Medical fluid tube system comprising an injection port

Abstract

Disclosed is a medical fluid tube system comprising at least one injection port element (41) that includes an injection port portion (41d) which forms a single piece with the injection port element, preferably a single piece made of the same material, or which is non-detachably arranged on the injection port element, wherein the injection port portion (41d) is in the form of a first coupling adapter part (3) of a CSTD system (1).

Description

[0001] Medical fluid line system with injection connection

[0002] Description

[0003] The present disclosure relates to a medical fluid line system, in particular an infusion set, preferably of the single-use type, having an injection port or injection connection for the selective fluidic connection of an injection device, such as a medical, preferably needle-free injection syringe, more preferably of the hand-operated cylinder-piston type.

[0004] Background of the Revelation

[0005] A medical fluid line system, in particular an infusion set, is usually (not necessarily always) a hose line system with a hose that is at least partially flexible, for example an infusion hose, one proximal end of which (i.e. pointing away from the patient's body) can be connected, particularly in the case of an infusion set, to a coupling, for example in the form of a Luer lock, a spike / thorn or similar connectors for connection, for example, to an infusion container such as an infusion bag or infusion bottle or to an infusion machine, and the other distal end of which (i.e. end facing the patient's body) has either a connection / connection coupling (e.g. constructed according to the Luer system) for an injection catheter or similar patient access or an infusion set-integrated patient access (injection catheter) itself.

[0006] Typically, such a fluid line system, preferably designed as a "single-use system," especially an infusion set, is also equipped with a so-called drip chamber (with integrated ventilation) directly downstream of the proximal coupling and a flow regulator for controlling and adjusting the flow rate of the infusion fluid, which in turn is usually mounted on the infusion tube downstream of the drip chamber. Such a flow regulator typically consists of a housing accommodating the infusion tube, to which a slide or handwheel is mounted for movement in the longitudinal direction of the tube. The housing defines a guide or slide track that is positioned at an (acute) angle to the longitudinal direction / longitudinal axis of the tube.This makes it possible to change the hose cross-section of the hose line and thus adjust the flow velocity by moving the slider or handwheel along this guide or sliding track.

[0007] A fluid line system as described above, in particular an infusion set, is often also provided or configured with at least one injection port / injection port element, which is referred to in technical terms as an "injection port" and which allows for the selective injection of a fluid / medication / medicinal agent into the infusion fluid. Such an injection port can be integrated or installed in the infusion tube upstream and / or downstream of the drip chamber, in particular downstream of the flow regulator.

[0008] In principle, such fluid line systems are not only offered as infusion sets, but can also represent extracorporeal tubing sets for blood treatment machines, heart-lung machines and similar treatment devices that are equipped with corresponding injection connections for medicinal substances or drugs.

[0009] State of the art

[0010] Various fluid line systems, such as infusion sets, with differently designed injection ports are known on the market. Such an injection port / injection port element typically has a (first and second) inlet and outlet connection section, for example, each in the form of a hose nozzle for the infusion tube, as well as a (third) injection port section for the injection device (hereinafter referred to simply as an injection syringe). These three ports / connection sections are usually arranged in a Y-shape (Y-port) or T-shape (T-port). The (third) access connection section can, for example, simply have an elastomer membrane, which is pierced with a needle on the injection syringe.However, after the needle has been punctured and withdrawn from the membrane, the surrounding area can become contaminated with syringe contents. This is because the membrane does not immediately form a tight / dry seal, and the needle is usually open, allowing fluid to drip from the syringe barrel upon withdrawal. Instead of an elastomer membrane, a Luer Lock connector can also be attached as the injection port section. This Luer Lock connector can be used directly with a Luer Lock syringe. The Luer Lock connector can be equipped with a valve to prevent fluid from escaping from the infusion set once the syringe is disconnected from the Luer Lock connector.

[0011] However, such valves do not close immediately when the syringe is disconnected, and therefore do not close dry. Furthermore, the problem of an open syringe remains after disconnection, posing a risk of environmental contamination from leaking syringe contents.

