# US 12,109,042 B2 · Neural locating system and method

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- Number: US 12,109,042 B2
- Document ID: US12109042B2
- Status: Granted
- Kind: B2
- Application number: 17/720,000
- Filed: 2022-04-13
- Published: 2022-12-22
- Granted: 2024-10-08
- Earliest claimed: 2016-10-05
- Assignees: Innovative Surgical Solutions, LLC
- Applicants: Innovative Surgical Solutions, LLC
- Inventors: Christopher Wybo
- Web page: https://patentgrep.com/patent/US12109042B2

## CPC

- A61B 5/4893: {Nerves}
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/061: {Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body (A61B1/00158 takes precedence)}
- A61B 5/1104: {induced by stimuli or drugs (A61B5/1102 takes precedence)}
- A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/294: for nerve conduction study [NCS]
- A61B 5/4029: {for evaluating the peripheral nervous systems (using bioelectric or biomagnetic signals A61B5/24)}
- A61B 5/4519: {Muscles (measuring muscular strength A61B5/224; using electromyography [EMG] A61B5/389)}
- A61B 5/6852: {Catheters}
- A61B 5/7425: {Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image}
- A61B 34/30: Surgical robots
- A61B 34/32: operating autonomously
- B25J 9/1666: {Avoiding collision or forbidden zones}
- A61B 5/6885: {Monitoring or controlling sensor contact pressure}
- A61B 2018/00071: {Electrical conductivity}
- A61B 2018/00964: {Features of probes}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B25J: MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES ({manipulators specially adapted for use in surgery A61B34/70; manipulators used in cleaning hollow articles B08B9/04}; manipulators associated with rolling mills B21B39/20; manipulators associated with forging machines B21J13/10; {manipulators associated with picking-up and placing mechanisms B23P19/007}; means for holding wheels or parts thereof B60B30/00; {vehicles with ground-engaging propulsion means, e.g. walking members B62D57/02, B62D57/032; devices for picking-up and depositing articles or materials between conveyors B65G47/90, B65G47/91; manipulators with gripping or holding means for transferring packages B65H67/065}; cranes B66C; {manipulators used in the protection or supervision of pipe-line installations F17D5/00; walking equipment adapted for nuclear steam-generators F22B37/006}; manipulators specially adapted for, or associated with, nuclear reactors G21C; {apparatus used for handling wafers during manufacture or treatment of semiconductor H10P72/50})

## Abstract

A nerve mapping system includes an elongate medical device, a non-invasive mechanical sensor, and a processor. The elongate medical device includes a distal end portion configured to explore an intracorporeal treatment area of a subject, and the distal end portion includes an electrode. The non-invasive mechanical sensor is configured to provide a mechanomyography output signal corresponding to a monitored mechanical response of a muscle innervated by the nerve. The processor is in communication with the electrode and the sensor, and is configured to provide a plurality of electrical stimuli to the electrode. Each of the plurality of stimuli is provided when the electrode is located at a different position within the intracorporeal treatment area. The processor determines the likelihood of a nerve existing at a particular point using the magnitudes of each of the stimuli and the detected response of the muscle.

## Claims

### Claim 1

A nerve mapping system comprising:
an elongate medical device including a distal end portion configured to explore an intracorporeal treatment area of a subject, the distal end portion including an electrode;
a non-invasive mechanical sensor configured to provide a mechanomyography output signal corresponding to a monitored mechanical response of a muscle innervated by the nerve; and
a processor in communication with the electrode and the non-invasive mechanical sensor, wherein the processor is configured to:
provide a plurality of electrical stimuli to the electrode, each of the plurality of stimuli having a respective magnitude, and each of the plurality of stimuli provided when the electrode is located at a different respective position within the intracorporeal treatment area of the subject, wherein the plurality of electrical stimuli includes:
a first electrical stimulus provided when the electrode is at a first location within the intracorporeal treatment area, wherein the first electrical stimulus has a first current magnitude that does not induce a threshold mechanical response of the muscle; and
a second electrical stimulus provided when the electrode is at a second location within the intracorporeal treatment area, wherein the second electrical stimulus has the first current magnitude;
detect a response of the muscle, via the mechanomyography output signal, to the second electrical stimulus; and
identify an area surrounding the first location as not containing a nerve.

### Claim 2 (depends on 1)

The nerve mapping system of claim 1, wherein the plurality of electrical stimuli further includes one or more additional electrical stimuli provided when the electrode is at the second location, wherein the one or more additional stimuli each have a current magnitude less than the first current magnitude; and
wherein the processor is further configured to determine the likelihood of a nerve existing at a particular point within the intracorporeal treatment area adjacent the second location area using the respective magnitudes of each of the one or more additional electrical stimuli and the detected response of the muscle to each of the plurality electrical stimuli.

### Claim 3 (depends on 1)

The nerve mapping system of claim 1, further comprising a locating device operative to detect the location of the electrode within the intracorporeal treatment area;
wherein the processor is in communication with the locating device and is operative to identify the area surrounding the first location using the detected location of the electrode when the electrode is at the first location.

