Cement-directing orthopedic implants

• US 20050261781A1
• Filed: 04/14/2005
• Published: 11/24/2005
• 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
• Granted Patent: US 7,465,318 B2
• Time in Patent Office: Days
• US Class Current: 623/23.540
• 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 device for use in treating orthopedic defects in a procedure comprising inserting the device into a pre-formed cavity within a bony member and injecting bone cement or other orthopedic filler material into an interior region of the device, said device comprising:

a collapsible, self-expanding mesh structure having a first, collapsed configuration and a second, expanded configuration, said first, collapsed configuration enabling the device to be inserted into the pre-formed cavity through a cannula and said second, expanded configuration being sufficient to maintain walls of the cavity apart from each other;

wherein said device has regions of differential permeability or flow resistance to said bone cement or other orthopedic filler material such that when bone cement or other orthopedic filler material is injected into the interior region of the device, the bone cement or other orthopedic filler material flows out of the device in one or more predetermined preferred directions.

2. The device of claim 1, wherein, when in said second configuration, the device does not compress cancellous bone when the device is positioned within the cavity and the cavity is formed within cancellous bone.

3. The device of claim 1, wherein said mesh structure itself has regions of differential permeability or flow resistance.

4. The device of claim 3, wherein said mesh structure is a co-braided structure comprising primary members and secondary members occupying interstices between said primary member and wherein said mesh structure has regions of increased permeability or decreased flow resistance in which secondary members are not present.

5. The device of claim 1, wherein said mesh structure has at least one region in which the mesh opening size of said region is greater than the mesh opening size of surrounding regions, whereby bone cement or other orthopedic filler material flows preferentially out of the device through said at least one region of greater mesh opening size.

6. The device of claim 1, further comprising at least one flow-retarding baffle member.

7. The device of claim 6, wherein said flow-retarding baffle comprises a coating formed on select regions of said mesh structure.

8. The device of claim 6, wherein said flow-retarding baffle comprises a sheet-form material that is attached to select regions of said mesh structure.

9. The device of claim 6, wherein said flow-retarding baffle member comprises one or more wing-like members extending from said mesh structure.

10. The device of claim 1, wherein said mesh structure itself has regions of differential permeability or flow resistance and wherein said device further comprises at least one flow-retarding baffle member.

11. The device of claim 1, wherein said device is generally hollow and has first and second ends, both of which are closed

12. The device of claim 11, wherein said first ends is fastened closed and said second end is unrestrained.

19. The device of claim 1, wherein said device comprises a stent.

13. A cement-directing device, comprising

a) a compressible, shape-restoring hollow mesh structure having a compressed shape and an expended shape, wherein the compressed shape is capable of being inserted into and moved through a cannula, the expanded shape being approximately football-shaped, and the mesh structure having sufficiently open mesh area to create minimal added flow resistance to bone cement inserted into the device;

and

b) wherein the mesh structure has at least a first mesh opening size and a second mesh opening size, the first and second mesh opening sizes creating a composite flow resistance to bone cement, the first mesh opening size being selected to facilitate the flow of cement in preferred directions, and the second mesh opening size being selected to impede the flow of cement in non-preferred direction.

20. The device of claim 13 wherein said device comprises a stent.

14. A cement-directing device, comprising:

a) a compressible, shape-restoring hollow mesh structure having a compressed shape and an expended shape, wherein the compressed shape is capable of being inserted into and moved through a cannula, the expanded shape being approximately football-shaped, and the mesh structure having sufficiently open mesh area to create minimal added flow resistance to bone cement inserted into the device; and

b) at least one baffle member attached to the hollow mesh structure and configured to direct the flow of bone cement in preferred directions and to impede the flow of bone cement in non-preferred directions.

21. The device of claim 14 wherein said device comprises a stent.

15. A cement-directing device suitable for use in repairing a bone defect, said device comprising a generally tubular, collapsible and self-expanding mesh framework, said device having regions of differential permeability or resistance to the flow of bone cement therethrough;

wherein said mesh framework has interstices that are sized to permit a bone cement injection needle to pass through said mesh framework to inject bone cement into an interior cavity of said device; and

wherein bone cement that is injected into said interior cavity in sufficient quantity to extravasate out of said cavity extravasates preferentially through regions of greater permeability or lower resistance to the flow of bone cement;

whereby the direction of extravasation is controlled by the location of said regions of differential permeability.

16. The device of claim 15, further comprising one or more baffling members attached to said mesh framework, said baffling members providing regions of decreased permeability to the flow of bone cement.

17. The device of claim 15, wherein said regions of differential permeability or resistance to the flow of bone cement therethrough are provided by regions of differential mesh density.

18. The device of claim 17, wherein said mesh framework is a multi-layer structure.

22. The device of claim 15, wherein said device comprises a stent.