United States Patent [19] &
`Edwards
`
`[11] Patent Number:
`[45]. Date of Patent:
`
`4,945,477
`Jul. 31, 1990
`
`[54] MEDICAL INFORMATION SYSTEM
`[75] Inventor: D. Craig Edwards, Bellevue, Wash.
`[73] Assignee: First Medic, Bellevue, Wash. -
`[21] Appl. No.: 111,985
`[22] Filed:
`Oct. 22, 1987
`[51] Int. Cl* ............................................... A61N 1/36
`[52] U.S. Cl. ...............
`... 364/413,06; 128/419 D
`[58] Field of Search ........................... 364/415, 413.06;
`128/702, 705, 692, 419 D, 419 S
`References Cited
`U.S. PATENT DOCUMENTS
`4,216,462 8/1980 McGrath et al. ................... 364/415
`4,295,474 10/1981 Fischell ............................... 128/692
`4,417,306 11/1983 Citron et al. ........................ 128/702
`4,506,677 3/1985 Lambert .............................. 128/692
`4,576,170 3/1986 Bradley et al. ................. 128/419 D
`4,610,254 9/1986 Morgen et al. ................. 128/419 D
`
`[56]
`
`
`
`4,614,192 9/1986 Imran et al. .................... 128/419 D
`4,622,979 11/1986. Katchis et al.
`... 128/702
`4,785,812 11/1988 Phil et al. .....
`... 128/696
`4,800,883 1/1989 Winstrom ....................... 128/419 D
`FOREIGN PATENT DOCUMENTS
`8202836 9/1982 PCT Int’l Appl. ............. 128/419 D
`Primary Examiner—Jerry Smith
`Assistant Examiner—Kim Thanh T. Bui
`Attorney, Agent, or Firm—Seed and Berry
`[57]
`ABSTRACT
`A medical information system. Data from electrodes are
`digitized and received by a microprocessor which
`causes them to be stored in a memory in accordance
`with a predetermined priority scheme. The data stored
`in the memory means can be read out to a monitor, a
`printer, or another computer for further processing.
`
`16 Claims, 8 Drawing Sheets
`
`
`
`; to
`Take & Seconds
`of Data
`
`Sample pata
`from Añº
`Convertar
`
`S?ors ?ata sample
`in Non-Volatile
`Memory
`
`FITBIT, INC. v. LOGANTREE LP
`Ex. 1014 / Page 1 of 14
`
`

`
`%323$
`
`£.=So>I202Iucmmouoaaouuxfi..mtnm~.v_.w.oU
`
`
`
`
`
`U.S. Patent
`
`3
`
`$38:
`
`.w.mmcmt
`JEmEm§mmmE
`
`>mEm.5QUENEQQE:
`
`9
`
`0£020
`9mE.:.I~m.mt
`
`NN
`
`usQ_
`
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIL.1
`
`1...
`
`4_____________
`
`4,945,477
`
`1tw
`
`00>.3EmE
`
`_3:9...
`
`Ex.1014/Page2 0f14
`
`Ex. 1014 / Page 2 of 14
`
`
`
`
`
`

`
`U.S. Patent
`
`Jul. 31, 1990
`
`Sheet 2 of 8
`
`4,945,477
`
`88
`
`J??ulud
`
`99
`
`| ---- |
`
`z 0 Inôl-I
`
`
`
`
`
`Ex. 1014 / Page 3 of 14
`
`

`
`U.S. Patent Jul. 31, 1990
`
`Sheet 3 of 8
`
`4,945,477
`
`RUN REPORT
`HEARTSTART 2000
`REPORT DATE_1__
`TECHNICANS
`
`. . 11 FEB 87
`EPISODE DATE . . . .
`EPISODE DATE . . . . . 17:44 : 19
`SELF CHECK .
`.
`. . .
`.
`. . . . . OK
`CONFIGURATION .
`. .
`. SEMI-AUTO
`
`PART NUMBER . . . . . . 900050
`SERIAL NUMBER . . .
`.
`. 000447
`SOFTWARE VERSION . . .
`. . 10
`MCU S.W. VERSION . . . . .
`.
