JPS62270166A - Administration set - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION This invention relates to an administration set, and more particularly to an administration set suitable for injecting fluid into a patient by gravity flow from a fluid container through the administration set into some form of tubing introduced into a patient. Regarding the set.

More particularly, the present invention relates to an administration set consisting of a fluid reservoir, a flow regulator, and a barostat device that compensates for pressure changes during injection. This invention primarily relates to a set used for intravenous infusion of fluids, but may also be used for other forms of fluid administration.

A typical intravenous administration set also includes a needle that can be inserted into a suitable fluid container through a sterile boat.

The term fluid in this specification is used in the same manner as it is used generally in reference to liquid.

The tube extending from the needle is usually introduced into a filtration section containing a gauze-type filter, which is especially necessary to trap any clots when blood is injected. The fluid then passes through a graduated orifice and then drips through the drip space, so that the flow m (flow rate) can be easily observed. A clear infusion tube carries the fluid from the drip site to a hollow needle, cannula or catheter that is inserted into the appropriate vein, usually in the patient's arm.

These devices inserted into a vein are commonly referred to as cannulae. The flow regulator typically consists of a regulating clamp placed downstream of the drip site and squeezing the infusion tube. The fluid container is suspended approximately 6 feet above the floor and is in the form of a collapsible plastic bag or rigid bottle. The rigid bottle has a filtered air inlet and may be integral with the dispenser or may be equipped with a separate hollow needle device. (The set is manufactured from non-polluting, non-pyrogenic materials, free of particulates on its inner surface, usually sterilized by the manufacturer and supplied in suitable sealed packaging.

Several difficulties arise when injecting with conventional forms of administration sets. The flow rate changes because the back pressure changes. This backpressure is caused by the blood pressure in the arm vein and the resistance to flow of the infusate as it passes through the tight vein. This tightening can be strong enough to stop the flow of the injectate. Even when using a collapsible container, the flow rate is reduced by reducing the pressure head as the fluid in the container decreases. Also, be sure to replace the fluid container with a full one before it becomes completely empty! ! must be observed. If the container is emptied, the fluid level will rapidly fall within the set until it reaches an equilibrium point, usually just above the shoulder of the sink. At that point, the pressure generated by the fluid exactly balances the pressure in the arm veins. If the patient or set moves under these conditions, the patient's blood can easily flow back into the cannula and clot. As the fluid level descends within the injection tube, the fluid draws in air, which is then very difficult to remove.

Some collapsible plastic containers contain no or very little air, but when these containers are emptied, the internal pressure in the system decreases and equilibrates with the brachial vein pressure, causing the patient to When the cannula moves, blood easily flows back into the cannula.

Also, if the injection is not stopped when transferring the needle from a nearly empty container to a full container, air may be sucked into the set. Therefore, the flow regulator must be closed to stop the flow and then carefully readjusted to the desired flow rate when the flow is restarted.

Although there must be sufficient air within the drip section, air often escapes above the filtration section during operations, such as those associated with fluid container replacement. Replacing this lost air without getting some air into the injection tube is a tedious operation.

When this backpressure changes, fluctuations in flow rate occur due to changes in venous backpressure and/or drop in pressure head by first using a flexi-pull diaphragm in conjunction with inlet and outlet ports fixed to the fluid flow path. (e.g. UK Patent No. 2012393 and British Patent No. 15)
19558). In GB2012393, the flow rate is set by this diaphragm and must be adjusted whenever the flow rate needs to be changed. By separating these functions, the inventive administration set allows the flow rate to be changed in a simple manner and the barostat device automatically adjusts to the new flow rate.

British Patent No. 7,561,288 describes a fluid flow control device in the form of a straight collapsible conduit whose cross-sectional shape changes with variations in the light pressure differential.

These patents do not disclose, let alone suggest, the use of a fluid reservoir in combination with a barostat device, which is a requirement of the present invention.

The dosing set of the present invention has been devised to remedy many of the shortcomings noted above by providing a dosing set in which the flow m is not significantly affected by some or all of the normal unstable pressure fluctuations. There is. Said? iiii Regulating is performed by a barostat device installed downstream of the flow regulator. The barostat device is limited to sufficiently increasing the pressure at its inlet to a pressure that is substantially equal to or differs by a constant value from the 1ill II positive pressure acting on the device. This control pressure may simply be atmospheric pressure. Since the pressure downstream of the flow regulator is normally reduced by a pressure value that varies with fluctuations in venous backpressure, by increasing this pressure to a constant value close to atmospheric pressure, the barostat device is effectively , which acts as a barrier to prevent all but significantly large pressure fluctuations from flowing back to the flow regulator and affecting flow.

This process is similar to building a dam to prevent tidal fluctuations at the bottom of a river from affecting levels at the top of the river. In this case, the higher the height of the dam, the greater the degree of protection it provides. The administration set of the present invention is also constructed to maintain infusion for a convenient period of time after the fluid container is emptied by supplying from an upstream fluid reservoir in a flow-regulated manner. Preferably, the barostat device is located at the same level as the outlet of the reservoir;
This causes the pressure at the reservoir outlet to be close to the control pressure, in this case atmospheric pressure, as the fluid decreases.

Thus, even when the container is empty, the reservoir will release fluid at a reduced rate and eventually flow will stop before the reservoir is completely empty. This device is similar to, for example, a tap at the bottom of the barrel, with the outlet slightly above the bottom of the barrel to allow the fluid inside the barrel to flow out. This tap represents a flow regulator whose outlet downstream is at atmospheric pressure, just as downstream of the flow regulator is at a level similar to the atmospheric pressure maintained by the barostat device. This device reliably maintains a slow infusion over a significant period of time, ensures that no air enters the lower part of the administration set even when the reservoir is emptied, and that the virtually closed barostat device ensures that the infusion tube Because there is a column of fluid held within, blood will not flow back into the cannula against the pressure created by this column of fluid.

