SImOS   Smart Implants for Orthopedic Surgery Prof. Dr. Peter Ryser EPFL on behalf of SImOS partners
Outline <ul><li>General objectives and the concept of the project </li></ul><ul><li>Consortium and tasks </li></ul><ul><li...
General objectives <ul><li>More than 1 Mio / year hip and knee prosthesis are implanted in EU and US </li></ul>
Introduction: on the concept of the project:   Provide in-vivo parameters for the clinicians and prosthesis designers <ul>...
A multidisciplinary consortium <ul><li>one project with several subprojects  19 months </li></ul><ul><li>5 EPFL Labs, CHUV...
Introduction:  the concept of the project Force & motion sensors Electronics Sensors interface Communication Packaging Bio...
International state-of-the-art  <ul><li>Bergmann group 1 </li></ul><ul><ul><li>Force and moments </li></ul></ul><ul><li>D ...
Large-scale demonstrator architecture A smaller version of the demonstrator, acquiring the signals of the force sensors in...
Remote Powering Best performance under the influence of the metallic parts. [Atasoy, Prime2010] Reader Antenna Implanted A...
Force sensors Si TiW Al PI Ti Pt Ti Strain gauge Fabrication Design Realization Specifications Excitation: 1.5V Power: 0.7...
Motion sensors d + (L) AMR sensors Magnet AMR sensors Artificial  Neural Network  Reference sensor angle  rms  error duri...
Sensor electronics design <ul><li>Discrete components based system </li></ul><ul><li>4 analog channels </li></ul><ul><li>D...
Analog Digital Convertor <ul><li>Low-power Sigma-Delta Modulator ADC conversion. </li></ul><ul><li>So far, two Implementat...
First technology demonstrator <ul><li>A first demonstrator has been developed for validating the system.  </li></ul><ul><l...
First technology demonstrator
From large scale demonstrator… to knee simulator <ul><ul><li>Definition of micro-fabrication process and materials for for...
Additional founding <ul><li>Commercial knee simulator </li></ul><ul><li>Requested amount 212 kCHF </li></ul><ul><li>Starti...
Prospect for the next milestones <ul><li>Development of an improved large-scale demonstra tor </li></ul><ul><li>Definition...
<ul><li>Peter Ryser  EPFL/STI/IMT/LPM2 </li></ul><ul><li>Kamiar Aminian EPFL/STI/IBI/LMAM </li></ul><ul><li>Catherine Deho...
<ul><li>Thank you for your attention! </li></ul>
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SImOS

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This project seeks to design innovative tools to measure in vivo biomechanical parameters of joint prostheses, orthopaedic implants, bones and ligaments. These tools, partly implanted, partly external, will record and analyze relevant information in order to improve medical treatments. An implant module includes sensors in order to measure the forces, temperature sensors to measure the interface frictions, magneto-resistance sensors to measure the 3D orientation of the knee joint as well as accelerometers to measure stem micro-motion and impacts. An external module, fixed on the patient.s body segments, includes electronic components to power and to communicate with the implant, as well as a set of sensors for measurements that can be realized externally.

This equipment is designed to help the surgeon with the alignment or positioning phase during surgery. After surgery, by providing excessive wear and micro-motion information about the prosthesis, it will allow to detect any early migration and potentially avoid later failure. During rehabilitation, it will provide useful outcomes to evaluate in vivo joint function. The tools provided can also be implanted during any joint surgery in order to give the physician the information needed to diagnose future disease such as ligament insufficiency, osteoarthritis or prevent further accident. The proposed nanosystems are set to improve the efficiency of healthcare, which is both a benefit to the patient and to society. Although the scientific and technical developments proposed in this project can be applied to all orthopaedic implants, the technological platform which is being built as a demonstrator is limited to the case of knee prosthesis. In addition, by reaching the minimum size achievable thanks to clever packaging techniques and also by reducing, or even removing, the cumbersome battery, it paves the way for a new generation of autonomous implantable medical devices.

