CA1083002A - Electronically controlled intravenous infusion set - Google Patents

Electronically controlled intravenous infusion set

Info

Publication number
CA1083002A
CA1083002A CA250,883A CA250883A CA1083002A CA 1083002 A CA1083002 A CA 1083002A CA 250883 A CA250883 A CA 250883A CA 1083002 A CA1083002 A CA 1083002A
Authority
CA
Canada
Prior art keywords
valve
drop
drip chamber
pulse
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA250,883A
Other languages
French (fr)
Inventor
Robert J. Lefevre
Robert E. Thomas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Burron Medical Products Inc
Original Assignee
Burron Medical Products Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US05/637,206 external-priority patent/US4038981A/en
Application filed by Burron Medical Products Inc filed Critical Burron Medical Products Inc
Application granted granted Critical
Publication of CA1083002A publication Critical patent/CA1083002A/en
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16886Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body for measuring fluid flow rate, i.e. flowmeters
    • A61M5/1689Drip counters

Landscapes

  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Fluid Mechanics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Title of the Invention ELECTRONICALLY CONTROLLED
INTRAVENOUS INFUSION SET

Abstract of the Invention An electronically controlled, gravity-feed, intravenous infusion set in which a length of intravenous tubing is connected with a drip chamber to convey a fluid to be administered intravenously, the improvement comprising a normally closed internal valve in said set operable to prevent flow of fluid through the set and operated to open position to enable passage of a drop of fluid through the set, and an electrically controlled actuator operatively associated with the valve to operate the valve to its open position at a predetermined frequency of operation and to hold the valve open until a drop forms and falls to thus determine the drip rate of fluid through the set, said internal valve thus enabling control of flow of fluid through the set without necessitating crimping or other deformation of the set and thereby resulting in dependable and accurate control of the flow rate of the fluid to be administered intravenously.

Description

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Thls invention relates to a parenteral administra-tion set, and more particularly, to an intravenous infusion set for administering fluid to a patient and the like.
Still more particularly, the invention relates to a disposable parenteral or intravenous infusion set which has an internal valve that is electronically controlled to accurately regulate the rate at which the fluid is fed intravenously to a patient.
In the prior art, various means have been used to -~ -control the rate of flow through IV sets for thus regulating the rate of intravenous administration of fluid to a patient.
For example, manual flow control means have been provided in ; , the form of clamps or the like, which are positioned on a length of IV tubing and are adjusted to pinch ~he tubing to enable more or less flow through the tubing and thus into the veins of a patient. Such devices are subject to irregular operation, however, due to changes in Eluid pressure or due ~ `
to human error in setting the clamps and the like. Elec-tronically controlled devices have also been utilized, wherein an external, electromechanically operated valve is associated with the IV tubing to pinch the tubing and thus control the rate of flow therethrough dependent upon a signal from a timer which is preset to give a predetermined ``~
number of signals per unit of time. In such electronically controlled or operated devices, the circuits are relatively complicated and expensive, azd the valve means utilized ...,:, ~ .
-2-~ ~' ' 83~1~Z, pinch or crimp or otherwise deform the tubing to control flow therethrough, thus substantially increasing the expense of the units and reducing the reliability thereof. For example, pinching of the IV tubing results in cold flow of the tubing with a consequent change in the flow rate there- -~
through. Still other prior art devices use elec~rically controlled valves which flutter, or operate at some multiple of the desired drip rate, or internal drop sensing means are used.
In accordance with the present invention, a solid state circuit is utllized to control an electromagnetically operated valve in the IV set to control the rate of flow therethrough. The set is of the gravity feed type and thus will not continue to feed fluid in the event the needle goes through a vein and into the surround mg tissue. The valve itself is an internal valve operable between open and closed positions without requiring deformation of the tubing or other parts of the set, and in one form of the ;, invention comprises a reciprocating ball member which is .
normally maintained seated under the action of gravity and ~ ~ -fluid pressure above the ball to thus prevent flow through - ~
the set and eleetromagnet means are disposed adjacent the ~ ~ ;
ball to lift the ball from its seat whenever a signal is sent to the electromagnet means by a timer or clock mechanism. ~ ;
The timer generates a plurality of pulses per unit of time at a constant repetition rate, as determined by the setting on the clock or timer, and directly corresponding to the desired number of drops of IV fluid per unit of time.
; Moreover, permanent magnet means are preferably provided on --the set to hold the valve open in the event of a power :. ,
-3-1~133~02 failure or the like, or to ef:Eect ~lushillg of the set, or to transport the patient from one location to another, and a conventi.onal clamp means may be used to regulate the flo~ in such event. ~xternal drop detecting means are also used, thus eliminating completely any penetration or deformation of the set.
The present invention may be summarised according to a first broad aspect as an electronically controlled intravenous infusion set, comprising:
a supply of intravenous fluid, a drip chamber connected with said supply;
a length of IV tubing connected with the drip chamber; said drip chamber and length of IV tubing comprising a fluid flow passage means; valve means conn-ected in the intravenous inusion set downstream of the supply of IV fluid within the flow passage means and being operated between open and closed positions; valve operating means external of the flow passage means and opera~
tive to operate the valve means between open and closed positions to control flow of IV fluid through the intravenous infusion set; electrical circuit : ~.
means connected with the valve operating means to control operation of the valve means, said circuit means including a variable timer means having means to generate a plurality of pulses per unit of time at a constant repetition rate and directly corresponding to a desired number of drops of IV fluid per unit of time, a bistable latching flip-flop connected between the timer means and the valve operating means and operative to maintain the valve ,: :
opsrating means de-energized until a pulse is received from the timer means and then operative to enable energization of the valve operating means to open the valve and hold the valve open until a drop falls, drop detector means operatively associated with the drip chamber to sense a drop falling through the drip chamber, said drop detector means operatively connected with the bistable latching flip-flop to reset the flip-flop and thus de- :
energize the valve operating means when a drop is sensed by the drop ;~
detector means to enable the valve to close, and no-drop detector means oper-atively connected with the drop detector means and with the timer means and bistable latching flip-flop and operative to indicate a no-drop condition when a pulse is received from the timer means~)ut no pulse is received from ~33(~(~2 the drop detector means~ and operative to lock the latching flip-10p and prevent energization of the valve operating means when sa:id no-drop condition is sensed.
According to another broad aspect, the present invention providesin an in~ravenous infusion set including a drip chamber adapted to be connected with a supply of IV fluid and a length of IV tubing connected with the drip chamber, the improvement comprising an electromagnetically operated valve means in the drip chamber for controlling the rate of flow through the intravenous infus.ion set, said valve means comprising an extension on the lower end of the drip chamber, an axially upwardly facing valve seat in the extension, a magnetically attractive valve in the extension cooperable with the valve seat and maintained in closed position under the action of gravity, ;
electromagnet means externally of the drip chamber adjacent the valve to operate the valve to its open position upon energization of said electro-magnet means, and electronic control means connected with said electromagnet ~ :
means to operate said electromagnet means to open said valve at predetermined in~ervals of time to establish a desired drip rate through said drip chamber, ~-said electronic control means comprising a variable timer means having means to generate a preset number of pulses per unit of time, a switch means connected with the timer means and with the electromagnet means and operative to energize the electromagnet means to open the valve when a pulse is generated by said timer means and to maintain the electromagnet energized and hold the valve open until a drop falls, drop detector means operatively associated with the drip chamber to sense the falling drop and generate a : - ;.
pulse in response thereto, said drop detector means connected with said switch means to reset said switch means and thus de-energize said electro- ~ `
magnet means and close said valve when said drop falls, and no-drop i detector means operatively connected with said timer means to receive the ~
pulses therefrom and connected with said drop detector means to receive :;
pulses therefrom when a drop is detected, the ou~put of said no-drop . :~
detector means connected with said switch means, and said no~drop detector means operative when no drop falls, and two pulses are thus sequentially 4a-.4 .~ ~:

~3~3~2 received from the timer means in the a~sence o~ an intexvenlng pulse from the drop detector means, to :inh:ibit the switch means and prevent energization of the electromagnet means.
According to a further broad aspect, the present invention provides an electronically controlled intravenous infusion set for use with a supply of intravenous fluid, comprising: a drip chamber connected with said supply; a length of IV tubing connected with the drip chamber for receiving IV fluid from the drip chamber; said drip chamber and length of IV ::
tubing comprising a fluid flow passage means; valve means wi~hin the flow passage means and operable between open and closed positions; valve operating means external of the flow passage means and operative to operate the valve ; ~
means between open and closed positions to control flow of IV fluid through . .~ -.
the intravenous infusion set; electrical circuit means connected with the .
valve operating means to control operation of the valve means, said circuit .;~
means including variable timer means having means to generate a plurality - :-of pulses per unit of time directly corresponding to a desired number of : ~
drops of IV fluid per unit of time, irst switch means connected in the . ~ .
circuit means between the timer means and the valve operating means and :
operative to maintain the valve operating mecms de-energized until a pulse is received from the timer means and then operative to energize the valve operating means to open the valve and hold it open until a drop falls, drop detector means operatively associated with the drip chamber to sense a drop : -.
falling through the drip chamber and generate a pulse in response thereto, said drop detector means operatively connected with the first switch means to send the pulse generated upon sensing a drop to the first switch means to reset the switch means and thus de-energize the valve operating means when :~a drop is sensed by the drop detector means, and no-drop detector means includin~ a second switch means operatively connected in the circuit means with the first switch means to send a signal to the first switch means to inhibit the first switch means and prevent energization of the valve operat~
ing means in the absence of drop pulses between successive clock pulses.
According to ye~ another broad aspect, the present invention ....... . . .

13~83~)2 provi~es an elec~ronically controlled intravenous infusion s~t for use with a supply of intravenous fluid, said set co~prising in combination, a drip chamber adapted to be connected wi~h said supply, a length of IV tubing connected with the drip chamber for receiving IV fluid trom said drip chamber, said drip chalnber and length of IV tubing comprising a fluid flow passage, valve means within said flow passage and operable between open and closed positions, valve operating means external of the flow passage and operative to operate the valve means between open and closed positions to control flow of IV fluid through the intravenous infusion set, electrical circuit means connected with the valve operating means to control operation of the valve means, said circuit means including variable timer means for generating a plurality of pulses per unit o time directly corresponding to a desired number of drops of IV fluid per unit of time, switch means connected in the circuit means between the timer means and the valve operating means for e:Efecting energization of the valve operating means alld opening of the valve means in response to the pulses generated by said timer means, drop detector means operatively associated with the drip chamber to sense a drop falling through said drip chamber and produce a signal in response thereto, means responsive to the signal produced by said drop detector means and operative ~ -upon said switch means to reset said switch means and thus de-energize the valve operating means and close the valve means when a drop is sensed by the drop detector means, and no-drop detector means responsive to the pulses produced by said timer means and the signal produced by said drop detector means for detecting the absence of drop pulses between successive clock -pulses and inhibiting said switch means in response thereto.
The solid state circuit is exceptionally simple and reliable and is, therefore, substantially more economical than prior art devices and utilizes both integrated circuits and discrete components. All logic -~
functions are accomplished via integrated circuits, and discrete components are used to limit and ampli~y current, establish time periods of the integrated circuits and form bias networks. The integrated circuits used are conventional N 7473 J-K bistable flip~flops, a conventional monostable ~ -4c-'~ .

