Neurostimulator

• US 20150231396A1
• Filed: 01/23/2015
• Published: 08/20/2015
• Est. Priority Date: 03/24/2011
• Status: Abandoned Application

• Current Assignee: California Institute of Technology, Institute of Technology (Select Education Group LLC), Regents of the University of California (University of California), University of Louisville
• Original Assignee: California Institute of Technology, Regents of the University of California (University of California), University of Louisville
• Inventors: Burdick, Joel W., Tai, Yu-Chong, Naber, John F., Keynton, Robert S., Edgerton, Victor Reggie, Roy, Roland R., Gerasimenko, Yury, Harkema, Susan J., Hodes, Johnathan, Angeli, Claudia A., Nandra, Mandheerej S., Desautels, Thomas Anthony, Jackson, Douglas J., Terrafranca, Nicholas A., Upchurch, Steven L.
• Application Number:
  US14/604,625
• Publication Number:
  US 20150231396A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/09 Rehabilitation or training
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• 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 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

A neurostimulator devices and systems for use with groups of electrodes placed within a subject'"'"'s body. The devices and systems can include training devices and/or pulse generation systems.

Claims

1. A neurostimulator system comprising:

a stimulation assembly connectable to a plurality of electrodes, the stimulation assembly being configured to deliver stimulation to selected electrodes within the plurality of electrodes when the stimulation assembly is connected to the plurality of electrodes and wherein the stimulation assembly includes a pulse generating system;

a sensor interface connectable to the one or more sensors, the sensor interface being configured to receive signals from the one or more sensors when the sensor interface is connected to the one or more sensors; and

at least one processor connected to the stimulation assembly, the pulse generating system, and the sensor interface, the at least one processor is configured to direct the stimulation assembly and the pulse generating system to deliver at least one complex stimulation pattern to the selected electrodes, and to receive the signals from the sensor interface, the at least one processor being further configured to modify the at least one complex stimulation pattern delivered by the stimulation assembly based on the signals received from the sensor interface, the plurality of electrodes and the pulse generating system.

2. The system of claim 1, wherein the at least one complex stimulation pattern comprises a first stimulation pattern followed by a second stimulation pattern.

3. The system of claim 1, wherein the at least one processor is configured to perform a machine learning method based on the signals received from the sensor interface to determine a set of stimulation parameters, and the at least one processor modifies the at least one complex stimulation pattern based at least in part on the set of stimulation parameters.

4. The system of claim 1, wherein the at least one processor is configured to receive and record electrical signals from the plurality of electrodes.

5. The system of claim 1, wherein the at least one processor is configured to receive electrical signals from the plurality of electrodes, and modify the at least one complex stimulation pattern based at least in part on the electrical signals received from the plurality of electrodes.

6. The system of claim 1, wherein the plurality of sensors comprise at least one of an electromyography sensor, a joint angle sensor, a flex sensor, an accelerometer, a gyroscope sensor, a flow sensor, a pressure sensor, a temperature sensor, a vibration sensor, a chemical sensor, a light sensor, a photonic sensor, and a load sensor.

7. The system of claim 1, wherein the neurostimulator system produces improved neurological function comprising at least one of voluntary movement of muscles involved in at least one of standing, stepping, reaching, grasping, voluntarily changing positions of one or both legs, voluntarily changing positions of one or both arms, voluntarily changing position of one'"'"'s neck, voiding the subject'"'"'s bladder, voiding the subject'"'"'s bowel, breathing, coughing, chewing, swallowing, speaking, blinking, focusing visual fields, postural activity changing core (trunk) position, and locomotor activity, or improve muscle tone, or improved autonomic control of at least one of voiding the subject'"'"'s bladder, voiding the subject'"'"'s bowel, cardiovascular function, respiratory function, digestive function, body temperature, and metabolic processes.

8. The system of claim 1, wherein the pulse generating system is a MEDTRONIC®

INTERSTIM®

, MEDTRONIC®

ENTERRA®

, ENTEROWAVE®

GI Neuromodualtion System, ST. JUDE MEDICAL®

ACCENT™

Pacemaker, ST. JUDE MEDICAL®

MICRONY™

Pacemaker, ST. JUDE MEDICAL®

ZEPHYR™

Pacemanker, ST. JUDE MEDICAL®

CURRENT™

Plus ICD, ST. JUDE MEDICAL®

ELLIPSE™

ICD, CAMERON HEALTH®

SQ-RX Pulse Generator, MEDTRONIC®

VIVA™

XT, MEDTRONIC®

VIVA™

S, MEDTRONIC®

PROTECTA™

XT, MEDTRONIC®

PROTECTA™

S, BOSTON SCIENTIFIC®

PRECISION SPECTRA®

, NEVRO®

SENZA®

system, STIMWAVE®

Freedom SCS system, or Axionics Sacral Neuromodulation System.

9. The system of claim 1, wherein the stimulation assembly is a MEDTRONIC®

RESTORESENSOR®

, MEDTRONIC®

RESTOREULTRA®

, MEDTRONIC®

RESTOREADVANCED®

, MEDTRONIC®

RESTOREPRIME®

, MEDTRONIC®

PRIMEADVANCED®

, MEDTRONIC®

ITREL®

4, BOSTON SCIENTIFIC®

PRECISION PLUS™

SCS System, BOSTON SCIENTIFIC®

PRECISION SPECTRA™

SCS SYSTEM, SPINAL MODULATION™

AXIUM™

neurostimulator, ST. JUDE MEDICAL®

EON MINI™

, ST. JUDE MEDICAL®

EON C™

, or ST. JUDE MEDICAL®

EON Rechargeable IPG., NEVRO®

SENZA®

Neuromodualtion System, MAIN STAY MEDICAL REACTIV8, NEVRO®

MATRI SOLEVE, NEVRO®

SENZA®

, BOSTON SCIENTIFIC®

PRECISION SPECTRA®

, STIMWAVE®

Freedom SCS system, or Axionics Sacral Neuromodulation System.

