SIM UNIVERSITY SCHOOL OF SCIENCE AND TECHNOLOGY INTELLIGENT CONTROLLER SYSTEM FOR AN INTRAMEDULLARY NAIL STUDENT : MD FUAD (Z0706372) SUPERVISOR : STEPHEN LOW PROJECT CODE : JULY 2009/ENG499 A project report submitted to SIM University in partial fulfillment of the requirements for the degree of Bachelor of Electronics May 2010 ABSTRACT Modern day technology breakthrough in limb lengthening and strengthening can enable an individual to gain up to 60mm in height in about two months for the upper and lower bones extremities of the legs. This technology also helps those who have had an injury that caused shortened or deformed limb bones or those that were born with limb length inequality to overcome their shortcoming. Compared to current day conventional bone extension surgery method, it is much simpler and safer to be use and perform. The nail which is a metal steel implant is inserted into the hollow of a bone that has been cut crosswise. It can be activated by a wireless control unit to increase in length at 1mm a day and will gradually lengthens as the bone’s cut ends grow and fuse. The design for this involves an internal unit which is implanted beneath the skin and tissues and an external unit. A reliable communication channel needs to be design for both these units to communicate so that it will be able to control linear drive movement for the nail and also sends information back from the nail to the user. At the heart of this design will be a microcontroller unit with software code using any of the microcontroller programming language written to suit the needs of this project. At the same time, the internal unit will be making use of wireless power transmission (inductive coupling) to obtain its required power supply. However, for this project, wireless power transmission is only done as a literature study (secondary objective) and testing out will be done with normal power supply to the internal circuit. 2 ACKNOWLEDGMENTS First and foremost, I would like to thank my tutor Mr. Stephen Low for his guidance, knowledge sharing and patience that he has given me throughout this period. His relentless questioning helps me in determining the path to be taken for each and every step of the project. I am also thankful that he always replies my email promptly and ever willing to meet up with me despite his hectic schedule. I would also like to thank Mr. Firdaus Wahid for all the technical knowledge that he shares with me. He also helps a lot on the logistics side of things, such as purchasing of components and acquiring lab access where it is conducive for me to work on my project. I also greatly appreciate the help and support given by Samson Santosh Nickson (Mr Stephen’s fellow project student), who’s constant motivation keeps me going. He also helps me a lot on the assembly language whenever I encounter difficulties with it. Last but not least, I would like to thank my family for the constant encouragement and support that they had given me. 3 TABLE OF CONTENTS S/NO TITLE / DESCRIPTION PAGE ABSTRACT 2 ACKNOWLEDGEMENTS 3 TABLE OF CONTENTS 4 LIST OF FIGURES 7 LIST OF TABLES 9 LIST OF APPENDICES PART 1: INTRODUCTION 10 1.1 Background 11 1.2 Project Objective 12 1.3 Overall Objective PART 2: MANAGEMENT METHOD 12 2.1 Project Breakdown 13 2.2 System Development Method PART 3: LITERATURE REVIEW 14 3.1 Basic Circuit Theory 16 3.1.1 Closed and Open Circuit 16 3.1.2 Voltmeters and Ammeters 16 3.1.3 Sources 16 3.1.4 Switches 17 3.1.5 Resistors, Resistance and Conductance 17 Microcontroller Fundamentals 19 Building Block Structure of Microcontroller 19 3.2 3.2.1 3.2.1.1 Central Processing Unit 20 3.2.1.2 Memory 20 3.2.1.3 Bus 20 3.2.1.4 Input/Output Unit 20 3.2.1.5 Serial Communication 20 3.2.1.6 Timer Unit 21 3.2.1.7 Watchdog 21 3.2.1.8 Analog to Digital Converter 21 3.2.2 22 Programming Languages Use for Microcontroller 4 3.3 Background of Intramedullary Nail and Having an Intelligent 22 3.4 Biomedical Material 23 3.4.1 Biomaterials Metals 23 3.4.2 Synthetic Polymers 23 3.5 Circuit Design Implementation to Drive the Motor PART 4: SYSTEM DESIGN 24 4.1 System Description 25 4.2 Microcontroller Selection 26 4.3 Motor Selection 26 4.4 Motor Driver Selection 28 4.5 Transceiver Selection 29 4.6 Circuit Design PART 5: IMPLEMENTATION OF IDEAS 30 5.1 Idea Implementation 32 5.2 Software Implementation PART 6: TESTS AND RESULTS 33 6.1 Motor and Driver 35 6.1.1 Motor Rotates in Clockwise Direction 36 6.1.2 Motor Rotates in Anti-Clockwise Direction 37 Software 38 6.2 PART 7: PROBLEM AND DIFFICULTY 7.1 Problems and Difficulties Encountered 39 PART 8: LITERATURE STUDY OF WIRELESS POWER TRANSMISSION (SECONDARY OBJECTIVE) 8.1 Introduction 40 8.2 System Overview 40 8.3 Power Transmitting Coil 41 8.4 Coil Driver 41 8.5 Power Receiving Call 42 8.6 Experiments and Results 43 8.7 Human Tissue Safety 44 8.8 Conclusion and Discussion 46 5 PART 9: CONCLUSION AND RECOMMENDATIONS 9.1 Conclusion 47 9.2 Future Recommendations 47 PART 10: CRITICAL REVIEW AND REFLECTIONS 10.1 Critical Review and Reflections 48 GLOSSARY 49 REFERENCES 51 APPENDICES 53 6 LIST OF FIGURES DESCRIPTION Figure 1: X-ray showing the portion of a fracture with an intramedullary nail PAGE 11 Figure 2: Block diagram of a two way communication between microcontroller system and nail implant 12 Figure 3: WBS for intelligent controller system for an intramedullary nail 13 Figure 4: Flow chart of system design 15 Figure 5a: A schematic diagram of a resistor 18 Figure 5b: A pull-up resistor 18 Figure 5c: A pull-down resistor 18 Figure 6: An example of a microcontroller’s building block 19 Figure 7: The inside view of a microcontroller 21 Figure 8: Block diagram of a complete intramedullary nail system 25 Figure 9: PIC16F676 microcontroller pin assignments 26 Figure 10: Dimension of a DC motor 27 Figure 11: Dimension of a DC motor with gear 27 Figure 12: Functional block diagram of the BA6289 driver 28 Figure 13: BA6289 driver pin assignments 29 Figure 14: TRM-433-LT transceiver pin assignments 30 Figure 15: Schematic diagram of external circuit 30 Figure 16: Schematic diagram of internal circuit 31 Figure 17: Schematic diagram of proof of concept circuit 31 Figure 18: Flowchart methodology for nail extension 32 7 Figure 19: Flowchart methodology for nail retraction 33 Figure 20: Algorithm of the software implementation 34 Figure 21: Circuit setup for test 35 Figure 22: Circuit and waveforms for motor clockwise movement 36 Figure 23: Circuit and waveforms for motor anti-clockwise movement 37 Figure 24: System overview 40 Figure 25: Full-bridge Class D inverter 42 Figure 26: Q values of different coils 42 Figure 27: The power-receiving schematic 43 Figure 28: Result of rotation experiment 44 Figure 29a: Mid-coronal and mid sagittal section display 45 Figure 29b: Whole-body skin and skeletal structure 45 Figure 29c: Coil alignment 45 Figure 30: Distribution map of induced current density 46 Figure 31: Distribution map of SAR 46 8 LIST OF TABLES DESCRIPTION Table 1: Comparisons of the commonly used implant metals PAGE 23 Table 2: Comparisons of the commonly used polymers 24 Table 3: An example of a truth table of a motor driver 24 Table 4: Comparisons of the more commonly types of motors 26 Table 5: BA6289 driver pin descriptions 28 Table 6: TRM-433-LT transceiver pin descriptions 29 Table 7: The truth table of motor driver BA6289F 35 Table 8: Results of second test 38 9 LIST OF APPENDICES DESCRIPTION Appendix 1: Relevant US and European standard Appendix 2: Electrical field strength dependent on fat layer thickness (Anders J Johansson, June 2004) Appendix 3: Electrical field strength dependent on fat layer thickness (Anders J Johansson, June 2004) Appendix 4: Gantt chart Appendix 5: Medical implant construction rules (Winfried Mayr, Manfred Bijak, Dietmar Rafolt, Stefan Sauermann, Ewald Unger, Hermann Lanmuller, Feb 2001) Appendix 6: Laboratory equipment application PAGE 53 53 54 54 55 56 10 PART 1: INTRODUCTION 1.1 Background An intramedullary nail implant is a metal steel rod forced into the medullary cavity of a bone and has long been used to treat fractures of long bones of the body. In 1939, a German surgeon call Gerhard Kuntscher inaugurated this method of intramedullar nailing of bone fractures for those World War II soldiers. Before that, treatment of such fractures was only limited to traction or plaster, both of which required long periods of inactivity. One of the most significant advantages of intramedullary nail implant that stood out over other methods is that it shares the load with the bone, instead of entirely supporting it. Because of this, patients are able to use their extremity more quickly and thus results in earlier return to activity. However, intramedullary nail implant cannot be used for all fractures, and there are often complaints of pain and other symptoms at the site where the metal steel rod are inserted. Due to this, a second operation may be needed to remove them if patients have these painful symptoms. Therefore a two way communication system, which is facilitated by a wireless link, will be able to make real-time adaptations according to patient’s condition without having to remove the implant. In 1999, the Federal Communications Commission (FCC) allocates 402-405 MHz of band frequency