UroCycler: UroCycler, Automatic Bladder Management System

by David Flinchbaugh

The UroCycler is a life changing device that significantly improves quality of life for people that have to use indwelling urinary catheters,preventing urinary tract infections and bladder spasms.
West Islip, NY United States Medical Device Managed Care Prevention

All Team Company Patients Physicians Hospital Innovation Details Supporters Comments Updates

About our project

The problem we solve: The UroCycler is improving the quality of life for indwelling urinary catheter users and their caregivers. Indwelling urinary catheter users live in fear of getting urinary tract infections, incur the pain of bladder spasms and they and those around them have to deal with the noxious odor of their drainage bags.

About our solution: The UroCycler Automatic Bladder Management System effectively serves as a “brain” for an indwelling urinary catheter and drainage system. The UroCycler enables the bladder to retain urine, allowing for the washing out of the bladder. This occurs when the urine in the bladder reaches a certain level. The UroCycler has an anti-reflux valve which blocks urine in the drainage bag from going back into the bladder.

Progress to date:

The UroCycler is a proven product, and over 30,000 units were previously sold years ago. The UroCycler received 10 industry awards for its innovation, received three (3) 510Ks from the FDA. We have several thousand expired UroCyclers in stock which we are using for trials. A study by Bayfront Medical Center found that the use of the UroCycler had reducing the occurrence of urinary tract infections by 91% in their facility, and significantly accelerated the rehabilitation of bladders. Over 40 healthcare companies were happy with the performance of the UroCycler, many of which provided testimonials as to the related benefits associated with UroCycler use. UroCycler Inc. has produced a sample run of parts using our existing molds and is contracting with USA companies to manufacture and assemble the parts and to perform validations and tests required by the FDA.  The UroCycler will be manufactured and assembled as previously done and will be undergoing validation and tests it previously passed.

About Our Team

Creator: David Flinchbaugh

Location: Florida

Education: Union College (B.S. Physics and Math) Univer

Bio: Dr. David E. Flinchbaugh, has been involved with science and engineering throughout his career. He has a wealth of experience gained from his past positions starting with the I.B.M. Engineering Labs and Central Hudson Gas & Electric in New York. He earned degrees from Union College (B.S. in both Physics and Math) and the University of Connecticut (M.S., Ph.D.), plus teaching credits from Case Institute of Technology, and diplomas from Harvard University, Univ. of Colorado, and Florida Technological University. His multi-disciplined approach as an Atomic Physicist, strong background in optics, lasers, and sensors, as a Health Physicist, and as a registered Professional Electrical Engineer (FL & PA) has led him to create 262 inventions to date. The most significant of these are the 1960 Cesium-Ion LASER, for United Technologies Research Labs, the 1980 Remotely Operated Service Arm (ROSA), for Westinghouse and licensed to Mitsubishi, Siemens, and Toshiba, and the one he is most passionate about, his “UroCycler” Automatic Bladder Management System. An internationally known physician has called this invention “the most significant new product breakthrough for urology in seventy years”. The I.E.E.E. Orlando Section honored this 50-year member as 2010 “Entrepreneur of the Year”. In 1998 the Environmental Excellence Award. He is a Senior Member of the Florida Engineering Society, whose “Engineer of the Year Award” he received in 1984 at their National Engineer’s Week Banquet. In the years since 1985 he has been elected to the rank of “Fellow” of the I.E.E.E., of the Society of Manufacturing Engineers/ Robotics and Automation, of the Optical Society of America, and of the American Society for Laser Medicine & Surgery. He hosts the Inventor’s Council of Central Florida & instructs for the Red Cross, the Boy Scouts, Hugh O’Brien Youth League. David is married to his wife of 62 years, Heidi, and they have 4 children.

