Auto adjusting system for brain tissue stimulator

• US 7,801,618 B2
• Filed: 06/22/2007
• Issued: 09/21/2010
• Est. Priority Date: 06/22/2007
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Pless, Benjamin D
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/767,432
• Publication Number:
  US 20080319511A1
• Time in Patent Office: 1,187 Days
• Field of Search: 607/59, 607/60, 607/62, 607/63
• US Class Current: 607/59
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/384 Recording apparatus or displays specially adapted therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An implantable neurostimulator for treating disorders such as epilepsy, pain, movement disorders and depression includes a detection subsystem capable of detecting a physiological condition and a therapy subsystem capable of providing a course of therapy in response to the condition. The therapy subsystem includes an auto-adjust module for automatically adjusting one or more parameters of the therapy so that the therapy subsystem can provide an adjusted parameter to the patient and solicit the patient'"'"'s feedback concerning the adjustment without requiring the presence of, or immediate involvement with, a clinician or physician. The patient feedback can be analyzed by computer, clinician or a combination of both to determine an optimal range of parameters for subsequent courses of therapy. In this manner, information useful in tuning the neurostimulator therapy parameters to optimize them for individual patient can be acquired automatically outside of the traditional clinical setting, saving time and minimizing patient fatigue that otherwise would be experience in marathon, in-clinic tuning sessions. The auto-adjust module also can be configured to prompt the patient to provide feedback even when parameters are not being adjusted, so as to acquire information for a baseline or about any placebo effect when the patient is otherwise expecting changes to the therapy to be made.

Claims

1. A device for delivering therapy to a patient and soliciting information about the therapy from the patient comprising:

a therapy module configured to provide a therapy characterized by at least one parameter to the patient;

a detection module configured to automatically detect a physiological event in the patient;

a controller configured to automatically determine the at least one parameter of the therapy based on the detected physiological event;

a prompting module configured to prompt the patient to express the patient'"'"'s opinion about the therapy; and

an input module configured to receive an input corresponding to the patient'"'"'s expressed opinion;

wherein the controller is further configured to automatically determine whether to change the at least one parameter of the therapy based on the detected physiological event and the expression of the patient'"'"'s opinion about the therapy.

2. The device of claim 1, wherein the controller further comprises settings for changing the therapy.

3. The device of claim 2, wherein the therapy comprises electrical stimulus, the settings for changing the therapy comprising an allowable range of values for the at least one parameter of the electrical stimulus.

4. The device of claim 1, wherein the controller further comprises a memory configured to store information about the changes made to the therapy.

5. The device of claim 4, wherein the controller further comprises a communication module configured to download information about the changes made to the therapy.

6. The device of claim 1, further comprising a communication module configured to communicate with an external reporting device configured to receive and record patient opinions about the adjusted therapy.

7. The device of claim 6, wherein the prompting module is configured to trigger the external reporting device to issue a prompt to the patient.

8. The device of claim 1, wherein the prompting module is configured to prompt the patient a plurality of times each time a change to the therapy is made by the controller.

9. The device of claim 1, wherein the controller is configured to change the at least one parameter a plurality of times, the prompting module being configured to prompt the patient at least once between each change performed by the controller.

10. The device of claim 9, wherein the prompting module is configured to prompt the patient more than once between two of the changes performed by the controller.

11. The device of claim 1, wherein the prompting module comprises a bone conduction microphone configured to provide an audible signal to the patient.

12. The device of claim 1, wherein the therapy module, the detection module, the controller, and the prompting module are configured to be implanted in a human body.

13. A method of delivering electrical stimulation therapy provided to a patient with an implantable neurostimulator and soliciting information about the therapy from the patient comprising:

delivering a first course of electrical stimulation therapy with the implantable neurostimulator with a first value of at least one parameter of the electrical stimulation;

automatically detecting with the implantable neurostimulator a physiological event in the patient;

automatically changing the first value to a second value of the least one parameter based on the detected physiological event;

delivering a second course of electrical stimulation therapy with the implantable neurostimulator to the patient with the second value;

prompting the patient to provide input reflecting the patient'"'"'s opinion about the therapy;

receiving an input corresponding to the patient'"'"'s expressed opinion about the therapy;

automatically determining whether to change the at least one parameter of the therapy prior to delivering a third course of electrical stimulation therapy based on the detected physiological event and the input reflecting the patient'"'"'s opinion about the changed therapy; and

if, it is determined to change the at least one parameter of the therapy prior to delivering a third course of electrical stimulation therapy, changing the at least one parameter of the therapy based on the detected physiological event and the input reflecting the patient'"'"'s opinion about the therapy.

