Elastomeric infusion pump

Abstract

The invention relates to an elastomeric infusion pump (1; 101) and to an infusion pump assembly having such an infusion pump (1; 101). The infusion pump (1; 101) is designed and intended to convey a medicament, wherein the infusion pump (1; 101) has a core (6), which carries an elastomeric bladder (4), which in turn is designed and intended to receive and apply pressure to the medicament and displace the medicament. The bladder (4) has a tube (10) on the patient side and is connected to an inlet connection (8) of the infusion pump on the supply side. The supply-side inlet connection (8) is formed by a female coupling part or female coupling partner (female dry break) (18; 118; 218) of a closed transfer device (closed system transfer device (CSTD)). The female coupling part (18; 118; 218) has a main body (22; 122; 222) which carries a first elastomeric septum (26; 126; 222). The main body also has a holding device for preferably releasably holding a main body (34; 134) of a male coupling part (20; 120) or male coupling partner (male dry break) of the closed transfer device.

Description

[0001] Elastomeric infusion pump

[0002] Description

[0003] Technical field

[0004] The present disclosure relates to an elastomeric infusion pump for drug delivery.

[0005] Background of the Revelation

[0006] In medicine, liquid medications or drugs are administered via technically simple elastomeric infusion pumps that do not require any energy input during the delivery or infusion of the medication or drug.

[0007] State of the art

[0008] To prevent contact between individuals not undergoing treatment and unintentional contact between patients and hazardous drugs, Closed System Transfer Devices (CSTDs) are used in the (manufacturing and) administration of ready-to-use preparations. A key component of CSTDs are coupling systems that enable the safe transfer of hazardous drugs and, after disconnection, create a dry seal, known as dry breaks. This protects the surrounding area from contamination, for example, through leaks or droplets forming on the surface. The coupling system consists of two parts: a male coupling (male dry break) and a female coupling (female dry break). WO 2022 / 232405 A1 of the applicant and EP 2 463 201 B1, for example, depict such coupling systems.

[0009] Elastomeric infusion pumps are known from the prior art that do not require an electrical energy source, such as a pump motor or a syringe pump drive, during the delivery or infusion of the medication. Such pumps are BB2536P-WG-0004.

[0010] 2 / 20

[0011] Infusion pumps have a bladder into which the medication to be administered is filled via a preparation-side or supply-side inlet. The bladder expands elastically into a balloon-like state. This stores the energy required to release the medication over extended periods. A tube leading to the patient is connected to a patient-side outlet of the bladder, and this tube may be equipped with an adjustable flow restrictor. The patient-side end of the tube has a patient-side outlet port for the elastomeric infusion pump.

[0012] US Patent 8,523,815 B2, filed by the applicant, discloses such an elastomeric infusion pump. It has a supply-side inlet port (directly) on the bladder, through which the medication to be administered is filled into the bladder, and a patient-side outlet port, which is connected to the bladder outlet via tubing. Inside the bladder is a cylindrical core consisting of two parts that can be telescopically pushed into and pulled apart. This changes the length of the bladder. This offers advantages in the production of elastomeric infusion pumps of different sizes. For standardization purposes, the patient-side outlet port can be designed as a Luer-lock connector.

[0013] Under the trademark name Easypump II of the applicant, an elastomeric infusion pump is known which has Luer-Lock connections at both connections, i.e. at the patient-side output connection and at the supply-side input connection.

[0014] A disadvantage of such elastomeric infusion pumps is that the constant pressure exerted by the inflated bladder on the Luer-lock connectors inevitably leads to some leakage when connecting and disconnecting the pump to other components, resulting in the loss of some medication from the bladder or tubing to the patient. In particular, Luer-lock connectors are open cones that, after fluid transfer containing medication and subsequent disconnection, retain traces of the drug within the open cone. Depending on the medication used, this can pose a risk to people in the vicinity, such as hospital or pharmacy staff, or even to the patient.