[0012] Also generally known in the field of medical technology are so-called “vial-to-vein closed system drug-transfer devices” (CSTD systems), i.e. closed / self-sealing vial liquid withdrawal / transmission devices, of which a concrete embodiment is disclosed by way of example in WO 2022 232405 A1 and whose basic mode of operation is illustrated in the attached Figs. 1 and 2.

[0013] According to Fig. 1, such a CSTD system has a first coupling adapter part, which is provided or configured at a distal end portion, for example, with a Luer lock or similar coupling, for example, to be connected to a vial / ampoule containing a medicinal agent or to a fluid line system leading to the patient. This first coupling adapter part forms a housing with an internal fluid channel that is open in the proximal direction, wherein this proximal opening is closed by a membrane or similar seal. Furthermore, the housing of the first coupling adapter part preferably forms an undercut on the inside.

[0014] The CSTD system cited as an example from this prior art further comprises a second coupling adapter part, consisting of a housing forming inner undercuts, in which a piston with an inner channel is mounted for axial movement. A hollow needle is mounted for relatively axial movement in the inner channel, the proximal end of which, remote from the needle tip, is held by an anchor sleeve that rests against the housing or is inserted into a proximal central housing socket. At the distal end of the piston, the inner channel is closed by a membrane or similar seal, with the needle tip initially covered by this seal. Finally, elastic locking arms extending longitudinally in the distal and proximal directions are provided on the piston of the second coupling adapter part, the proximal and distal end sections of which are shaped into locking hooks.In addition, the anchor sleeve forms a connection, for example for a syringe, at its proximal end region facing away from the needle, which is not shown in Figs. 1 and 2.

[0015] According to Fig. 2, to achieve an outwardly closed / self-sealing fluid connection with, for example, a vial or a fluid line system, the distal Luer Lock connector is coupled to the vial or the fluid line system. The first coupling adapter part is thus connected to the vial / fluid line system in a fluid-tight manner. The syringe mentioned as an example is then coupled to the proximal connection of the second coupling adapter part in a fluid-tight manner. Finally, the second coupling adapter part or the piston mounted therein is placed onto the membrane of the first coupling adapter part, and the housing of the second coupling adapter part is moved towards the housing of the first coupling adapter part until the locking arms are engaged in the undercuts of the first and second coupling adapter parts.During this sliding movement, the needle pierces the membrane of the first and second coupling adapter part and establishes a fluid connection between the vial / fluid line system and the syringe.

[0016] To disconnect, the locking arms are disengaged from all undercuts using a button on the second coupling adapter part, and the housing of the second coupling adapter part is retracted relative to the first coupling adapter part. This simultaneously removes the needle from the two sealing membranes. Only now do the two membranes separate from each other, preventing any fluid from dripping from the syringe or the vial / fluid line system.

[0017] An important component of such CSTDs are the two coupling adapter parts (dry connections / dry breaks), which enable the safe transfer of liquid (medicine) and seal dry after the connection has been separated / disconnected, thus protecting the environment from contamination (e.g. through leaks or the formation of drops on the surfaces of the coupling partners / coupling adapter parts after the connection has been separated). These CSTD coupling adapter parts can be installed on various products, not just a vial and a syringe. Among other things, the first coupling adapter part described above could, for example, also be connected to a Luer-Lock injection port of an infusion set of this type via the Luer-Lock connection formed on it, in order to then be able to connect a syringe with the corresponding second coupling adapter part (counter adapter part / syringe adapter part) to it.It can then also be assumed that both coupling adapter parts of the CSTD system will be dry after disconnection and that the inner channels of both coupling adapter parts will remain tightly closed.

[0018] However, it has been shown that even the known CSTD system of the above-described design must be connected to the injection port of a known medical fluid line system infusion set via the Luer Lock connection at the distal end of the first coupling adapter part. This Luer Lock connection can in principle be disconnected again and therefore poses a potential risk of environmental contamination from fluid dripping from the injection port. Therefore, known CSTD systems are not suitable for making an injection port on an infusion set contamination-proof.

