throbber
@IEEE
`
`Advancing Technology
`for Humanity
`
`DECLARATION OF GERARD P. GRENIER
`
`I have never been convicted
`1, Gerard P. Grenier, am over twenty-one (21) years of age.
`of a felony, and I am fully competent to make this declaration.
`I declare the following to be true
`to the best of my knowledge, information and belief:
`
`1.
`
`I am Senior Director of Publishing Technologies of the Institute of Electrical and
`Electronics Engineers, Inc. (“IEEE”).
`
`2.
`
`IEEE is a neutral third party in this dispute.
`
`3. Neither I nor IEEE itself is being compensated for this declaration.
`
`4. Among my responsibilities as Senior Director of Publishing Technologies, I act as a
`custodian of certain records for IEEE.
`
`5.
`
`I make this declaration based on my personal knowledge and information contained
`in the business records of IEEE.
`
`6. As part of its ordinary course of business IEEE publishes and makes available
`technical articles and standards. These publications are made available for public
`download through the IEEE digital library, IEEE Xplore.
`
`7.
`
`It is the regular practice of IEEE to publish articles and other writings including
`article abstracts and make them available to the public through IEEE Xplore. IEEE
`maintains copies of publications in the ordinary course of its regularly conducted
`activities.
`
`8. The article below has been attached as Exhibits A to this declaration:
`
`
`
`
` R.G. Haahr, et al. “A wearable “electronic patch” for wireless continuous
`monitoring of chronically diseased patients” 5th International Summer
`School and Symposium on Medical Devices and Biosensors, 2008, June 1
`
`— 3, 2008.
`
`9.
`
`I obtained a copy of Exhibit A through IEEE Xplore, where it is maintained in the
`ordinary course of IEEE’s business. Exhibit A is a true and correct copy of the
`Exhibit as it existed on or about October 25, 2016.
`
`10. The article abstracts from IEEE Xplore shows the date of publication. IEEE Xplore
`populates this information using the metadata associated with the publication
`
`445 Hoes Lane Piscataway, NJ 08854
`
`Apple Inc.
`APL1019
`
`0001
`
`US. Patent No. 8,989,830
`
`Apple Inc.
`APL1019
`U.S. Patent No. 8,989,830
`
`0001
`
`

`
`11. R.G. Haahr, et al. “A wearable “electronic patch” for wireless continuous monitoring
`of chronically diseased patients” was published in the 5"‘ International Summer
`School and Symposium on Medical Devices and Biosensors, 2008. The 5”‘
`International Summer School and Symposium on Medical Devices and Biosensors,
`2008 was held from June 1 — 3, 2008. Attendees of the conference were provided
`copies of the publication no later than the last day of the conference. The article is
`currently available for public download from the IEEE digital library, IEEE Xplore.
`
`12. I hereby declare that all statements made herein of my own knowledge are true and
`that all statements made on information and belief are believed to be true, and further
`that these statements were made with the knowledge that willful false statements and
`the like are punishable by fine or imprisonment, or both, under 18 U.S.C. § 1001.
`
`I declare under penalty ofperjury that the foregoing statements are true anyorrect.
`Executed on:
`I
`/fl//" ////__...1--
`
`n___/f
`
`, ‘
`
`0002
`
`0002
`
`

`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`0003
`
`

`
`IEEE Xplore Document ­ A wearable “electronic patch” for wireless continuous monitoring of chronically diseased patients
`10/25/2016
` IEEE.org IEEE Xplore Digital Library

` IEEE­SA
`
` IEEE Spectrum
`
`More Sites

` Cart (0) Create Account 
`
`
`Personal Sign In
`
`|
`|
`|
`|
`|
`|


`
`Institutional Sign In
`
`BROWSE
`
`MY SETTINGS
`
`GET HELP
`
`WHAT CAN I ACCESS?
`
`SUBSCRIBE
`

`
`Related Articles
`
`A portable,
`low­power,
`wireless two­
`lead EKG
`syst...
`
`A WBAN
`System for
`Ambulatory
`Monitoring of
`Physic...
`
`A wearable
`ECG­recording
`system for
`continuous
`ar...
`
`Browse Conferences > Medical Devices and Biosensor...
`
`A wearable “electronic patch” for wireless continuous
`monitoring of chronically diseased patients
`
`466
`Full
`Text Views
`
`3P
`
`atent
`Citations
`
`13
`Paper
`Citations
`
`Purchase or Sign In
`to View Full Text
`
`5
`Author(s)
`

