Medical Infusion Set and Method for Preparing It for Use
Patent Information
- Authority / Receiving Office
- IL · IL
- Patent Type
- Applications
- Current Assignee / Owner
- B BRAUN MELSUNGEN AG
- Filing Date
- 2024-12-17
- Publication Date
- 2026-08-01
AI Technical Summary
The existing medical fluid line systems, particularly infusion sets, face challenges in efficiently and safely priming and filling with medical fluids, especially when handling cytostatic drugs, which can be hazardous due to their carcinogenic properties and potential for gas leakage.
A pre-assembled medical fluid line system with end-side dry-break couplings, where both couplings are designed as male dry-breaks, and the male dry-break associated with the infusion catheter can be connected to a female dry-break equipped with a prime-stop function, simplifying the priming process and ensuring safety against fluid and gas leakage.
The proposed solution significantly simplifies the priming process of medical fluid line systems, reduces the risk of contamination and gas leakage, especially when handling cytostatic drugs, and enhances user safety and efficiency during infusion therapy.
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Abstract
Description
[0001] Medical infusion set and method for preparing it for use
[0002] Description
[0003] The present disclosure relates to a medical fluid line system, in particular an infusion set, and a method for preparing it for use.
[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 therapy, 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, form a dry seal, 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. From the illustration according to Figure 2, it can be seen that the arrangement is such that the two housing parts 4 and 15 can be pushed into one another in a rotationally secure manner. This is made possible by the fact that the housing 15 has 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 inner side walls 12 of the receiving opening
[0014] 18 take on a guiding function and ensure anti-twisting protection.
[0015] Fig. 1 B shows the function of the CSTD system 1 according to Fig. 1 .
[0016] 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.
[0017] 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
[0018] 19 is in fluid connection with the fluid channel 5 of the first coupling adapter part 3.
[0019] Separating / deconnecting both coupling adapter parts 3, 13 takes place in exactly the reverse order, wherein 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 out of the syringe or the vial / the fluid line system.
[0020] 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).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.
[0021] Higher-quality infusion sets (infusion equipment) used in infusion therapy are now using so-called prime-stop caps. An example of such a prime-stop cap is shown in Figures 3 and 4. Before an infusion set is connected to the patient, the set's line must be primed (filled with fluid without any air bubbles) to prevent air from entering the patient's bloodstream.
[0022] If a Prime Stop cap is not available, the user must connect the infusion set line to a container of fluid, remove the protective cap on the patient side, and fill the line with fluid (usually by gravity) until the first drops emerge from the patient end of the line. These drops must be collected, which requires additional effort from the staff. Furthermore, each individual line must wait for a specific time until it begins to drip.
[0023] Using a Prime-Stop cap (designated by reference numeral 29 in Figures 3 and 4) instead of a normal protective cap has the advantage that the liquid is automatically retained at the patient end of the infusion set line during priming / filling (reference numeral 30). Unlike a normal protective cap, the Prime-Stop cap is equipped with an additional hydrophobic filter membrane 31 through which gases can escape from the line, but not liquid. Therefore, the Prime-Stop cap can remain at the patient end of the infusion set line during priming / filling without any liquid medication or its aerosols escaping and thus contaminating the environment. On the one hand, this protects both the user and the patient, and on the other hand, it saves valuable working time, as the line can be filled automatically and without supervision.
[0024] Despite the protection against liquid leakage, there is still a risk that gases from dangerous medications (such as cytostatics) will escape into the environment via the hydrophobic filter membrane 31 and thus endanger the user.
[0025] In infusion therapy, especially in the administration of CMR drugs, methods have already been proposed to address such problems. This approach is explained below with reference to Figures 5 to 7:
[0026] In principle, it is conceivable to use a dry break (preferably a male dry break 13) on both ends of the infusion set lines 30. As shown in Figure 5, a male dry break 13 can be installed directly on the container side and a standard Luer Lock patient connector 33 on the patient side, which can accommodate a PrimeStop cap 29.
[0027] In this state, the infusion set line 30 can be filled. This is done using a separate container 35 with non-toxic infusion solution. As shown in Figure 6, the infusion line with the male dry break 13 is connected to the container 35 via a container spike 37 with a female dry break 3 at the end. Filling is performed on the patient side, depending on the patient's needs, with or without the prime stop function.
