Medical spike with outgassing protection

Abstract

Disclosed is a medical venting device, preferably in the form of an insert or attachment, which has a connection section for connection to an injection and / or venting port of a medical device or component and is equipped or can be equipped with at least one filter which is inserted into or attached to the medical venting device, wherein the filter is an activated carbon filter or contains activated carbon as a filter material.

Description

[0001] The present disclosure relates to a medical venting device and a medical spike set with a spike equipped with a corresponding venting device with cleaning or outgassing protection function. Background of the invention

[0002] In medical technology, fluid supply systems such as infusion sets, extracorporeal blood lines for dialysis machines or heart-lung machines, and similar devices are used to convey fluids such as blood, aqueous solutions, etc., and / or to administer medical agents and medications. Such a medical fluid supply system, for example an infusion set, is usually (but not necessarily always) a tubing system with at least a section of flexible tubing, such as an infusion tube, one of which is proximal (i.e.,The end pointing away from the patient's body, particularly in the case of an infusion set, has a coupling, for example in the form of a Luer lock, a medical spike / pin, or similar connectors for connection to, for example, an infusion container such as an infusion bag or infusion bottle, or to an infusion pump, and its other distal end (i.e., towards the patient's body) has either a connection / coupling (e.g., based on the Luer system) for an injection catheter or similar patient access, or an infusion set-integrated patient access (injection catheter) itself.

[0003] A medical spike, as understood by those skilled in the art, is a rigid tube (piercing spike) tapered at one free end, preferably with a handle formed on it, wherein either a fluid line system as defined above is permanently connected to the opposite end of the rigid tube, or a coupling such as a Luer lock is provided to which, for example, a fluid line system as defined above can be connected. In some cases, such a spike may also be designed with an injection port and / or venting port. Such an injection / venting port is, in some cases, designed and configured to be pierced by a syringe needle in order to inject a medical fluid / medicine via, for example, a hand-operated syringe.Alternatively, such injection ports are also equipped with couplings, especially according to the Luer principle, in order to connect a syringe or the like directly to them.

[0004] Medical spike designs with a so-called dry connection (also known as a vial-to-vein closed system drug transfer device, or CSTD system) already exist. These are frequently used to safely transfer potentially dangerous / toxic medications, for example, from a syringe into an infusion bag / bottle, without any moisture or liquid escaping. Furthermore, the medical spike / prong serves to transport an infusion solution, filled into an infusion container, from the container to the patient via an infusion set / infusion set as described above. Connectors based on the Luer principle, as well as the aforementioned CSTD systems, can be used to connect such an infusion set to the medical spike.When using the spike as a fluid outlet on an infusion container, a vent is required for pressure equalization with non-collapsible containers, such as rigid bottles rather than bags, as otherwise fluid withdrawal would be interrupted. For this purpose, the spike is equipped with an (additional) vent port, which connects to the already connected infusion container either via the fluid outlet channel in the spike or via an air channel running parallel to it within the spike.Alternatively, it is also possible to use the aforementioned injection port as a vent port, for which a filter is inserted into it through which ambient air can be drawn in, especially when infusion fluid is taken from the rigid infusion container and the infusion container does not have its own equalization device.

[0005] The aforementioned “Vial-to-Vein Closed System Drug-transfer Devices” (CSTD systems), i.e., closed / self-sealing vial fluid withdrawal / transfer devices, are well known in the field of medical technology. Examples from WO 2022 232405 A1 illustrate their basic functionality, as detailed in the attached documents. Fig. 1 and Fig. 2 is shown and its content is expressly made the subject of this application.

[0006] According to the Fig. 1. Such a CSTD system has a first coupling adapter part (also referred to as the first dry-break connection component) which is provided or designed at a distal end section, for example, with a Luer lock or similar coupling, in order to be connected, for example, to a vial / ampoule containing a medicinal product or to a fluid line system leading to the patient at a designated location (for example, at a spike). This first coupling adapter part forms or has a housing with an internal fluid channel that is open in the proximal direction, this proximal opening being closed by means of a membrane or similar seal. Furthermore, the housing of the first coupling adapter part preferably forms an undercut on its inner side.

