CN1711116A - connector device - Google Patents

Abstract

The present invention relates to a connector device adapted for connecting an enteral feeding set to a laminated paper packaging system containing enterally administrable medicines or nutrients.

Description

connector device

technical field

The invention relates to a connector device for an enteral infusion set (enteral feeding device) and a laminated paper (multilayer paper) packaging system according to the features of the independent claim, a device comprising the connector device Prefabricated enteral infusion system, a kit comprising the connector device, an enteral infusion set and a laminated paper packaging system, and a kit comprising the prefabricated enteral infusion system and a laminated paper packaging system .

Background technique

Such a connector device, such as a sterile connector device, can help to establish a connection between a supply line such as an enteral nutrition infusion set and a laminated paper packaging system such as Tetra ^Brik® , which contains A pharmaceutical or nutritional fluid or composition for administration to a patient by allowing the composition contained in the laminated paper packaging system to flow through the connector device into the enteral infusion set.

Many people in hospitals or nursing homes cannot take nutritional supplements or medicines. These persons or patients typically receive flowable medical substances such as fluids in the intestines containing the required nutrients and/or medications via the patient supply line of an enteral infusion set that is associated with a flowable fluid containing the medications or nutrients. The packaging system of the substance is connected. These flowable substances of pharmaceutical or nutritional products are usually contained in flexible packaging systems such as flexible pouches. Such bags are disadvantageous for economic as well as other reasons.

A large number of laminated paper packaging systems such as Tetra Brik ^(R) are used in the food industry. The system provides convenient cost-effective and lightweight paperboard containers for a variety of pourable products such as liquids. These cardboard containers are available in various sizes, from 0.2 liters to 1.5 liters and even larger. Because they are light-opaque, they are well suited for use in light-sensitive enterally injectable compositions such as vitamin-containing compositions. For pharmaceutical fluids to be infused into a patient, these fluids generally need to be sterile. Laminated paper packaging systems can be sterilized, keeping even the most perishable liquid foods fresh and nutritious for months without refrigeration or added preservatives. Finally, the laminated paper packaging system can be closed aseptically and hermetically, thereby preventing contamination and/or oxygen from entering the container. Such a laminated paper packaging system may advantageously be used to contain pharmaceutical or nutritional compositions such as enteral medicines or nutritional fluids.

However, the existing enteral infusion sets are not suitable for connection, eg direct connection, with the existing laminated paper packaging system. Therefore, pharmaceutical or nutraceutical compositions such as fluids must be filled into an intermediate container, which is then connected to the supply line of the enteral infusion set. This is inconvenient for patients and medical personnel. It is also difficult to ensure sterility.

Contents of the invention

It is therefore an object of the present invention to provide a connector device which can be easily manipulated and directly connected to existing laminated paper packaging systems as well as existing enteral infusion sets.

According to the present invention, a connector device for an enteral infusion set and a laminated paper packaging system is proposed. The connector set consists of:

A device adapted to be mounted on the enteral infusion set, a device adapted to be mounted on the laminated paper packaging system, and a device adapted to enable a composition contained in the laminated paper packaging system to be released from the laminated paper packaging system The system flows through the connector device to the channel of the enteral infusion set. This connector arrangement allows a direct connection of the connector to the enteral infusion set and the laminated paper packaging system in a convenient manner. The direct connection to the laminated paper packaging system and/or the enteral set may be oxygen tight and/or sterile.

In an embodiment of the connector device according to the invention, the means adapted to be mounted on the enteral infusion set comprises a rigid tubular part for connection with the supply line of the enteral infusion set. The tubular member contains part of the channel for the composition to be infused. By friction-fitting the generally flexible supply line of the enteral infusion set on the rigid tubular part of the connector device, the flexible supply line can be connected to the connector device so that the connection between the connector device and A channel is established between the enteral infusion sets. Alternatively or additionally, an adhesive may be used to securely and tightly mount the supply line on the tubular member. The means adapted to be mounted on the laminated paper packaging system includes an internally threaded portion adapted to be screwed onto a corresponding externally threaded portion of a frame member of the laminated paper packaging system. That is, the connection of the connector to the laminated paper packaging system may be achieved by a threaded connection of the type of cap screwed onto the neck of the container. In order to establish a passage between the interior of the laminated paper packaging system and the connector device, the connector device also includes a The laminated paper packaging system means. That is, once the connector device is screwed onto the frame member of the laminated paper packaging system, the laminated paper packaging system is opened, thereby establishing a connection between the interior of the laminated paper packaging system and the connector device. one channel. On the other hand, as mentioned above, the passage between the connector device and the enteral infusion set can be established by mounting the supply line of the enteral infusion set on the tubular part of the connector device. Therefore, a complete channel can be established between the interior of the laminated paper packaging system and the enteral infusion set, so that the composition contained in the laminated paper packaging system can flow into the enteral infusion solution through the connector device device.

In a more specific embodiment of the connector device according to the invention, the means for opening the laminated paper packaging system comprises a cutting element directed from the connector device in the direction of the laminated paper packaging system protrude. The cutting member is used to cut through the laminated paper packaging system when the connector is screwed onto the frame member of the laminated paper packaging system, thereby opening the laminated paper packaging system. This type of opening device is a direct opening device, since the cutting of the laminated paper packaging system is performed by the cutting element itself.

In another more specific embodiment of the connector device according to the invention, the means for opening a laminated paper packaging system comprises an actuator directed from the connector device towards the The direction protrudes to act on a lever system provided in the frame part of the laminated paper packaging system, which breaks the laminated paper packaging system when acted on by the actuator. This type of opening device is an indirect opening device, since the actuator does not itself open the laminated paper packaging system, but actuates a lever system which opens the laminated paper packaging system. Therefore, this type of opening device requires a lever system in the frame part of the laminated paper packaging system.