[0028] After filling, a male dry break 13 can then be connected on the patient side via the Luer Lock patient connector 33, as shown in Figure 7. In this way, a filled (primed) infusion line, closed at both ends by the male dry breaks 13, could be assembled for the infusion process. This line can be connected to a container containing toxic medication via a container spike with a female dry break and, on the patient side, to a patient connection with a female dry break. Connecting and disconnecting the lines is safe, as the dry break couplings, thanks to their closed and dry-sealing function, cannot contaminate either the environment or the user with toxic medication.
[0029] The invention is based on the object of improving the process of filling / priming the medical fluid line system.
[0030] This object is achieved by a medical fluid line system, in particular a CSTD infusion set, having the features of patent claim 1 and by a method having the features of patent claim 8.
[0031] The special feature of the invention is that it provides a pre-assembled, saleable infusion set module in which both end-side dry-break coupling parts are designed as male dry-breaks, and in which the male dry-break assigned to the infusion catheter can be connected to a female dry-break with a prime-stop function. In this way, the user can avoid the subsequent work step of screwing the male dry break onto the Luer Lock connection, because the infusion set module can be delivered directly with two dry breaks at the end. The medical fluid line system can be opened on the patient side via a first female dry-break, and fluid can be withdrawn from the container via a second female dry-break via a container spike to prime or fill the medical fluid line system.The priming and filling process is thus considerably simplified by integrating a PrimeStop function into the female dry break associated with the infusion catheter.
[0032] In this way, the process for priming a CSTD infusion set can be greatly simplified. The required steps are limited to: a) providing a CSTD infusion set module with end-side dry-break couplings, one of which is configured for connecting an infusion container or an infusion pump and the other for connecting an infusion catheter, wherein it is available as a pre-assembled, ready-to-sell infusion set module in which both end-side dry-break coupling parts are designed as male dry-breaks; b) connecting female dry-breaks on both sides, of which the female dry-break connectable to the male dry-break associated with the infusion catheter is equipped with a prime-stop function; and c) priming the CSTD infusion set module
[0033] The Prime-Stop function can advantageously be provided by equipping the female dry-break associated with the infusion catheter with a known Prime-Stop cap, thereby simplifying the construction of the medical fluid line system.
[0034] According to one variant, the Prime-Stop cap can be detachably connected to the female dry-break, simplifying the modular design of the medical fluid line system. This variant also allows the Prime-Stop cap to be connected to the female dry-break to form a single, manageable unit.
[0035] The Prime-Stop cap can be glued, welded, pressed or connected to the Female Dry-Break in any other way that is difficult to separate, for example by means of a snap connection.
[0036] The Prime-Stop function is advantageously provided by a hydrophobic filter membrane integrated into the Female Dry-Break or the Prime-Stop cap.
[0037] This hydrophobic filter membrane can also be combined with an activated carbon filter.
[0038] In this case, the handling procedure can be further simplified; in this variant, the priming of the CSTD infusion set module can be carried out with any drug to be administered, even dangerous ones.
[0039] Alternatively, the activated carbon filter itself can be made hydrophobic and integrated into either the female dry-break or the prime-stop cap. According to one advantageous variant, the dry-break couplings are equipped with joining surfaces that provide anti-twist protection when the dry-break couplings are connected. This ensures that the dry-break couplings remain precisely aligned during the joining process.
[0040] Exemplary embodiments of the invention are explained in more detail below using schematic drawings. They show:
[0041] Figures 1A, 1B and 2 show a CSTD system of known construction and known function;
[0042] Figures 3 and 4 show a known arrangement of a prime stop cap (29, 129) on a Luer lock connector;
[0043] Figures 5 to 7 show stages of assembling a CSTD infusion set to provide a primed system;
[0044] Figure 8 shows an infusion set module as a component of the medical fluid line system according to the invention;
[0045] Figure 9 shows the infusion set module shown in Figure 8, completed for priming the medical fluid line system according to a first variant;
[0046] Figure 10 shows the infusion set module shown in Figure 8, completed for priming the medical fluid line system according to a further variant;
[0047] Figure 11 shows the view of a female dry-break coupling (3, 3*) with prime-stop function according to a first embodiment;
[0048] Figure 12 shows the sectional view according to Xll-Xll in Figure 10;
[0049] Figure 13 shows the view of a female dry-break coupling (3, 3*) with prime-stop function according to a second embodiment;
[0050] Figure 13A shows the sectional view according to AA in Figure 13;
[0051] Figure 14 shows the view of a female dry-break coupling (3, 3*) with prime-stop function according to a third embodiment;
[0052] Figure 14A is the sectional view along AA in Figure 14;
[0053] Figure 15 shows the view of a female dry-break coupling (3, 3*) with prime-stop function according to a fourth embodiment;
[0054] Figure 15A shows the sectional view along AA in Figure 15; Figure 16 shows the view of a female dry-break coupling (3, 3*) with prime-stop function according to a fifth embodiment;
[0055] Figure 16A is the sectional view along AA in Figure 16;
[0056] Figure 17 shows the view of a female dry-break coupling (3, 3*) with prime-stop function according to a sixth embodiment; and
[0057] Figure 17A shows the sectional view according to AA in Figure 17.
