PFI-RP: Temporary implantable device to perform minimally invasive urethral reconstruction; meeting engineering challenges for transition to small-volume production manufacturing.

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The broader impact/commercial potential of this Partnerships for Innovation – Research Partnerships (PFI-RP) project will address the urological health of American men suffering from urethral stricture disease. This condition causes blockage of urine flow and can lead to infection, pain, and damage to the bladder and kidneys. Existing treatments are not optimal. Current endoscopic management (stricture incision or dilation) is relatively simple to perform but has a high recurrence rate. Open surgery is effective but often requires tissue grafting and is technically challenging, time consuming and not readily accessible. Combining the best of these treatment strategies requires a bioengineering solution leveraging understanding of urethral physiology, material science, wound healing and mechanical miniaturization. Developing a platform to accomplish endoscopic minimally invasive urethral graft reconstruction will simplify an otherwise complex procedure for both patients and surgeons, improving access and availability of this novel technology across a wider regional and socioeconomic spectrum. This tool will decrease cost of care while minimizing recovery for the roughly 300,000 American men treated annually for this complex and debilitating condition. The proposed project addresses the need for a minimally invasive tissue grafting system for treating urethral stricture disease in three phases: 1) Develop a device to secure a tissue graft to the interior of the urethra at the site of stricture and ensure delivery and fixation specifications across an array of engineered testing platforms; 2) Conduct safety-focused preclinical validation, including biocompatibility testing and outcome evaluation in a stricture-induced large animal model with a temporary implant left in place without migration until engraftment is complete, leaving the urethral caliber restored; and 3) Develop a small volume production process, followed by fabrication and testing of the resulting implants. The output of this PFI-RP project will be a prototype system.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.