DE3035301A1 - DOUBLE INFUSION DEVICE - Google Patents

Description

MILLIPORE CORPORATION
Bedford, Massachusetts, V.St.A.

Double infusion device

The invention relates to devices for intravenous infusion and in particular double infusion devices (so-called Piggyback infusion devices) and devices that can be used therein that allow automatic switching between allow two parenteral fluids to be administered at different rates.

Liquids to be administered intravenously, such as Parenteral solutions are over from a storage container A flexible tubing system is routed to a cannula or catheter connected to the patient's venous system stay in contact. With current therapy is

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In many cases it is desirable to use a first, so-called primary solution, such as physiological saline solution or dextrose solution To be administered at a slow infusion rate to keep the cannula or catheter from becoming blocked to be kept free by blood clots. As the day progresses, the flow of the first liquid becomes periodic interrupted and a second fluid such as an antibiotic or other medicine through the same cannula administered at a higher flow rate. After administering the second solution the infusion of the first solution is resumed. Such infusion devices for administration two such liquids from separate storage containers via separate lines that are in one Y-pieces with a common, single line that is connected to the patient are already commonly known and referred to as 'piggyback sets'.

Usually the second solution, which is administered at a higher flow rate, is also under a greater hydrostatic pressure administered from a greater height of the reservoir due to gravity results. Furthermore, pumps or the like can also be used for this purpose. Such devices are of numerous Patents such as U.S. Patents 4,105,029 and 4,116,646.

Known such double infusion devices have a mechanical or an air-blocking membrane valve on, with which the flow of the first liquid is interrupted when the second liquid flows, wherein the greater hydrostatic pressure of the second fluid

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is exploited. However, it is to be assumed that that all such previous devices rely on the use of a single throughput control device such as a roller clamp provided downstream of the Y-piece to accommodate the two Solutions to change desired flow rate. The doctor, nurse, or other operator must therefore connect the feed line of the second liquid and its flow rate adjust and then correct the flow rate of the first liquid again. Occurring here Errors can result in a significantly excessive infusion burden for the patient with the first solution lead over-infusion.

The invention is based on the object of a double infusion device as well as to indicate usable devices with which the independent setting of different Flow rates of the first and second liquid, the automatic shutdown of the Flow of the first liquid during the administration of the second liquid and the automatic restart the flow of the first liquid at the correct flow rate without operator intervention be made possible. The concept of the device according to the invention is also intended to allow the mixing of the substantially avoid the first and second fluids, allow venting, being prevented is that the patient is infused air, as well as a substantially complete administration of the allow second liquid.

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The problem is solved according to the claims.

The double infusion device according to the invention for IV infusion comprises

- A first hose line, one end of which can be connected to a storage container for a first liquid is,

- A second hose line, one end of which has a storage container for a second, higher one Liquid located at the pressure head can be connected,

- A Y-shaped connecting part, with which the other end of the first and the second hose line are connected,

and

- an outflow hose from the Y-shaped connector goes out and directs the infusion fluids to the patient,

and is indicated by

- a shut-off valve device in the ₁ flow _{path of} the first liquid, which prevents the flow of the second liquid into the first hose line,

a first adjustment device for the flow rate below the Y-shaped connecting part for adjustment or control of the higher

• throughput of the second liquid;

and

- one provided above the first adjustment device

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second adjustment device for the flow rate to adjust or control the flow rate the first liquid.

The shut-off valve device is preferably an air-blocking hydrophilic microporous membrane, which is explained in more detail below. In contrast to mechanical Shut-off valves are diaphragm valves of this type by pressure changes caused by the second setting device for the throughput of the first liquid are not disturbed. The first adjustment device for the second liquid, there is preferably a conventional owl clamp on the outflow tube, which is attached to the higher flow rate is adjustable. The second adjustment device can also consist of a conventional one There are roller clamps provided on the first hose line, but any one can also be used Another suitable device for throttling the flow rate of the first liquid without throttling the Throughput of the second liquid with its higher throughput and higher pressure are used. If the second adjustment device is provided above the X-shaped connecting part, is preferably in

A hydrophilic microporous membrane is provided for the flow path of the second liquid through the device, which, when damp or wet, is permeable to liquid, but not to air.