`
` Rasmus G. Haahr ; 
`
` Sune Duun ; 
`
` Erik V. Thomsen ; 
`
` Karsten Hoppe ; 
`
` Jens Branebjerg
`

`
`View All Authors
`
`Abstract
`
`Authors
`
`Figures
`
`References
`
`Citations
`
`Keywords
`
`Metrics
`
`Media
`
`Abstract:
`We present a wearable health system (WHS) for non­invasive and wireless monitoring of physiological signals. The system is made as an electronic
`patch where sensors, low power electronics, and radio communication are integrated in an adhesive material of hydrocolloid polymer making it a
`sticking patch. The patch is made with a reusable part and a disposable part which contains the adhesive material and the battery. This part is changed
`once every week. The patch has a size of 88 mm by 60 mm and a thickness of 5 mm. It is made for attachment on truncus or the greater muscle
`groups. The patch is demonstrated in two applications: Monitoring of electromyography (EMG) and arterial oxygen saturation by pulse oximetry (SpO ).
`2
`The pulse oximetry sensor is made of a concentric backside Silicon photodiode with a hole in the middle for the two light sources. This makes it suitable
`for reflectance pulse oximetry. For the EMG application three standard dry silver electrodes are used separated by 10 mm.
`
`Published in: Medical Devices and Biosensors, 2008. ISSS­MDBS 2008. 5th International Summer School and Symposium on
`
`Date of Conference: 1­3 June 2008
`
` INSPEC Accession Number: 10411592
`
`Date Added to IEEE Xplore: 09 December 2008
`
`DOI: 10.1109/ISSMDBS.2008.4575018
`
` ISBN Information:
`
`Publisher: IEEE
`

`
` Contents
`

`

`
` Download Citations
`
`I. Introduction
`During the last decade there have been an increasing interest in new technology and innovative
`systems for the health care system. Significant factors such as limitations in the health care system's
`resources, the aging population, and chronic conditions are motivating research.
`
`View References
`
`Read document
`
` Email
`
` Print
`
` Request Permissions
`
`Keywords
`
`IEEE Keywords
`Biomedical monitoring, Patient monitoring, Electromyography, Wireless sensor networks, Sensor
`systems, Wearable sensors, Low power electronics, Radio communication, Polymers, Batteries
`
`INSPEC: Controlled Indexing
`wearable computers, adhesives, biosensors, electromyography, patient monitoring, polymers
`

`

`
`Full Text
`
`Abstract
`
`Authors
`
`Figures
`
`References
`
`Citations
`
`Keywords
`
` Share
`http://ieeexplore.ieee.org/document/4575018/
`
`1/3
`
` Download PDF
`
` Export
`
`0004
`
`

