Granted Patent B2

US 12,490,997 · App. 18/776,871 · Granted Dec 9, 2025

Inventor: Victor L. Schoenle (Greenfield, MN)

Assignee: Cardiovascular Systems, Inc.

A61B17/22012A61M25/10182A61M25/10184A61M25/104A61B2017/00154A61B2017/22001A61B2017/22062

Abstract

Claims (37)

1 . A method for treating an at least partially calcified lesion in a target blood vessel, comprising:

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 a first series of pressure pulses and thus applying a first plurality of pressure magnitudes within the first pressure pulse period to the calcified lesion with a reduced pressure period defined by and between successive magnitudes of the first plurality of pressure magnitudes, each pressure pulse of the first series of pressure pulses creating a pressure magnitude that is of a higher pressure than the first pressure magnitude;

transferring the first series of pressure pulses and first plurality of pressure magnitudes from the inflatable balloon to the target blood vessel for applying the higher pressure by each pressure pulse of the first series of pressure pulses to the target blood vessel and breaking up calcification of the calcified lesion; and

reducing the pressure applied by the inflatable balloon to the target blood vessel for a first decompression period that is longer than any reduced pressure period after the application of the first plurality of pressure magnitudes.

2 . The method according to claim 1 , further comprising the steps of:

using the controller over a second pressure pulse period after the first decompression period for creating a second series of pressure pulses and thus applying a second plurality of pressure magnitudes within the second pressure pulse period to the calcified lesion, each second pressure pulse of the second series of pressure pulses creating a pressure magnitude that is of a higher pressure than the first pressure magnitude pressure;

transferring the second pressure pulses and second plurality of pressure magnitudes from the inflatable balloon to the target blood vessel for applying higher pressure by each second pressure pulse to the target blood vessel and further breaking up calcification of the calcified lesion; and

reducing the pressure applied by the inflatable balloon to the target blood vessel.

3 . The method of claim 2 , further comprising a second decompression period following the step of reducing the pressure applied by the inflatable balloon to the target blood vessel that is after the step of transferring the second pressure pulses from the inflatable balloon to the target blood vessel.

4 . The method of claim 3 , further comprising the steps of:

using the controller over a third pressure pulse period for creating a third series of pressure pulses, each third pressure pulse of the third series of pressure pulses creating a pressure magnitude that is of a higher pressure than the first pressure magnitude; and

transferring the third pressure pulses from the inflatable balloon to the target blood vessel for applying higher pressure by each third pressure pulse to the target blood vessel and further breaking up calcification of the calcified lesion.

5 . The method of claim 4 , further comprising deflating the inflatable balloon after a final pressure pulse period and removing the inflatable balloon and the balloon catheter from the target blood vessel.

6 . The method of claim 1 , wherein the first plurality of pressure magnitudes for each of the first plurality of pressure pulses are substantially the same magnitude within the first pressure pulse period.

7 . The method of claim 2 , further comprising using a processor in operative connection with the controller, the processor including memory with programmed instructions for defining each of the first and the second pressure pulse periods along with the first decompression period, for including a specified number of first and second pressure pulses, the frequency of the first and second pressure pulses, the time span of the first and second pressure pulse periods, and the time span of the first decompression period.

8 . The method of claim 1 , wherein the step of transferring the first pressure pulses from the inflatable balloon to the target blood vessel comprises, in each first pressure pulse, a radial expansion of the inflatable balloon and thus the applied higher pressure to the target blood vessel.

9 . The method of claim 7 , wherein the step of using the processor includes executing the programmed instructions and using the controller for increasing a 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.

10 . The method of claim 7 , 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 while breaking up calcified material of the calcified lesion.

11 . The method according to claim 1 , wherein the step of creating the first decompression period after the first pressure pulse period causes a relaxing of the blood vessel wall for mitigating blood vessel wall non-elastic deformation or blood vessel wall damage.

12 . A method for treating an at least partially calcified lesion in a target blood vessel, comprising:

introducing a balloon catheter with an angioplasty inflatable balloon within the target 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 angioplasty balloon against the target blood vessel;

using a controller over a first pressure pulse period for creating a first series of pressure pulses and thus applying a first plurality of pressure magnitudes within the first pressure pulse period to the calcified lesion with a reduced pressure period defined by and between successive magnitudes of the first plurality of pressure magnitudes, at least one pressure pulse of the first series of pressure pulses creating a pressure magnitude that is of a higher pressure than the first pressure magnitude;

transferring the first series of pressure pulses and first plurality of pressure magnitudes from the inflatable angioplasty balloon to the target blood vessel for applying the higher pressure by each first pressure pulse of the first series of pressure pulses to the target blood vessel;

reducing the pressure applied by the inflatable angioplasty balloon to the target blood vessel for a first decompression period that is longer than any reduced pressure period and after the application of the first plurality of pressure magnitudes;

using the controller over a second pressure pulse period for creating a second series of pressure pulses and thus applying a second plurality of pressure magnitudes within the second pressure pulse period to the calcified lesion, at least one pressure pulse of the second series of pressure pulses creating a pressure magnitude that is of a higher pressure than the first pressure magnitude;

transferring the second pressure pulses from the inflatable angioplasty balloon to the target blood vessel for applying pressure by each second pressure pulse of the second pressure pulse series to the target blood vessel; and

reducing the pressure applied by the inflatable angioplasty balloon to the target blood vessel for a second decompression period after the application of the second plurality of pressure magnitudes, wherein the treatment breaks up calcification of the calcified lesion, and elastically deforms the blood vessel without damaging the blood vessel.

13 . A method for treating an at least partially calcified lesion in a target blood vessel, comprising:

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 series of pressure pulses and thus applying a plurality of pressure magnitudes within the pressure pulse period to the calcified lesion with a reduced pressure period between successive magnitudes of the first plurality of pressure magnitudes, wherein the reduced pressure period has a minimum pressure that is greater than zero, and each pressure pulse of the series of pressure pulses creating a pressure magnitude that is of a higher pressure than the first pressure magnitude;

transferring the series of pressure pulses and plurality of pressure magnitudes from the inflatable balloon to the target blood vessel for applying the higher pressure by each pressure pulse of the series of pressure pulses to the target blood vessel and breaking up calcification of the calcified lesion; and

reducing the pressure applied to the target blood vessel for a first decompression period that is longer than any reduced pressure period after the application of the plurality of pressure magnitudes.

Assignments (1)

Continuity (4)

References Cited (69)