Harvesting of Iliac Autogeneous Cancellous Bone

DESCRIPTION (Provided by Applicant): Autogenous cancellous bone is currently the "gold standard" for bone graft material and is used in more than 500,000 procedures per year in the U.S. However, the present methods of harvesting cancellous bone is associated with significant morbidity from surgical scars, blood loss, pain, prolonged surgical time and rehabilitation, exposure to blood products, and infection risk. Foster-Miller is proposing "mining" large quantities of cancellous bone using a novel flexible boring tool that is inserted through a single standard 1.2 cm, minimally invasive, skin incision. The boring tool will follow the internal contour of iliac crest cortex and will extract core samples of cancellous bone and bone marrow (up to 10 cc per sample). Risk of damage or perforation of the ilium cortex bone will be minimized. This approach will minimize the amount of patient morbidity and should expand the use of autograft harvesting. The system will be disposable and designed for low cost manufacture. During Phase II, the system design will be refined, and multiple systems will be produced and demonstrated on animals and cadavers in preparation for pre-clinical approval and commercialization. PROPOSED COMMERCIAL APPLICATION: The prime intent for this device is for harvesting autogenous cancellous bone and bone marrow for which there are more than 500,000 procedures per year, performed in the U.S. alone. Upon introduction of this tool and increased familarity among surgeons, the use for this tool could be expanded to include harvesting of bone and bone marrow to treat acute fractures, fracture nonunions, bone defects, and to achieve therapeutic arthrodesis.