Urinary Catheter Valve with Pressure Release Mechanism

1. . 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 Performance Testing Design Solution • Loss of bladder control usually requires continuous drainage of urine through an indwelling Foley catheter with attached drainage bag1,2. 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 • 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 • 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 (40-80cm ) and critically high pressures (100-160cm). 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? i A ii • 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) • 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) • 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) B iii Discussion Engineering Design Specifications • 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. C • Engineering Characteristics • 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 • Customer Requirements • 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 iv Recommendations Design Prototype • 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 Prototype Development • Construction (cont’d) • 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 • Materials • Cryovial • ½ inch plastic pipe fittings • ¼ inch Latex tubing iv Selected References ii iii • Construction • Cryovial end removed • Cryovial cap hollowed to fit and connect pipe • Removal of excess piping to leave only fitted end i • 1 Hutton, 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. • 4Keerasuntonpong 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. • 5Flinchbaugh, David E. “Urinary Drainage Valve with Sampling Port.” US Patent D478662. 19 Aug. 2003. • 6Beaufore, Spencer W., and Glenn D. Brunner. “Urinary Flow Control Valve.” US Patent 7037303. 2 May 2006. • 7 Blake, William S., and William J. Dwyer. “Universal Valve for Foley Type Catheter.” US Patent D546946. 17 Jul. 2007. • 8 Kubalak, Thomas P. “Urine Collection Bags for Urinary Catheter System.” US Patent 7001370. 21 Feb. 2006. • 9 Blake, Thomas E., et al. “Vehicle Pressure Relief Valve Having Peripherally Secured Flaps and Method of Manufacturing the Same.” US Patent 7302962. 4 Dec. 2007. D E D. Completed Prototype, External View. E. Completed Prototype attached to standard Foley catheter and 600cc urine collection bag.