to the Medical Communication Implant (MICS). This particular band frequency was chosen because it enables the design of low power transmitter and antenna arrangement which is small enough for implanted applications while still achieving reasonable transmission range. As there are no other radios that operate in this same band of frequency, there will also be no interference risks. On top of it, this range also has propagation characteristics that are conducive to transmission within the human body. (Federal Communications Commission, 1999. Medical Implant Communication Service (MICS) Part 95. Available at: www.fcc.gov [Accessed 23 August 2009]) Figure 1: X-ray showing the portion of a fracture with an intramedullary nail. (Picture courtesy of Dr Sarbjit Singh, Orthopedic Surgeon, Mount Elizabeth Hospital, Singapore) 11 1.2 Project Objective The primary objective of this project is to develop an intelligent controller system for an intramedullary nail that provides a two way communication between the user and the nail where a microcontroller system will be develop to control a linear drive movement and at the same time sends information back from the nail to the microcontroller and eventually the user. An assembly language program will be used to generate the codes to control the intelligent. Data between the implant and the free air space surrounding the patient will be transmitted and received via the transceiver. Based on the allocated budget, careful study for the selection of the components must be taken into consideration. A very important factor is the size of these components as some of them will be implanted internally. Thus all possibilities need to be explore so that it can be inserted into the patient via the 12mm diameter incision that is made. The grade of the component chosen must also meet medical requirements, such as not degrade in its properties and not cause any adverse reactions within the human body. For final assembly and testing out, animal trials shall be used instead of human body. The secondary objective of this project will be to do a literature study on the feasibility of using wireless power transmission to transmit power to the implant. Figure 2: Block diagram of a two way communication between user, microcontroller system and nail implant 1.3 Overall Objective The adding of intelligent to an intramedullary nail allows it to be reprogrammed and changed to suit the needs of the patient without having to make changes to the electronics hardware. This will simplify the design, resulting in the use of few components. Through re-programming, it also helps to reduce pain felt by the patient. Therefore, unnecessary surgery can be avoided. 12 PART 2: MANAGEMENT METHOD 2.1 Project Breakdown In planning a project, it is normal to be momentarily overwhelmed and confused when the details and scope of a project begins to come into picture. The way to overcome this is by breaking the project into pieces and organizes them in a logical way using work breakdown structure (WBS). WBS is a result oriented family tree that captures all the work of a project in an organized way. Often portrayed as a hierarchical tree, it can also be a tabular list of categories of product, data or service and tasks that appears in the Gantt chart schedule. (Work Breakdown Structure, Wikipedia. Available at: http://en.wikipedia.org/wiki/Work_breakdown_structure [Accessed 5 May 2010]) For this project, using WBS, four main tasks are identified and they are research and planning, circuit design, software development and hardware assembly and testing. Under each main task, a few sub tasks branches within it. Figure 3: WBS for intelligent controller system for an intramedullary nail 13 2.2 System Development Method Currently in the industry, there are a few system development methods that are being practiced such as waterfall, prototyping, spiral and Structured System Analysis and Design Method (SSADM). The waterfall model maintains that one should move to next phase only when its preceding phase is completed and perfected. There is no jumping back and forth or overlap between them. (History of the Waterfall Model, Select Business Solutions. Available at: http://www.selectbs.com/adt/analysis-and-design/what-is-the-waterfall-model [Accessed 5 May 2010]) (Waterfall Model, Wikipedia. Available at: http://en.wikipedia.org/wiki/Waterfall_model [Accessed 5 May 2010]) The prototyping model is a system where a prototype is built, tested, and then reworked as necessary until an acceptable prototype is finally achieved. From there, the complete product can be developed. It works best in scenarios where not all of the project requirements are known in detail ahead of time. It is also often call as an iterative or a trial and error model. (Prototyping Model, SearchCIO-Midmarket.com Definitions. Available at: http://searchcio-midmarket.techtarget.com/sDefinition/0,,sid183_gci755441,00.html [Accessed 5 May 2010]) The spiral model depends on the nature of the project and its associated risks. With low risks, it is something similar to waterfall. However when with high risks, it is more of a prototyping model. (Spiral Model, Wikipedia. Available at: http://en.wikipedia.org/wiki/Spiral_model [Accessed 5 May 2010]) The SSADM model is very much function oriented and event driven. It is widely used in the industry as it is simple to use, has clear procedures and high traceability due to good Quality Assurance (QA) practices such as revision and change control. It also supports diagrams representation of information and enhances communication between different parties concerns. (Structured System and Design Method, Wikipedia. Available at: http://en.wikipedia.org/wiki/SSADM [Accessed 5 May 2010]) Specifically for this project, the prototyping model was chosen as many of the project requirement and specification had yet to be confirmed and thus it needs to be build on trial and error basis. Furthermore, the initial build up till the proof of concept will need to build on prototype approach 14 Figure 4: Flow chart of system design 15 PART 3: LITERATURE REVIEW 3.1 Basic Circuit Theory A circuit consists of circuit elements and wires. Wires appear on schematics as being straight lines. Nodes appear on a schematic when 2 or more wires connect, and are usually marked with a dark black dot. Circuit elements are "everything else" in a sense. Most basic circuit elements will have their own symbols for recognizing factor, although some will be drawn as a simple box image, with the specifications written somewhere that is easy to find. Below we look into further details of circuit theory related to this project. 3.1.1 Closed and Open Circuit A closed circuit is one in which a series of devices complete a connection between the terminals, and charge is allowed to flow freely. An open circuit on the other hand is a section of a circuit where there is no connection. Current does not flow between the terminals of an open circuit, although a voltage may be applied between the terminals, and capacitance may exist between them. At steady state, there is no current flow in an open circuit. Often the term "shorting" is widely used in circuit analysis. Shorting an element in a circuit means placing a wire across the terminals of the element. Because current will take the least resistance path, shorting an element redirects all current around it. Because the potential difference between the terminals of the device is zero, no current can flow through it. This must be done carefully, because reducing the resistance of a certain portion of a circuit to zero can raise the current to infinity, and this will damage the circuit. 3.1.2 Voltmeters and Ammeters Voltmeters are used to measure the voltage across an element and ammeters are used to measure the current flowing through a wire. An ideal voltmeter has an infinite resistance (in reality, several megohms), and acts like an open circuit. A voltmeter is placed across the terminals of a circuit element to determine its voltage. An ideal ammeter has zero resistance (in reality, a few ohms or less), and acts like a short circuit. Ammeters are placed in-line in a circuit, so that all the current from one terminal flows through to the other terminal. 3.1.3 Sources Sources come in 2 basic forms: Current and voltage sources. These sources may be further broken down into independent and dependent sources. 