The control pressure within the barostat device is that of atmospheric pressure plus the fluid column above the barostat device minus the pressure generated by the portion of the fluid column within the fluid reservoir.

In this case, as fluid flows out of the container, this ail
l fall pressure and the pressure at the inlet of the barostat device,
The pressure downstream of the flow regulator is defined as the pressure generated by the fluid column above the fluid level in the fluid reservoir plus the fluid column below the fluid level in the reservoir that is equal to the pressure upstream of the flow regulator. do.

This means that the pressure gradient across the flow regulator does not change and therefore the flow rate does not change until the effective fluid level in the system drops to the level of the fluid level in the reservoir. Therefore, the pressure that normally drives injection is
Matches the height of the fluid column in the reservoir. This type of barostat device also acts similarly to the previously described device, releasing at a reduced flow rate without completely emptying the reservoir, and all changes other than significantly large changes in backpressure are caused by the flow rate. The adjustment acts as a barrier to prevent pressure gradients and flow from being affected.

The control pressure of the barostat device may be generated by the entire fluid column above the device (the embodiments shown in FIGS. 5 and 6). to counteract the force of the control pressure so that fluid can still flow through the device.
Preferably, the device has an elastic element that acts on the flexible element in such a way that the pressure at the inlet of the device is significantly lower than the control pressure by a fixed value. This form of barostat does not drain fluid from the reservoir at a reduced rate, but stops the flow before the reservoir is completely emptied. Other means may also be used to prevent the reservoir from being completely emptied, in which case it is not necessary to place the barostat device at the same level as the bottom of the reservoir.

The administration set can also provide a means to estimate backpressure or to indicate when backpressure becomes significant enough to begin to affect flow M.

The administration set also provides a means to prevent air loss from the drip site and a means to eliminate the need to close the flow regulator when changing fluid containers.

The administration set also includes means for introducing the drug or for connecting to the second container at the reservoir inlet, the reservoir inlet and the air channel leading to the barostat device being closed together or separately. It is made to be possible.

The invention therefore provides a dosing set comprising a fluid reservoir, a barostat device and a flow regulator, the fluid reservoir being upstream of the flow regulator and the barostat device being downstream of the flow regulator.

The barostat device compensates for any fluctuations in the pressure of the fluid by keeping the pressure at its inlet in a constant relationship with atmospheric pressure or a pressure related to atmospheric pressure. The flow rate is held at a substantially constant value. These pressures are applied from outside1
In the case of a nozzle, the control pressure is called the control pressure, and the control pressure flows from its outlet. The preferred form of this invention is that the barostat is suitably added to the blocking flexible element.

According to the second aspect of the invention, the fluid storage section is comprised of a fluid storage section, a barostat device, and a flow ω adjustment 11, the barostat device is located downstream of the flow regulator, and the fluid storage section is located upstream of the flow m regulator. However, the barostat Ruff consists of a flexible element that provides resistance to the flow required by atmospheric pressure to raise the pressure at its inlet to near atmospheric pressure, and the fluid reservoir is located approximately at the same height as the inlet of the barostat device. An administration set is provided having an outlet.

Suitably, the barostat device and the fluid reservoir are integrally formed, ie they constitute two parts of a single component administration set.

The barostat device simply consists of a collapsible channel made of a short 19-wall inflated tube of a suitable flexible plastic material, such as a plastic material, the thin walls of which constitute the flexible elements. The internal cross-section of the flow path changes with small variations in the difference between the externally applied control pressure and the internal pressure.

The channel is also made to close by external pressure applied to the collapsible region.

An embodiment of this aspect is illustrated in FIG. 1 described below. In use, the barostat device is preferably positioned in the fluid flow path of the administration set approximately in the middle of the vertical spacing between the fluid container and the patient's shoulder. When the flow regulator is set to limit flow, a reduced pressure is created in the fluid column downstream of the flow regulator and in the fluid column within the barostat device. Due to the atmospheric pressure exerted on the flexible walls of the barostat device,
These walls close and provide sufficient resistance to flow to raise the pressure at the inlet of the device to a small constant difference from atmospheric pressure (referred to as the closing pressure). The fluid passing through the flow regulator increases the pressure at the inlet of the barostat device slightly above the closing pressure, sufficient to direct a small volume of fluid through the device toward the mind. Open the flexible wall.

The usually high resistance of barostat devices helps to separate the fluid column into upper and lower parts.

This upper part alone provides the force that propels the fluid through the flow meter, and the flow adjustment determines the flow of injection. The pressure developed by the lower part of the fluid column is typically greater than sufficient to overcome the normal backpressure caused by the cannulated venous configuration and brachial venous blood pressure, and the backpressure is m prevents significantly affecting the pressure gradient through the regulator, thus keeping the flow rate relatively constant.

When experimentally varying the backpressure in the lower fluid column, for example by raising or lowering the level at the cannula outlet, only small variations in flow rate of ±5% were observed. When the backpressure exceeds the pressure provided by the lower fluid column, the flexible walls of the barostat device open wide;
Further increases in backpressure begin to reduce the pressure head in the upper column, reducing the injection flow pile. The wide opening in the wall of the barostat device can be arranged so that there is a perceptible visual or tactile warning that high backpressure is present and obstructing flow.

A suitable barostat device has a collapsible channel formed in an inverted U-shape or an inverted V-shape with an inlet and an outlet in close proximity. The use of channels arranged in this way means that the collapsible region of the device will be less distorted, no matter how the surrounding flexible structures are distorted. For example, if the inflow and outflow channels are further apart or in diametrically opposed positions, as would occur if the collapsible channel were straight, the collapsing region would be more prone to distortion, resulting in the collapse Varying the closing pressure and compensation characteristics of the device.