In another embodiment of the connector device according to the invention, the means adapted to be mounted on the enteral infusion set comprises a rigid tubular part for connecting the supply line of the enteral infusion set. The tubular member contains part of the channel for the composition to be infused. By friction-fitting the generally flexible supply line of the enteral infusion set on the rigid tubular part of the connector device, the flexible supply line can be connected to the connector device so that the connection between the connector device and A channel is established between the enteral infusion sets. Alternatively or additionally, an adhesive may be used to securely and tightly mount the supply line on the tubular member. So far, the connection of the supply line of the enteral infusion set is the same as that described above. However, compared with the above-described embodiment, the device adapted to be installed on the laminated paper packaging system includes a spike for piercing the interior of the laminated paper packaging system, and a spike for securing the connector device. connected to the connecting device on the laminated paper packaging system. The means for connecting the connector means to the laminated paper packaging system can take different forms, examples of which will be described in further detail below. The spike also includes an extension of the portion of the channel contained within the tubular member that enters the interior of the laminated paper packaging system so as to be accessible between the interior of the laminated paper packaging system and the enteral infusion set. Create a complete channel.

As already explained above, the connecting means for fixedly connecting the connector device to the laminated paper packaging system can take different forms. In one embodiment, the connecting means comprises a flange, the upper surface of which faces towards the laminated paper packaging system. An adhesive layer is provided on the upper surface so that when the upper surface of the flange pierced by the spikes and having the adhesive layer is pressed against the laminated paper packaging system, the connector device and the layer Pressed paper packaging system is connected. The person using the connector only needs to puncture the laminated paper packaging system with the sharp thorn and press the flange with the adhesive layer on the upper surface against the laminated paper packaging system to make the connector device Bonded to this laminated paper packaging system. For storage purposes, the adhesive layer can be protected with a protective cover, such as foil, which has to be peeled off before mounting the connector device.

In another embodiment, the connecting means for fixedly connecting the connector device to the laminated paper packaging system comprises two flanges extending parallel around the spike and at a distance axially spaced from each other. The flange located closer to the tip of the spike is made of flexible material, while the flange located further from the tip of the spike is made of rigid material. The flexibility of the flange located closer to the spike facilitates insertion of the flange after a hole has been formed in the laminated paper packaging system by the point of the spike. The flange further from the tip of the spike remains outside the laminated paper packaging system and against the outer wall of the laminated paper packaging system. The two flanges are axially spaced from each other at a certain distance in order to achieve a secure fit of the connector device, that is, to securely close the laminated paper packaging system between the two axially spaced flanges. wall. The connector may be made by injection moulding, and the flexible flange may eg be molded with the connector from a suitable flexible material such as rubber or a flexible polyolefin.

All embodiments of the connector device described above do not necessarily include a venting device, but it is advantageous to include the venting device so that the laminated paper packaging system retains its properties after being emptied of the composition to be infused. shape. Such a venting device may for example comprise a valve mechanism which allows air to enter therethrough but prevents the composition to be infused from exiting and/or flowing through the venting device.

In another embodiment of the connector device according to the invention, the connector device further comprises a sight tube. One end of the sight tube is connected to the channel for the composition to be infused, and the other end of the sight tube is connected to a venting device. The breather itself includes an air inlet and a spike configured to penetrate the interior of the laminate packaging system to a predetermined depth. During emptying of the laminate packaging system, air may enter the laminate packaging system through the vented spikes penetrating the interior of the laminate packaging system to a predetermined depth, thereby allowing pressure equalization. As a result, the level of the fluid in the sight tube is level with the level of the fluid contained in the laminate packaging system so that the laminate package can be seen by the user even though the laminate packaging system itself may be opaque The level of fluid contained in the system.

Another aspect of the present invention relates to a prefabricated enteral infusion system comprising an enteral infusion set and a connector device non-detachably connected to the enteral infusion set, wherein the connector device is the above-mentioned connection device. This prefabricated enteral administration system only needs to be connected to the laminated paper packaging system, and does not require the assembly of infusion sets and connectors. Such a prefabricated enteral administration system further reduces the risk of contamination, especially if the system is used as a single-use system, ie discarded after use rather than being sterilized and reused.

In an embodiment of the prefabricated enteral administration system according to the invention, the system may comprise a pump unit arranged in the supply line of the enteral administration set for supplying fluid from the laminated paper packaging system Inside.

In another embodiment of the enteral infusion set according to the invention, the system comprises a transparent intermediate pouch for containing the quantity of composition contained in the laminated paper packaging system. Essentially, the system is designed to be gravity fed, essentially emptying the fluid contained in the laminated paper packaging system into the clear intermediate pouch so that the user can always see the remaining amount of fluid. In fact, the intermediate bag is part of the prefabricated system, which ensures a high degree of safety against contamination while allowing visibility of the remaining volume of fluid.

Another embodiment of the prefabricated enteral administration system according to the present invention includes a dosing means that controls the rate of infusion of the composition to the patient. This embodiment allows the rate of infusion to be controlled regardless of the speed of pump or gravity feed.

Another aspect of the present invention relates to an enteral infusion kit comprising an enteral infusion set, a connector device as described above, and a laminated paper packaging system containing a composition to be infused enterally into a patient. Such a kit is advantageous because the patient has a complete system that only needs to be assembled together ready for use, without the need to maintain an inventory of each component of the system.

Another aspect of the present invention relates to an enteral administration kit comprising a prefabricated enteral administration system as described above and a laminated paper packaging system containing a composition to be enterally infused into a patient. Such a kit also has the same advantages as mentioned in the preceding paragraphs, but simplifies assembly so that the risk of contamination can be further reduced.

The enteral infusion kits described above can be assembled together aseptically, ie can form a closed, eg sterile closed system. The term "sterile" as used herein means, for example, the absence of microorganisms, such as the substantial absence of microorganisms, at the time of use.