16 Current sources are sources that output a specified amount of current. The voltage produced by the current source will be dependent of the output current and the resistance of the load (ohm's law). Voltage sources produce a specified amount of voltage. The amount of current that flows out of the source is dependent on the voltage and the resistance of the load (ohm's law). If a voltage source is shorted (a resistance-less wire is placed across its terminals), the current output approaches infinity. No voltage source in existence can output infinity current, thus the source will usually melt or explode long before it reaches that particular value. This is an important point to keep in mind. An example of voltage source is a battery, which is specified as being 6V or 9V. The amount of current that the circuit draws from the battery determines how long the battery life is. Independent sources produce current or voltage at a particular rate that is dependent only on time. These sources may output a constant current/voltage, or they may output current or voltage that varies with time. Dependent sources are current or voltage sources whose output value is both dependent on time and another value from the circuit. A dependent source may be based on the voltage over a resistor, or even the current flowing through a given wire. The following are possible; - Current-controlled current source - Current-controlled voltage source - Voltage-controlled current source - Voltage-controlled voltage source 3.1.4 Switches A switch then is a circuit element that is an open-circuit for all time t < T0, and acts like a closed-circuit for all time t ≥ T0. U (t) = {0, if t < T0 U (t) = {0, if t ≥ T0 Function above provides a mathematical model to describe circuit elements that change between Boolean states (high/low). 3.1.5 Resistors, Resistance and Conductance Resistors are circuit elements that allow current to pass through them, but restrict the flow accordingly to a specific ratio called resistance. Flow that is restricted by resistors is said to be "lost to the resistor". Resistors are commonly used as heating elements, because energy lost to the resistor is frequently dispersed into the surroundings as heat. Each resistor has a given resistance. Implementing resistors on a design are commonly used either as a pull-up resistor where it is place below VCC and the short is eliminated or a pull-down resistor where it pulls the signal down to the ground instead of up to VCC. 17 Figure 5a: A schematic diagram of a resistor Figure 5b: A pull-up resistor (Picture courtesy of everything2.com) Figure 5c: A pull-down resistor (Picture courtesy of everything2.com) Resistance is measured in terms of units called Ohms (volts per ampere), which is commonly abbreviated as Ω. Ohms is also used to measure the quantities of impedance and reactance. The variable most commonly used to represent resistance is r or R. It is defined as R = ρL/A, where ρ is the resistivity of the materials, L is the length of the resistor, and A is the cross-sectional area of the resistor. Conductance is the inverse of resistance. Conductance has units of siemens (S), referred to as mhos (ohms backwards, abbreviated as an upside-down Ω). Conductance can be useful to describe resistors in parallel, since the sum of conductance is equal to the equivalent conductance. However, this is rarely used in practice. The variable most commonly used to describe conductance is G. It is defined as R=1/G. 18 3.2 Microcontroller Fundamentals A microcontroller is a device that integrates various components of microprocessor system into one single microchip. It interacts with the outside world through on-board interfaces. Its main function is to co-ordinate the flow of information between separate memories and peripherals which are located outside it. The connections to a microprocessor include address, control and data busses which allow it to select one of its peripherals and send to or retrieve data from it. Therefore, a microcontroller incorporates the following; - CPU - Memory (ROM and RAM) - Parallel digital I/O - Serial I/O port - Timer module - Analog to digital converter (ADC) 3.2.1 Building Block Structure of Microcontroller Figure 6: An example of a microcontroller’s building block 19 Below we look into details of these blocks. 3.2.1.1 Central Processing Unit A block that have a built in capability to multiply, divide, subtract, and move its content from one memory location into another. Its memory locations are called registers. Registers on the other hand are memory locations whose role is to help with performing various mathematical operations or any other operations with data wherever data can be found. For example, if user wishes to add the contents of two memory locations and return the result again back to memory, there would be a need for a connection between memory and CPU. To simply put it, it must have some "way" through for data to go from one block to another. 3.2.1.2 Memory This is a part of the microcontroller whose function is to store data. For a certain input it gets the contents of a certain addressed memory location. However there are two things to take note which are the addressing and memory location. Memory consists of all memory locations, and addressing is selecting one of them. This means that user needs to select the desired memory location, and on the other hand wait for the contents of that location. Besides reading from a memory location, it must also provide for writing onto it. This is done by supplying an additional line called control line. This line is designated as r/w (read/write). It is used in the following way, if r/w=1, reading is done, and if opposite is true then writing is done on the memory location. 3.2.1.3 Bus There are two types of buses, address and data bus. Address bus consists of as many lines as the amount of memory user wish to address and it serves to transmit address from CPU memory. Data bus on the other hand is as wide as data needed and it serves to connect all blocks inside the microcontroller. 3.2.1.4 Input/Output Unit When working with I/O port, it is necessary to choose which port user need to work with, and then to send data to, or take it from. The port acts like a memory location. Something is simply being written to or read from and it could be noticed on the pins of the microcontroller. 20 3.2.1.5 Serial Communication It is possible to receive and send data simultaneously at the same time. A full-duplex mode block which enables this is called serial communication. Unlike the parallel transmission, data moves bit by bit or in a series of bits. After the reception of data, user needs to read it from the receiving location and store it in memory. In sending data, the process is reversed. 3.2.1.6 Timer Unit In order to utilize serial communication, there is the need to add on few additional blocks. One of those is the timer block which is significant because it can give user information about time, duration, protocol etc. The basic unit of the timer is a free-run counter which is in fact a register whose numeric value increments by one in even intervals, so that by taking its value during periods T1 and T2 and on the basis of their difference user can determine how much time has elapsed. 3.2.1.7 Watchdog This block is a free-run counter where the program needs to write a zero in it every time it executes correctly. In case that program gets "stuck", zero will not be written and counter will reset the microcontroller. This will result in executing the program again, and correctly this time around. That is an important element of every program so as to be reliable without man's supervision. 3.2.1.8 Analog to Digital Converter As the peripheral signals are usually different from what microcontroller can understand (one and zero/high and low), thus they have to be converted into a pattern which can be understood by a microcontroller. This task is performed by a block for analog to digital conversion. This block is responsible for converting information from analog value to a binary number and to follow it through to a CPU block so that it can then be process further. Figure 7: The inside view of a microcontroller 21 3.2.2 Programming Languages Use for Microcontroller For all application, a microcontroller alone is not enough. User needs a program that can be executed. Programming can be done in several languages. Assembler, C and Basic are the more commonly used. Assembler is a lower level language that is programmed slowly, but takes up the least amount of space in memory and gives the best results where the speed of execution is concerned. C is easier to be written and to be understood but is slower in execution compared to assembler. Basic is the easiest among all but it is also slower than assembler when it comes to execution. Therefore user needs to consider carefully the demands for speed of execution and the size of memory available. After the program is written, user would install the microcontroller into a device and run it. The microcontroller would then need to be connected to a power supply. As it detects and receives power supply, microcontroller will perform a small check up on itself, look up the beginning of the program and start executing it. 3.3 Background of Intramedullary Nail and Having an Intelligent Intramedullary nail implant was originally intended to correct shortened or deformed limb caused by injuries, diseases or other causes like congenital defect. However, it is more popularly use this days for individuals who wants to increase their height. An individual can gain lengths of up to 60mm for the upper and lower bones of the legs. As long as they are at least 13 years of age and in good health, this can be done. (Yeo Hai Teck, 2007. ENG499, Final report) As compared to conventional bone extension surgery, intramedullary nail implant is much safer and simpler to perform. The device is inserted into the hollow of a bone that has been cut crosswise (with a diameter of 20mm). It is than activated by the user using either a supported GUI or PC to increase the