjacent a calcified region of a body, 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 calcified region adjacent the balloon,

wherein the shock wave generator comprises a plurality of shock wave sources distributed within the balloon, wherein the plurality of shock wave sources comprises more than two shock wave sources.

2. The apparatus of claim 1, wherein the balloon is elongated having a longitudinal dimension and wherein the plurality of shock wave sources extend along a portion of the longitudinal dimension.

3. The apparatus of claim 1, wherein the balloon has a sidewall and wherein the shock wave sources are in non-touching relation with respect to the balloon sidewall.

4. The apparatus of claim 3, wherein the shock wave generator is an electrical arc shock wave generator and wherein the shock wave sources include a plurality of electrodes.

5. The apparatus of claim 4, wherein the electrical arc shock wave generator further includes at least one counter electrode adapted to be in contact with the liquid and to receive a voltage polarity opposite a voltage polarity applied to the plurality of electrodes.

6. The apparatus of claim 5, wherein the shock wave generator includes an elongated conductor and an insulator overlying the elongated conductor, and wherein the insulator has a plurality of discrete openings, each opening for exposing the elongated conductor to the fluid, to form the plurality of electrodes.

7. The apparatus of claim 6, further comprising an insulated wire forming the elongated conductor and the overlying insulator.

8. The apparatus of claim 7, further comprising an elongated carrier, wherein the carrier extends through the balloon and is sealed thereto, and wherein the insulated wire is wrapped about the carrier within the balloon.

9. The apparatus of claim 8 wherein the carrier includes a guide wire lumen.

10. The apparatus of claim 8, wherein the insulated wire is wrapped about the carrier to form electrode coil turns and wherein the apparatus further includes a conductor wire wrapped about the carrier within the balloon and in between the electrode coil turns to form the counter electrode.

11. The apparatus of claim 5, wherein the shock wave generator includes an elongated cylindrical conductor and an insulator overlying the elongated cylindrical conductor, and wherein the insulator has a plurality of discrete openings, each opening for exposing the elongated cylindrical conductor to the fluid, to form the plurality of electrodes.

12. The apparatus of claim 11, further comprising an elongated carrier extending through the balloon and being in sealed relation thereto, wherein the elongated cylindrical conductor overlies the carrier within the balloon.

13. The apparatus of claim 12, wherein the elongated carrier includes a guide wire lumen.

14. The apparatus of claim 1, wherein the shock wave generator is an electrical arc shock wave generator, wherein the shock wave sources include a plurality of electrodes, wherein the apparatus further includes an elongated carrier having a longitudinal dimension extending through the balloon and being in sealed relation thereto, wherein the elongated carrier has a guide wire lumen extending along at least a portion of the longitudinal dimension of the elongated carrier, and wherein at least some of the plurality of electrodes are distributed along the elongated carrier within the balloon.

15. The apparatus of claim 14 wherein the elongated carrier is formed of an insulating material, wherein the shock wave generator includes at least one conductor extending within the elongated carrier in spaced apart relation to the guide wire lumen and along at least a portion of the longitudinal dimension of the elongated carrier, and wherein a plurality of discrete portions of the elongated carrier insulating material are removed to expose corresponding portions of the at least one conductor to form the at least some of the plurality of electrodes.

16. The apparatus of claim 15 wherein at least some of the removed discrete portions of the elongated carrier insulating material contain a conductive filling and wherein the conductive fillings are conductively secured to the elongated conductor.

17. The apparatus of claim 14 wherein the elongated carrier is formed of an insulating material, wherein the shock wave generator includes at least first and second elongated conductors extending within the elongated carrier in spaced apart relation to each other and the guide wire lumen and along at least a portion of the longitudinal dimension of the elongated carrier, and wherein a plurality of discrete portions of the elongated carrier insulating material are removed to expose corresponding portions of the at least first and second conductors to form the at least some of the plurality of electrodes.

18. The apparatus of claim 17 wherein the removed discrete portions of the elongated carrier insulating material that expose corresponding portions of one of the at least first and second conductors are greater in dimension than the removed discrete portions of the elongated carrier insulating material that expose corresponding portions of another one of the at least first and second conductors.

19. The apparatus of claim 18 wherein at least some of the removed discrete portions of the elongated carrier insulating material contain a conductive filling and wherein at least some of the conductive fillings are conductively secured to the elongated conductors.

20. The apparatus of claim 5, wherein the plurality of electrodes are arranged in series circuit relation.

21. The apparatus of claim 5, wherein the plurality of electrodes are arranged in parallel circuit relation.

22. The apparatus of claim 5, further comprising a power source and a multiplexer that selectively couples the power source to the plurality of electrodes, one at a time.

23. The apparatus of claim 5, wherein the plurality of electrodes are arranged in a plurality of series circuit arrangements and wherein the apparatus further comprises a multiplexer that selectively couples the power source to the series circuit arrangements, one at a time.

24. The apparatus of claim 1, wherein the plurality of shock wave sources are arranged along a path defining a loop.

25. The apparatus of claim 1, wherein the balloon is configured to be placed adjacent leaflets of a valve, the balloon having a first chamber to be adjacent one side of the leaflets and a second chamber to be adjacent an opposite side of the leaflets, and wherein the plurality of shock wave sources are arranged to define a loop of shock wave sources within one of the first and second chambers of the balloon.

