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

• US 8,412,335 B2
• Filed: 06/04/2012
• Issued: 04/02/2013
• Est. Priority Date: 07/13/2000
• Status: Expired due to Fees

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Gliner, Bradford Evan, Balzer, Jeffrey, Firlik, Andrew D.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/487,472
• Publication Number:
  US 20120253421A1
• Time in Patent Office: 302 Days
• Field of Search: 607/45, 607/46
• 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

System and method for automatically optimizing the stimulus parameters and/or the configuration of electrodes to provide neural stimulation to a patient, the system includes an electrode array having a support member configured to be implanted into the 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 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. A method for optimizing electrical stimulation for an implantable stimulation device used to treat a patient'"'"'s neurological disorder, wherein the stimulation device comprises 1) an electrode array having a plurality of electrodes that is positioned at a target therapy site such that the array is above the skull and below the dura over the target therapy site;

and

     2) a sensing device that is capable of sensing the patient'"'"'s response to the electrical stimulation, the method comprising;

selecting a configuration of electrodes on the electrode array in which a first electrical stimulus is applied to the configuration of electrodes that have been positioned at the therapy site;

selecting an alternate configuration of electrodes on the electrode array in which a second electrical stimulus is applied to the alternate configuration of electrodes that have been positioned at the therapy site, wherein the selecting the alternate configuration of electrodes comprises correlating a plurality of sensed responses based upon sensing the patient'"'"'s response to the applied first or second electrical stimulus using the sensing device with corresponding electrode configurations to determine an electrode configuration/response trend and determining a new electrode configuration that is expected to improve efficacy according to the electrode-configuration/response trend; and

choosing a therapeutic configuration of electrodes corresponding to the sensed patient'"'"'s response that is within a desired range and/or provides an improved response compared to other sensed responses;

wherein the method further comprises (i) applying the electrical stimulation using the chosen therapeutic configuration of electrodes according to a plurality of stimulation frequencies to identify a bracketed range of optimal stimulation frequencies by sensing the patient response to each of the applied stimulation frequencies; and

(ii) choosing a therapeutic stimulation frequency within the bracketed range of optimal stimulation frequencies that provides an improved patient response.

2. The method of claim 1, wherein sensing the patient'"'"'s response comprises using a noninvasive imagining technique to measure cortical changes in a cortical neural tissue.

3. The method of claim 1, wherein the patient'"'"'s neurological disorder is depression.

4. The method of claim 1 wherein the selecting and choosing steps are performed manually.

5. The method of claim 1 wherein the selecting and choosing steps are performed automatically via a controller.

6. The method of claim 1 wherein an initial electrode configuration is preselected and stored in memory of the controller.

7. A method for optimizing therapeutic stimulation parameters for a patient suffering from pain or depression using therapy electrodes that have been positioned at a target therapy site within the central nervous system, the method comprising:

applying an electrical stimulus at a sub-threshold current intensity level relative to a threshold level for neurons at the target therapy site;

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

selecting an alternate stimulus parameter while maintaining a constant electrode configuration, wherein the alternate stimulus parameter comprises decreasing the sub-threshold current intensity to a lower level;

applying the alternate stimulus parameter;

correlating a change in a sensed response to determine a stimulus/response relationship that is expected to improve efficacy according to the stimulus/response relationship;

repeating the applying, sensing, selecting and correlating procedures using the alternate stimulus parameter; and

choosing the electrical stimulus corresponding to the sensed response that is within a desired range and/or provides a better result compared to other sensed responses.

8. The method of claim 7 further comprising repeating (a) the decreasing the sub-threshold current intensity to a lower level, (b) re-applying decreased sub-threshold stimulus the lower current intensity to the neurons, and (c) further determining whether application of the decreased sub-threshold current intensity further decreased a membrane activation threshold for the population of neurons until the membrane activation threshold by or to a selected level.

9. The method of claim 7 wherein applying a sub-threshold electrical stimulus includes applying the electrical stimulus from a location within the patient'"'"'s skull, external to a cortical surface of the patient'"'"'s brain.

10. The method of claim 7 wherein applying the electrical stimulus includes applying the electrical stimulus at a sub-cortical location.

11. The method of claim 7 wherein applying the electrical stimulus includes applying the electrical stimulus to a deep brain location.