United States Patent
`
`[19]
`
`Sancoff et al.
`
`[11] Patent Number:
`
`5,078,683
`
`[45] Date of Patent:
`
`Jan. 7, 1992
`
`[54] PROGRAMMABLE INFUSION SYSTEM
`
`OTHER PUBLICATIONS
`
`lllllllllllllllflllili
`USOO5078683A
`
`[75]
`
`Inventors: Gregory E. Sancoff, Leucadia; Mark
`Mcwilliams, San Diego; Howard S.
`Barr, Escondido; Edward T. Cordner,
`Jr., Carlsbad; Russell C. Barton,
`Monrovia, all of Calif.
`
`Assignee: Block Medical, lnc., Carlsbad, Calif.
`
`Appl. No.: 513,937
`
`Filed:
`
`May 4, 1990
`
`Int. Cl.’ ............................................. .. A61M 5/20
`U.S. Cl. ...................................... .. 604/67; 604/31;
`417/474; 128/DIG. 13
`Field of Search ................. .. 604/65, 67, 131, 189,
`604/153, 245, 246, 30, 31; 128/DIG. l2, DIG.
`13; 417/44, 45, 474
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`for the
`Pharmacia Deltec—one page advertisement
`CADD—1, CADD—PCA and CADD—Plus, dated 9/88.
`Provider One—-sixteen page instruction manual, 2/90.
`Provider 6000—sixty-four page operating manual (un-
`dated).
`Provider 5500—one page advertisement (undated).
`Infumed 400—one page advertisement (undated).
`Multiplex Series 100 Fluid Management System—three
`page borchure (1988).
`I Flow Multi—Drug Infusion System—four page bro-
`chure (undated).
`
`Primary Examiner—Stephen C. Pellegrino
`Asstlvtant Examiner—Steven J. Shumaker
`Attorney, Agent, or Firm—Baker, Maxham, Jester &
`Meador
`
`[57]
`
`ABSTRACT
`
`A programmable infusion system includes a disposable
`IV tubing apparatus for conveying intravenous fluid
`from a source to a patient. A compact, portable case has
`a receptacle for removably receiving a segment of the
`disposable apparatus. A peristaltic pump is mounted in
`the case for engaging the segment of the disposable
`apparatus and pumping intravenous fluid therethrough.
`A motor is mounted in the ease and is connected for
`driving the pump upon energization thereof. A bar code
`reader is mounted in an edge portion of the case for
`sensing a bar code label attached to the source of intra-
`venous fluid, such as a bag. The bar code label repre-
`sents the prescribed fluid delivery parameters. These
`are read and displayed in alphanumeric form by the
`system when the edge portion of the case containing the
`bar code reader is passed over the label. A micro-con-
`troller mounted in the case energizes the motor so that
`the peristaltic pump conveys the fluid through the dis-
`posable apparatus in accordance with the delivery rate
`parameters.
`
`8 Claims, 6 Drawing Sheets
`
`ACTA EX. 1023-001
`
`.
`
`................... .. 604/891
`
`.
`1/1985 Borsanyi et al.
`4,493,706
`. .......... 604/66
`4,551,133 11/1985 Zegers de Bey] et al.
`4,553,958 ll/1985 LcCocq ................................. 604/67
`4,559,038 12/1985 Berg et al.
`.
`4,559,040 12/1985 Hores et al.
`4,565,542
`1/1986 Berg .
`4,573,994
`3/1986 Fischell et al.
`4,650,469
`3/1987 Berg et al.
`.
`4,653,987
`3/1987 Tsuji et al.
`.
`4,671,792 6/1987 Borsanyi
`.
`4,681,566 7/1987 Fenton, Jr. et al.
`4,762,518
`8/1988 Kreinick .
`.
`4,798,590
`1/1989 O‘Leary et al.
`4,853,521
`8/1989 Claeys et al. ........................ 235/375
`4,925,444 5/1990 Orkin et al.
`604/80
`4,966,579 10/1990 Polaschegg ......................... .. 60-4/65
`4,976,590 12/1990 Baldwin .
`4,978,335 12/1990 Arthur, II1 ............................ 604/67
`4,997,347 3/ 1991 Roos .
`
`................ 604/135
`
`ACTA Ex. 1023-001
`
`

`
`U.S. Patent
`
`Jan. 7, 1992
`
`Sheet 1 of 6
`
`5,078,683
`
`.
