3,639,907
`(151
`United States Patent
`
` Greatbatch (45) Feb. 1, 1972
`
`
`[54]
`
`INTERROGATED TELEMETRY ALARM
`SYSTEM FOR PHYSIOLOGICAL
`MONITORING
`
`3,434,151
`
`3/1969 Baderetalw 346/33 ME
`
`Primary Examiner—Donald J. Yusko
`Attorney—Christel and Bean
`
`{72]
`Inventor: Wilson Greatbatch, Clarence, N.Y.
`ABSTRACT
`[57]
`_Inc.,
`{73] Assignee: Mennen-Greatbatch
`Electronic,
`Clarence, N.Y. Apparatus for monitoring fromasingle station a physiological
`
`;
`ayy,
`conditionof eachofa plurality of remotely located patients. A
`Sept. 2, 1969
`[22] Filed:
`radio transmitter at the station generates sequentially a plu-
`[21] Appl. No.: 854,582
`rality of tone signals, one for each patient and each ofa dif-
`ferent frequency, on a commoncarrier. A radio receiver with
`eachpatient has a bandpass correspondingto a particular one
`of the tone signals. Each receiver when addressed activates a
`radio transmitter with the patient for transmitting to a single
`receiver. at
`the station a coded signal
`indicative of the
`physiological state of the patient, derived from signal generat-
`ing means operatively connected to the patient. Thesignals
`received at the station are sequentially routed, decoded, and
`appliedto suitable indicators.
`4 Claims, 2 Drawing Figures
`
`.
`References Cited
`UNITED STATES PATENTS
`5/1966
` Vuilleumier etal. ..............340/183 X
`
`,
`
`Cr eoSeeeneeeegenteers340/150,346/33 METae!“9/00
`
`[58]
`Fie!d ofSearch... "340/150BLA83:346133 ME:
`128/2.1 A, 2.05R
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`[56}
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`CONTINUOUS
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`DECISION
`
`
`IPR2018-01093
`Apple Inc. Ex. 1007 Page 1
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`IPR2018-01093
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`PATENTED FB Ig 839gQ7-
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`INVENTOR.
`Unlson Greathatch
`BY
`
`Christel+ean
`
`ATTORNEYS.
`IPR2018-01093
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`IPR2018-01093
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`3,639,907
`
`1
`INTERROGATED TELEMETRY ALARM SYSTEM FOR
`PHYSIOLOGICAL MONITORING
`
`2
`BRIEF DESCRIPTION OF THE DRAWING FIGURES
`
`5
`
`FIG. 1 is a schematic block diagram of physiological moni-
`toring.-apparatus in accordance with the present invention;
`and
`FIG. 2.is.a schematic block diagram showing in more detail
`a portion of the apparatusofFIG.1.
`
`BACKGROUND. .OF THE INVENTION
`.
`.
`.
`Thepresentinvention relates to the telemetry art and, more
`particularly, to a system for monitoring the physiological con-
`DETAILED DESCRIPTION:OF THE ILLUSTRATED
`“dition ‘of eachof a large numberofpatients by the telemetry.
`EMBODIMENT
`Physiological monitoring of a large numberof: patients by 9
`‘automatic. means is becoming increasingly necessary. as
`in.a-preferred arrangementof physiological monitoring ap-
`shortages of hospital personnel increase and as hospital activi-
`-paratus constructed in accordancewith the presentinvention,
`‘-ties expand and become morehighly specialized. Upon leav-
`the-equipmentdesignated generally at 10 on the left hand side
`ing intensive care units, patients are in hospital areas which
`of FIG. Lis stationary, being in a fixed location relative to the
`often are relatively less rigidly observed, and in such areas au- 15 patients: being monitored. For convenience hereafter,
`the
`tomatic: physiologicat monitoring can reduce ‘the: mortality
`components.in this portion of the apparatuswill be designated
`rate from cardiac arrest and fibrillation. As. hospital care
`with the:term, station. The nurses’s station on a hospital floor
`progresses from its present state, additional intensive care
`or ‘the central monitoring station in an intensive care unit are
`units, each of a more specialized nature, are envisioned and 99 examplesof where station apparatus 10 can belocated.
`will augmentthe needfor automatic physiological monitoring.
