Session: 15-01-01: ASME International Undergraduate Research and Design Exposition

Paper Number: 145748

145748 - Redesign of Surgical Fixation Device – a Senior Design Project 

This report details the redesign of US Patent 10,966,772, a surgical cable fixation device. The original device, owned by Able Medical Devices, posed challenges in terms of the intricate design and high manufacturing expenses. Able Medical Devices partnered with Northern Michigan University Mechanical Engineering Technology undergraduate students’ senior design project to redesign the surgical fixation device, given the name of Project Falcon. The fixation device is vital for the application of tension to Able Medical's in-line cable implant system, especially in orthopedic trauma surgeries focusing on periprosthetic fractures. Serving as the external tensioning mechanism, it enables surgeons to connect, tension, and securely fasten the implant to fractured bones. Project Falcon seeks to develop a single-use sterile packaged device that aligns with customer requirements, including safety, cost-effectiveness, and user-friendliness. The prototype resembles a specialized screwdriver, boasting crucial features such as a collet for cable retention, an ACME thread for tension application, a cannulated driver for tightening the implant’s set screw, a tightening knob for clamping the collet onto the cable, and a tensioning knob for adjusting cable tension. Chosen for its ability to fulfill specified tasks while allowing for cost-effective mass production in the future, the design incorporates a blend of stainless steel and ABS plastic parts, ensuring compliance with medical device standards outlined by ISO 10993-1. Moreover, adherence to medical device standards ensures the safety and efficacy of the device in clinical settings, instilling confidence in both surgeons and patients. A systematic design process was employed to identify critical functions, eliminate complex components, and devise a solution that aligns with established goals. The design emphasizes simplified mechanical mechanisms, a reduced number of parts, and manufacturability. Through this redesign, the objective was to advance the development of a unique implant system and introduce a new product to the medical industry. Each aspect of the design was meticulously scrutinized to ensure optimal performance and adherence to customer specifications. By simplifying mechanical mechanisms and reducing the number of parts, the design not only enhances efficiency but also streamlines manufacturing processes, ultimately resulting in a more cost-effective solution. Successful testing has been conducted on critical mechanical components of the assembly. Beginning with 3D model Finite Element Analysis, then verified by physical testing of the ACME screw shear strength, collet to cable retention test, and the cannulated distal tip torsion test. The development and testing of the device served as a proof of concept for Able Medical Devices to continue progressing towards a marketable device.  Project Falcon represents a significant step forward in orthopedic surgery, offering a solution that addresses critical needs while paving the way for future advancements in the field.

Presenting Author: Alexander Carpenter Northern Michigan University

Presenting Author Biography: Northern Michigan University Mechanical Engineering Technology undergraduate student who interned at Able Medical Devices and did the work as part of a senior design project.

Authors:

Alexander Carpenter Northern Michigan University
Seth Hornick Northern Michigan University
Kaden Clausen Northern Michigan University
Seth Norberg Northern Michigan University