Professional Documents
Culture Documents
Abstract
Purpose – The purpose of this paper is to compare four different additive manufacturing (AM) processes to assess their suitability in the context
of upper extremity splinting.
Design/methodology/approach – This paper describes the design characteristics and subsequent fabrication of six different wrist splints using four
different AM processes: laser sintering (LS), fused deposition modelling (FDM), stereolithography (SLA) and polyjet material jetting via Objet Connex.
The suitability of each process was then compared against competing designs and processes from traditional splinting. The splints were created using
a digital design workflow that combined recognised clinical best practice with design for AM principles.
Findings – Research concluded that, based on currently available technology, FDM was considered the least suitable AM process for upper extremity
splinting. LS, SLA and material jetting show promise for future applications, but further research and development into AM processes, materials and
splint design optimisation is required if the full potential is to be realised.
Originality/value – Unlike previous work that has applied AM processes to replicate traditional splint designs, the splints described are based on
a digital design for AM workflow, incorporating novel features and physical properties not previously possible in clinical splinting. The benefits of
AM for customised splint fabrication have been summarised. A range of AM processes have also been evaluated for splinting, exposing the
limitations of existing technology, demonstrating novel and advantageous design features and opportunities for future research.
Keywords Textile, Additive manufacture, Heterogeneous, Orthotic, Wrist splint
Paper type Research paper
1. Introduction offer superior fit and comfort and, in many circumstances, can
be less bulky than off-the-shelf items. They can also be made
Wrist splints provide multi-faceted treatment outcomes to
to accommodate extremes of size and deformity that is not
patients, including pain relief through immobilisation of
always possible with off-the-shelf items, which inevitably have
affected joints (Callinan and Mathiowetz, 1996; Jacobs,
limits on their adjustability. Custom-made splints maintain
2003). Wrist immobilisation splints, for example, are designed
their shape at all times, while off-the-shelf items need to be
to immobilise the wrist while allowing mobility of all digits to
adjusted each time they are put on, and it is not always
promote endurance to everyday tasks (Pagnotta et al., 2005).
possible to replicate the adjustment precisely on each
There are two main categories of splints: prefabricated
occasion. Consequently, off-the-shelf splints cannot
“off-the-shelf” splints and custom-made splints. Prefabricated
accommodate every patient, and there will always be a need
splints can be bought from a variety of stores such as
for custom-made splints.
pharmacies, but may also be prescribed by splinting
This paper focusses on the creation of custom-made splints,
practitioners, such as occupational therapists or
as its end use is considered synonymous to fundamental
physiotherapists. Prefabricated splints may come in a range of
benefits of Additive Manufacturing in terms of Mass
sizes (e.g. small, medium and large) which assumes a
Customisation with regards to anatomical fit, function and
“one-size-fits-all” strategy, and not necessarily tailored to suit
appearance. While splints can be designed for many purposes,
an individual unless adjusted by the user or a splinting
practitioner. Alternatively, custom-made splints are produced
and distributed exclusively by splinting practitioners to suit
each individual patient’s lifestyle, as well as anatomical Many thanks to Dr Candice Majewski of the University of Sheffield and Dr
demands relative to their condition. Custom-made splints Dominic Eggbeer and Sean Peel of the National Centre for Product
Design & Development Research, Cardiff, for building the SLS and SL
prototype splints respectively. Thanks to Nigel Bunt and Sarah Drage of
HK Rapid Prototyping Ltd. for building the black and white Objet Connex
The current issue and full text archive of this journal is available on
splint; to Mark Tyrtania at LaserLines for the FDM splint; and to Phil
Emerald Insight at: www.emeraldinsight.com/1355-2546.htm
Dixon, Loughborough University, for assistance with the building of
numerous Objet Connex prototypes. The research was carried out as part
of a PhD research project, funded by Loughborough University.
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this study focussed on wrist immobilisation splints intended to Figure 2 Traditional splint fabrication process (Paterson et al.,
alleviate the symptoms of rheumatoid arthritis as an exemplar 2012). Image courtesy of SFF Symposium
application. An image of an immobilisation splint can be
found in Figure 1. If prescribed by a splinting practitioner, create a rough splint outline. Note anatomical
patients are typically provided with wear instructions, landmarks
including how to don/doff the splint and the expected wear
Cut template out
schedule. Each wear schedule is tailored to suit the patient,
their lifestyle and the suggested optimal treatment approach to Make
their condition, determined by their therapist (Lohman et al., adjustment(s)
2001).