[0019] Brief description of the revelation

[0020] In view of this problem of the prior art, which has been recognized by the applicant, the object of the present disclosure is to provide a medical fluid line system, in particular an infusion set, with at least one injection connection which represents a reduced risk of contamination for the environment compared to the prior art.

[0021] This object is achieved by a medical fluid line system, in particular an infusion set, having the features of claim 1. Advantageous aspects of the fluid line system, in particular infusion sets, are the subject of the subclaims, which may also be claimed individually and separately from the respective other aspects.

[0022] Accordingly, the disclosure basically provides a medical fluid line system, preferably an infusion set, with at least one injection connection / injection connection element (injection port) which is firmly inserted into a fluid line, preferably a fluid hose of the fluid line system. For example, the injection connection element can have a T- or Y-shaped (first), preferably sleeve-shaped, inlet connection section and a (second), preferably sleeve-shaped, outlet connection section, both of which are connected to one another (in one piece) via an intermediate piece or a distribution box, to which a (third) injection connection section is firmly arranged (molded / glued / formed), which is aligned in particular at an angle (e.g., perpendicular) to the inlet and outlet connection sections. The injection connection section is thus non-detachable (preferably in one piece, if necessary).integrally) with the fluid line / fluid hose. A first coupling adapter part of a CSTD system of generally known construction (as known, for example, from WO 2022 232405 A1, the content of which is therefore also made the subject of the present application) is permanently attached to the (third) injection connection section, or the injection connection section is designed or formed into such a first coupling adapter part of a CSTD system and is thus a fixed, non-detachable component of the injection connection element of the fluid line system. For this purpose, for example, the distal Luer Lock connection of the first coupling adapter part of a CSTD system, known from the previously described prior art, is replaced by the T- or Y-shaped injection connection element. This can be achieved, among other things, by, for example,The housing of the first coupling adapter part (not a nozzle-like, protruding Luer Lock connector as in the prior art) is formed with a plug-like housing section that engages a clamp-like socket formed on the injection connection element. In other words, the housing of the first coupling adapter part is matched to the (third) injection connection section of the injection connection element, preferably according to the plug-socket principle, such that these two components form a frictional and / or positive fit in its final state, forming the injection connection section.

[0023] For example, it is also possible to form the housing of the first coupling adapter part with a receiving opening or bore (extending into the housing of the first coupling adapter part), into which an injection connection piece formed on the injection connection element is firmly inserted (thereby forming the (third) injection connection section). To ensure non-detachability, the clamp-like socket or connection piece and the first coupling adapter part, or its housing, can be (additionally) glued or welded together.

[0024] The function of a (third) injection connection section constructed in this way corresponds to that of the previously described CSTD system known construction, i.e., in order to inject a medical fluid into the injection port now designed as a CSTD component (first coupling adapter part), the first coupling adapter part forming the (third) injection connection section only has to be connected to the corresponding CSTD counter-adapter (CSTD counter-component), i.e. the second coupling adapter part, in such a way that the two membranes in the first and second coupling adapter parts come to rest on one another and are then pierced by the needle (hollow needle) held thereon as the housing of the second coupling adapter part is (further) advanced, in order to then introduce the fluid to be injected from a syringe pre-attached to the second coupling adapter part into the fluid line (infusion line / infusion tube).During the final disconnection of the syringe or its counter adapter / second coupling adapter part / syringe adapter, the membranes on both the first and second coupling adapter parts close dry and keep the syringe or the injection connection sealed to the outside.

[0025] As already indicated above, the (third) injection connection section can also be formed directly onto the housing of the first coupling adapter part. In this case, there is no need for a plug-socket-like connection, for example in the form of a connecting piece that must be inserted into a receiving bore on the housing of the first coupling adapter part, or in the form of a clamp receptacle into which the housing of the first coupling adapter part is inserted and possibly glued. Instead, the syringe connection element, which may be T- or Y-shaped, is formed as a single piece with the housing of the first coupling adapter part of the CSTD system.

[0026] The (first and second) inlet and outlet connection sections, preferably referred to above as hose nozzles, can also be shaped differently, for example as sleeves for the internal, non-detachable reception of the respective hoses of the fluid line system or the like.