[0015] Brief description of the Revelation

[0016] The purpose of the present disclosure is to create an elastomeric infusion pump that is universally applicable to pharmaceuticals, especially dangerous pharmaceuticals, without endangering medical personnel and patients.

[0017] In particular, the purpose of this disclosure is to provide an elastomeric infusion pump that prevents any leakage from the supply-side inlet port, even when the bladder is distended and the resulting constant pressure occurs during connection and disconnection of the infusion pump to and from other components. One such other component is, for example, a syringe. Leakage should be prevented, for example, when a connected syringe is disconnected from the supply-side inlet port after the expressed medication has distended the bladder. This leakage should also be prevented, for example, when a second medication is mixed with a first medication already present in the bladder, which has already distended the bladder, and a second syringe is connected for this purpose.

[0018] These tasks are solved with the combination of features of claim 1 and with the combination of features of claim 12.

[0019] The elastomeric infusion pump according to the disclosure is designed and configured for delivering a drug, wherein the infusion pump has a core that carries an elastomeric bladder, which in turn is designed and configured for receiving, pressurizing, and displacing the drug. The bladder has a tube on the patient side and is connected to a supply-side inlet port of the infusion pump. The supply-side inlet port is formed by a female coupling part or female coupling partner (female dry break) of a (systemically) closed system transfer device (CSTD). The female coupling part has a main body that carries a first elastomeric septum. The main body further has a retaining device for preferably releasably holding a main body of a male coupling part orThe male coupling partner (male dry break) of the closed transfer device ensures that even when the bladder is under tension and the resulting constant pressure is maintained during connection and disconnection of the infusion pump to and from other components, any leakage from the supply-side inlet port is prevented.

[0020] For this purpose, preferably the first septum can be pressed against a second elastomeric septum of the male coupling part, and afterwards the first septum can be penetrated by a hollow needle of the male coupling part.

[0021] In a particularly preferred embodiment of the disclosed infusion pump, the bladder is connected via tubing to a patient-side outlet port formed by a male dry break or a female dry break of a further (systemically) closed transfer device (CSTD). In the case of a female dry break, it may have a main body carrying a first elastomeric septum and a retaining device for preferably releasably holding a main body of a male dry break of the further closed transfer device. The further (systemically) closed transfer device eliminates the need to close and reopen a clamp attached to the tubing.

[0022] Preferably, the first septum, more often of the female coupling part, can be pressed against a second elastomeric septum, more often of the male coupling part, on the patient side. Subsequently, the septum of the female coupling part can preferably be penetrated by a hollow needle of the male coupling part. BB2536P-WG-0004

[0023] 5 / 20

[0024] The female coupling parts on both sides can be different adapters. This allows for modular retrofitting of existing elastomeric infusion pumps with different conventional connections on both sides (patient side and supply side).

[0025] The female coupling parts on both sides can be identical. Because of these identical parts, the infusion pump is simpler to manufacture, and its operation is also easier for medical personnel to learn, as the same steps are required on both sides (patient side and supply side).

[0026] To protect against contamination, the female coupling part or parts may each have a removable protective cap, which is preferably placed on and removable from the respective female coupling part.

[0027] In a technically simple further development of the infusion pump, the core has a fixed length and is preferably a single piece. Preferably, to protect the bladder, a sheath is attached to two opposing end sections of the core, surrounding the bladder.

[0028] To improve the kinking properties, it is preferred if the hose has a triangular inner cross-section and / or outer cross-section.

[0029] To protect the female coupling part on the supply side, it is preferred if it can be covered by a cap.

[0030] The end cap is preferably captive, connected to a retaining ring attached to the Kem by means of a swivel joint, the retaining ring surrounding the supply-side female coupling part.

[0031] In preferred embodiments, the female coupling part or the two (female) coupling parts are each formed by an adapter which, in the case of the supply-side female coupling part, has a Luer-lock connection on the bladder side and / or in the case of the patient-side coupling part, on the hose side. In this way, prior art infusion pumps with Luer-lock connections can be easily retrofitted in terms of both equipment and manufacturing by connecting such an adapter to one or both Luer-lock connections.

