Implantable Endpad Mike By: Michael DiCicco, Stephen Osterhoff, and Trevor Taormina Advisors: Gordon Maniere, Dr. Nasir, Dr. Meyer

Agenda Research Plan Problem Statement Project Design Needs Statement Timeline Cost Student Outcomes Anticipated Challenges Roles & Responsibilities Acknowledgements Problem Statement Needs Statement Transtibial Amputation Current Market Background of Problem Solution Project Goals Steve

Problem Statement Amputees have poor fitting prosthetics that cause pain and discomfort due to tissue loading at cut surface. 185,000 lower limb amputees annually Trevor * Mostly related to Diabetes Sources: CDC, NDF & Amputee Coalition of America

Needs Statement An implantable end pad (IEP) that advances recovery and supports mobility for below knee amputees. This product will allow patients to walk comfortably by protecting tissue and bone. Mike

Transtibial Amputation Basic Amputation Process Tibia is sectioned – typically mid line section Bone is smoothed out to remove jagged edges Muscle & skin flaps over cut section Sutured closed Patient recovery and fitted to new prosthetic

Current Market Solution Prosthetic socket formed around amputation and limb is attached. Titanium Rod connected to tibia protruding from skin attaching to prosthetic Fusion of Tibia and Fibula Steve

Background of Problem Constant change in patient’s fluid retention There is no load distribution between bone and tissue This leads to pain and discomfort Complications can lead to bone spurs Reduction in quality of life for an estimated 80% of patients Trevor

Proposed Solution Implantable End Pad Unique Tear Drop Shape Absorb excessive forces Return weight bearing loads to skeleton structure Load distribution across tissue Unique Tear Drop Shape Based on how prosthetics are modified to fit the limb Mimics natural walking gait/loads Offset insertion site provides stability for higher loads on anterior tibia Mike

Research Plan-Overview Review current literature Proof of concept-Computational modeling Mechanical testing Trevor

Project Goals Computational Modeling Mechanical Testing Load transfer between IEP & skeletal structure Fixation methods between IEP & skeletal structure No fixation | Poly-methyl-methacrylate (PMMA) Bone Cement Mechanical Testing Material Sample Cyclical fatigue testing IEP Model Fixation Cyclical compression testing No Fixation | Suture Fixation | PMMA Bone Cement Tibia Steve

Research Plan- Review Current Literature Clinical trials with material FDA ISO 13485, 14971, 10993 & ASTM D695-10 Prosthetics, Amputees & Amputations Common problems Mike 13485 medical devices quality management systems requirements for regulatory purposes 14971 Risk management to determine the safety of medical device 10993 biocompatibility prior to clinical study Source: DSM website

Research Plan – Material Bionate – Polycarbonate Polyurethane (PCU) FDA Approved Previously used in load bearing implants (spine & hip) Shore 80A | 90A | 55D |75D | Steve

Research Plan – Proof of Concept Computational modeling MIMICS ® SOLIDWORKS® | CATIA® COMSOL® Trevor MIMICS generation of 3d bone geometry SOLID refinement of model and device modeling COMSOL finite element analysis

Research Plan – Proof of Concept Computational – FE modeling IEP  Cone + Half Sphere Bone  Cylinder Stress Mapping Realistic IEP model developed by White Light Scanning Mike

Research Plan- Mechanical Testing Compression ASTM D695-10: Standard Test Method for Compressive Properties of Rigid Plastics Cyclic testing Implant Fixation Attachment to sawbones Suturing, Bone Cement Steve

Project Design – Methods, Control, & Analysis Load - 3.3x male body weight Body weight range within 95th percentile Controls No fixation Analysis Strain Gages Visual Analysis Optical Microscope SEM Age Group 95th 30 to <40 years 273 lbs 40 to <50 years 276 lbs 50 to <60 years 271 lbs Trevor change chart Source: 3.3x BW - Wehner, Tim, Lutz Claes, and Ulrich Simon. "Internal Loads in the Human Tibia during Gait."Clinical Biomechanics 24.3 (2009): 299-302

Timeline Date Task November – December Computational Modeling January Material Testing |Design Refinement February Prototype Development |Mechanical Testing March Mechanical Testing April Mechanical Testing | Data Analysis May Final Presentation Mike

Cost Materials Costs Testing Equipment Provided by Lawrence Tech IEP Material Provided by DSM Test Fixtures $300-$500 Strain Gages $30-40 ea. Electronic Setup (Strain Gages) $100 Total $430-$640 **Planning to apply for funding LESA, NCIIA Program Steve

Student Outcomes Proof of Concept Mechanical Testing Computation simulations Mechanical Testing Prototype Development Cost Efficient Trevor

Anticipated Challenges FDA’s Regulation  Interpretation Finite Element Modeling  Accuracy Mechanical Testing  Fixation | Machine Interface Time Constraints Mike

Roles and Responsibilities Technical Expertise Team Members Prosthetist- Gordon Maniere DSM – Rich Miller WEC – Gregory Wolf Advisor- James Masiak CFO-Jack Wheeler Faculty Advisor- Dr. Meyer Faculty Advisor- Dr. Nasir Surgeon – Dr. Jon Iljas, DMC & St. Mary’s Mercy Michael DiCicco Data Collection Device Design Protocol Development Stephen Osterhoff Finite Element Analysis Prototype Fabrication FDA Interpretation Trevor Taormina Scheduling and Documentation Mechanical Testing Steve

Acknowledgments Trevor

Questions? ? All