METHOD AND DEVICE FOR TREATING
INTERVERTEBRAL DISC HERNIATIONS
This application claims the benefit of U.S. Provisional Application No. 60/326,009 filed on Oct. 9, 2001. 5
BACKGROUND OF THE INVENTION
The present invention relates generally to a method and device for treating intervertebral disc herniations using an endoscopic procedure. Particularly, this invention relates to a distraction disc anthroplasty device and method for treating intervertebral disc herniations. More particularly, the invention relates to a device and method of treating intervertebral disc herniations using a temporary flexible balloon device in the treated disc to alleviate pressure between adjacent vertebrae located in the cervical, thoracic, or lumber areas of the spine.
Intervertebral disc herniations are a major source of back pain. Herniations and ruptures of intervertebral discs may 2o also cause pain and numbness in the leg, feet and arms of affected patients. Herniated, or ruptured, discs may be caused by traumatic injury due to accident, illness, the aging process as well as a multiplicity of undefined causes.
Intervertebral discs are located between adjacent verte- 25 brae of the spine and are comprised of an annulus portion surrounding the nucleus pulposus or pulp. A herniation of an intervertebral disc results from a weakened, torn or stretched area of the annulus. Pulp from the nucleus extrudes through the herniated area in the annulus producing pressure on the 30 spinal column and/or adjacent nerves and thereby causing pain. Removing the pulp reduces pressure on the spinal column or adjacent nerves caused by the herniation.
In the past, intervertebral disc injuries have been treated with implantable disc spacers, for example. These prior art 35 methods typically involve invasive surgery which requires relatively long recovery times for the patient.
It is an object of this invention to produce a minimally invasive interposition arthoplasty procedure which allows for short-term recovery from surgery and the patient's early 40 return to normal activity.
SUMMARY OF THE INVENTION
The present invention relates to method and device for 45 treating a herniated intervertebral disc. The intervertebral disc may be located in the cervical, thoracic or lumbar area of the spine. The method of the invention includes an endoscopic procedure to create an access port in the annulus portion of the herniated or ruptured intervertebral disc. 50 Using a guide tube through the access port, pulp is removed from the nucleus area of the disc. Next, the tissues of the inner surface of the annulus may be annealed to shrink and tighten the annulus so that any ruptured or injured areas can continue the ingrowth process of fibrocartiligenous tissue 55 deposition. A natural or synthetic material may be placed into the disc space in order to promote tissue growth. A balloon assembly having a valve is inserted into the disc space via the endoscopic guide tube. The balloon is then filled with fluid to distract the adjacent vertebrae or to go occupy a portion of the intervertebral disc space. The guide tube is then removed from the access port. When fibrocollagenous tissue has grown into the distracted space, usually a few months to a few years, another endoscopic procedure is performed to remove the balloon assembly. 65
The balloon assembly includes a nubbin or end portion which may be incorporated into the balloon structure to
engage and maintain the access port in the disc annulus. The nubbin and/or other portions of the balloon structure may be radio lucent to improve visualization of the balloon assembly during insertion, expansion and removal. The balloon assembly also includes a valve member for filling and deflating the balloon member. Alternatively, the balloon assembly may be constructed of a dissolvable material.
An object of the present invention is to provide a novel method and device of treating intervertebral disc herniations, known as a major source of back pain. The process provides a minimally invasive procedure which allows for short-term recovery from surgery and the patient's early return to normal activity.
Another object of the invention is to improve visualization of the balloon assembly during insertion, expansion and removal from the intervertebral disc space. A further object of the invention is to promote tissue ingrowth in the intervertebral disc space.
These and other benefits of this invention will become clear from the following description by reference to the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a top sectional view showing a ruptured intervertebral disc;
FIG. 2 is a top sectional view showing a guide tube advanced through the access port in the anterior of the disc annulus;
FIG. 3 is a top sectional view showing the pulp removed from the disc;
FIG. 4 is a top sectional view showing the balloon assembly expanded by a fluid;
FIG. 5 is a top sectional view showing the filled balloon structure and the instrumentation removed; and
FIG. 6 is a lateral sectional side view showing the filled balloon maintaining distraction of the adjacent vertebrae.
DESCRIPTION OF THE PREFERRED
The present invention relates to a method and device for treating intervertebral disc herniations using endoscopic procedure. The method provides a minimally invasive procedure which allows for short-term recovery from surgery and a patient's early return to normal activity.
FIG. 1 shows a top sectional view of a herniated disc 15 of a spine 12. Spine 12 is shown to have a vertebral canal 28 and having posterior region 19 and anterior area 23. Disc 15 is shown having annulus portion 16 surrounding nucleus portion 17. Nucleus portion 17 is made up of pulp 18. The disc 15 is shown to be herniated or ruptured at herniation 20, whereby pulp 21 is shown extruding from nucleus 17 and through annulus 16 into the posterior region 19 of the spine thereby causing pain to the patient. The expressed or extruded pulp 21 from the disc space may be an irritant to nerve tissue that lie posterior to the vertebral column and may be a cause of back pain. It may also be the cause of referred pain and numbness to affected arm, hand, leg or foot areas.
The endoscopic procedure initially involves a surgical skin incision of approximately 3 mm in the skin and through which an endoscopic guide tube 14 is passed. FIG. 2 shows guide tube 14 inserted into disc 15 through annulus 16 and into nucleus 17. Trocar 24 is inserted within the guide tube 14 and is used to aide in forming access port 22 so that