PRIME-STOP COVER

Abstract

Described is a prime-stop cap (129; 229) for a medical fluid line system, in particular a CSTD infusion set (40), comprising a coupling section (AK) for fluid-tight connection to a connector (33) and a functional section (AF) for receiving a hydrophobic filter material (31). The functional section (AF) forms a chamber (50) on the side facing away from the coupling section (AK), in which an activated carbon filter (52) is enclosed.

Description

The present disclosure relates to a prime stop cap for use in medical fluid conduit systems, particularly infusion sets.BACKGROUND OF THE DISCLOSUREA medical fluid line system, in particular infusion set, is usually (not necessarily always) a hose line system with a hose which is flexible at least in sections, for example infusion hose, the proximal end of which (i.e. the end facing away from the patient body) can be connected, in particular in the case of an infusion set with a coupling, for example in the form of a luer lock, a spike / spike or similar connectors for connection, for example, to an infusion container such as infusion bag or infusion bottle or to an automated infusion machine and the other distal end of which (i.e. the end facing the patient 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.As a rule, such a fluid line system, in particular infusion set, preferably provided as a "single-use system", is also provided with a so-called drip chamber (with integrated ventilation) directly downstream of the proximal coupling and a flow regulator for monitoring and adjusting the flow rate of the infusion liquid, which in turn is mounted on the infusion tube mostly downstream of the drip chamber. According to the standard, such a flow controller consists of a housing receiving the infusion tube, on which a slide or hand wheel is mounted so as to be movable in the longitudinal direction of the tube, for which purpose the housing defines a travel gate or slide path which is set at an (acute) angle to the longitudinal direction of the tube / longitudinal axis of the tube. This makes it possible to change the hose cross section of the hose line by moving the slide or hand wheel along this link or slide track and thus to set the flow speed.In principle, however, such fluid line systems are not only offered as infusion sets, but can also represent extracorporeal tube sets for blood treatment machines, heart-and-lung machines and similar treatment devices, which can also be provided with corresponding injection ports for medical active substances or medicines.Prior ArtCMR medicaments which are used, for example, for cancer therapy damage, in particular, growth-intensive tumor cells in the therapeutic application. Many of these drugs have themselves cancer-producing properties due to their mechanism of action. In order to prevent persons not under therapy from contacting CMR drugs, so-called closed system transfer devices (CSTD) are increasingly used in the production and administration of preparations ready for administration. Important constituents of CSTDs are coupling systems, also called dry breaks, which allow the secure transfer of CMR drugs and seal them off dry after the connection has been separated, in order to protect the environment from contamination (for example due to leaks or droplet formation on the surfaces of the coupling partners after the connection has been separated). Such a so-called dry break coupling consists of two parts, a male dry break and a female dry break. There are already various manufacturers of CSTD dry breaks on the market, for example under the names Chemfort (from Simple), ChemoLock (from ICU medical), Equashield (from Equashield) or PhaSeal (from BD).An embodiment variant of such a "vial-to-vein closed system drug transfer device" (CSTD system), i.e. a closed / self-sealing vial-liquid withdrawal / passage device, is described by way of example in the publication WO 2022 232405 A1, the disclosure of which is expressly incorporated into the present application, and is shown in FIGS. 1 and 2, to which reference is already made here. FIGS. 1A and 1B show sectional views of the CSTD system in the decoupled state (FIG. 1A ) and in the coupled state (FIG. 1B ), respectively. FIG. 2 shows the CSTD system in a perspective illustration.As shown in FIGS. 1A and 2, this CSTD system 1 has in summary a first coupling adapter part 3, referred to below as female dry break, with a housing 4, in which an axially extending through fluid channel or a fluid channel component 5 is formed or inserted, which is closed on a proximal flange-on side 7 by means of a membrane 9. The fluid channel component 5 forms together with the housing 4 on the distal end section of the first coupling adapter part 3 a (luer lock) coupling 6, by means of which the first coupling adapter part 3 can be connected to a medical device, for example to a vial / ampoule containing a medical active substance. The housing 4 or the fluid channel component 5 of the first coupling adapter part 3 also form a number of latching elements in the form of undercuts 11.The CSTD system 1 further has a second coupling adapter part 13, referred to below as a male dry break, having a housing 15 which forms a number of latching elements in the form of undercuts 16, a slide or 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 is held in the housing 15 at its proximal end portion (facing away from the needle tip) by means of a retaining anchor or an anchor sleeve 20, and a number of elastically deformable latching arms 21 which are fixed or formed on the piston 17 and are provided and designed to come into latching engagement both with the undercuts 11 of the first coupling adapter part 3 and with the undercuts 16 of the second coupling adapter part 13.