SHOCKWAVE VALVULOPLASTY CATHETER SYSTEM

• US 20150238209A1
• Filed: 04/22/2015
• Published: 08/27/2015
• Est. Priority Date: 11/05/2008
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Original Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Inventors: HAWKINS, Daniel, ADAMS, John M.
• Granted Patent: US 9,421,025 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 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 2017/22054 with two balloons
• 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 2017/22068 Centering
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/38 for producing shock effects

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.

Claims

1-46. -46. (canceled)

47. An intravascular valvuloplasty system for breaking calcium deposits on the leaflets of an aortic valve, each leaflet connected to a wall and having a concave region, comprising:

an elongate body;

a balloon being inflatable with a liquid via an inflation lumen provided in the elongate body, wherein the inflated balloon has a portion shaped to fit within the concave region of a leaflet and between the leaflet and the wall; and

a shock wave generator for generating shock waves that propagate through the liquid for impinging upon the leaflets and breaking calcium deposits on the leaflets, the balloon being configured to remain intact as the shock waves are produced by the shock wave generator.

48. The system of claim 47, wherein the balloon is at the distal end of the elongate body.

49. The system of claim 47 wherein the shock wave generator includes an electric arc generator.

50. The system of claim 49 wherein the electric arc generator includes at least one pair of electrodes and a power supply connected to the electrodes for generating high voltage pluses between the electrodes.

51. The system of claim 50 wherein the pair of electrodes comprises an inner electrode and an outer electrode shield that surrounds the inner electrode.

52. An intravascular valvuloplasty method for breaking calcium deposits on the leaflets of an aortic valve, each leaflet connected to the wall of the aorta and having a concave region, comprising:

advancing an elongated tube into the region of the aortic valve, said tube including a fluid lumen, said elongated tube including a balloon on the distal end thereof, said balloon carrying a shock wave generator located between the tube and the inner surface of the balloon;

inflating the balloon with a liquid delivered through the fluid lumen in a manner so that a portion of the balloon fits within the concave region of a leaflet between the leaflet and the wall; and

energizing the shock wave generator to produce a shock wave within the balloon that propagates through the liquid for impinging upon the valve leaflet in order to break calcium deposits on the leaflet wherein the balloon is configured to remain intact as the shock wave propagates through the liquid.

53. The method of claim 52 wherein the shock wave generator includes an electric arc generator and the step of energizing the shock wave generator is performed by delivering high voltage pulses from a power supply to the electric arc generator.

54. The method of claim 53 wherein the electric arc generator includes at least one pair of electrodes.

55. The method of claim 54 wherein the pair of electrodes comprises an inner electrode and an outer electrode shield that surrounds the inner electrode.

56. An intravascular valvuloplasty method for breaking calcium deposits on an aortic valve having leaflets, comprising:

advancing an elongated tube into the region of the aortic valve, said tube including at least one fluid lumen, said elongated tube carrying two balloon chambers near the distal end thereof;

inflating the balloon chambers with a liquid delivered through the at least one fluid lumen, with one balloon chamber being positioned on one side of the valve and the other balloon chamber being positioned on the other side of the valve, each of said balloon chambers having a shock wave generator located therein; and

energizing both of the shock wave generators in both balloon chambers so that the shock waves generated thereby impinge on both sides of the leaflets in order to break calcium deposits on the leaflets wherein the balloon chambers are configured to remain intact as the shock wave propagates through the liquid.

57. A method as recited in claim 56 wherein the shock wave generators in both balloon chambers are synchronized so that the shock waves generated thereby impinge concurrently on both sides of the leaflets.

58. A method as recited in claim 57 wherein both balloon chambers are inflated via a common fluid lumen.

59. A method as recited in claim 57 wherein the balloon chambers are inflated with separate fluid lumens.

60. The method of claim 57 wherein each shock wave generator includes an electric arc generator and the step of energizing the shock wave generators is performed by delivering high voltage pulses to the electric arc generators.

61. The method of claim 60 wherein each electric arc generator includes at least one pair of electrodes.

62. The method of claim 61 wherein the pair of electrodes comprises an inner electrode and an outer electrode shield that surrounds the inner electrode.