`
`'
`
`;
`
`as
`
`:-
`
`i !i
`
`[
`
`(
`
`-
`
`O
`
`/
`_L
`_s_TE2?/sTor= 70
`vznxrv
`
`72 7
`
`jq%\
`
`____\___.____
`
`——12
`
`Séius
`‘
`PRIME
`
`............._.-..I....._ ..
`,
` "-‘ I"-' iv-'-7-"=5 -- -- -3'-"-'-7.‘-_-‘-'5‘ T./""1,/._0_\
`--é.!IEA:'!_"_
`'
`' “_’d.2j-éE;§v-a-run-s-n-t-and
`\
`
`UUUDUUUUUUUUUUUU
`
`UUUUUDUUUDUDUUDU
`
`E:-n‘E-_" 3— on
`
`*2
`
`FIG. 2
`
`ACTA EX. 1023-002
`
`ACTA Ex. 1023-002
`
`

`
`U.S. Patent
`
`0 5,078,683
`
`ACTA EX. 1023-003
`
`ACTA Ex. 1023-003
`
`

`
`Jan. 7, 1992
`
`Sheet 3 of 5
`
`5,078,683
`
`ACTA EX. 1023-004
`
`ACTA Ex. 1023-004
`
`

`
`U.S. Patent
`
`Sheet 4 of 5
`
`5,078,683
`
`BATTERY :1 sense
`BATTERY :2 SENSE
`EXT.
`POWER sans:
`BUBBLE DET. sense
`
`111158
`120
`172
`
`54
`
`16‘
`
`
`
`..__'[:......_..—-
`
`09D
`
`114a
`114
`
`1
`
`Illlflilll
`
`CONTROLLER
`
`154
`
`uoToR
`DRIVE
`CIRCUITRY
`
`122
`
`51
`
`.
`
`152
`
`IR
`uooeu
`
`Tx. RX
`
`124
`
`MOTOR
`SHAFT
`ENCODER
`
`134
`
`°°s°";g5cIH°N
`
`LCD
`
`DISPLAY
`BAR coo:
`
`CONTROLLER
`
`_
`
`o1sposAaL5 1 9
`noon SVITCH
`
`KEYPAD/SWITCH
`oacoosn
`
`PUMP SHAFT 127
`ENCODER
`
`BUZZER.
`ALARM.
`LED
`
`145
`
`126
`
`48
`
`1
`
`150
`
`112
`
`READER
`HEAD
`
`KEYPAD
`0R
`SWITCHES
`
`ACTA EX. 1023-005
`
`ACTA Ex. 1023-005
`
`

`
`Sheet 5 of 6
`
`5,078,683
`
`FIG. 12A
`
`POVlER—UP
`
`INITIALIZATIO
`
`TURN-ON BAR CODE
`
`READER-PROMPT
`
`USER TO READ
`
`BAR-CODE
`
`TYPE VALID?
`
`IS TIMEOUT
`
`EXCEDED?
`
`VERIFY PRESCRIPTION
`
`INPUT. PRINT SCREEN‘
`
`HAS PRESCRIPTION
`
`BEEN VERIFIED?
`
`INSTRUCT USER TO
`
`LOAD OR UNLOAD
`
`DISPOSABLE
`
`PRIME PUMP AND
`
`RUN DIAGNOSTICS
`
`T0 FIG. 128
`
`TO FIG.
`
`12B
`
`ACTA EX. 1023-006
`
`ACTA Ex. 1023-006
`
`

`
`U.S. Patent
`
`Sheet 6 of 6
`
`5,078,683
`
`FROM FIG.12A
`
`FROM FIG.12A
`
`INFORM USER -
`
`PUMP READY
`
`HAS START
`
`BEEN PUSHED?
`
`PUMP STARTS
`
`(INTERRUPTS RUNNING)
`
`HAS STOP
`
`BEEN PRESSED?
`
`GENERATED WARNING?
`
`INFORM USER &
`STOP IF NECESSARY
`
`FIG. 12B
`
`10
`84
`88
`86
`PIE» PHARMACY OR
`VERIFUSE 1 “°"E BASE ._ NURSE snmon
`
`LINE
`
`FIG.