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 on a distal coupling or flange side 25 of the second coupling adapter part 13 by means of a membrane 27.It can be seen from the illustration according to FIG. 2 that the arrangement is made such that the two housing parts 4 and 15 can be pushed into one another in a rotationally secure manner. This is made possible in that the housing 15 has a receiving opening 18 which is rectangular in cross section and in which the housing 4 of the first coupling adapter part 3 can be received with a fit, wherein cheeks 10 of the housing 4 perform a guiding function in cooperation with side inner walls 12 of the receiving opening 18 and ensure a rotation prevention.FIG. 1B shows the function of the CSTD system 1 according to FIG. 1.Consequently, for establishing a fluid connection between the first and second coupling adapter parts 3, 13 in a first movement time window, 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 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, wherein, as a result of this further forward movement, in a second movement time window, the hollow needle 19 pierces both membranes 9, 27 lying against one another and thereby establishes 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 latching of the latching arms 21 in the undercuts 11 and 16 of the two coupling adapter parts 3, 13.As explained above, the hollow needle is held at its proximal end by the anchor sleeve 20, which simultaneously also constitutes a connection / connector for a syringe, for example, 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.A disconnection / disconnection of both coupling adapter parts 3, 13 takes place in exactly the reverse sequence, wherein after disengagement of the latching arms 21 by means of buttons, by a subsequent movement of the second coupling adapter part 13 away from the first coupling adapter part 3, the hollow needle 19 is first pulled out of the two membranes 9, 27 (i.e. according to the protruding second movement time window) and subsequently (i.e. according to the protruding first movement time window) the two membranes 9, 27 are lifted from one another without any liquid being able to drop either from the syringe or from the vial / fluid line system.An important component of such CSTDs is therefore the two coupling adapter parts (dry connections / dry breaks), which allow secure transfer of liquid (pharmaceutical) and after the connection has been separated / disconnected, seal off in a dry manner, in order to protect the environment from contamination (e.g. due to leaks or droplet formation 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 different products, i.e. not only on a vial and a syringe. Among other things, the above-described first coupling adapter part could also be connected via the luer lock connection formed thereon to an injection port of the luer lock type of an infusion set of the present type, for example, in order to subsequently be able to connect a syringe with the corresponding second coupling adapter part (counter adapter part / syringe adapter part) thereon. It is then also to be assumed that both coupling adapter parts of the CSTD system close off dry after disconnection and the inner channels of both coupling adapter parts remain tightly closed.In the case of higher-quality infusion sets (infusion cutlery) from infusion therapy, as is illustrated by way of example in FIG. 3 and designated by 40, the procedure is to use what are known as prime stop caps. This prime stop cap, which is designated by the reference numeral 29 and is illustrated in detail in FIGS. 4 and 5, is placed on the patient side on a connector 33 with a luer lock coupling 6 (luer lock patient connector). It is equipped with a hydrophobic filter membrane 31 through which gases can escape from the line, but no liquid, so that the infusion set 40 can be "primed" (filled with liquid without air bubbles) before being connected to the patient by connecting the Male Dry Break 13 to a container spike, not shown in detail, and a Female Dry Break to a liquid container.The prime stop cap can therefore remain at the patient end of the infusion set line 30 during priming / filling without the escape of liquid medication or its aerosols and thus contamination of the environment. On the one hand, this protects both users and patients, and on the other hand, this saves valuable working time since the filling of the line can take place automatically and without supervision.Despite the protection against liquid escape, however, there is still the risk that gases from hazardous medications (such as cytostatic agents) escape into the environment via the hydrophobic filter membrane 31 and thus jeopardize the user.The invention is based on the object of creating a prime stop cap with which the priming of the medical fluid line system can be carried out with better certainty for the user.This object is achieved by a prime-stop cap having the features of claim 1.According to the invention, an activated carbon filter is accommodated enclosed in the prime-stop cap, i.e. installed in such a way that there is no longer any risk of hazardous gases escaping. The activated carbon filter can adsorb the hazardous constituents of the escaping gases and thus clean the escaping air such that it no longer represents a risk for the user of the infusion set or for the patient. It has been found that such an activated carbon filter can be designed to be quite small in terms of volume, i.e. can remain limited to a few cubic centimeters, so that the prime-stop cap has to be formed only slightly larger compared to a conventional cap and no changes have to be made at the coupling section in order to provide a secure hold at the connector.In this case, an additional activated carbon filter can be installed behind the hydrophobic filter membrane on the patient side. Alternatively or additionally, an activated carbon filter can be installed directly, which has hydrophobic properties.If the chamber accommodating the activated carbon filter is in the form of an axially extending hollow prism, the activated carbon filter is easily mounted from the axially open side of the hollow prism. The prism can have a polygonal or also circular shape, so