Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2001-05-18
2003-03-11
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S017160
Reexamination Certificate
active
06530955
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
The present disclosure relates generally to intervertebral implants for spinal fusion and, more particularly, to a ramp-shaped intervertebral implant having a top surface and a bottom surface and at least one opening extending between the top and bottom surfaces.
2. Background of Related Art
Surgical procedures for fusing adjacent vertebrae together to treat back pain in patients with ruptured or degenerated intervertebral discs, spondylolisthesis or other pathologies are well known. Typically during such a procedure, a spinal implant is placed into the intervertebral space in a position to engage adjoining vertebrae. The implant is constructed from a biocompatible material which is adapted to fuse with the adjacent vertebrae to maintain proper spacing and lordosis between the adjacent vertebrae, i.e., maintain the disc space.
A variety of different types of intervertebral implants have been developed to perform this function including spinal fusion cages, threaded bone dowels and stepped bone dowels. Exemplary implants are disclosed in U.S. Patent Applications filed on even date herewith, under Certificate of Express Mail Label Nos. EL260888080US and EL071686220US, and entitled “Intervertebral Implant” and “Keyed Intervertebral Dowel”, respectively, the entire disclosures of which are incorporated herein by reference.
One type of intervertebral implant has a wedge configuration. U.S. Pat. No. 5,425,772 to Brantigan discloses a wedge-shaped implant having an anterior end, a posterior end, front and rear walls, top and bottom walls and sidewalls. The implant is constructed from biocompatible carbon reinforced polymer or alternately of traditional orthopedic implant materials such as chrome cobalt, stainless steel or titanium. The top and bottom walls are tapered from the anterior end of the implant to the posterior end such that the anterior end of the implant has a height greater than the height of the posterior end of the implant. The top and bottom of the implant are continuous and unslotted and include a series of transverse teeth or serrations extending thereacross. A slot configured to receive bone graft material extends through the implant between the sidewalls.
During insertion of Brantigan's implant into the intervertebral space, the adjoining vertebrae are tensioned and a portion of disc tissue between the vertebrae is cut and removed to form channels between the vertebrae. The implant is positioned in the channel such that the teeth formed on the top and bottom surfaces of the implant engage the adjoining vertebrae. During a surgical spinal fusion procedure, two of Brantigan's implants are inserted between the adjoining vertebrae to be fused.
U.S. Pat. No. 5,443,514 to Steffee also discloses a wedge-shaped implant having upper and lower toothed surfaces, a pair of parallel side surfaces, a pair of end surfaces and a plurality of openings extending between the side surfaces. The implant is constructed from an injection molded chopped carbon fiber reinforced polymer. The openings facilitate blood flow and bone growth from one side of the implant to the other. Steffee's implant is adapted to receive an insertion tool which during insertion of the implant between adjoining vertebrae rotates the implant from a horizontal to a vertical orientation. During a surgical procedure, two of Steffee's implants are positioned between adjoining vertebrae.
Conventional wedge-shaped intervertebral implants, including those described above, have several drawbacks. For example, although autograft wedges are known, e.g., iliac crest wedges, typically, conventional wedge-shaped implants are constructed from materials which do not remodel but rather remain in place forever or until removal is necessitated, i.e., at least some or all of the implant is not replaced by new bone, but rather the implant itself is incorporated into the body. Since the implants usually become adherent to the adjoining vertebrae, if removal of the implant is ever necessitated, the procedure to effect removal is complicated and dangerous to the patient. Moreover, in conventional wedge-shaped implants, the opening(s) to facilitate bone ingrowth extend transversely through the implant and as such do not open in communication with the adjoining vertebrae. Thus, bone ingrowth and eventual fusion will occur more slowly.
Accordingly, a need exists for an improved wedge-shaped intervertebral implant which can be easily manufactured from a material which will be remodeled within the body and will more quickly become adherent to adjoining vertebrae.
SUMMARY
In accordance with the present disclosure, a ramp-shaped intervertebral implant which is constructed from animal or human cadaveric bone or bone composites, or from any biocompatible material having the requisite strength requirements suitable for implantation, is provided. The ramp-shaped implant includes a body having a first side, a second side and upper and lower surfaces. An opening extends through a central portion of the body between the upper and lower surfaces and a series of ridges are formed over at least a portion of at least one of the upper and lower surfaces. The implant decreases in height from the first end of the implant to the second end of the implant.
In a preferred embodiment, the implant is formed from the diaphysis or metaphysis of a long bone. More particularly, the implant is formed by first cutting a cortical ring from a long bone. Next, the cortical ring is secured within a holding fixture and the sidewalls of the cortical ring are machined to provide the implant with a desired shape. As such, the implant may retain its natural configuration or some or all of the sidewalls can be machined to form the implant to any configuration including rectangular, circular, C-shaped, etc. The intramedullary canal of the cortical ring defines an opening which extends from the top surface to the bottom surface of the implant. The implant is then placed in a second holding fixture and the top surface is machined to provide the appropriate taper and the ridges. These steps can be performed simultaneously using, for example, a three-dimensional computer operated milling machine. Alternately, the steps can be performed consecutively. Next, the implant is repositioned in the holding fixture and the bottom surface of the implant is machined to provide the appropriate taper and the ridges. The side surfaces may also be machined to vary the width of the implant along the longitudinal axis of the implant. A C-shaped implant can be formed by making a cut across the medial lateral plane of the cortical ring to expose the intramedullary canal. Thereafter, a ramp or taper can be provided in the anterior/posterior plane. Because the implant is constructed of bone, after insertion into the body of a patient, the implant will remodel within the body. New bone of a patient will eventually replace some or all of the implant. Thus, if removal of the implant is ever necessitated, the implanted bone and/or the remodeled bone can be easily reamed out. Moreover, since the opening extends between the top and bottom surfaces of the implant, bone growth material which is packed into the opening directly contacts the adjoining vertebrae. Thus, fusion of the implant and adjoining vertebrae will occur more quickly.
Alternately, the ramp-shaped intervertebral implant can be formed from any biocompatible material having the requisite strength requirements via any known process including but not limited to molding and machining.
REFERENCES:
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patent: 5047058 (1991-09-01), Roberts et al.
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patent: 5306309 (1994-04-01), Wagner et al.
patent: 5314478 (1994-05-01), Oka et al.
patent: 5425772 (1995-06-01), Brantigan
patent: 5425773 (1995-06-01), Boyd et al.
patent: 5443514 (1995-08-01), Steffee
patent: 5
Boyce Todd M.
Boyle John W.
Daugherty Mark
Kaes David R.
Martz Erik O.
Dilworth & Barrese LLP
Isabella David J.
Osteotech Inc.
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