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

• US 9,089,713 B2
• Filed: 10/24/2007
• Issued: 07/28/2015
• 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): Gedeon, Brian T
• Application Number:
  US11/877,897
• Publication Number:
  US 20080058773A1
• Time in Patent Office: 2,834 Days
• Field of Search: 128/903, 607 17- 20
• US Class Current: 1/1
• 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 providing medical therapy to a patient comprising:

a memory for storing a selected set of alert events for which alerting is defined to occur defining a set of medically relevant events based upon data sensed from said patient or a specified measurement of time related to an adjustment of therapy;

an implanted device containing at least one conduit, said implanted device configured for (1) monitoring said patient, (2) detecting said medically relevant events including at least one type of acute medical event that is sensed by said implanted device from said patient that are defined as alert events, providing therapy, and communicating with an external patient programmer;

a processor of a control subsystem configured to determine if said alert event has been detected by the implanted device, and if so automatically providing an alert signal to alarm said patient using at least one sensory modality;

an alert module configured to provide the alert signal according to at least one send alert rule responsive to said alert events detected by said implantable medical device based at least partly on the data sensed from said patient;

said external patient programmer configured for obtaining at least two types of patient response to the alert signal that is provided when (1) said external programmer receives at least one patient response during a first time interval, said first time interval being defined by said alert rule, or (2) said external programmer receives no response from said patient within said first time interval;

said processor being further configured to perform at least a first operation defining an adjustment to a therapy program according to at least one patient response rule of an alert protocol when said patient responds within said first time interval, said processor being further configured to automatically perform at least one second operation for determining whether or not to administer a predetermined therapy to said patient in the absence of a patient response within a second time interval defined by said alert rule, and, wherein at least one send alert rule and at least one patient response rule comprise a patient alert rule set which is selected in relation to at least one characteristic of a specified alert event, wherein the said at least one characteristic includes a severity value of the medically relevant event.

2. The system claim 1 wherein the send alert rule causes a parameter of the alert signal to increase at least once over an interval for which a patient input is not provided.

3. The system of claim 1 wherein the send alert rule causes the provision of an alert signal indicating a missed alert subsequent to a specified interval elapsing for which a patient input is not provided.

4. The system of claim 1 wherein the send alert rule causes the alert signal to be cancelled after a specified interval elapses for which a patient input is not provided and further causes the therapy adjustment to occur according to an input response rule that is selected for the type of alert event.

5. The system of claim 1 wherein the send alert rule causes the alert signal to be adjusted in a manner specified by the send alert rule after a specified interval elapses for which a user input is not provided.

6. The system of claim 1 wherein said processor is configured to adjust a therapy program that operates within the implanted device, and said therapy adjustment is related to at least one of the group of:

monitoring, alerting, and stimulation.

7. The system of claim 1 wherein said processor configured to adjust a therapy program is within the patient programmer, and said therapy adjustment is based upon at least one of the operations selected from the group of monitoring, alerting, and stimulation.

8. The system of claim 1 wherein said adjustment to the therapy program includes adjusting at least one criterion which is used to alert according to the detected at least one medically relevant event.

9. The system of claim 1 wherein said adjustment to the therapy program includes adjusting a value of a patient state parameter.

10. The system of claim 1 wherein the therapy includes providing stimulation according to a selectable stimulation protocol that is used to provide cardiac therapy to the patient.

11. The system of claim 1 wherein the alert signal includes a proposed adjustment to operate according to a sleeping protocol of the therapy program.

12. The system of claim 1 wherein the alert signal includes a proposed adjustment to operate according to an awake protocol of the therapy program.

13. The system of claim 1 wherein the alert signal includes a proposed adjustment to operate according to an exercise protocol of the therapy program.

14. The system of claim 1 wherein an alert event within the set of alert events is related to detection of ischemia.

15. The system of claim 1 wherein the external patient programmer is configured to receive a patient response which permits the selection of a delay operation which causes the proposed operation associated with the alert signal to be delayed a selected amount before it occurs.

16. The system of claim 1 wherein the external patient programmer is configured to receive a patient response which permits the selection of at least one of the following:

(1) a ‘

remind’

response which causes the therapy adjustment to be delayed and an alert signal to be re-sent at a later time; and

(2) a ‘

delay’

operation which causes the therapy adjustment to be delayed for a selected time interval before it is provided.

17. The system of claim 1 further comprising a sensor for sensing a signal that is processed by a processing module and patient state module to determine whether a patient state is one of the following:

asleep, awake, or exercising, and wherein this patient state information is used to adjust the patient alert rule set.

18. The system of claim 1 further comprising a patient state module which is configured to both calculate a patient state value and to determine if a change in patient state has occurred.

19. The system of claim 18 wherein the patient state module calculates a patient state value using a real-time clock which provides time-of-day information used in the calculation of the patient state.

20. The system of claim 1 further comprising a patient state module configured for use with a sensing system that is in communication with the implantable device and which provides sensed data information that is related to the calculation of patient state.

21. The system of claim 1 further comprising a sensor coupled to the system for sensing a signal that is processed by a processing module and patient state module to determine whether a patient state is one of:

asleep, awake, or exercising, and wherein this patient state information is used to adjust therapy.