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1. 1 1 6 8 PES REAL TIME U S Patent Apr 25 2000 Sheet 3 of 13 6 053 887 200 Fig 5 gt YES POWER ON INITIALIZATION AND SELF TEST 204 202 ANY REMAINING VOL OR TIME 2 NO 212 230 25 PERIODS PROGRAM PCA PROGRAM 25 PERIODS LOCKOUT MODE 2 DO LOCKOUT SEQUENCE 214 mo PROGRAMMABLE U S Patent Apr 25 2000 Sheet 4 of 13 6 053 887 9 6 302 STORE PROGRAMMED PARAMETERS PROGRAMMING COMPLETE STORE RUN PARAMETERS 310 STORE TOTAL VOLUME INFUSED STORE TOTAL VOLUME INFUSED 318 NEW RATE VOLUME STORE TOTAL VOLUME INFUSED ALARM TYPE INFUSION COMPLETE STORE TOTAL VOLUME INFUSED STORE TOTAL VOLUME INFUSED MALFUNCTION TYPE STORE RESUMED PARAMETERS LOCKOUT PROGRAMMING COMPLETE STORE MODES LOCKED OUT STORE GIVEN NOT GIVEN BOLUS AMOUNT BOLUS REQUEST U S Patent Fi9 6A Apr 25 2000 Sheet 5 of 13 MONITOR READ THERMOMETER STORE TEMPERATURE READ BLOOD PRESSURE SENSOR STORE BLOOD PRESSURE READ BLOOD GAS SENSOR STORE BLOOD GAS COMPOSITION READ PULSE RATE SENSOR STORE PULSE RATE READ OXYGEN SENSOR STORE OXYGEN CONTENT 352 354 356 358 360 362 364 366 368 370 6 053 887 350 U S P
2. 1 MEDICAL TREATMENT APPARATUS AND METHOD This is a continuation of prior application Ser No 08 703 543 filed Aug 27 1996 now U S Pat No 5 895 321 which is hereby incorporated herein by reference in its entirety BACKGROUND OF THE INVENTION The present invention is directed to a medical treatment apparatus and method for automatically administering a medical treatment to a patient via a medical treatment device such as an infusion pump disposed at a first location and a monitoring and or controlling device disposed at 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 device 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 Prior art systems have been described which monitor the medical condition of a patient at a patient location using a sensing apparatus which has various types of sensors such as a sensor for generating heart rate data and a temperature sensor for monitoring the temperature in the ear canal of the patient Such a prior art system included a remote mon
3. PUMP ECHO CORRECT 2 ERROR MESSAGE SEND ACKNOWLEDGEMENT 482 484 486 U S Patent Apr 25 2000 Sheet 11 of 13 6 053 887 500 502 DATA DUMP AGTIVE YES 504 NO RESET DATA 508 DUMP FLAG DATA DUMP COMMAND NO TRANSMIT ERROR MESSAGE 506 RESPOND TO OTHER COMMAND SET TRANSMIT POINTER TO OLDEST DATA SET DATA DUMP FLAG FETCH FIRST DATA BYTE UPDATE TRANSMIT POINTER 510 FORMAT DATA IN ASCH ENABLE TRANSMIT INTERRUPT SEND FIRST DATA BYTE Fi9 13 U S Patent Apr 25 2000 Sheet 12 of 13 6 053 887 550 TRANSMIT DATA DUMP AGTIVE YES RESPOND TO 556 OTHER INTERRUPT ALL DATA SENT NO FETCH NEXT DATA BYTE DISABLE TRANSMIT INTERRUPT UPDATE TRANSMIT POINTER FORMAT DATA IN ASCII SEND DATA BYTE RESET DATA DUMP FLAG Fig 14 U S Patent Fig 15 PATIENT NAME MALFUNCTIONS AND ALARMS THERAPIES PROGRAMMED LJ THERAPIES STARTED THERAPIES COMPLETED THERAPIES RESUMED DISPLAY Apr 25 2000 PATIENT ID NUMBER Bec L PUMP TURNED ON PUMP TURNED OFF Lj PUMP ON HOLD PUMP RESTARTED ALL DATA Sheet 13 of 13 6 053 887 BEGINNING ENDING DATE DATE EA 7 PIGGYBACKS C TITRATIONS AND RATECHANGES BOLUS STATUS PATIENT 105 DJ INFUSION DATA SAVE TO DISK 6 053 887
4. 604 246 Heck and Robert Fischell pp 66 71 from book chapter 5 291 190 3 1994 Scarola et aly reete 340 825 06 entitled MiniMed Technologies Programmable Implantable 5 295 002 3 1994 Fukushima 364 188 Infusion System describing clinical trials from Nov 1986 JET Stat ebal IMED Status Infusion Management System 6 page 5 317 506 5 1994 Coutr et al 364 413 02 5 338 157 8 1994 Blomquist 417 2 brochure IMED Corporation San Diego CA no date listed 5 361 758 11 1994 Hall et al 128 633 James D Foley and Andries Van Dam Fundamentals of 5 368 562 11 1994 Blomquist et al 604 65 Interactive Computer Graphics selected pages from Chap 5 376 070 12 1994 Purvis et al 604 31 ters 1 and 2 Addison Wesley Publishing Company 1982 5 378 231 1 1995 Johnson et al 604 67 reprinted with corrections 1983 U S Patent Apr 25 2000 Sheet 1 of 13 6 053 887 THERMOMETER 42 Fig 1 pa 0 40 34 26 TELEPHONE TELEPHONE ET TELEPHONE SENSOR 36 30 44 BLOOD GAS SENSOR 28 www 22 24 38 N 48 50 12 REMOTE 20 52 MONITOR 54 CONTROLLER PULSE RATE 58 16 SENSOR 56 14 CATHETER T SENSOR 20 Fig 2 MMC ee E ERE E 24 68 74 64 66 70 82 F REC 34 U S Patent Apr 25 2000 Sheet 2 of 13 6 053 887 CONTROLLER 18 7
5. 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 If the data dump flag was not active as determined at step 502 the routine 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 whe
