Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2000-08-18
2004-07-06
Brown, Michael A. (Department: 3764)
Surgery
Instruments
Orthopedic instrumentation
C623S017120
Reexamination Certificate
active
06758849
ABSTRACT:
BACKGROUND
1. Field of the Invention
The present invention relates to artificial spinal fusion implants to be placed across the intervertebral space left after the removal of a damaged spinal disc, and in particular to an improved, at least partially cylindrical, spinal fusion implant for implantation where two threaded cylindrical implants of requisite height would not fit within the transverse width of the spine.
2. Description of the Related Art
In the past, Cloward, Wilterberger, Crock, Viche, Bagby, Brantigan, Michelson and others have taught various methods involving the drilling of holes across the disc space between two adjacent vertebrae of the spine for the purpose of causing an interbody spinal fusion. Cloward taught placing a dowel of bone within that drilled hole for the purpose of bridging the defect and to be incorporated into the fusion. Viche taught the threading of that bone dowel. Bagby taught the placing of the bone graft into a metal bucket otherwise smooth on its surface, except for rows of radially placed holes communicative to the interior of the basket and to the bone graft. The Bagby device was disclosed as capable of being used in a horse. Brantigan taught the use of inert blocks preferably made of metal and having that metal at its external surface imitate the porosity of bone. Brantigan theorized that the bone dowel could be replaced entirely with a metal plug, that, while not itself active in the fusion, would nevertheless serve to support the vertebrae from within the disc space while allowing fusion to occur around it.
U.S. Pat. No. 3,844,601 issued to Ma et al. on Nov. 19, 1974, teaches a method and instrumentation for preparing rectangular spaces across the disc space into the adjacent vertebrae and for preparing a rectangular graft of the bone itself that is inserted in the rectangular spaces.
U.S. Pat. No. 4,743,256 issued to Brantigan on May 10, 1988 teaches the use of an inert artificial spacer in the shape of a rectangle in place of using a rectangular bone graft as taught by Ma et al.
U.S. Pat. No. 4,878,915 issued to Brantigan on Nov. 7, 1989, teaches the use of fully cylindrical inert implants for use in interbody spinal fusion. Such implants do not participate in the bone fusion process but act as inert spacers and allow for the growth of bone to the outer surfaces of the implants.
U.S. Pat. No. 4,834,757 issued to Brantigan on May 30, 1989, teaches a rectangular shaped, hollow spinal fusion implant for use in lieu of a rectangular bone graft or Brantigan's earlier artificial inert spacer.
U.S. Pat. No. 5,015,247 issued to Michelson on May 14, 1991, teaches the use of a thin-walled, highly perforated, threaded, hollow cylindrical implant closed or closable at both ends, so as to be compressably loaded with bone or other fusion promoting materials. Additionally, the Michelson device may then be coated with a bone production inducing chemical such as hydroxyapatite. The Michelson patent, also discloses an improved method of drilling holes across the disc space and into the two adjacent vertebrae and safely installing cylindrical implants such that the entire surgical procedure may be conducted through a hollow cylindrical tube. The hollow cylindrical tube may be left in place throughout the surgical procedure and serves to hold the adjacent vertebrae in place relative to each other, permits the guarded drilling of the holes across the disc space, and permits the insertion of the implant through that same tube into the hole drilled across the disc space and into the adjacent vertebrae.
As regards this method of performing interbody spinal fusion using essentially cylindrical threaded implants, a special problem arises (see
FIG. 1
) when an attempt is made to place two cylindrical implants (considered to be the preferred number as it is a much more stable construct and has more surface area than a single implant placed centrally) side-by-side across a disc space and into the two adjacent vertebrae where the height of the disc space is such that it requires an implant of a diameter so large to penetrate into and significantly engage each of the adjacent vertebrae that it is no longer possible to place two such implants side-by-side and to still have them contained within the transverse width of the spine. If an attempt is made to remedy the problem by using smaller diameter implants placed side-by-side such that both would then be able to fit within the transverse width of the spine, then the implants would be of insufficient height to adequately engage the bone. If an attempt is made to remedy the problem by abandoning the side-by-side double implant construct in favor of a single, centrally placed implant, then where the implant is sufficiently large enough to occupy a sufficient portion of the transverse width of the disc space to promote firm stability, its vertical height and excursion into the vertebrae would be so severe that if any two consecutive disc spaces were to be operated upon, the vertebrae in between would be cut in half.
U.S. Pat. No. 5,055,104 issued to Ray on Oct. 8, 1991 (“Ray Patent”) discloses an implant comprising a helical coil without wall members that is assembled after the coils are placed in the disc space between the vertebrae, which supposedly can then be removed after the vertebrae have become fused together. The Ray implant is defective and unworkable in that it is incapable of being used in the manner in which it is described as it is not possible to insert into hard bone an isolated helical coil without any wall members to support such a coil, which coil would be analogous structurally to a slinky. (See Ray Patent, FIGS. 1 and 7). Further, the Ray implant is unduly complex, because it would require the difficult, if not impossible, task of assembly within the disc space. FIG. 3 of the Ray Patent clearly reveals that Ray does not teach the use of a truncated cylindrical implant, but merely teaches the use of a truncated, helical coil appearing as a sharpened spring totally lacking any wall member which could be considered cylindrical. Therefore, Ray teaches only the use of an isolated thread which can only be inserted by rotation and cannot be linearly advanced.
If the overwhelming obstacles of the impossibility of inserting an isolated thread without wall members and the problem of the assembly within the disc space could be overcome, then the Ray implant, would still be unsafe for its intended purpose as it would be at high risk of spontaneous disassembly and mechanical failure. Further, there would be insufficient room to safely rotate such a device for insertion as it is the very lack of such room that requires the use of a device having a decreased transverse width.
There is therefore, the need for a spinal fusion implant that is capable of being inserted into a hole drilled across the disc space between two adjacent vertebrae and partially into the two adjacent vertebrae such that the spinal fusion implant is capable of fitting within the transverse width of the spine when placed side-by-side next to a second of its kind.
SUMMARY OF THE PRESENT INVENTION
The present invention is an improved interbody spinal fusion implant that is capable of being inserted into a hole drilled across the disc space between two adjacent vertebrae and into the two adjacent vertebrae such that the spinal fusion implant is capable of fitting within the transverse width of the spine when placed side-by-side next to a second of its kind. The spinal fusion implant of the present invention comprises a thin-wall, multi-perforate, cylinder or partial cylinder, made of material appropriate for human implantation and having preferably, but not necessarily, one closed end and one end capable of being closed, such that an internal chamber can be filled and hold any natural or artificial osteoconductive, osteoinductive, osteogenic, or other fusion enhancing material. The spinal fusion implant of the present invention relies on roughenings of the outer surface to enhance its stability. Depending on the dimension of the transver
Brown Michael A.
Martin & Ferraro LLP
SDGI Holdings Inc.
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