Institute of Micro Technology and Medical Device TechnologyComputational design and rapid manufacturing of certified devices, mechanisms and robots

Prof. Dr. Tim C. Lüth

n The focus of the Institute of Micro Technology and Medical Device Technology is to accelerate the process of developing ideas into pro- ducts. In research and science, the time required for implementation is a significant factor for success. Therefore, rapid prototyping and rapid manufacturing technologies are part of our main research interest. We are systematically developing and analyzing new rapid technologies, as well as applying them in the areas of precision engineering, micro tech- nology and medical device technology. We are systematically validating our research devices to achieve reliable scientific results. In the areaof medical technology, we develop according to ISO 13485, certify our devices according to MDD/FDA and perform clinical studies according to ISO 14155.

Contact

www.mimed.mw.tum.de sekretariat@mimed.de Phone +49.89.289.15190

This year a new clinical prototype was developed in cooperation with our long term partner inomed Medizintechnik GmbH. During the ZIM project Intraope- rative Tremor Assessment, funded by the Federal Ministry for Economic Affairs and Energy (BMWi). A sensor module was developed that can assist the neurologist assessing the Parkinson symptoms during the implantation of deep brain stimulation electrodes. The sensor communicates with the inomed Neuro-Monitoring System and provides essential information, where to implant the electrode and hence possiblyimprove the operation outcome. The Proto- type was developed regarding the medical device directive. Its clinical evaluation withour clinical partners at the Klinikum Groß-

hadern is ongoing. The system is planned to be included in inomed’s product-portfo- lio at the end of 2016.

Task-Oriented, Computational Kinematic Design

Kinematic synthesis of a compact, origami-inspired spatial car door guidance linkage, which eases getting into a car in cramped

parking spots (MiMed)

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Theandfundamental ideamechanism andtheoryconsist designingmechanical devicestask-specific mobility and dimensions andrepalsothedesign methodologies mechanical and motionsystemsdevelopedthe Latestexamples ofsuchsystems includelapaor endoscopic medicaldevices, assistivetransfer devices elderly people up to specifically moveable carTheserelymechanical linkages,whichknownform an essential functional basis defining motionproperties

detailed machine designs. In this context, the major goal of the kinematic design group is to provide

computer-aided analysis and synthesis methods that allow for the design and prototyping of novel task-specific motion systems. Due to a task-specific number of degrees-of-freedom such systemsmay provide robust and energy-efficientsolutions in a variety of different technical applications. Recent research results of the group include the development ofnew computational analysis and synthe- sis methods for a novel compact classof origami-inspired spatially movable linkages as well as a novel CAD-integratedkinematic design tool addressing virtual

prototyping of motion systems. Another highlight this year was the 11th German Conference on Linkages and Transmis- sion Systems (11. Getriebekolloquium), organized by the Institute.

A spherical two-degree-of- freedom linkage for the spatial orientation of endoscopes and a corresponding workspace analysis (MiMed)

Open Dynamic Real-time Interconnection of Medical DevicesThe rapid progress in the digitalizationof devices and systems in the operating room and clinic allows for thoroughly novel methods in diagnostics, planning, therapy, post-operative care and clinical documentation. During an intervention, devices and systems aggregate digital data that could be used for variouspurposes – say, intraoperatively to support the surgeon or postoperatively for subsi- diary documentation of the intervention. However, the interfaces providing thisdata are not yet standardized and hence cannot be used for automatic processing by other devices.The networks and navigation group at the MiMed has a leading role in the German flagship project ‘OR.Net‘. The goal of this project is the establishment of a com- munication standard for devices and ITin the operating room and clinic. With itsin-depth experience in the field of real time communication and development of real time capable devices, MiMed supportsthe project in the elaboration of viable solutions for (closed loop) control of time critical devices such as drills, coagulators, shavers, ultrasonic knives etc. The newest results are continuously transferred to MiMed’s lectures. MiMed’s knowledgein the field of regulatory affairs is equally

important, as existing strategies and regulations in the field of medical devices must be modified to allow for certification

of open, dynamically changing inter- connections.During the course of the last year, the networks and navigation group has elaborated technologies to exchange real time critical data of medical devices over an open and standardized communication infrastructure. To this end, the group has developed several modules allowing the connection of existing devices to the real time communication network. To prove the benefit of data presented in a standard- ized fashion, the group has developed a module that interconnects two distinct navigation cameras and merges

