||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||Ill
`
`US 20(320032336Al
`
`(t9) Ulllted States
`(12) Patent Application Publication (10) Pub. N0.: US 2002/0032386 A1
`
`Sackncr et al.
`(43) Pub. Date:
`Mar. 14, 2002
`
`(S4) SYSTEMS AN l) METHODS FOR
`AMBULATORY MONITORING OF
`PHYSIOLOGICAL SIGNS
`
`(57)
`
`ABSTRACT
`
`(76)
`
`Inventors: Marvin A. Sackner, Miami Beach, lit.
`(US); Dana Michael Inman, Miami.
`FI.(US}
`
`Correspondence Address:
`I’ENNIIC 8: EDMONDS l.l.P
`COUNSELIDRS AT LAW
`1155 Avenue of the Americas
`New York, NY 10036-2711 (US)
`
`(21) Appl. NO':
`(22
`Filed:
`
`"9"!836’384
`Apr. 17, 2001
`
`Related U.S. Application Data
`
`(53) Nomprovisional of provisional
`gut-1971589, filed U" Apr. 17’ 2000.
`
`application No.
`
`Publication Classification
`
`Int. Cl.7 ................................ A611} 51’08; A618 SIUZ
`(51)
`(52) US. Cl.
`........................... 600,536; MIL-“484; 600,509
`
`The present invention relates to the field of ambulatory and
`non—invasive monitoring of a plurality of physiological
`parameters of
`a monitored individual. The
`invention
`includes a physiological monitoring apparatus with an
`improved monitoring apparel worn by a monitored indi-
`vidual, the apparel having attached sensors for monitoring
`parameters reflecting pulmonary function, or parameters
`reflecting cardiac function, or parameters reflecting the
`function of other organ systems, and the apparel being
`designed and tailored to be comfortable during the individu-
`al’s normal dailyr activities. 'lhe a
`arel is
`referabl
`also
`suitable for athletic activities. The sensErs prefirably
`include one or more ECG leads and one of more inductive
`piethysmographic sensor with conductive loops positioned
`
`closely to the individual to preferably monitor at least basic
`cardiac parameters, basic pulmonary parameters, or bolh.
`The monitoring apparatus also includes a unit [or receiving
`data from the sensors, and for storing the data in a computer—
`readable medium. The invention also includes systems corn-
`prising a central data repository [or receiving, storing, and
`processing data generated by a plurality ol~ physiological
`monitored apparatus, and for making stored data available to
`the individual and to health care providers.
`
`APPLE 1017
`
` 1
`
`APPLE 1017
`
`1
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 1 0f 10
`
`US 2002/0032386 A1
`
`
`
`2
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 2 0f 10
`
`US 2002/0032386 A1
`
`
`
`3
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 3 0f 10
`
`US 2002/0032386 A1
`
`
`
`4
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 4 0f 10
`
`US 2002/0032386 A1
`
`
`
`5
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 5 0f 10
`
`US 2002/0032386 A1
`
`
`
`6
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 6 0f 10
`
`US 2002/0032386 A]
`
`
`
`7
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 3' 0f 10
`
`US 2002/0032386 A]
`
`
`
`8
`
`

`

`Patent Application Publication
`
`Mar. 14, 2002 Sheet 8 0f 10
`
`US 2002/0032386 A]
`
`
`
`9
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 9 0f 10
`
`US 2002/0032386 A1
`
`
`
`10
`
`10
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 10 of 10
`
`US 2002/0032386 A1
`
`FIG.10
`
`H"I|IIJ_I
`
`
`
`
`
`
`11
`
`11
`
`

`

`US 2002/0032386 A1
`
`Mar. 14, 2002
`
`SYSTEMS AND METHODS FOR AMBULATORY
`MONITORING OIr PHYSIOLOGICAL SIGNS
`
`1. FIELD OF THE INVENTION
`
`[0001] The present invention relates to the field of ambu-
`latory and non-invasive monitoring of an individual’s physi-
`ological parameters. In particular, the invention relates to a
`monitoring apparatus with an improved apparel worn by a
`monitored individual, the apparel having attached sensors
`for monitoring parameters reflecting pulmonary function, or
`parameters reflecting cardiac function, or parameters reflect-
`ing the function of other organ systems. The invention also
`includes systems for receiving, storing, and processing
`physiological-parameter data, and for making it available to
`the individual and to health care providers.