`
`1 1
`
`ACTA EX. 1023-007
`
`ACTA Ex. 1023-007
`
`

`
`1
`
`5,078,683
`
`2
`
`PROGRAMMABLE INFUSION SYSTEM
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application is related to co-pending U.S. patent
`application Ser. No. 07/518,777 entitled DISPOS-
`ABLE INFUSION APPARATUS AND PERlSTAL-
`TIC PUMP FOR USE THEREWITI-l, filed on even
`date herewith.
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates to medical devices, and
`more particularly, to an improved programmable infu-
`sion system for delivering intravenous drugs at a con-
`trolled rate to a patient.
`It is often necessary to intravenously supply patients
`with pharmaceutically active liquids over a long period
`of time at a controlled rate. It is desirable that this be
`
`accomplished while the patient is in an ambulatory
`state.
`
`The prior art includes devices that employ a bag
`filled with fluid medication that
`feeds by gravity
`through IV tubing having drip or other controllers. It is
`difficult for a patient to be ambulatory with a gravity
`fed infusion device. In addition, flow control in this
`type of device is very limited.
`Another prior art infusion apparatus comprises an
`elastic bladder forming a liquid container, an elongated
`cylindrical housing enclosing the bladder, a flow con-
`trol valve, and tubing for supply of the liquid to the
`patient. The elastic walls of the bladder expand along
`the walls of the cylindrical housing when filled with the
`liquid, and provide the pressure for expelling the liquid.
`The bladder is typically filled by hand with a syringe
`which often requires an inordinate amount of force.
`Another drawback is that the bladder is forced to ex-
`
`pand into an unnatural elongated configuration along
`the housing walls as it is filled. As a result of this unnatu-
`ral configuration, the pressure of the bladder varies
`widely with the volume of liquid therein. Therefore, in
`most cases this type of elastic infusion apparatus does
`not have a reasonably stable pressure and flow rate over
`the infusion period. Most of such devices either have a
`flow rate that decreases with pressure, which decreases
`with volume, or one that remains roughly constant until
`the end where it surges. Attempts have been made to
`control pressure and flow rates by means of compli-
`cated and expensive flow control valves and devices.
`Other approaches have utilized exotic and expensive
`elastic materials in an effort to control the pressures and
`flow rates.
`
`Another type of infusion apparatus uses pressurized
`gas as the driving force for the intravenous liquid. In
`such systems there may be hydraulic feedback through
`the pneumatic source in order to precisely regulate
`hydraulic pressure. See for example U.S. Pat. Nos.
`4,430,078 of Sprague, 4,335,835 of Beigler et al., and
`4,327,724 of Birk et al. Such pneumatically driven infu-
`sion devices tend to have reducing flow rates and pres-
`sures as the stored pressurized gas source is exhausted.
`Still another type of infusion apparatus employs a
`peristaltic or other positive displacement pump which is
`electrically driven. Programmable infusion pumps have
`been provided having the capability for precise tailor-
`ing of the fluid delivery rate parameters in different
`modes, such as, continuous, intermittent, PCA (patient
`controlled analgesic) and TPN (total parenteral nutri-
`
`tion). Originally such programmable infusion pumps
`were large and not well suited for ambulatory patients.
`They used complex and expensive replacement pump
`cartridges to maintain sterility. More recently, small
`programmable infusion pumps have been available with
`disposable plastic cartridges that engage a peristaltic
`pump. However such cartridges have been bulky and
`expensive and have required excessive drive power in
`the pumps, leading to rapid battery drain.
`A major drawback of existing programmable infusion
`systems is that they require trained operators to pro-
`gram the same. There is an ever increasing desire in the
`health care field to get patients out of expensive hospital
`care environments and back to their homes. Many such
`patients require intravenously administered medications
`but are unable to program existing programmable infu-
`sion systems themselves and trained operators cannot
`economically visit their homes. In addition, many such
`patients are unable to change the delivery rates in ac-
`cordance with subsequent physician prescriptions. Fur-
`thermore, they cannot effectively verify the prescribed
`delivery parameters.
`Accordingly,
`it would be desirable to provide an
`improved programmable infusion system for delivering
`intravenous drugs at a controlled rate to an ambulatory
`patient that can be more easily programmed by a pa-
`tient, and which will allow patient verification of the
`prescribed delivery parameters.
`SUMMARY OF THE INVENTION
`
`It is therefore the primary object of the present inven-
`tion to provide an improved programmable infusion
`pump for an ambulatory patient which enables intrave-
`nous fluid delivery parameters to be readily pro-
`grammed and verified by the patent.
