Methods and systems for semi-automatic adjustment of medical monitoring and treatment

• US 8,965,509 B2
• Filed: 10/31/2007
• Issued: 02/24/2015
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): BEHRINGER, LUTHER G
• Application Number:
  US11/932,955
• Publication Number:
  US 20080071314A1
• Time in Patent Office: 2,673 Days
• Field of Search: 600/300, 600/347, 600/508, 607/17, 607/30, 607/48, 607/59
• US Class Current: 607/32
• 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 system configured for currently providing for medical therapy in fully-automatic, semiautomatic, and user-initiated manners including:

an implantable medical device configured to provide therapy, the implantable medical device comprising;

a memory coupled to the processor containing therapy program operations that have been programmably defined with an automatic parameter value which indicates the operation is to be implemented in an automatic, semiautomatic, or user-initiated fashion;

a processor configured for calculating a patient state value and implementing therapy program operations according to both the automatic parameter value and the patient state value, the processor being further configured to adjust its operation in relation to a patient alert rule based on the characteristics of the alert event and then contingently adjusting the alerting and operating of the device if an external patient programmer does not provide a signal indicative of a patient response within a predetermined interval; and

an external patient programmer for allowing a patient to input a patient response and for communication with the implanted medical device; and

an alerting module configured for providing alert signals when selected events occur for which alerting has been defined.

2. A medical monitoring and alerting system including:

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

an implanted device having a signal processor coupled to the sensor for conditioning an analog electrical signal corresponding to the medically relevant signal, thereby producing a conditioned digital signal;

an alert module configured to provide an alert signal related to an alert event type;

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

an external patient programmer for presenting alert signals to a patient, communicating with other components of the system and for obtaining patient input;

at least a first processor coupled to the signal processor, the alert module, the external patient programmer, and the programmable memory, the at least first processor configured to;

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

(ii) determine a type of the alert event based upon a characteristic of the alert event;

(iii) determine if the type of alert event is one of;

(a) a semiautomatic event defined in a semi-automatic event set, or (b) an automatic event defined in an automatic event set as a function of the alert event type; and

,

(iv) operate in the case where the alert event is defined as an automatic event so as to automatically perform an operation associated with the alert event, and operate in the case where the alert event is defined as a semi-automatic alert event by sending an alert request to the alert module, thereby causing the alert module to generate and present to a patient an alert signal based upon a characteristic of the alert event, and then operating as a function of the alert event characteristic in response to patient input provided within a selected interval or to the lack thereof;

the at least first processor being further configured to adjust its operation in relation to a patient alert rule that contingently adjusts the alerting and operating of the device if the external patient programmer does not provide a signal indicative of a patient response;

wherein the sensor, the signal processor, the alert module, the programmable memory, the external patient programmer and the at least first processor are disposed so that the medical alert system is designed to alert at least the patient whereby the patient can be ambulatory and the system only defines a patient alert rule in relation to an alert provided to the patient.

3. The system of claim 2 further including at least a second processor to operate in the case where the event is a semi-automatic event to determine whether the input has been received by the external patient programmer within a specified interval after sending the alert request, and if such input has not been received within the specified amount of time, then select and perform one of a plurality of responsive operations, said operation selected according to the characteristic of the alert event.

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

5. The system of claim 2 wherein the alert events are cardiac related alert events and are classified—

as either a serious medically relevant event type or a non-serious medically relevant event type.

6. The system of claim 2 wherein the semi-automatic event set includes alert events having smaller magnitudes than the alert events of the automatic event set.

7. The system of claim 2 wherein selected alert events are programmatically assigned by a user to one of the semi-automatic event set and the automatic event set.

8. The system of claim 2 wherein a patient state value is calculated by a patient state module and includes one of:

a patient state value reflecting a current patient state, a patient state value reflecting a change in patient state, and a patient state value reflecting the current patient state for a period of time.

9. The system of claim 8 wherein selected alert events are assigned to the semi-automatic event set and the automatic event set according to the patient state value calculated by a patient state module.