length of their bones with up to 1mm a day. It would then normally takes about three months or more for the bone to gain its normal strength. (Yeo Hai Teck., 2007. ENG499, Final report) The hardware design of the intelligent controller system mainly involves a transceiver and a splatch antenna implanted internally and also externally (for two way communication). However today, not much is known of the communication channel between the nail implant and the free air space surrounding it externally. The Federal Communications Commission (FCC) had allocated 402-405 MHz frequency band to Medical Communication Implant (MICS). This band range is suitable for implanted applications as it is small enough and at the same time able to allow the design of low-power transceiver and antenna arrangement that can achieve reasonable transmission range. It also does not pose any interference risk. (Federal Communications Commission, 1999. Medical Implant Communication Service (MICS) Part 95. Available at: www.fcc.gov [Accessed 23 August 2009]) (Anders J Johansson1, Anders Karlsson2., 2004 Wave-propagation from medical implants) 22 Good transceiver and antenna circuit design is a very critical factor in obtaining good range and stable throughput. As this is for implant application, the size of the hardware and its circuit will also have to be considered. Finally, when all the hardware is assemble together, a microcontroller will be deployed to execute control. 3.4 Biomedical Material In our daily lives, we often have to depend on biomaterials and biomedical devices which are used throughout our body. However there are stringent controls placed upon the application of devices and the materials that can be used. When a medical implant device is placed into human body, it concerns the effect of the physiological environment on the material and device. Specifically for this project, any biomedical material used will not only have to satisfy its design requirements but must also not degrade in its properties and not cause any adverse reactions within the human body. Below is an explanation of bio metals and synthetic polymers in further details. (Yeo Hai Teck., 2007. ENG499, Final report) 3.4.1 Biomaterials Metals Due to their toughness and strength, metals are widely used as biomaterials. The more commonly used implant metals such as stainless steel, titanium and cobalt alloys are generally biocompatible. However there will be some people who are allergic to ions released from these metals. One of the major problems with metals is the generation of fine wear particles that can lead to inflammation and implant loosening. (Tristan Burg., 2001. Owen Standard) Table 1: Comparisons of the commonly used implant metals 3.4.2 Synthetic Polymers Polymers have physical properties that are almost similar to natural tissues in human body and are thus widely used as implant materials. Its usage includes wound dressings, tendon replacements, intraocular lens replacement and joint linings. The polymers that are commonly used include polyethylene (PE), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE) and polyurethane (PU). These 23 materials are well tolerated in the human body. However, the additives and molecules released due to polymer breakdown can lead to allergic and inflammatory responses. (Tristan Burg., 2001. Owen Standard) Table 2: Comparisons of the commonly used polymers 3.5 Circuit Design Implementation to Drive the Motor In determining the circuit design that will be able to drive the motor in the nail implant, the first most important thing is to identify the truth table logic of the motor driver that will be used. Upon that, these basic factors shall be incorporated into the circuit design. - Identifying of the pins on the microcontroller unit that will be assign to the forward and reverse switch. - Identifying of the pins on the microcontroller unit that will be assign as the inputs. - Based on the truth table logic of the motor driver that will be used, the software code shall be written for the logic (high/low) detection and settings for these pins accordingly. - The pins on the microcontroller unit that had been assigned as inputs will have to be connected to the motor driver so that the appropriate input to output logic conversion will take place. This conversion will be done by the motor driver itself. - The pins on the motor driver which had been identified as outputs are to be connected to the motor. With proper coordination of these factors in the design set-up and software code writing, user will be able to drive the motor accordingly. Table 3: An example of a truth table of a motor driver 24 PART 4: SYSTEM DESIGN 4.1 System Description Figure 8 depicts a block diagram of the complete system. It includes mainly an external circuit, user interface, function selector and an implanted internal circuit. The internal circuit gets its power supply from the receiver coil which will have power transmitted to it wirelessly via the transmitter coil. It is possible to achieve very low average power consumption since the entire cycle can be completed in less than a few seconds. The transceiver on the external circuit will transmit command from the MCU commander while the transceiver on the internal units will receive command to the MCU slave for execution. This system is to produce linear motion in bi-directional motor drive systems. Figure 8: Block diagram of a complete intramedullary nail system 25 4.2 Microcontroller Selection The selection of which microcontroller to be use is very much based on the aspect of its size and functions. For this project, the width of the microcontroller should approximately not be more than 10mm due to the 12mm diameter incision that is made. Some of its necessary specification requirements needed are; - 8-bits. - 128 bytes of RAM. - 4k bytes of on-chip ROM. - 2 timers, 1 serial port and 4 ports which are 8-bits wide each. - 2 or 3 16-bits counters and programmable full-duplex serial port with its baud rate provided by one of its timers. - Minimum of 32 I/O lines (four 8-bits ports) with RAM. With all this in mind, Microchip’s PIC16F676 was found to be suitable and thus chosen as the microcontroller for this project due to its powerful but yet easy to program (only 35 single word instructions) capability. Figure 9: PIC16F676 microcontroller pin assignments 4.3 Motor Selection As with the microcontroller, the diameter of the body of the chosen motor must also not be more than 10mm. Table 4 looks at the more commonly types of motors that are available in the market such as DC motor, stepper motor and servo motor. Comparison details between them need to be reviewed so as to select the most suitable type of motor to be use. Table 4: Comparisons of the more commonly types of motors 26 After reviewing all the comparisons and weighing the pros and cons, it was initially decided that stepper motor is to be use since it is simple and interfaces well to microcontroller systems. At the same time, the output power needed for this project is also not very high. However the smallest diameter of the body of a stepper motor that is available in the market is 12mm. With this, DC motor was the obvious choice left. In the search for a suitable DC motor, Faulhaber stands out as the world’s largest consolidated portfolio of miniature and micro drive system technologies. With a technology focus on the self-supporting, skew-wound, ironless rotor, DC motor and precision system components such as gearboxes, encoders and motion controllers, it specializes in complex and high precision area of application such as medical devices, handling automation, telecommunications and precision optics. Thus the Faulhaber model of choice of DC motor for this project is 1024 M 003 S with G10/1 gear due to its size properties. Figure 10: Dimension of a DC motor Figure 11: Dimension of a DC motor with gear 27 4.4 Motor Driver Selection A half amp full bridge driver for small 3V, 5V and 12V DC motor with below considerations should be selected; - Split ± voltage power supply option for output drivers. - Load switching capabilities to 0.5A. - Operating voltage of +2.5V to 15V. - Low standby current. - CMOS/TTL compatible input logic. - Over temperature shutdown protection. - Over current limit protection. - Over current fault flag output. - Direction, braking and PWM control. - Width approximately not more than 10mm. Rohm BA6289 driver is chosen to be the motor driver for this project as it is one of the few in the market that meets these considerations and at the same time available for small quantity purchase. Figure 12: Functional block diagram of the BA6289 driver Table 5: BA6289 driver pin descriptions 28 Figure 13: BA6289 driver pin assignments 4.5 Transceiver Selection The key considerations in transceiver selection are; - Its communication standards protocol. - Its hardware platform. - Its communication modes. - Its application interface. - Range capability of more than 2m. - Capability of allowing device to sleep in order to save power. - Width approximately not more than 10mm. LINX Technologies transceiver TRM-433-LT meets most of these consideration and thus is the chosen transceiver for this project. Table 6: TRM-433-LT transceiver pin descriptions 29 Figure 14: TRM-433-LT transceiver pin assignments 4.6 Circuit Design Figure 15: Schematic diagram of external circuit - Emergency: Press the button and the power supply will be cut-off. - Motor Accordion: Press the button and a command will be send to the MCU slave in the internal circuit to move the motor in accordion motion. - Motor Forward: Press the button and a command will be send to the MCU slave in the internal circuit to move the motor in forward motion. - Motor Reverse: Press the button and a command will be send to the MCU slave in the internal circuit to move the motor in reverse motion. 