`
`10/25/2016
` Share
`
` Alerts
`
`IEEE Xplore Document ­ A wearable “electronic patch” for wireless continuous monitoring of chronically diseased patients
`INSPEC: Non­Controlled Indexing
`pulse oximetry, wearable electronic patch, wireless continuous monitoring, chronically diseased
`patients, wearable health system, noninvasive monitoring, physiological signals, adhesive material,
`hydrocolloid polymer, electromyography, arterial oxygen saturation
`
`Back to Top
`
`Authors
`
`Rasmus G. Haahr
`Technical University of Denmark, Department of Micro and Nanotechnology,
`Oersted Plads building 345 east, 2800 Kgs. Lyngby, Denmark
`
`Sune Duun
`Technical University of Denmark, Department of Micro and Nanotechnology,
`Oersted Plads building 345 east, 2800 Kgs. Lyngby, Denmark
`
`Erik V. Thomsen
`Technical University of Denmark, Department of Micro and Nanotechnology,
`Oersted Plads building 345 east, 2800 Kgs. Lyngby, Denmark
`
`Karsten Hoppe
`Delta A/S, Venlighedsvej, 4, 2970 Hørsholm, Denmark
`
`Jens Branebjerg
`Delta A/S, Venlighedsvej, 4, 2970 Hørsholm, Denmark
`
`Related Articles
`» A portable, low­
`power, wireless
`two­lead EKG
`syst...
`T.R.F. Fulford­
`Jones; Gu...
`
`» A WBAN System
`for Ambulatory
`Monitoring of
`Physic...
`E. Jovanov; A.
`Milenkovic...
`
`» A wearable ECG­
`recording system
`for continuous ar...
`R. Fensli; E.
`Gunnarson; ...
`
`» A Wearable
`Physiological
`Sensor Suite for
`Unobtru...
`Robert Matthews;
`Neil J. ...
`
`» A wireless ECG
`system for
`continuous event
`record...
`R. Fensli; E.
`Gunnarson; ...
`
`» Data mining
`techniques to
`detect motor
`fluctuatio...
`P. Bonato; D.M.
`Sherrill;...
`
`» Physiological
`information
`acquisition through
`wir...
`Hongliang Ren;
`M.Q.­H. M...
`
`» Monitoring body
`kinematics and
`gesture through
`se...
`D. De Rossi; F.
`Lorussi; ...
`
`» Security issues in
`biomedical
`wireless sensor
`net...
`Tassos Dimitriou;
`Krontir...
`
`» An unobtrusive in­
`home monitoring
`system for dete...
`T.L. Hayes; M.
`Pavel; J.A...
`
`http://ieeexplore.ieee.org/document/4575018/
`
`2/3
`
`0005
`
`

`
`10/25/2016
`
`IEEE Xplore Document ­ A wearable “electronic patch” for wireless continuous monitoring of chronically diseased patients
`

`
`IEEE Account
`
` Purchase Details
`
` Profile Information
`
` Need Help?
`
`» Change Username/Password
`
`» Payment Options
`
`» Communications Preferences
`
`» Update Address
`
`» Order History
`» View Purchased Documents
`
`» Profession and Education
`» Technical Interests
`
`» US & Canada: +1 800 678 4333
`» Worldwide: +1 732 981 0060
`» Contact & Support
`
`Personal Sign In Create Account

`|
`
`About IEEE Xplore Contact Us

`|
`

`|
`
`Help
`

`|
`
`Terms of Use
`

`|
`
`Nondiscrimination Policy
`

`|
`
`Sitemap
`

`|
`
`Privacy & Opting Out of Cookies
`
`A not­for­profit organization, IEEE is the world's largest technical professional organization dedicated to advancing technology for the benefit of humanity.
`© Copyright 2016 IEEE ­ All rights reserved. Use of this web site signifies your agreement to the terms and conditions.
`
`http://ieeexplore.ieee.org/document/4575018/
`
`3/3
`
`0006
`
`