Title: CTO

Advanced Degree(s): PHD

About Team Members

Elliot Halpern
CEO, 70+ college credits
Biography: Elliot L. Halpern – Profile Elliot Halpern is an entrepreneur, and a proven business professional, with more than 40+ years' experience in business management and operations. He has been involved with a wide range of business disciplines; telecommunications technology, licensing, interactive entertainment production, marketing, and sales. Mr. Halpern founded and ran TeleGistics Inc., a telecommunications consulting company that helped companies to design, develop, implement, and manage cutting-edge technologies. Mr. Halpern successfully pioneered, designed, developed and implemented some of the USA’s most advanced deployments of telecom technology, all of which were done on time, and whose solutions stood the test-of-time. Some of his former clients included MCI, Becton Dickinson, Drew University, Dialogic Corporation and Systemax. Mr. Halpern formed TeleServe Communications Inc., an independent MCI Sales Agency (1993-2001) and grew long distance sales revenue to more than four million dollars ($4,000,000) per year. Mr. Halpern is the founder and CEO of Life Changing Healthcare LLC; whose focus is on improving quality of life and reducing the cost of healthcare. His current focus is on recommencing the manufacturing of the UroCycler and the development of Life Changing Healthcare’s ‘Healthy American for a Healthy America™ (HAHA)' initiative. Mr. Halpern spoke at various Industry Symposiums (ACUTA and Interface) and served for two years as a faculty member of Columbia University’s School for Continuing Education, where he developed the curriculum and taught telecommunications technology and telecommunications management. Mr. Halpern is married for 47 years to his wife Denice and they have three children.
Title: CEO
Advanced Degree(s): 70+ college credits
LinkedIn: www.linkedin.com/in/elliot-halpern-98810b9

Dr. Robert Greene
Medical Director, Pre-Med at Union College in Schenectady, NY and MD Degree at Tufts University School of Medicine in Boston, MA.
Biography: Dr. Greene is a Board-Certified Internal Medicine specialist. He is originally from New York City and graduated from the prestigious Bronx High School of Science with Honors. He was Pre-Med at Union College in Schenectady, NY and then earned his MD Degree at Tufts University School of Medicine in Boston, MA. He trained at Montefiore Hospital, the teaching hospital of the Albert Einstein College of Medicine and then did additional training at Case Western Reserve University Hospitals in Cleveland, OH, where he was also a Teaching Fellow in the Department of Medicine. He founded and managed a large private Internal Medicine practice for over twenty years in Northern Westchester County, New York. He worked with the Cenegenics Medical Institute, a program for reducing risk factors and optimizing health that now has 21 offices in the US and internationally.
Title: Medical Director
Advanced Degree(s): Pre-Med at Union College in Schenectady, NY and MD Degree at Tufts University School of Medicine in Boston, MA.

Heidi Flinchbaugh
VP of Operations, Major Field Biology - B.A., Vassar College, Poughkeepsie, NY, M.S. Cornell University, Ithaca, New York
Biography: Heidi Flinchbaugh worked for various companies (Silver Cross Hospital, Western Reserve University Medical Center) in the capacity of a Laboratory technologist where she ran tests, obtained samples from patients, maintained laboratory records and wrote medical reports. She used aseptic techniques, prepared culture media, maintained patient records. She also prepared teaching materials and helped students perform tests. Kept accurate laboratory records and helped with report writing. Mrs, Flinchbaugh was Engineering Assistant to the Director of the Ion Propulsion Department at United Technologies Research Laboratories. She operated test equipment, took data, plotted results and operated computer programs for data analysis and preparation of reports. Earned great respect as a talented proof-reader, created experimental component drawings, interfaced with all depart-ments necessary to get equipment built and operating. She also researched and documented engineering schematics, design diagrams, and test specifications with engineering personnel. She was the Office Manager for UroSolutions, Inc., the company that initially manufactured and sold the UroCycler Automatic Bladder Management System, where she was responsible for a wide range of tasks. Heidi Flinchbaugh is married to Dr. David Flinchbaugh, UroCycler Inc.'s CTO, for 62 years and they have three children.
Title: VP of Operations
Advanced Degree(s): Major Field Biology - B.A., Vassar College, Poughkeepsie, NY, M.S. Cornell University, Ithaca, New York

About Our Company

UroCycler Inc.