30 Figure 16: Schematic diagram of internal circuit Due to limitation of time to work on this project, the task was simplified to just proof of concept of the idea. Thus only one main circuit is to be developed and it is call the proof of concept circuit to test out workability of the idea implementation and also its electronics. Figure 17: Schematic diagram of proof of concept circuit 31 PART 5: IMPLEMENTATION OF IDEAS 5.1 Idea Implementation As with the specification set out for this project, the nail should only extend or retract by a maximum of 0.25mm at a time and a maximum of 1mm per 24hrs. As a whole, the nail should also only be extended or retracted up to a maximum of 60mm. Therefore, this will be a key aspect of the microcontroller implementation. Figure 18: Flowchart methodology for nail extension 32 Figure 19: Flowchart methodology for nail retraction Another thing to take note is that on top of having forward and reverse movement, accordion movement is also needed for this. This is because the accordion like pumping action will help to hydrate and increase the fluid circulation to the tissues around the nail. (Kane M., 1985. Journal of Orthopedic and Sports Physical Therapy) 5.2 Software Implementation Therefore, with all these in mind, the software implementation for this project had been set out to have below intelligent. - Forward/Reverse movement should not be more than 0.25mm (13 secs) extension /retraction per each time. - Accordion movement moves forward than reverse continuously, with that 13 secs for each direction. - Counter 1 set a count of (N+1) every time the forward switch is pressed. - Counter 1 set a count of (N-1) every time the reverse switch is pressed. - Timer starts timing once it detects the first switch being activated (N+1 or N-1). This timer together with counter 1 will get refresh every 24hrs. 33 - The forward switch will not be able to be activated if the counter 1 reads a value of > 4 for (N+1) so as to prevent an extension of more than 1mm per 24hrs. - The reverse switch will not be able to be activated if the Counter 1 reads a value of < -4 for (N-1) so as to prevent a retraction of more than 1mm per 24hrs. - After 24hrs and counter 1 gets refresh, whatever value the count is reading is to be stored in another counter (Counter 2). Whenever Counter 2 reads a value of > 240 or < -240, it will prevent any movement from taking place. This is to ensure the nail can only be extended or retracted to a maximum of 60mm. (60/0.25 = 240) Figure 20: Algorithm of the software implementation 34 PART 6: TESTS AND RESULTS 6.1 Motor and Driver The first test to be carried out pertains to the motor and driver. The tests are; - Motor rotates in clockwise direction. - Motor rotates in anti-clockwise direction. Figure 21: Circuit setup for test Table 7: The truth table of motor driver BA6289F 35 6.1.1 Motor Rotates in Clockwise Direction Figure 22: Circuit and waveforms for motor clockwise movement Channel A (Output 1): Display the enable signal was pull to high logic with a voltage of 4.265V. The current reading taken was 0.046A. (Minimum current needed for Faulhaber 1024 M 003 S DC motor is 0.016A) Channel B (Output 2): Display the enable signal was pull to low logic. 36 6.1.2 Motor Rotates in Anti-Clockwise Direction Figure 23: Circuit and waveforms for motor anti-clockwise movement Channel A (Output 1): Display the enable signal was pull to low logic. Channel B (Output 2): Display the enable signal was pull to high logic with a voltage of 4.234V. The current reading taken was 0.044A. (Minimum current needed for Faulhaber 1024 M 003 S DC motor is 0.016A) 37 6.2 Software The second and final test to be carried out pertains to the software. The tests are; - Per every time motor rotates in clockwise direction, ~0.25mm of extension takes place. - Per every time motor rotates in anti-clockwise direction, ~0.25mm of retraction takes place. - Within 24hrs, when 1mm of extension has taken place, motor will not carry out any movements. - Within 24hrs, when 1mm of retraction has taken place, motor will not carry out any movements. With the help of the mechanical jig of the nail implant that comes with a distance reader which was provided by the school, the test for the above was able to be carried out. Table 8: Results of second test 38 PART 7: PROBLEM AND DIFFICULTY 7.1 Problems and Difficulties Encountered One of the main problems encountered while doing this project was the inability to get the Faulhaber 1024 M 003 S DC motor to work even though the entire circuit up to the motor driver portion was working fine. After further debugging, the main problem identified was; - The motor driver pin 2 (motor voltage) was connected to a 1K resistor which was connected to VCC. - This connection was done based on examples from the BA6289 driver datasheet. - Conclude that the reason for a need for this 1K pull-down resistor was to protect the motor from receiving a very high current input from the driver if the VCC use is very high since the driver has an operating voltage capability of up to 15V. - However, since the VCC use in this case is only 5V, the pull-down resistor causes the current to be of a very low value. (< 0.005A) - The Faulhaber 1024 M 003 S DC motor on the other hand needs a minimum current of 0.016A. Thus, the 1K resistor was removed and the motor driver pin 2 was connected directly to VCC. With that, the Faulhaber 1024 M 003 S DC motor manage to work. 39 PART 8: LITERATURE STUDY OF WIRELESS POWER TRANSMISSION (SECONDARY OBJECTIVE) 8.1 Introduction In order to deliver stable and sufficient power supply to a human tissue safely, a wireless power transmission system based on inductive coupling is presented. The system consists of a primary coil outside and a multiple secondary coils inside the body. The primary coil is driven to generate a uniform alternating magnetic field covering the whole of the alimentary tract and the multiple secondary coils receive energy regardless of the position and orientation relative to the generated magnetic field. The human tissue safety of the electromagnetic field generated by transmitting coil was evaluated, based on a high-resolution realistic human model. 8.2 System Overview Wireless power transmission comprises two subsystems, the power transmitter and the power receiver. The power transmitter generates alternating magnetic field through the transmitting coil, driven by the power amplifier. Energy is delivered by inductive coupling between the transmitting and receiving coils. The received AC voltage is rectified and regulated to DC voltage. The transmitting coil is normally the primary side and the receiving coil is the secondary side. Because there is a large air gap between them, they form a loosely coupled transformer. In order to improve the power transmission efficiency, the primary and secondary side coils should be compensated by capacitors, thus forming serial or parallel resonant circuits on each side. The serial resonant circuit is preferable in this weakly coupled system because of its better load performance. The power transmitter and receiver work in resonant state, in which the resonant frequency of both sides must be identical. The frequency of the alternating magnetic field is determined by the resonant circuit of the power transmitter. Selection of the magnetic field frequency is critical and is determined mainly by the characteristics of the receiving coil, which must be designed for highpower transmission efficiency. (Robert Huston., 2000. International Journal of Medical Robotics) Figure 24: System overview 40 8.3 Power Transmitting Coil The function of the power-transmitting coil is to generate an alternating magnetic field compatible with the power receiver. A solenoid coil with an inner diameter greater than the transverse dimension of the human body is simple and easy to implement, but it has a serious drawback. The magnetic field is not uniform in such a coil. In positions near the coil, the magnetic field is much stronger than that in the central positions. This will make the received power too excessive in one position but too weak in another, causing instability when the power receiver works in different positions. Another problem is the potential adverse health effect to the tissues near the coil, because the magnetic field would go beyond the safety threshold. A uniform magnetic field should be adopted to avoid these two problems. A uniform magnetic field can be generated by having two identical circular coils that are placed symmetrically on each side of the experimental area, along a common axis and separated by a distance equal to the radius of the