Biomedical Engineering Reference
In-Depth Information
lay the raw materials, and perform additional processing to preserve the printed tissue. Whereas basic
3D printers heat plastic filament and lay melted plastic in patterned layers, 3D bioprinters must store,
handle, and construct biological materials, a much more demanding manufacturing environment that
requires the hardware needed to create live tissue, a much more difficult task than simply layering
melted plastic.
Indeed, 3D bioprinters may handle many types of biological and nonbiological materials, and may
require specialized reservoirs to store living cells and biological binding agents, and specialized hard-
ware to treat printed tissue with nanomaterials or other materials to produce biocompatible tissue and
organs. The nanomaterial handling hardware may be incorporated into 3D bioprinters to coat printed
tissues with nanoparticles. As one would expect, the hardware involved in creating live tissue is very
complex, and the innovators and investors paving the future require assurance that their investments in
successful innovations will not be usurped by copycats.
Another important piece of hardware used in 3D printing is the 3D scanner. Scanners simplify and
expedite the process of replicating objects, including living tissue. 3D scanners have existed for years
as patentable machines (
Song et al., 2000
), but as tissue engineering improves with the use of 3D bio-
printing and nanotechnology, scanning technology will also improve. 3D scanners allow individuals to
scan a piece of living tissue, determine its cellular structure and composition, and generate instructions
for a 3D bioprinter to replicate the tissue.
16.5.2
SOFTWARE
3D bioprinters and nanomaterial handling devices are highly automated computerized machines. The
complex process for printing and processing living tissue involves many factors that must be continu-
ously monitored and controlled, including temperature, acidity, wetness, oxygenation, and nutrition for
the printed cells. Even relatively basic 3D printers that extrude materials to build biodegradable scaf-
folds for shaping cell growth must heat materials to specific temperatures, navigate one or more print
heads within a three-dimensional environment, and extrude a specific amount of materials, all with high
precision. These complex, repetitive steps are performed automatically by the programmed 3D bioprint-
er, and the software controlling the 3D bioprinter may be protectable by both patents and copyrights.
To revisit the distinctions between copyright and patent protection for software, copyright protec-
tion prevents anyone from copying source code from the author's program, and using the same source
code in a different program without the author's permission. Copyright protection in this case prevents
competitors from simply copying-and-pasting source code, but does not prevent competitors from de-
veloping equivalent software using different coding. Software patents can protect the functionality of
the 3D printer, such as the steps performed by the 3D printer processors executing the software, and the
settings used to produce a product. Patenting 3D bioprinter software allows the innovators to prevent
others from simply copying the software and tweaking the code to avoid copyright infringement.
In addition to the software programs that operate 3D bioprinting equipment, software for creating
digital “blueprints,” and the digital blueprints themselves, may be protected by patents and copyrights.
These digital blueprints can be created automatically by 3D scanners (and 3D scanner software), or
manually by CAD software developed especially for tissue engineering. Again, copyrights would pro-
tect the specific source code underlying the software, whereas patents can protect the functionality of
the software and a broader description of the 3D printer instructions for creating the tissue, such as
dimensions, cellular arrangement, and other operational parameters.
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