Extracorporeal Counter-Irritation Device

Jessica BrisbinAlexandra JefferdsNichole McPherson

Nicholas Werner

University of PittsburghSenior Design – BioE 1160-1161

Overview

• Needles are used in many common medical procedures:

• Immunizations

• Administration of drugs

• Starting IVs and catheters

• Fear of needles (6-22% US population)

Overview

• An Extracorporeal Counter-Irritation

• Alleviates the pain, anxiety, and discomfort associated with needle sticks.

• Provides auditory, visual, and tactile stimuli.

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

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.

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

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)

Engineering technologies/methodologies

• Materials

• Standard electronics parts

• Music chip

• Xbox controller motor (high resistance)

• Fabrication

• Circuit board

• Loose wires & solder

• Paint (kid-friendly)

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)

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

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)

Project management

• Most tasks were group effort

• Chief Responsibilities:

• Jessica: Obtained parts

• Alexandra: Built ECI device

• Nichole: Solidworks, manager

• Nick: Testing, Verification & Validation

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

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)

Color Analog Scale

Preliminary Testing

• Randomized set of trials on group members

• Controlled factors

• With/without device

• Arm used

• Time between trials

• Hardness of “snap”

Results

n=2

Verification and Validation

• Verification

• Housing (< 6 in2)

• Weight (< 8 oz)

• Working components

• Reduction of pain/anxiety

• Validation

• Focus Group → Approved

• Clinical Testing

Acknowledgements

• Sources of funding

• Generous gift of Drs. Hal Wrigley and Linda Baker

• Department of Bioengineering

• James J. Menegazzi, PhD

• Dr. Daniel Thomas

Questions?