# US 2019/0167134 A1 · Systems and methods for nerve mapping and monitoring

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- Number: US 2019/0167134 A1
- Document ID: US20190167134A1
- Status: Published application
- Kind: A1
- Application number: 16/025,249
- Filed: 2018-07-02
- Published: 2019-06-06
- Earliest claimed: 2012-10-19
- Assignees: SidewayStrategies LLC
- Applicants: SidewayStrategies LLC
- Inventors: Jonathan D. Block; Hieu T. Ball
- Web page: https://patentgrep.com/patent/US20190167134A1

## CPC

- A61B 5/4893: {Nerves}
- A61B 1/32: Devices for opening or enlarging the visual field, e.g. of a tube of the body
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/4029: {for evaluating the peripheral nervous systems (using bioelectric or biomagnetic signals A61B5/24)}
- A61B 5/6847: {mounted on an invasive device}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61B 5/296: for electromyography [EMG]
- 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

Embodiments can include a nerve mapping and monitoring system that can include a multi-polar stimulation unit, an electrical connector, an instrument having a grid array, where the grid array can comprise a plurality of electrodes, where each of the plurality of electrodes can be configured to be stimulated by the multi-polar stimulation unit, a recording element, where the recording element can be configured to detect a muscle response elicited by the grid array, and a computer, where the computer can be configured to monitor the muscle response elicited by the grid array such that neural structures can be identified and avoided.

## Claims

### Claim 1

(canceled)

### Claim 2

A nerve mapping and monitoring system comprising:
a grid array of a plurality of electrodes positioned on a surface of a surgical instrument configured to be inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site, wherein:
each of the plurality of electrodes is configured to be stimulated individually and independently, and
every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations; and
a computer system configured to cause delivery of sequential variable multi-polar stimulation to electrodes of the grid array of electrodes according to a plurality of stimulation configurations to scan the grid array and elicit evoked potential responses, wherein the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes of the grid array of electrodes.

### Claim 3 (depends on 2)

The nerve mapping and monitoring system of claim 2, wherein the computer system is further configured to monitor the evoked potential responses and combine information gathered based on the evoked potential responses to generate a virtual map of locations and proximities of neural structures in the tissue site so as to enable nerve mapping and monitoring.

### Claim 4 (depends on 3)

The nerve mapping and monitoring system of claim 3, wherein the virtual map includes:
a graphical representation of the surgical instrument including a graphical representation of the grid array of electrodes and the locations of the respective electrodes of the grid array of electrodes overlaid on the graphical representation of the surgical instrument; and
one or more colors overlaid on the graphical representation of the surgical instrument including the graphical representation of the grid array of electrodes, wherein the one or more colors indicate the locations and proximities of the neural structures in relation to the surgical instrument and to each electrode of the grid array of electrodes on the surface of the surgical instrument.

### Claim 5 (depends on 4)

The nerve mapping and monitoring system of claim 4 further comprising:
a display, wherein the display is configured to visually represent the virtual map of locations and proximities of neural structures in the tissue site.

### Claim 6 (depends on 3)

The nerve mapping and monitoring system of claim 3 further comprising:
a recording element, wherein the recording element is configured to detect evoked potential responses elicited by stimulation of combinations of electrodes of the grid array of electrodes according to the plurality of stimulation configurations.

### Claim 7 (depends on 2)

The nerve mapping and monitoring system of claim 2, wherein the surgical instrument comprises at least one of: a surgical probe, a tissue dilator, a retractor system.

### Claim 8 (depends on 2)

The nerve mapping and monitoring system of claim 2, wherein the surgical instrument comprises a combination of a retractor system, a plurality of tissue dilators, and a surgical probe, and wherein each of the retractor system, the plurality of tissue dilators, and the surgical probe includes at least a portion of the grid array of electrodes.

### Claim 9 (depends on 2)

The nerve mapping and monitoring system of claim 2, wherein the grid array of electrodes are arranged on the surface of the surgical instrument in a plurality of rows and a plurality of columns.

### Claim 10 (depends on 2)

The nerve mapping and monitoring system of claim 2, wherein the computer system is capable of utilizing stimulation configurations comprising every pattern or combination of active and inactive electrodes of the plurality of electrodes.

### Claim 11 (depends on 2)

The nerve mapping and monitoring system of claim 2, wherein the computer system is further configured to adjust one or more stimulation parameters when causing delivery of stimulation to electrodes of the grid array, wherein the one or more stimulation parameters include at least one of: current level, voltage level, or pulse width.

### Claim 12

A method of nerve mapping and monitoring, the method comprising:
by one or more processors executing program instructions:
causing delivery of sequential variable multi-polar stimulation to electrodes of a grid array of electrodes according to a plurality of stimulation configurations to scan the grid array and elicit evoked potential responses, wherein:
the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes of the grid array of electrodes,
electrodes of the grid array are positioned on a surface of a surgical instrument inserted into a tissue site of a patient to map locations and proximities of neural structures in the tissue site,
each of the plurality of electrodes is configured to be stimulated individually and independently, and
every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations; and
monitoring the evoked potential responses and combining information gathered based on the evoked potential responses to enable nerve mapping and monitoring.

### Claim 13 (depends on 12)

The method of claim 12 further comprising:
by the one or more processors executing program instructions:
generating a virtual map of locations and proximities of neural structures in the tissue site based at least in part on the information gathered based on the evoked potential responses.

### Claim 14 (depends on 13)

The method of claim 13, wherein the virtual map includes:
a graphical representation of the surgical instrument including a graphical representation of the grid array of electrodes and the locations of the respective electrodes of the grid array of electrodes overlaid on the graphical representation of the surgical instrument; and
one or more colors overlaid on the graphical representation of the surgical instrument including the graphical representation of the grid array of electrodes, wherein the one or more colors indicate the locations and proximities of the neural structures in relation to the surgical instrument and to each electrode of the grid array of electrodes on the surface of the surgical instrument.

### Claim 15 (depends on 13)

The method of claim 13 further comprising:
by the one or more processors executing program instructions:
outputting the virtual map for display on an electronic display.

### Claim 16 (depends on 12)

The method of claim 12, wherein the surgical instrument comprises at least one of: a surgical probe, a tissue dilator, a retractor system.

### Claim 17 (depends on 12)

The method of claim 12, wherein the surgical instrument comprises a combination of a retractor system, a plurality of tissue dilators, and a surgical probe, and wherein each of the retractor system, the plurality of tissue dilators, and the surgical probe includes at least a portion of the grid array of electrodes.

### Claim 18 (depends on 12)

The method of claim 12 further comprising:
by the one or more processors executing program instructions:
adjusting one or more stimulation parameters when causing delivery of stimulation to electrodes of the grid array, wherein the one or more stimulation parameters include at least one of: current level, voltage level, or pulse width.

### Claim 19

A method of nerve mapping and monitoring, the method comprising:
inserting surgical instrument into a tissue site of a patient, wherein the surgical instrument includes a grid array of a plurality of electrodes, wherein each of the plurality of electrodes is configured to be stimulated individually and independently, and wherein every one of the plurality of electrodes is configured to be stimulated as part of at least mono-polar, bi-polar, and tri-polar stimulation configurations;
causing delivery of sequential variable multi-polar stimulation to electrodes of the grid array of electrodes according to a plurality of stimulation configurations to scan the grid array and elicit evoked potential responses, wherein the plurality of stimulation configurations include at least mono-polar, bi-polar, and tri-polar stimulation configurations of different electrodes of the grid array of electrodes; and
monitoring the evoked potential responses and combining information gathered based on the evoked potential responses to enable nerve mapping and monitoring.