Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2000-01-06
2002-09-10
Philogene, Pedro (Department: 3732)
Surgery
Instruments
Orthopedic instrumentation
C606S080000, C623S017110
Reexamination Certificate
active
06447512
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to spinal fixation and fusion systems. The invention also generally relates to an insertion guide used during the insertion of a spinal implant system, wherein the implant system is used for correction, fixation, and/or stabilization of the spine.
2. Description of the Related Art
Intervertebral disks that become degenerated due to various factors such as trauma or aging typically have to be partially or fully removed. Removal of an intervertebral disk can destabilize the spine, making it necessary to replace the vertebral disk to maintain the height of the spine and to fuse the spine. Spinal implants are often used to prevent collapse of the spine. In a typical spinal fusion procedure, an intervertebral disk is removed and implants are inserted in the disk space between neighboring vertebrae. The implants maintain normal disk spacing and help restore spinal stability.
The implants may be constructed of any biocompatible materials sufficiently strong to maintain spinal distraction including, but not limited to, bone, stainless steel, or inert metals. Implants are typically packed with bone graft or a synthetic bone graft substitute to facilitate spinal fusion. Implants may have a variety of shapes, which include, but are not limited to, threaded cylinders, unthreaded cylinders, and parallelepipeds.
An anterior spinal fusion procedure is often preferred to a posterior spinal fusion procedure. An anterior spinal fusion procedure may require less bone removal and muscle distraction than a posterior spinal fusion procedure. Also, an anterior spinal fusion procedure may involve less risk of nerve damage than a posterior spinal fusion procedure. In an anterior spinal fusion procedure, a surgical opening in the abdomen may be up to ten inches deep. A protective sleeve may be used during preparation and insertion of a spinal implant. The protective sleeve may serve to protect abdominal organs, blood vessels and other tissue during the spinal implant procedure. The sleeve typically extends above the surgical opening during use. The sleeve may maintain distraction of the vertebrae. Also, the sleeve may serve as an alignment guide for tool and implant insertion during the surgical procedure.
Protective sleeves typically have distractors on a distal end. Distractors are projections that may be inserted into a disk space during a spinal fusion procedure. The distractors may serve to achieve and maintain distraction of adjacent vertebrae. Distractors may also help to secure the protective sleeve to the spinal column during the procedure. Protective sleeves may have one tube or two parallel tubes.
FIG. 1
shows a single-tube protective sleeve, and
FIG. 2
shows a dual-tube protective sleeve.
FIG. 1
illustrates a single-tube protective sleeve
30
used in a spinal fusion procedure. A spinal fusion procedure involves the insertion of one or more implants in a disk space between two vertebrae. Protective sleeve
30
includes a substantially long, hollow tube
32
, two distractors
34
on opposite sides of an end of the tube, and two spikes
36
(only one shown) on opposite sides of the end of the tube. Protective sleeve
30
is typically sufficiently long to allow access to a spinal column of a large patient during an anterior procedure. Protective sleeve
30
may also be used in a posterior spinal fusion procedure.
A spinal fusion procedure using implants typically involves the insertion of two implants that are bilaterally positioned in an intervertebral disk space. During an anterior procedure, the disk space is prepared by performing a discectomy and by distracting the vertebrae adjacent the disk space. A cap (not shown) is placed on end
38
of the protective sleeve
30
opposite distractors
34
to protect the end of the sleeve during insertion. Distractors
34
may then be hammered into the disk space by striking the cap with a mallet (not shown). Spikes
36
are hammered into disk bone on the vertebrae and help to stabilize protective sleeve
30
during the procedure. Distractors
34
serve to separate the adjoining vertebrae to approximately normal spacing.
After insertion, a hole is drilled in the disk space by inserting a tool with a reaming head attachment through tube
32
and rotating the tool until a predetermined depth is reached. In some procedures, the hole is then tapped by inserting a tool with tap head attachment through tube
32
and rotating the tool until a predetermined depth is reached. The top and bottom of the reamed and tapped hole may extend into the end plates of the adjacent vertebrae. After the hole is prepared, an implant may be inserted in the hole by attaching the implant to an implant insertion tool and inserting the implant through tube
32
. For untapped holes, the implant may be hammered into the hole by striking the implant insertion tool with a mallet. For tapped holes, the implant may be threaded into the hole by turning the implant insertion tool. Then, the protective sleeve
30
may be removed.
If a second implant is to be inserted, the protective sleeve
30
is hammered in the disk space opposite the first implant and the procedure is repeated. Alternatively, the protective sleeve
30
may remain inserted in the disk space, and a second single-tube protective sleeve
30
may be inserted adjacent to the protective sleeve.
The optimal alignment and spacing of implants in a spinal fusion procedure may be determined before surgery. Achieving the predetermined alignment and spacing during surgery is often important for optimal fusing of the adjacent vertebrae. Protective sleeve
30
has characteristics that may make achieving alignment difficult. First, each of the two holes is aligned, reamed, and tapped in a separate procedure. It is often difficult to align and space the holes correctly. Second, the alignment of protective sleeve
30
must be maintained after insertion. Any slight movement of protective sleeve
30
, which may act like a lever arm, may result in misalignment of the hole.
FIG. 2
illustrates a dual-tube protective sleeve
40
used in a spinal fusion procedure involving the insertion of two implants into a disk space. Protective sleeve
40
includes substantially long, hollow tubes
32
, one or more distractors
34
and one or more spikes
36
. Protective sleeve
40
is typically long enough to allow access during an anterior procedure to an intervertebral disk in a large patient. Spinal fusion using implants with protective sleeve
40
involves the insertion of two implants, bilaterally positioned in parallel in an intervertebral disk space. During an anterior procedure, the disk space is prepared by performing a discectomy and by distracting the vertebrae adjacent the disk space. A cap (not shown) is placed on the end
42
of protective sleeve
40
opposite distractor
34
to protect the sleeve during insertion. Distractor
34
is then hammered into the disk space by striking the cap with a mallet (not shown). Spikes
36
are hammered into disk bone on the adjacent vertebrae to help stabilize protective sleeve
40
during the procedure. Distractor
34
serves to separate the adjoining vertebrae to approximately normal spacing. After insertion, holes are reamed in the disk space by inserting a tool with a reaming head attachment through tubes
32
and rotating the tool until a predetermined depth is reached. In some procedures, the holes are tapped by inserting a tool with a tap head attachment through tubes
32
and rotating the tool until a predetermined depth is reached. The top and bottom of the reamed and tapped holes may extend into the end caps of the adjacent vertebrae. After the holes are prepared, implants are inserted in the holes by attaching the implants to an implant insertion tool and inserting the implants through tubes
32
. For untapped holes, the implants are hammered into the hole by striking the implant insertion tool with a mallet. For tapped holes, the implants are threaded into the holes by turning the implant insert
Hochshuler Stephen H.
Landry Michael E.
Larsen John M.
Wagner Erik J.
Conley & Rose & Tayon P.C.
Meyertons Eric B.
Philogene Pedro
Spinal Concepts Inc.
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