6. 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 6A is a flowchart of a routine 350 for periodically storing patient medical condition data generated by the sensors 40 44 48 52 56 of FIG 1 in the nonvolatile RAM 104 Referring to FIG 6A at step 352 the thermometer 40 is read and at step 354 data generated by the thermometer 40 is stored in the RAM 104 At step 356 the blood pressure sensor 44 is read and at step 358 data generated by the sensor 44 is stored in the RAM 104 At step 360 the blood gas sensor 48 is read and at step 362 data generated by the sensor 48 is stored in the RAM 104 At step 364 the pulse rate sensor 52 is read and at step 366 data generated by the sensor 52 is stor
7. according to claim 8 wherein the sensor comprises at least one of a blood pressure sensor a blood gas sensor a pulse rate sensor and a blood oxygen sensor 10 An apparatus as defined in claim 8 wherein the remote monitor comprises a display for displaying the medical condition data 11 An apparatus as defined in claim 8 wherein the sensor generates an output signal representative of the condition of the patient and wherein the output signal is input to the programmable medical treatment device 12 medical apparatus comprising a medical treatment device for administering a medical treatment directly to a patient at a patient site the medical treatment device being disposed at the patient site a sensor disposed at the patient site for detecting a medical condition of the patient the sensor being connected to the patient and to the medical treatment device wherein the medical treatment device includes a memory storing medical condition data relating to the medical condition of the patient detected by the sensor a remote controller at a second location remote from the patient site for controlling the medical treatment 10 15 20 16 device the remote controller comprising a device for controlling the medical treatment device to change the medical treatment administered to the patient and a remote monitor disposed at the second location opera tively coupled to the sensor via a telephone link and the medical treatme
8. al 33 125 5 485 408 1 1996 Blomquist 364 578 4 624 661 11 1986 Arimond 604 151 5 509 422 4 1996 Fukami 128 670 4 676 776 6 1987 Howson 604 31 5 522 396 6 1996 Langer et al 128 696 4 696 671 9 1987 Epstein et al 604 67 5 544 651 8 1996 Wilk 128 633 4 731 051 3 1988 Fischell 606 67 5 555 638 9 1996 Evers et al set 604 66 4 756 706 7 1988 Kerns et 604 66 5 573 506 11 1996 Vasko 604 65 4 797 840 1 1989 Fraden 364 557 5 582 593 12 1996 Hultman tt 604 65 4 803 625 2 1989 Fu et al 364 413 03 5 643 212 7 1997 Coutr et al 604 131 4 810 243 3 1989 Howson 604 31 4 828 545 5 1989 Epstein et al 604 66 OTHER PUBLICATIONS 4 850 972 7 1989 Schulman et al 604 151 m E 1 4 865 584 9 1989 Epstein et 604 67 Electronic s Article of Feb 1990 by Jack Shandle entitled 4 901 221 2 1990 Kodosky et al 364 200 Who Will Dominate the Desktop in 905 pp 48 50 4 925 444 5 1990 Orkin et al st 604 80 Chapter 5 entitled Direct Manipulation from Shneiderman 4 933 843 6 1990 Scheller et al 364 413 01 Designing the User Interface Strategies for Effective 4 942 514 7 1990 Miyagaki et al 364 190 Human Computer Interaction Addison Wesley Publish 4 952 928 8 1990 Carroll et al 340 825 54 ing Company Second Edition 1992 reprinted with cor 4 995
9. 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 date ending date 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 The ability to generate patient medical condition data via the sensors 40 44 48 52 56 and transfer that data to the remote monitor controller allows a health care professional to review and analyze the patient medical condition data and alter the infusion therapy applied to the patient by the infusion pump 12 based upon such review and analysis Alternatively instead of such manual analysis by a health care professional an automatic means for analyzing the patient medical condition data and altering the infusion therapy could be provided 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 f
10. 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 The program mable medical device includes various types of sensors for generating patient medical condition data which is transmit ted to the remote monitor controller The medical treatment provided to the patient can be changed in response to analysis of the patient medical data at the remote location 15 Claims 13 Drawing Sheets REMOTE MONITOR CONTROLLER 6 053 887 Page 2 U S PATENT DOCUMENTS 5 395 321 3 1995 Kawahara et al 604 67 5 395 329 3 1995 Fleitschhackor et al 604 95 4193971 11 1979 a aa S uya 128 702 5 400 246 3 1995 Wilson et al 364 146 4 413 314 11 1983 Slater et al 364 188 5 412 400 5 1995 Takahara et al 345 19 4 449 538 5 1984 Corbitt et al 128 760 5 429 602 7 1995 Hauser sees 604 65 4 531 527 7 1985 Reinhold Jr et al 128 696 5 469 855 11 1995 Pompei et al 128 664 4 561 443 12 1985 Hogrefe et al 128 419 PG 5 482 446 1 1996 Williamson et al 417 474 4 586 260 5 1986 Baxter et