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SImOS

  1. 1. SImOS Smart Implants for Orthopedic Surgery Prof. Dr. Peter Ryser EPFL on behalf of SImOS partners
  2. 2. Outline <ul><li>General objectives and the concept of the project </li></ul><ul><li>Consortium and tasks </li></ul><ul><li>International state of the art </li></ul><ul><li>Architecture of the technology demonstrator </li></ul><ul><li>Remote powering and data transmission </li></ul><ul><li>Force and motion sensors </li></ul><ul><li>Sensor electronics interface </li></ul><ul><li>Knee simulator </li></ul><ul><li>Next steps </li></ul>
  3. 3. General objectives <ul><li>More than 1 Mio / year hip and knee prosthesis are implanted in EU and US </li></ul>
  4. 4. Introduction: on the concept of the project: Provide in-vivo parameters for the clinicians and prosthesis designers <ul><li>Estimate contact force </li></ul><ul><ul><li>Correct unbalanced wearing </li></ul></ul><ul><ul><li>Provide adequate rehabilitation </li></ul></ul><ul><ul><li>Model force distribution </li></ul></ul><ul><ul><li>Design new generation of prosthesis </li></ul></ul><ul><li>3D joint angles by fusing with skin mounted sensors </li></ul><ul><ul><li>Extract kinematics metrics relying on movement limitation </li></ul></ul><ul><li>Provide micro-motion of the prosthesis relative to the bone </li></ul><ul><ul><li>Estimate loosening using vibrating plate-form </li></ul></ul>
  5. 5. A multidisciplinary consortium <ul><li>one project with several subprojects 19 months </li></ul><ul><li>5 EPFL Labs, CHUV, Symbios </li></ul><ul><li>Focus to one functional demonstrator </li></ul><ul><li>Specifications, modeling, simulation, prototyping </li></ul><ul><li>Integration and test </li></ul><ul><li>Monthly review meetings with all team members </li></ul>
  6. 6. Introduction: the concept of the project Force & motion sensors Electronics Sensors interface Communication Packaging Biomechanical modeling Surgical implantation
  7. 7. International state-of-the-art <ul><li>Bergmann group 1 </li></ul><ul><ul><li>Force and moments </li></ul></ul><ul><li>D ’ Lima group 2 </li></ul><ul><ul><li>Force and moments </li></ul></ul><ul><li>Serpelloni group 3 </li></ul><ul><ul><li>Force and moments </li></ul></ul><ul><li>No kinematics studies </li></ul><ul><li>missing clinics thematic </li></ul>1. Biomechanics laboratory of Charit é -Universit ätsmedizin, Berlin, Germany 2. Orthopaedic Research Laboratories, Scripps Clinic, San Diego, USA 3. Department of Information Engineering, University of Brescia, Brescia, Italy
  8. 8. Large-scale demonstrator architecture A smaller version of the demonstrator, acquiring the signals of the force sensors inside the polyethylene part of the prostheses, has been developed. Sensor Analog front-end Microcontroller Communication Power management Magnetometers HMC5843 I2C Accelerometers I2C/SPI Analog sensors Sensor Interface vdd2.7 vdd1.8 I2C Vdd1.8 vdd1.8 I2C/SPI vdd2.7 ip1 ip2 in1 in2 DISCRETE COMPONENTS CPLD PMU Power management unit MAX17710 vdd2.7 vdd1.8 MCU I2C and/or SPI SPI JTAG SPI MSP430 Serial memory JTAG Bridge For ISP CPLD JTAG Battery and/or supercap RF transponder TMS 37157 SPI
  9. 9. Remote Powering Best performance under the influence of the metallic parts. [Atasoy, Prime2010] Reader Antenna Implanted Antenna Image source: http://healthtopics.hcf.com.au/TotalKneeReplacement.aspx External coil circumferences the knee Internal coil inside the insert
  10. 10. Force sensors Si TiW Al PI Ti Pt Ti Strain gauge Fabrication Design Realization Specifications Excitation: 1.5V Power: 0.7mW Gauge factor: ~2 Volume: 0.24mm 2
