Methods and Systems for semi-automatic adjustment of medical monitoring and treatment.

• US 20080061961A1
• Filed: 10/31/2007
• Published: 03/13/2008
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Michael John
• Original Assignee: Michael John
• Inventors: John, Michael
• Granted Patent: US 8,831,735 B2
• Time in Patent Office: Days
• US Class Current: 340/539.12
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient

Abstract

Systems and methods are described for adjusting the operation of implantable stimulation devices used to provide medical monitoring and treatment. Several hierarchical algorithms are described which operate according to conditionally obtaining a patient response to an alert signal. In one such strategy semi-automatic therapy adjustment occurs by automatically issuing patient alert messages when selected operations are to occur, and using a patient'"'"'s response to the alert message that is provided within a selected time limit in order to contingently adjust therapy. Methods are also described for resolving conflicts which may occur when time information and sensed data information each indicate different patient states are occurring. Although treatment of neural and cardiac disorders is emphasized, the techniques can be applied to the monitoring and treatment of any medical disorder with an implanted device.

Claims

1. A medical alert system including:

a sensor adapted to detect a medically relevant signal from a patient;

an analog-to-digital converter coupled to the sensor for digitizing an analog electrical signal corresponding to the medically relevant signal, thereby producing a digital signal;

an alert module configured to provide an alert signal;

a programmable memory for storing a plurality of responsive operations associated with different alert types;

a user input subsystem for obtaining user input;

a processor coupled to the analog to digital converter, the alert module, the user input subsystem, and the programmable memory, the processor configured to;

(i) detect the occurrence of an alert event by analyzing the digital signal;

(ii) determine the type of the alert event;

(iii) send an alert request to the alert module upon detecting the occurrence of the alert event, thereby causing the alert module to generate an alert signal related to a characteristic of the event;

(iv) determine whether the input has been received by the user input subsystem within a specified amount of time after sending the alert request, and if such input has not been received within the specified amount of time, select and perform one of the plurality of responsive operations corresponding to the type of alert;

wherein the sensor, the analog to digital converter, the alert module, the programmable memory, the user input subsystem and the processor are disposed so that medical alert system functions when the patient is ambulatory.

2. The system of claim 1 wherein the sensor is an electrode and the medically relevant signal reflects a physiological measure.

3. The system of claim 1 wherein the responsive operation includes causing the alarm subsystem to alter the characteristics of the alert signal according to a function which depends on the alert signal type.

4. The system of claim 3 wherein the responsive operation includes causing the alarm subsystem to alter the temporal characteristics of the alert signal.

5. The system of claim 4 wherein the responsive operation includes causing the alarm subsystem to increase the intensity level of the alert signal over time.

6. The system of claim 1 wherein an additional responsive operation is selected upon the detection of another alert event occurring prior to receiving patient input.

7. The system of claim 1 wherein the type of alert event depends on patient state.

8. The system of claim 7 wherein the patient state includes information regarding whether the patient is awake or asleep.

9. A medical alert system including:

a sensor adapted to detect a physiological signal from a patient;

an analog-to-digital converter coupled to the sensor for digitizing an analog electrical signal corresponding to the physiological signal, thereby producing a digital signal;

an alert module configured to provide an alert signal;

a programmable memory for storing a plurality of responsive operations corresponding to a plurality of alert types, wherein the responsive operations each pertain to a type of alert signal;

a user input subsystem for obtaining user input;

a processor coupled to the analog to digital converter, the alert module, the user input subsystem, and the programmable memory, the processor configured to;

(i) detect the occurrence of an alert event by analyzing the digital signal;

(ii) determine the type of the alert event;

(iv) determine a patient state value;

(iii) select one of the alert signal types according to both the type of alert event and the patient state value, and send a corresponding alert request to the alert module upon detecting the occurrence of the alert event, thereby causing the alert module to generate an alert signal according to the alert signal type;

wherein the sensor, the analog to digital converter, the alert module, the programmable memory, the user input subsystem and the processor are disposed so that medical alert system functions when the patient is ambulatory.

10. The system of claim 9 wherein the patient state value includes information regarding whether the patient is awake or asleep.

11. The system of claim 10 wherein the alarm signal type is a silent alarm if the patient state value indicates the patient is asleep.

12. The system of claim 9 wherein the patient state value includes information regarding whether the patient'"'"'s heart rate is outside of a selected range.

13. A system for treating a human patient with an implantable device, the system including:

An implanted device treatment module configured for operating according to at least a first treatment protocol;

An alerting module for operating according to an alert protocol and for producing an alert event when an operating condition is satisfied and for providing an alert signal to a user in response to an alert event;

An external programmer having an input response module for obtaining a user input response;

Wherein at least one of the treatment protocol and the alert protocol causes the modification of treatment operations and alerting operations across a duration for which a response is not provided by a user, said modification occurring to at least one patient input response rule.

14. The system of claim 13 wherein the alert signal is provided to the user using at least one of:

implanted alerting circuitry; and

, and external patient programmer.

15. The system of claim 13 wherein the patient input response rule causes the alert signal to vary over time in a fixed manner.

16. The system of claim 13 wherein the patient input response rule causes the alert signal to vary over time in a programmable manner.

17. The system of claim 13 wherein the patient input response rule causes the alert signal to vary over time contingent upon the characteristics of the alert event.

18. The system of claim 13 wherein the patient input response rule causes the alert signal to vary across different sensory modalities over time.

19. The system of claim 13 wherein the patient response rule cause the treatment protocol to be modified as a function of the number of specified alert signals have occurred.

20. The system of claim 13 wherein the patient response rule cause the treatment protocol to be modified after a volume characteristic of the alert signal has been increased a number of specified times.

21. The system of claim 13 wherein the patient response rule cause the treatment protocol to be modified after a modality characteristic of the alert signal has been changed a number of specified times.

22. The system of claim 13 wherein the patient response rule cause the treatment protocol to be modified in a programmable manner that varies across time.

23. The system of claim 20 wherein the patient response rule causes modification of treatment operations to automatically occur if an additional alert event occurs, and meets a selected criterion, while awaiting a patient input response.

24. The system of claim 13 wherein the treatment is electrical.

25. The system of claim 13 wherein the treatment is a drug.