Methods and devices for correcting spinal deformity with pharmaceutical-eluting pedicle screws

Patent metadata

Field	Value
Publication number	US-9327015-B2
Application number	US-73046910-A
Country	US
Kind code	B2
Filing date	Mar 24, 2010
Priority date	Oct 23, 2009
Publication date	May 3, 2016
Grant date	May 3, 2016

Abstract

A method of correcting spinal deformity, which includes locating pharmaceutical-loaded implants adjacent to targeted spinal growth plates, and then eluting the pharmaceutical onto the growth plates. Preferably, the method involves correcting spinal deformity by simply inserting a pharmaceutical-eluting pedicle screw onto the concave side of a scoliotic curve. In some embodiments, the screw has a cannulated internal reservoir that contains a growth-inhibiting pharmaceutical (such as a tetracycline) and at least one fenestration that allows the pharmaceutical to elute onto the vertebral body growth plate.

First claim

We claim:

1. A method of correcting spinal deformity comprising the steps of:
a) locating a cycline-loaded implant adjacent to a spinal growth plate in a patient having a scoliotic spinal deformity, and
b) eluting the cycline onto the growth plate in an amount effective to retard bone growth in the spinal growth plate,

wherein the implant has a distal exit port adapted for eluting a cycline, and
wherein the distal exit port is located in a vertebral body,
wherein the cycline is substantially eluted onto the growth plate on a convex side of the spinal deformity,
wherein the implant comprises a cannulated bone screw, and
wherein the screw is remotely activated to initiate or accelerate cycline elution at a desired time and location.

2. The method of claim 1 wherein the bone screw has a cannulated internal reservoir that contains the cycline.

3. The method of claim 2 wherein the bone screw has a shaft comprising an outer surface and fenestrations, the fenestrations providing fluid connection between the reservoir and the outer surface and allowing the cycline to elute therethrough.

4. The method of claim 3 wherein cycline release from the screw is actuated by compressing an inner mandrel onto a matrix comprising the cycline.

5. The method of claim 4 wherein the inner mandrel is a guide wire or a threaded shaft.

6. The method of claim 3 wherein the reservoir contains a pump.

7. The method of claim 1 wherein the screws allows passive micro pumping motions via sectional modulus variations, thereby enabling self pumping of the cycline based upon stress or strain from either patient movements, vertebral body movements, or vertebral body growth expansion levels.

8. The method of claim 1 wherein the bone screw is threaded.

9. The method of claim 1 wherein the bone screw is unthreaded.

10. The method of claim 1 wherein the cycline is tetracycline.

11. The method of claim 10 wherein the cycline is a tetracycline analog.

12. The method of claim 10 wherein the cycline is contained within a matrix comprised of either a surface-eroding or a bulk-eroding resorbable polymer.

13. The method of claim 1 wherein the cycline consists essentially of the A ring of tetracycline.

14. The method of claim 1 further comprising the step of:
c) refilling the reservoir with the cycline.

15. The method of claim 14 wherein the refilling is accomplished after an assessment of spinal correction due to cycline elution.

16. The method of claim 1 further comprising the step of:
c) attaching the screw to a correction rod.

17. The method of claim 1 wherein the remote activation is accomplished by energy delivery.

18. The method of claim 17 wherein the energy is selected from the group consisting of ultrasound, radiofrequency, and light.

19. The method of claim 17 wherein the pharmaceutical is located within a matrix that is located within the screw, and the remote delivery of energy excites the matrix, enabling cycline release.

20. The method of claim 19 wherein the matrix comprises an energy absorbing material.

21. The method of claim 20 wherein the energy absorbing material is selected from the group consisting of collagen, a porous polymer, a resorbable polymer, a nano-tube, and a fiber.

22. The method of claim 1 wherein the implant is at least partially located in a pedicle.

Assignees

• Serhan Hassan
• O'Neil Michael J
• Lilienfeld Sean
• Dimauro Thomas M
• Depuy Synthes Products Inc

Inventors

• Serhan Hassan
• O'Neil Michael J
• Lilienfeld Sean
• Dimauro Thomas M

Classifications

• A61K38/30 Primary

  Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 {(insulin-like growth factor binding protein A61K38/1754)} · CPC title

• A61B2017/561

  Implants with special means for releasing a drug · CPC title

• A61B17/7098

  wherein the implant is permeable or has openings, e.g. fenestrated screw (hollow surgical screws A61B17/864) · CPC title

• A61B2017/00893

  pharmaceutically effective · CPC title

• A61B17/864

  hollow, e.g. with socket or cannulated · CPC title