Intrathecal Trial Update – New port (hopefully)

Posted Wednesday June 27, 2012 by Melissa

Soph-a-port mini

So we recently learned about the new port-a-cath that is contemplated to be used in the next phases of the intrathecal clinical trial. If you’ve followed along, you’ll know that the current port has suffered from a number of problems, mostly due to the high activity level of our kids. The current port was already approved in the EU, but if I understand correctly, it was used mostly with CP and/or wheelchair bound or low-activity patients.

Well, it was tested in monkeys before our trial and I always joke that “Don’t you know that our Hunter boys are much more active than monkeys? They might not swing from the trees, but they jump from the furniture, wrestle with their brothers, and crash into just about anything!”

Soph-a-port mini

Soph-a-port mini

So, a more sturdy port was in order. Enter Sophysa’s soph-a-port mini.

Now, although I understand that Shire has an agreement with this company, my understanding is that it is not currently approved by the FDA for use in the United States and it still must go through that process, which may take until the end of the year, if I understand correctly. Notice my caveats…. 😉

However, I am happy to say that I am encouraged by the new port. The design seems sturdy for our kids and I’m hopeful that it can withstand their high activity level and I don’t have to constantly be concerned about a broken port each month, especially with a treatment that would likely have to happen each month for the rest of his life (which will hopefully be long as a result!).

With the new port also comes a new catheter (the “tube” that carries the drug from the device around the side, into the spinal fluid). The current catheter also suffered from some durability issues, as I understand, and keeping it in the spinal canal was sometimes a challenge. I am told that the issue of them sliding out is is a not uncommon side effect of spinal catheters, however. This may be addressed by a kind of butterfly clip at the base of the spine to keep the catheter from sliding out.

If you want to learn more about the catheter, visit the Sophysa site or read the specs.

In the end, I still have some questions that need answering, so I would love to crowdsource additional questions if you have them, so post below:

  1. What is the comparison of the catheter diameter, inside and out, to the current one?
  2. Are there multiple holes around the end of the catheter, as in the current one, to (as I understand) allow for easier distribution of drug and prevent failure due to blockage?
  3. What is the comparison of the septum size?
  4. Are docs experienced in placing this type of luer-lock connector? If not, will they be trained?
  5. More information about the butterfly piece to possibly be placed below the entrance to the spinal canal?

Thank you for any additional thoughts you provide!

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2 Responses to “Intrathecal Trial Update – New port (hopefully)”

  1. Hi Melissa,
    I know Sophyssa also makes shunts for hydrocephalus and are similar other than the fluid drains in to the stomach or other site and longer catheter. I know my own neurosurgeon has been digging in to if there is a different catheter (such as from lumbar external drains) that would hold up better under pressure/flow of CSF and for a catheter that is bigger in diameter than the lumbar shunt/VP shunt catheters. I think these issues are very common in the IT Ports as well as in the Hydro-shunts and as much to do with pressure dynamics, spine structure and flow pressure.
    It’s almost a litle eery how similar the IT Port issues are to shunt issues (but very similar set up) and similar issues – I know ive been curiously waiting to see what you guys would get to see if we could dismantle that port set up and if the catheter where in fact bigger use it for my 2nd shunt. Who knows but my neurosurgeon is thinking along these lines.
    I know that butterfly clips are always used in LP shunts and they do not always prevent the catheter from slipping out of place (we dealt with this 3 or 4 times last year with my first LP shunt) but they can also anchor the device I believe with multiple clips at different places although this may vary for IT Ports as the catheter may not go as high.
    I know this probably isnt really helpful but just our experience.
    Good Luck,


  2. […] far as I know, we are still waiting for final FDA approval of use of the new port, both of us current participants in the extension study, as well as for Phase III trial […]