The splints are custom-designed and custom-fabricated using high-resolution imaging and computer-aided design and were created directly from a CT scan of the babies’ trachea/bronchus. We then use the CT images to create a splint using a 3D printer out of a material called biopolymer. Once the splint is implanted during surgery, it acts as a scaffold as the tissue repairs itself. It’s then absorbed into the body over the next 3 years.
3D printing will be a challenge for the FDA as you obviously can make custom implants and can readily change design. This raises issues about how to implement FDA quality systems requirements (QSR). Also, how do you verify and validate such processes? These are challenges that we face and will require new approaches in regulatory science. I think the most interesting challenge is how to implement QSR for 3d printing.
In future projects like these, do you still see the cost of R&D being expensive for individuals? I imagine every part has to be designed/tailored to suit that individual and their needs, but of all the R&D costs that went into this particular one, I would hope this isn't something that needs to be repeated with each individual.
Is their a scenario in which you can sort of design a database of blueprints and then sort of tailor them to the individual for a cheaper cost?
Yes, I think (and companies are already doing this) database of CT and MRI scans will be stored to complement a patients own scans. If the patients defect is such that we cannot design a patient part based on symmetry (i.e. like an ear or knee), we can register other patients anatomy and mathematically morph it to fit the patient in need. They we can design and build the implant. I think the R&D costs will come down, but regulatory and legal costs will be difficult to reduce. You are correct though, that with current software we can create an image specific design in an hour or two.
I was just reading about this here and now I get to ask you guys questions! Reddit is really cool sometimes!
What was the standard treatment for this condition prior to 3d printing? How has 3d printing improved this and are you guys doing any sort of formal evaluation of this compared to the previous standard? I imagine with such an innovative (and apparently very successful) procedure this is the sort of thing you'd like to start spreading to other hospitals as quickly as possible - how is that sort of thing normally done, if say another peds ENT wanted to do this for a patient? Were there any special surgical techniques you had to use for this or is it pretty standard and you're just using a better implant so the learning curve would actually be on the biomedical engineering side?
Also one thing confused me with the way the article was written. Had these babies already had open heart surgery to correct their heart defects by the time they came to you and this operation was essentially to correct the weak airway?
Also how did you guys create the model of the baby's trachea. Do you print another 3d model based on MRIs or something? (edit: article said CT scan. how do you convert that to a 3d printed model???)
Sorry for all the rapid fire questions but this is fascinating to me.
Edit: one last question. What material are the 3d "implants" made of that make them biodegradable and how does this differ from regular 3d printing material. How does cost compare when making a custom 3d printed object vs buying stents/implants etc traditionally? Also how did you guys sterilize it?
edit2: feel free to ignore any of the portions of my post that you already answered. I was typing it before a lot of other answers were posted but it took so long that you've answered a lot of these by now!
There was no effective treatment. Both of these boys were in the intensive care unit, on high-pressure ventilation. They were on high dose intravenous sedation and narcotics. Garrett had been put into a coma and Kaiba had been repeatedly paralyzed to try to keep them alive.
These children died. The FDA trial we are putting together looks at this issue. We will not need many patients to show effectiveness because the results are so dramatic. The airway was corrected concurrent with optimization of the heart defects.
The trachea and splint were created based upon the same CT scan. In fact, the splint was created based upon the virtual airway on CT. Both were printed to help me see how the fit would actually work before performing the operation. The material is polycaprolactone. Sterilized with ethylene oxide. The 3D-printer required a customized patch to allow laser sintering of this. (SH is brilliant).
3D printer that was used to restore breathing in two babies with collapsed airways There are very few FDA approved materials for 3D-printing. This needs to be remedied ASAP. GG
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