DE7610866U1 - VALVE UNIT FOR INFUSION AND FLUSHING DEVICES - Google Patents

Description

G 76 10 866.2 July 9, 1976

Dr. Helmut Biedermann, Innsbruck / Austria

Valve device for infusion or rinsing devices

The innovation relates to a valve device for Infusionsbzw. Flushing devices, which the drain lines at least two infusion containers can be interposed and their valve position is dependent on the infusion medium pressures, wherein the drainage lines or the like merge into one another before entering the venous catheter.

Intravascular infusion therapy, especially continuous intravenous infusion and artificial feeding (24 ⁿ / d) over longer periods of time, is playing an increasing role in almost all medical fields today. In proportion to this, the time required to maintain and control the infusion devices has also increased. If the infusion devices can only be insufficiently supervised, e.g. due to a lack of nursing staff, the continuous flow is not guaranteed and cannulas

"- 2 -

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and catheters are moved by stasis or backflow of blood. The previous practice, two devices with different drip speeds, for example, through Y-pieces or cannulas pierced into the feeding hose lines couple has the disadvantage of constant and often undesirable mixing of the infusion solutions and their additives. Chemical Reactions or mutual neutralization of the active ingredients can result.

Coupling via a 3-way stopcock requires timely switching and thus constant attention in order to avoid stasis to prevent.

Furthermore, it has hitherto been customary to couple and uncouple the infusion devices directly to and from the injection cannula or the catheter. Unpleasant consequences of this manipulation, such as piercing the vein wall, slipping out the injection cannula, Kinking of the catheter or soiling of the bed sheets had to be accepted. At night the patients were at Change of infusion bottles always woken up. Similar Problems arise with irrigation devices that are suitable, for example, for wound irrigation.

An infusion device is known in which two infusion containers are held at different heights and where on A valve is arranged at the coupling point between the two tubing lines of the infusion container.

This arrangement avoids excessive mixing of the two infusion liquids, but one must of the bottles act as so-called keep-vein-open bottles.

In contrast, the innovation is based on the task of providing a valve device for infusion or rinsing devices create, which allows a simple coupling of two or more infusion containers, in which the infusion container without Maintenance run one after the other and the content of which is

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Depending on the setting, not over one area of the infusion and only minimally over another area of the infusion mixed.

This object is achieved according to the invention in that each container-side inlet of the valve device has one Valve unit is assigned with valve seat and closing part.

The particular advantages of the innovation are the reduced maintenance effort, the continuous flow, which largely prevents clogging of the cannulas or catheters, and restricts the manipulation of cannulas and catheters.

The infusion containers arranged at different heights result in a liquid column of different heights and thereby a different pressure at the inlets of the valve, the higher liquid column being the valve closes opposite the lower liquid column and the infusion liquid flows out of the higher container.

If the infusion liquid has flowed out of the higher infusion container unmixed to such an extent that the liquid columns are the same height, the valve opens and the infusion liquid now runs out of both containers at the same time, with a slight mixing of the

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-A-

Infusion fluids, depending on the cross-section of the container or lines.

It is advantageously provided that the bottom of an infusion container is above the liquid level of the second full one Infusion container is arranged.

The valve device according to the innovation is preferably designed as a check valve.

The device described below is characterized by several advantages:

Uncomplicated construction and easy handling, labor saving, all commercially available infusion bottles and devices can be used, provided their coupling pieces comply with the standard, the 1st infusion bottle empties completely unmixed, the 2nd then only mixes in the ratio of the cross-sections B ₁ to A ₃ (maximum 1: 900 with today's infusion systems), as long as the infusion device A is not disconnected. The venous system and thus the patient himself can be spared by:

continuous flow,

Fixed coupling of the injection cannula or catheter with the feeding tube (bottle change more hygienic, risk of displacement of the injection cannulas and catheters considerably reduced). As far as possible, avoiding annoyance for the patient (especially at night) by maintaining the infusion system;

(fewer controls required, bottles are exchanged outside the patient's bed).

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The danger of Luftembollfc, even with a change of flasohen is Can be safely avoided if the fixed coupling between the central venous catheter and the supply tube is secured (Bayonet lock or screw lock, rubber strap, adhesive plaster) and the Y-piece at least 10 cm below the Vena cava levels to droop in the patient lying flat comes (about mattress height).

