ECE496Y Final Report Individual Evaluation Form

Student Project ID: Student Name: Section: 6 2011158 Project Title: Implantable Medical Stimulator Supervisor: J. Taglione Professor Prodic Bahiny Sivapathasundaram Administrator:

Adequate

Excellent

Document Introduction: clear background, motivation, goals, requirements Final Design: system diagram, system and module level descriptions, assessment of strengths and weaknesses Testing and Verification: adequate documentation, discussion of results, comparison of results to requirements Summary and Conclusions: summary of accomplishments and challenges, success in achieving project goals Presentation: clear writing, grammar, organization, use of tables, diagrams, figures Project Final outcome: success in achieving stated project goals, technical complexity Individual effort and contributions Administrators grade (/10): General Comments: Section average (/10):

Marginal

Provide a rating for each section. Circle to indicate problem areas.

Administrators signature:

Poor/unclear

Administrators Evaluation
Good

Comments (also see comments in report)

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ECE496Y Final Report Individual Evaluation Form

Student Project ID: Student Name: Section: 6 2011158 Project Title: Implantable Medical Stimulator Supervisor: J. Taglione Professor Prodic Gabilasan Gengatharan Administrator:

Adequate

Excellent

Document Introduction: clear background, motivation, goals, requirements Final Design: system diagram, system and module level descriptions, assessment of strengths and weaknesses Testing and Verification: adequate documentation, discussion of results, comparison of results to requirements Summary and Conclusions: summary of accomplishments and challenges, success in achieving project goals Presentation: clear writing, grammar, organization, use of tables, diagrams, figures Project Final outcome: success in achieving stated project goals, technical complexity Individual effort and contributions Administrators grade (/10): General Comments: Section average (/10):

Marginal

Provide a rating for each section. Circle to indicate problem areas.

Administrators signature:

Poor/unclear

Administrators Evaluation
Good

Comments (also see comments in report)

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The Edward S. Rogers Sr. Department of Electrical and Computer Engineering University of Toronto

ECE496Y Design Project Course Group Final Report

Title: Project I.D.#:

Implantable Medical Stimulator

2011158
Name: Email:

Team members:

(Select one member Bahiny Sivapathasundaram* to be the main contact. Mark with *) Gabilasan Gengatharan

bahiny.sivapathasundaram@utoronto.ca gabilasan.gengatharan@utoronto.ca

Supervisor: Section #: Administrator: Submission Date:

Professor Prodic 6 J. Taglione March 22, 2012

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Group Final Report Attribution Table

Section Background info Final Design Testing and Verfication Student Names Bahiny Sivapathasundaram RS, RD RS, RD RS, MR, ET Gabilasan Gengatharan RS, MR, ET RS, MR, ET RS, RD

All

RS, RD, MR, FP

RS, FP, ET, CM

Abbreviation Codes:
Fill in abbreviations for roles for each of the required content elements. You do not have to fill in every cell. The All row refers to the complete report and should indicate who was responsible for the final compilation and final read through of the completed document. RS responsible for research of information RD wrote the first draft MR responsible for major revision ET edited for grammar, spelling, and expression OR other All row abbreviations: FP final read through of complete document for flow and consistency CM responsible for compiling the elements into the complete document OR - other If you put OR (other) in a cell please put it in as OR1, OR2, etc. Explain briefly below the role referred to: OR1: enter brief description here OR2: enter brief description here

Signatures By signing below, you verify that you have read the attribution table and agree that it accurately reflects your contribution to this document.
Name Name Signature Signature Date: Date:

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Executive Summary (author: B. Sivapathasundaram)

Implantable medical stimulator is used widely in the medical world to replace an organ or structure. Powering such devices should be done efficiently and user friendly. We have designed it using planar inductors as the magnetic coupling energy transfer component and a dc-ac converter circuit that is attached to other basic components to allow for energy storage and accommodating transfer to the implanted device. We precisely calculated the values of each component in the circuit and made sure it is small enough to be attached to the body. This implanted device is going to be charged externally so we must use a small storage and transfer circuit that will be implanted with the device. Hence we used a super capacitor as a battery which allows for less frequent charging periods. The design accounts for minimal heat production to abstain from harming the human body. Skin impedance is avoided using the magnetic coupling from the planar inductors as we are transmitting the energy through the skin in the form of magnetic wave. A dc-ac converter is used as it is more power efficient than the dc-dc converter and we effectively supply the implant with the appropriate voltage and current necessary to charge it. We have budgeted this project at around $200. We have broken down the work into three sub divisions, transmitting the energy, energy transfer to the implant and the implants mechanisms. We decided to implement an actual circuit for the first two sections and used animal leather instead of a human skin for testing purposes for the transmitting of energy. The project resulted in the creation of a successful design model of a charging mechanism that will effectively charge a commercially available device: Medtronics Soletra Neurostimulator. This is the implantable medical stimulator and we believe it can definitely benefit future implantable devices by making them smaller and consumer friendly.

