Withdrawal and delivery spike

Abstract

The invention relates to a withdrawal and delivery spike (10) for withdrawing and delivering medical liquids, comprising a piercing spike (16) for establishing a fluid connection to a first container (42), wherein the piercing spike (16) is arranged on a handle part (20), and wherein the piercing spike (16) comprises a venting-channel section (24) of the venting channel (14) and a liquid-channel section (22) of a liquid channel (12), and comprising a connecting port (32) for establishing a fluid connection to a second container (44). A movable section (40) is formed between the connecting port (32) and the handle part (20) such that the connecting port (32) and the handle part (20), together with the piercing spike (16) arranged thereon, can be moved relative to one another, in particular can be pivoted relative to one another.

Description

[0001] Applicant:

[0002] B. Braun Melsungen AG

[0003] Carl-Braun-Straße 1

[0004] 34212 Melsungen

[0005] General Power of Attorney: 752200.6

[0006] 03910042WC 19.02.2026

[0007] BUR / SPE

[0008] Title: Extraction and Feeding Spike

[0009] Description

[0010] The invention relates to a dispensing and feeding spike for extracting medical fluids from containers.

[0011] In human and veterinary medicine, injections, infusions, and other procedures are used to administer medical fluids for therapeutic purposes. For example, an injection involves introducing a fluid containing a drug into a patient's bloodstream. The fluid is often drawn from a container, such as a bottle or vial, using an injection syringe. A container can hold a single dose or multiple single doses of the fluid. Alternatively, the container can be filled with a dry substance that is dissolved in a solvent introduced into the container before injection.

[0012] The opening of such a container is closed, for example, with a sealed port, a septum, or a plug.

[0013] As an alternative to the described procedure of piercing the septum or stopper with the injection needle and withdrawing an injection dose of fluid from the vial using the syringe connected to the injection needle, an adapter for the vial can be used. Connecting the adapter to the vial establishes a fluid connection to the interior of the vial, for example, by a hollow prong or similar device piercing the septum. The adapter has a fluid port that is in fluid contact with the hollow prong, allowing fluid to be withdrawn from or added to the vial. This fluid port could be, for example, a connector for a push-fit connection, such as a Luer connector.The connection preferably has a female Luer cone, since injection syringes and other devices for fluid withdrawal typically have a male Luer cone. The Luer connection can be of the "Luer-Slip" or "Luer-Lock" type. The fluid connection can also be a connection with a different type of coupling element. Such an adapter is also known as a withdrawal spike or a closed system transfer device. A withdrawal spike, such as the one described in patent EP 1 192 927 Bl, has a piercing pin with a vent channel and a fluid channel. The piercing pin is connected to a handle. This handle has a connecting nozzle that is linked to the fluid channel.When using the extraction spike, the piercing pin is inserted into the container, for example, through a suitable stopper. A syringe or hose is then connected to the connector. Liquid can then be drawn from the container into the syringe or hose via the extraction spike. The container and the syringe or hose are positioned opposite each other by means of the extraction spike, with the openings of the container and syringe facing each other.

[0014] Point the hose in opposite directions.

[0015] For example, the container holding the liquid can be hung upside down, with the syringe opening facing upwards. This allows liquid to flow downwards into the syringe during dispensing, while air is drawn upwards into the container. The dispensing spike is also suitable for adding liquid to the container. To add liquid to the container, the container is inverted so that the syringe is positioned above it, and the liquid is added from above. However, a problem with this method is that when adding liquid from the syringe into the container from above, it is not possible to expel air from the syringe. This is only possible if the syringe is held with the opening facing upwards.However, if the syringe is held with the opening facing upwards, the container is again located above the syringe, and the backflow of air from the syringe into the container carries the risk of blocking the ventilation filter, as liquid, especially due to the higher pressure in the container, can enter the ventilation channel.

[0016] The invention is based on the objective of creating a removal spike that enables improved handling, in particular improved ergonomics and improved use also in automated systems, thereby eliminating the problems described above.

[0017] This problem is solved with a removal and feeding spike according to claim 1.