10. The system of claim 8 wherein the type of alert event is adjusted based, on a current patient state value calculated by a patient state module, said value being evaluated using a patient state rule applied to recent patient state values.

11. The system of claim 8 wherein the patient state value is calculated to reflect the likelihood that the patient is awake or asleep or exercising.

12. A medical monitoring and alert system which is configured to concurrently provide for therapy including:

a sensing subsystem including a sensor to sense a medically relevant signal from a patient;

an external patient programmer for obtaining patient input, and allowing the patient to communicate with an implanted device;

a programmable memory for storing a plurality of responsive operations corresponding to a plurality of treatment events, said treatment events being defined as one of;

an automatic event defined in an automatic event set;

a semi-automatic event defined in a semi-automatic event set; and

, a user-initiated event defined in a user-initiated event set;

at least a first processor configured to automatically accomplish at least one operation defined for the automatic event set upon detection of an automatic event signal;

semi-automatically accomplish at least one operation defined for the semiautomatic event set upon detection of a semi-automatic event signal, said detection causing the alert module to provide an alert signal according to a patient alert rule related to the characteristic of the event, and then operating responsively to patient input provided within a selected interval or to the lack thereof as a function of the event characteristic; and

, accomplish at least one operation defined for the user-initiated event set upon the user providing input defined for the user-initiated event;

the at least first processor being further configured to adjust its operation in relation to a patient alert rule that contingently adjusts the alerting and operating of the device if the external patient programmer does not provide a signal indicative of a patient response within a predetermined interval;

an alert module configured to provide alert signals for selected events;

wherein the alert module, the programmable memory, the external patient programmer, implanted device, and the at least first processor operate to alert at least the patient wherein the alert system only defines a patient alert rule in relation to an alert provided to the patient.

13. The system of claim 12 wherein the sensing subsystem comprises a sensor which provides a sensed signal and which is coupled to an analog-to-digital converter which transforms the sensed signal into a digital signal and wherein the at least first processor is also coupled to the analog to digital converter, the at least first processor configured to:

(i) detect the occurrence of a treatment event which is defined as an alert event by analyzing the digital signal;

(ii) determine the type of the alert event from the defined characteristic;

(iii) determine if the type of alert event is defined for either the semi-automatic event set or the automatic event set; and

,

(iv) operate in the case where the event is defined in the semiautomatic event set by operating to select an alert signal type according to both the type of alert event and a 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; and

to operate while awaiting a patient input response to the alert signal based upon at least one patient input response rule and one send alert rule of an alert rule set; and

,

(v) operate in the case where the event is defined by the automatic event set by automatically performing an associated operation.

14. The system of claim 13 further including a patient state module for calculating a patient state value.

15. The system of claim 14 wherein the patient state value includes information regarding whether a feature of the sensed data is outside of a selected range.

16. The system of claim 13, further including a treatment subsystem which provides at least one of electrical and drug therapy.

17. The system of claim 12 wherein the alert signal is provided to the user using at least one of:

implanted alerting circuitry; and

, alerting circuitry of an external patient programmer.

18. The system of claim 12 wherein the alert signal is related to an alert event related to a metabolic disorder.

19. The system of claim 12 wherein the alert signal is an alert event related to a diabetic disorder.

20. The system of claim 12 wherein the alert signal is an alert event related to a neurological disorder.

21. The system of claim 12 wherein the alert signal is an alert event related to a cardiac disorder.

22. The system of claim 21 wherein the cardiac disorder involves ischemia.

23. The system of claim 12 wherein the user-initiated event is defined by patient input and includes one of the taking of medication, adjustment of drug delivery, and exercise.

24. The system of claim 12 wherein the treatment is provided to a target which is at least one of the following:

the brain;

a cardiovascular target;

a vagus nerve;

a cranial nerve;

a target which modulates the parasympathetic nervous system;

a target which modulates the sympathetic nervous system.

25. The system of claim 12 wherein at least one of semi-automatic and fully-automatic events are defined as events which are used by the processor to implement a control-law which regulates the provision of therapy.