3D Titanium Printing and TIES Implant Device: My Experience and Future Considerations

I came across this article on Oct 3rd, 2023 within the Med-tech Press in which Mats Cordell - Technical Director of OstomyCure had this to say regarding the TIES Titanium implant device: For those wishing to access the actual article [which I have copied - not selectively edited] - the link reference is here: https://www.mddionline.com/design-engineering/how-3d-printing-enabled-giant-leap-forward-ostomy-patients

It reads thus:

Copy of Copy of Pedersen POV 1-9-23-5.png In this Behind the Design story, learn how 3D printing made manufacturing the OstomyCure TIES implant much more feasible. Amanda Pedersen | Jan 26, 2023 Materials, 3D printing technologies, and applications are all poised to make meaningful advances in 2023 and beyond. Already there are medical devices in development and on the market that simply wouldn't be viable products without advancements in 3D printing. The TIES implant is a perfect example of a device that would not be where it is today without 3D printing. The TIES implant, being developed by Oslo, Norway-based OstomyCure, is a titanium port designed to be implanted within a stoma. It is intended to be used with an attachable lid to effectively open and close the stoma. The idea is that patients can empty their stoma at their own convenience as opposed to it continuously emptying into a bag, causing discomfort, noise, smell, and inconvenience. The company has been developing the technology for well over a decade and while it isn't perfect (some patients still experience leakage around the stoma) the technology represents a giant leap forward for patients living with a stoma and relying on an ostomy bag. OstomyCure recently reached a crucial milestone in its pivotal clinical trial: 20 patients have been implanted with the device in the UK, Sweden, Poland, Austria, and India. The company said the patients will be monitored for six months to fully assess the safety and performance of the device. The data from these patients will then be included in the company's submission for a CE mark under the new Medical Device Regulation (MDR) in the European Union. "Completing this milestone for our pivotal clinical trial is a crucial step in bringing this novel device closer to regulatory clearance and introducing it to a large patient population urgently in need of solutions to improve their quality of life," said OstomyCure CEO Johan Jarte. "We will quickly compile the data ready for our EU regulatory submissions. We are incredibly grateful for the commitment and enthusiasm of patients and clinicians who have taken part in the trial." Image courtesy of OstomyCure The TIES implant, a titanium implant designed to be implanted into a stoma, giving ostomy patients more control over their stoma. 'Without 3D printing we would not have been able to come this far' Early iterations of the TIES implant were made using conventional manufacturing equipment, Mats Cardell, chief technology officer at OstomyCure, told MD+DI. "It was very complicated, very expensive technology, and still not a perfect design," Cardell said. So, the company began 3D printing the implant in 2012, which was still the early days of metal 3D printing, he said. "Then we could optimize the design," Cardell said. "There is much more freedom in designing things in 3D printing." With 3D printing, the surface of the titanium implant is also better for tissue in-growth because it is a rougher surface, Cardell said. "I'd say without 3D printing we would not have been able to come this far," he said. "It has been a cornerstone for us." Behind the design of the lid The company's design and engineering focus in the early years was on the implant itself, making sure it was safe and effective. At that time, the thinking behind the lid portion of the device was simply that it needed to be a cap. So, the first-generation lid design was rather basic. A second-generation lid was designed which was better than the first, Cardell said, but the patient had to remove the lid to empty their stoma. The problem with that is there tends to be pressure inside the stoma and as soon as the lid was removed stool would spurt out all over the person's hands. "So, it wasn't very user-friendly even if it was safe and working really good as a lid," Cardell said. "Then we decided to go for a third version of the lid which would have a little hatch in it so you can actually open the hatch while the lid was still on, and this was possible to do from the outside. First you put a bag on top of the lid and then from outside the bag you can open this hatch and you would empty the stoma into the bag." That was "nice thinking," he said, but it still didn't work as well as the team had hoped. "So now we're into the fourth generation of this where we have combined the safe and nice design from the [second generation] lid but it has an opening so you can open it into a pouch without soiling your hands," Cardell said. "... We're quite happy with this design." As the company recruits more patients into the clinical trial and gathers additional user feedback, Cardell said the lid design will likely evolve further. He also acknowledged that every patient is different and patient preference is likely to differ from one user to the next, so the company is thinking about additional accessories to accommodate those various user preferences. The lids can be washed and reused but are intended to be replaced weekly.

 

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End of Article

 

My comments and balanced support thoughts are thus:

As a user of the 3D-titanium printed TIES device implanted within my body in May 2019, I was encouraged by the then CEO of the company, to adopt a base belief that the titanium printing technology would afford a 'workable' design for the human tissue to grow into and adhere to, and our human cells would be 'fooled' into growing and integrating within the device.

As a Crohn's Disease patient with no active symptoms for many, many years - I was put forward by the lead investigator Prof Jayne, a colorectal surgeon, researcher, and professor of surgery in Leeds, UK to become a member of the patient body for TIES implant trial.

I was in for an unpleasant surprise... For whilst it would appear that my immune system tolerated the device for a short time - within the space of 15 May 2019 and 4th September 2019 not only was there leakage around the interface of the device but there was a significant failure of the lids with possibly some necrotic tissue generated during the surgery, contributing to and resulting in significant destruction and adverse reaction by my body prior to the device being removed surgically - leaving me in a position far less desirable than when I presented myself for inclusion onto the trial.