`
`2. BACKGROUND OF TIIE INVENTION
`
`In the following, the term “plethysmography” (and
`[0002]
`its derivative words) means measurement of a crossusec-
`tional area of the body, such as a crossvsectional area of the
`chest or of the abdomen, or a body part, such as. a cross-
`sectional area of the neck or of an arm. (This meaning is
`somewhat more limited than is standard in the medical arts.)
`Further,
`the phrase "inductive plethysrnography" means
`herein plethysmographic measurements which depend on
`inductance determinations.
`
`[0003] Measurement of pulmonary and cardiac physi~
`ological parameters by means of inductive plethysmography
`is known. For example, many measurement methods and
`apparatus are disclosed in the following US. patents, the
`entire disclosures of which are incorporated herein, in their
`entireties, by reference, for all purposes.
`
`(1) The ’872 patent: US. Pat. No. 4,308,872,
`[0004]
`issued Jan. 5,
`l982 and titled “Method and Apparatus for
`Monitoring Respiration,” discloses a method and apparatus
`for monitoring respiration volumes by measuring variations
`in the patient's chest crests sectional area, or variations in
`both chest and abdomen cross sectional areas, each area
`being measured by determining the inductance of an exten-
`sible electrical conductor closely looped around the body,
`and the measurements being calibrated by measuring the
`area variations for a few breaths while directly measuring
`corresponding volumes of breath, preferably while the
`patient assumes at
`least two body positions, for example
`sitting and supine.
`
`(2) The ’534 patent: US. Pat. No. 4,373,534,
`[0005]
`issued Feb. 15. 1983 and titled "Method and Apparatus for
`Calibrating Respiration Monitoring System," discloses
`methods and systems in which respiration volume is deter-
`mined by weighting signals representing abdominal and
`chest crosspsectional areas, where the weighting factors are
`determined by a procedure involving measuring respiration
`volume by an alternate measuring apparatus along with
`unweighted chest and abdomen signals, the measurements
`occurring for a first series of breaths based with a first
`relative chest and abdominal contribution and for a second
`series of breaths based on a second relative chest and
`abdominal contribution.
`
`(3) The ’252 patent: US. Pat. No. 4,452,252,
`[0006]
`issued Jun. 5, 1984 and titled “Non-invasive Method for
`Monitoring Cardiopulmonary Parameters," discloses
`a
`
`method for monitoring cardiopulmonary events by inductive
`plethysmographic measurement of a cross-sectional area of
`the neck, and further discloses a method for monitoring
`mouth volume by inductive plethysmographic measurement
`of a cross-sectional area of the head in a plane which extends
`through the mouth.
`
`(4) The ‘015 patent: US. Pat. No. 4,456,015,
`[001W]
`issued Jun. 26, 1984 and titled "Non-invasive Method for
`Semiquantitative Measurement of Neck Volume Changes,"
`discloses a method of plethysmographic measurement of a
`subject’s neck volume by providing an extensible conductor
`closely circling the neck and, first, calibrated against cross-
`sectional area so that neck volume may be determined from
`the conductor’s inductance, and also, second, calibrated
`against invasively-measured intrapleura] pressure so that the
`intrapleural pressure may also be determined from the
`conductor’s inductance, and also so that intrapleural pres-
`sure may also be obtained from measured neck volume.
