Secure limited components for use with medical devices

• US 10,252,070 B2
• Filed: 08/10/2016
• Issued: 04/09/2019
• Est. Priority Date: 09/08/2015
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Volpe, Shane S., Sevo, Ernast
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/233,245
• Publication Number:
  US 20170065823A1
• Time in Patent Office: 972 Days
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

In some examples, an ambulatory medical device is provided. The ambulatory medical device includes at least one sensor configured to acquire data descriptive of the patient, one or more processors in communication with the at least one sensor, a patient care component executable by the one or more processors, and a limited functionality component executable by the one or more processors. The patient care component is configured to perform one or more primary operations of the ambulatory medical device at least in part by accessing the data descriptive of the patient. The limited functionality component is configured to exchange information with a communication device and to not affect the one or more primary operations of the ambulatory medical device.

Claims

1. An ambulatory medical device comprising:

a battery configured to supply power to the ambulatory medical device;

at least one sensor configured to acquire signals descriptive of a cardiac function of a patient, the at least one sensor including at least one sensing electrode;

at least one processor operably coupled to the at least one sensor;

at least one memory operably coupled to the at least one processor and storing one or more instructions executable by the at least one processor to convert the signals to data descriptive of the cardiac function of the patient;

at least one patient care component executable by the at least one processor and configured to perform one or more primary operations of the ambulatory medical device at least in part by accessing the data descriptive of the cardiac function of the patient, the one or more primary operations including monitoring the cardiac function of the patient; and

a limited functionality component executable by the at least one processor and configured to process one or more commands to exchange information with a communication device, the limited functionality component being configured to not affect the one or more primary operations performable by the at least one patient care component during operation of the limited functionality component.

2. The ambulatory medical device of claim 1, wherein the information exchanged with the communication device comprises one or more commands received from the communication device and the limited functionality component is configured to execute the one or more commands.

3. The ambulatory medical device of claim 2, wherein at least one command of the one or more commands is further configured to initiate transmission of information from the ambulatory medical device to the communication device.

4. The ambulatory medical device of claim 3, wherein the at least one command is configured to initiate transmission of the information from the ambulatory medical device to the communication device (a) in response to a predetermined condition, (b) during an occurrence of the predetermined condition, (c) in response to user input, (d) in response to a predetermined triggering event, (e) continuously over a period of time, (f) in during periodic time intervals, or (g) during aperiodic time intervals.

5. The ambulatory medical device of claim 4, wherein the information is descriptive of at least one of the cardiac function of the patient and a status of the ambulatory medical device.

6. The ambulatory medical device of claim 4, wherein the information comprises at least one of electrocardiogram data, heart sound data, patient location data, ambulatory medical device status data, patient name, electrode fall-off status, and compliance data.

7. The ambulatory medical device of claim 2, further comprising a user interface component operably coupled to the at least one processor, wherein the limited functionality component is configured to send one or more interface commands to the user interface component based on the one or more commands received from the communication device.

8. The ambulatory medical device of claim 1, wherein the one or more primary operations of the ambulatory medical device comprise monitoring the patient for a predetermined patient condition, providing information relating to the predetermined patient condition to a user interface, receiving user input relating to the predetermined patient condition from the user interface, determining a therapy for the patient on detecting the predetermined patient condition, and providing the therapy to the patient in response to detecting the predetermined patient condition.

9. The ambulatory medical device of claim 1, wherein:

the at least one sensor comprises a sensing electrode operably coupled to the at least one processor;

the patient care component is configured to monitor a cardiac function of the patient based on the data acquired by the sensing electrode; and

the one or more primary operations of the ambulatory medical device comprise operations relating to detecting a cardiac condition of the patient based on the cardiac function of the patient.

10. The ambulatory medical device of claim 9, further comprising at least one treatment electrode operably coupled to the at least one processor and configured to provide a defibrillating shock, wherein the one or more primary operations of the ambulatory medical device comprise operations relating to treating the cardiac condition of the patient via the at least one treatment electrode upon detecting the cardiac condition.

11. The ambulatory medical device of claim 1, wherein:

the at least one patient care component is configured to;

manipulate primary data stored in the memory; and

manipulate secondary data stored in the memory; and

the limited functionality component is configured to not affect the one or more primary operations of the ambulatory medical device at least in part by being configured to manipulate the secondary data but be limited to read-only access of the primary data.

12. The ambulatory medical device of claim 1, wherein:

the memory is configured to provide a primary data store and a secondary data store;

the at least one patient care component is configured to;

manipulate primary data stored in the primary data store; and

manipulate secondary data stored in the secondary data store; and

the limited functionality component is configured to not affect the one or more primary operations of the ambulatory medical device at least in part by being configured to manipulate data stored in the secondary data store but be limited to read-only access of data stored in the primary data store.

13. The ambulatory medical device of claim 1, wherein the at least one processor is configured to execute the at least one patient care component via a first processing thread and to execute the limited functionality component via a second processing thread.

14. The ambulatory medical device of claim 1, wherein:

the memory is configured to provide a primary data store and a secondary data store;

the at least one processor comprises a primary processor and a secondary processor;

the at least one patient care component is executable by the primary processor and is configured to;

manipulate primary data stored in the primary data store; and

manipulate secondary data stored in the secondary data store; and

the limited functionality component is executable by the secondary processor and is configured to not affect the one or more primary operations of the ambulatory medical device at least in part by being configured to manipulate data stored in the secondary data store but be limited to read-only access of data stored in the primary data store.