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theirdata to enlarge the visual range of the navigation system. Furthermore, the group has engineered a module that allows the merging and dynamic manipulation of

Plurality of medical devices generating digital data in the operating room (MiMed)

Data fusion module connecting two navigation cameras with one navigation panel (MiMed)

image data that stem from various image sources. A test platform, specifically designed for the project, is capable of measuring delay and jitter of transferred data to ensure real time capability of all network participants.To address regulatory affairs issues and risk management, the group works on two additional projects: one is a librarythat generates digital models of the interconnected device architecture based on formal descriptions of the standalone devices. The other is the design and implementation of a database system for the consistent documentation of medical devices – a system that was honored with the best paper award on an internationalconference of experts.

Technology for an Aging Society –Custom Structures for Wearable AidsNursing often requires high physical effort of care-givers. Patient transfers, in particular, increase their risk for musculoskeletal disorders. One of ourgoals is to improve this situation through wearable aids that enhance strength and assist during intense labor. Therefore,we evaluate cutting-edge technologies such as passive strength enhancing textiles, e.g. Japanese Smart Suits, ata cooperating nursing home in order to extract promising principles. Additionally, we collaborate with specialists in orthoses and prostheses in order to acquire the necessary skills to create custom-crafted structures that fit the human body. Com- bining these approaches we deduce new fields that go beyond the state of the art.In particular, we focus on techniques that produce physically optimized wearable structures automatically based on their biomechanical parameters, for example the automated layout of cutting patterns.

Rigid custom structure made by handcraft methods(MiMed)

These automated techniques are expec- ted to benefit orthopedic technologies directly as well as improve the physical human-machine interface of wearable robots. These individualized wearable aids will assist during patient transfers and thereby improve the situation of both care-givers and elderly people.

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Automated Design Concepts for 3D-Printing

One common task in engineering and other technical disciplines is the reali- zation of ideas as functional prototypes. Since the 1980’s 3D-printing technologies are used for the production of singleparts for prototypes. If standard machine elements or complex and personalized structures should be 3D-printed, themost time-consuming and therefore expensive part is the design process. In order to speed up the design process one research area of our lab focuseson design automation. The idea is to implement design algorithms for standard machine elements such as springs, gearwheels, shafts or clips that can automatically adjust the parameters

Research Focusn Medical navigation and roboticsn 3D printing of robots and instrumentsn Additive production technology n Micro-technological production n Synthesis of kinematicsn Assistance systems for aging society

Competencen Automatic CAD-construction/MATLABn Synthesis of joint mechanismsn 3D measurement technology (optical,

EM)n Roboticsn Mechatronic controln Quality management (ISO 9000/13485)

Infrastructuren Precision mechanics workshop

(ISO13485)

n Micro-technology laser treatmentn Additive manufacturing systems

(3D printing, FDM, SLS, freeformer)n Certified ERn Electronics workshop

based on desired mechanical properties, the available 3D-printing technology and the chosen material. Besides the mecha- nical durability of designed parts wealso predict their producibility based on tolerances and limitations of 3D-printing technology, such as layer height, laser focus diameter, minimal wall thicknessor minimal gap width. One of last year’smilestones was the publication of a first usable library with basic design algo- rithms implemented in MATLAB. Ongoing projects focus on design algorithmsfor the automated individualization of surgical tools and manipulators or the automated design of gear drives.

