Anatomical-Models EN
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Regulatory Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 2
Introduction
3D printed models are becoming increasingly useful tools in today’s practice of personalized,
precision medicine. As cases become more complex and treatments truly unique, visual and
tactile anatomical models can enhance understanding and communication in the process of
reaching a patient-specific solution.
Healthcare professionals, institutions, and organizations across the globe are using 3D printed
anatomical models as reference tools for preoperative planning, intraoperative visualization,
and sizing or pre-fitting medical equipment for both routine and highly complex procedures
that have been documented in hundreds of publications.1 Physicians often save time preparing
for and conducting surgeries, leading to drastically reduced operating room costs while
lowering patient risk, anxiety, and recovery time.
This guide offers a practical, step-by-step walkthrough for physicians and technologists to go
from patient scan to 3D printed model, reviewing best practices for setting up a CT/MRI scan,
segmenting datasets, and converting files to a 3D-printable format.
Anatomical models printed on Formlabs machines are already being used across several
sub-specialties of surgery, including but not limited to orthopedic, cardiothoracic, vascular, oral
and maxillofacial (OMFS), oncology, plastics, reconstructive, urology, and pediatric. This tutorial
provides an overview of steps that can be applied to any Digital Imaging and Communications
in Medicine (DICOM) dataset, which is the standard format for image storage in any modern
picture archiving and communication system (PACS).
Form Wash and Form Cure for post-processing 3D prints (recommended for medical models)
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 3
Applications and Benefits of 3D Printed
Anatomical Models
Formlabs is an industry-leading provider of 3D printers and materials used by healthcare providers to
support the practice of medicine. Please consider your intended use, local regulations, medical imaging
software clearances, material data sheets, biocompatibility requirements, protected health information,
and institutional standards before 3D printing or using anatomical models.
Numerous published case studies and ongoing efforts have demonstrated the potential of 3D
printing in a clinical setting. Published use cases include preoperative planning3, intraoperative
use4, patient-specific instrument guides5, custom-tailored implants6, molds for bone cement⁷ or
polymethyl methacrylate (PMMA) implants8, prostheses9, and trays.
These use cases have seen success in a variety of fields and surgical specialties, including
orthopedic, cardiac, oral and maxillofacial (OMFS), vascular, neurological, cardiothoracic,
musculoskeletal, plastics and non-facial reconstructive surgery, oncology, pediatrics,
interventional radiology, and others.
“As much as I’d like to think that my brain can reconstruct a 3D interpretation
from a 2-D CT scan, I was surprised by the relative inaccuracy of the approach
that I’ve been using for 20 years. The 3D printed models have been invaluable
in planning, particularly when using the daVinci robot.”
Dr. Ronald Hrebinko
Urologist and Associate Professor of Urology
University of Pittsburgh School of Medicine
3D printed models can also have substantial benefit for educating medical residents, fellows,
and students10. Patient-specific models are especially appealing when considered against
the cost of cadaveric specimens and animal testing and their associated requirements for
laboratory space, surgical instruments, and disposal.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 4
Top 5 Medical Disciplines Leveraging 3D Printing Technology
PUBLICATIONS ON PLANNING, EDUCATION, AND VISUALIZATION
240
180
120
60
0
Cardiac Orthopedic Vascular Neurosurgical Hepatobiliary
Explore our collection of research publications to learn more about how Formlabs printers and materials have been
used in healthcare.
Widespread use of advanced visualization in radiology has been key for diagnosis and
communication among physicians. While these visualizations have traditionally lived in 2D
planes from CT or MRI scans as DICOM files, software developers have recently created
tools to reconstruct diagnostic images as 3D anatomic renderings.
3D printed models are a natural progression from these various 3D visualization options,
and offer many additional benefits, such as tactile feedback and other tangible information,
that visualizations cannot.
For example, examining a custom 3D printed model led an orthopedic surgeon in the UK to
find a lower risk solution to a young boy’s abnormal forearm injury.
“Access to the model changed the standard treatment indicated by the CT scans from a
four-hour complex osteotomy to a simple, much less invasive 30-minute soft tissue procedure,”
said Dr. Michael Eames.
The successful surgery was completed in just under 30 minutes—a decrease of over three
hours from the originally planned time in the operating room, saving the hospital an estimated
$5,500. Subsequently, the patient spent less time in postoperative care and recovered faster11.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 5
Workflows from Scan to
3D Printed Model
Generating 3D printable files and 3D printed models requires specific
considerations and minor modifications in the medical imaging workflow.
