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

• US 20070167991A1
• Filed: 12/29/2006
• Published: 07/19/2007
• Est. Priority Date: 08/05/1998
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Bioneuronics Corporation
• Inventors: DiLorenzo, Daniel
• Granted Patent: US 9,320,900 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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'"'"'s response to a plurality of neuromodulation therapies, the method comprising:

delivering a neuromodulation therapy that is adapted to prevent and/or manage a symptom of a subject suffering from a neurological or psychiatric disorder, wherein the neuromodulation therapy is specified by a set of parameters;

recording the set of parameters of the neuromodulation therapy and a subject'"'"'s response to the neuromodulation therapy;

delivering a subsequent neuromodulation therapy to the subject, wherein at least one parameter of the set of parameters of the subsequent neuromodulation therapy is automatically changed relative to the set of parameters of the previously delivered neuromodulation therapy; and

recording the set of parameters of the subsequent neuromodulation therapy and a subject'"'"'s response to the subsequent neuromodulation therapy.

2. The method of claim 1 wherein the symptom comprises seizure activity and the neurological disorder comprises epilepsy.

3. The method of claim 1 wherein recording the set of parameters of the neuromodulation therapy and the subject'"'"'s response to the neuromodulation therapy and recording the set of parameters of the subsequent neuromodulation therapy and the subject'"'"'s response to the subsequent neuromodulation therapy are performed in a memory in an implantable neuromodulation system.

4. The method of claim 3 further comprising wirelessly transmitting data that is indicative of the recorded parameters of the neuromodulation therapy and the subject'"'"'s response to the neuromodulation therapy and data that is indicative of the recorded set of parameters of the subsequent neuromodulation therapy and the subject'"'"'s response to the subsequent neuromodulation therapy from the memory of the implanted neuromodulation system to a memory of an external device that is external to the subject'"'"'s body.

5. The method of claim 1 further comprising analyzing the data that is indicative of the subject'"'"'s response to the neuromodulation therapy and the subject'"'"'s response to the subsequent neuromodulation therapy to determine a substantially optimal set of parameters for a later delivered neuromodulation therapy.

6. The method of claim 5 wherein the neuromodulation therapy and subsequent neuromodulation therapy are delivered to the subject using an implantable neuromodulation system, the method further comprising wirelessly programming the implantable neuromodulation system with the determined optimal parameters.

7. The method of claim 5 wherein the neuromodulation therapy and subsequent neuromodulation therapy are delivered to the subject using an implantable neuromodulation system, wherein the implantable neuromodulation system is automatically programmed to use the substantially optimal set of stimulation parameters for a later delivered neuromodulation therapy.

8. The method of claim 1 further comprising analyzing the subject'"'"'s response to the neuromodulation therapy and subject'"'"'s response to the subsequent neuromodulation therapy to determine efficacy of the neuromodulation therapy and efficacy of the subsequent neuromodulation therapy.

9. The method of claim 1 further comprising wirelessly transmitting data that is indicative of the set of parameters of the neuromodulation therapy and the subject'"'"'s response to the neuromodulation therapy and data that is indicative of the set of parameters of the subsequent neuromodulation therapy and the subject'"'"'s response to the subsequent neuromodulation therapy from an implantable neuromodulation system to a memory of a device external to the subject'"'"'s body,

wherein recording the parameters of the neuromodulation therapy and the subject'"'"'s response to the neuromodulation therapy and recording the parameters of the subsequent neuromodulation therapy and the subject'"'"'s response to the subsequent neuromodulation therapy are performed in the memory of the device external to the subject'"'"'s body.

10. The method of claim 1 wherein the neuromodulation therapy comprises electrical stimulation delivered via electrodes and the set of parameters 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.

11. The method of claim 1 wherein the neuromodulation therapy comprises intracranial electrical stimulation.

12. The method of claim 1 wherein the neuromodulation therapy comprises peripheral nerve electrical stimulation.

13. The method of claim 16 wherein the peripheral nerve comprises a vagus nerve.

14. The method of claim 1 wherein the neuromodulation therapy comprises delivery of medications.

15. The method of claim 14 wherein delivery of medications is performed with an implanted medication dispenser.

16. The method of claim 1 wherein the neuromodulation therapy and subsequent neuromodulation therapy(ies) are delivered when the symptom is detected and/or predicted through analysis of an EEG signal from the subject.

