# US 2013/0253299 A1 · Monitoring and regulating physiological states and functions via sensory neural inputs to the spinal cord

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- Number: US 2013/0253299 A1
- Document ID: US20130253299A1
- Status: Published application
- Kind: A1
- Application number: 13/843,023
- Filed: 2013-03-15
- Published: 2013-09-26
- Earliest claimed: 2012-03-20
- Assignees: University of Pittsburgh—Of the Commonwealth System of Higher Education
- Inventors: Douglas Weber; Robert Gaunt; Timothy Bruns
- Web page: https://patentgrep.com/patent/US20130253299A1

## CPC

- A61N 1/36139: {with automatic adjustment}
- A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle}
- A61B 5/202: {Assessing bladder functions, e.g. incontinence assessment}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/4064: {Evaluating the brain (for intracranial pressure A61B5/031; for cerebral blood gases A61B5/14553; using EEG A61B5/369)}
- A61B 5/4255: {Intestines, colon or appendix}
- A61B 5/4393: {Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation}
- A61B 5/4519: {Muscles (measuring muscular strength A61B5/224; using electromyography [EMG] A61B5/389)}
- A61B 5/4824: {Touch or pain perception evaluation (A61B5/4821 takes precedence)}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36071: {Pain}
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- A61N 1/36107: {Sexual dysfunction (stimulating genital organs A61N1/36007)}
- A61B 5/112: {Gait analysis}
- A61B 5/205: {Determining bladder or urethral pressure}
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/04: Arrangements of multiple sensors of the same type
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Methods and apparatuses for monitoring and regulating physiological states and functions are disclosed. Several embodiments include application of one or more microelectrode arrays to a dorsal root ganglion for measurement of sensory neuron activity, or stimulation of sensory reflex circuits. The methods and apparatuses can be used, for example, for monitoring or controlling bladder function in a patient.

## Claims

### Claim 1

A method of monitoring a physiological state of an organ or a tissue in a patient, comprising contacting at least one dorsal root ganglion in the patient with a microarray, wherein the microarray comprises a plurality of individual electrodes, the method further comprising a calibration phase and a monitoring phase, wherein:
(A) the calibration phase comprises:
measuring sensory neuron activity with the individual electrodes; and
correlating the sensory neuron activity measured with the individual electrodes in the array with the physiological state of the organ or the tissue in the patient to identify individual electrodes in the array that measure the sensory neuron activity associated with the physiological state; and
(B) the monitoring phase comprises:
measuring the sensory neuron activity associated with the physiological state with the identified individual electrodes; and
outputting an indication of the physiological state of the organ or the tissue to an effector, a user interface, a computer readable storage medium, and/or a local or remote computer system, to monitor the physiological state of the organ or the tissue in the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the microarray penetrates the dorsal root ganglion.

### Claim 3 (depends on 1)

The method of claim 1, wherein the microarray is closely coupled to the surface of the dorsal root ganglion.

### Claim 4 (depends on 1)

The method of claim 1, wherein the effector is a neuroprosthesis, an orthosis, an exoskeleton, an assistive device, or a drug pump.

### Claim 5 (depends on 1)

The method of claim 1, wherein the user interface alerts the patient to the indication of the physiological state.

### Claim 6 (depends on 1)

The method of claim 1, wherein the plurality of individual electrodes comprises at least 5 electrodes with a surface area of less than 200,000 μm2 each.

### Claim 7 (depends on 1)

The method of claim 1, wherein:
(1) the organ is a bladder or a bowel and the physiological state is fullness;
(2) the organ is a bladder or a bowel and the physiological state is lack of fullness;
(3) the organ is a stomach or intestine and the physiological state is fullness;
(4) the organ is a stomach or intestine and the physiological state is lack of fullness;
(5) the tissue is a muscle and the physiological state is contraction;
(6) the tissue is a muscle and the physiological state is relaxation; or
(7) the organ or tissue is an organ or tissue comprising a sensory receptor and the physiological state is sensation.

### Claim 8 (depends on 7)

The method of claim 7, wherein the organ or tissue is an organ or tissue comprising a sensory receptor and the physiological state is sensation of pain, heat, cold, and/or a mechanical stimulus.

