WO2000002618A1

WO2000002618A1 - A system for administration of infusion and irrigation liquids and a device incorporated in the system

Info

Publication number: WO2000002618A1
Application number: PCT/SE1999/001152
Authority: WO
Inventors: Clas Wallenborg; Martin Tillander
Original assignee: Pharmadule Ab
Priority date: 1998-07-07
Filing date: 1999-06-24
Publication date: 2000-01-20
Also published as: SE9802338D0; SE9802338L; AU4945599A

Abstract

The invention relates to an administration system for administering infusion solutions and irrigation liquids. The system includes a closed container that contains infusion liquid or irrigation liquid, and an administration set having an inlet end for connection to the container and an outlet end for connection to a syringe. The system includes an adapter (33) which is designed for connection between the closed container (1; 4) and the inlet end (14) of the set (13). The invention also relates to a device included in said system.

Description

A SYSTEM FOR ADMINISTRATION OF INFUSION AND IRRIGATION LIQUIDS AND A DEVICE INCORPORATED IN THE SYSTEM.

Technical field of the invention The present invention relates to a system for administrating infusion solutions and irrigation liquids. The system includes a closed infusion solution or irrigation liquid container and an infusion set that has an inlet end for connection to the container and an outlet end for connection to a syringe or hypodermic needle. The invention also relates to a device included in said administration system.

Background of the invention

There is a great need for ways in which different types of infusion solutions and irrigation liquids, such as for instance such solutions as sodium chloride solutions, nutrient solutions or solutions that contain different pharmaceuticals can be administered to patients both safely and inexpensively. High demands are placed on the equipment used for these purposes. The equipment is of a disposable kind, i.e. intended for single use only, and is required to be sterile, reliable, functional, and user-friendly. Particular demands are also placed on the material from which the various parts of the equipment are made. A very large number of disposable units are used for the above said purposes. It is important that these units can be produced and handled in the most cost-effective manner possible.

Such an infusion solution or irrigation liquid administrating system will normally consist of two separately packaged units, namely a closed container that contains an infusion solution or an irrigation liquid, and a so-called infusion set or administration unit, which is intended for connection to both the solution container and also to the syringe or irrigation cannula and the patient. A large number of separate types of solution containers and administration sets that shall be mutually combined when used are available commercially at present. The infusion solution and irrigation liquid container may have the form of a shape permanent glass or plastic bottle or flask, although it is now more usual to pre-pack infusion solutions in different types of collapsible containers, such as collapsible plastics containers. The collapsible plastic containers are more advantageous, since they are transparent, relatively light in weight, and require relatively small storage space when empty. The flexibility, or suppleness, of the containers also affords the advantage that the infusion set coacting with the container does not need to be vented. Some containers are provided with special injection ports that include a pierceable membrane of another material, such as natural rubber material for instance. Other containers are produced in one piece from one and the same plastic material, such as from polypropylene, polyethylene or PVC plastic for instance.

As mentioned above, the infusion and irrigation set are intended for connection to a solution-containing container, by piercing the container with an insertion spike provided on the set. An infusion set may consist mainly of the insertion spike, which may be connected, either directly or via a hose, to a drip tube that opens into a drip chamber which is provided on its bottom with a liquid filter, a hose whose one end is connected to the bottom of the drip chamber, a flow regulator provided on the hose, and a Luer lock fitting connected to the other end of said hose and intended for connection to a syringe or hypodemic needle.

Corresponding irrigation liquid sets of simpler design and lacking a drip chamber are used when irrigating body cavities and in surgical operations.

The different parts of the infusion liquid and irrigation liquid sets are designed to fulfil international standards or national pharmacopoeia in certain countries, or other binding national regulations. Thus, the sets may have different respective designs, depending on current local regulations. The products of different manufacturers will therefore differ with respect to certain significant details, partly because of the aforesaid specific national regulations, but also because of production/technical reasons and other reasons. For instance, the insertion spikes of different sets may be made of mutually different materials, such as different plastic materials or different metals, for instance steel. The configuration and properties of the insertion spike will therefore vary, inter alia due to the use of different materials in the spikes.