The reservoir provided upstream of the flow regulator preferably has flexible and collapsible walls and continues to supply liquid to the patient at a slow flow rate after the fluid container is emptied. To prevent complete emptying of the reservoir and to significantly slow the flow rate, the inlet to the barostat device should be at the same or substantially the same height as the outlet to the reservoir when empty. will be placed in

Flow finally stops when the pressure head plus atmospheric pressure caused by the height difference between the level of fluid in the reservoir and the inlet to the barostat device just equals said closing pressure. For a typical infusion, if the flow regulator is set to a dose of, say, 3 Ω per day, the reservoir of the container, which is only 3011, will be reduced by approximately 3 hours after the container is emptied. It is possible to maintain the flow rate. The reservoir is not completely emptied due to the location of the barostat inlet, so air is prevented from entering the injection tube. For blood to flow back into the cannula, the blood pressure in the vein must be greater than or equal to the pressure created by the fluid column below the barostat device, so that even when flow eventually stops, it will not flow back into the cannula. When an empty fluid container is replaced with a full one, the reservoir automatically fills up again, so there is no need to close the flow regulator and therefore do not disturb its settings. Although the regulator must be installed in the tube connecting the outlet of the storage part and the inlet of the barostat device, a drip part may also be provided.

The tube is conveniently arranged as a suspended U-shaped or double S-shaped loop.

This loop can trap any air that attempts to escape upwardly from the drip site. This can occur, for example, when the fluid container is compressed enough to compress the air within the drip site and cause the fluid to squirt outward.

This air is returned to the drip site when forward flow is resumed. The drip section can also be placed downstream of the barostat device, but again any escaping air is trapped and returned by the forward flow.

To filter out undesirable particulate matter, a fine-mesh gauze filter is usually required and is placed either immediately downstream of the needle or within the body of the drip site.

- When the administration set provided by the first aspect of the invention is used with a collapsible type of fluid container, the flow of the infusion is reduced by reducing the pressure head at the top of the fluid column as the fluid exits the container. ω (flow velocity) also decreases.

This change in pressure head and flow rate makes the collapsible vessel
It can be significantly reduced by holding it horizontally by appropriately designed slings or trough-shaped braces.

(Hereinafter, blank spaces) As a third aspect, the present invention provides an administration set that is a modification of the above-mentioned administration set.

In other words, even if a collapsible type fluid container is used,
This is a dosing set in which the flow m is substantially unaffected when fluid is discharged from the container. This embodiment of the administration set allows the section of the fluid column located above the barostat device to be shortened by lengthening the section of the fluid column located below the barostat device to compensate for fluctuations in backpressure from the vein. It is designed to increase the pressure head available for use. The stability of the barostat device is therefore also increased and a convenient method of measuring said back pressure is provided.

An embodiment of this aspect of the invention is shown in FIGS. 2 and 2A.

A third aspect of the invention provides the following administration set. That is, a dosing set arranged substantially as described above, in which the flexible element of the barostat device, by air pressure in the reservoir, increases the pressure at the inlet of the barostat device to atmospheric pressure plus the fluid above the barostat device. Bypass tube, bypass tube that provides resistance to flow through the device and allows fluid to bypass the fluid reservoir, where it is necessary to raise the pressure at the inlet of the barostat device to the pressure (column minus the pressure generated in the part of the column in the reservoir) and a resistive flow path at the exit from the fluid reservoir.

A collapsible tube is suitably provided downstream of the barostat device.

The fluid reservoir is located just below the button.

One channel carries fluid from the needle to the bottom of the reservoir. This device ensures that the incoming fluid traps the air initially present at the top of the reservoir. Although the barostat device is still located at the level of the outlet of the reservoir, the air pressure on its flexible element is not from atmospheric pressure, and the barostat device is connected to the air trapped at the top of the fluid reservoir. It is housed in an airtight chamber with communication via air channels. When a collapsible type of fluid container is used, the pressure of the fluid upstream of the flow regulator decreases as the fluid in the container is discharged and reduced. A similar pressure drop occurs for fluid and air within the reservoir. This pressure drop in the reservoir is transmitted via the air channel to the flexible element of the barostat device and reduces the pressure at its inlet, thus reducing the pressure of the barostat device.
Since the 1-stat device is located downstream of the flow rate regulator, a pressure saw difference is created through this regulator to maintain the flow rate constant.

The bypass tube allows fluid to flow from the needle directly into the tube leading to the regulator, and when the fluid container is emptied, the collapsible segment or region located at the top of the bypass tube collapses, causing the container to collapse. This prevents air from escaping and fluid from being siphoned out of the fluid reservoir. When the collapsible region collapses, the reservoir is only gradually released through the resistance flow path into the tube connected to the flow regulator, and even if the adjustment interval is set to a high flow rate,
．． Flow through the system can be maintained for 1 hour.

The barostat device must be maintained at a pressure similar to that on the flexible element, with the pressure at its input being variable but greater than the pressure at its outlet.

Ideally, this inlet pressure should not fluctuate due to variations in outlet pressure. Barostat devices of the type constructed with collapsible channels are more sensitive to variations in outlet pressure. A simple way to make the inlet pressure of such a device independent of the outlet pressure is to place a collapsible tube downstream of the barostat device.

Since this collapsible tube is exposed to atmospheric pressure, holding the outlet pressure constant near atmospheric pressure effectively insulates the outlet pressure of the barostat device from downstream fluctuations. Once the backpressure becomes large enough to reduce the pressure and therefore the flow m through the flow regulator, the backpressure becomes greater than the atmospheric pressure in the area of the collapsible tube causing the thin wall to expand. Simply squeezing this inflated collapsible tube causes backflow in the IV tube of the IV section in a manner similar to that which occurs when compressing the collapsible channel of the barostat device in previously described embodiments of the invention. , indicating that backpressure is impeding flow.

