Development of the Telemetrical Intraoperative Soft Tissue Tension Monitoring System in Total Knee Replacement with MEMS and ASIC Technologies

__________________________________________ iv – ________________________________________________________________________ The alignment of the femoral and tibial components of the Total Knee Arthoplasty (TKA) is one of the most important factors to implant survivorship. Hence, numerous ligament balancing techniques and devices have been developed in order to accurately balance the knee intra-operatively. Spacer block, tensioner and tram adapter are instruments that allow surgeons to qualitatively balance the flexion and extension gaps during TKA. However, even with these instruments, the surgical procedure still relies on the skill and experience of the surgeon. The objective of this thesis is to develop a computerized surgical instrument that can acquire intra-operative data telemetrically for surgeons and engineers. Microcantilever is chosen to be used as the strain sensing elements. Even though many high end off-the-shelf data acquisition components and integrated circuit (IC) chips exist on the market, yet multiple components are required to process the entire array of microcantilevers and achieve the desired functions. Due to the size limitation of the off-chip components, an Application Specific Integrated Circuit (ASIC) chip is designed and fabricated. Using a spacer block as a base, sensors, a data acquisition system as well as the transmitter and antenna are embedded into it. The electronics are sealed with medical grade epoxy.

[1]  Kristofer S. J. Pister,et al.  An ultralow-energy ADC for Smart Dust , 2003, IEEE J. Solid State Circuits.

[2]  Christoph Hagleitner,et al.  A CMOS-based tactile sensor for continuous blood pressure monitoring , 2004, Design, Automation and Test in Europe.

[3]  S. E. Irby,et al.  Instrumented implant for measuring tibiofemoral forces. , 1996, Journal of biomechanics.

[4]  E. Kolesar,et al.  Object imaging with a piezoelectric robotic tactile sensor , 1993, Proceedings of the IEEE 1993 National Aerospace and Electronics Conference-NAECON 1993.

[5]  Richard D Komistek,et al.  Correlation of compartment pressure data from an intraoperative sensing device with postoperative fluoroscopic kinematic results in TKA patients. , 2005, Journal of biomechanics.

[6]  D. D’Lima,et al.  e-Knee: Evolution of the Electronic Knee Prosthesis Telemetry Technology Development , 2001, The Journal of bone and joint surgery. American volume.

[7]  G Bergmann,et al.  Four-channel telemetry system for in vivo measurement of hip joint forces. , 1991, Journal of biomedical engineering.

[8]  R. Woledge,et al.  The forces in the distal femur and the knee during walking and other activities measured by telemetry. , 1998, The Journal of arthroplasty.

[9]  K. Najafi,et al.  A single-channel implantable microstimulator for functional neuromuscular stimulation , 1997, IEEE Transactions on Biomedical Engineering.

[10]  D. Davy,et al.  Telemeterized in vivo hip joint force data: A report on two patients after total hip surgery , 1991, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[11]  G. Gautschi Piezoelectric Sensorics: Force Strain Pressure Acceleration and Acoustic Emission Sensors Materials and Amplifiers , 2002 .

[12]  R. Stuart Mackay Radio Telemetering from Within the Human Body , 1959 .

[13]  J. H. Smith,et al.  A New Analytical Solution for Diaphragm Deflection and its Application to a Surface-Micromachined Pressure Sensor , 1999 .

[14]  Takashi Maeno,et al.  Artificial finger skin having ridges and distributed tactile sensors used for grasp force control , 2001, Proceedings 2001 IEEE/RSJ International Conference on Intelligent Robots and Systems. Expanding the Societal Role of Robotics in the the Next Millennium (Cat. No.01CH37180).

[15]  M. Shults,et al.  A telemetry-instrumentation system for monitoring multiple subcutaneously implanted glucose sensors , 1994, IEEE Transactions on Biomedical Engineering.

[16]  J. Mensch,et al.  Knee morphology as a guide to knee replacement. , 1975, Clinical orthopaedics and related research.

[17]  John A. Nairn,et al.  On the Use of Shear-Lag Methods for Analysis of Stress Transfer in Unidirectional Composites , 1997 .