In some cases, problems can arise when an administration set shall be connected to a one-piece container that does not include a special injection port with a pierceable rubber membrane. Difficulties can arise when endeavouring to pierce an insertion spike, for instance a metal spike, into the wall of the container. This problem may arise because the spike material from which the insertion spike is made and/or because the spike design is not compatible with the material used in the penetration or piercing surface in the container and/or with the design of said surface. Insufficient friction between the components may result in leakage and loosening of the spike from the container. Another drawback is that after applying the infusion set, a pharmaceutical cannot be added safely to the infusion solution when the container lacks an injection port with a piercable rubber membrane. In some cases, for instance when a steel spike penetrates a plastic container without a piercable rubber membrane, the inlet orifice of the spike may become clogged with material that is cut loose from the penetration surface and then accompanies the flow of liquid into said orifice. The material may be clogged in the orifice or may accompany the flow of liquid into the set.

Summary of the inventive concept

The object of the present invention is to provide a system of the aforedescribed kind that will enable different administration sets to be combined and safely connected to solution containers without piercable rubber membranes, and also to enable, e.g., pharmaceuticals to be added simply and safely to the infusion solution in said container.

This object is achieved in accordance with the invention by connecting to the closed container an adapter to which the inlet end of the administration set and/or a pharmaceutical administering cannula can be connected in a manner which provides a tight and safe connection between the system components. According to one preferred embodiment of the invention, the adapter includes an inner transit passageway which opens at one end into an adapter spike designed to penetrate the closed container. According to another preferred embodiment, the adapter transit passageway opens at its other end into an adapter port that includes a piercable membrane intended for penetration by an insertion spike or cannula.

Brief description of the drawings

The invention will now be described in more detail with reference to the accompanying drawings, in which

Figures 1a-1b illustrate by way of example two different containers for infusion liquid or irrigation liquid;

Figure 2 illustrates schematically an administration set chosen by way of example;

Figures 3a-3b illustrate a first embodiment of an adapter according to the invention and show the adapter in two different states; Figures 4a-4b illustrate a second embodiment of an inventive adapter in a manner corresponding to the manner in Figures 3a-3b;

Figures 5a-5b illustrate a third embodiment of an inventive adapter in a manner corresponding to the manner in Figures 3a-3b; and

Figure 6 illustrates schematically a system according to the invention.

Detailed description of preferred embodiments of the invention

Shown in Figure 1a is a first exemplifying embodiment of an infusion liquid or irrigation liquid container 1 made of soft plastic material, such as polypropylene. The container 1 includes a perforated suspension tab 7 on one side and a connecting pipe 5 on its other side. The connecting pipe 5 forms an opening through the container wall and is closed by means of a snap-off closure means 3, i.e. a closure means that is snapped-off when the container shall be used. When connecting-up the container, an insertion spike or cannula is inserted into the pipe 5, which is now open. Another container (not shown) comprises an inlet pipe which is permanently sealed subsequent to filling the container with the solution concerned, and a connecting pipe which is closed by means of a twist-off closure means. The connection pipe is also provided with an internal closure means formed by of a membrane which is pierceable by an insertion spike or cannula when the external closure means has been twisted off. Another largely used type of solution container (not shown) is a flask-like polyethylene container of a one- piece structure and which, after being filled with the solution concerned, is closed and sealed in the neck of the bottle.