83~C12 flip-flop identified as ~otorola Part No~ C 3803, and conventional 555 integrated circuit chips. The circuit includes a variable clock or timerJ
a drop detector, a pulse shaper, a drop pulse extender, a drop indicator, a latch, a no-drop detector, a no~drop alarm and a no~drop indicator. ~s determined by the frequency adjustment of the clock, when a predetermined interval of time has elapsed, the clock will undergo a negative transition and send a negative pulse to the latch. This causes the latch to send a pulse or to generate a forward bias on a transistor switch, which energizes the electromagnet and thus opens the valve to enable a drop to form in the `-drip chamber. When the drop fallsJ it is sensed by the drop detector, which is entirely external of the flow path and which includes light sensi-tive means optically coupled across the drip chamber so that a falling drop interferes with the optical coupling, and which '~ ~ " ,'"' '' ~''~' '..

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4d~ ~

,~
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~3n(~2 sends a signal to the pulse shaper, wherc the signal is amplified and squared ~Ip and then conducted to the drop pulse extender, which extends the width of the pulse to thus result in energization of ~he drop indicator for a period of time sufficient to be observed. The pulse shaper also sends a pulse to the latch or switch means to reset the latch and remove the bias from the transistor switch to thus de-energize the valve and enable the valve to close.
The outpu~ of the variable clock is also connected with the no-drop detector to trigger the no-drop detector, and an output of the drop pulse extender is also connected ~ -with the no-drop detector to reset the no-drop detector.
This output of the drop pulse extender undergoes a change of state substantially simultaneously with the cha~ges of state of the pulse shaper. Thus, if no drop is detected, the - -no-drop detector will~not be reset and the output of the ~:
no-drop detector, which is fed to the J input of the latch, will cause the latch to respond to the next clock pulse by driving its Q output low, and will thereafter maintain the ;
latch at a "zero" as long as no drops are detected. The no-drop detector is itself locked up by the drop indicating output from the drop pulse extender, such that the no-drop detector will not be energized or change states every time a signal is received from the clock, which would in turn enable the latch to be triggered every other cloGk pulse.
The output from the latch and the reset output from the drop pulse extender are also connected with the no-drop alarm, such that under normal operating conditions the output of the drop pulse extender and of the latch will go negative at the same time, and the no-drop alarm will not '.~ :
_5_ 3~

be triggered, ~md the no-drop inclicator wlll not be turned on. ~lowever, whencver a no-drop condition occurs, the out-put from the drop pulse extender will stay at a "one" state, enabling the no-drop alarm to be triggered on the next negative transit-ion from the latch, and the no-drop indicator ~ :
will thus be turned on indicating a fault condition.
Further, the drop de~ector includes a pair of photodiodes or other sensing means disposed adjacent one another on one side of the drip chamber and accordingly the sensitivity of the unit is significantly increased, such that in the event of fogging or the like of the drip chamber wall, the sensor is s~ill sensitive enough to detect the presence of a falling drop. Moreover) the use of two sensing means ;
results in a broader field of view and thus a drop can be detected even though the set may no~ be supported in a true vertical position. Still further, if one sensor fails, the other can still sense the presence of a falling drop. ~ ~
Accordingly, with the present invention an s exceptionally accurate and reliable electronically controlled intravenous infusion set is provided which is both simple and economical, and the circuit is maintained in a locked or latched condition under normal circumstances, and is ~llocked or unlatched for each drop. Moreover, in accordance -with the present invention, a unique drip chamber has a valve in the outlet portion thereof for controlling flow through an IV set provided w-ith the present invention.
Objects of the Invention It is an object of this invention to provide an electronically controlled IV set for accurately controlling :

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the rate of flow of fluid being administered intravenously to a patient, and wherein an internal valve means and external drop sensing means are provided in the set operative to control flow through the set in response to a signal pro-vided ~rom a timer mechanism and operative to control flow without pinching, penetrating, or otherwis~ deforming the IV set.
Another object of this invention is to provide an electronically controlled IV set for intravenous ad- ~-ministration of fluids to a patient wherein an electro-magnetically operated valve is provided in the set and a control circuit is connected with the valve and includes ~;
both integrated circuits and discrete components, with all logic functions being accomplished via integrated circuits, and wherein the circuit is operative to maintain the valve de-energized or latched under normal conditions, and to ~;
unlock or energize the valve for obtaining each drop.
A further object of the invention is to provide a drip chamber for an IV set, wherein a valve for controlling flow through the drip chamber is provided in a lower portion of the drip chamber itself.
Yet another object of the invention is to provide `~
an intravenous infusion set in which an electronically controlled valve is utilized to control the drip rate through the set, and wherein magnet means are provided for holding the valve open to enable flushing of the set or to ~ ~
enable flow even in the event of a power failure or if the ; ~`
patient i~ b.ing transported from one location to another.

_7 ~830~2' : , Bricf Description of the Drawings Figure 1 is a perspective view of a first form of the inv~ntion, wherein the sensing device is mounted to the drip chamber of an IV set and the control valve and circuitry therefor ar~ connected with the IV tubing between the ends thereof.
Figure 2 is an enlarged, exploded view of the drip chamber and sensing device of the first form of the invention.
Figure 3 is an enlarged, perspective view of the control valve and a portion of the IV tubing and of the electromagnet means for operating the valve.
Figure 4 is a greatly enlarged, fragmentary view in section of the valve and its relationship with the electromagnet means.
Figure 5 is a schematic view of the circuit for the electronic .~
control of the invention. ~ -: . ~
Figure 6, appearing on the same drawing sheet as Figure 3, is a diagrammatic plan view of a first form of photoelectric sensing means in accordance with the invention.
'~
Figure 7, appearing on the same drawing sheet as Figure 3, is a chart illustrating the signal relationship of the clock, latch and pulse ~ ~ ;
shaper of the invention.
Figure 8, appearing on the same drawing sheet as Figurè 3, ls a schematic circuit diagram of a second form of drop detector in accordance wlth the invention.
Figure 9 is a view similar to Figure 3, of the permanent magnet means for holding the valve open.
Figure 10 is a schematic view of a second form of electronically controlled IV set in accordance with the invention, wherein the sensing device, control valve and circuitry therefor are all positioned on the drip chamber.