`Station apparatus 10.comprises a radio transmitter 11 hav-
`‘Automatic physiological monitoring by telemetry has‘been
`ing.a radiating antenna .12 which transmitter functions,briefly,
`proposed and is particularly advantageous because of the
`to generate a radiofrequencysignal consisting of a plurality of
`‘ability to ‘continuously monitor an ambulatory patient.—coded-tones on a commoncarrier. There would be generated,
`Heretofore, the number of patients that could-be .accom-..5 -more specifically, a different tone or a combination of dif-
`' ferent tones:for each: patient, and the tones would be trans-
`‘modated economically by telemetry was limited to about 10
`patients due to equipment and frequency spectrum limita-
`mitted sequentially. A sequencing means 13suitable for this
`‘purpose is operatively connected through a'line 14 to trans-
`-tions. For example, there must be interference-free reception
`mitter 11. Station apparatus 10 further comprises a radio
`from-one patient about 200 feet from a receiving antenna and
`receiver..15 having a receiving antenna:16 which receiver
`delivering only 2 or 3 microvolts of signal to'the receiver, and
`functions; :briefly, to receive radiofrequencysignals on a dif-
`yet anotherpatient on an.adjacent telemetry channel and posi-
`ferent channelrelative to.that of transmitter 11. More specifi-
`tioned only about 10 feet from the same. antenna must ‘not
`cally, receiver-15 responds to-signals received from patients
`‘contribute any crosstalk. Otherwise, an alarm might: be
`being monitored whichsignals indicate the physiological con-
`received from the wrong patient. In addition, the channel
`dition of each patient: Receiver 15 is operatively connected
`‘separations must be unequalso as.to avoid unwanted modula-
`‘through a line 17-to a decoding circuit 18 which alsois opera-
`tion products from mixed.
`transmitter signals,:from mixed
`tively connected to sequencing means 13.through a line 19.
`receiver. local oscillators and from various1,F. signals traveling
`The..purpose of this arrangement
`is.
`to. route properly a
`through the system.
`received and decodedsignal to a particular one of a plurality
`SUMMARY OF THE INVENTION
`of indicators:20, one for each patient, which are connected to
`the output. of:decoder 18 through lines designated 21. Indica-
`It is, therefore, an object of this invention to :provide-ap-
`tors 20:preferably:are lamps or other visual devices whichtell
`paratus for continuously monitoring the physiological condi-
`the observer. immediately when a. particular patient is ex-
`tion:of each of a large number of.patients, such ‘as about’100,
`periencing a physiological disorder, as will. be described in
`‘moredetail hereafter.
`by: telemetry.
`“lt is‘a further object of this. invention .to provide such ap-
`The -physiological monitoring apparatus of the present in-
`paratus whichis readily usable with ambulatorypatients.
`vention. also ‘includes. components, designated 25,25’, 25",
`it is an:additional object:of this-invention to: provide such
`etc., in FIG..1, there being one componentor unit for each pa-
`‘apparatus which: providesa rapid'indication. of the type-of pa-
`tient, and the different units for different patients being distin-
`‘tient disordergiving ‘rise to.an-alarm,deferred-accessto:stored
`guished in'FIG. 1 by the useof primed designations. Each unit
`"physiological data, and continuous readoutof datafrom a:-pa-
`25.preferably is.of a size and construction readily adapted to
`‘tient in'alarm.
`be carried by an ambulatory: patient and for.this reason will be
`‘It is'a further object ofthepresent invention to:provide such
`referred to as being patient-carried. Each patient-carried. unit
`apparatus which can‘ monitor a:large numberof patients’ at a
`-includes,- briefly, a radio receiver, the antenna of -which is
`relatively:fast rate, for’example the total: number of patients
`‘designated 26 in FIG. 1, adapted to respond to a particular
`every 10 or 20 seconds.
`-one of the coded tones generated bytransmitter 11 at. station
`‘The ‘present
`invention”provides: physiological:monitoring
`‘J0.:Each.unit 25 further: includes.a radio. transmitter con-
`apparatus including a radio receiver with each patientcand
`nected: in. controlled relation to- the receiver. and ‘which func-
`connected in controlling relation to a corresponding: radio
`tions;..when:.activated,
`to.
`transmit. from..an..antenna:.27,
`transmitter with each patient, each receiver having a different
`radiofrequencysignals indicative of that patients’s physiol ogi-
`: frequency passband. The receivers are addressed sequentially
`cal. condition. These signals are received by receiver 15 at sta-
`-by-a radio transmitter. at a monitoring station whichgenerates
`tion.10..Eachunit’25. further. includes. input terminals 28, 29
`65°
`sequentially a corresponding:plurality of coded tones on a
`‘for.receiving electrical.
