Using polymer technology to reduce the incidence of post-operative spinal adhesions
Of the nearly 1 million spine surgeries performed each year in the United States, approximately two-thirds are performed in the lumbar region of the spine (mid to lower section), with the remaining one-third in the cervical region (upper section).
Clinical studies suggest that around 15% of the lumbar procedures result in subsequent surgery within five years, as the patient experiences further degeneration of the discs intended to maintain proper separation of the vertebra. As the discs degenerate, the surrounding nerves become impinged, which results in debilitating pain.
Spinal patients could benefit from two types of anti-adhesion products
Due to the trauma and bleeding that unavoidably occur during these procedures, adhesions form in two distinct anatomic locations of the spine: internal to the spine involving the spinal canal and between the exterior surface of the spine and adjacent soft tissue. The adhesion occurrence is dependent on both the type of procedure performed and the region of the spine where the procedure is performed.
As a result, there appears to be a need for two types of anti-adhesion products:
- A barrier-type product that separates the exterior surface of the spine from the adjacent tissues during the post-operative healing period
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A product that can be placed inside the spine to surround and protect the spinal canal from adhering to the inner surface of the spine
SpineShield™ Adhesion Barrier Film – providing barrier protection
Similar to REPEL-CV® Adhesion Barrier, our proprietary polymer technology allows us to produce bioresorbable films with varying mechanical and in vivo characteristics, which may act as a temporary barrier to reduce the formation of adhesions between apposing tissue surfaces. In spine surgery, such products could be used in the cervical region where procedural entry is achieved through the anterior side of the spine. At the conclusion of the spine surgery, a barrier film could be placed over the anterior surface to reduce the risk of adhesions forming between the spine and the esophagus.
Similarly, the recently developed artificial discs, which are placed in the lumbar region through an anterior entry, create the risk of adhesions forming between the spine and the abdominal aorta, thereby complicating reentry in the event of a revision procedure.
RELIEVE™ Adhesion Barrier Gel – surrounding and protecting the spinal cord
Reverse thermal gels may be ideally suited for use in the traditional lumbar spine surgical procedures to reduce the formation of peridural adhesions. The bioresorbable gel would be injected around the spinal cord to reduce the risk of the spinal cord adhering to the surrounding inner surface of the spine.
We are using our proprietary bioresorbable reverse thermal gel polymer technology to create viscous gels for these indications. The novelty of this technology is, in part, associated with its ability to rapidly transition from a liquid at room temperature to a viscous gel when exposed to the temperature of internal tissue surfaces.