`Our invention comprises a programmable infusion
`system which includes a disposable IV tubing apparatus
`for conveying intravenous fluid from a source to a pa-
`tient. The system further includes a compact, portable
`case having a receptacle for removably receiving a
`segment of the disposable apparatus. A peristaltic pump
`is mounted in the case for engaging the segment of the
`disposable apparatus and pumping intravenous fluid
`therethrough. A motor is mounted in the case and is
`connected for driving the pump upon energization
`thereof. A bar code reader is mounted in an edge por-
`tion of the case for sensing a bar code label attached to
`the source of intravenous fluid, such as a bag. The bar
`code label represents the prescribed fluid delivery pa-
`rameters. These are read by the system when the edge
`portion of the case containing the bar code reader is
`passed over the bar code label. The bar code reader
`generates bar code signals representative of the fluid
`delivery parameters. A display is mounted in the case
`for visualizing information in alphanumeric form. A
`micro-controller mounted in the case receives the bar
`
`code signals and causes the display to provide a visual
`indication of the delivery rate parameters in alphanu-
`meric form for verification by the patient. The micro-
`controller energizes the motor so that the peristaltic
`pump conveys the fluid through the disposable appara-
`tus in accordance with the delivery rate parameters.
`In the illustrated embodiment of our invention the
`system includes a keypad mounted in the case for en-
`abling the user to send commands to the micro-com
`troller. A detector mounted in the case optically detects
`the presence of a bubble inside the segment of the dis-
`
`ACTA EX. 1023-008
`
`ACTA Ex. 1023-008
`
`

`
`5,078,683
`
`3
`posable apparatus and sends a bubble detect signal to
`the micro-controller. An occlusion detector mounted in
`
`the case detects an abnormal expansion of the segment
`of the disposable apparatus inside the case and sends an
`occlusion detect signal to the micro—controller.
`In accordance with another aspect of our invention, a
`programmable infusion system is provided with the
`capability for communicating with a remote computer
`for receiving and conveying to the micro-controller
`commands for causing it to modify the delivery rate
`parameters. Thus the patient may communicate over a
`modem with a pharmacy or a nurse station so that a
`different infusion administration can be implemented.
`The delivery rate parameters read in from the bar
`code label or communicated from the remote computer
`may include volume per unit time and total volume.
`They may also include various delivery modes selected
`such as continuous, Bolus, periodic and aperiodic.
`The preferred embodiment of our programmable
`infusion system has the capability for detecting an inter-
`rupt condition such as the failure to load a disposable
`apparatus therein, an occlusion in the disposable appara-
`tus, a motor failure, a pump failure, or a bubble in the
`disposable apparatus. The micro-controller can then
`de-energize the motor in response to the detection of an
`interrupt condition and cause the display means to dis-
`play a warning of the interrupt condition in alphanu-
`meric forrn. It can also cause an audible warning to be
`generated, such as a succession of beep tones, and a
`visible warning to be given in the form of an illuminated
`red LED. The system also preferably has the capability
`for detecting when the source of intravenous fluid is
`nearly empty and for activating the audible and/or
`visible warning in response thereto to advise the patient
`to replace the near empty bag of intravenous solution.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 illustrates a preferred embodiment of our
`programmable infusion system. The case of the system
`which contains the pump and electronics is illustrated in
`phnatom lines. The disposable of our preferred embodi-
`ment is illustrated in relation to conventional IV tubing,
`IV bag, spike connector and leur fittin g. The IV tubing
`segments are broken at various locations to make this
`figure compact.
`FIG. 2 is an enlarged fragmentary view of the case of
`our invention illustrating a disposable installed therein
`and its relationship to the peristaltic pump of the sys-
`tem.
`
`FIG. 3 is a further enlarged view of the perstaltic
`pump and the door of the disposable of our preferred
`embodiment. The IV tubing segments are not shown in‘
`this figure.
`FIG. 4 is an enlarged view of the three segments of
`tubing that form part of the disposable of the preferred
`embodiment of our invention.
`FIG. 5 is an enlarged side elevation view of one of the
`fingers of the perstaltic pump of the preferred embodi-
`ment showing how it squeezes shut the intermediate
`tubing segment of the disposable.
`FIG. 6 is a side elevation view of one of the cam
`wheels of the perstaltic pump of our preferred embodi-
`ment. The motion of the cam wheel is illustrated in
`
`phantom lines.
`FIGS. 7-9 illustrate details of the disposable door,
`tube clamp and IV tubing couplings.