No
A process model for designing and fabricating a Does template fit?
shear stress, directional misalignment and pressure over bony Make adjustments
Yes
prominences, which, in turn, can induce pressure sores Heat splint to affix Spot-heat splint
fasteners?
(Coppard, 2001). Furthermore, the presence of a No Implements
thermoplastic splint with uniform thickness and limited No
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exoskeletal assistive devices, ranging from clubfoot treatment individuals have explored the feasibility of AM splinting. For
methods (Gervasi et al., 2009; Smith, 2011b; Cook et al., example, Fraunhofer IPA used an EOS P100 LS system with
2010), spinal braces (Summit and Trauner, 2010a) and PA2200 powder (EOS GmbH Electro Optical Systems,
ankle–foot orthoses (Gibson et al., 2013; Faustini et al., 2008; Krailling, Germany) to offer a single example of an attractive
Mavroidis et al., 2011; Pallari et al., 2010), the latter being the solution to traditional splinting (Grzesiak, 2010). The benefit
focus of a Framework 7 European project called A-Footprint. of LS in this instance was the ability to introduce intricate
The majority of these works have focussed on the use of laser locking mechanisms which would have required less
sintering (LS); the benefits of which include relatively low part post-processing to remove unsintered powder acting as
cost compared to other AM processes and the ability to support structures. While Fraunhofer IPA have explored the
retrieve unsintered powder for future use. Furthermore, the integration of Voronoi patterns to their prototype (J.
fact that unsintered powder subsequently behaves as support Breuninger, personal communication, 26 November 2010),
for down-facing structures is also a significant advantage, as Evill (2013) has proposed the use of LS for splinting wrist
this enables the creation of complex geometries without fractures, incorporating a honeycomb structure with
incurring significant clean-up time and subsequent costs interlocking fasteners. Palousek et al. (2013) also explored AM
associated with manual post-processing while reducing the for splinting, but the intent was limited to reverse engineering
build time. Additive manufactured textiles (AMT) described a single existing splint that had been designed for traditional
by Bingham et al. (2007) demonstrate benefits of AM in terms manufacturing techniques, and this attempt failed to recognise
of part consolidation and assembly builds while proposing or explore the fundamental opportunities of design for AM
functional articulating wearable structures. Various AMT principles such as improved aesthetics and or light-weight
linkage designs and arrays have been explored for lattice type structures.
stab-resistant body armour, demonstrating its capabilities in In terms of material jetting technologies, Carpal Skin by
generating functional constructs to enable movement of the Oxman (2010) explored the multiple material build
intended wearer (Johnson et al., 2013). Furthermore, AMT’s capabilities available with Objet Connex systems (Stratasys,
look visually appealing, and although their integration into Eden Prairie, MN, USA). A range of Shore hardnesses were
artefacts to date remains a niche topic, the scope for integrated incorporated alongside stiffer materials in one build, resulting
aesthetical yet discrete functional AM textiles into in a heterogeneous splint. The term “synthetic anisotropy”
custom-fitting wearable devices is entirely feasible. was established to communicate the effect of directional
Extending the use of AM in context of assistive devices, influencers in the form of a specified pattern distribution to
Gibson et al. (2013) investigated the suitability of a low-cost, allow or restrict movement, the dispersion of which was
extrusion-type three-dimensional (3D) printer; their dictated by an algorithm sourced from a pain map defined by
justification being a low cost, in-clinic approach to fabrication an individual (PopTech, 2009; Oxman, 2011). While this
through the use of a RapMan 3D print extrusion system (3D approach explores the opportunities of design for AM, no
Systems, Rock Hill, SC, USA). Furthermore, Mavroidis et al. clinical validity has been published to date. Taking an
(2011) used stereolithography (SLA) (3D Systems, Rock Hill, alternative stance to performance, functionality and design
SC, USA) for ankle–foot orthoses, as a range of materials strategies of integrated features, Paterson et al. (2012)
could be used to offer different properties; for example, explored the potential integration of multiple materials into
Arptech’s DSM Somos 9,120 Epoxy (Arptech Pty Ltd, wrist splints under the direction of qualified and experienced
Victoria, Australia) offered a flexible solution while being clinicians who specialise in the design and fabrication of
biocompatible. SLA also demonstrates a high level of surface custom-fitted wrist splints within the National Health Service
quality and resolution when compared to original STL data. (NHS) in the UK. The research focussed on developing a
In the context of using material jetting systems for fabrication specialised workflow designed for splinting practitioners to
of assistive devices, Smith (2011a) describes the developments allow them to design splints in a virtual environment to
of the Miraclefeet organisation and North Design Labs with support AM; the manuscript focussed specifically on the
Objet Connex systems into custom-made paediatric clubfoot intent for placing multiple materials to behave as hinges or
orthoses. The most significant benefit of the approach was cushioned features as opposed to traditional fabrication
through exploiting the multimaterial-build capabilities on processes where a similar approach would be impossible to
offer, enabling heterogeneous builds including a range of replicate.