`.signals:.indicative of the. patient’s
`‘commoncarrier. Each receiver;-when addressed, activates the
`_aphysiological condition. For example,.when. the apparatus of
`‘-.the:present invention is.used to monitor the. cardiac behavior
`“transmitter which is controls which, in.turn,-transmits a coded
`of. each. of-a:number of-patients, input. terminals 28, 29 are
`»gignal indicative of the patient’s: physiological condition to a
`single radio receiver at the :monitoring:station: whereupon the
`. connected directly to the patient, being: placed in or on his
`70 ‘chest in a conventional manner, and the-voltages thereon in-
`signal is routed and decoded.
`..dicative of cardiac behavior are amplified and: processed by
`i The foregoing and-additional advantages and.characterizing
`additional. circuitry.
`in. component 25 as--will be. described
`features of the present invention‘ will become.clearly. apparent
`- hereafter: Alternatively, terminals 28,29 may be connected to
`tipon a reading of the’ensuing ‘detail description of-anillustra-
`.. the output of an-appropriate transducer operatively connected
`“tive embodiment together'with theincluded:drawing depicting
`‘the same.
`.to the patient.
`.
`
`30
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`35
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`40
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`45:
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`‘50
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`‘55
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`75
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`3,639,907
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`3
`FIG. 2 shows in more detail a preferred form of each pa-
`tient-carried unit 25 especially suitable for monitoring cardiac
`behavior. A radio receiver 30 is operatively connected to an-
`tenna 26 and has a particular frequency passband which per-
`mits reception of a particular one of the coded tones from sta-
`tion transmitter 11. Receiver 30 is connected through a line
`31 in controlling relation to a radio transmitter 32 which, in
`turn, is operatively connected to antenna 27. By virtue of this
`arrangement, receiver 30 when addressed by one ofthe coded
`tones from station transmitter 11 activates transmitter 32
`which, in turn, radiates from antenna 27a codedsignal indica-
`tive of that patient’s physiological condition, in this particular
`example a signal codedin terms of cardiac behavior.
`Transmitter 32 is provided with information concerning the
`patient’s cardiac behavior by the following arrangement. Input
`terminals 28, 29 are connected to the input of a preamplifier
`33 whichis designed to have an amplification factor of about
`1,000 when the apparatus is employed in cardiac monitoring.
`In this particular situation the signals on terminals 28, 29 in-
`dicative of the patient’s heartbeat will have an amplitude of
`only about 2-3 microvolts. The amplified signals appearing at
`the output of preamplifier 33 are applied through a line 34 to
`the input of a decision circuit 35, the purpose of whichis to
`determine whetherthe signals are indicative of normal or ab-
`normal physiological behavior. For example, in monitoring of
`cardiacactivity, the repetition rate of signals applied to circuit
`35 is the information parameter. Circuit 35, which can include
`standard frequency responsive and logic networks,in this par-
`ticular example makes a comparative determination as to
`whether the rate is normal, indicating that the cardiac condi-
`tion of the patientis satisfactory, too fast indicating tachycar-
`dia/fibrillation, or too slow indicating bradycardia/arrest. The
`frequency parameter on the inputsignal to circuit 35 can be
`converted therein to an amplitude or pulse width parameter
`on the output thereof. For example, circuit 35 can be con-
`structed to provide no output when the rate is normalbut to
`provide an output or alarm signal wheneither of the above-
`mentioned disorders is detected, the particular one being
`determined by output signal amplitude, duration or even.
`polarity.
`There is also included a commandcircuit 36, the input of
`which is connected througha line 37 to the output of decision
`circuit 35. The output of commandcircuit 36 is applied
`througha line 38 to a coding means39,operatively connected
`to transmitter 32 through a line 40. The purpose of command
`circuit 36 is to transform the signals received from decision
`circuit 35,
`indicative of the patient’s condition,
`into cor-
`responding signals which are suitable to command operation
`of coding means 39 to generate a coded signal corresponding
`to the particular condition of the patient. Coding means 39
`can have several known forms, depending upon the mannerin
`which the outputsignal of transmitter 32 is to be modulated in
`terms of information concerning the physiological condition
`of the patient. The signal from transmitter 32 can, for exam-
`ple, be a coded.tone in a one of three code indicating patient
`satisfactory, bradycardial/arrest alarm or tachycardia/arrest
`alarm. A fourth state might be addedto the codeindicating no
`signal from the transmitter so that the particular patient’s
`equipment can be repaired or replaced. Instead of coded
`tones, other types of modulation, for example pulse width,
`might be employed.
`It is apparent, therefore, that command circuit 36 can have
`several known forms depending upon the nature of coding
`means 39 and the typeof signals required to operateit. In cer-
`tain applications it also may be possible to incorporate the
`function of commandcircuit 36 into either or both of decision
`circuit 35 and coding means 39.