`FIG. 10 is an overall functional block diagram of the
`electronics of our preferred embodiment.
`
`45
`
`55
`
`4
`FIG. 11 is a functional block diagram illustrating the
`modem communication of the preferred embodiment of
`our system with a remote pharmacy or nurse station.
`FIGS. 12A and 12B taken together comprise a flow
`diagram illustrating a logical operation of the preferred
`embodiment of our infusion system.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`Referring to FIG. 1, the illustrated embodiment 10 of
`our programmable infusion system includes a compact,
`portable rectangular case 12. By way of example, the
`case may be made of injection molded plastic and may
`measure approximately seven inches in length by ap-
`proximately three and one-half inches in width (right
`side in FIG. 1) by approximately one inch in thickness
`(right side in FIG. 1).
`A disposable IV tubing apparatus 14 (FIG. 2) may be
`releasably loaded or installed in a receptacle 16 (FIG. 2)
`in a long side edge of the case 12. The proximal end
`disposable IV tubing apparatus 14 is connected to a
`conventional spike 20 (FIG. 1). The patient inserts the
`spike into a conventional bag 22 of intravenous fluid in
`which the desired medications are dissolved. The distal
`
`end of the disposable IV tubing apparatus 14 is con-
`nected to a conventional male leur fitting 26 which in
`turn connects to a conventional IV catheter (not illus-
`trated). A disposable IV fluid conveying means is a
`necessary requirement
`in an infusion system since it
`ensures sterility. It also prevents residual amounts of
`medication from one IV drug administration from being
`inadvertently delivered when a new IV drug adminis-
`tration commences.
`
`Referring to FIG. 2, a peristaltic pump 30 is mounted
`inside the case 12 adjacent the receptacle 16. A pump-
`ing member 32 of the pump engages a linearly disposed
`intermediate segment 34 of the disposable IV tubing
`apparatus 14. The pumping member 32 comprises nine
`individual
`fingers 32a which slide back and forth
`toward and away from the intermediate IV tubing seg-
`ment 34. The fingers 320 are moved by corresponding
`cam wheels 36 (FIG. 6). A flexible boot 33 (FIG. 2)
`surrounds the fingers and forms an interface between
`the fingers and the intermediate segment 34 of IV tub-
`ing. The peripheral edges of this boot are sealed to
`internal walls of the case to protect the pump from
`contamination. Each carn wheel 36 (FIG. 5) has a
`splined mounting hole 37 therethrough which is offset
`from the center of the wheel. Each finger 32a comprises
`a rectangular block having a circular hole in which a
`corresponding one of the cam wheels 36 rotates. The
`hole has a diameter slightly larger than the outside
`diameter of the wheel so that the wheel can rotate inside
`the hole and thereby pull the fmger back and forth. The
`motion of one of the cam wheels is illustrated in phan-
`tom lines in FIG. 6.
`
`The cam wheels 36 are mounted on a splined shaft 38
`in progressive, ofiset alignment for individually recipro-
`cating respective ones of the fingers 32a in a predeter-
`mined, timed sequence. The linearly disposed segment
`34 of IV tubing is progressively squeezed by the fingers
`320 so that intravenous fluid in the tubing is pumped
`therethrough.
`The intermediate IV tubing segment 34 is preferably
`made of vinyl or silicone and has a maximum Durome-
`ter of seventy-five measured on the Shore A scale. By
`using a highly pliant, non-stiff resilient flexible tubing
`segment of this type, it is possible for the individual
`
`ACTA EX. 1023-009
`
`ACTA Ex. 1023-009
`
`

`
`5,078,683
`
`6
`preferably a sixteen character by two line, super twist
`liquid crystal display. One end of the case 12 (right side
`in FIG. 2) is provided with a male electrical connector
`78 for establishing electrical connection with an exter-
`nal DC power supply (not
`illustrated). An infrared
`transmitter 80 and an infrared receiver 82 are also
`mounted at this end of the case 12 so that the case can
`
`5
`
`5
`fingers 32a of the peristaltic pump 30 to each squeeze
`off and completely close the tubing segment during one
`cycle of its respective cam wheel. This squeezing off is
`illustrated in FIG. 6. This ensures a true positive dis-
`placement pump in which a single rotation of the
`splined shaft 38 will cause a predetermined volume of
`fluid to be pumped through the disposable IV tubing
`apparatus 14. Having such a non-stiff disposable IV
`tubing apparatus 14 also ensures that less torque is re-
`quired to rotate the splined shaft 38, thereby resulting in
`an overall reduction in energy consumption when the
`peristaltic pump is electrically driven from battery
`power as hereafter described.