~ .

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Figure 11 is a fragmentary, enlarged view in section of the drip chamber of Figure 10, showing the position of the valve in relation to the drip chamber.
Detailed Description of the Invention In the drawings, wherein like reference numerals indicate like parts throughout the several views~ ~n IV
set is indicated generally at 10 and includes a bottle or bag or other suitable supply 11 of IV fluid F, suitably suspended or supported from a hook H carried by an upright post or support S. A drip chamber 12 is connected to the bottom of the supply 11 in a conventional manner, and -typically the drip chamber I2 has a piercing end 12a thereon which is inserted into the bottom end of the supply ll. A
suitable filter means 13 is preferably provided in the drip chamber 12 for filtering contamlnants froni the fluid F. A
length of IV tubing 14 is connected with the drip chamber at one end and is connected with an internal valve means 15 at its other end~ and a second length of IV tubing 16 is connected at one of its ends with the valve means 15 and at its other end with a suitable needle or the like 17 for insertion into the arm or the like A of a patient for intra-venous administration of fluids to the patient. The drip chamber and length of IV tubing define a fluid flow passage means for the IV fluid. -A suitable electronic control means 18 is operatively associated with the valve means 15 and is caused to energize the valve means in response to a preset signal. The control means 18 is also connected with a suitable photoelectric sensing means 19 positioned on the drip chamber 12 for '.
_ g _ ~330~Z
sensing a drop of fluid ~ falling through the drip chamber and sending a signal to the control means to reset it. A
manually operated clamp 20 of substantially conventional construction is provided on the IV tubing 16.
The photoelectric sensing device or drop detector 19 is preferably of molded plastic and comprises a generally U-shaped housing 21 having an elongate slot or notch 22 in one side thereof, with a generally U-shaped channel or groove.23 in the body extending around the notch 22 adjacent the upper portion thereof. A suitable light source 24 is : :
in the housing 21 adjacent one side of the notch 22, and a suitable light sensitive means 25, such as a pair of photo-diodes 25a and 25b or the like, is in the housing 21 at .
the other side of notch 22 in alignment with the light source 24. The provision of a pair of photodi.odes 25a and 25b, disposed side-by-side on the opposite side of the drip .~
chamber 12 from the light source 24, as seen in Figure 6, ~:
substantially eliminates the danger of an improper or ;;~
erratic reading in the event the drip chamber wall becomes ~ fogged or drops form. on the wall thereof, since the two photodiodes significantly increase the sensitivity of the device~ and even in the event of the photodiodes 25a or 25b becoming partially blocked by such fogging or drops forming on the wall of the drip chamber, the circuit remains balanced, whereby a drop falling through the drip chamber will interrupt the beam of light to the photodiode ~ :
and cause a voltage change at the photodiode 25a to thus generate a signal to operate the device. Further, by using two photodiodes~ even if the device is not accurately vertically suspended, the sweep of ~he sensor is such that a falling drop is still detected, even though it does not -10- :, : :

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fall through the center of the device. In use, the drop detector 19 is mounted to the drip chamber 12 by inserting the drip chamber into the notch 22 with the flange 12b at the upper end of the drip chamber received in the groove 23 in the housing 21, and with the light source 24 and light sensitive means 25 disposed substantially at diametrically opposi~e sides of the drip chamber 12, so that a drop falling through the drip chamber will interrupt the beam of light from light source 24 and cause a voltage change at the photodiode 25, to thus transmit a signal to the control means 18.
The control means 18 includes a suitable housing or control box 26 in which the circuitry is contained, and an electrically controlled valve operating housing 27a in which a pair of electromagnets 28 and 29 are disposed on opposite sides of a slot or notch 30~ which is slightly enlarged at Its rear side or edge 31 and is constructed in relation to the size of the valve means 15, such that the valve means may be inserted through the slot 30 and pulled downwardly into the enlarged portion 31.
The valve means pTeferably comprises a one-piece, elongate, plastic, tubular valve housing 32, having a radially ~ -outwardly directed flange 33 on the upper end thereof, which is arranged to seat against the upper surface of the housing '~
27a to accurately locate the housing and valve ball 34 contained therewithin relative to the electromagnets 28 ;;~
and 29. The housing 32 is tapered inwardly between its ends to define an upwardly facing valve seat 35 against which the ~,. : , ,; ::
valve ball 34 seats under the action of gravity and the pressure of fluicl above the valve, and the lower end 36 of -"' ;',"'~ ~' ' ~ - 1 1 - ~'`' ,. ' ' 163133~
the housing is gradually inwardly tapered for reception thereover of the end of IV tubing 16. The inlet section 14 of IV tubing to the valve 15 is secured within the upper portion of the valve housing 32J and the lower end of the IV
tubing 14 is abutted against a narrow, annular~ upwardly facing shoulder 37 in the bore of the upper portion of housing 32 to correctly space the end of the IV tubing 14 from the ball valve 34.
As seen in Figures l and 9, a permanent magnet or housing means 27b is also provided on the control unit 18J ;
and is substantially similar to the electromagnet means 27a in Figure 3J except that rather than electromagnets 28 and 29, permanent magnets 28' and 29' are provided. Thus, if it is desired to flush the setJ the valve means 15 is merely placed in position in housing 27b and the permanent magnet means holds the valve openJ and with clamp 20 opened, full flow is achieved through the set to flush it. Moreover in the event of a power failure or the likeJ the valve means 15 may be positioned in the permanent magnet housing and the clamp 20 adjusted to obtain the desired flow rate. Still ~urtherJ if it is necessary or desirable to transfer the patient from one location to anotherJ the permanent magnet and clamp can be used to control flow while the patient is in transit.
The control circuit for controlling operation of ; ~;
the ball valve 34 and thus for controlling the drop rate, and accordingly the rate of f1OW of fluid through the set, includes variable timer means 39 having means to generate a plurality of pulses per unit of time direct~y corres-ponding to a desired number of drops of IV fluid per unit of timeJ first switch means 40, 41 connected in the circuit -'' '' ;~ .

