Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2000-10-16
2002-09-24
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C424S093700, C623S908000
Reexamination Certificate
active
06454804
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to the treatment of diseased or traumatized intervertebral discs, and more particularly, to the use of engineered disc tissues in conjunction with such treatment.
BACKGROUND OF THE INVENTION
Intervertebral discs provide mobility and a cushion between the vertebrae. At the center of the disc is the nucleus pulposus. The nucleus pulposus is surrounded by the annulus fibrosis, which is comprised of cells (fibrocyte-like and chondrocyte-like), collagen fibers, and non-fibrillar extracellular matrix. The components of the annulus are arranged in 15-25 lamellae around the nucleus pulposus. The fibers in the lamellae alternate their direction of orientation by 30 degrees between each band.
The annulus fibrosis has three important functions. First, the annulus contains the nucleus pulposus. Second, the annulus fibrosis, with other ligaments, connects the vertebrae of the spine. Lastly, the annulus fibrosis helps to control movement between the vertebrae.
The fibers of the annulus can tear causing pain and possible extrusion of the nucleus pulposus. Extrusion of the nucleus pulposus is known as a disc herniation. Disc herniations can compress nerves or the spinal cord resulting in arm or leg pain and dysfunction. Surgery to repair disc herniations leaves a hole in the annulus fibrosis. The hole in the annulus acts as a pathway for additional material to protrude into a nerve, resulting in a recurrence of the herniation.
To date, the treatment of tears or defects of the annulus fibrosis has relied for the most part on eliminating the defective disc or disc function. This may be accomplished by fusing the vertebra on either side of the disc. In terms of replacement, prior-art techniques replace either the nucleus or the nucleus and annulus functions. My co-pending U.S. patent application Ser. No. 09/322,516, and Patent Cooperation Treaty Application Serial No. PCT/US/14708 describe methods and devices to occlude annular defects.
SUMMARY OF THE INVENTION
Although transplantation of living cells risks rejection by graft host reaction, this invention broadly recognizes that transplantation of the extracellular matrix of the annulus fibrosis is unlikely to incite graft host reaction. In the preferred embodiment, fibrocytes are harvested, cultured, then added to annulus fibrosis extracellular matrix obtained from recently deceased humans or animals. The combined annulus fibrosis is then introduced into the injured or diseased disc.
The cells or engineered tissues may be introduced using any surgical technique, including percutaneous or laparoscopic approaches. As one delivery mechanism, a passageway may be formed through the annulus fibrosis, with the cells or engineered disc tissue being introduced into the disc through the passageway. In particular, the engineered disc tissue may be sewn or otherwise adhered to the inside or outside of the existing annulus fibrosis using a surgical procedure performed from the posterior or anterior portion of the body.
The method of the invention may further include the step of adding one or more therapeutic substances to the cells or annular tissue prior to transplantation. Such therapeutic substances could include culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, immunosuppressive medications, or any useful combination thereof.
The teachings of this invention may be combined with any compatible nucleus replacement procedure, as well as the embodiments described in co-pending U.S. patent application Ser. No. 09/690,536 entitled “Annulus Fibrosis Augmentation Methods And Apparatus,” the entire contents of which are incorporated herein by reference.
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Gifford Krass Groh Sprinkle Anderson & Citkowski PC
Jackson Suzette J.
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