# US 11,110,288 B2 · Systems and methods for configuring a wearable medical monitoring and/or treatment device

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- Number: US 11,110,288 B2
- Document ID: US11110288B2
- Status: Granted
- Kind: B2
- Application number: 15/841,705
- Filed: 2017-12-14
- Published: 2018-05-03
- Granted: 2021-09-07
- Earliest claimed: 2012-03-02
- Assignees: ZOLL Medical Corporation
- Applicants: ZOLL Medical Corporation
- Inventors: Thomas E. Kaib
- Web page: https://patentgrep.com/patent/US11110288B2

## CPC

- A61N 1/3931: {Protecting, e.g. back-up systems}
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 80/00: ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
- A61N 1/3925: {Monitoring; Protecting}
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system including an ambulatory medical treatment device is provided. The ambulatory medical treatment device includes a memory, a treatment component configured to treat a patient, at least one processor coupled to the memory and the treatment component, a user interface component, and a system interface component. The user interface component is configured to receive an update session request and to generate the update session identifier responsive to receiving the request. The system interface component is configured to receive an encoded request including an identifier of an update session and device update information, to decode the encoded request to generate a decoded request including the device update information and the identifier of the update session, to validate the decoded request by determining that the update session identifier matches the identifier of the update session, and to apply the device update information to the ambulatory medical treatment device.

## Claims

### Claim 1

A system configured to update remote medical devices, the system comprising:
a memory storing device update information specifying one or more patient settings of an ambulatory medical treatment device configured to be worn by a patient and to provide a treatment protocol to the patient if the patient experiences a cardiac arrhythmia event treatable by one or more therapy shocks to be delivered to the patient during provision of the treatment protocol,
wherein the one or more patient settings comprise rate threshold information for identifying the cardiac arrhythmia event and energy setting information for the one or more therapy shocks to be delivered to the patient during provision of the treatment protocol if the patient experiences the cardiac arrhythmia event, the treatment protocol comprising applying the one or more therapy shocks to the patient if the patient experiences the cardiac arrhythmia event;
a network interface; and
at least one processor coupled to the memory and the network interface and configured to
receive a configuration change request to update the one or more patient settings of the ambulatory medical treatment device, the one or more patient settings defining at least a portion of the treatment protocol to be provided to the patient when the patient experiences the cardiac arrhythmia event,
receive an authorization request comprising authorization credentials for authorizing one or more updates to the one or more patient settings of the ambulatory medical treatment device,
verify the authorization credentials in the authorization request,
establish a secure communication channel with the ambulatory medical treatment device via the network interface in response to verification of the authorization credentials,
receive an authentication request comprising an identifier of an update session,
generate a configuration update request comprising
one or more updates to the one or more patient settings of the ambulatory medical treatment device, thereby defining an updated treatment protocol to be provided to the patient by the ambulatory medical treatment device if the patient experiences the cardiac arrhythmia event treatable by the one or more therapy shocks, and
the identifier of the update session,
encode the configuration update request to generate an encoded configuration update request,
transmit the encoded configuration update request to the ambulatory medical treatment device via the secure communication channel, and
receive an acknowledgement code from the ambulatory medical treatment device, the acknowledgement code comprising an indication that the ambulatory medical treatment device successfully applied the one or more updates to the one or more patient settings of the ambulatory medical treatment device so that the ambulatory medical treatment device operates according to the one or more updates to the one or more patient settings of the ambulatory medical treatment device to provide the updated treatment protocol to the patient if the patient experiences the cardiac arrhythmia event treatable by the one or more therapy shocks.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the at least one processor is configured to encode the configuration update request at least in part by encrypting the configuration update request.

### Claim 3 (depends on 1)

The system of claim 1, wherein the one or more updates to the one or more patient settings of the ambulatory medical treatment device further comprise information descriptive of device settings to be applied to the ambulatory medical treatment device.