~0~330~3Z
means bctween the timer means and the valve operating means and operative to maintain the valve operating means de-energized Imtil a pulse is received from the timer means and then operative to energize the valve operati.n~ means to open the valve and hold it open until a drop falls, drop detector means 19 operatively associated with the drip chamber to sense a drop falling through the drip chamber and generate a pulse in response thereto, said drop detector means operatively connected with the first switch means to send the pulse generated upon sensing a drop to the first switch means to reset the switch means and thus de-energize the valve operating means when a drop is sensed by the drop detector means, and no-drop detector means including a . ~
second swi.tch means 46 operatively connected in the circuit .
means with the first switch means to send a signal to the .
first switch means to inhibit the first switch means and prevent energization of the valve operating means in the absence of drop pulses between the successive clock pulses. .
As seen In Figure 5, the drop-detector l9 includes .
a pair of NPN photo transistors Ql and Q2 arranged as a comparative circuit, and light striking the emitter-base junctions of the transistors causes current to flow through the emitter bias resistor R3, the transistors Ql and Q2 and the load resistors Rl and R2.to the supply voltage Vcc. .;
In this conducting state, the collector voltage is low, at .
some point near ground. When the light source is interrupted by a drop, current flow drops through the circuit and the collector voltage rises to a level near the supply voltage. .
This action appears as a pulse at the input of the dif- ; .-ferentiating network, including capacitor Cl and resistor R6. .. ~

-13- ~;`. :
.,. .~'';~' 1~3C~)2 In the event the drip chamber becomes fogged or if droplets form on the sur~ace of the drip chambei~ wall and such fogging or droplets reduce the amount of light striking the photo-transistors ~1 and Q2, the circuit will remain balanced.
A drop falling past the phototransistor will thus cause a pulse to appear at the input of the differentiating network and thus at the input to pin 2 of the 555 integrated circuit chip IC-2 of the pulse shaper 38. 9 A timer or clock 39 also includes a 555 integrated circuit chip IC-l, having its output pin 3 connected with clock input pin 5 of J-K bistable flip-flop BS-l of latch 40.
The frequency at which the output of IC-l changes states - ~ :
can be varied by changing the setting of potentiometer P
connected with pins 2, 6 and 7 of IC-l, and thus the drip rate of the IV set can be varied in accordance with the change in frequency of the signal from pin 3 of the clock 39. The output of IC-l alternates between a logic "one" and a logic "zero" and the negative transition of going from a "one" to a "zero" determlnes when a drop starts to form, since the negative signal of the clock is conducted to the input pin 5 of the J-K bistable flip-flop BS-l of the latch 40, and this causes the flip-flop BS-l to change states. In other words, the ~ output of BS-l is normally a "zero" out and is fed into the base of a transistor switch 41, which is ;~
connected between a source of power and the electromagnet means 28 and 29 is normally in a nonconducting state, such that the electromagnets are normally de energized. A
"zero" on the base of the transistor keeps it turned off.
However, when BS-l changes states, as, for example, when ;
the negative pulse is received at pin 5 from pin 3 of the ~ ~

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-14- ~ ~

108~ 2 clock, the Q output of BS-l goes to a "one" and the transistor switch 41 is now biased forward, enabling current to flow from the power supply ~o the electromagnets 28 and 29, thus opening the valve and Rnabling a drop to form in the drip chamber 12. When the drop falls, it interrupts the light path to the photodiodes 25a and 25b in the drop detector circuit, and this interruption causes a sudden change in the photodiodes' resistancel resulting in a voltage change that is capacitively coupled to the input pin 2 of IC-2. Every time a drop falls, a negative pulse is produced at the .
output pin 3 of IC-2, and this negative pulse is sent to a ~- -reset pin 6 of BS-l in the latch 40 to reset the bistable flip-flop BS-l. The Q output of BS-l now goes back to a "zero", turning off the transistor switch, which stops the current flow to the electromagnet, enabling the magnetically responsive ball or other type valve 34 to seat on its sea~
35 under the influence of gravity and fluid pressure above the ball. Thus, only one drop at a time can fall, at a predetermined rate established by the setting of the ~0 potentiometer P of the clock 39. In o~her words, the fluid ,: - ~:-path of the IV set is opened on the negative transition of s the IC-l output and is closed on the negative transition of the IC-2 output, i.e., when a drop falls from the drip device in the IV chamber. The output of IC-2 in the pulse shaper is also used to trigger a monoskable multivibrator -~
MS-l in a drop pulse extender 42. This extension of the . . .:
pulse from the pulse shaper 38 is necessary, since the Q
output of the monostable multivibrator MS-l is used to turn , .~.
on a light emitting diode 43 in the drop indicator 44 via an NPN driver transistor 45. If the output of IC-2 was used ,.~ , .