A major advantage of the innovation according to the design is in the equivalence of the connected containers.

Two exemplary embodiments of the innovation are attached below the drawing described in more detail, but without the innovation should be restricted to it. Show it:

Fig. 1 schematically shows an embodiment of one with a Infusion device equipped with two infusion containers according to the innovation,

2 schematically shows such an infusion device with four infusion containers,

Fig. 3 schematically an infusion device with three infusion containers,

4 shows a schematic section through the valve device according to Fig. 1, and

5 shows a schematic section through a valve device for an infusion device according to Fig.

In the embodiment according to FIG. 1, the suspension of the infusion bottles A ₁ and B ₁ at different heights at the confluence creates a pressure difference which

- 6 -

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• ^ ■■ ··· “vÄ

"a ·" of the intermittently switched valves becomes echlleßwh. settle dee 'l ^ ol ^ itttf ^ iolilfdil ¹ ^ ^^} s0 ^ 0 ^ liii ^^ iß ^ i ^ fueioneflaoche A- | opens aioh öaa valve V and the infueione-

aioh too

The air columns in the two drop counters correspond each other roughly tmd can be negated.

The klGgloee function of the establishment is as follows Factors dependent.

a) Vo * level difference of the liquid level

b) the specific gravity of the infusion solutions

c) the weight and position of the valve balls

If the valve ball lies above the inflow opening _p , the opening is better closed by its weight, the premixing occurs later and is less.

d) The viscosity of the solutions.

e) The prevention of a negative pressure in the upstream bottle so that it does not become a relative one overpressure can occur in the downstream bottle. (The air flow in closed infusion bottles must be ensured5 a poorly dripping blood container e.g. must be pressed in with artificial pressure.)

f) Regulating the dripping speed of the upstream bottle by means of the pinch valve G on the common outlet G ₂ . (If one closes the cock A ₁ , further than G ,, one creates under certain circumstances an artificial relative negative pressure in system A compared to system B.)

b, c, d are negligible quantities if the difference in level of the liquid level is caused by an additional safety distance (empirically found value for d ₂ = 5 cm)

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is enlarged. The functionality of the facility becomes increased by the use of a bayonet lock, screw lock or a rubber strap and the attachment of a Drop counter on the hose line Gg.

The simple formula for calculating the suspension height of the downstream bottle B is therefore ₁ s

h _B. h _A - (d., + d ₂ )

The operation of the system ;

1. The infusion bottle A ₁ is coupled to the infusion device A ₂ -A ^ in the usual way. The cutlery is filled in the usual way, so that only a short column of air remains in the drop counter.

2. The Y-piece G ₁ with the valves V and V ^ as well as the discharge line V ₂ is now coupled (Fig. 1) and also filled free of air, the valve V closing automatically. As a result, the dripping speed is only regulated with the tap Gj, while A ^ remains open.

3. G ₂ is connected to the injection cannula, permanently connected to it and secured. This coupling then no longer needs to be released, since bottles are exchanged at G ₁ or V and V ₁ . The Y-piece should hang at mattress height (with the patient lying flat).

4. While bottle A _{1 is} emptying, an infusion _{bottle B with the infusion device (B 2} - B ^) can be connected to the system (at valve V) after venting at any time. Note that the liquid level of B _{1 is} at least 5 cm below the lower edge of A ₂ . Then A ₁ , A ₂ and to part A, up to the level of the liquid level of B ₂

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• · · Μ

emptied, then the valve V opens and the infusion bottle B ^ also begins to empty, »whereby the dripping speed can also be lower, preprogrammed in B ^, alf? di ^ j from A ₁ («important e.g. for Kallumzueatz)

5. If the emptied infusion bottle A _{1 is to be} replaced, the uncoupling takes place at V ₁ and this valve closes automatically. The infusion bottle B ₁ with infusion device takes the place of the infusion _{bottle A 1} , (B., sic_ now emptied

'according to the same principles as 2u before A ₁ , with a

third bottle connected to valve V _{1 in place of A 1}

can be). Furthermore, V ₁ closes when the liquid level of B _{1 is raised} above the level of the liquid level of A ₁ .