`
`(5) The ’40? patent: US. Pat. No. 4,648,407,
`[0008]
`issued Mar. 10, 1987 and titled "Method for Detecting and
`Differentiating Central and Obstructive Apneas in New-
`borns," disclosing methods for detecting the presence and
`origin of apnea in newborns by concurrently monitoring
`relative movement of the cranial bones (which have been
`found to move with respiration as a function of intrapleural
`pressure}. preferably by a surface inductive plethysmo—
`graphic transducer, and nasal ventilation, preferably by a
`nasal cannula,
`thermistor,
`thermocouple or CO2 sensor,
`wherein absence of changes in both cranial bone movement
`and respiratory air flow at the nose indicates of the presence
`of central apnea, while absence of nasal air flow accompa-
`nied by continuing cranial bone movements indicates of
`obstructive apnea.
`
`(6) The ’962 patent: U.S. Pat. No. 4,777,962,
`[0009]
`issued Oct. 18, 1988 and titled “Method and Apparatus for
`Distinguishing Central Obstructive and Mixed Apneas by
`External Monitoring Devices Which Measure Rib Cage and
`Abdominal Compartmental Excursions During Respira-
`tion,“ discloses an apparatus and method for distinguishing
`between different
`types of apneic episodes. The method
`includes measuring a new index, 'Ibtal Compartmental Disv
`placementi’I'idal Volume (TCDNT), and measuring the
`phase relation between the abdominal and rib cage contri-
`butions to total respiration volume, wherein an episode is
`classified as central, obstructive or mixed based on the value
`of TCDIVT and the phase relation.
`
`(7) The ‘640 patent: US. Pat. No. 4,801,640,
`[0010]
`issued Feb. 28, 1989 and titled “Stretchable Band—type
`Transducer Particularly Suited for Respiration Monitoring
`Apparatus," discloses an improved,
`low-cost stretchable
`band incorporating a conductor for disposition about
`the
`human torso or other three dimensional object, and particu-
`larly intended for use with respiration monitoring by means
`of inductive plethysmography, a method for making the
`band, which method is suitable to mass production tech-
`niques, and an improved enclosure housing circuitry releas-
`ably connected to the conductor in the band when the band
`is incorporated in respiration monitoring apparatus.
`
`(8) The ”473 patent: US. Pat. No. 4,815,473, issued
`[0011]
`Mar. 28, 1989 and titled "Method and Apparatus for Moni-
`toring Respiration,” discloses a method and apparatus for
`monitoring respiration volumes by inductive plethysmo-
`
`12
`
`12
`
`

`

`US 2002/0032386 A1
`
`Mar. 14, 2002
`
`graphic measurement of variations in a patient ’5 chest cross
`sectional area, or preferably, variations in both chest and
`abdomen areas during breathing, and a method for calibratv
`ing such an apparatus by measuring cross—sectional area
`variations for a few breaths while directly measuring cor-
`responding volumes of breath, preferably while the patient
`assumes at least two body positions, for example sitting and
`supine.
`
`“‘19) The ‘766 patent: US. Pat. No. 4,860,?66,
`[0012]
`issued Aug. 29, 1989 and titled “Noninvasive Method for
`Measuring and Monitoring Intrapleural Pressure in New»
`boms," discloses measuring intrapleural pressure of a new-
`born subject by detecting relative movement between adja~
`cently-proximate cranial bones, preferably, using a surface
`inductive plethysmographic transducer secured on the sub-
`ject’s head across at least two adj acently-proximate cranial
`bones, and a method of calibrating such measurements by
`temporarily manually occluding the subject’s nose or, if
`intubated,
`the endotracheal
`tube,
`to measure the airway
`pressure during such occlusion as the subject makes an
`inspiratory effort and comparing the measured pressure to
`the measured signal.
`
`(10) The '109 patent: US. Pat. No. 4,834,109,
`[0013]
`issued May 30, 1989 and titled “Single Position Non-
`invasive Calibration Technique,” discloses an improved
`method for calibrating inductive plethysmographic measure—
`ment of respiration volume by totaling, during a period of
`breathing, a plurality of values of a parameter indicative of
`the relative amplitude, for each breath, of uncalibrated rib
`cage and abdomen signals, and by dividing the average
`variability of the means of the total of the values of one of
`the rib cage and abdomen signals by the average variability
`of the mean of the total of the values of the other signal, the
`quotient being so derived represents a signal weighting
`factor for determining respiration volume.
