CATHETER! l4
Contents
1. 364 550 irr 5 207 642 5 1993 Orkin et al 1 36 5 230 623 7 1993 Guthrie et al ss 433 72 Crone Jaromir Belic and Roger W Jelliffe M D A 5 201 190 3 1994 Scarola et al 340 825 06 Programmable Infusion Pump Controller taken from 30th 5 295 062 3 1994 Fukushima 364 188 Annual Conference On Engineering in Medicine and Biol 5 338 157 8 1994 Blomquist ee 417 2 Nov 5 9 1977 pp A 35826 through A 35837 5 376 070 12 1994 Purvis et al 604 31 Block Medical Growing With Home Infusion Therapy SO 2691246 taken from INVIVO The Business and Medicine Report 5 412 400 5 1995 Takahara et al 345 119 d 5 485 408 1 1996 Blomquist 364 578 Apr 1991 pp 7 9 5 558 638 9 1996 Evers et al Selected pages from Chapter 1 and 2 by Foley et al 5 573 506 11 1996 Vasko Fundamentals of Interactive Computer Graphics 1982 U S Patent Oct 24 2000 Sheet 1 of 12 6 135 949 REMOTE MONI TOR CONTROLLER INFUSION PUMP CATHETER 14 20 FIG 2 SE LEE EE A 62 E EN o 68 66 64 76 74 ER 70 82 MOUSE ELM mm PERA ASMA EN U S Patent Oct 24 2000 Sheet 2 of 12 6 135 949 1 0 INTERFACE BACKLIGHT DISPLAY U S Patent Oct 24 2000 Sheet 3 of 12 6 135 949 200 FIG 5 INITIALIZATION AND SELF TEST anes 202 2042. ANY REMAINING VOL a TIME PROGRAM CONTINUOUS 264 REPORT ALARMS U S Patent Oct 24 2000 Sheet 4 of 12 6 135 949 FIG 6 302 STORE PROGRAMMED PARAMETERS STORE RUN PARAMETERS STORE TOTAL VOLUME INFUSED STORE TOTAL VOLUME INFUSED NEW RATE VOLUME PROGRAMMING COMPLETE STORE TOTAL VOLUME INFUSED ALARM TYPE INFUSION COMPLETE STORE TOTAL VOLUME INFUSED STORE TOTAL VOLUME INFUSED MALFUNCTION LOCKOUT PROGRAMMING COMPLETE STORE MODES LOCKED OUT 338 STORE GIVEN NOT GIVEN BOLUS AMOUNT BOLUS CENOEST NO 6 135 949 Sheet 5 0112 Oct 24 2000 U S Patent Sl 913 VIVA NOISNANI D VIVA IT a OJANSIY SIIdvYIaHL O 501 1 231194 O 031YVISIY dWnda Q313 ldWOO SIIdVYIHL O SNLVLS 50108 o NO dNnd O GQ318V1S S3ldVu3Hi O SSONVHOSLVY SNOILVYLIL O 440 0O3INYNL 0 Q3WWVH9OHd S3ldVH3Hl O S32V84A99Id a NO dW d D SWYV1V SNOLLONNITIVA 0 pu lets EEE 31VQ 3LvG Y3IGWNN SNIGN3 ONINNI938 QI AN3ILVD 3WNVN AN3ILV VIVO 2 914 vol U S Patent Oct 24 2000 Sheet 6 of 12 6 135 949 y 380 5 382 SET POINTER NEXT ADDRESS 384 IS POINTER AT LAST ADDRESS 386 SET POINTER TO FIRST ADDRESS 388 WRITE TIME STAMP IN LOG 390 WRITE EVENT DATA IN LOG
3. 8 is a flowchart of a routine 380 for storing data in the memory locations 372 Referring to FIG 8 at step 382 the pointer 376 is set to the address of the next memory location 372 in which data is to be stored At step 384 if the pointer 376 is at the last memory location in which data may be stored the routine branches to step 386 where the pointer is set to the address of the first memory location in which data may be stored As a consequence of steps 384 386 the contents of the memory locations 372 are periodically overwritten with new data however the number of memory locations 372 is sufficiently large so that several months of data for example is stored before being overwritten At steps 388 and 390 the data is stored in the memory location 372 specified by the pointer 376 the data includes a time stamp generated from the real time clock 106 and event data specifying the particular infusion event FIGS 9 10 and 12 are flowcharts of various routines that are performed by the remote monitor controller 20 As described in more detail below the remote monitor controller 20 may be used to monitor the operation of the infusion pump 12 to control the operation of the infusion pump 12 and or to transfer infusion data and patient data from the infusion pump 12 so that such data can be reviewed by a health care professional at a location remote from the patient The remote monitor controller 20 is designed to interface with differ
4. FIG 8 U S Patent Oct 24 2000 Sheet 7 of 12 6 135 949 IDENTIFY PUMP TYPE JR 402 SEND PUMP FIG 9 ID REQUEST 410 READ CHARACTERS FROM PUMP DETERMINE gt 406 PUMP TYPE YES 408 ERROR MESSAGE 4 NO CORRECT YES RESPONSE 412 TIMER EXPIRED NO SEND PUMP DISPLAY RE QUEST READ CHARACTERS FROM PUMP 422 ERROR MESSAGE DETERMINE PUMP TYPE 426 U S Patent USER SELECTS MODE COMMAND N MODE 52 NO 4 465 La MODE 6 DISPLAY PUMP MONITOR 467 GET PUMP S DISPLAY FROM PUMP SHOW PUMP S DISPLAY ON SCREEN Oct 24 2000 Sheet 8 of 12 6 135 949 450 23 GET PUMP S DISPLAY FROM PUMP DISPLAY PUMP KEYPAD COMMAND INPUT SHOW PUMP S NO DISPLAY ON SCREEN TRANSMIT COMMAND TO PUMP DOWNLOAD DATA LOG DOWNLOAD DATALOG YES VIEW DATA LOG YES FIG IO U S Patent Oct 24 2000 Sheet 9 of 12 6 135 949 78 RESET NO YES RUN PUMP REV TIT HOLD ae od sous FIG 8 FIG IIB 191151 Lo fm re U S Patent Oct 24 2000 Sheet 10 of 12 6 135 949 COMMAND PUMP SEND PUMP COMMAND READ CHARACTERS FROM PUMP PUMP ECHO CORRECT ERROR MESSAGE SEND ACKNOWLEDGEMENT 458 y 480 482 488 490 FIG 12 U S Patent Oct 24 2000 Sheet 11 of 12 6 135 949 500 FIG 13 RECEIVE
5. If the pump is not to be programmable the program branches to step 216 where a lockout sequence is performed by requesting the user to input which infusion modes should be locked out If the pump is to be program mable by the patient the program bypasses step 216 The infusion pump 12 has five basic modes of infusion 1 a continuous mode in which the pump delivers a single volume at a single rate 2 an auto ramp mode in which the pump delivers liquid at a rate that gradually increases to a threshold rate stays constant at the threshold rate and then gradually decreases 3 an intermittent mode in which the pump delivers discrete liquid volumes spaced over relatively long periods of time such as a liquid volume every three hours 4 a custom mode in which the pump can be pro grammed to deliver a unique fusion rate during each of 25 different time periods and 5 a pain controlled analgesic PCA mode during which the pump will periodically infuse boluses of analgesic in response to periodic requests by the patient At step 218 the pump 12 generates on the display 92 the prompt Continuous to the user If the user desires to use the pump in its continuous mode the user answers yes via the keypad 90 and the program branches to step 220 at which the continuous mode is programmed by the user by entering a number of infusion parameters such as the desired infusion rate the volume to be infused etc At step 218 if the user