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Group Highlights and Individual Contributions

Group Highlights (author: G. Gengatharan)
Our project demonstrates that it is very possible to cordlessly charge an implanted device in the body in a manner that is convenient for the consumer as well as allowing producers of implanted medical devices more flexibility with their design. During the course of this project we ran into many difficulties in accomplishing this task and although we were expecting to create a more efficient model, we did succeed in accomplishing our primary objective of modeling the energy transfer mechanism. We have successfully designed the second component of our implantable medical stimulator, which was the storage and energy transfer mechanism. We used efficient circuit designing techniques to minimize the amount of components, which reduces cost and heat production which still transferring the same amount of energy. We discovered ways of minimizing the size of the circuit by using a super capacitor as our energy storage device instead of an actual battery, which is heavy and big. Through these breakthrough design decisions we increased the efficiency of our device. The project we tackled was very hard and accomplishing this much is definitely a huge achievement. We have learned that if this idea becomes more commercially viable, it will definitely provide a breakthrough in the creation of more consumer-friendly biomedical devices.

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Bahinys Individual Contribution (author: B. Sivapathasundaram)

I built the AC-DC converter as proposed in Task #1 on the Gantt chart. I used the diode circuit building techniques we learned in ECE231to create an AC-DC diode converter that efficiently converted the AC signal that would come from the magnetically coupled charging mechanism and stored it into the capacitor. I fixed the problems we had earlier with the energy storage in the super cap. I also took on the major role in finding an efficient method of cordlessly charging the implanted device. I initially was designing a magnetically coupled charging mechanism; however, there were many problems with that. One of which was that the skin impedance was too high; this resulted in increasing the strength of the magnetic field across the skin, which we constrained to be low due to health precautions. Another problem was that we were constrained by the small size of the patch we wanted put the magnetic strip in to charge the device, it was too small and wasnt working. There were many problems to this solution, and our research on other mechanisms proved that cordlessly charging the implant required a very sophisticated charging device which we do not have the time, money, or skill to make. This is why I believe that this design project should be more research intensive in order to use the best magnetically charging mechanism out there and thats why we prototyped the device with an unrealistic simple charging mechanism just to convey our idea across. Furthermore, I did some material testing and researching on metals that can be used to build the device so that when we implant it, the body doesnt reject it. I have discovered that titanium, chromium, and platinum are the best metals to create the device from.

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Gabilasans Individual Contribution (author: G. Gabilasan)

I have been working on the more biomedical research side of things. I have comprised a list of implantable medical devices and their respective specifications that can work with our magnetic coupling system we were developing. And although the cordless charging component is averting to a more research based method, it ties in well with my biomedical research to create a proposal for a more user-friendly system in implantable medical stimulation. For example I discovered an implanted neurostimulation system in the market that slows down the progression of Parkinsons disease; however, the implant needs to be opened up every few years and charged again [2]. The combination of this system and the wireless charging mechanism we found [1] could create a breakthrough in the medical implantation field where the need to reopen an implant for charging purposes can be eliminated. I also did research in creating the pulse generator. This is a very easy task to do, but very difficult to research into what exact pulse we require to stimulate certain muscle fibers and neurons. My research showed that even a small DC signal above the threshold of 30mV would create an action potential in a neuron that would be carried throughout the body and cause muscle movement. The pulse system is just a model and I figured out that I could just make a basic pulse generator that does not need to meet the specific muscle stimulation requirements but can just produce a pulse to just prototype the design. In addition, I have also helped Bahiny out with the initial testing of the charging mechanism to transfer the energy across the animal leather.

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Acknowledgements
We wish to thank the people listed below who helped us. Without their help, support, and guidance our implanted medical stimulator project would have never came into existence. Professor Aleksandar Prodic: Our supervisor who helped us develop the initial idea and assisted us in designing the main system architecture. Mr. John Taglione: Our administrator who supported and advised us throughout the course of this project. Mike Mehramiz: Design Center Manager who helped us with some PCB design. Professor Khoman Phang: For teaching us throughout the course on how to do engineering design and the many things associated with it. These people were fundamental in this project and we would have never been able to do this project without their help and guidance.

