EP0862470A1 - Dispositif de regulation du debit d'un liquide - Google Patents

Dispositif de regulation du debit d'un liquide

Info

Publication number
EP0862470A1
EP0862470A1 EP96935920A EP96935920A EP0862470A1 EP 0862470 A1 EP0862470 A1 EP 0862470A1 EP 96935920 A EP96935920 A EP 96935920A EP 96935920 A EP96935920 A EP 96935920A EP 0862470 A1 EP0862470 A1 EP 0862470A1
Authority
EP
European Patent Office
Prior art keywords
fluid
chamber
flow
level
region
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.)
Withdrawn
Application number
EP96935920A
Other languages
German (de)
English (en)
Other versions
EP0862470A4 (fr
Inventor
Phillip H. Darling, Jr.
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.)
Individual
Original Assignee
Individual
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 US08/674,552 external-priority patent/US5730730A/en
Application filed by Individual filed Critical Individual
Publication of EP0862470A1 publication Critical patent/EP0862470A1/fr
Publication of EP0862470A4 publication Critical patent/EP0862470A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1411—Drip chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means 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
    • A61M5/16804—Flow controllers
    • A61M5/16818—Flow controllers by changing the height of the reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means 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
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A61M5/16881—Regulating valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3382—Upper level detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A61M5/40—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using low-level float-valve to cut off media flow from reservoir