[0007] The CSTD system cited as an example from this prior art further comprises a second coupling adapter component (also referred to as a dry-break syringe component), consisting of a housing with internal undercuts in which a piston with an internal channel is axially movably mounted. A hollow needle is mounted relatively axially displaceable within the internal channel, its proximal end, furthest from the needle tip, being held by an anchor sleeve that rests against the housing or is inserted into a proximal central housing socket. The internal channel is closed at the distal end face of the piston by means of a membrane or similar seal, with the needle tip initially covered by this seal. Finally, the piston of the second coupling adapter component features elastic locking arms extending longitudinally distally and proximally, the proximal and distal end sections of which are formed into locking hooks.Furthermore, the anchor sleeve forms a connection at its proximal end area facing away from the needle, for example for a syringe which is inserted into the . Fig. 1 and Fig. 2, however, is not shown.

[0008] According to the Fig. 2. To achieve an externally closed / self-sealing fluid connection with, for example, a vial or fluid line system, the distal Luer lock connection is coupled to the vial or fluid line system. This creates a fluid-tight connection between the first coupling adapter part and the vial / fluid line system. Next, the syringe mentioned in the example is fluid-tightly coupled to the proximal connection of the second coupling adapter part. Finally, the second coupling adapter part, or rather the piston housed within it, is placed onto the diaphragm of the first coupling adapter part, and the housing of the second coupling adapter part is moved towards the housing of the first coupling adapter part until the locking arms engage with the undercuts of the first and second coupling adapter parts.During this shifting movement, the needle pierces the already adjacent membranes of the first and second coupling adapter parts and establishes a fluid connection between the vial / fluid line system and the syringe.

[0009] To disconnect, the locking arms are disengaged using a button on the second coupling adapter part, releasing all undercuts. The housing of the second coupling adapter part is then retracted relative to the first coupling adapter part, simultaneously pulling the needle out of the two sealingly adjacent diaphragms. Only now do the two diaphragms separate, preventing any liquid from dripping from either the syringe or the vial / fluid system.

[0010] An important component of such CSTDs are the two coupling adapter parts (dry breaks), which enable the safe transfer of liquid (drug) and seal dry after disconnection to protect the surrounding area from contamination (e.g., from leaks or droplet formation on the surfaces of the coupling partners / adapter parts after disconnection). These CSTD coupling adapter parts can be used on various products, not just a vial and a syringe.Among other things, the first coupling adapter part described above (dry-break connection component) could, for example, be connected via its Luer-lock connector to an injection port of the Luer-lock type on an infusion set of this type, particularly a medical spike, in order to subsequently connect a syringe with the corresponding second coupling adapter part (counter-adapter part / dry-break syringe component). It can then also 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. State of the art:

[0011] As mentioned above, the medical spike is used, for example, to administer medication from a syringe into a bag / bottle (e.g., via the injection port) and to deliver the infusion fluid from the infusion bag / bottle into the patient's body via the connected infusion set. For controlled fluid withdrawal from the infusion container, the spike is typically equipped with a vent hole. The opening of this hole is fitted with a filter that draws in air, thus equalizing the pressure inside the infusion bag / bottle (infusion container) during fluid withdrawal. These filters prevent contaminants from the ambient air from entering the infusion container, thereby preventing contamination of the fluid inside.

[0012] If the same spike, equipped with a typical standard filter (e.g., a hydrophobic air particle filter), is used for certain medical purposes such as administering hazardous / toxic medications, hazardous / toxic air (or aerosols) inside the infusion container can escape into the environment via the standard filter, potentially harming doctors, nurses, and pharmacists. The same applies, of course, to patients currently receiving the medication from the infusion container and who must therefore be in close proximity to it.

