Novel bladder catheterization device

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Minnesota Healthsolutions Corporation $1,068,096 on September 15, 2025, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to develop and evaluate a prototype novel bladder catheterization device.

The device addresses a critical clinical gap in urologic management. Over one million Americans—including more than 250,000 people with spinal cord injury, 120,000 with spina bifida, and populations living with prostate enlargement, diabetes, multiple sclerosis, and other neurodegenerative diseases—depend on catheters for bladder drainage due to neurogenic bladder. Up to 10 percent of patients in long-term care facilities are catheter-dependent. Current bladder management methods carry significant morbidity and inconvenience; the proposed system incorporates several innovative features designed to create a simpler, more reliable, and safer catheterization approach.

Minnesota Healthsolutions Corporation, a woman-owned small business based in Minneapolis, Minnesota, will perform the work through August 31, 2027. The company specializes in medical device innovation and has previously received federal support from multiple NIH institutes for device development projects including dialysis cannulation needles, safety devices, and digital health interventions.

Abstract

This project relates to the development of a novel catheterization device which will create a new method for bladder drainage. IT is estimated that over one million americans, including tens of thousands of children, have a neurogenic bladder (bladder failure) requiring use of a catheter to drain urine. This includes over 250,000 people with spinal cord injury, 120,000 people living with spina bifida, and a subset of the tens of millions of americans living with prostate enlargement, diabetes, multiple sclerosis and other neurogenerative diseases. Up to 10 percent of patients in long-term care facilities are catheter-dependent. Current bladder management methods are associated with significant morbidity and inconvenience. Developing a simple, reliable, and safe catheterization approach would provide a novel bladder drainage method in a field where meaningful innovation is necessary. The proposed project explores a novel bladder catheterization system with several innovative features. A prototype device will be developed and evaluated.