Methods and systems for determining subject-specific parameters for a neuromodulation therapy

• US 9,320,900 B2
• Filed: 12/29/2006
• Issued: 04/26/2016
• Est. Priority Date: 08/05/1998
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: DiLorenzo, Daniel John
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US11/647,700
• Publication Number:
  US 20070167991A1
• Time in Patent Office: 3,406 Days
• Field of Search: 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/372 : Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/3787 : from an external energy source

Abstract

A neurological control system for modulating activity of any component or structure comprising the entirety or portion of the nervous system, or any structure interfaced thereto, generally referred to herein as a “nervous system component.” The neurological control system generates neural modulation signals delivered to a nervous system component through one or more neuromodulators to control neurological state and prevent neurological signs and symptoms. Such treatment parameters may be derived from a neural response to previously delivered neural modulation signals sensed by one or more sensors, each configured to sense a particular characteristic indicative of a neurological or psychiatric condition.

Claims

1. A method of monitoring a subject, the method comprising:

monitoring high frequency head vibration, muscle vibration, or speech production using an acoustic sensor mounted in the subject'"'"'s head and coupled to a stimulating and recording circuit contained in an enclosure implanted in the subject;

monitoring head movement and position with respect to gravity using an accelerometer mounted in the patient'"'"'s head and coupled to the stimulating and recording circuit;

delivering a first neuromodulation therapy with the stimulating and recording circuit to manage a neurological symptom of the subject, wherein the first neuromodulation therapy is specified by a first set of parameters derived at least in part from a comparison of a disease state estimate and a reference input corresponding to a target disease state, wherein the disease state estimate is based at least in part on a patient motion signal of the accelerometer and an acoustic signal of the acoustic sensor;

recording the subject'"'"'s response to the first neuromodulation therapy with the stimulating and recording circuit, the subject'"'"'s response to the first neuromodulation therapy being calculated from a first set of data received from the accelerometer communicating with the subject and the acoustic sensor;

wirelessly transmitting the subject'"'"'s response to the first neuromodulation therapy from the stimulating and recording circuit to an external device that is external to the subject'"'"'s body;

delivering a second neuromodulation therapy with the stimulating and recording circuit, the second neuromodulation therapy specified by a second set of parameters, wherein the second set of parameters is defined by at least one parameter of the first set of parameters being automatically changed to a different value to provide the second set of parameters;

recording the subject'"'"'s response to the second neuromodulation therapy with the stimulating and recording circuit, the subject'"'"'s response to the second neuromodulation therapy being calculated from a second set of data received from the accelerometer and the acoustic sensor;

wirelessly transmitting the subject'"'"'s response to the second neuromodulation therapy from the stimulating and recording circuit to the external device; and

monitoring the responses to the first neuromodulation therapy and the second neuromodulation therapy from the external device.

2. The method of claim 1 wherein the monitoring of the responses comprises analyzing at least the first and second sets of data to determine an optimized set of parameters for a later delivered neuromodulation therapy.

3. The method of claim 2 wherein the first neuromodulation therapy and the second neuromodulation therapy are delivered to the subject using an implanted neuromodulation system, the method further comprising:

wirelessly programming the implanted neuromodulation system with the optimized set of parameters.

4. The method of claim 2 wherein the first neuromodulation therapy and the second neuromodulation therapy are delivered to the subject using an implanted neuromodulation system, wherein the implanted neuromodulation system is automatically programmed to use the optimized set of parameters for the later delivered neuromodulation therapy.

5. The method of claim 1 wherein the monitoring of the responses comprises analyzing the subject'"'"'s response to the first neuromodulation therapy and the subject'"'"'s response to the second neuromodulation therapy to determine an efficacy of at least one of the first neuromodulation therapy and the second neuromodulation therapy.

6. The method of claim 1 wherein the monitoring of the responses comprises recording at least one of the first set of parameters, the subject'"'"'s response to the first neuromodulation therapy, the second set of parameters, and the subject'"'"'s response to the second neuromodulation therapy, and wherein the recording is performed in a memory of the external device.

7. The method of claim 1 wherein the first neuromodulation therapy and/or the second neuromodulation therapy comprises an electrical stimulation delivered via at least one electrode and the different value comprises at least one of electrode configuration, stimulation current, stimulation voltage, stimulation frequency, pulse width, frequency of pulses within a burst, pulses per burst, frequency of bursts, duration of bursts, and pulse train count.

8. The method of claim 1 wherein at least one of the first and second neuromodulation therapies comprises vagus nerve stimulation.

9. The method of claim 1 wherein the accelerometer is one of a plurality of accelerometers.

10. The method of claim 1 wherein the recording of at least the subject'"'"'s response to the first neuromodulation therapy and the subject'"'"'s response to the second neuromodulation therapy comprises using a physiological sensor communicating with the subject.

11. The method of claim 10 wherein the physiological sensor is configured to sense subject respiration.

12. The method of claim 1 wherein the external device is configured to report a neurological state of the subject.

13. The method of claim 1, further comprising:

monitoring subject movement using an enclosure mounted accelerometer contained in the enclosure and coupled to the stimulating and recording circuit; and

monitoring muscle vibration using a second acoustic sensor coupled to the stimulating and recording circuit.