3D Print a Healthier You: Episode I – Diagnostics & Demonstrations

There is another medical revolution in the making besides printing your own drugs. Surgical procedures stand to benefit early from all of the advances in 3D printing. From diagnostics to replacement “parts,” highly personalized small-scale manufacturing lends itself perfectly to the world of individualized medicine and procedures.

A bit of background: In the late 90s I had the opportunity to play around with some “UNIX” workstations at a radiology clinic (likely SGI O2s if memory serves) to generate 3D models from a series of CT or MRI scans.

Volume rendering of head via Wikipedia (source:3D Slicer's Visual Blog)

Volume rendering of head via Wikipedia (author: 3D Slicer’s Visual Blog)

The ability to model the vascular system for example, allowed the radiologist to develop a better diagnosis. The next logical step is to print that model out.

A February 2013 article “Modeling the Heart” by Vicki Louk Balint [Raising Arizona Kids via 3ders] outlines how 3D models of pediatric patients help both the doctors and the patients before surgery at Phoenix Children’s Hospital:

Using a heart model to prepare for surgery is like finding your way with a GPS instead of a paper map, says Daniel Velez, M.D., a congenital heart surgeon at PCH. With the models, a surgeon can see, and touch, the actual size of the structure before surgery even begins. “To be able to tell the parents more precisely what I’m going to do, and what I’m going to encounter—even though I do tell them about variations and variabilities to the plan—I’m more at ease and more certain,” he says.

[youtube=http://www.youtube.com/watch?v=HbCHuZ3I5a8]

Unlike drug delivery (as Jamie pointed out two weeks ago where there is an obvious conflict with pharmaceutical patents) the legal consequences of these techniques post-Mayo Collaborative Services v. Prometheus Laboratories, Inc. are unclear. As a refresher, the SCOTUS decision in Prometheus boiled down to:

If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.”

and finally

We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.
* * *
For these reasons, we conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid. And the Federal Circuit’s judgment is reversed.

I would argue that the modeling and printing of a series of scans is analogous to the “recitation of a law of nature”.  Given the Court’s reluctance to impede the progress of medicine in this arena it’s less likely that the technique would run afoul of a process patent. As well it seems doubtful that there would be regulatory consequences due to the demonstrative rather than diagnostic nature of this technique.  It does however provide for an exciting potential in improving both the doctor-patient relationship and the approaches to the surgery itself.

 

This will be part of a continuing series of posts detailing the medical advances that intersect with 3D printing, and some of the legal ramifications that follow. Next up: Implanting 3D printed objects

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