`
`Proceedings of the 5th International Workshop on Wearable and Implantable Body Sensor Networks, in conjunction with
`The 5th International Summer School and Symposium on Medical Devices and Biosensors
`The Chinese University of Hong Kong, HKSAR, China. Jun 1-3, 2008
`
`A Wearable “Electronic Patch” for Wireless Continuous Monitoring of
`Chronically Diseased Patients
`
`Rasmus G. Haahr, Sune Duun, Erik V. Thomsen, Karsten Hoppe, and Jens Branebjerg
`
`Abstract— We present a wearable health system (WHS) for
`non-invasive and wireless monitoring of physiological signals.
`The system is made as an electronic patch where sensors,
`low power electronics, and radio communication are integrated
`in an adhesive material of hydrocolloid polymer making it a
`sticking patch. The patch is made with a reusable part and a
`disposable part which contains the adhesive material and the
`battery. This part is changed once every week. The patch has
`a size of 88 mm by 60 mm and a thickness of 5 mm. It is
`made for attachment on truncus or the greater muscle groups.
`The patch is demonstrated in two applications: Monitoring of
`electromyography (EMG) and arterial oxygen saturation by
`pulse oximetry (SpO2). The pulse oximetry sensor is made of a
`concentric backside Silicon photodiode with a hole in the middle
`for the two light sources. This makes it suitable for reflectance
`pulse oximetry. For the EMG application three standard dry
`silver electrodes are used separated by 10 mm.
`
`I. INTRODUCTION
`
`During the last decade there have been an increasing
`interest in new technology and innovative systems for the
`health care system. Significant factors such as limitations in
`the health care system’s resources, the aging population, and
`chronic conditions are motivating research.
`In this context non-invasive wearable health systems
`(WHS) for monitoring elderly and chronically diseased
`people outside hospitals have been developed. Various ap-
`proaches have taken place for continuously monitoring of
`vital signs. H. Asada et. al presented in 1998 a system
`made as a small finger ring sensor [1]. A European project
`“Sensation” have followed the same the approach [2]. J.
`Kang et. al have developed an instrument worn on the wrist
`[3]. Devices attached to truncus have not been made, but
`sensors have been integrated in textiles or clothes [4], [5].
`Following these ideas an European project “Wealthy” have
`developed an integrated system [6], [7].
`The vision for our research is to create a technology which
`allows for continuously monitoring of elderly and chronically
`diseased on a 24/7 basis. Furthermore, the sensor system
`must be able to function for a week without having to be
`changed. The technology should be convenient, versatile,
`easy to use, well integrated in the modern health care system
`and should provide safety and service for the patients.
`
`Manuscript received February 25, 2008. This work was party supported
`by the Danish Ministry of Science, Technology and Innovation.
`Rasmus G. Haahr, Sune Duun, and Erik V. Thomsen are with the Tech-
`nical University of Denmark, Department of Micro and Nanotechnology,
`Oersted Plads building 345 east, 2800 Kgs. Lyngby, Denmark (Phone:
`+ 45 45255700; Fax: +45 45887762; e-mail: rasmus.haahr@mic.dtu.dk,
`sdu@mic.dtu.dk, evt@mic.dtu.dk).
`Karsten Hoppe and Jens Branebjerg are with Delta A/S, Venlighedsvej
`4, 2970 Hørsholm, Denmark (e-mail: kh@delta.dk, jab@delta.dk).
`
`978-1-4244-2253-1/08/$25 ©2008 IEEE
`
`66
`
`Fig. 1. The “Electronic Patch”. The patch has as a size of 88 mm by 60
`mm and is 5 mm thick.
`
`In this paper we report the recent development of a patient
`monitoring system the ”Electronic Patch” shown in Fig.
`1 which we previously have proposed [8], [9]. The patch
`can monitor various physiological signals, analyze these and
`when needed either transmit an alarm or continuously stream
`data over a wireless network.
`In this paper we describe the Electronic Patch in the
`application of monitoring electromyography (EMG), and
`pulse oximetry for monitoring the oxygen saturation (SpO2)
`and heart rate. For the latter case we have previously reported
`a design of a novel ring shaped photodiode [10] which have
`a concentric detection of light transmitted from two light
`emitting diodes (LEDs) placed in a hole in the center of the
`chip.
`
`II. POSSIBILITIES AND LIMITATIONS FOR WEARABLE
`AND NON-INVASIVE MONITORING
`
`Today clinical care and monitoring of elderly and chroni-
`cally diseased is typically done by frequent health examina-
`tions at the hospital or local physician. A new paradigm for
`patient monitoring where wearable and wireless systems are
`introduced to complete routine health examinations induce
`possibilities for monitoring health conveniently anywhere at
`all times. In non critical applications it can log physiological
`information and thereby improve treatment. In critical appli-
`cations it can automatically transmit an alarm and data if a
`medical incident is detected.
`
`A. Possibilities
`
`WHS are preferably non-invasive to limit infection risks.
`A variety of physiological data can be measured by non-
`invasive techniques e.g. electrocardiogram (ECG), elec-
`tromyogram (EMG) electroencephalogram (EEG), blood
`
`0007
`
`