`. 4
`
`\ 50
`
`-
`
`52
`A
`
`EVENT LOG:
`--------- DATE: 11 FEB 87
`17:44: 19 UNIT ON
`17:44:22 UNIT OFF
`17 : 44; 26 UNIT ON
`17:44: 35 "CHECK PATIENT." MESSAGE GIVEN - TREATABLE RHYTHM DETECTED
`17:44: 36 START ANALYSIS
`17 : 44; 40 START CHARGING
`17:44 : 43 COMMIT TO TREAT
`17:44: 48 READY TO SHOCK
`17:44: 50 SHOCK NUMBER 1 DELIVERED, 200 JOULES
`17:44: 59 START ANALYSIS
`17:45 : 06 SHOCK NOT INDICATED
`17:45 : 21 "CHECK PATIENT." MESSAGE GIVEN - TREATABLE RHYTHM DETECTED
`17:45 : 24 START ANALYSIS
`17:45 : 28 START CHARGING
`17:45 : 31 COMMIT TO TREAT
`17:45 : 36 READY TO SHOCK
`17:45 : 37 SHOCK NUMBER 2 DELIVERED, 200 JOULES
`17:45 : 46 START ANALYSIS
`17:45 : 50 START CHARGING
`17:45 : 53 COMMIT TO TREAT
`17:46: 06 READY TO SHOCK
`17:46:09 SHOCK NUMBER 3 DELIVERED, 360 JOULES
`17 : 46 : 22 "CHECK PATIENT." MESSAGE GIVEN - TREATABLE RHYTHM DETECTED
`17 : 46 : 26 START ANALYSIS
`17:46 : 33 SHOCK NOT INDICATED
`17:46:33 UNIT OFF
`
`SER. N.O. 000447 EPISODE DATE: 11 FEB 87 TIME: 17:44: 19 PAGE 1
`
`Figure 3A
`
`Ex. 1014 / Page 4 of 14
`
`

`
`U.S. Patent Jul. 31, 1990
`RECORDED ECG DATA:
`62
`17:44:26’
`
`Sheet 4 of 8
`
`4,945,477
`
`62
`17:44:29°
`
`
`
`
`
`Presenting Rhythm-64
`17:44: 32^- 62
`
`53
`
`17:44: 35 - 62
`
`54
`
`• - - - -
`
`: - - -
`
`: - - -
`
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`
`55
`
`17:44: 38-62
`
`Start Analysis-66
`56
`17:44: 41"> 62
`
`
`
`
`
`17:44: 44°N-62
`
`
`
`57 Start º 68
`Charging
`
`58
`
`Commit -- 70
`to Treat
`
`59
`
`SER. NO. 000447 EPISODE DATE: 11 FEB 87 TIME: 17:44: 19 PAGE 2
`Figure 3B
`
`Ex. 1014 / Page 5 of 14
`
`

`
`U.S. Patent Jul. 31, w Sheet 5 of 8
`SHOCK NUMBER 1 DATA
`TIME DELIVERED .
`. .
`. . 17:44: 50
`ENERGY DELIVERED . . 200 JOULES
`
`BATTERY . . . . . GOOD
`IMPEDANCE . . 52 OHMS
`
`4,945,477
`
`17:44: 52
`
`17:44: 55
`
`• * * * * * * *w -- * * * *
`
`,-- - - r - - -
`
`* * *
`
`-------
`
`17:44: 58
`
`17:45 : 01
`
`Star Analysis -
`
`17:45 : 22
`
`17:45 : 25
`
`
`
`
`
`17:45 : 28
`
`Start Analysis
`17:45 : 31
`
`
`
`
`
`Start Charging
`
`Commit to Treat
`
`SER. N.O. 000447 EPISODE DATE: 11 FEB 87 TIME: 17:44: 19 PAGE 3
`-
`Figure 3C
`
`Ex. 1014 / Page 6 of 14
`
`

`
`U.S. Patent Jul. 31, 1990
`
`Sheet 6 of 8
`
`4,945,477
`
`SHOCK NUMBER 2 DATA
`TIME DELIVERED .
