I came accross this article on Oct 3rd 2023 within the Med-tech Press in which Matts 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 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 for 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 OstomyCureThe 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-Titanieum 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 Chrones 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 immunity 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 nacrotic 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 patients 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 TRIALLING 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 throoughly 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 FINACIAL 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 ENDEAVOUR 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 imformation 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 guarentees are ever given, the data actually known concerning the very real potential risks are not made known to the newly presenting patient body volunteer and certainily not adequately covered when Potential Patients put themselves forward for consideration when applying to join these medical - CLOSED SINGLE STUDY INDUSTRY SPONSORED CLINICAL TRIALS.
What DOES happen in reality is that - IF YOU ARE LUCKY - as I have been, to be fortueate, and have the courage not only to stand up and be counted and take on the legal battle to be properly looked after - AND IT HAS BEEN A BATTLE - WHICH IS STILL ONGOING after Four Years so far - THEN, and only then, is one afforded the remedial surgical and possibly psychological treatment that is required to address the aftermath of such a traumatic experience .... Believe me when I share the fact that one's very real NEED is actually picked up by, in my case, by a very experienced and CARING TEAM WHO DO HAVE A TRUE VOCATION for what they have spent their life learning and application in doing - Performing at an excellence level for the benefit of their Patients who come to the end of the line with a dire need for help and repair ... Clinicians who pick up the pieces by using their medical experience to do their very best in human resources and medical excellence ... by literally picking up what has been left inadequately unaddressed by Others. Some Clinicians actually are so moved they cry when they are unable to help their Patients within the constraints of 'a broken system'.
All the forgoing, IS NOT TO BE MISUNDERSTOOD - Because, although it may be selectively quoted and editied in subsequent time - I ALSO FREELY ACKNOWLEDGE - with a very real appreciation - THERE DOES NEED TO BE INNOVATION - for without which there can be no advancements in medicine., med-tech, surgical techniques and WELL DESIGNED PROTOCOLS within SAFE AND RESPONSIBLE PRODUCT DEVELOPMENT WHICH CAN ATTRACT THE SIGNIFICANT FUNDING THAT IS REQUIRED TO PROGRESSIVELY MOVE FORWARD FOR THE TRUE BENEFIT OF HUMANITY. I am - even now - a very positive proponet of cutting edge research and development - BUT - IF EVER I AM IN A POSITION TO PUT MYSELF FORWARD AGAIN - I WOULD BE FAR MORE CAUTIOUS AND INSIST UPON FAR MORE OPEN SOURCE DATA PRIOR TO PLACING MY TRUST and BLIND FAITH that Medical Ethics and Protocols are adequately in place to protect and actually fund the resources required for picking up the pieces when outcomes are not positive.
Vocation and devotion within a handful of indivuduals is by no means what very often drives the motivational forces behind the many medical professionals, entreprenerial companies and investors who - whilst facilitating opportunities, do not always balance their moral and financial obligations FOR THE GREATER GOOD. Society needs to actively take responsibility - not to strangle innovation - but to help it - by overhauling and improving opportunity for RESPONSIBLE DEVELOPMENT. Caring and FEELING must not be seen as a weakness within the Medical Profession - nor must it be seen as a weakness withinth Industry Leadership either - because BALANCE must be in place for true advancement to be sustainable. In the very wise words of an experienced lawyer - the law does not provide for the kind of moral solution that is sought - It can merely try to ensure that one is not overlooked and ignoreed and at the end of the day can only help by taking a considered aspect of certain elements of what might be addressed - in the order of priority of that which is most needed in the shorter term.
A Good Lawyer does not bring his emotions into play when advising a client.
A Good Physician and Surgeon is as honest as he is informative and is as gracious as his vocation allows and will - if he is a good Practitioner - do his best to the limit of his experience - One can ask for no more.
Sometimes one is well Blessed when finding oneself in a very lucky position to experience active professional care and Unconditional love combined - THAT IS A TRUE RARITY - And if you ever encounter it - PLease TREAT IT WELL - FOR IT too is highly vulnerable - as much as you are - IT IS NOT ONLY THE PATIENT WHO TREADS A UNIQUE PATH IN OUR JOURNEY THROUGH LIFE!
I WISH TO TAKE THIS OPPORTUNITY OF THANKING, not only those WHO ARE CLOSE TO ME, but I thank the entire TEAMS - many Members of which, I have no knowledge as to their individul contributions - for we ALL have our parts to play.
As a Thank You and in the wise words of a very generous Contributor to this Site, BE PRESENT and live in the moment - in whatever 'Place' you can find to be Within Yourself - Try not to escape Self Responsibility and try never to pass the blame for what occurs to anyone in particular - for there is always a greater perspective at play than we wholy realise at any one time.
I thank you, most humbly for stayiong 'with me' and reading these words ..... For they are intended, in some small way, to HELP OTHERS who are in greater need than myself - For sometimes we can be too self focussed to be able to be receptive and supportive of the needs of Others. "Thank You to Everyone".
There is real 'release' when one can begin to speak honestly of one's own experiences in life - In my ancient years I am openly just begining to realise this.
Thanks for BEing here.
Gratefully,
Jayne.