Description of drawings

Other advantageous embodiments are clear from the following description of embodiments of the invention with reference to the accompanying drawings, in which:

Figure 1 shows an exploded cross-sectional view of an embodiment of a connector device according to the present invention connected to the supply line and laminated paper packaging system of an enteral infusion set;

Figure 2 shows an enlarged cross-sectional view of the connector device shown in Figure 1;

Figure 3 shows a cross-sectional view of another embodiment of a connector device according to the present invention, which is adapted to open the laminated paper packaging system indirectly when connected to the laminated paper packaging system;

Figure 4 shows a cross-sectional view of the steps of connecting an embodiment of a connector device according to the present invention to a laminated paper packaging system;

Figure 5 shows a cross-sectional view of another embodiment of a connector device according to the present invention in connection with a laminated paper packaging system;

Figure 6 shows a cross-sectional view of another embodiment of a connector device according to the present invention in connection with a laminated paper packaging system;

Figure 7 shows a cross-sectional view of another embodiment of a connector device according to the present invention;

Figure 8 shows yet another embodiment of a connector device according to the invention, and

Figure 9 shows various embodiments of a prefabricated enteral administration system according to the present invention, which already has a connector device.

Detailed ways

The term "composition" as used herein refers to a flowable substance, especially a fluid, and especially an enteral composition, comprising nutraceutical and pharmaceutical ingredients such as nutraceuticals and pharmaceuticals. According to the invention, these compositions are contained in a laminated paper packaging system. Additionally, the term "fluid" refers to such compositions.

The term "laminated paper packaging system" refers to paper packaging systems of the types such as Tetra Brik ^® , Tetra Brik Aseptic ^® , Tetra Pak ^® , Tetra Prisma ^® , Tetra Recart ^® , Tetra Square ® , Tetra Top ^® , Elopak ^® , Combiblok ^{® ,} Pure Pak ^ 's laminated paper packaging system. The laminated paper packaging system may have a volume of from about 0.125 liters to about 2 liters, preferably from about 0.200 liters to about 1 liter. Most preferred sizes include about 0.200, about 0.250 and about 1 liter.

Such laminated paper packaging systems may comprise layers of fibrous material such as paper or (cardboard) covered on each side with a thermoplastic material such as polyethylene. On the side of the laminated paper packaging that will be in contact with the composition, there may also be a layer of barrier material, such as aluminum foil, which may also be covered with a thermoplastic layer. Such laminated paper packaging systems are disclosed, for example, in US 6223924 or EP 1088765, which are incorporated herein by reference. Methods of sterilizing such laminated paper packaging systems are known to those skilled in the art. Packaging machines have also been developed to aseptically fill and seal sterilized food products or compositions into such laminated paper packaging systems, such as sterilized laminated paper packaging systems.

The connector device according to the invention makes it possible to establish a connection between the supply line of an enteral infusion set, for example an enteral infusion set, and a laminated paper packaging system. When the connector device is, for example, sealably connected to the enteral infusion set and the laminated paper packaging system, the device allows the composition contained in the laminated paper packaging system to pass from the laminated paper packaging system through the connector The device flows into the enteral infusion set. As used herein, the term "sealably connected" refers to a connection that temporarily or permanently prevents leakage of the composition as the composition flows through the connector device, thereby forming a liquid-tight connection. The connection between the connector device of the present invention and the laminated paper packaging system and/or enteral infusion set may also be airtight, eg impermeable to oxygen, and/or sterile.

The term "enteral infusion set" as used herein includes all components starting from the supply line, for example a tubular supply line, located between the aforementioned connection device and the patient. As will be explained below, a plastic bag sealingly connected to the tubular supply line may be provided in the enteral infusion set. This plastic bag is basically collapsible. The plastic bag may also be substantially transparent, such as transparent. The plastic bag may also be used for venting or to contain air such as sterile air.

The plastic bag is detachably or permanently attached to the connector device. The permanent connection of the connector device to the plastic bag can be achieved, for example, by methods including but not limited to: heat induction, ultrasonic welding or friction welding or any other method known in the art. The plastic bag can be directly or indirectly connected to the connector means, for example via a supply tube. Such plastic bags may have a volume of about 100ml to about 1 liter, for example 200ml to about 500ml, for example about 250ml.

The composition can be delivered by gravity, and the infusion set can have a roller holder for controlling the flow rate (infusion rate). Alternatively or additionally, the enteral infusion set may comprise a pump, such as the Compat ^(R) type pump from Novartis Nutrition Corporation (Minneapolis, Minnesota). These details are explained further below.

1 and 2, a connector device 1 is sealably connected to an enteral infusion set 3 such as a supply line 2 and a laminated paper packaging system 4 of the enteral infusion set 3 . The connector device 1 may comprise an externally threaded portion 5 adapted to engage with a corresponding internally threaded portion 30 of the enteral infusion set 3 . By screwing the part 30 of the enteral infusion set 3 onto the part 5 of the connector 1, the sealing flange 31 of the supply line 2 of the enteral infusion set 3 is sealingly engaged with the end face of the part 5 of the connector device 1, A tight connection is thereby established between the enteral infusion set 3 or supply line 2 and the connector device 1 .

At the opposite end of the connector device 1 there is provided an internally threaded portion 6 having an internal thread 12a. The internally threaded portion 6 is adapted to be screwed onto a corresponding externally threaded portion of the frame member 11 having corresponding threads 12b to connect the connector device 1 to the laminated paper packaging system 4 .

The inner threaded portion 6 of the connector device 1 has a diameter, for example an inner diameter, of between about 1.0 cm and about 3.5 cm, preferably between about 1.3 cm and about 3.0 cm, more preferably between about 1.5 cm and about 2.5 cm Between, and especially preferably between about 1.8cm and about 2.3cm. The most preferred diameter of the part 6 of the connector device 1 is eg an inner diameter of about 2 cm, eg 2.1 or 2.2 cm.