Definitions

  • the present invention relates generally to apparatus for controlling rates of li ⁇ ui ⁇ s and, more particu ⁇ larly, to apparatus for maintaining accurate, precise and stable liquid flow rates in medical liquid ⁇ elivery sys- terns, such as intravenous (IV) fluid delivery systems.
  • IV intravenous
  • IV intravenous
  • Gravity-driven IV liquid delivery systems or devices known to the present inventor utilize variable orifice flow control valves to control the flow rate of fluids to a patient undergoing treatment.
  • Such known valves require a constant pressure drop, ⁇ P, across the orifice to maintain a stable, accurate and precise flow rate of fluid into patients to which the systems or devices are connected.
  • Some of these known flow control systems or devices utilize one or more fixed orifices and adjust the pres ⁇ sure drop, ⁇ P, across the orifice (s) to set the fluid flow rate.
  • This pressure drop (the absolute sum of the positive ana negative pressure) across tne or ⁇ f ⁇ ce(s) calibrated for a liquid of known viscosity and density determines the instantaneous fluid flow rate througn the orifice (s) .
  • variable and fixe ⁇ orifice fluid flow control systems attempt to circumvent or accommodate the normal decrease in positive fluid nead pressure as the supply liquid level drops as, for example, liquid is drained from an IV bottle, and also variations in nega- tive or suction pressure in the patient delivery line, as may, for example, be caused by patient movement or changes in the patient's venous pressure.
  • Variable orifice flow control valves of some known IV flow control devices are marked with flow rates that appear to assume an average pressure drop, ⁇ P, across the orifice, with no control of supply head pressure or pa ⁇ tient line suction.
  • ⁇ P average pressure drop
  • the fluid flow control valves disclosed in U.S. Patent numbers 4,789,000; 4,802,506 and ⁇ , 807, 660 are considered representative of this type device.
  • Instructions provided with commercial versions of the just-mentioned type or IV flow control devices caution users initially to count the number of liquid drops falling through an associated drip chamber in a prescribed period of time to establish an accurate flow rate, and thereafter to adjust the valve frequently to maintain a relatively constant liquid delivery rate as the supply liquid head and/or the patient line pressures changes .
  • the region above the liquid m the secondary chamber is connected to the atmosphere (that is, the region is at atmospheric pressure), so there is no coupling through the air between the supply head pressure and the head pressure in the chamber.
  • the head pressure on a fixed outlet orifice located in the bottom of the secondary chamber determines the rate of flow, whicn may be adjusted by sliding the secon ⁇ dary chamber up or down on the tube from the supply source, thereoy adjusting the head pressure of the liquid in the secondary chamber.
  • a liquid collection chamber be- low the orifice collects the liquid and a flexible tube conducts the liquid from the collection chamber to a pa ⁇ tient.
  • This collection chamber is also vented to atmos ⁇ phere so that changes in the liquid height in the patient line or changes in venous back pressure are uncoupled from the orifice and will have no effect on the flow rate through the orifice.
  • U.S. patent number 4,340,050 discloses the use of a collapsible bag for the supply source.
  • the bag dis ⁇ charges liquid into a liquid-receiving chamber which is vented to the atmosphere.
  • a float-type valve is piv ⁇ otally mounted in the liquid-receiving chamber for main ⁇ taining a constant liquid level.
  • a second chamber having fixed orifices at various heights and which is fluidly connected to the liquid-receiving cham- ber, can be moved up and down relative to the liquid- receiving chamber to vary the head pressure on the ori ⁇ fices. Liquid passing through the orifices collects in the bottom of the second chamber and is conducted to a patient through a flexible IV tube.
  • This second chamber is vented to the atmosphere above the liquid on both sides of the orifices, thereby uncoupling the orifices from any pressure changes in the IV line connected to the patient .
  • U.S. patent number 4,588,396 discloses the use of a tube which connects a rigid supply source to a liquid- receiving chamber in which a constant liquid level is maintained in the manner disclosed in above-mentioned U.S. patent nu oer 3,929,157.
  • the air above the liquid in the receiving chamber which is the source of displace ⁇ ment air in the supply vessel, is vented to atmosphere through a metering valve which is used for flow rate con ⁇ trol, instead of an orifice being used in the IV liquid path.
  • Liquid is disclosed as flowing out of this collec- tion chamber through a sealed drip chamber which is con ⁇ nected to a patient delivery line. It appears, however, that changes in the height of the liquid in the patient line will couple through the air in the sealed drip cham ⁇ ber to the liquid in the collection chamber and affect the flow rate through the system.
  • patent num ⁇ ber 4,613,325 discloses an IV flow rate control system that amplifies and uses a velocity dependent pressure drop across a restriction in the flow path to modulate the size of an upstream variable orifice flow control. There does not, however, appear to be disclosed any means for isolating the flow restriction from supply head or patient line pressure variations.
  • a gravity flow fluid flow regulating device with constant fluid head that is particularly for regulating the flow of fluids, such as IV fluids, from a fluid source into a patient's body.
  • the flow regulating device comprises a first, constant fluid head chamber having an upper fluid inlet end region and a lower, fluid outlet region. Included is a second, drip, chamber hav ⁇ ing an upper fluic mlet end region and a lower, fluid outlet end region, the lower fluid outlet eno region be- ing configured for having attached thereto a fluid deliv ⁇ ery tube, such as a conventional IV fluid delivery tube for providing IV fluid into a patient's body.
  • fluid flow regulating means connected in fluid flow relation- ship between the fluid outlet end region of the first chamber and the fluid inlet end region of the second chamber, the regulating means being configured for regu ⁇ lating the gravity flow of fluid from the first chamber into the second chamber.
  • first, upper, fluid level control means dis ⁇ posed in the first chamber for causing, when the connect ⁇ ing means connect the first chamber to a preexisting source of fluid for receiving a flow of fluid therefrom, a preestablished fluid level to be substantially main- tained in the first cna ber as tne fluid level in the source decreases .
  • the first, upper, fluid level control means m- elude an inlet orifice at the fluid inlet end region of the first chamber and a first, upper, float valve dis ⁇ posed in a free-floating relationship insi ⁇ e the first cham ⁇ er.
