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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

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

10. 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

11. Research Plan- Review Current Literature
Clinical trials with material
FDA
ISO 13485, 14971, & 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

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

13. 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

14. 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

15. 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

16. 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):

17. 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

18. 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

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

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

21. 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

22. Acknowledgments
Trevor

23. Questions? ?
All