Overview of Status of Analysis, Design, Fabrication, Tests, etc.
Got work space assigned by Ian Richardson
Got basic instructions from Chris Cassidy on 3D printer and printing material. We will be able to use the 3D resin printer that prints flexible material. However, we have to give the file to Chris who will print it for us, we cannot do it ourselves.
Met with Dr. Kalmaz on Thursday 2:00pm to go over preliminary designs and get her input.
Accomplishments from Previous Week
Viewed Dr. Kalmaz doing colonoscopy procedure
Kickoff the project
Brainstormed on the design
Received schematics of the colonoscope which will help with our designs.
Goals for Next Week (list names after each item). Use specific and measurable objectives.
Finish Risk Reduction Presentation (everyone)
continue design (everyone)
Sponsor Comments from Last Meeting and Actions Taken to Address these Comments (indicate date of comments and if via email or in person)
Major change: inner seal doesn't matter as much as friction. Dr. Kalmaz would prioritize the amount of friction on the colonoscope rather than the integrity of the seal. She told us of this rubber band device that goes over the endoscope and a tube. However, the rubber clamps down hard on the scope and makes it difficult to maneuver the scope, so many doctors would rather take the band off and have a leak rather than struggle to perform the procedure.
A human sphincter is around 2-3cm long.
there is a children version of the colonoscope and an adult version. The difference between the two is that the children version has a smaller diameter of about 1-2mm.
She would want a one size fit all device, or maybe a children version and an adult version.
May contact Dr. Savides on information about printing flexible medical devices since he's doing the same and getting a patent on his stuff.
She can get a form for her patients to sign so that we may test our prototypes on them.
A human sphincter can expand large enough that our device will go in and won't cause much harm, as long as it's within reason.
(Kalmaz 16 March 2017)
Instructor Comments from Last Meeting and Actions Taken to Address these Comments (indicate date of comments and if via email or in person)
FDA approval isn't our focus. It's much too short of a time period to get one, as it takes years and years of testing. We can opt for a Non-Significant Risk Study, where we would prove that the medical device we come up with won't do any major risk or harm, and we can get it used on people for testing. Materials would be a problem to find a nice one that is biocompatible. (Gillet 16 March 2017).
Some materials we can use can be from the Stratasys printer that belongs to Professor Tolley. It uses Tangoblack and Variclear resin. These two resin are their special ones that thye mix together. Tangoblack is flexible and Variclear is stiff. The durometer of the printed material can be decided from the ratio of the resins. Neither are FDA approved yet. We can also cast our material using PDMS plastic. PDMS is flexible and definately FDA approved. However, there's no printed version, and so we may have to use silicone or urethane to cast our parts.(Young 16 March 2017).
Need to find a pure printer that does nothing but the biocompatible materials otherwise it may be contaminated with random crap that may introduce nasty chemicals or unwanted stuff onto a part that's going into a person.
Should sterilize our part before going into a person.
There's list of FDA approved materials online to sift through.
Comments from Other Students in the Class (indicate date of comments and if via email or in person)
N/A
Risks and Areas of Concern
Inner Seal
Outer Seal
Movement of piece
Too much friction
Resources or Information Required but not Available
testing on mannequins or pig corpses
3D printable flexible material that's also FDA approved.
Schedule
Describe upcoming milestone
Update Gantt chart.
Budget (list amount spent and amount remaining)
$0 spent
Progress on Report and Webpage
Got access to this Webpage