Shock wave balloon catheter with insertable electrodes

• US 10,357,264 B2
• Filed: 12/06/2016
• Issued: 07/23/2019
• Est. Priority Date: 12/06/2016
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated
• Original Assignee: Shockwave Medical, Incorporated
• Inventors: Kat-Kuoy, Denny
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/370,900
• Publication Number:
  US 20180153568A1
• Time in Patent Office: 959 Days
• 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 2017/22025 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: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A translatable shock wave treatment apparatus is suitable for use in treating calcified lesions in vascular structures having small diameters. An elongate member carrying a collapsed angioplasty balloon is first inserted into the occluded blood vessel. The angioplasty balloon is inflated with a conducting fluid to pre-dilate the narrow blood vessel prior to introducing electrodes and applying shock wave therapy. After the blood vessel is at least partially opened, a translatable electrode carrier equipped with one or more shock wave emitters is advanced into the angioplasty balloon. Shock waves are then propagated through the fluid to impart energy to calcified plaques along the vessel walls, thereby softening the calcified lesions. Following the shock wave treatment, multiple inflation and deflation cycles of the angioplasty balloon can be administered to gently compress the softened lesion and complete dilation of the blood vessel.

Claims

1. An apparatus, comprising:

an elongate member having a distal end and a proximal end and including a central lumen for receiving a guide wire;

a balloon attached to the distal end of the elongate member;

a cylindrical member carrying a plurality of electrodes said member being, slidable along and over a length of the elongate member from an initial position outside the balloon to a destination position wherein the electrodes are positioned inside the balloon.

2. The apparatus of claim 1, further comprising an inflation device operable to inflate the balloon to a diameter exceeding that of the elongate member.

3. The apparatus of claim 1, further comprising a channel configured to direct fluid into the balloon.

4. The apparatus of claim 1, further comprising a handle coupled to the electrode carrier, the handle being operable to slide the electrode carrier along the length of the elongate member.

5. The apparatus of claim 4 wherein the handle is disposed at the proximal end of the elongate member.

6. The apparatus of claim 1 wherein the elongate member is suitable for introduction into a blood vessel.

7. The apparatus of claim 6 wherein a diameter of the elongate member is less than 2.0 mm.

8. The apparatus of claim 1 wherein the electrode carrier further comprises emitters stationed at surface locations of the electrode carrier.

9. The apparatus of claim 8, further comprising a high voltage pulse generator electrically coupled to the emitters.

10. The apparatus of claim 9 wherein each emitter, when energized by the high voltage pulse generator, transmits a current by arcing.

11. The apparatus of claim 1, further comprising one or more markers stationed at destination locations along the distal end of the elongate member.

12. A method, comprising:

providing a balloon attached to a distal end of an elongate member;

providing an electrode carrier slidably mounted on the elongate member at a position outside of, and proximal to, the balloon, the electrode carrier including an emitter attached thereto;

advancing the balloon into a portion of a vascular structure to be treated;

partially inflating the balloon with a fluid;

translating the electrode carrier along the elongate member to a position at least partially inside the balloon; and

initiating a shock wave in the fluid by energizing the emitter.

13. The method of claim 12 wherein translating the electrode carrier entails, prior to the initiating step, sliding the electrode carrier along a length of the elongate member so that the electrode carrier is fully inside the balloon.

14. The method of claim 12 wherein the elongate member is a catheter.

15. The method of claim 12 wherein translating the electrode carrier further includes aligning the electrode carrier with a marker.

16. The method of claim 12 wherein inflating the balloon increases an inside diameter of the vascular structure.

17. The method of claim 12, further comprising, prior to inflating the balloon, rotating the electrode carrier so as to position the emitter adjacent to a target area of the vascular structure.

18. The method of claim 12 wherein the vascular structure includes one or more of a coronary artery, a peripheral artery, and a valve.

19. The method of claim 12, further comprising further inflating the balloon after initiating the shock wave.

20. The method of claim 19, further comprising when the electrode carrier is only partially inside the balloon, translating the electrode carrier further inside the balloon and repeating initiating the shock wave.

21. A device for use in an angioplasty procedure, the device comprising:

an elongate member having a distal end and a proximal end, the elongate member extending linearly along a central axis;

a balloon attached to the distal end of the elongate member;

an inflation pump attached to the proximal end of the elongate member, the inflation pump in fluid communication with the balloon;

an electrode carrier translatable along the elongate member from the proximal end of the elongate member outside the balloon to a position within the balloon;

a plurality of electrodes attached to the electrode carrier; and

a high voltage pulse generator electrically coupled to the electrodes, the high voltage pulse generator causing the electrodes to arc and propagate a shock wave within the balloon.

22. The device of claim 21, further comprising a marker at a destination position on the elongate member.

23. The device of claim 21, further comprising a handle coupled to the electrode carrier.