System and method for administering different medicaments and / or solutions from separate iv containers, and associated set as CSTD reconnect iv filter adapter

Abstract

A system is described, in particular a CSTD infusion set, for administering different medicaments and / or solutions, including hazardous medicaments, e.g. CMR drugs, from separate IV containers (C1 to Cn) which can be attached, in each case via a dedicated container adapter (CA) composed of spike (32) and female dry break (34), to a common infusion line (30) with male dry break (40). The special feature consists in that a CSTD reconnect infusion filter adapter (50) is provided which can be installed optionally, i.e. when so required, between the infusion line (30) and the container adapter (CA) and which is composed of an infusion line section (60) with infusion filter (70) integrated therein, a male dry break (13) fitted at the upstream end, and a female dry break (3) lying at the downstream end.

Description

[0001] System and method for administering different medications and / or solutions from separate IV containers, as well as associated set as CSTD Reconnect IV Filter Adapter

[0002] Description

[0003] The present disclosure relates to a system and a method for administering different medications and / or solutions from separate IV containers, as well as an associated set as an optionally usable CSTD Reconnect IV Filter Adapter for a medical fluid line system, in particular for an infusion set.

[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. 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] For administering CMR drugs or other dangerous medications, a so-called 'CSTD Reconnection System' is already available on the market, as shown, for example, in Figure 3. The main component is the reconnection of the shared infusion line 30 from one container C1 to Cn to the other, since infusion therapy (especially cancer therapy using CMR drugs) often involves administering multiple medications sequentially from different IV containers. Normally, when administering CMR or other toxic medications, an infusion line with a spike would not be removed from one IV container and reconnected to another IV container, as a spike is an open system, and reconnecting it would pose a risk to the environment, caregivers, and patients with toxic medications.

[0022] In the CSTD Reconnection System - as shown in Figure 3 - a separate Container Adapter CA is used for each container C1 to Cn. The Container Adapter consists of a conventional Spike 32 on one side and a Female Dry Break 34 on the other side. For each IV container C1 to Cn required for the therapy, a separate Container Adapter CA is used, which cannot be removed from the respective container during the entire preparation and administration process (and also afterwards).

[0023] IV container is removed. The infusion line is transferred from one IV container to another via the dry break coupling, as each CSTD Reconnect infusion line 30 has a male dry break 40 connector.

[0024] CSTD-Reconnect infusion lines are available with and without an integrated inline infusion filter (pore size 0.2 pm). An inline infusion filter with a pore size of 0.2 pm serves to retain particles, bacteria, and fungi that would otherwise be infused unhindered into the patient. This poses a significant risk, especially for critically ill patients, including cancer patients.

[0025] Studies have shown that many risks can be significantly reduced through the use of inline infusion filters. For many medications, the use of infusion filters is therefore explicitly prescribed in the Summary of Product Characteristics (SmPC) and is also supported by numerous guidelines, such as:

[0026] ESPGHAN / ESPEN / ESPR / CSPEN - Guidelines on Pediatric Parenteral Nutrition {2018): "PN solutions may be administered through a terminal filter: Lipid emulsions {or all-in-one mixes) can be passed through a membrane pore size of 1.2 - 1.5 pm; aqueous solutions can be passed through a 0.22 pm filter 1 '

[0027] ASPEN - Update on the Use of Filters for Parenteral Nutrition (2020): "using a 1.2 micron in-line filter for administration of total nutrient admixtures (TN As), dextroseamino acid admixtures and Lipid injectable emulsion (ILE)"

[0028] ASPEN 2021 : "healthcare organizations that da not filter PN admixtures or ILE reevaluate these decisions and consider the small price of filters in comparison to increased morbidity and mortality that may result from not filtering ILE or PN." WoCoVa - Consensus on the clinical use of in-line filtration during intravenous infusions (2021 ): "in-line filters may play a role in reducing systemic complications in the pediatric and neonatal populations, particularly in the critically ill or in children receiving PN [. .. ]. More clinical studies are needed."

[0029] INS - Infusion Therapy Standards of Practice (Jan. 2021 , Vol. 44): "Consider filtration of solutions and medications to:

[0030] Reduce microbubbles {<1 mm in diameter) of air entrained in infusion solutions and medications. ( ... ),

[0031] Reduce particulate matter in critically ill patients that can cause thrombogenesis, impaired microcirculation, and alter immune response. ( ... ), Reduce the incidence of phlebitis associated with peripheral venous catheters ( ... ). In-line filtration with 0.2-micron filter in surgical patients resulted in a significant reduction in phlebitis rates at 48h ( ... )

[0032] Filter PN solutions with the correct filter pore size.

[0033] Use a 0.2-micron filter for PN solutions without Lipid injectable emulsions (ILEs) and change every 24 hours.

[0034] Use a 1.2-micronfilter for PN solutions containing ILE (also known as total nutrient admixture [TN A]) and change every 24 hours.

