Urocycler, BioFlo AutoValve, and other automatic catheter valves
  • wrmiddleton December 2013
    I've recently been doing some extensive research on automatic catheter valves, i.e. a valve that, when a certain bladder internal pressure is reached, automatically opens, voids the bladder until pressure drops to zero, then closes and repeats the cycle.

    A number of years back an engineer of medical devices here in the US developed and patented the UroCycler - which I am told worked phenomenally well. He received a number of awards for the device, had it patented under 20 separate patents in several countries - but never successfully marketed the device - possibly due again to low usage population and high cost of production. The last record of it being on the market I can find was around 2010. It was USD $110 each. I've seen the demo and training videos produced to sell the device, and it's impressive.

    Recently a Florida company - coincidentally in the precise city as the home base of the inventor of the UroCycler - released a very similar product called the BioFlo AutoValve. The company is BioDerm, a medical company specializing in medical dermatological products and operating room specialties. It is supposed to work on the same principle, and their demo video looks eerily like that of the Urocycler. I managed to obtain a sample of the device (don't know if it's pre-production or a beta test of the production version), and as the device listings had no pricing information it looked as though it's still going through approvals. Its principle is the same as the Urocycler - magnetic fields controlling a valve.

    I was unfortunately disappointed in the latter device. While in their videos it did indeed release full open with a water column (pressure) of a certain value over the control valve, then reset & reseal, it only did so when there was a full column of water over the device, with a closed mechanical valve between the device and the drain line. When the mechanical valve was opened fully, as when a drain bag valve is opened, the magnetic valve opened and functioned. However, when exposed to the steady, slow trickle that is the manner the kidneys present fluid to the bladder, it just leaked by slowly and never held a seal good enough for the bladder to commence filling. I don't know if this is a sealing issue with the magnet to Delrin or Nylon seat not being fully competent, or simply a pre-production design that's not fully resolved - there were clearly some obvious manufacturing issues with the sample I received.

    The principle is wonderful, and very elegant and simple - so simple, that's probably why it took a while for someone to put it to use in this application. Also the development of very high field strength, small magnets was needed in order for this principle to work. Basically, there is a fixed magnet, and a 'floating' magnet that controls the valve opening and acts as the actual valve. They are separated by a stem with fluid passages in it that keep them a specific distance apart. At this distance, the field between the magnets is sufficient to hold the 'floating' magnet against its seat (the bottom of the fixed magnet support stem) and form a seal. There is a hole inside the stem, open to the chamber with the fixed magnet - and the pressure coming in from the catheter. When the pressure exceeds the holding force of the magnetic field, the 'floating' magnet is pushed away from the seat, and urine flows out of the valve. In principle, the separation of the magnets causes the 'floating' magnet to move far enough away from the 'fixed' magnet, that the field attraction is reduced enough to allow full urine flow until there is little to no pressure in the upper chamber. At that point, with the magnets at a greater separation distance, the lower field strength can pull the 'floating' magnet back up to its seat, stop drainage, and the process resumes.

    The problem - this requires very precise distancing of the magnets, magnets of precise and very consistent field strengths, and a seating surface for the 'floating' magnet that is pliable enough to allow for good sealing and not break down with many cycles - as if the seal breaks down or compresses with age, and the magnets are allowed to become closer together, the pressure to separate them rises quickly as their intense field strength grows quickly at these close distances.

    If anyone knows anything further about these devices - especially if the Urocycler is still available anywhere, or is going to become available again at any time, I'd appreciate the information. The Urocycler was at one time represented by a company in Australia called Urosolutions Australasia Limited PTY. None of the original Urocycler companies that I can find are still in business.

    Thanks!!
  • Janet December 2013
    Thanks so much for taking the trouble to do the extensive research on automatic catheter valves. I will ask Roger to reply to your post.
    Janet
  • mrscrouch February 27
    It looks a bit like no one else has bothered to read all this. I think the mysterious and expensive world of patenting actually kills off a lot of good ideas, while ineffective bladder emptying is killing off an awful lot more catheter victims!

  • oscar March 6
    Hi all there is a German? company making something like that but not over in UK atmo as asked about them.
    Not sure if auto opening but i guess auto closes?
    http://www.pfmmedical.com/en/productcatalogue/pfm-medical/catheter_valves_and_plugs/staeubli_kv_200_eh/index.html

    Seem to have a few types there.
    the medical world is full of corporate bullies like many other trades patents can be bad but also very good as stops alot of dodgey copies but also props up corrupt companies so it's dog chasing it's tail type thing.
    winners and losers so have to see what side you land on!
  • Janet March 11
    I will ask Roger to comment on the'state of the art' of catheter valves to bring us up to date
  • Roger March 12
    Regrettably I am reluctant to give a decisive opinion about catheter valves. I am of the opinion that urine should be stored in the bladder, not in a bag on the leg. The filling and emptying of the bladder has a vital physiological role in maintaining the bladder's impermeable membrane which plays such an important role in the bladder's antibacterial defence mechanism. I have read about the urocycler but I cannot understand why there have not been more reports about clinical trials relating to its use. The flip-flo catheter valve (and there are good alternatives to this) should be used by catheter users who have the manual dexterity and cognitive ability to use it safely but catheter valves are not universally available worldwide. I do find this field particularly confusing without more reliable, factual information.

    I apologise for being so indecisive but I am actively seeking results from good clinical trials and would welcome more information.

    Roger

  • Roger - I agree completely with your comment about the purpose & function of the normal fill & drain cycle - my reason for bringing up these devices is that they show some real promise for effectively mimicking that normal cycle in those of us who are catheterized. The potential for these magnetic valves to actually hold urine flow in the same manner as the sphincter muscles do - then release when the bladder is full to allow drainage to occur - is quite promising indeed. Whether the outflow is drained to a toilet or stored in a bag once released is (personal opinion) a side issue - it's the possibility of recreating the normal fill/release cycle for those of us who have lost that ability naturally that's intriguing - and worth investigation.

    My other concern is that producers of these devices actually provide a product that works. Producers of medical products are not free of the problems of less than honorable entities that produce products that do not function usefully, but still get heavily advertised as being beneficial and still reach the market.
  • An additional note - on doing a website check today, it appears that BioFlo is now a company of their own, not affiliated with BioDerm. The website is new, and the product numbers have changed, as has the appearance of the device and the instructional videos. Maybe they've corrected the issues the original device had as well?? Their current advertising indicates that the valve will hold urine pressures to 20cm H20, then release to void. The sample I had would not resist a small trickle, much less hold back to 20cm water column -
  • mrscrouch March 20
    Mr C always uses a flip-flo, but on occasion has forgotten how long it's been off (or on). Then I gave him a kitchen timer and after each 'empty' he sets it for 4 hours. Now we can both see at a glance how he's doing.
  • wrmiddleton,

    I am a quad in the central florida area that currently uses the Urocycler and have been for many years and I know that the Urocycler is still around. They are trying to get the Urocycler back available for sale but im not sure when.

    I am happy to answer any questions about my experience with using the Urocycler for over 4 years.
  • Hi Rick - thanks for your reply - I'm curious where you still obtain the Urocycler, or are you working out of an inventory you stockpiled before their general availability went away? If there is still someone that's selling these, I'd sure like to get hold of a few -
  • wrmiddleton,

    I am using those I have stockpiled.

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