Two-stage method for treating calcified lesions within the wall of a blood vessel

• US 10,702,293 B2
• Filed: 08/19/2019
• Issued: 07/07/2020
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Original Assignee: Shockwave Medical, Incorporated (Johnson & Johnson)
• Inventors: Adams, John M., Hawkins, Daniel, Alferness, Clifton A.
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US16/544,516
• Publication Number:
  US 20190365400A1
• Time in Patent Office: 323 Days
• Field of Search: 606127, 606128, 606159, 606194
• 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 17/22029 Means for measuring shock waves
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22058 reflective
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22062 to be filled with liquid

Abstract

A method is disclosed for treating calcified lesions within a wall of a blood vessel. The first step includes breaking apart a calcified lesion using a plurality of shockwaves generated in an angioplasty balloon of an angioplasty catheter device. The angioplasty balloon is dilated via a fluid to a first extent to fit against at least a portion of the wall of the blood vessel. A plurality of electrical pulses are delivered to a pair of electrodes disposed within the fluid inside the balloon. The electrical pulses have an amplitude sufficient to create plasma arcs in the fluid to generate shockwaves that are conducted through the fluid and through the balloon to the blood vessel, to crack the calcified lesion. After breaking apart the calcified lesion, the angioplasty balloon is allowed to further expand to a second extent greater than the first extent, thereby expanding an opening in the blood vessel.

Claims

1. A method for treating calcified lesions within a wall of a blood vessel in a patient, the method comprising:

i) breaking apart a calcified lesion within the wall of the blood vessel using a plurality of shockwaves generated in an angioplasty balloon of an angioplasty catheter device, wherein

the angioplasty catheter device includes a guidewire sheath and is disposed on a guidewire while the angioplasty balloon is dilated via a fluid to a first extent to fit against at least a portion of the wall of the blood vessel, and

breaking apart the calcified lesion comprises delivering, via a pulse generator, a plurality of electrical pulses to an electrode pair disposed within the angioplasty balloon and exposed to the fluid, each pulse having an amplitude sufficient to create a plasma in the fluid, wherein

the plurality of pulses create a plurality of plasma arcs at the electrode pair such that the plurality of shockwaves is conducted through the fluid and through the angioplasty balloon to the blood vessel, thereby delivering mechanical energy to the calcified lesion to crack the calcified lesion; and

ii) allowing the angioplasty balloon to further expand to a second extent greater than the first extent in response to the breaking apart of the calcified lesion, thereby expanding an opening in the blood vessel.

2. The method of claim 1, wherein delivering the plurality of pulses comprises varying, between a series of two pulses of the plurality of pulses, at least one of a pulse duration or a voltage magnitude to alter a shockwave intensity.

3. The method of claim 1, wherein delivering the plurality of pulses comprises varying, during delivery, a repetition rate of the plurality of pulses.

4. The method of claim 1, wherein the amplitude of each pulse of the plurality of pulses is within a range of 1000 to 3000 volts.

5. The method of claim 1, wherein the plurality of shockwaves each travel radially through the fluid and through the angioplasty balloon, the plurality of shockwaves delivering energy through an extent of the angioplasty balloon from a proximal end of the angioplasty balloon to a distal end of the angioplasty balloon.

6. The method of claim 1, wherein allowing the angioplasty balloon to further expand comprises smoothing an intima of the blood vessel.

7. The method of claim 1, wherein allowing the angioplasty balloon to further expand comprises smoothing and restoring an intima of the blood vessel.

8. The method of claim 1, wherein cracking the calcified lesion comprises focusing the plurality of shockwaves.

9. The method of claim 1, wherein cracking the calcified lesion comprises detecting a cardiac R wave of a heart of the patient and wherein creating the plurality of plasma arcs comprises synchronizing each arc of the plurality of plasma arcs with the cardiac R wave.

10. The method of claim 1, wherein cracking the calcified lesion comprises pulverizing at least a portion of the calcified lesion.

11. The method of claim 1, wherein the electrode pair is disposed radially external to the guidewire sheath.

12. The method of claim 1, wherein the distal end of the guidewire sheath extends beyond the distal end of the balloon.

13. The method of claim 1 wherein when the angioplasty balloon is dilated to the first extent, the angioplasty balloon fits snugly against the wall of the blood vessel.

14. The method of claim 1 wherein the fluid is a conductive liquid.

15. A method of treating calcified lesions within the wall of a blood vessel comprising:

inserting a guide wire into the blood vessel;

advancing an angioplasty catheter into the blood vessel over the guide wire, said angioplasty catheter having a guidewire sheath, a fluid-fillable angioplasty balloon, and a shockwave generator located within the angioplasty balloon, wherein the shockwave generator is defined by a pair of spaced apart electrodes disposed inside the angioplasty balloon and exposed to the fluid;

expanding the angioplasty balloon with the fluid so that the angioplasty balloon presses against at least a portion of a calcified wall of the blood vessel;

after the expanding, supplying one or more electrical pulses to the shockwave generator, each pulse sufficient to create a plasma arc between the pair of spaced apart electrodes resulting in a mechanical shock wave within the angioplasty balloon that passes through the fluid, through the angioplasty balloon, and into the calcified wall of the blood vessel to crack calcified lesions within the calcified wall of the blood vessel; and

after the supplying, allowing the angioplasty balloon to further expand in response to the cracking of the calcified lesions thereby expanding an opening in the blood vessel.

16. The method of claim 15, further comprising detecting cardiac R waves of the patient'"'"'s heart, wherein

supplying the one or more electrical pulses comprises timing the one or more electrical pulses to synchronize the mechanical shock waves with the detected R waves.

17. The method of claim 15, wherein the angioplasty balloon is radially symmetric about a longitudinal axis of the angioplasty catheter, wherein

the guide wire sheath surrounds the longitudinal axis.

18. The method of claim 15, wherein the electrode pair are disposed radially external to the guidewire sheath.

19. The method of claim 15, wherein the distal end of the guidewire sheath extends beyond the distal end of the balloon.

20. The method of claim 15, wherein when the angioplasty balloon is initially expanded, the angioplasty balloon fits snugly against the wall of the blood vessel.

21. The method of claim 15 wherein the fluid is a conductive liquid.