3D Micro-Printing: A new Era for Med-Tech Applications - EPFL

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3D Micro-Printing: A new Era for Med-Tech Applications - EPFL
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                 3D Micro-Printing: A new Era
                 for Med-Tech Applications
                 How three-dimensional thinking is turning a piece of material into smart medical
                 devices
                 Alexander Steimle

  Meet us at     In recent years, 3D printing has at-
Photonics West   tracted increasing attention in many
  North Hall     industries. From bioprinting of living
 Booth 4320      organs to engine and airplane compo-
                 nents, a variety of 3D printing tech-         3.0 mm
                 niques are already in use today, mainly
                 differentiated by the additive or sub-
                 tractive manufacturing approach. But
                 what’s the application potentiality in
                 the med-tech industry with regards to
                 3D printing at micro-scale? And how         Fig. 1 Safe puncture tool made of a single glass substrate (Source: Instant Lab & Galatea Lab)
                 innovative three-dimensional think-
                 ing can tackle human diseases such as       cording to a McKinsey report [1], 100 to         factors for device functionalization.
                 the retinal vein occlusion (RVO) and        200 billion US dollars per year could be         The FEMTOPRINT technology is a
                 create transformative products?             generated from direct manufacturing by           pio­neering subtractive manufacturing
                                                             2025, especially in markets with com-            technique, Prism Award finalist in 2015
                 The prospect of machines that can print     plex, low-volume and highly customiz-            among others. It is based on a two-step
                 objects the same way an inkjet printer      able parts such as medical implants, with        process of ultrashort-pulsed laser radi-
                 creates images on paper, or like ancient    elimination of tooling costs, reduction          ation in transparent materials, followed
                 Greek sculptors used a chisel to create     in wasted material and handling costs.           by chemical wet etching, to selectively
                 statues of mythological figures, has in-        In the majority of the cases, addi-          remove the exposed material and form
                 spired enthusiasts to declare 3D printing   tive manufacturing techniques such as            three-dimensional shapes (Fig. 2). The
                 a significant contributor of the 4th in-    selective laser sintering (SLS), stereo-         laser beam, focused inside glass, locally
                 dustrial revolution, also called the Dig-   lithography (SLA) or fused deposition            modifies the refractive index of the mate-
                 itization Era. Direct manufacturing out     modeling (FDM) are used, where one               rial and creates patterns that can be used
                 of 3D printing is considered a promising    layer at a time is created, each layer on        to realize integrated optical components
                 source of potential economic impact in      top of the previous until the final object       or to develop, by chemical etching, even
                 industry for the upcoming years. Ac-        is complete. The processes vary between          three-dimensional structures, with high
                                                             material melting and subsequent depo-            precision, aspect ratio and complexity.
                                                             sition, or through solidifying material          Today, this technology platform is a stan-
      Company                                                using lasers. Although the technologies          dardized process compliant to the ISO
                                                             are evolving rapidly, there are still lim-       13485:2016, and a micromachining ref-
      FEMTOprint                                             itations in building speed, limited ob-          erence in the industrial manufacturing of
      Muzzano, Switzerland                                   ject size, precision and resolution, lim-        micro-devices. Further to optical patterns
      FEMTOprint SA is a Swiss high-tech company man-        ited material strength and homogeneity,          and 3D components, new complemen-
      ufacturing 3D printed microdevices out of glass and    incompatibility to high temperatures or          tary capabilities include glass-to-glass en-
      other transparent materials (e.g. fused silica and     living tissues such as the human body,           capsulation at low temperature, hole drill-
      borosilicate) with sub-micron resolution, enabling
                                                             and in some cases the need for mechan-           ing, glass cutting, and a self-developed
      the integration of fluidic, optical and mechanical
      functionalities in single monoliths at nano- and       ical support structures and a post-pro-          thermal polishing process to reduce the
      micro-scale. Through the innovative FEMTOPRINT         cessing step for residual removing and           surface roughness below 10 nm Ra.
      tech-platform, Prism Award Finalist (2015) and ISO     smoothen surface.                                    The advantages of the technique
      13485:2016 certified, the company is transforming          At the micro scale, a more pre-              consent the reduction of manufacturing
      the way industrial, highly complex microsystems are    cise technique, namely the subtrac-              steps, tools and costs. The direct writing
      conceived.
                                                             tive manufacturing, has gained sig-              process works in an out-of-cleanroom
                                        www.femtoprint.ch    nificant success where high precision,           environment. It does not need masks,
                                                             complexity and resolution are critical           post-processing to remove residuals and

       32        Laser Technik Journal        1/2018                                                       © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim
3D Micro-Printing: A new Era for Med-Tech Applications - EPFL
Additive Manufacturing

                                                                                           Healthy retina                     Retinal vein occlusion
           Laser exposure                    Chemical etching