Figure 1b illustrates another example of a solution-filled transparent container 4 made of soft plastic material, preferably polypropylene or polyethylene. The container includes an inlet pipe 6 which is permanently closed after filling the container with the solution 2 concerned, and also includes a perforated suspension tab 8 adjacent to the inlet pipe 6, said suspension tab being used to hang the container from a stand or the like placed adjacent the patient. The opposite side of the container has a connection part 10 projecting out from the container. The bottom surface of the connection part forms an insertion area 12 having one or more injection weakenings. The container is blow-moulded to form a closed container. The container is filled by first cutting the inlet pipe 6 so as to obtain a filling opening, and thereafter the container is filled and the inlet pipe is sealed. The sealed container is then packaged. Figure 2 shows an infusion set which is intended for connection to an infusion solution container, for instance a container of the type shown in Figure 1. The inlet end of the infusion set has a spike or piercing device 14 with one or more inlet openings 16 which connect said spike with the surroundings through an inner throughflow passageway or transit passageway (not shown). The outer end of the spike 14 is designed to readily pierce or penetrate the various rubber or plastic materials in an infusion solution container. The spike may be produced from different plastic or metal materials. The spike is protected by a removable cap 18, which ensures that the inner part of the set will remain sterile when handling the unit. The transit passageway of the spike 14 is connected, either directly or via an intermediate hose, to a drip tube 20 which extends to and opens out into a drip chamber 22. It is preferred that a liquid filter 24 is provided on the bottom of the drip chamber 22. A flexible and transparent hose 26 is connected to the drip chamber 22. The hose 26 preferably has a length greater than 1.5 m and carries a flow regulator 28. The flow regulator is constructed to enable the drip rate to be adjusted or to enable the flow to be cut off completely. The outlet end of the hose 26 is connected to a standard Luer lock fitting 30, which is protected by a removable cap 32. The protective cap 32 ensures the inner sterility of the Luer lock fitting and the set during handling.

Figures 3-5 illustrate three different exemplifying embodiments of inventive adapters. As will be described in more detail below with reference to Figure 6, one part of the adapter, i.e. the spiked end thereof, is intended to penetrate or pierce the solution container, and the other part of the adapter, i.e. the adapter port, is intended to be penetrated by the spiked member of the administration set or by some other type of cannula or needle means. The adapter is manufactured, sterilised and packaged as a separate unit and can thus be used as a separate unit when a particular need arises, as described above.

The adapter may alternatively be one-sided, although this is not clearly apparent from the Figures. Similar to the aforedescribed double-sided adapter, the single-sided adapter includes a spiked portion in one end of the adapter. The other part of the adapter is open and lacks the adapter port of the double-sided adapter, i.e. lacks a pierceable member and surrounding sleeve. The one-sided adapter is intended for use as an emptying adapter, by inserting the spike of the adapter into a closed container filled with infusion solution or irrigation liquid and enabling the container to be emptied of its contents through the outwardly open transit passageway in the adapter. Figures 3a-3b illustrate an embodiment of an inventive adapter. Figure 3a shows the adapter sterile packaged while Figure 3b shows the adapter in a prepared state for connection to a solution container and administration set (or some other cannula or needle means). Although not shown, the adapter includes a transit passageway which extends from the adapter spike 34 to the adapter port 36. The spike 34 of the adapter is solid and tapered at its outer end 37 to facilitate effective penetration of the connection area in the solution container. In the embodiment of Figure 3, there is provided slightly inwards of the adapter spike 34 end an inlet opening 38 which connects the surroundings of the spike with the transit passageway. The adapter spike 34 may conveniently be made of a plastic material, such as polycarbonate or ABS plastic for instance, although the use of other materials is possible within the scope of the invention. Figure 3a shows how the adapter spike 34 and the transit passageway are protected by a removable cap 35 during handling of the adapter.

The second part of the adapter, the adapter port 36, includes a flared extension of the adapter spike, through which the transit passageway extends and the orifice of which is covered by a pierceable membrane 40 made of some suitable material, for instance rubber. The orifice and the membrane 40 are embraced by a metal sleeve 38' which holds the membrane and which is provided with a central penetrating opening 41 (see Figure 3b). Figure 3a shows how the membrane is protected by a removable cover 42, which is joined to the metal sleeve by means of thin connections that break when endeavouring to loosen the cover. The cover 42 cannot therefore be replaced, which is an additional safeguard for the user who is ensured of the sterility of the membrane when the cover has not been removed.