IMAGE ACQUISITION
Image acquisition is the first step that is already integrated into the
workflow. The most common imaging methods useful for 3D printing are CT
and MRI. In general, 3D models can be printed from any volumetric image
dataset (slices) with sufficient contrast to differentiate tissues. Cone Beam
CT is also commonly used for dental and ENT imaging, but the contrast
resolution may be poorer than with traditional CT, making segmentation
more difficult12. Find guidelines for setting up patient scans for 3D models in
the second portion of this white paper.
IMAGE SEGMENTATION
The main objective of this step is to reduce the complexity of the original
image, leaving the characteristics of interest intact and isolated. After a
radiologist acquires the DICOM, they must obtain the regions of interest
(ROI) to be rendered as a 3D printable object. The process of identifying
and separating tissues and other regions of interest is called segmentation.
Depending on the complexity of the model, this is either performed by a
radiology technologist under the direction of the radiologist or
by the radiologist directly. When the segmentation is done, it is reviewed
with the surgeon for final approval13.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 6
Thresholds may need to be dynamic and involve more complex algorithms to account for factors
such as CT noise and beam hardening that may produce artifacts and other undesired results.
Another option is to use region growing to automate segmentation, where an algorithm assigns
voxels as belonging to one part or another based on similarity or deviation from its surrounding
voxels. Additional adjustments and refinements may be necessary.
After segmentation is finished, convert segmented objects into a file type that a 3D printer can
use. This file type is typically an STL or OBJ file format.
After the conversion, perform any necessary physical adjustments that are more common in 3D
modeling, such as smoothing out surfaces, filling holes, and fixing other minor features. These
adjustments can be performed by a technician on a variety of CAD or CAM software and should
always include physician review to ensure that the output is clinically useful.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 7
In-house 3D printing enables healthcare providers to quickly create high-resolution medical models.
3D PRINTING
Once the final file is ready, it can be exported and sent to a 3D printer for fabrication. There are
several key factors to consider when choosing the right 3D printing technology, including: the
cost of the printer, software, and materials; print speed, accuracy, and resolution; ease of use
and access to customer service; and the type of printing materials, including biocompatibility
and the ability to be sterilized for certain use cases.
After printing, parts must be washed in isopropyl alcohol (IPA) to remove excess resin and,
depending on the material and applications, post-cured in a cure chamber. All biocompatible
resins require post-curing before use, and Formlabs Standard Resins, such as White and Clear
Resin, increase in strength and stability after post-curing.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 8
POTENTIAL SOFTWARE AND HARDWARE OPTIONS FOR ON-SITE 3D PRINTING
Note: only one software is required per section, which represent steps in the workflow. This list
is meant to facilitate reference and research only and is not an endorsement of any particular
software or vendor. For those who want anatomical models without segmentation or printing
on-site, specialized service providers offer conversion, segmentation, and/or printing services
for a fee (e.g., Anatomage, Armor Bionics, Axial3D, and Materialise).
Please consider your local regulatory guidelines and intended uses before selecting a
software solution.
Conversion + Segmentation
Materialise Mimics* ITK-SNAP
14
3D Slicer 4DICOM
Axial3D Seg3D
Osirix Embodi3D (DICOM to STL conversion, no segmentation)
Ossa 3D Vitrea Vital Images
Anatomage Medical Design Studio
Printer
Formlabs Form 2 or Form Cell system Formlabs Fuse 1
Print Post-Processing
Formlabs Finishing Kit Form Wash and Form Cure
Ultrasonic Cleaner (e.g., GT Sonic) CUREBox CB-4051
* Formlabs and Materialise have partnered to offer an end-to-end bundle in the US, Europe,
and Japan. Mimics inPrint is a dedicated software solution to create accurate virtual
anatomical models based on medical images and to prepare files for 3D printing. Integrated
into clinical environments (PACS), Mimics inPrint includes pre-defined workflows with a direct
link to Formlabs 3D printers.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 9
Setting Up Patient Scans for 3D Models
Some conventional medical imaging scans cannot be converted into high-quality 3D models
to produce clear, accurate anatomic structures of interest. Plain radiographs (X-rays) and
ultrasounds are not commonly used for 3D printing, and these imaging modalities are not
recommended.