6. monitor controller may be used to monitor the operation of the medical device control the operation of the medical device and or to transfer data from the medical device to the remote monitor controller The apparatus may allow voice communication between the remote monitor controller and the patient who is receiving treatment via the medical device while the medical device is being monitored and or con trolled from the remote location The remote monitor controller may also include means for determining the type of medical device to which it is connected 9 Claims 12 Drawing Sheets REMOTE MONITOR CONTROLLER 6 135 949 Page 2 U S PATENT DOCUMENTS 5 643 212 7 1997 Coutre et al 4 696 671 9 1987 Epstein et al OTHER PUBLICATIONS 4 731 051 3 1988 Fischelll 604 67 4 810 243 3 1989 Howson aaa 604 31 IEEE 488 and VXIbus Control Data Acquisition and 4 828 545 5 1989 Epstein et al Analysis the Most Choices select pages taken from 4 901 221 2 1990 Kodosky et al 364 200 National Instruments Application Software Products and 4 925 444 5 1990 Orkin et al Application Software Overview 1991 17 pages 4 942 514 7 1990 Miyagaki etal 364 190 LabVIEWO2 User Manual Chapter 2 The Front Panel 24153 8277 10 1392 Coufre et al taken from National Instruments Corporation Jan 1990 pp 5 155 693 10 1992 Altmayer et al
7. 502 DATA DUMP ACTIVE 504 RESET DATA DUMP FLAG 508 DATA DUMP COMMAND 2 TRANSMIT ERROR MESSAGE 506 SET TRANSMIT POINTER TO OLDEST DATA 50 RESPOND OTHER COMMAND SET DATA DUMP FLAG 514 FETCH FIRST DATA BYTE UPDATE TRANSMIT POINTER FORMAT DATA IN ASCII ENABLE TRANSMIT INTERRUPT SEND FIRST DATA BYTE 524 U S Patent Oct 24 2000 Sheet 12 of 12 6 135 949 TRANSMIT 550 552 DATA DUMP ACTIVE RESPOND TO OTHER INTERRUPT 556 ALL DATA SENT NO FETCH NEXT DATA BYTE UPDATE TRANSMIT POINTER FORMAT DATA IN ASCII SEND DATA BYTE DISABLE TRANSMIT INTERRUPT RESET DATA DUMP FLAG 568 FIG 14 6 135 949 1 APPARATUS FOR MONITORING AND OR CONTROLLING A MEDICAL DEVICE This is a continuation of prior application Ser No 08 691 872 filed Aug 2 1996 now U S Pat No 5 807 336 which is hereby incorporated herein by reference in its entirety BACKGROUND OF THE INVENTION The present invention is directed to an apparatus for monitoring and or controlling a medical device such as an Infusion pump from a remote location An infusion pump is used to automatically administer liquid medicant to a patient The liquid medicant is supplied from a source of medicant and pumped into the patient via a catheter or other injection devi
8. 20 25 30 35 40 45 50 55 60 65 10 It should be noted that the virtual keypad shown in FIG 11A is the same as the actual keypad 90 of the pump 12 which is shown in FIG 3 except that the on off key of the pump 12 is replaced with a reset key in the virtual key display Where a different type of pump having a different keypad is attached to the remote monitor controller 20 that particular keypad is displayed on the display device 78 An example of a different virtual keypad is shown in FIG 11B Various virtual keypad configurations may be stored in the memory of the remote monitor controller 20 each virtual keypad configuration having a pump type code associated therewith Since the remote monitor controller 20 initially determined the type of pump to which it was attached via the routine of FIG 9 it can retrieve from memory and display the corresponding virtual keypad for that type of pump After the virtual keypad is displayed the health care professional may control the operation of the infusion pump 12 by selecting any of the virtual keys with the mouse 82 Other ways of selecting the keys could be utilized such as a touch sensitive screen or a display screen activated by radiation sensors The infusion pump 12 responds to com mands entered via its keypad 90 and to commands generated from the remote monitor controller 20 At steps 456 and 458 any commands entered by the health care professional are tra
9. United States Patent ro Russo et al US006135949A 1 Patent Number 6 135 949 45 Date of Patent Oct 24 2000 54 APPARATUS FOR MONITORING AND OR CONTROLLING A MEDICAL DEVICE 75 Inventors Sam Russo Lisle Sho Chen Northfield both of 111 Larry Wilson Poway Calif Joseph P Moser Wheaton Alan E Jordan San Diego Calif 73 Assignee Baxter International Inc Deerfield Ill 21 Appl 09 152 573 22 Filed Sep 14 1998 Related U S Application Data 63 Continuation of application No 08 691 872 Aug 2 1996 Pat No 5 807 336 51 MEC lin 61 5 00 152 US CL eren 600 300 604 131 58 Field of Search 600 300 604 207 604 246 131 607 60 128 004 56 References Cited U S PATENT DOCUMENTS 4 413 314 11 1983 Slater et al 364 188 4 561 443 12 1985 Hogrefe et al 4 676 776 6 1987 Howson et List continued on next page OTHER PUBLICATIONS McMorris et al Are Process Control Rooms Obso lete taken from Control Engineering pp 42 47 Jul 1971 Abbott Laboratories LIFECARE Blue Line System prod uct literature copyrighted 1990 L C Sheppard Computer Based Clinical Systems Auto mation and Integration taken from 39th ACEMB Sep 13 16 1986 pp 73 75 Selective portions of Chapter 9 of Mayhew Principles and Guidelines In Software User Interface Design 1992 Electronic s Article of Feb 1990 by Jack S
10. a transmit buffer XMIT 70 for transmitting data bytes and a receive buffer REC 72 for receiving data bytes The remote monitor controller 20 has a keyboard 74 connected to the I O circuit 66 via a line 76 a display device 78 such as a CRT connected to the I O circuit 66 via a line 80 and an input device such as an electronic mouse 82 connected to the I O circuit 66 via a line 84 The remote monitor controller 20 can also include one or more disk drives such as a hard disk drive or a floppy disk drive FIG 3 is a front view of one embodiment of the infusion pump 12 shown schematically in FIG 1 Referring to FIG 10 15 20 25 35 40 45 50 55 60 65 4 3 the pump 12 has an input device in the form of a keypad 90 via which a user may input data and commands and a display 92 for displaying textual messages to the user A block diagram of the electronics of the infusion pump 12 is shown in FIG 4 Referring to FIG 4 the pump 12 includes a controller 100 an electrically programmable read only memory EPROM 102 having a built in I O interface 102a a nonvolatile RAM 104 a real time clock 106 and the display 92 all of which are interconnected by a communications bus 108 The display 92 has a backlight 110 which is selectively activated by an enable signal generated on a line 112 interconnecting the controller 100 and the backlight 110 Both the RAM 104 and the real time clock 106 are connected to a batt
