# US 12,708,772 B2 · Accessing spinal network to enable respiratory function

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- Number: US 12,708,772 B2
- Document ID: US12708772B2
- Status: Granted
- Kind: B2
- Application number: 15/740,323
- Filed: 2016-07-11
- Published: 2018-07-05
- Granted: 2026-08-18
- Earliest claimed: 2015-07-13
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Daniel C. Lu
- Web page: https://patentgrep.com/patent/US12708772B2

## CPC

- A61N 1/3611: {Respiration control (stimulating respiratory organs A61N1/3601)}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36175: {Pulse width or duty cycle}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence)
- A61N 1/3615: {Intensity}
- A61N 1/36171: {Frequency}
- 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)

## Abstract

In various embodiments, methods are provided for improving, and/or regulating, and/or restoring respiration in a subject with a respiratory deficiency. In certain embodiments the methods involve neuromodulating the cervical spinal cord of a subject by administering transcutaneous stimulation to the cervical spinal cord or a region thereof at a frequency and intensity sufficient to regulate and/or to restore respiration; and/or neuromodulating the cervical spinal cord of a subject by administering epidural stimulation to the cervical spinal cord or a region thereof at a frequency and intensity sufficient to regulate and/or to restore respiration; and/or neuromodulating the cervical spinal cord of a subject with a magnetic stimulator at a frequency and intensity sufficient to regulate and/or to restore respiration.

## Claims

### Claim 1

A method of improving, and/or regulating, and/or restoring respiration in a subject with a respiratory deficiency, said method comprising:
administering, via at least one electrode placed on a dorsal spinal cord of the subject, epidural stimulation to the dorsal spinal cord using a stimulation selected to cause neuromodulation of interneurons of the dorsal spinal cord to generate a respiratory rhythm caused by a firing pattern of a respiratory central pattern generation (CPG), wherein the respiratory rhythm is caused by an activated respiratory drive of the subject;
receiving at least one of an O2 saturation, an end tidal CO2, a heart rate, and a tidal volume of the subject using one or more sensors; and
adjusting at least one of a pulse amplitude, a pulse-width, a pulse frequency, and a duty cycle of said epidural stimulation based on the at least one of the O2 saturation, the end tidal CO2, the heart rate, and the tidal volume to provide a desired tidal volume, O2 saturation, and end tidal CO2.

### Claim 2 (depends on 1)

The method of claim 1, wherein:
a stimulation pattern is altered in response to respiration rate and/or tidal volume; and/or
said stimulation pattern is altered in response to heart rate.

### Claim 3 (depends on 1)

The method of claim 1, wherein said respiratory deficiency is due to a spinal cord injury.

### Claim 4 (depends on 3)

The method of claim 3, wherein said spinal cord injury is clinically classified as motor complete.

### Claim 5 (depends on 3)

The method of claim 3, wherein said spinal cord injury is clinically classified as motor incomplete.

### Claim 6 (depends on 1)

The method of claim 1, wherein:
said respiratory deficiency is due to a neurodegenerative disorder; or
said respiratory deficiency is due to an ischemic brain injury; or
said subject is at risk for sudden infant death syndrome (SIDS); or
said subject is in intensive care unit patient with decreased respiratory drive; or
said respiratory deficiency is acute respiratory distress syndrome (ARDS), or acute respiratory failure; or
said respiratory deficiency is due to alcohol intoxication and/or a drug overdose; or
said respiratory deficiency is due to a drug overdose.

### Claim 7 (depends on 1)

The method of claim 1, wherein said method further comprises administering at least one monoaminergic agonist to said subject.

### Claim 8 (depends on 1)

A stimulator configured to induce epidural in a cervical region of a subject according to claim 1.

### Claim 9 (depends on 1)

The method of claim 1, wherein said neuromodulating utilizes:
a stimulator configured to induce epidural stimulation in a cervical region of a subject at a frequency and amplitude that improves, and/or regulates, and/or restores respiration in a subject with a respiratory deficiency; and
one or more sensor selected from the group consisting of a sensor that detects chest wall movement and/or expansion.

### Claim 10 (depends on 9)

The method of claim 9, wherein:
said stimulator is configured to induce epidural stimulation of a cervical spinal cord.

### Claim 11 (depends on 9)

The method of claim 9, wherein:
said stimulator is coupled to a sensor that detects chest wall movement and/or expansion.

### Claim 12 (depends on 9)

The method of claim 9, wherein feedback is provided to the stimulator from sensors assessing chest wall movement, and/or O2 saturation, and/or end tidal CO2 and uses this information to adjust stimulation parameters.

### Claim 13 (depends on 1)

A method of removing a subject from a respirator, said method comprising:
inducing or maintaining respiration is a subject using a method of claim 1 while said subject is removed from the respirator (ventilator) and/or after said subject is removed from said respirator.

### Claim 14 (depends on 1)

The method of claim 1, wherein there is no tonic respiratory muscle contraction during inspiration and expiration phases of breathing in said subject during neuromodulation of a cervical spinal cord.