Location: 244 Higbie Ln
West Islip, NY 11795

Founded: 2019

Website: https://urocycler.com/

Product Stage: Prototype/MVP

YTD Sales: Working on it

Employees: 3-5

How We Help Patients

People who have to use an indwelling urinary catheter would benefit greatly by their use of the UroCycler® Automatic Bladder Management System:

1. Prevents against the occurrence of urinary tract infection.

2. Reduces or eliminates bladder spasms.

3. Rehabilitates the bladder.

4. Reduces the odor of the drainage bag.

5. Has a built in test port to draw urine.

How We Help Physicians

The UroCycler improves the mental and physical wellness of their patients, especially with regard to their becoming far less likely to incur a urinary tract infection or bladder spasms. The UroCycler provides a test port for the drawing of urine samples.

The Bayfront Medical Center Clinical trial reported that the UroCycler trial's results were impressive. It stated that the UroCycler has saved staff and patient's time due to the reduced need for bladder retraining programs, lowered the cost in continence services and products (by about $69.00 per day per incontinent patient)). The UroCycler also helped Bayfront's patients mental state (dignity).

How We Help Hospitals

Hospitals must cover the cost to treat urinary tract infections that occur in the hospital at their own expense. The UroCycler reduces the occurrence of urinary tract infections and lower the cost to care for patients with indwelling urinary catheters.The previous statement is supported by The Bayfront Medical Center Clinical trial which reported that the UroCycler has saved staff and patient's time due to the reduced need for bladder retraining programs, lowered the cost in continence services and products (by about $69.00 per day per incontinent patient)).

 

Innovation Details

Intellectual Property Summary

The following issued patents are associated with the UroCycler® Automatic Bladder Management System.

5,114,412 Magnetic Bladder Cycler
5,587,244 Low Pressure Medical Silicone Gasket
6,673,051 Magnetic Valve Bladder Cycler Drainage & Use Method with Urinary Catheters (link attached)
D478662 Urinary Drainage Valve with Sampling Port
D460522 Low Pressure Fluid Flow Control Valve
4,865,588 Magnetic Bladder Cycler and Use Method

The company is preparing additional patents related to the UroCycler. 

 

Patent Link
https://patents.google.com/patent/US6673051B2/en

Clinical Information

 

The following excerpts were taken directly from the clinical trial on the UroCycler by Bayfront Medical Center in St. Petersburg Florida. Please note: The IVQSS and Magnetic Prosthetic Sphincter System referred to below is one and the same as the UroCycler Automatic Bladder Management System

Here is information on the study:

1. Letter summarizing their findings:

"The retrospective Bayfront Medical Center (BMC) study is now complete- Results were sent to the Institution Research Board (IRB). Changes in the study proposal were approved and there appear to be no challenges or questions regarding the study data.

The IVQSS 1000 results are impressive. The Magnetic Prosthetic Sphincter System has saved staff and patient's time due to the reduced need for bladder retraining programs, lowered the cost in continence services and products (by about $69.00 per day per incontinent patient)). Overall has given our patients their dignity back. We experienced an 87% success rate in retraining the bladder within 72 hours with patients experiencing urinary retention. Further, as an infection control advocate, I have found no associated Urinary Tract Infections with the use of this product.

I have enjoyed collaborating on this study and wish you and everyone at BMS great success with this effective product. You may use any part of my communication with you as testimonial in marketing materials.