11. ata stored in the medical device and a routine for viewing data from the medical device 6 The medical apparatus of claim 1 wherein the medical device comprises a controller for controlling the interaction of the medical device with the patient 5 10 14 7 The medical apparatus of claim 1 wherein the apparatus for allowing voice communication comprises a first voice data modem operatively coupled to the medi cal device and a second voice data modem operatively coupled to the remote apparatus the first and second voice data modems being coupled to the communication link 8 The medical apparatus of claim 1 wherein the commu nication link comprises a telephone line 9 The medical apparatus of claim 1 wherein the medical device comprises a programmable infusion pump
12. ce The manner in which the liquid is infused is controlled by the infusion pump which may have various modes of infusion such as a continuous mode in which the liquid medicant is continuously infused at a constant rate or a ramp mode in which the rate of infusion gradually increases then remains constant and then gradually decreases Typically the monitoring of an infusion pump is per formed by reviewing a visual display means incorporated in the infusion pump and the control of the infusion pump is performed by activating an input device such as a keypad incorporated with the infusion pump Consequently the monitoring and or control of an infusion pump is performed at the same location at which the infusion pump is disposed SUMMARY OF THE INVENTION The invention is generally directed to a medical apparatus having a programmable medical device disposed at a first room location and a remote monitor and or controller dis posed at a second room location In one aspect the invention is directed to a medical apparatus having a medical device for administering a medical treatment to a patient the medical device being disposed at a first room location and including means for administering the medical treatment to the patient and memory means for storing data regarding the medical treat ment administered to the patient The medical apparatus also includes a remote monitor for monitoring the medical treat ment administered to the pat
13. ded upon the occurrence of each event is listed in the right hand column of Table 1 The time at which the infusion data is recorded which is determined by the real time clock 106 is also stored along with the infusion data TABLE 1 EVENT DATA RECORDED Power On Date and Time Program Infusion parameters See Table 2 Run Infusion parameters See Table 2 Hold Total Volume Infused Restart Time of Restart Rate Changes Total Volume Infused Rate Volume Alarms Total Volume Infused Alarm Type Infusion Complete Total Volume infused Malfunctions Total Volume Infused Malfunction Type Resume Infusion parameters See Table 2 Maintenance Date Date Patient ID Patient ID Number Serial No Serial Number Language Change New Language Lockout Modes Locked Out Pressure Select Bolus Request Titration Power Off Version No New Pressure Setting Given Not Given Bolus Amount New Parameters Time of Power Off Software Version Number Referring to Table 1 and FIG 6 when the power to the infusion pump 12 is tured on the date and time of the power turn on is recorded When the pump is completely programmed pursuant to one of steps 220 224 228 232 6 135 949 7 236 FIG 5 as determined at step 302 the programmed Infusion parameters are stored at step 304 along with the time of such storage The particular parameters that are stored depend upon which infusion mode was programmed Several examples of infusion parameters tha
14. does not want to use the continuous mode the user answers No and the program branches to step 222 Steps 222 236 are generally the same as steps 218 and 220 except that the user may be prompted for different infusion parameters depending on which of the five possible infusion modes is selected After the completion of one of the steps 220 224 228 232 or 236 the program branches to the ready to run step 210 When the user presses the Run key the pump 12 enters the run mode 260 and infuses the patient with a liquid medicant in accordance with the infusion mode selected at one of steps 218 222 226 230 234 and the infusion parameters entered at one of steps 220 224 228 232 236 The pump 12 remains in the run mode 260 until the Hold key is pressed as determined at step 262 Upon the occur 10 15 20 30 35 40 45 50 55 60 65 6 rence of alarm condition an alarm is reported at step 264 At step 262 if the hold key is pressed the infusion is stopped at step 266 and the pump 12 waits for the run key to be pressed at step 268 or the on off switch to be turned off at step 270 Summarizing the operation described above if the pump is to be utilized in lockout mode a medical assistant turns the pump on programs the desired infusion mode at one of steps 220 224 228 232 236 and then turns the pump off The programmed infusion parameters will be retained in the memory 104 The
15. edical device transmit display data including a plurality of characters shown on the visual display device of the one programmable medical device means for receiving the display data and means for determining the type of the one programmable medical device based upon the display data The display data may include a number of characters and the determining means may include means for determining the type of the one programmable medical device based upon the number of characters in the display data The means for automatically determining the type of the one programmable medical device may also include means of a first type for automatically determining the type of the one programmable medical device and means of a second type for automatically determining the type of the one program mable medical device These and other features and advantages of the present invention will be apparent to those of ordinary skill in the art in view of the detailed description of the preferred embodiment which is made with reference to the drawings a brief description of which is provided below BRIEF DESCRIPTION OF THE DRAWINGS FIG 1 is a block diagram of an apparatus for adminis tering medical treatment to a patient and monitoring the condition of the patient FIG 2 is a block diagram of the electronic components of the remote monitor controller shown schematically in FIG 1 FIG 3 is a front view of one embodiment of the infusion pump shown schemat