[0035] Use a separate 1.2-micron filter for separately infused ILE; attach to an injection site below or after the 0.2-micron filter used for dextrose / amino acid solution. Change the Lipid emulsions filter every 12 hours.

[0036] RKI - Prevention of infections arising from vascular catheters (2017): “For those treated in intensive care, particle filters should be used in the infusion system {air separation, less systemic inflammatory response reaction}." (translated from German)

[0037] French National Authority for Health (Haute Autorite de Sante) (France - 2018): Recommendation for parenteral nutrition in neonatology: "Use antibacterial (0.22 pm) and particulate (1.2 pm) in-line filters. Antibacterial filters cannot be used with lipids." (translated from French) recommend the use of inline infusion filters.

[0038] For certain therapies, several medications are administered consecutively via the same set. However, it may happen that some of the medications must be filtered, while others may not be. A disadvantage of the inline infusion filters integrated into the Reconnection infusion line is that either

[0039] - a set without an infusion filter is used for all medications in the therapy and thus none of the medications are filtered (consequences see above), or

[0040] - a set with an integrated inline infusion filter is used for all medications in the therapy and thus all medications are filtered.

[0041] If inline infusion filters are used for medications that, according to the product information, should not be filtered, there is a risk of the filter becoming clogged. This requires the entire infusion line to be replaced, which, in the context of cancer therapy, is associated with significant risks and costs: - Risk of contamination for the environment, caregivers, and patients: To replace the infusion line, the line filled with CMR or toxic drugs must be disconnected at the patient connection. Since the patient connection is an open system, there is no protection against contamination with toxic medication.

[0042] - Medication errors: Prematurely replacing the infusion line and restarting therapy results in the patient not receiving the prescribed dose and a delay in treatment. This can negatively impact treatment outcomes and cause enormous distress for the patient.

[0043] - Additional workload for nurses: Replacing infusion lines due to clogged infusion filters creates additional workload for nurses. Healthcare facilities are already struggling with a shortage of nurses.

[0044] - Additional costs due to medication loss: Due to the premature replacement of the infusion line, the medication in the line (oncology medications are sometimes very expensive) must be discarded, which entails considerable unnecessary costs for the healthcare facility.

[0045] In addition, clogging of the infusion filters significantly reduces user acceptance of infusion filter systems.

[0046] The use of conventional extension lines with infusion filters is also not an option for drug-specific filtering when using the CSTD Reconnect System. Conventional infusion filter extension lines would be inserted between the infusion line and the patient connection. However, contamination-free disconnection is not possible at this point because the patient connector is an open system. This would also be very cumbersome for the user.

[0047] The invention is therefore based on the object of providing a system and a method for administering dangerous medications, such as CMR drugs, from various IV containers, which succeeds in solving the problems mentioned above with little equipment complexity and with minimal time expenditure for the user.

[0048] This object is achieved with regard to the system by the features of claim 1 and with regard to the method by the features of claim 3. A CSTD Reconnect infusion filter adapter used according to the invention is the subject of claim 4.

[0049] According to the invention, a CSTD Reconnect infusion filter adapter is provided, which comprises a short infusion line or infusion line section with an integrated infusion filter, which is equipped with a male dry break at the upper, i.e., upstream end and a female dry break at the lower, i.e., downstream end. The set thus assembled can thus be used optionally, i.e., as needed, as an intermediate line between a CSTD Container Adapter and the CSTD Reconnect infusion line.

[0050] The system offers the user the significant advantage of drug-specific infusion filter use, meaning it can be used only for those medications that require and / or permit an infusion filter. Disconnection occurs exclusively via the dry break coupling, so there is never any risk of contamination with toxic medications during preparation and administration.

[0051] The other disadvantages mentioned above (medication errors, additional workload for nursing staff, additional costs due to medication loss) are also prevented by using the CSTD Reconnect infusion filter adapter according to the invention.

[0052] An embodiment of the invention is explained in more detail below using schematic drawings. They show:

[0053] Figures 1A, 1B and 2 show a CSTD system of known construction and known function;

[0054] Figure 3 shows a schematic representation of a known CSTD reconnection system for administering different medications from a plurality of IV containers;

[0055] Figure 4 shows an embodiment of a CSTD reconnect infusion filter adapter according to the invention; and; Figure 5 shows a system according to the invention for administering different medications from a plurality of IV containers.

[0056] In Figures 4 and 5, reference numeral 50 designates a set which can be used as an adapter in a system (as shown in Figure 3) for administering a variety of medications and / or solutions, including hazardous medications such as CMR drugs, from separate IV containers C1 to Cn, each equipped with its own CSTD container adapter CA. This set 50 consists of an infusion line piece 60 with an integrated infusion filter 70, a male dry break 13 attached to the upstream end for connection to a container adapter CA, and a female dry break 3 located at the downstream end for connection to a male dry break 40 of a common CSTD infusion line 30. The set 50 thus forms a CSTD reconnect infusion filter adapter.