[0013] In principle, it is possible to install an extraction system or similar device at this location to remove hazardous / toxic gases / aerosols escaping from the ventilation hole / opening. However, this is complex and expensive. Another option is to attach an exhaust pipe, such as a hose, to the ventilation hole to vent the hazardous / toxic gases / aerosols to a more distant location. Similar solutions are used, for example, in automotive engineering to remove battery gases from the engine compartment. However, this measure is complicated to use regularly and therefore not particularly practical. Brief description of the Revelation

[0014] In view of this problem, the purpose of the present disclosure is to provide a medical venting device and preferably a (equipped or equippable) medical component, in particular a spike, which reduces the risk of contamination of ambient air by gases (aerosols) released through a vent hole / opening.

[0015] This problem is solved by a medical venting device and preferably by a medical component, in particular a spike, with the features of the independent claims. Advantageous aspects of the medical venting device and the component (spike) are the subject of the dependent claims, which may also be claimed individually and separately from the other aspects.

[0016] The core of the disclosure therefore consists of equipping the venting device with an activated carbon filter, or activated carbon material for the absorption of hazardous gases, instead of or in addition to a standard filter such as a hydrophobic air particle filter, which in turn is designed and intended to retain dirt particles in the ambient air, thereby reducing the overall risk of the escape of hazardous / toxic air (aerosols) and at the same time reliably compensating for, for example, the internal pressure of a spike or the internal pressure in an (infusion) container connected via the spike.

[0017] The venting device may already be an integral part of the medical component, such as a medical spike, or it may be designed as an attachment, insert, or similar additional part which is mounted or mountable on / in the medical component.

[0018] A preferred design approach to solve the problem of (significant) leakage of hazardous / toxic air (or aerosols) and also of liquid leakage from the ventilation system (blind plug effect) is the use of an activated carbon filter, installed in the following preferred manner:

[0019] The installation or connection of the activated carbon filter in / on the venting device should be designed in such a way that, in addition to the longitudinal air / gas flow through the activated carbon filter that inevitably occurs due to the necessary flow path along the length of the venting device, the additional possibility is created to superimpose this longitudinal air / gas flow with a transverse air / gas flow through the activated carbon filter. This lengthens the flow path within the activated carbon filter / activated carbon material, thus enabling better overall airflow through the activated carbon filter / activated carbon material and therefore more thorough and effective filtration should hazardous / toxic air (or aerosol) escape from the medical component, such as a spike / thorn, via the venting device.

[0020] More specifically, the venting device forms a gas flow path in the longitudinal direction of the venting device or in extension to a vent bore in the medical component (spike), wherein the gas flow path includes / comprises at least one filter compartment for receiving activated carbon (activated carbon filter), with a gas inlet for gases coming from the medical component, such as the spike, and a gas outlet for these gases into the environment, wherein the gas inlet and the gas outlet are offset from each other both in the longitudinal direction and in the transverse direction of the longitudinally extending flow path.

[0021] From a design perspective, the venting device forms a longitudinal / venting duct containing at least one filter compartment housing an activated carbon filter or activated carbon material. The filter compartment is separated from the ambient air by an outer transverse wall (of the duct), which includes an external opening for fluid communication between the filter compartment and the environment. Alternatively or additionally, the filter compartment is separated from the inner venting duct by an inner transverse wall (of the duct), which also includes an internal opening for fluid communication between the filter compartment and the inner venting duct. The outer or inner opening is radially / transversely offset from the central / longitudinal axis of the venting duct.In the case that both passage openings are arranged radially / transversely offset to the longitudinal axis of the channel, both passage openings are additionally offset in the circumferential direction, preferably diametrically opposite each other.

[0022] Preferably, the vent channel has two filter compartments in the axial / longitudinal direction, separated from each other by the inner (channel) transverse wall, in which the inner through-opening is formed off-center to the central / longitudinal axis of the vent channel. The compartment closest to the environment is separated from the environment by the outer (channel) transverse wall, in which the outer through-opening is also formed off-center to the central axis of the vent channel, thus being axially offset from the inner through-opening and (essentially) diametrically opposed to the inner through-opening, or at least angularly offset from it.