The valve according to the invention is characterized by:

a) a short way of the ball 3 (the flow volume should be that of the narrowest point of the infusion tubes just correspond

b) concentric guidance of the ball through at least three strips 8,

c) Manufacture of valve chamber and valve seat from one piece

d) The ball (the cone or the flap) may be wrapped in soft sealing compound or inserted a soft sealing ring into the inlet opening

\ irend.

Matching cover caps 4 or plugs keep the valve ends sterile, the shape of which must correspond to the coupling pieces of the respective infusion devices. A venous pressure measuring device can easily replace the draining hose line G ₂

installed, or connected via a 3-way stopcock between G ₂ and the injection cannula or the venous catheter.

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Scheme of a ball valve: </ £

1. Main part

2nd main piece

Bullet

Cover cap

Valve guide, outside with thread or bayonet lock (for Disposable valves: glue point), inside strips 8 for the valve ball 5

Current direction

The exemplary embodiments according to Figures 3? 2 and 3 represent technical more complex variants of the invention. By coupling zv / eggs or several infusion bottles or devices, via a block valve. The functional reliability of the device is increased, the handling is made easier and new application possibilities arise «,

Function mechanism:

Two or more infusion containers are suspended at different heights, connected to the block valve BV and connected to the venous catheter or cannula by means of a separate, shared hose line. The pressure of the the highest liquid column closes all other valves and only the highest infusion container can empty itself. If the liquid level of A sinks below the liquid level of B, the infusion container B begins to empty automatically (with a slight Mixing the solutions). The same thing happens when any liquid level is reached by raising the bottle above the level the liquid level of the infusion container A is raised. The flow is never interrupted.

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The conditions for the infusion device to function properly according to this embodiment are roughly the same as in the previous one (level difference the liquid level, spec. Weight and viscosity of the infusion solutions, weight and location of the Valve balls, prevention of negative pressure in the emptying bottle, regulation of the dripping speed by means of a clamp on the outgoing hose line.) It is also important that

close the valves completely tightly, otherwise unused connection points will drip (which can be caused by plugs or caps can be prevented) and a mixing of the solutions due to backflow in lower-hanging systems can follow;

the outlet of the common chamber 11 is located at the highest point of the block valve, so that a reliable venting of the system is possible already during filling (the chamber wall should be transparent); A drop counter is interposed on the outgoing hose line G ₂ as a further safeguard against possible air bubbles;

securing the coupling points of the outgoing hose line attached (e.g. bayonet catch or rubber strap; the coupling point on the block valve can also be glued become, which would remove a weak point); and that the block valve BV is at least 10 cm below the level of the vena cava of the patient comes to hang - about at mattress height with the patient lying).

If these last two conditions are met, an air seal can also be used if the system is otherwise carelessly operated can be prevented with certainty, since there is always overpressure in the common chamber K - either through the water column an emptying bottle or due to the relative overpressure in the venous system, even with negative values.

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-Valley

The exemplary embodiments according to FIGS. 2 and 3 have further advantages;

1. The flow is also never interrupted (not even for a short time when repositioning the infusion devices), since the bottle hanging at the highest level always continues to drip. It Thus, for example, constant blood levels of drugs for therapeutic as well as research purposes can be maintained can be achieved and maintained.

2. A larger number of bottles, limited only by the height of the infusion stand, can be connected in series. In practice, a maximum of two to three bottles will usually drain one after the other without maintenance, since patients with continuous infusion are checked more frequently anyway and the mixing _{quotient increases with the number of bottles - for example, if bottle C 1} drips (Fig. 3), this is how it mixes their contents with the remnants in tubes A and B (maximum 1: 1: 900 for today's infusion containers). This mixing quotient is not high, but the risk of chemical reactions increases with the number of bottles.

3. When the bottles are in the third position (in the exemplary embodiment according to FIG. 2 a total of three times two each), parallel are switched, their number is theoretically unlimited. At least the infusion program for 24 hours can be ready for infusion to be assembled:

Three bottles drop one after the other, maintenance-free and from the second bottle onwards, slightly mixed, while the the rest by hanging up or opening the clamps Emptying can be brought. The exchange and replacement of bottles is possible at any time.