`
`(11) The '277 patent: US. Pat. No. 4,986,277,
`[0014]
`issued Jan. 22, [991 and titled "Method and Apparatus for
`Non-invasive Monitoring of Central Venous Pressure,” dis-
`closes a method and apparatus for measuring central venous
`pressure (CW) and changes in CVP along with an improved
`transducer (50) for measuring CVP in infants, wherein a
`plethysmographic transducer is disposed on the neck of a
`subject (or on the head in the case of infants), the signal from
`the transducer is processed to obtain a cardiac component,
`and the vertical distance from the transducer to a reference
`level is adjusted until a position is located at which the signal
`changes between a venous configuration and an arterial or
`mixed venous—arterial configuration, at which position the
`vertical distance approximates CVP.
`
`(12) The '540 patent: US. Pat. No. 5,040,540,
`[0015]
`issued Aug. 20, 199] and titled "Method and Apparatus for
`Non-invasive Monitoring of Central Venous Pressure, and
`Improved Transducer Therefor,“ discloses an improved
`method and apparatus for measuring central venous pressure
`(CVP), and changes in CVP, along with an improved trans-
`ducer for measuring CVP in infants.
`
`(13) The ’935 patent: US. Pat. No. 5,159,935,
`[0016]
`issued Nov. 3, 1992 and titled “Non—invasive Estimation of
`Individual Lung Function," discloses a non-invasive method
`and apparatus for piethysrnographic monitoring individual
`lung function by disposing a transducer on the torso above
`the lung to be monitored, the transducer producing a signal
`
`corresponding to movement of the torso portion there
`beneath which,
`in turn, corresponds to changes in the
`volume of the underlying lung, and also a method and
`apparatus for monitoring regional lung volume changes by
`utilizing transducers positioned on the torso to encompass
`only a portion of the underlying lung.
`
`(14) The '151 patent: US. Pat. No. 5,178,151,
`[0017]
`issued Jan. 12, 1993 and titled “System for Non-invasive
`Detection of Changes of Cardiac Volumes and Aortic
`Pulses,” discloses a method and an apparatus therefor for
`monitoring cardiac function in an animal or human subject
`including the steps of placing a first movement detecting
`transducer on the torso, said transducer overlying at least
`part of two diametrically opposed borders of the heart or
`great vessels; generating a signal indicative of the movement
`of the torso portion subtended by the transducer, said signal
`including a cardiac component comprising at least a seg-
`mental ventricular volume waveform or a segmental aortic
`pressure pulse waveform and assessing cardiac function by
`monitoring changes in said ventricular volume waveform or
`said aortic pressure pulse waveform.
`
`(15} The '678 patent: US. Pat. No. 5,301,678,
`[0018]
`issued Apr. 12, 1994 and titled “Stretchabte Band-'I'ype
`Transducer Particularly Suited for Use with Respiration
`Monitoring Apparatus,“ an improved, low-cost stretchable
`band incorporating a conductor for disposition around the
`human torso or other three—dimensional object, and particu~
`larly intended for use with plethysmographic respiration
`monitoring apparatus, is disclosed.
`
`(to) The ’968 patent: US. Pat. No. 5,331,968,
`[0019]
`issued Jul. 26, 1994 and titled “Inductive Plethysmographic
`Transducers and Electronic Circuitry Therefor,” discloses an
`apparatus and method for improving the detection of the
`inductance “signal” generated by an inductive plethysmo-
`graph by modifying the design of the inductive plethysmo-
`graph and also by improving the design of the associated
`circuitry, both of which permit the associated circuitry may
`be located remotely rather than on the transducer.