`. . . . 17:45 : 37
`ENERGY DELIVERED . . 200 JOULES
`
`BATTERY . . . . . GOOD
`|MPEDANCE . . 52 OHMS
`
`17:45 : 40
`
`17:45 : 43
`
`17:45 : 46
`
`17:45 : 49
`
`
`
`
`
`Start Analysis
`17:45 : 52
`
`Start Charging
`17:45 : 55
`
`
`
`
`
`Commit to Treat
`17:45 : 58
`
`17:46:01
`
`SER. N.O. 000447 EPISODE DATE: 11 FEB 87 TIME: 17:44: 19 PAGE 4
`Figure 3D
`
`Ex. 1014 / Page 7 of 14
`
`

`
`U.S. Patent Jul. 31, 1990
`
`Sheet 7 of 8
`
`4,945,477
`
`SHOCKNUMBER 3 DATA
`BATTERY . . . . . GOOD
`TIME DELIVERED . . . .
`. 17:46: 09
`IMPEDANCE . . 54 OHMS
`ENERGY DELIVERED . . 360 JOULES
`17:46: 12
`17:46: 15
`
`• * : * * * * * * *, * - - - - - - - - - - -, - - - - - - - - : * * * * * * * *, * * * : - - - - - - - - - - - - - - - - * * * * *... • * *
`
`17 : 46 : 18
`
`17:46:21
`
`• * ~ :- - -
`
`: - -
`
`* - - -
`
`• * : - - - - - - - - - -
`
`• -: * * * *
`
`17:46:24
`
`
`
`17:46:27.
`
`* * * * * * * * * * *
`
`Start
`Analysis
`
`END REPORT -- MEDICAL CONTROL MODULE READY FOR REUSE
`
`SER. NO. 000447 EPISODE DATE: 11 FEB 87 TIME: 17:44: 19 PAGE 5
`Figure 3E
`
`Ex. 1014 / Page 8 of 14
`
`

`
`U.S. Patent Jul. 31, 1990
`
`Sheet 8 of 8
`
`4,945,477
`
`
`
`C
`
`
`
`
`
`
`
`Figure 4
`
`First
`9 seconds
`
`P raߧhas
`of Data
`
`134
`
`Store
`Annotation
`
`120
`
`
`
`122
`
`N
`
`Monitor N
`Mode
`2
`
`y
`
`C
`Sample Data
`from A/D
`Converter
`
`Store Data Sample
`in Non–Volatile
`Memory
`
`Any
`Annotations
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Establish
`Priority of
`Episode
`
`
`
`Erase Oldest
`Episode of
`Lower Priority,
`if Any
`
`Ex. 1014 / Page 9 of 14
`
`

`
`º
`
`1
`
`MEDICAL INFORMATION SYSTEM
`
`TECHNICAL FIELD
`This invention relates to a system for gathering and
`presenting information pertaining to a medical event,
`and more particularly, to a system for gathering and
`presenting information pertaining to an out-of-hospital
`cardiac medical emergency to concerned medical pro
`fessionals.
`
`10
`
`15
`
`30
`
`4,945,477
`2
`the important and interesting portions of the recorded
`EKG signal. Unfortunately, this method requires a sig
`nificant amount of a physician's time and effort to sort
`out the information to determine the care given to the
`patient.
`DISCLOSURE OF THE INVENTION
`It is an object of the present invention to provide a
`medical information system capable of automatically
`preparing a report of a patient’s medical state in an
`out-of-hospital situation.
`It is another object of the present invention to pro
`vide a medical information system capable of storing
`information related to a medical emergency.
`It is still another object of the present invention to
`provide a medical information system capable of simul
`taneously recording both a signal representative of a
`patient’s medical state and notations of the treatment
`provided to the patient.
`Yet another object of the present invention is to pro
`vide a medical information system that can record rele
`vant medical information and later provide a human
`readable report of that stored medical information.
`These and other objects are provided by the medical
`information retrieval system of the present invention,
`which is used for receiving, compiling, and storing data
`relating to the medical state of a patient. The medical
`information system comprises means for producing a
`signal indicative of the patient’s medical state, memory
`means for storing data, and an elapsed-time clock for
`measuring time elapsed since the receipt of a start sig
`nal. In addition, the medical information system com
`prises a microprocessor connected to the means for
`producing the patient’s medical state signal, the mem
`ory means, and the elapsed-time clock, and adapted to
`receive and sample the medical state signal and generate
`a start signal in response to one or more first predeter
`mined conditions in the sampled medical state signal.