10. A neurostimulator training system comprising:

a plurality of electrodes arranged in an electrode array implantable adjacent to body tissue;

a neurostimulator device connected to the plurality of electrodes and configured to deliver complex stimulation patterns to the plurality of electrodes;

at least one training device; and

a computing device configured to transmit stimulation parameters to the neurostimulator device, the neurostimulator device being configured to generate the complex stimulation patterns based at least in part on the stimulation parameters received from the computing device, the computing device being further configured to determine the stimulation parameters based on at least in part on data collected by the one or more sensors. Restorative

11. The neurostimulator training system of claim 10, wherein the at least one training device includes robotics, exoskeletons, treadmills, canes, walkers, crutches, body weight support systems, physical therapy, or a combination thereof.

12. The neurostimulator training system of claim 10, wherein the at least one training device is an EKSO™

Bionic Suit by EKSO™

BIONICS®

, a REWALK™

system by Argo Medical Technologies, a THERASTRIDE™

system by INNOVENTOR®

, a RT300 system by Restorative Therapies, a RT200 system by Restorative Therapies, a RT600 system by Restorative Therapies, or a LOCOMAT®

system by HOCOMA®

.

13. The neurostimulator training system of claim 10, wherein the neurostimulator device is connected to the one or more additional sensors outside the at least one training device, and configured to transmit the physiological data collected by the one or more additional sensors to the computing device.

14. The neurostimulator training system of claim 13, wherein the one or more additional sensors comprise at least one of a surface electromyography electrode sensor, a joint angle sensor, a flex sensor, a foot force plate sensor, an in-shoe sensor, an accelerator, a gyroscope sensor, a flow sensor, a pressure sensor, a temperature sensor, a motion capture system, a vibration sensor, a chemical sensor, a light sensor, a photonic sensor, and a load sensor attached to or positioned adjacent the body of the subject.

15. The neurostimulator training system of claim 10, wherein the electrode array is implantable adjacent at least one of a portion of the spinal cord, one or more spinal nerves, one or more nerve roots, one or more peripheral nerves, the brain stem, the brain, and an end organ.

16. The neurostimulator training system of claim 10 configured to use with the subject having a spinal cord with a dura, wherein the electrode array is implantable along a portion of the dura of the spinal cord or along the dorsal root.

17. The neurostimulator training system of claim 10, further comprising:

at least one recording electrode connected to the neurostimulator device, the neurostimulator device being configured to receive and record electrical signals received from the at least one recording electrode.

18. The neurostimulator training system of claim 10, wherein the stimulation assembly further comprises a pulse generating system.

19. The neurostimulator training system of claim 18, wherein the pulse generating system is a MEDTRONIC®

INTERSTIM®

, MEDTRONIC®

ENTERRA®

, ENTEROWAVE®

GI Neuromodualtion System, ST. JUDE MEDICAL®

ACCENT™

Pacemaker, ST. JUDE MEDICAL®

MICRONY™

Pacemaker, ST. JUDE MEDICAL®

ZEPHYR™

Pacemanker, ST. JUDE MEDICAL®

CURRENT™

Plus ICD, ST. JUDE MEDICAL®

ELLIPSE™

ICD, CAMERON HEALTH®

SQ-RX Pulse Generator, MEDTRONIC®

VIVA™

XT, MEDTRONIC®

VIVA™

S, MEDTRONIC®

PROTECTA™

XT, MEDTRONIC®

PROTECTA™

S, BOSTON SCIENTIFIC®

'"'"'s PRECISION SPECTRA®

, NEVRO®

SENZA®

system, STIMWAVE®

Freedom SCS system, or Axionics Sacral Neuromodulation System.

20. The neurostimulator training system of claim 10, wherein the stimulation assembly is a MEDTRONIC®

RESTORESENSOR®

, MEDTRONIC®

RESTOREULTRA®

, MEDTRONIC®

RESTOREADVANCED®

, MEDTRONIC®

RESTOREPRIME®

, MEDTRONIC®

PRIMEADVANCED®

, MEDTRONIC®

ITREL®

4, BOSTON SCIENTIFIC®

PRECISION PLUS™

SCS System, BOSTON SCIENTIFIC®

PRECISION SPECTRA™

SCS SYSTEM, SPINAL MODULATION™

AXIUM™

neurostimulator, ST. JUDE MEDICAL®

EON MINI™

, ST. JUDE MEDICAL®

EON C™

, ST. JUDE MEDICAL®

EON Rechargeable IPG., NEVRO®

SENZA®

High Frequency Neuromodualtion System, MAIN STAY MEDICAL REACTIV8, NEVRO®

MATRI SOLEVE, NEVRO®

SENZA®

, BOSTON SCIENTIFIC®

'"'"'s PRECISION SPECTRA®

, STIMWAVE®

Freedom SCS system, or Axionics Sacral Neuromodulation System.