Remote access for ambulatory medical device

• US 10,426,342 B2
• Filed: 03/31/2017
• Issued: 10/01/2019
• Est. Priority Date: 03/31/2016
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Hresko, Patrick, Pavel, Trisha A., Mason, Zachary D., Volpe, Shane S.
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/475,282
• Publication Number:
  US 20170296056A1
• Time in Patent Office: 914 Days
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

An ambulatory medical device includes a sensor configured to acquire a signal indicative of a physiological condition of a patient, a controller operatively coupled to the sensor and configured to monitor the physiological signal, and to perform a diagnostic test, and a remote access manager operatively coupled to the controller and configured to monitor for a command from a remote system to perform the diagnostic test, and to cause the controller to perform the diagnostic test in response to the command. In the device, the remote access manager may be further configured to transmit data representing an operational status of the ambulatory medical device to the remote system. The operational status of the controller may result from performing the diagnostic test. The remote access manager may be further configured to send the data representing the operational status of the ambulatory medical device in real time or substantially in real time.

Claims

1. An external ambulatory medical device comprising:

an electrocardiogram (ECG) sensor configured

to couple to a skin of a patient, and

to monitor an ECG signal of the patient over an extended period of time;

a controller operatively coupled to the ECG sensor and configured to monitor the ECG signal over the extended period of time;

at least one therapy electrode operatively coupled to the controller and configured to deliver at least one therapeutic defibrillating shock to the patient; and

a remote access manager operatively coupled to the controller and configured

to monitor for a command to communicate with a remote system,

to establish a communication session with the remote system in response to the command for communication between the external ambulatory medical device and the remote system in real time or substantially in real time, and

to cause the controller to reconfigure one or more response buttons of the controller to perform a different operational function in response to detecting an anomalous condition of the one or more response buttons based on information received via the communication session.

2. The external ambulatory medical device of claim 1, further comprising a user interface operatively coupled to the controller, wherein the remote access manager is configured to allow a remote technician to guide the patient through one or more steps relating to the external ambulatory medical device via the user interface.

3. The external ambulatory medical device of claim 1, wherein the remote access manager is configured to provide at least one of device configuration and diagnostic test results to a remote technician over the communication session.

4. The external ambulatory medical device of claim 1, wherein the remote access manager is further configured to cause the controller to re-configure a component of the external ambulatory medical device in response to detecting an anomalous condition of the component.

5. An external ambulatory medical device comprising:

an electrocardiogram (ECG) sensor configured

to couple to a skin of a patient, and

to monitor an ECG signal of the patient over an extended period of time;

a user interface comprising a first user input element and a second user input element, the first user input element configured to control a first operational function of the external ambulatory medical device, the second user input element configured to control a second operational function of the external ambulatory medical device;

a controller operatively coupled to the ECG sensor and to the user interface, the controller configured

to monitor the ECG signal over the extended period of time, and

to reconfigure the user interface to cause the first user input element to control the second operational function instead of the first operational function;

at least one therapy electrode operatively coupled to the controller and configured to deliver at least one therapeutic defibrillating shock to the patient; and

a remote access manager operatively coupled to the controller and configured

to monitor for a command to communicate with a remote system, and

to establish a communication session with the remote system in response to the command for communication between the external ambulatory medical device and the remote system in real time or substantially in real time.

6. The external ambulatory medical device of claim 5, wherein the remote access manager is further configured to cause the controller to reconfigure one or more response buttons of the controller based on information received via the communication session.

7. An external ambulatory medical device comprising:

an electrocardiogram (ECG) sensor configured

to couple to a skin of a patient, and

to monitor an ECG signal of the patient over an extended period of time;

a controller operatively coupled to the ECG sensor and configured to monitor the ECG signal over the extended period of time;

at least one therapy electrode operatively coupled to the controller and configured to deliver at least one therapeutic defibrillating shock to the patient;

a user interface;

a data communications interface configured to establish a communication session with a remote computing device; and

a remote access manager operatively coupled to the controller and configured

to monitor for a command from a remote computing device to establish the communication session between the external ambulatory medical device and the remote computing device,

to cause the data communications interface to initiate the communication session in response to the command from the remote computing device,

to receive from the remote computing device at least one of a request to control a component of the external ambulatory medical device and a request to receive an operational status of the external ambulatory medical device via the communication session,

to receive, from the remote computing device via the communication session, at least one of an application and a plug-in component configured to be deployed in the controller of the external ambulatory medical device,

to cause the user interface to display an instruction indicative of the operational status of the external ambulatory medical device wherein the instruction comprises at least one of

discontinuing use of the external ambulatory medical device and contacting a remote technician where the operational status is critical operational status, and

continuing use of the external ambulatory medical device and contacting the remote technician where the operational status is non-critical operational status.