An oral collapsible tube is placed downstream of the drip site.
．． If the length is 30-40c+n, this tube can provide a means to measure the value of back pressure from the vein. This long form of collapsible tube remains collapsed at the level of the apex of what can be considered a column of fluid held by back pressure from the vein. Below this level, the collapsible tube expands, and by gently touching the tube with one finger and another, you can move it from the collapsed to expanded state, even in a dimly lit hospital room. Transitions can be easily measured.

The nurse can thus measure the value of backpressure and, as in the previously described forms of the invention, be alerted if the backpressure is so high that it is interfering with flow. The occurrence of back pressure can be tracked. This elongated form of collapsible tube can also function as a barostat device in the previously described embodiments of the invention, where the flexible element is influenced by atmospheric pressure rather than the pressure within the reservoir.

In another aspect, the present invention provides an administration set that is modified from the above-mentioned administration set as follows. That is, medicines and other substances can be introduced into the reservoir, and the reservoir inlet can be closed and modified to prevent leakage when moving the needle to other fluid containers.

This embodiment of the administration set is modified so that the varacostat device can be deactivated so that the pressure within the reservoir can be increased to significantly increase the flow rate. An embodiment of this aspect is shown in FIGS. 3 and 4.

The fourth aspect of the invention provides an administration set similar to the second aspect except for the configuration described below. That is, fluid flows from the puncture needle through the closable tube and the introducer directly into the main body of the reservoir, with a portion of the reservoir extending upwardly and lateral to said closable tube. A closable region located in the reservoir connects the air channel with an outlet tube leading up from the bottom of the reservoir to the collapsible segment and then down to the flow regulator, and one resistive flow path leading to the collapsible segment. bypassed to the sible segment,
Further, the drip section is placed upstream of the flow regulator or downstream of the barostat device.

In the above aspect of the invention, the reservoir forms part of the fluid flow path from the fluid container to the patient so that a drug or other substance can be added to the reservoir for administration to the patient. . For example, some of the fluid in the reservoir can be squeezed back into the fluid container, and a clamp is used to close off the closable tube leading from the needle to the reservoir.

The introduction of, for example, a medicament is then carried out through a rubber introduction site (injection site) downstream of the clamp, and the reservoir is squeezed several times to thoroughly mix this medicament with the fluid remaining in the reservoir. . Upon removal of the clamp, infusion resumes at the original flow rate and the drug is administered in a controlled manner.

When large volumes of pharmaceutical solutions or other substances need to be injected, they can be dispensed from the second container. It is injected by means of an auxiliary set consisting of a needle and a short tube connecting the needle to a short, thin, sharp hollow needle. The closable tube is clamped as described above and the short needle is fully inserted into the introducer below the clamp.

This auxiliary set of needles is then inserted into the outlet of the second container, which is suspended from the hook used to hold the first container. Injection is thus performed exactly as before, except that the fluid is from the second container.

When the second container is emptied, the reservoir again maintains flow at the decelerated outlet through the resistive flow path. The nurse can then remove the empty second container at a convenient time and simply remove the auxiliary set and clamp when the previous solution needs to be injected.

If you want to quickly transition from the first fluid to the second fluid,
First the fluid in the reservoir is compressed back into the first container, then the clamp is installed and then the auxiliary set is connected.

When a clamp is attached to a closable tube, significant pressure is created within the reservoir when the tube is compressed.

However, this increase in pressure does not increase the flow rate as it is transmitted via the air entering the upwardly extending portion of the reservoir and the air channel leading therefrom to the airtight chamber surrounding the barostat device. Therefore, the barostat device continues to maintain a constant flow rate even when the reservoir pressure is abnormally high. The connection between the upper extension of the reservoir and the air channel has a closable region and is located behind or in front of the closable portion of the closable tube leading from the needle. This closable region can be easily clamped or held within a clamp used to close the openable tube, allowing both (the closable region and the closable portion) to be held together between the thumb and fingers. It is made so that when you grab it, it flattens and closes completely. Under these circumstances, both the fluid inlet to the reservoir and the air inlet to the air channel are closed, and compressing the reservoir significantly increases the flow rate from the administration set. This method is useful once the administration set is full of fluid, and can be repeated in an emergency to deliver fluid when it is indeed necessary to infuse at a very high rate. When using a lubricable container [by compressing the air from the airtight chamber and placing a clamp on the closable region of the air channel], the increase in flow rate is not as drastic.

This operation completely disables the barostat device and the flow rate can be further increased by collapsing the collapsible container with a conventional blood bag pressurization device.

In a fourth aspect of the invention (in Meng) the drip part is placed upstream of the flow regulator and the barostat device and raised to a slightly more convenient height, and furthermore if the drip part is made of a soft material. , even if there is an excessive amount of air in it,
It has the advantage that excess air can be forced into the reservoir and container by first closing the flow regulator and then squeezing in a controlled manner.

As another aspect of the present invention, there is provided a 19-preparation set which is the above-mentioned administration set modified as follows. That is, a dosing set that uses a barostatic device whose inlet pressure is maintained significantly below the control pressure, the limiting pressure of which is the pressure produced by the entire fluid column extending above it. This form of barostat device requires an elastic element acting on the flexible element against the force of the limiting pressure.

Such barostat devices usually consist of two rigid chambers separated by an elastic septum, a membrane, connecting an elastic element and a flexible element. The control chamber of one of these chambers is connected to the fluid column upstream of the flow regulator, and the outlet chamber of the other chamber receives the injectate that has passed through the flow regulator. The fluid then exits the outflow chamber through an exit orifice located centrally near the septum. The pressure in the outflow chamber is lower than the control pressure due to the resistance to flow imposed by the flow regulator. When the pressure within the outlet chamber is reduced in this manner, the elastic diaphragm approaches the outlet orifice and obstructs the flow to the outlet, preventing further reduction in said pressure. Thus, the fluid within the effluent is maintained at a pressure below the limiting pressure by a constant value determined by the elasticity of the diaphragm and the dimensions of the structure of the device.