15. The ambulatory medical device of claim 1, wherein the limited functionality component is configured to not affect the one or more primary operations of the ambulatory medical device at least in part by being configured to limit execution of one or more commands received from the communication device.

16. The ambulatory medical device of claim 15, wherein the limited functionality component is configured to limit execution of the one or more commands to those one or more commands that do not affect the one or more primary operations of the ambulatory medical device.

17. The ambulatory medical device of claim 15, wherein the limited functionality component is configured to either limit or shut down execution of the one or more commands based at least on one of a threshold number of commands per time period, a threshold number of commands based on a type of the at least one processor, a threshold number of active streams, a threshold percentage utilization of the at least one processor, a threshold percentage memory consumed, and a threshold number of threads.

18. The ambulatory medical device of claim 15, wherein the limited functionality component is configured to either limit or shut down execution of the one or more commands upon detecting that an amount of battery power transgresses a threshold value.

19. The ambulatory medical device of claim 1, wherein the limited functionality component is configured to authenticate the information received from the communication device as originating from one or more previously identified communication devices.

20. The ambulatory medical device of claim 19, wherein the limited functionality component is configured to authenticate the information received from the communication device using at least one of password authentication and certificate-based authentication.

21. The ambulatory medical device of claim 1, further comprising a user interface component operably coupled to the at least one processor, wherein the limited functionality component is configured to send one or more interface commands to the user interface component, the one or more interface commands being configured to initiate output of one or more messages via the user interface component, the one or more messages being predefined within the ambulatory medical device.

22. The ambulatory medical device of claim 1, further comprising a user interface component operably coupled to the at least one processor, wherein the limited functionality component is configured to:

execute an interface command configured to modify a message to be output by the user interface component; and

send one or more interface commands to the user interface component, the one or more interface commands comprising at least one interface command configured to initiate output of the message.

23. The ambulatory medical device of claim 22, wherein the interface command is configured to not affect the one or more primary operations of the ambulatory medical device at least in part by being configured to determine whether the message can be modified based on identifying whether the message is flagged as restricted from modification.

24. The ambulatory medical device of claim 1, wherein the at least one sensor comprises at least one of a tissue fluid sensor, a heart sounds sensor, a lung sounds sensor, an accelerometer, and a pulse oximeter.

25. The ambulatory medical device of claim 1, wherein the limited functionality component includes an application program interface implemented using at least one of a representational state transfer, JavaScript object notation, extensible markup language, transmission control protocol socket, and encrypted uniform resource locator parameters.

26. The ambulatory medical device of claim 1, wherein the ambulatory medical device comprises a plurality of therapy electrodes configured to provide a treatment to the patient.

27. The ambulatory medical device of claim 26, wherein the plurality of therapy electrodes comprises one or more adhesive electrodes configured to adhesively attach to patient'"'"'s skin and provide the treatment to the patient.

28. A system comprising:

a communication device in communication with an external sensor; and

an ambulatory medical device configured to communicate with the communication device, the ambulatory medical device comprising;

a battery configured to supply power to the ambulatory medical device;

at least one sensor configured to acquire signals descriptive of a cardiac function of a patient;

one or more processors operably coupled to the at least one sensor and in communication with the at least one sensor;

at least one memory operably coupled to the one or more processors and configured to store one or more instructions executable by the one or more processors to convert the signals to data descriptive of the cardiac function of the patient;

a patient care component executable by the one or more processors and configured to perform one or more primary operations of the ambulatory medical device at least in part by accessing the data descriptive of the cardiac function of the patient; and

a limited functionality component executable by the one or more processors and configured to execute commands received from the communication device, the limited functionality component being configured to not affect the one or more primary operations performable by the patient care component during operation of the limited functionality component.

29. The system of claim 28, wherein the ambulatory medical device comprises a user interface component and the commands comprise at least one command configured to:

receive information descriptive of the communication device; and

request that the user interface component display the information.

30. The system of claim 29, wherein the information describes at least one of an image stored on the communication device, a signal strength of a network connection between the ambulatory medical device and the communication device, and an amount of power remaining in a battery comprised within the communication device.

31. The system of claim 28, wherein the communication device is comprised within the ambulatory medical device.

32. The system of claim 28, wherein:

the communication device is further configured to;

generate a request to execute a command to configure a threshold value for a patient parameter monitored by the ambulatory medical device; and

transmit the request to the limited functionality component; and

the limited functionality component is further configured to;

receive the request;

parse the request to identify the command and the threshold value;

execute the command;

monitor, in response to executing the command, the patient parameter to determine whether the patient parameter transgresses the threshold value; and

transmit a notification to a recipient device where the patient parameter transgresses the threshold value.

33. The system of claim 32, wherein the patient parameter comprises at least one of heart beats per minute (bpm) and time elapsed since the patient last complied with a prescribed treatment schedule and the threshold value comprises at least one of 180 bpm and a prescribed time interval within the prescribed treatment schedule, wherein the prescribed treatment schedule requires at least one of a rehabilitation session and taking medication.

34. The system of claim 28, wherein the communication device comprises a device interface configured to establish communication with the ambulatory medical device.

35. The system of claim 34, wherein the communication device comprises a smart phone.

36. The system of claim 34, wherein the communication device comprises a tablet computer.