In the embodiment shown in FIG. 2 , the laminated paper packaging system 4 is sealed by a cover layer 10 . In order for the composition contained in the laminated paper packaging system 4, such as a fluid, to be delivered, the cover layer 10 must be opened in order to establish a feed line from the inside of the laminated paper packaging system 4 through the connector device 1 to the enteral infusion set 3 2 channels. Therefore, the embodiment shown in FIG. 2 requires means for opening the laminated paper packaging system 4 when the connector device 1 is screwed onto the frame member 11 .

A frame member 11 is integrally formed within the laminated paper packaging system 4 and is preferably fixed thereon so as to define the cover layer 10 . The frame member 11 of the laminated paper packaging system 4 may be of the type associated with spin ^(R) lids or stream ^(R) lids, eg available from Tetra Pak Switzerland AG. Such frame members are known to those skilled in the art and are described, for example, in EP0947433, EP1088765, EP1262412, US 6382462, US 6422412 or US6223924, which are incorporated herein by reference. The frame member 11 can be integrated integrally within the laminated paper packaging system by techniques known to those skilled in the art, such as by application of hot melt adhesives, micro-fire welding or laser welding. The frame-like part 11 can be closed by a second barrier layer, for example a foil, such as aluminum foil, especially a pull tab, which can be removed. In another embodiment of the present invention, the frame member 11 may be closed with a standard cap such as a reclosable cap such as a screw cap or a press cap. In this case, the cover layer 10 covering the opening of the laminated paper packaging system 4 can be accessed after the lid has been removed from the frame part 11 .

The opening means may comprise, for example, a cutting member 13 protruding from the connector device 1 in a direction towards the laminated paper packaging system 4 , more particularly towards the cover layer 10 . When connecting the connector device 1 to the laminated paper packaging system 4, for example by pressing the connector device 1 onto the laminated paper packaging system 4 and/or screwing the connector device 1 onto the frame member 11, The cutting member 13 cuts through the laminated paper packaging system 4 to create a passage for fluid from the inside of the laminated paper packaging system 4 through the connector device 1 to the supply line 2 of the enteral infusion set 3 .

The cutting member 13 may comprise one or more cutting tools such as spikes 14, cutting teeth, knives, or any other suitable structure known to those skilled in the art, such as with a ^spin® cover or stream available from Tetra PakSwitzerland AG. ^® cap-related types, and the types described, for example, in EP0947433, EP1088765, EP1262412, US 6382462, US 6422412 or US6223924, which are incorporated herein by reference.

The length, position or number of the cutting members 13, e.g. protruding means, may be adapted to penetrate the laminated paper when the connector device 1 is connected, e.g. sealed, to the laminated paper packaging system 4 by e.g. Packaging system4. Alternatively, the cutting member 13 , for example a protruding means, may extend beyond the bottom of the part 6 of the connector device 1 .

According to the invention, the opening means, such as the cutting member 13, may be offset from the center, such as the central axis, of the connector device 1 .

In another embodiment of the invention, the opening means such as the cutting member 13 may be located in the center of the connector device 1 . For example, the opening means, such as the cutting member 13, may be of elongate shape, eg on an extension of the part 5 of the connector means 1 adapted to be connected to the supply line.

According to the invention, the opening means, such as the cutting member 13, may be hollow, eg may contain a fluid channel.

In another embodiment of the invention, the opening means such as the cutting member 13 may consist of a tubular part, for example with a reverse thread, which is arranged inside the connector device 1 and is adapted to be able to connect the frame by comprising The external thread of the internal thread in the frame part 11 engages with the frame part 11 and moves in the direction of the laminated paper packaging system 4 when the connector device 1 is connected, for example sealed, to the laminated paper packaging system 4 . Such a tubular part may, for example, have on its lowermost flange at least one cutting means adapted to pierce the laminated paper packaging system 4 when the tubular part is engaged with the frame part 11 . Such opening devices are known to those skilled in the art, for example as described in EP0947433, EP1088765 or EP1262412 in connection with ^stream® lids or ^spin® lids as described for example in EP0947433, EP1088765 or EP1262412, which patents are incorporated in the present application. Invention References.

As an alternative, FIG. 2 shows a connection between the connector device 1 and the laminated paper packaging system 4, for example by pressing the connector device 1 onto the laminated paper packaging system 4 and/or screwing the connector 1 onto the frame member 11. Another embodiment of the means for opening the laminated paper packaging system 4 when the packaging system 4 is connected. According to this embodiment, there is provided an actuator 16 protruding from the connector device 1 in a direction towards the laminated paper packaging system 4 , more particularly towards the cover layer 10 . The frame-like part 11 of the laminated paper packaging system 4 can have an opening system 15 , eg a lever system, associated with the frame-like part 11 , for example integrated in the frame-like part 11 . When the connector device 1 is connected to the laminated paper packaging system 4 by pressing the connector device 1 onto the laminated paper packaging system 4 and/or screwing the connector 1 onto the frame member 11, the start The member 16 acts on the lever system 15 and presses the lever system 15 towards the cover 10 so that the cover 10 is ruptured. In this way, a fluid passage is established from the interior of the laminated paper packaging system 4 through the connector device 1 to the supply line 2 of the enteral infusion set 3 .

The opening system 15 can be moved, for example, from a first position, in which the opening system does not open the laminated paper packaging system 4, for example out of contact with the laminated paper packaging system, to a second position, in which it opens System Opening The laminated paper packaging system 4 protrudes below the frame-like part 11, for example. Preferably, the opening system 15 can be integrated with an elastic hinge (not shown), which can be integrated with the frame part 11 .

The starter 16 can be provided to be recessed, i.e. it does not protrude beyond the connector 1 in order to ensure that the connector device 1 is fully screwed onto the frame-like part 11 of the laminated paper packaging system 4. Opening is triggered eg breaking of the laminated paper packaging system 4 .

The actuator 16 and corresponding systems for opening the laminated paper packaging system 4 are known to those skilled in the art. For example, the actuating member 16 of the connector device 1 is of the type of actuating system described in relation to a ^spin® cover or a stream® ^cover , for example in EP0947433, EP1088765, EP1262412, US 6223924, US 6422412 or US 6382462, which patents serve as reference for the present invention. references.

