US20080039700A1 - Hydration monitoring - Google Patents
Hydration monitoring Download PDFInfo
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- US20080039700A1 US20080039700A1 US11/841,947 US84194707A US2008039700A1 US 20080039700 A1 US20080039700 A1 US 20080039700A1 US 84194707 A US84194707 A US 84194707A US 2008039700 A1 US2008039700 A1 US 2008039700A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
- A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4869—Determining body composition
- A61B5/4875—Hydration status, fluid retention of the body
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- A—HUMAN NECESSITIES
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/6802—Sensor mounted on worn items
- A61B5/6804—Garments; Clothes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6831—Straps, bands or harnesses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6832—Means for maintaining contact with the body using adhesives
- A61B5/6833—Adhesive patches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/60—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
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Abstract
Systems and techniques for monitoring hydration. In one implementation, a method includes measuring an electrical impedance of a region of a subject to generate an impedance measurement result, and wirelessly transmitting the data to a remote apparatus. The probe with which impedance is measured may in the form of a patch adhesively secured to the subject.
Description
- This application is a continuation-in-part of U.S. application Ser. No. 11/410,519, filed on Apr. 23, 2006, which application is a continuation-in-part of U.S. application Ser. No. 10/032,765 filed Oct. 29, 2001, which claims the benefit of U.S. Provisional Application Ser. No. 60/301,897, filed Jun. 29, 2001. This application is also a continuation of U.S. application Ser. No. 10/922,370 filed Aug. 20, 2004, which claims the benefit of U.S. Provisional Application Ser. No. 60/496,558, filed Aug. 20, 2003 and U.S. Provisional Application Ser. No. 60/570,852 filed May 13, 2004. All of the above mentioned applications are incorporated by reference in their entireties.
- This disclosure relates to monitoring the hydration of organisms.
- Many species of organisms are largely water. The amount and/or disposition of water in an individual organism (i.e., the hydration of the organism) is often correlated with the health of the individual organism. For example, an excess or a scarcity of water can be indicative of acute and/or chronic disease states.
- One example of such an acute disease state is acute dehydration. Dehydration is the excessive depletion of body water. There are a number of causes of acute dehydration including heat exposure, prolonged vigorous exercise, and diuretics. For example, the US Air Force Field Manual (FM 3-04.301—Aeromedical Training for Flight Personnel) describes that when ambient temperature is increased above 82-84° F., sweat production by humans increases abruptly and dehydration may result. Humidity can also impact sweat production and lead to dehydration. For example, with 115° F. and 10% humidity, a human can function normally with water and salt replenishment. However when humidity is 80%, the same person can become incapacitated within 30 minutes at 115° F. due to excessive depletion of body water.
- One example of a chronic disease state associated with an excess of water is pulmonary edema. Pulmonary edema is the extravascular accumulation of fluid in the lungs. There are a number of causes of pulmonary edema including mitral stenosis or left ventricular failure. Pulmonary edema can be associated with congestive heart failure.
- Another example of such a chronic disease state is hyperhydration. Hyperhydration is a state in which the body includes an excessive amount of water. In patients undergoing kidney dialysis, hyperhydration may lead to hypertension and increased mortality.
- Accordingly, this disclosure describes systems and techniques for monitoring the hydration of an organism. Hydration can be monitored, e.g., to identify dehydration or other disease state of the organism.
- In one implementation, a device includes a portable hydration monitoring probe dimensioned to be continuously borne by an organism. The probe includes a supply of electrical power, an electrode to exchange electrical energy from the supply with a local portion of the organism bearing the probe, a controller to generate data representing a result of the hydration monitoring, the result reflecting a local bioelectric impedance based on the exchange of electrical energy at the electrode, and a data communication device configured to wirelessly communicate the data representing the hydration monitoring result to a remote apparatus.
- This and other implementations can include one or more of the following features. The portable hydration monitoring probe can include a patch probe.
- These and other systems and techniques can be implemented to realize one or more of the following advantages. Hydration can be monitored to identify a variety of disease states. Monitoring can be long term, using portable probes dimensioned to be borne by the monitored organism. The impact of skin surface temperature on hydration measurements can be considered when analyzing hydration monitoring results. Hydration monitoring results can be communicated using wireless communication links that do not hinder the mobility of ambulatory subjects.
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FIG. 1 shows a probe for monitoring the hydration of an organism. -
FIG. 2 shows a bioelectric impedance spectroscopy probe for monitoring the hydration of an organism. -
FIG. 3 shows a bandage bioelectric impedance spectroscopy probe. -
FIGS. 4A and 4B illustrate example deployments of a bioelectric impedance spectroscopy probe and a bandage probe to monitor hydration. -
FIGS. 5 and 6 show a portable strap bioelectric impedance spectroscopy probe. -
FIGS. 7, 8A , 8B, 8C, 9A, and 9B illustrate example deployments of a strap probe to monitor hydration. -
FIGS. 10A and 10B show other strap bioelectric impedance spectroscopy probes. -
FIG. 10C shows a graph of example hydration monitoring results that can be obtained using a bioelectric impedance monitor and a skin temperature thermometer. -
FIG. 11 shows a system for monitoring the hydration of an organism. -
FIG. 12 shows a data collection apparatus that is usable in a system for monitoring the hydration of an organism. -
FIG. 13 shows another system for monitoring the hydration of an organism. -
FIG. 14 shows another system for monitoring the hydration of an organism. -
FIG. 15 shows an example of a model equivalent circuit that can be used in monitoring the hydration of an organism. -
FIG. 16 illustrates an example deployment of multiple strap probes to monitor hydration. -
FIG. 17 shows another system for monitoring the hydration of an organism. -
FIG. 1 shows aprobe 100 for monitoring the hydration of an organism.Probe 100 includes abody 105, anenergy source 110, and asensing circuit 115.Body 105 can be a flexible member in that it can be contoured to follow the skin surface or other portion of an organism, such as, for example, a patch or strap. Body 105 supports probe/organism interfaces interfaces interfaces interfaces -
Energy source 110 can be, e.g., an optical energy source or an electric energy source. For example, energy source can be an alternating and/or direct current and/or voltage source.Energy source 110 is connected toinputs leads Leads source 110 for exchange with the portion of the organism coupled tomain body 105. For example, leads 140, 145 can be electrical wires capable of carrying an electric current for exchange with the portion of the organism, or leads 140, 145 can be optical waveguides capable of carrying light for exchange with the portion of the organism followed bymain body 105. - In one electrical embodiment, a
sensing circuit 115 comprises a differential amplifier connected toelectrodes leads electrodes leads Leads source 110 toamplifier 115.Leads electrodes amplifier 115.Amplifier 115 can sense voltages acrosselectrodes electrodes more results 160. It will be appreciated thatamplifier 115 could be implemented as two or more amplifiers that separately sense relative voltages across any desired electrode pairs. Current sensing could also be implemented to directly measure the current output fromsource 110. - In operation,
main body 105 flexes to follow a portion of an organism and maintaininputs outputs Source 110 generates one or more types of energy that is conducted overleads interfaces Sensing circuit 115 generates aresult 160 based on the sensed signals.Result 160 reflects, at least in part, the hydration of the monitored organism. - Probe 100 can generate result(s) 160 continuously or intermittently over extended periods of time. For example, result 160 can be a subset of the comparisons of the sensed parameters at
interfaces inputs -
FIG. 2 shows one implementation of a probe for monitoring the hydration of an organism, namely a bioelectricimpedance spectroscopy probe 200. Bioelectric impedance spectroscopy is a measurement technique in which the electrical conductivity of all or a portion of an organism is measured. When the conductivity of the entirety of an organism is measured such as by passing current from one ankle to an opposite wrist or between both hands, this can be referred to as whole body bioelectric impedance spectroscopy. When the conductivity of a portion of an organism is measured such as by a cluster of more locally placed electrodes, this can be referred to as segmental (or regional) bioelectric impedance spectroscopy. In either case, the measured electrical conductivity can reflect the hydration of the measured organism or the measured portion of the organism. - Bioelectric impedance spectroscopy generally involves the exchange of electrical energy with the organism. The exchanged electrical energy can include both alternating current and/or voltage and direct current and/or voltage. The exchanged electrical energy can include alternating currents and/or voltages that alternate at one or more frequencies. For example, the alternating currents and/or voltages can alternate at one or more frequencies between 100 Hz and 1 MHz, preferably at one or more frequencies between 5 KHz and 250 KHz.