`
`pressure, heart rate, photoplethysmogram (PPG), phonocar-
`diogram (PCG), oxygen saturation (SpO2), saturation of
`carbon monoxide (SpCO), skin temperature, respiration fre-
`quency, respiration volume, sweat production, tissue perfu-
`sion, and motion. There are several measuring principles that
`can be used for non-invasive monitoring of such physiolog-
`ical signals.
`1) Electrical: Electric potentials are used for ECG, EMG
`and EEG and used for monitoring the hearth and nervous
`systems. Impedance measurements can be used for monitor-
`ing the respiration frequency and resistance for monitoring
`the skin temperature.
`2) Optical: Optical measurements with non-coherent light
`is typically based on absorption for measuring PPGs,
`whereas coherent light can be used for laser Doppler blood-
`flow monitoring. PPGs have had an increased interest in the
`recent years due to potential of extracting more physiological
`parameters such as blood pressure [11], [12].
`3) Mechanical: Mechanical sensors can be used for mea-
`suring respiration volume, motion, blood pressure, phonocar-
`diogram (PCG), and ultrasound based measurements.
`4) Chemical: Chemical measurements are typically inva-
`sive and have therefore limited possibilities in non-invasive
`systems. However,
`there are electrochemical sensors that
`measure CO2 and O2 transcutaneously. Analysis on sweat
`is also possible, but this is not clinical practice today.
`
`B. Limitations
`
`In general WHS are limited by two main factors: Comfort
`and power consumption. An additional third factor is motion
`artefacts which is a well-know problem for some types of
`measurements e.g. ECG and PPG.
`For WHS to work on a 24/7 basis attached to people
`living an everyday life the attachment must neither be
`physical nor visual annoying for the person so that the person
`is comfortable wearing it. WHS should therefore be bio-
`compatible and must not cause pressure to the tissue which
`will prevent blood circulation.
`The size of the systems is obviously also a limiting
`factor and in general WHS should be as small as possible
`and follow natural body shapes to provide most comfort.
`In the case WHS are attached directly to the body they
`must therefore be as flat as possible and not thicker than a
`few millimeters. Alternatively, WHS could be integrated in
`things that people would wear anyway e.g. clothes. Typical
`locations for attaching WHS are the finger or wrist e.g. [1],
`[3]; however, these locations are not convenient in daily
`activities. Locations on truncus hidden by clothes seems
`more attractive. These locations have previously been utilized
`in systems where sensors are incorporated in clothes [4], but
`this approach does not offer a firm attachment of the sensors
`directly to the body.
`The power consumption for WHS is a critical issue and
`is limited either by the battery or by the amount of energy
`that can be harvested from the body e.g. thermoelectrically.
`Since the size of WHS should be as small as possible the
`systems cannot have large batteries and due to convenience
`
`Ring shaped photodiode with LEDs in the center mounted on
`Fig. 2.
`bottom side of PCB.
`
`they should last as long as possible. Power is consumed by
`the sensors, frontend electronics, digital processing of data,
`and radio communication.
`Sensors for some physiological signals require very little
`power e.g. potential measurements as EMG. But other physi-
`ological signals require more energy consuming sensors e.g.
`pulse oximetry due the driving current for the LEDs. For
`some applications it is therefore necessary to focus both on
`the energy consumed by the sensors as well as the successive
`frontend electronics and digital signal processing.
`Power management can be done by several approaches.
`In general radio communication should be limited since this
`is highly power consuming. It is therefore advantageous to
`have signal analysis done in the WHS and then only transmit
`data or just an alarm when abnormalities arise.
`The nature of the physiological signals should also be
`considered. Some change in the scale of hours e.g. tem-
`perature some change in the scale of minutes e.g. oxygen
`saturation and some change in the scale of seconds e.g. the
`status of the heart as monitored by ECG. The requirement to
`the measuring frequency is therefore different between these
`types of signals. By measuring quasi continuously with a
`period corresponding to the natural period of the change in
`the signals power can be conserved without losing critical
`information.
`
`III. OVERVIEW OF THE ELECTRONIC PATCH SYSTEM
`
`Based on the following considerations we have developed
`a WHS as an electronic patch. The Electronic Patch is
`a genuine platform which is compatible with many types
`of sensors. In this paper we describe two applications:
`monitoring of EMG and SpO2 by pulse oximetry. The EMG
`sensor is intended for detection of convulsions during sleep
`and the pulse oximetry sensor is intended for people suffering
`from heart disorders, chronical lung diseases (COLD), sleep
`apnea, and professionals during work such as fire fighters.
`The Electronic Patch consists of a printed circuited board
`(PCB) where sensors are mounted on the bottom, and the
`top contains all the electronics and radio communication.
`The PCB is encapsulated in a hard plastic box and attached
`to the body by an adhesive material of hydrocolloid polymer.
`
`A. Sensors
`
`The EMG sensor have a standard design made by three
`silver electrodes distributed evenly on the PCB with a
`separation of 10 mm. The pulse oximetry sensor comprises
`a concentric photodiode with two LEDs in the middle a red
`
`67
`
`0008
`
`