coil. Each coil carries an equal current flowing in the same direction. The magnetic field generated can be static, time-varying DC or AC, depending on applications. The current in each coil should be the same phase in order to generate a low-frequency magnetic field. (Robert Huston., 2000. International Journal of Medical Robotics) 8.4 Coil Driver To drive the transmitting coil, an inverter that can change the DC power to AC power is needed. In order to achieve a high efficiency, a Class D inverter should be selected. The DC input voltage is converted to a quasi-square wave by full-bridge switches to excite the transformer primary coil. In order to reduce over-voltage and switching losses of Q1, Q2, Q3 and Q4 (MOSFETs) in conventional Class D inverters, a snubber network is implemented. A square wave signal with a duty cycle of 50%, produced by the timing generator, is fed to the driver to generate a sinusoidal driving current in the LC tank. An adjustable inductor, Lr, is serially connected with the LC tank formed by the transmitting coil, L, and the resonant capacitor, C. Because the inductance of the power-transmitting coil and the capacitance of the resonance capacitor may change, the adjustable inductor acts as a regulator to maintain the specified resonance frequency through the variation of its inductance. The resonant capacitor must resist a high AC voltage up to several KV, because of the high Q value of the transmitting coil. The capacitor should have a Q value as high as possible to reduce heat generation. A ceramic vacuum capacitor with a capacitance of 250pF and a high-frequency peak working voltage of 21KV is adopted. (Robert Huston., 2000. International Journal of Medical Robotics) 41 Figure 25: Full-bridge Class D inverter 8.5 Power Receiving Coil In order to deal with the orientation problem, a multiple receiving coil orientated in three different directions is design. The winding wire should be able to reduce the skin effect and proximity effect losses in coils. In addition, the quality factor of the receiving coil should be optimized through appropriate design parameters to reduce the power loss and increase the power link efficiency. The most important design parameter is the number of turns of each coil. Because the usable space is restricted, the number of turns determines the number of strands. In order to find the optimized configuration, tests are performed on one-dimensional coils with different turns and strands wound on cubic ferrite cores with the same size of 6.6 × 6.6 × 5.5mm. The Q values of each coil were tested at different frequencies as illustrated in Figure 26. In the testing, the Q of one coil was measured when the other coils opened. Test results shows that the configuration of more strands and fewer turns is preferable. Figure 26: Q values of different coils A schematic of the power-receiving circuit is shown in Figure 27. Three LC series resonant circuits, formed by 3D coils L1, 2, 3 and their resonant capacitor C1, 2, 3, were power receiving front-ends. A series resonant circuit, rather than a parallel resonant circuit, was selected because its impedance was lowest at the resonant 42 frequency. A large current instead of a high voltage can be acquired to drive the load. A full-bridge rectifier, rather than a full-wave rectifier, was used in the receiving circuits. The full-wave rectifier has the features of the same efficiency as a full-bridge rectifier while few diodes are needed, but it needs twice the number of turns than that of the full-bridge rectifier, which means more space is required when same power is retrieved. From the point of view of space, a full-bridge rectifier is more suitable as it can provide mover power when the given space is fixed, which is essential to the wireless power link. The extra space occupied by the diodes can be counteracted by adopting smaller packages. A Schottky barrier diode with low forward voltage was adopted to reduce power loss in the rectification process. Parallel connection, rather than serial connection, was selected to summarize the contributions of three coils after rectification. In parallel connection, only the coil which produces the maximum voltage among the three will contribute its power to the load; the other two cannot form a return circuit because of the clamping of the diode. In serial connection, the receiving power may increase because all the three coils may contribute their power, but the power loss from the diode also increases. In addition, the receiving circuits may operate out of resonance because of interference when all the three coils form the return circuit; this would result in a remarkable drop of the receiving power. After the parallel connection, a filter capacitor, Cf, and a zener diode, DZ, were adopted. The filter capacitor was used to smooth the rectified voltage and the zener diode to protect against possible over-voltage. Because there is a need for a fixed voltage for its operation, a regulator should be connected after rectifier. For the sake of conversion efficiency, a switching mode DC converter was adopted instead of a conventional linear regulator. The DC converter, designed with a step-down converter chip and a few other chip components, was demonstrated to have an efficiency of 85–90%. All the power receiving circuits except the receiving coil could be implemented in a circular double-sided PCB. (Robert Huston., 2000. International Journal of Medical Robotics) Figure 27: The power-receiving schematic 8.6 Experiments and Results In order to investigate the performance of the designed wireless power transmission system, position and orientation stability tests is necessary. In these tests, receiving power was acquired by measuring the voltage of the load resistance, Rd which was temporarily connected with Cf in the receiving circuit shown in Figure 27. The DC converter and zener diode were removed during the tests to get rid of the influence of these components. The load resistance was set to 15R, approximating the series resistance of the power-receiving coils. The magnetomotive force of the power transmitting coil was 39 ampere-turns. The frequency of the magnetic field was 43 400KHz. In the position stability test, receiving power was recorded on a mesh grid of 20 × 20mm on a plane across the axis of the power-transmitting coil, and the receiving coil was maintained in a fixed orientation, with the electromagnetic field perpendicular to one of the three coils. An orientation stability test had to be carried out, using a rotatable stage located at the centre of the transmitting coil. The rotation mode was adopted for all possible orientations that would be covered in the rotation when ϕ was kept at 45◦. The receiving power was acquired every 10◦ in 360◦ rotation, and the result is illustrated in Figure 28. According to the analysis of orientation stability above, the optimal orientation in power receiving occurs when θ = 0◦ and 180◦ in rotation, and the worst orientations are 54◦, 126◦, 234◦ and 306◦. The experimental result in Figure 28 also shows that it is in accordance with the theoretical analysis, and the maximum and minimum receiving power was 790 and 310mW. From the theoretical analysis and experiments, it was revealed that some degree of orientation stability could be achieved by using a 3D power-receiving coil. Because the orientation stability was tested in the centre of the transmitting coil, which is the worst position in the power transmission, the power of 310mW in the orientation stability test was thus the minimum power received. (Robert Huston., 2000. International Journal of Medical Robotics) Figure 28: Result of rotation experiment 8.7 Human Tissue Safety The concern for human tissue safety of power transmission could not be avoided in this study, since an excessive electromagnetic field generated by the transmitting coil might damage the human body. According to the 1997 guideline of international commission on non-ionizing radiation protection (ICNIRP), for the frequency range 100KHz–10MHz, electromagnetic influences on biological tissue include thermal effects and stimulant action. The thermal effect is a result of the generation of Joule heat, while the non thermal effect involves exciting neurons and muscles by the induced current. The specific absorption rate (SAR, W/Kg) is often used as an index of the thermal effect and current density (A/m2) is often used as an index of the non44 thermal effect. Since the SAR and the current density in human tissues cannot be acquired by experiment, a numerical simulation method, based on a high-resolution human anatomical model, was adopted in the study. A semi-automatic image segmentation technique was performed to identify and segment the image into regions of different tissues or organs, based on sectional image and anatomical knowledge. The physical properties of the tissues or organs, such as conductivity, permittivity and density were specified to the corresponding tissues after identification. The conductivity, permittivity of human tissues comes from parametric models for the dielectric spectra of tissues and the tissue densities were based on Reference Man of the ICRP, for some tissues whose densities were not included in the references, a