US-20260124043-A1 - PEDICLE-BASED INTRADISCAL FIXATION DEVICES AND METHODS

US20260124043A1US 20260124043 A1US20260124043 A1US 20260124043A1US-20260124043-A1

Abstract

Pedicle-based intradiscal fixation devices, systems, instruments, and methods thereof. The implant or a portion thereof may be composed of a shape-memory material, which has a curved shape-memory orientation and a temporarily straight orientation. The implant may be configured to be inserted into a pedicle of an inferior vertebra, through the vertebral body of the inferior vertebra, and into the vertebral body of the superior vertebra to thereby stabilize the inferior and superior vertebrae.

Inventors

Chad Glerum
Mark Weiman
Tyler Hessler
Albert Hill
Myles Sullivan

Assignees

GLOBUS MEDICAL, INC.

Dates

Publication Date: 20260507
Application Date: 20251229

Claims (13)

1 . An implant for stabilizing an inferior vertebra and a superior vertebra, the implant comprising: a screw portion extending from a proximal end to a distal end; an anchor portion extending from a proximal end to a distal end, the distal end having a tip configured to engage bone; a housing portion having a first portion with an opening extending from a first end to a second end and configured to receive the screw portion; wherein the anchor portion includes a one or more tracks configured to engage corresponding tracks to engage with the housing portion; wherein the distal end of the anchor portion is positioned in the inferior vertebra in the first position and is positioned in the superior vertebra in the second position.
2 . The implant of claim 1 , wherein the anchor portion slidingly pivots with respect to the screw portion during articulation from the first position to the second position.
3 . The implant of claim 1 , wherein the articulation assembly comprises a rod connected to the distal end of the screw portion and the proximal end of the anchor portion.
4 . The implant of claim 3 , wherein the rod is connected to the screw portion by a first pin and the first rod is connected to the anchor portion by a second pin.
5 . The implant of claim 1 , wherein the proximal end of the screw portion includes a recess configured to receive an instrument for inserting the implant.
6 . The implant of claim 1 , wherein the anchor portion is curved along its length.
7 . The implant of claim 1 , wherein at least part of the screw portion is threaded.
8 . The implant of claim 1 , wherein the distal end of the anchor portion is positioned on an axis of the screw portion in the first position and the distal end of the anchor is positioned spaced from the axis in the second position.
9 . The implant of claim 1 , wherein the tip is pointed.
10 . The implant of claim 1 , wherein the tip is blunt.
11 . An implant for stabilizing an inferior vertebra and a superior vertebra, the implant comprising: a screw portion extending from a proximal end to a distal end; an anchor portion extending from a proximal end to a distal end, the distal end having a tip configured to engage bone; a housing portion having a first portion with an opening extending from a first end to a second end and configured to receive the screw portion; wherein the anchor portion includes a one or more tracks configured to engage corresponding tracks to engage with the housing portion; wherein the distal end of the anchor portion is positioned in the inferior vertebra in the first position and is positioned in the superior vertebra in the second position. Wherein the housing portion is comprised of two or more concentric tubes.
12 . The implant of claim 11 , wherein the housing portion is comprised of a first tube and a second tube, the second tube positioned within the first tube.
13 . The implant of claim 11 , wherein the screw portion is curved and extends through the two or more concentric tubes of the housing portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 17/815,377 filed Jul. 27, 2022, which is a continuation application of U.S. patent application Ser. No. 16/868,676, filed on May 7, 2020 (published as U.S. Pat. Pub. No. 2021-0307924), which is a continuation-in-part of U.S. patent application Ser. No. 16/842,285, filed Apr. 7, 2020 (published as U.S. Pat. Pub. No. 2021-0307922, all of which are incorporated by reference herein in their entireties for all purposes. FIELD OF THE INVENTION The present disclosure relates to surgical devices, and more particularly, to pedicle-based intradiscal fixation devices and associated methods. BACKGROUND OF THE INVENTION Common procedures for handling pain associated with intervertebral discs that have become degenerated due to various factors such as trauma or aging may include the use of pedicle screw fixation and/or intervertebral fusion for fusing one or more adjacent vertebral bodies. Generally, bilateral pedicle screw fixation, for example, with a rod construct, may be used to treat degenerative disc disease and a multitude of other spine pathologies as a standard of treatment to stabilize two or more adjacent vertebral bodies, for example, as an adjunct to spinal fusion. Unfortunately, a number of iatrogenic pathologies are associated with pedicle screw fixation including, but not limited to, misplacement of screws, muscle/ligamentous disruption during insertion, adjacent segment disease due to superior adjacent facet violation by the inferior pedicle screw construct, increased procedural time, and/or instrumentation failure. There exists a clinical need for a fixation system and method that reduces the iatrogenic effects of a bilateral pedicle screw construct from a posterior approach while stabilizing two adjacent vertebral bodies that may be used as an adjunct to spinal fusion. SUMMARY OF THE INVENTION In accordance with the application, pedicle-based devices, systems, and methods are provided. In particular, pedicle-based intradiscal fixation devices are provided, which may be used as a standalone device or may be used in conjunction with a traditional interbody fixation device. The method of fixation may include inserting the device through the pedicle of an inferior vertebra, into the vertebral body of the inferior vertebra and securing the device to the vertebral body of the adjacent superior vertebra. The pedicle-based intradiscal fixation devices and methods described herein may improve access-related morbidity while providing sufficient stabilization force for spinal fusion. According to one embodiment, an implant for stabilizing an inferior vertebra and a superior vertebra includes a first member and a second member connected to the first member. The implant has a first, initial insertion orientation and a second, final implantation orientation different from the first, initial insertion orientation. The first member is configured to be inserted through a pedicle of the inferior vertebra and the second member is configured to engage bone of the superior vertebra in the second, final implantation orientation. According to another embodiment, methods of intradiscal fixation are provided. A method for stabilizing an inferior vertebra and a superior vertebra may include: posteriorly accessing a spine of a patient; inserting an implant having a first member and a second member into a pedicle of the inferior vertebra in a first, initial orientation; inserting the first member of the implant into a vertebral body of the inferior vertebra; and modifying the implant into a second, final implantation orientation and inserting the second member of the implant into a vertebral body of the superior vertebra, wherein the implant traverses a disc or disc space between the inferior and superior vertebrae, and the second, final implantation orientation thereby fixates the inferior and superior vertebrae. According to one embodiment, the implant may include a pedicle screw, a housing affixed to the pedicle screw, and an anchor moveably connected to the housing. The implant has a collapsed position whereby the anchor is positioned close to the pedicle screw, and the implant has an extended position whereby the anchor is moved away from or extended from the pedicle screw. The pedicle screw is configured to be inserted through a pedicle of the inferior vertebra in the collapsed position, and the anchor is configured to engage bone of the superior vertebra in the extended position. The pedicle screw implant may include one or more of the of the following features. The pedicle screw may have a proximal end including a recess configured to receive an instrument for inserting the pedicle screw and a distal end configured to be inserted into the pedicle of the inferior vertebra. The pedicle screw may include one or more threads configured to engage bone. The housing may include a first portion configured to receive the