Intracranial MEMS Based Pressure Sensor for Siphon Regulatory

Intracranial MEMS Based Pressure Sensor for Siphon Regulatory Devices A “Bottom of the Pyramid” solution for living with hydrocephalus Nick Dunn, Nick Fountoulakis, Ian Flaherty, Alex Winters

Today’s Presentation § § § § Introducing the Bottom of the Pyramid market Hydrocephalus in the developing world Fabrication of pressure sensor Wireless telemetery Remote monitoring via mobile phone Computer software program/mainframe Packaging of overall device Funding opportunities

Bottom of the Pyramid § The Bottom of the Pyramid is the largest but poorest social economic group § More than 4 billion people living on $2 a day or less § Majority of these people live in parts of Africa, China, and India § They represent an un-served or underserved market § “Active engagement at the Bottom of the Pyramid markets requires a new and an innovative approach to business. Retrofitting business models from the developed markets will not work” C. K. Prahalad The Fortune at the Bottom of the Pyramid

§ 45 blind worldwide, 9 million blind in India § Goal to eradicate needless blindness in India § Specialize in providing quality eye care, perform cataract surgery § Manufacture intraocular lens in early 90’s import lenses from west $200 now they make lens of international standards $5 a piece

§ Prosthetic foot in the United States $8000 § Jaipur Foot was designed to simulate normal foot movement and provide a quality solution for the masses § Produced a $30 prosthetic foot § Main center in Jaipur, India treats 60 patients a day § Multiple doctor visits are needed to have custom fitted prosthetic device in United States

Hydrocephalus § Excess cerebrospinal fluid (CSF) accumulates in the ventricles of the brain § Hydrocephalus affects 3 in every 1000 infants worldwide § Treated with surgery by inserting a ventricular shunt system § Shunt system is regulated by fixed pressure valve § Doctor visits are needed to check up on the system

Our Bottom of the Pyramid Solution § Produce catheter system for regulation of hydrocephalus of international standards at an affordable price § Educate women in villages of signs and symptoms of hydrocephalus so treatment can be sought time appropriately § Utilize expanding cell phone market to provide remote monitoring

Proposed Hydrocephalus Monitoring System § A MEMS based pressure sensor will be surgically implanted into the skull § This will monitor over extended periods of time the internal pressure due to build up of cerebrospinal fluid § Pressure readings will be relayed via telephone to the computers at a hospital § Optical Charging of lithium battery using photodiode array

A Capacitive MEMS-Based Pressure Sensor

Micromachined Capacitive Pressure Sensor • Highly sensitive (0. 37 MHz / torr sensitivity) • Healthy pressure range is between -5 to 10 torr. • Our device will be able to measure pressures in the range of -25 to 200 torr • Basic idea is that changes in pressure cause membrane to deflect and decreases the distance between the two plates, thereby changing the capacitance. • Changes in capacitance are then converted to a frequency encoded signal that is processed by external electronics that can be housed in the packaged integrated circuit (IC) die.

Simplified Process Flow For Sensor Fabrication a) Anisotropic etch with KOH Si. O 2 c) Shallow Boron Diffusion and deposition of Dielectric material Dielectric P+ Si Si b) Deep Boron Diffusion creates the supporting rim for diaphragm e) Electrostatic Bonding to glass wafer patterned with metal electrode and metalsilicon lead transfer. Dissolution of wafer. P+ Si glass metal

LC CMOS Oscillator • Differential Cross-coupled topology technology • The oscillation frequency is very sensitive to changes in capacitance of the tank capacitor (sensor). • The inductors L and C 0 are selected to keep the oscillation frequencies in the ISM band of 2. 4000 -2. 4835 GHz. • Signals can be transmitted over longer distances than RF waves and doesn’t require the use of large inductors which would make system MRI incompatible. • A CMOS timer is employed as a bias control to save precious battery power.

LC CMOS Oscillator (cont) • Differential Cross-Coupled Topology • Historical Colpitts Oscillator Design of Integrated Circuits for Optical Communications Vs.

