Cement-directing orthopedic implants

• US 8,100,973 B2
• Filed: 09/30/2008
• Issued: 01/24/2012
• Est. Priority Date: 04/15/2004
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Soteira, Inc. (Globus Medical, Inc.)
• Inventors: Sennett, Andrew R., Gruber, William Harwick, Richard, Joseph Ernest
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): Carter, Tara
• Application Number:
  US12/241,979
• Publication Number:
  US 20090030468A1
• Time in Patent Office: 1,211 Days
• Field of Search: 606 92- 94, 606/191, 606/192, 606/198, 606/199, 623 1711- 1716, 623/1.35, 623/11.11, 623/23.7, 623/23.54
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0023 differing in porosity

Abstract

A cement-directing structure for use in cement-injection bone therapy includes a collapsible, self-restoring braided structure with regions of differential permeability to the bone cement. The regions of differential permeability may be provided by areas where the braided mesh density is greater or lesser than surrounding areas and/or by means of a baffle. After the structure is placed in a void within a bony structure, cement is injected into the interior of the structure then oozes out in preferred directions according to the locations of the regions of differential permeability.

Claims

1. A method of treating a vertebral body comprising the steps of:

creating a cavity in a vertebral body;

inserting a collapsible multi-layered braided mesh structure into the cavity, wherein (i) the multi-layered braided mesh structure comprises at least one primary member and at least one secondary member, (ii) the secondary member has been removed in at least one region of the mesh structure to form at least one cement flow window therethrough, and (iii) the primary member remains over the at least one cement flow window; and

injecting a bone cement into the braided mesh structure, wherein the bone cement flows preferentially out of the braided mesh structure through the at least one flow window.

2. The method of claim 1, wherein the at least one primary member comprises a elastic, heat-setting monofilament wire member.

3. The method of claim 1, wherein the at least one primary member has sufficient mechanical strength and elasticity to self-expand toward its nominal shape upon complete insertion into a bone cavity.

4. The method of claim 1, wherein the at least one secondary member comprises a polymer.

5. The method of claim 1, wherein at least one of the secondary member is more elastic than the at least one primary member.

6. The method of claim 1, wherein the at least one secondary member is layered over the at least one primary member.

7. The method of claim 1, wherein the at least one secondary member is interwoven with the at least one primary member.

8. The method of claim 1, wherein the collapsible multi-layered braided mesh structure further comprises a dip coating.

9. The method of claim 1, wherein a combined cross-sectional area of the flow windows is greater than a cross-sectional area of a bone cement injection element for injecting a bone cement into the expanded braided mesh structure.

10. A method of treating a vertebral body comprising the steps of:

creating a cavity in a vertebral body;

inserting a collapsible self-expanding multi-layered braided mesh structure into the cavity in a collapsed configuration;

allowing the mesh structure to self-expand to an expanded configuration within the cavity without substantially distracting material outside the boundary of the cavity; and

injecting a bone cement into the expanded braided mesh structure, wherein the braided mesh structure comprises regions of different permeability to the bone cement and wherein the bone cement flows preferentially out of the braided mesh structure through at least one region of greater permeability.

11. The method of claim 10, wherein a combined cross-sectional area of an exit flow path through the permeability regions is greater than a cross-sectional area of a bone cement injection element for injecting a bone cement into the expanded braided mesh structure.

12. The method of claim 10, wherein the collapsible multi-layered braided mesh structure comprises a dip coating.

13. The method of claim 12, wherein the collapsible multi-layered braided mesh structure comprises at least one hole in at least one of the dip coating and one layer of the multi-layered braided mesh structure.

14. The method of claim 10, wherein the inserting step comprises inserting the multi-layered braided mesh structure such that a region of greater permeability is positioned such that bone cement is directed in at least one of a substantially anterior-superior and anterior-inferior direction.

15. The method of claim 14, wherein the inserting step comprises inserting the multi-layered braided mesh structure such that a plurality of regions of greater permeability are positioned such that bone cement is directed in both a substantially anterior-superior and anterior-inferior direction.

16. The method of claim 10, wherein the multi-layered braided mesh structure comprises at least one primary member and at least one secondary member, and wherein the secondary member has been removed in at least one region of the mesh structure to form the at least one region of greater permeability.

17. An expandable orthopedic device adapted for placement in a cavity formed in bone, comprising:

a collapsible, self-expanding multi-layered braided mesh structure at least partially permeable to a bone cement, wherein (i) the multi-layered braided mesh structure comprises at least one primary member and at least one secondary member, (ii) the at least one secondary member has been removed in at least one region of the mesh structure to form at least one cement flow window therethrough, and (iii) the primary members remain over the at least one cement flow window.

18. The device of claim 17, wherein the primary members comprise elastic, heat-setting monofilament wire members.

19. The device of claim 17, wherein the primary members have sufficient mechanical strength and elasticity to self-expand toward their nominal shape upon complete insertion into a bone cavity.

20. The device of claim 17, wherein the secondary members comprise a polymer.

21. The device of claim 17, wherein at least one of the secondary members is more elastic than the primary members.

22. The device of claim 17, wherein the secondary members are layered over the primary members.

23. The device of claim 17, wherein the secondary members are interwoven with the primary members.

24. The device of claim 17, wherein the collapsible multi-layered braided mesh structure further comprises a dip coating.

25. The device of claim 17, wherein the first permeability region comprises a region wherein at least one secondary member has been removed.

26. The device of claim 25, wherein the at least one secondary member is removed by at least one of laser and mechanical cutting.