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

Project Timeline

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.

Device Implementation

Step 2

Performing the incision.Performing the incision.

Device Implementation

Step 3

Removal of the cutting device.Removal of the cutting 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

Questions

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