,~
-15- ~ ~
-.~ :
:

directly, the light emitting diode 43 would not be turncd on long enough to be de~ected visually.
A second J-K bistable flip-flop BS-2 is employed to detect a no-drop condition, and its clock input pin 1 is connected to the output pin 3 of IC-l. A connection is also made between pin 6 of monostable multivibrator MS-l and reset pin 2 of the bistable flip-flop BS-2 to reset the flip-flop BS-2 when a pulse is fed from the output Q' of the multi-vibrator MS-l. The negative transitions of the output Q' from pin 6 of monostable multivibrator MS-l occur almost exactly in time wi~h those of IC-2, and accordingly, under `~
normal operating conditions the changing of states of the bistable flip-flop BS-l and the bistable flip-flop BS-2 will be coincident. -Pin 13 of bis~able flip-flop BS-2 in the no-drop detector 46 is connected with pin 7 of the J input of the bistable flip-flop BS-l of the latch 40, and in normal operation will be high, causing the latch 40 to switch the Q output thereof from a low to a high in response to each clock pulse. However, when a no-drop condition occurs, as for example, when the IV bottle is empty or ~/; ;
the tubing is plnched and the like, the flip-flop BS-2 will not be reset after being triggered by a pulse from IC-l, thus the Q' output of BS-2 will now stay a~ a logic "zero", ;~
and this "zero"~ applied to the input pin 7 of BS-l, will `~
cause the flip-flop BS-l to respond to subsequent clock pulses by driving the Q output to a zero and keeping such Q
output at a "zero" as long as no drops are detected.
Further, the bistable flip-flop BS-2 is locked up by feeding a signal to pin 3 thereof from the Q output ;~
or pin 8 of monostable multivibrator MS-l. If this were ',, ~, ', . -. :, " . , . - , -, .. .

3~0Z

not done7 the bistable flip-flop BS-2 would change states with every ncgative transition from the chip IC-l of clock 39 and bistable flip-flop BS-l of latch 40 would, there~ore, be triggered every other clock pulse. ~ ;
A no-drop condition is visually indicated by turning on a light emitting diode 47 in a no-drop indicator 48 via a third bistable flip-flop BS-3 in a no-drop alarm 49.
The clock input pin 1 of BS-3 is connected with the Q output or pin 9 of BS-l and the reset input of BS-3 at pin 2 is fed by the Q' output of monostable multivibrator MS-l. Under normal operating conditions, the Q' output of MS-l and the Q
output of BS-l will go negative at the same time, and when this happens, BS-3 will not trigger and the no-drop light emitting diode 47 will not be turned on. However, whenever a no-drop condition occurs, the Q' output of multivibrator MS-l -~
will stay at a "one" state, enabling flip-flop BS-3 to be triggered on the next negative transition from flip-flop -~
BS-l. When the flip-flop BS-l is triggered, the no-drop light emitting diode is turned on, indicating a fault condi-tion. After the Q output of flip-flop BS-l goes negative, triggering the flip-flop BS-3, it will remain locked in that state because of the inhibiting action of the flip-flop BS-2 in the no-drop detector 46. The unit, under these `~
conditions, will remain locked up until the fault condition ~ i is corrected.
In the chart of Figure 7, the line tl indicates the negative transition of a clock pulse, and at this point the latching flip-flop BS-l goes to logic "one" and the transistor switch 41 is turned on, enabling the electromagnets to be energized and a drop, therefore, starts to fall. At - -~
time t2 the drop falls and is detected by the photodiodes '': ''~ ~ .- , . .

1a)83~:)6~

and a reset pulse from -the pulse shayer resets the latching flip-flop BS-l and the electromagnets are de-energi~ed. As can be seen, the signals produced and thus the drip rate of the set are precise and can be predetermined and controlled with great accuracy and reliability.
In Figures 10 and 11, a modified form of the invention is illustrated, and in this form of the invention, the operation of the components is exactly as described above and the circuitry is as described above. However, in this form of the invention, rather than providing the ball valve means 15 in the length of IV tubing, the ball valve 15' is provided in ~he lower end of a modified drip chamber l2', and the electromagnets 28 and 29 are positioned adjacent the extension on a lower end of the drip chamber 12' to attract the ball 34 upwardly away from the seat 35 to enable a drop to form in the drip chamber 12', as described previously.
Thus, the sensing means and electromagnets are housed -in a member 48, which is preferably sui~ably supported, and the drip chamber 12' is also operatively positioned relative to the member 48, so that the drop sensing means `
is positioned ~o sense a drop falling through the drip chamber and so that the electromagnets are positioned to raise the ball from its seat.
In Figure 8, a modified sensing means 19' includes only a single photodiode 25 to sense a falling drop. In all other respects, the apparatus and operation are as ~i ~.
described previously.
In s~mation, a switch means is connected between the timer means and the valve operating means and is operative to maintain the valve operating means de-energized ,, ~ .. . . .- , .

D~;~

until a pulse is received from the tinler means and then is operative to energize the valve operating means to open the valve and hold it open until a drop falls. A drop de*ector means is operatively associated with the drip chamber to sense a drop falling through the drip chamber and to generate a pulse in response thereto, and the drop detector means is operatively connected with the switch means to send the pulse generated upon sensing a drop to the switch means to reset the switch means and thus de-energize the valve operating means when a drop is sensed by the drop detector means. A no-drop detector means, including a switch rneans, is operatively connected with the drop detector means to receive a pulse therefrom as each drop is sensed, and is connected with the timer means to receive each pulse there-from, and is operatively connected with the switch means to send a signal to the switch means to lock or inhibit the switch means and prevent energization of the valve operating , ~ :
means when a pulse is received from the timer means, but no pulse is received from the drop detector means.
It is clear, therefore, that the no-drop detector is operative to indicate a no-drop condition when a i pulse is received from the timer means, bu* nc pulse is received from the drop de~ector means, and operative to lock ;~
the latching flip-flop and prevent energization of thc valYe operating means when said no-drop condition is sensed. ~ -:; :
In other words, the no-drop detector means is operative when no drop falls, and two pulses are thus sequentially generated by the timer means in the absence of an intervening pulse `
from the drop detector means, to send a signal to the switch means to inhibit the switch means and prevent energization of the electromagnet means.

