# US 10,765,790 B2 · Detection of pump thrombosis

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- Number: US 10,765,790 B2
- Document ID: US10765790B2
- Status: Granted
- Kind: B2
- Application number: 15/969,030
- Filed: 2018-05-02
- Published: 2019-08-22
- Granted: 2020-09-08
- Earliest claimed: 2018-02-20
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Aleksandre T. Sambelashvili; David A. Anderson; James K. Carney; David M. Steinhaus; Narendra K. Simha
- Web page: https://patentgrep.com/patent/US10765790B2

## CPC

- A61M 5/172: electrical or electronic
- A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines
- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- 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
- A61M 60/232: Centrifugal pumps
- A61M 60/237: the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
- A61M 60/279: Peristaltic pumps, e.g. roller pumps
- A61M 60/30: Medical purposes thereof other than the enhancement of the cardiac output
- A61M 60/422: the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
- A61M 60/515: Regulation using real-time patient data
- A61M 60/538: Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M 60/585: User interfaces
- A61M 60/857: Implantable blood tubes
- A61M 2205/18: with alarm
- A61M 2205/3303: Using a biosensor
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3507: with implanted devices, e.g. external control
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 6)

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

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 1)

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

### Claim 16 (depends on 15)

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

### Claim 17 (depends on 1)

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.

### Claim 18 (depends on 17)

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.

### Claim 19 (depends on 17)

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.

### Claim 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.

### Claim 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.

### Claim 22 (depends on 21)

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.

### Claim 23 (depends on 21)

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.

### Claim 24 (depends on 21)

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.

### Claim 25 (depends on 21)

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.

### Claim 26 (depends on 21)

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.

### Claim 27 (depends on 26)

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.

### Claim 28 (depends on 26)

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

### Claim 29 (depends on 21)

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

### Claim 30 (depends on 21)

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

### Claim 31 (depends on 21)

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

### Claim 32 (depends on 21)

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

### Claim 33 (depends on 21)

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.

### Claim 34 (depends on 33)

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

### Claim 35 (depends on 21)

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

### Claim 36 (depends on 35)

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.

### Claim 37 (depends on 21)

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.

### Claim 38 (depends on 37)

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.

### Claim 39 (depends on 37)

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.

### Claim 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.

### Claim 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.