Shore hardnesses alongside more rigid materials to Having identified the relative strengths of four different AM
incorporate functional parts, such as flexible hinges and soft systems along with existing work into other custom-fitted
edge features for improved functionality and comfort. devices, the authors chose to explore opportunities in upper
Despite the previous studies into AM for lower limb extremity splinting for improved fit, functionality and
prosthetics and orthotics, the suitability of AM technologies in aesthetics. Features which were considered as potentially
the context of upper extremity (i.e. hand, wrist and forearm) beneficial included a “best fit first time” approach to provide
splinting is yet to be compared and evaluated, with suitable a customised fit for a patient relative to their anatomical and
courses of action established for future development. To date, rehabilitation needs, and AMT elements for hinges using LS
there has only been limited research and development into for easier donning and doffing. Furthermore, the authors
AM upper extremity splinting. The application has been chose to explore the opportunities for integrating varying
implied by Summit and Trauner (2010b), Fried et al. (2004) Shore hardnesses into wrist splints using the Objet Connex
and Fried (2007), and although no commercial approach has system, to include functional features such as integrated
been proposed yet, a number of research institutes and elastomer hinges or cushioned features over bony
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prominences. These new opportunities were impossible to repeatable, static data source in case a repeat scan was
deliver in traditional splinting, but are now entirely feasible as required later in the research process (Paterson, 2013). This
a result of AM. By exploring new, novel integrated form of data acquisition was to enable this research only and
applications into upper extremity splinting, future avenues for is not suggested for future clinical practice. The plaster cast
product development could be pursued. It was anticipated was scanned with a ZCorp ZScanner 800 hand-held 3D laser
that with these potential benefits, patient compliance would scanner (3D Systems, Rock Hill, SC, USA). The same scan
be improved. data were used for all subsequent splint designs, and therefore,
each demonstrated almost identical anatomical topographies
2. Aims and objectives (excluding integrated features such as lattices and fasteners),
which would therefore fit the participant used to generate the
The research reported in this paper represents one stage of a plaster cast. Using these scan data, six different splints were
long-term research project exploring the whole process of designed in a range of 3D CAD software packages and
digital splint design and manufacture, from data acquisition plugins:
through to data manipulation in 3D computer-aided design 1 Autodesk® Maya® 2011 (Autodesk, San Rafael, CA,
(CAD) to support AM. This paper describes the exploration USA).
of AM prototypes through comparison and subsequent 2 Geomagic Studio 2012 (3D Systems, Rock Hill, SC,
suitability of different AM processes based on the digital USA).
design workflow developed and described by Paterson (2013). 3 McNeel Rhinoceros® Version 4.0 (Robert McNeel &
By investigating previous research activity and potential AM Associates, Seattle, WA, USA).
process benefits, several design characteristics were planned ● Grasshopper plugin (Robert McNeel & Associates,
for upper extremity splint integration for this investigation. Seattle, WA, USA).
