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

• US 20080109050A1
• Filed: 10/31/2007
• Published: 05/08/2008
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Michael John
• Original Assignee: Michael John
• Inventors: John, Michael
• Granted Patent: US 9,037,254 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• 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 semi-automatically adjusting a treatment protocol in a system having an implantable stimulator, the method comprising the steps of:

determining that an adjustment in the treatment protocol should occur;

proposing the adjustment to a patient by automatically providing an alert signal;

waiting a specified time interval for a patient response; and

,

implementing the adjustment if a response condition is evaluated as true.

2. The method of claim 1 wherein the alert signal provides 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. an indication of why the adjustment will be made;

f. a question requiring a response that is at least one of;

a binary choice;

a quantitative value; and

;

a subjective value;

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

,

h. an alert signal that occurs approximately simultaneously with said proposed adjustment.

3. The method of claim 1 additionally including the step of refraining from providing a second alert signal to a patient until after a specified delay.

4. The method of claim 1 additionally including the step of refraining from sending a second alert signal to a patient until after a specified delay if the patient response is a “

reject”

response which rejects the proposed adjustment.

5. The method of claim 1 wherein the patient response causes said response condition to be evaluated as true.

6. The method of claim 1 wherein surpassing a specified time interval after said alerting to a proposed adjustment causes said response condition to be evaluated as true.

7. The method of claim 1 additionally including the step of delaying said implementing of said proposed adjustment in the treatment protocol for a period specified by the patient due to the patient response being a delay response.

8. The method of claim 1 wherein determining that an adjustment to the treatment protocol should occur includes detecting an alert event a indicated by a measure derived from 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 in blood;

blood glucose concentration data; and

, data related to diabetes.

9. The method of claim 1 wherein a proposed adjustment in 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.

10. The method of claim 1 wherein alerting a patient to a proposed adjustment in the treatment protocol by providing an alert signal further includes the step of providing a secondary alert signal that requests that the user input a value for the proposed type of adjustment, which is subsequently used when making the adjustment.

11. 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 over which the adjustment occurs; and

, at least one location for which the adjustment will occur.

12. The method of claim 1 wherein the method is invoked when the stimulator is not operating according to a second method which is a fully-automatic method in which the user is neither alerted to nor questioned about the operations that are automatically implemented by the device.

13. The method of claim 1 wherein the method is invoked when the stimulator is not operating according to a second method which is a non-automatic method in which the user may manually adjust the treatment protocol from time-to-time to cause treatment to occur in a desired manner.

14. The method of claim 1, wherein said system has a therapy program, wherein the program includes a module which allows the user 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.

15. A system for treating a medical disorder in a human patient, the system comprising:

an implantable device configured to operate using a first operating protocol and to provide a treatment to the patient;

wherein the implantable device is configured to use a hierarchical algorithm to selectively activate a second operating protocol based on an operating condition.

16. The system of claim 15 wherein the operating condition is met contingently upon the detection of a patient state which is defined in the alert event set and for which sensing operations are modified by increasing the number of sensor which are used to sense data.

17. The system of claim 15 wherein the operating condition is met contingently upon the detection of a patient, state which is defined in the alert event set and for which sensing operations are modified by increasing the number of stimulators which are used to provide therapy.

18. A system for monitoring a medical disorder in a human patient, the system comprising:

an implantable device configured to operate using a first operating protocol and to provide a monitoring of the patient;

wherein the implantable device is configured to use a hierarchical algorithm to selectively activate a second operating protocol based on an operating condition.

19. The system of claim 18 wherein the operating condition is met contingently upon the detection of a patient state which is defined in an alert event set and for which sensing operations are modified by increasing the number of sensors which are used to sense data.

20. The system of claim 18 wherein the operating condition is met contingently upon the detection of a patient state which is defined in an alert event set and for which sensing operations are modified by increasing the types of sensors which are used to sense data.