DESIGN NAME: AIS-C
PRIMARY FUNCTION: Stand Alone System
INSPIRATION: The Genesys Spine team set-out to try to create the first ever direct-anterior Anchored Interbody System that could be visually confirmed and revised.
UNIQUE PROPERTIES / PROJECT DESCRIPTION: There are very few non-screw based Cervical Stand-Alone systems because they are often difficult to effectively revise compared to screws which can simply be unthreaded. The Genesys Spine Cervical Stand-Alone System enables surgeons to utilize a direct anterior approach which allows for a smaller, mid-line incision. The system utilizes a quick, simple, non-impacting Anchor insertion method that does not need an awl or drill. No extra steps are required to lock the Anchors into position and the locking mechanism provides visual confirmation of engagement, but allows for Anchor removal when desired.
OPERATION / FLOW / INTERACTION: Cervical spine fusions require stabilization of the joint to allow complete fusion to occur. Traditional cervical spine fusions required an interbody to be coupled with a cervical plate to limit motion and provide stability. With the Genesys AIS-C Cervical Stand-Alone System, the fixation was incorporated into the interbody which can eliminate the need for a cervical plate or other forms of supplemental fixation.
PROJECT DURATION AND LOCATION: The project was initiated in July of 2014 at the Genesys Spine Headquarters in Austin, TX.
FITS BEST INTO CATEGORY: Medical Devices and Medical Equipment Design
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PRODUCTION / REALIZATION TECHNOLOGY: Conceptualized in Solid works, 3D printed for functional testing and physician review, then fine-tuned using ANSYS mechanical Finite Element Analysis. Once the geometry was selected, design verification parts were manufactured and tested according to ASTM standard test methods.
SPECIFICATIONS / TECHNICAL PROPERTIES: The Genesys Spine AIS C Cervical Stand-Alone System is offered in two footprints: Small (14mm X 12mm) and Large (17mm X 14mm). The offered interbody heights range from 5mm - 12mm. There are three available configurations to conform to varying patient anatomies: Parallel, Lordotic, and Convex.
TAGS: Stand-Alone, Non-screw-based fixation, Cervical, Anchored, Interbody, Genesys Spine, Direct Anterior, Zero-Step Locking Mechanism, Cervical Fusion System, Anchored Interbody
RESEARCH ABSTRACT: Genesys Spine initiates all new projects by conducting research in three main areas: 1) Perform a review of white papers pertinent to the field of interest. 2) Conduct a MAUDE database review and research complaints as well as any other available post-market surveillance. 3) Present our findings to surgeons and clinicians to gain feedback. Design surgeons are formally selected based on their surgical repertoire and experience and work with our team on final outputs.
CHALLENGE: The hardest part of this design and project was developing a locking mechanism that did not require any additional steps to deploy, would allow the Anchors to pass by during initial system deployment, would not allow the Anchors to back-out prematurely, yet could be easily removed or revised by the surgeon. Balancing each of these requirements was a long iterative process that required significant engineering analysis and surgeon interaction. In the end, the Genesys Spine team was able to produce a system that is expected to lead the industry for years to come.
ADDED DATE: 2018-07-02 16:01:59
TEAM MEMBERS (1) : Lead Designer: Landon Gilkey, Project Leader: Benjamin Keller, Lead Quality Manager: William Sowers. Additional Team Members: Brian Bergeron, Francois Follini, and Chloe Lance
IMAGE CREDITS: J. Landon Gilkey
PATENTS/COPYRIGHTS: Patent Application number: 15/605334
http://www.freepatentsonline.com/y2017/0340453.htm
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