Particular focus was placed on improving aesthetics, fit and 4 PTC Pro/Engineer Wildfire 5.0 (PTC, Needham, MA,
function of splints and by exploring existing design features USA).
into the context for upper extremity splinting. 5 FreeForm Modelling Plus (3D Systems, Rock Hill, SC,
The aim of this paper was to demonstrate and evaluate the USA).
suitability of a range of AM processes to deliver custom-fitting
wrist splints, using the following objectives: The justification for using a wide range of CAD programs was
● Objective 1: To evaluate the design and fabrication of related to the underlying research; a separate and previous
homogeneous AM splints. stage in the overall research project was to develop a
● Objective 2: To evaluate the design and fabrication of specialised CAD workflow that effectively replicated the splint
heterogeneous (multiple material) AM splints with design process used by splinting practitioners/clinicians.
functional features, e.g. an elastomer hinge and soft edges. Therefore, there was a need to establish suitable tools which
● Objective 3: To demonstrate varied part consolidation, could ideally replicate and/or improve upon traditional
resulting from AM processes through integrated fastener fabrication methods and techniques in a virtual environment
features. within 3D CAD programs. Several different CAD packages
● Objective 4: To evaluate the integration of a textile-hinge to were used during this phase of the research, as each program
demonstrate assembly build capabilities. had different tools, offering different strengths and limitations
● Objective 5: Establish relative strengths and limitations of which were considered appropriate for splinting applications.
each AM process relative to recognised best practice in Tools and CAD strategies were developed in that phase of the
splint design. research to create a customised software workflow, and these
● Objective 6: Establish areas for future research and methods were taken forward to the design and fabrication of
development relating to design of wrist splints for AM. the customised AM splints described in this paper. The design
workflow and exploration of CAD approaches is described
fully by Paterson (2013) and is the subject of publications
3. Method pending. In short, this workflow translates into a 3D CAD
One of the fundamental requirements of the AM splinting environment, the same design intent as the traditional design
approach was to deliver a customised fit to the patient, as this approach. Therefore, the “design rules” for the design of
is a standard requirement in traditional custom-made splints is adhered to in the digital workflow and this has been
splinting. To deliver this, the patient’s skin surface topography evaluated and approved by a number of qualified splinting
would be required to capture the patient’s anatomical data. professionals. The design steps include, for example, defining
These data could then be used to extract and subsequently the boundary of the splint following anatomical landmarks,
generate a 3D virtual form of a splint to match their topography. defining the material thickness, rounding edges and alleviating
Before AM splints could be fabricated for evaluation, 3D pressure on sensitive areas. Over and above the traditional
CAD splint models had to be generated. The organic approach, the choice of lattice pattern is introduced to reduce
topography of a forearm and hand was required to generate an weight, improve ventilation and enhance aesthetics. This
accurate profile for CAD manipulation. Scan data were workflow has been developed to facilitate recognised clinical
acquired from a healthy volunteer by 3D laser scanning a practice within a digital environment and has been critically
plaster cast, as described by Paterson et al. (2010). A plaster evaluated by experienced and qualified clinical professionals.
cast was used to eradicate concerns with noise that would Four different 3D CAD models were created in total,
otherwise be collected through involuntary movement and designed for homogeneous AM fabrication using:
tremor during scanning. The plaster cast provided a 1 LS: EOS P100 Formiga, made with EOS PA2200 50:50
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powder (EOS GmbH Electro Optical Systems, Krailling, with the main structures of the splint using a Boolean Union
Germany). This process was used to explore opportunities function.
to integrate textile elements into a splint for added The AMT element was specifically designed to exploit the
functionality. freedom of form available through LS (Figure 3), as support
2 FDM: Stratasys Dimension SST1200es, made with ABS structures commonly required by other AM systems would
(Stratasys, Eden Prairie, MN, USA). not be required in this instance. Because un-sintered powder
3 SLA: 3D Systems 250, made with Accura® Xtreme resin provides support for overhangs, LS was considered the most
(3D Systems, Rock Hill, SC, USA). effective approach, as overhangs in AMT linkages were
4 PolyJet matrix material jetting: Objet Connex 500, made abundant. Clean-up time was also considered, as the
with FullCure® 515 and FullCure®535 to generate un-sintered powder would only require removal via
RGD5160-DM (Stratasys, Eden Prairie, MN, USA), high-pressure air jets and vibration to remove excess powder
displaying ABS-like properties. between linkages. Other processes could be used such as 3D
jetting/printing techniques, for example. However, depending
Finally, a heterogeneous splint was designed to exploit the
on the exact process and material combination used, support
multiple material capabilities of Objet Connex technologies,
material removal could result in additional time and, in some
by using TangoBlackPlus and VeroWhitePlus to generate
cases, could damage the AMT linkages. SLA would also prove
DM9840FLX and DM9850FLX material ranges (Stratasys,
ineffective for this approach because supports would be
Eden Prairie, MN, USA). Although outputs were similar to
required for links within the textile element which would
those of the study by Oxman (2012), the combination with
prove difficult and time-consuming to remove.
