# US 10,946,202 B2 · Communications in a medical device system with link quality assessment

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- Number: US 10,946,202 B2
- Document ID: US10946202B2
- Status: Granted
- Kind: B2
- Application number: 16/247,304
- Filed: 2019-01-14
- Published: 2019-05-16
- Granted: 2021-03-16
- Earliest claimed: 2015-03-18
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Keith R. Maile; Brendan E. Koop; Brian L. Schmidt; Michael J. Kane; Jacob M. Ludwig; Jeffrey E. Stahmann; Lance E. Juffer
- Web page: https://patentgrep.com/patent/US10946202B2

## CPC

- A61N 1/37288: {Communication to several implantable medical devices within one patient}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/0028: {Body tissue as transmission medium, i.e. transmission systems where the medium is the human body}
- A61B 5/02: Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/08: Measuring devices for evaluating the respiratory organs
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 5/6869: {Heart}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- H04B 13/005: {Transmission systems in which the medium consists of the human body}
- A61N 1/37205: {Microstimulators, e.g. implantable through a cannula}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 1/3727: {characterised by the modulation technique}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H04B: TRANSMISSION

## Abstract

Methods and devices for testing and configuring implantable medical device systems. A first medical device and a second medical device communicate with one another using test signals configured to provide data related to the quality of the communication signal to facilitate optimization of the communication approach. Some methods may be performed during surgery to implant one of the medical devices to ensure adequate communication availability.

## Claims

### Claim 1

A method of configuring communication between implantable medical devices comprising:
in a first medical device having a plurality of electrodes configured for outputting a conducted signal, generating a first conducted signal using a selected pair of electrodes;
in a second medical device, receiving and analyzing the first conducted signal;
in the second medical device, communicating a second signal related to an outcome of the analysis of the first conducted signal while the first conducted signal is being received.

### Claim 2 (depends on 1)

A method as in claim 1 further comprising receiving the second signal in the first medical device while the first conducted signal is still being generated.

### Claim 3 (depends on 2)

The method of claim 2 wherein the second signal is a conducted signal received by the first medical device using a different pair of electrodes than the pair used for generating the first conducted signal.

### Claim 4 (depends on 1)

The method of claim 1 further comprising receiving the second signal with an external device configured for communication with at least one of the first medical device and the second medical device.

### Claim 5 (depends on 4)

The method of claim 4 wherein:
the second medical device analyzes the first conducted signal and calculates communication metrics of the first conducted signal as received by the second medical device;
the second signal encodes data related to the communication metrics of the first conducted signal as received by the second medical device; and
the external device is configured to provide real time feedback to a user related to the communication metrics.

### Claim 6 (depends on 5)

The method of claim 5 wherein the external device provides real time feedback in the form of a message indicating adjustment of positioning of at least one of the first or second medical devices is desired.

### Claim 7 (depends on 1)

The method of claim 1 wherein the first and second medical devices are each leadless cardiac pacemakers.

### Claim 8 (depends on 1)

The method of claim 1 wherein the first medical device is a leadless cardiac pacemaker, and the second medical device is an implantable cardioverter defibrillator.

### Claim 9

A method of configuring communication between implantable medical devices during an implantation procedure of a first medical device in a patient in whom a second medical device is already implanted, the method comprising:
during an implantation procedure for the first medical device, testing communication between the first medical device and the second medical device;
determining that communication is suboptimal; and
in response to determining that communication is suboptimal, adjusting an orientation of the first medical device.

### Claim 10 (depends on 9)

The method of claim 9 wherein at least one of the first medical device and the second medical device is configured for communication with an external programmer, the method further comprising obtaining a feedback signal from the external programmer which indicates in real time a quality of a communication link between the first medical device and the second medical device.

### Claim 11 (depends on 9)

The method of claim 9 wherein the first medical device is a leadless cardiac pacemaker and the second medical device is an implantable cardioverter defibrillator.

### Claim 12 (depends on 9)

The method of claim 9 wherein the first medical device is a leadless cardiac pacemaker (LCP) which is implanted by advancing an implantation catheter to a desired location and then securing the LCP at the desired location and decoupling the implantation catheter from the LCP, wherein the step of testing communication is performed while the LCP is coupled to the implantation catheter and before the LCP is secured at the desired location.

### Claim 13 (depends on 9)

The method of claim 9 wherein the step of testing communication between the first medical device and the second medical device comprises:
the first medical device generating a first conducted signal using a selected pair of electrodes;
the second medical device receiving the first conducted signal;
the second medical device calculating communication metrics based on the first conducted signal; and
the second medical device communicating the calculated communication metrics to an external programmer.

### Claim 14 (depends on 9)

The method of claim 9 wherein the step of testing communication between the first medical device and the second medical device comprises:
generating a first conducted signal from the first medical device to the second medical device comprising an output pattern for a selected period; and
receiving the conducted signal by the second medical device and calculating a first communication metric of the first conducted signal as received;
wherein the selected period exceeds an expected or detected length of a recurring biological cycle.

### Claim 15 (depends on 9)

The method of claim 9 wherein the first and second medical devices are each leadless cardiac pacemakers.

### Claim 16

A method of operation in an implantable medical device system comprising an external programmer and first implantable medical device and a second implantable medical device, the method being configured for communication quality monitoring during a procedure to implant the second medical device while the first medical device is already implanted, the method comprising:
the first medical device generating a communication test signal prior to completion of placement of the second medical device during the procedure to implant the second medical device;
the second medical device receiving and analyzing the communication test signal from the first medical device;
the second medical device generating an output indicating a quality of the communication test signal as received;
the programmer providing an indication to a physician performing the implantation procedure related to the quality of the communication test signal as received by the second medical device.

### Claim 17 (depends on 16)

The method of claim 16 wherein the step of the second medical device generating an output indicating a quality of the communication test signal comprises the second medical device communicating to the programmer in real time, such that the step of the programmer providing an indication is performed in real time.

### Claim 18 (depends on 16)

The method of claim 16 wherein the step of the second medical device generating an output indicating a quality of the communication test signal comprises the second medical device communicating back to the first medical device and the first medical device communicating to the programmer to facilitate the programmer providing the indication to the physician.

### Claim 19 (depends on 16)

The method of claim 16 wherein the first and second medical devices are each leadless cardiac pacemakers.

### Claim 20 (depends on 16)

The method of claim 16 wherein the first medical device is a subcutaneous implantable cardioverter defibrillator and the second medical device is a leadless cardiac pacemaker.