  • the first, upper, free-floating valve is configured for clocking the inlet orifice to stop the gravity flow of fluid through the orifice from a con ⁇ nected source of fluid when the fluid level in the first cnamber is at the preestablished level and for unblocking the inlet orifice to permit a gravity flow of fluid througn the orifice from the fluid source when the fluid level in tne first chamber falls below the preestablished level .
  • first venting means located at an upper region of the first chamber above the preestablished fluid level therein for venting the first chamber to ambient sur ⁇ rounding pressure and second venting means located at an upper region of the second chamber for venting the second chamber to ambient surrounding pressure.
  • At least a side wall region of the second chamber is constructed of a transparent material so that a rate of fluid dripping through the second chamber can be observed by a user of the device.
  • the fluid flow regulating means comprise a valve body having a rotatably-mounted valve stem for incremental rotational movement between a first, fully-closed position which blocks the gravity flow of fluid from the first chamber into the second chamber and a second, fully-open position in which the gravity flow of fluid from the first chamber into the second chamber is at a maximum flow.
  • the valve stem is disposed in the valve body for being manually set at any selected rotational position between the first and second positions so as to thereby enable a user of the device to selectively control the gravity flow of fluid from the first chamber into the second chamber.
  • An indicator dial calibrated with respect to rotational po ⁇ sitions of the valve stem may be provided for enabling a user to read fluid flow rates from the first chamber into the second chamber associated with different rotational positions of the valve stem.
  • a second, lower, flow control means comprises a sec ⁇ ond, lower valve that is disposed in free-floating rela ⁇ tionship inside the second chamber for closing the lower, fluid outlet end region when fluid in the second chamber falls to a preestablished lower level to prevent the in ⁇ clusion of air from the outlet region of the second cham ⁇ ber, for example, into the fluid conduit to a patient's body and for alternatively closing the fluid inlet to the second chamber when the fluid in the second chamber rises to a preestablished upper level.
  • the fluid flow regulating means of the flow con ⁇ trol device comprise a flexible fluid conduit connected in fluid flow relationship between the outlet end region of the first chamber and the fluid inlet end region of the second chamber.
  • means are in ⁇ cluded for selectively controlling the vertical distance between the preestablished fluid level in the first cham ⁇ ber and the fluid inlet region of the second chamber.
  • a first, constant fluid head chamber having an upper fluid inlet end region and a lower, fluid outlet region; and a sec- ond, drip chamber having an upper fluid inlet end region and a lower, fluid outlet end region, the lower fluid outlet end region being configured for having attached thereto a conventional discharge tube, the second chamber being aligned with the first chamber along a common lon- gitudinal axis.
  • fluid flow regulating means for regu ⁇ lating the gravity flow of fluid from the first chamber into tne second cnamber, the fluid flow regulating means comprising means for selectively moving the first and second chambers along the longitudinal axis.
  • means for enabling a fluid-flow connection be ⁇ tween the fluid inlet end region of the first cnamoer and a lower, discharge region of a preexisting source of fluid that is open to ambient surrounding pressure through a collapsible container or a filtered vent.
  • a fluid level control for causing, when the connecting means connects the first chamber to the preexisting source of fluid for receiving a flow of fluid therefrom, a preestablished fluid level to be substantially maintained in said first chamber as the fluid level in the connected source decreases, the fluid level control means including an orifice at the fluid inlet end region of the first chamber and a free- floating float valve disposed in the first chamber con- figured for blocking the orifice to stop a gravity flow of fluid through tne orifice from the source wnen the fluid level in the first chamber is at a preestablished level and for floating downwardly and unblocking the ori ⁇ fice to permit a gravity flow of fluid through the ori- fice from the source when the fluid level in the first chamber falls below the preestablished level and until the fluid level returns to the preestablished level, whereby the valve floats upwardly and again blocks off the flow of fluid through the orifice.
  • the fluid flow includes an indicator calibrated with respect to vertical positioning of the second chamber relative to the first chamber for enabling a user to read fluid flow rates from the first chamber into the second chamber associated with different rela ⁇ tive vertical positions of the first and second chambers.
  • closing means in the second chamber includes a float valve having a closure region which closes a fluid discharge opening in the lower, fluid discharge outlet end region when the fluid level in the second chamber is below a preestablished lower level and closes a fluid mlet opening into the second chamber when the fluid level in the second chamber reaches a preestablished upper level.
  • a scale calibrated with respect to relative ax ⁇ ial movement between the first and second chambers for enabling a user to set a selected fluid flow rate from the first chamber mto the second chamber.
  • Means are provided for frictionally locking the first and second chambers in any selected relative posi ⁇ tion therebetween.
  • a fluid flow control device and first and second variations thereof, particu ⁇ larly for use in an IV supply system which, as an illus- tration, provides a constant fluid head as the fluid level in a source of IV fluid to which the device is con ⁇ nected decreases as the fluid is introduced into and through the device into a patient's body.
  • FIG. 1 is a pictorial drawing which illustrates a typical manner in which the flow rate control device of the present invention may be used to advantage, there be ⁇ mg shown the device connected to an exemplary IV solu- tion or fluid container and showing the output of the de ⁇ vice being connected, through an IV tube, into the arm of a reclining patient;
  • FIG. 2 is a partial perspective drawing of the flow rate control device of the present invention, showing the external configuration thereof and showing the upper, in ⁇ let end of the device connected to a lower region of an exemplary IV fluid container and snowing the lower, out ⁇ put end of the device connected to an upper end region of a patient fluid delivery tube and showing a transparent drip chamber portion of the device;