### Claim 4 (depends on 1)

The system of claim 1, wherein the memory further stores a device identifier that uniquely identifies the ambulatory medical treatment device and the configuration update request further comprises the device identifier of the ambulatory medical treatment device.

### Claim 5 (depends on 1)

The system of claim 1, wherein the memory further stores a patient identifier that uniquely identifies a patient assigned to the ambulatory medical treatment device and the configuration update request further comprises the patient identifier.

### Claim 6 (depends on 5)

The system of claim 5, wherein the patient identifier comprises a biometric identifier that is unique to the patient.

### Claim 7 (depends on 1)

The system of claim 1, further comprising the ambulatory medical treatment device.

### Claim 8 (depends on 7)

The system of claim 7, wherein the ambulatory medical treatment device comprises
a device memory storing configuration information specifying at one or more patient settings of the ambulatory medical treatment device;
a treatment component configured to deliver the one or more therapy shocks to the patient during provision of the treatment protocol;
one or more processors coupled to the device memory and the treatment component and configured to operate the ambulatory medical treatment device as specified by the configuration information;
a user interface component executable by the one or more processors and configured to
receive a request to initiate an update session, and
generate an update session identifier responsive to receiving the request to initiate the update session; and
a system interface component executable by the one or more processors and configured to
receive the encoded configuration update request comprising an identifier of the update session and the one or more updates to the one or more patient settings of the ambulatory medical treatment device;
decode the encoded configuration update request to generate a decoded configuration update request comprising the one or more updates to the one or more patient settings of the ambulatory medical treatment device and the identifier of the update session;
validate the decoded configuration update request at least in part by determining that the update session identifier matches the identifier of the update session comprised in the decoded configuration update request; and
apply, in response to validating the decoded configuration update request, the one or more updates to the one or more patient settings of the ambulatory medical treatment device to the configuration information, thereby altering the one or more patient settings of the ambulatory medical treatment device.

### Claim 9 (depends on 8)

The system of claim 8, wherein the system interface component is configured to decode the encoded configuration update request at least in part by decrypting the encoded configuration update request.

### Claim 10 (depends on 8)

The system of claim 8, wherein the system interface component is further configured to:
detect at least one of success and failure of the update session; and
rollback any of the one or more updates to the one or more patient settings of the ambulatory medical treatment device applied in response to failure of the update session.

### Claim 11 (depends on 8)

The system of claim 8, further comprising a display coupled to the one or more processors, wherein the user interface component is further configured to:
display the update session identifier on the display; and
display an indication of at least one of success and failure of the update session on the display.

### Claim 12 (depends on 10)

The system of claim 10, wherein the device memory further stores a unique identifier of the ambulatory medical treatment device, the encoded configuration update request comprises a device identifier of the ambulatory medical treatment device, and the system interface component is configured to validate the decoded configuration update request at least in part by determining that the device identifier of the ambulatory medical treatment device comprised in the decoded configuration update request matches the unique identifier of the ambulatory medical treatment device stored in the device memory.

### Claim 13 (depends on 12)

The system of claim 12, wherein the device memory further stores a unique identifier of the patient, the encoded configuration update request further comprises a patient identifier of the patient, and the system interface component is configured to further validate the decoded configuration update request at least in part by determining that the patient identifier comprised in the decoded configuration update request matches the unique identifier of the patient stored in the device memory.

### Claim 14 (depends on 13)

The system of claim 13, wherein the patient identifier comprised in the decoded configuration update request and the unique identifier of the patient stored in the device memory comprise biometric identifiers.

