Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2000-08-14
2002-07-16
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C424S093700
Reexamination Certificate
active
06419702
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to the treatment of diseased or traumatized intervertebral discs, and more particularly, to transplantation of the nucleus pulposis in conjunction with such treatment.
BACKGROUND OF THE INVENTION
Intervertebral discs provide mobility and a cushion between the vertebrae. At the center of each disc is the nucleus pulposus which, in the adult human, is composed of cells and an insoluble extracellular matrix which is produced by the nucleus itself. The extracellular matrix is composed of collagen, proteoglycans, water, and noncoliagenous proteins. The nucleus pulposus is surrounded by the annulus fibrosis, which is composed 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 cells of the nucleus pulposus have chondrocyte-like features. In an adult human, the cells of the nucleus pulposis obtain nutrients and eliminate waste by diffusion through blood vessels in the endplates of the vertebrae adjacent to the disc. Blood vessels do not course into the nucleus pulposis. The relative vascular isolation of the nucleus pulposis imparts isolation of nucleus pulposis cells from the body's immune system.
To date, the treatment of degenerative disc disease 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, most prior-art techniques use synthetic materials to replace the entire disc or a portion thereof. My pending U.S. patent application Ser. No. 09/415,382 discloses disc replacement methods and apparatus using synthetic materials.
Unfortunately, disc replacement using synthetic materials does not restore normal disc shape, physiology, or mechanical properties. Synthetic disc replacements tend to wear out, resulting in premature failure. The problems associated with the wear of prosthetic hip and knees are well known to those skilled in orthopedic surgery. The future of treating degenerative disc disease therefore lies in treatments which preserve disc function. If disc function could be restored with biologic replacement or augmentation, the risk of premature wearout would be minimized, if not eliminated.
SUMMARY OF THE INVENTION
This invention is directed to a method of treating a diseased or traumatized intervertebral disc through the transplantation of nucleus pulposis cells in conjunction with the extracellular matrix. Broadly according to the method live nucleus pulposus cells are harvested from a human or animal donor, such that the harvest includes at least a portion of the extracellular matrix, after which the harvested cells and extracellular matrix are introduced into the disc being treated. The harvested nucleus pulposus cells are preferably kept viable until placed into the disc being treated.
A preferred embodiment includes morselizing the harvested nucleus pulposus cells and extracellular matrix, forming a passageway through the annulus fibrosis, and transplanting the harvested nucleus pulposus cells and extracellular matrix into the disc through the passageway. For example, the harvested nucleus pulposus cells and extracellular matrix may be introduced into the disc using a needle and syringe or small cannula.
One or more therapeutic substances may be added to the harvested nucleus pulposus cells and extracellular matrix including culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications. Alternatively the step of transplanting the harvested nucleus pulposus cells and extracellular matrix may include percutaneously or laparoscopically injecting the engineered disc tissue into the disc being treated.
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patent: 6060053 (2000-05-01), Atala
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patent: 6352557 (2002-03-01), Ferree
Lumbar Intervertebral Disc Transfer a Canine Study Steven L. Frick MD et al. Spine vol. 19 No. 16, pp 1826-1835.*
Orthipedics Today, Jul. 2000. “Proceedings 13th Annual Meeting” North American Spine Society, Oct. 1998. “Proceedings 14th Annual Meeting” North American Spine Society, Oct. 1999.
Gifford Krass Groh Sprinkle Anderson & Citkowski PC
Jackson Suzette J.
Willse David H.
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