Coursesn Microsystem Technologyn Medical Device Technologyn Automation in Medicinen Admission of Medical Devicesn Kinematics

ManagementProf. Dr. Tim Lüth, DirectorDr.-Ing. Franz Irlinger, Academic DirectorRenate Heuser, SecretaryCornelia Härtling, Secretary

Adjunct ProfessorsProf. Dr. Walter Kucharczyk, IAS FischerSenior Fellow (Univ. Toronto)Prof. Dr. Gero Strauß, Medical Coordinator(Univ. Leipzig)Prof. Dr.-Ing. Joerg Vollrath, Electronics,Olching, Kempten

Research ScientistsDipl.-Ing. Kassim Abdul-SaterSuat Cömert, M.Sc.Dipl.-Ing. Johannes Coy Christian Dietz, M.Sc. Dipl.-Math. Max Dingler Tatiana Eliseeva, M.Sc.Dipl.-Ing. Konrad EntsfellnerChristina Hein, M.Sc.

Test stand with input parameters(MiMed)

Automatically designed and3D-printed gear drive (MiMed)

Dipl.-Ing. Michael Horper Franziska Klein, M.Sc. Dipl.-Ing. Eva GrafDipl.-Ing. Joachim KreutzerYannick Krieger, M.Sc. Dipl.-Ing. Ismail KuruDipl.-Ing. Tobias LüddemannDipl.-Ing. Arne Menz Dipl.-Ing. Jonas Pfeiffer Jelena Prša, M.Sc. (Hons) Samuel Reimer, M.Eng.Dipl.-Ing. Daniel Roppenecker Dipl.-Ing. Dominik Rumschöttel Dipl.-Ing. Mattias TrägerDipl.-Ing. Erik Loewe, IND, ExternalCandidate

Technical StaffGerhard Ribnitzky, Foreman Markus Wörl, Assistant Markus Geltl, Assistant Fabian Haimerl, ApprenticeThomas Weiß-Vogtmann, ApprenticeMichael Stanglmeir, Apprentice

Publications 2015

Journal Papersn Abdul-Sater, K.; Winkler, M. M.; Irlinger, F.;

Lueth, T. C. (2015): Three-Position Synthesis of Origami-Evolved, Spherically Constrained Spatial RR Chains, ASME Journal of Mechanisms and Robotics, Volume 8, Issue 1, August 2015, p. 11, DOI: 101115/1.4030370.

n D‘Angelo, L. T.; Abdul-Sater, K.; Pflügl, F.; Lueth,

T. C. (2015): Wheelchair Models With Integrated Transfer Support Mechanisms and Passive Actu- ation, ASME Journal of Medical Devices, Volume 9, Issue 1, March 2015, pp. 011012-1 – 011012-13, DOI: 10.1115/1.4029507.

n Mehrkens, J.H.; Coy, J.A.; Bötzel, K.; Lüth, T.C.(2015): Intraoperative objective assessment and quantification of rigidity, akinesia, and tremor for optimized target-selection during DBS-implantation in Parkinson’s disease, in: MDS 19th International Congress of Parkinson’s Disease and Movement Disorders. Volume 30, June 2015 Abstract, Volume30, June 2015 Abstract Supplement. Presented at the Movement Disorders 2015, San Diego, p. 588.

n Meining, A.; Roppenecker, D.B.; Lüth, T.C. (2015):Development and Evaluation of a 3D-Printed Overtube System Made for Endoscopic Submuco- sal Dissection (ESD) in Gastrointestinal Endoscopy, Volume 81, Issue 5, Supplement, May 2015, pp. AB157–AB158, DOI: 10.1016/j.gie.2015.03.100.