- Different frequencies of electrical energy can be used to measure conductivity in different portions of the organism. For example, in some organisms, lower frequency electrical energy may be conducted preferentially through tissues having fewer membranous components whereas higher frequencies may be conducted through a larger variety of tissues. In many cases, it is advantageous to make impedance measurements at two or more different frequencies in the same region. As explained further below, DC measurements can help characterize impedance over the skin surface. Thus, measurements at different frequencies made by a single probe can provide information regarding both the amount and disposition of water within a probed organism or within a probed portion of the organism.
- Referring again to
FIG. 2 , bioelectricimpedance spectroscopy probe 200 includes abody 205, acurrent source 210, a digital-to-analog converter 215, anamplifier 220, an analog-to-digital converter 225, amemory 230, and acontroller 235.Body 205 is a flexible member that supports two workingelectrodes sensing electrodes Body 205 can be flexible enough to follow a portion of the human body to maintainelectrodes Body 205 can be sized to probe the conductivity of the entirety of an organism and thus perform whole body bioelectric impedance spectroscopy. In some advantageous embodiments described in detail herein,body 205 is sized to probe the conductivity of a portion of an organism and thus perform segmental bioelectric impedance spectroscopy. - Working
electrodes Sensing electrodes Electrodes electrodes electrodes -
Electrodes body 205 on the outer surface of the skin of a monitored organism. Alternatively,electrodes body 205 beneath the skin of a monitored organism. For example,electrodes electrodes electrodes body 205 at positions that are separated from one another by more than approximately ten times the thickness of the skin. When hydration is monitored in humans,electrodes electrodes - In one implementation, working
electrodes electrodes electrodes electrodes -
Current source 210 is a source of alternating and/or direct electrical current. As deployed inprobe 200,current source 210 can drive electrical current from workingelectrode 245 to workingelectrode 250 through and/or along a monitored organism. In one implementation,current source 210 is capable of driving between 10 microamperes and 10 milliamperes, preferably between 100 microamperes and 1 milliamperes, of one or more frequencies of alternating and/or direct current through or along electrical impedances characteristic of humans. Typically, current is held at a known or measured substantially constant value, and voltage is measured to provide an impedance value. It is also possible to apply a constant voltage and measure the amount of current. Digital-to-analog converter 215 can be an integrated circuit or other electronic device that converts a digital signal into a corresponding analog signal. As deployed inprobe 200, digital-to-analog converter 215 can convert digital control signals fromcontroller 235 into analog control signals to control the output of electrical current fromcurrent source 210. -
Amplifier 220 can be a differential voltage amplifier in that it amplifies a voltage difference on sensingelectrodes current source 210 driving electrical current from workingelectrode 245 to workingelectrode 250 through and/or along the monitored organism. Analog-to-digital converter 225 can be an integrated circuit or other electronic device that converts this sensed voltage difference into a corresponding digital signal for reading bycontroller 235 and/or storage inmemory 230. -
Memory 230 can be a data storage device that can retain information in machine-readable format.Memory 230 can be volatile and/or nonvolatile memory. For example,memory 230 can be a RAM device, a ROM device, and/or a memory disk. -
Controller 235 is a device that manages the generation and flow of data inprobe 200.Controller 235 can be hardware configured to perform select operations or a data processing device that performs operations in accordance with the logic of a set of machine-readable instructions. In some implementations, controller can receive information related to the management of the generation and flow of data inprobe 200 via one or more input devices. In some implementations,controller 235 can output information fromprobe 200 via one or more output devices. Custom ASICs or gate arrays can be used, as well as commercially available microcontrollers from, for example, Texas Instruments and Motorola. - The operations performed by
controller 235 can include regulating the timing of hydration measurements and the timing of the transmission of hydration measurement results, logic operations, signal processing, and data analysis. For example, data analysis can be used to determine the bioelectric impedance of portions of a monitored organism. For example, equivalent circuit impedance analysis in the time or frequency domain can be performed. Instructions for performing such operations can be stored in a read only memory portion ofmemory 230, temporary values generated during such operations can be stored in a random access portion ofmemory 230, and the results of operations can be stored in a non-volatile portion ofmemory 230. - In operation,
current source 210 drives one or more frequencies of alternating and/or direct current between workingelectrodes Amplifier 220 buffers and amplifies the potential difference betweensensing electrodes digital converter 225 converts this signal into a digital form that can be received bycontroller 235 for storage atmemory 230, as appropriate. In some implementations,controller 235 may controlsource 210 to change the frequency and/or magnitude of current generated. The control ofsource 210 can be performed in light of the magnitude of the signal(s) output byamplifier 220 and/or in light of instructions received bycontroller 235 over one or more input devices. -
FIG. 3 shows one implementation of a portable bioelectric impedance spectroscopy probe, namely a bandage (or “patch”)probe 300. Probe 300 can be self-powered in thatmain body 205 includes (in addition toelectrodes battery 305.Probe 300 is portable in thatprobe 300 can be moved from a fixed location and is adapted to perform at least some of the signal generation and processing, control, and data storage functions ofcurrent source 210, a digital-to-analog converter 215, anamplifier 220, an analog-to-digital converter 225, amemory 230, and acontroller 235 without input from a fixed device. For example, probe 300 can be borne by the monitored organism.Circuitry 310 can be, e.g., an application specific integrated circuit (ASIC) adapted to perform these functions.Circuitry 310 can also be a data processing device and/or one or more input/output devices, such as a data communication device. -
Main body 205 also advantageously includes an adhesive 315. Adhesive 315 can be adapted to adhere to the skin surface of the monitored organism and thereby maintainelectrodes main body 205. - A
portable probe 300 allows a monitored organism to be ambulatory while hydration monitoring occurs. This allows for data collection to be extended beyond periods of confinement. Thus, hydration monitoring can be continued while an organism participates in various activities at different locations, over durations suitable for identifying the onset of disease states. -
FIGS. 4A and 4B respectively illustrate example deployments of bioelectricimpedance spectroscopy probe 200 andbandage probe 300 to monitor hydration.FIG. 4A shows a pair ofprobes 200 deployed along asteering wheel 400 so that a driver's hands will come into intermittent electrical contact with one or both ofprobes 200. During this intermittent contact, the driver's hydration can be monitored. -
FIG. 4B showsbandage probe 300 deployed to adhere to the torso ofperson 405.Bandage probe 300 is sized to probe the conductivity of a portion ofperson 405. In particular,bandage probe 300 adheres to the front chest ofperson 405 with one end located in the vicinity of the xiphoid process.Bandage probe 300 extends axially and downward from the xiphoid process towards the lateral side ofperson 405. - This positioning of
bandage probe 300 may facilitate the monitoring of hydration in the underlying tissue and lung, as well as the identification of disease states such as pulmonary edema. -
FIGS. 5 and 6 show another implementation of a bioelectric impedance spectroscopy probe, namely aportable strap probe 500.Main body 205 ofstrap probe 500 is a strap or a belt that can form a loop to encircle the body, or a portion of the body, of a monitored individual. Such an encirclement can maintainelectrodes electrodes electrodes battery 305, andcircuitry 310,main body 205 also includes adata communication device 505 having atransceiver 510.Data communication device 505 can be a wireless communication device that can exchange information betweencircuitry 310 and an external entity. Wireless data link 1125 can carry information using any of a number of different signal types including electromagnetic radiation, electrical signals, or acoustic signals. For example,data communication device 505 can be a radio frequency communication device.Transceiver 510 can be an assembly of components for the wireless transmission and reception of information. The components can include, e.g., an RF antenna. The wireless receiver/transmitter circuitry can be made part of any embodiment described herein. - The two sets of sensing
electrodes electrodes electrodes electrodes electrodes strap probe 500 over time. -
FIGS. 7, 8A , 8B, 9A, and 9B illustrate example deployments of implementations ofstrap probe 500 to monitor hydration in aperson 405. InFIG. 7 ,strap probe 500 is sized to encircle the torso ofperson 405 and is deployed to probe the conductivity of the torso ofperson 405. Such a positioning ofstrap probe 500 may facilitate the monitoring of hydration in the underlying tissue and lung, as well as the identification of disease states such as pulmonary edema. - In
FIG. 8A ,strap probe 500 is sized to encircle the thigh ofperson 405 and is deployed to probe the conductivity of the thigh ofperson 405. Such a positioning ofstrap probe 500 may facilitate the monitoring of hydration in the underlying tissue, as well as the identification of disease states such as acute or chronic dehydration. - In
FIG. 5B ,strap probe 500 is sized to encircle the lower leg ofperson 405 and is deployed to probe the conductivity of the lower leg ofperson 405. As shown,strap probe 500 encircles the ankle, butstrap probe 500 can also encircle the foot, the calf, or a toe to probe the conductivity of the lower leg. Such a positioning ofstrap probe 500 may facilitate the monitoring of hydration in the underlying tissue, as well as the identification of disease states such as congestive heart failure where water accumulates in the lower legs. - In
FIG. 8C ,strap probe 500 is sized to encircle the bicep ofperson 405 and is deployed to probe the conductivity of the bicep ofperson 405. Such a positioning ofstrap probe 500 may facilitate the monitoring of hydration in the underlying tissue, as well as the identification of disease states such as acute or chronic dehydration. - In
FIG. 9A ,strap probe 500 is incorporated into a pair ofpants 905 and sized to encircle the torso ofperson 405 to probe the conductivity of the torso ofperson 405. Incorporating aprobe 500 intopants 905 may reduce the intrusiveness ofprobe 500 and help ensure that a monitored individual deploysprobe 500. - In
FIG. 9B ,strap probe 500 is incorporated into asock 910 and sized to encircle the lower leg ofperson 405 to probe the conductivity of the lower leg ofperson 405. Incorporating aprobe 500 intosock 910 may reduce the intrusiveness ofprobe 500 and help ensure that a monitored individual deploysprobe 500. - As discussed further below, in some deployments, multiple probes at different locations may be used to monitor the hydration of a single individual. The measurement results from the different probes can be compared and correlated for calibration and error minimization. Other techniques that measure biological parameters can also be used in conjunction with single or multiple probes. The biological parameter measurements can be compared and correlated with the probe measurements to calibrate the measurements and minimize the error associated with the measurements. As one example, bioelectric impedance measurements made using a QUANTUM X body composition analyzer (RJL Systems, Inc., Clinton Twp., MI) and/or a Hydra 4200 bioimpedance analyzer (Xitron Technologies Inc., San Diego, Calif.) can be compared and correlated with probe measurements.