that the activated carbon filter can also be formed with a simple geometry.In this case, the prime-stop cap can be detachably connected to the connector, for example a patient connector, according to a variant, which simplifies the modular construction of the medical fluid line system. This variant also allows the prime-stop cap to be connected to the connector to form a unit that can be handled in a uniform manner.If, in contrast, the prime-stop cap is welded, pressed or connected to the connector in some other way in a difficult-to-release manner, for example by means of a snap connection, a particularly compact structure results, which allows a further reduction in the overall volume.The prime-stop cap can be installed at various locations of a medical fluid line system, in particular a CSTD infusion set. Advantageous possible uses are the subject matter of claims 7 to 9.Exemplary embodiments of the invention are explained in more detail below with reference to schematic drawings. The following are shown: FIGS. 1A, 1B and 2 show a CSTD system of known construction and function; FIG. 3 shows the representation of an infusion set with mounted conventional prime stop cap on a luer lock connector; FIGS. 4 and 5 show detailed representations (top view and section according to V-V) of the prime stop cap according to FIG. 3 ; FIG. 6 shows the top view of a first embodiment of the prime stop cap according to the invention; FIG. 6A shows the sectional representation of the prime stop cap according to FIG. 6 in a sectional guide according to A-A in FIG. 6 ; FIG. 7 is a top view of another embodiment of the prime stop cap according to the invention; and FIG. 7A shows the sectional representation of the prime stop cap according to FIG. 7 in a sectional guide according to A-A in FIG. 7 ;FIGS. 6 and 6A show a first embodiment of the prime stop cap 129 according to the invention, which is mounted, by way of example, on a Luer lock patient connector 33 with Luer lock coupling 6. For this purpose, the prime stop cap 129 has a coupling section AK for fluid-tight connection to the luer lock patient connector 33 and a functional section AF for receiving a hydrophobic filter material. In the exemplary embodiment shown, the filter material is formed by a hydrophobic filter membrane 31.The functional section AF forms, on the side facing away from the coupling section AK, a chamber 50 in which an activated carbon filter 52 is accommodated in a sealingly enclosing manner on the edge side. The activated carbon filter 52 is constructed in such a way that it can adsorb the hazardous constituents of the gases that may escape during priming of the infusion set 40 and thus clean the emerging air in such a way that it no longer represents a risk for the user of the infusion set or for the patient.The chamber 50 is in the form of an axially extending hollow prism in which the activated carbon filter 52 is accommodated with an exact fit. The cross-section of the chamber 50 can be varied within wide limits; it can be, for example, circular or polygonal, such as rectangular. Thus, in the embodiment of Fig. 6, the chamber 50 receives the activated carbon filter 52 and the hydrophobic filter membrane 31.The embodiment of the prime-stop cap 229 according to FIG. 7 differs from the embodiment according to FIG. 6 in that an activated carbon filter 252 is used which itself has hydrophobic properties. Thus, a hydrophobic filter membrane can be omitted.The illustrations of FIGS. 6 and 7 do not show in detail how the coupling section AK of the prime stop caps 129, 229 is connected to the luer lock patient connector 33. Different variants are possible here. The coupling section AK can be connected, for example, in a releasable manner to the luer lock patient connector 33, preferably to form a unit that can be handled in a single manner.The coupling section AK can also be bonded, welded, pressed or connected in some other way in a difficult-to-release manner, for example by means of a snap connection, to the Luer lock patient connector 33.The use of the prime stop caps with a luer lock connector 33 of a CSTD infusion set 40 has been described above. The above-described prime stop caps can, however, also be used at a wide variety of locations of a medical fluid line system, in particular an infusion set, such as e.g. a female dry break 3 or an injection port of a CSTD infusion set 40.The invention thus provides a prime-stop cap for a medical fluid line system, in particular a CSTD infusion set, having a coupling section for fluid-tight connection to a connector and a functional section for receiving a hydrophobic filter material. In order to simplify priming of the medical fluid line system and at the same time make it safer when using more dangerous medications (such as cytostatics), the functional section forms, on the side facing away from the coupling section, a chamber in which an activated carbon filter is accommodated in a enclosed manner.List of reference characters1 CSTD system 3, 3* first coupling adapter part (female dry break) 4 housing 5 fluid channel component 6 (luer lock) coupling 7 proximal flange-on side 9 membrane 10 cheeks as guide surfaces in 4 11 undercuts 12 side inner walls 13 second coupling adapter part (male dry break) 15 housing 16 undercuts 17 piston 18 receiving opening in 15 19 hollow needle 20 anchor sleeve 21 latching arms 23 (central) through channel 25 coupling or flange-on side 25 of second coupling adapter part 13 27 membrane 29, 129, 229 PrimeStop cap 30 fluid line 31 hydrophobic filter membrane 33 luer lock patient connector 50 chamber 52, 152, 252 activated carbon filterReferences included in the specificationThis list of documents cited by the applicant has been produced in an automated manner and is only included for the better information of the reader. The list is not part of the German patent application or utility model application. The DPMA does not take any adhesion for any faults or omissions.Patent Literature citedWO 2022 232405 A1

