IMPROVED BAG FOR INFUSIONS

Abstract: Bag (10) for infusion having two inlets/outlets (20, 40), said inlets/outlets (20, 40) being arranged at a minimum distance from each other and from the liquid filled part of the bag for infusion. This makes possible safe and convenient handling. Preferably one of said inlets/outlets comprises a membrane, penetrable with a cannula, and the other inlet/outlet comprises a threaded coupling (50) and a mechanical valve.

Description: IMPROVED BAG FOR INFUSIONS The present invention concerns an improved bag for infusions and in particular a bag for infusion, said bag being suitable for the admixture of intravenously administered pharmaceuticals. The background of the invention Bags for infusion, containing a non-therapeutical liquid, for example saline (9 mg per ml NaCl) or glucose (50 mg per ml) are routinely used for the administration of pharmaceuticals. A hospitalised patient is given a bag for infusion, connected via a cannula to suitable vein, mostly a vein on the back of the hand. Pharmaceuticals to be administered intravenously to the patient can then be injected in the bag for infusion. In many cases the pharmaceutical is prepared in the hospital pharmacy or at the ward by medical personnel, by injecting the pharmaceutical in the bag for infusion. US-A-5,053,012 provides an example of this: in the general context of the document, which relates to an apparatus for pressurising infusion bags (and thus only indirectly with infusion bags as such), a conventional infusion bag 12 is shown in Fig 1, fitted with an outlet port 16 adapted to be punctured by a coupler 18 of a recipient set. The bag 12 is furthermore fitted with an injection port 28 for the purpose of injecting a drug into the liquid in the bag to be administered. Another example is provided in DE-A-3, 244,151: it discloses a medical storage bag made of a flexible plastic material which has at least one outlet nozzle sealed with a mem- brane. The outlet nozzle has an adapter piece with an annular bead on the internal surface, which permits use of differently dimensioned connecting needles of infusion devices without having to use excessive force to penetrate the membrane. However, when handling very potent pharmaceuticals, such as cytostatic agents for the treatment of cancer, the preparation of the bag for infusion is performed under rigorous security precautions. When preparing doses where the active substance is stored in freeze-dried form, part of the content is transferred from the bag for infusion to the pharmaceutical vial and returned to the bag. For the handling of such vials, a transfer adapter has been developed, which includes a special two-way cannula or needle having a protective cylinder, said cylinder being of a diameter adapted to the cap of the vial. Commercially available bags for infusion can be divided in three main categories: soft bags, semi-rigid and rigid bags. Soft bags are manufactured of poly vinyl chloride PVC, semi-rigid bags are manufactured of one or a mixture of the polymer materials polyacetate (PA), polypropylene (PP) and polyethylene (PE) and the rigid, almost bottle-like containers are manufactured of one of the above polymer materials PA, PP and PE. In accordance with the aim of eliminating the use of PVC-containing plastics, the use of semi-rigid bags is increasing. These also have other benefits, such as better barrier proper- ties and less transport of chemicals, for instance softeners, from the bag material to its contents. This is an important consideration, especially in long term treatment of chronically ill patients. The use of semi-rigid bags has however some drawbacks: the commonly used transfer adapters can not be used, because they are blocked by the liquid containing part of the bag, which entail an increased risk for the medical personnel of coming in contact with potent and possibly toxic pharmaceuticals or being harmed by the sharp end of the cannula. Consequently there exists a need for new infusion bag constructions, making possible a more safe and convenient handling. Summary of the invention The new bag for infusion according to the attached claims eliminates the above drawbacks. Short description of the drawings The invention will be described in closer detail below, with reference to the enclosed drawings, in which Fig. 1 shows a bag for infusion according to the present invention, Fig. 2 is a side view of the bag in Fig. 1, Fig. 3 is detailed cross-sectional view of the first inlet/outlet of the bag in Fig. 1, Fig. 4 is detailed cross-sectional view of the second inlet/outlet of the bag in Fig. 1, Fig. 5 shows, in perspective view, the different components; vial, transfer adapter and bag according to the present invention. Description of the invention A normal bag for infusion comprises a liquid filled cavity of a certain, suitable volume. This volume is generally in the interval of one hundred to one thousand millilitres. The bag further comprises means for suspension, for example a loop arranged in the bag material, above and outside the liquid filled area. Finally, a bag for infusion comprises one or more inlets/outlets for the addition and/or withdrawal of liquid. Said inlets/outlets comprise, according to the prior art, at least one membrane suitable to be penetrated with a cannula. The other inlet/outlet, if altogether present, can be a cou- pling such as a threaded coupling or a bayonet mount for the attachment of a syringe or tubing. With reference to Fig. 1 and 2, an infusion bag 10 according to one embodiment of the present invention has two inlets/outlets 20, 40 for the addition and/or withdrawal of liquid. The first inlet/outlet 20, shown in more detail in Fig. 3, comprises a membrane 30, and the second inlet/outlet 40, shown in more detail in Fig. 4, comprises a mechanical valve 50. The valve 50 opens when a syringe 100 is inserted, as illustrated in Fig. 5, and closes when said syringe 100 is removed, and the membrane 30 has a removable seal 60, adapted to be combined with both a needle and an infusion apparatus, and said membrane being enclosed in a casing 70, adapted to fit in a transfer adapter 90. Importantly, this first and second inlet/outlet 20, 40 are extended from the liquid filled part of the bag 10 for infusion in order to avoid hindering the normal use of a transfer adapter 90. Additionally, the first and second inlet/outlet 20, 40 are arranged at a distance from each other, said distance allowing convenient access to the inlets/outlets 20, 40. Preferably, one of these two inlets/outlets 20 comprises a penetrable membrane 30, preferably enclosed in a Tulip -type membrane holder or port, adapted for use with a so- called transfer adapter 90. The other inlet/outlet 40 comprises, according to one embodiment of the invention, a coupling with an outer thread, preferably the male part of a so-called Luer ® -lock. Further, according to the present invention, said inlet/outlet 40 comprising the coupling preferably comprises a valve 50 which, under mechanical influence, allows the transport of fluid in or out of the bag 10 for infusion. One example of such valve is an elastic plug 80, arranged in narrowing of the inlet/outlet 40, reachable with the tip of a syringe 100 when said syringe is locked to the threaded coupling. The tip of the syringe 100 compresses the elastic plug 80 and thereby the inlet/outlet 40 is held open. As stated above, it is an important characteristic of the present invention is that these two inlets/outlets 20, 40 are at a suitable distance from each other. Preferably they are placed at least 40 millimetres from the liquid filled part of the bag 10 for infusion. Further the centreline of each two inlets/outlets 20, 40 run parallel at the distance of at least 35 mm.

