A Novel New Approach to Treatment of Catastrophic Urinary Dysfunction John B. Devine II, M.D., FACOG 1,2, Stanley E. Rittgers, PhD (Ret.) 1,3, Michael D. Serene, M.D. (Ret.) 1,4 1 3D Urologic, LLC, Akron, OH, 2 Gulf Coast Medical Group, Venice, FL, 3 The University of Akron, Akron, OH, 4 Akron General Medical Center, Akron, OH Background: Many patients face daily problems with urinary retention and incontinence. We will describe a new device to assist those patients with severe urinary dysfunction non responsive to all other current therapy. This would include military personnel or service members with who have experienced traumatic pelvic or spinal cord injury requiring urogenital reconstruction or bypass to protect the upper urinary tract and maintain kidney function. This device will assist in improving quality of life and activities of daily living for these unfortunate patients. In doing so, also provide a significant reduction in long-term costs associated with caring for these patients on a daily basis and in long term care facilities. Over the past 10 years significant investment has been made in stem-cell exploration and tissue engineering for urogenital reconstruction with limited success, this option will address the needs of this population of patients currently underserved. Method: We will describe our approach in the creation of a novel lower urinary tract augmentation implant (Figs 1-4) with a new mechanical valve system replacing the urethral outlet and functioning as an artificial urinary sphincter. This device will be surgically implanted preserving the bladder and ureters functioning as a normal collecting system and operable by patient and\or caregiver without touching genitalia. A biologically compatible silicone material will be used to create a collection base and drainage tube to function as the lower portion of the urinary tract eliminating the need for chronic indwelling catheterization with its inherent risk of chronic infection. Results: To date we have successfully completed over 26,000 compression open and close cycling of our artificial urethral sphincter (Fig 3), which is equivalent to over 18 years of in-vivo use. At this point, no compromise of the silicone rubber material mechanically or visually has been noted.
Conclusion: Current therapeutic options available for patients with catastrophic urinary dysfunction have been major surgical procedures resulting in creation of neo-bladders with portions of the intestinal pouch or chronic indwelling catheters. None of the options to date have provided the return to quality of life and improvement of activity of daily living these patients deserve. With so many of our military personnel returning with catastrophic pelvic injuries and spinal cord damage this novel option provides an answer to the question of how do we treat these brave individuals? Our next step will be additional in-vitro bench testing of our materials and device and then pre-clinical trials to gather the safety and efficacy data required to bring this device to market to add another tool to the armamentarium we physicians have to assist patients with severe lower urinary tract dysfunction. In the future, a hybrid device configuration of our lower urinary tract augmentation biomaterial implant could be the exploration of an alloplastic bladder substitution (Fig 5) using the same novel mechanical valve system for bladder carcinoma patients in lieu of cystectomy and urinary diversion surgery. Targeted Patient Populations: Warfighters and Veterans of Past and Present 1. Anatomic Bladder Dysfunction: Urogenital Trauma, Carcinoma (bladder, prostate, and urethral) Military Causes: Dismounted Complex Blast Injury, depleted uranium, agent orange... 2. Neurogenic Bladder Dysfunction: Spinal Cord Injury, Multiple Sclerosis, Parkinson's Disease, Spina Bifida Military Causes: explosions, vehicle accidents, depleted uranium, agent orange... Source: www.publichealth.va.gov/diseases-conditions.asp 3. Neurologic Deficiencies: Traumatic Brain Injury, Alzheimer's and other dementias Source: www.alz.org/care/alzheimers-dementia-incontinence.asp
Technology - Advantages Designed by pelvic reconstructive surgeon, PhD Biomedical Engr professor (biofluids specialty), C6-C7 spinal cord injury patient Restores bladder function and rehabilitates patient 100% dryness eliminates incontinence Urine self contained mimics natural bladder Void on-demand and via urethra Gender and Causation Neutral - for both male\female patients and cause of dysfunction doesn't matter Device comprised of 2 nonmetallic biomaterials: silicon rubber and PEKK Biomaterials approved by FDA for other permanent long term implant applications; FDA Master Files exist 100% mechanical; NO electronics nor magnetics to interfere with life saving pacemaker or defibrillator devices One surgery - surgeon can customize form and fit to presented case 3 Devices in 1 Technology: Artificial Urinary Sphincter, Lower Urinary Tract Augmentation, and Alloplast Bladder Substitute Fig 1-3D Printed Model
Fig 2 - Exploded View
Fig 3 - Cut Away View - Valve in Open & Closed Positions
Fig 4 - Lower Urinary Tract Augmentation Fig 5 - Alloplast Bladder
Objective #1
Describe a novel new device that can be surgically implanted into the patients with catastrophic urinary dysfunction; restoring quality of life and improving activities of daily living Objective #2 Identify a patient population currently under served with therapeutic options for their urinary dysfunction Objective #3 Evaluate the function of a biologically compatible silicone material to incorporate into native urogenital tissue, to form a functional urinary collection and emptying system