- As another example, skin temperature measurements can be used in monitoring the hydration of an individual. In general, skin surface temperature will change with changes in blood flow in the vicinity of the skin surface of an organism. Such changes in blood flow can occur for a number of reasons, including thermal regulation, conservation of blood volume, and hormonal changes. In one implementation, skin surface measurements are made in conjunction with hydration monitoring so that changes in apparent hydration levels, due to such changes in blood flow, can be considered.
- In some deployments, one or more probes can be moved to different portions of a single individual over time to monitor the hydration of the individual. For example, a probe can monitor the hydration of an individual at a first location (e.g., the torso) for a select period (e.g., between about 1 to 14 days, or about 7 days), and then the same probe can be moved to a different location (e.g., the thigh) to monitor the hydration of the same individual for a subsequent time period. Such movement of a probe can extend the lifespan of a probe and increase the type of information gathered by the probe. Further, movement of the probe can minimize surface adhesion loss and any decrease in hygiene associated with the monitoring.
- The movement of a probe such as
probe 500 to a new location on the body, or the attachment of a new probe at a different location, may result in a change in baseline impedance measurements even when the hydration of the monitored organism has not changed. A baseline measurement is a standard response to hydration monitoring. The standard response can be indicative of the absence of a disease state or of the absence of progression in a disease state. Changes in the baseline impedance measurements can result from changes in factors unrelated to a disease state. For example, changes in the baseline impedance measurements can result from different skin thicknesses, body compositions, or other differences between two locations. Measurements made at the different locations can be normalized to account for such differences in baseline measurements. Such a normalization can include adjustments in gain and/or adjustments in offset. Gain adjustments may be based on the absolute value of the impedance measurement(s), the impedance difference(s) observed at the old and the new locations, or combinations thereof. Offset adjustments can generally be made after gain adjustments and can be based on absolute impedance values and/or other factors. Alternatively, analysis thresholds used to identify disease states can be adjusted. - In some implementations, the monitored individual may be placed in a non-ambulatory state (e.g., supine and resting) in order to acquire directly comparable baseline measurements at different locations. Multiple probes need not be attached to the same organism in order to normalize baseline measurements. For example, hydration measurement results obtained using a first probe at a first location can be stored and compared with hydration measurement results obtained later using a second probe at a second location. This can be done, e.g., when the time between the collection of the results at the first location and the collection of the results at the second location is relatively short, e.g., less than 1 hr. If the replacement patch is not attached to the patient within this period, comparison of bioelectric impedance values to other calibration standards, e.g., body weight and body weight change, urine specific gravity, blood osmolality, can also be used for such comparisons.
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FIG. 10A shows another implementation of a strap probe, namely astrap probe 1000. In addition toelectrodes battery 305,circuitry 310,data communication device 505, andtransceiver 510,main body 205 also includes anoutput device 1005.Output device 1005 can be a visual display device (such as a light emitting diode or a liquid crystal display), an audio output device (such as a speaker or a whistle), or a mechanical output device (such as a vibrating element). - In operation,
output device 1005 can present information regarding the hydration monitoring to a monitored individual. The presented information can be received byoutput device 1005 fromcircuitry 310 and can indicate monitoring results and/or alerts. Monitoring results can include the current hydration state of an individual as well as indications that certain disease states, such as acute dehydration, are present or imminent. Monitoring alerts can include indications of current or imminent apparatus malfunction, such as loss of contact between any ofelectrodes -
FIG. 10B shows another implementation of a strap probe, namely astrap probe 1010. In addition toelectrodes battery 305,circuitry 310,data communication device 505, andtransceiver 510,main body 205 also includes askin temperature thermometer 1015.Thermometer 1015 can be a temperature sensing element that senses temperature in ranges encountered on the skin surface of the monitored organism.Thermometer 1015 can be, e.g., a thermister, a thermocouple, a mechanical thermometer, or other temperature-sensing device. This temperature sensor can be part of any probe embodiment described herein. - In operation,
thermometer 1015 can present information regarding skin surface temperature tocircuitry 310. The presented information can be used bycircuitry 310 to perform data analysis and other aspects of hydration monitoring.Circuitry 310 can also transmit all or a portion of the temperature information to other devices using, e.g.,data communication device 505 andtransceiver 510. - With measurements of hydration and temperature at in the same vicinity of an organism, changes in apparent hydration levels due to changes in skin surface blood flow can be identified and accommodated in data analyses.
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FIG. 10C shows agraph 1020 of example hydration monitoring results that were obtained using a bioelectric impedance monitor and a skin temperature thermometer.Graph 1020 shows the observedimpedance 1025 of a region on the thigh of a monitored individual as a function ofskin temperature 1030.Graph 1020 includes a pair oftraces Trace 1035 shows the impedance measured with an electrical energy input signal having a frequency of 20 kHz, whereastrace 1040 shows the impedance measured with an electrical energy input signal having a frequency of 100 kHz. -
Traces -
Traces - The observed changes in skin temperature are believed to result, at least in part, from local vasodilation as the body sheds excess heat generated during exercise. Such changes in vasodilation appear to decrease local impedance.
- Over time, both the measured impedance and temperature moved in the direction of the values observed before jogging. The movement showed a linear relationship between measured impedance and measured skin temperature at both 20 kHz and 100 kHz. This relationship can be used to accommodate the impact of skin surface temperature on hydration monitoring results, as discussed further below. If desired, local vasodilation or vasoconstriction can be measured by other or additional methods such as with optical methods. A vasodilation parameter, whether measured or calculated via a temperature measurement or some other means may be used to correct absolute impedance measurements to appropriately determine impedance changes over time due to hydration changes.
- At the end of the recovery period, the measured impedance of the thigh was 50.27 ohms at 20 kHz and 34.30 ohms at 100 kHz, for a net increase in impedance of 4.91 ohms (10.8%) at 20 KHz and 3.44 ohms (1.1%) at 100 KHz. Similar results have been observed with other subjects and other test conditions.
- This approximately 11% net increase in measured bioelectric impedance at 20 kHz and 100 kHz is believed to reflect the water loss associated with the observed decrease in body weight (i.e., the decrease of about 1.7%).
- The measurement results in
traces circuitry 310 to perform data analysis and other aspects of hydration monitoring. For example, the impact of skin surface temperature on hydration monitoring results can be accommodated. In one example, the relationship between bioelectric impedance and temperature illustrated bytraces - Such combinations of skin surface temperature measurements and hydration monitoring results can be used to improve hydration monitoring. For example, bioelectric impedance measurements can be adjusted based on local skin surface temperature measurements made in the vicinity of the probe. This can improve the predictive value of impedance measurements, even relative to whole body impedance measurements where impedance measurement that reflect the electrical impedance through the entire body may not precisely correlate with temperature measurements made at one or two body locations.