[0018] According to claim 1, a dispensing and feeding spike for dispensing medical fluids from containers and feeding fluids into containers is provided. The dispensing and feeding spike comprises a fluid channel for providing a fluid connection between two containers, a vent channel for providing pressure equalization, and a piercing mandrel for establishing a fluid connection with a first container, wherein the piercing mandrel is arranged on a handle portion, and wherein the piercing mandrel comprises a vent channel section and a fluid channel section. The dispensing and feeding spike further comprises a connection nozzle for establishing a fluid connection with a second container, wherein the connection nozzle comprises an insertion channel connected to or connectable to the fluid channel.The first container is, for example, a receptacle holding a suitable liquid and sealed with a suitable stopper. The second container is, for example, a syringe that can be connected to the fitting. The fitting is appropriately designed.

[0019] A fluid connection between the container and the syringe is provided via the fluid channel of the extraction and supply spike.

[0020] According to the invention, a movable section is formed between the connecting nozzle and the handle part, together with the piercing pin arranged thereon, so that the connecting nozzle and the handle part, together with the piercing pin arranged thereon, are movable relative to each other, in particular pivotable relative to each other. The liquid channel can run through the movable section or be formed through the movable section.

[0021] The extraction and feeding spike according to the invention eliminates the need for a rigid coupling between the two containers, in particular the syringe and the container.

[0022] Rather, the two containers with an existing fluid connection can be moved relative to each other, and thus brought into different positions relative to one another. In particular, the containers no longer necessarily have to be arranged opposite each other. For example, the containers with an existing fluid connection can be moved relative to each other into a position where they are opposite each other and their openings point in opposite directions. This could, for example, be a first operating position of the extraction and feed spike.

[0023] For example, the containers with an existing fluid connection can be moved relative to each other into a position where they are arranged side by side and their openings point in the same direction. This could, for example, be a second operating position for the dispensing and feeding spike.

[0024] Advantageously, the orientation / position of the containers relative to each other can be changed by moving the connecting nozzle and handle part together with the piercing mandrel attached to it by means of the movable section, without breaking the fluid connection between the two containers.

[0025] In an advantageous embodiment, the movable section is designed such that the connecting nozzle and the piercing mandrel can be brought into opposite orientations, and also into the same orientation, particularly parallel orientations. This could, for example, be a second operating position for the dispensing and feeding spike. Opposite orientations mean that the connecting nozzle and the piercing mandrel point in opposite directions, so that a respective container is connected to the connecting nozzle and the piercing mandrel from opposite directions. Same orientations mean that the connecting nozzle and the piercing mandrel point in the same direction, so that a respective container is connected to the connecting nozzle and the piercing mandrel from the same direction.is connected.

[0026] If the connection nozzle and the piercing mandrel are in opposite orientations, the two containers can also be arranged in opposite directions, i.e., one container with the opening facing upwards and one container with the opening facing downwards, and in particular opposite each other. This can, for example, be a first operating position of the dispensing and feeding spike.

[0027] If the connecting nozzle and the piercing mandrel are in the same orientation, the two containers can also be arranged in the same orientation, i.e., both containers with the opening facing upwards (or downwards), particularly side by side. This can, for example, be a second operating position for the dispensing and feeding spike.

[0028] It may be provided that the movable section is designed such that the extraction and feeding spike ( 10) has a substantially straight extension along a longitudinal axis in a first operating position and assumes an extension angled to the longitudinal axis, in particular a double angled or curved extension, in a second operating position.

[0029] The movable section is designed such that, in the first operating position, the extraction and feeding spike runs essentially straight along a longitudinal axis, giving it an outer shape roughly resembling an I. This means that the individual sections of the extraction and feeding spike are aligned relative to each other in this position without any discernible angle, resulting in a nearly linear shape in which the piercing mandrel and the connecting nozzle have opposite orientations. That is, the ends of the extraction and feeding spike point in opposite directions. In the second operating position, however, the extraction and feeding spike is angled relative to the longitudinal axis, in particular double-angled, or bent, in particular semi-circular. In this position, the piercing mandrel and the connecting nozzle, i.e., the ends of the extraction and feeding spike, point in approximately the same direction, giving it an outer shape roughly resembling a U.It can therefore be provided that the extraction and feeding spike in a first operating position essentially comprises a straight extension, for example an I-shape, and in a second operating position essentially an angled shape, for example a U-shape.