,:~:~ i,. . .
-19- , . ,,:: ,: , :: ''': ', ;' ' .':
.: , :

~083(~0Z

As this inv0ntion may be embodied in several forms without departing from the spirit or essential characteristics thereof, the present embodiment is, therefore, illustrative and not restrictive, since the scope of the invention is defined by the appended claims rather than by the description preceding them, and all changes that fall within the metes and bounds of the claims ~ :
or that form their functional as well as conjointly coopera- : -tive equivalents are, therefore, intended to be embraced by those claims. ~;
~' :

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,~ , . ~, , '~

, ' ~. '' - ~ -, , , ~ ~ . . .. . .

Claims (14)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An electronically controlled intravenous infusion set, conprising: a supply of intravenous fluid, a drip chamber connected with said supply; a length of IV
tubing connected with the drip chamber; said drip chamber and length of IV tubing comprising a fluid flow passage means;
valve means connected in the intravenous infusion set downstream of the supply of IV fluid within the flow passage means and being operated between open and closed positions;
valve operating means external of the flow passage means and operative to operate the valve means between open and closed positions to control flow of IV fluid through the intravenous infusion set; electrical circuit means connected with the valve operating means to control operation of the valve means, said circuit means including a variable timer means having means to generate a plurality of pulses per unit of time at a constant repetition rate and directly corresponding to a desired number of drops of IV fluid per unit of time, a bistable latching flip-flop connected between the timer means and the valve operating means and operative to maintain the valve operating means de-energized until a pulse is received from the timer means and then operative to enable energization of the valve operating means to open the valve and hold the valve open until a drop falls, drop detector means operatively associated with the drip chamber to sense a drop falling through the drip chamber, said drop detector means operatively connected with the bistable latching flip-flop to reset the flip-flop and thus de-energize the valve operating means when a drop is sensed by the drop detector means to enable the valve to close, and no-drop detector means operatively connected with the drop detector means and with the timer means and bistable latching flip-flop and operative to indicate a no-drop condition when a pulse is received from the timer means but no pulse is received from the drop detector means, and operative to lock the latching flip-flop and prevent energization of the valve operating means when said no-drop condition is sensed.
2. An electronically controlled intravenous infusion set as in Claim 1, wherein the drop detector means includes means therein for generating a pulse each time a drop is sensed thereby, a pulse shaper means operatively connected with the drop detector means to amplify and square the pulse generated by the drop detector means, a drop pulse extender operatively connected with the pulse shaper to extend the width of said shaped pulse, and a drop indicator operatively connected with the drop pulse extender to receive the extended pulse therefrom and to visually indicate a drop falling through the drip chamber.
3. An electronically controlled intravenous infusion set as in Claim 2, wherein the pulse shaper and timer both include integrated circuit chips, the latching flip-flop and the no-drop detector means both include J-K bistable flip-flops, and the drop pulse extender means includes a monostable multivibrator.
4. An electronically controlled intravenous infusion set as in Claim 3, wherein a no-drop alarm means is operatively connected with the latching flip-flop and with the drop pulse extender to indicate when a no-drop condition occurs, said no-drop detector means operatively connected with the drop pulse extender to lock the no-drop detector means and said no-drop detector means operatively connected with the latching flip-flop to lock the latching flip-flop when the no-drop detector means is locked, to thus prevent operation of the valve means under no-drop conditions.
5. An electronically controlled intravenous infusion set as in Claim 1, wherein said drop sensing means comprises a molded plastic housing of generally U-shaped configuration and has an elongate notch in one side thereof for receiving the drip chamber, and means in said housing for securing the drip chamber in a predetermined operative position, said drop sensing means having a light source and a light sensitive means therein on opposite sides of the notch therein and disposed to be positioned at sub-stantially diametrically opposite sides of the drip chamber to sense a drop falling through the drip chamber.
6. An electronically controlled intravenous infusion set as in Claim 5, wherein the valve operating means and circuit means are contained in a housing means, said housing means having means thereon for attachment thereto of the valve means and IV tubing, so that the valve means is maintained in a predetermined operative position relative to the valve operating means.
7. An electronically controlled intravenous infusion set as in Claim 6, wherein the valve means comprises an elongate tubular valve body mounted between the ends of the length of IV tubing, said valve body having an inwardly tapered portion defining an axially facing valve seat, a magnetically responsive ball in the body cooperative with the valve seat and movable under the action of gravity to a closed position, said valve operating means comprising electromagnets positioned relative to the ball to raise the ball from its seat when the electromagnets are energized.
8. An electronically controlled intravenous infusion set as in Claim 6, wherein the drop sensing means and the valve operating means are disposed in a housing having means for operatively positioning the drip chamber in the housing, said drip chamber having an extension on one end thereof, an axially facing valve seat in said extension, a valve in said extension cooperable with said valve seat between open and closed positions, and said valve operating means comprising electromagnets positioned relative to said ball to operate said ball to its open position away from said seat.
9. An electronically controlled intravenous infusion set as in Claim 1, including a housing, said valve operating means mounted on said housing, said housing having means for attachment thereto of said length of IV tubing, said valve means being in the length of IV tubing and positionable in said housing in operative relationship with said valve operating means, and a permanent magnet means carried by the housing and having means for operative association therewith of said valve means to maintain the valve means in open position to enable flushing of the intravenous infusion set and to enable flow of IV fluid in the event of a power failure or the like.
10. In an intravenous infusion set including a drip chamber adapted to be connected with a supply of IV
fluid and a length of IV tubing connected with the drip chamber, the improvement comprising an electromagnetically operated valve means in the drip chamber for controlling the rate of flow through the intravenous infusion set, said valve means comprising an extension on the lower end of the drip chamber, an axially upwardly facing valve seat in the extension, a magnetically attractive valve in the extension cooperable with the valve seat and maintained in closed position under the action of gravity, electromagnet means externally of the drip chamber adjacent the valve to operate the valve to its open position upon energization of said electromagnet means, and electronic control means con-nected with said electromagnet means to operate said electromagnet means to open said valve at predetermined intervals of time to establish a desired drip rate through said drip chamber, said electronic control means comprising a variable timer means having means to generate a preset number of pulses per unit of time, a switch means connected with the timer means and with the electromagnet means and operative to energize the electromagnet means to open the valve when a pulse is generated by said timer means and to maintain the electromagnet energized and hold the valve open until a drop falls, drop detector means operatively associated with the drip chamber to sense the falling drop and generate a pulse in response thereto, said drop detector means connected with said switch means to reset said switch means and thus de-energize said electro-magnet means and close said valve when said drop falls, and no-drop detector means operatively connected with said timer means to receive the pulses therefrom and connected with said drop detector means to receive pulses therefrom when a drop is detected, the output of said no-drop detector means connected with said switch means, and said no-drop detector means operative when no drop falls, and two pulses are thus sequentially received from the timer means in the absence of an intervening pulse from the drop detector means, to inhibit the switch means and prevent energization of the electromagnet means.
11. A drip chamber as in Claim 10, wherein a permanent magnet means is operatively positionable relative to said valve to maintain the valve in open position to enable flushing of the intravenous infusion set and to enable flow of IV fluid in the event of a power failure or the like.
12. A drip chamber as in Claim 11, wherein said valve is a ball valve.
13. An electronically controlled intravenous infusion set for use with a supply of intravenous fluid, comprising: a drip chamber connected with said supply; a length of IV tubing connected with the drip chamber for receiving IV
fluid from the drip chamber; said drip chamber and length of IV tubing comprising a fluid flow passage means; valve means within the flow passage means and operable between open and closed positions; valve operating means external of the flow passage means and operative to operate the valve means between open and closed positions to control flow of IV fluid through the intravenous infusion set; electrical circuit means connected with the valve operating means to control operation of the valve means, said circuit means including variable timer means having means to generate a plurality of pulses per unit of time directly corresponding to a desired number of drops of IV fluid per unit of time, first switch means connected in the circuit means between the timer means and the valve operating means and operative to maintain the valve operating means de-energized until a pulse is received from the timer means and then operative to energize the valve operating means to open the valve and hold it open until a drop falls, drop detector means operatively associated with the drip chamber to sense a drop falling through the drip chamber and generate a pulse in response thereto, said drop detector means operatively connected with the first switch means to send the pulse generated upon sensing a drop to the first switch means to reset the switch means and thus de-energize the valve operating means when a drop is sensed by the drop detector means, and no-drop detector means including a second switch means operatively connected in the circuit means with the first switch means to send a signal to the first switch means to inhibit tile first switch means and prevent energization of the valve operating means in the absence of drop pulses between successive clock pulses.
14. An electronically controlled intravenous infusion set for use with a supply of intravenous fluid, said set comprising in combination, a drip chamber adapted to be connected with said supply, a length of IV tubing connected with the drip chamber for receiving IV fluid from said drip chamber, said drip chamber and length of IV tubing comprising a fluid flow passage, valve means within said flow passage and operable between open and closed positions, valve operating means external of the flow passage and operative to operate the valve means between open and closed positions to control flow of IV fluid through the intravenous infusion set, electrical circuit means connected with the valve operating means to control operation of the valve means, said circuit means including variable timer means for generating a plurality of pulses per unit of time directly corresponding to a desired number of drops of IV fluid per unit of time, switch means connected in the circuit means between the timer means and the valve operating means for effecting energization of the valve operating means and opening of the valve means in response to the pulses generated by said timer means, drop detector means operatively associated with the drip chamber to sense a drop falling through said drip chamber and produce a signal in response thereto, means responsive to the signal produced by said drop detector means and operative upon said switch means to reset said switch means and thus de-energize the valve operating means and close the valve means when a drop is sensed by the drop detector means, and no-drop detector means responsive to the pulses produced by said timer means and the signal produced by said drop detector means for detecting the absence of drop pulses between successive clock pulses and inhibiting said switch means in response thereto.
CA250,883A 1975-12-03 1976-04-23 Electronically controlled intravenous infusion set Expired CA1083002A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US637,206 1975-12-03
US05/637,206 US4038981A (en) 1974-07-26 1975-12-03 Electronically controlled intravenous infusion set