11. 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 and monitoring the condition of the patient Referring to FIG 1 the appa ratus 10 includes 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 v
12. 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 rence of an 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 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 th
13. to implement the transmit command step 458 shown schemati cally in FIG 10 Referring to FIG 12 the pump command is 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 knows 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 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 pump controller 10 15 20 25 30 35 40 45 50 55 60 65 12 100 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
14. 268 2 1991 Ash et al 73 861 05 rections 1993 5 07868 1 1992 Sanot ei al 604 67 Literature of Baxter s MultiPlex Series 100 Fluid Man 5 100 380 3 1992 Epstein et al 604 67 agement System 2 pp no date listed _ 5 109 849 5 1992 Goodman et al 128 633 Literature of Baxter Introducing MultiPlex Series 100 5 115 133 5 1992 Knudon 250 341 Fluid Management System copyright 1988 5 116 312 5 1992 Blankenship et al 604 66 Literature describing Baxter s Flo Gard amp 6201 Volumetric 5 137 023 8 1992 Mendelson et al 128 633 Infusion Pump copyrighte 1992 5 152 296 10 1992 Simons 128 670 Literature of I Flow Corporation advertising its Vivus 4000 5 153 827 10 1992 Coutr et al 364 413 02 Infusion System iD dd One page article by Jerry Hirsch entitled Portable IV Frees s 1 67 235 12 1992 SERO d dd 18 1664 Patients printed in The Orange County Register D section 5 191 891 3 1993 Righter 128 710 Nov 21 1991 5 207 642 5 1993 Orkin et al 604 65 Bedder et al Cost Analysis of Two Implantable Narcotic 5 213 099 5 1993 Tripp Jr 128 633 Delivery Systems Journal of Pain And Symptom Manage 5 226 425 7 1993 Righter 128 710 ment vol 6 No 6 Aug 1991 pp 368 373 5 230 623 7 1993 Guthrie et al 433 72 Peter Lord Hossein Allami Mark Davis Raul Dias Patrice 5 256 157 10 1993 Samiotes et al
15. A 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 New Pressure Setting Given Not Given Bolus Amount Titration New Parameters Power Off Time of Power Off Version No Software Version Number Referring to Table 1 and FIG 6 when the power to the infusion pump 12 is turned on the date and time of the power turn on is recorded When the pump is completely programmed pursuant to one of steps 220 224 228 232 236 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 that 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 I
16. 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 CR 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 response 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 s
17. SENSOR Block Medical Growing With Home Infusion Therapy taken from INVIVO The Business and Medicine Report Apr 1991 pp 7 9 TEEE 488 and VXIbus Control Data Acquisition and Analysis the Most Choices select pages taken from National Instruments Application Software Products and Application Software Overview 1991 17 pages LabView 2 User Manual Chapter 2 The Front Panel taken from National Instruments Corporation Jan 1990 pp 1 36 J C Crone Jaromir Belic and Roger W Jelliffe M D A Programmable Infusion Pump Controller taken from 30th Annual Conference on Engineering in Medicine and Biol ogy Nov 5 9 1977 pp A 35827 through A 35837 Selective portions of Chapter 9 of Mayhew Principles and Guidelines In Software User Interface Design Prentice Hall PTR Englewood Cliffs New Jersey 1992 List continued on next page Primary Examiner Michael Buiz Assistant Examiner Daphna Shai Attorney Agent or Firm Perry Hoffman 57 ABSTRACT A medical treatment apparatus is provided with a program mable medical device disposed at a first room location and a remote monitor and or controller disposed at a second room location The programmable medical device is used to administer a medical treatment to a patient and the remote monitor controller maybe used to monitor the operation of the medical device control the operation of the medical device and or to transfer data from the medical