- Factors unrelated to hydration may influence local skin surface temperature measurements. These factors include the rate of convective cooling, the wind velocity, the presence of thermal insulation such as clothing, and ambient temperature gradients. Such factors that tend to influence heat exchange between the portion of the body of interest and the environment may be accounted for directly (e.g., using additional temperature or humidity sensors) or indirectly (e.g., using standard tables and known values applied to parameters such as the thickness of insulating clothing). The accounting for such factors can include adjustments to the local temperature used to compare hydration monitoring results.
- In some implementations, hydration monitoring results obtained at portions of a monitored organism that have a known temperature relationship with another portion where skin surface measurement(s) are made can be adjusted based on that known relationship. Also, other factors including weight, height, age, general fitness level, degree of exertion, time of day, stage in a hormonal cycle, and gender can also be used to adjust hydration monitoring results and improve the predictive value of such results.
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FIG. 11 shows asystem 1100 for monitoring the hydration of an organism.System 1100 includes one ormore probes 100 along with one or moredata collection apparatus 1105, adata management system 1110, an input/output device 1115, and adata storage device 1120.Probe 100 includes a wirelessdata communication device 505 that is capable of establishing awireless data link 1125 withdata collection apparatus 1105. Wireless data link 1125 can transmit data using any of a number of different signals including electromagnetic radiation, electrical signals, and/or acoustic signals. Whenprobe 100 is subdermal,data link 1125 can be a transdermal link in thatdata link 1125 conducts data along a path through the skin. - The data communicated along wireless data link 1125 can include a probe identifier. A probe identifier is information that identifies
probe 100. Probe 100 can be identified, e.g., by make or model. Probe 100 can also be identified by a unique identifier that is associated with a singleindividual probe 100. The probe identifier can include a serial number or code that is subsequently associated with data collected byprobe 100 to identify that this data was collected byprobe 100. In some embodiments, each individual electrode, or a patch or strap containing a set of electrodes incorporates an integrated circuit memory having a stored unique or quasi-unique electrode/patch identifier. An interface between the patch or electrodes and thecommunication device 505 can be implemented so that thecommunication device 505 can send electrode or patch identifiers as well as a separate identifier for the other electronics coupled to the patch. In this way, different parts of the probe can be separately replaced, while still allowing complete tracking of the physical data generation, analysis, and communication apparatus used to gather all impedance data. - The data communicated along wireless data link 1125 can also include messages to probe 100. Example messages include commands to change measurement and/or data analysis parameters and queries regarding the status and/or operational capabilities of the probe. Data communication along wireless data link 1125 can also include information related to the initialization and activation of
probe 100. Initialization can include the communication of a probe identifier todata collection apparatus 1105. Initialization can also include the commencement of measurement activities including, e.g. the start of an internal clock that regulates the timing of hydration measurements and the transmission of hydration measurement results. Such data communication can be conducted as an ongoing dialogue withdata collection apparatus 1105. -
Data collection apparatus 1105 is a device that generally supplementsprobe 100 by including components and/or features that complement the components and/or features ofprobe 100. For example, such components or features may be too large, too memory intensive, require too sophisticated data processing, and/or only be used too intermittently to be included onprobe 100.FIG. 12 shows one implementation of adata collection apparatus 1105.Data collection apparatus 1105 can be a portable device in thatdata collection apparatus 1105 can be moved from a fixed location and perform at least some functions without input from a fixed device. For example,data collection apparatus 1105 can be a handheld device that can be borne by a monitored individual. -
Data collection apparatus 1105 includes a localuser input portion 1205, a localuser output portion 1210, a wirelessdata communication portion 1215, and a wireddata communication portion 1217 all arranged on abody 1220. Localuser input portion 1205 includes one or more components that receive visual, audio, and/or mechanical input from a user in the vicinity ofdata collection apparatus 1105. For example, localuser input portion 1205 can include akeypad 1225 and amode selection button 1230.Keypad 1225 can receive alphanumeric input from a user.Mode selection button 1230 can receive an operational mode selection from a user. The operational modes ofdata collection apparatus 1105 are discussed further below. - Local
user output portion 1210 includes one or more components that provide visual, audio, and/or mechanical output to a user in the vicinity ofdata collection apparatus 1105. For example, localuser output portion 1210 can include adisplay panel 1235.Display panel 1235 can be, e.g., a liquid crystal display screen.Display panel 1235 includes various regions that display specific information to a local user. In particular,display panel 1235 includes a batterycharge display region 1240, an operationalmode display region 1245, a time/date display region 1250, a measurementresult display region 1255, and analert display region 1260. - Battery
charge display region 1240 includes a graphical device that indicates the charge remaining on a battery or other power element that powersdata collection apparatus 1105. Operationalmode display region 1245 includes a text list of the various operational modes ofdata collection apparatus 1105. The listed operational modes include a test mode, a set-up mode, a synchronization mode, and a measurement mode. The text indicating measurement mode (i.e., “MEAS”) includes anindicium 1265 that indicates that the current operational mode ofdata collection apparatus 1105 is the measurement mode. Time/date display region 1250 includes text indicating the current time and date. Measurementresult display region 1255 includes text and/or graphical elements that indicate the result(s) of a hydration measurement made by one ormore probes 100.Alert display region 1260 includes a text and/or graphical warning that the probe measurement results are indicative of one or more disease states being present or imminent.Alert display region 1260 can also indicate that a malfunction ofprobe 100 and/ordata collection apparatus 1105 is occurring or imminent. - Wireless
data communication portion 1215 can include a firstwireless communication transceiver 1265 and a secondwireless communication transceiver 1270.Transceivers transceivers transceivers -
Transceivers transceiver 1265 can be dedicated to the exchange of data with one ormore probes 100 over one or morewireless data links 1125, whereastransceiver 1270 can be capable of exchanging data with other data collection apparatus and/or with one or moredata management systems 1110.Transceivers - Wired
data communication portion 1217 can include one or more connector ports 1274 adapted to receive a plug or other terminal on one or more wired data links. The wired data links can be capable of exchanging data with other data collection apparatus and/or with one or moredata management systems 1110. The wired data link can be an optical data link and/or an electrical data link. Electrical data links can be analog or digital. The data links can operate in accordance with data communication protocols such as the TCP/IP suite of communications protocols. -
Body 1220 can be sealed to isolate electrical and other components (not shown) that perform operations such as drivingportions Body 1220 can be sized and the components selected to allowdata collection apparatus 1105 to be self-powered by an internal power supply (not shown). For example,data collection apparatus 1105 can be powered by an internal rechargeable battery. The components can be, e.g., data storage devices, data processing devices, data communication devices, and driving circuitry for managing the input and output of data fromdata collection apparatus 1105. -
Body 1220 can be designed to operate as an independent unit as shown orbody 1220 can be designed to integrate with separate communication devices. For example,body 1220 can be designed to integrate with a cellular phone or personal data assistant to form all or a portion of wirelessdata communication portion 1215. - Returning to
FIG. 11 ,system 1100 can include awired data link 1130 and/or awireless data link 1135 for the exchange of data betweendata collection apparatus 1105 anddata management system 1110. Wired data link 1130 can terminate at a connector port 1274 ondata collection apparatus 1105, and wireless data link 1135 can terminate attransceiver 1270 ondata collection apparatus 1105. -
Wireless data link 1125, wireddata link 1130 and wireless data link 1135 can exchange data in accordance with one or more communication protocols. The communication protocols can determine the format of the transmitted information and the physical characteristics of the transmission. Communication protocols can also determine data transfer mechanisms such as synchronization mechanisms, handshake mechanisms, and repetition rates. The data structures of the protocol may impact the rate of data transfer using the protocol. Data can be organized in blocks or packets and transmissions can be made at specified intervals. For example, a transmission block can include synchronization bits, an address field that includes information identifying the data source, a data field containing the hydration monitoring data, and a checksum field for testing data integrity at the receiver. The length of a data block can vary, e.g., to reduce power consumption and increase device lifetime. The same data can be transmitted multiple times to ensure reception. - In one implementation, exchanged data is organized in packets that include four sections, namely, a header section, a 64 bit address section that includes a probe identifier identifying a probe 100 (and/or an electrode or electrode set identifier), an encrypted data section, and a check-sum or error correction section. The data section can be encrypted using an algorithm that relies upon the address section.