4. An air embolism, such as that specific to a bottle change can occur is avoided with this system if the above conditions are met. A reverse current blood in the system is prevented by the valves.

5. The risk of germs being carried over into the bloodstream is much lower because the patient is being manipulated and the patient's obstruction when changing bottles

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fall away. This helps and can reduce thromboses, especially attachment thromboses on venous catheters especially in low-resistance (e.g. immunosuppressive treated transplant patients) and in patients with intravascular or intracardial implants can be a significant advantage. Even regular, Intermittent medication is done by placing a larger container attached to the block valve is, temporarily hung on the highest level and after dripping in the desired amount back to the waiting position is reset. A certain safeguard against overdosing in the event of a lack of attention can be given by bringing the liquid level of the downstream bottle to the level of the dosage mark, whereupon both bottles empty after the desired amount has been dispensed, whereby the dripping speed of the individual bottles inversely proportional to the ratio of the cross-sectional size diminished.

To operate an infusion device according to FIGS. 2 and 3:

An infusion stand, for example, which is equipped with at least three double hooks, of which the two lower hooks are adjustable in height, serves as a suspension device. ⁿ nA holder for the block valve BV is included. ■. Before the start of therapy, the infusion stand is hung with all of the infusion bottles and devices specified in the infusion program.

a) Infusion bottles and devices are used in the usual way filled and hung at different heights.

b) The block valve with the attached hose line · - '■' ■ · '· G ₂ is attached to the permanently mounted holder on the infusion stand (approximately at mattress height of the patient's bed)

c) The infusion devices are connected to the block valve

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closed and the chamber K as well as the Sohlauohleltusiß from the infusion bottle A ("the highest hanging and first emptying)" filled air-free, if we * a pot master at G ₂ la fills the usual way

d) open the terminals of devices A, B and event, C ₁

e) The infusion stand is rolled up to the patient's bed, a venous cannula or catheter is inserted and the hose line G _{2 is connected} to it and secured (this connection should be very tight - it does not need to be loosened until the end of the program.)

f) The drop speed is now regulated with the clamp G on the outgoing hose line G ₂ and read on the drop counter connected there (otherwise on the drop counter of the bottle being emptied)

g) An additional bottle can be added to springs at any time be connected or disconnected (the flow is never interrupted as long as there is still a bottle that can be emptied depends on the system).

h) Small containers for short intermittent infusions are simply coupled to the system and attached to the hanged highest level. After emptying, the next container continues to drip. There is also the possibility to infuse small amounts quickly and easily from large containers without the need to recouple it's so.)

i) A venous pressure measuring instrument can be connected between the drop counter and the clamp of the draining tube G ₂ .

The measuring tube is filled through the bottle that is just being emptied. During the measurement, either the clamps of all cutlery must be closed or an additional clamp is attached to the draining hose G ₂ between the drop counter and the junction of the measuring

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■ '* ■■■■' ν ■ ■ '■.' 'I "'

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open during the Meseuiig).

Block valve BY corresponds in vesontllchen to the already described valve V. Ke consists of several main parts 12 and a corresponding number of balls 13 (possibly also cones, flaps or membranes). _{The draining hose line G 2 is} coupled to the housing of the common chamber 11 from which there is a drain. Did joints may be glued or screwed or bayonet locks 14 may be, depending on whether the valve is intended for single use or multiple uses and _1st:; ,. . should be sterilized. Ee the possibility that

ff 4 ^ common chamber 11 to be constructed as a drip chamber at the same time.

Fig. 2

Simplified scheme of the most favorable combination options with the infusion-ready device according to FIGS. 2 and 3 (FIG. 2 a block valve with four, FIG. 3 with three connections):
h ( _ABG ) level of the liquid level of the

filled infusion container ^h Ax excessive level of containers in waiting position;

also suitable for intermittent infusions A bottle that empties first B bottle that empties second (automatically) C ₄ ο -χ bottle that empties third (automatically) :.

or after opening the clamp) Di ο -x parallel to C _{4 o} , switched bottles that are

Depending on your choice, empty together with C (automatically)

or whose clamp must first be opened or

that need to be raised to a higher level,

as soon as C is empty
I, II, III various recommended combinations of

C and D (A and B remain in the same position) Gp outgoing hose line BV Blockv © ntil

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Explanation of symbols:

"'' '^ Hose clamp closed (continuously drawn Hose lines are open) Hose line not yet connected to the block valve

If this combination is selected, the connection to the block valve is in the area of the arrow

ι j coupling of hose lines C and D (e.g. by means of a Y-piece R)

_TT -. » another possibility, which nods separately-

was asked.