According to a preferred embodiment, the invention is a new type of connector for use with conventional ^ v-inf-ugionsleitfen / an net is through

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- a first and a second entrance chamber with inlets for the first "or the second liquid,

- an outlet chamber with an outlet for both liquids

and

- an intermediate chamber between the entrance and the
Exit chamber,

wherein the first entrance chamber and the intermediate chamber
separated by a microporous, hydrophilic membrane
are separated, which in the wet state for liquids,
but not for air at the maximum pressures in the
Chambers is permeable and is arranged in the upper part of the device so that aie retains air in contact with its downstream side when the pressure in the intermediate chamber exceeds the pressure in the first entrance chamber
exceeds.

In conjunction with conventional IV infusion lines and the additional use of adjustment devices for the throughput of the first and second liquid, the
Device for automatic switching between the solutions at different throughputs desired for the respective liquid.

If the adjustment device for the first liquid is provided on the line for the first liquid above the Y-shaped connector, a second microporous hydrophilic membrane should be the intermediate chamber from either the second chamber for the second liquid
or the AuslajB ^ ^{: amrae: E>} or preferably separate from both chambers in order to allow air to be drawn in from one

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Avoid ventilated, empty reservoir for the second liquid. The latter option is preferred here in order to achieve protection against a malfunction of one of the membranes. It can furthermore, deaerators with hydrophobic membranes can also be provided. If an adjustment device for the first Liquid is used which is not below atmospheric pressure at the liquid inlet for the second liquid Generated lying pressure, only the membrane is required, which separates the chamber for the first liquid .

The invention is explained in more detail below with reference to the drawing; show it:

1: a schematic representation of an embodiment of the invention, in the shut-off diaphragm valves in the (Dropfkammern, a conventional Y-shaped connector and two conventional clamps for adjustment the throughput are used;

2: a cross section through a Y-shaped connecting part according to the invention for use in a further embodiment of the invention;

Fig. 3: a plan view of the upper, the membrane bearing surface of the lower part of a second embodiment of a Y-shaped connecting part for use in a further Atisführungform the invention

Contraption;

Fig. 4-: a view of the lower part of Fig. 3 from below;

Pig. 5: a cross-section along the line 5-5 of FIG ! "fig. 3» with the lid of the lower part in Exploded view is shown in cross section;

6: a side view of the device of FIGS. 3 ″ to 5 with the cover and the hydrophilic ones Membranes in longitudinal section;

7: a schematic longitudinal section through the The device of FIGS. 3 to 6 in a modified form for reasons of clarity for the purpose of explanation the mode of operation when the first liquid is administered

and

Fig. 8: a schematic cross-sectional view similar 7 to explain the administration the second liquid.

In Fig. 1 a so-called Piggybaek-IV double infusion device is shown, which has a storage container JO _- for the first and a storage container Λ2 for the second liquid, a first hose line _14, a second hose line j16, a conventional Y-shaped

Having connecting part IiS "and an outflow line 20, which ends in a needle 22 for piercing a patient's vein.

The hose lines J4 and 1_6 end with their upper ends in identical drip chambers 24, the piercing spikes 26 for connection to the storage containers IQ; and Λ2 as well as vent connections 28. The drip chambers 24 also have a hydrophilic microporous membrane 2 £ which extends across the flow paths of the liquid, as disclosed, for example, in US patent application Ser. He. 824 908 and US Pat. No. 4,116,646.

The membranes are in contact with air on their downstream side and have a bubble point that is above the pressures in the system. The membranes are therefore permeable to liquid flowing down when they are moist, but retain air or liquid in the upstream direction. For this purpose, membranes with bubble points greater than about 0.14 are bar (2 psi) suitable for ^ example, membranes having pores of approximately .. The liquid solution in the reservoirs 1O _- and Λ2 thus can flow through the membranes, wherein a passage of fluid and Air in the opposite direction is prevented. The membranes thus serve as shut-off valves and, since they prevent the entry of air, maintain a column of liquid in the hose lines J4 and _16 and their corresponding drip chambers. If necessary, the storage containers can therefore easily be moved around or moved to another location without the need to restart the infusion with removal of the air.

In normal operation, the first liquid flows from the reservoir JK) due to gravity through the hose line _14, the connecting part 1_8, the outflow line _2O and the needle 22 into the patient's vein, the lower flow rate correspondingly with a? conventional, adjustable roller clamp J5O. During the flow of the first liquid, the shut-off clamp _32 prevents the second liquid from flowing out of the storage container Λ2 if this is connected to the connecting part Jj8. If, on the other hand, the second liquid is to be administered from the storage container 1_2, which is provided above the storage container JK), in order to achieve a greater hydrostatic pressure, the hose line Jj6 is connected and the parking clamp ^ Z is opened. Since the pressure of the second liquid is greater, it flows through the connecting part _18 and has the effect that the first liquid no longer flows through the hose line _14. The higher throughput of the second liquid is controlled or adjusted by the roller clamp 34 provided on the outflow line 20. If roller clamp 34 is initially set, no further adjustment is required for subsequent flow of the first liquid, the flow rate of which is controlled by roller clamp J50. If the setting of roller clamp J> 4 is more open, there is accordingly no disturbance compared to the throughput set with roller clamp j50_.