[0023] In this preferred configuration, the activated carbon filter is located in the outer compartment closest to the environment, and a (standard) air particle filter, preferably of a hydrophobic type, is located in the other (inner) compartment. Accordingly, air / gas flowing from the medical component first passes through a hydrophobic standard filter / air filter. If liquid is present in the vented (ventilation) channel, it is blocked by the hydrophobic air filter, and the air then passes through the inner opening into the outer compartment containing the activated carbon filter. Finally, the air flows laterally through the filter and exits through the outlet, i.e., through the outer opening.

[0024] Both alternative measures described above create, in addition to the axial gas / air flow, a transverse flow due to the offset of the openings with respect to the longitudinal axis of the duct in the compartment closest to the environment, thus lengthening the flow path within the activated carbon filter. Air filtration with such a system is more effective than with a standard air filter or an activated carbon filter with normal (exclusively axial) flow. It should be noted again that it is not necessary for both of the aforementioned through-openings in the (duct) transverse walls to be offset from each other. Rather, it would suffice if only one of the two through-openings in the (duct) transverse walls were offset from the central axis of the vent duct.

[0025] To provide two compartments for the individual and separate accommodation of filters, the venting device can have a housing preferably divided into two parts in the longitudinal direction of the channel, wherein the first compartment is formed in the first housing part, which is open on a flange side of the first housing part, and the second compartment is formed in the second housing part, which is closed on a flange side of the second housing part by the inner (channel) transverse wall, so that when the second housing part is flanged to the second housing part, the inner (channel) transverse wall closes the first compartment.

[0026] Preferably, the second compartment in the second housing part is open on the inner (channel) transverse wall and is closed by attaching / inserting the venting device to / into the medical component / spike.

[0027] For example, the connection on the housing of the venting device could be a Luer lock. It is also conceivable to equip the venting device with a hinged cover that pivots onto its housing, allowing the external opening to be closed, thus giving the venting device the function of a blanking plug.

[0028] Instead of the aforementioned spike as a medical component with activated carbon venting, the drip chamber of an infusion set could also be considered as the medical component.

[0029] The spike can be connected to an infusion set via a CSTD system, which is preferably located at one of the end sections opposite the spike tip. Instead of using a dry connection at the end according to the CSTD principle, a tube with additional components can also be connected. For example, the spike could have an integrated or directly connected drip chamber with activated carbon venting, as described above.

[0030] Furthermore, if the activated carbon filter itself is hydrophobic, an additional hydrophobic air filter is optional. Brief description of the characters

[0031] The disclosure is explained in more detail below with reference to preferred embodiments and the accompanying figures.

[0032] They show: Fig. 1 and Fig. 2 a CSTD system of known structure and known function, Fig. 3 a venting device according to a first preferred embodiment in combination with a medical spike, Fig. 4 a venting device according to a second preferred embodiment and Fig. 5 a spike with (integrated or directly connected) drip chamber with a venting device according to the disclosure. Character description

[0033] In the Fig. Figure 1 shows a liquid extraction / passage device 1 (generally known by the abbreviation CSTD system) which belongs to the aforementioned state of the art, to which reference is hereby expressly made again.

[0034] This CSTD system 1 comprises a first coupling adapter part 3 with a housing 4 in which an axially extending through-flow fluid channel or fluid channel component 5 is formed or inserted, which is closed at 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 the first coupling adapter part 3 is / can be connected to a medical device, such as a medical fluid supply system or a spike. The housing 4 or the fluid channel component 5 of the first coupling adapter part 3 also forms a number of locking elements in the form of undercuts 11.

[0035] The known CSTD system 1 further has a second coupling adapter part 13 with a housing 15, which forms a number of detent elements in the form of undercuts 16, a piston 17 which is relatively displaceable in the housing 15, a hollow needle 19 which is relatively displaceable in the piston 17 and which is held at its proximal end section (away from the needle tip) by a retaining anchor or an anchor sleeve 20 in the housing 15, and a number of elastically deformable detent arms 21 which are fixed or formed on the piston 17 and are designed and configured to engage with both the undercuts 11 of the first coupling adapter part 3 and the undercuts 16 of the second coupling adapter part 13.

