New Bionic Sphincter/valve Designed to Eliminate the Need to Wear Collection Bags (Going Thru FDA Approval Process)

I have a medical device company that is working on a simple bionic sphincter/valve implant (which will be placed around the vessel or canal that has been formed to carry either a patient's urine or fecal material to the stoma) that is designed to control the flow of that fluid or material prior to it spilling out of the stoma, with the expectations of eliminating the need of wearing an outer collection bag, as the user will control the opening and closing of the valve using a car-key-like activator, and will simply open the valve during any bathroom break he or she schedules, and using a reusable funnel, empty the waste directly into a toilet.

Accordingly, I am looking to get as much feedback and support as I can directly from the ostomy/stoma community to help us proceed through our USFDA (and other countries') regulatory approvals so we can get our product to those that need it.

Your feedback and comments will be greatly appreciated.

I feel like this would be a breakthrough in ostomy technology. If it were to work the way you say it would, I feel like people would gladly undergo the process to install one of these bionic sphincter contraptions.

Hi, isn't that what a bird is, but not mechanical?

This would be a great thing! I would definitely want to go for it. I hope this happens real soon.

Interesting, would like more information. Is it anything like Colosafe? Although I don't think their product is bionic. Ever hear of it? This is a link that I learned of it on YouTube: http://www.youtube.com?feature=share&index=9

Getting Support in the Ostomy Community with LeeAnne Hayden | Hollister

Dear All: Much thanks for your initial input, and I will get to answering your questions within the next couple of days, but our small valve/sphincter device is quite different from any of the products you inquired about, as you will see from my follow-up description (and comparison to the BCIR and the ColoSafe).

Sounds like a good idea! Let's hope it works in practice.

Thanks SpeterH this all sounds interesting.

SpeterH, do you know why when I click onto your name it doesn't show a profile?

Geez. I thought I had already done that, but it seems there is still nothing posted. I'll get to it soon, and great thanks for the input.

Sign me up lol its better than the idea I told my surgeon I was going to shoot a deer cut the arse outta it and get him to sew it on. He told me I'd drop little turds all over and I'd get tracked easier.

I suspect anything is better than what the industry is currently offering patients, but freeing a stoma patient from wearing bags is our mission.

Dear all: Again, if you are reading this blog, I hope to get as much feedback from you (and questions) as possible.

Sign me up as one of the first human guinea pigs! This sounds like a dream come true. Though I doubt it will materialize in my lifetime - I am sure it will be the option picked over this surgery. That is, if the insurance companies would approve it and not wait another 20 years to decide if it's medically necessary. They need to put a mentally necessary clause in their policies.
Mrs. A: SpeterH still does not have a profile, which is weird. But weirder still is that he is not the one who initiated this post? However, the news is great, his terminology and knowledge seem too detailed for this to be some sort of scam operation. (Unless he starts asking us for money.)

Firstly, apologies to all who have been looking for my profile, but I just looked for it myself and found that my relatively brief profile is on the site, but it may be under an alternative email address: peters@pmdemail.com. Notwithstanding, and in response to Zywie, your feedback is quite important to me and my company, as we still have to go through the final human trials to garner the approval of the USFDA and other regulatory agencies around the world, and there is nothing better than to have the strong support from those that actually need the device. We will never be asking for money from the ostomy community, but continue to solicit your strong support as there are many established companies in the market right now that make billions on selling you all collection bags and all the other supplies associated with the current status quo that would not like to see our device enter the market. And as to how soon this can get to market may, in fact, have everything to do with your collective support (and it could be relatively soon if we can garner the regulatory approvals in Europe first). Please keep your cards and letters coming.

Thanks for the reply, PMD. The money part was a sort of joke. You'd be surprised what some people have tried on these sites (or maybe you wouldn't be surprised). Anyway, as I said, I'm all for it. I hate this bag and the daily maintenance on it. I could go on and on about all the things I hate about this. I hope it comes to fruition soon. But I know you are going to have a fight on your hands. It's the main reason the U.S. does not have a viable health plan in place for its citizens.