`The fingers 32a preferably have small teats 32b (FIG.
`6) projecting from the ends thereof. These teats engage
`and squeeze the intermediate IV tubing segment 34. It
`has been determined that these teats ensure that the
`tubing segment 34 will be completely squeezed off dur-
`ing each cycle of each finger. It is important to under-
`stand that the intermediate tubing segment 34 must have
`a minimum amount of stiffness and resilience or else it
`will not open and close in a manner that will permit it to
`function as a peristaltic pump. Preferably the tubing
`segment 34 has a minimum Durometer of thirty-five
`measured on the Shore A scale.
`Referring again to FIG. 2, the programmable infusion
`system 10 includes means for releasably mounting the
`intermediate IV tubing segment 34 adjacent the pump-
`ing member 32. The intermediate tubing segment 34 is
`mounted to a door 40 having a hook-shaped member
`40a (FIG. 3) at one end and a compressible clasp 40b at
`the other end. The hook-shaped member 40a of the
`door may be engaged by the patient with a shoulder 16a
`(FIG. 2) located at one end of the receptacle 16 in the
`case 12. The other end of the door is then swung in and
`the clasp 40b snaps into the other end of the receptacle
`16. The intermediate IV tubing segment 34 is squeezed
`between the individual fingers 32a and a compressible,
`resilient pad 42 (FIGS. 3 and 6) supported by the inner-
`side of the door 40. This pad may be made of polyure-
`thane foam.
`
`The shaft 38 (FIG. 3) which supports the cam wheels
`36 is joumaled at opposite ends in ball bearings 44. A
`gear 46 rigidly mounted on one end of the shaft 38
`meshes with another gear 48 (FIG. 2) rigidly mounted
`on another shaft 50 of a DC motor module 51 having an
`internal 141:1 gear reduction. In other words, one-hun-
`dred and forty-one rotations of the armature of the DC
`motor turns the shaft 50 one revolution and thus the
`cam shaft 38 one revolution.
`
`Referring to FIG. 4, the disposable IV tubing appara-
`tus 14 has a proximal tubing segment 52 and a distal
`tubing segment 54 connected to opposite ends of the
`intermediate IV tubing segment 34 by means of con-
`plings 56 and 58. These couplings are attached to the
`underside of the door 40 as hereafter described in con-
`junction with FIG. 9.
`Referring again to FIG. 1, a liquid crystal display 146
`is mounted in the case 12. A bar code reader head 110
`
`(FIG. 2) is mounted in the edge of the case 12 opposite
`the disposable receptacle 16 so that a patient holding the
`case can scan the bar code label 112 (FIG. 1) on the IV
`bag 22. Four independently actuable push-buttons 70,
`72, 74 and 76 (FIG. 1) are positioned on the front face
`of the case 12. Together these push-buttons form a
`four-button keypad which enables the patient to send
`commands to a micro-controller in the system as hereaf-
`ter described in great detail. The LCD display 146 is
`
`be inserted into a home base unit shown diagrammati-
`cally at 84 in FIG. 11. The home base unit 84 contains
`a modem for establishing communication over tele-
`phone lines 86 with a personal or other computer also
`equipped with a modem at a pharmacy or nurse station
`88. The home base unit 84 is physically configured to
`provide a receptacle in which the lower end of the case
`12 may be positioned. The home base unit also has a
`infrared transmitter and an infrared receiver which are
`
`physically located adjacent the infrared receiver and
`infrared transmitter,
`respectively, of the system 10
`when the system is plugged into the home base unit.
`Once a communication link has been established with
`
`the _computer at the pharmacy or nurse station 88, the
`modem will provide infrared TXD and R X D signals to
`the micro-controller of the system 10 to allow re-pro-
`gramming of the fluid delivery control rate instructions.
`The transmission and reception of data from the system
`via the infrared transmitter and detector 80 and 82 may
`be accomplished through a conventional RS-232 data
`link.