18. United States Patent ro Levitas et al US006053887A 11 Patent Number 6 053 887 4 Date of Patent Apr 25 2000 54 MEDICAL TREATMENT APPARATUS AND METHOD 75 Inventors Doron Levitas Shan Padda both of Chicago Alan E Jordan San Diego Calif Sam Russo Lisle Larry Wilson Poway Calif 73 Assignee Baxter Healthcare Inc Deerfield Ill Notice This patent is subject to a terminal dis claimer 21 Appl No 09 206 075 22 Filed Dec 4 1998 Related U S Application Data 63 Continuation of application No 08 703 543 Aug 27 1996 Pat No 5 895 371 Cle NE A61M 31 00 32 USE re etes 604 49 604 65 58 Field of Search 604 65 66 67 604 49 50 151 152 153 154 155 56 References Cited U S PATENT DOCUMENTS 3 739 943 6 1973 Wilhelmson et al 222 59 3 858 574 1 1975 Page 128 205 T 3 910 257 10 1975 Fletcher et al 128 2 1 A List continued on next page OTHER PUBLICATIONS A H McMorris J L Kelleway B Tapadia and E L Dohm ann Are Process Control Rooms Obsolete taken from Control Engineering pp 42 47 Jul 1971 Abbott Laboratories The Blue Line System Lifecare copy right 1990 L C Sheppard Computer Based Clinical Systems Auto mation and Integration taken from 39th ACEMB Sep 13 16 1986 pp 73 75 PRESSURE SENSOR OXYGEN
19. atent Apr 25 2000 Sheet 6 of 13 6 053 887 372 374 376 PUMP DATA PATIENT DATA J 380 382 F19 8 SET POINTER TO NEXT ADDRESS 384 IS POINTER AT LAST ADDRESS 2 SET POINTER FIRST ADDRESS 388 WRITE TIME STAMP IN LOG WRITE EVENT DATA IN LOG 390 U S Patent Apr 25 2000 Sheet 7 of 13 6 053 887 IDENTIFY 400 402 Fig 9 404 READ CHARACTERS 410 FROM PUMP DETERMINE lt gt 406 PUMP TYPE 48 ERROR CORRECT YES MESSAGE RESPONSE 412 NO SEND PUMP DISPLAY REQUEST READ CHARACTERS FROM PUMP 420 422 TIMER EXPIRED NO ERROR MESSAGE DETERMINE PUMP TYPE 4 26 U S Patent Apr 25 2000 Sheet 8 of 13 6 053 887 USER SELECTS MODE yf 0 COMMAND DISPLAY GET PUMP S MODE PUMP DISPLAY 2 KEYPAD FROM PUMP 52 NO SHOW PUMP S NO DISPLAY ON SCREEN 4 EXIT COMMAND COMMAND TO PUMP x 465 474 DOWNLOAD SS NO Dum NO DATA LOG DOWNLOAD DATALOG YES VIEW DATA LOG DISPLAY PUMP MONITOR 67 GET PUMPS DISPLAY FROM PUMP 4 SHOW PUMP S DISPLAY ON SCREEN 468 EXIT MONITOR MODE U S Patent Apr 25 2000 Sheet 9 of 13 6 053 887 78 Ei PERU mas FIG 11 78 Fig U S Patent Apr 25 2000 Sheet 10 of 13 6 053 887 458 V 480 COMMAND PUMP COMMAND READ CHARACTERS FROM PUMP
20. dapted to be connected to the patient a conduit connected to the liquid injection device a pumping mechanism for pumping a liquid drug through the conduit and into the patient via the liquid injection device and a controller for controlling the pumping mechanism a sensor for detecting a medical condition of the patient the sensor being disposed at the first room location and being connected to the patient and to the programmable treatment device wherein the programmable medical treatment device fur ther comprises a memory storing medical condition data relating to the medical condition of the patient detected by the sensor a remote controller for controlling the programmable medical treatment device the remote controller being disposed at a second room location remote from the first room location at which the programmable medical treatment device is disposed the remote controller comprising a controller for controlling the programmable medical treatment device and a remote monitor operatively coupled to the sensor via the programmable medical treatment device effec tive for retrieving the stored medical condition data from the memory for monitoring the medical con dition detected by the sensor and apparatus for transmitting the stored medical condition data relating to the medical condition of the patient detected by the sensor from the first room location to the remote monitor 6 053 887 15 9 A medical apparatus
21. e infusion the program would proceed from step 212 directly to the ready to run step 210 which would 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 6 053 887 7 of events which trigger the storage of data are listed in the left hand column of Table 1 and the infusion data that is recorded 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 DAT
22. e 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 schematically 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 FIG 6 illustrates a number of data recording steps per formed during the operation of the infusion pump FIG 6A is a flowchart of a routine for storing patient condition data generated by the sensors of FIG 1 FIG 7 is a representation of a portion of the memory of the infusion pump FIG 8 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 main operating 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
23. ed 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 infusion data and patient medical condition 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 professional at the remote monitor controlle