`
`Crystal, 32 MHz
`
`LEDs current control, I2C protocol
`
`MCU and RF
`
`Analog-digital converter
`
`Op.amps. (photodiode)
`
`Memory
`
`Op.amp. (thermistor)
`
`Fig. 3. Top side of the PCB showing the types of electronic components
`which is utilized in the pulse oximetry version of the Electronic Patch.
`
`(660 nm) and infrared (940 nm) [10]. The sensor is shown
`in Fig. 2.
`
`B. Electronics
`
`The top side of the PCB contains the electronics as shown
`in Fig. 3. It contains analog frontend electronics, a low
`power microprocessor with a built-in radio, and memory. The
`microprocessor uses from 190 µA at 32 kHz with the radio
`off to 27 mA at 32 MHz with the radio on. The power usage
`of the microprocessor will be application dependent. In the
`pulse oximetry sensor we also have an I2C current controller
`to control the LEDs. The patch is powered by a coin size 3
`V Lithium-ion battery with 170 mAh.
`
`C. Wireless communication and network
`
`The wireless networking in the Electronic Patch is based
`on a 2.4 GHz radio and a proprietary protocol which allows
`the patch to work in a wireless personal area network,
`but not as an independent system in direct contact with
`service providers or hospitals. However, this contact can be
`made by external access points connected to the internet
`e.g. smart phones. Access points could also be installed
`in the person’s home or other daily environments. The
`advantage using this solution is that power consuming long
`distance communication is placed outside the patch. This
`configuration also supports the service of many patches.
`For instance in the case of assisted living homes where
`many elderly could be monitored by individual patches each
`connected to the same network of access points covering
`the entire estate. A proprietary protocol has been employed
`instead of the ZigBee and Bluetooth protocols due to lower
`power consumption. The drawback is a limited range of a
`few meters. This would be increased by using the Bluetooth
`protocol.
`
`D. Mechanical assembly
`
`The mechanical assembly is shown in Fig. 4 and the final
`patch with the pulse oximetry sensor is shown in Fig. 5.
`Sensors and electronics are encapsulated in a bio-compatible
`plastic housing which protect the electronics from sweat and
`moisture. The pulse oximetry sensor is further protected by
`a transparent membrane and the EMG sensor has an epoxy
`seal. With this solution the system can even be warn during
`a shower.
`The patch comes in two parts: 1) A reusable sensor part
`consisting of a bottom- (f) and middle plastic housing (d),
`
`68
`
`(a) Adhesive patch
`
`(b) Plastic housing - top
`
`(c) Battery
`
`(d) Plastic housing- middle
`
`(e) Printed circuit board, PCB
`
`(f) Plastic housing - bottom
`
`(g) Bio-compatible “window”
`
`Fig. 4. CAD drawing of the parts in the electronic patch and how they
`are assembled.
`
`The assembled patch with a pulse oximetry sensor made as a
`Fig. 5.
`concentric photodiode around two LEDs placed in the center. The little
`square frame around the LEDs is to prevent light going directly from the
`LEDs into the photodiode.
`
`sensors and electronics (e). 2) A disposable part consisting
`of the adhesive patch (a), top housing (b), and battery (c).
`The adhesive patch has to be changed once every week due
`to dead skin cells. This is therefore the period which the
`battery has been designed to last. The adhesive patch is
`designed for attaching the plastic housing onto the skin and
`the hydrocolloid polymer allows for diffusion of moisture
`away from the skin.
`
`IV. EMG APPLICATION
`
`Electromyography is a method of detecting muscle activ-
`ity. The methods relies on the change of membrane potential
`of the muscle cells with muscle activity. The resting muscle
`cell have a potential across the cell membrane of approxi-
`mately -90 mV. During muscle activity the membrane poten-
`tial change to approximately 15 mV. This can occur both in
`spikes when the muscle is stimulated or constantly when
`the muscle contraction is tetanic. EMG can be measured
`both non-invasively on the skin surface above the muscle
`or invasively by needles.
`We have used a standard configuration for surface EMG
`where the potential
`is measured between two electrodes
`relative to a third electrode placed in between. The measured
`signal is amplified, and to save power an analog circuit for
`detection of spikes have been employed. The microprocessor
`is then only turned on whenever spikes are detected and
`the muscle is active. This is demonstrated in Fig. 6 where
`the yellow (top) curve is the recorded EMG signal and
`
`0009
`
`