### Claim 15

A method to update remote medical devices executed by a computer system comprising a memory, a network interface, and at least one processor coupled to the memory and the network interface, the memory storing device update information specifying one or more patient settings of an ambulatory medical treatment device configured to be worn by a patient and to provide a treatment protocol to the patient if the patient experiences a cardiac arrhythmia event, the method comprising:
receiving, by the at least one processor, a configuration change request to update the one or more patient settings of the ambulatory medical treatment device, the one or more patient settings defining at least a portion of the treatment protocol to be provided to the patient if the patient experiences a cardiac arrhythmia event treatable by one or more therapy shocks to be delivered to the patient during provision of the treatment protocol, wherein the one or more patient settings comprise rate threshold information for identifying the cardiac arrhythmia event and energy setting information for the one or more therapy shocks to be delivered to the patient during provision of the treatment protocol if the patient experiences the cardiac arrhythmia event, the treatment protocol comprising applying the one or more therapy shocks to the patient if the patient experiences the cardiac arrhythmia event;
receiving, by the at least one processor, an authorization request comprising authorization credentials for authorizing one or more updates to the one or more patient settings of the ambulatory medical treatment device;
verifying, by the at least one processor, the authorization credentials in the authorization request;
establishing, by the at least one processor, a secure communication channel with the ambulatory medical treatment device via the network interface in response to verification of the authorization credentials;
receiving, by the at least one processor, an authentication request comprising an identifier of an update session;
generating, by the at least one processor, a configuration update request comprising
one or more updates to the one or more patient settings of the ambulatory medical treatment device, thereby defining an updated treatment protocol to be provided to the patient by the ambulatory medical treatment device if the patient experiences the cardiac arrhythmia event treatable by the one or more therapy shocks, and
the identifier of the update session;
encoding, by the at least one processor, the configuration update request to generate an encoded configuration update request;
transmitting, by the at least one processor, the encoded configuration update request to the ambulatory medical treatment device via the secure communication channel; and
receiving, by the at least one processor, an acknowledgement code from the ambulatory medical treatment device, the acknowledgement code comprising an indication that the ambulatory medical treatment device successfully applied the one or more updates to the one or more patient settings of the ambulatory medical treatment device so that the ambulatory medical treatment device operates according to the one or more updates to the one or more patient settings of the ambulatory medical treatment device to provide the updated treatment protocol to the patient if the patient experiences the cardiac arrhythmia event treatable by the one or more therapy shocks.

### Claim 16 (depends on 15)

The method of claim 15, further comprising:
receiving, by the ambulatory medical treatment device, a request to initiate an update session;
generating, by the ambulatory medical treatment device, an update session identifier responsive to receiving the request to initiate the update session;
receiving, by the ambulatory medical treatment device, the encoded configuration update request comprising an identifier of the update session and the one or more updates to the one or more patient settings of the ambulatory medical treatment device;
decoding, by the ambulatory medical treatment device, the encoded configuration update request to generate a decoded configuration update request comprising the one or more updates to the one or more patient settings of the ambulatory medical treatment device and the identifier of the update session;
validating, by the ambulatory medical treatment device, the decoded configuration update request at least in part by determining that the update session identifier matches the identifier of the update session comprised in the decoded configuration update request; and
applying, by the ambulatory medical treatment device in response to validating the decoded configuration update request, the one or more updates to the one or more patient settings of the ambulatory medical treatment device to configuration information, thereby altering the one or more patient settings of the ambulatory medical treatment device.

### Claim 17 (depends on 15)

The method of claim 15, wherein generating the configuration update request comprises storing a device identifier that uniquely identifies the ambulatory medical treatment device within the configuration update request.

### Claim 18 (depends on 15)

The method of claim 15, wherein generating the configuration update request comprises storing a patient identifier that uniquely identifies a patient assigned to the ambulatory medical treatment device within the configuration update request.