`
`Referring to FIG. 4, the intermediate IV tubing seg-
`ment 34 preferably has an inside diameter of approxi-
`mately 0.l25 inches. Silicone and VINYL tubing can be
`commercially obtained having the desired stiffness. The
`proximal segment 52 and the distal segment 54 are each
`preferably made of clear polyvinyl chloride (PVC)
`having an outside diameter of approximately 0.140
`inches and an inside diameter of approximately 0.088
`inches. This clear PVC tubing is larger in both inside
`and outside diameter than the conventional PVC tubing
`segments 55a and 55b (FIG. 1) which connect the seg-
`ments 52 and 54 to the spike 20 and male lure fitting 26,
`respectively.
`In an actual prototype of our preferred embodiment,
`the designed maximum delivery rate is approximately
`three hundred milliliters per hour. The minimum de-
`signed delivery rate is approximately 0.1 milliliters per
`hour. The delivery resolution is approximately 0.1 milli-
`liters per hour for 0.01 through 99.9 milliliters per hour
`and approximately one milliliter per hour for approxi-
`mately one hundred to three hundred milliliters per
`hour. In the prototype, the designed maximum volume
`to be infused (VTBI) is one thousand milliliters and the
`minimum volume to be infused (VTBI) is approxi-
`mately 0.1 milliliters. The designed “keep vein open”
`(KVO) rate is approximately one milliliter per hour for
`one through three hundred milliliter per hour rates and
`approximately 0.1 through 0.99 milliliters per hour for
`0.1 through 0.99 milliliter per hour rates.
`Referring to FIG. 7, the door 40 has a rectangular
`aperture 90 formed adjacent the hook-shaped member
`400. A resilient metal tubing squeezer 92 has an upper
`end 920 which is tightly received in the aperture 90 in
`the door 40. The squeezer 92 has a pair of parallel
`downwardly extending arms which terminate in coiled
`sections 92b. Referring to FIG. 8, when the disposable
`is assembled, the intermediate segment 34 is squeezed
`shut between the coiled sections 92b. When the door 40
`is installed into the receptacle 16 of the case 12, the
`hook-shaped member 40a is engaged with the shoulder
`
`ACTA EX. 1023-010
`
`ACTA Ex. 1023-010
`
`

`
`l0
`
`15
`
`7
`160 (FIG. 2). The other end of the door having the clasp
`40b is then swung toward the case. As this happens, the
`coiled sections 9212 of the tubing squeezer 92 engage
`upstanding projections 94 (FIG. 8) in the receptacle.
`These projections are spaced so that the coiled sections
`are displaced outwardly away from the intermediate
`tubing segment 34 thereby unclamping the same. This is
`illustrated in phantom lines in FIG. 8. The squeezer
`performs a very important function. Namely,
`if the
`disposable IV tubing apparatus 14 should be inadver-
`tently removed from the case 12 it will squeeze off the
`intermediate tubing section 34 and prevent freeflow of
`intravenous fluid by gravity action.
`Referring to FIG. 3, the clasp 40b consists of a V-
`shaped element. The door 40 is preferably made of
`injection molded plastic and the V-shaped clasp 40b is
`compressible upon swinging the clasp into the recepta-
`cle 16 in the case. This allows a wedge-shaped projec-
`tion 96 on the clasp 40b to clear and snap into engage-
`ment behind an L-shaped latch 98.
`Further details of the disposable IV tubing apparatus
`14 are visible in FIG. 9. The coupling 56 is received in
`a slot in a bracket 102 which extends from the underside
`of the exterior wall of the door 40 near the clasp 40b.
`The coupling 56 is solvent, welded or bonded to the
`bracket 102. The coupling 58 is similarly received in
`another recess formed in the hook-shaped member 4041.
`Again the coupling 58 is solvent bonded to the member
`40:1. A magnet 106 (FIG. 9) is attached to the bracket
`102 and detected by a Hall effect switch 108 (FIG. 3)
`adjacent the receptacle 16. The Hall effect switch is
`connected to the micro-controller hereafter described
`so that the output thereof will indicate whether or not a
`disposable has been correctly loaded into the case 12.
`Referring again to FIG. 2, the bar code reader head
`110 is capable of sensing the bar code label 112 (FIG. 1)
`attached to the bag 22 of intravenous fluid. The bar
`code label 112 represents encoded information regard-
`ing the prescribed fluid delivery parameters. These are
`read by the system when the edge portion of the case 12
`containing the bar code reader head 110 is swiped or
`passed over the bar code label 112. The bar code reader
`112 is connected to a bar code controller circuit 148
`(FIG. 10) which generates bar code signals representa-
`tive of the fluid delivery parameters. One suitable com-
`mercially available bar code reader is the Welch Allyn
`022 088 (TBD#) three of nine code compatible.
