The world’s first semi-permanent, minimally invasive, smart catheter system for Neurogenic Bladder.
After Derek Herrera was paralyzed by a sniper in Afghanistan, he decided to start a company to improve quality of life for people living with paralysis.
I knew my life would change, but I didn’t know that managing my bladder would be the most challenging task I faced on a daily basis. As a individual living each day with paralysis resulting from spinal cord injury, I understand just how terrible the current standard of care can be for managing Neurogenic Bladder. Every day, I have to insert small dispoable catheters into my body in order to relieve my bladder of urine. These devices have changed very little over the past century and I believe it is time to innovate radically to improve the quality of life for people like me.
What is The Connected Catheter?
The Connected Catheter is a technological solution for patients with neurogenic bladder. Our solution is a semi-permanent, minimally-invasive, “smart catheter” system that measures bladder pressure and wirelessly transmits data to a smartphone, allows the user to control a valve to empty the urine from the bladder, eliminates the need for intermittent catheters and drainage bags, can be inserted/removed by the user (or clinician) in minutes, and is fully encapsulated in the body to reduce the risk of infection.
The user data will be cataloged through a cloud-based software program and will provide meaningful insight for clinicians and researchers. Clinicians will be able to utilize this data for predictive analytics, identifying and treating potential issues in their earliest stages, and researchers will have new metrics to analyze any potential correlations between bladder pressure and other clinical indications. Currently, no one has captured this uro-dynamics data in a meaningful way.
How does it work?
The Connected Catheter includes both a valve and a miniaturized (passive RF) pressure sensor. The device will be inserted into the bladder of an individual with minimally invasive means by the individual or by a clinician to accurately detect the pressure exerted by the urine in the bladder. This device will be made out of safe, FDA-approved materials that will be tested for accuracy, reliability and safety prior to being inserted in the bladder designed to withstand the environment in the bladder, and not irritate the bladder wall lining.
Dynamic software algorithm will monitor bladder pressures and once the pressure threshold (~40cm H2O) is reached in the bladder, an alert will be sent to the user’s smartphone (or other external device) notifying the user that their bladder is approaching the safe limit. The user will then go to a bathroom where they can safely empty their bladder by squeezing the duckbill check valve at the base of the penis. The user will be able to control emptying of the bladder by applying a gentle amount of pressure to the valve (similar to a CamelBak Bite Valve).
Will The Connected Catheter’s valve leak?
The valve is designed so that when the bladder reaches a certain pressure (just below the safe limit), the valve will open with or without user input. This feature is critically important and will dramatically change the way that neurogenic bladder is treated because currently, with ICP, a person’s bladder can reach a level where the pressure is high enough to cause the bladder to spasm. If the bladder sphincter does not open when the bladder spasms, then urine will be shot back up to the kidneys where it is likely to cause a kidney infection (bladder detrusor-sphincter dyssynergia). With The Connected Catheter, we can eliminate the possibility of the bladder ever reaching a dangerous level, and improve patient safety because the valve will open whether or not a user is actively managing this function.
How long does it last?
The Connected Catheter is designed to stay in a patient’s body up to 28 days before it must be replaced.
How is it inserted and removed?
The Connected Catheter will be inserted into the bladder of an individual with minimally invasive means by the individual or by a clinician. The device will be able to be easily removed by an individual or by a clinician within a matter of minutes.
What does the pressure sensor do?
The miniaturized pressure sensor utilizes passive RF technology to accurately detect the pressure exerted by the urine in the bladder. Dynamic software algorithm will monitor bladder pressures and once the pressure threshold (~40cm H2O) is reached in the bladder, an alert will be sent to the user’s smartphone (or other external device) notifying the user that their bladder is approaching the safe limit.
Can women use The Connected Catheter?
At present, the development of The Connected Catheter is focused for use by male patients. Spinal Singularity aims to develop a version for female versions once the male version has been fully developed.
What is neurogenic bladder?
Every year, millions of people suffer from neurogenic bladder in the USA. This condition is a dysfunction of the urinary bladder due to disease of the central nervous system or peripheral nerves involved in the control of micturition (urination). Individuals with neurogenic bladder may not feel the urge to void or feel a sense of bladder distension.
People suffering from this condition use catheters to relieve their bladders of urine, and they often cannot determine when or how often they need to void because they lack sensation. This puts individual users at risk for increased complications (such as urinary tract infection and false passage) and results in a waste of medical supplies, such as disposable intermittent catheters.
How do I support the development of The Connected Catheter?