3D Printed Incision Guide for Spine Surgery

Overview

Currently, when spine surgeons operate on a patient’s spine in the operating room, they use surface landmarks and X-rays to determine the correct level. The use of X-ray for spinal surgery adds additional time and radiation risks to the procedure and is typically only useful for the lumbar and cervical spine. The thoracic spine is more prone to wrong-level surgery due to shadowing effects from other parts of the body that can be shown on scans. Current methods to determine the correct level are too invasive, costly, or inadequate. This project proposes a non-invasive, cost-friendly device that will determine the correct spinal incision site and minimize radiation exposure to the patient.

Objectives

The purpose of our design is to provide a low-cost, non-invasive guide for the initial incision of the back during thoracic spine surgery. The device should reduce radiation exposure to the patient by decreasing the frequency of scans necessary to locate the intended area of operation.

Approach

– Literature and patent searches were conducted to provide a foundation of background information to better understand the current methods and procedures utilized in spinal surgery and to find existing products on the market

– A site visit was conducted to gather input in order to determine the needs of the physicians who will be operating the treatment device

– A needs weighting matrix was utilized to assess and rank the various needs of the device

– Various concepts were generated to provide a broad range of options, such as mechanical or software-based devices

– Selection criteria were created from a concept scoring matrix and existing literature

– Manufacturing specifications and a process plan were created using CAD modeling

– Multiple prototypes were created, and a Failure Modes and Effects Analysis was conducted

– The final prototype was fabricated by 3D printing for testing

– Future testing for this device would involve 3D scanning and taking MRI images of a cadaver in the position that they will be operated

Outcomes

– A novel device was developed that reduces risk of wrong-site and wrong-level exposure in spinal surgery

– The device reduces time and number of scans necessary to locate the intended level of operation

– There is reduced invasiveness due to less radiation exposure to the patient and physicians

– The device is individualized for each patient to meet varied needs

– The sponsor will be able to produce a low-cost device that can be utilized in developing countries