NEUROSTIMULATOR

• US 20140180361A1
• Filed: 03/26/2012
• Published: 06/26/2014
• Est. Priority Date: 03/24/2011
• Status: Active Grant

• 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., Angeli, Claudia A., Nandra, Mandheerej S., Desautels, Thomas Anthony, Jackson, Douglas J., Hodes, Johnathan, Upchruch, Steven L., Terrafranca, Nicholas A. Jr.
• Granted Patent: US 9,409,023 B2
• Time in Patent Office: Days
• US Class Current: 607/49
• 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 device for use with groups (e.g., more than four groups) of electrodes. The neurostimulator may include a stimulation assembly configured to deliver different stimulation to each of the groups. The neurostimulator may also include at least one processor configured to direct the stimulation assembly to deliver stimulation to the groups. The stimulation delivered to at least one of the groups may include one or more waveform shapes other than a square or rectangular wave shape. The processor may receive data from one or more sensors and use that data to modify the stimulation delivered. The neurostimulator may be configured to communicate with an external computing device. The neurostimulator may send data to and/or receive data and/or instructions from the computing device. The computing device may use information collected by one or more sensors to at least partially determine stimulation parameters to communicate to the neurostimulator.

Claims

1-51. -51. (canceled)

52. A device for use with a plurality of electrodes, and one or more sensors, the device comprising:

a stimulation assembly connectable to the plurality of electrodes, the stimulation assembly being configured to deliver stimulation to selected ones of the plurality of electrodes when the stimulation assembly is connected to the plurality of electrodes;

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;

at least one processor connected to both the stimulation assembly and the sensor interface, the at least one processor being configured to direct the stimulation assembly to deliver at least one complex stimulation pattern to the selected ones of the plurality of 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.

53. The device of claim 52, wherein the at least one complex stimulation pattern comprises a first stimulation pattern followed by a second stimulation pattern,

wherein the second stimulation pattern is delivered to a second portion of the selected ones of the plurality of electrodes less than about one microsecond after the first stimulation pattern is delivered to a first portion of the selected ones of the plurality of electrodes, and

wherein the first stimulation pattern is delivered to a first portion of the selected ones of the plurality of electrodes, and the second stimulation pattern is delivered to a second portion of the selected ones of the plurality of electrodes, the first portion being different from the second portion.

54. The device of claim 52, 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.

55. The device of claim 52, wherein the at least one processor is configured to receive and record electrical signals from the plurality of electrodes, wherein the at least one processor is configured to transmit the recorded electrical signals to a computing device and to receive information therefrom, the at least one processor being configured to modify the at least one complex stimulation pattern based at least in part on the information received from the computing device;

or

wherein the at least one processor is configured to record the signals received from the sensor interface, transmit the recorded electrical signals to the computing device, and receive information from the computing device, the at least one processor being configured to modify the at least one complex stimulation pattern based at least in part on the information received from the computing device.

56. The device of claim 52, 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.

57. The device of claim 52, wherein the plurality of sensors comprise at least one of an electromyography sensor, an evoked potential sensor, a joint angle sensor, an accelerometer, a gyroscope sensor, a flow sensor, a pressure sensor, a load sensor, and a temperature sensor.

58. The device of claim 52, wherein the device is configured to aid a subject having a neurologically derived paralysis in a portion of the patient'"'"'s body, the subject having a spinal cord with at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated,

wherein when the at least one complex stimulation pattern is applied to a portion of the spinal cord of the patient, the at least one complex stimulation pattern is below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) neurological signals originating from the portion of the patient'"'"'s body having the paralysis, and (b) supraspinal signals.

59. The device of claim 52, wherein the device is configured to aid a subject having a neurologically derived paralysis in a portion of the patient'"'"'s body, physical training inducing induced neurological signals in the portion of the patient'"'"'s body having the paralysis, the subject having a spinal cord with at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated, and adding the induced neurological signals has no additional effect on the at least one selected spinal circuit, the induced neurological signals being below the first stimulation threshold and insufficient to activate the at least one selected spinal circuit,

wherein when the at least one complex stimulation pattern is applied to a portion of the spinal cord of the patient, the at least one complex stimulation pattern is below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) a portion of the induced neurological signals, and (b) supraspinal signals.