`the
`improvement including selecting the impedance matching
`transformer joining an inductive plethysmograph to an oscil—
`lator such that
`the inductance of its primary winding is
`greater than about ten times the reflected inductance of the
`inductive plethysmograph and the cable joining it
`to the
`transformer, or circling the conductor of the inductive
`plethysmograph therein around the relevant body portion a
`plurality of times, or selecting the cable connecting the
`inductive plethysmograph to the transformer such that the
`ratio ofthe diameter of its screen to the diameter ofits center
`conductor is minimized for reducing the inductance per unit
`length thereof.
`
`(17) ’l‘ne ’425 patent: US. Pat. No. 5,588,425,
`[0020]
`issued Dec. 31, 1996 and titled “Method and Apparatus for
`Discriminating Between Valid and Artifactual Pulse Wave-
`forms in Pulse Oximetry," discloses a method and apparatus
`for use in pulse oximetry for discriminating between valid
`pulse waveforms, determined with a photoelectric plethys-
`mograph, from which arterial oxygen saturation levels are
`accepted, and artifactual pulse waveforms,
`from which
`saturation levels are rejected, according to whether the
`systolic upstroke time of each pulse waveform is within a
`predetermined range, it having been discovered that systolic
`upstroke times for valid pulse waveforms are in a consistent,
`
`13
`
`13
`
`

`

`US 2002/0032386 A1
`
`Mar. 14, 2002
`
`La.)
`
`narrow range which varies only slightly from subject to
`subject and which may be defined empirically for each
`subject or established by a default setting applicable to all
`subjects.
`
`preferred apparatus is a garment which, while including
`inductive plethysmographic and other physiologic sensors,
`is suflicienlly comfortable and unobtrusive to be worn for
`most activities of daily life.
`
`(18) The ’388 patent: US. Pat. No. 6,015,388.
`[0021]
`issued Jan. 18, 2000 and titled “Method for Analyzing
`Breath Waveforms as to Their Neuromuscular Respiratory
`Implications," discloses a method for measuring respiratory
`drive by determining a peak inspiratory flow and a peak
`inspiratory acceleration from a breath waveform derived
`from rib cage motion and abdominal motion measured by
`external respiratory measuring devices, such as those based
`on inductive plethysmography.
`the measured respiratory
`drive being usable to initiate inspiration by a mechanical
`ventilator and for determining an index describing a shape of
`the waveform for controlling a continuous positive air
`pressure (CPAP) device.
`
`(19) The ’203 patent: US Pat. No. 6,047,203,
`[0022]
`issued Apr. 4, 2000 and tilted “Physiologic Signs Feedback
`System," discloses a non—invasive physiologic signs moni—
`toring device which includes a garment,
`in a preferred
`embodiment, a shirt, with electrocardiogram electrodes and
`various inductive plethysmographic sensors sewn, embroi-
`dered, embedded, or otherwise attached to the garment with
`an adhesive, signals generated by the sensors being trans-
`mitted to a recordingfalarm device where they are logged
`and monitored for adverse or other preprogram med condifi
`tions, which is signaled by When an adverse condition or
`other preprogrammed condition occurs, a message is com—
`municated to the patient by either an audio message or a
`display. The recordingfalarm unit is also conneclabte to a
`remote receiving unit
`for monitoring by a health care
`professional or other machine.
`
`[0023] However, nowhere in the art of inductive plethys-
`mography are found teachings of practical and clIective
`apparatus for non-invasive, ambulatory monitoring, of pul-
`monary and cardiac parameters. Such practical and cfiective
`monitoring apparatus would be of great benefit by assisting
`the transfer of health care from traditional hospital—based
`care, which is administered by trained health care workers,
`to homevbased self care, which is administered by the
`individual patient during, if possible, the patient’s normal
`daily activities. This transfer in health care has been found
`socially desirable because it may reduce health care costs
`and may increase patient involvement in and commitment to
`their treatment plans. Non-invasive and ambulatory moni-
`toring apparatus may assist this transfer, because it elimi-
`nates the risks associated with invasive sensors placed
`within the body, such as inlravascular catheters, risks which
`are considerably heightened outside of the hospital.