`
`Current[µA],IRLEDon
`
`63.4
`
`63.2
`
`63.0
`
`62.8
`
`Red LED on
`IR LED on
`
`34.3
`
`34.2
`
`34.1
`
`34.0
`
`Current[µA],redLEDon
`
`0
`
`1
`
`2
`
`3
`Time (s)
`
`4
`
`5
`
`Photoplethysmograms measured with Electronic Patch pulse
`Fig. 7.
`oximetry sensor
`
`has the best signal to noise ratio. One such ring sensor is
`seen in Fig. 5.
`To ease the assembly we have chosen to make backside
`photodiodes which have the junction and both contacts on the
`side facing the PCB. Therefore, no wirebonding is necessary.
`To shield from ambient light and to optimize transmission
`at the two wavelengths of interest i.e. 660 nm and 940 nm a
`two layer antireflection filter consisting of 550 nm PECVD
`Silicon Nitride on 50 nm thermal dry Silicon Oxide has
`been employed. This filter reach optical transmission > 98%
`at 660 nm and 940 nm and suppressing other wavelengths
`to approximately 50 % in the range 600 nm - 1100 nm.
`For wavelengths below 600 nm the tissue absorbtion is very
`strong and hence ambient light at these wavelengths does not
`course problems. The photodiodes are also patterned with
`Aluminum on the side of the light entrance to give a well-
`defined area of light gathering.
`Photopletsysmograms like the one shown in Fig. 7 have
`been recorded with the fabricated sensor. From the PPGs the
`pulse and the oxygen saturation can be calculated.
`To further optimize the power consumption of the pulse
`oximetry sensor the duty cycle of the LEDs, DLED, can be
`considered. The minimal duty cycle that is possible, when at
`least 95 % of the LED power must be maintained, is given by
`the sampling frequency and the bandwidth of the photodiode
`amplifier circuit [15]. In our case we get
`
`DLED ≃ 2 · fs/BW = 2 · 1kHz/4kHz = 50%
`
`(2)
`
`When lit the LEDs typically use 20 mA at 1.5 V. The I2C
`current controller needs 10 mA at 3 V to deliver 20 mA at
`1.5 V. Having a duty cycle of 50% on the LEDs the I2C
`current controller on average will use 5 mA at 3 V. If we
`measure continuously the LEDs alone would use the battery
`in 34 hours. Therefore, we would like to reduce the LED
`power consumption by at least a factor of 10. Because then
`we can measure continuously for a week and only use 85
`mAh or half the battery power available on the LEDs. One
`way to do this will be to improve the speed of the photodiode
`amplifier circuit by lowering the photodiode capacitance.
`
`VI. DISCUSSION
`
`The Electronic Patch have at this time been tested in the
`laboratory and on persons wearing it for periods of one week.
`
`The yellow (top) graph shows a recorded EMG signal by the
`Fig. 6.
`Electronic Patch. The blue (bottom) curve indicates the turn on and off of
`the microprocessor which is controlled by an analog frontend spike detecting
`circuit.
`
`the blue (lower) curve indicates the turn on and off of the
`microprocessor. The microprocessor then analyze the EMG
`signal and evaluate if convulsions are taking place.
`
`V. PULSE OXIMETRY APPLICATION
`
`A pulse oximetry sensor detects pulse and arterial oxygen
`saturation. It is an optical technique invented by T. Aoyagi in
`1972 [13] and is based on absorption changes of light with
`the blood flow. Pulse oximetry relies on the difference in the
`absorption spectra between oxygenated haemoglobin (HbO2)
`and deoxygenated haemoglobin (Hb). In [9] it is shown that
`the ratio between absorption coefficients of HbO2 and Hb
`makes wavelengths of 660 nm and 940 nm suitable.
`For the pulse oximetry application we have chosen to cus-
`tom design pn Silicon photodiodes. This allows for optimiza-
`tion of the photodiodes for the pulse oximetry application.
`To minimize the necessary driving current of the LEDs we
`have fabricated large area photodiodes which are concentric
`around the LEDs and hence optimized for collection of
`backscattered light from the tissue [10]. This approached was
`pioneered by Y. Mendelson [14]; however, with the use of
`several discrete photodiodes. The photodiodes have a chip
`size of 14 mm by 14 mm and with various active areas
`ranging from 22 mm2 to 121 mm2. This area is up to 20
`times larger than what is used in a Nellcor wired reflectance
`sensor. The largest photodiode is shown in Fig. 2. We have
`described the fabrication process elsewhere [10].
`Increasing the photodiode area also increases the capaci-
`tance and this will lower the speed of the photodiode, hence
`there is a tradeoff between photodiode area and speed. In
`our system we use a sampling rate, fs, of 1 kHz. The
`capacitances of the largest photodiodes are 24 nF ±2 nF.
`Given a photodiode transimpedance amplifier circuit with a
`104 amplification the bandwidth, BW , will approximately
`be given by:
`
`BW ≃ (CPD · RAmp)−1 = (24nF · 10kΩ)−1 = 4 kHz (1)
`
`We have fabricated several 1 mm wide rings with radii
`from 3.5 mm to 6.5 mm. This is done to gain knowledge
`about at what radii on a specific body location the signal
`
`69
`
`0010
`
`

