College - Author 1
College of Engineering
Department - Author 1
Biomedical Engineering Department
Degree Name - Author 1
BS in Biomedical Engineering
College - Author 2
College of Engineering
Department - Author 2
Biomedical Engineering Department
Degree - Author 2
BS in Biomedical Engineering
College - Author 3
College of Engineering
Department - Author 3
Biomedical Engineering Department
Degree - Author 3
BS in Biomedical Engineering
Date
6-2024
Primary Advisor
Britta Berg-Johansen, College of Engineering, Biomedical Engineering Department
Abstract/Summary
We were tasked by Dr. Dimitri Delagrammaticas, an orthopedic surgeon, to develop an automatic impaction device to use in hip arthroplasties. The goal of this project is to create and design the mechanical internals for an electric impactor device to aid in the impaction of orthopedic devices and reduce the risk of surgeon injuries. The stakeholders include our sponsor Dimitri Delagrammaticas and other orthopedic surgeons, patients in need of hip arthroplasty, hospitals, and Dr. Berg-Johansen. Dr. Berg-Johansen will be reviewing the design process and documentation for the duration of the senior design project. The Automated Orthopedic Impactor will solely focus on hip replacement surgery due to this surgery’s specific need of consistent impact force when using the broach and mallet.
This document will include information about what devices currently exist on the market, patent results, customer observations, and technical literature in the Background section. The Objectives will explore the IFU, Engineering Specification Table, customer requirements, QFD, and House of Quality. Project Management will further explain the overall design process and key deliverables, as well as estimated testing techniques.
The report will further include Morphology, Concept Evaluation, Conceptual Model, and FMEA to discuss potential designs and explain the process. The front runner concept was then further developed and will be discussed in the Detailed Design, as well as Prototype Manufacturing Plans. The Manufacturing Process Instructions will include specific steps and photos to describe how the functional prototype was created. A summary of Test Plans will be included to explain each engineering specification and describe the steps, test type, sample size, materials, and certifications. This section will also include a detailed protocol for experimental set up, experimental groups, data acquisition, data analysis for each test, expected results, and the team member leading each test. The results from the testing protocols will be summarized in the testing data and analysis section. Instructions for use will be included to communicate how to safely and efficiently use the automated impactor device. Lastly, the report will be concluded with a discussion of the testing results and review the overall success of the project and device.
The design process began by identifying the problem, customer, and the market. Once a current device on the market was found, the engineering specifications were determined to match similar performance to this predicate device. Customer requirements were determined by our sponsor, Dr. Delagrammaticas and his vision for how the device should perform. Prototyping the device then began and design changes were made to address functionality issues. The final design was then manufactured and tested using a series of protocols to determine if engineering specifications were met.
Key customer requirements included reliability and consistency. These requirements were translated into specifications such as the average and standard deviations of force and location, and were repeatedly tested to measure accurate values. The tests found that the impactor mechanism worked with an average force output of 14.2 Newtons with a standard deviation of 3.7 Newtons, and an average deviation in impact location was 8.3 millimeters. While all of these values were higher than expected, the final prototype demonstrated that the design was functional and could be improved on.
URL: https://digitalcommons.calpoly.edu/bmedsp/195