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

• US 20080058773A1
• Filed: 10/24/2007
• Published: 03/06/2008
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Michael John
• Original Assignee: Michael John
• Inventors: John, Michael
• Granted Patent: US 9,089,713 B2
• Time in Patent Office: Days
• US Class Current: 604/891.1
• 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. A system for performing monitoring operations to provide medical monitoring of a patient comprising

an implanted medical monitoring device configured to communicate with an external patient programmer using a first communication subsystem,

an external patient programmer having a second communication subsystem for communicating with said implanted medical device, said programmer having a patient alert module which is configured to provide an alert signal and to obtain a user input from the patient which is evaluated according to at least one patient response rule to produce a user input result;

said programmer also being configured to use the result in order to make an adjustment to the monitoring operations.

2. The system of [claim 1] wherein said adjustment to monitoring operations is implemented by the implanted device to which the result is communicated.

3. The system of [claim 1] wherein the adjustment to the monitoring operations includes adjusting at least one criterion which is used to detect a medically relevant event.

4. The system of [claim 1] wherein the adjustment to the monitoring operations includes adjusting at least one criterion which is used to alert according to detected at least one medically relevant event.

5. The system of [claim 1] wherein the adjustment to the monitoring operations includes adjusting a value of a patient state parameter.

6. The system of [claim 1] wherein the alert signal includes a proposed adjustment which includes adjusting the monitoring operations a predefined manner.

7. The system of [claim 1] wherein the alert signal includes a proposed adjustment to operate according to a sleeping protocol.

8. The system of [claim 1] wherein the alert signal includes a proposed adjustment to operate according to an awake protocol.

9. The system of [claim 1] wherein the alert signal includes a proposed adjustment to operate according to an exercise protocol.

10. The system of [claim 1] wherein the patient response rule requires a patient response to be provided within a specified duration in order to avoid a ‘

no response’

response from occurring, the rule further including operations for what to do if a ‘

no response’

response occurs.

11. The system for providing medical treatment of [claim 1] wherein the external patient programmer permits the patient to provide a response using a patient interface which permits the selection of an ‘

accept operation’

response which causes the proposed adjustment in the monitoring operations to occur.

12. The system for providing medical treatment of [claim 1] wherein the external patient programmer permits a user to provide a response using a patient interface which permits the selection of a ‘

delay operation’

which causes the proposed operation to be delayed a selected amount before it occurs.

13. The system for providing medical treatment of [claim 1] wherein the external patient programmer permits a user to provide a response using a patient interface which permits the selection of a an operation selected according to a menu control for navigating through a menu and selecting a menu item.

14. The system for providing medical treatment of [claim 1] wherein the external patient programmer permits a user to provide a response using a patient interface which permits the selection of a ‘

remind’

operation which causes the alert signal to be resent at a later time.

15. The system of [claim 1] wherein the patient alert is performed by the external patient programmer upon receiving a code sent from the implanted device and wherein the code refers to a patient alert routine including send alert rules and patient response rules, and whereby the amount of communication is decreased compared to that which would be required for sending the information that is represented by the code which is sent.

16. A system for providing medical treatment using an implanted device, the system comprising:

a memory for storing a selected set of alert events for which alerting will occur;

a processor configured to determine if an alert event has occurred, and if so automatically alerting said patient by initiating an alert signal;

an alert module configured to provide the alert signal according to at least one send alert rule;

a user input subsystem for obtaining user input;

wherein the processor is further configured to adjust a treatment program according to at least one patient response rule of an alert protocol which defines

at least one operation to perform for at least one type of user input that is provided by a user within a specified interval, and

at least one operation to perform for at least one type of user input that is not provided by a user within a specified interval; and

,

wherein at least one send alert rule and at least one patient response rule comprise a patient alert rule set.

17. The system for providing medical treatment of [claim 16] wherein the send alert rule causes a parameter of the alert signal to increase at least once over an interval for which a user input is not provided.

18. The system for providing medical treatment of [claim 16] wherein the send alert rule dictates the occurrence of an alert signal indicating a missed alert subsequent to a specified interval elapsing for which a user input is not provided.

19. The system for providing medical treatment of [claim 16] wherein the send alert rule causes the alert signal to be cancelled after a specified interval elapses for which a user input is not provided.

20. The system for providing medical treatment of [claim 16] wherein the send alert rule causes the alert signal to be suspended temporarily after a specified interval elapses for which a user input is not provided.

21. A system for providing medical therapy having an implanted device for treatment of a disorder comprising:

an implantable device for providing therapy, said implantable device configured for obtaining the output of a patient state module which calculates patient state and which determines if a change in patient state has occurred;

a patient notification module for automatically providing an alert to the patient if a change in patient state has occurred and awaiting a patient response for a selected amount of time prior to contingently making a treatment adjustment according to at least on of;

the patient response, a lack of patient response.

22. The system of claim [claim 21] wherein the patient state module utilizes a real-time clock that is in communication with the implantable device and which provides time-of-day information related to the determination of patient state.

23. The system of claim [claim 21] wherein the patient state module utilizes a sensor that is in communication with the implantable device and which provides sensed data information that is related to the determination of patient state.

24. A system of [claim 21], further comprising a sensor coupled to the system for generating a signal indicative of whether a patient state is asleep or awake, wherein this patient state information may also be used to enable the selection of which of two or more treatment protocols should guide therapy.