`The microprocessor is further adapted to store samples
`of the medical state signal and the respective elapsed
`times of occurrence in the memory means in response to
`one or more second predetermined conditions in the
`sampled medical state signal. The samples are stored in
`accordance with a predetermined priority scheme. In a
`further embodiment, the medical information system
`can comprise means for producing a human-readable
`output from the stored data.
`In yet another embodiment, a medical information
`system can further comprise means for entering com
`mands to the microprocessor, the commands being
`stored in the memory means as an activity record. The
`medical information system can record and report epi
`sode data, relating an event to its actual time of occur
`rence. Finally, the medical information system can in
`clude means for receiving the memory into which the
`data have been stored and reading out the data in a
`human-readable form.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a block diagram of a medical information
`system adapted to receive and store medical state sig
`nals and activity records in conjunction with a medical
`emergency;
`FIG. 2 is a block diagram of an apparatus for receiv
`ing a memory in which has been stored a medical state
`signal and activity record data and for providing a hu
`man-readable record therefrom;
`
`BACKGROUND ART
`In the past, information concerning medical emergen
`cies has been gathered in a variety of ways. Usually, a
`written report is completed by the technical personnel
`involved. This report is based on details concerning the
`sequence of events and the patient condition and
`progress from the time of arrival of the personnel until
`the patient’s arrival at the hospital. It is also based on
`other information pertinent to this out-of-hospital event,
`20
`including electronic signals indicative of the patient's
`medical state. Naturally, during the medical emergency,
`it is difficult to write down any relevant information
`that is not recorded. This means that much of the infor
`mation needed to complete a report about the emer
`25
`gency must be recalled by the personnel involved in the
`emergency. In addition, any information that is re
`corded, for example, on a paper strip chart recorder,
`must be fully reviewed to be edited for the significant
`events and be correlated with non-recorded procedures
`applied to the patient.
`Typically, the medical training of the personnel who
`treat the patient and report on the treatment ranges
`between 100 and 2000 hours. This represents a wide
`variety of skill in treatment and in the gathering of
`35
`information, which can lead to inconsistent reporting of
`the medical emergency.
`After the patient and attending technicians arrive at
`the hospital, the receiving physician often requires ac
`curate information about the patient’s condition as soon
`as possible. This need for information is particularly
`important in a cardiac emergency, where proper care
`must often be provided very quickly and where treat
`ments such as defibrillation are often administered dur
`ing the trip to the hospital.
`45
`In addition to these considerations, there are often
`legal requirements for providing reports concerning the
`medical emergency. The attending technician is usually
`allowed to practice certain medical procedures based
`on state laws and under standing orders from a physi
`cian who is responsible for medical control. Thus, in
`order to provide for acceptable medical control, the
`responsible physician must review the medical emer
`gency in detail. This typically requires the physician to
`review the written reports, the patient’s records, and
`other sources of information. Often the physician will
`find it necessary to interview the technician and/or
`other personnel to obtain an accurate understanding of
`the care provided to the patient.
`One common method for gathering information and
`generating such reports is by using a tape recorder.
`Typically, such a tape recorder is attached to a piece of
`equipment that is used in the emergency, and pertinent
`information is recorded. In a cardiac emergency, the
`tape recorder can be attached to the defibrillator or a
`65
`monitor and both the electrocardiogram (EKG), signal
`and the technician's voice recorded. The physician can
`then listen to the voices on the tape and make copies of
`
`50
`
`55
`
`60
`
`Ex. 1014 / Page 10 of 14
`
`

`
`10
`
`15
`
`25
`
`e
`4,945,477
`3
`FIGS. 3A-3E are representative samples of an output
`produced by a human-readable output device; and
`FIG. 4 is a flow chart of a computer program which
`controls the storage of samples of medical state signals
`and related annotations by the system of FIG. 1.
