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

• US 9,037,254 B2
• Filed: 10/31/2007
• Issued: 05/19/2015
• 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): Stice, Paula J
• Application Number:
  US11/933,372
• Publication Number:
  US 20080109050A1
• Time in Patent Office: 2,757 Days
• Field of Search: 600/300, 607/60
• 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. A method for adjusting a treatment protocol in a system having an implantable stimulator, the method comprising the steps of:

configuring a processor within the system for selectively setting between (1) a fully automatic mode, and (2) a semi-automatic mode of operation, wherein a mode of operation may be selectively and reversibly switched between said fully automatic mode and said semi-automatic mode of operation;

wherein when said fully automatic mode of operation has been selected, operation of said system is devoid of either requesting or awaiting a patient'"'"'s input and when said semi-automatic mode of operation has been selected;

the processor in the semi-automatic mode of operation being further configured for;

determining whether an adjustment of the treatment protocol is needed for implementing an adjustment of the treatment provided by the implantable stimulator by implementing the following steps;

proposing the adjustment of the treatment to the patient by automatically sending an alert signal to the patient, said alert signal being selected from the group consisting of visual signal, auditory signal, vibrotactile signal, or textual signal;

delaying implementation of the adjustment of the treatment protocol for a specified time interval awaiting a patient response; and

,

operating the processor to implement a patient response rule that is responsive to (a) a predetermined patient response, or (b) no patient response provided by the patient within a selected interval.

2. The method of claim 1 wherein the alert signal provides the patient with at least one of:

a. an indication of at least one adjustment of the treatment protocol that will be made;

b. a list of possible adjustments presented in order of preference;

c. a list of possible adjustments presented in order of likelihood computed from past patient responses;

d. a choice between at least two adjustments that could be made;

e. a question requiring a response that is selected from the group consisting of a binary choice, a quantitative value, and a subjective value; and

,

f. an alert signal which occurs at least 1 minute prior to the time that the proposed adjustment is scheduled to occur.

3. The method of claim 1 additionally including the step of refraining from sending a second alert signal to the patient, which proposes the same adjustment as the first alert signal, until after a specified delay if the patient response to the first alert signal is a “

reject”

response which rejects the proposed adjustment.

4. The method of claim 1 wherein the patient response rule defines a response condition which is evaluated as true if a specified time interval after said alert signal is sent is exceeded without the patient providing patient input.

5. The method of claim 1 additionally including the step of delaying said implementing of said proposed adjustment of the treatment protocol for a period specified by the patient according to the patient response, wherein the patient response is a delay response.

6. The method of claim 1 wherein determining that an adjustment to the treatment protocol should occur includes detecting an alert event using the evaluation of sensed data, wherein the sensed data are at least one of the following types of data:

electrical;

chemical;

optical;

hemodynamic;

pressure;

pO2;

pH;

temperature;

conductivity;

impedance;

data obtained using mechanical sensors;

strain gauge;

accelerometer;

EEG, EMG, ECG and EKG data;

evoked response data;

nerve conduction data;

data measured from blood;

blood glucose concentration data; and

, data related to diabetes.

7. The method of claim 1 wherein said proposed adjustment of the treatment protocol includes operating at least one of the stimulation and sensing subsystems of the implanted device to achieve one of:

turning off;

turning off for a specified interval;

turning on; and

, turning on for a specified interval responsive to a patient state.

8. The method of claim 1 wherein the alerting said patient to said proposed adjustment of the treatment protocol by providing an alert signal further includes the step of providing an indication that the patient should input a value for the proposed adjustment, and receiving this patient input, said input which is subsequently used when making the adjustment.

9. The method of claim 1 wherein the adjustment is for a characteristic of the treatment which is at least one of:

the magnitude of the adjustment;

the duration of the adjustment;

the rate of transition to the adjustment; and

, at least one site at which stimulation occurs for which the adjustment will occur.

10. The method of claim 1 wherein during the automatic mode the patient is alerted to selected operations that occur automatically and is not prompted to supply patient input to allow the operations, whereby the patient is notified about an operation that will occur automatically.

11. The method of claim 1 wherein during at least the automatic mode of operation the processor is further configured to allow the patient to manually adjust the treatment protocol in order to manually cause treatment to occur in a desired manner.

12. The method of claim 1, further including configuring a processor within the system for selectively setting a manual mode and wherein said system includes an implantable stimulator having a module which is configured to work with a patient programmer to allow the patient to toggle between different modes of operation, and wherein the different modes provide for different types of adjustment of the operation of the system, the modes including at least two of:

a fully automatic mode, a semi-automatic mode, and manual mode.

13. The method of claim 1 wherein selective setting of mode occurs according to user input reflecting the patient'"'"'s preference and wherein the inputs selects for only one mode to be active.

14. The method of claim 1 wherein selective setting of mode occurs at different times according to patient state.

15. The method of claim 1 wherein selective setting of mode occurs at different times according to detection of at least one event.

16. The method of claim 1 further including configuring a processor within the system for selectively setting a manual mode and wherein selective setting of mode causes a particular adjustment of the treatment to occur according to a protocol that is defined to occur at least one of a semi-automatically, fully automatically, or manually depending upon whether the selected mode is semi-automatic, fully automatic or manual.

17. The method of claim 16 wherein selective setting of mode is selected contingently upon whether the patient state indicates the patient is either awake or sleeping.