[0032] In a specific design of one or both adapters, a hexagon is formed on the outer circumference of the Luer-Lock connector.

[0033] However, it is also possible, according to the disclosure, for the female coupling part or the two (female) coupling parts to be formed directly on the pump side or hose side, without being parts or sections of an adapter. In other words, according to the disclosure, the provision of Luer-lock connections can also be completely dispensed with.

[0034] The infusion pump arrangement according to the disclosure comprises an elastomeric infusion pump designed and configured for delivering a drug. The elastomeric infusion pump has a core that carries an elastomeric bladder, which in turn is designed and configured for receiving, pressurizing, and displacing the drug. The bladder has a tube on the patient side and is connected to a supply-side coupling. The supply-side coupling is formed by a closed system transfer device (CSTD) comprising a female dry break and a male dry break. The female dry break has a main body that carries a first elastomeric septum and a retaining device for preferably releasably holding a main body of the male dry break.A second elastomeric septum of the male coupling part can be pressed against the first septum, or is pressed against it, and both septa are penetrable by a hollow needle of the male coupling part. Thus, even when the bladder is under tension and the resulting constant pressure is maintained during connection and disconnection of the coupling, any leakage is prevented. In a particularly preferred configuration of the infusion pump arrangement as disclosed, a patient-side coupling is connected to the tubing, which is also formed by a (systemically) closed transfer device (CSTD). The patient-side transfer device also has a female coupling part or coupling partner (female dry break) and a male coupling part or coupling partner (male dry break).The female coupling part also has a main body on the patient side, which carries a first elastomeric septum and has a retaining device for preferably releasably holding a main body of the male coupling part. A second elastomeric septum of the male coupling part can be pressed against the first septum or is pressed against it, and the two septa are penetrable by a hollow needle of the male coupling part or are penetrated by it. This eliminates the need to open and close a clamp attached to the tube.

[0035] In a specific embodiment of the closed transfer device or the two closed transfer devices, a carrier or slide is bidirectionally movable between a contact position and a passage position in the (respective) male coupling part. The second septum is held on the carrier, and the female coupling part can be fixed (clipped on). In the contact position (of the carrier), the two septa are in contact with each other and are away from the hollow needle. In the passage position of the carrier, the two adjacent septa are penetrated by the hollow needle.

[0036] To increase operational safety, at least one indicator can be integrally formed on the carrier, which is visible through a first locking window of the male coupling part in the insertion position. Furthermore, the indicator can also be visible through a second locking window of the male coupling part in the passage position.

[0037] A method for starting an infusion with an infusion pump arrangement according to the preferred embodiment with the bilateral closed transfer devices is further disclosed. This method comprises the steps:

[0038] - Filling the bladder with the medication,

[0039] - Preferably disinfect the two coupling parts of the patient-side closed transfer device,

[0040] - Position the two patient-side septa and press them against each other,

[0041] - Starting the infusion by penetrating both patient-side septa with the hollow needle of the patient-side coupling part.

[0042] The applicant reserves the right to claim this method. This method has the advantage that the locking clamp, which is often arranged on the tubing of prior art elastomeric infusion pumps, can be omitted. It also follows that the steps of opening and closing the clamp can be eliminated.

[0043] If the procedure uses the further development of the infusion pump, whose two closed transfer devices can assume the insertion position and the passage position, then the procedure results in the following: the pressing of the two patient-side septa against each other is achieved by pressing the two main bodies of the patient-side closed transfer device in the insertion position, and the penetration of the two patient-side septa by the patient-side hollow needle is achieved by pressing the two main bodies together in the insertion position.