Publications (1)

Publication Number Publication Date
CA1083002A true CA1083002A (en) 1980-08-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA250,883A Expired CA1083002A (en) 1975-12-03 1976-04-23 Electronically controlled intravenous infusion set

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JP (1) JPS5268777A (en)
AU (1) AU1333876A (en)
CA (1) CA1083002A (en)
DE (1) DE2625479A1 (en)
FR (1) FR2333520A1 (en)
MX (1) MX146510A (en)
NL (1) NL7605025A (en)
SE (1) SE7605094L (en)

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* Cited by examiner, † Cited by third party
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JPS5767748U (en) * 1980-10-11 1982-04-23
JPS6138591Y2 (en) * 1981-05-11 1986-11-07
US4519792A (en) * 1982-12-06 1985-05-28 Abbott Laboratories Infusion pump system
DE9017231U1 (en) * 1990-12-21 1992-04-16 Critikon GmbH, 2000 Norderstedt Gravity infusion regulator

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1433037A (en) * 1964-04-27 1966-03-25 Corbin Farnsworth Apparatus for controlling the administration of liquids
US3252623A (en) * 1965-07-22 1966-05-24 C F Liquidation Corp Apparatus for monitoring dispensing of liquid
US3890968A (en) * 1971-06-25 1975-06-24 Sci Systems Inc Fluid flow control means

Also Published As

Publication number Publication date
FR2333520A1 (en) 1977-07-01
MX146510A (en) 1982-07-07
SE7605094L (en) 1977-06-05
AU1333876A (en) 1977-11-03
NL7605025A (en) 1977-06-07
SE7605094A0 (en) 1977-06-04
DE2625479A1 (en) 1977-06-08
FR2333520B1 (en) 1980-09-19
JPS5268777A (en) 1977-06-07

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