Method of replacing nucleus pulposus and repairing the...

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone

Reexamination Certificate

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Details

C606S092000

Reexamination Certificate

active

06206921

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to surgical methods generally, and is more specifically related to a process of repairing the intervertebral disk of mammals.
BACKGROUND OF THE INVENTION
Intervertebral disks are prone to injury. Due to the low blood supply to this area, intervertebral disks are slow to heal, and may not materially heal. When the annulus fibrosus is torn, or punctured, the nucleus pulposus can migrate. A ruptured/prolapsed annulus fibrosus is demonstrated in
FIG. 1. A
mechanical translation of the disk material is demonstrated in FIG.
2
.
Annulus fibrosus, as referred to herein, is the marginal or peripheral portion of an intervertebral disk. The intervertebral disk is a disk with fibrous bands surrounding the nucleus pulposus occupying the space between two vertebra. The anatomy of the disk provides a cushion to allow motion, limit motion and provide space, distancing the vertebra off the nerves and compressible tissue. Part of the vertebrae are bony blocks, which, when stacked one upon the other, form the anterior portion of the spine. Annulus fibrosus is also known as annulus fibrosus disci intervertebralus. The nucleus pulposus is a substance of jelly-like consistency found in the center of a intervertebral disk.
The effect of a ruptured/prolapsed annulus fibrosus may result in spasm, and neurological compromise, such as the compressed nerve indicated in FIG.
1
and other compressible soft tissues, i.e. arteries, veins. Degeneration of the condition may increase over time, resulting in chronic and debilitating pain. The condition is usually disabling.
Suppressive measures include steroidal injection, removal of the nucleus pulposus, and fusion either by donor bone, coral or by metal bracing. If disk removal is performed, a healthy part of the disk is often taken, eradicating the function of the joint, and accelerating the degeneration of adjacent segments of the body, as the body attempts to stabilize. This approach frequently leaves the patient immunologically and structurally compromised, if not permanently disabled.
Isolated treatment to only the damaged structures employing the most noninvasive procedure possible is preferred. This approach allows as much of the healthy tissue as possible to remain, and to retain normal neurological function. While the offending material can be removed, the material must be replaced with a material which will perform the function formerly performed by the material removed. A need exists for a process which limits the material removed from the intervertebral disk, and which replaces the material so removed with a composition that is physiologically acceptable to the human body, and which allows the intervertebral disk to retain motion and characteristics of normal joint function, including cushioning the joint as compression is introduce from the stacking of the vertebrae. The material must be pliable in its application, and non-dispersing after replacement.
SUMMARY OF THE PRESENT INVENTION
The present invention is a process of repairing the disk through replacing the nucleus pulposus. The process of the invention desires minimal invasiveness. Motion within the vertebrae, and joint function and cushioning in the intervertebral disk, are regained by the process.
The process involves removal of the nucleus pulposus and only as much of the annulus fibrosus and intervertebral disk as is necessary. The tissue so removed is replaced by a material which is resilient and non-dispersant upon setting, and within a temperature range of 35° and 42° C. After application of the material, and after the material is set, the resiliency of the material permits motion of the vertebrae, and performs the cushioning and joint functions of the intervertebral disk. The material is physiologically acceptable to the human body.
SUMMARY OF THE DRAWINGS
FIG. 1
shows, inter alia, a ruptured/prolapsed annulus fibrosus and the resulting migrated nucleus pulposus of an intervertebral disk.
FIG. 2
demonstrates mechanical translation of a ruptured/prolapsed annulus fibrosus.
FIG. 3
demonstrates the replacement of the nucleus pulposus and the ruptured/prolapsed portion of the annulus fibrosus by the introduction of gutta percha via a mechanically facilitating device.
FIG. 4
demonstrates the intervertebral disk after repair with gutta percha.


REFERENCES:
patent: 5047055 (1991-09-01), Bao et al.
patent: 5545229 (1996-08-01), Parsons et al.
patent: 5800549 (1998-09-01), Bao et al.

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