Infection Prevention Urinary Catheter

The goal of the project is to design and develop a urinary catheter that can reliably reduce the incidence of Catheter-Associated Urinary Tract Infections (CAUTIs).

=Problem Definition=

Background
Catheter-Associated Urinary Tract Infections (CAUTI)
 * Indwelling urinary catheters are very commonly used in both hospitals and nursing homes to help relieve patients with urinary incontinence or urinary retention. The use of a catheter allows the patient to empty their bladder. Most of the time they are used until the person can take back control of the bodily function; however, in many instances with elderly people or those who have a permanent injury of illness, catheters are used long-term or permanently. While it is a very important device used in the healthcare industry, there is a large problem associated with the use of the traditional Foley catheter. The long-term use of a catheter (2 weeks or more) is associated with very high rates of Catheter-Associated Urinary Tract Infections (CAUTIs).


 * CAUTIs are the most common type of nosocomial (hospital-related) infection
 * About 23% of patients in US hospitals require the use of a urinary catheter
 * The risk of acquiring a CAUTI increases by about 3-7% each day that an indwelling urinary catheter remains inside the patient
 * These infections cause more than 13,000 deaths in the United States every year, and also create over $400M worth of increased costs to the care facilities that have to pay for treatments, etc. resulting from the CAUTI.

The clients for this urinary catheter re-design project were made aware of this healthcare problem by a relative who is currently a medical student. As a well-known issue with urinary catheters, Dr. John Crepeau and George Tanner of the University of Idaho were compelled to present this problem with the hopes of creating a new urinary catheter that would prevent harmful CAUTIs, spare thousands of lives, and save millions of dollars for the healthcare industry.

Value Proposition

 * Currently, in the medical field, CAUTIs are perceived as an inevitable illnesses. Team Infection protection focuses on CAUTI prevention to give patients and healthcare workers peace of mind.

Deliverable

 * Develop a catheter design that will reduce bacterial growth and build-up within the urinary tract. The design must be manufacturable on a large scale basis, and it must be adaptable in size.

Specifications
=Design Considerations=

=Project Learning=

Understanding the Root Cause of Infection
While using a catheter, a patient will become more susceptible to bacterial encroachment. The body has a natural defense to UTIs through recurrent urination throughout the day. A catheter inhibits the flow of urine in direct contact the urethra. Instead, urine flows intraluminally through the waste channel, and the urethra is left stagnant.

The anatomy of the human body leads to heightened risks of infection. Escherichia coli (E. coli) is the most common type of bacteria that causes UTIs. The E. coli typically migrates from the anal cavity to the external urethral orifice (opening). Once the bacteria has entered the urinary tract, it can spread all throughout the urethra to the bladder, and if not treated, into the bloodstream.

Early Prototyping Methods
=Chosen Design (preCAUTIon Catheter)= {| ! scope="col" width="width:30em;" | ! scope="col" width="width:20em;" |

Composition

 * This design features 3 ports and 3 distinct channels. The largest channel is for waste drainage.  The remaining two channels are the same size, with one being for the balloon anchor, and the other for urethra irrigation.The outer profile of the catheter includes a spiral to create space within the urethra.



How It Works

 * The catheter was designed to bio-mimic the natural bodily function, urination. To do so, the design allows for an irrigation solution to be injected into the appropriate irrigation port. The flushing solution travels through the catheter tube up to the base of the balloon, where the fluid is released to the urethra.  The fluid then spirals down and out of the urinary tract, while maintaining contact with the maximum urethral tissue surface area.


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=Validation=

Bacteria Test

 * Results
 * The "cloudy" streaks on the control plate indicate substantial bacterial growth on the Foley catheter. The few spots on the experiment plate demonstrate the preCAUTIon Catheter's ability to effectively remove bacteria from the urethra.



How the Foley Catheter is Made

 * The first step in the manufacturing of a Foley catheter is the production of the long, thin tube that will be inserted into the bladder. The liquid rubber silicone is poured into a room temperature vulcanization (RTV) rubber mold.  The mold is shaped like the desired catheter with either two or three outputs.
 * The silicone is then heat cured. This procedure can take anywhere from 0.5 to 40 hours. Once cooled, the tube is withdrawn from the mold.
 * A small opening is then punched in the distal end of the tube furthest away from the two outputs.
 * A thin band of cured latex is slipped over the tube by hand to form a sheath around the tube. It is positioned so that the latex covers the opening that has been punched in the tube.
 * To form the balloon, the entire length of the tube is dipped in latex, which creates an overcoat layer and bonds the band to the tube proximate to the distal and proximal ends of the band, forming the balloon. This adds to the thickness of the balloon and is used to adjust the outer diameter of the tube to the desired size.
 * The catheter is then transported to the packaging center where it is put into a kit with a needleless syringe (to fill the balloon) and a drainage bag
 * Read more about catheter production here

Slight Change in the Manufacturing Process

 * To produce the preCAUTIon Catheter on a large scale, the only projected adjustment in the manufacturing process would be to alter the mold in which the silicone is poured. The remaining steps will remain the same.

=Project Conclusion=
 * The innovative design allows for the removal of harmful bacteria from the urinary tract​


 * The preCAUTIon Catheter Provides a relatively atraumatic insertion, with potential to make removal less traumatizing than it currently is


 * The design can be easily manufactured based on current practices​


 * Additional testing is required to further assess the design

=Team Members=

=Additional Documentation=

Project Schedule



Meeting Agenda



Meeting Minutes



Presentations



Budget