Specs • ISM band of 2. 4000 – 2. 4835 GHz • Tank capacitor variation of 1. 3 to 3. 5 p. F (deflection of the membrane) • L = 22. 9 n. H , C 0= 0. 17 p. F • For core transistors (M 1, M 2) w/l ratio of 15. 5 and 2. 3 m. A of bias current. • CMOS timer circuit is employed to switch bias on and off with a period of T = ms, and a pulse width of T 0 = 1 µs. 10 • Duty cycle T 0/T = 0. 0001 corresponds to an average current of 1. 1 µA (very low). • Total DC current and consumed power is 11. 5 m. A and 34 m. W • 3 V 30 m. A/h battery will allow lifetime of ~2 months.

Power • As previously stated Total DC current and consumed power is 11. 5 m. A and 34 m. W • A 3 V 30 m. A/h Lithium coin cell will be used to power the device. • Device will be recharged with an optical setup.

Optical Charging • The photodiode array is embedded in the scalp directly above where the module sits in the bore hole in the skull. • Laser diode (810 nm near infared) shown through lens to focus on photodiode array • Results show that for photodiode area of 2. 1 cm , 17 min of exposure with power density of 22 m. W/cm can send enough energy to recharge a standard 3 V pacemaker battery. • Technology still young, inefficient 10 -20% transmittance through skin 2 mm thick.

Packaging Side View of Device Antenna CMOS/ASIC Battery

Packaging Cont. 10 mm A titanium casing will be acquired from a machine shop. One potential is Titanium Fabrication Corporation from NJ. Prices are quoted. Welded 8. 85 mm

Catheter System § § § Medtronic is a supplier of catheters to India and the world Supply Our Sensor with Medtronic Catheters prior to their Delivery to Hospitals § Bypass need to fabricate catheters or purchase them Making current technology a little bit better § Reduce inpatient care § Doctor’s will know when they have to adjust valves § Better quality of life for patients and doctors

Biotelemetry for “Bottom of the Pyramid” Applications Nick Dunn, Nick Fountoulakis, Ian Flaherty, Alex Winters

Issues Covered § § Review of Wireless Telemetry Concepts Challenges inherent in Wireless System Design Overview of our device’s Telemetry system Role of Cellphones § In our device, and in developing a “bottom of the pyramid” device

Telemetry Review § § § Wireless telemetry is a unique solution to the challenge of allowing for communication between an external device, and the MEMS device that is implanted in the body. Coupling allows for the readings (measured capacitance readings and external pressure) from the pressure sensor to be sent to an external device/database. This is not limited to data transfer, however; operational parameters, manual shunt controls, and error mitigation as well! Improves quality of life for the patient as well; allows the patient to “stay attached” to sophisticated monitoring and treatment devices, without bulky machines or repeated hospital visits.

Challenges in Telemetry § § Medication Adherence has been shown to be the most important factor determining Medical Outcomes, according to the World Health Organization. We seek to create simple and customized wireless technology, tailored specifically for our desired “Bottom of the Pyramid” market, that will provide excellent healthcare to these regions, while being designed to accommodate deficiencies inherent in resource-limited settings.

Our Telemetry System § § § Wireless telemetry is a unique solution to the challenge of allowing for communication between an external device, and the MEMS device that is implanted in the body. The patients (in India) will use their cellular telephone to receive the signals from the hospital, and to send data back to the medical staff. This can be performed by holding the cellphone, with any additional amplification add-ons attached, up to the device. From here, the signals can be sent directly over the phone, and the device can operate in the same way as it did with our CMOS and RF model. http: //baby. indstate. edu/isb/publications/1 5 th_isob_proceedings/7/7. htm

Cellphone Use § § § One of the biggest additions to our device to tailor it to our “Bottom of the Pyrimid Market”, India, was to have the communication device we use to relay the information from patient to doctor be a CELLPHONE. Leading global telecommunications companies begun developing customized products and telecom solutions for India. As a result, cellphone use in India skyrockets, and developing products that assume cellphone ownership of the general populace becomes much more viable. However, the Healthcare issues that face resource-limited settings are still present, including: http: //www. indiamag. in/wpcontent/uploads/2010/11/Bharti-Airtel. jpg • • • Lack of sufficiently trained medical professionals for Hospitals. Overcrowding in Hospitals/Clinics… not enough of them! Lack of Sanitation, improper medication, lack of adherence to regimen, etc.