[0044] Brief description of the characters

[0045] Figure 1 is an elastomeric infusion pump according to a first embodiment of the present disclosure;

[0046] Figure 2 is an elastomeric infusion pump according to a second embodiment of the present disclosure;

[0047] Figure 3 is a view and a cutaway representation of a female coupling part of the elastomeric infusion pump from Figure 1; Figure 4 is a view and a cutaway representation of a male coupling part with which the elastomeric infusion pump from Figure 1 is further developed into an infusion pump arrangement according to a first embodiment of the present disclosure;

[0048] Figure 5 is a perspective view of a female coupling part of the elastomeric infusion pump from Figure 2;

[0049] Figure 6 is a perspective view of a male coupling part with which the elastomeric infusion pump from Figure 2 is further developed into an infusion pump arrangement according to a second embodiment of the present disclosure;

[0050] Figure 7 is a translucent representation of a variant female coupling part for use on the infusion pump from Figure 2; and

[0051] Figure 8 is a cutaway view of the female coupling part from Figure 7.

[0052] Description of the implementation examples

[0053] Below, various embodiments of the present disclosure are described on the basis of the accompanying figures.

[0054] Figure 1 shows an elastomeric infusion pump 1 according to a first embodiment of the present disclosure. In a design known per se from the prior art, the infusion pump 1 has a casing 2 in which a bladder 4 is protected and attached to end sections of a core 6 (located on the left and right in Figure 1). The length of the core 6 is fixed. Therefore, the size of the bladder 4 is also fixed in the corresponding direction (horizontally in Figure 1). Retaining rings 7 are attached to the end sections of the cores 6, which hold the aforementioned parts together. However, the bladder 4 can expand elastically in the circumferential direction until it rests against the inside of the casing 2. This occurs by pushing a medication or drug into the casing through a supply-side inlet port 8.

[0055] The infusion pump 1, or more precisely its bladder 4, can then expel the medication (to the right in Figure 1) without any further energy input and administer it to a patient. For this purpose, the medication flows through a tube 10 to a patient-side outlet port 9. A flow restrictor 14 is provided in the tube 10. Upstream of the flow restrictor 14, a bubble and particle filter 16 is provided in the tube 10.

[0056] According to the disclosure, both the supply-side input port 8 and the patient-side output port 9 are each formed by a female coupling part 18 (female dry break) of a (systemically) closed transfer device (CSTD). The two female coupling parts 18 are explained in more detail with reference to Figure 3.

[0057] The supply-side female coupling part 18 can be covered by a stable closure cap 12, which is coupled to the supply-side retaining ring 7 via a swivel joint.

[0058] Figure 2 shows an elastomeric infusion pump i 01 according to a second embodiment of the present disclosure. This corresponds largely to that of the first embodiment shown in Figure 1. The only difference is that the supply-side inlet port 8 and the patient-side outlet port 9 are designed differently.

[0059] According to the disclosure, both the supply-side inlet port 8 and the patient-side outlet port 9 of the infusion pump 101 from Figure 2 are each formed by a different female coupling part 118 (female dry break) of a different (systemically) closed system transfer device (CSTD). The two female coupling parts 118 are explained in more detail with reference to Figure 5. Figure 3 shows a view and a sectional view of the female coupling part 18, of which two are provided in the infusion pump 1 from Figure 1. The female coupling part 18 has a one-piece main body 22 in which a channel 24 is formed, through which the drug is conveyed away from an elastomeric septum 26 in the case of the supply-side coupling part 18 and towards the septum 26 in the case of a patient-side coupling part 18.The septum 26 is positively inserted into the main body 22 by means of a circumferential radial shoulder and is held by it. The septum 26 has a concentric projection that extends away from the main body 22 (to the right in Figure 3).

[0060] The female coupling part 18 is formed by an adapter that has a Luer-lock connection 44 on the bladder side and / or hose side. This allows the female coupling part to be attached to a Luer-lock connection of a state-of-the-art infusion pump.

[0061] In the lower cutaway view of Figure 3, it can be seen that the main body 22 of the female coupling part 18 has locking projections 28 which can be engaged by corresponding locking projections 30 of the male coupling part 20 shown in Figure 4 in the sense of a releasable clip connection.

