Resorbable interbody device

• US 9,775,721 B2
• Filed: 07/28/2014
• Issued: 10/03/2017
• Est. Priority Date: 07/10/2009
• Status: Active Grant

• Current Assignee: Novum Medical Incorporated
• Original Assignee: Bio2 Technologies, Inc.
• Inventors: Liu, James Jenq, Lewis, Casey S., Krevolin, Janet L.
• Primary Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US14/444,262
• Publication Number:
  US 20150073556A1
• Time in Patent Office: 1,163 Days
• Field of Search: 623 1711- 1716, 606279
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00329 Glasses, e.g. bioglass
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/10 Ceramics or glasses
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C03C 11/00 Multi-cellular glass ; Porous or hollow glass or glass particles
• CPC Class Codes: C03C 4/0014 Biodegradable glass

Abstract

A spinal interbody device fabricated of fully resorbable bioactive glass materials is used to maintain the intervertebral spacing in a fusion of adjacent vertebrae. The spinal interbody device can include regions of porous material having various levels of bioactivity so that fusion through ingrowth of bone tissue can be provided while regions of the spinal interbody device can continue to maintain the intervertebral space.

Claims

1. A spinal interbody implantable device comprising:

a body having a first end surface at a proximal end of the body and a second end surface opposite thereto at a distal end of the body, the body extending between the first and second surfaces to define opposing top and bottom vertebral engaging surfaces, the body further defining side surfaces, the distance between the first and second surfaces defining a height of the body;

the body having a structural region extending from the first surface to the second surface and composed essentially of a porous bioactive glass material having an anatomic load bearing strength in the human spine, the structural region having a first level of bioactivity;

the body having a porous region extending from the first surface to the second surface, the porous region having a second level of bioactivity;

the second level of bioactivity being greater than the first level of bioactivity;

the structural region and the porous region each exhibiting resorption when implanted in human tissue; and

the body being adapted to be inserted into the space between adjacent vertebrae associated with the height wherein an ingrowth of tissue responsive to the respective first level of bioactivity and the second level of bioactivity promotes fusion.

2. The spinal interbody implantable device according to claim 1 wherein the porous region is located in a central cavity of the body.

3. The spinal interbody implantable device according to claim 1 wherein the structural region is an amorphous bioactive glass.

4. The spinal interbody implantable device according to claim 1 wherein the porous region is an amorphous bioactive glass.

5. The spinal interbody implantable device according to claim 1 wherein the structural region is a silica glass.

6. The spinal interbody implantable device according to claim 1 wherein the structural region is a phosphate glass.

7. The spinal interbody implantable device according to claim 1 wherein the structural region is a glass-ceramic and the porous region is an amorphous glass.

8. The spinal interbody implantable device according to claim 1 wherein the structural region is located in a central cavity of the body.

9. The spinal interbody implantable device according to claim 1 further comprising a second porous region extending from the first surface to the second surface, the second porous region having a third level of bioactivity, the second porous region exhibiting resorption when implanted in human tissue.

10. The spinal interbody implantable device according to claim 9 wherein the second porous region is located on an outer peripheral surface of the body.

11. The spinal interbody implantable device according to claim 9 wherein the third level of bioactivity is greater than the first level of bioactivity.

12. The spinal interbody implantable device according to claim 9 wherein the second porous region has a composition that is the same as a composition of the porous region.

13. A spinal interbody implantable device comprising:

a body having a first end surface at a proximal end of the body and a second end surface opposite thereto at a distal end of the body, the distance between the first surface and the second surface defining a height of the body;

the body having a first region extending from the first surface to the second surface and composed of bioactive glass fiber bonded into a structure of interconnected pores, the first region having a first porosity;

the body having a second region extending from the first surface to the second surface, the second region composed essentially of a bioactive glass fiber bonded into a structure of interconnected pores, the second region having a second porosity, the second porosity being greater than the first porosity; and

the body being adapted to be inserted into the space between adjacent vertebrae associated with the height having contact with opposing vertebral surfaces wherein an ingrowth of tissue responsive to the respective first porosity and the second porosity promotes fusion.

14. The spinal interbody implantable device according to claim 13 wherein the first region is located in a central cavity of the body.

15. The spinal interbody implantable device according to claim 13 wherein the first region is an amorphous bioactive glass.

16. The spinal interbody implantable device according to claim 13 wherein the second region is an amorphous bioactive glass.

17. The spinal interbody implantable device according to claim 13 wherein the first region is a silica glass.

18. The spinal interbody implantable device according to claim 13 wherein the first region is a phosphate glass.

19. The spinal interbody implantable device according to claim 13 wherein the first region is a glass-ceramic and the second region is an amorphous glass.

20. The spinal interbody implantable device according to claim 13 further comprising a third region extending from the first surface to the second surface, the third region having a third level of porosity, the third region exhibiting resorption when implanted in human tissue.

21. The spinal interbody implantable device according to claim 20 wherein the third region is located on an outer peripheral surface of the body.