  • FIG. 3 is a longitudinal cross sectional view taken along line 3-3 of FIG. 2 showing the internal construc- tion of the flow rate control device and showing a first, upper, free-Iloat ng float valve, a flow regulating valve and a second, lower, free-floating float valve for con ⁇ trolling and regulating fluid flow through the device;
  • FIG. 4 is a partially cutaway perspective drawing of a representative one of the first and second free- floating float valves, showing the external configuration thereof with upper and lower end caps configured for hav ⁇ ing only minimal edge contact with their respective de- vice chambers;
  • FIG. 5 is a perspective drawing of a variation flow rate control device having first and second chambers which are vertically movable relative to one another for regulating tne flow cf fluid from a first chamber into a second, drip, chamber;
  • FIG. 6 is a longitudinal cross sectional view taken along line 6-6 of FIG 5, showing the internal construc ⁇ tion of the first variation device, including a first, upper, free-floating float valve and a second, lower, free-floating float valve for fluid flow through the de ⁇ vice;
  • FIG. 7 is a partial cross sectional view similar to FIG. 6, showing the second chamber of the variation de ⁇ vice elevated to a maximum-enabled position relative to first chamber;
  • FIG. 8 is a perspective drawing of a second variation fluid rate control device, which is similar to the first variation fluid flow rate control de ⁇ vice, showing m-lme first, upper and second, lower chambers and showing index markings corresponding to fluid flow rats end further showing, by way of illustra ⁇ tion, the device set for delivering 200 Ml/Hr. of salme to a patient;
  • FIG. 9 is a longitudinal cross section drawing taken along line 9-9 of FIG. 8, showing internal construction of the second variation fluid flow rate control device, including first, upper and second, lower float valves;
  • FIG. 10 is a transverse cross sectional draw ⁇ ing taken along line 10-10 of FIG. 8, showing further in ⁇ ternal features of the second variation fluid flow control device;
  • FIG. 11 is a partially cut-away perspective drawing of the upper float valve of the second variation fluid flow control device showing its annular construction;
  • FIG. 12 is a longitudinal cross sectional drawing, similar to FIG. 9 showing internal construction of the second variation flow rate control device of FIG. S when set for maximum flow rate;
  • FIG. 13 is a longitudinal cross sectional drawing similar to FIG. 9 showing internal construction of the second variation flow rate control ⁇ evice of FIG. 8 when set for zero flow rate.
  • FIG. 1 there is depicted a flow rate control de ⁇ vice or system 10, in accordance with the present inven ⁇ tion.
  • Device or system 10 is shown, by way of illustra ⁇ tive example, and as more particularly described below, connected, at an upper inlet end region, in fluid receiv ⁇ ing relationship to a conventional IV supply source of container 12, which is depicted as being supported at an elevated level by a conventional IV stand 14.
  • a lower end region of device 10 is shown connected in a fluid discharging relationship to the upper end of a conven ⁇ tional IV fluid supply conduit or tube 16 which nas a lower end connected to a canula (not shown) mserted mto an arm 18 of a patient 20 shown reclining on a hospital bed 22.
  • flow rate control device or system 10 is externally constructed of a generally tubular upper shell segment 30, naving joined to an upper end thereof a lower region 32 of a hollow inlet member 34, and a tubular lower shell segment 36, having joined to a lower end thereof an upper end region 38 of a discharge member 40.
  • a lower end region 42 of upper shell segment 30 is joined to the upper end of lower shell segment 36 so as to form a slender, vertically-elongated and substantially closed device body *J .
  • an upwardly-projecting end region 46 of inlet member 34 (which is preferably con ⁇ structed from a medical-grade plastic) is formed in the shape of a slender, tapered, hollow spike having a rela ⁇ tively sharp, beveled upper end 48 which enables fluid- flow penetration of the inlet member througn a seal or plug 50 at a lower, discharge end region 52 of fluid con ⁇ tainer 12 to thereby enable the gravity flow of fluid from the container into upper segment 30.
  • a downwardly-extending end region 54 of discharge member ⁇ 0 is formed in slender tubular shape for receiv ⁇ ing an upper end of tube or conduit 16 to enable fluid flow from device 10 into patient 20.
  • internal surfaces of up ⁇ per shell segment 30 and inlet member 3-- largely form or define a first, upper chamber 60
  • internal surfaces of lower shell segment 36 and discharge member 40 largely form or define a second, lower chamber 62.
  • At least regions, and preferably all, of lower shell segment 36 are formed of a transparent material, (for ex- ample, medical grade plastic such as polystyrene) , so that fluid flowing through lower chamber 62 in the form of droplets 64 can be viewed and counted by a user of de- vice 10 to obtain and/or monitor the fluid flow rate (for example, in milliliters per hour) through the device.
  • a transparent material for ex- ample, medical grade plastic such as polystyrene
  • fluid flow regulating means 66 whicn regulate the gravity flow of fluid from first, upper chamber 60 into second, iower cnamoer 62, and consequently through device 10.
  • first, upper, fluid flow controlling means 70 are disposed in first, upper chamber 60 for maintaining a predetermined, uniform fluid level 72 in such cnamber as level 74 of fluid 76 (FIG. 2j container 12 cnanges as fluid flows from tne contamer into and tnrough device 10. That is, upper fluid flov; controlling means 70 provide a constant fluid pressure heao in device 10 regardless of the chang ⁇ ing pressure head in fluid contamer 12 as fluid is drawn therefrom.
  • lower, fluid flow controlling means 80 are disposed in second, lower chamber 62 for stopping the flow of fluid from such cnamber mto tube 16 when the fluid level in such chamber falls below a predetermined minimum level 82 so as to prevent tne introduction of air into fluid being discharged from device 10.
  • Second, lower, fluid flow containing means 80 are also config ⁇ ured, relative to the height of second chamber 62 for shutting off the flow of fluid mto the lower chamber from upper chamber 60 when the fluid level in the lower chamber reaches a preestablished maximum level 84 (shown in phantom lines, FIG. 3) .
  • An upper vent tube 90 is connected through a side wall of upper member 34 to vent upper chamber 60 to at ⁇ mosphere.
  • a conventional micropore filter element 92 is installed in filter tube 90 to maintain sterility of the upper chamber.
