Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
2002-06-13
2003-11-11
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S908000, C404S093000
Reexamination Certificate
active
06645247
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 tissues in conjunction with such treatments.
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. My U.S. Pat. No. 6,245,107 and Patent Cooperation Treaty Application Serial No. PCT/US/14708 describe methods and devices to occlude annular defects.
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. This may be accomplished using natural or synthetic materials, or a combination of natural and artificial components. Although transplantation of living cells risks rejection by graft host reaction, certain of my previous disclosures, including those in U.S. patent application Ser. Nos. 09/688,716 and 09/638,726 (now U.S. Pat. No. 6,340,369) recognize that transplantation of the extracellular matrix of the annulus fibrosis is unlikely to incite graft host reaction. As such, 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.
SUMMARY OF THE INVENTION
Certain of my co-pending patent applications and issued patents referenced above disclose the step of adding one or more substances to disc-related cells or annular tissue prior to transplantation. Such substances could include culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, immuno-suppressive medications, or any useful combination thereof. These previous disclosures further teach that such substances and materials may be combined with any compatible nucleus replacement procedure, including the embodiments described in co-pending U.S. Pat. No. 6,371,990 and the continuations thereof, all of which are incorporated herein by reference.
According to this invention, autograft or allograft tendons are used to strengthen the annulus fibrosis and to augment or replace the nucleus pulpous. In accordance with the method, tendons such as the palmaris longus are harvested from the patient, a suitable living donor, or a recently deceased human. The tendons are sewn or otherwise attached to the inside of the annulus fibrosis, through a hole in the annulus fibrosis, for example.
The tendons aid the nucleus and/or replace the nucleus by absorbing the compression forces between vertebrae and by transferring the compression forces to the augmented annulus fibrosis. Allograft tendons are preferably treated, with tissue banking techniques well known to those skilled in the art, to prevent disease transmission and graft rejection. The invention can be used to augment discs in the cervical, thoracic, or lumbar spine.
REFERENCES:
patent: 4349921 (1982-09-01), Kuntz
patent: 4950296 (1990-08-01), McIntyre
patent: 6248131 (2001-06-01), Felt et al.
patent: 6264695 (2001-07-01), Stoy
patent: 6419704 (2002-07-01), Ferree
patent: 6454804 (2002-09-01), Ferree
patent: 6503277 (2003-01-01), Bonutti
North American Spine Society 13 Annual Meeting, San Francisco Hilton and Towers. Oct. 28-31, 1998; Barron Lonner Md., Et. al., “Tissue Engineered Regeneration of the Intervertebral Disc”.
Orthopedics Today, Jul. 2000.
“Proceedings 14th Annual Meeting” North American Spine Society, Oct. 1999.
“Proceedings 13th annual Meeting” North American Spine Society, Oct. 1998.
Steven Frick MD, SPINE vol. 19, No. 16, pp. 1826-1835, 1994.
Gifford Krass Groh Sprinkle Anderson & Citkowski PC
Jackson Suzette J.
Willse David H.
LandOfFree
Supplementing engineered annulus tissues with autograft of... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Supplementing engineered annulus tissues with autograft of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Supplementing engineered annulus tissues with autograft of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3123364