integrated aesthetic lattice structures was also targeted as an
In addition, mushroom-like fasteners were integrated into
output in this context. With the exception of the Objet
the design to demonstrate part consolidation of fasteners
Connex heterogeneous build, material choice was not
within the build, as opposed to detached fasteners used on
considered important within this investigation, as the research
traditional splints such as Velcro.
focussed on highlighting potential differences in AM systems
and their specific capabilities. However, the authors
3.2 Homogeneous circumferential build designs
acknowledge that material choice is crucial in many aspects in
Two circumferential splint designs were modelled in 3D CAD
assessing part quality and delivering for the intended need.
(Figure 4). The splints were designed in two corresponding
Material choice to the extent of being able to vary properties in
parts to enable donning and doffing. The design was intended
the heterogeneous build was, however, important for the
to behave as a “pinch-splint”, where the user could pinch the
multimaterial splint, as this was considered the most
important characteristic to display in this context.
In the next section, each of these designs will be described Figure 3 Splint prototype with textile hinge, colour-coded to
in more detail, corresponding to the AM process considered represent grouped manifold sections. Modelled using Matlab, Rhino
most appropriate for the design. Different designs were and Grasshopper for linkage integration
fabricated on different AM systems to demonstrate the
versatility of AM systems relative to their particular strengths
described in Section 1 (Introduction). Furthermore, LS was
only used for the fabrication of a textile splint, as previous
studies described in Section 1 have already demonstrated
homogeneous splint prototypes using LS; the development of
a textile element in this case was therefore considered a
potential novel contribution to knowledge.
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1.
2.
3.
4.
2.
1.
KEY
1. Low Shore rating elastomer edges
2. Rigid splint structure
3. Cushioning elastomer located over bony prominence
4. Elastomer hinge
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Abby Megan Paterson et al. Volume 21 · Number 3 · 2015 · 230 –243
arm hair, causing discomfort if extracted from hair follicles Figure 8 Accura® Xtreme splint, built on a 3D Systems 250
(i.e. trapping and pulling out body hairs). However, larger (Paterson et al., 2012). Prototype courtesy of Dr D. Eggbeer, Product
links would reduce this risk. Cleaning such a splint would also Design Development Research (PDR), Cardiff. Image courtesy of SFF
prove problematic unless immersed in a detergent or washed symposium. Image courtesy of SFF Symposium
with an automated process/system such as a dishwasher, as
proposed by Fried (2007). LS parts can withstand
dishwashing, and this has been discussed with reputable LS
suppliers, although, to date, this has not been rigorously tested
or reported. As a preliminary test, the researchers placed the
splint in a dishwasher at various temperatures (45, 50 and
65°C) along with branded dishwasher detergent, with no
visible after-effects.
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Customised wrist splints Rapid Prototyping Journal
Abby Megan Paterson et al. Volume 21 · Number 3 · 2015 · 230 –243
clinical application. However, this could be minimised by Figure 11 FullCure®515/FullCure®535with ABS-like properties, built
using patterns that formed self-supporting structures which on the Objet Connex 500 model
would eliminate the majority of the supports and the issues
encountered in their removal. A simple example is shown in
Figure 10. The disadvantage of this approach would be a
reduction in aesthetic possibilities and limited patient choice
of pattern.
Finally, a fourth homogeneous splint built on the Objet
Connex is shown in Figure 11. An initial visual and tactile
interpretation of surface quality was considered acceptable
compared to other AM processes described in this paper. In
addition, the fastener design and overall splint structure was
able to perform and withstand its intended function in flexing
to allow the user to don and doff by pinching the palmar
aspect of the splint, and subsequently, demonstrated part
consolidation in the context of AM splint fabrication.
