Innovative Neurogenic Bladder Management for Females and Those with Poor Upper Extremity Motor Function Who Cannot Volitionally Void

Specific Aims: “Neurogenic Bladder Management Solution to Promote Independence and Reduce Long Term Morbidity for Patients Unable to Perform Intermittent Catheterizationandquot; The objective of this proposed SBIR Phase I project is to complete the prototyping, design refinement, and engineering validation of the EZ-SP device, a novel solution for those unable to perform clean intermittent catheterization (CIC), the act of passing a catheter through the urethra into the bladder multiple times a day. CIC is generally employed when a patient is unable to volitionally void as a result of neurologic injury or disease (most commonly spinal cord injury, multiple sclerosis or spina bifida). The EZ-SP is specifically intended to aid those with poor upper extremity (UE) motor function, who lack the dexterity to perform CIC, and females, who have difficulty accessing the urethra (groups that comprise more than 200,000 of the 370,000 patients in the Unites States with neurogenic bladder dysfunction). Our device is intended to increase bladder specific quality of life, increase urologic convenience and replace alternative bladder management strategies (leakage into diapers, foley/suprapubic catheters, and reconstructive catheterizable stoma creation) which result in increased patient morbidity when compared to CIC. The EZ-SP device provides an option for those who cannot perform independent CIC by:  Enabling use in persons with poor UE motor function and those that have difficulty accessing theirurethra by way of an easily accessible drainage port just below the umbilicus  Providing a simple “magnetic click connector” that requires minimal UE motor function in order tofacilitate attachment to a urinary drainage device  Improving cosmesis (low profile with no urinary drainage bag attached to the patient)  Minimizing maintenance by requiring device changes only once per month in an outpatient setting  Offering safe device placement with a simple 15-minute outpatient procedure  Providing a andquot;one-size-fits-allandquot; construct to facilitate adoption by hospital and practitioners  Significantly minimizing device encrustation compared to other indwelling tubes via active drainage ofurine from the bladder rather than passive drainage (hence bladder debris will be actively removed) The target deliverable of Phase 1 will be a complete bench-tested commercial prototype of the EZ-SP system (tube and drainage system) that is suitable for subsequent clinical testing in Phase 2. To achieve this objective, this proposed Phase 1 project seeks to confirm the feasibility of the proposed technological approach by fulfilling the following specific aims  Specific Aim 1: Optimization of the Dual-Lumen Catheter and its Anchoring Mechanism  Specific Aim 2: Optimization of the Fixation Wafer  Specific Aim 3: Optimization of the Click-Connector Drainage System with Human Factors Assessment For each of Aims 1-3, the supporting milestones (sub-aims) will be structured as follows: Milestone 1: Successful fabrication of prototype components – Specific tasks will include: Finalizing component design requirements, key performance parameters, and specifications Selection/specification of candidate component material(s) 3D computer-aided design modeling of alternate component designs/geometries, and identification of key modifiable dimensions/parameters for performance optimization Successful prototype fabrication Milestone 2: Performance characterization of prototype components – Specific tasks will include: Design andamp; fabrication of component testing hardware (test fixtures, tissue phantoms, etc.) and procedures Component performance characterization using key performance parameters and specifications defined in Milestone 1 Milestone 3: Iterative design refinement andamp; engineering validation – Specific tasks will include: Modification of component dimensions/parameters based on performance characterization results anddirect patient feedback Iterative re-prototyping and re-testing of prototype components to achieve required performance Commercial tooling, fabrication, and performance validation of final component designProject Narrative In the United States, there are over 370,000 persons who are unable to volitionally void due to neurologic disease (most commonly spinal cord injury, spina bifida and multiple sclerosis). Of these persons, more than half (200,000) are unable to perform recommended clean intermittent catheterization (CIC), the act of passing a catheter through the urethra multiple times per day, due to limitations in upper extremity motor function or difficulty accessing their urethra due anatomic placement (most females). As a result, many opt to use alternative bladder managements such as leakage into diapers, indwelling catheters or requiring reconstructive surgery, each of which are associated with decreased bladder specific quality of life and increased morbidity. The purpose of this project is to improve bladder management options for those with neurologic dysfunction who lack the means to intermittently catheterize their bladder.