[0036] For the relatively movable mounting of the hollow needle 19 in the piston 17, the piston has a (central) through-channel 23, which is closed by means of a membrane 27 at a distal coupling or flange side 25 of the second coupling adapter part 13. Such a second coupling adapter part 13 serves, for example, to connect a syringe to an injection port or an infusion set to a spike.

[0037] The Fig. Figure 2 shows the function of the CSTD system 1 according to the Fig. 1.

[0038] Accordingly, to establish a fluid connection between the first and second coupling adapter parts 3, 13, the diaphragm 27 of the second coupling adapter part 13 is pressed against the diaphragm 9 of the first coupling adapter part 3 in a sealing manner during a first movement window. During a second movement window, the housing 15 of the second coupling adapter part 13 is moved further forward towards the housing 4 of the first coupling adapter part 3. This further forward movement causes the hollow needle 19 to pierce both adjacent diaphragms 9, 27, thereby establishing a fluid connection between the through-flow fluid channel 5 and the hollow needle 19. The movement of the second coupling adapter part 13 during the second movement window ends with the locking arms 21 engaging in the undercuts 11 and 16 of the two coupling adapter parts 3, 13.

[0039] As explained above, the hollow needle 19 is held at its proximal end by the anchor sleeve 20, which also serves as a connection / connector for, for example, a syringe, and whose interior is in fluid communication with the fluid channel 5 of the first coupling adapter part 3 via the hollow needle 19.

[0040] The separation / disconnection of both coupling adapter parts 3, 13 takes place in exactly the reverse order, whereby after disengaging the locking arms 21 by subsequently moving the second coupling adapter part 13 away from the first coupling adapter part 3, the hollow needle 19 is first pulled out of the two diaphragms 9, 27 (i.e. according to the aforementioned second movement time window) and then (i.e. according to the aforementioned first movement time window) the two diaphragms 9, 27 are lifted apart from each other.

[0041] Fig. Figure 3 now shows a medical component, preferably in the form of a spike 31, on which a (main) connection, preferably as a first coupling adapter part 3 according to the CSTD principle described above for connecting, for example, an infusion set of known design (not shown further), and a venting device 33 according to the present disclosure are arranged.

[0042] The venting device 33 has a housing with a spike connection 35, for example according to the Luer principle, and a cap 37 formed integrally with the connection 35, which constitutes an outer transverse wall and in which an outer vent bore 39 (outlet of a first compartment 41) is formed. The cap 37 and the connection 35 together form a first compartment 41, which is fluidly connected to the outer vent bore 39. An activated carbon filter 43 and a hydrophobic particle filter 45 are housed in this first compartment 41 in the longitudinal direction of the venting device, with the activated carbon filter 43 being positioned closer to the cap 37 than the particle filter 45, which is located below the cap 37.The first compartment 41 is open on the underside of the venting device 33, facing away from the cap 37, and is only closed to the outside by means of a corresponding venting connection on the medical component / spike 31 when the venting device is mounted. The venting connection, the first compartment 41, and the external venting bore 39 together form a venting channel or venting passage, which defines a flow path along which (filtered) gases / aerosols can escape from the medical component / spike 31 into the environment.

[0043] The cap 37 forms a number of spacer ribs on its underside facing the compartment 41, against which the activated carbon filter 43 rests, with (air) gaps forming between the spacer ribs, which ensure better airflow around and through the activated carbon filter 43.

[0044] In the Fig. Finally, a cover 47 hinged to the housing of the venting device 33 can be seen, with which the venting bore 39 can be temporarily closed.

[0045] The Fig. Figure 4 shows a venting device 33 according to a second preferred embodiment.

[0046] In this case, the housing of the venting device 33 consists of two housing parts 33a and 33b, wherein the outer housing part 33a is formed with the outer vent bore 39 and the inner housing part 33b, located below it, forms the connection 35. Furthermore, the cover 47 is hinged to the outer (upper) housing part 33a, with which the outer vent bore 39 can be closed.