  • a lower vent tube 94 having a micropore filter element 96 is connected through a lower, side wall region of upper shell segment 30 to vent lower chamber 62 to atmosphere while maintaining sterility of the chamber.
  • Flow regulating means 66 comprises a generally conventional, screw-type, fluid flow regulating valve which includes flow respective up ⁇ per and lower vertical fluid channels 100 and 102 formed in a lower region 104 of upper shell section 30. Fluid channels 100 and 102, which enable the flow of fluid from upper chamber 60 into upper regions of lower chamber 62 are interrupted by a valve shaft 106 having a tapered flow control section 108.
  • An external control knob 110 connected to a proximal end of shaft 106 enables a user to rotate the shaft so that tapered section 108 is drawn to the right.
  • This ac- tion opens, in varying degrees, the flow path between channels 100 and 102 so as to provide a variable cross section conduit enabling the regulation of fluid flow from upper chamber 60 into lower chamber 62, to the de ⁇ sired or required flow rate.
  • a fluid flow indicating scale 112 may be provided beneath knob 110 to indicate, according to the rotational position of the knob, the precise fluid flow rate through regulating means 66. However, the flow rate may be veri ⁇ fied by a user by counting the rate at which fluid drop- lets 64 fall through second chamber 62.
  • a conventional O-ring seal 114 is installed around valve stem 106 to prevent fluid leakage past the shaft and from device 10.
  • upper flow control means 70 comprises a buoy ⁇ ant first float valve 120 which is sized and configured for freely floating in a vertical direction mside of up ⁇ per chamber 60.
  • first float valve 120 comprises a light-weight, cylindrical plastic tubular body 122 having generally square, upper and lower end caps 124 and 126, respectively.
  • the outer diameter, Di, of body 122 is smaller than inner diameter, D 2 , of upper chamber 60 (FIG. 3) .
  • all corners 128 thereof extend radially outwardly from body 122, in a symmetrical manner about a vertical axis 129 of valve 120, and terminate in short arcuate eno or corner surfaces 130 wnich define a circle having a diameter, D , which is slightly smaller that the inside diameter, D 2/ of upper chamber 60.
  • Edge surfaces 130 function as guide surfaces making minimal contact with tne inside of upper chamoer 60 as valve 120 floats freely up and down, ac ⁇ cording to the fluid level in the cnamber.
  • an upper surface 132 thereof is slightly convex and has a small flat circular central surface region 134 whicn functions as a flow-blocking surface when valve 120 floats upwardly in upper chamoer 60 until such surface bears agamst, and blocks the gravity flow of fluid from a mating fluid on- fice 136 at the lower end of a tubular downward extension 138 of spike 46 (FIG. 3) .
  • upper and lower valve end caps 124 and 126 are identical to one another and are joined to re ⁇ spective upper ano lower ends of body 122 in a manner sealing first float valve 120 against fluid leaks which would affect buoyancy of the valve.
  • second, lower flow con ⁇ trolling means 80 comprise a second, lower valve 140 which is identical in function, and also preferably in construction, to above-described first, upper valve 120.
  • Lower valve 140 is free to float up and down in second chamber 62 between lower and upper preestablished fluid levels 82 and 84, respectively, according tc the fluid level in the second chamber, and thereby opening and closing an outlet orifice or opening 150 at the bottom of the second chamber and an inlet orifice or opening 152 through which fluid s dropped into the second chamber.
  • the overall length, L, of device 10 may be about 18 centimeters and the outside diameter, OD, of sections 30 and 36 may be about 2.5 centimeters. It can be appreci ⁇ ated that the constant fluid column height across flow control 66 is essential to the precision cf fluid flow control provided Dy device 10.
  • device 10 When constructed and assembled in the above- described manner, device 10 is ready for being operation ⁇ ally installed between fluid container 12 and fluid tube 16 into a patient 20 by inserting device sp ⁇ e 46 through container seal 50 and installing fluid tube 16 onto de ⁇ vice bottom projection 5 ⁇ (FIGS. 1-3) .
  • first float valve 120 Upon such installation (assuming that fluid is con ⁇ tained in contamer 12, that device 10 is hanging in a substantially vertical orientation as depicted in FIGS. 2 and 3, and that flow regulator valve 66 is closed) first float valve 120 will initially be resting at the bottom of first chamber 60 and second float valve 140 will be resting at the bottom of second chamber 62. As fluid flows into first chamber 60 from fluid container 12, the fluid level in the first chamber will rise, causing first float valve to float upwardly toward fluid inlet opening 136.
  • first float valve 120 When the preestablished fluid level 72 is reached in first chamber 60, first float valve 120 will have floated to an elevation where upper surface region 134 of valve upper cap 124 blocks off further fluid flow into the first chamber.
  • Flow regulator valve 66 is then opened slowly to establish the desired or required fluid flow rate from first chamber 60 into second chamber 62 (for example, by counting the number of droplets 64 falling through the second chamber over a given time interval) .
  • This flow of fluid from first chamber 60 into second chamber 62 causes the fluid level in the first chamber to fall, thereby causing first float valve 120 to float downwardly and open mlet opening 136 so that additional fluid can flow from container 12 nto the first cnamber until the preestablished fluid level is again reached and the first float valve again seals off fluid flow to the first chamber.
  • first float valve 120 floats down ust a sufficient distance to permit a simi ⁇ lar drop of fluid to be flowed from fluid container 12 into the first chamber before the first float valve floats back up and again shuts off the inflow of fluid from the fluid contamer.
  • Second float valve 140 in second chamber 62 func ⁇ tions in a reverse manner to meter fluid from the second chamber into tube 16 and on to patient 20.
  • second float valve After ini ⁇ tially being lifted upwardly by fluid received from first chamber 60 accumulating in lower regions of second cham ⁇ ber 62 to the preestablished minimum level, second float valve unblocks outlet opening 150 sufficiently to permit a drop equivalent of fluid to be discharged into tube 16. This causes a decrease in the fluid level in second cham ⁇ ber sufficient for second float valve to float down and reclose discharge opening 150 until the valve is relifted by a next drop of fluid dropping into the second chamber, such that each drop of fluid entering second chamber 62, a like volume is discharged therefrom into tube 16 and thence to patient 20.
  • FIGS 5-7 A first variation fluid flow control device 10a is depicted in FIGS 5-7.
