CA2423603A1 - Spinal intervertebral implant and method of making - Google Patents

Spinal intervertebral implant and method of making Download PDF

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Publication number
CA2423603A1
CA2423603A1 CA002423603A CA2423603A CA2423603A1 CA 2423603 A1 CA2423603 A1 CA 2423603A1 CA 002423603 A CA002423603 A CA 002423603A CA 2423603 A CA2423603 A CA 2423603A CA 2423603 A1 CA2423603 A1 CA 2423603A1
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CA
Canada
Prior art keywords
bone
channel
fibers
forming
implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002423603A
Other languages
French (fr)
Other versions
CA2423603C (en
Inventor
Lawerence A. Shimp
Steven Annunziato
Erik Martz
David R. Kaes
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Warsaw Orthopedic Inc
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Individual
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Publication date
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Publication of CA2423603A1 publication Critical patent/CA2423603A1/en
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Publication of CA2423603C publication Critical patent/CA2423603C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891—Plurality of protrusions
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30904—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • A—HUMAN NECESSITIES
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    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
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    • A61F2310/00005—The prosthesis being constructed from a particular material
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    • A61F2310/00179—Ceramics or ceramic-like structures

Abstract

A C-shaped or ring shaped implant formed of cortical bone has its C-shaped or inner channel filled with a bone promoting material which is preferably demineralized bone fibers formed as a flexible wet sheet or may be cancellous bone, pressed bone fibers formed from demineralized cortical bone chips soaked in acid, or a flex material formed of demineralized bone growth promoting bone fibers. The discrete bone filler element may be secured by a bonding agent, pins or screws, metal, polymer or bone material. The bone filler material is preferably bonded by filling a section of a long bone medullary cavity with wet bone fibers and then drying the fibers to bond them to the outer bone.

Claims (31)

1. A spinal implant for fusing together two adjacent vertebra of a human or an animal comprising:
a first discrete bone element of a first type of bone having opposing first and second sides extending between first and second end surfaces and a channel in communication with the opposing first and second sides intermediate the end surfaces, the first bone element exhibiting negligible bone growth factors, the bone for implantation between and engaged with adjacent vertebra;
a second discrete fibrous bone element formed of demineralized cortical bone fibers or powder, the second element for promoting bone growth between said adjacent vertebrae, the second bone element having a shape that is complementary to said channel for forming an integral implant unit with said bone of the first type ; and means for securing the first element to the second element.
2. The implant of claim 1 wherein the first element has third and fourth sides transverse the first and second sides, the channel being in communication with the third side to form a chamber open at the third side.
3. The implant of claim 1 wherein the means for securing the first element to the second element comprises one of a bonding medium for bonding the elements to each other, a pin and a screw which passes into each said element.
4. The implant of claim 1 wherein the means for securing the first element to the second element comprises a filament.
5. The implant of claim 4 wherein the first element has third and fourth sides transverse the first and second sides, the channel being in communication with the third side to form a chamber open at the third side, the second element forming a portion of said third side, the filament being wound about the end surfaces and said third and fourth sides.
6. The implant of claim 5 wherein an annular groove is formed about said elements in said end surfaces and in said third and fourth sides.
7. The implant of claim 4 wherein said filament is one of a suture or animal tissue.
8. The implant of claim 1 wherein the means for securing comprises molecular bonding.
9. The implant of claim 1 wherein the first bone element has a given peripheral configuration, the second element comprising fibrous flex material having the configuration surrounding and abutting the first element in at least one plane.
10. The implant of claim 9 wherein the implant has a C-shaped channel in communication with three adjacent sides, said second element filling said channel.
11. The implant of claim 10 wherein the second element is sheet material of uniform thickness and extending radially outwardly from the first element in regions outside the channel.
12. A method of forming a fusion implant comprising:
forming a cortical bone into a discrete bone element having first and second opposing surfaces with a channel in communication with the opposing surfaces;
forming a channel filling material of bone fibers;
filling the interior channel with the fibers;
demineralizing the fibers prior to or after the filling, and then securing the fibers to the discrete bone element.
13. The method of claim 12 wherein the securing step includes bonding the fibers to the discrete bone element.
14. The method of claim 12 wherein the securing step includes wetting the fibers prior to or after filling the channel and then bonding the fibers to the discrete element.
15. The method of claim 14 wherein the bonding step includes drying the wet fibers in the channel.
16. The method of claim 12 wherein the step of forming the channel filling material of bone fibers includes forming the fibers into a flexible sheet.
17. The method of claim 16 including forming the sheet into a spiral and inserting the spiral into the channel.
18. The method of claim 12 wherein the forming the discrete bone element includes forming the cortical bone into a structure having a C-shaped cavity forming the channel.
19. The method of claim 12 wherein the forming the discrete element includes forming the discrete bone element into a ring.
20. The method of claim 19 wherein the step of forming the channel filling material includes forming bone chips and/or powder of cortical bone and demineralizing the chips and/or powder prior to filling the channel.
21. The method of claim 19 wherein the step of filling the channel includes filling the channel with wetted chips and the step of bonding includes drying the filled implant.
22. The method of claim 12 including forming the fibers into a flexible wet sheet, forming the sheet into a configuration generally matching that of the channel, filling the channel with the formed wet sheet and the bonding step includes drying the wet sheet in the channel.
23. The method of claim 22 including compacting the sheet in the filled implant.
24. The method of claim I9 including dividing the ring into two further implants each comprising a first bone element having a chamber open to three adjacent sides of the first bone element, forming the fibers into at least one flexible sheet and filling the chamber with the at least one flexible sheet.
25. The method of claim 24 wherein the step of securing the fibers to the first element includes wrapping the first element and at least one flexible sheet with a filament.
26. The method of claim 24 wherein the step of securing the fibers includes securing the at least one flexible sheet to the first bone element with a pin.
27. The method of claim 24 wherein the step of securing the fibers includes wetting the sheet prior to or after insertion into the channel and then drying the wet sheet.
28. The method of claim 27 including compacting the inserted sheet prior to drying.
29. The method of claim 12 wherein the filling the channel step includes forming the fibers into at least one sheet of flexible fibrous material, wetting the at least one sheet of fibrous material, wrapping the fibrous wet material about the discrete bone element and then drying the wet material to bond it to the discrete bone element.
30. The method of claim 12 wherein the step of forming the channel filling material of bone fibers includes demineralizing a cortical bone section so that it forms a flexible sheet.
31. The method of claim 27 including compacting the inserted sheet prior to and during drying.
CA2423603A 2000-11-03 2001-11-02 Spinal intervertebral implant and method of making Expired - Fee Related CA2423603C (en)

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US70537700A 2000-11-03 2000-11-03
US09/705,377 2000-11-03
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