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Transforming Orthotics with 3D Printing and Industry 4.0

by • February 24, 2016 • No Comments

By Andrew Hanson, Applications Engineer, Stratasys and Scott Rader, General Manager, Medical Solutions

Traditional ankle-foot orthotic

Traditional ankle-foot orthotic

Orthoses, frequently referred to as orthotics, are passive devices worn by folks to sustain an injured or weakened body part. Whilst most
folks can be acquainted
with the use of temporary braces after an injury, a worthwhile proportion of orthotics are used
for long term care to address multiple conditions. These conditions include foot drop of muscle weakness or neural injure due to suffering a stroke, multiple sclerosis, peripheral nerve injuries and other disease system
es. Orthoses are in addition
used
to sustain stabilizing a painful osteoarthritic joint, and correcting a joint deformity.

With aging populations of the world
, the number of folks who use orthoses has grown worthwhilely in the past three decades. Projections indicate that
7.3 million folks in the United States can use orthoses to combat the impacts of paralysis, deformity or orthopedic impairments by 2020.

But while demand increases, manufacturing techniques have not changed dramatically in decades.

CYBER Team, aiming to revolutionize orthotics via Industry 4.0

The University of Michigan has partnered with Altair Engineering and Stratasys to form the CYBER team. And the CYBER Team was not long ago
selected and funded by America Makes (the National Additive Manufacturing Innovation Institute) to work together on a solution that
can leverage 3D printing and Industry 4.0 to change the turn it into, comfort, utility and customization of Ankle Foot Orthotics (AFO). This solution can incorporate digital turn it into, additive manufacturing through 3D printing, and leverage industry leaders at the University of Michigan Orthotics and Prosthetics Center to donate on emerging Industry 4.0 trends.

In order to achieve this, the CYBER team can turn it into the digital workflow for additive manufacturing (AM) turn it into, while connecting the digital thread in a cloud-based cyber physical system
that can connect fused
deposition versioning (FDM®)
additive manufacturing innovation and Altair®OptiStruct® software for the production of customized ankle-foot orthoses (AFO).

The Pain Point of Ankle Foot Orthotic Manufacturing Currently

The traditional system
for manufacturing a patient a customized AFO uses (A & B, see image below) abilityed orthotists and technicians to take an “impression” of an individual’s lower leg with fiberglass cast tape; (C) pouring liquid plaster into this impression to turn it into a positive version; (D) modifying the plaster version by hand to account for bony prominences as well as pressure tolerant areas (E) vacuum forming a thermoplastic sheet around the version; (F) hand-trimming the plastic orthosis to final shape; and and so adding any necessary padding and straps preceding fitting the AFO to the patient1.

Traditional system
 for manufacturing custom ankle-foot orthotics

Traditional system
for manufacturing custom ankle-foot orthotics

The pain points of this system
starts with a typical donatey time of two to four weeks due to the abilityed labor require
d, insurance authorization system
es, and the demand on this resource of the numerous patients requiring this care in orthotic centers. The system
uses a worthwhile amount of disposable plaster materials, has limited captalent to optimize the structure or the mass
due to a constant sheet thickness across the orthosis, and does not incorporate modern analytical techniques that
ensure optimization of the durablity
and flex of the AFO to maximize a patient’s mobility.

“Whilst custom AFOs have always been turn it intod with a patient’s custom shape, additive manufacturing provides improved possibilities to truly customize the manufacturing of an AFO. The talent to adjust trim lines and change the type or thickness of plastic has provided a few basic options for tuning the flexibility of an AFO,” said Jeff Wensman, BSME, CPO, Clinical/Technical Director, University of Michigan, Orthotics and Prosthetics Center. “But, additive manufacturing, and specifically the CYBER team, is creating a system
to in fact
‘engineer’ and ‘turn it into’ an AFO for a specific patient. Different amounts or types of material can be printed to provide a specified stiffness and allow areas of flexibility, based on the patient presentation. This amazing
innovation opens up an entirely new tool box that
the clinician can use to enhance patient outcomes.”

The CYBER Solution: Making Industry 4.0 Real in Ankle Foot Orthotic Manufacturing

Stress loading and concentration analysis can allow for AFO part optimization, tailored for individual patient prescriptions

Stress loading and concentration analysis can allow for AFO part optimization, tailored for individual patient prescriptions

The CYBER team has come together to directly address these pain points that
affect patients and care-givers, while accelerating and reducing the cost of donatey of optimized ankle foot orthoses.