The most commonly obtained imaging modalities for evaluation of internal structures are CT
scans and MRI imaging. These scans generate a DICOM file. DICOM is the standard for storing
and transmitting medical images and can be considered a series of slices.
DICOM images cannot be edited in 3D design software or sent directly to a printer. In order
to convert a DICOM file into a format suitable for 3D printing, such as an STL or OBJ file, a
separate software is required to calculate the surface area of the structure of interest. This
surface will then become the 3D model.
Almost any DICOM file with sufficiently fine detail (e.g., thin slices) can be converted into a
format that allows for 3D printing of the structure(s) of interest.
The articles below may be helpful when preparing, printing, and post-processing
anatomical models:
Design Specs and Best Practices for Geometric Features Post-Processing Basics
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 10
Criteria for Generating a Printable Scan
The first consideration when turning a CT or MRI scan into a 3D model is what needs to be
shown; bones, vessels, and solid organs all need to be modeled in different ways. A model
with obsolete structures not only distracts from the focus of the model, but will also be more
difficult to manufacture. A scan with proper characteristics makes it easier to create a 3D
printable model. Basic features to consider are intravenous contrast and slice thickness.
For 3D models of bone structures, noncontrast images will likely be sufficient for accurate,
detailed printing. Contrast-enhanced scans are almost always required for models that include
solid organs, tumors, or vascular structures.
The effect of intravenous contrast is shown with these two axial (transverse) images of CT scans of the upper
abdomen. In the righthand scan the aorta is enhanced, whereas on the lefthand scan the aorta appears quite similar
to the adjacent soft tissues. Contrast allows for isolation of desired structures in post-processing. Source: Embodi 3D
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 11
In addition to contrast enhancement, slice thickness and resolution are equally important to
consider when planning for 3D model creation. Most clinically useful scans are obtained with
adequate resolution for 3D printing. However, if you try to 3D print an anatomical model from a
scan with thick slices, your model will have a rough finish. According to numerous sources, it is
very important to use scans with slices less than thinner than 1.25 mm when creating a model
for 3D printing.
Two CT scans of the chest. The image on the left shows a coronal view built from slices that are 5 mm thick, whereas
the righthand scan demonstrates a similar view of the chest using slices that are only 1 mm thick. The thick slices in
the lefthand image generate coarse structures that will lead to a lower quality printed model. Source: Embodi 3D
The thickness of slices captured by a CT or MRI scan translates directly into the detail
generated in a 3D scan. Depending on the item of focus, image sections should be
reconstructed with isotropic voxels of 1.25 mm or less15. According to a presentation by the
Mayo Clinic in March 2016, slices as thick as 1.5–3 mm may be used for larger structures,
whereas 0.75 mm may be used for fine bone16. Thicker sections may compromise model
accuracy, while very thin sections (e.g., <0.25 mm) could require extensive segmentation and
STL refinement, particularly in the presence of image artifact. Cardiac models demonstrate
sufficient accuracy with 0.5 mm sections, but thin objects such as the orbital floor may require
thinner sections17. Generally, thicker sections may produce unclear or less accurate printed
models. Nevertheless, unnecessarily thin sections may create significantly more work in the
post-processing phase.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 12
Regulatory Considerations
Please consider local regulations, material data sheets, patient information, and institutional
requirements before 3D printing or using anatomical models. For physicians in the US, refer
to the latest FDA presentation summarizing its guidance document18. Please note that these
documents and guidelines are subject and likely to change. Always confirm you comply with
the latest recommendations.
Conclusion
Barriers to entry for personalized, precision medicine are rapidly lowering. The advent of
affordable professional-grade desktop 3D printers has enabled healthcare providers to
produce patient-specific anatomical models for a variety of specialities with inspiring results. In
some cases, the initial cost of high-quality a printer was covered by the costs associated with
time saved in the OR room after a surgeon used a 3D printed model to prepare for a single
complex procedure19.
“Medicine is not one size fits all, and when a tool like desktop 3D printing comes
along that allows you to create personalized medical solutions, it is a no brainer
to utilize it to its fullest capacity.”
Todd Goldstein PhD
Instructor, Feinstein Institute for Medical Research
Director, 3D Printing Lab, Northwell Ventures, Northwell Health
Contact us to learn more about introducing 3D printing into your institution and join the
community of innovators in precision medicine.
FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 13
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FORMLABS WHITE PAPER: How to 3D Print Anatomical Models for Preoperative Planning and Enhanced Patient Consent 14