Distraction instrument with fins for maintaining insertion...

Surgery – Instruments – Orthopedic instrumentation

Reexamination Certificate

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C606S08600R

Reexamination Certificate

active

06277122

ABSTRACT:

The present invention relates to an apparatus for separating vertebral bodies to perform surgery or install implants in the disc space between vertebral bodies, and more specifically relates to an apparatus with one or more fins that extend from a substantial part of the tapered end and the body of the apparatus in order to maintain its insertion location between the vertebrae.
BACKGROUND
Distraction is a common surgical procedure to operate on the spine. It is used to prepare a spine for fusing two opposing (adjacent) vertebrae or to install an implant in the disc space between two opposing vertebrae. Distraction can be performed anteriorly (from the front of the patient) or posteriorly (from the back). But regardless of the approach, the procedure generally begins by first exposing that portion of the spine, which the surgeon has determined to require repair, and then removing all or part of the damaged spinal disc between the two opposing vertebrae in question.
After removing the spinal disc, the surgeon then typically inserts what the layperson may describe as one or more wedges between the two vertebrae. Each wedge is mounted on the end of a shaft and successively taller wedges are inserted between the two vertebrae until the surgeon obtains the desired separation (“distraction”) between them. Once the desired separation is obtained, the surgeon then slides what the layperson may describe as a special tube over the shaft while the last wedge is still located between the vertebrae. This special tube is often referred to as a “guide sleeve”. The guide sleeve is generally taller than the wedge that separates the vertebrae. Hence, the distal end (the end toward the patient) of the guide sleeve butts against the outside of the top and bottom vertebrae. Typically, the guide sleeve has a top spike and bottom spike that extend from its distal end, and these spikes are respectively placed in contact with the top and bottom vertebrae. Further, the end of the guide sleeve may have lateral extensions to extend into the disc space between the top and bottom vertebrae and around each side of the wedge. The spikes are then driven into the vertebrae by striking the proximal end of the outside sleeve distractor with a hammer or some other impact device. With the spikes placed into the vertebrae and the lateral extensions slid in the disc space, the wedge is no longer necessary to hold the vertebrae apart. The spikes and lateral extensions now serve that function, and the wedge can be pulled out from the disc space through the inside of the guide sleeve. With the wedge removed, the surgeon is then free to work through the inside of this special tube to prepare the disc space for fusion or install implants.
With the foregoing explanation in mind, some nomenclature is important to fully understand the following specification. If the wedge/tip used to separate the vertebrae is approximately as tall as it is wide, the operation is called a “single barrel” procedure. Alternatively, if the wedge/tip is approximately twice as wide as it is tall, the operation is called a “double barrel” procedure. This terminology has largely risen for metaphoric reasons. The cross-section of a guide sleeve used in a double-barrel procedure resembles the cross-section of a double-barrel shotgun, and the cross-section of the guide sleeve used in a single-barrel procedure resembles the cross-section of a single-barrel shotgun.
The insertion location of the wedges between the vertebrae is of critical importance in most any surgery involving vertebral distraction. The wedge/tip determines the placement of the guide sleeve, which in turn commonly determines the exact placement of an implant or fusion material within the disc space. Hence, prior art devices, such as that presented in U.S. Pat. No. 5,484,437 to Michelson seek to limit inadvertent migration of the wedge by incorporating sharp pegs into the top and bottom sides of the wedge. The pegs in that design, however, do not contact vertebral tissue until the distractor/wedge has all but fully separated the vertebrae in question. As a result, that prior art design may allow the distractor/wedge to migrate during insertion into the vertebral space, before the sharp pegs have the opportunity to function.
What is needed is a medical device that can immediately secure its position within the disc space between two vertebral bodies, once the surgeon places the device in contact with the spine. The following devices address this need.
SUMMARY OF THE INVENTION
In one aspect, this invention is a tip for a medical device that distracts two opposing vertebral bodies. The tip has (1) a hub, (2) a boss, and (3) a first longitudinal fin. The boss is attached to the hub and has a body, a tapered portion, and a vertex. The first longitudinal fin is attached to the boss, and projects from at least a portion of the boss's external surface. But in addition, the first longitudinal fin also extends over at least a portion of the length of the body and substantially extends over the length of the tapered portion of the boss.
In another aspect, this invention is a tip for a medical device that distracts two opposing vertebral bodies. The tip has (1) a hub, (2) a boss, (3) a first longitudinal fin, and (4) a second longitudinal fin. The boss is attached to the hub and has a body, a tapered portion, and a vertex. The first and second longitudinal fins are attached to the boss, and project from at least a portion of the boss's external surface. But in addition, the longitudinal fins also extend over at least a portion of the length of the body and substantially extend over the length of the tapered portion of the boss.
As used in this specification, the term “hub” is a part of this invention that holds the boss. The hub may have various shapes such as a wedge, a tube, a rectangle, a square, a parabola, or a dome.
As used in this specification, the term “boss” is a part of this invention that holds the longitudinal fins. The boss may have various shapes such as a wedge, a tube, a rectangle, a square, a parabola, or a dome.
As used in this specification, the term “substantially extending over the length of said tapered portion”, which is used to describe the placement of a longitudinal fin on the present invention, means that the longitudinal fin distally extends over the tapered portion for no less than about 40 percent of the total length of the tapered portion, measured over the external surface of the tapered portion, between the tapered portion's proximal and distal ends.


REFERENCES:
patent: 2437329 (1948-03-01), Moore
patent: 2514665 (1950-07-01), Myller
patent: 2701559 (1955-02-01), Cooper
patent: 2854981 (1958-10-01), Morrison
patent: 4059115 (1977-11-01), Jumashev et al.
patent: 4263903 (1981-04-01), Griggs
patent: 4545374 (1985-10-01), Jacobson
patent: 4877020 (1989-10-01), Vich
patent: 5179915 (1993-01-01), Cohen et al.
patent: 5391169 (1995-02-01), McGuire
patent: 5484437 (1996-01-01), Michelson
patent: 5630819 (1997-05-01), Ashby et al.
patent: 5700264 (1997-12-01), Zucherman et al.
patent: 5720751 (1998-02-01), Jackson
patent: 6059790 (2000-05-01), Sand et al.
patent: 6086595 (2000-07-01), Yonemura et al.

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