  11. 11. Motion sensors d + (L) AMR sensors Magnet AMR sensors Artificial Neural Network  Reference sensor angle rms error during Rotation : 0.6 deg Translation : 0.8 deg Sensitive dist. range L=25mm L=8mm L=5mm d
  12. 12. Sensor electronics design <ul><li>Discrete components based system </li></ul><ul><li>4 analog channels </li></ul><ul><li>Digital controller (FPGA + µController) </li></ul><ul><li>Digital offset calibration </li></ul><ul><li>Temperature calibration </li></ul><ul><li>Force Sensor Power Consumption </li></ul><ul><ul><li>Power = 2 mW @ Cont. Operation </li></ul></ul><ul><ul><li>Power = 20  W @ 1% Duty Cycle </li></ul></ul><ul><li>Electronics Power Consumption </li></ul><ul><ul><li>Power = 405  W @ Cont. </li></ul></ul>Analog front-end 8 Channel Readout Electronic Remotely powered 1 Channel board Test boards
  13. 13. Analog Digital Convertor <ul><li>Low-power Sigma-Delta Modulator ADC conversion. </li></ul><ul><li>So far, two Implementations were studied: </li></ul><ul><li>DC Current = 24 µA, Bandwidth = 10 kHz, Sampling clock = 2 MHz, SNDR > 64 dB, Technology 0.18  m CMOS </li></ul><ul><li>DC Current = 100 µA, Bandwidth = 16 kHz, Sampling Clock = 2 MHz, SNDR > 80 dB, V dd = 1.8 Volt, Technology 0.18  m CMOS </li></ul>[1] S.Ali, S.Tanner, P-A.Farine “A Novel 1V, 24uW, Sigma Delta Modulator using Amplifier and Comparator based technique, with 64.7dB SNDR and 10KHz Bandwidth”, IEEE Int. Conf. on Circuits and Systems, December 2010 1. 3-rd order amplifier and comparator based SC SDM 2. Multi-bit SDM with DAC calibration
  14. 14. First technology demonstrator <ul><li>A first demonstrator has been developed for validating the system. </li></ul><ul><li>Only signals from analog force sensors are acquired </li></ul><ul><li>A microcontroller is programmed for data acquisition and transmission </li></ul><ul><li>The signals are transmitted to an external reader by a Passive Low- Frequency RFID Transponder Interface </li></ul>
  15. 15. First technology demonstrator
  16. 16. From large scale demonstrator… to knee simulator <ul><ul><li>Definition of micro-fabrication process and materials for force sensors array fabrication </li></ul></ul><ul><ul><li>Tape-out of final sensor electronics ASIC </li></ul></ul><ul><ul><li>Development of the implanted transceiver </li></ul></ul>Knee simulator (MTS) Improve large-scale to in vitro demonstrator
  17. 17. Additional founding <ul><li>Commercial knee simulator </li></ul><ul><li>Requested amount 212 kCHF </li></ul><ul><li>Starting date June 2011 </li></ul>
  18. 18. Prospect for the next milestones <ul><li>Development of an improved large-scale demonstra tor </li></ul><ul><li>Definition of micro-fabrication process and materials for force sensors array fabrication </li></ul><ul><li>Tape-out of final sensor electronics ASIC </li></ul><ul><li>Development of the implanted transceiver </li></ul><ul><li>Set-up of the commercial knee simulator </li></ul>
  19. 19. <ul><li>Peter Ryser EPFL/STI/IMT/LPM2 </li></ul><ul><li>Kamiar Aminian EPFL/STI/IBI/LMAM </li></ul><ul><li>Catherine Dehollain EPFL/STI/GR-SCI-STI/ </li></ul><ul><li>Pierre André Farine EPFL/STI/IMT/ESPLAB </li></ul><ul><li>Philippe Renaud EPFL/STI/IMT/LMIS4 </li></ul><ul><li>Brigitte Jolles-Haeberli CHUV/DAL </li></ul><ul><li>Vincent Leclercq Symbios Orthopédie SA </li></ul><ul><li>Scientists: Arnaud Bertsch, Eric Meurville, Steve Tanner, Hossein Rouhani </li></ul><ul><li>PhD students: Arash Arami, Matteo Simoncini, Oguz Atasoy, Willyan Hasenkamp, Shafqat Ali </li></ul>Thanks to all the team members
  20. 20. <ul><li>Thank you for your attention! </li></ul>

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