Prime-stop cap

Abstract

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

Description

[0001] Prime Stop Cap

[0002] Description

[0003] The present disclosure relates to a prime stop cap for use in medical fluid conduit systems, particularly infusion sets.

[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] 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, which can also be equipped with corresponding injection connections for medicinal substances or drugs.

[0008] State of the art

[0009] CMR drugs, which are used in cancer therapy, for example, primarily damage growth-intensive tumor cells during therapeutic application. Many of these drugs themselves have carcinogenic properties due to their mechanism of action. To prevent contact with CMR drugs by people not undergoing treatment, so-called "closed system transfer devices" (CSTDs) are increasingly being used in the manufacture and administration of ready-to-use preparations. An important component of CSTDs are coupling systems, also known as dry breaks, which enable the safe transfer of CMR drugs and, after the connection has been separated, seal the device dry, thus protecting the surrounding area from contamination (e.g., through leaks or the formation of drops 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 Simpliva), ChemoLock (from ICU medical), Equashield (from Equashield) or PhaSeal (from BD).

[0010] One embodiment of such a "vial-to-vein closed system drug transfer device" (CSTD system), i.e., a closed / self-sealing vial liquid withdrawal / transfer device, is described by way of example in the document WO 2022 232405 A1, the disclosure of which is expressly incorporated into the present application, and is shown in Figures 1 and 2, to which reference is already made here. Figures 1A and 1B each show sectional views of the CSTD system in the uncoupled (Figure 1A) and coupled (Figure 1B) states. Figure 2 shows the CSTD system in a perspective view.

[0011] As shown in Figures 1A and 2, this CSTD system 1 comprises a first coupling adapter part 3, hereinafter referred to as a female dry break, having 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 side 7 by means of 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 coupling the first coupling adapter part 3 can be connected to a medical device, for example to a vial / ampoule containing a medicinal agent. The housing 4 or the fluid channel component 5 of the first coupling adapter part 3 also form a number of locking elements in the form of undercuts 11.

[0012] The CSTD system 1 further comprises a second coupling adapter part 13, referred to below as the Male Dry Break, comprising a housing 15 which forms a number of locking elements in the form of undercuts 16, a carriage or piston 17 mounted so as to be relatively displaceable in the housing 15, a hollow needle 19 mounted so as to be relatively displaceable in the piston 17, 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.

[0013] 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.

[0014] From the illustration in Figure 2, it can be seen that the arrangement is such that the two housing parts 4 and 15 can be pushed together in a rotationally secure manner. This is made possible by the housing 15 having a receiving opening 18 with a rectangular cross-section, 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 in cooperation with side inner walls 12 of the receiving opening

[0015] 18 take on a guiding function and ensure anti-twisting protection.

[0016] Fig. 1 B shows the function of the CSTD system 1 according to Fig. 1 .

[0017] 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, whereby 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.

[0018] 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 connected via the hollow needle

[0019] 19 is in fluid connection with the fluid channel 5 of the first coupling adapter part 3.

[0020] Separating / disconnecting both coupling adapter parts 3, 13 takes place in exactly the reverse order, whereby after disengaging the locking arms 21 by means of a button, 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 without any liquid being able to drip from the syringe or the vial / fluid line system. An important component of such CSTDs are therefore the two coupling adapter parts (dry connections / dry breaks), which enable the safe transfer of liquid (medicine) and, after separating / disconnecting the connection, provide a dry seal in order to protect the environment from contamination (e.g.by leaks or droplets forming 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 on 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 provided 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 be assumed that both coupling adapter parts of the CSTD system will seal dry after disconnection and that the internal channels of both coupling adapter parts will remain tightly closed.

[0021] With higher-quality infusion sets (infusion equipment) used in infusion therapy, as shown by way of example in Figure 3 and designated 40, the use of so-called Prime-Stop caps is becoming more common. This Prime-Stop cap, designated by reference numeral 29 and shown in detail in Figures 4 and 5, is placed on the patient side onto 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 not 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.

[0022] The Prime Stop cap can therefore remain in place at the patient-side end of the infusion set line 30 during priming / filling without any leakage of liquid medication or its aerosols, thus contaminating the environment. This protects both the user and the patient, and saves valuable working time, as the line can be filled automatically and unattended. Despite the protection against liquid leakage, there is still a risk that gases from dangerous medications (such as cytostatics) could escape into the environment through the hydrophobic filter membrane 31, thus endangering the user.

[0023] 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 improved safety for the user.

[0024] This problem is solved by a prime stop cap having the features of patent claim 1.

[0025] According to the invention, an activated carbon filter is enclosed in the Prime-Stop cap, i.e. installed in such a way that there is no longer any risk of dangerous gases escaping. The activated carbon filter can adsorb the dangerous components of the escaping gases and thus purify the escaping air so that it no longer poses a danger to the user of the infusion set or to the patient. It has been found that such an activated carbon filter can be made quite small in volume, i.e. can be limited to just a few cubic centimeters, so that the Prime-Stop cap only needs to be slightly larger than a conventional cap and no changes need to be made to the coupling section to ensure a secure hold on the connector.

[0026] An additional activated carbon filter can be installed behind the hydrophobic filter membrane on the patient side. Alternatively, or in addition, an activated carbon filter with hydrophobic properties can be installed directly.

[0027] If the chamber housing the activated carbon filter is shaped like an axially extending hollow prism, the activated carbon filter can be easily mounted from the axially open side of the hollow prism. The prism can be polygonal or circular in shape, allowing the activated carbon filter to be designed with a simple geometry.

[0028] According to one variant, the Prime-Stop cap can be detachably connected to the connector, for example, a patient connector, which simplifies the modular design of the medical fluid line system. This variant also allows the Prime-Stop cap to be connected to the connector to form a single, manageable unit.