Venting means 7 may be provided to allow air to enter the interior of the laminated paper packaging system 4 to compensate for fluid flowing out of the laminated paper packaging system 4 . The venting device may comprise a valve mechanism which allows air to enter through the valve mechanism while preventing the composition to be infused from exiting through the valve. A filter 9 such as a bacterial filter may be provided in order to filter the air and prevent contamination such as bacteria from entering the supply line 2 and/or the connector device 1 and/or the laminated paper packaging system 4 .

It should be understood that this venting device can alternatively be located within the supply line 2 of the enteral infusion set 3 or within the laminated paper packaging system 4 . Preferably, the ventilation means are located in the connector device 1 , especially preferably in the part 6 of the connector device 1 connected to the laminated paper packaging system 4 . In addition, a visual device (not shown here, which will be described in detail below) for visualizing the fluid level may be provided.

According to the invention, after the laminated paper packaging system 4 is opened, it can be opened, for example, by using an opening device such as a helically movable single cutter as described in EP 1088765 (this patent is hereby incorporated by reference) or by means of a prior art Any other suitable means known to prevent the laminated paper packaging system 4 from obstructing the flow of the composition contained therein.

The airtightness of the connection between the connector device 1 and the laminated paper packaging system 4 can be ensured by methods known in the prior art, such as using adhesives, glues, gaskets, by using foam or elastomers, Either by direct top contact, or by the so-called "olivetightness type" as occurs in the screw caps of bottles containing carbonated beverages. It should be understood that a person skilled in the art is well within the ability to select a suitable sealing system.

Figure 3 shows an embodiment of a connector device 1 according to the invention. As explained with reference to FIGS. 1 and 2, the connector device 1 of FIG. 3 can be screwed by means of an internally threaded portion that is screwed to the frame member 11 of the laminated paper packaging system 4. on a corresponding externally threaded portion (not shown in Figure 3). As explained in detail above, the actuator 16 acts on a lever system 15 provided in the frame-like part 11 of the laminated paper packaging system. The supply line 2 (not shown in FIG. 3 ) of the enteral infusion system 3 can be sealingly connected to the rigid tubular part 5b of the part 5 of the connector device 1 by frictional engagement, i.e. by placing the enteral infusion set The supply line 2 of 3 moves into the annular groove 8a in order to achieve a tight fit, eg snap and fit. A circumferential projection protruding from a portion 5 of the connector device 1 adapted to be connected to a supply line can engage a flange at the end of the supply line, allowing the connector device 1 to be sealably connected to the supply line (Fig. 3 not shown) on. After joining, it can be sealed by sealing such as sonic or ultrasonic welding, friction welding, heat induction, or by using adhesives such as hot melt adhesives or glue, or by any other method known in the art. The connector device 1 is further attached to the supply line 2 .

As shown in Figure 3, the vent means 7 may be arranged such that the air passage 7a allows air, eg filtered by the filter 9, to enter the laminated paper packaging system (not shown) but not to enter the fluid passage 5a. Outflow of the composition from the laminated paper packaging system through the air passage 7a may be prevented using a flexible membrane forming a filter 9 adjacent to the inner opening of the air passage, as described for example in US 4997429, which Patents are references in this article. Such venting devices are known and are commercially available for use with existing enteral infusion sets, such as the Compat ^(R) type from Novartis Nutrition Corporation (Minneapolis, Minnesota). The ventilation means 7 may be arranged such that the air channel 7a is arranged substantially in the center of the connector device 1 .

The supply line 2 of the enteral infusion set 3 may include a portion having an enlarged diameter, e.g., a larger diameter than other parts of the supply line, such as a drip chamber, so that fluid flow from the laminated paper packaging system 4 can be seen . This enlarged part of the supply line 2, eg the drip chamber, can be substantially transparent. This part may be placed close to the connector device 1, or may be a part (not shown) of the supply line 2 which is directly connected, eg interlocked or connected to the connector device.

Referring to Figure 4, the basic steps for connecting an embodiment of the connector device 1 to a laminated paper packaging system 4 are shown. The laminated paper packaging system 4 includes an aperture 21 in the paperboard, or a portion of reduced thickness, for example, which may form apertures through some layers of the laminated paper packaging material and one or more barrier layers of aluminum and/or polyethylene The portion extending above the hole, the hole 21 can be a straw hole (ie a hole covered by aluminum foil 17) or a through hole (ie an opening). The hole 21 may be of any suitable shape or size, for example circular or rectangular, for example about 0.3 to 3 cm in diameter, for example about 0.6 to about 2 cm, for example about 1.2 to about 1.5 cm, for example about 1.3 to about 1.4 cm, preferably The ground is about 0.6cm. The hole 21 can be covered by a tear tab 18 , for example a double tear tab, which has to be removed before connection with the connector device 1 . For example, the tear tab 18 can be peeled off.

The connector device 1 may comprise a portion 5 forming a rigid tubular part for connecting the supply line 2 (not shown in FIG. 4 ) of the enteral infusion set 3, and a portion 5 for piercing the interior of the laminated paper packaging system 4. Spikes 20. Where the hole 21 is a straw hole, the spikes 20 pierce the aluminum foil 17 for insertion into the interior of the laminated paper packaging system 4 . The spikes 20 according to the invention are also capable of piercing any part of the laminated paper packaging system 4, for example a part of the laminated paper packaging system 4 that does not contain a reduced thickness portion and/or a hole, or contains a pre-cut portion Part of the laminated paper packaging system. The connector device 1 comprises a flange 50 whose upper surface (which is facing downwards in FIG. 4 ) faces the laminated paper packaging system 4 . An adhesive layer 19 may be provided on the upper surface of the flange 50 . The adhesive layer 19 may be, for example, a self-adhesive tape, which may be protected with a covering foil until use, or may be a layer of adhesive or sticky. Once the spikes 20 have pierced the interior of the laminated paper packaging system 4, the upper surface of the flange 50 with the adhesive layer 19 is pressed against the laminated paper packaging system 4 (see arrow in FIG. 4 ) so that The connector device 1 is connected, for example fixedly, to a laminated paper packaging system 4 .