                                                                                                                                                                Fig. 3 Com-
                                                       Ø 20 µm                                                                                                  parison of ret-
                                                                                                                                                                inal veins and
                                                                                                                                                                vision effect
                                                                                                                                                                of healthy
                                                                                                                                                                retina and
                                                        1.0 mm                                                                                                  RVO (Source:
                                                                                                                                                                Instant Lab,
                                                                                                                                                                Galatea Lab /
Fig. 2 Schematic view of the FEMTOPRINT process                                                                                                                 Web)

is a versatile solution for rapid proto-            quality. Thanks to the unique 3D capa-                     RVO can be treated by cannulation
typing and serial productions, reducing             bilities, innovative and cost-effective                 and injection of therapeutic agents in
new product development cycles. The                 medical tools, implants and diagnostic                  the affected vein to remove clots, which
novel technology is giving the oppor-               chips can be easily fabricated.                         are limiting the oxygen transportation
tunity to engineers to explore the third                FEMTOprint, in collaboration with                   into the retina (Fig. 4). However, can-
dimension at microscale with sub-mi-                Galatea Lab, Instant Lab (EPFL, Swit-                   nulation of small retinal veins is con-
cron resolution, adding feature-sized               zerland), and the Jules-Gonin ophthal-                  sidered very risky and challenging, due
complexity and integrate optical, me-               mic hospital (Lausanne, Switzerland),                   to multiple reasons. The fragility of the
chanical, fluidic and even electrical               recently joined their forces into a con-                puncturing tissues, the required punc-
functionalities to the device, resulting            sortium to realize a challenging, glass-                ture force (~20 mN) that is well below
in increased performances and reliabil-             based compliant puncture tool for ret-                  human sensing capability, surgeon hand
ity in a miniaturized space. The critical           inal vein occlusion (RVO), a common                     tremor, eye motion during surgery and
alignment of 2D microcomponents and                 retinal vascular disorder causing severe                the dimensions of the tool that need to
the time-consuming assembly steps are               loss of vision and affecting around 16                  be compatible with the vein [2]. Cur-
now overtaken issues. Adding even more              million patients worldwide over fifty                   rent medical treatments do not address
creativity and complexity, devices made             years old (Fig. 3).                                     the underlying cause of vein occlusion
with this technology can be coupled with
complementary fabrications like metal
evaporation to create embedded elec-
trodes, several functionalization to form
hydrophobic or hydrophilic surfaces, or
coupling waveguides to structure opto-
fluidic devices.                                                                                 drug injection
    Glass has a widespread technological
usage and is the main starting material
                                                                                                     clot
of the process. At microscale, from an
ordinary, amorphous material, it takes
on surprising properties – including,
but not limited to, optical transpar-                                               punctured vein
ency, thermal and chemical stability,
                                                    Fig. 4 Schematic view of a retinal vein cannulation (Source: A. Gijbels, KU Leuven)
low thermal expansion, high elastic-
ity (as it is known from optical fibers),
                                                                 actuation stage       spring
biocompatibility, homogeneity and un-
usual dielectric properties – that offers                                                                   3D pivots
a powerful combination for new types
of med-tech tools, biomedical chips
with antibacterial surface treatments,
micro-nozzles for nebulizers, integrated                                                                                                               needle
optical devices and interconnects, to                                tuning stage
end up in micromechanical watch com-                                                  beam
ponents with embedded microfluidic
channels and shock absorber.
    In the med-tech industry, the capa-
bilities of the technology significantly                                                                                                    1.0 mm
contribute to the improvement of med-
ical engineering and, therefore, of life            Fig. 5 SEM image of the puncture tool (Source: Instant Lab and Galatea Lab)

© 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim                                                                 Laser Technik Journal            1/2018            33
3D Micro-Printing: A new Era for Med-Tech Applications - EPFL
www.photonicsviews.com

                                                       Energy
                                                                           unstable                                                                                           tool is suitable also for long injection
                                                                                                                               Force
                                                                                                                                                                              time. In an experimental trial, the tool
                                                                                                                                                                              successfully cannulated pig eye retinal
                                                                                            ∆E                                                                                veins (Fig. 8). In its final configuration,
                                                                                                                                                                              the surgical tool can be used in either
                                                                                                                                                                              stand-alone mode or mounted onto a
                                                                                                                                                            Position          robotic system.
                                                                                                                                                                                  The results of this challenging proj-
                                                                        stable
                                                                                                                                                                              ect demonstrated once more the capa-
                                                                                                Position                       Threshold force                                bility to boost engineering creativity
                                                                                                                                                                              and design real three dimensional free
                  Fig. 6 Strain energy reaction force of a bistable mechanism (Source: Instant Lab and                                                                        forms, taking advantage of material
                  Galatea Lab)                                                                                                                                                properties to obtain medical applica-
                                                                                                                                                                              tions at sub-micron resolution, with
                                                  30                                                                     600
                                                                measurement                                                            measurement                            high accuracy and complexity, accord-
                                                                simulation                                                             simulation
                   Forward switching force [mN]