24. ed in the RAM 104 At step 368 the blood oxygen sensor 56 is read and at step 370 data generated by the sensor 56 is stored in the RAM 104 The routine 350 may be performed periodically such as every minute for example Other ways of reading the sensors could be utilized and the particular manner in which the sensors are read is not considered important to the invention 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 and patient medical condition data the data stored during the steps of FIG 6A are stored Referring to FIG 7 the infusion data is stored in a number of memory locations 372 and the medical condition data is stored in a number of memory locations 374 Data may be written to the memory locations 372 utilizing a pointer 376 which speci fies the memory location at which data should be next stored FIG 8 is a flowchart of a routine 380 for storing data in the memory locations 372 374 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 w
25. he 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 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 bypasse
26. ia a voice link 10 15 20 25 30 35 40 45 50 55 60 65 4 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 The infusion pump 12 is connected to five conventional sensors which are connected to the patient and which detect various medical conditions of the patient The sensors include a thermometer 40 connected to the infusion pump 12 via a line 42 a blood pressure sensor 44 connected to the pump 12 via a line 46 a blood gas sensor 48 connected to the pump 12 via a line 50 a pulse rate sensor 52 connected to the pump 12 via a line 54 and a blood oxygen sensor 56 connected to the pump 12 via a line 58 Not all of the sensors 40 44 48 52 56 are required for operation of the apparatus 10 and other types of sensors could be used 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 memory 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 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 c
27. ircuit 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 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 battery 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
28. ith new data however the number of memory 6 053 887 9 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 Data may be stored in the memory locations 374 in the same manner 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 different 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
29. itor ing device provided at a location remote from the sensing apparatus to which sensing data was transmitted and the remote monitoring device transmitted control signals to the sensing apparatus at the patient location to control the operation of the sensing apparatus such as by controlling the sampling rate of the sensors Such a prior art system also included display means at the remote location for generating visual displays relating to the sensed medical conditions One example of such a prior art system is disclosed in U S Pat No 3 910 257 to Fletcher et al That patent discloses a sensing apparatus in the form of a bio belt unit 11 12 and a remote monitoring device in the form of a data acquisition unit 14 The bio belt unit 11 12 incorporates different types of sensors including an ear canal sensor 21 and a plurality of ECG electrodes 22 The data acquisition unit 14 receives patient medical data from the bio belt unit 11 12 and also transmits control commands to control the operation of the bio belt unit 11 12 See e g FIG 2 column 5 lines 1 7 column 6 lines 6 10 and column 6 lines 39 47 of the Fletcher et al patent U S Pat No 5 038 800 to Oba also discloses the concept of providing a patient monitoring apparatus at a patient location and a remote monitoring device having the capa bility of receiving patient medical data from the patient monitoring apparatus and controlling the operation of the patient monito
30. 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 in connection with FIGS 13 14 If the user inputs 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
31. n 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 102 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 is any remaining volume of liquid to be infused by the pump or 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 t
32. n data and or patient 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 6 053 887 13 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 remote 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
33. nfused 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 10 15 20 25 30 35 40 45 50 55 60 65 8 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 step 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