homologous density was assigned. When these two steps were finished, a human electromagnetic calculation model was achieved. This model was imported into a commercial software package by the format of voxel data; after setting the parameters of the transmitting coil, current density and SAR that can be calculated by finite integration technique. Figure 29a-c shows the display of the human model that was established. The model consists of 56 kinds of tissues or organs, with a resolution of 0.33mm in transverse section and 2mm between slices. The maximum current densities in the cutting plane for a frequency of 400KHz are shown in Figure 30 for a current density distribution of an x–z plane at y = 0 cm and an y–z plane at x = 16.1cm, respectively. The results showed that current density was large at places near the transmitting coils and in tissues consisting of muscle. The maximum current density, calculated as above, was 3.82A/m2, below the ICNIRP basic restrictions (4A/m2). The maximum SAR distributions in the cutting plane as an average value of 10g for a frequency of 400KHz are shown in Figure 31, for a SAR distribution of an x–z plane at y = 4.8cm and a y–z plane at x = 0cm, respectively. SAR was large at places near the coils and in fat and muscle tissues. The maximum SAR, calculated as above, was 0.329W/Kg, far below the ICNIRP basic restrictions (10W/Kg). (Robert Huston., 2000. International Journal of Medical Robotics) a b c Figure 29a: Mid-coronal and mid sagittal section display Figure 29b: Whole-body skin and skeletal structure Figure 29c: Coil alignment 45 Figure 30: Distribution map of induced current density Figure 31: Distribution map of SAR 8.8 Conclusion and Discussion At least 310mW of usable powers can be transmitted under the worst geometrical conditions. The maximum specific absorption rates (SAR) and current density of human tissues are 0.329W/Kg and 3.82A/m2, respectively, well under the basic restrictions of the ICNIRP. The designed wireless power transmission is shown to be feasible and potentially safe in a future application. (Robert Huston., 2000. International Journal of Medical Robotics) 46 PART 9: CONCLUSION AND RECOMMENDATIONS 9.1 Conclusion The main approach taken for this project had been to design and develop a microcontroller system that controls a linear drive system for an intramedullary nail that meets a set of technical specifications according to the user requirements. Studies and classification of biomedical implantable devices and wireless power transmission were also undertaken. The motivation behind this was being able to play a part in helping those who desire to gain additional heights or those who have had an injury that caused shortened or deformed limb bones or were born with limb length inequality to overcome their shortcoming. The main advantage of this project is that it allows the system to be reprogrammed and changed to suit the needs of the patient without having to make changes to the electronics hardware. Therefore, through re-programming, it helps to reduce pain felt by the patient and unnecessary surgery can be avoided. One of the main achievements of this project is in the implementation of ideas. Even though the concept and design is not entirely original, the idea implemented was unique and not done before. Looking back to the project objective earlier, testing out on animal trials was not carried out as project was developed more on the basis of proofing of concept due to time limitations. Thus, the transmitting and receiving portion was left out and the physical circuit develop was also not according to specific size requirements as miniaturization of hardware was not look into. 9.2 Future Recommendations Up to this point, there remain a few things where future work can be done to bring this project to a higher level and fully complete it. They are; - Physical development of the transmitting and receiving portion. - Physical development of the internal circuit according to specific size requirement with proper miniaturization of hardware. - Physical development of wireless power transmission. - Look into the possibility of enabling the user to use their handphone via sms to control the nail, with the help of a GSM module. 47 PART 10: CRITICAL REVIEW AND REFLECTIONS 10.1 Critical Review and Reflections In the beginning of this project, I was very lost and low in confidence of getting it done. The overall picture of the project looks to be very daunting. Other than having a good knowledge of electronics engineering and microcontroller programming, biomedical knowledge is also needed especially in the biomechanics of the upper and lower extremities. Thus, a lot of biomedical research needs to be done. There were also many electronics and circuitry knowledge which I wasn’t sure of and I was also not highly proficient in microcontroller programming languages. However, through those initial meetings I had with Mr. Stephen and Mr. Firdaus, slowly but surely I begin to clear my doubts and build up my confidence. Along with all the research and learning that I done through this period, the skills, knowledge and experienced obtained during my studies in Unisim through these subjects (HESZ331, TZS323, ENG311, ENG327 and ENG328) do comes in handy as backbones for the project. As a whole, it had been a very good experience and an eye opener for me as to what research, development and project planning is all about. It has truly been beyond classroom learning. 48 GLOSSARY Linear drive system: Movable machine element, such as slide, carriage or the like, and relative movement between the guide element and the base element is obtained by a toothed or gear belt engaging into a rack, in which, for example, the rack is located on the base element and the gear belt is driven by a drive motor or the like located on the movable machine element, slider or carriage. Microcontroller: A type of microprocessor emphasizing self-sufficiently and costeffectiveness, in contrast to a general-purpose microprocessor. Potential difference: The amount of energy per unit charge needed to move a charged particle from a reference point to a designated point in a static electric field; voltage. Pull-up resistor: A resistor that is connected between the power-supply line and a logic line and ensures that the line is normally pulled up to the supply potential. Opencollector logic devices may be connected to the logic line and each device is then capable of pulling the line low to the ground. Pull-down resistor: A resistor that is connected between the ground and a logic line and ensures that the line is normally pulled down to the ground potential. Opencollector logic devices may be connected to the logic line and each device is then capable of pulling the line up to the power-supply line. Full-duplex mode: Capable of transmitting and receiving over the same channel simultaneously. In pure digital networks, this is achieved with two pairs of wires. In analog networks or in digital networks using carriers, it is achieved by dividing the bandwidth of the line into two frequencies, one for sending, and the other for receiving. Transceiver: A device that has both a transmitter and a receiver which is combined and share common circuitry or a single housing. If no circuitry is common between transmit and receive functions, the device is a transmitter-receiver. Antenna: Also known as an aerial, a transducer designed to transmit or receive electromagnetic radio waves. Interference: Any disturbance that interrupts, obstructs, or otherwise degrades or limits the effective performance of electronics and electrical equipment. It can be induced intentionally, as in some forms of electronic warfare, or unintentionally, as a result of spurious emissions and responses, intermodulation products, and the like. Stepper motor: A brushless, synchronous electric motor that can divide a full rotation into a large number of steps. When commutated electronically, the motor’s position can be controlled precisely, without any feedback mechanism. DC motor: An electric motor that runs on direct current (DC) electricity. 