### Claim 9 (depends on 1)

The method of claim 1, wherein the organ is a bladder, urethra, and/or urethral sphincter, the physiological state is bladder pressure, bladder volume, urethral pressure, urethral flow, urethral sphincter distension, and/or urethral sphincter contraction, and the indication of the physiological state is outputted to the user interface.

### Claim 10 (depends on 1)

The method of claim 1, wherein the organ is a rectum and/or an anal sphincter, the physiological state is rectal pressure, rectal volume, anal sphincter distension and/or anal sphincter contraction, and the indication of the physiological state is outputted to the user interface.

### Claim 11 (depends on 1)

The method of claim 1, wherein the physiological state comprises a symptom of a movement disorder.

### Claim 12 (depends on 11)

The method of claim 11, wherein the symptom of the movement disorder is tremor, rigidity, and/or spasticity, due to the movement disorder in the patient.

### Claim 13 (depends on 12)

The method of claim 12, further comprising treating the symptom of the movement disorder in the patient, wherein
the patient has a neuroprosthesis that activates to treat the symptom; and
outputting the indication of the symptom comprises outputting a signal that activates the neuroprosthesis to treat the symptom in the patient.

### Claim 14 (depends on 13)

The method of claim 13, wherein the neuroprosthesis is a brain stimulator.

### Claim 15 (depends on 1)

The method of claim 1, comprising monitoring a pressure ulcer in the patient, wherein the tissue is a tissue susceptible to pressure ulcer, the physiological state is harmful tissue compression, and wherein outputting the indication of harmful tissue compression in the tissue susceptible to the pressure ulcer monitors the pressure ulcer in the patient.

### Claim 16 (depends on 15)

The method of claim 15, wherein the indication of harmful tissue compression in the tissue susceptible to the pressure ulcer is outputted to a user interface that alerts the patient of the harmful tissue pressure.

### Claim 17 (depends on 1)

The method of claim 1, comprising closed-loop control of a limb action in the patient, wherein
the physiological function is limb action comprising posture, movement and/or force generation;
the tissue is muscle;
the physiological state is limb posture, movement, force, and/or or stiffness in the patient;
the patient has a prosthesis, orthosis, exoskeleton, or other assistive device that activates to control the limb action in the patient; and wherein
outputting the indication of limb state comprises outputting a signal that activates the neuroprosthesis to control the limb action in the patient.

### Claim 18 (depends on 1)

The method claim 1, further comprising inducing a physiological function of an organ or a tissue in a patient, comprising a second calibration phase and an inducement phase, wherein:
(C) the second calibration phase comprises:
stimulating sensory neuron activity with individual electrodes to activate a sensory reflex circuit that induces the physiological function of the organ or the tissue;
measuring activation of the physiological function of the organ or the tissue;
correlating activation of the physiological function with the stimulated sensory neuron to identify individual electrodes that can activate the sensory reflex circuit that induces the physiological function; and
(D) the inducement phase comprises:
activating the sensory reflex circuit by stimulating sensory neuron activity with the identified individual electrodes to induce the physiological function in the patient.

### Claim 19 (depends on 18)

The method of claim 18, wherein the inducement phase is under user control.

### Claim 20 (depends on 18)

The method of claim 18, wherein outputting the indication of the physiological state of the organ or the tissue triggers stimulation of the sensory neuron activity with the identified individual electrodes to activate the sensory reflex circuit that induces the physiological function in the patient.

### Claim 21 (depends on 18)

The method of claim 18, comprising inducing bladder and/or bowel continence in the patient, wherein
(1) the organ is a bladder, urethra, and/or urethral sphincter, the physiological state is lack of bladder fullness and/or incontinence, and the physiological function is continence, and wherein outputting the indication of physiological state triggers stimulation of the sensory neuron activity with the identified individual electrodes to activate a sensory reflex circuit that induces bladder continence in the patient; or
(2) the organ is a rectum and/or anal sphincter, the physiological state is lack of bowel fullness and/or incontinence, and the physiological function is continence, and wherein outputting the indication of the physiological state triggers stimulation of the sensory neuron activity with the identified individual electrodes to activate a sensory reflex circuit that induces bowel continence in the patient.

