SHOCKWAVE VALVULOPLASTY WITH MULTIPLE BALLOONS

• US 20140046353A1
• Filed: 08/08/2013
• Published: 02/13/2014
• Est. Priority Date: 08/08/2012
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Original Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Inventors: ADAMS, John M.
• Granted Patent: US 9,554,815 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 17/2202 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 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.

Claims

1. A device for treatment of a heart valve, wherein the heart valve has a plurality of cusps each having a concave portion, comprising:

a first elongate body;

a first balloon sealably enclosing a portion of the first elongate body;

a first shock wave source coupled to the first elongate body and enclosed within the first balloon;

a second elongate body;

a second balloon sealably enclosing a portion of the second elongate body;

a second shock wave source coupled to the second elongate body and enclosed within the second balloon; and

wherein the first and second balloons are independently inflatable with a liquid and are sized and shaped such that when inflated with the liquid, a portion of the balloons contact the valve, and wherein the portion of the balloons that contact the valve approximate the size and shape of a concave portion of a valvular cusp.

2. The device of claim 1, further comprising a third elongate body, a third balloon sealably enclosing a portion of the third elongate body, and a third shock wave source coupled to the third elongate body and enclosed within the third balloon, wherein the third balloon is independently inflatable with a liquid.

3. The device of claim 1, wherein the shock wave sources are movable within their respective balloons.

4. The device of claim 3, wherein the shock wave sources are rotatable about a longitudinal axis of their respective elongate bodies.

5. The device of claim 3, wherein the shock wave sources are advanceable along a longitudinal axis of their respective elongate bodies.

6. The device of claim 1, further comprising at least one stand-off on the external surface of at least one of the balloons.

7. The device of claim 6, wherein the at least one stand-off comprises a curved ridge along a segment of the external surface of the balloon.

8. The device of claim 1, wherein the elongate bodies comprise a compressed configuration and an expanded configuration, wherein in the compressed configuration, a distal portion of the elongate bodies is relatively straight and in the expanded configuration, the distal portion of the elongate bodies is curved.

9. A device for treatment of a heart valve, wherein the heart valve has a plurality of cusps each having a concave portion, comprising:

a first elongate body;

a first balloon sealably enclosing a portion of the first elongate body;

a first shock wave source coupled to the first elongate body and enclosed within the first balloon;

a second elongate body;

a second balloon sealably enclosing a portion of the second elongate body;

a second shock wave source coupled to the second elongate body and enclosed within the second balloon;

a third elongate body,

a third balloon sealably enclosing a portion of the third elongate body,

a third shock wave source coupled to the third elongate body and enclosed within the third balloon, and

wherein the first, second and third balloons are independently inflatable with a liquid and are sized and shaped such that when inflated with the liquid, a portion of the balloons contact the valve, and wherein the portion of the balloons that contact the valve approximate the size and shape of a concave portion of a valvular cusp.

10. The device of claim 9, further comprising at least one stand-off on the external surface of at least one of the balloons.

11. The device of claim 10, wherein the at least one stand-off comprises a curved ridge along a segment of the external surface of the balloon.

12. The device of claim 9, wherein the elongate bodies comprise a compressed configuration and an expanded configuration, wherein in the compressed configuration, a distal portion of the elongate bodies is relatively straight and in the expanded configuration, the distal portion of the elongate bodies is curved.

13. A method for applying shock waves to an aortic valve comprising:

introducing shock wave device into a patient'"'"'s vasculature, the shock wave device comprising a first elongate body, a first balloon sealably enclosing a portion of the first elongate body, a first shock wave source coupled to the first elongate body and enclosed within the first balloon, a second elongate body, a second balloon sealably enclosing a portion of the second elongate body, and a second shock wave source coupled to the second elongate body and enclosed within the second balloon, wherein the first and second balloons are independently inflatable with a liquid;

advancing the shock wave device within the vasculature to contact an aortic valve having a first cusp and a second cusp;

inflating the first balloon with a liquid, wherein inflating the first balloon causes the first balloon to be aligned within a concave portion of the first cusp; and

activating the first shock wave source to apply a shock wave to the first cusp.

14. The method of claim 13, further comprising:

deflating the first balloon after activating the first shock wave source;

inflating the second balloon with a liquid, wherein inflating the second balloon causes the second balloon to be aligned within a concave portion of the second cusp; and

activating the second shock wave source to apply a shock wave to the second cusp.

15. The method of claim 13, further comprising:

inflating the second balloon with a liquid, wherein inflating the second balloon causes the second balloon to be aligned within a concave portion of the second cusp;

confirming that the first balloon and the second balloon are each aligned within the concave portions of the first and second cusp respectively; and

activating the second shock wave source to apply a shock wave to the second cusp.

16. The method of claim 15, wherein the first and second shock wave sources are activated substantially simultaneously.

17. The method of claim 16, wherein the first cusp is a right semilunar cusp and the second cusp is a posterior semilunar cusp.

18. The method of claim 16, wherein the first cusp is a left semilunar cusp and the second cusp is a posterior semilunar cusp.

19. The method of claim 16, wherein the first cusp is a right semilunar cusp and the second cusp is a left semilunar cusp.

20. The method of claim 13, wherein the shock wave device further comprises a third elongate body, a third balloon sealably enclosing a portion of the third elongate body, and a third shock wave source coupled to the third elongate body and enclosed within the third balloon, wherein the third balloon is independently inflatable with a liquid.