`BEST MODE FOR CARRYING OUT THE
`INVENTION
`The medical information system of the present inven
`tion can be operated in conjunction with a defibrillation
`unit of the type described in co-pending U.S. patent
`application Ser. No. 935,248, assigned to the assignee of
`the present application. The defibrillation unit, which
`can operate in manual, semiautomatic or automatic
`modes, is capable of interacting with the medical infor
`mation system. The system components in FIG. 1 that
`are used only with the defibrillation unit are contained
`in the area designated by reference numeral 6. These
`components are message display 7, impedance measure
`ment unit 8, analog-to-digital (A/D) converter 9, and
`20
`defibrillator 10. Microprocessor 11, used with both the
`defibrillation unit and medical information system 12,
`generates signals that tell whether the defibrillation unit
`is in its ANALYZE mode or its MONITOR mode,
`whether the defibrillation unit is prepared to administer
`a shock, and what the values of various parameters are
`(for example, the recommended energy level of a shock
`to be administered). The defibrillation unit accepts con
`trol signals from medical information system 12, such as
`commands to enter either the ANALYZE mode or the
`30
`MONITOR mode, and what level of shock should be
`administered, and when to administer the shock.
`It will be understood by those skilled in the art that
`the present medical information system can, with ap
`propriate modifications to its software, interact with
`35
`medical signal sources (other than a defibrillation unit)
`that indicate a particular medical state.
`A patient 13, who may be experiencing a medical
`emergency related, for example, to a cardiac condition,
`is being monitored by conventional electrocardiograph
`(EKG) electrodes 14. The electrical signal produced by
`the EKG electrodes 14 is received by preamplifier 15
`over cable 16. Preamplifier 15 amplifies the low-level
`analog signal on cable 16 to a level that can be displayed
`on a monitor 17 along with alphanumeric symbols that
`can, for example, specify the measurement conditions.
`The signal from the preamplifier 15 is also received by
`an analog-to-digital (A/D) converter 18, which forms
`digital samples of the amplified signal relating to the
`medical state of patient 13. This digitized signal is sent
`to microprocessor 11, which operates according to a
`program contained in a read-only memory (ROM) 19.
`The program controls the interactions between the
`medical information system and the defibrillation unit.
`Additional traces showing the operation of the defibril
`lator are illustrated in FIGS. 3C-E.
`Microprocessor 11 can also receive signals from con
`trols 20. Controls 20 are activated by an operator in
`order to cause certain operations to occur within the
`medical information system or certain data to be stored.
`Among the signals that can be activated from controls
`20 (containing, for example, a membrane keyboard) are
`ANALYZE and MONITOR signals. The ANALYZE
`signal is generated if the ANALYZE button on controls
`20 is pressed. If the ANALYZE button is not pressed,
`then the MONITOR signal is generated. These signals
`cause the defibrillator to enter a corresponding mode.
`Controls 20 also contain an ENERGY SELECT button
`
`4
`for choosing the energy level of the shock to be admin
`istered to the patient, a SHOCK button for causing
`microprocessor 11 to enable defibrillator 10 to adminis
`ter the shock to patient 13, and possibly a keyboard or
`bar code input device for inputting information relating
`to the patient, such as the patient’s name, address, age,
`special medical conditions, etc. In addition, micro
`processor 11 receives a signal from real-time clock 21.
`The real-time clock signal can comprise digital data to
`be stored with digitized samples of the patient's medical
`state signal in a memory 22, such as a nonvolatile, ran
`dom access memory (RAM).
`A/D converter 18 can be caused to produce samples
`every ten milliseconds for a period of three seconds.
`This produces 300 digital samples that can be stored in
`non-volatile RAM 22, under the control of micro
`processor 11. The medical state signal can be an EKG
`signal.
`Memory 22 can be caused to store up to 50 three
`second segments of medical state sample data (i.e.,
`15,000 individual signal samples). In addition, memory
`22 can be caused to receive and store data relating to
`any activation of controls 20, data from additional sen
`sors, such as battery voltage sensors, and data relating
`to individual episodes, such as their real time of occur
`rence.
`After microprocessor 11 has stored 50 episodes (i.e.,
`150 seconds) of EKG samples in memory 22, the micro
`processor institutes a priority scheme, by which it deter
`mines which episodes of EKG data will be retained in
`memory 22. The data with the lowest priority are over
`written in the memory by new, higher priority data.