### Claim 22 (depends on 18)

The method of claim 18, comprising inducing bladder and/or bowel voiding in the patient, wherein the organ is a bladder, urethra, and/or urethral sphincter, the physiological state is bladder voiding, and the physiological function is bladder voiding, and wherein outputting the indication of physiological state triggers stimulation of the sensory neuron activity with the identified individual electrodes to activate a sensory reflex circuit that induces bladder voiding in the patient/

### Claim 23

A method of inducing a physiological function of an organ or a tissue in a patient, comprising contacting at least one dorsal root ganglion in the patient with a microarray, wherein the array comprises a plurality of individual electrodes, and further comprising a calibration phase and an inducement phase, wherein:
(A) the calibration phase comprises:
stimulating sensory neuron activity with the individual electrodes to activate sensory neurons and/or a sensory reflex circuit that induces the physiological function of the organ or the tissue;
measuring activation of the physiological function of the organ or the tissue; and
correlating activation of the physiological function with the stimulated sensory neuron activity to identify individual electrodes that can activate the sensory neurons and/or the sensory reflex circuit that induces the physiological function; and
(B) the inducement phase comprises:
activating the sensory neurons and/or sensory reflex circuit by stimulating the sensory neurons with the identified individual electrodes to induce the physiological function of the organ or tissue in the patient.

### Claim 24 (depends on 23)

The method of claim 23, wherein the microarray penetrates the dorsal root ganglion.

### Claim 25 (depends on 23)

The method of claim 23, wherein the microarray is closely coupled to the surface of the dorsal root ganglion.

### Claim 26 (depends on 23)

The method of claim 23, wherein the inducement phase is under user control.

### Claim 27 (depends on 23)

The method of claim 23, wherein
(1) the organ is a bladder, urethra, and/or a urethral sphincter; or
a rectum and/or an anal sphincter; and
the function is voiding;
(2) the organ is a bladder, urethra, and/or a urethral sphincter; or
a rectum and/or an anal sphincter; and
the function is continence;
(3) the organ is a penis, and the function is erectile function or ejaculation;
(4) the organ is a brain and the function is sensation of a mechanical or an environmental stimulus;
(5) the organ is a brain and the function is neuronal activity that masks or blocks sensation of pain; or
(6) the tissue is a muscle and the function is contraction or relaxation.

### Claim 28 (depends on 23)

The method of claim 23, comprising controlling limb movement in the patient, wherein the physiological function is limb movement and the tissue is muscle, wherein
(A) the calibration phase comprises:
stimulating a threshold sensory neuron activity with the individual electrodes to activate a sensory reflex circuit that induces the limb movement in the patient;
measuring activation of the limb movement; and
correlating activation of the limb movement with the stimulated threshold sensory neuron activity to identify individual electrodes that can activate the sensory reflex circuit that induces the limb movement; and
(B) the inducement phase comprises:
activating the sensory reflex circuit by stimulating the threshold sensory neuron activity with the identified individual electrodes to induce the limb movement in the patient.

### Claim 29 (depends on 23)

The method of claim 23, wherein the plurality of individual electrodes comprises at least 5 electrodes with a surface area of less than 200,000 μm2 each.

### Claim 30

An apparatus for monitoring the physiological state of an organ or a tissue in a patient, comprising:
a microelectrode array for implanting or close coupling to a surface of at least one dorsal root ganglion of the patient, wherein the array comprises a plurality of individual electrodes;
a circuit for assessing sensory neuron activity measured through the individual electrodes of the array;
a circuit for calculating the physiological state of the organ from the sensory neuron activity;
a mechanism for alerting the patient of the physiological state of the organ or the tissue or for storing the physiological state for reference; and
a mechanism for regulating a neurostimulator, drug pump or other effector using feedback signals from the organ or tissue; and
optionally comprising a mechanism for the patient to select the function to be controlled.

### Claim 31

An apparatus for inducing a physiological function of an organ or a tissue in a patient, comprising:
a microelectrode array for implanting or close coupling to a surface of at least one dorsal root ganglion of the patient, wherein the array comprises a plurality of individual electrodes; and
a stimulator operably connected to the microelectrode array, wherein the stimulator is adapted to provide an electrical stimulus to the individual electrodes to activate the sensory circuits; and
optionally comprising a mechanism for the patient to select the function to be controlled.