16. ent types of infusion pumps In order to determine which type of infusion pump the remote monitor controller 20 is operatively coupled a pump identification routine 400 performed after the communication link between the remote monitor controller 20 and the infusion pump 12 is estab lished Referring to FIG 9 at step 402 the remote monitor controller 20 transmits a pump identification ID request to the infusion pump 12 via the communication link 38 In response to the pump ID request the pump 12 transmits a multi character ID code back to the remote monitor controller 20 The ID code may include for example one or more characters identifying the pump model and or one or more characters identifying the software version of the pump At step 404 the remote monitor controller 20 reads the characters sent from the pump 12 until all characters are received as determined at step 406 or until a predetermined time period e g five seconds elapses The time period may be determined by a timer not shown The remote monitor controller 20 may determine that all characters have been received by for example identifying one or more termina tion characters such as a carriage return character lt CR gt followed by a line feed character lt LF gt Step 408 determines whether a correct response was received from the pump 12 which may be determined checking the characters received from the pump 12 against a list of possible ID codes If a correct r
17. ery 114 which supplies power to them only in the absence of system power The controller 100 has a transmit buffer 116 and a receive buffer 118 connected to the communications bus 108 The controller 100 controls the medicant infusion rate by periodically transmitting a control signal to an amplifier circuit 120 via a line 122 to drive a pump motor 124 which drives a pumping mechanism 126 such as a rotary pump wheel not shown adapted to make contact with a portion of the liquid conduit 16 FIG 1 connected to the catheter 14 The controller 100 receives periodic inputs from a shaft encoder SE sensor 130 which is disposed on the shaft of the motor 124 The SE sensor 130 may be a two phase motion sensing encoder which provides two signal outputs to the controller 100 The rotational speed of the motor 124 and its direction of rotation are determined by the controller 100 based upon the rate and phase relationship between the two signal outputs The SE encoder 130 periodically transmits the signals to the controller 100 via a line 132 Each time the signals are transmitted an interrupt is generated and the controller 100 compares the actual position of the motor shaft with its desired position and transmits a new control signal such as a pulse width modulated signal to the amplifier 120 via the line 122 to ensure that the actual speed of the motor 124 corresponds to the motor speed required for the desired medicant infusion rate The in
18. esponse was received the routine branches to step 410 where the pump type is determined for example by comparing the received pump ID code with at least one possible ID code which identifies a particular type of infusion pump or by compar ing the received pump ID code with a number of possible ID codes each of which identifies a particular type of infusion pump As used herein the type of infusion pump may relate to the model of the pump or the software version of the pump If a correct response was not received as determined by step 408 at step 412 the routine determines whether the predetermined time period measured by the timer has 6 135 949 9 expired prior to receiving a termination character If so the routine branches to step 414 where an error message is generated due to the pump s failure to respond to the pump ID request At step 412 if some type of response not a correct response was received before the timer expired the routine branches to step 416 Steps 416 426 comprise a second way of determining the type of infusion pump 12 connected to the remote monitor controller 20 which is based on the number of characters in the display 92 of the pump 12 For example a first type of infusion pump may have a display capable of displaying 12 characters whereas a second type of infusion pump may have a display capable of displaying 12 characters Steps 416 426 determine the type of infusion pump based on the number
19. handle entitled Who Will Dominate the Desktop in the 90s INFUSION PUMP Chapter 5 entitled Direct Manipulation from Shneiderman Designing the User Interface Strategies for Effective Human Computer Interaction published 1992 Literature of the Baxter s MultiPlex Fluid Management System 1988 Literature of the Baxter MultiPlex Fluid Management Sys tem copyrighted 1988 Literature describing Baxter s Flo Gard 6201 Volumetric Infusion Pump copyrighted 1992 Literature of I Flow Corporation advertising its Vivus 4000 Infusion System One page article by Jerry Hirsch entitled Portable IV Frees Patients printed in The Orange County Register Article by Bedder et al entitled Cost analysis of Two Implantable Narcotic Delivery Systems published Mar 14 1991 Pp 66 71 from book chapter entitled MiniMed Technolo gies Programmable Implantable Infusion System describ ing clinical trials from Nov 1986 Advertisement describing IMED STATUS Infusion Management System List continued on next page Primary Examiner Max Hindenburg Attorney Agent or Firm Wallenstein amp Wagner 57 ABSTRACT A medical apparatus is provided with a programmable medical device disposed at a first room location and a remote monitor and or controller disposed at a second room loca tion The programmable medical device is used to admin ister a medical treatment to a patient and the remote