34. nt device effective for retrieving the stored medical condition data from the memory for monitoring the medical condition detected by the sen Sor 13 The medical apparatus of claim 12 further comprising apparatus for enabling bi directional voice data communi cation over the telephone line between the medical treatment device and the remote controller 14 The medical apparatus according to claim 12 wherein the sensor comprises at least one of a blood pressure sensor a blood gas sensor a pulse rate sensor and a blood oxygen sensor 15 The medical apparatus as defined in claim 12 wherein the medical treatment device comprises a programmable infusion pump for infusing a drug into the patient
35. oftware 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 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 10 15 20 25 30 35 40 45 50 55 60 65 10 of infusion pump may have a display capable of displaying 32 characters Steps 416 426 determine the type of infusion pump based on the number 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 receiv
36. ping mechanism The invention is also directed to a method of administer ing a medical treatment to a patient via a programmable medical treatment apparatus The method includes the steps of a automatically administering a medical treatment to a patient with a programmable medical treatment apparatus disposed at a first room location b detecting a medical condition of the patient with a sensor at the first room location c transmitting medical condition data relating to the medical condition from the first room location to a second room location and d transmitting a control com mand from the second room location to the programmable medical treatment apparatus at the first room location to change the medical treatment automatically administered during step a the control command being based upon the medical condition data transmitted during step c The method may also include the step of analyzing the medical condition data prior to transmitting the control command the step of displaying the medical condition data on a visual display disposed at the second room location and the step of storing the medical condition data in the memory of a remote monitor controller disposed at the second room location These and other features and advantages of the present invention will be apparent to those of ordinary skill in the art 6 053 887 3 in view of the detailed description of the preferred embodiment which is made with referenc
37. r 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 and or patient medical condition data is transferred from the pump 12 to the remote monitor controller 20 and a view data mode in which the infusion data and patient 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 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 moni
38. re 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 1s performed Referring to FIG 14 at step 552 the status of the data dump flag is checked 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 portions of the infusio
39. ring apparatus from a remote location The patient monitoring apparatus is provided as a number of bedside monitors 3A 3C and the remote monitoring appa ratus is provided is in the form of a central monitor 2 The Oba patent discloses that bedside monitors 3A 3C and the central monitor 2 are interconnected via a local area network LAN The operation of the bedside monitors 3A 3C can be controlled from the central monitor 2 See for example column 4 lines 4 11 column 4 lines 24 27 and column 4 lines 40 42 of the Oba patent 10 15 20 25 30 35 40 45 50 55 60 65 2 U S Pat No 4 803 625 to Fu et al also discloses the concept of providing a patient monitoring apparatus at a patient location and a remote monitoring device having the capability of receiving patient medical data from the patient monitoring apparatus As shown in FIG 2 of the Fu et al patent the patient monitoring apparatus is provided in the form of a number of home units 60 each of which includes a number of sensors including a blood pressure module 92 a scale module 84 a temperature module 86 and an ECG electrode unit 90 Each of the home units 60 is connected to a central unit 20 via a modem 62 connected to each home unit 60 and a modem 22 connected to the central unit 20 The Fu et al patent also generates medication reminders to a patient See for example FIG 13 SUMMARY OF THE INVENTION The invention i