Whilst I hope that the company is able to invest in the safety precautions of developing a directly attachable bespoke collecting device which can be appended directly onto the titanium collar - I am, in the meantime, encouraged by the statements concerning the ongoing improvements the company is committed to in its continuance of investment and development of the polymer lids - for this is an essential investment area - coupled with the non-mentioned safety element of containment of output from a patient's stoma.

TWO FUTURE TOPICS FOR DISCUSSION RAISE HERE - THE EFFECTS AS YET NOT FULLY UNDERSTOOD OF POLYMERS IN THE ENVIRONMENT - AND IN PARTICULAR WITHIN OUR MULTI-CELLED BODILY ENVIRONMENT - AND THE EFFICACY OF 'Completeness of Systems' - IE NOT JUST TRIALING A ONE COMPONENT DEVICE - BUT TRIALING all bespoke components THAT NEED TO BE IN PLAY TO COUNT AS AN INTEGRATED SYSTEM: Transcutaneous Implant Evacuation System, TIES, in my humble opinion needs to be thoroughly tested with all components being bespokely designed as a system.

Companies must find the means to attract adequate funding before being allowed to run at risk to their patient bodies - FOR COMPANIES DO NEED TO ACCESS ADEQUATE FINANCIAL INVESTMENT Before a proportion of those funds then raised are RING-FENCED FOR THE ACTUAL ADVANCEMENT AND PROTECTION OF THE PATIENT BODY.

IMHO IT IS MORALLY DUBIOUS FOR ANYTHING SHORT OF SUCH AN ENDEAVOR BEING PUT IN PLACE BY LEGISLATION WHICH, ULTIMATELY WILL HELP NOT ONLY THE PATIENT BODY BUT ALSO THE PEACE OF MIND OF THOSE FACILITATORS WHO DO INVEST THEIR BEST INTENTIONS AND EFFORTS WITHIN THEIR OWN FIELDS OF EXCELLENCE. Clearly, what is NOT discussed in such trade press as these articles with only the positive spin, is the human impact experience of the patients who place their faith and trust in clinical researchers to whom patients look and ideally can rely upon, for their information for reality and for expertise and excellence. Instead, it would appear that sometimes within reality no mention of past knowledge of previous patients' actual outcomes - documented within closed trials - is shared; And, moreover, whilst no guarantees are ever given

Hello Jayne.

Thank you for posting the link and thank you even more for your comments on the 'system' surrounding the TIES experiments.
I know that patients undergoing such experiments are often called 'guinea pigs', but I sincerely believe that they should be treated as humans with a value way beyond the development of some new technique. Any such research should be bound by legislation, which requires these firms to support (and compensate) any patients who are harmed physically or mentally by their procedures. The legal requirements should also outlaw 'gagging orders', that require participants to keep quiet about things that go wrong.  They obviously don't object to people speaking up when things go right!

Best wishes

Bill

Well... We do a lot of Ti 3D printing at work. So I'm really familiar with it. I have a colostomy due to a medical device failure; plastic hernia repair mesh. It migrated into my bladder and colon. It perforated my colon... bladder saved just in time. The mesh worked perfectly for 15+ years. But long term, it failed.

I'll keep my wafer and bag. It's outside the body, so it's easy to keep an eye on.

I have heard of TIES. It sounds like a good development in its field. When will it be available for patients? Is it a simple procedure? Even with the lid as it is at present, it does look like a big breakthrough. I noticed that the surgeon who led you to that trial and you have the same first name. That could be a lucky coincidence. Best wishes.

Novel devices' progress is not always assured:

Indeed, yes Bowsprint, the surgeon who implanted me - the Chief Investigator of the CO3TIES Clinical Trial - happens to have the same surname as one of my Christian names!

The serendipity is moot - for my TIES surgery was neither unplanned nor was it successful.

-However, one may say - for the greater good of bowel patients who follow - the sponsor company now states the unsuitability of TIES for any patient subject who has a Crohn's disease diagnosis - so that the associated risk of CD will not carry forward the same high risk for experimentation within the trial environment.

Moreover - as all trial data is closed and not available for public perusal, transparent ongoing assessment is not possible.

TIES has to progress through many more trial stages and obtain its CE Mark status under the tougher rules within the European markets and also be scrutinized by the FDA prior to trial commencement in the States.

It is also far from clear how many implants make it through trial conditions - statistics may be selectively quoted according to the criteria under review.

It might appear the magic number of 20 data sets might be a minimum to reference within medtech/pharma convention to enable further R&D funding and stage progress to commercialize value and so facilitate advancement of concept.

Time Frame Speculation:

TIES seems unlikely to be available for patients to access as a routine procedure any time soon.

[BCID and other modifications of aspiration and inner pouch systems have been under development, over time - and are way ahead of TIES - yet, they too are not without their complications - they are by no means 'available' as a gold standard for any enquiring self-elect patient!

 

Stay safe - be bold - but become fully informed too!

 

Sadly, freedom from the 'bag' is not yet upon the horizon; it remains the exception from the norm - and when it is, can be, 'elusive' and temporary!

 

Jayne