### Claim 19

A non-transitory computer readable medium specifying one or more patient settings of an ambulatory medical treatment device configured to be worn by a patient and to provide a treatment protocol to the patient if the patient experiences a cardiac arrhythmia event, the non-transitory computer readable medium encoded with instructions executable by at least one processor to implement a process to update remote medical devices, the process comprising:
receiving a configuration change request to update the one or more patient settings of the ambulatory medical treatment device, the one or more patient settings defining at least a portion of the treatment protocol to be provided to the patient if the patient experiences a cardiac arrhythmia event treatable by one or more therapy shocks to be delivered to the patient during provision of the treatment protocol, wherein the one or more patient settings comprise rate threshold information for identifying the cardiac arrhythmia event and energy setting information for the one or more therapy shocks to be delivered to the patient during provision of the treatment protocol if the patient experiences the cardiac arrhythmia event, the treatment protocol comprising applying the one or more therapy shocks to the patient if the patient experiences the cardiac arrhythmia event;
receiving an authorization request comprising authorization credentials for authorizing one or more updates to the one or more patient settings of the ambulatory medical treatment device;
verifying the authorization credentials in the authorization request;
establishing a secure communication channel with the ambulatory medical treatment device via a network interface in response to verification of the authorization credentials;
receiving an authentication request comprising an identifier of an update session;
generating a configuration update request comprising
one or more updates to the one or more patient settings of the ambulatory medical treatment device, thereby defining an updated treatment protocol to be provided to the patient by the ambulatory medical treatment device if the patient experiences the cardiac arrhythmia event treatable by the one or more therapy shocks, and
the identifier of the update session;
encoding the configuration update request to generate an encoded configuration update request;
transmitting the encoded configuration update request to the ambulatory medical treatment device via the secure communication channel; and
receiving an acknowledgement code from the ambulatory medical treatment device, the acknowledgement code comprising an indication that the ambulatory medical treatment device successfully applied the one or more updates to the one or more patient settings of the ambulatory medical treatment device so that the ambulatory medical treatment device operates according to the one or more updates to the one or more patient settings of the ambulatory medical treatment device to provide the updated treatment protocol to the patient if the patient experiences the cardiac arrhythmia event treatable by the one or more therapy shocks.

### Claim 20 (depends on 19)

The computer readable medium of claim 19, wherein generating the configuration update request comprises storing a device identifier that uniquely identifies the ambulatory medical treatment device within the configuration update request.

### Claim 21 (depends on 1)

The system of claim 1, wherein the cardiac arrhythmia event comprises at least one of a defibrillation event and a pacing event.

### Claim 22 (depends on 21)

The system of claim 21, wherein the defibrillation event comprises at least one of a ventricular tachycardia event and a ventricular fibrillation event, and the pacing event comprises a bradycardia event.

### Claim 23 (depends on 1)

The system of claim 1, wherein the one or more updates to the one or more patient settings of the ambulatory medical treatment device further comprise updates to one or more of the rate threshold information for identifying the cardiac arrhythmia event and the energy setting information for the one or more therapy shocks to be delivered to the patient during provision of the treatment protocol.

### Claim 24 (depends on 15)

The method of claim 15, wherein the cardiac arrhythmia event comprises at least one of a defibrillation event and a pacing event.

### Claim 25 (depends on 24)

The method of claim 24, wherein the defibrillation event comprises at least one of a ventricular tachycardia event and a ventricular fibrillation event, and the pacing event comprises a bradycardia event.

### Claim 26 (depends on 15)

The method of claim 15, wherein the one or more updates to the one or more patient settings of the ambulatory medical treatment device further comprise updates to one or more of the rate threshold information for identifying the cardiac arrhythmia event and the energy setting information for the one or more therapy shocks to be delivered to the patient during provision of the treatment protocol.

### Claim 27 (depends on 19)

The computer readable medium of claim 19, wherein the cardiac arrhythmia event comprises at least one of a defibrillation event and a pacing event.

### Claim 28 (depends on 27)

The computer readable medium of claim 27, wherein the defibrillation event comprises at least one of a ventricular tachycardia event and a ventricular fibrillation event and the pacing event comprises a bradycardia event.

### Claim 29 (depends on 19)

The computer readable medium of claim 19, wherein the one or more updates to the one or more patient settings of the ambulatory medical treatment device further comprise updates to one or more of the rate threshold information for identifying the cardiac arrhythmia event and the energy setting information for the one or more therapy shocks to be delivered to the patient during provision of the treatment protocol.