guided tracheostomy airway device university of pittsburgh senior design – bioe 1160/1161 elaine...
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Guided Tracheostomy Airway Device
University of PittsburghSenior Design – BioE 1160/1161
Elaine Blyskun, Katie Horvath, Elaine Blyskun, Katie Horvath, Gregg Housler, Andrew RowlandGregg Housler, Andrew Rowland
April 18, 2006
James Menegazzi, PhD (Department of Emergency Medicine, University of Pittsburgh)
Surgical intervention is required for Surgical intervention is required for critically injured patients in need of critically injured patients in need of respiratory support that cannot be orally respiratory support that cannot be orally intubated.intubated.
Cricothyrotomy
Background
FDA Regulation
• TITLE 21 - FOOD AND DRUGS• CHAPTER I -- FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES
PART 868 – ANESTHESIOLOGY DEVICES • Subpart F - Therapeutic Devices • Sec. 21CFR868.5090 Emergency airway needle.• (a) Identification. An emergency airway needle is a
device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.
• (b) Classification. Class II (performance standards).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=868.5090
Currently Marketed Devices
• Cook: Melker Cricothyrotomy
• Scalpel, wire guide, dilator, different diameter catheters
• Weaknesses: complicated, no sternal notch guide, no method of securement
• Strengths: custom catheter fit, catheter guide
• FDA 510k K013916
www.cookcriticalcare.com,
www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=PMN&ID=K013916
Currently Marketed Devices
• Cook: Wadhwa Emergency Airway
• Needle, catheter
• Weaknesses: No catheter guide, no sternal notch piece, no method of securement
• Strengths: versatile www.cookcriticalcare.com
The Problem
Current tracheostomy devices…
1) …have multiple parts and steps that make the procedure complicated and lead to operator error
2) …do not efficiently address the dynamics between functionality and versatility.
Address several concerns with current Address several concerns with current devices to provide an improved approach to devices to provide an improved approach to a standardized cricothryotomy kit.a standardized cricothryotomy kit.
Design and test a working prototype that satisfies two main design criteria:
1) Reduce the number of working pieces for device implementation, and
2) Reduce the number of steps needed by the operator for implementation
Project Goal
Group Member Contributions
Research
ClinicalCompetitors
Products
Prior Artwork
Search Biomaterials
Elaine ◘ Katie ◘ ◘ ◘Gregg ◘ ◘
Andrew ◘
Group Member Contributions
3D Solid Modeling
Ordering/ Prototyping
Clinical Testing
Elaine ◘ ◘Katie ◘Gregg ◘
Andrew ◘ ◘
Notes prior to design;
• sternal notch
• stabilization of device post-op
• posterior tracheal wall puncture
• tracheal deviation due to compounding thoracic/pulmonary complications
Design Requirements
Proposed Solution
Redesign Solution
1. Flange placed in the sternal notch
2. Rigid, adhesive pads that will secure the device
3. Three piece, three step device
Version 1 –
sternal notch locator
device stabilization
posterior tracheal wall protection
advanced tracheal deviation complications
Version 1.1,1.2 –
improved sternal notch locator
device stabilization
posterior tracheal wall protection
advanced tracheal deviation complications
Version 2 –
improved sternal notch locator
improved device stabilization
posterior tracheal wall protection
advanced tracheal deviation complications
Design Timeline
Version 1
Version 1.1, 1.2
Version 2
Device Implementation
Step 1
Location of the sternal notch and Location of the sternal notch and placement of the device.placement of the device.
Quality System Considerations
Materials
• Prototype - standard SLA polymer (DSM® SOMOS 11120 Water Shed Polymer)
Human Factors Analysis
• Initial Hazards Analysis
• Failure Mode Effects Analysis
• Fault Tree Analysis
Device Evaluation Plan
Procedure for Attaining Data: 1. Quantitative: instruct and time
clinicians as they perform tracheostomy on sacrificed pigs using our device, competitor’s device
*Number of runs will depend on number of animals available to us each day
2. Qualitative: clinicians complete questionnaire
Device Evaluation Plan
• Questionnaire –
other devices vs. our device
• Clinicians will rate degree of:
• easiness, overall sentiments, skill required, quality of devices
• Attempted experiments on porcine models: multiple prototypes failed to puncture skin
• Dull cutting trocar
• Unable to take quantitative data
• We attained qualitative feedback from clinicians
Device Evaluation
Results
• James Menegazzi, PhD• “Practical for out of hospital care”• “For patients whom traditional airways
have failed… [this] device can provide a life saving route for ventilation”
• Key features that distinguish it from other kits• Cutting trocar• Sternal notch guide• Angled housing guides placement and
anchors tube
Results
• Henry Wang, MD, MPH
• “Innovative piece is the sternal notch template”
• Design a template with two guide points
• Standardized kits can be restrictive
• Once problems addressed, perform experiments to attain quantitative data to fully determine redesign success
Future Work
Acknowledgements
• James Menegazzi, PhD• Henry Wang, MD, MPH• Professor Mark Gartner• University of Pittsburgh
• Department of Bioengineering• Department of Emergency Medicine• Swanson Institute for Technical
Excellence• Drs. Linda Baker and Hal Wrigley for their
generous contribution
Predicate Device• 510(k) Premarket Notification Database
• Number K013252 • Regulation Number 868.5090 Class II• Name PATIL EMERGENCY CRICOTHYROTOMY
CATHETER SET• Applicant COOK, INC. Bloomington, IN • Date Received 09/28/2001 • Decision Date 02/21/2002• Decision substantially equivalent (SE)• Classification Adv. Comm. - Anesthesiology • Review Advisory Committee - Anesthesiology