[0030] The dispensing and feeding spike can be moved from the first operating position to the second operating position, and vice versa, by means of the movable section, by moving the connecting nozzle and the handle part together with the piercing mandrel arranged thereon relative to each other, in particular by pivoting. It can be advantageous to design the dispensing and feeding spike, in particular the movable section, such that the dispensing and feeding spike, in particular the movable section, can lock or engage in the first and / or the second operating position and / or in intermediate positions, i.e., positions between the first and second operating positions. Suitable locking means can be provided for this purpose. By locking or engaging, the dispensing and feeding spike can remain stable in the respective position.

[0031] Several options are available for the design of the movable section. For example, the movable section is formed by or comprises: at least one articulated connection and / or at least one pivot connection and / or a flexible section.

[0032] A hinge is an example of a flexible joint. A hinge is, for example, multi-part, specifically comprising a hinge axis and a bearing. A hinge can also be a film hinge.

[0033] A rotary joint is, for example, a thread or includes a circumferential groove and a sliding element that slides in the circumferential groove.

[0034] A flexible section comprises a flexible material, such as a suitable plastic, and / or a flexible shape, for example, in the form of a bellows, which is accordion-like and, in particular, foldable. According to one embodiment, the fluid channel in the movable section is formed by a flexible material, for example, in the form of a flexible hose. If the fluid channel runs through the movable section, the flexible hose can be arranged within the movable section. If the fluid channel is formed by the movable section, the flexible hose can form the movable section.

[0035] According to one embodiment, means are provided, in particular snap hooks, for fixing at least one container, or both containers, to the dispensing and feeding spike. The means are advantageously designed such that the container(s) can be temporarily and releasably fixed to the dispensing and feeding spike.

[0036] The connection fitting can be designed, for example, as a Luer or Luer-Lock fitting, as a fitting according to ISO 80369-6 with tamper-evident connectors, in particular an NRFit® fitting, as a self-closing valve, or as a dry coupling. A Luer or Luer-Lock fitting is a standardized connection system for infusions and injections in the medical field. A fitting according to ISO 80369-6 is a standardized system with tamper-evident, small-bore connectors, also known in particular as an NRFit® fitting. This application refers to the ISO 80369-6:2016 version. A self-closing valve can, for example, open when a container is connected to the delivery and delivery spike and close automatically when the container is disconnected. An exposed valve allows for easy disinfection.A dry coupling, for example, seals with a low-leakage valve that ensures drip-free and safe connection and splash-free separation when uncoupling.

[0037] A self-closing valve and / or a dry coupling can also be combined with a Luer or Luer-Lock connection and / or an NRFit® connection.

[0038] The described dispensing and feeding spike is primarily used for manually connecting two containers. However, it can also be used in automated or semi-automated applications.

[0039] Further embodiments relate to a device for the automatic or semi-automatic dispensing of medical liquids from a first container and for the automatic or semi-automatic supply of liquids to a second container. Such a device is, for example, a device for the automatic or semi-automatic preparation of medications. The device comprises holding means for the first container and holding means for the second container, a dispensing and supply spike according to one of the preceding claims for connecting the first container to the second container, and an actuator for moving, in particular pivoting, the first container relative to the second container. The two containers are held on the device by the holding means and can be moved relative to each other by the actuator.

[0040] For example, the two containers can be placed in opposite orientations, i.e., one container with the opening facing upwards and one container with the opening facing downwards, and in particular, arranged opposite each other. Alternatively, the two containers can also be placed in the same orientation, i.e., both containers with the opening facing upwards (or downwards), and in particular, side by side.

[0041] According to one embodiment, the piercing pin of the extraction and supply spike is connectable to the first container for establishing a fluid connection, and the connecting nozzle of the extraction and supply spike is connectable to a second container, in particular a syringe, for establishing a fluid connection, and so that the connecting nozzle with the second container and the handle part together with the piercing pin arranged thereon and the first container are movable relative to each other, in particular pivotable relative to each other.