The adapter shown in Figures 4a-4b differs from the adapter of Figures 3a- 3b in that the adapter spike 44 includes a number of narrow, elongated inlet openings 46 disposed symmetrically around the spike slightly inwards the spike end. The other part 48 and the adapter spike 44 form a unit made of plastic material, for instance acrylic plastic or ABS plastic. Similar to the embodiment shown in Figures 3a-3b, a rubber membrane 50 is enclosed in the end part 48 forming an adapter port 49 which coacts effectively with an insertion spike or cannula or some other needle means. The adapter spike and its transit passageway are protected by a cap 45 and a removable bonnet 52 on the adapter port 49. The bonnet 52 is deformed as it is released, so that it cannot be replaced on the end part 48. The user will thus be assured that the membrane is sterile. In the embodiment according to Figures 5a-5b, the bonnet 52 of the Figure

4a embodiment has been replaced with a breakable hat 54. The hat 54 is made of the same material as the adapter spike 56 and the end part 53, and is easily breakable from the end part by virtue of weakenings provided in the wall to this end. As with the earlier embodiments, the protective hat cannot be replaced in its sterility safeguarding position. Similar to the embodiment according to Figures 4a- 4b, a rubber membrane 60 is arranged in the end part 53. In this embodiment, the adapter spike 56 is fully tubular and tapered by cutting obliquely the tubular wall and is protected by a cap 55. In this embodiment, the inlet opening 58 is open in the penetrating direction. The adapter spike may also be tapered by cutting each side of the tubular wall obliquely forming a spike centrally in the tube. In a further embodiment (not shown) of the inventive adapter, the other part of the adapter, the adapter port, is provided with a sterility protector in the form of a protective foil, for instance aluminium foil. The protective foil is fastened to the adapter port in some suitable manner, for instance glued thereto, so as to protect the rubber membrane. For instance, the aforesaid one-sided adapter (not shown) may be provided with a removable protective bonnet or hat, similar to the adapter according to Figures 4a-4b or Figures 5a-5b, or a protective foil. As mentioned above, however, the one-sided adapter does not include the membrane 50 or 60.

Figure 6 shows the connection of an inventive adapter 33 between a solution container 4 of the kind shown in Figure 1 and an administration set 13, for instance of the kind shown in Figure 2. After having removed the cap 18 (see Figure 2) from the sterile insertion spike 14 of the administration set 13, the insertion spike 14 is inserted through the adapter membrane, after having removed its protective covering. The insertion area 12 of the solution container is then pierced by the adapter spike 34, subsequent to having removed its protective cap. In the case of a solution container 1 according to Figure 1a, the adapter spike is inserted into the connecting tube 5 instead, after having broken off its closure means 3. In this case, the connector tube 5 may be completely open or may be provided with an inner membrane which is penetrated by the adapter spike upon insertion. When required, a further adapter (not shown in Figure 6) may be connected to the solution container parallel with the adapter 33 shown in Figure 6. The parallel adapter can be used to supply a pharmaceutical, medicament or some other substance to the solution 2 in the container 4, through the adapter port. The inventive adapter can be applied to the container solely to enable a pharmaceutical, medicament or some other solution to be added, whereas the administration set is connected in parallel directly via the insertion spike of the set. The adapter membrane is made of a material having resilient properties and the elasticity of which is such as to prevent the membrane from being torn by the insertion spike of the infusion set. This will ensure that an effective seal is obtained and that the frictional forces generated will be sufficient to retain the insertion spike, this effect being independent of the configuration of the insertion spike and the material from which it is made. An administration set that has been connected to a solution container with the aid of an intermediate adapter, can be released from a completely or partially filled container without leakage of remaining solution from the container.

The adapter spike includes an outer spike which effectively penetrates an insertion area in a solution container in a manner to obtain satisfactory tightness at the penetration opening. The material from which the adapter spike is made generates in the penetration cut a frictional force that is sufficient to ensure that the adapter spike will be held firmly in the insertion area of the container.