26. The apparatus of claim 1, wherein the balloon is configured to be placed adjacent leaflets of a valve, the balloon having a first chamber to be adjacent one side of the leaflets and a second chamber to be adjacent an opposite side of the leaflets, and wherein the plurality of shock wave sources are arranged to define a first loop of shock wave sources within the first chamber of the balloon and a second loop of shock wave sources within the second chamber of the balloon.

27. The apparatus of claim 24, wherein the balloon has a sidewall and wherein the shock wave sources are in non-touching relation with respect to the balloon sidewall.

28. The apparatus of claim 27, wherein the shock wave generator is an electrical arc shock wave generator and wherein the shock wave sources include a plurality of electrodes.

29. The apparatus of claim 28, wherein the electrical arc shock wave generator further includes a counter electrode adapted to be in contact with the liquid and to receive a voltage polarity opposite a voltage polarity applied to the plurality of electrodes.

30. The apparatus of claim 28, wherein the shock wave generator includes an elongated conductor and an insulator overlying the elongated conductor, and wherein the insulator has a plurality of discrete openings, each opening for exposing the elongated conductor to the fluid, to form the plurality of electrodes.

31. The apparatus of claim 30, wherein the balloon is elongated having a longitudinal dimension and wherein the plurality of electrodes extend along a portion of the longitudinal dimension.

32. The apparatus of claim 31, wherein the balloon is configured to be placed adjacent leaflets of a valve, the balloon having a first chamber to be adjacent one side of the leaflets and a second chamber to be adjacent an opposite side of the leaflets, and wherein the plurality of electrodes are arranged to define a loop of electrodes within one of the first and second chambers of the balloon.

33. The apparatus of claim 31, wherein the balloon is configured to be placed adjacent leaflets of a valve, the balloon having a first chamber to be adjacent one side of the leaflets and a second chamber to be adjacent an opposite side of the leaflets, and wherein the plurality of electrodes are arranged to define a first loop of electrodes within the first chamber of the balloon and a second loop of electrodes within the second chamber of the balloon.

34. The apparatus of claim 31, further comprising an insulated wire forming the elongated conductor and the overlying insulator.

40. The method of claim 29, wherein the distributing step includes distributing the shock wave sources along a path defining a loop.

35. An apparatus, comprising:

an elongated carrier;

a balloon carried on the elongated carrier in sealed relation thereto, being adapted to be placed adjacent a calcified region of a body, and being inflatable with a liquid; and

an electrical arc shock wave generator within the balloon, the electrical arc shock wave generator comprising more than two electrodes distributed within the balloon, each electrode adapted to produce shock waves that propagate through the liquid for impinging upon the calcified region adjacent the balloon, and a counter electrode adapted to be in contact with the liquid and to receive a voltage polarity opposite that applied to the more than two electrodes.

36. A method comprising:

inserting a balloon in a body adjacent a calcified region;

inflating the balloon with a liquid to cause the balloon to contact the calcified region;

placing, within the balloon, a shock wave generator including more than two shock wave sources and distributing the more than two shock wave sources within the balloon; and

causing the shock wave sources to form shock waves that propagate through the liquid and impinge upon the calcified region.

37. The method of claim 36, wherein the inserting step includes inserting the balloon into an artery or vein of the body.

38. The method of claim 36, wherein the balloon is elongated having a longitudinal dimension and wherein the distributing step includes distributing the shock wave sources along a portion of the longitudinal dimension.

39. The method of claim 36, wherein the inserting step includes inserting the balloon into a valve of the body.

41. The method of claim 39, wherein the balloon is configured to be placed adjacent leaflets of the valve, the balloon having a first chamber to be adjacent one side of the leaflets and a second chamber to be adjacent an opposite side of the leaflets, wherein the inserting step includes inserting the balloon into the valve with the first chamber adjacent one side of the leaflets and the second chamber adjacent the opposite side of the leaflets, and wherein the distributing step includes distributing the shock wave sources along a path defining a loop of shock wave sources within one of the first and second chambers of the balloon.

42. The method of claim 39, wherein the balloon is configured to be placed adjacent leaflets of the valve, the balloon having a first chamber to be adjacent one side of the leaflets and a second chamber to be adjacent an opposite side of the leaflets, wherein the inserting step includes inserting the balloon into the valve with the first chamber adjacent one side of the leaflets and the second chamber adjacent the opposite side of the leaflets, and wherein the distributing step includes distributing the shock wave sources to define a first loop of shock wave sources within the first chamber of the balloon and to define a second loop of shock wave sources within the second chamber of the balloon.

43. The method of claim 39, wherein the balloon has a sidewall and wherein the distributing step includes distributing the shock wave sources in non-touching relation with respect to the balloon sidewall.

44. The method of claim 39, wherein the shock wave generator is an electrical arc shock wave generator, wherein the shock wave sources include a plurality of electrodes, and wherein the causing step includes applying voltage pulses between the plurality of electrodes and a counter electrode to form the shock waves.

45. A method comprising:

inserting a balloon in a body adjacent a calcified region;

inflating the balloon with a liquid to cause the balloon to contact the calcified region;

placing within the balloon more than two electrodes in non-touching relation to the balloon and adjacent the calcified regions;

placing a counter electrode in contact with the liquid; and

applying voltage pulses between the more than two electrodes and the counter electrode, the voltage pulses having a first polarity applied to the two or more electrodes and a second polarity applied to the counter electrode causing the more than two electrodes to form shock waves that propagate through the liquid and impinge upon the calcified region.