[0047] According to the Fig. 4 The outer (upper) housing part 33a forms the first compartment 41, in which the activated carbon filter 43 is housed. In this case, the outer (upper) housing part 33a represents the outer transverse wall in which the outer vent hole 39 is located. The first compartment 41 is centrally located with respect to the connection 35, with the outer vent hole 39 being positioned off-center, i.e., radially offset from the central axis of the connection 35 or the first compartment 41. Finally, the first compartment 41 is open on its inner or lower side with respect to the cap 37 and is only closed by the second housing part 33b. For this purpose, the second housing part 33b has an (upper) partition or closing wall 49, which forms an inner transverse wall in which an inner vent hole 51 is formed. Below the partition or closing wall 49, i.e.,A second, inner compartment 53 is formed between the partition or closing wall 49 and the vent connection / connection section of the venting device 33. This compartment houses the hydrophobic air particle filter 45, which is fluidly connected to the activated carbon filter 43 via the inner vent bore 51. According to the second embodiment, the vent connection, the inner second compartment 53, the inner vent bore 51, the outer first compartment 41, and the outer vent bore 39 together form the vent channel that defines the flow path.

[0048] As in the Fig. As shown in Figure 4, the inner vent bore 51 is preferably also offset from the central axis of the connection or the outer first compartment and further preferably on the side diametrically opposite the outer vent bore 39. In this way, the flow path within the first compartment 41 does not run exactly coaxially to the central axis of the connection or the first compartment 41, but the flow path has a component in the transverse or radial direction to connect the two vent bores 39 and 51.

[0049] The Fig. Figure 5 shows an alternative medical component in the form of a spike 31 equipped or designed with a drip chamber 55, wherein in this case the venting device 33 is arranged on the drip chamber, whereas the venting connection on the spike may be closed by a blanking plug 57. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2022 232405 A1

[0005]

Claims

[1] Medical venting device (33), preferably in the form of an insert or attachment, which has a connecting section for connection to an injection and / or venting port of a medical device or component (31) and an external through-hole or venting bore (39) and is or can be equipped with at least one filter (43) which is inserted into or placed in the medical venting device (33), characterized by that the filter (43) is an activated carbon filter or contains activated carbon as a filter material. [2] Medical venting device (33) according to claim 1, characterized by an outer transverse wall (37) which separates the activated carbon filter (43) from the external environment and which has the outer through- or venting bore (39) which fluidly connects the activated carbon filter (43) to the external environment. [3] Medical venting device (33) according to claim 2, characterized byan inner transverse wall (49) which, together with the outer transverse wall (37), forms a first compartment (41) for receiving the activated carbon filter (43) and which has an inner through-hole or venting bore (51) which is provided and designed to fluidically connect the first compartment (41) to the injection and / or venting port of the medical device or component (31). [4] Medical venting device (33) according to claim 2, characterized by a housing with two separate, interconnectable housing parts (33a, 33b), of which one housing part (33a) forms the outer transverse wall (37) and the first compartment (41) and the second housing part (33b) forms the inner transverse wall (49) closing the first compartment (41) and a second compartment (53) on a side of the inner transverse wall (49) facing away from the first compartment (41). [5] Medical ventilation device (33) according to one of the preceding claims, characterized by that an additional air particle filter (51), preferably a hydrophobic air particle filter, is provided, which is arranged on a side of the activated carbon filter (43) facing away from the outer through- or venting bore (39). [6] Medical ventilation device (33) according to claims 4 and 5, characterized by that the additional air particle filter (51) is accommodated in the second compartment (53). [7] Medical spike set with a spike (31), comprising a tapered piercing tube section forming a fluid supply and / or fluid removal channel and a vent port opening into the fluid supply and / or fluid removal channel or into a secondary channel extending parallel thereto in the piercing tube section, characterized by a medical venting device (33) according to one of claims 1 to 6. [8] Medical spike set according to claim 7, characterized by that the spike (31) has a connection which is provided and designed for connecting the medical venting device (33). [9] Medical spike set according to claim 7, characterized by that the spike (31) is directly coupled to a drip chamber (55) or is formed integrally therewith, preferably in one piece, wherein the medical venting device (33) is arranged on the drip chamber (55).

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