TRANSCUTANEOUS IMPLANT EVACUATION SYSTEM
Well I must say this is very intriguing, is it something I would consider? possibly. It feels very futuristicky ( is that a word?) but as my husband says, if you lost a leg you wouldn’t think twice about using a prosthetic. Same with glass eyes etc… my only thoughts are the issues that those women had with the mesh for prolapsed bladders etc and the pain and complications they experienced, but this was made from polypropylene and the TIES® is titanium.
It is still in early stages, but not that early, I wrote to Ostomycure who own TIES® and they wrote back with some information that they are happy for me to share. It is not available for sale as yet but it’s quite exciting.
“TIES Solution has received the CE Mark in June 2016. We are planning to look for approval in Canada and Australia in the near future and as well to submit TIES for FDA approval in the near future but this is going to take at least 24-36 months.
We are implementing an additional clinical trial in hospitals in Sweden and the UK. The study will be performed by Dr David James in Leeds and Dr Ed Westcott at St Thomas’ in London.
The lid has to be changed every week. We’ll post the added centers on our website as they commit.
Please find attached pictures from an article that gives more information on TIES. Please also visit our website www.ostomycure.com . We shall post regularly news, articles and product information.”
Regarding your questions:
1. TIES has received the CE mark which means it has successfully met the regulatory safety requirement regarding class IIb medical devices including clinical testing in human beings.
2. We are developing a special lid with a hatch that clips onto the device’s external part without touching the skin. A clip-on plate that also does not touch the skin allows the fixation of a conventional single use bag for the drainage of the waste. After drainage, the plate is removed (and can be re-used). The hatch is cleaned and closed until the next time for drainage. It can also be worn during the night if so wished. The lid protrudes about 15mm above the skin.
3. The concept is all about providing a continent ileostomy that eliminates the need of conventional skin glued bags.
4. There is no cramping or discomfort. When it is time to drain the waste, the patient “feels” it, similarly when one still has a physiological digestive system (colon, rectum).
5. In the first 6 weeks the patient needs to wear the bag as usual to allow the tissue to grow into the titanium device. After that time the lid can be used. The number of times the patient needs to go to the toilet diminishes over time when the intestine above the device tends to enlarge slowly to create a natural “pouch”. But the number of times depends largely on the length of the remaining intestine, the diet and the amount of food ingested.
6. There is no erosion or excavation since the patients are not in an inflammatory situation. In UC and Crohn, once the inflammatory part has been removed and an ileostomy put in place, there should not be any inflammation.
7. Should the device need to be removed, the surgeon will dissect around it and perform a conventional ileostomy as it was before.
Johan Järte MD
I still have more questions but they can be answered as needed. Like the urge thing and what you do to empty. I can see from the above photos that you attach a bag when needed but then what? does it just seep out ? do we kind of strain like with an anus? or does the act of opening it trigger evacuation?
As I am googler, I found the care manual that you get following the surgery. It seems you bend slightly forward to drain the internal pouch (that will eventually form ) it might take a while initially but should get quicker as things heal. Care has to be taken not to knock anything until you are fully healed.
One minute I think it sounds wonderful and I would consider it if given the opportunity, and then another minute I think it sounds very scary and robocop like. I also wonder if you can see the cap bit more under clothes than the actual bags we have now, definitely through tight clothes I would think.
Will it take off ? only time will tell.