[0006]

Claims

A prime stop cap (129; 229) for a medical fluid line system, in particular a CSTD infusion set (40), having a coupling section (AK) for fluid-tight connection to a connector (33) and a functional section (AF) for receiving a hydrophobic filter material (31; 252), characterized in that the functional section (AF) forms, on the side facing away from the coupling section (AK), a chamber (50) in which an activated carbon filter (52; 252) is accommodated in a enclosed manner.The prime stop cap (129; 229) of claim 1, characterized in that the chamber (50) receives the activated carbon filter (52) and a hydrophobic filter membrane (31).The prime-stop cap (129; 229) according to claim 1, characterized in that the activated carbon filter (252) is hydrophobic.A prime-stop cap (129; 229) according to any one of claims 1 to 3, characterized in that the chamber (50) is in the form of an axially extending hollow prism.The prime stop cap (129; 229) according to any one of claims 1 to 4, characterized in that the coupling section (AK) is detachably connected to the connector (33), preferably connected to form a unit that can be handled in a single manner.Prime-stop cap (129; 229) according to one of Claims 1 to 4, characterized in that the coupling section (AK) is bonded, welded, pressed or connected to the connector (33) in a manner which is difficult to release in some other way, for example by means of a snap connection.Use of the prime stop cap (129; 229) according to any one of claims 1 to 6 with a luer lock connector (33) of a CSTD infusion set (40)Use of the prime stop cap (129; 229) according to any one of claims 1 to 6 with a female dry break (3) of a CSTD infusion set (40).Use of the prime stop cap (129; 229) according to one of claims 1 to 6 with an injection port of the infusion set (40).

Images