Manufacturing Process for Infection-preventing Catheter

Every year hundreds of thousands of urinary catheters are utilized in hospitals. Over time bacteria builds up in the urethra potentially causing a catheter associated urinary tract infection (CAUTI). CAUTIs cause over thirteen thousand deaths a year in the U.S. and cost hospitals in excess of $400 million dollars. In a past capstone project, U of I students designed a revolutionary catheter that can greatly reduce or eliminate the risk of a CAUTI. Team Manity’s goal is to create a manufacturing process and designing a fluid catching device for the catheter. Our work will move this catheter into the market where it can save lives and money.

=Problem Definition= In the US thousands of people are hospitalized each year with the need to have a urinary catheter inserted. Worldwide the urinary catheter market is worth 3.4 billion USD and will increase by an estimated 5.5% per year. In the US the market is evaluated at roughly 1/3 of the global market with nearly 250 million USD reserved for Foley/indwelling urinary catheters. This has increased the prevalence of catheter associated urinary tract infections or CAUTIs in hospital patients. This creates an added cost of 400 million USD for US hospitals having to pay to fix the CAUTI and settlements. The above information has created a niche market for a new product that could greatly decrease or eliminate all hospital and home CAUTIs.

Creating a catheter device that operates like a Foley catheter but can decrease the prevalence of bacteria over long periods of time would be beneficial for hospitals. This could dramatically reduce their costs in paying for this issue while providing patient comfort.

=Background=

=Deliverables= The desired function of the catheter is to eliminate the risk of CAUTIs (catheter associated urinary tract infections) in patients that require long term catheterization. That risk will be eliminated by flushing the urethra with a saline fluid, using the catheters’ unique design. A flushing fluid catching device will capture the flushed fluid and deposit it into a container to eliminate messes. This catheter will be able to remain inserted for extended periods of time with a much lower risk of the patient contracting a UTI. Also, the desired function of the manufacturing process is to produce quality parts within tolerances at a fast pace. The manufacturing process will need to be safe and cost effective. This will enable the team to produce enough catheters to start the testing phase of the product.

=Specifications= Including the time to carefully anchor the catheter within the bladder, insertion should take no more than 45 seconds.

The flow rate must be no less than 4 mL/s. This will be the minimum requirement for all different sizes of catheters.

For the design process and proof of design we will be focusing on 18 Fr. After proof of design the catheter will be scalable to the any size in the size range of catheters from 8 Fr to 36 Fr.

The catheter shall be available in lengths ranging from 6-16 inches.

Must be functionally stable inside the body for long periods of time.

The process to make a single part should be less than 2 minutes.

For initial prototype production, the manufacturing of the catheters must be able to take place within a small facility.

The manufacturing process will be compliant with FDA standards for catheter production. The manufacturing will take place within a sterile environment along with autoclaving (or some other form of sterilization) the units prior to packaging. The materials should be approved by the FDA and the design will need to be tested before approval.

=Value Proposition Statement= Every year hundreds of thousands of urinary catheters are utilized in hospitals. Over time bacteria builds up in the urethra potentially causing a catheter associated urinary tract infection (CAUTI). CAUTIs cause over thirteen thousand deaths a year in the U.S. and cost hospitals in excess of $400 million dollars. In a past capstone project, U of I students designed a revolutionary catheter that can greatly reduce or eliminate the risk of a CAUTI. Team Manity’s goal is to create a manufacturing process and designing a fluid catching device for the catheter. Our work will move this catheter into the market where it can save lives and money.

=Design Considerations=

=Team Members= Niklas Gillihan: Mechanical Engineer undergraduate student at the University of Idaho.

Tyler Haglund: Biological Engineer undergraduate student at the University of Idaho.

Matt Hodgens: Mechanical Engineer undergraduate student at the University of Idaho.

=Project Learning=

=Final Design=

=Validation=

=Additional Documentation=

=Sources and Works Cited= https://www.cdc.gov/infectioncontrol/guidelines/cauti/background.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4673556/

https://www.marketsandmarkets.com/Market-Reports/urinary-catheter-market-132934629.html

https://www.cdc.gov/hai/ca_uti/uti.html