[0027] Due to the disclosed concept, the first coupling adapter part of the CSTD system is, as it were, permanently / non-removably provided with the (T- or Y-shaped) injection port at the distal end / end section of the associated housing instead of a coupling (as in the prior art), or forms a unit with it, with the injection port in turn being permanently integrated into a line-Z-hose section of the fluid line system. This eliminates, or at least significantly reduces, the risk of fluid leakage in the previous coupling area of ​​a known first coupling adapter part according to the prior art.

[0028] Short description of the characters

[0029] The disclosure is explained in more detail below using preferred embodiments with reference to the accompanying figures.

[0030] They show:

[0031] Figs. 1 and 2 a CSTD system of known structure and known function,

[0032] Figs. 3 and 4 show various basic structures of a medical fluid line system, preferably in the form of an infusion set,

[0033] Figs. 5 and 6 show different basic structures of injection ports as they are used in medical fluid line systems, preferably an infusion set,

[0034] Fig. 7 shows an injection port according to a first embodiment of the disclosure in installed state,

[0035] Fig. 8 shows an injection port according to a second embodiment of the disclosure in installed state and

[0036] Fig. 9 shows the interaction of the injection port according to the disclosure with the associated second coupling adapter part (CSTD. Counter component) of the CSTD system.

[0037] Character description

[0038] Fig. 1 shows a liquid extraction and transfer device 1 (generally known by the abbreviation CSTD system), which belongs to the state of the art mentioned at the beginning, to which reference is hereby expressly made again.

[0039] In summary, this CSTD system 1 comprises a first coupling adapter part 3 with a housing 4 in which an axially extending through-flow fluid channel or a fluid channel component 5 is formed or inserted, which is closed at a proximal flange side 7 by a membrane 9. The fluid channel component 5, together with the housing 4, forms a (Luer Lock) coupling 6 at the distal end section of the first coupling adapter part 3, with which the first coupling adapter part 3 is / can be connected to a medical device, such as a medical fluid line system. The housing 4 or the fluid channel component 5 of the first coupling adapter part 3 also forms a number of locking elements in the form of undercuts 11.

[0040] The known CSTD system 1 further comprises a second coupling adapter part 13 with a housing 15 which forms a number of locking elements in the form of undercuts 16, a piston 17 which is mounted in the housing 15 so as to be relatively displaceable, a hollow needle 19 which is mounted in the piston 17 so as to be relatively displaceable and which is held in the housing 15 at its proximal end section (facing away from the needle tip) by means of a holding anchor or an anchor sleeve 20, and a number of elastically deformable locking arms 21 which are fixed or formed on the piston 17 and are provided and designed to engage in a locking manner with both the undercuts 11 of the first coupling adapter part 3 and the undercuts 16 of the second coupling adapter part 13.

[0041] For the relatively displaceable mounting of the hollow needle 19 in the piston 17, the latter has a (central) through-channel 23 which is closed by a membrane 27 on a distal coupling or flange side 25 of the second coupling adapter part 13.

[0042] Fig. 2 shows the function of the CSTD system 1 according to Fig. 1.

[0043] Accordingly, to establish a fluid connection between the first and second coupling adapter parts 3, 13, the membrane 27 of the second coupling adapter part 13 is pressed sealingly against the membrane 9 of the first coupling adapter part 3 in a first movement time window. In a second movement time window, the housing 15 of the second coupling adapter part 13 is moved further forward in the direction of the housing 4 of the first coupling adapter part 3. This further forward movement in a second movement time window causes the hollow needle 19 to pierce both adjacent membranes 9, 27, thereby establishing a fluid connection between the through-fluid channel 5 and the hollow needle 19. The movement of the second coupling adapter part 13 in the second movement time window ends with the locking arms 21 engaging in the undercuts 11 and 16 of the two coupling adapter parts 3, 13.

[0044] As stated above, the hollow needle is held at its proximal end by the anchor sleeve 20, which at the same time also represents a connection / connector for, for example, a syringe and whose sleeve interior is in fluid communication with the fluid channel 5 of the first coupling adapter part 3 via the hollow needle 19.