However, a significant amount of support material (FullCure
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Abby Megan Paterson et al. Volume 21 · Number 3 · 2015 · 230 –243
Figure 12 Heterogeneous splint; assorted materials within one AM compression and tension forces resulting in split lines. An
build, using the Objet Connex additional hinge could have been placed along the radial
aspect so both sides of the splint could have been opened to
TangoBlack Plus FullCure VeroWhite
help donning. Similarly, the shape of the splint hinge was
inappropriate, as it was formed in 3D CAD by two parallel
planes intersecting the splint geometry. If one considers a
living hinge in a polypropylene DVD case; for example,
rotation around a single axis results in a uniform distribution
of compression and tension exerted throughout the length of
the hinge structure. However, because of the organic
topography of the splint, compressive and tensile stresses
varied throughout the structure, subsequently, having a higher
tensile concentration towards the borders of the splint, while a
higher compression concentration was demonstrated on the
inner region of the hinge. Therefore, the shape of the hinge
element may have benefitted from being a varied shape to suit
the topography. Although not formally documented, a very
DM9850FLX DM9840FLX
slight level of creep was also observed over time, resulting in a
slight twist in the splint. This is most likely due to the fact that
Figure 13 Failures in the multimaterial elastomer hinge (Paterson the splint has been stood upright on display for extended
et al., 2012). Image adapted, courtesy of SFF Symposium periods and it would be reasonable to assume that were the
splint worn for extended periods, it would be more likely to
retain the intended shape. Therefore, future research would be
required to assess the extent of creep, as well as establishing
design rules to reduce local strain and therefore avoid failures
at the hinge. However, surface quality and resolution was
considered adequate in comparison to FDM and LS.
Unfortunately, the multimaterial build required a large
volume of support material (FullCure 705), as shown in
Figure 14. Much like the ABS-like splint, the support material
was removed with a high-pressure water jet. Not only does this
increase cost in terms of material consumption but also costs
relating to labour time.
Table I compares evaluation criteria relative to each AM
process used within this investigation.
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Figure 14 Support material required for the Objet multi-material that prove the safety of the entire design, materials and
build in upright position manufacturing process.
Cost analysis must also be performed to determine which
process, if any, can be cost effective in terms of clinical
demands. Although current practice involves the use of cheap
materials, the labour costs could be cut dramatically. This is
especially the case when fabricating duplicate splints, for
example. In current practice, the entire crafting process must
be repeated for each and every splint – there are no economies
of scale. When using AM, repeat splints would incur materials
costs only. It is also important to consider the hidden costs of
time and travel involved in clinic appointments for the patient
as well as the clinician. The AM process can eliminate repeat
prescription time; if a patient requires a replacement/duplicate
splint as a result of previous failure or the desire for a different
aesthetic design, the patient would not need a repeat clinic
session with their practitioner to fabricate a new splint.
Instead, a request could be logged, and a duplicate splint
ordered instantaneously. Such an order could be added to a
queue for manufacture, and then dispatched when the build is
complete; a similar approach to the latter stages of the
proposed automated process by Fried (2007). This reduction
in clinic time could reduce demands on the clinic, potentially
reducing waiting times and patient waiting lists. In turn, this
could improve patient satisfaction in the health-care system.
The economic advantages of an AM approach are predicated
on replacing a high labour cost manual crafting process with a
much more efficient design then manufacture process.
Consequently the economic factors are very much context
dependent. It can be envisioned that in high labour cost
regions, the AM approach may greatly reduce labour costs to
the extent that the higher material costs of AM are more than
compensated for. This work has been conducted within a UK
and ideally would both be made available features in National Health Service context, but future work on costing
specialised 3D CAD for clinicians to explore in the future. will enable a more direct calculation of economic benefit in
In terms of integrated functionality, the heterogeneous different contexts around the world. Similar arguments for the
splint was the most versatile, and could be exploited in a range
potential benefits of a digital design and manufacture process
of situations, as highlighted by Paterson et al. (2012). If the
have also been explored in maxillofacial prosthetics by
digitised splinting approach were to be introduced as a
Eggbeer (2008). Another implication in cost effectiveness is
realistic option for clinics, the choice of AM process would be
improved compliance, leading to improved patient outcomes
dependent on the needs of the patient, as prescribed by their
in the longer term. The impact of patient involvement (i.e.
therapist, but a thorough understanding of different AM
choosing patterns and colours) and enhanced aesthetics on
processes and relevant AM materials would be needed by the
compliance is the subject of current research by the authors.
therapists.
