Extracorporeal Counter-Irritation Device

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Extracorporeal Counter-Irritation Device
University of Pittsburgh Senior Design BioE
1160-1161

• Jessica Brisbin
• Alexandra Jefferds
• Nichole McPherson
• Nicholas Werner

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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
• Childrens 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
n2
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Verification and Validation

• Verification
• Housing (lt 6 in2)
• Weight (lt 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?