Detection of pump thrombosis

• US 10,765,790 B2
• Filed: 05/02/2018
• Issued: 09/08/2020
• Est. Priority Date: 02/20/2018
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sambelashvili, Aleksandre T., Anderson, David A., Carney, James K., Steinhaus, David M., Simha, Narendra K.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/969,030
• Publication Number:
  US 20190255235A1
• Time in Patent Office: 860 Days
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/279 Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/30 Medical purposes thereof other than the enhancement of the cardiac output
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/585 : User interfaces
• CPC Class Codes: A61M 60/857 : Implantable blood tubes

Abstract

An example pump thrombosis detection system includes a transducer and processing circuitry. The transducer may be configured to generate a signal representative of a mechanical wave from a mechanical circulatory support device. The processing circuitry is communicatively coupled to the transducer. The processing circuitry may be configured to determine an indication of pump thrombosis based on the signal and, based on the indication of pump thrombosis, control the pump thrombosis detection system to at least one of generate an alert or initiate an intervention.

Claims

1. A pump thrombosis detection system comprising:

a transducer configured to generate a signal representative of a mechanical wave from a mechanical circulatory support device; and

processing circuitry communicatively coupled to the transducer, wherein the processing circuitry is configured to;

identify a first portion of the signal representative of at least one harmonic of the mechanical wave,

normalize, based on a second portion of the signal, the first portion,

determine, based on the normalized first portion, an indication of pump thrombosis, and

based on the indication of pump thrombosis, control the pump thrombosis detection system to at least one of generate an alert or initiate an intervention.

2. The system of claim 1, wherein the pump thrombosis detection system further comprises a user interface communicatively coupled to the processing circuitry, wherein the user interface is configured to display the alert to a user, wherein the alert comprises the indication of pump thrombosis.

3. The system of claim 1, wherein, to initiate the intervention, the processing circuitry is configured to control an operational state of the mechanical circulatory support device.

4. The system of claim 1, wherein the intervention comprises thrombolytic agent delivery, wherein the pump thrombosis detection system further comprises a drug delivery device, and wherein the processing circuitry is further configured to control the drug delivery device to deliver the thrombolytic agent.

5. The system of claim 1, wherein the transducer is configured to be implanted in a patient in a position remote from the mechanical circulatory support device.

6. The system of claim 1, wherein the transducer is one of within or coupled to an implantable medical device remote from the mechanical circulatory support device.

7. The system of claim 6, wherein the implantable medical device comprises at least one of a pacemaker, an implantable cardioverter-defibrillator, insertable cardiac monitor, or a cardiac resynchronization therapy device.

8. The system of claim 6, wherein the processing circuitry comprises processing circuitry of the implantable medical device.

9. The system of claim 1, wherein the processing circuitry comprises processing circuitry of a remote server system.

10. The system of claim 1, wherein the transducer is within or coupled to an externally-wearable device or portable device.

11. The system of claim 1, wherein the mechanical wave is an acoustic wave or a vibration generated by the mechanical circulatory support device.

12. The system of claim 1, wherein the transducer comprises an electromagnetic transducer, an electrostatic transducer, capacitive micromachined transducer, or a piezoelectric transducer.

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

determine at least one feature of the first portion of the signal; and

compare the at least one feature to a threshold value.

14. The system of claim 13, wherein the at least one feature comprises the at least one harmonic of the mechanical wave.

15. The system of claim 1, wherein the at least one harmonic comprises the third harmonic of the mechanical wave.

16. The system of claim 15, wherein the processing circuitry is further configured to normalize the third harmonic based on at least one different harmonic.

17. The system of claim 1, wherein the transducer is further configured to generate a second signal representative of a baseline mechanical wave of the mechanical circulatory assist device without pump thrombosis.

18. The system of claim 17, wherein the processing circuitry is configured to determine the indication of pump thrombosis based on the signal and the second signal.

19. The system of claim 17, wherein the processing circuitry is further configured to:

determine a threshold based on the second signal; and

determine the indication of pump thrombosis based on the signal and the threshold.

20. A pump thrombosis detection system comprising:

a transducer configured to generate a signal representative of a mechanical wave from a mechanical circulatory support device, wherein the transducer is one of within or coupled to an implantable medical device remote from the mechanical circulatory support device;

processing circuitry communicatively coupled to the transducer, wherein the processing circuitry is configured to;

identify a first portion of the signal representative of at least one harmonic of the mechanical wave,

normalize, based on a second portion of the signal, the first portion of the signal, and

determine, based on the normalized first portion, an indication of pump thrombosis; and

a user interface communicatively coupled to the processing circuitry, wherein the user interface is configured to alert a user of the indication of pump thrombosis.