[0058] In Figure 8, reference numeral 40 denotes a section of a medical fluid line system, namely a CSTD infusion set. This section is designed as a preassembled, ready-to-sell infusion set module. This infusion set module has a male dry-break coupling 13 on each side of the fluid line 30, in which, for example, a drip chamber 42 and a flow regulator 44 are provided. The function of this dry-break coupling 13 was explained above with reference to Figures 1 and 2. One of these couplings, the container-side coupling, is designed for connecting an infusion container or an infusion pump, and the other, the patient-side coupling, is designed for connecting an infusion catheter.
[0059] This infusion set module 40 can be prepared for priming in a simple manner. To do so, as shown in Figure 9, the male dry break 13 assigned to the infusion catheter, i.e., the patient-side dry break, is connected to a female dry break 3* with a prime stop function. On the other side, the fluid line 30 is connected to the container 35 via the male dry break 13 and a container spike 37 with a conventional female dry break 3 at the end. In this state, the medical fluid line system can be primed, i.e., filled with fluid.
[0060] The required Prime-Stop function can be provided by a hydrophobic filter membrane integrated into the Female Dry-Break or into a Prime-Stop cap.
[0061] In the embodiment shown in Figure 9, the Prime Stop function is integrated into the female dry-break 3* in such a way that a hydrophobic blocking element is installed in the female dry-break. Details of such a female dry-break 3* are shown in Figures 13 and 13A. A hydrophobic filter membrane 31 is located at the front end of an axial extension 46 of the housing 4 facing away from the membrane 9.
[0062] Figures 10 to 12 show a variant in which the Prime-Stop function is provided by a Prime-Stop cap 29 attached to a conventional female dry-break 3—for example, as shown in Figure 2—in which a hydrophobic filter membrane 31 is seated. The Prime-Stop cap 29 can be detachably connected to the female dry-break, preferably connected to form a single, manageable unit. It can be glued, welded, pressed, or otherwise connected to the female dry-break 3 in a manner that is difficult to detach, for example, by means of a snap connection.
[0063] With the variants described above, the priming of the medical fluid line system must be carried out with a non-toxic infusion solution.
[0064] To further improve the handling of the medical fluid line system and allow immediate priming with medications (such as cytostatics) whose gases must not be released into the environment and thus endanger the user, an activated carbon filter can be integrated into the Female Dry-Break. These variants of the Female Dry-Break are shown in Figures 14 to 17.
[0065] The embodiment of the Female Dry-Break 3* according to Figure 14 differs from the embodiment according to Figure 13 in that the extension 46 of the housing 4 projecting beyond the hydrophobic filter membrane 31 has an extension 48 for forming a chamber in which an activated carbon filter 52 is accommodated.
[0066] In the variant of the Female Dry-Break 3* shown in Figure 15, whose housing is essentially the same as that shown in Figure 14, a modified, hydrophobic activated carbon filter 152 is used, allowing it to fulfill the prime-stop function. The hydrophobic filter membrane can thus be omitted.
[0067] The variants in Figures 16 and 17 are characterized by the fact that the activated carbon filters are integrated into a modified Prime Stop cap.
[0068] The embodiment according to Figure 16 shows a prime-stop cap 131, which still accommodates a hydrophobic filter membrane 31, but which forms an axial extension 148 for accommodating an activated carbon filter 52. Finally, the embodiment according to Figure 17 corresponds to that of Figure 16 with regard to the design of the prime-stop cap 129. However, a hydrophobic activated carbon filter 152 is used there, so that a hydrophobic filter membrane can be omitted. The prime-stop function is thus provided by the activated carbon filter 152 alone.
[0069] All variants of the female dry-breaks shown have in common that they preferably have a housing with axially aligned cheeks 10, as shown in Figure 2. These cheeks are received with a fit in the polygonal or rectangular opening 18 of the male dry-break 13 when the dry-break coupling parts are joined, so that an anti-twist device is provided.