`The data given the highest priority are the presenting
`rhythm (i.e., the first nine seconds after the medical
`information system has been turned on and the impe
`dance of electrodes 14 determined to be acceptable).
`The data given the second highest priority in storage
`are the EKG samples taken around the first defibrilla
`tion shock. All three-second EKG segments from the
`time that the ANALYZE button in controls 20 is
`pressed until fifteen seconds after the defibrillation pulse
`is delivered will be stored.
`Third priority is given to EKG samples taken around
`the last occurring defibrillation shock. In this case, all
`three-second EKG segments between the time of acti
`vation of the ANALYZE button in controls 20 are
`stored until fifteen seconds after the last defibrillation
`pulse is delivered are also stored.
`Fourth priority is given to EKG samples taken
`around the second defibrillation shock, then those
`around the third defibrillation shock, and so forth.
`These stored three-second EKG segments include those
`from the time the ANALYZE button in controls 20 is
`pressed until fifteen seconds after the defibrillation pulse
`is delivered.
`The fifth priority for storage in memory 22 is given to
`the three-second intervals following activation of the
`ANALYZE switch in controls 20 that did not result in
`a shock being delivered to patient 13.
`Last priority for data stored in memory 22 is given to
`six-second samples taken once each minute while the
`medical information system is in the MONITOR mode.
`In addition to the medical information signal data
`stored in connection with each signal segment, other
`data stored are episode annotations, such as the time and
`date that the episode started, identification of the pres
`enting rhythm (in the case that the signal is an EKG),
`and the unit serial number. Also stored with the EKG
`
`45
`
`50
`
`55
`
`65
`
`Ex. 1014 / Page 11 of 14
`
`

`
`4,945,477
`6
`5
`Segment data are activity record annotations, such as
`sis represented by the first three EKG segments, the
`times of occurrence (to the nearest second) of pressing
`data collected are analyzed and a decision to recom
`the ANALYZE button, the ENERGY SELECT but
`mend that a shock be applied is made immediately after.
`ton, or the SHOCK button of controls 20. Other data
`the EKG segment 58. This time is indicated by activity
`that are recorded are the inter-electrode impedance just
`record 70—“Commit.”
`prior to defibrillation, the energy value of the shock to
`In a semiautomatic defibrillation unit, the next event
`be delivered, the time at which the MONITOR mode
`is to prompt the unit's operator to depress the
`was entered, and the reason why. Further data stored in
`“SHOCK” button in the controls 20 to administer the
`an activity record are summaries of the analyses done
`shock to the patient 10. The time when the SHOCK
`while the medical information system is in the MONI
`10
`button is pressed is indicated by “Event Record” (FIG.
`TOR and ANALYZE modes. Data from the MONI
`3A). The resulting effect on the EKG signal can readily
`TOR mode include the number of analyses that resulted
`be seen by reference to EKG segment 59. As also indi
`in shock, non-shock, or noise.
`cated by Event Record 52, the operator has pressed the
`After appropriate EKG sample data, support data,
`ANALYZE button immediately after the shock is ad
`and annotations have been stored in memory 22 by the
`ministered (see EKG segment 58 in FIG. 3B). Nine
`apparatus of FIG. 1, memory 22 can be removed from
`seconds later, the analysis has determined that a shock
`that apparatus and connected to the apparatus shown in
`to the patient is not indicated and the defibrillator enters
`FIG. 2. Memory 22 connects to a second microproces
`the MONITOR mode. This is designated by annotation
`Sor 30, which is operating according to a program
`record 76.
`stored in second ROM 32. Data are read from memory
`20
`The human-readable report of FIG. 3 contains a sum
`22 and converted to a form appropriate for display by
`mary of shock data relating to the first episode. The
`microprocessor 30, which transmits the resulting digital
`summary is designated by numeral 78, and summarizes
`data to digital-to-analog (D/A) converter 34. D/A
`information relating to the conditions under which the
`converter 34 produces an analog signal that can be sent
`shock is administered.
`to a viewable terminal device, such as a monitor 36.