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Probe 100,data collection apparatus 1105, anddata management system 1110 can all confirm a successful exchange of data using a confirmation such as an electronic handshake. An unsuccessful exchange of data can be denoted by transmission of an error message, which can be responded to by a retransmission of the unsuccessfully exchanged data. - In some implementations,
probe 100,data collection apparatus 1105, anddata management system 1110 can exchange data at a number of different frequencies. For example, whensystem 1100 includes multipledata collection apparatus 1105, eachdata collection apparatus 1105 can transmit data overwireless data link 1135 using a different frequency carrier. As another example, whensystem 1100 includesmultiple probes 100, eachprobe 100 can transmit data overwireless data link 1125 using a different frequency carrier. It will be appreciated that a variety of multiple access techniques such as time or code division, could be alternatively used. - The data communicated along
wireless data link 1125, wireddata link 1130, and wireless data link 1135 can be encrypted in whole or in part. The encryption can be symmetric or asymmetric. The encryption can rely upon encryption keys based on the probe identifier or on alphanumeric codes transmitted with the encrypted data. The encryption may be intended to be decrypted by aspecific probe 100, a specificdata collection apparatus 1105, or a specificdata management system 1110. In one implementation, data communicated along wireddata link 1130 is encrypted using 128 bit encryption at the SSL layer of the TCP/IP protocol. - Both proprietary and public protocols can be used to exchange data between
probe 100,data collection apparatus 1105, anddata management system 1110. For example, the global system for mobile communications (GSM), Bluetooth, and/or the internet protocol (IP) can be used. - In one implementation,
wireless link 1125 is a spread-spectrum RF signal at wireless medical band frequencies such as the Medical Implant Communications Service (MICS) (400-406 MHz) or the Wireless Medical Telemetry Service (WMTS) (609-613 MHz and 1390-1395 MHz). -
Data management system 1110 is a data processing device that conducts operations with the data collected byprobe 100 that relates to hydration of the organism. The operations can be conducted in accordance with the logic of instructions stored in machine-readable format. The conducted operations can include the processing of such data, the display of such data, and the storage of such data. -
Data management system 1110 can be remote fromdata collection apparatus 1105 in thatdata management system 1110 need not be part of a local data communication network that includesdata collection apparatus 1105. For example,data management system 1110 can be a data processing apparatus that is accessible by one or more medical personnel. - The processing of data by
data management system 1110 can include data analysis to identify disease states in monitored organisms or problems with the monitoring. For example,data management system 1110 can perform impedance analysis using model equivalent circuits to determine hydration levels at different locations in a monitored organism. - The display of data by
data management system 1110 can include the rendition of the results of hydration monitoring on one or more input/output devices 1115. Input/output device 1115 can include visual, auditory, and/or tactile display elements that can communicate information to a human user (such as medical personnel). For example, input/output device 1115 can include a monitor, a speaker, and/or a Braille output device. Input/output device 1115 can also include visual, auditory, and/or tactile input elements such as a keyboard, a mouse, a microphone, and/or a camera. Input/output device 1115 can thus render visual, auditory, and/or tactile results to a human user and then receive visual, auditory, and/or tactile input from the user. - The storage of data by
data management system 1110 can include the storage of the results of hydration monitoring on one or moredata storage devices 1120 that retain information in machine-readable format.Data storage devices 1120 can include volatile and/or nonvolatile memory. For example,data storage devices 1120 can be a RAM device, a ROM device, and/or a memory disk. - In operation, all or some of the constituent components of
system 1100 can operate in one or more operational stages. For example, during a test stage, the constituent components ofsystem 1100 can test themselves to determine that they are functional. For example,probe 100 anddata collection apparatus 1105 can confirm that they are capable of exchanging data alonglink 1125, anddata collection apparatus 1105 anddata management system 1110 can confirm that they are capable of exchanging data along one or more oflinks inputs outputs inputs outputs electrodes probe 100 can confirm thatelectrodes - During a setup stage, parameters relating to the monitoring of the hydration of an individual can be arranged. For example, a
probe 100 can determine the baseline measurement result for a given hydration level in a portion of a monitored organism and adjust monitoring parameters accordingly. For example, the input signal level can be increased to accommodate dry skin and high transdermal impedances.Data collection apparatus 1105 can receive user input over one or more of localuser input portion 1205, wirelessdata communication portion 1215, and wireddata communication portion 1217. The received input can identify monitoring parameters that are to be adjusted, such as the level at which an alert is to be sounded atprobe 100 and/ordata collection apparatus 1105.Data management system 1110 can also receive user input relating to the arrangement of monitoring parameters. For example,data management system 1110 can receive input from medical personnel over input/output device 1115 indicating that hydration measurement results are to be transmitted byprobe 100 to data collection apparatus overlink 1125 once every four hours. This timing parameter can be relayed fromdata management system 1110 overlink 1130 todata collection apparatus 1105 which relays the timing parameter overwireless link 1125 to probe 100. - Parameters relating to the communication of information over one or more of
links system 1100 can select communication protocols or parameters for communication protocols. - During a synchronization stage, clocks in two or more of
probe 100,data collection apparatus 1105, anddata management system 1110 are synchronized to enable synchronous data transmission along one or more oflinks data collection apparatus 1105 transmits synchronization characters todata management system 1110 over wireddata link 1130.Data management system 1110 can receive the synchronization characters and compares the received characters with a synchronization pattern. When the received characters correspond sufficiently with the synchronization pattern,data management system 1110 can exit the synchronization stage and exchange other data synchronously withdata collection apparatus 1105 overlink 1130. Such a synchronization process can be repeated periodically. - In one implementation,
data collection apparatus 1105 can receive and/or display a serial number or other identifier of asynchronized probe 100. - During a measurement stage, one or
more probes 100 can collect data relating to the hydration of one or more monitored individuals. Theprobes 100 can perform data processing on the collected data, including bioelectric impedance data analysis, filtering, and, event identification. - The
probes 100 can transmit data relating to the hydration monitoring (including results of processing and analyzing collected data) to one or moredata collection apparatus 1105. The transmitted data can include a probe identifier that identifies the transmittingprobe 100. The transmitted data can be encrypted. -
Data collection apparatus 1105 can receive the data transmitted fromprobe 100 and update localuser output portion 1210 based on the received data. The updating can include indicating, in operationalmode display region 1245, thatprobe 100 is monitoring hydration, displaying, in measurementresult display region 1255, recent monitoring results, and generating, inalert display region 1260, an alert to a user who is local todata collection apparatus 1105. The alert can indicate, e.g., that a monitored individual is suffering from one or more disease states or that monitoring has somehow become impaired. -
Data collection apparatus 1105 can also command one ormore probes 100 to transmit data relating to the hydration monitoring overlink 1125. For example,data collection apparatus 1105 can transmit a query to probe 100. The query can request thatprobe 100 provide information regarding some aspect of the hydration monitoring. For example, a query can request thatprobe 100 transmit a confirmation that hydration monitoring is occurring overlink 1125, a query can request thatprobe 100 transmit a recent measurement result overlink 1125, or a query can request thatprobe 100 transmit one or more events of a particular character overlink 1125.Data collection apparatus 1105 can transmit queries to probe 100 periodically, e.g., every hour or two. -
Data collection apparatus 1105 can also relay some or all of the data transmitted fromprobe 100 todata management system 1110. The data can be relayed over one ormore data links Data collection apparatus 1105 can relay such data directly, i.e., without performing additional analysis on the information, ordata collection apparatus 1105 can perform additional processing on such before relaying a subset of the data todata management system 1110.Data collection apparatus 1105 can notify a local user that data has been relayed by displaying a data relay notice on localuser output portion 1210. Alternatively, data can be relayed bydata collection apparatus 1105 without notification to a local user. -
Data collection apparatus 1105 can also receive user input over one or more of localuser input portion 1205, wirelessdata communication portion 1215, and wireddata communication portion 1217. The received input can identify thatdata collection apparatus 1105 is to transmit data to one ormore probes 100 overlink 1125. For example, the received input can identify thatdata collection apparatus 1105 is to instructprobe 100 to generate an alarm signal indicating that a monitored person suffers under a disease state. As another example, the received input can identify thatdata collection apparatus 1105 is to transmit a query to aprobe 100 overwireless link 1125. As another example, the received input can identify thatdata collection apparatus 1105 is to transmit aninstruction instructing probe 100 to change a parameter of the hydration monitoring, including one or more threshold values for identifying a disease state. -
Data collection apparatus 1105 can also perform data processing and storage activities that supplement the data processing and storage activities ofprobe 100. For example,data collection apparatus 1105 can perform more extended data analysis and storage, including signal processing and analysis. For example,data collection apparatus 1105 can perform impedance analysis using model equivalent circuits to determine hydration levels at different locations in a monitored organism. As another example,data collection apparatus 1105 can perform trending analyses that identify a general tendency of hydration levels to change over extended periods of time, ordata collection apparatus 1105 can perform comparisons between hydration levels obtained usingmultiple probes 100. Themultiple probes 100 can monitor the hydration of a single organism, or the multiple probes can monitor the hydration of multiple organisms.Data collection apparatus 1105 can compare and correlate monitoring results from multiple probes to calibrate one ormore probe 100 and minimize errors during monitoring. -