20. hecked If the flag is not active meaning that a data dump operation is not in progress the routine branches to step 554 where the routine responds to the other interrupt If the data dump flag is active then the routine branches to step 556 where it determines whether all of the segmented 10 15 20 25 30 35 40 45 50 55 60 65 12 portions of the infusion data have been transmitted This may be accomplished for example by determining if the transmit pointer 513 and the pointer 376 FIG 7 are pointing to the same memory location If all the requested data has been sent the routine branches to step 558 where the transmit interrupt is disabled and then to step 560 where the data dump flag is reset to logic 0 effectively ending the data transfer operation If not all the data has been transferred as determined at step 556 the routine branches to step 562 where the data byte specified by the transmit pointer 513 is retrieved from the RAM 104 At step 564 the position of the transmit pointer is updated to point to the address of the next data byte to be transmitted At step 566 the data byte retrieved at step 562 is formatted in ASCII and at step 568 the refor matted data byte is transmitted from the infusion pump transmit buffer 116 to the remote monitor controller 20 over the data link 38 The transmit interrupts generated by the controller 100 to transfer the segmented data portions to the remo
21. ically in FIG 1 FIG 4 is a block diagram of the electronic components of the infusion pump of FIG 3 FIG 5 is a flowchart of the overall operation of the infusion pump 6 135 949 3 FIG 6 illustrates a number of data recording steps formed during the operation of the infusion pump FIG 7 is a representation of a portion of the memory of the infusion pump FIG is a flowchart of a store data routine which can be used to store data relating to the operation of the infusion pump and data relating to the condition of a patient FIG 9 is a flowchart of a routine which may be used to identify the type of infusion pump to which the remote monitor controller is coupled FIG 10 is a flowchart of a mode select routine of the remote monitor controller FIGS 11A 11B illustrate portions of visual displays generated by the remote monitor controller FIG 12 is a flowchart of a command pump routine that is performed by the remote monitor controller FIG 13 is a flowchart of a receive routine that is per formed by the infusion pump FIG 14 is a flowchart of a transmit routine that is performed by the infusion pump and FIG 15 is an illustration of a graphical user menu that may be displayed by the remote monitor controller DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT FIG 1 illustrates one embodiment of an apparatus 10 for administering medical treatment to a patient Referring to FIG 1 the apparatus 10 incl
22. ient the remote monitor being disposed at a second room location remote from the first room location and means for transferring the data from the medical device to the remote monitor while the medical device is administering the medical treatment to the patient The data may be transmitted to the remote monitor in segmented noncontinuous data portions and the means for transferring the data to the remote monitor may include means for repeatedly transmitting portions of the data from the medical device to the remote monitor and means for generating an interrupt when one of the data portions has been transmitted to the remote monitor the interrupt causing the transmitting means to transmit another of the data portions from the medical device to the remote monitor In a second aspect the invention is directed to a medical apparatus having a medical device for administering a medical treatment to a patient the medical device being disposed at a first room location and including means for administering the medical treatment to the patient and memory means for storing data regarding the medical treat ment administered to the patient The medical device also includes a remote monitor for monitoring the medical treat 10 15 25 30 40 45 50 55 60 65 2 ment administered to the patient the remote monitor being disposed at a second room location remote from the first room location a communication link operatively coup
23. in connection with FIGS 13 14 If the user inputs a view data log request as determined at step 474 the routine branches to step 476 where data previously downloaded at step 472 can be viewed on the display device 78 of the remote monitor controller 20 The user may exit the mode select routine 450 via step 478 FIG 12 illustrates one routine that could be used to implement the transmit command step 458 shown schemati cally in FIG 10 Referring to FIG 12 the pump command 15 transmitted from the remote monitor controller 20 at step 480 and then the infusion pump 12 transmits to the remote monitor controller 20 an echo of the command so that the remote monitor controller 20 known that command was received properly by the pump 21 The characters making up the echo are received at steps 482 484 and if the echo is not 6 135 949 11 correct an error message is displayed to the health care professional At step 490 the remote monitor controller 20 sends an acknowledgement of the echo to the pump 12 The transfer of data from the infusion pump 12 to the remote monitor controller 20 shown schematically in step 468 of FIG 10 is accomplished via a receive interrupt service routine 500 and a transmit interrupt service routine 550 that are performed by the infusion pump 12 Flowcharts of the routines 500 550 are shown in FIGS 13 and 14 The receive routine 500 shown in FIG 13 is invoked upon the generation of a receive interrupt by the pum
24. ine branches to step 508 where the message just received in the receive buffer 118 is checked to determine whether it is a data dump command If it is not then the routine branches to step 510 where the pump 12 responds to the command If the message is a data dump command the routine branches to step 512 where a transmit pointer 513 see FIG 7 is set to the oldest data in the RAM 104 that has not yet been transmitted to the remote monitor controller 20 At step 514 the data dump flag is set to logic 1 since a new data transfer operation is beginning At step 516 the data byte specified by the transmit pointer 513 is retrieved from the RAM 104 and at step 518 the position of the transmit pointer 513 is updated e g incremented to point to the address of the next data byte to be transmitted At step 520 the data byte retrieved at step 516 is formatted in ASCII at step 522 the transmit interrupt is enabled and at step 524 the reformatted data byte is transmitted from the infusion pump transmit buffer 116 to the remote monitor controller 20 over the data link 38 When the first data byte is sent out from the transmit buffer 116 a transmit interrupt is generated by the controller 100 to indicate that the transmit buffer 116 is empty and that another data byte can be transmitted Upon the generation of the transmit interrupt the transmit routine 550 is performed Referring to FIG 14 at step 552 the status of the data dump flag is c