The particular design of the adapter and its properties enable practically all existing administration sets to be connected to infusion solution containers in a very simple and cost-effective manner. The adapter also enables a pharmaceutical to be supplied to the infusion solution and enables the solution container to be fully emptied or partially emptied whenever the need arises.

It will be understood that the described and illustrated embodiments of the invention have solely been given by way of example and that the invention can be varied in many ways within the scope of the following claims. For instance, each of the illustrated and described adapter spikes can be combined with all of the described adapter ports within the scope of the invention.

Claims

1. An administration system for infusion solutions and irrigation liquids, comprising a closed container (1 ; 4) containing infusion or irrigation liquid (2), and an administration set (13) whose inlet end (14) is intended for connection to the container (4) and whose outlet end (30) is intended for connection to a syringe, characterised in that the system includes an adapter (33) which is adapted for connection between the closed container (4) and the inlet end (14) of the administration set (13).

2. A system according to claim 1 , characterised in that the adapter (33) includes an inner transit passageway which opens at one end into a spiked part (34; 44; 56) of the adapter, said spiked part being adapted to penetrate the closed container (1 ; 4).

3. A system according to claim 2, characterised in that the other end of the adapter transit passageway opens into an adapter port (35; 49; 59) that includes a pierceable membrane (40; 50; 60).

4. A system according to claim 3, characterised in that one end of the transit passageway opens into one or more inlet openings (38; 46) disposed in the side of the adapter spike (34; 44) slightly inwards from its outer end (37).

5. A system according to claim 4, characterised in that the outer end (37) of the adapter spike is solid and tapered.

6. A system according to claim 3, characterised in that the adapter spike (56) is tubular and cut obliquely at its outer part.

7. A system according to any one of claims 3-6, characterised in that the membrane (40; 50; 60) is a rubber membrane.

8. A system according to any one of claims 3-7, characterised in that the membrane (40; 50; 60) is protected from the surroundings by a removable sterility safeguarding element (42; 52; 54) which is deformed when being removed to expose the membrane.

9. A system according to any one of the preceding claims, characterised in that the system includes a further adapter (33) which is connected to the closed container (1 ; 4) and intended to be penetrated by a cannula in order to deliver an additional solution, such as a pharmaceutical solution.

10. A device included in a system for administering infusion solutions and irrigation liquids, characterised in that said device forms an adapter (33) which has a first part for connection to a closed container (1 ; 4) that contains infusion liquid or irrigation liquid (2), and a second part for connection to an inlet end (14) of an administration set (13) and/or a cannula for delivering solution to the container (1 ; 4).

11. A device according to claim 10, characterised in that said device includes an inner transit passageway whose one end opens into an adapter spike (34; 44;

56) which is adapted to penetrate the closed container (1 ; 4).

12. A device according to claim 11 , characterised in that the other end of the adapter transit passageway opens into an adapter port (36; 49; 59) that includes a pierceable membrane (40; 50; 60).

13. A device according to claim 12, characterised in that one end of the transit passageway opens into one or more inlet openings (38; 46) disposed in the side of the adapter spike (34; 44) slightly inwards from its outer end (37).

14. A device according to claim 13, characterised in that the outer part (35) of the adapter spike is solid and tapered.

15. A device according to claim 12, characterised in that the adapter spike (56) is tubular and cut obliquely at its outer part.

16. A device according to any one of claims 11-15, characterised in that the membrane (40; 50; 60) is a rubber membrane.

17. A device according to any one of claims 11-16, characterised in that the membrane is protected against the surroundings by a releasable sterility safeguarding element (42; 52; 54) which is deformed as it is removed to expose the membrane.

18. A device for connection to a container that contains infusion solution or irrigation liquid, characterised in that the device is a container emptying adapter having an inner transit passageway whose one end opens into an adapter spike adapted to penetrate the closed container (1 ; 4).

19. A device according to claim 18, characterised in that the other end of the transit passageway of said emptying adapter is opened to a removable sterility safeguarding element.