`25
`The shock data are followed by monitor mode data,
`Microprocessor 30 can also be caused, by activation of
`designated by numeral 80. These data are a summary of
`appropriate buttons in controls 38, to transmit data
`the indications provided by the medical information
`representing the data stored in memory 28 to printer 40.
`system while it is in the MONITOR mode.
`Alternatively, by depressing an appropriate button in
`FIG. 3C shows a later sequence of EKG segments,
`controls 38, microprocessor 30 can be caused to send
`wherein the patient’s cardiac activity has reverted to a
`digital data to a conventional computer 42 for further
`state of fibrillation. In this case, the medical information
`processing.
`system is in the MONITOR mode, as designated by
`FIGS. 3A-3E show examples of human-readable
`annotation record 82. For example, by the time
`representations of the data stored in memory 22 of FIG.
`12:06:36, the medical information system has deter
`2.
`35
`mined that the patient's heart has resumed fibrillation
`With reference to FIG. 3A, the human-readable re
`and caused a prompting “CHECK PATIENT." mes
`port first includes a “Run Report” 50, including such
`sage to be displayed to the user of the fibrillation unit,
`information as the report date and the names of the
`stating that a shock is indicated. In response, the user
`technicians who operated the medical information sys
`has initiated the ANALYZE mode by pressing the
`tem during the event that is being reported. Other data
`ANALYZE button in controls 20 (see FIG. 1). This is
`include the date and time of the emergency, the defibril
`designated by annotation record 84.
`lator serial number, the status of the system after it has
`As shown by activity record 86, the user of the defi
`performed a self-check, and the configuration of the
`brillation unit has responded to the prompt by pressing
`defibrillation circuit used in connection with the present
`the ANALYZE button in controls 20. The user has also
`medical information system.
`initiated a charging cycle for the defibrillator capacitor,
`An “Event log” 52 is printed immediately below the
`as indicated by annotation record 88. Activity record 90
`Run Report. The Event log is a chronological record of
`shows that the user has elected to administer a 360-Joule
`the important events in the operation of the unit. It
`shock, and, in annotation record 92, a “shock indicated”
`shows the times that the machine is turned on and off,
`message is displayed.
`when various operator messages are displayed, when
`50
`The user has pressed the SHOCK button in controls
`the operator commands are given, and when various
`20 at the same time that activity record 94 is displayed
`activities in the operation of the unit, such as the deliv
`in FIG. 3D and has initiated the ANALYZE mode at
`ery of a shock, occur.
`.
`the time indicated by activity record 96.
`The report then follows with a series of EKG traces,
`Normal cardiac activity, shown after the shock has
`shown in FIGS. 3B-E. Each three-second EKG seg
`55
`been administered, as indicated by activity record 94,
`ment is labeled with its actual beginning time 62. Each
`continues for the remainder of the time shown in FIGS.
`EKG segment can also be labeled with activity records,
`3D and 3E. Annotation record 98 shows that the analy
`such as those designated by numerals 64–70.
`The data shown in EKG segments 53–55 represent
`sis started at 12:07:01 has determined that a shock is not
`indicated, and informs the user that the medical infor
`the EKG samples taken when the machine is first
`mation system is entering its MONITOR mode.
`turned on. According to the priority scheme maintained
`Following the report on the second episode, a sum
`by microprocessor 11 in FIG. 1, this presenting data is
`mary of shock data relating to the second episode is
`given the highest priority. The ANALYZE button in
`controls 20 is then depressed during segment 56. This
`presented, as indicated at 100. These data include infor
`time is indicated by activity record 66—“Start Analy
`mation regarding the shock that has been delivered.
`65
`As a final step, the medical information system pro
`sis.” In the next three-second EKG segment 55, the
`vides an event log 102 with a summary of all activity
`capacitor of the defibrillation unit is charging, as indi
`cated by activity record 68. During the period of analy
`and annotation records and their times of occurrence.