  • elements and features of device 10a that are identical to those de ⁇ scribed above for device 10 are given the same reference numbers.
  • Those elements and features of device 10a which are similar or equivalent to those elements and features described above for device 10 are given the same refer- ence numbers followed by an "a.” Entirely different ele ⁇ ments and features of device 10a are given new reference numbers .
  • device 10a comprises a first, tubular upper shell segment 30a and a second, lower tubu- lar shell segment 36a.
  • Upper segment 30a is constructed to form an internal first chamber 60 having a first float valve 120 disposed therein.
  • First chamber 60 is vented to atmosphere by a vent 90.
  • Lower segment 36a is con ⁇ structed to form a second chamber 62 having a second float valve 140 disposed therein.
  • Second chamber 62 is vented to atmosphere through a vent 94.
  • a tapered, tubular spike 46a at the top of upper segment 30a is provided for penetrating through a seal 50 at a lower end 52 of a fluid source 12 (FIG. 6) to permit the gravity flow of fluid through an orifice 136 at the lower end of extension 138 into first chamber 60.
  • Respective upper and lower segments 30a and 36a of device 10a are constructed in substantially the same man ⁇ ner, and function in the same way, described above, as corresponding upper and lower segments 30 and 36 of de ⁇ vice 10.
  • the principal difference between device 10a and de ⁇ vice 10 is that the gravity flow of fluid from first chamber 60 of upper segment 30a into second cnamber 62 of lower segment 3ba is re ⁇ uiated by the relative vertical position between the upper and lower segments.
  • a flexible f_u ⁇ d conouit 200 _s connected between a lower region of upper segment 30a and an upper region of lower segment 36a (FIGS. 5 and 6) .
  • Flow regulating means 66a comprises a vertical sup ⁇ port member 202 wnich extends downwardly from tuoular re ⁇ gion 204 at the bottom of upper segment 30a.
  • Vertically slidingly mounted over memoer 202 is a slide 206 which is connected to lower segment 36a so as to extend sidewardly therefrom (FIGS. 5-7)
  • the relative neignt, n, between upper segment 30a and lower segment 36a can be easily adjusted, to regulate the flow of fluid from first cnamoer 60 into second cham ⁇ ber 62, by slidmq slide 206 (and consequently the lower segment) up or down on support memoer 202.
  • the effect of sliding lower segment 36a upwardly or downwardly on sup ⁇ port member 202 actually varies tne height, h, between fluid level 72 in first chamber 60 and fluid discharge opening 152 into second cnamber 60.
  • a fixed orifice 207 installed anywhere m conduit 200 in the fluid path between the lower portion of upper segment 30a and the upper portion of lower segment 36a provides an accurate, calibratec relationship between fluid height, h, and fluid discnarge rate nto second chamber 60.
  • a scale 208 may be engraved or other wise formed on support member 202 wnich is calibrated, for example, in milliliters per hour, to correspond to the precise fluid flow provided for various positions of slide 206 along the support member. As mentioned above, however, fluid flow rates can be verified by observing the drip rate of fluid through second chamber 62 (that is, by counting droplets 64 as they fall through the second chamber) .
  • Locking means 210 for example a clamp, are preferably provided for clamping slide 206 at any selected point along support member 202.
  • FIGS 8-13 A second variation fluid flow control device 10b, which is an "in-line" version of above described first variation device 10a, is depicted in FIGS 8-13.
  • elements and features of device 10b that are identical to those described above for device 10 are given the same reference numbers.
  • Those elements and features of device 10b which are similar or equivalent to those elements and features described above for device 10 or first variation 10a are given the same reference num ⁇ bers followed by a "b.” Entirely different elements and features of device 10b are given new reference numbers starting at reference number 300.
  • device 10b dif ⁇ fers in external appearance from above-described ⁇ evice 10a, its function and operation are similar, except for the construction (described below) of flow regulating means 66b, to first variation flow rate control device 10b.
  • device 10b comprises a first, tubular upper shell segment 30b and a second, lower tubular shell segment assembly 36b.
  • Upper segment 30b is constructed to form an internal first chamber 60b having a first, annular-shaped float valve 120b disposed therein.
  • First chamber 60b is vented to atmosphere by a vent 90.
  • Lower segment or segment assembly 36b is constructed of an upper, inner tubular portion 300 and a lower tubu- lar segment 302 to form a second chamber 62b having a second float valve 140b disposed in the lower tubular segment thereof. Further comprising lower segment 36b is an outer, tubular shell portion 304 which is disposed around upper, inner tubular portion 300 and is spaced ra ⁇ dially outwardly tnerefrom( IGS . 9, 10, 12 and 13) . As shown in such FIGS., second chamoer 62b is vented to at- mosphere through a vent 94.
  • Upper segment 30b and lower segment assembly 36b of device 10b function in the same general way, described above, as corresponding upper and lower segments 30a and 36a of device 10a.
  • the principal difference between de- vice 10b and 10a is that the upper segment 30b and lower segment assembly 36b are "in line" with one another; that is, they are vertically aligned relative to one another along a common vertical axis 129b. This is in contrast to upper and lower segments 30a and 36a of device 10a, wnich are positioned in a general side-oy side, offset relationship.
  • flow rate control from fluid source 12 through the device is controlled by relative vertical movement between upper and lower seg- ments 30a and 36a.
  • fluid flow rate from fluid source 12 through device 10b is controlled by relative vertical movement between upper segment 30b and lower segment assembly 36b.
  • a tapered, tubular spike 46b at the top of upper segment 30b is provided for penetrating through a seal 50 at a lower end 52 of a fluid source 12 (FIGS. 8 and 9) to permit the gravity flow of fluid through an orifice 13 ⁇ b at the lower end of an extension 138b into first chamber 60b (FIG. 9) .
  • a fitting 306, such as a female luer fit ⁇ ting, at the lower end of lower segment 302 enables a pa- tient feed tube 16b to be connected to device 10b.
  • Upper float valve 120b is constructed in an annular configuration as snown in FIGS. 9-13, and as is best shown in FIG. 11.
  • Comprising upper float valve 120b are a tubular outer wall 122b of circular cross section and a tubular inner wall 310 also of circular cross section, which is concentric with the outer wall
  • Both inner and outer walls 310 and 122b are of e ⁇ ual lenqths