`FIG. 10 is a functional block diagram of the electron-
`ics of the preferred embodiment 10 of our system. It
`includes a micro-controller 114. One suitable micro-
`controller is MOTOROLA 68HCl lFl-FN which has a
`built-in A/D interface 114a. DC battery power may be
`supplied to the micro-controller 114 through inputs 116
`and 118. DC power from an external power supply may
`be supplied via line 120 which is connected to male 55
`electrical connector 78 (FIG. 2) mounted at one end of
`the case 12. The motor module 51 which drives the
`
`peristaltic pump 30 is itself driven by motor drive cir-
`cuitry 122 (FIG. 10) which is controlled by the micro-
`controller 114. A motor shaft encoder 124 is associated
`with the shaft of the motor in the module 51 and pro-
`vides signals to the micro-controller on line 126.
`Operating instructions in the form of a computer
`program for carrying out all of the logical operations of
`the system are stored in a peripheral memory connected 65
`to the micro-controller. In the preferred embodiment,
`this memory takes the form of an erasable programma-
`ble read only memory (EPROM) 128 (FIG. 10). The
`
`5,078,683
`
`8
`micro-controller also receives signals on line 127 from a
`pump shaft encoder. The signals on lines 126 and 127
`are used by the micro-controller in delivering a prede-
`termined volume of intravenous fluid at a predeter-
`mined rate.
`The Hall effect switch 108 is connected to the micro-
`controller via line 129 so that the micro-controller can
`tell
`if a disposable apparatus 14 has been correctly
`loaded. An occlusion detect switch -130 (FIG. 3) is
`mounted to the bottom wall 132 of the receptacle 16 in
`the case. This switch is connected via line 134 (FIG. 10)
`to the micro-controller 114. Returning again to FIG. 3,
`the occlusion switch 130 has a vertically reciprocable
`actuating pad 136 which is depressed and actuated
`when there is a blockage in the disposable 114 causing
`the intermediate segment 34 to expand abnormally. This
`detection of an occlusion is sensed by the micro-con-
`troller which de—energizes the peristaltic pump to pre-
`vent further pumping until the condition has been de-
`tected. The micro-controller also sends visual and audi-
`
`ble warnings to the patient as hereafter described in
`greater detail. The occlusion switch 130 is mounted on
`a bracket 138, the position of which is vertically adjust-
`able by turning screw 140 to thereby adjust the sensitiv-
`ity of the occlusion detection.
`An audible (buzzer) and LED alarm are indicated
`diagrammatically at 142 in FIG. 10. The alarm 142 may
`include a red LED 144 (FIG. 2) mounted at one end of
`the case 12. The LCD display 146 is also mounted at the
`same end of the case 12 for visualizing the fluid delivery
`parameters in alphanumeric form.
`One suitable commercially available display is a six-
`teen character by two line, super twist liquid crystal
`display, with no back light, available from NBC, of
`Japan. The display 146 provides a visual verification to
`the patient of the delivery parameters which have been
`entered either by reading a bar code label or by modem
`connection with a remote computer at the pharmacy or
`nurse station. The display 146 also provides a visual
`indication of the operation of the system while pump-
`ing. It further provides a visual indication of any opera-
`tional
`faults or failures as hereinafter described in
`
`greater detail.
`Referring again to FIG. 10, the bar code reader head
`112 is connected to the bar code micro-controller 148
`which is in turn connected to the micro-controller 114.
`
`One suitable commercially available bar code micro-
`controller is the Welch Allyn LTS 3 C-CMOS decoder
`3 of 9 compatible. The DC power supplied on lines 116
`and 118 may be provided by a pair of nine-volt lithium
`or alkaline batteries. The motor encoder 124 may pro-
`vide sixteen pulses per revolution. One suitable com-
`mercially available motor module having a built-in gear
`reduction and encoder is sold under the trademark MI-
`CRO-MO. The pump shaft encoder which provides the
`signals to the micro-controller on line 127 may be pro-
`vided by a simple Hall effect switch which provides one
`pulse per revolution of the shaft.
`The push button switches 70, 72, 74 and 76 which
`together comprise a keypad 69 (FIG. 10), are connected
`to a conventional keypad/switch decoder 150 which in
`turn is connected to