Fig. 5 shows a further embodiment of a connector device 1 according to the invention. The embodiment of the connector device 1 shown on the left hand side of Fig. 5 comprises a part 5, ie a tubular part, for connecting the supply line of an enteral infusion set. Additionally, two flanges 50, 51 may be provided. The flanges 50, 51 may extend in parallel around the spike 20 and may be axially spaced from each other by a predetermined distance. The predetermined spacing may be selected such that both the laminate packaging system 4 and the aluminum foil 17 are properly disposed between the flanges 50 and 51 . The flange 51 closer to the tip of the spike 20 may be made of a flexible material, while the flange 50 may be made of a rigid material. The flexibility of the flange 51 is important in this embodiment of the invention, since the flange 51 must be introduced through the hole 21 (see FIG. 4 ) into the interior of the laminate packaging system without damaging the laminate packaging system. In order to allow such introduction, the flange 51 must be sufficiently flexible. Once the spikes 20 have been inserted into the interior of the laminate packaging system 4, the laminate packaging system 4 and the aluminum foil 17 can be squeezed appropriately between the flange 51 and the flange 50 so that a tight fit is established. The composition can then flow from the interior of the laminate packaging system 4 through the channels 5a thus formed.

The connector device 1 shown on the left-hand side of FIG. rim 51, but the material for the area of the flange 51 must be a flexible material such as rubber or a suitable flexible polyolefin, while the remainder of the connector device 1 may be molded from a rigid material such as polypropylene.

The embodiment shown in the center of FIG. 5 differs substantially from the embodiment shown on the left-hand side in that it does not have a flange 51 extending around the spike 20, but instead provides a recess 52 and the entire connector arrangement 1 is made of rigid material.

For the embodiment shown on the right-hand side of Fig. 5, also the entire connector device 1 is made of rigid material. Spike 20 has a thickened portion 53 in the area of hole 21 (see FIG. 4 ) so that the outside diameter of spike 20 is slightly larger than the inside diameter of hole 21 to form a tight press fit.

FIG. 6 shows another embodiment of the connector device 1 . This embodiment has a sight tube 22 which acts as a level indicator. One end of the sight tube 22 can be connected to the channel 5a for the composition to be infused, and the other end of the sight tube can be connected to a ventilator. The vent means may comprise an air inlet 26 and optionally may have a valve mechanism and a filter, and a spike 27 arranged to penetrate the interior of the laminated paper packaging system 4 to a predetermined depth. In the example shown in FIG. 6 , the vented spikes 27 penetrate the top wall of the laminated paper packaging system 4 , but the spikes 27 could also penetrate the side walls of the laminated paper packaging system 4 . Sight tube 22 is connected to this venting means through portion 25 so that the pressure inside laminated paper packaging system 4 and in sight tube 22 is equalized. Thus, the composition within laminated paper packaging system 4 and the composition within sight tube 22 are at the same level. Therefore, the sight tube 22 can be used as a liquid level indicator.

The breather comprising spikes 27 may be fixedly connected to the laminated paper packaging system 4 by means of a flange 24, the surface of the flange 24 facing the laminated paper packaging system 4 may be provided with glue or adhesive, or Attachment to the laminated paper packaging system may be by any other suitable method.

Figure 7 shows another embodiment of a connector device according to the invention. The connector device 1 has a rigid tubular part for connection to the supply line of an enteral infusion set (not shown in Fig. 7) and is surrounded by an annular groove 8a. The method of fixedly connecting the supply line of the enteral infusion set to the rigid tubular member has been described in detail with reference to the embodiment shown in FIG. 3 , so it will not be repeated here. The connector 1 comprises a spike 20 or cannula, for example a vented spike, having a flange 20b. The surface of the flange 20b facing the laminated paper packaging system 4 (not shown) may have an adhesive layer 19, which has been described in detail above. Spikes 20 comprise two separate channels, a channel for the composition to exit the laminated paper packaging system and a channel 7a for air to enter the interior of the laminated paper packaging system. As already stated, the vent means 7 may comprise a suitable filter membrane to prevent the ingress of contaminants and the egress of the composition through the air channel 7a. The channel 5a of the spike 20 may be slotted along a portion of the length of the spike 20 shown as 5b. Spikes 20 can be of any shape.

Spikes 20, such as the piercing portion of spikes 20, may also include threads.

Spikes 20 may have a length of about 0.5 to about 10 cm, such as about 0.5 to about 7 cm, such as about 3.5 cm, such as about 6.5 cm. The diameter of the spikes 20 may be slightly larger than the diameter of the hole of the laminated paper packaging system 4, for example a few mm larger than the diameter of the hole of the laminated paper packaging system 4, for example between 0.2 and 0.8 mm, for example about 0.4 mm. Spikes 20 may have a diameter of about 0.3 cm to about 3 cm, for example about 0.4 cm to about 3.2 cm, for example about 0.6 cm to about 2.4 cm, for example about 1.4 cm to 1.7 cm or about 1.5 cm to 1.6 cm, preferably about 0.6cm, such as about 0.64cm.

The length of the fluid channel 5a of the spike 20 may be equal to or shorter than the length of the air channel 7a. The length of the fluid channel 5a may be shorter than the air channel 7a. The length of the fluid channel may be from about 0.5 to about 5 cm, such as from about 0.5 to about 3 cm, such as from about 1 cm, so that the laminated paper packaging system can be completely emptied eg when the laminated paper packaging system is placed upside down. The diameter of the fluid channel 5a may be at most about 15 mm, for example at most about 6 mm, for example 6.4 mm, more preferably between about 3 and about 15 mm, for example between about 6 and about 15 mm, for example between about 13 and 14 mm, for example About 13.5mm.

