SPINAL FIXATION SYSTEMS

• US 20180280061A1
• Filed: 05/21/2018
• Published: 10/04/2018
• Est. Priority Date: 07/13/2007
• Status: Active Grant

• Current Assignee: Mighty Oak Medical Inc
• Original Assignee: Mighty Oak Medical Inc
• Inventors: Frey, George, Kana, Gregory
• Granted Patent: US 10,653,454 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• CPC Class Codes: A61B 2017/561 Implants with special means for releasing a drug
• CPC Class Codes: A61B 2017/8655 with special features for locking in the bone
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/4687 Mechanical guides for implantation instruments
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00047 Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00059 Chromium or Cr-based alloys
• CPC Class Codes: G09B 23/30 Anatomical models G09B23/281 - G09B23/288 take precedence

Abstract

The present disclosure includes fixation devices that comprise one or more porous elements or fenestrations to aid in osteo-integration of the fixation device. These fixation devices may be additively manufactured using biocompatible materials such that the solid and porous aspects of the screw are fused together into a single construct. Spinal stabilization systems are also disclosed having spanning portions extending between and securable to pedicle screw assemblies, the spanning portions have stiffness characteristics that may be variable or selectively adjustable, and/or have non-linear behavior with respect to force versus distortion. Additionally, the systems may utilize a plurality of spanning portions in which two or more of the spanning portions have different stiffness characteristics. Methods for fabricating and using the foregoing devices are also described herein.

Claims

1. A spinal stabilization system securable with a plurality of vertebrae, the system comprising:

at least one anchor for each of at least two vertebrae;

a spanning structure extending between and securable with the anchors wherein the spanning structure has an adjustable mechanical performance characteristic achieved by;

adjustment of differing materials of the spanning structure characterized in that the spanning structure comprising at least a first and second cross-sectional area arranged in at least two layers about substantially the entire length of the spanning structure; and

the adjustable mechanical performance characteristic is further achieved by;

adjustment of the thickness of the at least first and second cross-sectional area of the spanning structure.

2. The system of claim 1 wherein the adjustable mechanical performance characteristic is a bending stiffness.

3. The system of claim 2 wherein the bending stiffness is adjustable in an orientation corresponding to the orientation of the at least two vertebrae.

4. The system of claim 2 wherein the bending stiffness is adjustable in anterior, posterior, lateral, and torsional modes.

5. The system of claim 2 wherein the bending stiffness is variable in both longitudinal and transverse planes relative to the vertebrae.

6. The system of claim 2 wherein the spanning structure concludes a first layer comprising an outer member and a second layer comprising an inner portion, each extending the entire length of the spanning structure, and wherein the bending stiffness is selectable by selection of the material of the inner portion.

7. The system of claim 6 wherein the material of the inner portion is introducable after securing the outer member with the anchors.

8. The system of claim 6 wherein the inner portion is comprised of a plurality of inner components, and the bending stiffness may be selected by selecting a number of the components to be disposed within the outer member.

9. The system of claim 8 wherein the bending stiffness is adjustable by removal or addition of the inner components.

10. The system of claim 6 wherein the bending stiffness is adjustable by orientation of the inner portion relative to the outer member.

11. The system of claim 10 wherein at least one of the outer member and the inner portion having eccentrically positioned regions of reduced cross-sectional area that rotation of the regions provides a direction for lowered stiffness.

12. The system of claim 6 further comprising an outer member cross-sectional area that is smaller than the inner portion cross-sectional area, and the outer member and inner portion are able to be positioned substantially within another structural member, the combined members being retained with a first end securable with a first vertebral body, and a second end operatively fixable with a second vertebral body.

13. The system of claim 6 further comprising at least one helical coil spring concentrically located inside at least one other helical coil spring, wherein the outer helical coil spring is anchorable to each vertebral body and wherein the inner helical coil spring is retainable to each anchorage point at each vertebral body.

14. The system of claim 13 wherein the bending stiffness is adjustable by adjusting at least one physical characteristic of the one or more helical coil spring elements.

15. The system of claim 14 wherein the physical characteristic of the one or more helical coil spring elements includes at least one of the number of coils, the diameter of the coils, and the length of the spring.

16. The system of claim 13 wherein the spanning structure includes a pair of springs each having a plurality of coils, wherein a first of the springs provides a compression characteristic and a second of the springs provides an expansion characteristic.

17. The system of claim 1 having:

a plurality of spanning structures extending between and securable with the anchor, each spanning structure having an adjustable mechanical performance characteristic;

wherein the plurality of spanning structures are arranged in layers extending substantially the distance between the at least two vertebrae;

wherein each of the spanning structures is adjusted to impart a different stiffness characteristic between its respective anchors; and

wherein in the mechanical performance characteristic of each of the spanning structures is adjustable after being secured with the anchors.

18. The system of claim 17 wherein the mechanical performance characteristic for at least one of the spanning structures is a bending stiffness, and the mechanical performance characteristic for at least one of the spanning structures is a compression/expansion stiffness.

19. The system of claim 17 wherein at least one spanning structure mechanical performance characteristic is adjustable via a percutaneous incision in a patient'"'"'s skin.

20. The system of claim 17 wherein at least one spanning structure is adjustable via an end thereof.

21. The system of claim 17 wherein the system is adjustable via an implanted key or tool without an incision.