Bone substitute for training and testing and method for making

Education and demonstration – Anatomy – physiology – therapeutic treatment – or surgery... – Anatomical representation

Reexamination Certificate

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Details

C623S016110

Reexamination Certificate

active

06471519

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates in general to substitutes for bone, and, in particular, to a bone substitute that has the look and feel, and cutting and drilling properties of human bone thereby making it especially useful as a bone model for teaching and training medical students and for testing surgical equipment.
Drilling bone to permit use of internal screws for fixation of fractures, to implant artificial joints, to fix intramedullary implants and to utilize various other procedures is a widespread and important surgical technique. Obviously, the above surgical procedures involve precise cuts and drilling of sensitive tissues.
Unfortunately, there is a shortage of human bone tissue on which to practice new techniques and procedures. Cadaver bone is difficult and often expensive to obtain and is a serious potential biohazard as well. Currently, surgeons practice new drilling techniques on blocks of plastic or polyurethane, assuming this material closely mimics the drilling behavior of live human bone which, however, is not the case.
Previous studies on the drilling of bone have focused on orthogonal cutting and machining, and wear of machine parts, but there is currently no easy way to comprehend data concerning distinguishing drilling behavior of materials for comparison. In any event, what is needed are new materials which when molded will drill and cut like bone in order to provide better training for medical students and more realistic testing for surgical equipment manufacturers.
SUMMARY OF THE INVENTION
The invention provides a bone substitute whose properties closely mimic real bone when drilled or cut and comprises an inner core comprising a foamable polymer or other soft material to mimic cancellous bone and an outer shell formed around the inner core to mimic compact bone. The outer shell comprises a polymer such as an epoxy resin and a particulate filler such as a mineral added thereto to form a slurry for casting or molding around the inner core.
The particulate filler, which hardens the bone substitute and reduces the amount of polymer required, includes, but is not limited to, hydroxyapatite, aluminum oxide (Al
2
O
3
), silicon carbide (SiC) or mullite. For even better results, titanium oxide (Tio) can be added along with either Al
2
O
3
or SiC to modify the interaction between the polymer and the mineral and thereby reduce wear on surgical tools.
In one embodiment, the outer shell comprises an epoxy resin and from 5% to 15% by weight of Al
2
O
3
and from 20-45% by weight of TiO. In another embodiment, the outer shell comprises the epoxy resin and from 2.5% to 30% by weight of SiC and from 20% to 45% by weight of TiO.
To make a bone of the invention the first step is to make a female mold from an original (human) bone part. Then a bone substitute part is created from the female mold and reduced by a uniform thickness. A mold is created from the bone substitute part to replicate an inner core of the bone substitute; the inner core is then molded from a foamable polymer and suspended in the female mold. Finally, the outer shell is formed by pouring or injecting the epoxy resin/Al
2
O
3
(or SiC)/TiO slurry into the female mold with the inner core suspended therein.
The resulting bone substitute drills and cuts substantially like real bone thereby providing medical students with an accurate feel during surgical training, and equipment manufacturers with an accurate hardness for testing surgical devices.


REFERENCES:
patent: 3662405 (1972-05-01), Bortz et al.
patent: 4106219 (1978-08-01), Schneider et al.
patent: 4662888 (1987-05-01), Field
patent: 5314492 (1994-05-01), Hamilton et al.

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