IP Library › Granted Patent US 12,337,164
Granted Patent B2
US 12,337,164 · App. 17/405,553 · Granted Jun 24, 2025

HVAD flow pulsatility tracker

Inventors: Veronica Ramos (Homestead, FL); Neethu Lekshmi Vasudevan Jalaja (Miami, FL); Michael Brown (Dresher, PA)
Assignee: HeartWare, Inc.
A61M60/546A61M60/178A61M60/232G05B23/027G16H40/67G16H50/30G16H50/70A61M2205/18A61M2205/702G16H10/60
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Quick Facts
Patent No.
US 12,337,164
App. No.
17/405,553
Granted
Jun 24, 2025
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 (39)

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

at least one from the group consisting of:

(a) estimating a flow rate of blood exiting the implantable blood pump;

(b) measuring a flow pulsatility of blood exiting the implantable blood pump; and

(c) measuring a trough of a flow pulsatility waveform of blood exiting the implantable blood pump;

comparing the at least one from the group consisting of (a), (b), and (c) against a predetermined threshold, the predetermined threshold being an average flow rate, pulsatility, or trough based on a predetermined population of patients with implantable blood pumps experiencing substantially no adverse events; and

generating an alert if at least one from the group consisting of (a), (b), and (c) deviates from the respective predetermined threshold by a predetermined amount.

2. The method of claim 1 , wherein the predetermined amount is at least one standard deviation.

3. The method of claim 2 , wherein the alert is indicative of sub-optimal performance.

4. The method of claim 1 , wherein the predetermined amount is at least two standard deviations.

5. The method of claim 4 , wherein the alert is indicative of an adverse event.

6. The method of claim 5 , wherein the adverse event is suction.

7. The method of claim 1 , wherein the implantable blood pump is a centrifugal blood pump.

8. The method of claim 1 , wherein (a), (b), and (c) are recorded in a log-file, and wherein comparing the at least one from the group consisting of (a), (b), and (c) against the threshold includes comparing the recorded log-file against the predetermined threshold.

9. The method of claim 1 , wherein (a), (b), and (c) are measured or estimated in real-time, and wherein comparing the at least one from the group consisting of (a), (b), and (c) against the threshold includes comparing the real-time estimation or measurement of (a), (b), and (c) against the predetermined threshold.

10. The method of claim 1 , wherein the predetermined population of patients with implantable blood pumps experiencing substantially no adverse events each had implanted a same model implantable blood pump.

11. A system for predicting an adverse event in a patient having an implantable blood pump, comprising:

a controller having processing circuitry in communication with the implantable blood pump and being configured to:

at least one from the group consisting of:

(a) estimate a flow rate of blood exiting the implantable blood pump;

(b) measure a flow pulsatility of blood exiting the implantable blood pump; and

(c) measure a trough of a flow pulsatility waveform of blood exiting the implantable blood pump;

compare the at least one from the group consisting of (a), (b), and (c) against a predetermined threshold, the predetermined threshold being an average flow rate, pulsatility, or trough based on a predetermined population of patients with implantable blood pumps experiencing substantially no adverse events; and

generate an alert if at least one from the group consisting of (a), (b), and (c) deviates from the respective predetermined threshold by a predetermined amount.

12. The system of claim 11 , wherein the predetermined amount is at least one standard deviation.

13. The system of claim 12 , wherein the alert is indicative of sub-optimal performance.

14. The system of claim 11 , wherein the predetermined amount is least two standard deviations.

15. The system of claim 14 , wherein the alert is indicative of an adverse event.

16. The system of claim 15 , wherein the adverse event is suction.

17. The system of claim 11 , wherein (a), (b), and (c) are recorded in a log-file, and wherein the controller being configured to compare the at least one from the group consisting of (a), (b), and (c) against the threshold includes the controller being configured to compare the recorded log-file against the predetermined threshold.

18. The system of claim 11 , wherein (a), (b), and (c) are measured or estimated in real-time by the controller, and wherein the controller being configured to compare the at least one from the group consisting of (a), (b), and (c) against the threshold includes the controller being configured to compare the real-time estimation or measurement of (a), (b), and (c) against the predetermined threshold.

19. The system of claim 11 , wherein the predetermined population of patients with implantable blood pumps experiencing substantially no adverse events each had implanted a same model implantable blood pump.

20. A system for predicting an adverse event in a patient having an implantable blood pump, comprising:

a controller having processing circuitry in communication with the implantable blood pump and being configured to:

(a) estimate a flow rate of blood exiting the implantable blood pump;

(b) measure a flow pulsatility of blood exiting the implantable blood pump; and

(c) measure a trough of a flow pulsatility waveform of blood exiting the implantable blood pump;

compare (a), (b), and (c) against a predetermined threshold, the predetermined threshold being an average flow rate, pulsatility, and trough based on a predetermined population of patients with a same model implantable blood pump experiencing substantially no adverse events; and

generate an alert if (a), (b), and (c) deviates from the predetermined threshold by at least one standard deviation, the alert being indicative of suction.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2021
From: RAMOS, VERONICA; VASUDEVAN JALAJA, NEETHU LEKSHMI; BROWN, MICHAEL
To: HEARTWARE, INC.
Reel/Frame 057216/0556 →
Continuity (3)
Continuation In Part 16809731 · Mar 5, 2020
Provisional Application 62816957 · Mar 12, 2019
Related Publication 20210379361A1 · Dec 9, 2021
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