Data collection apparatus 1105 can also compare and/or correlate the results of hydration monitoring with the results of monitoring other biological parameters. For example,data collection apparatus 1105 can compare and correlate the results of hydration monitoring with the results of heart monitoring, drug delivery schedules, and temperature monitoring.Data collection apparatus 1105 can receive the other monitoring results over one or more of localuser input portion 1205, wirelessdata communication portion 1215, and wireddata communication portion 1217. For example,data collection apparatus 1105 can receive the other monitoring results over one or more oflinks -
Data collection apparatus 1105 can also exchange data with other devices and systems (not shown inFIG. 11 ). For example,data collection apparatus 1105 can receive other monitoring results directly from other monitoring instruments. As another example,data collection apparatus 1105 can transmit data relating to the results of hydration monitoring to other local or remote parties. The other parties can be external entities in that they do not share a legal interest in any of the constituent components ofsystem 1100. For example, the other parties can be a medical group that has contracted with an owner ofsystem 1100 to monitor hydration of an individual. -
Data management system 1110 can receive the results of hydration monitoring fromdata collection apparatus 1105 over one or both ofdata link -
Data management system 1110 can conduct operations with the received data, including processing the data to identify disease states and problems with the monitoring. For example,data management system 1110 can perform impedance analysis using model equivalent circuits to determine hydration levels at different locations in a monitored organism. As another example,data management system 1110 can perform trending analyses that identifies a general tendency of hydration levels to change over extended periods of time, ordata management system 1110 can perform comparisons between hydration levels obtained usingmultiple probes 100. Themultiple probes 100 can monitor the hydration of a single organism, or the multiple probes can monitor the hydration of multiple organisms.Data management system 1110 can compare and correlate monitoring results from multiple probes to calibrate one ormore probe 100 and minimize errors during monitoring.Data management system 1110 can also perform analyses that require hydration monitoring results from statistically significant numbers of organisms. Such analyses can include billing assessments, geographic assessments, epidemiological assessments, etiological assessments, and demographic assessments. -
Data management system 1110 can render the results of hydration monitoring on one or more input/output devices 1115 and store the results of hydration monitoring on one or moredata storage devices 1120.Data management system 1110 can also provide the results of the data processing todata collection apparatus 1105 and/or probe 100 overdata links probe 100 should generate an alarm signal indicating that a monitored organism suffers under a disease state.Data management system 1110 can also provide such indications to external entities, including medical personnel interacting with input/output device 1115 and medical personnel in the vicinity of the monitored organism. For example, an emergency medical technician (EMT) can be informed that a monitored individual in the EMT's vicinity suffers from acute dehydration. As another example,data management system 1110 can also post an indication in an external system such as the clinical information system of a healthcare organization or an Internet portal. - In one implementation,
data management system 1110 can request, fromdata collection apparatus 1105 and/or probe 100, that additional monitoring activities be performed. The request can be spurred by the results of analyses performed atdata collection apparatus 1105 and/or the analyses performed atdata management system 1110. The request can also be spurred by a human user such as medical personnel interacting with input/output device 1115. The requests can be based on the results of hydration monitoring. The additional monitoring activities can be directed to other biological parameters, or the additional monitoring activities can be directed to gaining more information about the hydration of the monitored individual. For example,data management system 1110 can identify surveys and/or survey questions that are to be presented to a monitored organism to facilitate hydration monitoring. A survey is a series of questions designed to gather information about the hydration of a monitored organism. A survey is generally presented to a monitored organism, but a survey can also be presented to individuals having contact with the monitored organism. A survey can be presented, e.g., over a telephone or through the mail. Survey and survey questions can be generated before monitoring begins and stored, e.g., atprobe 100,data collection apparatus 1105, and/ordata management system 1110. - Survey questions can be directed to ascertaining, e.g., body position of a monitored organism, length of time that the monitored organism has been in one position, the diet of the monitored organism, the activity level of the monitored organism, or the time zone of the monitored organism. Example survey questions include “Are you currently exercising?”, “Did you remove the probe?”, and “Have you recently taken a diuretic?” The questions presented during a survey can depend upon the responses to previous questions. For example, if a monitored individual has removed
probe 100, subsequent questions can be deleted. - Responses to the questions in the survey can be received using, e.g., an interactive voice recognition system (IVRS) or keypad entry on a touch tone phone.
Data management system 1110 can present the survey itself ordata management system 1110 can direct another system to present the survey. The responses to survey questions can be scored based upon a predetermined criteria set and used in further analyses in hydration monitoring. -
FIG. 13 shows another implementation of a system for monitoring the hydration of an organism, namely asystem 1300. In addition to one or moredata collection apparatus 1105,data management system 1110, input/output device 1115, anddata storage device 1120,system 1300 includes a collection ofmultiple probes network 1317 in which data can be transferred amongstprobes network 1317,probe 1305 exchanges data withprobe 100 over awireless data link 1320.Probe 1310 exchanges data withprobe 1305 over awireless data link 1325.Probe 1315 exchanges data withprobe 1310 over awireless data link 1330. The data exchanged amongstprobes data links - Such a “hopping”
network 1317 may extend the range and robustness of data communication insystem 1300. -
FIG. 14 shows another implementation of a system for monitoring the hydration of an organism, namely a system 1400. In addition to one or moredata collection apparatus 1105,data management system 1110, input/output device 1115, anddata storage device 1120, system 1400 includes apharmaceutical dispenser 1405.Pharmaceutical dispenser 1405 is a device that provides compositions for ameliorating a disease state of an individual.Pharmaceutical dispenser 1405 can provide such a composition to an individual automatically (i.e., without human intervention) orpharmaceutical dispenser 1405 can provide such a composition in conjunction with the efforts of one or more individuals. For example,pharmaceutical dispenser 1405 can be an implanted controlled-release drug delivery device orpharmaceutical dispenser 1405 can be a pill dispenser that is accessible by a monitored individual or by medical personnel. -
Pharmaceutical dispenser 1405 includes acommunications element 1410.Communications element 1410 can placedispenser 1405 in data communication with the constitutent components of system 1400. For example, in one implementation,communications element 1410 can establish awireless data link 1415 betweendispenser 1405 anddata collection apparatus 1105. - In operation,
pharmaceutical dispenser 1405 can receive data such as dispensation instructions from the constitutent components overcommunications element 1410. For example, when one or more ofprobe 100,data collection apparatus 1105, anddata management system 1110 identify, based at least in part on the results of hydration monitoring, that a monitored individual suffers under one or more disease states,pharmaceutical dispenser 1405 can receive instructions overelement 1410 that instructdispenser 1405 to provide a composition to the monitored individual that ameliorates the identified disease state. - In response to the receipt of dispensation instructions,
pharmaceutical dispenser 1405 can provide a composition for ameliorating a disease state to the monitored individual. For example,pharmaceutical dispenser 1405 can release a drug into the monitored individual's body orpharmaceutical dispenser 1405 can prepare a dosage of medicine for the monitored individual. The dispensation of a composition bypharmaceutical dispenser 1405 can be recorded at one or more memory devices in system 1400, e.g., for use in analyzing the results of hydration monitoring. -
FIG. 15 shows an example of a modelequivalent circuit 1500 that can be used in monitoring the hydration of an organism. In particular, modelequivalent circuit 1500 that can be used to model the electrical conductivity of an organism.Circuit 1500 models the impedances observed in bioelectric impedance spectroscopy using aprobe 200 that supportselectrodes skin surface 1505 of anorganism 1510. -
Model circuit 1500 includes a series ofsurface impedances transdermal impedances subdermal impedances Surface impedances electrodes Surface impedances surface impedances -
Transdermal impedances Transdermal impedance 1530 includes aresistive component 1565 and areactive component 1570.Transdermal impedance 1535 includes aresistive component 1575 and areactive component 1580.Transdermal impedance 1540 includes aresistive component 1585 and areactive component 1590.Transdermal impedance 1545 includes aresistive component 1595 and areactive component 1597.Reactive components resistive components -
Subdermal impedances subdermal impedances - In one implementation, in bioelectric impedance spectroscopy,
probe 200 supportselectrodes skin surface 1505.Current source 210 can drive electrical current betweenelectrodes electrodes equivalent circuit 1500 as well as the impedance of different paths acrossequivalent circuit 1500. - For example, when direct current is driven across
circuit 1500, a large portion of the direct current will pass throughsurface impedances electrodes surface impedances circuit 1500, some portion of the alternating current can pass throughsurface impedances transdermal impedances subdermal impedances electrodes impedances surface impedances - The impact of various factors on the electrical conductivity of an organism can be accommodated by changing the mathematical analysis of
model circuit 1500 or by changing aspects of data collection. For example, whensurface impedances electrodes surface impedances - Model
equivalent circuit 1500 can be used in conjunction with custom approaches to data analysis for monitoring the hydration of an organism. Such data analysis approaches can be used to interpret monitoring data and to identify changes in the amount and distribution of water in a monitored organism. Data analysis approaches can also be used to incorporate results of other bioparameter measurements and responses to survey questions into the hydration monitoring. - Data analysis approaches can be performed in accordance with the logic of a set of machine-readable instructions. The instructions can be tangibly embodied in machine-readable format on an information carrier, such as a data storage disk or other memory device. The instructions can also be embodied in whole or in part in hardware such as microelectronic circuitry.
