Urinary Catheter Valve with Pressure Release Mechanism BMED

. Urinary Catheter Valve with Pressure Release Mechanism BMED 4601, Team 16 : Jonathan Horowitz, Sharon Horowitz, Kelly Straub, Jason Xenakis Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, Georgia Sponsor: Muta M. Issa, MD, FACS, MBA Atlanta VA Medical Center, Atlanta, Georgia Project Brief Loss of bladder control usually requires continuous drainage of urine through an indwelling Foley catheter with attached drainage bag 1, 2. However, following problems are associated with such methods: • Patient complaints 3 : • Inconvenience and discomfort • Embarrassment and social anxiety • Patient health hazards 4 : • Increased risk of urinary tract infection • Bladder muscle atrophy i A ii B A. External side view of valve. The short length of rigid polypropylene tubing (i) has, at its proximal end, a hollow, ridged adaptor that interfaces with the distal end of the Foley catheter tubing. (ii) B. Internal side view of valve: open and closed. The distal end of this tubing has a “male” thread pattern. Another short length of rigid tubing with a “female” thread pattern is attached to the “male” end. (iii) C. Cross-sectional view of valve channel: open and closed. When the distal section of tubing is rotated, the latex liner twists and contracts (similar to the human iris), occluding the passageway. (iv) iii The design solution: • Eliminates need for continuous drainage • Incorporates manual valve to allow for bladder evacuation when desired • Introduces emergency pressure release mechanism • Introduces a smaller capacity leakage bag Engineering Design Specifications Customer Requirements Engineering Characteristics • Comfort, ease of concealment • Ease of use • Allow patient to evacuate bladder when desired • Allow release of urine at sustained heightened bladder pressure • Prevent bladder atrophy • Prevent bladder and urinary tract infection • Valve length: 3 inches • Valve diameter: 0. 5 inches • Valve weight: 5 grams • Potential urine collection volume: 400 -600 cc • Potential emergency release volume: 50 -250 cc • Inexpensive, disposable material • Compatibility with Foley catheter • Sterile Packaging Performance Testing Design Solution C iv Construction (cont’d) • Cryovial • ½ inch plastic pipe fittings • ¼ inch Latex tubing • Piping smoothed and fitted securely into hollowed end of cryovial • Fitted piping glued into place within cryovial • Latex tubing run through both ends and secured with a strong adhesive • Completed valve secured onto distal end of standard Foley catheter for testing Construction • Cryovial end removed • Cryovial cap hollowed to fit and connect pipe • Removal of excess piping to leave only fitted end 40 cm 80 cm 100 cm 120 cm 140 cm 160 cm Volume Released 18 m. L 35 m. L 50 m. L • Compatible with widely accepted standard Foley indwelling catheter. • By eliminating externally visible bag, overall patient comfort is increased. • Eliminates potential backflow of urine into catheter from bag, decreasing risk of urinary tract infection. • Normal cyclical distention and relaxation of bladder prevents muscle atrophy. • Manual valve allows for convenient, voluntary evacuation of bladder. • Emergency pressure relief mechanism of valve prevents urinary reflux into ureters. • Performance testing proves intended functionality. Recommendations ii Selected References iii 1 Hutton, D Volumetric Flow Rate 3 m. L/min 10 m. L/min 21 m. L/min • Modify internal latex liner so that more twisting is required to seal shut. This will allow the patient to better customize the valve pressure sensitivity. • Report on commercial marketability • Completion of patent application process • Potential additional attachments: • Valve cap • 400 -600 cc disposable collection bag iv i Pressure Sensivity Sealed Releases Fluid Discussion Design Prototype Development Materials To imitate sustained bladder pressure, the valve was attached to a vertical water column. The water column was filled to simulate both normal physiological pressures (40 -80 cm ) and critically high pressures (100160 cm). This method allowed for the determination of the following performance testing criteria: • Pressure Sensitivity – Does the valve release fluid at the applied pressure? • Volumetric Flow Rate – At the start of fluid release, what is the flow rate? • Volume Released – What is the total volume released until valve reseals? E D. Completed Prototype, External View. E. Completed Prototype attached to standard Foley catheter and 600 cc urine collection bag. J. “The role of catheter valves in urinary incontinence”. Geriatric Medicine. 2004 Aug; 34 (8): 16 -8. 2 Jahn P, Preuss M; et al. “Types of indwelling urinary catheters for long-term bladder drainage in adults”. Cochrane Database of Systematic Reviews (COCHRANE DATABASE SYST REV), 2007(4). 3 Fraczyk L. , Godfrey H. ; Feneley R. “A pilot study of users’ experiences of urinary catheter drainage bags”. British Journal of Community Nursing. 2003 Mar; 8(3): 104, 106 -7, 110 -1. 4 Keerasuntonpong A. , et al. “Incidence of urinary tract infections in patients with short-term indwelling urethral catheters: a comparison between a 3 -day urinary drainage bag change and no change regimens”. American Journal of Infection Control”. 2003 Feb; 31(1): 9 -12. 5 Flinchbaugh, David E. “Urinary Drainage Valve with Sampling Port. ” US Patent D 478662. 19 Aug. 2003. 6 Beaufore, Spencer W. , and Glenn D. 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