`
`[0024] Citation or identification of any reference in this
`Section, including the patents listed above, or in any section
`of this application shall not be construed that such reference
`is available as prior art to the present invention.
`
`3. SUMMARY OF THE INVENTION
`
`[0025] The present invention has for its objects practical
`and effective apparatus for non—invasive and ambulatory
`monitoring of key pulmonary and cardiac parameters along
`with a system that may be used for interpretation and use of
`monitoring data to improve health care outcomes and to
`reduce health case costs.
`In preferred embodiments,
`the
`
`in a first embodiment, the present
`In more detail,
`[0026]
`invention includes a monitoring apparatus for non-inva-
`sively monitoring physiological parameters of an individual
`comprising: a monitoring garment comprising a shirt for the
`torso of the individual to be monitored, one or more induc-
`tive plethysmographic (IF) sensors, each [P sensor compris—
`ing an inductance sensor including at least one conductive
`loop arranged to closely encircle the torso, wherein the
`inductance of the conductive loop is responsive to the
`cross-sectional area of the torso enc10sed by the loop, a
`cardiac cycle sensor for generating signals responsive to
`occurrence ofcardiac ventricular contractions, a signal cable
`for carrying signals from the sensors, and a microprocessor
`unit comprising a micropmcessor for receiving signals from
`the signal cable and for recording digital data derived from
`all
`received signals in a
`removable computer-readable
`memory media.
`
`In first aspects of the lirst embodiment, the cardiac
`[0027]
`cycle sensor comprises at
`least one electrocardiogram
`(ECG) electrode attached to the individual to be monitored;
`the cardiac cycle sensor comprises at least one IP sensor
`closely fitting about the neck of the individual to be moni-
`tored, wherein signals the inductance of the 1? sensor is
`responsive to cardiac ventricular contractions because the
`cross-sectional area of the neck is responsive to carotid
`artery pulsations generated by cardiac ventricular contrac-
`tions and the inductance of the IP sensor is responsive to the
`cross-sectional area of the neck;
`the computer-readable
`medium comprises a magnetic disk; the computer—readable
`medium comprises a flash memory module (64 MB or
`more).
`
`the
`In second aspects of the first embodiment,
`[0028]
`monitoring garment further comprises a band for the neck of
`the individual to be monitored, and the IP sensors comprise
`a neck inductive piethysmographic sensor operatively
`arranged for generating signals responsive to jugular venous
`pulse. carotid arterial pulse, respiration-related inlra-pleural
`pressure changes. contraction of neck muscles, and swalv
`lowing deflections, and the signal cable further comprises an
`attachment to the conductive loop of the neck 1? sensor; the
`IP sensors comprise at least one abdominal IP sensor includ-
`ing one or more conductive loops and at least one rib cage
`IP sensor including one or more conductive loops opera-
`tively arranged for measuring breathing patterns of the
`patient;
`the IP sensors comprise at
`least one thoracic [P
`sensor including a two or more conductive loops operatively
`arranged for measuring ventricular stroke volume; the [1’
`sensors comprise at least one lower abdominal IP sensor
`operatively arranged for measuring inlra-lower-abdominal
`contractions and dilations; the IP sensors comprise at least
`one two hemithoracic Il’ sensors operatively arranged for
`measuring breathing and paradoxical motion between two
`hemithoraces of the patient.