`
`30
`
`15
`
`45
`
`Ex. 1014 / Page 12 of 14
`
`

`
`5
`
`10
`
`15
`
`8
`
`4,945,477
`7
`FIG. 4 is a flow chart of a computer program which
`I claim:
`1. A medical information recording system for use
`controls the storage of samples of medical state signals
`with a patient having a medical state, said system re
`and related annotations by the system of FIG. 1. After
`entering the program through block 120, microproces
`ceiving and storing data relating to the medical state of
`said patient, comprising:
`sor 11 (see FIG. 1) determines whether the medical
`monitor means for producing a monitoring ECG
`information system is the MONITOR mode in accor
`signal indicative of the patient’s medical state;
`dance with a command entered through controls 20
`analysis means for analyzing said ECG signal to de
`(block 122). If the system is not in MONITOR mode,
`the program control shifts to decision block 124, which
`termine if a defibrillation shock is indicated; defri
`brillator means for applying a defibrillator shock to
`determines whether the medical information system is
`said patient;
`in its first nine seconds of operation. If it is not, control
`sampling means for obtaining samples of said moni
`returns to block 126, where sample data are taken from
`toring signal, said samples having respective char
`A/D converter 18. If the medical information system is
`still in its first nine seconds of operation, microproces
`acteristics;
`memory means for storing said samples, said memory
`sor 11 is configured (through, for example, proper set
`means having a capacity limited to storing a prede
`ting of countdown registers) to take further data (block
`termined number of said samples; and
`128). Control then returns to block 126.
`processing means connected to said sampling means
`After data are sampled from A/D converter 18, the
`and said memory means for storing said samples in
`data are stored in nonvolatile memory 22 (block 130).
`Next, the computer program causes microprocessor 11
`said memory means, said processing means further
`20
`including prioritizing means operative whenever
`to determine whether any annotations, resulting from
`the number of samples obtained by said sampling
`either an activity record or an episode, have been cre
`means exceeds the storage capacity of said memory
`ated since the last sample was taken.
`means, said prioritizing means overwriting previ
`Those skilled in the art of computer programming
`ously obtained samples stored in said memory
`will recognize that the occurrence of such annotations
`25
`can be signaled by, for example, interrupts that result
`means with subsequently obtained samples, de
`pending upon the characteristics of said previously
`from pressing a button in controls 20. Other annotations
`and subsequently obtained samples.
`can result from recognition by a computer program that
`a medical event (for example, arrhythmia) requiring
`2. The medical information recording system of claim
`1 wherein presenting samples obtained when said moni
`defibrillation has occurred. If an annotation is recog
`30
`tor initially produces said monitoring signal have the
`nized by decision block 132, control passes to block 134,
`highest priority and are stored in said memory means
`where the annotation is stored in nonvolatile memory
`and never overwritten with subsequently obtained sam
`22. Otherwise, control passes from decision block 132 to
`ples.
`decision block 136, where the program determines
`3. The medical information recording system of claim
`whether 150 three-second episodes have been stored in
`35
`2 wherein samples obtained contemporaneously with a
`nonvolatile memory 22. If fewer than 150 episodes have
`defibrillation shock first applied to said patient have a
`been stored, control of the program returns to decision
`second priority and are stored in said memory means as
`block 122 to receive further sampled data from A/D
`long as said presenting samples do not fill said memory
`converter 18. If, on the other hand, 150 episodes of data
`means, and wherein said samples obtained contempora
`have been stored in nonvolatile memory 22, control
`neously with a first defibrillation shock applied to said
`passes to block 138, where the priority of the most
`recently sampled episode is established. Episode prior
`patient are never overwritten with subsequently ob
`tained samples.
`ity has been defined above. The record program then
`4. The medical information recording system of claim
`moves to block 140, which causes microprocessor 11 to
`3 wherein samples obtained contemporaneously with a
`erase the oldest episode of lowest priority stored in
`defibrillation shock last applied to said patient have a
`nonvolatile memory 22. The next oldest episode is
`moved into the portion of memory 22 just erased, fol
`third priority and are stored in said memory means as
`long as said samples obtained contemporaneously with
`lowed by a similar shifting of the next episode data, and
`so forth, until space is made available in memory 22 in
`a defibrillation shock first applied to said patient do not
`fill said memory means, and wherein said samples ob
`the area dedicated to storing the most recently recorded
`episode. The episode most recently sampled is then
`tained contempor