25. infusion data from the pump 12 to the remote monitor controller 20 and viewing the data The user may perform one of those functions by selecting an operational mode displayed on the display device 78 FIG 2 of the remote monitor controller 20 via the mouse 82 These modes include a command mode in which a health care profes sional at the remote monitor controller 20 may transmit command signals to the infusion pump 12 to control its operation a monitoring mode in which the infusion pump 12 will continually transmit the contents of its visual display 92 to the remote monitor controller 20 a download data mode in which infusion data is transferred from the pump 12 to the remote monitor controller 20 and a view data mode in which the infusion data may be viewed on the display 78 of the remote monitor controller 20 FIG 10 illustrates a flowchart 450 of the basic operation of the remote monitor controller 20 Referring to FIG 10 at step 452 if the user selected the command mode described above the routine branches to step 454 where a display of the keypad 90 of the infusion pump 12 is shown on the display device 78 The display shown at step 454 comprises a plurality of virtual entry keys having a spatial configura tion substantially the same as the entry keys of the keypad 90 of the particular infusion pump type which is connected to the remote monitor controller 20 An example of such a visual display is shown in FIG 11A 10 15
26. led between the medical device and the remote monitor means for transferring the data from the medical device to the remote monitor via the communication link and means for allowing voice communication between the medical device and the remote monitor via the communication link while the data is being transferred from the medical device to the remote monitor In a third aspect the invention is directed to an apparatus having remote means for communicating with one of a plurality of medical devices each of which is designed to administer a medical treatment to a patient the one medical device being disposed at a first room location and the remote means being disposed at a second room location remote from the first room location The remote means includes means for automatically determining the type of the one programmable medical device and means for receiving data relating to the medical treatment of the patient after the type of the one programmable medical device has been deter mined The apparatus also includes data communication means coupled to the remote means for transferring data between the remote means and the one programmable medical device The one programmable medical device may have a visual display device and the means for automatically determining the type of the one programmable medical device may include means for transmitting a display request to the one programmable medical device to request that the one pro grammable m
27. medical assistant would then turn the pump back on press the No key in response to the Programmable prompt at step 214 enter the lockout information at step 216 and then turn the pump off again When the patient subsequently turned on the pump to perform the infusion the program would proceed from step 212 directly to the ready to run step 210 which could prevent the patient from altering the infusion parameters If the lockout mode was not utilized the medical assistant or the patient could turn the pump on program the desired infusion mode and then press the Run key to start the infusion without ever turning the pump off During programming and operation the infusion pump 12 automatically records in the non volatile memory 104 all significant infusion data to generate a complete historical data record which can be later retrieved from the memory 104 and used for various purposes including clinical pur poses to aid in determining how effective a particular infusion therapy was and treatment purposes to confirm that the prescribed infusion was actually delivered FIG 6 illustrates various steps at which infusion data is recorded that are performed during the overall pump opera tion shown generally in FIG 5 The infusion data recorded in the memory 104 is set forth in Table 1 below A number of events which trigger the storage of data are listed in the left hand column of Table 1 and the infusion data that is recor
28. ng a medical device for interacting with a patient disposed at a first location a remote apparatus for monitoring and or controlling the medical device the remote apparatus being disposed at a second location remote from the first location a communication link operatively coupled between the medical device and the remote apparatus apparatus for transferring data and or commands between the medical device and the remote apparatus via the communication link and apparatus for providing voice communication between the medical device and the remote monitor controller via the communication link contemporaneously while data and or commands are being transferred between the medical device and the remote monitor controller 2 The medical apparatus of claim 1 wherein the remote apparatus comprises a routine for programming the medical device and a routine for monitoring the medical device 3 The medical apparatus of claim 1 wherein the medical device comprises a device for administering a medical treatment to a patient 6 135 949 13 4 The medical apparatus of claim 1 wherein the medical device comprises a device for monitoring a medical condi tion of the patient 5 The medical apparatus of claim 2 wherein the medical device comprises a memory for storing data regarding the medical device s interaction with the patient and operation of the medical device and wherein the remote apparatus comprises a routine for downloading d
