# US 12,213,726 B2 · Devices and methods for the diagnosis and treatment of discogenic back pain

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- Number: US 12,213,726 B2
- Document ID: US12213726B2
- Status: Granted
- Kind: B2
- Application number: 18/502,803
- Filed: 2023-11-06
- Published: 2024-02-29
- Granted: 2025-02-04
- Earliest claimed: 2019-01-25
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc
- Inventors: Jared Wilsey
- Web page: https://patentgrep.com/patent/US12213726B2

## CPC

- A61B 18/1477: {Needle-like probes}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61B 5/4566: {Evaluating the spine (A61B5/4561 takes precedence)}
- A61B 5/4824: {Touch or pain perception evaluation (A61B5/4821 takes precedence)}
- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 18/20: using laser
- A61M 5/178: Syringes
- A61M 5/34: Constructions for connecting the needle {, e.g. to syringe nozzle or needle hub (connecting catheter tubes to hubs A61M25/0014)}
- A61M 5/347: {rotatable, e.g. bayonet or screw (A61M5/344 takes precedence)}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61B 2017/00261: {Discectomy}
- A61B 2018/0044: {Spinal cord}
- A61M 2210/1003: Spinal column
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- 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

A device is provided for supplying electrical current to an intervertebral disc. The device comprises a cannula having a proximal end and a distal end and a longitudinal axis therebetween. The distal end comprises a beveled tip for contacting a region of the intervertebral disc, and an electrode disposed within or on a surface of the cannula adjacent to the distal end. The electrode is configured to discharge the electrical current to the region of the intervertebral disc. Methods of diagnosing and/or treating discogenic back pain are also provided.

## Claims

### Claim 1

A method of diagnosing and treating discogenic back pain, the method comprising administering electrical current from a device to a region of an intervertebral disc, the device comprising a cannula having a proximal end and a distal end and a longitudinal axis therebetween, the distal end comprising a beveled tip for contacting the region of the intervertebral disc, an electrode disposed within or on a surface of the cannula adjacent to the distal end, the electrode configured to discharge the electrical current to the region of the intervertebral disc to evoke a pain response; and administering an effective amount of a neurotoxin to the region of the intervertebral disc to reduce the discogenic back pain, wherein the electrical current is administered to the region of the intervertebral disc comprising a selected area of a healthy intervertebral disc of a patient, and the method further comprises recording a first evoked action potential threshold of the healthy intervertebral disc of the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method further comprises identifying the discogenic back pain by detecting a pain response from the patient when the electrical current is administered.

### Claim 3 (depends on 2)

The method of claim 2, wherein the method further comprises injecting a selected area of the region of the intervertebral disc identified with the pain response with a local anesthetic and a neurotoxin administered by the cannula to treat the selected area of the intervertebral disc with the pain response.

### Claim 4 (depends on 1)

The method of claim 1, wherein the proximal end is configured to be coupled to an electrical generator comprising an electrical pulse generator.

### Claim 5 (depends on 1)

The method of claim 1, wherein the region of the intervertebral disc comprises an annulus fibrosus of the intervertebral disc.

### Claim 6 (depends on 1)

The method of claim 1, wherein the method comprises positioning a patient such that a spine of the patient flexes before administering the electrical current.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method further comprises administering an additional electrical current to a selected area of an additional intervertebral disc of the patient with the device; identifying the discogenic back pain by detecting an additional pain response from the patient when the additional electrical current is administered to the selected area of the additional intervertebral disc; recording a second evoked action potential threshold of the additional intervertebral disc of the patient; and comparing the first evoked action potential threshold with the second evoked action potential threshold to treat the discogenic back pain.

### Claim 8

A method of diagnosing discogenic back pain, the method comprising administering electrical current from a device to a region of an intervertebral disc, the device comprising a cannula having a proximal end and a distal end and a longitudinal axis therebetween, the distal end comprising a beveled tip for contacting the region of the intervertebral disc; an electrode disposed within or on a surface of the cannula adjacent to the distal end, the electrode configured to discharge the electrical current to the region of the intervertebral disc, wherein the beveled tip has an air gap disposed in an inner layer of the beveled tip and the electrode is adjacent to the beveled tip such that the air gap insulates the electrical current and the electrical current is discharged only through the beveled tip, wherein the region of the intervertebral disc comprises an annulus fibrosus of the intervertebral disc such that the beveled tip is configured to facilitate separation of collagenous fibers of the annulus fibrosus by rotating parallel to a lamella of the annulus fibrosus.

### Claim 9 (depends on 8)

The method of claim 8, wherein the proximal end is configured to be coupled to an electrical generator.

### Claim 10 (depends on 9)

The method of claim 9, wherein the electrical generator is an electrical pulse generator.

### Claim 11 (depends on 10)

The method of claim 10, wherein the electrical pulse generator is configured to discharge from about 0.5 mAMP to about 50 mAMP pulses of the electrical current.