[0042] The movable, in particular pivotable, and in particular foldable, dispensing and feeding spike also offers the possibility in the device of keeping one of the containers, in particular the second container, in particular the syringe, in an unchanged position during the entire automatic or semi-automatic dispensing of medical fluids, in particular from the first container, and / or feeding of fluids, in particular into the second container. Thus, with such devices, fewer movements of the containers and / or fewer moving parts are required overall. Further advantages will become apparent from the description and the accompanying drawings. Exemplary embodiments of the invention are shown in the drawings and are explained in more detail in the following description.In this context, identical reference symbols in different figures denote identical or at least functionally comparable elements. When describing individual figures, reference may also be made to elements from other figures. They each show, in schematic form:

[0043] Fig. 1 shows a first embodiment of a removal and feeding spike in a side view and partially cut away.

[0044] Fig. 2 a) and b) shows a withdrawal and feed spike according to a further embodiment in a first and a second operating situation with two containers,

[0045] Fig. 3 a) and b) shows a withdrawal and feed spike according to a further embodiment in a first and a second operating situation, in a cutaway view.

[0046] Fig. 1 shows a dispensing and feeding spike 10 for dispensing medical fluids from containers and feeding fluids into containers (not shown in Fig. 1).

[0047] The extraction and supply spike includes a fluid channel 12 to provide a fluid connection between two containers and a venting channel 14 to provide pressure equalization.

[0048] The dispensing and feeding spike comprises a piercing mandrel 16 for establishing a fluid connection with a first container. The piercing mandrel 16 has a tip 18 at one end, in particular for piercing a stopper of a bottle or other container, and is arranged at the opposite end on a handle part 20.

[0049] The handle part 20 is used for gripping with the hand when inserting the piercing pin 16 into a plug, and can be designed accordingly ergonomically.

[0050] The piercing mandrel 16 includes a ventilation channel section 22 of the ventilation channel 14 and a liquid channel section 24 of the liquid channel 12.

[0051] The handle part 20 simultaneously serves as a housing for at least one further section of the liquid channel 12 and another section of the ventilation channel 14. In this example, the handle part 16 also includes a first filter chamber 26 with a liquid filter and a second filter chamber 28 with an air filter. The liquid channel 15 is connected to the first filter chamber 26, and the air channel 16 is connected to the second filter chamber 28.

[0052] The handle section has a ventilation opening 30, which is connected to the second filter chamber 28. In the airflow path, between the air channel 16 and the ventilation opening 30, is a membrane of the air filter contained in the second filter chamber 28. The extraction and supply spike 10 further includes a connection nozzle 32 for establishing a fluid connection with a second container, for example, a syringe, which can be connected to the connection nozzle 32. The connection nozzle 32 is appropriately designed. The connection nozzle 32 includes an insertion channel 34 that is connected to, or can be connected to, the fluid channel 12. In this example, the connection nozzle 32 is designed as a Luer-lock connector 36. Other variants are conceivable. In this example, a valve 38 is provided inside the connection nozzle 32.In the example, valve 38 comprises a self-closing slot or opening structure which is in the closed position shown in the drawing without the influence of external pressure.

[0053] A movable section 40 is formed between the connecting piece 32 and the handle part 20, so that the connecting piece 32 and the handle part 20, together with the piercing mandrel 16 arranged thereon, are movable relative to each other, in particular pivotable relative to each other. The movable section 40 is shown schematically in Fig. 1. The liquid channel 12 runs through the movable section 40.

[0054] Due to the movable section 40, there is no longer a rigid coupling between the two containers, in particular the syringe and the container, as is the case with extraction spikes known from the prior art.

[0055] Rather, the two containers connected to the extraction and supply spike 10, with their existing fluid connection, can be moved relative to each other and thus brought into different positions relative to one another. In particular, the containers no longer necessarily have to be arranged opposite each other. Advantageously, the orientation / position of the containers relative to each other can be changed by moving the connecting nozzle 32 and the handle part 20 together with the piercing mandrel 16 attached thereto by means of the movable section 40, without breaking the fluid connection between the two containers.

[0056] The design and function of the movable section 40 is explained below with reference to Figures 2 a), 2 b), 3 a) and 3 c).