[0057] The infusion filter can be of conventional design, for example with a pore size in a range of 0.15 to 0.25 pm.

[0058] The special feature of the system is that the CSTD Reconnect infusion filter adapter 50 can optionally be used exclusively when a medication is administered from an IV container that should and may be filtered. Thus, a method is provided for handling a system, in particular a CSTD infusion set, for administering different medications and / or solutions, including dangerous medications such as CMR drugs, from separate IV containers, in which only those IV containers C1 to Cn containing medication solutions that may and / or should be filtered are connected to the common CSTD Reconnect infusion line 30 via a CSTD Reconnect infusion filter adapter 50 described above.

[0059] The system shown and the CSTD Reconnect Infusion Filter Adapter 50 offer the particular advantage that the infusion filter 70 can be used for specific medications. It can therefore only be used for those selected and suitable medications that require and / or permit an infusion filter. Disconnection occurs only via the dry break coupling, so there is no risk of contamination with toxic medications at any time during preparation and administration. All other disadvantages of known systems described above, such as medication errors, additional workload for nursing staff, additional costs due to medication loss, etc., are also prevented by using the CSTD Reconnect Infusion Filter Adapter 50 according to the invention.

[0060] The invention thus creates a system, in particular a CSTD infusion set, for administering various medications and / or solutions, including dangerous medications such as CMR drugs, from separate IV containers, each of which can be connected to a shared infusion line with a male dry break via its own container adapter consisting of a spike and a female dry break. The special feature is that an optional CSTD Reconnect infusion filter adapter is provided, i.e., can be installed as needed between the infusion line and the container adapter. This adapter consists of an infusion line section with an integrated infusion filter, a male dry break attached to the upstream end, and a female dry break located at the downstream end.

[0061] List of reference symbols

[0062] I CSTD system

[0063] 3, 3* first coupling adapter part (Female Dry Break)

[0064] 4 housings

[0065] 5 Fluid channel component

[0066] 6 (Luer Lock) coupling

[0067] 7 proximal flange side

[0068] 9 Membran

[0069] 10 cheeks as guide surfaces in 4

[0070] II Undercuts

[0071] 12 side interior walls

[0072] 13 second coupling adapter part (Male Dry Break)

[0073] 15 Housing 16 Undercuts

[0074] 17 pistons

[0075] 18 aperture in 15

[0076] 19 hollow needle

[0077] 20 anchor sleeve

[0078] 21 locking arms

[0079] 23 (central) through channel

[0080] 25 Coupling or flange side 25 of the second coupling adapter part 13

[0081] 27 Membran

[0082] 30 Infusion line

[0083] CA Container Adapter

[0084] 32 Spike

[0085] 34 Female Dry Break

[0086] 40 Male Dry Break

[0087] 50 CSTD Reconnect Infusionsfilter Adapter

[0088] 60 Infusionsleitungsstück

[0089] 70 Infusionsfilter

Claims

Patent claims 1. System, in particular CSTD infusion set, for administering different medications and / or solutions, including dangerous medications, such as CMR drugs, from separate IV containers (C1 to Cn), each of which can be connected to a common infusion line (30) with a male dry break (40) via its own container adapter (CA) consisting of a spike (32) and a female dry break (34), characterized by a CSTD Reconnect infusion filter adapter (50) which can be optionally installed between the infusion line (30) and the container adapter (CA), which is constructed from an infusion line section (60) with an integrated infusion filter (70), a male dry break (13) attached to the upstream end and a female dry break (3) located at the downstream end.

2. System according to claim 1, characterized by an infusion filter (70) with a pore size in a range of 0.15 to 0.25 pm.

3. Method for handling a system, in particular a CSTD infusion set, for administering different medications and / or solutions, including dangerous medications such as CMR drugs, from separate IV containers (C1 to Cn), each of which can be connected to a common infusion line (30) with a male dry break (40) via its own container adapter (CA) consisting of a spike (32) and a female dry break (34), characterized in that only those IV containers (C1 or C2 or C3 or Cn) which contain medication solutions which may and / or should be filtered are connected to the common infusion line (30) via a CSTD Reconnect infusion filter adapter (50), which is constructed from an infusion line piece (60) with an integrated infusion filter (70), a male dry break (13) attached to the upstream end and a female dry break (3) located at the downstream end.

4. Adapter for use in a system, in particular a CSTD infusion set, for administering a variety of medications and / or solutions, including dangerous medications such as CMR drugs, from separate IV containers (C1 to Cn), each of which can be connected to a common infusion line (30) with a male dry break (40) via its own container adapter (CA) consisting of a spike (32) and a female dry break (34), comprising a set (50) of infusion line piece (60) with an integrated infusion filter (70), a male dry break (13) attached to the upstream end for connection to the container adapter (CA) and a female dry break (3) located at the downstream end for connection to a male dry break (40) of a CSTD infusion line (30).

5. Adapter according to claim 4, characterized by an infusion filter (70) with a pore size in a range of 0.15 to 0.25 pm.

Images