This constant pressure differential across the flow regulator maintains a constant flow rate even as the fluid container and then the reservoir empty and the limiting pressure decreases. This type of barostat fitting does not prevent the reservoir from being completely emptied. A collapsible segment or other suitable device is therefore placed at the bottom outlet of the reservoir to ensure that air does not enter other parts of the administration set. Alternatively, if the reservoir is of the collapsible type with a collapsible region at its inlet, this is particularly useful for achieving the same purpose, since it prevents the inflow of air.

An embodiment of this aspect is shown in FIGS. 5 and 6.

In a fifth aspect, the present invention provides an administration set made substantially as described in the four aspects above. That is, the flexible element of the barostat device is influenced by the elastic element to a pressure downstream of the flow regulator that is lower by a constant value than the pressure upstream of the flow regulator by the pressure of the fluid upstream of the flow regulator. It provides the necessary resistance to flow through the device to maintain the inlet pressure, thus preventing the reservoir from becoming completely empty of fluid.

If the administration set of the first aspect of the invention is modified to include a barostat device of this type, the reservoir is provided with a collapsible region at its inlet or outlet. The fluid leaving the reservoir is fli11tII]
It is easily sent to the flow regulator through the filter. Fluid then flows from the flow regulator to the inlet of the outlet chamber, passing between the rim of the outlet orifice and the elastic septum and into the injection tube. As before, the drip section can be provided upstream of the flow regulator or downstream of the barostat device.

This relatively simple form of the administration set of the invention has the advantage that the flow rate remains constant even when a collapsible container is used, but it must be made large because the fluid m in the reservoir decreases rapidly. The disadvantage is that it does not.

When this type of barostat device is used in the administration set of other aspects of the invention, an air-filled space in the upper part of the reservoir and in the air channel for transmitting pressure to the flexible element is not required. The control chamber is connected to, or is part of, an outlet flow path from the reservoir, which flow path is connected to a collapsible segment located approximately at the same level as the reservoir inlet. It rises and connects C. This outlet channel descends further and there is a resistance channel connecting the rising and descending sections.

After exiting this outlet channel, the fluid passes through a flow regulator and then into an outflow chamber. When the fluid in the reservoir begins to decrease, the collapsible pigment in the outlet channel is closed and the entire flow is transferred to the resistance channel, which is the only means to ensure that the fluid ω in the reservoir gradually decreases. be converted. Furthermore, means are provided to prevent the reservoir from being completely emptied. This type of barostat device is relatively insensitive to variations in backpressure from the vein, so there is no need for a collapsible tube downstream of it.

Suitable elements of the administration set of this invention are made of polymeric materials that can be thermally or radiofrequency welded sealed to themselves or to other suitable polymers. Suitable polymers include flexible vinyl chloride, which is commonly used to make pharmaceutical fluid containers, tubing, and the like. If grooves are required, place a sheet of polymer over a formed metal mold with the desired pattern of grooves, place the sheet tightly against the metal mold and apply vacuum to bring it into close contact with the grooves, and then Seal the two sheets to the first sheet in the required manner. The elements of the administration set can be assembled and sealed such that the fluid reservoir and barostat device are integrally formed. If tubing openings, inlets and outlets, and resistance flow paths are required, insert a metal rod of the appropriate diameter into the sealing process, then remove the rod and seal the tubing etc. in the resulting removed space. formed by

The present invention also provides a reservoir and barostat device configured as described above suitable for use with a flow regulator.

Preferred embodiments of the invention will now be described with reference to the accompanying drawings as examples.

FIG. 1 is an explanatory diagram of the configuration of the administration set according to the second aspect of the present invention, and FIG. Fig. 2A is an enlarged structural explanatory diagram of the barostat device used in the first four aspects of this invention, and Fig. 3 is an explanatory diagram of the configuration of the administration set according to the fourth aspect of this invention. FIG. 4 is an explanatory diagram of the configuration of another administration set according to the fourth aspect of the present invention, FIG. 5 is an explanatory diagram of the configuration of the administration set according to the fifth aspect of this invention, and FIG. FIG. 7 is a configuration explanatory diagram of another administration set of the fifth embodiment.

(Margins below) In Fig. 1, the reservoir 1 is formed by heat-sealing two soft vinyl chloride resin sheets with a thickness of approximately Q, 4 mm using a method similar to that used in manufacturing a normal collapsible fluid container. will be produced. The capacity of this storage section 1 is approximately 30
xI. By tube 2 of about 25C1,1,
A regular type needle 3 is connected to the upper end of the storage section 1. Another tube 4 emerges from the outlet at the lower end of the reservoir 1 and is connected to a flow conditioner 5 which may be of the typical roller clamp type or of other more complex types.

The tube 4 is 180° before or after this regulator 5.
It bends and rises to the outlet area of the reservoir 1 and enters the barostat device 6. The barostat device 6 is manufactured by the high frequency heat sealing method in the same manner as the storage section 1, except that a thin polyvinyl chloride (PVC) sheet with a thickness of 0.15 is used. An inverted V-shaped collapsible channel is fabricated as follows. First, gently fold the thin PVC sheet, then fold the two pieces into the
Seal along straight lines that intersect at an acute angle of 0° (first
seal part).

