IP Library › Granted Patent US 11,413,445
Granted Patent B2
US 11,413,445 · App. 16/809,731 · Granted Aug 16, 2022

Method of monitoring health conditions of a patient having an implantable blood pump

Inventors: Michael Brown (Dresher, PA); Amy B. Cheng (Columbia, MD); Veronica Ramos (Homestead, FL); Neethu Lekshmi Vasudevan Jalaja (Miami, FL); Alonso Trejo-Mora (Lansdale, PA)
Assignee: HEARTWARE, INC.
A61M60/50A61M60/148A61M60/562A61M2205/18A61M2205/3334A61M2205/50
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Quick Facts
Patent No.
US 11,413,445
App. No.
16/809,731
Granted
Aug 16, 2022
Kind
B2
Abstract

A method of predicting an adverse event in a patient having an implantable blood pump including correlating a pulsatility value to a flow trough value associated with the blood pump to determine a flow peak value; dividing the determined flow peak value by a pump current to determine a pulsatility peak value; tracking a first moving average of the pulsatility peak value, the first moving average defining a threshold range; tracking a second moving average of the pulsatility peak value, the second moving average being faster than the first moving average; and generating an alert when the second moving average deviates from the threshold range.

Claims (60)

1. A method of predicting an adverse event in a patient having an implantable blood pump, the method comprising:

correlating a pulsatility value to a flow trough value associated with the blood pump to determine a flow peak value;

dividing the determined flow peak value by a pump current to determine a pulsatility peak value;

tracking a first moving average of the pulsatility peak value, the first moving average defining a threshold range;

tracking a second moving average of the pulsatility peak value, the second moving average being faster than the first moving average; and

generating an alert when the second moving average deviates from the threshold range.

2. The method of claim 1 , further comprising recording a plurality of alert occurrences over a time period, and based on the plurality of alert occurrences, determining a risk factor associated with a predicted onset of the adverse event.

3. The method of claim 2 , further comprising, based on the determined risk factor, automatically classifying a patient's physiological state among a ranking system.

4. The method of claim 1 , further comprising determining a standard deviation of the first moving average, the first moving average and the standard deviation defining the threshold range.

5. The method of claim 1 , wherein the first moving average is a twenty-four-hour moving average and the second moving average is approximately a two-hour duration.

6. A system of predicting an adverse event in a patient having an implantable blood pump, the system comprising:

the blood pump; and

a processor in communication with the blood pump, the processor having process circuitry configured to:

correlate a pulsatility value to a flow trough value associated with the blood pump to determine a flow peak value;

divide the determined flow peak value by a pump current to determine a pulsatility peak value;

track a first moving average of the pulsatility peak value, the first moving average defining a threshold range;

track a second moving average of the pulsatility peak value, the second moving average being faster than the first moving average; and

generate an alert when the second moving average deviates from the threshold range.

7. The system of claim 6 , wherein the process circuitry is configured to record a plurality of alert occurrences over a time period, and based on the plurality of alert occurrences, determine a risk factor associated with a predicted onset of the adverse event.

8. A method of predicting an adverse event in a patient having an implantable blood pump, the method comprising:

tracking an average pulsatility value associated with the blood pump;

tracking a plurality of parameters associated with the blood pump, the plurality of parameters including an average flow trough value, an average flow value, and a standard flow trough deviation value, the standard flow trough deviation value being measured with respect to the average flow trough value;

correlating the average pulsatility value to the plurality of parameters;

determining an adverse event index value using the correlated average pulsatility value relative to the plurality of parameters;

comparing the adverse event index value to a predetermined threshold range; and

generating an alert when the compared adverse event index value deviates from the predetermined threshold range.

9. The method of claim 8 , further comprising correlating the average pulsatility value to a scaling coefficient.

10. The method of claim 8 , further comprising correlating the standard flow trough deviation value to an offset value.

11. The method of claim 8 , further comprising determining a plurality of adverse event index values during a plurality of time periods, comparing the plurality of adverse event index values to each other, and based on the compared plurality of adverse event index values, classifying a patient's physiological state among a ranking system.

12. The method of claim 8 , wherein the average pulsatility value and the plurality of parameters associated with the blood pump are expressed as a waveform, and the adverse event index value exceeding the predetermined threshold range is expressed as an abnormal feature of the waveform.

13. A system of predicting an adverse event in a patient having an implantable blood pump, the system comprising:

the blood pump; and

a processor in communication with the blood pump, the processor having process circuitry configured to:

track an average pulsatility value associated with the blood pump;

track a plurality of parameters associated with the blood pump, the plurality of parameters including an average flow trough value, an average flow value, and a standard flow trough deviation value, the standard flow trough deviation value being measured with respect to the average flow value;

correlate the average pulsatility value to the plurality of parameters;

determine an adverse event index value using the correlated average pulsatility value relative to the plurality of parameters;

compare the adverse event index value to a predetermined threshold range; and

generate an alert when the compared adverse event index value deviates from the predetermined threshold range.

14. A method of predicting an adverse event in a patient having an implantable blood pump, the method comprising:

identifying a flow trough value associated with the blood pump during use;

comparing the flow trough value to a standard deviation flow value and an average flow value;

determining a flow trough index value using the compared flow trough value to the standard deviation flow value and the average flow value; and

generating an alert when the flow trough index value deviates from a predetermined threshold range.

15. The method of claim 14 , further comprising, based on the determined flow trough index value, quantifying a suction prevalence associated with the blood pump.

16. The method of claim 14 , further comprising determining a plurality of flow trough index values, and based on the determined plurality of flow trough index values, quantifying a suction prevalence associated with the blood pump.

17. The method of claim 16 , further comprising, based on the suction prevalence, classifying a patient's physiological state among a ranking system.

18. The method of claim 14 , further comprising:

determining a presence of a negative flow trough value relative to a flow scale,

if the negative flow trough value is present, correlating the flow trough value to a constant, and

following correlating the flow trough value to the constant, determining the flow trough index value.

19. The method of claim 18 , further comprising multiplying the flow trough index value by a corrective factor.

20. The method of claim 14 , further comprising dividing the standard deviation flow value and the average flow value.

21. A system of predicting an adverse event in a patient having an implantable blood pump, the system comprising:

the blood pump; and

a processor in communication with the blood pump, the processor having process circuitry configured to:

identify a flow trough value associated with the blood pump during use;

compare the flow trough value to a standard deviation flow value and an average flow value;

determine a flow trough index value using the compared flow trough value to the standard deviation flow value and the average flow value; and

generate an alert when the flow trough index value deviates from a predetermined threshold range.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2020
From: BROWN, MICHAEL; CHENG, AMY B.; RAMOS, VERONICA; VASUDEVAN JALAJA, NEETHU LEKSHMI; TREJO-MORA, ALONSO
To: HEARTWARE, INC.
Reel/Frame 052023/0100 →
Continuity (2)
Provisional Application 62816957 · Mar 12, 2019
Related Publication 20200289730A1 · Sep 17, 2020
Cited By (17)
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