Infusion bag and infusion system

#The present invention relates to an infusion bag in accordance with the preamble of claim 1, and an infusion system in accordance with the preamble of claim 10. Particularly, the invention relates to an infusion bag and an infusion system exhibiting a high degree of imperviousness against leakage when supplying medically effective substances to the infusion bag

#Infusion bags are utilized for intravenous delivery of fluids and medically effective substances to human beings or animals. For this reason, the infusion bag is provided with at least one outlet channel through which fluid can flow to a connecting device such as, for example, a cannula. When preparing the fluids which are to be administrated to the body from the infusion bag, it is common that medically effective substances are supplied to a pre-sealed infusion bag which is filled with a transport fluid, usually in the form of sodium chloride solution or a glucose solution. In certain cases, medically effective substances are harmful to other persons than the patient who has been prescribed predetermined doses as a result of an indication of a specific disease. This is particularly the case when long-term exposure is concerned, which can happen to medical staff when handling and preparing drugs for an extended period of time. For example, this is the case when preparing infusion bags containing cytotoxins, antibiotics and antiviral drugs. For this reason, there are special directions requiring preparation in safety cabinets and use of personal protective equipment, which implies that handling cannot take place without using these protective measures and devices. As a rule, the preparation is performed by means of injecting the medically effective substance through a membrane arranged in connection with an inlet channel arranged through the wall of the infusion bag. When performing this type of injection, leakage often occurs when the penetrating needle is withdrawn after having penetrated the membrane. Since the penetrating needle is often coarse, a major leakage may occur. A droplet of medically effective substance will be transported from the tip of the cannula 5 to the area surrounding the perforation in the membrane, at which leakage occurs.

#Accordingly, it is an object of the present invention to reduce the risk of exposure to medically effective substances when preparing infusion bags. A second object is to provide infusion bags which enable the preparation to take place in any optional location without any leakage occurring, something which reduces staff resources needed for the preparation, reduces the preparation time; and also can provide treatment advantages and reduce the need of personal protective equipment and special peripheral equipment in the form of safety cabinets. The above-mentioned objects are achieved by means of an infusion bag according to the characterising portion of claim 1 and an infusion system according to the characterising portion of claim 8, by means of the infusion bag being provided with an inlet channel, arranged in connection with an integrated communicating member having an opening where a first flexible membrane is arranged in said opening to be accessible to a second flexible membrane arranged on a connecting member, and wherein said communicating member exhibits means for holding said second flexible membrane with a pressure against said first membrane, so that droplet formation on the surface of the first membrane is prevented, wherein occurrence of leakage after injection is prevented.

#An embodiment of the invention will be described in greater detail with reference to the attached drawings, in which:

#FIG. 1 shows a side view of an infusion bag.

#FIG. 2a shows a first embodiment of a communicating member, and

#FIG. 1 shows a side view of an infusion bag which is generally denoted with 1. The infusion bag 1 exhibits an internal space 2 which is surrounded by walls 3 of a preferably flexible material. According to one embodiment of the invention which is shown in FIG. 1, a front wall 3a is connected to a back wall 3b along two opposite side edges 4, 5, an upper edge 6 and a lower edge 7. The connection can be accomplished by means of welding or, alternatively, gluing. In this manner, the internal space 2 is formed between the joined edges 4-7. However, the invention is not limited to a special design of an infusion bag, but it can be manufactured in any way which is well-known to the skilled person. An outlet channel 8 and an inlet channel 9 are arranged through a wall of the bag 1. Preferably, said channels are arranged in connection with the lower edge 7 of the bag, which preferably is reinforced along the lower edge 7 in order to give stability to the outlet channel 8 and the inlet channel 9. In one embodiment of the invention, this has been achieved by means of a tube 10 which has been inserted and fixed between the front wall 3a and the back wall 3b to form an outlet channel 8. When mounted, the tube already can be provided with means for sealing the channel until use. These sealing means can be of any type well-known to the skilled person; alternatively the tube 10 can be sealed after having been mounted.

#Furthermore, the inlet channel 9 has been formed inside a communicating member 11. The communicating member is integrated with the walls of the infusion bag. This means that the communicating member is permanently fixed to the walls, either by means of the communicating member being integral with the walls, or the communicating member having been fixed by means of welding, gluing, or another permanent joint. The communicating member 11 exhibits an opening 12 through which a first flexible membrane 13 is arranged in an accessible way, wherein a second flexible membrane 50 arranged on a connecting member can be pressed against the first flexible membrane 13 forms a seal which prevents liquid from passing from the interior of the infusion bag to the environment. Furthermore, the communicating member 11 comprises means for holding said second flexible membrane 50 with a pressure against said first membrane 13. These means for holding can be constituted of, for example, a snap locking means having a resilient finger which engages a recess. The finger or the recess can be arranged on the communicating member, alternatively, the finger as well as the recess can be arranged on both the communicating member and the connecting member. In a preferred embodiment, which is shown in FIG. 3 (3a, 3b, 3c), these fingers surround said opening 12 and are aligned along the axis of symmetry of the opening. According to a preferred embodiment, said holding means comprise first guiding members 14 which are intended to interact with corresponding second guiding members 52 on said connecting member. Furthermore, said first guiding members exhibit a rest surface which forms an angle to a general plane of the axial extension of said opening, wherein said connecting member is intended to be transported along said axial extension in relation to the communicating member by means of rotation.

#FIGS. 2(2a, 2b) and 3 (3a, 3b, 3c) show alternative embodiments of the communicating member 11. In the embodiment shown in FIG. 2, the communicating member 11 is constituted by a substantially cylindrical body having an axial through-channel 9. The cylindrical body exhibits a first portion 16, which is intended to be permanently integrated with the walls of the infusion bag. Furthermore, the communicating member exhibits a second portion 17 which is intended to be connected to a connecting member 51. In a preferred embodiment, the diameter of the second portion 17 exceeds the diameter of the first portion, wherein a good sealing is achieved between walls and communicating member at the same time as the communicating member is easy to handle in relation to a connecting member. In the embodiment shown in FIG. 2, the first membrane is mounted superficially in connection with the first end surface 18 of the communicating member. The first membrane is fixed in the communicating member in a way well-known to the skilled person, for example by means of being fitted into a coaxially designed groove which is arranged in the channel 9. By means of this design, the communicating member is adapted to a connecting member 51 which is placed coaxially outside the communicating member.