17. The method of claim 1 wherein the subject'"'"'s response comprises a brain activity response that is monitored with one or more brain electrodes that are in communication with the implantable neuromodulation system.

18. A method of determining patient-specific, substantially optimal stimulation parameters of a stimulation signal for managing a patient with epilepsy, the method comprising:

analyzing an EEG signal from a patient to detect and/or predict seizure activity;

delivering a first stimulation signal to the patient with an implanted stimulation and recording unit when the analysis of the EEG signal detects and/or predicts seizure activity, wherein the stimulation signal comprises a set of stimulation parameters;

recording the patient'"'"'s response to the first stimulation signal;

automatically determining parameters for a second stimulation signal, wherein the second stimulation signal comprises at least one changed parameter from the set of predetermined stimulation parameters of the first stimulation signal;

delivering the second stimulation signal with the implanted stimulation and recording unit when analysis of the EEG signal from the patient detects and/or predicts subsequent seizure activity;

recording the patient'"'"'s response to the second stimulation signal;

wirelessly transmitting data that is indicative of the patient'"'"'s response to the first stimulation signal, the set of parameters of the first stimulation signal, response to the second stimulation signal, and set of parameter of the second stimulation signal to a device that is external to the patient'"'"'s body;

analyzing the patient'"'"'s response to the first stimulation signal and response to the second stimulation signal to determine substantially optimal stimulation parameters; and

programming the implanted stimulation and recording unit with the determined substantially optimal stimulation parameters.

19. A system for delivering a neural modulation output to a subject suffering from a neurological or psychiatric disorder, the system comprising:

an assembly adapted to acquire a signal from a subject that is indicative or predictive of a symptom of the neurological or psychiatric disorder and to deliver a neural modulation output to the subject to manage and/or prevent the symptom of the neurological or psychiatric disorder;

an implantable device coupled to the assembly, the implantable device configured to automatically sweep through a plurality of neural modulation outputs that comprise different sets of neural modulation parameters; and

a memory that is adapted to store the different sets of stimulation parameters and the subject'"'"'s response to the neural modulation outputs that comprise different sets of neural modulation parameters.

20. The system of claim 19 wherein the neurological disorder comprises epilepsy and the symptom comprises seizure activity.

21. The system of claim 19 wherein the memory is disposed in an external device, the system further comprising the external device that is configured to be external to the subject'"'"'s body and is in wireless communication with the implantable device, the wireless communication being used to transmit the different sets of neural modulation parameters and the subject'"'"'s response to the neural modulation outputs that comprise different sets of neural modulation outputs from the implantable device to the memory of the external device.

22. The system of claim 21 wherein at least one of the external device and implantable device is configured to analyze the subject'"'"'s response to the neural modulation outputs that comprise different sets of neural modulation parameters to determine efficacy of the neural modulation outputs.

23. The system of claim 19 wherein the implantable device sweeps through the different sets of neural modulation parameters to determine substantially optimal neural modulation parameters of the neural modulation output to treat the subject'"'"'s neurological or psychiatric disorder.

24. The system of claim 23 wherein the substantially optimal neural modulation parameters are manually programmed by a user using an external device that is in wireless communication with the implantable device.

25. The system of claim 23 wherein the implantable device is programmed to automatically use the substantially optimal neural modulation parameters for later delivered neural modulation outputs.

26. The system of claim 19 wherein the neural modulation output comprises electrical stimulation and the assembly comprises a plurality of electrodes, wherein the neural modulation parameters comprise 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.

27. The system of claim 19 wherein the assembly comprises a plurality of electrodes, wherein a subset of electrodes are configured to acquire the physiological signals and a subset of electrodes are configured to deliver the neural modulation output.

28. The system of claim 19 wherein the neuromodulation output comprises intracranial electrical stimulation.

29. The system of claim 19 wherein the neuromodulation output comprises peripheral nerve electrical stimulation.

30. The system of claim 29 wherein the peripheral nerve comprises a vagus nerve.

31. The system of claim 19 wherein the neuromodulation output comprises delivery of medications.