Regarding the exemplary embodiments according to FIGS. 2 and 3: A pressure infusion is also possible in principle with these exemplary embodiments, since the other valves would automatically close when the pressure in a container and device were increased. For this, however, the coupling points up to the roller clamp on the hose line G _{2 must be made more} solid and secured, since there is increased pressure in this entire section. After the pressure has decreased, the highest container will automatically continue to drip.

With maintenance-free infusion of three bottles one after the other, the arrangement of the containers leads to a considerable loss in height of the liquid level and thus to a reduction in the dripping speed. Tests with water showed that at an infusion height of 150 cm (= 100%) the liquid level drops by 5 - 20 % by the height of the container (25 cm).

Container height + drop counter + 5 cm (37.5 cm) 10 - 21 % the same twice (75 cm) 20 - 45 %

Loss of dripping speed means (depending on the initial, selected drip speed - the slower,

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the greater the loss), so that would result in Infusion of 3 containers in the worst case the Xnfualonsgeschwindigkelt reduce to a good half. If this is undesirable, either readjust the speed or the containers must be hung at least lower edge to upper edge, which is the mixing ratio slightly increased, but saves about a third in height.

In the exemplary embodiments discussed above, the control pressure at the valve is determined by the height of the liquid column, i.e. essentially by the height of the suspension of the individual infusion containers.

However, it is entirely possible within the scope of the invention to also use the liquid in the infusion containers or also the To pressurize Infuei'Oiis containers as such and thus to achieve different pressures at the valve inlet.

An example of this would be to design the infusion container as a bag and to put these bags in corresponding pressure cuffs to insert.

In all these versions, however, it should be borne in mind that appropriate fuses are provided that none Air, for example, comes from a source of compressed air into the patient's veins.

To the exemplary embodiments:

In order to achieve an even distribution of the daily amount of infusion, it is proposed that the container, such as Already common practice to mark in such a way that marks per 100 ml are attached and from the bottom to the outlet opening are numbered consecutively. With an average daily infusion of 2500 ml, 100 ml corresponds approximately to this

Hourly amount; larger or smaller quantities can be based on can also be easily adjusted using a conversion table.

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Claims (8)

. ™ With · * ·· ♦ «f» G 76 1o 866.2 *! · 'Β4 * September protection claims: 1. ^ Valve unit for infusion or rinsing devices, ^ which the drain lines of at least two infusion containers can be held in between and which is dependent on the mean infusion pressures, with the drainage lines Before entering the venous catheter or the like merge into one another, characterized in that a closing part with a valve seat is assigned to each inlet of the valve. 2. Valve unit according to claim 1, characterized in that each inlet is at least one in one piece Main part (2, 12) on which the valve seat (7, 17) for the closing part, e.g. a ball (3, 13) as well as optionally a valve guide for the closing part is formed. 3. Valve unit according to claim 1 or 2, characterized in that the valve unit has a common Has outlet. 4. Valve unit according to claim 2, characterized in that the ball (3, 13) with a resilient jacket is provided. 5. Valve unit according to claim 2, characterized in that. the valve seat is provided with a sealing ring. 6. Valve unit according to claims 1 or 2, characterized in that the closing part, for example a ball (3, 13), is arranged above the valve seat. 7. Valve unit according to claim 2 and / or 3, characterized in that the outlet above the inlets is arranged. 7610866 12/30/76 , · IH I · 0 I ft »Μ ti ·· t O) Af f «it» ι i f κι ι · «r j 8. Valve unit according to one of claims 1 to 6, characterized characterized in that the closing parts and valve seats assigned to each inlet are designed to be shock-proof are. 7610866 12/30/76