29. nsmitted to the infusion pump 12 and at steps 460 and 462 the display of the pump 12 is transferred to the remote monitor controller 20 and displayed on the display device 78 of the remote monitor controller 20 At step 464 if the user exits the command mode the routine branches back to step 452 At step 465 if the health care professional selected the monitor mode the routine branches to step 466 where a visual display of the pump display 92 is shown on the display device 78 At step 467 the contents of the pump display 92 are transferred to the remote monitor controller 20 and at step 468 those contents are displayed in the visual display generated at step 466 At step 469 if the user exits the monitor mode the routine branches back to step 452 otherwise the routine branches back to step 467 so that the contents of the pump display 92 are continuously shown on the display device 78 at step 468 the display 92 of the infusion pump 12 changes in accordance with the pump operation so that the pump operation can be monitored by viewing the display 92 Step 467 may be accomplished for example by transmitting a pump display request to the pump 12 via steps similar to steps 416 420 described above If the health care professional inputs a request to down load data from the pump 12 to the remote monitor controller 20 as determined at step 470 the routine branches to step 472 where the data transfer is accomplished as described below
30. of characters in the display At step 416 the remote monitor controller 20 transmits a pump display request to the infusion pump 12 to request the pump 12 to transmit the content of its display 92 At step 418 the remote monitor controller 20 reads the display characters transmitted from the pump 12 At step 420 if a predetermined period of time has elapsed or if a terminating character is received the routine branches to step 422 At step 422 if the predetermined time period measured by the timer elapsed prior to the receipt of a terminating character the routine branches to step 424 where an appropriate error message is generated At step 426 the type of pump is determined based on the number of display characters that were received The routine could also exit step 420 if a predetermined number of characters are received In that case where the remote monitor controller 20 was designed to interface with two different types of infusion pumps one having a display capability of 12 characters and another having a display capability of 32 characters if the remote monitor controller 20 received more than 12 display characters at step 420 it would immediately be able to determine that the pump type corresponded to a pump with a 32 character display capa bility The remote monitor controller 20 allows four basic func tions to be performed including controlling the infusion pump 12 monitoring the operation of the pump 12 trans ferring
31. p controller 100 The receive interrupt indicates that a message has been received in the receive buffer 118 of the controller 100 from the remote monitor controller 20 When a download data command is sent to the infusion pump 12 as determined at step 466 of FIG 10 a data dump flag is set to logic 1 indicating that a data transfer or dump from the pump 12 to the remote monitor controller 20 is in progress The data transfer is performed in a segmented fashion Instead of sending all of the infusion data and patient data stored in the RAM 104 to the remote monitor controller 20 in a single continuous stream the data is sent in segmented portions each of which is separated in time from its adjacent portions by a period of time e g 100 microseconds Referring to FIG 13 when the routine begins at step 502 a character or message will have been just received in the receive buffer 118 At step 502 if the data dump flag is active meaning that a data transfer is already in progress then the routine branches to step 504 where the data dump flag is set to logic 0 effectively terminating the data dump operation and an error message is transmitted to the remote monitor controller 20 at step 506 This is done to prevent the data dump operation from interfering with any commands that are transmitted from the remote monitor controller 20 to the infusion pump 12 Tf the data dump flag was not active as determined at step 502 the rout
32. s any 6 135 949 5 remaining volume of liquid to be infused by the pump any additional time remaining for an infusion which would be the case where the pump was temporarily turned off during an infusion the program branches to step 206 where the user is asked via a message displayed on the display 92 whether the previous infusion should be resumed If the user answers yes via the keypad 90 the program branches to a ready to run step 210 If the previous infusion is not to be resumed the program branches to step 212 The infusion pump 12 has a lockout mode in which the user may be prevented from programming the infusion parameters such as the volume to be infused or the rate of infusion For example the pump 12 could be programmed by a medical assistant to deliver a particular infusion having a particular flow profile flow rate and volume to be infused After programming that infusion the medical assistant could place the pump in lockout mode which would prevent the patient from changing any of the infusion parameters At step 212 if the pump 12 has been previously placed in lockout mode the program branches directly to the ready to run step 210 bypassing all programming steps At step 212 if the pump is not in lockout mode the program branches to step 214 at which point the program prompts the user via the display 92 to input whether the patient should be allowed to program the pump during the subsequent infusion
33. t are stored for each of a number of infusion modes are illustrated in Table 2 set forth below TABLE 2 INFUSION MODE INFUSION PARAMETERS Infusion Mode Infusion Rate Volume To Be Infused Delay Time Total Bag Volume KVO Rate Infusion Mode Infusion Rate Volume To Be Infused Delay Time Total Bag Volume Duration of Up Ramp Duration of Down Ramp KVO Rate Infusion Mode Total Infusion Time Number of Doses Dose Time Dose Volume KVO Rate Continuous Auto Ramp Intermittent When the pump enters the run mode 260 FIG 5 as determined at step 306 the time at which the run mode was begun along with the parameters pursuant to which the infusion is performed are stored at step 308 At step 310 if the hold key is pressed then the time at which the hold key was pressed along with the total volume infused at the time the hold key was pressed are stored at step 312 The pump also stores any infusion rate changes such as changes caused by switching from a continuous rate to a keep vein open KVO rate or in the intermittent mode changing from a KVO rate to a higher infusion rate the presence of which are detected at step 314 The new rate and the time at which the new rate started are stored at step 316 At step 318 if any alarms are generated the alarm type the time at which the alarm occurred and the total volume infused at the time of the alarm are recorded at step 320 If the infusion is completed as determined at s