Then, in an acute angle of the mouth, place a triangular seal part with both sides parallel to the first seal part and the fold, with a distance between the first seal part and the triangle being about 1 c, and a distance between the fold edge and the triangle. They are made symmetrically so that the distance between them is approximately 5 mm. The length of the two limbs of the channel created in this way is approximately 2 am. Fluid enters along the wide rim 7 and exits through the narrow rim 8. The folds are created when the internal pressure drops below atmospheric pressure.
This helps to prevent the narrow rim 8 from collapsing. This collapse occurs at the apex of the two limbs at the apex of the inverted V shape. Both sheets are made to remain completely flat during the sealing process, so that the absence of a bead of molten PVC prevents the flow path from collapsing and becoming completely closed. This flow path acts as an active part of the barostat device 6 and as a means for another 180° change in direction of flow. A similar tube 9 descends from the outlet of the barostat device to the inlet of a conventional drip section 10. The somewhat sensitive barostat device is protected and retained by placing it in a laterally ff VJ pocket 11 using the same material as the reservoir 1. The barostat device 6 is held securely within this pocket 11 by a bonding heat seal technique that brings together the thin PVC sheet of the device 6 with the thicker sheets from the inlet and outlet tubes and the reservoir.

A small through hole 13 is provided in the thick outer sheet to ensure that the thin wall of the barostat fixture 6 is in equilibrium with the atmospheric pressure. A fine infusion tube 12 leads from the outlet of the drip section 10 to a conventional rubber T74 lumen and a luer fitting for connecting it to a cannula.

This improved dosing set is used in a similar manner to the conventional set, except that the liquid container can be completely emptied before being replaced by a full container. The reservoir continues to infuse and can be replaced at a convenient time by the nurse. When the flow rate decreases, the nurse should compress the barostat device with one finger and another finger.
It is possible to test whether the back pressure has exceeded -strongly.

The back pressure causes the barostat device to expand, and squeezing the device forces the expanded liquid into the drip site. When compression is stopped, backflow occurs and the inflation fluid is replaced by air rising through the IV tube. Air rising from the IV site is the most obvious indication of high backpressure and alerts the nurse to inspect the infusion tube and cannulation site.

In the administration set shown in FIG. 2, the reservoir 14 is made similar to that described above by sealing two sheets of soft PVC with a high frequency welder. One of the Li used in this welder is equipped with grooves that suck air with a powerful pump, and the PvC sheet adjacent to this electrode is sucked into these grooves. When sealed with the other sheet along the edge of such a groove, a tubular structure with a D-shaped cross section is created. Two of these tubular structures 15,16 are formed along one edge of the reservoir and are arranged such that they form the bypass tube 15 and the fluid flow path 16 at the reservoir inlet. On the other side of the reservoir, another groove forms an air channel 17 which leads from the top of the reservoir to a gas-tight chamber 18 containing a barostat arrangement 19, described below.

The outlet of the bypass tube 15 passes through a flow regulator 22 and is connected to the inlet of one of the barostat devices, while the outlet of the barostat device 19 is connected to the drip section 23.

The groove of the electrode forming the uppermost part of the bypass tube 15 is wide, and the short length part is filled with hard epoxy resin to flatten the tube and form the collapsible segment 20. Approximately 0.25m between two PVC sheets
A thin stainless steel wire of m diameter is inserted and sealed, and the wire is passed across the area separating the bottom of the reservoir 14 and the lower end of the bypass tube 15. After sealing is completed, the wire is pulled out to leave a narrow channel 21 about 2 cm long. This flow path provides a resistance flow path for fluid to exit the reservoir 14 when the container is emptied. When the reservoir is expanded by fluid, its edges may buckle causing kinks in the tubular structure.

This distortion can be significantly reduced by cutting a hollow or a series of grooves in the recessed reservoir molding of the suction electrode. This suction causes PV
After the C-sheet is drawn into the hollow or groove, the edges are sealed to give the reservoir wall a shape sufficient to more easily contain the fluid.

The barostat device 19 shown enlarged in FIG. 2A has a collapsible tube 26 formed downstream of the outlet opening 45 thereof. These are manufactured by sealing a PVC sheet approximately 0.15 mm thick using the same high-frequency sealing method used in the above embodiment to form an inverted V-shaped collapsible flow path as shown in Figure 2. In some cases, it is made of two separate sheets rather than one sheet folded. The upper inlet rim 27 is narrow and the descending rim is about 1c+n wide and extends about 3 CII long. The inlet opening 44 and the outlet opening 45 are made in the usual manner by inserting a metal mandrel and using appropriately shaped electrodes to bond and seal together the thick material. This seal completes the airtight chamber 18, and the apex of the internal triangular seal portion is located only about 5 mm below it. In this case, the collapse of the flow path is due to the outlet opening 45.
occurs directly above. The lowered shorter limb extends beyond this outlet opening and forms a collapsible tube 26. This collapsible tube 26 is protected by a pocket 28 of thick PvC material forming another bonding seal sealing the collapsible tube to the outlet tube and the thicker material. A through hole 29 is provided somewhere in this pocket 28 to constantly expose the walls of the collapsible tube to relatively constant atmospheric pressure. The shape of the airtight chamber 18 changes when its internal pressure changes, but since the collapsible flow path of the Halo 2 Tatsut device 19 is an inverted ■ shape or an inverted U shape, the flexible walls of this flow path have little effect on these changes. Not done. If this collapsible channel is similar to the collapsible tube 26 in the pocket and leads from one end of the chamber to the other, the collapsible channel will be significantly influenced by the changing shape of the chamber; The compensation function would be confused.

This collapsible tube may be provided downstream of the barostat and the drip section. This collapsible tube is 3
Inflated tube with 5cm gain and approximately 1cIII width. (
The infusion tube (not shown) is made of 0.15 mm thick medical grade soft PVC material and is connected to the inlet of the drip section 23 to direct fluid to the infusion tube and then to the patient. This tube is
It is designed to collapse completely when the internal pressure is lower than the external pressure. For example, if the edges are folded, they must be pressed perfectly flat, or if they are formed by welding, these welds can hold the inner surfaces even slightly apart. There should be no beads. This elongated collastible tube 26 is used to measure venous back pressure as described above. If it is used, the short form collapsible tube 26 in the pocket 28 immediately downstream of the barostat device 19 is not required.