When the second liquid has been administered and stops flowing, its pressure in the hose line drops, whereupon the first liquid from the storage container 10 is automatically fed through the roller clamp 30

set flow rate begins to flow, and no operator intervention is required to adjust the flow rate. Furthermore, no air can get into the connecting part ^ 8 through the hose line J6> and the vent connection 28 if the pressure in the hose line 14 below the roller clamp J5 <D is below atmospheric pressure, since this is caused by the moist membrane 2J? -is prevented. Accordingly, no special shut-off valve is required on the connecting part Λ8_.

If the second liquid is then to be administered, all that is necessary is to close the roller clamp 32, refill or replace the storage container 1 and reopen the roller clamp J2. If necessary, the storage container Λ2 can be filled with the second liquid in an amount that is sufficient for several presentations, whereby the roller clamps J52_ or similar storage devices with a timer can be opened and closed automatically at desired time intervals. If necessary, a final filter 36 , which can have a ventilation connection, can also optionally be switched into the outflow line 20 to ensure sterility.

While the device shown in FIG. 1 has an automatic switchover and the setting or maintenance of different throughputs
^ enables, prevents the diaphragm shut-off valve with

the membrane 2 £ in the drip chamber 24 on the hose line _16 the drainage of this liquid, which is what the doctor for individual administration of a second liquid

be desirable know. Accordingly, while the second liquid flowing in hose line _16> cannot flow into hose line ΛΑ , the liquids in hose line JKf can mix by diffusion. In cases where this is undesirable, the connecting part _18> and the diaphragm shut-off valves with the membranes 2 £ can be replaced by the special devices shown in FIGS.

The connecting part 40 shown in FIG. 2 represents a further development of the device known from US Pat. 2 shows a vertical section of this development which generally follows the diameter, the upper part being modified so that it has an inlet chamber 42 for the first liquid with an inlet 44 for connecting the first hose line 46 and a second inlet chamber 48 for the second liquid with an inlet ^ O for inserting a second hose or tube (not shown) through an elastic, pierceable closure 52 . The inlet chambers 42 and 48 open into the intermediate chamber ^ 4, which is separated from / by a hydrophilic microporous membrane j? 6_, which acts as a valve. The inlet chamber 42 also has a hydrophobic vent filter £ 8.

The central support 60 is designed as in the above-mentioned US-PS and has a on its outside Terminal sterilization filter 74 made of a hydrophilic, microporous membrane, which in a moist state for

Liquid is permeable, however, the passage of Air prevents. The carrier 60 "also has an outlet chamber 62, which with the outlet 64 for connection of the (not shown) outflow line for conveying the liquid to the patient in connection.

The carrier 60 has a membrane 66 on the upper side, the central area of which, as can be seen from the above-mentioned US Pat. Alterna is _se, as Fig. 2 shows a ring 72 provided around the central region of the diaphragm • 66_, which is sealed between the upper periphery of the passage 68 and the inner surface of the outer wall of the device 4O. The ring is hydrophilic and serves as additional protection against the passage of air from the entrance chamber 48 if the terminal sterilization filter 2ft fails. The hydrophilic ring can be provided using a separate material; however, a single hydrophilic membrane disk can also be used, the central area of which has been rendered hydrophobic by known methods, for example by treatment with silanes.

In operation, the first liquid passes from the higher reservoir through inlet 44 into the first

an inlet chamber 42 for the first liquid, the initially contained or otherwise entrained air is removed via the vent filter j? 8 by venting will. The first liquid flows from the input chamber 42 through the membrane j? 6 into the intermediate chamber ^ 4, where the intermediate amme r j? 4 partly with liquid fills, but a layer of air downstream in contact

with the membrane j56 remains, which represents an air seal against flow of the liquid in the reverse direction. The liquid then passes through the outer ring 2 of the membrane 66 into the annular chamber 2Qi, through the terminal sterilization filter 2Ü ^ - ^{n the} outlet chamber 62 and finally through the outlet 64. The throughput of the first liquid is as in the embodiment shown in FIG controlled or adjusted with a roller clamp (not shown) on the hose line 46 for the first liquid.