34. te monitor controller 20 are assigned a lower priority than the interrupts generated in response to input of the shaft encoder sensor 130 which is necessary to provide the desired infusion rate Consequently the transfer of the infusion data and patient data does not interfere with the ability of the pump 12 to provide the desired infusion rate and the data transfer can occur while the pump is infusing the patient with the medicant FIG 15 is an illustration of a graphical user menu that may be shown on the display device 78 of the remote monitor controller 20 The health care professional may select particular data for transfer or viewing via a number of different parameters such as beginning data ending data types of data etc The particular manner in which particular data may be selected for transfer or viewing is not consid ered important to the invention Modifications and alternative embodiments of the inven tion will be apparent to those skilled in the art in view of the foregoing description This description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode of carrying out the invention The details of the structure and method may be varied substantially without departing from the spirit of the invention and the exclusive use of all modifications which come within the scope of the appended claims 18 reserved What is claimed is 1 A medical apparatus comprisi
35. tep 322 the program branches to step 324 where the time at which the infusion was completed is stored along with the total volume infused At step 326 if there is a malfunction the malfunc tion type the time at which the malfunction occurred and the total volume infused at the time of the malfunction are recorded at step 328 At step 330 if the infusion is resumed when the pump is turned back on after having been turned off during an infusion the time at which the infusion is resumed along with the infusion parameters are stored at step 332 Upon the completion of the programming of a lockout sequence as determined at step 334 i e after step 216 of FIG 5 the time at which the programming of the lockout was completed is stored along with the infusion modes that were locked out At step 338 upon the detection of a bolus request the time at which the bolus was requested is stored at step 340 along with an indication whether the bolus was actually given and the amount of the bolus FIG 7 illustrates the data organization of a portion of the RAM 104 in which infusion data the data stored during the steps of FIG 6 is stored Referring to FIG 7 the infusion data is stored in a number of memory locations 372 Data 10 15 20 25 30 35 40 45 50 55 60 65 8 may be written to the memory location 372 utilizing a pointer 376 which specifies the memory location at which data should be next stored FIG
36. terrupts caused by the SE sensor 130 are assigned to the highest priority so that they are responded to immediately before any other actions are taken by the controller 100 The pump 12 has a number of other features not described herein which are disclosed in the following patent applications each of which is incorporated herein by refer ence U S Ser No 08 399 184 filed Mar 6 1995 entitled Infusion Pump Having Power Saving Modes U S Ser No 08 398 977 filed Mar 6 1995 entitled Infusion Pump With Selective Backlight U S Ser No 08 398 980 filed Mar 6 1995 entitled Infusion Pump With Different Oper ating Modes U S Ser No 08 398 886 filed Mar 6 1995 entitled Cassette For An Infusion Pump U S Ser No 08 399 183 filed Mar 6 1995 entitled Infusion Pump With Dual Latching Mechanism U S Ser No 08 398 887 filed Mar 6 1995 entitled Infusion Pump With Historical Data Recording The operation of the infusion pump 12 is controlled by a computer program stored in the EPROM 104 and executed by the controller 100 A flowchart 200 of the overall opera tion is illustrated in FIG 5 Referring to FIG 5 when the pump 12 is turned on at step 202 the pump is initialized and a test of the pump operation is performed The pump 12 may be turned off temporarily during an infusion in which case the pump 12 may continue the infusion when it is turned back on as described below At step 204 if there i
37. udes a programmable medical treatment means in the form of an infusion pump 12 which is connected to a liquid medicant injection device in the form of a catheter 14 via a liquid conduit schematically shown as 16 The apparatus 10 includes a remote monitor controller 20 which is disposed at a room location remote from the room location at which the infusion pump 12 is located The remote monitor controller 20 could be disposed in a different room of the same building in which the pump 12 is disposed or in a different building than the one in which the pump 12 is disposed The remote monitor controller 20 is connected to a conventional voice data modem 22 via a data link 24 and the modem 22 is also connected to a telephone 26 via a voice link 28 The infusion pump 12 is connected to a conventional voice data modem 30 via a data link 32 and the modem 30 is connected to a telephone 34 via a voice link 36 The two modems 22 30 are interconnected to bidirec tional voice and data communication via a communication link 38 which could be a telephone line for example FIG 2 is a block diagram of the electronics of the remote monitor controller 20 shown schematically in FIG 1 Refer ring to FIG 2 the remote monitor controller 20 includes a microprocessor MP 60 a read only monitor ROM 62 a random access memory RAM 64 and an input output I O circuit 66 all of which are interconnected by an address data bus 68 The microprocessor 60 has
Download Pdf Manuals
Related Search