Physical Sciences Inc. (PSI), in partnership with clinicians in the Massachusetts General Hospital Department of Oral and Maxillofacial Surgery, proposes to continue development of an innovative device for performing distraction osteogenesis (DO) of the mandible. The concept under development uses miniature hydraulics in a fully buried actuator capable of producing linear and curvilinear distraction trajectories. This new distractor will reduce patient responsibility by automating the motion process, permit clinicians to alter the distraction rate of motion as treatment progresses, and reduce distraction time by making the motion virtually continuous. It will also offer the option of fully-buried placement, with no linkages or electrical connections passing through skin. Phase I demonstrated feasibility of the concept with bench top measurements and tests with the prototype implanted in a pig cadaver. All of the proposed Phase I objectives were completed, and the team was able to complete several development steps beyond the proposed Phase I effort. We propose herein to build on the initial success with a Phase II program that will refine the design, produce several prototypes, and perform testing in live animals. Though additional testing will be required, the Phase II work will develop all of the essential components necessary to produce a clinically-useful distractor.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DE014803-02
Application #
6883670
Study Section
Special Emphasis Panel (ZRG1-MOSS-A (11))
Program Officer
Shum, Lillian
Project Start
2002-07-01
Project End
2007-04-30
Budget Start
2005-05-05
Budget End
2006-04-30
Support Year
2
Fiscal Year
2005
Total Cost
$339,214
Indirect Cost
Name
Physical Sciences, Inc
Department
Type
DUNS #
073800062
City
Andover
State
MA
Country
United States
Zip Code
01810
Peacock, Zachary S; Tricomi, Brad J; Lawler, Matthew E et al. (2014) Skeletal and soft tissue response to automated, continuous, curvilinear distraction osteogenesis. J Oral Maxillofac Surg 72:1773-87
Goldwaser, Batya R; Magill, John; Papadaki, Maria E et al. (2013) Continuous mandibular distraction osteogenesis: novel device and preliminary results in minipigs. J Oral Maxillofac Surg 71:e168-77
Peacock, Zachary S; Tricomi, Brad J; Murphy, Brian A et al. (2013) Automated continuous distraction osteogenesis may allow faster distraction rates: a preliminary study. J Oral Maxillofac Surg 71:1073-84
Goldwaser, Batya R; Papadaki, Maria E; Kaban, Leonard B et al. (2012) Automated continuous mandibular distraction osteogenesis: review of the literature. J Oral Maxillofac Surg 70:407-16
Magill, John C; Byl, Marten F; Goldwaser, Batya et al. (2009) Automating skeletal expansion: An implant for distraction osteogenesis of the mandible. J Med Device 3:14502