Synthetic bone graft materials are required to reduce the dependence upon harvested patient bone or donated cadaveric bone. All current bone graft materials fail to adequately meet the needs of orthopedic surgeons or patients. Existing products have difficulty in matching the structure of patient bone; the necessity of compounding in the operating suite limits the resulting structure to simple forms. Where a material does have a compatible structure to patient bone, then bonding to adjacent bone is lacking (pills, beads, or blocks of material, packed into a bone cavity).
A better material would: adhere to native bone; come ready made, with a defined micro-structure; and encourage the ingrowth of new bone tissue through growth stimulating agents. No such product exists yet.
“Bone Putty” is a malleable bone graft material, manufactured and held inert until the material is warmed to body temperature, at which point the material solidifies and adheres to adjacent bone. The material possesses osteoconductive properties, bonding to a patient’s native tissue and encouraging regrowth of bone into the implant. Ultimately, the material is completely absorbed and replaced with fresh bone.
The material is a significant advance over the current art in that it can be precisely formulated in a controlled manufacturing environment, it allows for the incorporation of reinforcing material, it is immediately ready to use upon removal from the sterile package, it does not require the surgical team to mix multiple compounds within the surgical suite, and it forms a solid structure upon implantation. Unlike existing products, the curing of the material occurs only after implantation and does not require the application of UV light, the addition of a chemical initiator, or the recruitment of environmental moisture.
This unique advantage, the ability to manufacture a controlled-activation bone graft material, allows the material properties to be tailored to fit the needs of the surgeon and the patient:
• tensile and compressive strength;
• rate of resorption;
• presence of radiocontrast;
• controlled release of bone growth initiators; and
• physical structure of the material.
All in a ready to use, sterile, non-pyrogenic, and moldable dosage form.
How does the product work? Bone Putty uses a temperature sensitive encapsulation technology to allow a polymerizable substance to be mixed with a curing agent. The curing agent is held in isolation by an insoluble encapsulant until the material warms to patient body temperature. The encapsulant then melts, allowing the polymerizable substance and the curing agent to mix and solidify. This technology allows the creation of a moldable material, which only hardens upon implantation. The cured material is inherently porous, allowing the ingrowth of new bone tissue. Since the material can be compounded and distributed, it allows the incorporation of structural reinforcement agents, bone growth stimulating agents, viscosity modifiers, and is capable of being formed with a wide range or internal micro-structures.
Bone putty is based upon patent pending technology. Non-provisional patent application
US 2012 / 0111229, Multi-Component, Temperature Activated, Tissue Adhesive, Sealing, and Filling Composition, was published on 05/10/2012.