[0070] Of course, modifications to the described embodiments are possible without departing from the basic concept of the invention. The medical fluid line system can also be used elsewhere in an infusion system if the goal is to simplify the priming process. For example, the medical fluid line system can also be combined with an infusion set module with an injection port.
[0071] The invention thus provides a medical fluid line system, in particular a CSTD infusion set, with end-side dry-break couplings, one of which is designed for connecting an infusion container or an infusion pump, and the other for connecting an infusion catheter. To improve the filling / priming process of the medical fluid line system, it has a preassembled, ready-to-sell infusion set module. Both end-side dry-break coupling parts of the infusion set module are designed as male dry-breaks, with the male dry-break associated with the infusion catheter being connectable to a female dry-break with a prime-stop function.
[0072] List of reference symbols
[0073] 1 CSTD system
[0074] 3, 3* first coupling adapter part (Female Dry Break)
[0075] 4 Housing fluid channel component
[0076] (Luer Lock) coupling proximal flange side
[0077] membrane
[0078] Cheeks as guide surfaces in 4
[0079] undercuts
[0080] Side inner walls second coupling adapter part (Male Dry Break)
[0081] Housing
[0082] undercuts
[0083] Pistons
[0084] Receiving opening in 15
[0085] hollow needle
[0086] Anchor sleeve
[0087] locking arms
[0088] (central) through channel
[0089] Coupling or flange side 25 of the second coupling adapter part 13
[0090] Membrane, 129 PrimeStop cap
[0091] Fluid line hydrophobic filter membrane
[0092] Luer Lock patient connector
[0093] container
[0094] Container spike
[0095] Infusion set module
[0096] Drip chamber
[0097] flow regulator
[0098] Process, 148 extension
[0099] Chamber, 152 activated carbon filters
Claims
Patent claims 1. Medical fluid line system, in particular CSTD infusion set, with end-side dry-break couplings, one of which is designed for connecting an infusion container or an infusion pump and the other for connecting an infusion catheter, characterized by the design as a pre-assembled, ready-to-sell infusion set module (40), in which both end-side dry-break coupling parts are designed as male dry-breaks (13), wherein the male dry-break (13) assigned to the infusion catheter can be connected to a female dry-break (3*) with a prime-stop function.
2. Medical fluid line system according to claim 1, characterized in that the prime-stop function is provided by a hydrophobic filter membrane (31) integrated into the female dry-break (3) or into a prime-stop cap (29).
3. Medical fluid line system according to claim 2, characterized in that the hydrophobic filter membrane (31) is combined with an activated carbon filter (52).
4. Medical fluid line system according to claim 1, characterized in that the prime-stop function is provided by a hydrophobic activated carbon filter (152) integrated into the female dry-break (3*) or into a prime-stop cap (29).
5. Medical fluid line system according to one of claims 2 to 4, characterized in that the prime stop cap (29) is detachably connected to the female dry break (3*), preferably connected to form a uniformly manageable unit.
6. Medical fluid line system according to one of claims 2 to 4, characterized in that the Prime-Stop cap (29) is glued, welded, pressed or otherwise connected to the Female Dry-Break (3*). is difficult to detach, for example by means of a snap connection.
7. Medical fluid line system according to one of claims 1 to 6, characterized in that the dry breaks (3, 13) have axially extending joining surfaces (cheeks 10, inner side walls 12) arranged in a polygon.
8. A method for handling a CSTD infusion set, comprising the following steps: a) providing a CSTD infusion set module with end-side dry-break couplings, one of which is designed for connecting an infusion container or an infusion pump and the other for connecting an infusion catheter, wherein it is present as a pre-assembled, ready-to-sell infusion set module (40), in which both end-side dry-break coupling parts are designed as male dry-breaks (13); b) connecting female dry-breaks (3) on both sides, of which the female dry-break (3) connectable to the male dry-break (13) assigned to the infusion catheter is equipped with a prime-stop function; and c) priming the CSTD infusion set module (40).
9. The method according to claim 8, wherein the priming is carried out by means of a non-toxic infusion solution.
10. The method according to claim 8, wherein the female dry break (3) connectable to the male dry break (13) associated with the infusion catheter is equipped with an activated carbon filter (52; 152), and the CSTD infusion set module (40) is primed with a drug to be administered.
11. The method according to claim 10, wherein the activated carbon filter (152) is hydrophobic.