40. rom the spirit of the invention and the exclusive use of all modifications which come within the scope of the appended claims is reserved What is claimed is 1 A medical apparatus comprising programmable medical device disposed at a first room location a sensor for detecting a medical condition of a patient the sensor being disposed at the first room location being connected to the patient and being connected to the programmable medical device wherein the programmable medical device comprises a memory storing medical condition data relating to the medical condition of the patient detected by said sen sor and a remote controller for controlling the programmable medical device the remote controller being disposed at a second room location remote from the first room location at which the programmable medical device is disposed the remote controller comprising a controller for controlling the programmable medical device and a remote monitor operatively coupled to the sensor via said programmable medical device effective for retrieving stored medical condition data from the memory for monitoring the stored medical condition detected by the sensor 10 15 20 30 35 40 45 50 55 60 65 14 2 The medical apparatus according to claim 1 wherein the sensor comprises at least one of a blood pressure sensor blood gas sensor a pulse rate sensor and a blood oxygen sensor 3 The medical apparatu
41. s directed to a medical treatment apparatus having programmable medical treatment means for auto matically administering a medical treatment directly to a patient the programmable medical treatment means being disposed at a first room location a sensor for detecting a medical condition of the patient the sensor being disposed at the first room location and being connected to the patient and a remote controller for controlling the programmable medical treatment means the remote controller being dis posed at a second room location remote from the first room location at which the programmable medical treatment means is disposed The remote controller includes means for controlling the programmable medical treatment means to allow the medical treatment being administered to the patient to be changed and the medical treatment apparatus also includes remote monitoring means operatively coupled to the sensor for monitoring the medical condition detected by the sensor the remote monitoring means being disposed at the second room location The programmable medical treatment means may be an infusion pump for infusing a drug into the patient the infusion pump being composed of a liquid injection device adapted to be connected to the patient a conduit connected to the liquid injection device a pumping mechanism for pumping a liquid drug through the conduit and into the patient via the liquid injection device and a controller for controlling the pum
42. s of claim 1 further comprising a routine for transmitting said stored medical condition data detected by said sensor responsive to a data dump com mand 4 An apparatus as defined in claim 1 further comprising a routine for transmitting medical condition data relating to said medical condition of the patient detected by the sensor from the first room location to the remote monitor at said second location 5 An apparatus as defined in claim 1 wherein the pro grammable device comprises an infusion pump for infusing a drug into the patient 6 An apparatus as defined in claim 1 wherein the pro grammable medical device comprises a liquid injection device adapted to be connected to the patient a conduit connected to the liquid injection device a pumping mechanism for pumping a liquid drug through the conduit and into the patient via the liquid injection device and a controller for controlling the pumping mechanism 7 An apparatus as defined in claim 1 wherein the sensor generates an output signal representative of the condition of the patient and wherein the output signal is input to the programmable medical device 8 A medical apparatus comprising programmable medical treatment device for automatically administering a medical treatment directly to a patient the programmable medical treatment device being dis posed at a first room location the programmable medi cal treatment device comprising a liquid injection device a
43. s 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 10 15 20 25 30 40 45 50 55 60 65 6 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 infusion 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 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
44. tor 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 6 053 887 11 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 transmitted 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
45. 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 6 053 887 5 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 interrupts 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 herei

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