When the second liquid is to be administered, the corresponding storage container is above the storage container attached to the first liquid to achieve greater hydrostatic pressure; furthermore will be his Hose line inserted, for example, with a hollow needle adapter of known design through the closure ^ g and the flow of liquid is started by loosening the shut-off clamp, as explained for FIG. The corresponding The flow rate is, as also explained in connection with FIG. 1, with an adjustable one Roller clamp set on the outflow line from outlet € 4 to patient. The second liquid then flows full from the corresponding storage container and through the associated lines into the intermediate chamber j? 4, however not through the membrane j> 6 into the input chamber 42 for the first liquid flow in, as the .membrane j? 6 blocked by air.

When the supply of the second liquid is used up, the flow of the first starts again automatically Liquid with the corresponding predetermined flow rate, such as through the hose line

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the air that has penetrated the second liquid is discharged via the passage €> 8 with ventilation and through the moist Sing £ 2 and the terminal sterilization filter £ 4 air is prevented from entering outlet 64. In addition to automatic switching and different Adjustment of the flow rates, the second liquid flows accordingly fully, with above the Membrane ^ 6 no liquid mixing can occur can. All valves are diaphragms that are not affected by negative or sub-atmospheric pressures be influenced, with no shut-off valves outside of the connecting part are required.

In Figs. 3 ″ to 6 is a preferred embodiment of the connecting part according to the invention, the mode of operation of which is explained in FIGS. 7 'and 8. the

Device has a lower part 80 and a cover 82 which - -

on, / are for example cast or pressed moldings.

The top of the lower part 80 has circumferential ribs 84 , 86 and 88 and ribs 90, the upper surfaces of which define a substantially planar surface. A hydrophilic microporous membrane 92 is provided thereon, which is sealed with an adhesive, by heating or preferably by bonding with a solvent. Although three separate membranes can be used which are sealed on the circumferential ribs 84, 86 and 88, respectively, a single membrane is preferably used. The part of the membrane which occupies the space ^ 3 between adjacent edges of the circumferential ribs 84 and 86 is preferably either removed by cutting or the like or made non-porous by impregnation or similar treatment in order to allow capillary flow through the space 9.3 sru

impede. The cover 82 is sealed in a liquid-tight manner on the upper outer circumference 94 of the lower part and results in an intermediate chamber 126 approximately 0.25 mm (10 mils) thick between the cover and the membrane surface.

Due to the distance between the membranes and the upper surface of the lower part at the bottom of the ribs 90, an entrance chamber 9 * 3 for the first liquid (within the circumferential rib 84), a second entrance chamber 100 for the second liquid (within the rib 86) and a Outlet chamber 102 (within rib 88), each chamber being, for example, about 0.64 mm (about 25 mils) deep. The lower part 80 has three molded or molded pipe connections 104 , 106 and 108 for connecting the first hose line, the second hose line or the outflow line of the double infusion device. The pipe connection 104 ends in an opening 110 which represents the inlet for the first liquid into the first input chamber _9_8; the tube 106 terminates in the opening 112 which is an inlet for the second liquid into the second input chamber 100 ; the tube 108 finally ends in the opening 116 which forms an outlet for the outlet chamber 102 .

The openings 118 and 120 are provided in the lower part or in the inlet chambers for the first or liquid; Above that, hydrophobic microporous membranes are densely arranged, which serve as ventilation filters in these chambers on the upstream side of the hydrophilic membranes located above.

The operation of the illustrated in Figs. 3-6

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The device is explained with reference to the schematic FIGS. 7 and 8. In FIG. 7, the device administers the first liquid 121 through the first line 122 with a throughput controlled by the control device 124. The first liquid 122 flows into the first input chamber 96 ' for the first liquid and through the membrane 92' into the intermediate chamber 126 ' below the cover 82' . An air bubble 128 J ₁ is formed in the upper part of the intermediate chamber 126 ' , venting through the moist membrane 92' being prevented. The liquid 121 flows from the intermediate chamber 126 back through the lower part of the membrane 92 ' into the outlet chamber 102' and then through the drain line 130 to the patient.

8 explains the administration of the second liquid 132 , which enters the second input chamber 100 ' under a greater hydrostatic pressure than the first liquid 121 and passes through the membrane 92' into the intermediate chamber 126 ' . An air bubble 128 covers the entire membrane 92 ' above the first inlet chamber 98' and thus prevents backflow. The second liquid 132 then passes from the intermediate chamber 126 ' through the lower part of the membrane 62' into the outlet chamber 102 ' and then via the drainage line 130 to the patient. The flow rate of the second liquid is controlled by the control device 1 3 , 4- , which in the open position has little influence on the throughput of the first liquid. The second liquid can in turn run off completely, and no mixing with the first liquid can occur in the first inlet chamber.