This next cloud-based cyber physical system
can allow clinicians to turn it into Ankle Foot Orthoses by utilizing an online portal, combining clinician expertise with automated tools to turn it into the patient’s prescription. The engineered cyber-physical system
provides the seamless integration of the cloud based algorithms with the physical component manufacture
to optimize overall part geometry and its corresponding tool-paths.

The advantages of an additive manufacturing solution for Ankle-Foot Orthoses are compelling:

  • Reduce the long donatey time: Typical donatey time is 2-4 weeks for AFOs. The team plans to reduce this donatey time to 1 day through the cyber-physical system
    .
  • Enhance the level of accuracy: Plaster shrinks after drying so plaster molds do not accurately duplicate the patient’s ankle and foot shape without iterations or the ability of a certified orthotist. The team plans to use precise
    , 3-dimensional scanning to provide precise
    size for swift, precise
    AFO accuracy while utilizing turn it into for additive manufacturing compensation techniques.
  • Eliminate multiple visits: This is taxing for users and caregivers, and drives cost.

The team plans to improve the manufacturing system
to provide single-visit patient care.

  • Enhance the limited turn it into freedom: Shapes of AFOs are limited by current manufacturing practices, that cannot fabricate orthoses that
    require
    additional intricate, functional turn it intos.

The team plans on enabling computational version and tool path based optimization to drive next AFO turn it into, while encouraging clinician input to provide manalized care. The average age of a lower extremity orthotic wearer is 70 years old; light-mass
ing and ease of use are important in this project.

Of course, no one man can properly execute all of the require
d knowledge to operate the current workflow require
ed to achieve this cyber-physical system
. Engineers, such as those at Stratasys and Altair, along with clinicians at orthotics & prosthetics centers, are the just folks knowledgeable adequate
to execute every specific task. Between multiple file types, the creation of structural and tool path optimization files, turn it into for additive manufacturing considerations, and orthotic most practices, the amount of guide computational analysis is daunting. Adding to the expertise require
ed, the current additive manufacturing workflow has drawbacks:

  • Machine throughput: The current additive manufacturing technologies do not provide high adequate
    throughput to enable the one-day visit for ankle-foot orthotics. A new turn it into methodology is require
    d to increase throughput and lower material usage, while maintaining structural integrity and functionality.
  • Multiple materials: Both stiff material for structural functionality and a soft material for effortless interfacing are require
    ed in one custom orthosis.
  • Lack of clinical interface and system
    integration
    : There is no software system
    that
    can seamlessly system
    all the data of the patient’s 3D scan geometry to shape of the orthosis, and to the printable command file.

Military Veterans May Be the First to Benefit

Aligning with the team’s dedication
to military veterans and their families, the US Veterans Administration (VA) in Ann Arbor, Michigan can be one of the initially partners to obtain this solution with the goal of deploying it to VA Orthotics & Prosthetics locations nationwide once testing is achieve. From 2005 to 2009, the yearly
VA spending on O&P related items has increased approximately 80%, of $907M to $1.6B. About 1.5 million orthoses were provided to veterans in 2009. These numbers are continually expanding
as the number of enrollments in VA Healthcare increases with the aging of the overall population. As concluded in the American Orthotic Prosthetic Association (AOPA) study, the savings for Medicare may be $1.3B per year by 2020 after full deployment of this solution to the VA network.2

The Cyber-Physical System workflow

The Cyber-Physical System workflow

The CYBER team believes that
cloud-based turn it into and additive manufacturing technologies provide the opportunity to improve healthcare professionals’ care to patients, with a goal to achieve a “One-Day Visit” in that patients can visit a clinic and walk away in their custom orthoses on the same day. Integrating additive manufacturing into orthotics and prosthetics patient care is an opportunity for the manufacturing community to manufacture a positive impact in healthcare; the good results of this project is expected to manufacture the manufacturing system
additional efficient and reliable, so that
orthotics and prosthetics service can be additional accessible to folks who require
it saving VA Healthcare and Medicare expense.

This project is scheduled to achieve its proof-of-concept in 2017.

To store up to date of
the latest makes it to in 3D printing for medical applications, please click here to sign up for the Stratasys Medical Innovation Series
.


Acknowledgement:

This material is based on research sponsored by Air Force Research Laboratory under agreement number FA8650-12-2-7230. The U.S. Government is authorized to reproduce and donate reprints for Governmental purposes notwithstanding any copyright notation thereon.

Disclaimer:

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of Air Force Research Laboratory or the U.S. Government.


1. Patient specific ankle-foot orthoses via rapid prototyping, Mavroidis et al., January 2011. Link: http://jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-8-1

2. Data on the market at http://mobilitysaves.org/

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