Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2000-02-28
2001-04-24
Mancene, Gene (Department: 3732)
Surgery
Instruments
Orthopedic instrumentation
C033S512000
Reexamination Certificate
active
06221077
ABSTRACT:
This invention relates to a human spine fixation template and method of making same.
BACKGROUND OF THE INVENTION
In the medical arts, it is common practice to affix a rod to a patient's spine in order to immobilize the spine in its length adjacent the affixed rod. In that practice, the surgeon determines the necessary length and configuration of a rod which is to be implanted into the patient, and that determination is based upon utilizing a template rod which the surgeon initially configures to the shape of the length of the spine which is to immobilized. That is, the surgeon initially bends and measures a bendable rod to conform to the affected part of the patient's spine. That rod becomes a template rod which is then utilized for the configuring of another rod which is to be implanted into the patient and secured to a portion of the length of the spine.
In that practice, it is important that there be no foreign matter introduced into the patient, and thus the template rod should not be the source of any foreign matter deposited into the patient when the surgeon is configuring that template according to the shape of the patient's spine. However, a rod of a preferred material, such as aluminum, can release contaminating foreign particles into the patient's body when the rod is subjected to the forces and action of bending, and of course that is undesirable. The introduction of foreign particulates is a major danger and concern in the implantation of spinal rods.
Accordingly, the present invention provides a template rod assembly which does not release any foreign matter into the patient, that is, the assembly's own flakings and the like, when it is being configured or bent adjacent the patient's spine. To accomplish this objective in the present invention, the template rod of this invention is provided with a sleeve which covers the rod and thereby precludes release of the particulates of the rod material. Such sleeve is preferably made of a silicone material which can be snugly positioned over the rod, and two end plugs are utilized for snugly sealing the assembled rod and sleeve at the ends of the assembly. As such, the template rod is fully protected and can be bent without leaving any foreign particles in the patient.
The present invention also includes the method of accomplishing the aforementioned and to do so in a manner which provide a a protected template rod and does so in an efficient and reasonably cost-effective manner.
Still further, the assembled rod and sleeve of this invention present incremental length indicia affixed along the length of the rod so the surgeon can determine the overall length, as well as the location, for the bends of the template rod. With that information, the surgeon can then use the template to select a final rod and to bend the final rod to conform to the length and configuration of the template rod and then implant the final rod into the patient.
In accomplishing all of the foregoing, the present invention provides the coextensive length of an assembled rod and sleeve with two end plugs which extend within the respective opposite ends of the sleeve to render the entire assembly of the rod, sleeve, and the two end plugs fluid and particle-release tight, all so that no fluid nor particulate can pass to of from the interior of the assembly. In that regard, the present invention has the two end plugs snugly assembled with the sleeve. Also, the two plugs serve to indicate the respective incremental length of the assembly at its opposite ends so that the overall length of the assembly includes the end plugs, and those two end plugs conform to the opposite end length increments along the length of the assembly.
The sleeve is of a transparent material, and thus indicia of length measurement on the rod can be seen through the encasing sleeve. Also, the plugs can be made of the same material as that of the sleeve to thus be non-offensive to the patient where the material is silicone or the like.
The assembly of the three components of the rod and the sleeve and the two end pugs can be snugly assembled, as mentioned above, without the need of any tools or special skills.
REFERENCES:
patent: 4807370 (1989-02-01), Trimble
patent: 5799407 (1998-09-01), Powell
patent: 5938662 (1999-08-01), Rinner
patent: 575828 (1924-04-01), None
Marchant Kevin K.
Rinner James A.
Beere Precision Medical Instruments, Inc.
Hansmann Arthur J.
Mancene Gene
Robert Eduardo C.
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