  • An upper end cap 132b, whicn is attached to upper ends of inner and outer walls 310 and 122b to seal off such upper ends, is formed having a small diameter, cen ⁇ trally located flat (or cone) 134D wnicn functions as a stop to shut off flow of fluid into upper chamber 60b through orifice 136b when upper float valve 120b is at its uppermost position, as depicted in FIG. 13
  • a washer-shaped lower end cap 126b which has a cen ⁇ tral opening 312 (FIG. 11) the size of inner wall 310, is attached to lower ends of the inner and outer walls 310 and 122b to seal off such lower ends .
  • End caps 132b and 126b and inner and outer walls 310 and 122b define an an ⁇ nular air space 314 between the inner and outer walls which provides buoyancy to float valve 120b.
  • a plurality of apertures 315 are formed axially through upper end cap 132b to enable the flow of liquid into a cylindrical space or region 316 side of inner wall 310 Region 316 has a diameter, D4 , wnich is some ⁇ what larger than the outside diameter, D5, of lower seg ⁇ ment portion 300 (FIG. 10) to enable clearance and the flow of fluid therebetween.
  • Lower float valve 140b which is substantially iden ⁇ tical in all respects, except possibly in overall size, with above-described lower float valve 140 is installed in lower segment portion 302 and is freely floating therein.
  • the fluid level in chamber 62b rises, thereby causing lower float valve 140b to float upwardly until the valve blocks open ⁇ ng 322 into the lower segment portion and the flow of fluid thereinto is stopped in the manner de- scribed above with respect to the operation of lower float valve 140 of device 10.
  • upper portion 300 of lower segment assembly 36b is installed upwardly through a central aperture 324 in a case portion 326 of upper segment 30b (for example, FIG. 9) .
  • An O-rmg seal 328 installed in base portion 326 around opening 324 provides a fluid seal between upper segment 30b ana lower segment 36b.
  • shell portion 304 of lower segment assembly 36b s formed having a slot 330 wnich extends downwardly from an upper edge 332 of the shell portion to a short distance above a bottom edge 334 of the shell portion.
  • slot 330 Associated with slot 330, when device 10b is assembled as shown m the various FIGS. 8-10 and 12-13, is an elongate, ridge or boss 336 wnicn is formed downwardly along upper segment 30b so as to project mto the slot (FIGS. 8 and 10) .
  • boss 336 There is preferably marked in or on boss 336, m a generally central position, an index mark or arrow 338.
  • upper portion 304 of lower seg ⁇ ment 36b is formed having an axially spaced apart pair of small, inwardly-directed circumferential beads or ridges 350 at an upper end of the upper portion.
  • a similar but outwardly projecting circumferential bead 352 is formed around the lower end region of upper segment 30b.
  • beads 350 bear lightly agamst an outer surface 354 of upper segment 30b and bead 352 bears ligntly against an inner surface 356 of lower segment portion 30*- so as to reduce the amount of force required to slide the lower segment up and down the upper segment for adjusting the flow rate of liquid through device 10b the manner described below.
  • Beads 350 perform the additional function of ena ⁇ bling the frictional locking of lower segment 36b to up- per segment 30b when a flow rate has been selected by moving the lower segment up or down the upper segment.
  • Such frictional locking is acco plisned by the partial rotation of lower segment 36b relative to upper segment 30b in the direction of Arrow B (FIG. 8) by an amount sufficient for eno regions of beads 350 to ride up onto boss 336.
  • upper portion 304 is constructed of a slightly flexible material, such as a tough plastic (for example, PVC, urethane or LEXAN), to enable such releasable, flexible locking of upper and lower segments 30b and 36b together.
  • liquid normally flows from source 12 through inlet orifice 136b and around the top of upper float valve 120b mto upper chamber 60b.
  • the liquid level in upper chamber 60b is at an equilibrium level 72b.
  • upper float valve 120b floats downward, thereby permitting more liquid to flow from source into upper chamber 60b until equilibrium liq ⁇ uid level 72b is reestablished.
  • cylindrical region 316 defined by inner wall 310 of upper float valve 120b is filled with liquid to liquid level 72b. Liquid from such region 316 is discharged into lower chamber 62b through an upper orifice 360 formed at the top of upper portion 300. From orifice 360 liquid drips in droplets 64 into lower regions of lower chamoer 62b ano onto lower float vaive 140b. Liquid accumulates (after startup) in lower chamber 62b until it reaches an equilibrium level 82 at whicn lower float valve 140b just floats up from discharge orifice 150b at the bottom of the lower cham ⁇ ber. Thereafter a drop of liquid is discharged from lower chamber 62b into patient conduit 16b for each drop
  • lower float valve 140b When there is no liquid in lower chamber 62b, lower float valve 140b closes off orifice 150b to prevent con- tamination of the lower chamber from the outside. On the other hand, if conduit 16b to the patient is blocked and liquid continues to be flowed into lower chamber 62b, the liquid level rises in lower chamber 62b causing lower float valve 140b to float upwardly until it blocks off inlet opening 322, thereby blocking the flow of liquid into the lower chamber.
  • the rate of liquid flowing into lower chamber 62b from upper chamber 60b depends on the liquid head, Hd, over upper orifice 360 (FIG. 9) . It is evident that when lower segment 36b is moved downwardly as far as permitted by bea ⁇ s 350 and 352 (FIG. 12), the liquid head, Hd, over orifice 360 (from liquid level 72b) is a maximum and the flow rate into patient conduit 16b is maximized. Note that FIG. 9 depicts an intermediate flow rate condition wherein lower segment 36b is at an intermediate position relative to upper segment 30b and liquid flow into pa- tient conduit 16b is less than the maximum.
  • FIG. 13 depicts a "no liquid flow" condition in which lower segment 36b is pushed upwardly as far as per ⁇ mitted relative to upper segment 30b.
  • an upper end surface 364 of upper portion 300 pushes upwardly on an under surface 366 of upper end cap 132b of the upper float valve, thereby pushing the end cap against mlet orifice 136b to positively stop liquid flow from source 12 into upper chamber 60b.
  • lower segment 36b is partially rotated relative to upper segment 30b in the direction of Arrow B (FIG. 8) to lock device 10b at the selected flow rate.
  • a constant liquid head, Hd is maintained in device 10b and assures that the selected flow rate is maintained.
  • a user may confirm the selected flow rate Dy counting drops 64 falling through lower portion 302 of lower segment 36b.
  • at least a por ⁇ tion of aside wall of lower portion 302 is constructed of a transparent material, such as a transparent plastic.

