Skelmet, Inc. — Department of Health and Human Services SBIR Phase I: NEI

Description

Project SummaryAbstract This project aims to determine the technical merit and feasibility of using cranio facial scans to produce a customD printed spectacle device to treat severe ptosisinability to open the eyesThere are many causes of ptosisbut it is most severe and disabling after brainstem strokesevere head traumaand Myasthenia GravisThe devicereferred to as the Magnetic Levator ProsthesisMLPwas developed by our academic partners and uses inexpensive and widely available static magnets to provide the force to open the eyeThe facial muscles of eye closure are intact and can overcome the magnetic force resulting in re animation of blinkingThey recently demonstrated that the MLP was safe and effective overweek during inpatient rehabilitationHoweverthe device used was a prototype and not cosmetically acceptable for use outside the hospitalThere is also the opportunity to improve the function of MLP using custom frame printingBecause of the non linear force distance relationship of static magnetic fields it is very important to have a well fitted frameIncorrect positioning or slippage due to low nose bridge facial anatomies can result in over or under correctionThe magnetic elements should be built into the frame and it should be able to accommodate prescription lensesIt should allow for force adjustment to meet the daily needs of the patient and population variation in force requirementsWe propose to accomplish this using our Skelmet Incproprietary software which can generate custom frames using cranio facial scans of each patient captured using an iPad with stereo camera attachmentWe will combine this with an approach also developed by our academic partner which aims to provide adjustable force in a static magnet system through angular rotation of the MLP spectacle magnetThis will be implemented via a dial on the side of the framePatients or the doctor should be able to dial up or down the magnetic force by adjusting the dialWe will confirm the feasibility of implementing the adjustable force approach in a custom printed frame Project Narrative There are no effective commercially available non surgical treatments for severe paralysis of eye openingptosisA device which uses magnetic force to restore eye lid movementthe magnetic levator prosthesisMLPis a promising non surgical approachWe aim to determine the feasibility of commercial production of the MLP usingD printingSpecifically we will use technology currently used to produce custom sunglass frames and determine if this is feasible to produce custom yet cost effective MLPs