`The patient-carried apparatus 25 also includes a tape-loop
`recorder, designated generally at 45, for providing deferred
`access to stored physiological data, for example about 10
`minutes of recorded ECG activity. The output of preamplifier
`33 accordingly is connectedby lines 46 and 47 to a recording
`head 48 of tape recorder 45. Tape recorder 45 would be
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`placed in operation at the patient's location wheneverit is
`desired that recording begin. Preferably, alarm activation
`would stop the tape so as to store the previous ten minutes of
`data precedingthe event andto this end the outputofdecision
`circuit 35 is connected by a line 49 to a controlled tape drive
`means 50.
`The physiological monitoring apparatus of the present in-
`vention operatesin the following manner.It is, in effect, an in-
`terrogation system, and is somewhatsimilar to the IFF system
`(Identification, Friend or Foe) used in military aircraft. The
`patient-carried radio transmitters, such as transmitter 32,all
`operate at the same frequency but transmit only when inter-
`rogated.
`In monitoring of cardiac behavior,
`the response
`modulation can be one of four audio tones, one for “no
`alarm,” the second for ‘“‘bradycardia/arrest alarm,” the third
`for “tachycardia/fibrillation alarm,” and the fourth for “no
`signal alarm.”
`Station transmitter 11 together with the patient-carried
`receivers, one of whichis receiver 30, constitute an interroga-
`tor. Transmitter 11 operates on a frequency different from
`that on which patient-carried transmitters 32 operate so that
`the overall system uses only two radiofrequency channels. The
`coded tones provided by transmitter 11, one for each patient,
`aré generated sequentially under control of sequencer 13
`which in one form can be a two-gang stepping switch. One
`gang provides sequencing of code generation by transmitter
`11, represented schematically by line 14, and the other gang
`controls routing of signals from receiver 15 through decoder
`18 to the particular one of the patient indicator 20. Since only
`a toneis elicited from each patient transmitter 32 in response
`to interrogation, i.e., the corresponding patient receiver 30
`being addressed by the particular coded tone from transmitter
`11, the patient scanningrateis very fast, sampling 100 patients
`every 10 or 20 seconds.
`Theinterrogator portion of the apparatus of the presentin-
`vention can comprise one of several interrogation systems
`commercially available, modified so as to be coded with
`respect to the patients being monitored. One is an induction
`coupled, low frequency variety wherein station antenna 12
`would comprise a wire surrounding the patients being moni-
`tored and antennae 26, 26’, etc., each with a particular pa-
`tient, would be induction-coupled to the wire in a manner
`similar to the coupling between transformer secondary and
`primary coils. A second variety is of the radiofrequency type,
`operating in the range of about 27 to about 54 megacycles,
`andincluding vibrating needs in the receivers for decoding.
`Decoder18 at the monitoring station 10 wouldincludestan-
`dard radio receiver detector circuitry, the exact nature de-
`pending uponthe type of modulation employedin the patient
`transmitters 32. It is contemplated that the speed of operation
`of sequencer 13 in relation to the time needed for a radio
`signal to travel from station 10 and for a response signal to
`return is such that one responsesignal will be properly routed
`to a patient indicator 20 before sequencer 13 advancesto the
`next step for generation of the next coded tonein transmitter
`11. The output of decoder 18, routed to the particularline 21,
`could be one ofthree voltage levels depending upon the na-
`ture of the alarm received. Each indicator 20 could include
`three lampsdifferentiated by color or by indicia according to
`the nature of the alarm, and there would be included also
`suitable voltage level responsive circuitry for energizing the
`lamps.
`transmitters 32
`The alarm signals generated by patient
`rather than being coded tones could be microsecond duration
`pulses. In this case, three radio receivers instead of a single-
`station receiver 15, could be employed to locate the particular
`patient by vector resolution techniques. Such techniques are
`well known, for example Loran, andin this particular situation
`three receivers measure the time difference in arrival of a
`signal from a single transmitter (patient transmitter 32) rather
`than three transmitters sending signals to a single receiver
`whichis the usual case.