                                                  25                                                                     500                                                  ing to the ISO 13485:2016 medical de-
                                                  20            cannulation                                                        cannulation                                vice certification and industrial stan-
                                                                                                           Stroke [µm]

                                                                                                                         400
                                                  15
                                                                   stroke                                                             stroke                                  dards for large volumes throughput.
                                                                                                                         300
                                                  10                                                                                                                          Acknowledgements
                                                                                                                         200
                                                   5                                                                                                                          This work is funded by the Swiss com-
                                                   0                                                                     100                                                  mission for technology and innova-
                                                       0        5     10       15     20   25       30                         0       5    10       15     20    25   30     tion, CTI. We thank all parties involved
                                                                           Tuning [µm]                                                           Tuning [µm]
                                                                                                                                                                              from the Jules-Gonin hospital, Galatea
                  Fig. 7 Experimental and numerical values of puncturing force and stroke for different tun-                                                                  Lab and Instant Lab for the support, as
                  ing displacements (Source: Instant Lab)                                                                                                                     well as Mr. Mohamed Zanaty and Mr.
                                                                                                                                                                              Thomas Fussinger for their contribu-
                  but only treat the complications such as                                                 fabricated out of a fused silica monolith                          tions to this work.
                  macular edema.                                                                           that integrates three major features:                                              DOI: 10.1002/latj.201800003
                     The developing group conceived,                                                       mechanical 3D cross pivots acting as a
                                                                                                                                                                              [1] J. Manyika et al.: Disruptive technologies:
                  manufactured and tested a passive com-                                                   bistable mechanisms (i.e., having two
                                                                                                                                                                                  Advances that will transform life, business,
                  pliant tool for retinal vein cannulation                                                 stable states and one unstable state), flu-                            and the global economy (2013) p. 111
                  (RVC) that relies on a buckling mechan-                                                  idic channels in the needle tip to vehic-                          [2] M. Zanaty et al.: Safe Puncture Tool for Ret-
                  ical principle to safely and precisely can-                                              ulate drugs and finally, optical elements                              inal Vein Cannulation (2017)
                  nulate veins in eye surgery, independent                                                 to measure applied forces (Fig. 5).                                [3] S. Henein: PhD thesis no 2194, EPFL
                                                                                                                                                                                  (2000).
                  of the actuation input. This has been                                                        The bistable mechanism releases
                  possible by combining the advanced                                                       a constant amount of energy when it
                  manufacturing capabilities of the                                                        passes from its unstable state to a stable
                  FEMTOPRINT technology with the                                                           state [3]. It follows that a threshold force
                  glass properties, like robustness and fa-                                                can be obtained by limiting the stroke                                     Author
                  vorable elasticity, transparency and bio-                                                of the mechanism (Fig. 6). This ensures
                  compatibility. The element was entirely                                                  safe and precise cannulation of the reti-                                                 Alexander Steimle
                                                                                                           nal vein, assuming a very thin wall, with                                               holds a degree in busi-
                                                                                                                                                                                                   ness administration
                                                                                                           puncturing force lower than the thresh-
                                                                                                                                                                                                   with a major in busi-
                                                                                                           old force, cannulation is guaranteed.                                                   ness development of
                                                                                                           The surgeon simply displaces the mech-                                                  the Haute École de
                                                                                                           anism across its unstable state.                                                        Gestion in Lausanne,
                                                                                                               Experiments conducted to-date have                                                  Switzerland. He has
                                                                                                           been very promising. The stability pro-                                                 been working in tech-
                                                                                                                                                                                                   nology and med-tech
                                                                                                           gramming of the double pinned bistable                             start-ups in Europe and Brazil, as an entre-
                                                                                                           beam gives control over puncture force                             preneur and from the VC perspective, where
                                                                                                           and stroke. The puncturing method has                              he led the advisory business (Criatec Fund
                                                                                                           then been validated by FEM simulations                             and Venerdì Investments). Back in Switzer-
                                                                                                           and experimental measurements (Fig. 7),                            land in January 2016, he joined FEMTOprint
                                                                                                                                                                              as a Business Developer and is currently
                                                                                                           demonstrating several advantages for
                                                                                                                                                                              Head of Sales and responsible for Med-tech
                                                                                                           both the patient and the surgeon: Punc-                            application developments.
                                                                                                           turing the force is independent of the
                                                                                                           surgeon force, actuation displacement                              Alexander Steimle, FEMTOprint SA, Via
Fig. 8 Measurement setup of the experiment on a pig eye                                                    is decoupled from puncturing position,                             Industria 3, CH-6933 Muzzano, Switzerland,
(Source: Instant Lab and Galatea Lab)                                                                      it’s insensitive to hand tremor and the                            Email: alexander.steimle@femtoprint.ch

       34         Laser Technik Journal                                               1/2018                                                                                © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim
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