Shock wave valvuloplasty device with moveable shock wave generator

• US 8,709,075 B2
• Filed: 10/04/2013
• Issued: 04/29/2014
• Est. Priority Date: 11/08/2011
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Original Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Inventors: Adams, John M., Goff, Thomas G.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/046,635
• Publication Number:
  US 20140039514A1
• Time in Patent Office: 207 Days
• Field of Search: 623/1.11, 623/2.11, 604/96.01, 604/101.01, 606/108, 606/159, 606/194
• US Class Current: 623/2.11
• 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 method for softening and/or breaking calcifications on tissue comprising:

placing a balloon adjacent to calcified tissue, wherein the balloon has a longitudinal axis;

inflating the balloon with a liquid;

introducing a shock wave generator into the balloon at a first location, wherein the shock wave generator is arranged to produce a shock wave within the balloon to propagate through the liquid for impinging upon the calcified tissue, and wherein the shock wave generator is mounted on an elongate element that is slidably enclosed within an elongate tube;

initiating a shock wave within the balloon from the first location;

changing the position of the shock wave generator within the balloon to a second location that is axially and/or longitudinally displaced from the first location; and

initiating a shock wave within the balloon from the second location to vary the shock wave impingement upon the calcified tissue.

2. The method of claim 1, wherein the shock wave generator includes at least one electrode, and wherein initiating a shock wave includes applying pulsating electrical energy to the at least one electrode.

3. The method of claim 2, 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.

4. The method of claim 3, 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.

5. The method of claim 2, 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.

6. The method of claim 2, 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.

7. The method of claim 1, further comprising the steps of introducing a second shock wave generator into the balloon arranged to produce a shock wave within the balloon to propagate through the liquid for impinging upon the calcified tissue, initiating a shock wave within the balloon with the second shock wave generator from a third location, changing the position of the second shock wave generator within the balloon to a fourth location that is axially and/or longitudinally displaced from the third location, and initiating a shock wave within the balloon with the second shock wave generator from the fourth location.

8. The method of claim 1, wherein an axial distance from the first location to the longitudinal axis of the balloon is different from an axial distance from the second location to the longitudinal axis of the balloon.

9. The method of claim 1, wherein the second location is longitudinally displaced from the first location.

10. The method of claim 1, wherein a distal portion of the elongate element has a pre-shaped bend, and wherein the step of changing the position of the shock wave generator includes advancing or retracting the elongate element within the elongate tube so that the second location of the shockwave generator is both longitudinally and axially displaced from the first location.

11. The method of claim 1, wherein the elongate element is rotatable within the elongate tube.

12. The method of claim 11, wherein changing the position of the shock wave generator comprises rotating the elongate element such that the shock wave generator is axially displaced from the first location.