[0045] Separating / deconnecting both coupling adapter parts 3, 13 takes place in exactly the reverse order, wherein after disengaging the locking arms 21 by subsequently moving the second coupling adapter part 13 away from the first coupling adapter part 3, first (i.e. according to the above second movement time window) the hollow needle 19 is pulled out of the two membranes 9, 27 and then (i.e. according to the above first movement time window) the two membranes 9, 27 are lifted away from each other.

[0046] Figures 3 and 4 show different fluid line systems, preferably in the form of infusion sets, as already described above in the prior art.

[0047] The infusion sets shown in Figs. 3 and 4 generally have an infusion tube 29 with a first connection or a first coupling 31 for connecting an infusion container or an infusion pump (not shown in more detail), wherein this first connection or this first coupling can be, for example, a Luer Lock (see Fig. 3) or directly a spike (see Fig. 4). Furthermore, the infusion tube 29 is provided with a second connection or a second coupling 33, for example a Luer Lock for connecting an infusion catheter, or the infusion catheter is already firmly connected to the infusion tube. Finally, the infusion sets shown generally also have a tube clamp 35 or similar blocking element (e.g. valve), with which a fluid flow in the infusion tube 29 can be blocked. Optionally, the infusion set can be designed, in particular according to Fig.4 may be equipped with a drip chamber 37 and a flow regulator 39 arranged downstream of it, as already described above.

[0048] According to the present disclosure, the infusion sets are provided with a number (e.g., one or two) of injection ports 41 that are firmly (integrally) integrated into the infusion tube 29 and thus cannot be separated from the infusion tube 29. General examples of such injection ports 41 are shown in Figs. 5 and 6.

[0049] Accordingly, an injection connection 41 can be a so-called T- or Y-piece (generally referred to as an injection connection element) with a (first) input connection section 41a and a (second) output connection section 41b, which are connected to each other via an intermediate piece 41c. A (third) injection connection section 41d opens into this intermediate piece 41c and is aligned at an angle (corresponding to the T- or Y-shape) to the input and output connection sections 41a, 41b.

[0050] The inlet and outlet connection sections 41a, 41b are intended and designed to be firmly and sealingly connected to the hose end sections of the infusion hose 29, thus connecting two hose sections to form a common infusion hose. Accordingly, the inlet and outlet connection sections 41a, 41b can be designed as so-called hose nozzles or as sleeves for receiving hose end sections.

[0051] At this point, it should also be pointed out that injection connections 41 of the present type (as already indicated above) can also be used in / with other fluid line systems, such as extracorporeal blood lines from / for dialysis machines, heart-lung machines and similar intensive medical devices.

[0052] Figs. 7 and 8 now show preferred embodiments of injection ports 41 according to the present disclosure.

[0053] Accordingly, the core of the present disclosure essentially consists in making or forming the injection connection or injection connection element 41 (for example in T- or Y-shape) of a medical fluid line system itself into the (distal) coupling 6 of the first coupling adapter part 3 of the CSTD system 1, as described above by way of example.

[0054] In other words, the (third) injection connection section 41d of the injection connection or injection connection element according to the disclosure (in its final manufacturing state) has the shape and function of the first coupling adapter part 3 of a CSTD system 1, as described above by way of example with reference to Figs. 1 and 2, wherein it is pointed out that the first coupling adapter part 3 can also have a different shape, possibly known from the prior art, than that shown in Fig. 1, as long as the basic function of a CSTD system according to the above definition is ensured. This is of course also associated with the fact that the shape of the second coupling adapter part 13 can deviate from the shape described above in order to correctly engage with the first coupling adapter part 3, as is shown in principle in Fig. 9.

[0055] It is therefore crucial to replace the (standard) coupling 6, described as a Luer Lock according to Figs. 1 and 2, by the injection connection or the injection connection element 41, as disclosed, by designing / converting its (third) injection connection section 41d as the first coupling adapter part 3 (see in particular Fig. 7).

