MEDSHAPE, INC. — Department of Health and Human Services SBIR Phase I: NIAMS

Description

DESCRIPTION provided by applicant The objective of this project is to develop novel patient specific geometrically complex Titanium Ti alloy plates made by additive manufacturing AM also called D printing for foot and ankle applications These plates will offer superior fixation and mechanical performance while minimizing the plate bulk volume Foot and ankle surgeries are common where over are performed each year in the U S for bunion repair alone The market for extremity fracture repair is expected to reach $ Billion annually by Current plates for foot and ankle repair are simple with mainly two dimensional geometries which do not conform well to the complex anatomy of the bones in the foot and ankle Therefore surgeons spend time bending plates to fit patient anatomy which does not always guarantee sufficient fixation The proposed AM created plates with tailored architectures will promote superior stability by improving fit maintaining strength reducing profile and reducing cost By using the AM technique of selective laser melting of Ti alloy the geometry can be tailored to the patient anatomy which will achieve better fit and reduce surgery time Complex architectures such as pores internal channels and thin walled sections will aid in bone growth optimization of mechanical properties and reduction of soft tissue irritation Channels can also serve as attachment points for suture or graft material In addition the use of AM plates decreases costs associated with traditional manufacturing where molds and tooling would need to be changed between patients This proposed project will be accomplished through three specific Aims Aim will tailor the design of patient specific Fandamp A plates featuring complex D features through finite element analysis FEA of models based upon anatomic imaging This Aim will be achieved by creating D models of devices based upon cadaveric foot anatomic imaging and evaluating the modelsandapos performance under multiple clinical loading scenarios Aim will assess the designs from Aim by comparing AM created plates and traditionally manufactured plates for mechanical performance and production efficiency This Aim will determine the production cost time and waste for each method and compare the mechanical performance under monotonic and cyclic loading regimes Aim will evaluate the fit and mechanical performance of AM created plates for specific pathologies in the cadaveric foot specimens imaged in Aim This Aim serves to validate the prior Aims by producing AM created plates to fit complex bones with varying pathologies The plate to bone apposition and mechanical performance will be evaluated by micro CT and mechanical testing respectively The successful completion of Phase I will demonstrate novel patient tailored AM created plates for treating foot and ankle pathologies that can sustain load bearing conditions These plates will enhance fixation and stability leading to improved clinical healing and fusion PUBLIC HEALTH RELEVANCE This project is relevant to the millions of patients who undergo foot and ankle repairs annually in the United States with bunion repairs alone accounting for over annual procedures The goal of this project is to develop novel complex patient tailored plates created through additive manufacturing for increasing plate to bone contact This contact will improve bone stability and fixation to improve healing increase bone fusion and reduce additional fractures