Systems, methods and devices for progressively softening multi-compositional intravascular tissue

Patent metadata

Field	Value
Publication number	US-12514602-B2
Application number	US-202418776835-A
Country	US
Kind code	B2
Filing date	Jul 18, 2024
Priority date	Jan 3, 2017
Publication date	Jan 6, 2026
Grant date	Jan 6, 2026

Abstract

Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

First claim

What is claimed is:

1 . A method for treating a blood vessel, including a blood vessel with a calcified lesion, the method comprising the steps of:
introducing a balloon catheter within the target blood vessel, an inflatable balloon of the balloon catheter positioned to impart pressure from the inflatable balloon to the calcified lesion; delivering fluid from a fluid reservoir in operative communication with the inflatable balloon for providing a first pressure magnitude of the inflatable balloon against the target blood vessel; using a controller over a first pressure pulse period for creating pressure pulses according to a pressure waveform within the first pressure pulse period, the controller creating a pressure pulse within the first pressure pulse period with a pressure magnitude period according to the pressure waveform and a pressure reduction period according to the pressure waveform with the pressure pulse having a pressure magnitude configured to break up calcification at the calcified lesion during a time period of 200 milliseconds or less followed by the pressure reduction period of 200 milliseconds or less, each pressure pulse creating the pressure magnitude that is of a higher pressure than the first pressure magnitude.

2 . The method of claim 1 , further comprising the step of transferring the pressure pulse from the inflatable balloon to the blood vessel for applying higher pressure as a result of the pressure pulse to the blood vessel.

3 . The method according to claim 2 , further comprising using a processor in operative communication with the controller, the processor comprising memory with programmed instructions, and executing the programmed instructions according to the pressure waveform.

4 . The method according to claim 3 , wherein the step of executing the programmed instructions includes using the controller for increasing the pressure that is transferred to the blood vessel wall at a pressure increase velocity of 150 psi during the time period of 200 milliseconds or less followed by a pressure reduction velocity within the pressure reduction period of 200 milliseconds or less.

5 . The method according to claim 3 , further comprising using the processor and controller in accordance with the programmed instructions so as not to deform a wall of the blood vessel non-elastically.

6 . The method according to claim 5 , further comprising the step of creating a decompression period after the first pressure pulse period, the decompression period thus relaxing the blood vessel wall to mitigate blood vessel wall non-elastic deformation or blood vessel wall damage.

7 . The method according to claim 6 , further comprising the steps of creating a second pressure pulse period with the decompression period between the first and second pressure pulse periods, and controlling the second pressure pulse period to have a second pressure waveform with pressure magnitudes and pressure reduction periods according to the second pressure waveform.

8 . The method according to claim 7 , wherein each pressure pulse period includes a series of pressure magnitudes and pressure reduction periods.

9 . The method according to claim 7 , wherein the first and second pressure waveforms are similar to one another.

10 . The method according to claim 7 , wherein the first and second pressure waveforms are different from one another.

11 . The method according to claim 7 , wherein a last pressure magnitude of a pressure pulse period is greater than a previous pressure magnitude of the same pressure pulse period.

12 . The method according to claim 7 , wherein a pressure magnitude increases during the second pressure pulse period and successive pressure pulse periods.

13 . The method according to claim 7 , wherein the pressure pulse periods have substantially the same duration.

14 . The method according to claim 7 , wherein the pressure magnitude during a final pressure pulse period is different than an immediately preceding pressure magnitude.

15 . A method for treating a blood vessel, including a blood vessel with a calcified lesion, the method comprising the steps of:
introducing a balloon catheter having an inflatable angioplasty balloon within the blood vessel; positioning the inflatable angioplasty balloon of the balloon catheter to impart pressure from the inflatable angioplasty balloon to the calcified lesion; delivering fluid from a fluid reservoir in operative communication with the inflatable angioplasty balloon for providing first pressure magnitude of the inflatable balloon against the target blood vessel; providing a controller having a processor in operative communication with the controller; using the controller over a plurality of pressure pulse periods for creating pressure pulses according to a pressure waveform within a pressure pulse period, the controller creating pressure pulses within the pressure pulse period with a pressure magnitude period according to the pressure waveform and a pressure reduction period according to the pressure waveform with each pressure pulse period having a pressure pulse with a pressure magnitude configured to break up calcification at the calcified lesion during a time period of 200 milliseconds or less followed by the pressure reduction period of 200 milliseconds or less, at least one pressure pulse creating a pressure magnitude that is of a higher pressure than the first pressure magnitude; and breaking up calcification of the calcified lesion by transferring the pressure pulse from the inflatable angioplasty balloon to the blood vessel, wherein the step of creating pressure pulses according to a pressure wave deforms a wall of the blood vessel elastically while breaking up calcified material of the calcified lesion without damaging the blood vessel.

16 . A method for treating a blood vessel, including a blood vessel with a calcified lesion, the method comprising the steps of:
introducing a balloon catheter within the target blood vessel, an inflatable balloon of the balloon catheter positioned to impart pressure from the inflatable balloon to the calcified lesion; delivering fluid from a fluid reservoir in operative communication with the inflatable balloon for providing a first pressure magnitude of the inflatable balloon against the target blood vessel; using a controller over a pressure pulse period for creating a plurality of pressure pulses and thus applying a plurality of pressure magnitudes within the pressure pulse period to the calcified lesion according to a pressure waveform within the pressure pulse period, the controller creating the plurality of pressure pulses within the pressure pulse period with a plurality of pressure magnitude periods according to the pressure waveform and a plurality of pressure reduction periods according to the pressure waveform with the plurality of pressure pulses having pulse magnitudes applying pressure configured to break up calcification at the calcified lesion, wherein the plurality of pressure magnitude periods are each applied during a time period of 200 milliseconds or less followed by the pressure reduction period of 200 milliseconds or less, each of the plurality of pulse magnitudes being of a higher pressure than the first pressure magnitude.

Assignees

• Cardivascular Systems

Inventors

• Schoenle Victor L

Classifications

• A61M25/10184

  Means for controlling or monitoring inflation or deflation · CPC title

• A61M25/10182

  Injector syringes · CPC title

• A61B2017/22001

  Angioplasty, e.g. PCTA · CPC title

• A61B2017/22062

  to be filled with liquid · CPC title

• A61B2017/00154

  pulsed · CPC title