[0056] According to this Fig. 7, this can be achieved, for example, in that the injection connection element 41 forms a preferably clamp-like receiving slot or shaft (based on the principle of a socket) 43 for forming the (third) injection connection section 41d, and the housing 4 of the first coupling adapter part 3 has, at its distal end section (instead of the previous Luer Lock), a plug-like outer contour, preferably with two opposing flattened side sections 4a matching the opposing clamps 43a defining the receiving slot 43. In this way, the housing 4 is permanently inserted between the clamps 43 into the receiving slot 43 and, if necessary, locked therein. An opening (not shown further) in the housing is in outwardly sealed contact with an opening in the intermediate piece 41c of the injection port 41.

[0057] Alternatively, instead of the clamps 43a, the injection port 41 could also have a truncated cone-shaped (injection) connection hollow socket, which is further preferably integrally connected to the inlet and outlet connection sections 41a, 41b via the intermediate piece 41c. In turn, the housing 4 of the first coupling adapter part 3 would then be provided with an opening or bore formed at its distal end section, into which the (injection) connection hollow socket 43b is permanently inserted, preferably by means of a press fit. In both of the aforementioned alternatives, the injection connection element 41 is / is a fixed (non-detachable) component of the first coupling adapter part 3, whereby the first coupling adapter part 3 is thus firmly and permanently integrated into the medical fluid line system via the inlet and outlet connection sections 41a, 41b.

[0058] It should be noted that the assembly sequence per se is not important. This means that for the final product, namely the medical fluid line system with the injection port as one component (first coupling adapter part) of a CSTD system, it is irrelevant whether the injection port is already integrated into the medical fluid line system via the inlet and outlet connection sections 41a, 41b before the first coupling adapter part or its housing 4 is fixed in the receiving slot 43 or on the connection piece, or whether the first coupling adapter part is already prepared with the entire injection port as a coupling and only then in the form of a prefabricated module is integrated into the medical fluid line system (e.g.

[0059] Infusion tubing set) is integrated / permanently inserted.

[0060] In order to ensure the inseparability between the connecting piece and the housing of the first coupling adapter part 3, both components, namely the housing 4 and the clamps / connecting pieces, can be glued or welded together (additionally or alternatively).

[0061] In Fig. 8, a second preferred embodiment according to the disclosure is shown as a possible alternative to the above embodiment.

[0062] Accordingly, the (third) injection connection section of the injection connection element (injection port) is already formed integrally with the remaining (first and second) input and output connection sections (and the intermediate piece), eliminating the need to join the connection piece and housing. In this case, only the membrane 9 of the first coupling adapter part 3 needs to be inserted into its housing 4. In summary, the present invention discloses a medical fluid line system comprising at least one injection connection element (41) having an injection connection section (41d) formed integrally, preferably integrally, with it or arranged non-detachably thereon, wherein the injection connection section (41d) is designed as a first coupling adapter part (3) of a CSTD system (1).

Claims

Patent claims 1. A medical fluid line system comprising at least one injection connection element (41) which is integrated or can be integrated into the medical fluid line system and which has an injection connection section (41d) which is formed integrally therewith, preferably integrally therewith, or arranged non-detachably thereon, characterized in that the injection connection section (41d) is designed as a first coupling adapter part (3) of a CSTD system (1).

2. Medical fluid line system according to claim 1, characterized in that the injection connection section (41 d) has or forms a receptacle to which a housing (4) of the first coupling adapter part (3) is non-detachably connected.

3. Medical fluid line system according to claim 2, characterized in that the receptacle is designed as a clamp with at least two opposing clamp arms (43a) which define a receiving slot (43) between them.

4. Medical fluid line system according to claim 3, characterized in that the housing (4) has, at least in the outer side regions facing the clamp arms (43a), preferably flattened clamp contact surfaces (4a) which are in a non-detachable frictional and / or positive connection with the clamp arms (43a).

5. Medical fluid line system according to claim 2, characterized in that the receptacle is designed as a hollow connection piece and the housing (4) has an insertion opening or bore into which the hollow connection piece is inserted in a non-detachable manner, preferably by press fitting and / or form-fitting.

6. Medical fluid line system according to one of claims 2 to 5, characterized in that the housing (4) and the receptacle are glued or welded together.

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