[0057] Figures 2a) and 3a) show, for example, a first operating position of the dispensing and feeding spike 10. Figure 2a) shows two containers 42 and 44, in this example a container 42 and a syringe 44. The container 42 and the syringe 44 are arranged opposite each other, and the openings of the containers 42 and 44 point in opposite directions.

[0058] In the first operating position, the dispensing and feeding spike 10 essentially has a straight extension, for example, an I-shape. The connecting nozzle 32 and the piercing mandrel 16 have opposite orientations, i.e., they point in opposite directions. Accordingly, a respective container 42, 44 is also connected to the connecting nozzle 32 and the piercing mandrel 16 from opposite directions. That is, the two containers 42, 44 are also oriented in opposite directions, i.e., container 44 with its opening facing upwards and container 42 with its opening facing downwards, and in particular, they are arranged opposite each other. In the first operating position, for example, liquid is drawn from container 42 into the syringe 44 located below container 42. In Fig. 3 a), the direction of liquid flow is indicated by arrow 46. Accordingly, when the liquid is taken from container 42, it flows downwards into syringe 44.At the same time, air can enter the container 42 through the ventilation opening 30 via the ventilation channel 14 for pressure equalization, see arrow 48.

[0059] Figures 2b) and 3b) show, for example, a second operating position of the extraction and feed spike 10. The containers 42 and 44 are arranged side by side so that the openings of the containers 42 and 44 point in the same direction.

[0060] In the second operating position, the dispensing and feeding spike 10 essentially has an angled shape, for example, a U-shape. The connecting nozzle 32 and the piercing mandrel 16 have a similar, in particular parallel, orientation, i.e., the connecting nozzle 32 and the piercing mandrel 16 point in the same direction, so that a respective container 42, 44 is connected to the connecting nozzle 32 and the piercing mandrel 16 from the same direction. The two containers 42, 44 are therefore also arranged in the same orientation, i.e., both containers 42, 44 with their openings facing upwards (or downwards), in particular side by side.

[0061] In the second operating position, for example, liquid is supplied from the syringe 44 into the container 42. At the same time, air can be removed from the syringe 44 without the risk of blocking the ventilation channel 14 or the filter chamber 28.

[0062] Due to the illustrated orientation of container 42 and syringe 44 in the second operating position, it is possible for air to be expelled from syringe 44 when liquid is added to the container, as syringe 44 is oriented with its opening facing upwards. Because container 42 is not located above syringe 44, and container 42 is also oriented with its opening facing upwards, there is no risk of blockage of the ventilation channel 14 or the second filter chamber 28. Blockage could occur if container 42 were oriented with its opening facing downwards, as in this case, when liquid is added to container 42, especially due to the higher pressure inside container 42, liquid could enter the ventilation channel 14.

[0063] In Fig. 3 b), the direction of liquid flow is indicated by arrow 50. Accordingly, the liquid flows into container 42 upon supply. Simultaneously, air can escape from container 42 via the ventilation channel 14 and the ventilation opening 30 to equalize the pressure in container 42, see arrow 52.

[0064] Due to the movable section 40, the containers 42 and 44, both connected to the extraction and feed spike 10, can be moved from the first operating position to the second operating position, and vice versa, particularly when a fluid connection is in place. This is achieved by moving the connecting nozzle 32 and the handle part 20 together with the piercing mandrel 16 arranged thereon relative to each other, in particular by pivoting.

[0065] Several options are available for training the movable section 40. According to the

[0066] According to the embodiment shown in Figs. 2 a) and 2 b), the movable section comprises two articulated connections 54. In this example, the articulated connections 54 are designed as a hinge. Each hinge comprises a hinge axis and a bearing. According to the embodiment shown in Figs. 3 a) and 3 b), the movable section comprises a bendable section 56. The bendable section 56 comprises, for example, a flexible form, such as a bellows, which is accordion-like and, in particular, foldable.