`
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`3,639,907
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`6
`controlledrelation to said receiver;
`c. a signal producing means adapted to be operatively con-
`nected to each patient for providing electrical signals hav-
`ing a parameter which varies in accordance with changes
`in a physiological characteristic of the particular patient,
`d. decision circuit means with each patient and having an
`input coupled to the output of said signal producing
`means, said decision circuit means comparing the varia-
`tions in said parameter with a predetermined normal
`value and providing an outputalarm signal in response to
`abnormalvariations in said parameter;
`e. coding means with each patient coupled to said decision
`circuit means and to said transmitter whereby the
`radiofrequency signal generated by each transmitter is
`coded in terms of the alarm state of the physiological
`characteristic of the particular patient;
`f. a radio transmitter at said station for generating sequen-
`tially a plurality of signals, the number being equalto the
`total number of patients being monitored and the
`frequency of each one corresponding to a particular pass-
`band of one of said receivers whereby said transmitter
`with each patientis periodically interrogated;
`g. a radio receiverat said station for receiving signals from
`said transmitter with each patient,
`h. decoding means connected to the outputofsaid station
`receiver and operative sequentially in synchronism with
`said station transmitter for decoding the physiological
`state signal from each patient; and
`i. a plurality of indicating means, one for each patient,
`operatively connected to said decoding means.
`2. Apparatus as defined in claim 1 wherein each signal
`producing means comprises:
`a. an input terminal adapted to be operatively connected to
`the particularpatient for sensing electrical signals indica-
`tive of cardiac behavior; and
`b. an amplifier having an input connected to said terminal
`and an output; and
`c. decision circuit means having an input connected to the
`outputofsaid amplifier, and wherein said decision circuit
`provides
`output alarm signals in response to an abnormalrate of
`signals applied to the input thereof.
`3. Apparatus as defined in claim 2 further including mag-
`netic tape recording means, the recording element of which is
`connectedto the outputof said amplifier and the drive means
`of which is connected in controlled relation to the output of
`said decision circuit for stopping said tape recording meansin
`responseto an alarm signal.
`4. Apparatus as defined in claim 2 further including means
`connectedin controlled relation to the outputof said decision
`circuit for coupling the output of said amplifier directly to said
`patient transmitter in response to an alarmsignal.
`*
`*
`*
`*
`*
`
`5
`The apparatus of the present invention advantageously pro-
`vides continuous monitoring of a large number, for example
`about 100, ambulatory patients. Monitoring is done at an ex-
`tremely fast rate, such as the total numberofpatients every 10
`or 20 seconds. Moreover, the patient-carried transmitters 32
`operate only upon interrogation,
`in a time-sharing mode,
`thereby reducing battery drain and permitting less frequent
`battery replacement. All patient transmitters are identical
`units and only the coding elementsin the patient receivers 30
`are different so transmitter construction and tuning is ad-
`vantageously quite simple.
`The apparatus of the present invention can include an addi-
`tional arrangement wherebyin response to the occurrence of
`an alarm, a continuous readoutofthe patient’s ECG signal au-
`tomatically is transmitted to the station. To this end line 46, on
`which the ECGsignalis available from the output of preampli-
`fier 33, is connected by a line 55 to the input of a component
`designated 56 in FIG. 2 for controlling the operation of trans-
`mitter 32 in this continuous readout mode. Component56is
`to operate only in response to the occurrence of an alarm
`signal. provided by decision circuit 35, and for this reason
`component 56 is connected in controlled relation through a
`line $7 and line 49 to the outputof decision circuit 35. Circuit
`56 is connected bya line 58 to transmitter 32 whereby the car-
`rier thereof is modulated with the patient’s ECG signal. Cir-
`cuit 56 in addition would be constructed to provide an addi-
`tional tone which when transmitted to station 10 would stop
`sequencing of transmitter 11 and hold it on the particular
`channel where the alarm had been received. To this end a
`frequency-responsive circuit, designated 60 in FIG. 1, is con-
`nected to the output of receiver 15 by a line 61 and adapted to
`respond to this particular tone. Circuit 60,
`in turn, is con-
`nected to sequencing means 13 by a line 62 to command
`stopping thereof.
`The receiver 15 at station 10 then would receive continuous
`ECGdata from the patient and would ignoreall other patients
`on the system until that particular patient’s transmitter had
`been cleared whereupon the system would again start
`sequencing throughthe total numberof patients. Readout and
`possibly also storage of the particular patient’s continuous
`ECG signal
`is performed by conventional
`equipment,
`designated 65, connected to the outputof receiver 15.
`It is therefore apparent that the present invention accom-
`plishes its intended objects. While a single specific embodi-
`ment thereof has been described in detail, this is done for the
`purposeofillustration without thoughtoflimitation.
`Iclaim:
`1. Apparatus for monitoring from a single station a
`physiological condition of each of a plurality of remotely
`located patients comprising:
`a. a radio receiver with each patient and each receiver hav-
`ing a different frequency passband,
`b. a radio transmitter with each patient and connected in
`
`5
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`20
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`25
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`30
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`35
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`45
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`50
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