Method for generating a monitoring signal using a supervising entity or safety module

• US 10,166,333 B2
• Filed: 09/11/2015
• Issued: 01/01/2019
• Est. Priority Date: 09/15/2014
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Friedli, Kurt, Mueglitz, Carsten, Schmitz, Ralf, Schwenker, Kai-Oliver, Eissenloeffel, Thomas
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/508,302
• Publication Number:
  US 20170290980A1
• Time in Patent Office: 1,208 Days
• Field of Search: 600365, 604 65- 67, 604131, 604151, 128DIG 1, 128 12, 128 13
• CPC Class Codes: A61B 5/747 in case of emergency, i.e. alerting emergency services
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

The present invention relates to method for generating a monitoring signal by monitoring laboratory values of a patient using a medical app (122). The medical app (122) is executed on a mobile device (102) of the patient, wherein the execution of the medical app (122) on the mobile device (102) of the patient is supervised by a supervising entity or safety module (106, 128), the supervising entity or safety module (106, 128) comprising at least executable program instructions (130). The medical app (122) comprises executable instructions for executing at least one sequence of processes for generating the monitoring signal. The processes comprise safety critical processes. The sequence of processes is triggered by the measurement of the blood glucose level of the patient. The method comprises executing a first process of the sequence of processes, wherein the execution results in the generation of an information, forwarding the information of the executed process to the supervising entity or safety module (106, 128), evaluating the received information by the supervising entity or safety module (106, 128) and executing a second process of the sequence of processes depending on the result of the evaluation.

Claims

1. A method for generating a monitoring signal by monitoring laboratory values of a patient using a medical app, the medical app being executed on a mobile device of the patient, wherein the execution of the medical app on the mobile device of the patient is supervised by a supervising entity or safety module, the supervising entity or safety module comprising at least executable program instructions, the medical app comprising executable instructions for executing at least one sequence of processes for generating the monitoring signal, the processes comprising safety critical processes, the sequence of processes being triggered by the measurement of the laboratory values, such as the blood glucose level of the patient, the method comprising:

executing a first process of the sequence of processes, wherein the execution results in the generation of an information,

forwarding the information of the executed process to the supervising entity or safety module,

evaluating the received information by the supervising entity or safety module, and

executing a second process of the sequence of processes depending on the result of the evaluation;

wherein identifiers are assigned to the processes of the sequence, wherein the supervising entity or the safety module is operable to access a sequence table, wherein the sequence table comprises entries specifying allowed sequences of processes, wherein the information comprises the identifier of the second process, wherein the supervising entity or the safety module verifies whether the second process may be executed subsequent to the first process by looking up the sequence table, and wherein in response to determining that the second process is not allowed to be executed subsequent to the first process the supervising entity or safety module interrupts the execution of the sequence.

2. The method of claim 1, the sequence of processes comprising processes for

measuring or determining at least one laboratory value of the patient,

comparing the measured values to predefined ranges of permitted values, and

in response to determining that at least one of the measured or determined values

is beyond the predefined range, generating the monitoring signal.

3. The method of claim 1, wherein the monitoring signal is adapted to trigger the mobile device to make an emergency call.

4. The method of claim 1, wherein the mobile device is connected to a medical device of the patient, wherein the monitoring signal is adapted to trigger the medical device to apply medication such that the laboratory values of the patient are moved into the perimeters of the predefined range.

5. The method of claim 1, wherein the monitoring signal is adapted to trigger the mobile device to emit a perceivable alarm signal.

6. The method of claim 1, wherein the execution of the first process results in the generation of an intermediate result, wherein the intermediate result is passed on to the second process for further processing, wherein the information comprises the intermediate result, wherein the supervising entity or safety module verifies whether the intermediate result is within a defined range of results, wherein the second process of the sequence is only executed if the result has been determined to be within the defined range of results.

7. The method of claim 6, wherein in response to determining that the result is within the predefined range, the supervising entity or safety module generates a trigger signal and transmits the trigger signal to the mobile device, wherein the trigger signal when received by the mobile device-triggers the mobile device to execute the second process.

8. The method of claim 6, wherein in response to determining that the intermediate result is not within the defined range of results, the supervising entity or safety module brings the mobile device into a safe state.

9. The method of claim 8, wherein in the safe state the functionality of the mobile device is reversibly reduced, such that the mobile device is no longer operable to make an emergency call and/or trigger a medical device to apply medication and/or emit a perceivable alarm signal while in the safe state.

10. The method of claim 1, wherein the supervising entity or safety module is adapted to create a log file during execution of the sequence of processes, the log file comprising the identifiers of processes which have already been executed in course of the execution of the sequence of processes.

11. The method of claim 10, wherein the sequence table further comprises information specifying a set of processes which have to be executed prior to the execution of the second process, wherein supervising entity or safety module further verifies whether the set of processes has been executed by looking up the sequence table and comparing the identifiers of the set of processes with the identifiers comprised in the log file.

12. The method of claim 10, wherein the supervising entity or safety module deletes the log file if the sequence of processes has been completed successfully.

13. The method any of claim 1, wherein in response to determining that the second process is not allowed to be executed subsequent to the first process the supervising entity or safety module brings the mobile device into a safe state.

14. The method of claim 1 wherein the supervising entity or safety module is operable to address the mobile device to conduct a data processing algorithm, wherein the supervising entity or safety module further provides the mobile device with data for processing using the data processing algorithm, wherein the mobile device in response to being addressed by the supervising entity or safety module conducts the data processing algorithm thereby generating a result, wherein the supervising entity or safety module in response to the mobile device generating the result, verifies the result and in response to successfully verifying the result triggers the mobile device to execute the second process.

15. The method of claim 14, wherein the supervising entity or safety module addresses the mobile device to conduct the data processing algorithm if no allowed range for the intermediate result received with the information is defined.

16. The method of claim 1, wherein the mobile device is connected to a measurement entity, wherein the mobile device when executing the process of measuring at least one laboratory value of the patient addresses the measurement entity to conduct a corresponding measurement and return corresponding measurement values.

17. A system comprising a mobile device being connected to a supervising entity or safety module, wherein the mobile device is operable to execute at least one medical app, wherein the execution of the medical app on the mobile device is supervised by the supervising entity or safety module, the supervising entity or safety module comprising at least executable program instructions, the medical app comprising executable instructions for executing at least one sequence of processes for generating the monitoring signal, the processes comprising safety critical processes, the sequence of processes being triggered by the measurement of laboratory values of the patient, the mobile device being operable to execute a first process of the sequence of processes, wherein the execution results in the generation of an information and to forward the information to the supervising entity or safety module, wherein the supervising entity or safety module is adapted to evaluate the information, wherein the mobile device is further adapted to execute the second process of the sequence of processes depending on the result of the evaluation, wherein identifiers are assigned to the processes of the sequence, wherein the supervising entity or the safety module is operable to access a sequence table, wherein the sequence table comprises entries specifying allowed sequences of processes, wherein the information comprises the identifier of the second process, wherein the supervising entity or the safety module verifies whether the second process may be executed subsequent to the first process by looking up the sequence table, and wherein in response to determining that the second process is not allowed to be executed subsequent to the first process the supervising entity or safety module interrupts the execution of the sequence.

18. The system of claim 17, wherein the supervising entity or safety module comprises at least one processor, a telecommunication interface and a memory, wherein the memory comprises at least executable instructions for evaluating the information, wherein the processor of the supervising entity or safety module is adapted to execute the executable instructions comprised in the memory, and wherein the supervising entity or safety module is adapted to communicate with the mobile device using the communication interface.