[0062] Figure 4 shows a view and a sectional representation of a male coupling part 20, with which the elastomeric infusion pump 1 from Figure 1 is further developed into an infusion pump arrangement according to a first embodiment of the present disclosure. The male coupling part 20, together with the female coupling part 18 from Figure 3, forms a closed transfer device (CSTD).

[0063] A second septum 27 is attached to a carrier 32, which is axially displaceable within a main body 34 of the male coupling part 20. The carrier 32 can also be referred to as a slide. The second septum 27 is located in the carrier 32 BB2536P-WG-0004

[0064] The second septum 27 is positively inserted by means of a circumferential radial shoulder and is held by it. The second septum 27 is thus axially displaceable relative to the main body 34. The detent projections 30 of the male coupling part 20 are also formed on the carrier 32.

[0065] The male coupling part 20 has a one-piece housing that can be manufactured by injection molding. A cover is manufactured together with the housing as a single main body 34. Due to the integration of the cover and the housing, the total number of parts and the total number of steps required to assemble the male coupling part 20 are low.

[0066] The main body 34 of the male coupling part 20 is designed to hold the carrier 32 in a contact position (first position) and a passage position (second position) while the female coupling part 18 is coupled to the carrier 32. For this purpose, the main body 34 has a pair of first locking windows 36 extending through the main body 34, as well as a pair of second locking windows 38, also extending through the main body 34. Lugs 40 of the carrier 32 engage in the first locking windows 36 to hold the carrier 32 in the contact position (first position). The lugs 40 engage in the second locking windows 38 to hold the carrier 32 in the passage position.

[0067] Depending on their position, the noses 40 are visible from the outside of the male coupling part 20 through the first locking windows 36 or through the second locking windows 38, so that the position of the carrier 32 and thus of the two septa 26, 27 and thus the operating state of the closed transfer device according to Figures 3 and 4 are visible from the outside.

[0068] In a first operating state and in the insertion position, the two septa 26, 27 are pressed together and held by the clip or snap connection of the closed transfer device. The clip or snap connection consists, on the one hand, of the aforementioned locking projections 28 of the main body 22 of the female coupling part 18 and, on the other hand, of the aforementioned locking projections 30 of the carrier 32 of the male coupling part 20. In a second operating state and in the flow position, the two septa 26, 27 are also pressed together and held by the clip or snap connection of the closed transfer device. In this state, the two septa 26, 27 are penetrated by a housing-fixed hollow needle 42 of the male coupling part 20, so that the drug can flow through the two coupling parts 18, 20.

[0069] Figure 5 is a perspective view of a female coupling part 118 of the elastomeric infusion pump 101 from Figure 2. In contrast to the first embodiment according to Figure 3, the female coupling part 118 has a first septum 126 that does not protrude but is enclosed by a ring formed integrally with the main body 122. Furthermore, a circumferential groove is visible in the main body 122, through which a circumferential locking projection 128 is formed.

[0070] The female coupling part 118 is formed by an adapter which has a Luer-Lock connection 44 on the bladder side or hose side.

[0071] Figure 6 is a perspective view of a male coupling part 120, with which the elastomeric infusion pump 101 from Figure 2 is further developed into an infusion pump arrangement according to the second embodiment of the present disclosure. Together with the female coupling part 118 from Figure 5, a second embodiment of a closed transfer device is formed. The male coupling part 120 is somewhat simpler in terms of its design and operation than the previous embodiment. One of two locking projections 130 can be seen, which, together with the locking projection 128 of the female coupling part 118 from Figure 5, form the releasable clip or snap connection.

[0072] When the female coupling part 118 from Figure 5 is inserted into the opening of the male coupling part 120, the two septa 126, 127 initially come into contact. Then the hollow needle (not shown) penetrates the two septa 126, 127. Finally, the two locking projections 130 engage behind the circumferential BB2536P-WG-0004

[0073] 14 / 20

[0074] Detent projection 128, and the flow between the two coupling parts 118, 120 is free and fixed in this position.

[0075] Figure 7 is a translucent representation and Figure 8 is a cutaway representation of a variant female coupling part 218 for use on the infusion pump 1 or 101 from Figure 1 or 2 and for use with the male coupling part 120 from Figure 6.