My company and I have been working on this advanced treatment for urinary and fecal incontinence for 15 years now, but I was flabbergasted to learn of this unique portion of sufferers in the ostomy community little more than 4 months ago when I was watching Tosh.O and an ostomy patient was profiled. The research I have done since then completely opened my eyes to the problem, with it being quite apparent that our device could be a huge quality-of-life improvement for virtually everyone who has had one of the stoma procedures done. I am dedicating our company to ensuring that this product becomes available to all those who need and want it, ASAP. Thanks again, Zywie, and please, if you are so inclined, encourage others in the community you may be in touch with, to also show some support for our efforts. Regards, Peter

Thanks again, Peter. While 99% of OstoMates are happy to be alive because of the surgery they had, I am 99% sure that if they had a choice, they'd rather be as close to normal functioning as they were before it. Unless this appliance or implant causes a lot of problems or is a difficult surgery, or, as I said before, the insurance/pharmacy companies block its release to the public, I wouldn't understand why anyone would choose not to have one.

Dear Zywie, I'm obviously fortunate that I do not currently require such surgery, but one never knows when such things can change. Nevertheless, I tried to put myself in the thought process as if I did require such, and came up with the exact conclusion you just eloquently stated: that I would be greatly relieved at first to be alive, but then must face the challenges of my new condition. It would seem a great improvement to be able to not have to deal with the bags. And to be a bit more specific, our modest implanted valve (that will act like a bionic sphincter), which will be fully controllable by the patient who will open and close it using a car-key-like activator, couldn't be easier to implant and use as some of our experimental implant procedures took less than 20 minutes, with 10 of those minutes being spent on the suture closing of the abdomen of the experimental subjects.

With my luck, my neighbour opens his garage door and I s... my pants. I think I'll wait until they use a 3D printer to produce a new colon for me. Then again at $3-$13 a bag change... and who knows it might be covered by insurance/government.

All kidding aside, when such technology becomes truly available, and PMD hasn't come up with something even better, we will be happy to stand aside and applaud such. However, the task at hand, even given a viable colon has finally been reproduced, goes well beyond this first step as now the scientists will have to also rebuild all of the necessary connective tissue (possibly dozens, if not hundreds of arteries, veins, nerves, and muscles), while the surgeon will then have to do the procedure to correctly reattach all of those tissue components to the appropriate predecessor tissue in one's body, obviously not an easy or inexpensive fix. And of course, the question then becomes; when will all of that be available to the public? For now, the idea of being able to get a simple sphincter/valve bionic device that will be totally controllable by the user, possibly within a year or two (given all continues to go well in our development program and we are able to obtain sufficient support from the ostomy community and others to help persuade the various regulatory agencies into doing an expeditious, but thorough, job on such a product's regulatory application), should certainly be a cause worth supporting. If there are any within the ostomy community that would be amenable to waiting one extra day (let alone an extra 5-6 years, if that) for such technology to become available rather than to take proactive action much sooner to vastly improve their quality of life, then so be it. We just want to be there ASAP for those that don't want to wait.

Yes, that will probably be in 20/30 years. I just like to poke fun at things. At the same time, if you check my blog, there is a reference to saving a baby's life. In addition, they now grow artificial cartilage for knees at a university in Washington. Soon (within 5/10 years) we'll have artificial red and white blood cells. For me, having a stoma is a nuisance, nothing more, but I commend your efforts; certainly, someone who is at the beginning of life would be well served by your solution.

No question that the technology you are referring to will be quite excellent future fixes for a broad range of medical problems that plague our populace at present, but I (and my company) will be quite proud to provide some substantive solutions to these current problems, and my thanks to you for taking the time to comment on the blog.

