What it does
Infection in peritoneal dialysis (PD) is one of the primary reasons why nephrologists recommend patients for in-center dialysis rather than PD. Relavo's invention, the PeritoneX, internally disinfects contaminated dialysis tube ends to prevent infection.
Your inspiration
The Relavo team was introduced to the problem of infection in PD by Dr. Alicia Neu at Johns Hopkins Hospital. We were immediately intrigued because it seemed like there were relatively simple solutions to a problem that impacted hundreds of thousands of people worldwide. We were shocked that nearly 1 in 2 PD patients contracted peritonitis, an infection of the peritoneal membrane, and were surprised that there were no solutions on the market to address this. Eager to fill this unmet niche, we developed the PeritoneX to make quality care at home more accessible to kidney failure patients and save the healthcare system millions of dollars.
How it works
The PeritoneX is a connection device that disinfects potentially contaminated PD tube ends after all connections have been made to eliminate the risk of peritonitis. During the PD set-up process, patients will connect corresponding tube ends into the PeritoneX, instead of directly to each other. The device will be implemented at each of the connection points. The number of connection points depends on patient size but typically ranges from 2 to 5. The device uses a vacuum mechanism to flush 0.55% sodium hypochlorite into the connection space to disinfect connected tube ends. After a 2 second dwell time, the syringe automatically retracts, withdrawing the solution from the chamber without requiring assistance from the patient. The patient may then proceed with dialysis treatment with the PeritoneX still attached. The disinfection process occurs in a closed system, which is maintained during dialysis treatment, to prevent secondary contamination events.
Design process
After being introduced to the problem of infection in PD, we conducted a literature search and observed the PD set-up procedure to better understand the dialysis space and clinical prevalence. We then conducted interviews with various stakeholders, such as pediatric and adult nephrologists, dialysis nurses, clinic medical directors, industry executives, and former patients, to validate the problem. Then, through root cause analysis and needs clustering, we determined that the optimal area of intervention was the tube connection point. A competitor analysis led us to choose a liquid antimicrobial solution as our disinfection method. Initial prototypes connected dialysis tubes and explored ways to release an antimicrobial solution into the connection space with simple patient interaction. However, due to toxicity concerns, we modified the design to also retract the solution to prevent it from entering the patient. We then considered the time required to kill microbes. Current prototypes have mechanisms for controlled antimicrobial release and retraction, and implement timing components to ensure a sufficient antimicrobial dwell time, which was found through time-kill kinetic assays. Through this process, we conducted over 30 stakeholder interviews and developed nearly 20 designs.
How it is different
Current methods to prevent peritonitis rely on education and best-practice procedures. However, these attempts are not standardized, and vary from clinic to clinic. Such efforts initially reduced peritonitis rates, but their results have stagnated. There are no comparable products in use that attempt to address the issues with current practices. The sole known competitor product, PuraCath’s Firefly, which uses ultraviolet (UV) radiation to disinfect the catheter connection, is not on the market. This multi-use device is incompatible with current systems as existing PD tubing is not penetrable by UV radiation. We developed the PeritoneX with these concerns in mind. Our device does not require the patient to be vigilant of contamination events, and maintains a closed system after disinfection, eliminating any risk of secondary contamination. Lastly, our device is fully compatible with PD systems from Baxter International, which make up over 70% of the market.
Future plans
Our next steps in product development include optimizing the delayed-retraction mechanism to control the antimicrobial retraction after a required dwell time. We will then conduct a usability study to obtain patient feedback, then validate the PeritoneX’s disinfection efficacy against species of microbes that commonly cause peritonitis, such as Staphylococcus epidermidis, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans, with an FDA-certified contract testing service. Following this, we will conduct an animal study with large mammals to demonstrate biocompatibility and safety before applying for FDA market clearance.
Awards
Johns Hopkins Technology Ventures - O’Connor Entrepreneurship Fund-$10,000, Summer Entrepreneurship Award-$10,000 VentureWell E-Team Stage 1-$5,000 Texas Christian University, Values + Ventures Competition, Honorable Mention-$2,500, Best Financial Forecast-$1,000 Johns Hopkins Business Plan Competition, 2nd place-$3,000
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