[0076] The female coupling part 218 of Figure 7 is also formed by an adapter, the main body 222 of which has a channel 24 and forms a Luer-Lock connection 44 on the bladder side or hose side according to the embodiment from Figure 3.

[0077] Furthermore, a circumferential groove can be seen in the main body 222, through which a circumferential detent projection 128 is formed, corresponding to the embodiment shown in Figure 5. Thus, the female coupling part 218 fits the male coupling part shown in Figure 6.

[0078] In contrast, a hexagon 246 is formed on the outer circumference of the Luer-Lock connector 44 for gripping by medical personnel.

[0079] Similar to the embodiment shown in Figure 5, the (first) septum 226 is slightly recessed relative to a circumferential edge of the main body 222.

[0080] In contrast, the first septum 226 has 248 studs on its (left in Figures 7 and 8) mounting side.

[0081] In the two embodiments of the elastomeric infusion pump 1; 101 shown in Figures 1 and 2, identical female coupling parts 18; 118 are used on both the supply and patient sides. Alternatively, different versions of female coupling parts 18; 118; 218 can be used on the two affected sides. Reference list:

[0082] 1 ; 101 elastomeric infusion pump

[0083] 2 cases

[0084] 4 bladder

[0085] 6 core

[0086] 7 retaining ring

[0087] 8 supply-side input connection

[0088] 9 patient-side output port

[0089] 10 hoses

[0090] 12 Cap

[0091] 14 flow restrictors

[0092] 16 particulate filters

[0093] 18; 118; 218 female coupling part

[0094] 20; 120 male coupling part

[0095] 22; 122; 222 Main body

[0096] 24-channel

[0097] 26; 126; 226 first septum

[0098] 27; 127 second septum

[0099] 28; 128 Holding device / Detent projection

[0100] 30; 130 Rastvorstell 32 Träger

[0101] 34; 134 Main body

[0102] 36 first locking window

[0103] 38 second locking window

[0104] 40 Nose

[0105] 42 Hollow needle

[0106] 44 Luer-Lock connector

[0107] 246 Hexagon

[0108] 248 studs

Claims

BB2536P-WC-0004 16 / 20 Claims 1. Elastomeric infusion pump (1; 101) configured and designed for delivering a drug, wherein the elastomeric infusion pump (1; 101) has a core (6) carrying an elastomeric bladder (4) configured and designed for receiving, pressurizing, and displacing the drug, wherein the bladder (4) has a tube (10) on the patient side, and wherein the bladder (4) is connected to a supply-side inlet port (8) of the infusion pump (1; 101), characterized in that the supply-side inlet port (8) is connected to a female coupling part (18; 118; 218) of a (systemically) closed transfer device (Closed System Transfer Device) is formed, wherein the female coupling part (18; 118; 218) has a main body (22; 122; 222) which carries a first elastomeric septum (26; 126; 226) and which has a retaining device (28; 128) for holding a main body (34; 134) of a male coupling part (20; 120) of the closed transfer device.

2. Elastomeric infusion pump (1 ; 101 ) according to claim 1 , wherein the bladder (4) is connected via the tube (10) to a patient-side outlet port (9) formed by a patient-side male coupling part (20; 120) or by a patient-side female coupling part (18; 118; 218) of a (systemically) closed transfer device.

3. Elastomeric infusion pump (1; 101) according to claim 1 or 2, wherein the bladder (4) is connected via the tube (10) to a patient-side outlet port (9), and the patient-side outlet port (9) is also formed by a patient-side female coupling part (18; 118; 218) of a (systemically) closed system transfer device, wherein the female coupling part (18; 118; 218) has a main body (22; 122; 222) which carries a first elastomeric septum (26; 126; 226) and which has a retaining device (28; 128) for holding a main body (34; 134) of a male coupling part (20; 120) of the closed system transfer device.

4. Elastomeric infusion pump (1 ; 101 ) according to claim 3, wherein the two female coupling parts (18; 118; 218) are unequal.