- Data analysis approaches can yield analysis results that can be displayed to a human user. The human user can be the monitored individual or another individual, such as a medical professional. The analysis results can be displayed in response to a prompt from the user or automatically, i.e., without user input. For example, the analysis results can be displayed automatically when hydration indicative of a disease state is identified. When hydration monitoring is performed using a
system 1100, analysis results can be displayed at aprobe 100, at adata collection apparatus 1105, and/or at a data management system 1110 (FIGS. 11, 13 , 14). Analysis results can be displayed using other output devices such as the postal service, facsimile transmission, voice messages over a wired or wireless telephone network, and/or the Internet or other network-based communication modalities. - Data analysis can be performed continuously or intermittently over extended periods of time. The analyzed data can be measurement results collected continuously or intermittently. The analyzed data can be a subset of the data collected or the analyzed data can be all of the data collected. For example, the analyzed data can be intermittent samples redacted from the results of continuous hydration monitoring.
- One advantage of the analysis of hydration monitoring results obtained over extended periods of time is that long term monitoring may be achieved. The monitoring can be long term in that diurnal, monthly, or other variations in hydration that are not associated with disease states can identified. The monitoring can be individualized in that the analysis results are relevant to a specific monitored organism.
- Data analysis can accommodate both long and short term variations in hydration that are not associated with disease states by reducing the effect of such variation on analysis. For example, data analysis can accommodate variations associated with respiration and other types of movement. For example, peak/trough analysis and/or frequency analysis of hydration monitoring results obtained from the chest can be used to determine the breathing period. This can be done, e.g., by identifying the rate of change between discrete data points in the measurement results. Once the breathing period is identified, specific measurement results (such as those associated with exhalation) can be identified and relied upon in subsequent analyses.
- Changes in impedance measurements due to electrode movement over time or with wear can also be accommodated in data processing routines if necessary.
- As another example, data analysis can accommodate diurnal or monthly variations. Such variations can be identified by peak/trough analysis and/or frequency analysis of longer term measurement results. For example, specific measurement results (such as those associated with exhalation) can be used to identify any reproducible diurnal and/or monthly variability in hydration. Such variability can be accommodated in subsequent measurement results by subtraction of the prior variability or other adjustment approaches.
- For example, the diurnal pattern of hydration monitoring results may indicate that there is a significant likelihood of a 3% decrease in a bioelectric impedance value for a specific organism in the late afternoon relative to early morning. Hydration measurement results obtained at either time may be adjusted or modified by interpolation to reflect the decrease. Such adjustments can be made to account for predictable or habitual patterns such as, e.g., daily exercise routines or eating/drinking habits.
- As another example of accommodating diurnal variations, only measurement results obtained during patterned times of regular breathing (for example, during sleep) are relied upon in subsequent analyses. Such patterned times can be identified, for example, by determining the rate of change in hydration monitoring results. Such patterned times can be used in conjunction with measurement results obtained with a known hydration status (e.g., the monitored individual is “dry” and unaffected by pulmonary edema) to adjust decision criteria and other analysis parameters.
- Other variations in hydration monitoring results, including random variations such as electronic stray signal or positional signal noise, can be accommodated using digital and/or analog filters, signal averaging, data discarding techniques, and other approaches.
- Data analysis of hydration monitoring results can be used to establish a baseline of typical hydration characteristics so that deviations from the baseline, e.g., in response to disease states or other stresses, can be identified. The baseline of typical hydration characteristics can be individualized and relevant to a specific monitored organism, or the baseline of typical hydration can reflect the average hydration of a population of individuals. For example, extended monitoring results can be analyzed to establish a population database of tolerances and ranges for the identification of individual disease states, deviations, and/or anomalies, as well as population trends (as discussed further below). Such a baseline can be obtained for healthy and/or diseased populations with a variety of demographic characteristics.
- In contrast, transient periodic hydration monitoring of an individual (such as, e.g., monitoring an individual for a short time once a day or once a week) is less likely to detect individual variations, deviations, or anomalies and does not contribute to the establishment of a population database.
- Data analysis can include the analysis of subsets of the total hydration monitoring results. The analyzed subsets can have common characteristics that distinguish the subsets from unanalyzed hydration monitoring results. For example, the analyzed subsets can have high signal-to-noise ratios, analyzed subsets can be obtained under dry conditions (e.g., when
surface impedances FIG. 15 ) are relatively high), analyzed subsets can be obtained when good contact is maintained between a monitored organism andinputs outputs 130, 135 (FIG. 1 ), or analyzed subsets can be obtained at the same time of day. - Data analysis operations can be performed at one or more of
probe 100,data collection apparatus 1105, and/ordata management system 1110. In one implementation, data analysis is distributed betweenprobe 100 anddata collection apparatus 1105. In particular,probe 100 can perform initial analyses, including signal processing, noise filtering, and data averaging operations. The operations can be performed on data from one or more measurements taken at one or more frequencies. The operations can be performed on raw data or on data where variations have been accommodated. For example, the operations can be performed on data collected at certain points during breathing. These initial analysis results can be transmitted, along with other information such as a probe identifier and a time/date stamp, todata collection apparatus 1105. Atdata collection apparatus 1105, data analysis operations can include the identification of trends or shifts in hydration associated with disease states such as pulmonary edema, as well as comparisons between received data and threshold values. - In another implementation, data analysis operations are performed primarily at
data collection apparatus 1105 and data analysis atprobe 100 is minimal. When data analysis atprobe 100 is minimal, data analysis and data storage can be consolidated atdata collection apparatus 1105 and probe 100 can include simplified circuitry with reduced power requirements and cost. - Data analysis can also be performed at
data management system 1110. Such data analysis can include multivariable analysis where hydration monitoring results are analyzed in light of other statistical variables such as weight, heart rate, respiration, time of day, month, eating patterns, physical activity levels, and other variables. The other statistical variables need not be entirely independent of the hydration monitoring results. The hydration monitoring results used in multivariable analysis can be obtained over extended periods (e.g., days, weeks, or months) from one or more organisms. The results of such multivariable analysis can be used to develop new and improved analyses of hydration monitoring results, including improved algorithms, improved pattern definition techniques, and/or artificial intelligence systems. - A variety of other analysis techniques can be applied to hydration monitoring results. These include the use of established guideline values for data that is used to determine fluid changes associated with the onset or progression of pulmonary edema. Also, clinician-modified variables such as tailored threshold values can be applied to permit increased accuracy and specificity.
- These and other analyses of hydration monitoring results can be made in light the results of monitoring other biological parameters such as respiration, heart rate, hormone (e.g., B-type natriuretic peptide (BNP)) levels, metabolite levels (e.g., blood urea nitrogen (BUN) and/or Na+/K+ levels), wedge pressure measurements, electrocardiogram measurements, and others. Analyses made in light of such other parameters may improve the information provided by the analysis process.
- Data analysis can include comparisons involving recent hydration monitoring results. For example, recent hydration monitoring results can be compared with previous hydration monitoring results, predicted results, or population results. Future hydration monitoring results can be predicted based on the current state of the monitored individual and on past hydration monitoring results obtained with the same or with other individuals or a population or demographic group. Such comparisons may include, for example, the use of population data tables, multiple reference measurements taken over time, or the results of trend analyses based upon extended hydration monitoring.
- Such comparisons can also involve other factors, including other bioparameters. For example, hydration monitoring results can be weighted by one or more factors before comparisons are performed. Examples of such factors include the monitored individual's age, weight, height, gender, general fitness level, ethnicity, heart rate, respiration rate, urine specific gravity value, blood osmolality measurement, time of day, altitude, state of hydration (either subjective or objective), cardiac waveforms, left ventricle ejection fraction, blood oxygen levels, secreted potassium or sodium ions levels, skin surface temperature, ambient temperature, core body temperature, activity/motion assessment, humidity, and other bioparameters.