Despite the aesthetic and functional advantages displayed in One of the aesthetic considerations available in clinics,
the results, several developments would be required before which could not be demonstrated fully, was the customisation
such processes may be feasible for adoption in clinical of colour choice. Colour ranges are currently limited in AM
situations. First, the development of suitable materials would processes; the 3D Systems ZPrinter 450 (3D Systems, Rock
need to be explored further, taking into consideration the Hill, SC, USA) can provide multicolour builds, while a range
long-term exposure to the skin. Although a number of AM of FDM machines can offer various single colour builds.
materials such as Objet’s MED610TM transparent, rigid However, within the scope of this investigation, colour choice
material and Stratasys’ ABS-M30i claim ISO 10993 amongst LS, SLA, FDM and PolyJet material jetting is
(biological evaluation of medical devices) and/or USP 23 limited. The Objet Connex gave the widest variety, allowing
Class VI approval in a range of conditions such as irritation for an integrated range from black to white. Other colours are
and hypersensitivity, regulations involve standardised tests achievable with the Objet Connex such as VeroBlue
which may not necessarily take into account specific design (RGD840), green (ABS-like RGD810) and transparent
and manufacturing processes. While this certification (VeroClear RGD810) (Stratasys, Eden Prairie, MN, USA),
demonstrates that the materials are inherently low in toxicity although Holmes (2012) speculates multicolour build
the requirements of the European Medical Device Directive capabilities in the future in response to work by Oxman
and the various international equivalents require clinical trials (2012). Some service providers are able to supply colour-dyed
239
Table I Summary of AM processes and comparative evaluation criteria
AM process LS (textile PolyJet
Evaluation criteria SLA splint) FDM PolyJet (Homogeneous) (Heterogeneous)
System 3D Systems 250 EOS P100 Stratasys Dimension Objet Connex 500 Objet Connex 500
Customised wrist splints
Abby Megan Paterson et al.
Formiga SST1200es
Material(s) Accura® Xtreme PA2200 ABS FullCure®515/FullCure®535 (ABS-like) TangoBlackPlus
VeroWhitePlus
DM9850FLX
DM9840FLX
Unique benefits – Textile element – – Heterogeneous
Build speed Poor (draining and post-curing Poor (heat-up and Poor Adequate Adequate
required) cool-down periods
required)
240
Surface quality Good Poor Poor Adequate Adequate
Accuracy and resolution Good Good Poor Good Good
Z plane build weaknesses? Mild Mild Severe Mild Mild
Rigid build supports required? Yes No Yes Yes Yes
Post-curing required? Yes No No No No
Rigid support removal required? Yes - removal by hand, No, although Yes, although WaterWorks™ Yes, using high-pressure water jet Yes, using high-pressure
followed by surface sanding removal of supports are soluble water jet
powder between
linkages is
required
Comparative material cost High £179.00 Lowest ⬃£55 High £290 Highest £246 and £267, respectively High TangoBlackPlus ⫽
(£/1 kg) (excl. VAT and shipping) £245 VeroWhite ⫽
£200
Rapid Prototyping Journal
Volume 21 · Number 3 · 2015 · 230 –243
Customised wrist splints Rapid Prototyping Journal
Abby Megan Paterson et al. Volume 21 · Number 3 · 2015 · 230 –243
LS parts, but, typically, colour choice is limited and colour splints in a dishwasher, and, as such, will form further research
fastness is an issue. to determine suitable variables for extending the life of a
It was hypothesised that the mechanical failures of the splint.
multimaterial splints were due to a number of factors, In Section 1 (Introduction), the authors identified that
including: previous researchers had limitations relating to clinical validity
● Limited tensile strength, elongation and tear resistance of for the use of upper extremity splinting. Similarly, the authors
flexible Objet materials, e.g. 0.5-1.5 MPa, 150-170 per also recognise and acknowledge that significant future
cent and 4-6 kg/cm, respectively, for FLX9840-DM research is required with respect to their own documented
material (figures according to Stratasys, 2013). Similar work before conducting clinical trials to consider the efficacy
issues were highlighted by Moore and Williams (2012) and of the approach for end use applications. This includes the
Eggbeer et al. (2012) (Figure 15). exploration of analytical studies relating to all design work to
● Degradation of material over a period of time (including consider material properties and structural integrity. The authors
creep). also acknowledge that further work must be explored into
● Suboptimal location/shape of the flexible hinge relative to suitable data capture methods to support the digitised splinting
the organic geometry of the splint, and the force exerted approach for suggested improvements to fit and function. In
when opening and closing the splint when donning and addition, comments relating to surface finish and surface
doffing. roughness were not quantified but preliminary in this case.