Alan Arnold RN, MS, CRRN

Rehabilitation Nursing Manager

Bayfront Medical Center

2. Clinical Trial Information

Bayfront Medical Center did a clinical study of 82 patients over a 13 month period:

Patient make-up:

Long term catherized Groups (18) - Conditions - Stroke, Alzheimer, Dementia, Immobile all had been catherized and on drainage from 4 weeks to 3 years. All had previously had CAUTIs. After trialing the UroCycler for 4 to 5 days their urine in general ran clear, PH values approached normal and culture studies improved. Of major note, odor was near normal.

Intensive care (12) : Polytrauma patients where urine monitoring was required, and the UroCycler was used in excess of 12 days and none recorded CAUTI. 

Major Surgical cases. (52) - mixed group of patients with Catheter and UroCycler all beyond 3 days, 1 for a week, none developed CAUTI.

Please note the following is in verbatim stating the key results from this study (page 12 of 63)

"91% of patients using the UroCycler did not get a urinary tract infection.

87% of patients with urinary retention experienced successful retraining of the bladder using the UroCycler.

The System works and will prove to be an invaluable device for the industry. There are many unmet needs with catheters and the UroCycler meets them"  

 

Regulatory Status

The UroCycler had received three (3) 510Ks from the FDA, which are not needed at this time.

UroCycler Inc. will re-register the UroCycler with the FDA and pay the requisite registration fee after it has completed FDA mandate validation and testing, which the UroCycler had previously passed.

 

How we will use the funds raised

The proceeds will be used to fund setting up the manufacturing of the UroCycler® and undertaking the mandated validation and testing required by the FDA. In addition, funds will be used to pay the requisite FDA registration fee of $4,800 to be paid after the requisite FDA validation and tests have been concluded. The breakdown of the use of these proceeds are as follows. 

FDA mandated validation and tests - $30,000 

Manufacturing of injection molded parts to make 4,000 units ($16,000 in non-recurring cost) - $34,000

Assembly and packaging of initial 1,440 units - $20,000

Medstartr Crowdfunding Related Costs - $20,000

Working Capital - $16,000 ( FDA fee, contingency and overhead).

Please note: UroCycler will be receiving advanced deposits from its master distributor which will cover the cost to assemble the remaining 2,560 UroCycler units, as well as cover the cost to make the parts for 25,000 more units. The cost to manufacture parts for an additional 25,000 units will be approximately $1.50 per unit substantially lower than the initial unit production cost of approximately $4.50 a unit.

 

 

Thank You

Please support our efforts to improve the quality of life for people around the world whose lives have been greatly diminished by their being sentenced to living their lives with an indwelling urinary catheter. 

Imagine if you, like 500,000 Americans, had to use an indwelling urinary catheter every day for the rest of your life and had to deal with:

1. The fear of contracting a urinary tract infection, one that could be life threatening and/or lead to death. One of the testimonials on the UroCycler was from a man, researcher for the National Institute of Health, who had numerous urinary tract infections and was not able to use a ioley catheter because of his allergies and resistance to antibiotics. As per his testimonial "Since I began employing the UroCycler, I am once more able to use Foley catheters, spend more time in my laboratory and have experienced neither UTI's or bladder spasms." Note: According to the Center for Disease Control and Prevention "Among UTIs acquired in the hospital, approximately 75% are associated with a urinary catheter. 

2. The shame of carrying a bag filled with urine that had a terrible odor.

3. The pain of bladder spasms.

4. The toll your care is taking on your caregivers.

5. The withdrawal from life that occurs when someone is ashamed or embarrassed about their condition. 

The UroCycler has made it far easier for indwelling urinary catheter users and their caregivers. It has significantly improved their physical and mental state, as proven by the numerous testimonials that have been given on the UroCycler.  

It is an absolute shame that this unquestionable 'life changing' medical device has been off the market for all too many years. UroCycler Inc. is committed to making the UroCycler® Automatic Bladder Management System available to all of the people worldwide who would benefit greatly by its use.  

Your contribution will enable indwelling urinary catheter users to live longer, healthier and more productive lives. 

Supporters

Comments

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David Flinchbaugh
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