`
`In third aspects, the first embodiment further com—
`[0029]
`prises one or more further sensors attached to the signal
`cable and selected from a group comprising a body position
`sensor for indicating a posture of the individual, a pulse
`oximeter for indicating arterial oxygenation saturation, and
`
`14
`
`14
`
`

`

`US 2002/0032386 A1
`
`Mar. 14, 2002
`
`a threat microphone for indicating talking and snoring; or at
`least two body position sensors, a first body position sensor
`mounted on the garment and a second body position sensor
`mounted on a thigh of the individual; and the IP inductive
`plethysmographic sensors are attached to the garment as an
`integral part of the garment via an attachment consisting of
`one of sewing, embroidering, embedding, weaving and
`printing the inductive plethysrnographic sensor into the
`garment; the microprocessor unit further comprises an audio
`device for generating audio indications to the individual
`being monitored; the microprocessor unit further comprises
`a display unit for displaying viewable messages to the
`individual being monitored; the microprocessor unit further
`comprises an input unit for the individual being monitored
`to input
`information or commands. to the microprocessor
`lll'lll.
`
`the
`In fourth aspects of the first embodiment,
`[0030]
`microprocessor unit Further comprises a memory accessible
`to the microprocessor, and wherein the memory comprises
`encoded software instructions for causing the microprocesn
`sor to read input data and to write output data derived from
`the input data in the removable computer—readable memory
`media;
`the memory further comprises encoded software
`instructions for causing the microprocessor to determine
`significant physiological events in the individual being
`monitored and to indicate audibly determined significant
`evean to the individual; the microprocessor unit comprises
`components for wirelessly transmitting determined events
`and the memory further comprises encoded software instruc-
`tions for causing the microprocessor to determine significant
`temporal physiological trends in the individual being moni-
`tored and to indicate audibly determined significant trends to
`the individual; the microprocessor unit comprises compo
`nents for wirelessly transmitting determined significant
`trends;
`the memory further comprises encoded software
`instructions for causing the microprocessor to compress data
`before writing to the removable computer-readable memory
`media.
`
`In fifth aspects of the first embodiment, the micro-
`[0031]
`processor u nit further comprises circuitry for deriving digital
`data from non—digital data received from the signal cable;
`the monitoring apparatus further comprises circuitry for
`generating a variable-frequency signal from each ll’ sensor,
`the generated frequency being responsive to the inductance
`of the conductive loop of the IP sensor, and wherein the
`microprocessor unit further comprises circuitry for deriving
`digital data from the generated variable-frequency signals.
`the digital data comprising encoding of the variable fre-
`quency of the signals with errors of 100 ppm or less.
`
`invention
`the present
`In a second embodiment,
`[0032]
`includes a monitoring apparatus for non-invasively moni-
`toring physiological parameters of an individual comprising:
`a monitoring garment comprising a shirt for the torso of the
`individual to be monitored, one or more inductive plethys-
`mographic (1P) sensors, each IP sensor comprising (i) a
`longitudinal band of elastic material attached to the garment
`for closely encircling the torso, (ii) an inductance sensor
`including at least one flexible conductive loop attached to
`the longitudinal band, wherein the inductance of the con—
`ductive loop is responsive to the cross-sectional area of the
`torso enclosed by the loop, and (iii) a tightening device for
`adjusting circumferential tightness of the IP sensor to sub-
`stantiaily prevent longitudinal movement of the IP sensor
`
`along the torso, and a microprocessor unit comprising a
`microprocessor for receiving signals from the IP sensors and
`for recording digital data derived from all received signals in
`a removable computer—readable memory media.
`
`In first aspects of the second lirst embodiment,
`[0033]
`longitudinal motion of each IP sensor is substantially pre-
`vented when the physiological parameters indicated by the
`inductance of the conductive loop of the sensor do not
`measurably change;
`the monitoring garment comprises
`excess fabric arranged to permit longitudinal stretching of
`the torso without applying force to the IP sensors sufficient
`to cause substantial
`longitudinal motion;
`longitudinal
`motion of each 11’ sensor is substantial
`if physiological
`parameters indicated by the inductance of the conductive
`loop of the sensor change as the monitoring garment is worn
`by the individual; the monitoring garment comprises fabric
`with sufficient longitudinal elasticity to permit longitudinal
`stretching of the torso without applying force to the [P
`sensors sufiicient to cause substantial longitudinal motion.
