SUMMARY
This invention describes an engineered nanostructure and method for bioactive glasses used for bone scaffolds and other biomedical applications.
The inventors have developed and patented a melt-quench-heat-etch (MQHE) method that is closely related to standard glass production technology. More
recently, the inventors have discovered that in addition to the specific glass composition, the nanostructure can greatly influence the biomedical
performance. Specifically, they have demonstrated superior in vitro performance of widely used 45S5 glass with an interconnected spinodally
phase-separated nanostructure than with isolated droplets in a matrix (cells respond more favorably to the morphology and composition with the superior
nanostructure). This concept can be extended to other bioactive silicate glass compositions that are prone to phase separation (e.g., derivatives of 45S5
doped with certain oxides or different ratios of its constituents). Also, the nanostructure can be further manipulated by controlling the melt cooling
process (melt temperature, mold temperature, casting procedure, batch size, heat treatment, etc.).
Competitive Advantage
The superior performance and manufacturability represent the key advantages and discriminators of this invention. Furthermore, the process is optimized for
Bioglass (the only FDA-approved bioactive glass) and is extendable to other bioactive silicate glass compositions. The process results in a structurally
stronger interconnected porous glass that is biodegradable and accelerates the bone forming process. The fabrication method for the invented material is
very close to that of current glass making, which will likely enable it to be commercialized first.
Lehigh Tech ID # 102513-01
Market Need/Opportunity
Some of the greatest drivers of the bone graft substitute market include the spinal fusion market (nearly 500,000 spine fusions in U.S. in 2009;
approximately 75% of all bone grafts in the U.S.), the foot reconstruction market (100,000 procedures per year), orthopedic trauma (1 million internal
fixation orthopedic trauma procedures in the U.S. in 2009), and joint reconstruction. According to a recent study by Frost and Sullivan, the bone
grafts and bone graft substitutes market was estimated to be over $1.60 billion in 2012 and is expected to reach $1.65 billion by 2016. Despite autografts still
being considered the standard material in bone grafting, there has been a gradual shift towards bone grafts and substitutes, particularly in the US and
Europe. While products are currently available for bone implants, there is still a demand for bone scaffold technology that can eliminate issues related to
cost, control of composition, pore size, and shaping of final product.
Status
Lehigh University is looking for a partner for further development and commercialization of this technology through a license. The inventor is
available to collaborate with interested companies.