slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Corneal Membrane Transplant Injector Kristen Berger Paul Bieniek David Brooks Marie Gill Dr. Ahmed Al-Ghoul April 13, 20 PowerPoint Presentation
Download Presentation
Corneal Membrane Transplant Injector Kristen Berger Paul Bieniek David Brooks Marie Gill Dr. Ahmed Al-Ghoul April 13, 20

Loading in 2 Seconds...

play fullscreen
1 / 26

Corneal Membrane Transplant Injector Kristen Berger Paul Bieniek David Brooks Marie Gill Dr. Ahmed Al-Ghoul April 13, 20 - PowerPoint PPT Presentation


  • 195 Views
  • Uploaded on

Corneal Membrane Transplant Injector Kristen Berger Paul Bieniek David Brooks Marie Gill Dr. Ahmed Al-Ghoul April 13, 2007. Cornea Surgery. Keratoplasty is used to treat many cornea diseases 2005 – Over 100,000 surgeries performed in U.S.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Corneal Membrane Transplant Injector Kristen Berger Paul Bieniek David Brooks Marie Gill Dr. Ahmed Al-Ghoul April 13, 20' - kaya


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

Corneal Membrane Transplant InjectorKristen BergerPaul BieniekDavid BrooksMarie GillDr. Ahmed Al-GhoulApril 13, 2007

cornea surgery
Cornea Surgery
  • Keratoplasty is used to treat many cornea diseases
  • 2005 – Over 100,000 surgeries performed in U.S.
  • More efficient surgical techniques have recently evolved (DSEK)

http://sarajdoktor.blogger.ba/

current surgery techniques dsek
Current Surgery Techniques: DSEK
  • 50% of keratoplasty procedures
  • Advantages
    • Only replaces diseased tissue
    • Smaller incision
    • Fewer stitches
  • Disadvantages
    • Donor tissue folded and inserted
    • Damage to endothelial cells
    • Interface haze
    • Loss of intraocular pressure

Gorovoy, M. S., Francis, W. P.

eye anatomy
Eye Anatomy

ANTERIOR CHAMBER

design objectives
Design Objectives
  • Safely deliver donor tissue to anterior chamber
  • Minimize contact with endothelium
  • Reduce incision size (<4mm)
  • Maintain intraocular pressure
requirements
Requirements
  • Compatible with existing equipment
  • Functions:
    • Irrigation
    • Aspiration
  • Easy to operate
  • Sterilizable
  • Biocompatible
  • Life in service - 5 years at 5 procedures/week
competitive analysis
Competitive Analysis
  • Currently, no device performs the same function
  • Similar devices
    • Irrigation/ aspiration devices
    • Lens implant devices

http://www.hsc.wvu.edu/som/eye/servicesCataract.asp

design alternatives
Design Alternatives

1.)

  • Curled membrane
  • Translatable suction platform
  • Too much friction

2.)

  • Wrapped membrane
  • Translatable oval suction tip
  • Triple lumen design
design end of first semester
Design – End of First Semester
  • Three component system
    • Stainless steel injector
    • Clear plastic cartridge
    • Stainless steel case
  • Fabrication
    • “If you guys think you can make

this, you’re crazy!” – Andy Holmes

    • Injector too complex to be machined as one piece
redesign issues
Redesign Issues
  • Design for Production – Consider Assembly
    • Vacuum and irrigation tubes; luer fittings
  • Simplification
    • Merging of case and cartridge
prototype fabrication
Prototype Fabrication
  • Cartridge – SLA
  • Injector parts
    • Stainless steel, SLA, PVC
    • Used lathe and mill
    • Hand-assembled
features
Features

Luer fittings for attachment to emulsifier

O-rings for water-tight seal between parts

Pin and guidance track to allow precise alignment of parts

Ergonomic grips

Surgical grade stainless steel for injector

Clear plastic cartridge for visualization during use

potential hazards
Damage to donor endothelial cells Category III

Inability to maintain the anterior chamber Category III

Failure to achieve suction Category III

Negative reaction of tissue to the device Category IV

Damage to patient’s eye Category IV

Severity:

Category I - Catastrophic

Category II - Critical

Category III - Marginal

Category IV - Minor

Potential Hazards
concept model
Concept Model
  • Testing of suction and irrigation on silicone corneas and contact lenses
preliminary prototype testing
Preliminary Prototype Testing
  • Test functions:
    • Suction
    • Irrigation
future prototype testing
Future Prototype Testing
  • Qualitative using animal cadaver eyes
    • Ease of use - ergonomics
    • Function
  • Works with phacoemulsification machine
    • Holds corneal membrane on injector
    • Maintains anterior chamber pressure
    • Safely transports the corneal membrane
      • Histology testing of corneal membrane and recipient eye
fda classification i
FDA – Classification I

Similar Devices:

Intraocular lens guide

  • 21 CFR 886.4300
    • “… a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.”

Ocular surgery irrigation device

  • 21 CFR 886.4360
    • A device used “… during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.”
fda classification i1
FDA – Classification I
  • General Characteristics
    • Non-life sustaining
    • Least complicated
    • Failure poses little risk
  • Premarketing submission 510(k)
    • Substantially equivalent to a legally marketed device not subject to a premarket approval (PMA)
    • Intraocular lens guide is exempt from 510(k) unless “ . . . if used as folders and injectors for soft or foldable IOL's.”
fda classification i2
FDA – Classification I
  • General Controls:
    • Quality assurance program
    • Suitable for intended use
    • Adequately packaged
    • Properly labeled
    • Establishment registration
    • Device listing forms
economic considerations
Economic Considerations
  • Cartridge
    • ~50,000 DSEK procedures per year in US
    • $1.10/cartridge production cost1
    • Injection mold: $15,000-25,0002
    • ABS: $2.00/lb2
    • Revenue = ($100 – $1.10)*50,000 = $5M per year
  • Injector
    • ~2,500 Hospitals and Surgery Centers
    • $100/injector3 (CNC)
    • $20/injector4 (MIM)
    • Injection mold: $25,0004
    • Revenue = ($1500 - $20)*(2,500 hospitals)*(3 units/hospital)/(5 yrs)

= $2.2M per year

1) http://www.geplastics.com/gep/eng/webted/webted.html

2) http://kazmer.uml.edu/Software/JavaCost/index.htm

3)http://www.jobshoptechnology.com/features/0302/mim.shtml

4) http://news.thomasnet.com/IMT/archives/2004/05/the_benefits_of.html?t=archive

project management
Project Management

Sept. Oct. Nov. Dec. Jan. Feb. Mar. Apr. May

Initial Research and Design

Proof of Concept

Concept proved 2/8/07

Redesign

Prototype Completed 4/6/07

Fabrication

Prototype Testing

team contributions
Team Contributions
  • Dave – Initial SolidWorks design, background research
  • Paul – Initial SolidWorks design, cartridge development, fabrication
  • Marie – Concept model testing, preliminary prototype testing, FDA regulatory research
  • Kristen – SolidWorks redesign, injector development and fabrication
  • All – DHF and SBIR
future directions
Future Directions
  • Biocompatibility Testing
  • Plastic tip redesign
    • Decrease size
    • Conduct stress tests
    • Make tip slanted
  • Durability Testing
  • Upscale to mass production
acknowledgements
Acknowledgements
  • Dr. Ahmed Al-Ghoul
  • Andy Holmes
  • Generous gift of Drs. Hal Wrigley and Linda Baker
  • Department of Bioengineering
thank you
Thank You!
  • Questions?