Final Presentation Final Draft
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Final Presentation Final Draft

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This is our final spinal tap presentaiton for our senior design project.

This is our final spinal tap presentaiton for our senior design project.

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  • 5 MONTHS AGO WE WERE GIVEN THE FOLLOWING PROBLEM:
  • COULD THIS BE MOVED BEFORE THE MONEY SHOT AS AN INTRODUCTORY TO CONCLUSION?
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • Describe the procedure
  • GET NEW PICTURE WITH WHITACRE NEEDLE INCLUDED IN RENDER.PLEASE FIX. 
  • Describe the procedure
  • Briefly describe the purpose of each and what was learned
  • NEEDS MORE DETAIL!!!!!
  • WILL.MUST USE SEXY VOICE AND UNBUTTON SHIRT AS YOU ANNUNCIATE.

Final Presentation Final Draft Final Presentation Final Draft Presentation Transcript

  • William H. Wilson IV Biomedical Engineering Emily Heeb Biomedical Engineering William Bowlus Biomedical Engineering Andy Jetter Biomedical Engineering Stephen Nelson Industrial Design Crystal Barron Nursing
  •  Design a cerebrospinal fluid collecting device to be used in under resourced environments by personnel with minimal training  Current difficulties of procedure: ◦ Finding insertion location ◦ Determining insertion depth
  • 18g Introducer Needle Provides a stable path towards the spinal column, but stops short of dura.
  • Flange Grips Ergonomic design provides stability and control during insertion.
  • Stylet Prevents coring when inserting the introducer. Twist removable cap.
  • Funneled Lead-in Assists user when inserting whitacre needle into the introducer.
  • 22g Whitacre Needle Provides access to dura while causing minimal trauma. Reduces post- puncture headache.
  • Dual Needle Approach Whitacre needle advances through the introducer needle
  • Advancement Knob Rotation allows for a gradual insertion rate of the whitacre needle
  • Threaded Region 4mm pitch needle advancement
  • Luer-lock Allows for connection of a monometer to measure CSF pressure.
  • Insertion Window Locates the L4-L5 intervertebral space
  • Alignment: Iliac Crest Aligns to the iliac crests, which identifies the L4-L5 intervertebral space
  • Alignment: Spine Aligns to the midline of the spinal column
  • Adhesive Allows for fixation to the patient
  •  Accommodates three different hand positions 1 3 2
  •  Usability Testing ◦ Cadaver Labs ◦ Tissue Coring Test ◦ User Drape Studies  Fluid Flow Analysis  Device Failure analysis ◦ Mechanical Failure ◦ AFMEA
  •  Cadaver Lab ◦ Test overall usability of device ◦ Cadaver tissue too rigid for assessment of functionality  Tissue Coring Test ◦ Investigated if a whitacre (bullet tip) needle will core tissue as it is advanced into the spinal column ◦ Tests performed on porcine tissue ◦ The whitacre needle did not core tissue while being advanced
  •  Assess fluid flow through various needles ◦ Determine time to visual CSF flow.  Results ◦ 18 Gage Quinke - 1 mL / 14 sec ◦ 22 Gage Quinke - 1 mL / 2.0 minutes ◦ 25 Gage Whitacre - 1 mL / 7.9 minutes ◦ CSF fluid in flash chamber - < 1 sec
  •  To assess the drape’s ability to properly locate the L4-L5 vertebral space  Study performed by untrained users ◦ Nursing and Biomedical Engineering Students  Results – Round 1 ◦ First Generation Drape  Average X deviation 1.10 cm  Average Y deviation 4.84 cm ◦ Drape did not meet horizontal or vertical accuracy specification
  •  Results – Round 2 ◦ Second Generation Drape  Average X deviation 0.80 cm  Average Y deviation 1.42 cm ◦ Better accuracy when applied to patient lying down ◦ Drape met horizontal accuracy specification  More work needed on vertical accuracy
  •  Application Failure Modes and Effects Analysis (aFMEA)  High Risk of Bumping the System while inserted in patient  Possible design control: Adhesive securing disc  Sufficient thread lubrication is imperative  Likelihood of user impatience while unscrewing the dial  Possible design control: Quick release feature  Likelihood of sterility compromise  Possible design control: Training supplement, significant emphasis in IFU
  •  Whitacre Needle Buckling ◦ Critical Buckling Force = 5 lbf ◦ Insertion Force = 2.25 lbf  Introducer most susceptible: ◦ Flange Bending Break ◦ Threaded Shaft Bending Break ◦ Threaded Shaft Torsion Break
  •  Flange Bending Break ◦ Utilized simple model to replicate a worse scenario ◦ Stress ≈ 700 psi  Threaded Shaft Bending Break ◦ Force applied at tip of shaft = 4 lbf ◦ Stress ≈ 2,700 psi  Threaded Shaft Torsion Break ◦ For Torque = 15 lbf in ◦ Shear Stress ≈ 2,250 psi Material Yield Stress ≥ 3,000 psi
  •  Material Yield Stress ≥ 3,000 psi  Minimized cost ◦ High importance for device success in target demographic  Injection Molding compatible  Durable
  •  Two types of polypropylene are top choices ◦ Polypropylene (50% Glass Fiber Filler)  Better Mechanical Properties  More Expensive  Opaque ◦ Polypropylene (Copolymer, UV Stabilized)  Translucent  Cheaper  Acceptable Mechanical Properties
  •  Polypropylene (copolymer, UV stabilized) ◦ Yield strength ≈ 3,670 psi ◦ Bulk cost ≈ $1.00/lb ◦ UV Radiation Durability: Good  Next Steps ◦ Additional tests to verify mechanical stability ◦ Investigate costs involved with manufacturing processing  Injection Molds, etc. ◦ Sterilization investigation
  •  Finalization of needle design ◦ Investigating Additional features  Quick Release of threads  Relative rotation for knob  Securing disc to skin  Revision of drape ◦ Still need to meet vertical accuracy requirement ◦ Refinement of application procedure ◦ Layout of alignment features
  •  Verification and Validation ◦ Clinical Efficacy  Porcine model  Clinical trials ◦ Production Trials  Testing on manufactured prototypes ◦ Durability testing: aging, drop testing, etc.