Conference-Papers (Peer Reviewed)n Abdul-Sater, K.; Laudahn, S.; Winkler, M. M.; Lueth,

T. C.; Irlinger, F. (2015): Ein Beitrag zur AnalyseOrigami-Inspirierter, Sphärisch ZwangsgeführterRR-Ketten, in Lüth, T.C., Irlinger, F. and Abdul-Sater, K. (Eds.), 11. Kolloquium Getriebetechnik, Garching (Munich), Germany, 28.-30. September 2015,pp. 125-146. DOI: 10.14459/2015md1276132.

n Abdul-Sater, K.; Irlinger, F.; Lueth, T. C. (2015):Three-Position Synthesis of Spherically Constrained Planar 3R Chains, ASME IDETC2015 Conference, August 02.-05.2015, Boston MA, p. 8, DOI:10.1115/1.4030370.

n Dingler, M.; Dietz, C.; Pfeiffer, J.; Lueddemann, T. and Lüth, T. (2015): A Framework for Automatic Testing of Medical Device Compatibility, to appear in: Proceedings of the 13th IEEE International Conference on Telecommunications (ConTEL),July 13th-15th, Graz, Austria. DOI: 10.1109/Con-TEL.2015.7231211

n Dingler, M.E.; Pfeiffer, J.H. and Lüth, T.C. (2015): A novel real time alarm detection device for the operating room, in: Proceedings of the 6th IEEE International Conference on Automation, Robotics and Applications (ICARA 2015), February 17-19,2015, Queenstown, New Zealand, pp. 490-494.DOI:10.1109/ICARA.2015.7081197

n Entsfellner, K.; Kuru, I.; Strauss, G.; Lueth, T.C. (2015): A new physical temporal bone and middle ear model with complete ossicular chain for simulating surgical procedures, accepted at IEEE International Conference on Robotics andBiomimetics (ROBIO 2015), Zhuhai, China, Dec 6-9,2015.

n Entsfellner, K.; Schuermann, J.; Coy, J.A.; Strauss, G.; Lueth, T.C. (2015): A modular micro-macro robot system for instrument guiding in middle ear surgery, accepted at IEEE International Conference on Robotics and Biomimetics (ROBIO 2015), Zhuhai, China, Dec 6-9, 2015.

n Goerlach, F.; Merkle J.; Lueddemann, T.; Lueth, T.C.(2015): Evaluation of Pattern-based Point Clouds forPatient Registration – A Phantom Study, accepted at International Conference on Intelligent Infor- matics and Biomedical Sciences, Okinawa Japan,28-30 November 2015.

n Goerlach, F.; Lueddemann, T.; Striffler, N.; Lueth, T.C. (2015): Multi-Layered, 3D Skin Phantoms of Human Skin in the Wavelength Range 650-850nm, accepted at International Conference on Intelligent Informatics and Biomedical Sciences, Okinawa Japan, 28-30 November 2015.

n Graf, E.C.; Kugler, C.; Lueth, T.C. (2015): AHandheld Mechanism for the Facilitated Implant Deployment for the Minimally-Invasive Closure of the Left Atrial Appendage, accepted at IEEE Inter- national Conference on Robotics and Biomimetics (ROBIO 2015), Zhuhai, China, Dec 6-9, 2015.

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n Kreutzer, J.F.; Kosch, F.; Ramesberger, S.; Reimer, S.M.F.; Lüth, T.C. (2015): Base station concepts of an automatic fluid intake monitoring system, accep- ted at IEEE International Conference on Robotics and Biomimetics (ROBIO 2015), 6-9.12.2015, Zhuhai, China.n Kreutzer, J.F.; Ramesberger, S.; Reimer,

S.M.F.;Entsfellner, K.; Lüth, T.C. (2015): Automatically detecting fluid intake using conductivity measu- rements of beverages in a cup, accepted at IEEE International Conference on Automation Science and Engineering 2015, pp. 1546-1551, DOI: 978-1-4673-8182-6/15

n Kuru, I.; Coy, J.A.; Lopez Ferrer, F.; Lenarz, T.; Maier, H.; Lüth, T.C. (2015): A new postoperative adjustable prosthesis for ossicular chain reconst- ruction, accepted at IEEE International Conference on Robotics and Biomimetics (ROBIO 2015),6-9.12.2015, Zhuhai, China.