In the administration set shown in FIGS. 3 and 4, the reservoir 30
．． The barostat device 31 in the chamber 32 and the short collapsible tube 26 in the pocket 34 are made of f'l'' in the same manner as described in the second embodiment and shown in FIGS. However, the needle 35 is connected to a short closable tube 48 with an introducer 36, which is often used as an introducer at the end of the infusion tube where the administration cut leads to the cannula connector. The other end of this short closable tube 48 is made of rubber with a conical expansion in the center of the type.
It is tightly sealed and goes directly into the body of the reservoir 30. One side of the top of the reservoir extends upwardly in a curved manner 37 and is positioned in front of the closable section 33 of said short closable tube 48, where, as in the previous embodiment, a lower airtight chamber is formed. 32. The groove of the molded electrode forming the connection between the curved extension 37 of the reservoir and the air channel 46 is filled with a hard epoxy resin so that the connection remains normally open to the air flow path. It is designed to be closable and to be completely closable, for example, by compressing the joint together with the closable portion of the short closable tube 48 between the thumb and fingers. In FIG. 3, the outlet channel 38 rises from the bottom of the reservoir 30 toward a collapsible region 1447 created by widening the groove of the electrode and filling a short length of it with epoxy resin. I understand. After leaving the collapsible segment 47, the outlet channel 38 descends into an outlet tube 39 which leads to a flow regulator R40 and a barostat 31. A resistance channel 41 is created between the upper part of the outlet channel 38 and the crown part. This resistance channel is formed by two P in the area between these parts of the outlet channel.
It is fabricated by introducing a thin stainless steel wire of approximately 0.25 mm diameter between the VC sheets, sealing, and then pulling it out, leaving a flow path. The drip section 42 has a flow rate adjustment hall 4.
0 upstream of the outlet tube 39 or downstream of the barostat device in the injection line 43. When the drip section 42 is in the second position upstream of the flow regulator as shown in FIG. 4, even if there is excess t1 of air, the compression It is preferably made of semi-flexible material so that excess air can be returned to the reservoir.

In the administration set shown in FIGS. 5 and 6, the barostat device is molded from a hard plastic material, such as hard PVC, and is made into two halves, each in the shape of a grate. The elastic diaphragm 50 is made of a thin sheet of a suitable rubber-like material, such as silicone rubber, about 0.3 mm thick and about 2 cm in diameter. This septum is drawn thickly in the drawing for clarity.

The rim of the lower dish molding is molded to fit into a small recess in the rim of the upper molding. An elastic diaphragm is placed across the rim and recess of the upper molding, and then the lower molding is pushed into the recess, gripping the diaphragm into a fluid-tight seal and stretching the diaphragm somewhat. The two molded parts are then secured together by radio frequency welding the four lugs (not shown) or some other method appropriate to the mode of assembly. This lower molding surrounds the outflow palm and is precisely formed with an exit orifice whose upper end rests at 1.41 T1 m in the face of the rim, and an inlet tube which enters the side. The upper molded product is the control room 52
It has a central inlet tube and laterally located outlet tubes as shown in FIG.

The outlet orifice of the outflow v51 leads to the drip tube of the drip part 53, and said lower molding may be made as part of the molding forming the upper surface of the drip part. In the administration set shown in FIG. 5, the needle 54 is connected to a reservoir 55, which has a diameter of about 0.4 mm as in the previous embodiment.
It is made by sealing two sheets of thick, soft PvC material. The collapsible segment 56 is formed like an outlet by filling the groove of the molding electrode with epoxy resin as described above and applying it over a narrow band spanning the groove so that it is flush with the surface of the electrode. Ru. 1
The main PvC tube is located at the exit of Chisu Omuro 52 and the outflow chamber 5.
A roller clamp 57 or a more sophisticated type of flow regulator is attached to this tube. A drip section 53 that discharges this fluid is connected to an injection tube 55.

The reservoir 60 of the administration set shown in FIG.
The outlet channel 61 is provided with an outlet channel 61 that descends toward the tube provided with the tube. When the fluid container is emptied, the collapsible segments 62 and 64 close as the pressure at the top of the reservoir falls below atmospheric pressure. The reservoir can therefore only release fluid through the resistance channel 65, which in the same manner as described above has a diameter of about 0.20 mm.
mm, and the injection can be extended for several hours.

Even if the reservoir is completely emptied, a collapsible segment 64 at its entrance prevents air from entering the administration set. Closable tube 67 and introduction section 6
6 is provided downstream of the puncture needle as in some of the embodiments shown previously. The barostat device may be rendered inoperable by clamping or closing the portion of the reservoir leading to the control chamber 52 with one finger and another finger, as in some of the previously shown embodiments. Can be done.