[18]  Yong Xu,et al.  IC-integrated flexible shear-stress sensor skin , 2003 .

[19]  B.D. McKean,et al.  A telemetry-instrumentation system for chronically implanted glucose and oxygen sensors , 1988, IEEE Transactions on Biomedical Engineering.

[20]  Kari Halonen,et al.  Circuit Techniques for Low-Voltage and High-Speed A/D Converters , 2002 .

[21]  John W. Jaquay Designers Guide to: Instrumentation amplifiers , 1977 .

[22]  Robert H. Walden,et al.  Analog-to-digital converter survey and analysis , 1999, IEEE J. Sel. Areas Commun..

[23]  D. Dennis,et al.  Correlation Between Condylar Lift-Off and Femoral Component Alignment , 2002, Clinical orthopaedics and related research.

[24]  S. N. G. Chu,et al.  Elastic Bending of Semiconductor Wafer Revisited and Comments on Stoney's Equation , 1998 .

[25]  Charles S. Smith Piezoresistance Effect in Germanium and Silicon , 1954 .

[26]  Richard D Komistek,et al.  An Intraoperative Pressure-Measuring Device Used in Total Knee Arthroplasties and Its Kinematics Correlations , 2004, Clinical orthopaedics and related research.

[27]  G. Bergmann,et al.  Hip joint loading during walking and running, measured in two patients. , 1993, Journal of biomechanics.

[28]  A. Uchiyama Endoradiosonde needs micro machine technology , 1995, MHS'95. Proceedings of the Sixth International Symposium on Micro Machine and Human Science.

[29]  W R Walsh,et al.  Intraoperative assessment of tibiofemoral contact stresses in total knee arthroplasty. , 1998, The Journal of arthroplasty.

[30]  M. Harris,et al.  An improved method for measuring tibiofemoral contact areas in total knee arthroplasty: a comparison of K-scan sensor and Fuji film. , 1999, Journal of biomechanics.

[31]  F. Campi,et al.  A dynamically reconfigurable monolithic CMOS pressure sensor for smart fabric , 2003 .

[32]  Bang-Sup Song,et al.  A 10-b 20-Msample/s low-power CMOS ADC , 1995, IEEE J. Solid State Circuits.

[33]  D. Polla,et al.  Experimental evaluation of MEMS strain sensors embedded in composites , 1999 .

[34]  D. D’Lima,et al.  An implantable telemetry device to measure intra-articular tibial forces. , 2005, Journal of biomechanics.

[35]  Liwei Lin,et al.  MEMS pressure sensors for aerospace applications , 1998, 1998 IEEE Aerospace Conference Proceedings (Cat. No.98TH8339).

[36]  Lutz-Peter Nolte,et al.  Development of a force amplitude- and location-sensing device designed to improve the ligament balancing procedure in TKA , 2005, IEEE Transactions on Biomedical Engineering.

[37]  P. Walker,et al.  Forces and moments telemetered from two distal femoral replacements during various activities. , 2001, Journal of biomechanics.

[38]  J. Jacob Wikner,et al.  CMOS Data Converters for Communications , 2000 .

[39]  A. Brokaw,et al.  A simple three-terminal IC bandgap reference , 1974 .

[40]  Robert G. Meyer,et al.  Analysis and Design of Analog Integrated Circuits , 1993 .

[41]  S. Bhansali,et al.  Piezoresistive MEMS pressure sensor and packaging for harsh oceanic environment , 2004, 2004 Proceedings. 54th Electronic Components and Technology Conference (IEEE Cat. No.04CH37546).

[42]  S. Taylor,et al.  Relations between compressive axial forces in an instrumented massive femoral implant, ground reaction forces, and integrated electromyographs from vastus lateralis during various 'osteogenic' exercises. , 1997, Journal of biomechanics.

[43]  B.P. Gogoi,et al.  Integration technology for MEMS automotive sensors , 2002, IEEE 2002 28th Annual Conference of the Industrial Electronics Society. IECON 02.