21. A method of detecting pump thrombosis comprising:

receiving, by processing circuitry communicatively coupled to a transducer, a signal representative of a mechanical wave generated by a mechanical circulatory support device;

identifying, by the processing circuitry, a first portion of the signal representative of at least one harmonic of the mechanical wave;

normalizing, by the processing circuitry, based on a second portion of the signal, the first portion;

determining, by the processing circuitry, based on the normalized first portion, an indication of pump thrombosis; and

based on the indication of the pump thrombosis, at least one of alerting, by a user interface communicatively coupled to the processing circuitry, a user of the indication of pump thrombosis or initiating an intervention.

22. The method of claim 21, wherein alerting the user comprises displaying on a display of the user interface an alert comprising the indication of pump thrombosis.

23. The method of claim 21, wherein the initiating the intervention comprises controlling, by the processing circuitry, an operational state of the mechanical circulatory support device.

24. The method of claim 21, wherein the initiating the intervention comprises controlling, by the processing circuitry, a drug delivery device to deliver a thrombolytic agent.

25. The method of claim 21, wherein the transducer is configured to be implanted in a patient in a position remote from the mechanical circulatory support device.

26. The method of claim 21, wherein the transducer is one of within or coupled to an implantable medical device remote from the mechanical circulatory support device.

27. The method of claim 26, wherein the implantable medical device comprises at least one of a pacemaker, an implantable cardioverter-defibrillator, insertable cardiac monitor, or a cardiac resynchronization therapy device.

28. The method of claim 26, wherein the processing circuitry comprises processing circuitry of the implantable medical device.

29. The method of claim 21, wherein the processing circuitry comprises processing circuitry of a remote server system.

30. The method of claim 21, wherein the transducer is within or coupled to an externally-wearable device or portable device.

31. The method of claim 21, wherein the mechanical wave is an acoustic wave or a vibration generated by the mechanical circulatory support device.

32. The method of claim 21, wherein the transducer comprises an electromagnetic transducer, an electrostatic transducer, capacitive micromachined transducer, or a piezoelectric transducer.

33. The method of claim 21, wherein determining the indication of pump thrombosis comprises:

determining, by the processing circuitry, at least one feature of the first portion of the signal; and

comparing the at least one feature to a threshold value.

34. The method of claim 33, wherein the at least one feature comprises the at least one harmonic of the mechanical wave.

35. The method of claim 21, wherein the at least one harmonic comprises the third harmonic of the mechanical wave.

36. The method of claim 35, wherein normalizing the first portion comprises normalizing, by the processing circuitry, the third harmonic based on at least one different harmonic.

37. The method of claim 21, wherein the method further comprises receiving, by the processing circuitry communicatively coupled to the transducer, a second signal representative of a baseline mechanical wave of the mechanical circulatory assist device without pump thrombosis.

38. The method of claim 37, wherein determining the indication of pump thrombosis comprises determining, by the processing circuitry, the indication of pump thrombosis based on the signal and the second signal.

39. The method of claim 37, wherein determining the indication of pump thrombosis comprises:

determining, by the processing circuitry, a threshold based on the second signal; and

determining, by the processing circuitry, the indication of pump thrombosis based on the signal and the threshold.

40. A medical device system comprising:

means to receive, by processing circuitry communicatively coupled to a transducer, a signal representative of a mechanical wave generated by a mechanical circulatory support device;

means to identify, by the processing circuitry, a first portion of the signal representative of at least one harmonic of the mechanical wave,

means to normalize, by the processing circuitry, based on a second portion of the signal, the first portion of the signal,

means to determine, by the processing circuitry, based on the normalized first portion, an indication of pump thrombosis; and

means to, based on the indication of the pump thrombosis, at least one of alert, by a user interface communicatively coupled to the processing circuitry, a user of the indication of pump thrombosis or initiate an intervention.

41. A non-transitory computer-readable storage medium comprising instructions that, when executed by processing circuitry of a medical device system, cause the processing circuitry to:

receive, by the processing circuitry communicatively coupled to a transducer, a signal representative of a mechanical wave generated by a mechanical circulatory support device;

identify a first portion of the signal representative of at least one harmonic of the mechanical wave;

normalize, based on a second portion of the signal, the first portion;

determine, based on the normalized first portion, an indication of pump thrombosis based on the signal; and

based on the indication of the pump thrombosis, at least one of alert, by a user interface communicatively coupled to the processing circuitry, a user of the indication of pump thrombosis or initiate an intervention.