[Brief explanation of the drawing]

Figures 1, 2, WJ3, 4 and 5 are explanatory diagrams of the configuration of an administration set according to an embodiment of the present invention, and Figure 2A is an embodiment of a barostat device used in the administration set of this invention. FIG. 1.14, 30, 50, 55.60... Fluid reservoir, 6.19.31... Barostat device, 5.2
2,40.57.63...Flow rate regulator, 10.23.42.53...Drip section, 44...
...Barostat device entrance, 20.47.56.
62.64...] Collapsible area, 26... Collapsible tube, 15...
...Bypass tube, 21.41.65...Resistance flow path, 33...
...Closable 4L 48...Closable tube, 46...
・Air channel. Agent Patent Attorney Shintabe Nogawa ゛・ −
1. Indication of the case Patent Application No. 68181 of 1988 2, Name of the invention Administration set 3, Relationship with the person making the amendment Patent applicant address United Kingdom, Northern Ireland, 47 Daylamore Drive, Belfast Name: Ellis Whiteside Clark 4, Agent: 530 Address: Quarter One Building, 1-3 Nishiten W45-chome, Kita-ku, Osaka Telephone: (06) 365-0718, i-・
1. -1 Name: Patent Attorney (6524) Shintabe Nogawa: Shi-L- Amend "and Figure 5" in the second line of page 53 of the specification to "Figures 5 and 6." , +7°j1': , :11

Claims (1)

[Claims] 1. Fluid reservoir (1, 14, 30, 50, 60), barostat device (6, 19, 31), and flow rate regulator (5
, 22, 40, 57, 63), wherein the fluid reservoir is provided upstream of the flow regulator and the barostat device is provided downstream of the flow regulator. 2. The barostat device (6) consists of a flexible element which provides a resistance to flow through the device by means of atmospheric pressure, which requires raising the pressure at the inlet of the barostat device to near atmospheric pressure; Administration set according to claim 1, characterized in that the reservoir (1) has its outlet at or approximately the same level as the inlet to the barostat device, preventing any emptying of the fluid reservoir during use. 3. The barostat device (19, 31) consists of a flexible element which adjusts the pressure at the inlet (44) of the barostat device to atmospheric pressure plus the fluid column above the barostat device minus the fluid column in the fluid reservoir. The reservoir (14, 30
), the fluid reservoir has its outlet (49) at the same or approximately the same height as the inlet (44) to the barostat device (29, 31), so that when in use the fluid reservoir Administration set according to claim 1, wherein the reservoir (14, 30) is prevented from being completely emptied. 4. The barostat device consists of an elastic element (50),
and the fluid column above the barostat device creates a resistance to flow through the device that requires the pressure downstream of the flow regulator (57, 63) to be maintained a constant value lower than the pressure upstream of the flow regulator. An administration set according to claim 1, which is administered by pressure. 5. A bypass tube (15) that bypasses the injection fluid to the fluid reservoir (14), a collapsible region (20) located at the upper end of the bypass tube (15), and a collapsible region (20) that allows the fluid to remain intact even if the collapsible region (20) is collapsed. A resistive channel (21) located at the outlet from the reservoir where the flow occurs.
The administration set of claim 3, comprising: 6. The outlet channel (38, 61) is connected to the fluid reservoir (30, 55
) rises to the collapsible region (47, 62) at the level of the reservoir inlet and then descends to bypass the collapsible region (47, 62)
, 65). 7. At the outlet or inlet of the fluid reservoir (55, 60),
A collapsible region (56, 64) or collapsible means is provided and when the fluid reservoir is completely emptied;
Claim 4 Preventing air from entering the outlet
Administration set of paragraphs. 8. Administration set according to any one of claims 2 to 7, comprising a closable tube (48, 67) upstream of the inlet to the fluid reservoir (30, 60). 9. Administration set according to claim 8, comprising an introduction part (36, 66) downstream of the closable tube (48, 67). 10, the fluid reservoir comprises an upper part (37) that connects with the air channel (46) in the closable region (33);
This closable region (33) is connected to the closable tube (4).
8), so the closable area (33) is
Administration set according to claim 3, which is closable either independently or together with the closable tube (48) and prevents air flow from or into the air channel (46). 11. Claim 2, in which the barostat device (6, 19, 31) is made of thin-walled flexible material.
Administration set of Section 3 or Section 3. 12. The administration set of claim 11, which forms an inverted V-shaped or inverted U-shaped flow path when the barostat device is open. 13. A thin-walled collapsible tube (26) is added downstream of the barostat device (19, 31), and this tube needs to raise the pressure at the outlet (45) of the barostat device (19) to a certain value. 4. The administration set of claim 2 or 3, wherein the resistance to flow through the device is provided by atmospheric pressure. 14. The fluid reservoir (1, 14, 30) and the barostat device (6, 19, 31) are formed as part of a single element of the administration set. administration set. 15, fluid reservoir (1, 14, 30), barostat device (6, 19, 31) and collapsible tube (2
14. The administration set of claim 13, wherein 6) is formed as part of a single element of the administration set. 16. The administration set according to any one of claims 2 to 15, wherein the infusion section (10, 23, 42, 53) is downstream of the barostat device (5, 14, 31, 50). 17. The drip part (10, 23, 42) is the meteor regulator (5,
22, 40). 18. The administration set of claim 16, wherein the collapsible tube forms part of the infusion tube. 19. A liquid reservoir and barostat device suitable for use with a flow regulator, wherein the barostat device is downstream of the fluid reservoir, and the barostat device and fluid reservoir are formed as part of a single element of a dosing set. . 20. The barostat device consists of a flexible element,
The flexible element provides a resistance to flow by atmospheric pressure that is necessary to raise the pressure at the inlet of the barostat device to near atmospheric pressure, and the fluid reservoir has its outlet at or about the same height as the inlet to the barostat device. A fluid reservoir and a barostat device according to claim 19. 21. The barostat device consists of a flexible element,
The flexible element provides resistance to flow through the barostat device, which requires raising the pressure at the inlet of the device to a pressure of atmospheric pressure plus (the fluid column upstream of the barostat device minus the pressure created by the fluid column in the fluid reservoir). 20. The fluid reservoir and barostat device of claim 19, wherein the fluid reservoir has an outlet at or about the same height as an inlet to the barostat device. 22. The barostat device consists of a flexible element, the flexible element is influenced by an elastic element, and it is necessary to maintain the pressure downstream of the flow regulator by a certain value lower than the pressure upstream of the flow regulator, through the device. 20. The fluid reservoir and barostat device of claim 19, wherein resistance to flow is provided by pressure generated by a fluid column above the barostat device.