SPINAL SINGULARITY, INC. — Department of Health and Human Services SBIR Phase I: 400

Description

ABSTRACT Development of Advanced Urinary Catheter for Reduction of Urinary Tract Infections and Improved Urologic Management Catheter associated urinary tract infections remain an outsized problem in healthcare systems worldwide Individuals who rely on urinary catheterization for management of chronic urinary retention disorders are particularly susceptible to CAUTI because of their chronic usage This SBIR Phase proposal details plans by which to complete the prototyping design refinement and preliminary engineering validation of a new fully internal male urinary catheter system The Connected CatheterTM is an advanced urinary catheter designed to reduce the incidence of urinary tract infections UTI as well as to increase urological convenience and autonomy for males with urinary retention disorders The Connected Catheter will be a chronically indwelling maximum of day service life urethral catheter that resides fully internally with its distal end in the base of the penile urethra The catheter tip will incorporate a magnetically actuated ball valve which enables the bladder to fill naturally and the user to control voiding by applying a magnet to the base of the penis The Connected Catheter aims to reduce the risk of catheter associated UTI CAUTI via several mechanisms including elimination of the trans urethral orifice span of standard Foley and the use of a unique Malecot retention mechanism that provides robust catheter fixation and complete bladder emptying while minimizing bladder lining abrasion and risk of genito urinary trauma caused by Foley catheters Relative to intermittent self catheterization the Connected Catheter aims to reduce the risk of both UTI and false passage urethral puncture as well as lower the associated cost of supplies all by minimizing the number of self catheterizations required The Connected Catheter will offer increased comfort and convenience to all of its users enabling natural bladder filling and easy voluntary voiding all with a fully internal device that can be easily inserted and extracted by the user with a novel set of sterile packaged single use insertion and extraction tools The target deliverable of Phase will be a complete bench tested commercial prototype of the Connected Catheter system suitable for subsequent validation and clinical testing in Phase This proposed Phase project is divided into four specific aims including the successful fabrication design optimization and engineering validation of the magnetically actuated valve the catheter anchoring mechanisms the catheter insertion and extraction tools and the fully assembled product Future development of the Connected Catheter system beyond the current project will include the development and incorporation of a wireless sensor capable of assessing bladder fullness for users with neurogenic bladder dysfunction who lack bladder sensation PROJECT NARRATIVE Urinary catheterization is the current standard of care for millions of American men with chronic urinary retention disorders including benign prostate hyperplasia and neurogenic bladder dysfunction However current urinary catheter designs are plagued by a host of drawbacks and medical complications including high urinary tract infection rates genito urinary trauma and diminished patient quality of life due to inconvenience and discomfort We are developing a solution that uses a fully internal valved catheter to reduce the number of times users have to catheterize themselves By developing this product we aim to reduce infections reduce the costs of supplies and care and improve patient satisfaction