Cellular Telemetry § § While originally being developed for improving landline voice communication, Cellular RF applications in medicine are a unique and convenient alternative to repeated hospital visits. The patient would likely need a modem, but that’s it! The device in the patient does not need to be active for data to be sent, stored, and implemented when sent by the hospital. Some advantages and disadvantages: • • Advantages to Cellular Telemetry Low profile, non directional antenna Easy to set up and low maintenance costs Two-way communications Event notification by pager, Internet, other cell phone, etc. http: //www. stevenswater. com/telemetry_com/cell_i nfo. aspx Disadvantages to Cellular Telemetry • Requires cell phone coverage area • Monthly service fee (may vary depending on local area cell phone service provider) • Cell phone service provides may change cell towers or communication protocol, thereby effecting communications to your remote location • Connection may be dropped during peck cellular transmissions activities

System Overview Telemetry Sensor Hospital Computer Phone Log Files Log File: • Date + Time • Pressure Reading • Patient ID Process Patient ID: Height + Weight Computer Program Analyze Pressure Readings + Display Determine If Valve Needs Alteration Or Other Patient Care Call Patient For Clinical Visit

Frequency Encoded Capacitance § The deflection of the diaphragm is related to pressure. § In capacitive pressure sensors, the capacitance is related to the deflection of the diaphragm and therefore the pressure. § The presssure sensor will send frequency encoded capacitance readings (tank circuit), § Fit data with these equations to determine and analyze the pressure.

Funding § Venture Capitalists § NSF Grants § § Bio. MEMS Research Hydrocephalus Research Biotechnology Global Initiatives § Non-Governmental § Hydrocephalus Association

Overview and Recap Preliminary: § Capacitive Pressure Sensor in Glass Casing § Valve Control in Catheter § RF Telemetry for Communication § Developed General Ideas

Interim § Biocompatibility + Regulations Check § Titanium Packaging Scheme § Conceptual Framework of Microwave Telemetry + Capacitive Sensing § Novel Valve Idea - Over enthusiastic § Targeting General Population in America § Developed Conceptual Framework Overall

The Final Proposal § Global Health Initiative through BOP design § Only 2500 cases per year in the US § ~10, 000 cases per year in India alone § Bigger Impact § Solidified Process Flow and Understand How to Analyze and Transmit Pressure Data § Wireless telemetry through mobile phone technology for patient mobility § Quantified Dimensions, Viable Pressures, and Power Consumption § Identified Potential Sources of Funding to Pursue the Project Thank you!

References 1) Kurtom, K. H. Siphon regulatory Devices: Their Role in The Treatment of Hydrocephalus. Nerurosurgery Focus 22, 2007 2) Tadigadapa, S. Applications of High Performance MEMS Pressure Sensors Based on Dissolved Wafer Process. Integrated Sensing Systems (ISSYS) Inc. 387 Airport Industrial Drive, Ypsilanti, MI 48198 3) Kawoos, U. et al. A permanently implantable intracranial pressure monitor Bioengineering Conference, 2005. Proceedings of the IEEE 2005. 4) U. S. Patent Number 6, 532, 834 B 1. Capacitive Pressure Sensor Having Encapsulated Resonating Components. March 18, 2003. 5) Goto, K et al. An Implantable Power Supply with an Optically Rechargeable Lithium Battery. IEEE Transactions on biomedical Engineering 48(7) 830 -833. 2001 6) W. P. Eaton and J. H. Smith, “Micromachined pressure sensors: review and recent developments, ”Smarter Material Structures Volume 6 530539 (1997)