`
`In second aspects of the second embodiment, the
`[0034]
`tightening device comprises a cinch band and a gripping
`device for releasably gripping excess cinch hand under
`tension; the tightening device comprises a drawstring;
`
`the second embodiment, com-
`In third aspects,
`[0035]
`prises a cardiac timing sensor for generating signals responn
`sive to cardiac ventricular contractions, and wherein the
`microprocessor unit further records digital data derived from
`signals received from the cardiac timing sensor; or a signal
`cable for carrying signals from the sensors to the micropro-
`cessor unit.
`
`invention
`the present
`third embodiment,
`In a
`[0036]
`includes a monitoring apparatus for non-invasively moni-
`toring physiological parameters of an individual comprising:
`a monitoring garment comprising a shirt for the torso of the
`individual to be monitored and a longitudinal fastener for
`opening and closing the shirt, one or more inductive plethys-
`mographic (Il’) sensors, each IP sensor comprising an induc—
`tance sensor including at least one flexible conductive loop
`arranged to closely encircle the torso, wherein the induc~
`tance of the conductive loop is responsive to the crossn
`sectional area of the torso enclosed by the loop, a cardiac
`timing sensor for generating signals responsive to occurw
`rence of cardiac ventricular contractions, a signal cable for
`carrying signals from the sensors comprising at least one
`module, wherein the module is coupled to and electrically
`completes the conductive loops of the IP sensors, wherein
`termini of the conductive loops may be uncoupled from
`module, and wherein the module comprises circuitry for
`generating signals responsive to the IP sensors, and a micro»
`processor unit comprising a microprocessor for receiving
`signals from the signal cable and for recording digital data
`derived from all received signals in a removable computer-
`readabie memory media.
`
`In first aspects of the third embodiment, at least one
`[0037]
`IP sensor further comprises a tightening device for adjusting
`circumferential
`tightness of the l? sensor to substantially
`prevent longitudinal movement of the ll’ sensor along the
`torso, and wherein the tightening device can be arranged not
`to impede unfastening of the shirt; the conductive loops of
`the IP sensors and the module further comprise mating
`connectors so that the conductive loops may be connected
`and disconnected from the module; the signals generated by
`
`15
`
`15
`
`

`

`US 2002/0032386 A1
`
`Mar. 14, 2002
`
`the module in response to each 11’ sensor comprise digital
`data encoding the frequency of an oscillator responsive to
`the inductance of the conductive loop of the [1’ sensor, the
`frequency being encoded with errors of 100 (or 10) ppm or
`less;
`
`the
`In second aspects of the third embodiment,
`[0038]
`signals generated by the module in response to each lP
`sensor comprise signals of variable frequency. the frequency
`being responsive to the inductance of the conductive loop of
`the IP sensor;
`the microprocessor unit further comprises
`circuitry for deriving digital data from the variable-fre-
`quency signals generated from each IP sensor, the digital
`data comprising encoding of the variable frequency of the
`signals with errors of 100 ppm or less; the microproceSsor
`unit Further comprises multiplex circuitry for permitting
`single deriving circuitry to derive digital data from a plu-
`rality of variable-frequency signals.
`
`invention
`the present
`In a fourth embodiment,
`[0039]
`includes a monitoring apparatus for non—invasively moni—
`toring physiological parameters of an individual comprising:
`a monitoring garment comprising a shirt for the torso of the
`individual to be monitored, one or more inductive plethys-
`mographic (1P) sensors, each IP sensor comprising an induc-
`tance sensor including at least one flexible conductive loop
`arranged to closely encircle the torso, wherein the induc-
`tance of the conductive loop is responsive to the cross-
`sectional area of the torso enclosed by the loop, a cardiac
`timing sensor for generating signals responsive to occur—
`rence of cardiac ventricular contractions, a signal cable for
`carrying signals directly from the conductive loops of the 1P
`sensors and for carrying signals from the sensor, electronic
`circuitry comprising (i) a multiplexing switch for connecting
`the con