IP Library Granted Patent US 12,646,612
Granted Patent B2
US 12,646,612 · App. 17/502,117 · Granted Jun 2, 2026

Early warning of LVAD thrombus formation

Inventors: Abhijit Kadrolkar (Minneapolis, MN); Robert W. Stadler (Shoreview, MN); Michael C. Brown (Dresher, PA)
Assignee: BOSTON SCIENTIFIC SCIMED, INC.
G16H40/63A61M60/148A61M60/178A61M60/216A61M60/422A61M60/508A61M60/585A61M2205/18A61M2205/3327A61M2205/50
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Quick Facts
Patent No.
US 12,646,612
App. No.
17/502,117
Granted
Jun 2, 2026
Kind
B2
Abstract

A method of determining an adverse event within a patient having an implantable blood pump including calculating a plurality of power consumption trends of the blood pump during a plurality of time periods using a low-pass filter, determining a plurality of power trend differences between the plurality of power consumption trends, calculating a total amount of the plurality of power trend differences during a time interval, and generating an alarm when the total amount of the plurality of power trend differences exceeds a pre-determined threshold.

Claims (46)

1 . A mechanical circulatory support system, the system comprising:

an implantable blood pump device comprising a motor, the implantable blood pump device being configured to cause blood flow in a patient; and

a controller device, in communication with the implantable blood pump device, the controller comprising a memory and processing circuitry configured to:

control the implantable blood pump device to operate the motor;

determine a first plurality of power consumption trends of the implantable blood pump device, while the motor is operating, using a first low-pass filter

determine a second plurality of power consumption trends of the implantable blood pump device, while the motor is operating, using a second low-pass filter;

determine a plurality of power trend differences, wherein each power trend difference of the plurality of power trend differences comprises a difference between a value of the first plurality of power consumption trends and a corresponding value of the second plurality of power consumption trends, wherein the value of the first plurality of power consumption trends is determined based on a first filter interval and the corresponding value of the second plurality of power consumption trends is determined based on a second filter interval that is greater in duration than the first filter interval;

determine an accumulation value based on an accumulation of the power trend differences during a time interval using an integrator; and

generate an alarm in response to the accumulation value exceeding a pre-determined threshold, wherein the alarm indicates an adverse event associated with the implantable blood pump device in the patient, the adverse event including one of a presence of thrombus, an occlusion in the patient, a gastrointestinal bleed in the patient, or an ingestion.

2 . The system of claim 1 , wherein:

to determine the first plurality of power consumption trends, the processing circuitry is configured to determine a short-term trend using the first low-pass filter; and

to determine the second plurality of power consumption trends, the processing circuitry is configured to determine a long-term trend using the second low-pass filter.

3 . The system of claim 1 , wherein the plurality of power trend differences comprise one or more of differences between a long term current average and a short term current average, differences between a long term voltage average and a short term voltage average, differences between a long term back electromotive force average and a short term back electromotive force average, or differences between a long term power consumption average and a short term power consumption average.

4 . The system of claim 1 , wherein the first low-pass filter comprises a first moving average filter for determining a first moving average and the second low-pass filter comprises a second moving average filter for determining a second moving average, wherein the second moving average is longer than the first moving average.

5 . The system of claim 1 , wherein the second low-pass filter has a cutoff frequency lower than a cutoff frequency of the first low-pass filter.

6 . The system of claim 1 , wherein the processing circuitry is further configured to determine the pre-determined threshold using a percentage of at least one power consumption trend of the second plurality of power consumption trends.

7 . The system of claim 1 , wherein the processing circuitry is configured to determine the pre-determined threshold as a patient-specific baseline based on the second low-pass filter.

8 . The system of claim 1 , wherein the processing circuitry is further configured to:

determine an expected power of the implantable blood pump device for a selected speed of the implantable blood pump device;

determine a speed-dependent threshold using the expected power;

determine a real-time pump power for the implantable blood pump device while the motor is operating at the selected speed;

compare the speed-dependent threshold to the real-time pump power; and

generate a second alarm in response to the real-time pump power exceeding the speed-dependent threshold.

9 . The system of claim 8 , wherein the processing circuitry is further configured to multiply the expected power by a percentage to determine the speed-dependent threshold.

10 . The system of claim 8 , wherein the speed-dependent threshold includes an upper limit and a lower limit relative to the expected power.

11 . The system of claim 1 , wherein the implantable blood pump device comprises an electromagnetic device.

12 . The system of claim 1 , wherein the implantable blood pump device comprises an implantable ventricular assist device.

13 . A method of determining an adverse event within a patient having an implantable blood pump, the implantable blood pump comprising a motor and being configured to cause blood flow in the patient, the method comprising:

controlling, by processing circuitry, the implantable blood pump to operate the motor;

determining, by the processing circuitry, a first plurality of power consumption trends of the implantable blood pump, while the motor is operating, using a first low-pass filter;

determining a second plurality of power consumption trends of the implantable blood pump, while the motor is operating, using a second low-pass filter;

determining a plurality of power trend differences between the plurality of power consumption trends, wherein each power trend difference of the plurality of power trend differences comprises a difference between a value of the first plurality of power consumption trends and a corresponding value of the second plurality of power consumption trends, wherein the value of the first plurality of power consumption trends is determined based on a first filter interval and the corresponding value of the second plurality of power consumption trends is determined based on a second filter interval that is greater in duration than the first filter interval;

determining an accumulation value based on an accumulation of the power trend differences during a time interval using an integrator; and

generating an alarm in response to the accumulation value exceeding a pre-determined threshold, wherein the alarm indicates an adverse event associated with the implantable blood pump in the patient, the adverse event including one of a presence of thrombus, an occlusion in the patient, a gastrointestinal bleed in the patient, or an ingestion.

14 . The method of claim 13 , wherein

determining the first plurality of power consumption trends of the implantable blood pump using the first low-pass filter comprises determining a short-term trend using the first low-pass filter; and

determining the second plurality of power consumption trends of the implantable blood pump using the second low-pass filter comprises determining a long-term trend using the second low-pass filter.

15 . The method of claim 13 , wherein the first low-pass filter comprises a first moving average filter defining a first moving average and the second low-pass filter comprises a second moving average filter defining a second moving average, wherein the second moving average is longer than the first moving average.

16 . The method of claim 13 , wherein the second low-pass filter has a cutoff frequency lower than a cutoff frequency of the first low-pass filter.

17 . The method of claim 13 , further comprising:

determining the pre-determined threshold using a percentage of at least one power consumption trend of the second plurality of power consumption trends.

18 . The method of claim 13 , further comprising:

determining an expected power of the implantable blood pump for a selected speed of the implantable blood pump;

determining a speed-dependent threshold using the expected power;

determining a real-time pump power for the implantable blood pump at the selected speed; comparing the speed-dependent threshold to the real-time pump power; and

generating a second alarm in response to the real-time pump power exceeding the speed-dependent threshold.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 19, 2024
From: HEARTWARE, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 069520/0137 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 15, 2021
From: KADROLKAR, ABHIJIT; STADLER, ROBERT W.; BROWN, MICHAEL C.
To: HEARTWARE, INC.
Reel/Frame 057801/0711 →
Continuity (3)
Continuation 16248888 · Jan 16, 2019
Provisional Application 62622488 · Jan 26, 2018
Related Publication 20220032035A1 · Feb 3, 2022
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