Claims: Claims 1. Bag (10) for infusion having two inlets/outlets (20, 40) for the addition and/or withdrawal of liquid, characterized in that a first inlet/outlet (20) comprises a membrane (30) and a second inlet/outlet (40) comprises a mechanic valve (50), said valve (50) opening when a syringe (100) is inserted and closing when said syringe (100) is removed, said membrane (30) having a removable seal (60), adapted to be combined with both a needle and an infusion apparatus, and said membrane being enclosed in a casing (70), adapted to fit in a transfer adapter (90). 2. Bag (10) for infusion according to claim 1, characterized in that said first and second inlet/outlet (20, 40) extend at least 40 mm from the liquid filled part of the bag (10) for infusion. 3. Bag (10) for infusion according to claim 1, characterized in that the centre lines of said first and second inlet/outlet (20, 40) run parallel at the distance of at least 35 mm. 4. Bag (10) for infusion according to any one of claim 1-3, characterized in that said bag is a bag manufactured of any one of the polymer materials PA, PP and PE or a mixture thereof, and having a volume less than or equal to 100 ml.

Inventors: LINDSTROEM STEFAN, LINDSTROEM, STEFAN
Applicants: LINDSTROEM STEFAN, PHARMALINK AB, LINDSTROEM, STEFAN
Application year: 1999
Main classification: A61J5
IPC codes: A61J1