[0067] In the examples, the liquid channel 12 in the movable section 40 is formed by a flexible material, for example in the form of a flexible hose. Extraction and supply spike, liquid channel, ventilation channel, piercing mandrel

[0068] Great

[0069] Handle section, liquid channel section, ventilation channel section, first filter chamber

[0070] second filter chamber ventilation opening connection nozzle insertion channel

[0071] Luer-lock connector valve

[0072] movable section of container

[0073] Injection

[0074] Direction of liquid Direction of air Direction of liquid Direction of air articulated connection flexible section

Claims

Patent claims 1. Dispensing and feeding spike ( 10 ) for withdrawing medical fluids from containers ( 42 , 44 ) and feeding fluids into containers ( 42 , 44 ), with a fluid channel ( 12 ) to provide a fluid connection between two containers ( 42 , 44 ), and a ventilation channel ( 14 ) to provide pressure equalization , with a piercing mandrel (16) for making a fluid connection with a first container (42), wherein the piercing mandrel (16) is arranged on a handle part (20), and wherein the piercing mandrel (16) comprises a ventilation channel section (24) of the ventilation channel (14) and a liquid channel section (22) of the liquid channel (12), and with a connecting nozzle (32) for establishing a fluid connection with a second container (44), wherein the connecting nozzle (32) comprises an insertion channel (34) connected to or connectable with the fluid channel (12), characterized in that a movable section (40) is formed between the connecting piece (32) and the handle part (20), so that the connecting piece (32) and the handle part (20) together with the piercing mandrel (16) arranged thereon are movable relative to each other, in particular pivotable relative to each other.

2. Extraction and feeding spike (10) according to claim 1, wherein the movable section (40) is designed such that the connecting nozzle (32) and the piercing mandrel (16) can be brought into an opposite orientation and the connecting nozzle (32) and the piercing mandrel (16) can be brought into a similar, in particular parallel, orientation.

3. Extraction and feeding spike (10) according to claim 1 or 2, wherein the movable section (40) is designed such that the extraction and feeding spike (10) has a substantially straight extension along a longitudinal axis in a first operating position and assumes an extension angled to the longitudinal axis, in particular a double angled or bent extension, in a second operating position.

4. Extraction and feeding spike (10) according to any of the preceding claims, wherein the movable section (40) is formed or comprises at least one articulated connection (54), and / or wherein the movable section (40) is formed or comprises at least one rotary connection, and / or wherein the movable section (40) is a bendable section (56) or comprises a bendable section (56).

5. Removal and feeding spike (10) according to claim 4, wherein the at least one articulated connection (54) is a hinge.

6. Removal and feeding spike (10) according to claim 4, wherein the rotary connection comprises a thread or a circumferential groove with a sliding element.

7. Extraction and feeding spike (10) according to claim 4, wherein the flexible section (56) comprises a flexible material and / or a flexible shape, for example in the form of a bellows.

8. Extraction and supply spike ( 10) according to one of the preceding claims, wherein the liquid channel ( 12 ) in the movable section (40) is formed by a flexible material, for example in the form of a flexible hose .

9. Dispensing and feeding spike ( 10) according to one of the preceding claims, wherein means are provided for fixing at least one container (42, 44 ) , or both containers (42, 44 ) , to the dispensing and feeding spike ( 10 ).

10. Extraction and feed spike ( 10) according to one of the preceding claims, wherein the connection nozzle (32 ) is designed as a Luer or Luer-Lock connection (36) , as a connection according to ISO 80369-6 with non-mixed connectors , as a self-closing valve (38 ) or as a dry coupling .

11. Device for automatically or semi-automatically dispensing medical liquids from a first container (42, 44) and for automatically or semi-automatically dispensing liquids into a second container (42, 44), the device comprising holding means for holding the first container (42, 44) and holding means for holding the second container (42, 44), a dispensing and dispensing spike (10) according to one of the preceding claims for connecting the first container (42, 44) with the second container (42, 44), and an actuator for moving, in particular pivoting, the first container (44) relative to the second container (42, 44).

12. Device according to claim 11, wherein the piercing mandrel (16) of the extraction and feed spike (10) is connectable to the first container (42) for establishing a fluid connection, and the connecting nozzle (32) of the extraction and feed spike (10) is connectable to a second container (44) for establishing a fluid connection, and such that the connecting nozzle (32) with the second container (44) and the handle part (20) together with the piercing mandrel (16) arranged thereon and the first container (42) are movable relative to each other, in particular pivotable relative to each other.

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