In one embodiment of the invention, the fluid channel 5a of the spike 20 may be offset from the center of the spike, eg, the central axis.

FIG. 8 shows another embodiment of the connector device 1 of the invention, which is a combination of the embodiments shown in FIGS. 6 and 7 . As shown in FIG. 8 , the connector device 1 includes a spike 20 and a sight tube 22 . One end of the sight tube 22 is connected to the channel for the composition, while the other end is connected to a ventilation device 71 . The breather 71 includes spikes 27 for penetrating a predetermined depth into the interior of the laminated paper packaging system 4 (not shown in FIG. Pierce the inside of the laminated paper packaging system.

An advantage of the embodiment shown in Figures 6 and 8 is that it allows the liquid level of the composition in the laminated paper packaging system to be visible while requiring no replacement of the laminated paper packaging system at all, because " "Liquid level indicator" is an external part, i.e. a part of the connector device 1 that is connected to the laminated paper packaging system regardless of its shape.

The connector device described may include an anti-tamper system adapted to indicate that the laminated paper packaging system has been connected to the connector device and/or that the laminated paper packaging system has been opened. Such an anti-tampering system may comprise an indicator member connected to part 6 (see FIG. 2 ) of the connector device, for example by one or more disconnectable connections, for example by a bridge. . These connections can be disconnected when the connector device is connected to the laminated paper packaging system, eg the framed part 11 of the laminated paper packaging system. Such anti-tamper systems are known to those skilled in the art and are described, for example, in US 6223924 or EP 0947433, which are incorporated herein by reference.

The anti-tampering system may comprise means provided in the connector device, such as a tubular part associated with the connector device 1 , adapted to move unidirectionally over the laminated paper packaging system 4 , eg over the frame-like part 11 . The device may comprise notches, for example configured in a saw-tooth shape and adapted to move unidirectionally, for example on detents provided in the frame part 11, so as to prevent the connector device 1 from being removed from the laminated paper packaging system 4 move up. Such devices are known to those skilled in the art and are described, for example, in EP 0947433, which is incorporated by reference in the present invention.

The connector device described above may be made of plastic or polymeric material including but not limited to polyolefins such as polypropylene or polyethylene. The connector device can especially be made of a material with low oxygen permeability. They may be opaque or substantially transparent, or may comprise a substantially transparent portion, such as portion 5 adapted for connection to the supply line of an enteral infusion set. As mentioned above, the connector device can be manufactured by a molding method such as injection molding.

A cap or seal may be placed on the outer end of the connector device 1 to prevent contamination of the connector device 1 prior to use. For example, a cover may be mounted on the part 5 (see FIG. 2 ) of the connector device and/or on the part 6 of the connector device, eg by screwing. The cover can be removed before the connector device 1 is connected to the supply line and/or to the laminate packaging system.

Another aspect of the present invention relates to a prefabricated enteral infusion set comprising one of the above embodiments of the connector device 1 and an enteral infusion set 3 . The connector device 1 is non-detachably connected to the enteral infusion set, in particular to the supply line 2 of the enteral infusion set 3 . The non-detachable connection of the connector device 1 and the supply line 2 can be achieved, for example, by methods including but not limited to: using hot melt adhesives such as glue, heat induction, ultrasonic welding and friction welding or known in the art Any other suitable method known. The connector device 1 may be molded on the supply line to form a single part. The material of the connector device 1 can form a seal, such as an air seal and/or a liquid seal, with the material forming the supply line of the enteral infusion set. Preferably, the prefabricated enteral administration system is a single-use system, ie discarded after one use, thereby reducing the risk of incomplete sterilization.

Figure 9 shows various embodiments of such a prefabricated enteral administration system. The three embodiments shown in the upper half are provided with a connector device 1 having a spike 20 (see FIG. 7 ) for piercing inside a laminated paper packaging system 4 (not shown), while in the lower half The illustrated embodiments each comprise a connector device 1 for screwing onto the laminated paper packaging system (see Figure 3) or a frame member 11 (not shown) of the laminated paper packaging system. Additionally, the illustrated embodiments all include a roller grip 70 for controlling the rate of infusion of the composition to the patient.

The embodiment shown in the left column of Fig. 9 also comprises a pump unit 60 arranged in the supply line 2 of the enteral infusion system for pumping the composition. The embodiments in the middle row all have a sight tube 22 (see FIG. 8 ) and a venting device including additional spikes 7 . Additionally, the embodiment shown in the middle column of Figure 9 also has a drip chamber 80 to make the flow visible. Finally, the embodiments shown in the right column of FIG. 9 each have a transparent intermediate bag 90 for containing the amount of composition contained in the laminated paper packaging system so that the laminated paper packaging system contains The contained composition is first discharged into the transparent intermediate bag 90 so that the emptying process is visible to the patient. In addition, a drip chamber 80 is provided so that the flow of the composition can be seen.

Ventilation transposition 7 is optional according to the invention, especially when the connector device 1 is connected to an enteral infusion set comprising a pump unit, or when the aforementioned prefabricated enteral infusion system comprises a pump unit.

As already stated above, such a prefabricated enteral administration system further reduces the risk of contamination and further simplifies handling.

According to the present invention, the connector device 1 and the prefabricated enteral infusion system described above are sterilizable, for example by ethylene oxide (ETO), gamma rays, beta rays, peroxides or techniques in the art. Any other suitable agent known to the person, such as a chemical agent, is distilled or sterilized.

Another aspect of the present invention relates to an enteral infusion kit comprising an enteral infusion set, an above-mentioned connector device, and a laminated paper packaging system containing Compositions. Such a kit is advantageous because the kit generally includes all parts necessary for infusion, so the patient does not need to control any stocks. The risk of incomplete sterilization is further reduced when all components are manufactured for single use.