5. Elastomeric infusion pump (1 ; 101 ) according to claim 3, wherein the two female coupling parts (18; 118; 218) are identical.

6. Elastomeric infusion pump (1 ; 101 ) according to one of the preceding claims, characterized in that the female coupling part (18; 118; 218) or the female coupling parts (18; 118) have / have a removable protective cap.

7. Elastomeric infusion pump (1 ; 101 ) according to one of the preceding claims, characterized in that the Kem (6) has a fixed length and is preferably one-piece.

8. Elastomeric infusion pump (1 ; 101 ) according to one of the preceding claims, characterized in that the tube (10) has a triangular inner cross-section and / or outer cross-section.

9. Elastomeric infusion pump (1 ; 101 ) according to one of the preceding claims, characterized in that the supply-side female coupling part (18; 118; 228) can be covered by a closure cap (12) which is coupled to a retaining ring (7) by means of a pivot joint.

10. Elastomeric infusion pump (1 ; 101 ) according to one of the preceding claims, characterized in that the female coupling part (18; 118; 218) or the coupling parts (18; 118; 218; 20; 120) is / are formed by an adapter which has / have a Luer-Lock connection (44) on the bladder side or hose side.

11. Elastomeric infusion pump (1 ; 101 ) according to claim 10, characterized in that the female coupling part (218) or coupling parts (218) have a hexagon (246) on the outer circumference of the Luer-Lock connector (44). BB2536P-WC-0004 18 / 20 12. Infusion pump arrangement with an elastomeric infusion pump (1; 101) configured and designed for delivering a drug, wherein the elastomeric infusion pump has a core (6) carrying an elastomeric bladder (4) configured and designed for receiving, pressurizing, and displacing the drug, wherein the bladder (4) has a tube (10) on the patient side, and wherein the bladder (4) is connected to a supply-side coupling (8), characterized in that the supply-side coupling (8) is formed by a closed system transfer device comprising a female coupling part (18; 118; 218) and a male coupling part (20; 120), wherein the female coupling part (18; 118; 218) comprising a main body (22; 122; 222) which carries a first elastomeric septum (26; 126; 226) and which has a retaining device (28; 128) for holding a main body (34; 134) of the male coupling part (20; 120), wherein a second elastomeric septum (27; 127) of the male coupling part (20; 120) can be pressed against or is pressed against the first septum (26; 126; 226), and wherein the first septum (26; 126; 226) can be penetrated or is penetrated by a hollow needle (42) of the male coupling part (20; 120).

13. Infusion pump arrangement according to claim 12, wherein a patient-side coupling (9) is connected to the tube (10), and the patient-side coupling (9) is also formed by a (systemically) closed system transfer device comprising a female coupling part (18; 118; 218) and a male coupling part (20; 120), wherein the female coupling part (18; 118; 218) has a main body (22; 122; 222) which carries a first elastomeric septum (26; 126; 226), and which has a retaining device (28; 128) for holding a main body (34; 134) of the male coupling part. (20; 120) having a second elastomeric septum (27; 127) of the male coupling part (20; 120) that can be pressed against or is pressed against the first septum (26; 126; 226), and wherein the first septum (26; 126; 226) is penetrable or penetrated by a hollow needle (42) of the male coupling part (20; 120).

14. Infusion pump arrangement according to claim 12 or 13, characterized in that a carrier (32) is movable (bidirectionally) in the male coupling part (20) between an attachment position and a passage position, wherein the second septum (27) is held on the carrier (32), and wherein the female coupling part (18) can be fixed on the carrier (32), wherein in the attachment position the two septa (26, 27) are in contact with each other and are away from the hollow needle (42), and wherein in the passage position of the carrier (32) the two septa in contact with each other (26, 27) are penetrated by the hollow needle (42).

15. Infusion pump arrangement according to claim 14 characterized in that at least one indicator is formed integrally on the carrier (32), which is visible in the installation position through a first locking window (36) of the male coupling part (120).

Images