1. Guided Tracheostomy Airway Device University of Pittsburgh Senior Design – BioE 1160/1161 Elaine Blyskun, Katie Horvath, Gregg Housler, Andrew Rowland April 18, 2006 James Menegazzi, PhD (Department of Emergency Medicine, University of Pittsburgh)

2. Surgical intervention is required for critically injured patients in need of respiratory support that cannot be orally intubated. Surgical intervention is required for critically injured patients in need of respiratory support that cannot be orally intubated. Cricothyrotomy Background

3. 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

4. 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/s earch.cfm?db=PMN&ID=K013916

5. 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

6. 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 devices to provide an improved approach to a standardized cricothryotomy kit. Address several concerns with current devices to provide an improved approach to a standardized cricothryotomy kit.

7. 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

8. Project Timeline

9. Group Member Contributions Research Clinical Competitors Products Prior Artwork SearchBiomaterials Elaine ◘ Katie ◘◘ ◘ Gregg ◘ ◘ Andrew ◘

10. Group Member Contributions 3D Solid Modeling Ordering/ Prototyping Clinical Testing Elaine ◘ ◘ Katie ◘ Gregg ◘ Andrew ◘◘

11. 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

12. 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

13. 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

14. Device Implementation Step 1 Location of the sternal notch and placement of the device.

15. Device Implementation Step 2 Performing the incision.

16. Device Implementation Step 3 Removal of the cutting device.

17. 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

18. 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

19. Device Evaluation Plan Questionnaire – other devices vs. our device Clinicians will rate degree of: easiness, overall sentiments, skill required, quality of devices

20. 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

21. 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

22. Results Henry Wang, MD, MPH “Innovative piece is the sternal notch template” Design a template with two guide points Standardized kits can be restrictive

23. Once problems addressed, perform experiments to attain quantitative data to fully determine redesign success Future Work

24. 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

25. Questions

26. 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