Landscapes

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

Abstract

Dispositif de régulation du débit d'un liquide comprenant une première chambre (60) ventilée de liquide, dont une extrémité supérieure d'entrée de liquide est pourvue d'une pointe creuse (46). Un obturateur (70) flottant dans la première chambre arrête la pénétration dans ladite chambre du liquide provenant d'un réservoir de liquide (12), ce qui crée une pression constante. Une extrémité inférieure de la première chambre est reliée, par l'intermédiaire d'un régulateur de débit (66) à une extrémité supérieure d'entrée d'une deuxième chambre (62) ventilée de goutte-à-goutte, dont l'extrémité inférieure est conçue pour être accouplée à un tube d'évacuation. Un deuxième obturateur (140) flottant librement dans la deuxième chambre, prévient la pénétration dans le tube d'évacuation du liquide provenant de ladite chambre, quand le niveau du liquide dans ladite deuxième chambre est égal ou inférieur à un niveau minimum prédéterminé et prévient la pénétration du liquide dans la deuxième chambre quand le niveau de liquide dans ladite chambre atteint un niveau prédéterminé.
EP96935920A 1995-09-29 1996-09-24 Dispositif de regulation du debit d'un liquide Withdrawn EP0862470A4 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US674552 1984-11-26
US463495P 1995-09-29 1995-09-29
US4634P 1995-09-29
US08/674,552 US5730730A (en) 1995-09-29 1996-07-01 Liquid flow rate control device
US71788296A 1996-09-23 1996-09-23
US717882 1996-09-23
PCT/US1996/015250 WO1997011729A1 (fr) 1995-09-29 1996-09-24 Dispositif de regulation du debit d'un liquide

Publications (2)

Publication Number Publication Date
EP0862470A1 true EP0862470A1 (fr) 1998-09-09
EP0862470A4 EP0862470A4 (fr) 1999-06-16

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ID=27357676

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Application Number Title Priority Date Filing Date
EP96935920A Withdrawn EP0862470A4 (fr) 1995-09-29 1996-09-24 Dispositif de regulation du debit d'un liquide

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Country Link
EP (1) EP0862470A4 (fr)
AU (1) AU723789B2 (fr)
CA (1) CA2235720C (fr)
WO (1) WO1997011729A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9731070B2 (en) 2014-06-30 2017-08-15 Carefusion 303, Inc. Passive start drip chamber
EP3710078A1 (fr) 2017-11-14 2020-09-23 Fresenius Medical Care Holdings, Inc. Élimination de microbulles à travers des sites de nucléation de chambre d'égouttage
CN109908427A (zh) * 2019-04-19 2019-06-21 长春市亿健科技有限公司 一种输液装置

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US4096879A (en) * 1976-08-19 1978-06-27 International Biomedical Laboratories, Inc. Adjustable fluid flow regulator
US4269222A (en) * 1979-03-27 1981-05-26 Palti Yoram Prof Constant flow device
GB2089944A (en) * 1980-12-23 1982-06-30 Wallace Ltd H G Flow Regulating Device
US4340050A (en) * 1980-12-29 1982-07-20 Delmed Inc. Medical fluid flow rate indicating/controlling device

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US3929157A (en) 1974-06-17 1975-12-30 Juan R Serur Fluid flow regulator
US3931818A (en) * 1974-07-22 1976-01-13 Michael Goldowsky Liquid administration apparatus
IL45485A (en) * 1974-08-18 1976-10-31 Yarden Medical Eng Ltd Constant-flow device for intravenous infusion set
US3989043A (en) * 1974-12-23 1976-11-02 John Dimeff Automatic flow control and automatic shut off for intravenous feeders
US4588396A (en) 1982-10-22 1986-05-13 Stroebel Maurice G Apparatus for gravity feed of liquid under constant hydrostatic pressure
US4807660A (en) 1984-07-13 1989-02-28 Aslanian Jerry L Flow control device for administration of intravenous fluids
US4789000A (en) 1984-07-13 1988-12-06 Aslanian Jerry L Flow control device for administration
US4802506A (en) 1984-07-13 1989-02-07 Aslanian Jerry L Flow control device for administration of intravenous fluids

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Publication number Priority date Publication date Assignee Title
US3667464A (en) * 1970-09-04 1972-06-06 Lawrence M Alligood Jr Fluid dispensing device
US4096879A (en) * 1976-08-19 1978-06-27 International Biomedical Laboratories, Inc. Adjustable fluid flow regulator
US4269222A (en) * 1979-03-27 1981-05-26 Palti Yoram Prof Constant flow device
GB2089944A (en) * 1980-12-23 1982-06-30 Wallace Ltd H G Flow Regulating Device
US4340050A (en) * 1980-12-29 1982-07-20 Delmed Inc. Medical fluid flow rate indicating/controlling device

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See also references of WO9711729A1 *

Also Published As

Publication number Publication date
EP0862470A4 (fr) 1999-06-16
CA2235720C (fr) 2002-08-06
AU7369696A (en) 1997-04-17
WO1997011729A1 (fr) 1997-04-03
CA2235720A1 (fr) 1997-04-03
AU723789B2 (en) 2000-09-07

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