- With trend analysis and prediction of future hydration state, it is possible to prevent serious hydration problems from occurring by providing treatment or intervention recommendations to the subject and/or a care provider prior to serious hydration problems occurring. For ambulatory healthy subjects, a downward hydration trend over a selected period can be detected and a recommended fluid intake could be presented automatically. The timing and nature of the recommendation could be also based at least in part on the age, gender, or other relevant factors. For some conditions, such as a prediction that fluid is building in lung tissue during the onset of pulmonary edema, a recommended intake of a pharmaceutical agent can be automatically provided.
- Hydration monitoring can proceed in a variety of different environments using a variety of different procedures to monitor a variety of different disease states. For example, in one implementation, where hydration is monitored for indications of pulmonary edema, monitoring can commence after an individual has been identified as at risk for pulmonary edema. For example, such an individual may have been admitted to a care facility for treatment of pulmonary edema. Hydration can be monitored as the individual is “dried out” and excess fluid load in the thoracic region is reduced. Hydration monitoring can be continued after the individual is “dried out.” For example, hydration monitoring can continue after such an individual is released from the care facility, and even as the individual returns to performing workday activities. Through all or a part of this time, hydration monitoring can be ongoing and rely upon a portable probe that can be moved from a fixed location by the individual and still perform at least some output signal generation. Analysis of the results of such hydration monitoring can be used to gather information about the reonset and/or progression of pulmonary edema, both in the monitored patient and in population groups that include the monitored patient.
- Hydration monitoring can be performed to achieve a variety of different objectives, including the identification of levels and distributions of water in organisms that are indicative of one or more acute or chronic disease states. Examples of such monitoring follow.
- Many individuals find themselves in activities or in environments that are conducive to dehydration. Such activities may include athletics, public safety activities performed by officers/firefighters, combat, and other activities requiring physical exertion. Such environments include hot and humid locales.
- In these cases, one or more strap probes can be deployed along a thigh of such individuals to continually monitor the hydration of such individuals. Alternatively, probes can be incorporated into clothing such as the pants and sock illustrated in
FIGS. 9A and 9B . - During the initialization of hydration monitoring, a range of data, including hydration monitoring results and the results of monitoring other bioparameters, can be transmitted to one or more data processing devices that perform analysis operations. The transmitted data can be used by such devices to establish a baseline from which relative changes in hydration can be determined. The transmitted data can include, e.g., urine specific gravity, blood osmolality, and/or other parameters indicative of hydration status, including, e.g., anthropometric data such as segment size, age, height, weight, and general fitness level.
- The established baseline can be returned to the probe and used by the probe to provide instantaneous alarms when hydration monitoring results indicative of dehydration are obtained. Further, the results of hydration monitoring generated by the probe can be transmitted to a data collection apparatus and/or data management system for analysis and archiving.
- A data collection apparatus and/or data management system can also identify hydration monitoring results that are indicative of dehydration. For example, when hydration decreases by a certain threshold amount (e.g., 3%), a data collection apparatus and/or data management system can record the decrease and then trigger an alarm signal at the probe and/or the data collection apparatus. For example, the extent of dehydration can be displayed along with a recommended fluid replacement volume and a recommended recovery time. Further, the alert can be relayed to a third party such as an athlete's coach, a supervisor, or medical personnel.
- Following a period of monitoring, the monitored individual can remove and replace a probe. The new probe can synched to the data collection apparatus and provided with new baseline impedance measurements.
- A data collection apparatus can be incorporated into a device commonly used by individuals who find themselves in activities or in environments that are conducive to dehydration. For example, a data collection apparatus can be incorporated into safety equipment, the handlebars of a bicycle, a helmet, or gloves. When hydration monitoring results indicative of a disease state such as dehydration are obtained, the data collection apparatus can alert the individual and/or others in the individual's vicinity of the results. For example, a light on the outside of a football player's helmet can flash to alert teammates and coaches of the player's hydration monitoring results. These alerts can be graded with the severity of the hydration monitoring results so that the player and teammates have timely warning prior to passing critical hydration thresholds, such as greater than 5% dehydration.
- Many individuals who operate motor vehicles are ambulatory but have their mobility restricted in that they are confined within the vehicle for extended times. Such vehicles include cars, airplanes, tanks, ships, and other transportation devices.
- Probes for monitoring the hydration of such individuals can be incorporated into motor vehicles, e.g., at a steering wheel, joystick, or other surface that contacts operating individuals either continually or intermittently. Intermittent contact can be accommodated by limiting data analysis to data obtained during periods of good contact between the probe and the monitored organism.
- Such vehicles can also include a data collection apparatus. In some implementations, the data collection apparatus can share generic components with the vehicle to perform various operations. Such components include vehicle display systems and data communication devices.
- When hydration monitoring results indicative of a disease state such as dehydration are obtained, the data collection apparatus can alert the individual and/or others in the individual's vicinity of the results. For example, a pit crew can be notified that a driver is becoming dehydrated or a commanding officer can be notified that soldiers in his/her command are becoming dehydrated.
- Although a number of implementations have been described, changes may be made. For example, bandage probes can be incorporated into clothing. Probe 100 can communicate with
data collection apparatus 1105 by a wired data link. Bothprobe 100 anddata collection apparatus 1105 can be incorporated into other items or equipment such as a vehicle, a radio unit, a shoe, football equipment, fire fighting equipment, gloves, hydration systems, bicycle handlebars, and other devices. Data communication alongdata link 1125 can be asynchronous, and the synch operational mode eliminated fromdata collection apparatus 1105. - As shown in
FIG. 16 , multiple probes (i.e., probes 500 and 500′) can be deployed at different locations at anorganism 405 to monitor the hydration of the organism. In particular,strap probe 500 is sized to encircle the thigh ofperson 405 and is deployed to probe the conductivity of the thigh ofperson 405, whereasstrap probe 500′ is sized to encircle the lower leg ofperson 405 and is deployed to probe the conductivity of the lower leg ofperson 405. - The measurement results from the
probes probe 500′. Such a calibration can include making differential measurements that accommodate variation in the hydration monitoring results that is unrelated to cardiac failure. -
FIG. 17 shows an implementation of a system that uses multiple probes for monitoring the hydration of an organism, namely asystem 1700. In addition to one or moredata collection apparatus 1105,data management system 1110, input/output device 1115, anddata storage device 1120,system 1700 includesprobes Probes single organism 405 as shown inFIG. 16 .Probes wireless data links 1125 withdata collection apparatus 1105 to communicate information used in hydration monitoring. - Accordingly, other implementations are within the scope of the following claims.
Claims (13)
1. A system for ambulatory physiological monitoring comprising:
at least one adhesive patch positioned on at least a portion of a subject, said patch comprising a plurality of sensors and at least one communication module, said sensors being configured to sense one or more physiological parameters comprising at least electrical impedance;
a data collection unit configured to receive information collected from said sensors from said communication unit.
2. The system of claim 1 , additionally comprising a remote data management system configured to receive information from said data collection unit and process said information.
3. The system of claim 1 , wherein said adhesive patch is secured to at least a portion of a thorax of said subject.
4. The system of claim 1 , additionally comprising a temperature sensor.
5. The system of claim 1 , additionally comprising a subsurface temperature sensor.
6. The system of claim 1 , wherein said data collection unit is also configured to process information before sending information to said remote data management system.
7. The system of claim 1 , comprising a timer for associating at least one measurement with an absolute time the measurement was taken.
8. The system of claim 1 , wherein said remote database is configured to establish an individual baseline parameter value.
9. The system of claim 1 , wherein the data management system provides feedback to the data collection unit and/or the communication module.
10. The system of claim 1 , wherein said feedback comprises diagnostic knowledge.
11. The system of claim 1 , wherein said feedback comprises actions and/or instructions.
12. The system of claim 1 , comprising a plurality of communication modules.
13. The system of claim 1 , comprising a plurality of data collection units.
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US7783344B2 (en) | 2010-08-24 |
JP5449647B2 (en) | 2014-03-19 |
JP2012143574A (en) | 2012-08-02 |
AU2004266725A1 (en) | 2005-03-03 |
EP1677674A2 (en) | 2006-07-12 |
WO2005018432A2 (en) | 2005-03-03 |
EP1677674A4 (en) | 2009-03-25 |
EP2382920A1 (en) | 2011-11-02 |
WO2005018432A3 (en) | 2005-05-06 |
US20050070778A1 (en) | 2005-03-31 |
CA2539547A1 (en) | 2005-03-03 |
JP2007502675A (en) | 2007-02-15 |
AU2004266725B2 (en) | 2011-03-10 |
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