Systems and methods for automatically optimizing stimulus parameters and electrode configurations for neuro-stimulators

• US 7,305,268 B2
• Filed: 10/15/2001
• Issued: 12/04/2007
• Est. Priority Date: 07/13/2000
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Northstar Neuroscience, Inc.
• Inventors: Gliner, Bradford Evan, Balzer, Jeffrey, Firlik, Andrew D.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/978,134
• Publication Number:
  US 20040158298A1
• Time in Patent Office: 2,241 Days
• Field of Search: 607/45, 607/46, 607/48, 607/62, 607 1- 3, 600/544, 600/545, 606/129
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Methods and devices for automatically optimizing the stimulus parameters and/or the configuration of electrodes to provide neural stimulation to a patient. In one embodiment, a system includes an electrode array having an implantable support member configured to be implanted into a patient and a plurality of therapy electrodes carried by the support member. The system can also have a pulse system operatively coupled to the therapy electrodes to deliver a stimulus to the therapy electrodes, and a sensing device configured to be attached to a sensing location of the patient. The sensing device generates response signals in response to the stimulus. The system can also include a controller operatively coupled to the pulse system and to the sensing device. The controller includes a computer operable medium that generates command signals that define the stimulus delivered by the pulse system, evaluates the response signals from the sensing device, and determines a desired configuration for the therapy electrodes and/or a desired stimulus to be delivered to the therapy electrodes.

Claims

1. In a computer, a method of automatically determining a favorable neuro-stimulation program for a patient, comprising:

applying an electrical stimulus having a plurality of stimulus parameters to a selected configuration of therapy electrodes that have been installed at a target therapy site of the central nervous system of a patient wherein applying an electrical stimulus includes applying an electrical stimulus at a sub-threshold level;

sensing a response to the applied electrical stimulus at a sensing device that has been installed at a sense location of the patient;

determining whether the response is within a desired range or an improvement over a previous sensed response from a different electrical stimulus and/or a different configuration of therapy electrodes;

selecting an alternate configuration of therapy electrodes and/or an alternate electrical stimulus, wherein the selecting procedure comprises computing an alternate stimulus parameter while maintaining a constant electrode configuration, and wherein computing the alternate stimulus parameter comprises correlating a plurality of different stimuli applied to the constant electrode configuration with corresponding sensed responses to determine a stimulus/response trend and estimating a new stimulus parameter that is expected to improve the efficacy according to the stimulus/response trend;

repeating the applying, sensing and determining procedures using the alternate configuration of therapy electrodes and/or the alternate electrical stimulus; and

choosing a configuration of therapy electrodes and/or an electrical stimulus corresponding to a sensed response that is within a desired range and/or provides a better result compared to other sensed responses.

2. The method of claim 1 wherein after choosing an electrical stimulus from one of the earlier applied electrical stimuli, the selecting procedure further comprises computing an alternate electrode configuration for use with the chosen electrical stimulus, and wherein computing the alternate electrode configuration comprises correlating a plurality of sensed responses with corresponding electrode configurations to which the constant stimulus parameters were applied to determine an electrode-configuration/response trend and estimating a new electrode configuration that is expected to improve the efficacy according to the electrode-configuration/response trend.

3. The method of claim 1 wherein the selecting procedure comprises increasing a stimulus parameter when a stimulus/response trend indicates that an increase in the stimulus parameter improves the efficacy of the stimulus.

4. The method of claim 1 wherein the selecting procedure comprises decreasing a stimulus parameter when a stimulus/response trend indicates that a decrease in the stimulus parameter improves the efficacy of the stimulus.

5. The method of claim 1 wherein the applying, sensing, determining, selecting, repeating and choosing procedures are repeated on the same patient within a period not greater than one week.

6. The method of claim 1 wherein the applying, sensing, determining, selecting, repeating and choosing procedures are repeated on the same patient on consecutive days.

7. The method of claim 1 wherein the applying, sensing, determining and selecting procedures are completed in a time period not greater than approximately 300 seconds.

8. The method of claim 1 wherein two iterations of the applying, sensing, determining and selecting procedures are repeated in a time period not greater than approximately 90 seconds.

9. The method of claim 1 wherein two iterations of the applying, sensing, determining and selecting procedures are repeated in a time period not greater than approximately 180 seconds.

10. The method of claim 1 wherein two iterations of the applying, sensing, determining and selecting procedures are repeated in a time period of approximately 20–

90 seconds.

11. The method of claim 1 wherein a single iteration of the applying, sensing, determining and selecting procedures is completed in a time period not greater than approximately 45 seconds.

12. The method of claim 1 wherein a single iteration of the applying, sensing, determining and selecting procedures is completed in a time period of approximately 10–

30 seconds.

13. The method of claim 1 wherein the sensing procedure comprises attaching EMG sensors to a sense site of the patient, detecting peripheral responses to the stimuli applied to the electrodes, and automatically sending the detected peripheral responses to the controller.

14. The method of claim 1 wherein the sensing procedure comprises detecting data related to neural activity using a functional MRI and automatically sending the data to the controller.

15. The method of claim 1 wherein the data comprises coordinates of neural activity relative to the therapy electrodes.

16. The method of claim 1 wherein the data comprises intensity levels of neural activity.

17. The method of claim 1 wherein applying an electrical stimulus includes applying an electrical stimulus at a subthreshold level below a level required to trigger a patient-detectable response.

18. The method of claim 1 wherein applying an electrical stimulus includes applying an electrical stimulus to a cortical target therapy site of the patient.

19. In a computer, a method of automatically determining a favorable neuro-stimulation program for a patient, comprising:

applying an electrical stimulus having a plurality of stimulus parameters to a selected configuration of therapy electrodes that have been installed at a target therapy site of the central nervous system of a patient wherein applying an electrical stimulus includes applying an electrical stimulus at a sub-threshold level;

sensing a response to the applied electrical stimulus at a sensing device that has been installed at a sense location of the patient;

determining whether the response is within a desired range or an improvement over a previous sensed response from a different configuration of therapy electrodes;

selecting an alternate configuration of therapy electrodes, wherein the selecting procedure comprises computing an alternate electrode configuration for use with the chosen electrical stimulus, and wherein computing the alternate electrode configuration comprises correlating a plurality of sensed responses with corresponding electrode configurations to determine an electrode-configuration/response trend and estimating a new electrode configuration that is expected to improve the efficacy according to the electrode-configuration/response trend;

repeating the applying, sensing and determining procedures using the alternate configuration of therapy electrodes; and

choosing a configuration of therapy electrodes corresponding to a sensed response that is within a desired range and/or provides a better result compared to other sensed responses.

20. The method of claim 19 wherein applying an electrical stimulus includes applying an electrical stimulus at a subthreshold level below a level required to trigger a patient-detectable response.

21. The method of claim 19 wherein applying an electrical stimulus includes applying an electrical stimulus to a cortical target therapy site of the patient.