# US 10,478,199 B2 · Methods, systems, and devices for diagnosing and treating intervertebral disc degeneration

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- Number: US 10,478,199 B2
- Document ID: US10478199B2
- Status: Granted
- Kind: B2
- Application number: 15/186,057
- Filed: 2016-06-17
- Published: 2016-12-22
- Granted: 2019-11-19
- Earliest claimed: 2015-06-19
- Assignees: Trinity Orthopedics, LLC
- Applicants: Trinity Orthopedics, LLC
- Inventors: James F. Marino; Dale Binke; Jamil Elbanna
- Web page: https://patentgrep.com/patent/US10478199B2

## CPC

- A61B 17/1671: {for the spine}
- A61B 17/1633: {Sleeves, i.e. non-rotating parts surrounding the bit shaft, e.g. the sleeve forming a single unit with the bit shaft (A61B17/1644 takes precedence)}
- A61B 17/1757: {for the spine}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/00323: {Cables or rods}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method of diagnosing, minimizing symptoms and/or treating the pathology of intervertebral disc degeneration includes introducing a first cannula through a vertebra along an axis of at least one pedicle of the vertebra from a generally posterior to a generally anterior direction and inserting a second cannula within a lumen of the first cannula, the second cannula constrained to a relatively straight configuration within at least a portion of the first cannula and assumes a nonlinear or curvilinear geometry external to the first cannula within at least a portion of a vertebral body of the vertebra and away from a longitudinal axis of the first cannula. The method includes forming a channel with the second cannula, the channel extending to or adjacent to a vertebral endplate of the vertebral body in order to create a defect through the vertebral endplate of the vertebra. Related systems, devices, and methods are described.

## Claims

### Claim 1

A method of accessing an intervertebral disc located within an intervertebral disc space adjacent a vertebra having a pedicle, a vertebral body and a vertebral endplate, the method comprising:
positioning a first cannula within the vertebra substantially along an axis of the pedicle, the cannula coursing, at least in part, along a first curvilinear path at a first trajectory through at least a portion of the vertebral body to the vertebral endplate;
advancing a translatable flexible curvilinear bone penetrating instrument through a lumen of the first cannula; and
penetrating the vertebral endplate with the translatable flexible curvilinear bone penetrating instrument to enter into the intervertebral disc space thereby creating a first defect in the vertebral endplate at a first location;
repeating the positioning, the advancing, and the penetrating steps thereby creating a plurality of additional defects in the vertebral endplate at additional unique locations;
wherein trajectories of additional curvilinear paths are the same as or different from the first trajectory of the first curvilinear path.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first cannula is positioned percutaneously from a posterior extracorporeal position.

### Claim 3 (depends on 2)

The method of claim 2, further comprising engaging a second cannula with the vertebra, wherein the second cannula is rigid and straight, wherein the first cannula is advanced through a lumen of the second cannula.

### Claim 4 (depends on 3)

The method of claim 3, further comprising rotating the first cannula relative to the second cannula.

### Claim 5 (depends on 4)

The method of claim 4, further comprising advancing or withdrawing the second cannula relative to the pedicle.

### Claim 6 (depends on 2)

The method of claim 2, further comprising advancing at least one therapeutic agent and/or diagnostic tool through the first cannula into at least one of the vertebra and the intervertebral disc space.

### Claim 7 (depends on 6)

The method of claim 6, wherein the at least one therapeutic agent is delivered via a catheter and the at least one therapeutic agent comprises one or more of analgesics, anaesthetics, anti-inflammatories, growth factors, cytokine inhibitors, metalloproteinase inhibitors, c Jun NH(2)-terminal kinase inhibitors, interleukin-6 inhibitors, Insulin Like Growth Factor (IGF-1), Insulin Like Growth Factor Binding Protein (IGFBP), BMP-2, or BMP-7; and
wherein the at least one diagnostic tool is delivered via the catheter and the at least one diagnostic tool comprises one or more of radio-dense materials or a pressure transducers.

### Claim 8 (depends on 1)

The method of claim 1, wherein the bone penetrating instrument comprises a microfenestrating trocar tip, a drill, a burr drill, a pick micro-fracturing drill, a fluted drill, or a laser.

### Claim 9 (depends on 1)

The method of claim 1, wherein the translatable flexible curvilinear bone penetrating instrument is a nitinol trocar or a drill.

### Claim 10 (depends on 1)

The method of claim 1, further comprising: placing a pedicle screw above and below the plurality of additional defects in the vertebral endplate so as to provide intervertebral distraction during a healing phase for chondrogenesis.

### Claim 11

A method of accessing an intervertebral disc located within an intervertebral disc space adjacent a vertebra having a pedicle, a vertebral body and a vertebral endplate, the method comprising:
percutaneously placing a guide pin generally along an axis of the pedicle;
advancing and engaging a first cannula over the guide pin, the first cannula being rigid and straight;
engaging the first cannula with the pedicle;
removing the guide pin;
advancing a second cannula with or without an obturator distal to the first cannula within the vertebral body, the second cannula comprising at least a portion configured to be curvilinear;
inserting a bone penetrating instrument within the second cannula, such that the bone penetrating instrument penetrates the vertebral endplate and enters the intervertebral disc space;
creating multiple boney defects in the vertebral endplate using at least the first cannula engaged with the pedicle, wherein the multiple boney defects are created along differing curvilinear paths.

### Claim 12 (depends on 11)

The method of claim 11, further comprising advancing within the first cannula one or more diagnostic tools and/or therapeutic agents.

### Claim 13 (depends on 12)

The method of claim 12, wherein the one or more therapeutic agents comprise one or more of analgesics, anaesthetics, anti-inflammatories, growth factors, cytokine inhibitors, metalloproteinase inhibitors, c Jun NH(2)-terminal kinase inhibitors, interleukin-6 inhibitors, Insulin Like Growth Factor (IGF-1), Insulin Like Growth Factor Binding Protein (IGFBP), BMP-2, or BMP-7.

### Claim 14 (depends on 12)

The method of claim 12, wherein the one or more diagnostic tools comprise one or more of radio-dense materials or a pressure transducers.