8. The external ambulatory medical device of claim 7, wherein the remote access manager is configured to allow the remote computing device to control a message displayed via the user interface of the external ambulatory medical device.

9. The external ambulatory medical device of claim 7, wherein the remote access manager is configured to provide, responsive to the request to receive the operational status of the external ambulatory medical device, at least one of device configuration and diagnostic test results to the remote computing device over the communication session.

10. The external ambulatory medical device of claim 7, wherein the remote access manager is further configured to cause, responsive to the request to receive the operational status of the external ambulatory medical device, the controller to perform a diagnostic test.

11. The external ambulatory medical device of claim 7, wherein the remote access manager is further configured to transmit, responsive to the request to receive the operational status of the external ambulatory medical device, data representing the operational status of the external ambulatory medical device to the remote computing device via the communication session.

12. The external ambulatory medical device of claim 7, wherein the remote access manager is further configured to send data representing the operational status of the external ambulatory medical device to the remote computing device in real time or substantially in real time.

13. The external ambulatory medical device of claim 7, wherein the user interface is configured to present the operational status of the external ambulatory medical device as a web page implementing a virtual user interface.

14. The external ambulatory medical device of claim 7, further comprising a security manager operatively coupled to the controller and configured to limit an ability of the remote computing device to control the external ambulatory medical device.

15. The external ambulatory medical device of claim 7, wherein the remote computing device is a base station configured to communicate with the controller, wherein the command from the remote computing device is routed to the controller via the base station.

16. The external ambulatory medical device of claim 7, wherein the remote computing device is a mobile personal device configured to communicate with the controller, wherein the command from the remote computing device is routed to the controller via the mobile personal device.

17. An external ambulatory medical device comprising:

an electrocardiogram (ECG) sensor configured

to couple to a skin of a patient, and

to monitor an ECG signal of the patient over an extended period of time;

a controller operatively coupled to the ECG sensor and configured to monitor the ECG signal over the extended period of time;

at least one therapy electrode operatively coupled to the controller and configured to deliver at least one therapeutic defibrillating shock to the patient

a user interface;

a data communications interface configured to establish a communication session with a remote computing device; and

a remote access manager operatively coupled to the controller and configured

to monitor for a command from a remote computing device to establish the communication session between the external ambulatory medical device and the remote computing device,

to cause the data communications interface to initiate the communication session in response to the command from the remote computing device,

to receive from the remote computing device at least one of a request to control a component of the external ambulatory medical device and a request to receive an operational status of the external ambulatory medical device via the communication session,

to cause the user interface to display an instruction indicative of the operational status of the external ambulatory medical device wherein the instruction comprises at least one of

discontinuing use of the external ambulatory medical device and contacting a remote technician where the operational status is critical operational status, and

continuing use of the external ambulatory medical device and contacting the remote technician where the operational status is non-critical operational status;

wherein the operational status of the external ambulatory medical device is critical while at least one of

the external ambulatory medical device is nonresponsive,

the external ambulatory medical device is in an invalid operating mode,

at least one of one or more response buttons are stuck and a response button signal error has occurred,

at least one of one or more patient parameters is deemed corrupted,

an update of the one or more patient parameters has failed,

at least one of the therapy electrode and the controller is deemed inoperative, and

the external ambulatory medical device fails a pulse test, and

wherein the operational status of the external ambulatory medical device is non-critical while at least one of

excessive noise on one or more ECG sensors is present,

an operational status where a battery has reached a critical charge level and needs to be recharged or changed,

at least one of one or more portions of a garment coupled to the external ambulatory medical device and configured to be worn about a torso of a patient is deemed to be in need of adjustment,

where one or more components of the therapy electrode is deemed to have been improperly assembled,

a pulse truncation fault is present,

a charge profile fault is present,

a gel fire fault is present,

a connection to a remote computing device exceeds a predetermined connection time threshold, the connection to the remote computing device may be deemed to have temporarily failed, or another data transfer or remote communication session may already be in progress, and

a connection to a base station exceeds a predetermined connection time threshold, the connection to the base station may be deemed to have temporarily failed, or another data transfer or remote communication session may already be in progress.