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Problem StatementProject Proposal•Design a device that will reduce the time of a medial malleolus fracture repair surgery•Design a device that simplifies the procedure for the surgeon•Design a device that will eliminate complication due to imprecise placement of screws•The device should form a sturdy bond with the tibia and provide a compressive force on the fractured bone•The device should also align the guide wires that will be inserted through the fracture to stabilize the bone before screw placement
Ankle Fracture Facts•550,000 ankle fractures each year in the United States•Caused by auto accidents, falls, sports injuries, miss-stepping.•Approximate cost of Ankle Surgery: $1325•Approximate length of Ankle Surgery: 1 hour
Impact •Shortening the time of surgery and making the procedure simpler will reduce risks and the cost of surgery
Device DesignBase Plate•Secures to the tibia•Two guide wire orientations•Connects to length adjuster via ball joint
Length Adjuster•Three components (1)Length adjuster base (2)Thumb screw (3)Length adjuster rod•Rotation of screw transmitted into linear motion •Allows the device to compress and uncompress by 1”•Connects to the end effector via ball joint
End Effector•Securely holds fractured piece to tibia•Two parallel holes ensure precise screw placement •Two piece assembly allows surgeon tocomplete surgery without removing entire device•Four spikes to grip bone
PurposeProblems with Current Solution•Securing fractured bone to tibia with clamps takes multiple steps and cannot withstand much stress•Screw and guide wires must be parallel which can be hard to accomplish by hand
Project Goals•Create a device that will quickly and securely affix to the tibia•Create a device that can be easily adjusted and aligned•Create a device that will fit within the surgical envelope•Create a device which is easily sterilizable
Safety and Cost EstimatesSafety Concerns•Device can withstand stresses of surgery•Device can be disassembled for easy sterilization
Cost Estimates•Prototype cost: $600•Final product cost: greater than $600•Cost Savings per surgery assuming 15 minute reduction in operating room time: $325 per surgery•Time to recover initial cost: approximately 3 surgeries
Accomplishments
Create design that solves current problems
Create Prototype of device
Device Features•Stainless Steel•Reusable•3” length fully uncompressed•¾” width•Two ball joints•Modular end effector
BackgroundCurrent Solution•The surgeon uses a bone clamp to hold the fractured bone in place. Because of the steep angle of the tibia surface, the surgeon usually drills a small hole to hook the bone clamp into in order to get a firm grip on the bone.
•Once the bone is held in place, two guide wires are independently pushed through the fractured bone. •This process is done by hand so correct placement and angle of theses wires are visually estimated.•Lastly, two cannulated bone screws are then screwed over the guide wires to form a permanent fixation
Our Device
Ankle Alignment Clamp for Medial Malleolus FractureGarrett Sauter1, Trey Kendall2
Advisors: Dave Martinez3, Dr. William DeVries4
1Biomedical Engineering Department - Vanderbilt University, 2Mechanical Engineering Department - Vanderbilt University, Zimmer3, Tennessee Orthopedic Alliance4
Exploded View
Medial Malleolus fracture
Bone Clamp
Medial Malleolus post surgery
Base plate
Length Adjuster
End Effector
References
http://www.springerlink.com/content/57lx94q6ck384ruc/fulltext.pdf
Assembled View
Prototype with Tibia
Side View
Above View