Therefore, further research is required to quantify the surface
However, further research is required to explore these areas,
roughness of AM splints, and the potential effect with the skin
with opportunities to establish interventions to overcome
if worn by a patient, such as abrasion. Lastly, the current
these limitations. Because the underlying research focussed on
research is limited in terms of the usability of splints, as
the 3D CAD processes to design splints for AM, performing
developments, to date, have not yet allowed for clinical trials.
mechanical tests on the prototypes was outside the remit of
Further work will be required to assess the usability of
this investigation. The authors have performed research using
different splint designs relative to a range of manual tasks (e.g.
finite element analysis on a number of the proposed designs to
driving) which patients can compare and contrast against their
enable comparison of the mechanical properties with
previously prescribed splints made with traditional methods.
traditional practice, and this work will be published in due
course. Structural analysis of homogeneous and
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Customised wrist splints Rapid Prototyping Journal
Abby Megan Paterson et al. Volume 21 · Number 3 · 2015 · 230 –243
technologies”, in Bourell, D., Crawford, R.H., feasibility of using computer-aided design to support the
Seepersad, C.C., Beaman, J.J. and Marcus, H. (Eds), fabrication of upper extremity splints using Additive
Proceedings of the 23rd Annual International Solid Freeform Manufacturing. She is now a lecturer in computer-aided
Fabrication Symposium, 6-8 August, University of Texas, design at the University of Manchester, exploring
Austin, TX, pp. 656-672. opportunities for Additive Manufacturing in the fashion
Poptech (2009), Neri Oxman: On Designing Form, available at: textiles industry, as well as pursuing her research into
www.youtube.com/watch?v⫽txl4QR0GDnU (accessed 17 rehabilitative products. Abby Megan Paterson is the
April 2010). corresponding author and can be contacted at:
Smith, S. (2011a), Micraclefeet and Objet Bring Innovation to a.m.paterson@lboro.ac.uk
Braces, available at: www.deskeng.com/articles/aabamt.htm
(accessed 7 August 2012). Richard Bibb has a degree in industrial design and a PhD
Smith, S. (2011b), Miraclefeet and Objet Bring Innovation to
in Additive Manufacturing. His research focusses on the
Braces, available at: www.deskeng.com/articles/aabamt.htm
application of advanced product design and development
(accessed 25 May 2011).
technologies in healthcare. This research explores the
Stratasys (2013), Objet Digital MaterialsTM Data Sheets [online
development and application of CAD and additive
PDF], available at: www.stratasys.com/materials/polyjet/⬃/
media/879CBF2F6582406C9C1B629F4F9E05D5.ashx manufacturing in the design, development and manufacture
(accessed 4 April 2013). of rehabilitation products, medical devices, prostheses and
Summit, S. and Trauner, K.B. (2010a), “Custom braces”, surgical guides. This includes utilising design approaches
casts and devices having limited flexibility and methods for such as user-centred design and co-design to ensure that the
designing and fabricating, US patent 20100138193A1. results of the research are appropriate and desirable to
Summit, S. and Trauner, K.B. (2010b), “Modular custom patients and clinicians as well as manufacturers.
braces”, casts and devices and methods for designing and
R. Ian Campbell is the Editor of the Rapid Prototyping
fabricating, US patent 20100268135A1.
Journal and a reader in computer-aided product design at
Veehof, M.M., Taal, E., Willems, M.J. and Van De Laar, M.A.F.J.
Loughborough University. His research interests relate to the
(2008), “Determinants of the use of wrist working splints in
development and applications of Additive Manufacturing
rheumatoid arthritis”, Arthritis Care & Research, Vol. 59 No. 4,
pp. 531-536. technologies, including the exploration and effective uses of
Wohlers, T.T. (2012), Wohlers Report 2012: Additive computer-aided design to support design for additive
Manufacturing and 3D Printing State of the Industry, Annual manufacturing.
Worldwide Progress Report, Wohlers Associates, Colorado.
Guy Bingham is a Lecturer in the Design School at
Loughborough University and a member of the Design
About the authors Practice Research Group. His research focus is concerned
Abby Megan Paterson is a former PhD student from with the design opportunities and implications of Additive
Loughborough University. Her research explored the Manufacturing.
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