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Table of Contents
Introduction Background and Motivation Project Goals and Requirements Final Design Basic System Level Overview Detailed Explanation of Design System Block Diagram Assessment of Final Design Testing and Verification Summary and Conclusions References Appendix A: Gantt Chart History 13 14 17 18 19 21 22 23 11 12

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Introduction
This report summarizes the motivation, research justification, design, and the implementation and testing of a prototype of the implantable medical stimulator as part of our final year design project course ECE496. The report concludes with suggestions of improvements and future work that can be done to implement the real implantable design.

Background and Motivation (author: B. Sivapathasundaram)

Implant, in medical terms, is a medical device that is used to substitute or replace a biological structure. Stimulators are devices that arouse the body or individual organs or other parts to increase functional activity. Implantable Medical Stimulators are widely used around the globe today due to the expanding prevalence of disorders. In addition, the rising popularity of cosmetic surgery has also boosted the demand for such implant stimulators. The main problem in implanting such stimulators is providing enough energy to them. Since it is going to be attached into a human body, it is a challenging task to provide the required energy to the device while taking care of the patients safety and ease. There are some remarkable past work on this field. A few of them are as follows: Research on implantable power supplies with an optically rechargeable lithium battery has been done before; it is a novel approach for supplying power to medical implants. The battery is charged using infrared light directed through the skin and to the device [3]. Moreover, research at the Florida International University on miniature dc-dc converters for medical implants seems very promising. A dc-dc converter is designed to be used in pacemakers and defibrillators which are electrical devices that set the heart beat using electric impulses [4]. The students of Tohoku University published a very interesting research article on artificial hearts recently. Again a dc-dc converter is used to provide the energy to a vibrating flow pump within a body [5]. Page 11 of 23

Project Goals and Requirements (author: G. Gengatharan)

The Goal of this project is to propose a method to provide energy to an implanted brain stimulator in an efficient manner so that the patient will be able to use the device with ease. The original problem in providing energy is once the implant is done, the patient should go back to have another surgery to change the battery cells after a certain period of time. By using this particular method, the patient does not need to have another surgery again after the implant since this device is going to charge the implant wirelessly using an external device that will be attached onto the skin. Our idea is to attach a small flat patch device to the skin that will draw energy from an outside source and wirelessly transmit that energy to the implanted device under the skin. This implanted device will be connected to a converter and then to a super capacitor, which will act as our battery. The converter will be connected to the implant and to another capacitor and this will provide the required energy to the implant. The capacitors act as chargers and are used to maintain the constant voltage across the converter and the implant and to store the charge. Project Requirements: 1. Create an efficient mode of energy that can be used to charge the capacitor and provide the required amount of energy to the implant. 2. This energy source should be small enough to be attached to the body and should be safe enough for the human body. The preferred size is 2 inch x 2 inch. 3. The frequency of re-charging must be reasonable, as the patient cannot be charging the device often. The preferred one is charging for 10 minutes for the usage of constant 10 hours. 4. The materials used should be harm less to the human body and should be easily accessible and flexible so it can be attached to the skin perfectly. 5. Since skin has higher impedance this method should try to avoid the skin impedance to be more efficient. 6. The dc current should be converted into ac current inside the body and then should be converted to the required amount of current to avoid damaging the inner organs.

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Final Design
Basic System Level Overview (author: G. Gengatharan)
Our design is based on two major components. The first component of our design is the transferring of energy cordlessly through the skin to charge the implant. In order to gain the energy to charge the implant several sources of energy can be used. It can be charged using current or using infrared rays that go through the skin or by magnetic coupling. Charging the device using the regular external current can be harmful to the skin as it is not advisable to directly charge the attached device using a direct current. Charging it by the infrared rays is useful for smaller amount of energy. Since we might need relatively larger than that we have decided to use the magnetic coupling with planar inductors, as it is safer and more efficient. Two planar inductors can be used with the primary inductor outside and the secondary one inside. The device to be attached to the skin can be made by plastic or by metal and we have decided to use plastic since it is very flexible and lasts longer and it is lighter than the metal. Planar inductors are chosen over normal inductors since they are flatter and can be easily attached to the outer skin. The second major component is to store that energy and charge the implant with the appropriate voltage and current according to its power specifications. In order to convert the current we can either use a dc-dc converter or a dc-ac converter. Even though dc-dc converter is less power efficient, in order to use the dc-ac converter one should be able to know the required power output. We have calculated the Power out to be 1mW and the Power Peak to be 144mW (Approximately 150mW) so we have decided to use the dc-ac converter, which is more power efficient.