[0029] If, on the other hand, the Prime-Stop cap is welded, pressed or otherwise connected to the connector in a way that is difficult to separate, for example by means of a snap connection, a particularly compact structure is created, which allows a further reduction in the installation volume.

[0030] The Prime Stop cap can be installed at various locations in a medical fluid line system, particularly a CSTD infusion set. Advantageous uses are the subject of claims 7 to 9.

[0031] Exemplary embodiments of the invention are explained in more detail below using schematic drawings. They show:

[0032] Figures 1A, 1B and 2 show a CSTD system of known structure and function;

[0033] Figure 3 shows an infusion set with a conventional Prime Stop cap mounted on a Luer Lock connector;

[0034] Figures 4 and 5 show detailed views (top view and section according to VV) of the Prime Stop cap according to Figure 3;

[0035] Figure 6 shows the top view of a first embodiment of the Prime Stop cap according to the invention;

[0036] Figure 6A shows the sectional view of the Prime Stop cap according to Figure 6 with a cut according to AA in Figure 6;

[0037] Figure 7 shows the top view of another embodiment of the Prime Stop cap according to the invention; and

[0038] Figure 7A shows the sectional view of the Prime Stop cap according to Figure 7 with a cutting line according to AA in Figure 7;

[0039] Figures 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 a 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 particular, the hydrophobic filter material is accommodated in the functional section AF. In the illustrated embodiment, the filter material is formed by a hydrophobic filter membrane 31.

[0040] 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 sealed around the edges. The activated carbon filter 52 is designed to adsorb the hazardous components of the gases that may escape during priming of the infusion set 40 and thus purify the escaping air so that it no longer poses a danger to the user of the infusion set or to the patient.

[0041] The chamber 50 is shaped like an axially extending hollow prism, in which the activated carbon filter 52 is precisely accommodated. The cross-section of the chamber 50 can be varied within wide limits; for example, it can be circular or polygonal, such as rectangular. In the embodiment according to Figure 6, the chamber 50 thus accommodates the activated carbon filter 52 and the hydrophobic filter membrane 31.

[0042] The embodiment of the Prime-Stop cap 229 according to Figure 7 differs from the embodiment according to Figure 6 in that it uses an activated carbon filter 252, which itself has hydrophobic properties. Thus, a hydrophobic filter membrane can be omitted.

[0043] The illustrations in Figures 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. Various variants are possible here. For example, the coupling section AK can be detachably connected to the Luer-Lock patient connector 33, preferably to form a uniformly manageable unit.

[0044] The coupling section AK can also be glued, welded, pressed or otherwise connected to the Luer-Lock patient connector 33 in a manner that is difficult to detach, for example by means of a snap connection.

[0045] The use of the Prime-Stop caps with a Luer-Lock connector 33 of a CSTD infusion set 40 was described above. However, the Prime-Stop caps described above can also be used at various locations in a medical fluid line system, in particular an infusion set, such as on a female dry-break 3 or an injection port of a CSTD infusion set 40.

[0046] The invention thus provides a prime-stop cap for a medical fluid line system, in particular a CSTD infusion set, comprising a coupling section for fluid-tight connection to a connector and a functional section for receiving a hydrophobic filter material. The hydrophobic filter material is preferably accommodated in the functional section. To simplify priming of the medical fluid line system and simultaneously increase safety when more dangerous medications (such as cytostatics) are used, the functional section forms a chamber on the side facing away from the coupling section, in which an activated carbon filter is enclosed.

[0047] List of reference symbols

[0048] I CSTD system

[0049] 3, 3* first coupling adapter part (Female Dry Break)

[0050] 4 housings

[0051] 5 Fluid channel component

[0052] 6 (Luer Lock) coupling

[0053] 7 proximal flange side

[0054] 9 Membran

[0055] 10 cheeks as guide surfaces in 4

[0056] II Undercuts

[0057] 12 side interior walls

[0058] 13 second coupling adapter part (Male Dry Break)

[0059] 15 housings

[0060] 16 undercuts

[0061] 17 pistons

[0062] 18 aperture in 15

[0063] 19 hollow needle

[0064] 20 anchor sleeve

[0065] 21 Locking arms (central) through-channel Coupling or flange side 25 of the second coupling adapter part 13 Membrane , 129, 229 PrimeStop cap Fluid line Hydrophobic filter membrane Luer Lock Patient connector Chamber , 152, 252 Activated carbon filter

Claims

Patent claims 1. Prime-Stop cap (129; 229) for a medical fluid line system, in particular a CSTD infusion set (40), with 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 a chamber (50) on the side facing away from the coupling section (AK), in which chamber an activated carbon filter (52; 252) is received.

2. Prime-Stop cap (129; 229) according to claim 1, characterized in that the chamber (50) accommodates the activated carbon filter (52) and a hydrophobic filter membrane (31).

3. Prime-Stop cap (129; 229) according to claim 1, characterized in that the activated carbon filter (252) is hydrophobic.

4. Prime stop cap (129; 229) according to one of claims 1 to 3, characterized in that the chamber (50) has the shape of an axially extending hollow prism.

5. Prime-Stop cap (129; 229) according to 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 uniformly manageable unit.

6. Prime-Stop cap (129; 229) according to one of claims 1 to 4, characterized in that the coupling section (AK) is glued, welded, pressed or otherwise connected to the connector (33) in a manner that is difficult to detach, for example by means of a snap connection.

7. Use of the Prime Stop cap (129; 229) according to one of claims 1 to 6 with a Luer Lock connector (33) of a CSTD infusion set (40) 8. Use of the prime stop cap (129; 229) according to one of claims 1 to 6 with a female dry break (3) of a CSTD infusion set (40).

9. 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).

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