Shockwave valvuloplasty with multiple balloons

• US 9,554,815 B2
• Filed: 08/08/2013
• Issued: 01/31/2017
• 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.
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): Schwiker, Katherine
• Application Number:
  US13/962,315
• Publication Number:
  US 20140046353A1
• Time in Patent Office: 1,272 Days
• Field of Search: 606/128, 604/101.01, 604/101.03, 604/101.05, 600/439, 600/471, 600/16, 600/18
• 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 17/22012 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 method for applying shock waves to an aortic valve having a first cusp and a second cusp each having a free edge comprising:

introducing a 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 the aortic valve;

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 facing the aorta;

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 facing the aorta and wherein the first and second balloons do not extend beyond the free edges of the first and second cusps respectively to permit blood to flow through the aortic valve; and

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

2. The method of claim 1, further comprising:

after inflating the second balloon with a liquid and before activating the first shock wave source, confirming that the first balloon and the second balloon are each aligned within the concave portions of the first and second cusp respectively.

3. The method of claim 1, wherein the first cusp is a right semilunar cusp and the second cusp is a posterior semilunar cusp.

4. The method of claim 1, wherein the first cusp is a left semilunar cusp and the second cusp is a posterior semilunar cusp.

5. The method of claim 1, wherein the first cusp is a right semilunar cusp and the second cusp is a left semilunar cusp.

6. The method of claim 1, 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.

7. The method of claim 1 further including activating the second shock wave source to apply a shock wave to the second cusp.

8. The method of claim 7, wherein the first and second shock wave sources are activated substantially simultaneously.

9. The method of claim 1 wherein the first and second balloons are inflated simultaneously.

10. The method of claim 1 wherein the first balloon is inflated before the second balloon is inflated.

11. A method for applying shock waves to an aortic valve having a first cusp and a second cusp comprising:

introducing a 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 the aortic valve;

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 facing the aorta;

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 facing the aorta;

thereafter, deflating the second balloon to permit increased blood flow through the aortic valve;

thereafter activating the first shock wave source to apply a shock wave to the first cusp;

after activating the first shock wave source, reinflating the second balloon with a liquid and deflating the first balloon; and

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

12. The method of claim 11 wherein the first and second balloons are initially inflated simultaneously.

13. The method of claim 11 wherein one of the first and second balloons is initially inflated before the other balloon is initially inflated.