14. The method of claim 13, further comprising recording the input from the patient.

15. The method of claim 14, wherein the input is stored in the implantable neurostimulator.

16. The method of claim 14, wherein the input is stored in an external patient-reporting device.

17. The method of claim 16, wherein the external patient-reporting device comprises a website linked to a handheld communication device.

18. The method of claim 16, wherein the external patient-reporting device comprises an Internet-enabled PC.

19. The method of claim 13, wherein prompting the patient to provide input further comprises providing a stimulus to the patient that is different from the electrical stimulation therapy characterizable by the at least one parameter.

20. The method of claim 13, wherein prompting the patient to provide input further comprises providing a signal from a bone conduction speaker to the patient.

21. The method of claim 13, wherein the at least one parameter comprises one of a duration, a frequency, an inter-pulse interval, and an amplitude of the electrical.

22. A device for delivering therapy to a patient comprising:

means for stimulating the patient according to a first treatment of stimulation, the stimulating means being implantable in the patient;

means for automatically detecting a physiological event in the patient;

means for automatically varying at least one parameter of the first treatment of stimulation based on the detected physiological event; and

means for prompting the patient to provide input about the therapy;

means for receiving an input corresponding to the patient'"'"'s expressed opinion;

wherein the varying means further automatically determines whether to vary the at least one parameter of the first treatment of stimulation based on the detected physiological event and the input about the therapy provided by the patient.

23. The device of claim 22, wherein the varying means includes means for varying at least one of pulse amplitude, pulse width, pulse-to-pulse interval, number of electrodes used, and duration of a stimulation signal of the first treatment.

24. The device of claim 23, wherein the varying means comprises means for changing the at least one of pulse amplitude, pulse width, pulse-to-pulse interval, number of electrodes used, and duration of a stimulation signal of the first treatment at a plurality of values in a range of parameters for automatically varying the first treatment.

25. The device of claim 22, wherein the prompting means includes means for requesting patient input a plurality of times without the varying means automatically varying the at least one parameter of the first treatment of stimulation.

26. The device of claim 22 further comprising means for recording the patient input.

27. The device of claim 26, wherein the recording means is collocated with the implantable stimulation means.

28. The device of claim 26, wherein the recording means comprises an external reporting means for receiving and recording the patient feedback.

29. A neurostimulator for delivering therapy to a patient and soliciting information about the therapy from the patient comprising:

a therapy module configured to provide electrical neurostimulation characterized by at least one parameter to the patient;

a detection module configured to automatically detect a neurological event in the patient;

a prompting module configured to prompt the patient to express the patient'"'"'s opinion about the electrical neurostimulation;

an input module configured to receive an input corresponding to the patient'"'"'s expressed opinion; and

a controller configured to automatically increase the at least one parameter of the electrical neurostimulation at a plurality of times, and configured to instruct the prompting module to prompt the patient after each increase, and configured to determine the at least one parameter for treatments of electrical neurostimulation subsequent to the plurality of times based on the detected neurological event and the expression of the patient'"'"'s opinion about the electrical neurostimulation.

30. A neurostimulator for delivering neurostimulation to a patient comprising:

a therapy module configured to provide electrical neurostimulation characterized by at least one parameter to the patient;

a detection module configured to automatically detect neurological seizures in the patient;

a prompting module configured to prompt the patient to express the patient'"'"'s opinion about the electrical neurostimulation;

an input module configured to receive an input corresponding to the patient'"'"'s expressed opinion; and

a controller configured to automatically change, according to a schedule of parameter changes, the at least one parameter of the electrical stimulation based on the detected neurological seizures, the expression of the patient'"'"'s opinion about the electrical stimulation, and the schedule of parameter changes, and further configured to automatically select the at least one parameter of the electrical neurostimulation for a regiment of therapy based on the parameter changes, the detected neurological seizures, and the expression of the patient'"'"'s opinion about the electrical stimulation.