### Claim 4 (depends on 3)

The nerve mapping system of claim 3, wherein the locating device includes at least one of a multi-axial spatial input device or a non-contact position locating device that utilizes ultrasound, electrical fields, magnetic fields, or fluoroscopy to locate the electrode within three-dimensional space.

### Claim 5 (depends on 1)

The nerve mapping system of claim 1, wherein the processor is configured to maintain a virtual workspace comprising a plurality of 3-dimensional voxels, the virtual workspace being representative of the intracorporeal treatment area of the subject; and
wherein the processor is configured to identify the area surrounding the first location as not containing a nerve by:
registering a location of the electrode within the virtual workspace when the first electrical stimulus is provided;
determining a range where the first electrical stimulus would be expected to depolarize a nerve given the first current magnitude; and
mark any voxels within the determined range of the registered location in the virtual workspace as not containing a nerve.

### Claim 6 (depends on 5)

The nerve mapping system of claim 5, wherein the processor is further configured to merge the virtual workspace with a CT, MRI, fluoroscope, or ultrasound image.

### Claim 7 (depends on 1)

The nerve mapping system of claim 1, further comprising a locating device operative to monitor the location of the distal end portion of the elongate medical device;
wherein the processor is further configured to:
estimate a distance estimate between the monitored location and the nerve using a previously acquired anatomical model; and
select the first current magnitude using the estimated distance.

### Claim 8 (depends on 7)

The nerve mapping system of claim 7, wherein the first current magnitude is selected from a bounded current range and is the largest current within the bounded current range that is expected to not induce the mechanical response of the muscle when applied at the estimated distance from the nerve.

### Claim 9 (depends on 1)

The nerve mapping system of claim 1, wherein each of the electrical stimuli provided to the electrode are transmitted to the intracorporeal treatment area in an omnidirectional manner.

### Claim 10

A nerve mapping system comprising:
an elongate medical device configured to explore an intracorporeal treatment area of a subject, the elongate medical device including:
a distal end portion;
a central axis intersecting the distal end portion and extending through a center of the elongate medical device;
an electrode disposed at an end of the elongate medical device and on the central axis; and
a non-invasive mechanical sensor configured to provide a mechanomyography output signal corresponding to a monitored mechanical response of a muscle innervated by the nerve; and
a processor in communication with the first and second electrodes and with the non-invasive mechanical sensor, wherein the processor is configured to:
provide a first electrical stimulus to the first electrode when the first electrode is at a first location within the intracorporeal treatment area, wherein the first electrical stimulus has a first current magnitude that is selected such that it does not induce a threshold mechanical response of the muscle;
provide a second electrical stimulus to the first electrode when the first electrode is at a second location within the intracorporeal treatment area, wherein the second electrical stimulus has the first current magnitude;
provide one or more additional electrical stimuli to the first or the second electrode when the first electrode is at the second location, wherein the one or more additional stimuli each have a current magnitude less than the first current magnitude;
monitor the mechanomyography output signal following the providing of each electrical stimulus;
determine, from the one or more additional electrical stimuli, a minimum current magnitude required to induce the threshold mechanical response of the muscle at the second location;
determine a distance from the second location to the nerve using the determined minimum current magnitude; and
identify an area surrounding the first location as not containing a nerve.

### Claim 11 (depends on 10)

The nerve mapping system of claim 10, wherein the processor is configured to select the first magnitude from a bounded current range such that it is the largest current within the bounded current range that is expected to not induce the mechanical response of the muscle when applied at an estimated distance between the first location and the nerve.

### Claim 12 (depends on 11)

The nerve mapping system of claim 11, wherein the processor is configured to estimate the distance between the first location and the nerve by monitoring the location of the electrode within the intracorporeal treatment area, and by comparing the estimated distance to an anatomical model.

### Claim 13 (depends on 12)

The nerve mapping system of claim 12, further comprising a locating device operative to detect the location of the electrode within the intracorporeal treatment area;
wherein the processor is in communication with the locating device and is operative to monitor the location of the electrode within the intracorporeal treatment area via the locating device.

### Claim 14 (depends on 13)

The nerve mapping system of claim 13, wherein the locating device includes at least one of a multi-axial spatial input device or a non-contact position locating device that utilizes ultrasound, electrical fields, magnetic fields, or fluoroscopy to locate the electrode within three-dimensional space.

### Claim 15 (depends on 10)

The nerve mapping system of claim 10, wherein the processor is further configured to:
register each of the first location and the second location within a virtual workspace;
indicate a portion of the virtual workspace surrounding the first location as not containing the nerve; and
indicate the presence of a nerve within the virtual workspace at the determined distance from the second location.

### Claim 16 (depends on 15)

The nerve mapping system of claim 15, wherein the processor is further configured to indicate a second portion of the virtual workspace as not containing the nerve, wherein the second portion surrounds the second location up to the determined distance.

### Claim 17 (depends on 15)

The nerve mapping system of claim 15, wherein the processor is further configured to merge the virtual workspace with a CT, MRI, fluoroscope, or ultrasound image.