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 paying for catheter associated UTIs and possible settlements.
=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=
For this project we have multiple specifications and criteria that we are working with. Some of these are from the start of the overall project others are built off of the previous capstone's work. Some of these specifications include:
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=
=Manufacturing Plan=
Throughout the project one of our main deliverables and goals was to develop a manufacturing plan for both products. For the catheter we aim to stick to industry standards for catheter manufacturing. This allows for a shorter timeline to get the product to the market and will be easier to do so. We are looking to create the catheters through extrusion or injection molding. The shaft piece of the catheter will be paired with the three channels which will be separately molded and pieced together later. AS previously mentioned this is currently what occurs in the industry and is what we propose for this product. Throughout the process the molding will occur within the necessary FDA clean room standards. This methods allows us to scale up the size of the catheter from 8Fr to 36Fr and the shaft of the catheter can be extruded to be many different lengths. 
:Catheter Manufacturing
The manufacturing process for the catheter will be injection molding and/or extrusion. Injection molding is the cheapest and easiest way to manufacture medical grade silicone catheters. This manufacturing process is already approved by the FDA, which is a large hurdle to get over when producing a medical device. Using injection molding and extrusion for the catheter will provide the precision necessary to make quality spiral ridges on the catheter. It will also produce quality functional channels inside the catheter. 
:Cup Manufacturing
The manufacturing process for the FFCD will be Type 1 Molded Pulp. Molded pulp is a material made from recycled paper products, such as cardboard or newspaper. It is used in a wide variety of applications, from egg cartons to electronics packaging. We chose this manufacturing process for the Flushing Fluid Catching Device because it aids our design in meeting our criteria. It is cheap​, environmentally friendly, sturdy, and very importantly, absorbent. Its price will be stable in the long run, and it also is easily stackable, which gives it reduced shipping costs. This manufacturing process is highly customizable, so it will be a simple thing to produce our cup. The cup will be made using Type 1 molded pulp, which is the thickest variety. It is durable enough to hold products that weigh anywhere from 10lbs to over 100.
=Catheter and Cup Price=
:Cup Price per Unit
After contacting multiple manufacturers there is a more concrete price point to produce the cups. As mentioned above we will be producing the cups using a Type 1 molded pulp product that can withstand 10 to 100 pounds. To start the production for this product there will be a design process that will cost about $500. After this the prototyping for the production parts can cost anywhere from $500-1,000. For the first 500 units from this specific supplier it will cost $1 per unit. This is not taking into account the designing time only the prototyping costs. After the first 500 units the price can drop considerably down to $0.02-0.1. This price per unit is reasonable for a one time use product that may not be needed everyday. 
:Catheter Price per Unit
Two way Foley catheters made from latex range from $6-10. Our goal for a price target is to remain competitive with this price point. We are looking at large initial costs to get a mold machined and prototyped. After the initial investments we are also looking at higher costs for the high grade medical silicone. The MED 5870 silicone will be expensive compared to other catheter products because of its longevity, being able to stay implanted for over 28 days. The silicone will cost roughly $150 per kilogram but this cost can be reduced considerably by purchasing in bulk later on. The mold has a wide price range starting near $20,000 but the cost per catheter associated to the mold and the manufacturers can be well below $1, closer to $0.50. The cost for the silicone will be near $4 each, so in total one unit will cost $4-6 per unit. There is a slim profit margin for the product but this can be expanded if the redesigned catheter has a slightly higher mark up. The added benefits the redesigned catheters offers can make it competitive on the market. 
=Final Design=
For our final design we will not be changing the catheter from the previous year capstone. The only change to the catheter will on size based on the size of French gauge and the overall length. The catheter will be similar to industry standard for a 2-way Foley catheter but will feature a revolutionary spiral pattern on the outside of the catheter. The spiral paired with a third port will allow for the space between the wall of the catheter and the urethra to be flushed with saline, reducing the chance to contact a catheter associated UTI.
Our final design for the fluid catching device will be the one shown here. This was our third prototype and will provide the most effective results in regard to comfort and function. This design will feature a low profile on the backside of the cup to remain comfortable. We kept just a small wall on the back side for it to still be able to hold liquid and any absorbent material needed. The front of the cup is largely unchanged except for the overall height, it still features the taped channel for the catheter and acts as a barrier for splashing. The sides were also reduced for comfort, but remain higher than the back of the cup for splashing and absorbent material to be pushed more towards the front. This will allow for all of the material to be contained within the cup and will not create any messes when used correctly. 
For the manufacturing of the cup we have concluded that molded pulp will be the best option. Molded pulp is a very cheap way to produce materials like egg cartons or packaging materials. It is made from recycled materials, is biodegradable and will still maintain the function we need. We have been in contact with manufacturers and to work with certain manufacturers our cup design may be slightly altered to fit their machines.
=Team Members=
	Nik Gillihan 
Major: Mechanical Engineering
Email: gill1605@vandals.uidaho.edu
	Tyler Haglund 
Major: Biological Engineering
Email: hagl9243@vandals.uidaho.edu
	Matt Hodgson 
Major: Mechanical Engineering
Email: hodg0221@vandals.uidaho.edu
=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