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Tooth Guard for the Laryngoscope University of Pittsburgh Senior Design – BioE 1160/1161 Nate Angeloff Mike Matthews Virginia Penascino Sean Ritchie April.

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Presentation on theme: "Tooth Guard for the Laryngoscope University of Pittsburgh Senior Design – BioE 1160/1161 Nate Angeloff Mike Matthews Virginia Penascino Sean Ritchie April."— Presentation transcript:

1 Tooth Guard for the Laryngoscope University of Pittsburgh Senior Design – BioE 1160/1161 Nate Angeloff Mike Matthews Virginia Penascino Sean Ritchie April 18, 2006 Mentors: Jim Menegazzi, PhD Manuel Vallejo, DMD, MD

2 Overview A Laryngoscope is an instrument used to examine the interior of the larynx during intubation. The traditional laryngoscope can be difficult to use. It can cause oral cavity and soft tissue damage Oral cavity damage can include tooth fracturing We designed a tooth guard that would slide over the Miller blade to provide a cushion against the forces applied to the upper and lower teeth This product is used in pre- hospital emergency care and in the hospital setting

3 Background Dental injury is the most common medical legal complaint against anesthesia providers (33%-38%) Average cost = $1,672 ± $2,378 (0 – $8,038) 62% of teeth damaged by the laryngoscope have been previously restored or are associated with periodontal disease Incidence of dental injury 0.02% - 0.7% (retrospective) 12.1% (prospective) UPMC paid for $25,000 worth of dental repair from October to June 2000

4 Teeth Most at Risk Upper maxillary central incisors are most at risk Single tooth usually involved - only 13% > 1 tooth Upper left maxillary central incisor is most at risk (51%*) 5% 8% 16% 51% 19% 0% *

5 Facts Damage is 5x more likely with a pre-existing dental condition Most injuries crown fractures + partial dislocations Non restored teeth incisal chipping Isolated teeth dislodgement Orthodontic treatment tooth mobility and root resorption

6 Problem Statement Current Solutions Gauze roll Oropharyngeal Airway Bite Block Bitegard Endoscopic Not for emergency situations Wont work during a difficult intubation

7 Features & Benefits The laryngoscope is not being redesigned. Instead we are manufacturing a sheath to cover the points on the blade that apply pressure to the teeth The sheath will be made out of a soft, elastic material to provide ample cushioning for the patients teeth The guard was manufactured and fitted to the blade so that visibility and lighting are minimally affected

8 Design Requirements The guard must fit in the oral cavity It needs to cover the area of the blade that contacts the upper maxillary incisors The width of the guard must be larger than the blade so that it contacts more teeth Using a soft material will cut down on incidental impact damages The least amount of material should be used to ensure greatest amount of visibility. This also minimizes cost

9 Proposed Solution The insertion site is machined to the exact specification of the Miller blade This could easily be made universal for other sizes and different manufactured blades The increased width and flattened sides of the guard helps distribute the force over more than one tooth

10 Prototype Fabrication SolidWorks model was sent to The prototype was fabricated using PolyJet Tango Elastomer in stereolithography

11 Materials New PolyJet Tango material that simulates the feel of flexible materials such as rubber or silicone Tango Black is the softest material they provide with a SHORE A hardness of 61 durometers Shore (Durometer) test measures the resistance of plastics toward indentation and provides an empirical hardness value Silicone rubber tubing ranges from 40 to more than 65

12 Set Up Two models of the upper jaw were obtained from the Wiser center The teeth in the model were all joined The sides of the upper maxillary incisors were shaved down using a razor blade Each jaw model was super glued and screwed to a piece of wood The wood was on a hinge which allowed the model jaw to pivot while the force transducer was placed directly underneath Using a prying motion with the laryngoscope, the teeth were broken

13 Testing First we broke model teeth with the guard and without the guard After the model teeth were broken, we inserted human teeth into the jaw mold The teeth were supplied by Dr. Vallejo and drilled at the dental school We were hoping for a larger force on the jaw when the guard was used Indicating the force was being dispersed over more teeth, preventing any of them from breaking

14 Results First the teeth were broken without the guard, the average force required for fracture was N These forces are for the model teeth, not real human teeth

15 Results (cont) This is us breaking a tooth without the guard on the laryngoscope

16 Results (cont) Next we attempted to break the teeth with the guard but were unsuccessful The guard spread the force out so much that none of the teeth broke, even when using as much force as possible

17 Results (cont) This is us attempting to break a tooth with the guard on the laryngoscope

18 Results (cont) Force Required to Fracture Without Guard (N) Force Required to Fracture With Guard (N) Trial 1221No Fracture Trial No Fracture Trial No Fracture Trial No Fracture Average No Fracture

19 Results (cont) Once the model teeth had been broken we drilled a hole in the model and inserted the human teeth We were unable to obtain data from the human teeth because the models broke before the teeth fractured

20 Jaw model after failure

21 Competitive Analysis Disposable and/or Sterilizable Cushioning Device for the Laryngoscope Teeth Protector for Laryngoscope Blade Free Patents Online: Laryngoscope Blade with Protective Insert

22 Competitive Analysis Current Solutions (on the market) Gauze roll 10/box – 10 boxes for $7.38 Oropharyngeal Airway ($0.70 each – in bulk $0.50 each) Bite Block – BiteGard (50/box) ($65) Endoscopic ($4.90 each) Used in approximately 2% of cases Our price - $1.20 per guard BiteGard

23 Competitive Analysis Strengths Distributes load over more teeth to decrease force on primary tooth Disposable Can be universal – Mac and Miller For emergency use Weaknesses Bulky Slipping from desired location

24 Quality System Considerations Manufacturability Simple Design Made out of PolyJet Tango Elastomer Stereo lithography to simulate rubber Proposed Siloxane manufacturing Human Factors Decrease the damage to the oral cavity caused by intubation Universal - Slides over Miller Blade but can be made to slide over Mac Blade also Easy to use Disposable

25 FDA Regulation TITLE 21--FOOD AND DRUGS CHAPTER IFOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 868 – ANESTHESIOLOGY DEVICES Subpart F – Therapeutic Devices Sec Dental protector Identification: A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity Classification: Class 1 Class I (general controls): The device is exempt from the pre-market notification procedures in subpart E of part 807 of this chapter subject to the limitations in US Food and Drug Administration:

26 Economic Considerations Market size One study indicates 500,000 intubations are performed worldwide per day A second study stated that 12,000 intubations were performed by paramedics per year in Pennsylvania This number does not include in- hospital intubations

27 Economic Considerations Siloxane with a shore hardness of 60 A will be manufactured by Instrumentation Industries or Cost = $15,000 + $0.20per Selling price = $1.20 per guard Potential market size = Earning potential

28 Design Alternatives The width is the most important component in the design The height was decreased to remove unnecessary material

29 Work Breakdown Nate Angeloff Mike Matthews Virginia Penascino Sean Ritchie Design XX Clinical Interviews X X X Material Research XX Stress Analysis X X Prototype XX Testing XX XX DHF XXXX

30 Acknowledgements Manuel Vallejo, DMD, MD John ODonnell, CRNA, MSN Jim Menegazzi, PhD Mark Gartner Generous gift from Dr. Linda Baker and Dr. Hal Wrigley

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