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Detailed Explanation of Design (author: B. Sivapathasundaram)

We chose planar inductors as our main method of transferring the energy across the skin. Planar Inductors are easily attachable to human skin and they are smaller in size. The challenge here is to make this inductor work with two detached halves of it.

One half of this planar inductor will be attached outside the skin and act as a primary coil while the other half of the inductor will be attached beneath the skin and act as the secondary coil. These two parts together will function as a transformer, so when a certain amount of current is sent through the primary coil it will induce current in the secondary coil, which will in turn charge the capacitor and this will power the implant. While powering the primary coil we can either use the current from the wall plug or use batteries. We chose lithium batteries since they last longer and have the capability to produce the required amount of power and avoid damage to the device. The Medical Implant we will be using here is Medtronics Neurostimulator which is used to slow down Parkinsons disease. We chose Neurostimulators over other stimulators because Neurostimulatos wont be affected by the signals/pulses created by our charging device.

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The following figure shows the position of the Neurostimulator:

We chose to attach the charging device on the right or left side of the shoulder near the collarbone, this will reduce the size of the charging device and maximise patients comfort. The required parameters for this implants are:

Since we are not going to purchase the actual implant we have decided to go with the above parameters as our target.

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In a nutshell, the primary coil that is attached to the outer skin will be charged using batteries and that will induce current in the secondary coil which is attached to the super capacitor (EDLC). Super capacitor is used here since it is larger in capacitance and can hold more energy and that will reduce the frequency of re-charging. Next to the super capacitor there will be a switch and another capacitor, which is attached to the dc-ac converter that is connected to the implant. We came up with the switch design to ensure the implant gets the required power during the charging of the primary coil. In other words, the super capacitor should be charged for 10 minutes and during that period the implant should still be provided with enough power. In order to make it possible we need a smaller capacitor attached to the converter that can power the implant for 10minutes. The required size of this capacitor is 0.08kF. The switch will be switched off during this period. The dc-ac converters in markets are used for higher voltages and since we are skipping the part of the dc-dc converter we should find a dc-ac converter that can turn the 1V direct current into 0.3536 Vrms alternating current since the implant requires 0 - 0.5 V alternating current. The power required by this implant , the voltage across the super capacitor should be 1V and the capacitor should be big enough to provide power to the implant for 24 hours continuously. So it should have the energy of 6.1kW. So we should use a super capacitor with 12.2kF. However we highly doubt the possibility of the said parameters. Since this requires a very large capacitor in size. However the Electric double-layer capacitor might reach several farads with an improvement of two orders of magnitude without changing the physical size of it. The maximum they can reach is 5000 farads so we have reduced the charging time to be every 10 hours, which will require the capacitance to be 5kF. Human body just wont accept anything, especially when we are trying to insert a part of our device, which includes the secondary coil, charging capacitor and the dc-ac

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converter we should make sure everything is biocompatible. We did our research and dedicated significant amount of time to carefully chose the materials and in order to make it bio compatible we can either cover the entire device with polyethylene glycol which is used in medicine or cover it with Ti or Pt case. Both of the methods mentioned will prevent the proteins from binding and thus will convince the body to accept it without treating it as a foreign object. Polyethylene glycol is mostly used for smaller scale medicines so here we will be using a Ti case since it is cheaper.

System block diagram (author: G. Gengatharan)

This block diagram will summarize the detailed explanation of the design section, which shows components of the design and how they interact with each other.

Power Source

Primary Planar Inductor (Transmitter)

Secondary Planar Inductor (Receiver)

Super Capacitor (EDLC)

DC-AC Converter with Capacitor

Switch

Implant

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Assessment of Final Design (author: G. Gengatharan)

The major strength of this design is, since it is charged externally it is a pain less easy procedure for the patient as the patient does not need to undergo a surgery to replace the battery cells. Also this is a portable design which is again an asset to the patient, relatively magnetic coupling is less harmful to the human body and once it is fixed this device will last for a long time. However since the size should be limited, the capacitors capacity will also be limited. Larger capacitance will require a bigger capacitor and thus will be inconvenient. Larger capacitance will help to lessen the frequency of re-charging but since the size is also concerned it is a challenge to choose an optimal capacitor that will be both small enough in size and big enough in capacitance. Even though it is a practical design, the actual testing cannot be done in a human brain or an organ. The human skin can be replaced by animal skin but the actual organ cannot be used for testing purposes because we do not have access to them, it is unethical to obtain a brain as well. Overall, the design accomplishes its primary task and from the theoretical viewpoint, we designed it for efficiency, which was explained above with the charging mechanism. We say theoretical because we ran into many problems building just the model of the device, but our design approach and our calculations verify that theoretically the design accomplishes its task as efficiently as possible compared to current technologies available in the field.