`
`Tests in a clinical setting have not been done at this time.
`Thus there are still questions to be examined regarding long-
`term use and actual benefits compared to traditional health
`monitoring and other wearable health monitoring systems.
`Likewise clinical experiments is also required to calibrate
`the pulse oximeter. However, this is a standard procedure.
`In contrast to other systems attached around the finger,
`wrist or integrated in clothes the Electronic Patch is mounted
`directly to the truncus or greater muscles groups offering a
`very firm attachment of the sensors and no wiring between
`several units. The Electronic Patch is therefore a versatile
`system and very simple to use.
`The reliability of WHS are both dependent on the attach-
`ment of the sensors and the algorithms used to analyze the
`signals. Development of algorithms which provide enough
`and reliable artificial intelligence are therefore important.
`The most suitable locations to measure depend on the
`application. For the EMG application the location must be
`the on muscle which is being examined. Typically, this will
`be the larger muscle groups e.g. biceps. In case of the pulse
`oximetry application further research have to be done in this
`direction. The Electronic Patch is not compatible with the
`typical locations for pulse oximetry i.e. the finger or forehead
`since this will be visually annoying for the patient. We are
`targeting a location on truncus either ventral or dorsal and
`we are currently investigating this. Pulse oximetry on the
`sternum have previously been demonstrated by [16], but it
`needs more investigation before it can be used clinically.
`The most suitable wireless network to use in WHS de-
`pendent on the application. If WHS are intended for contin-
`uously monitoring the WHS should be able to get online
`often and the power consumed by the radio is therefore
`important. However, in the applications where WHS only
`should transmit an alarm when a critical condition arises it
`is more important that the WHS can get online. Since it
`only need to transmit once it can use more power and in this
`case the global system for mobile communications (GSM)
`network could be employed.
`As we mention in this paper the large capacitances of
`the large area photodiodes impose a problem regarding the
`speed. This could be improved by pin photodiodes. Our
`fabrication process for the photodiodes are compatible with
`a step where an epitaxial layer of Silicon is grown making
`the photodiodes of the pin type.
`
`VII. CONCLUSION
`
`We have developed an Electronic Patch as a wearable
`health monitoring system. The Electronic Patch is a genuine
`platform which can be used with many types of sensors.
`The Electronic Patch is demonstrated in two very different
`applications EMG and pulse oximetry monitoring. These
`applications rely on two different measuring principles i.e.
`electrical and optical.
`For the pulse oximetry application a novel concentric
`photodiode is used which lower the requirement to the LED
`driving current. For the EMG application standard silver
`electrodes are used. The electronics in the Electronic Patch
`
`70
`
`are low power surface mountable components. The patch is
`powered by a 3 V Lithium-ion battery which last a week and
`is changed when the adhesive

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket