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

• US 7,899,545 B2
• Filed: 10/31/2007
• Issued: 03/01/2011
• 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): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/932,805
• Publication Number:
  US 20080097553A1
• Time in Patent Office: 1,217 Days
• Field of Search: 600/300, 607/30, 607/48, 607/59, 705 2- 3
• US Class Current: 607/60
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/20 : relating to practices or guidelines

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. An external patient programmer for providing medical monitoring comprising:

monitoring circuitry configured for implementing a monitoring program which operates according to a monitoring protocol having monitoring parameters;

alerting circuitry configured for alerting the patient by implementing an alert program and operating according to an alerting protocol having alert parameters, said protocol including providing patient alerting in response to detection of events and providing patient alerting of proposed changes to at least one monitoring protocol;

a patient input module configured for obtaining a patient input response and modifying at least one of the alerting protocol and the monitoring protocol based upon this response, and at least one patient response rule which evaluates this response and the recent history of alert events that has occurred;

a communication module configured for providing communication between the programmer and at least one implanted monitoring device which is configured to communicate with the external patient programmer.

2. The external patient programmer of claim 1, in which the at least one patient alerting protocol is adjusted based upon a patient state parameter.

3. The external patient programmer of claim 1, in which the at least one protocol is selected to be at least one of:

the monitoring protocol of the external patient programmer;

the alerting protocol of the external patient programmer;

the monitoring protocol of the implanted device;

the alerting protocol of the implanted device.

4. The external patient programmer of claim 1, in which the programmer further includes a real-time clock which is used to modify at least one protocol based upon time information.

5. The external patient programmer of claim 1, in which the implanted medical device operates to communicate data to the programmer, said data relating to proposed changes to at least one monitoring protocol.

6. The external patient programmer of claim 1, in which the detection of medical events is accomplished by the monitoring program of the programmer.

7. The external patient programmer of claim 1, in which the patient input response is used to adjust a parameter of a monitoring protocol.

8. The external patient programmer of claim 1, in which the patient alerting includes an alert signal which includes quantitative information about the proposed change to a monitoring protocol.

9. The external patient programmer of claim 1, further including an accelerometer which provides sensed data that is used in calculation of a patient state parameter which is used to adjust the monitoring protocol parameters.

10. The external patient programmer of claim 1, wherein the alerting protocol alerting parameters are modified based upon a patient'"'"'s heart rate being outside of a selected range.

11. The external patient programmer for claim 1, in which the patient input response is related to a quantity.

12. The external programmer of claim 1 wherein the detection of events is provided by the implanted medical device which is configured to monitor data, detect alert events, and communicate with the external programmer based upon such detection.

13. The external programmer of claim 1, further configured for communicating with the implanted medical device in order to modify at least one of an alerting protocol of the implanted device, a monitoring protocol of the implanted device, and a treatment protocol of the implanted device, said modification occurring based upon the patient response rule which provides the modification due to evaluation of at least one patient input response and the history of alert events.

14. The external programmer of claim 1 wherein the monitoring program monitors data communicated by said implanted device and is configured for accomplishing at least one of the functions selected from the group of evaluating data communicated by the implanted device, detecting alert events in the data communicated by the implanted device, detecting alert events, and creating a history of alert events.

16. The external patient programmer of claim 11, wherein one of the at least three possible patient input responses includes a non-binary patient input response which is at least one of a delay request which is an accept response which occurs after a specified delay and a remind request which causes the patient alerting to be halted and then repeated at a later time.

15. An external patient, programmer for providing medical monitoring comprising:

monitoring circuits configured for implementing a monitoring program which operates according to a monitoring protocol having monitoring parameters;

alerting circuitry configured for alerting the patient by implementing an alert program and operating according to an alerting protocol having alerting parameters, said protocol including providing patient alerting in response to detection of alert events and providing patient alerting of proposed changes to at least one monitoring, protocol;

a patient input module configured for obtaining one of at least three possible patient input responses and modifying at least one of the alerting protocol or the monitoring protocol based upon this response;

a communication module configured for providing communication between the programmer and at least one implanted monitoring device.

17. An external patient programmer for providing medical treatment in conjunction with at least one implanted device comprising:

treatment circuitry configured for implementing a monitoring and treatment according to a treatment program which operates according to a treatment protocol having treatment parameters;

alerting circuitry configured for alerting the patient by implementing an alert program and operating according to an alerting protocol having alerting parameters, said protocol including providing patient alerting in response to detection of medical events and providing patient alerting of proposed changes to at least one treatment protocol;

a patient input module configured for obtaining a patient input response and modifying at least one of the alerting protocol, treatment protocol, or the monitoring protocol based upon at least one patient response rule which evaluates this response in accordance with response rules defined in the alerting protocol and in relation to a recent history of alert events;

a communication module configured for providing communication between the programmer and the at least one implanted treatment device.

18. The external patient programmer of claim 17, further including a real-time clock for providing time data and a treatment protocol which proposes changes to the treatment protocol based upon the time data.

19. The external patient programmer of claim 17, further including a treatment protocol which alerts the patient to proposed changes to the treatment protocol which are made based upon analysis of data sent to the programmer by an implanted device.

20. The external patient programmer of claim 17, further configured to provide contingent operation based upon a characteristic of detected medical event in the case where said patient input is not obtained within a specified amount of time after said alerting is provided, said contingent operation being defined and adjusted according to patient response rules defined in the alerting protocol and in relation to the recent history of alert events that has occurred.