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Testing and Verification (author: B. Sivapathasundaram)

Initial testing was done using a typical transformer

A small piece (2in by 2in) of pigskin was inserted in the middle of the above transformer and we tried to produce current but the skin impedance of the pigskin was too high that we failed to produce any current. Also using a core transformer would not be able to help in this case, we then chose to use planar inductor.

DC-AC converter Testing

We carried out this test by applying a 1V current to a circuit model of our dc-ac converter, which was created in a computer program that we used for the ECE413 course. By our calculations we were expecting to get a output current of 0.3536 Vrms. Our implant requires about 0 - 0.5 V alternating current as input so the dc-ac output current would be enough. We tested it and our simulations showed that we did end up with an alternating current between 0.3 0.4 Vrms, which was a success.

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Compliance of Project Requirements:

This chart will describe if and how we met our project requirements: Requirement (# & title)
1. Efficient Energy Transfer

Target specification
Transfer 6.1kW of energy within the 10 min 2 inch x 2 inch

Final Result
Transferred very little energy Yes the designed model is 2 x 2 Due to the first one charging wasnt efficient Our design was based on the material being built on zinc We used planar inductors to magnetically transfer energy

Compliance (Pass/Fail)
Pass and fail

Comments and Documentation

This was very hard to do, our planar inductor design was failing on us, so we were only able to inefficiently transfer a little amount of energy Our design made sure the planar inductor fit in the 2 x 2 patch, maybe thats why we were not getting efficient charging I think our constraint was too high, but the planar inductor energy transfer design is what messed up this requirement as well Our design incorporated the material property from the very beginning

2. Small size of energy source 3. Fast charging

Pass

10 minute charging for 10 hours Safe material like zinc or chromium

Fail

4. Safe Material

Pass

5. Avoid Skin Impedance

Surpass skin impedance

Pass

The permeability of skin is equal to air so we took that into consideration when we designed the cordless charging mechanism with planar inductors

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Summary and Conclusions (author: G. Gengatharan)

Although, we did not entirely meet our project goals and requirements with the magnetic charging of the internal super capacitor with the planar inductors, we did accomplish the cordless energy transfer, which was the primary concern of this project. It was a very difficult task since we had to learn to design planar inductors, which was usually done by doctorate students focusing in the electromagnetic field. We believe the primary reason for the planar inductors not working was because we did not know all the design techniques involved in designing planar inductors to be efficient. This would require years of study but we did get some energy transfer to work which is an accomplishment in it self. Our energy transfer requirements were not met but we did manage to meet all of our other requirements due to brilliant design decisions outlined in this report. An example would be to remove the extra dc-dc converter from the initial design, which resulted in fewer amounts of components, less heat production, and less cost in designing the device. Our project deals with a breakthrough field in the development of biomedical devices. External charging would allow for smaller more efficient devices being implanted into humans to help treat serious medical condition that will help prolong life. We learned a lot from his project and we hope there is continued development in this field to better the lives of people who have conditions that are treatable through electrical stimulation.

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References
1. Dissanayake TD, Budgett DM, Hu P, Bennet L, Pyner S, Booth L, Amirapu S, Wu Y, Malpas SC. A novel low temperature transcutaneous energy transfer system suitable for high power implantable medical devices: performance and validation in sheep. Artif Organs. 2010 May;34(5):E160-7. PubMed PMID: 20633146. http://www.ncbi.nlm.nih.gov/pubmed/20633146 2. Solectra Neurostimulator. http://www.medtronic.com/patients/parkinsonsdisease/therapy/our-dbs-therapy-products/soletra/index.htm 3. Kazuya Goto, Tetsuya Nakagawa, Osamu Nakaramura and Satoshi Kawata, An Implantable Power Supply with an Optically Rechargeable Lithium Battery, IEEE Transactions of Biomedical Engineering : Volume 48, No7, July 2001. 4. Osama A, Mohammed, A Miniature dc-dc Converter for Medical Implants, Department of Electrical Engineering, Florida International University. 5. Hidetushi Matsuki, Yoshihiko Yamakata and Noriyoshi Chubachi , Transcutaneous dc-dc Converter for Totally Implantable Artificial Heart Using Synchronous Rectifier, Graduate School Of Engineering, Tohoku University, Sendai.

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Appendix A: Gantt Chart History

Gantt Chart From Proposal:

Gantt Chart From Progress Report:

Final Gantt Chart:

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