Another aspect of the present invention relates to an enteral administration kit comprising a prefabricated enteral administration system as described above and a laminated paper packaging system containing a composition to be enterally infused into a patient. Its advantages are basically the same as those mentioned in the previous paragraph. In addition, patient handling is easier since there is no need to assemble the connector device and enteral infusion set, which has been prefabricated as a single system and intended to be attached to the laminated paper packaging system, thereby reducing the risk of contamination.

The connector device and prefabricated enteral administration system described above are non-detachably connectable to the laminated paper packaging system. The irreversible connection of a connector device or a prefabricated enteral administration system to the laminated paper packaging system involves locking means arranged in the connector device, for example in the tubular part of the connector device, as described for example in EP 0947433, which Patents are references in this article.

The present invention provides the use of a laminated paper packaging system in the supply of an enteral line, the use comprising direct connection of the laminated paper packaging system, such as a sealed connection, to an enteral infusion set or the above-mentioned prefabricated enteral infusion via the connector means on the system.

The present invention also provides a method of enterally infusing a drug or nutritional product contained in a laminated paper packaging system to a patient in need, the method comprising passing a supply line of an enteral infusion set through an above-mentioned connector The device is sealably connected to a laminated paper packaging system, or the laminated paper packaging system is directly connected to a prefabricated enteral administration system as described above, such as using a Gravity unit or a pump unit. These units are known to those skilled in the art.

In another aspect of the present invention there is provided a method of removably connecting a connector device or a prefabricated enteral administration system as described herein with a laminated paper packaging system, the method comprising:

(a) removing a seal or lid such as a tear tab from the laminated paper packaging system, and

(b) opening the laminated paper packaging system and optionally

(c) Connect sight tube 22 to the connector device or prefabricated enteral administration system and to the laminated paper packaging system.

Claims (18)

1. A connector device for an enteral infusion set and a laminated paper packaging system, comprising: a device adapted to fit on the enteral infusion set, devices adapted to be mounted on the laminated paper packaging system, Adapted to allow a composition contained in the laminated paper packaging system to flow from the laminated paper packaging system through the connector device to the channel of the enteral infusion set. 2. A connector device according to claim 1, characterized in that the device adapted to be mounted on the enteral infusion set comprises a rigid tubular member for connection with the supply line of the enteral infusion set , the tubular member contains a portion of the channel for the composition to be infused; the device adapted to be mounted on the laminated paper packaging system includes an internally threaded portion adapted to be screwed onto the on a corresponding external threaded portion of a framed part of the laminated paper packaging system; the connector device also includes means for opening the Device for laminated paper packaging systems. 3. A connector device according to claim 2, characterized in that the means for opening the laminated paper packaging system comprises a cutting member directed from the connector device in the direction of the laminated paper packaging system Protrudes for cutting through the laminated paper packaging system when the connector is screwed onto the framed part of the laminated paper packaging system. 4. A connector device according to claim 2, characterized in that the means for opening the laminated paper packaging system comprises an actuating member acting on a frame-like member disposed on the laminated paper packaging system A lever system within that breaks the laminated paper packaging system when acted upon by the actuator. 5. A connector device according to claim 4, characterized in that the actuator protrudes from the connector device in a direction towards the laminated paper packaging system. 6. A connector device according to claim 1, characterized in that the device adapted to be mounted on the enteral infusion set comprises a rigid tubular member for connecting a supply line of the enteral infusion set, the a tubular member comprising a portion of the channel for the composition to be infused; the means adapted to be mounted on the laminated paper packaging system comprising a spike for piercing the interior of the laminated paper packaging system; and A connection means for fixedly connecting the connector means to the laminated paper packaging system, the prongs comprising an extension of the portion of the channel contained within the tubular member, which enters the laminated paper packaging inside the system. 7. A connector device according to claim 6, wherein the connecting means for fixedly connecting the connector device to the laminated paper packaging system comprises a flange, the upper surface of which flange Towards the laminated paper packaging system, an adhesive layer is provided on the upper surface so that when the spike penetrates and the upper surface of the flange with the adhesive layer is pressed against the laminated paper packaging system , connecting the connector device to the laminated paper packaging system. 8. A connector device according to claim 6, wherein the connecting means for fixedly connecting the connector device to the laminated paper packaging system comprises two flanges, the two flanges Extending parallel around the spike and axially spaced from each other at a predetermined distance, the flange located closer to the tip of the spike is made of a flexible material and the flange positioned further from the tip of the spike is made of Made of rigid material. 9. A connector arrangement according to claim 6 or 8, wherein the spike is slotted along part of its length. 10. A connector arrangement according to any one of claims 1 to 9, characterized in that the connector arrangement further comprises a vent means. 11. A connector device according to claim 10, wherein the venting means includes a valve mechanism which allows air to enter through the valve mechanism while preventing egress of the composition to be infused. 12. A connector device according to claim 10, characterized in that the connector device further comprises a sight tube, one end of which is connected to the channel for the composition to be infused, And the other end of the sight tube is connected with a venting device, and the venting device includes an air inlet and a spike arranged to penetrate a predetermined depth inside the laminate packaging system. 13. A prefabricated enteral infusion system comprising an enteral infusion set and a connector device non-detachably connected to the enteral infusion set, wherein the connector device is any of the preceding claims A connector device as described in one item. 14. A prefabricated enteral infusion system according to claim 13, further comprising a pump unit disposed in the supply line of the enteral infusion set. 15. A prefabricated enteral administration system according to claim 13, further comprising a transparent intermediate pouch for containing the quantity of composition contained in the laminated paper packaging system. 16. A prefabricated enteral infusion system according to any one of claims 13 to 15, further comprising a dosing device for controlling the rate of infusion of the composition to the patient. 17. An enteral infusion kit comprising an enteral infusion set, a connector device according to any one of claims 1 to 12, and a layer containing a composition to be infused enterally into a patient Pressed paper packaging system. 18. An enteral administration kit comprising a prefabricated enteral administration system according to any one of claims 13 to 16, and a laminated paper packaging system containing a composition to be enterally infused into a patient.

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