Hi, Peter, me again. Since I read this blog, it's all I think about. I'm 58, well past my years of reaching my goals and finding true love. Goals change a lot over the years and then tend to not be so important. True love, well, I thought I had that a few times. Married a man close to it, if not it - but he's gone now. However, I hate this whole set-up. What you are trying to provide would make whatever life I have so much better. I can only imagine the things it would do for a 19, 30, or even 40-year-old. Sorry, I can't declare I am happy my life was saved by this surgery. My family does, I do not. I don't feel it left me with much of a life. I have had to make do, get over, deal with, etc., etc., etc., so many things in life. Probably not much different than most people. Sorry, I'm not going to pretend I'm okay with this. The doctors did not and cannot prepare you for what life is going to be like after this surgery. If this happened to me in my 20s - I probably wouldn't be here. So much for saving my life. I have been trying to imagine what this is going to be like. Would we still have the alien peeking its way out of our stomach? Would the thing be attached somewhere inside to that? Would there be a bag similar to what we see on the outside, inside collecting our crap? How would it keep clean? Would we be worrying about infections because we can't clean it every time it gets full? How would we know it's full and we need to press the button? I have had this since last July (2013) and there are many times I don't even know I've crapped until I feel the warmth or look to check. I am constantly feeling the stupid tape to make sure it hasn't come up; sometimes I find out then it needs cleaning. Can the bag burst and cause all kinds of wonderful new problems? I don't think this is going to happen in my lifetime and if it does, I am, obviously, pessimistic I will be able to benefit from it. But I think it's something that can and will make life so much better for a lot of people until they invent the artificial butthole. (I am not scientific or have a high enough IQ to put that more eloquently.) I have read so many stories of people losing their, supposedly, better half because of the bag of shit on their stomach. Or that potential mates flee when they find out. Not only do we have to deal with this crap on a daily basis - but we have the fear that no one will want us because of it. And I wonder, if it never happened to me - if I'd be able to start a relationship with someone who had it? What you are proposing/working on - would make those odds a lot better. I could feel much better looking at myself in the mirror with a little patch or something similar over the alien than this whole attire I have to deal with. I could, at least, wear my favorite jeans again. To some women, that's half the battle. Anyway, I have those questions and may come up with more as I ponder this. Thanks for answering us so quickly. I hope this isn't the only site you are on - there are quite a few stoma sites on the airwaves.

Firstly, Zywie, the possibilities are that, given a sufficient amount of support, our product could potentially get to market (given all goes well with all the clinical studies) sometime within the next two years, at least someplace in our patent-covered markets if not yet the US (like Mexico or Europe, or even Brazil). Secondly, you can't imagine how much simpler this device is than you are imagining it, as it is a simple ring-like valve that circles a small section of the intestinal canal created by the stoma surgery that has one side with a plunger-head fitting into it that will simply push against one side of the intestinal (or other type of canal for those who have a urinary stoma), which plunger head is connected to a cable that either pushes the plunger closed or pulls it open (per the user just pressing a button on the car-key-like activator) as the cable is controlled by a small motor encased in our control box that is placed under the skin in the abdominal wall adjacent to where the valve is positioned around the intestine leading to the stoma.The remaining length of the intestine recovered by the surgeon will act as your new (though reduced in length) colon with the waste matter just queuing up inside your body just as is does now in the normal sequence of such things. Given that different surgical procedures may recover different lengths of one's intestinal tract wherein patients may have different lengths of time they can put off a bathroom visit, at least such control is put back in the patient's hands, with the collection bags becoming a thing of the past. I know I am sounding like a broken record on this, but it is so important that the ostomy community itself to be very proactive in supporting this type of endeavor because the companies that sell you all these bags and all the accompanying other consumables would never like to see such a product get to market, which certainly puts a roadblock in front of companies like PMD trying to truly fix this problem. In any event, if you have some suggestions regarding other chat rooms wherein we should be doing this same type of interaction, please let me know, and my great appreciation for your continued and moving input. It is what will make us even more determined to persevere.

This would be an answer to my prayers. I had rectal cancer which led to over radiation of the affected area. In turn I was left with paralyzed muscles which then left me with my colostomy. If this device were to be approved it would truly help me and others tremendously. Anything I can do to help - would be my pleasure.

I and my whole development and medical team are quite energized and inspired by the support you have all already expressed and remain quite dedicated to returning some new level of quality-of-life to those in the ostomy community that seek it. The more ostomy patients that indicate their support for our efforts, the more that can get done to bring these devices to the market at a much quicker pace. In fact, we just saw reports today that the USFDA is rethinking its fast track position on devices that could potentially greatly enhance the QoL of people, so please, communicate with others in the ostomy community and let's get this done sooner rather than later.