Pedicle-based intradiscal fixation devices and methods

Patent metadata

Field	Value
Publication number	US-12295859-B2
Application number	US-202217577845-A
Country	US
Kind code	B2
Filing date	Jan 18, 2022
Priority date	Apr 7, 2020
Publication date	May 13, 2025
Grant date	May 13, 2025

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.

First claim

What is claimed is:

1. An implant for stabilizing an inferior vertebra and a superior vertebra, the implant comprising:
an inner core extending from a proximal end to a distal end and comprising a proximal end cap at the proximal end and a distal end cap at the distal end;
an outer sheath positioned over the inner core and between the proximal end cap and the distal end cap; and
a nut configured to compress the outer sheath, wherein the implant is configured to be inserted through a pedicle of the inferior vertebra and into the superior vertebra,
wherein the nut is configured to move forward distally to transition the implant from an unlocked position in which the inner core and the outer sheath can straighten, to a locked position in which the outer sheath is tightened between the nut and the distal end cap such that such that the nut abuts the outer sheath and the implant has a curvilinear shape.

2. The implant of claim 1 , wherein the inner core is made of a shape-memory material, and wherein the inner core has a curved shape-memory orientation and a temporarily straight orientation.

3. The implant claim 1 , wherein the outer sheath includes a plurality of links, wherein the plurality of links are configured to be arranged in a generally linear configuration in the unlocked position or a curved configuration to mimic the shape of the inner core in the locked position.

4. The implant of claim 1 , wherein the proximal end cap includes a plurality of outer threads configured to retain the nut.

5. The implant of claim 1 , wherein the inner core is composed of a flexible material.

6. The implant of claim 5 , wherein the flexible material is Nitinol.

7. The implant of claim 1 , wherein in an unlocked position, the inner core and the outer sheath are configured to be straight to be loaded in a deployment tube.

8. The implant of claim 1 , wherein the inner core has an elongate body with a cylindrical shape.

9. A method for stabilizing an inferior vertebra and a superior vertebra, the method comprising:
posteriorly accessing a spine of a patient;
inserting an implant into a pedicle of the inferior vertebra, the implant including an inner core extending from a proximal end to a distal end and comprising a proximal end cap at the proximal end and a distal end cap at the distal end, an outer sheath positioned over the inner core and between the proximal end cap and the distal end cap, and a nut configured to compress the outer sheath;
inserting the implant into a vertebral body of the inferior vertebra;
inserting 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;
moving the nut forward distally to transition the implant from an unlocked position in which the inner core and the outer sheath can straighten, to a locked position in which the outer sheath is tightened between the nut and the distal end cap such that the nut abuts the outer sheath and the implant has a curvilinear shape.

10. The method of claim 9 , wherein the inner core is composed of a shape-memory material, and wherein the inner core has a curved shape-memory orientation and a temporarily straight orientation.

11. The method of claim 9 , wherein the outer sheath includes a plurality of links, wherein the plurality of links are configured to be arranged in a generally linear configuration in the unlocked position or a curved configuration to mimic the shape of the inner core in the locked position.

12. The method of claim 9 , wherein the proximal end cap includes a plurality of outer threads configured to retain the nut.

13. The method of claim 9 , wherein the inner core is composed of a flexible material.

14. The method of claim 13 , wherein the flexible material is Nitinol.

15. The method of claim 9 , wherein in an unlocked position, the inner core and the outer sheath are configured to be straight to be loaded in a deployment tube.

16. The method of claim 9 , further comprising drawing the implant into a straight deployment tube such that the inner core and outer sheath are straightened within the tube, and deploying the implant from the deployment tube, wherein the inner core returns to a curved shape.

Assignees

• Globus Medical Inc

Inventors

• Glerum Chad
• Weiman Mark
• Hessler Tyler
• Hill Albert
• Sullivan Myles

Classifications

• A61F2002/30092

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2002/30131

  horseshoe- or crescent- or C-shaped or U-shaped · CPC title

• A61B17/7032

  Screws or hooks with U-shaped head or back through which longitudinal rods pass · CPC title

• A61F2002/30841

  Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes · CPC title

• A61F2002/30886

  externally-threaded · CPC title