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= The use of indwelling urinary catheters is increasing rapidly. This has a lot to do with advanced care techniques and an ever-increasing population age. Roughly, 23% of all patients in hospitals will need a urinary catheter for some period of time. The length of time these catheters remain in place greatly increases the chance of a UTI. These UTIs start when bacteria enter the urethra and makes it's way up the urinary tract, possibly infecting the bladder, ureters and kidneys. These types of infections are extremely prevalent when a catheter is used and very dangerous. This leads to them being the number one nosocomial infection. Nosocomial meaning infections contracted in hospitals. The problem is compounded with the fact that UTI bacteria is the most common to be anti-biotic resistant.

Catheter associated urinary tract infections cause in excess of 13,000 UTI cases per year. This leads to costs of $400 million dollars USD per year. This problem is going to be compounded with the COVID-19 pandemic. As more people are being placed on ventilators or other forms of long-term care catheters will be used more frequently.

Currently, there are 4 main options for indwelling urinary catheters. The first option is a very simple design, this option is a straight catheter that only drains the bladder. These catheters are used for one tie and then thrown away. Typically made of plastic they are not meant for long-term use. 2-way catheters are the most common types of catheters. This catheter has 2 channels, one to drain the urine from the bladder and the other is for the balloon to be filled with saline. Filling the balloon with saline will block off the urethra forcing the urine down the catheter tube. Lastly are 3 and 4-way catheters which are very similar. These include the two channels but have a 3 channel that is used to irrigate the bladder. This allows saline to flush blood clots or other internal debris out of the bladder. The four-way catheter has a specific channel to allow for the irrigation of wound sites in the bladder. This allows for a clean wound site reducing the risk of infection.

=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=

Our initial idea for developing a fluid catching device for the redesigned catheter was to utilize bedpans. These are already a staple in hospitals and would mean no added cost for the use of our product.

Upon conferring with our client and lead instructor they wanted a single unit that could be marketed in tandem with the redesigned catheter. This led to the second photo above created in SolidWorks. This prototype has a channel cut out of the bottom to allow the catheter tube to rest in. There is also a hole in the device which allows a tube to be connected to the device and this would drain the flushing liquid back into the urinary collection bag.

Our final designed prototype was an edit on the first prototype. This prototype was 3D printed, this will allow us to test the product before we put a manufacturing process in place. Here we can refine the design for usability. This design has a "V" channel allowing for any size catheter to fit inside the channel. We also did not 3D print the hole for drainage into the final prototype. This is because we are allowing ourselves to have the ability to fill the catching device for absorbent material. This will negate the need for extra tubes coming out of the device. The device could then be a single-use system that would be thrown away after one use.

=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=

=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