n Lueddemann, T.; Schiebl, J.; Roppenecker, D.; Klein, F.; Lueth, T.C. (2015): Towards a Logic-Based Extension of a Relational Software Tool for Coherent Technical Documentation of Medical Devices, Proceedings of the International Symposium on Product Compliance Engineering (ISPCE), May18th-20th, Chicago, USA, pp. 1-6

n Pfeiffer, J.; Dingler, M.; Dietz, C.; Lueth, T.C. (2015): Requirements and Architecture Design for Open Real-Time Communication in the Operating Room, accepted at IEEE International Conference on Robotics and Biomimetics (ROBIO 2015),6-9.12.2015, Zhuhai, China.

n Prša, J.; Jain, R.; Irlinger, F.; Lueth, T.C. (2015): Automatic, Reference-Free and Conformity- Oriented Evaluation and Interpretation of CT- Models, IEEE International Conference on Computing and Network Communications, Technopark, Trivandrum, India, December 16-19.

n Prša, J.; Sobreviela, J.; Irlinger, F.; Lueth, T.C.(2015): Software Tool for Detection and Filling of Voids as a Part of Tool-Path Strategy Development for Droplet Generating 3D Printers. International Conference on Computer, Information, and Tele- communication Systems (CITS 2015), Gijon, Spain,15-17 July, DOI: 10.1109/CITS.2015.7297725.

n Träger, M.F.; Krohmer, E.; Krieger, Y.S.; Lüth, T.C. (2015), Automatisierte Konstruktion von Zahnradgetrieben für die Herstellung mittelsRapid-Prototyping-Verfahren, in Lüth, T.C., Irlinger, F. and Abdul-Sater, K. (Eds.), 11. Kolloquium Getriebetechnik, Garching (Munich), Germany,28-30 September 2015, pp. 235–254, DOI:10.14459/2015md1276149.

Conference Papersn Abdul-Sater, K.; Irlinger, F.; Lueth, T. C. (2015): Ein

Ansatz zur Kinematische Mehrposen-/Mehrkör- persynthese, First IFToMM DACH Conference, Dortmund, March 2015, p. 7.

n Rumschoettel, D.; Kagerer, M.; Irlinger, F.; Lüth, T.C.(2015), Kompaktmodell für die Charakterisierung eines piezoelektrischen Membrandruckkopfes, Mik- roSystemTechnik Kongress, Karsruhe, Deutschland,26-28 Oktober 2015, pp. 485-488

n Weihberger, O.; Krüger, T.; Mattmüller, R.; Coy, J.A.; Lüth, T.C.;(2015): Quantitative movement-parameter assessment with a novel wrist-mounted. sensor integrated measusrement device, in: Tagung Der Sektion Stereotaxie Und Radiologie. Presented at the Tagung der Sektion Stereotaxie und Radiologie, Magdeburg.

n Coy, J.A.; Mehrkens, J.H.; Bötzel, K.; Lüth,T.C.;(2015): Messsystem zur intraoperativen objek- tiven Beurteilung von Parkinsonsymptomen, Nr. FV650, in 88. Kongress der Deutschen Gesellschaft fürNeurologie mit Fortbildungsakademie – Abstracts– Düsseldorf, 23-26 September 2015, URN:nbn:de:101:1-20150901216,

n Coy, J.A.; Weihberger, O.; Krüger, T.; Lüth, T.C. (2015): Quantification of Parkinson Symptoms: A Joint Project between Research and Industry,in 9. Aachen-Dresden International Textile Confer- ence 2015,

Conference Postern Kuru, I.; Maier, H.; Müller, M.; Lenarz, T.; Lüth,

T.C. (2015): A new 3D printed functional human middle ear model, 7th International Symposium on Middle Ear Mechanics in Research and Otology,1.-5.07.2015, Aalborg, Denmark