49 Servo motor: A motor used for motion control in robots, hard disc drives and etc. Generally designed more like an alternator than a standard motor, most servos need special control circuitry to make them rotate electrically. Some can be used in reverse to generate alternating current. MOSFETs: A special type of field-effect transistor (FET) that works by electronically varying the width of a channel along which charge carriers (electrons or holes) flow. The wider the channel, the better the device conducts. The charge carriers enter the channel at the source, and exit via the drain. The width of the channel is controlled by the voltage on an electrode called the gate, which is located physically between the source and the drain and is insulated from the channel by an extremely thin layer of metal oxide. Resonant frequency: A frequency at which some measure of the response of a physical system to an external periodic driving force is a maximum. Three types are defined, namely, phase resonance, amplitude resonance, and natural resonance, but they are nearly equal when dissipative effects are small. Vacuum capacitor: A capacitor with separated metal plates or cylinders mounted in an evacuated glass envelope to obtain a high breakdown voltage rating. Filter capacitor: A capacitor used in a power-supply filter system to provide a lowreactance path for alternating currents and thereby suppress ripple currents, without affecting direct currents. Full-bridge rectifier: A full-bridge device, such as a diode, that converts alternating current to direct current. Full-wave rectifier: A full-wave device that converts the whole of the input waveform to one of constant polarity (positive or negative) at its output. Full-wave rectification converts both polarities of the input waveform to direct current (DC), and is more efficient. Regulator: Device or circuit that maintains a desired output under changing conditions. Zener diode: A silicon semiconductor device used as a voltage regulator because of its ability to maintain an almost constant voltage with a wide range of currents. Linear regulator: A voltage regulator based on an active device operating in its "linear region" or passive devices like zener diodes operated in their breakdown region. The regulating device is made to act like a variable resistor, continuously adjusting a voltage divider network to maintain a constant output voltage. It is very inefficient since it sheds the difference voltage by dissipating heat. Magnetomotive force: Force that produces a magnetic field. 50 REFERENCES 1. Yeo Hai Teck., 2007. ENG499, Final report 2. ISO 14155-1., 2003. Clinical investigation of medical devices for human subjects_ Part 1 3. ISO 14155-2., 2003. Clinical investigation of medical devices for human subjects_ Part 2 4. Federal Communications Commission, 1999. Medical Implant Communication Service (MICS) Part 95. Available at: www.fcc.gov [Accessed 23 August 2009] 5. Work Breakdown Structure, Wikipedia. Available at: http://en.wikipedia.org/wiki/Work_breakdown_structure [Accessed 23 August 2009] 6. Waterfall Model, Wikipedia. Available at: http://en.wikipedia.org/wiki/Waterfall_model [Accessed 23 August 2009] 7. Prototyping Model, SearchCIO-Midmarket.com Definitions. Available at: http://searchcio-midmarket.techtarget.com/sDefinition/0,,sid183_gci755441,00.html [Accessed 23 August 2009] 8. Spiral Model, Wikipedia. Available at: http://en.wikipedia.org/wiki/Spiral_model [Accessed 23 August 2009] 9. Structured System and Design Method, Wikipedia. Available at: http://en.wikipedia.org/wiki/SSADM [Accessed 23 August 2009] 10. Circuit Theory, Wikipedia. Available at: http://en.wikibooks.org/wiki/Circuit_Theory/All_Chapters [Accessed 27 January 2010] 11. Pull-up/Pull-down Resistor, Everything2.com. Available at: http://everything2.com/title/Pull-up+resistor [Accessed 10 February 2010] 12. Microcontroller, PIC Tutorial. Available at: http://www.pictutorials.com/what_is_microcontroller.htm [Accessed 27 January 2010] 13. Anders J Johansson1, Anders Karlsson2., 2004 Wave-propagation from medical implants 14. Tristan Burg., 2001. Owen Standard 15. Microcontroller PIC16F676 datasheet, Farnell. Available at: http://www.farnell.com/datasheets/19068.pdf [Accessed 23 August 2009] 51 16. DC motor 1024 M 003 S datasheet, Faulhaber. Available at: http://www.faulhaber.com/uploadpk/EN_1024S_MIN.pdf [Accessed 23 August 2009] 17. Motor driver BA6289 datasheet, Digikey. Available at: http://media.digikey.com/pdf/Data%20Sheets/Rohm%20PDFs/BA6289F,6417F.pdf [Accessed 23 August 2009] 18. Transceiver TRM-433-LT datasheet, LINX Technologies. Available at: http://www.linxtechnologies.com/Documents/TRM-xxx-LT_Data_Guide.pdf [Accessed 23 August 2009] 19. Kane M., 1985. Journal of Orthopedic and Sports Physical Therapy 20. Robert Huston., 2000. International Journal of Medical Robotics 21. Glossary search, Answers.com. Available at: http://www.answers.com/ [Accessed 8 May 2010] 22. Anders J Johansson., 2004.Wireless communication with medical implants: Antennas and propagation 23. Winfried Mayr., 2001. Basic design and construction of the Vienna FES implants 52 APPENDICES Standard United States FCC Title 47 CFR 95.601-95 Subpart E European Union En 301 839 (Part 1 and 2) European Union EN301 489-27 Description Title 47 of the Code of Federal, Part 95 explains operational rules and technical regulations applicable to MICS transmitters. Deals with RF aspects of implants in the 402 405MHz band, including unique test methods such as the use of a human torso simulator to recreate the effect of implantation in the body when measuring radio emissions. Also includes an RF interference avoidance specification for accessing the 402405MHz band to provide interference free operation in this band. Deals with EMC issues for 402-405MHz equipment. Aligns with EU Active implantable Medical Devices Directive so that manufacturers that comply with the standard can satisfy both directives without duplicating their testing for EMC. Appendix 1: Relevant US and European standard Appendix 2: Electrical field strength dependent on fat layer thickness (Anders J Johansson., 2004.Wireless communication with medical implants: Antennas and propagation) 53 Appendix 3: Electrical field strength dependent on fat layer thickness (Anders J Johansson., 2004.Wireless communication with medical implants: Antennas and propagation) Appendix 4: Gantt chart 54 1. All surfaces have to be of proven biomaterials that do not cause excessive tissue reactions even in the presence of slight inflammation of the adjacent tissue. The surfaces must not react chemically with resulting corrosion products. 2. The mechanical design of the implant has to be kept small in size and weight. Its surface has to be shaped as far as possible to the assigned anatomical site and it must not present corners and edges that could cause pressure damage. 3. All electrical conductors carrying direct current (DC) have to be sealed hermetically; consequently all electrical conductors that are exposed to moisture have to be kept DC-free. This requirement applies especially to the electrode outputs and the electrodes themselves, which directly interface with an electrolytic medium and are in danger of being destroyed rapidly if there is DC. 4. Antenna coils for transmission of energy and/or for data transmission have to be positioned inside a hermetic capsule or if that is not possible constructed in a manner that avoids both leakage current and change of electrical capacity between different windings of the coil. The coil is usually part of a resonant circuit that is susceptible to detuning or loss of efficiency. 5. Special care has to be taken when connecting metal parts. They must not differ excessively in electrochemical contact voltage. Electrochemically equivalent materials are to be preferred, alloys should be avoided if possible and welding techniques are preferable to soldering techniques. For soldering, acid-free flux and careful removal of residues are required. 6. Plastic materials, including the usual medical grade silicone and epoxy polymers, do not provide hermeticity. DC-loaded parts of the electric circuit have to be enclosed in a metal or ceramic case. 7. Metals that can be used to enclose implant electronics are made of the reactive metals titanium, tantalum or niobium with glass-to-metal-seals made from sodium-free borosilicate glass. Stainless steel is not suitable, because the alloy is decomposed during the welding process that seals the case. 8. For data transmission with a limited data rate it is possible to position the antenna coil inside a metal case. The carrier frequency is a compromise between the shielding factor of the case and the required data rate. To power an implant circuit via an RF-carrier the antenna has to be placed outside, and distant to, the metal case to achieve an acceptable efficiency. An alternative is to choose a ceramic case, but these are difficult to seal hermetically at low temperatures. 9. The usual strategy of combining a hermetic case with some external components embedded in a polymer requires additional care to avoid or at least to elongate leakage paths as far as possible. They originate normally where the electrodes penetrate the surface, and inside the implant they follow all the surfaces of embedded components. 10. Clean all surfaces before embedding them to avoid residual ions that cause corrosion as soon as they come into contact with moisture. The mould with the liquid sealing compound has to be evacuated at the very beginning to remove air bubbles, and the rest of the curing procedure has to be done under high purity nitrogen. Rapid temperature changes have to be avoided during polymerization to prevent homogeneities, strain and cracks within the cured material. Appendix 5: Medical implant construction rules (Winfried Mayr., 2001. Basic design and construction of the Vienna FES implants) 55 Equipment Portable DC Power Supply Oscilloscope Multimeter Soldering Station Application Provide the necessary DC power to the microcontroller and any other integrated circuits or other devices that require their own power supply. It is indispensable for this project in designing and debugging circuits. It is indispensable for this project in getting necessary measurements. Basic tool for building electronics circuit and PCB. Appendix 6: Laboratory equipment application 56