60. The device of claim 59, wherein when at least partially activated the at least one selected spinal circuit 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, voiding the subject'"'"'s bladder, sexual function, voiding the subject'"'"'s bowel, postural activity, locomotor activity, cardiovascular function, respiratory function, digestive function, autonomic function, motor function, vasomotor function, cognitive function, body temperature, and metabolic processes.

61. The device of claim 59, wherein the induced neurological signals comprise at least one of postural proprioceptive signals, locomotor proprioceptive signals, and the supraspinal signals.

62. The device of claim 52, further including at least one recording electrode, wherein the at least one processor is connected to the at least one recording electrode, and configured to receive and record electrical signals received from the at least one recording electrode.

63. The device of claim 52, wherein the selected ones of the plurality of electrodes include more than four groups of electrodes;

and the at least one complex stimulation pattern comprises different electrical stimulation for each of the groups of electrodes.

64. A system for use with a subject having body tissue, and one or more sensors positioned to collect physiological data related to the subject, the system comprising:

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

a neurostimulator device connected to the plurality of electrodes and configured to deliver complex stimulation patterns thereto; 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 the physiological data collected by the one or more sensors.

65. The system of claim 64, wherein the computing device is configured to perform a machine learning method implementing a Gaussian Process Optimization operable to determine the stimulation parameters.

66. The system of claim 64, wherein the neurostimulator device is configured to generate the complex stimulation patterns based at least in part on one or more stimulation parameters determined by the neurostimulator device.

67. The system of claim 66, wherein the neurostimulator device is configured to perform a machine learning method implementing a Gaussian Process Optimization operable to determine the one or more stimulation parameters.

68. The system of claim 64, wherein the neurostimulator device is connected to the one or more sensors, and configured to transmit the physiological data collected by the one or more sensors to the computing device which is connected to the one or more sensors, and configured to receive the physiological data from the one or more sensors.

69. The system of claim 68, wherein the one or more sensors comprise at least one of a surface EMG electrode, a motion capture system, a foot force plate sensor, an in-shoe sensor, an accelerator, and a gyroscope sensor attached to or positioned adjacent the body of the subject.

70. The system of claim 64, wherein the device is configured to aid the subject having a body, a spinal cord, and a neurologically derived paralysis in a portion of the subject'"'"'s body, the spinal cord having at least one selected spinal circuit that has a first stimulation threshold representing a minimum amount of stimulation required to activate the at least one selected spinal circuit, and a second stimulation threshold representing an amount of stimulation above which the at least one selected spinal circuit is fully activated, the system further comprising:

a training device configured to physically train the subject and thereby induce induced neurological signals in the portion of the patient'"'"'s body having the paralysis, the induced neurological signals being below the first stimulation threshold and insufficient to activate the at least one selected spinal circuit, the complex stimulation patterns being below the second stimulation threshold such that the at least one selected spinal circuit is at least partially activatable by the addition of at least one of (a) a portion of the induced neurological signals, and (b) supraspinal signals.

71. The system of claim 64, 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, a dura, a spinal nerve, a ganglia, a brain stem, a brain, a nerve fiber and an end organ.

72. The system of claim 64, 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.

73. The system of claim 64, wherein the electrode array is a high-density electrode array and adjacent ones of the plurality of electrodes are positioned within 200-500 micrometers of each other in the high-density electrode array.

74. The system of claim 64, wherein the stimulation parameters identify a waveform shape, amplitude, frequency, and relative phasing of one or more electrical pulses delivered to one or more pairs of the plurality of electrodes.

75. The system of claim 64, wherein each of the complex stimulation patterns includes a plurality of different electrical signals each delivered to a different pair of the plurality of electrodes.

76. A system including a network, a subject having body tissue, and one or more sensors positioned to collect physiological data related to the subject, the system comprising:

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

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

a first computing device connected to the network and 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 first computing device; and

a remote second computing device connected to the network, the first computing device being configured to transmit the physiological data collected by the one or more sensors to the second computing device, the second computing device being configured to determine the stimulation parameters based at least in part on the physiological data collected by the one or more sensors, and transmit the stimulation parameters to the first computing device.

77. The system of claim 76, wherein the first computing device is configured to receive instructions from the second computing device and transmit them to the neurostimulator device.

78. The system of claim 76, wherein the first computing device is configured to receive data from the neurostimulator device and communicate the data to the second computing device over the network.