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Extracorporeal Counter-Irritation Device
Jessica BrisbinAlexandra JefferdsNichole McPherson
Nicholas Werner
University of PittsburghSenior Design – BioE 1160-1161
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Overview
• Needles are used in many common medical procedures:
• Immunizations
• Administration of drugs
• Starting IVs and catheters
• Fear of needles (6-22% US population)
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Overview
• An Extracorporeal Counter-Irritation
• Alleviates the pain, anxiety, and discomfort associated with needle sticks.
• Provides auditory, visual, and tactile stimuli.
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Project Objectives
• For the child:
• Significantly reduce or eliminate anxiety and pain during needle sticks
• For the doctor, nurse, or technician:
• Allow him/her to focus on the medical procedure
• Not interfere or hinder in his/her ability to perform the medical procedure
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Competitive Analysis• Hypnosis
• Causes patient to be deeply calm, however it can wear off unexpectedly.
• Tactile Therapy
• Shown to work in most case, however draws extra attention to the site.
• Diversion Therapy
• Distracts the patient and lowers anxiety, but does nothing to prevent pain.
• Local/Topical Anesthesia
• Only affects top two-three layers of skin, which is not deep enough for most needle sticks.
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Design Alternatives
• Alternatives
• “Simon” game
• Device administers injection
• Choice of lights/music/vibration
• Relatively simple
• Not too distracting (no motion of patient)
• Product remains non-invasive
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Features & Benefits
• 3x2x1″ box (fits on small arms)
• Appealing color scheme (friendly to kids)
• Large on/off switch (easy for clinicians to use)
• Lights, music (distraction)
• Vibration (counter-irritation)
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Engineering technologies/methodologies
• Materials
• Standard electronics parts
• Music chip
• Xbox controller motor (high resistance)
• Fabrication
• Circuit board
• Loose wires & solder
• Paint (kid-friendly)
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Description
•Improvements needed•More streamlined case (animal shaped)•All off-the-shelf parts•Durable parts (music chip)•Biocompatible strap
•Marketing•Clients purchase for $30•Patient base: 20 million children under age 5 (US Census Bureau, 2000 data)•Market base: 7,569 hospitals (2005 data)
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Risk Analyses• Initial Hazards Analysis
• Case breaks → Electrical Shock• Remote, Severity III
• Flashing Lights → Seizure• Improbable, Severity I
• FMEA• Part failure → Device failure → Patient pain
• Occasional, Severity IV
• Human Factors Analysis• Rough handling exposes electrical components
• Occasional, Severity III
Severity I …….....…Severity IV
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Obstacles to Market• IRB
• Testing on children• FDA
• ECI Device• Low Risk → Class I Device
• Registration & Listing (21 CFR 807.20)• General Systems (21 CFR 820)• 510k
• EndoTwinn
• Class 1 Device
• Applies heat and vibration to tip of dental instrument (Root Canals)
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Project management
• Most tasks were group effort
• Chief Responsibilities:
• Jessica: Obtained parts
• Alexandra: Built ECI device
• Nichole: Solidworks, manager
• Nick: Testing, Verification & Validation
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Redesign Ideas
• Animal Shaped Case
• Enhance distraction, kid-friendly, dangling legs
• Cleat-like bumps on bottom of device
• Enhance effects of vibration
• Use disposable tourniquet
• Have decorative screen which clips onto the device between the patient and the procedure
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Experimental design
• Awaiting IRB approval
• Clinical pediatric trials upon approval
• Children’s Hospital
• Ages 5-8
• Receiving stick on back of the hand
• Color Analog Scale (CAS)
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Color Analog Scale
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Preliminary Testing
• Randomized set of trials on group members
• Controlled factors
• With/without device
• Arm used
• Time between trials
• Hardness of “snap”
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Results
n=2
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Verification and Validation
• Verification
• Housing (< 6 in2)
• Weight (< 8 oz)
• Working components
• Reduction of pain/anxiety
• Validation
• Focus Group → Approved
• Clinical Testing
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Acknowledgements
• Sources of funding
• Generous gift of Drs. Hal Wrigley and Linda Baker
• Department of Bioengineering
• James J. Menegazzi, PhD
• Dr. Daniel Thomas
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Questions?