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When the second liquid is completely administered, the pressure drops and the first liquid automatically begins to flow again at its predetermined lower flow rate. Any air that has penetrated through the ventilated second hose line is removed via the vent opening 120.

Membranes

If / between the intermediate chamber 126 ' and the inlet chambers 100' and 102 ' should be dispensed with, either of the two can be omitted, whereby adjacent chambers merge into one another. If the control device for the throughput of the first liquid does not generate a negative pressure at the inlet of the second input chamber, both membranes between the intermediate chamber 126 ^f and the input chamber 100 ' and 102' . can be omitted.

The invention is not restricted to the specified embodiments; the inventive concept also includes all analogous embodiments within the scope of the invention ge d ankens.

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Claims (1)

Expectations Ö Double infusion device for alternative infusion a first and a second infusion liquid at different pressures and throughputs and for automatic fluid changeover with a first hose line, one end of which with a storage container for a first infusion liquid is connectable, a second hose line, one end of which has a storage container for a second, higher one Infusion liquid located at the pressure level can be connected, a Y-shaped connecting part with which the other end of the first hose line and the second Hose line are connected, and an outflow conduit leading from the Y-shaped connector goes out and directs the infusion fluids to the patient, marked by a valve device (.25) in the flow path 604-C76 130016 / 069A first infusion fluid that allows the second infusion fluid to flow into the first Hose line (14) prevents a first adjustment device (34-) for the flow rate maintenance) of the Y-shaped connecting part (18) for setting the higher throughput the second infusion fluid and a second setting device (30) provided above the first setting device (34-) for the Flow rate for adjusting the throughput of the first infusion liquid without throttling of the flow of the second infusion fluid. 2. Double infusion device according to claim 1, characterized in that the locking valve tl device a hydrophilic microporous membrane (25) is in the flow path of the first infusion liquid, on the downstream side of which there is air and thus a reverse flow of the second infusion liquid prevented through the membrane. 3. Double infusion device according to claim 1 or 2, characterized. That it furthermore has a hydrophilic microporous membrane (25) in the flow path for the second infusion liquid, those in moistened with aqueous liquid Condition the passage of air to the patient prevented. 4-. Double infusion device according to one of claims 1 to 3? characterized in that the adjusting device .for the flow rate an adjustable clamp (30) on the tubing for the first infusion fluid is. 5. Double infusion device according to one of claims 1 to 4-, characterized in that the check valve device and the microporous Membrane are provided in the connecting part (18). 6. Double infusion device according to one of claims 1 to 5j further characterized by upstream of the. Check valve device and upstream , _M ,, breather _ .. the membrane provided for venting to the atmosphere, the hydrophobic microporous membrane exhibit. 7. Double infusion device according to one of claims 1 to 6, further characterized by an additional hydrophilic membrane in the flow path of each infusion liquid for additional protection against the passage of air to the patient. 8. connecting part for double infusion devices according to one of claims 1 to 7 » 13001S / 06ÖA marked by a first inlet chamber (42) with an inlet (44) for the first infusion liquid, a second inlet chamber (48) with an inlet (50) for the second infusion liquid, an outlet chamber (62) with a common outlet (64) for the two infusion liquids an intermediate chamber (54) between the outlet chamber (62) and the inlet chambers (42 and 48), wherein the intermediate chamber (54) and the first entrance chamber (42) for the first infusion liquid through a microporous, hydrophilic membrane -separated from each other, which, when wet, the first infusion liquid can pass through, but is not permeable to air at the maximum pressure in the chamber and located in the upper part of the device (40) so that the air is in contact with its downstream Page holds back and so a backflow of the second infusion liquid through the membrane prevented. The connector of claim 8 further characterized by a hydrophilic microporous Membrane ^ the intermediate chamber (54) from the inlet chamber (48) for the second infusion liquid and / or the outlet chamber (62) separates and is permeable to liquid but not to air. 130 * 18/06 »* 10. Connector according to claim 8 or 9, further characterized by hydrophilic microporous membranes. (^ -S ^e ^ ^e intermediate chamber (54-) from the inlet chamber / for the second infusion liquid and the outlet chamber (62). 11. Connecting part according to one of claims 8 to 10, characterized in that the membranes are arranged substantially in the same plane are. 130016/0894