Medical spike with outgassing protection

Abstract

The invention relates to a medical ventilation device preferably in the form of an insert or add-on, which has a connection portion for connection to an injection and / or ventilation port of a medical device or component and is equipped or can be equipped with at least one filter which is inserted in or placed on the medical ventilation device, wherein the filter is an activated carbon filter or contains activated carbon as a filter material.

Description

[0001] Medical spike with outgassing protection

[0002] Description

[0003] The present disclosure relates to a medical ventilation device and a medical spike set with a spike equipped with a corresponding ventilation device with cleaning or outgassing protection function,

[0004] Background of the invention

[0005] In medical technology, fluid line systems such as infusion sets, extracorporeal blood lines from / for dialysis machines or heart-lung machines and similar working devices are used, which are intended for the guidance of fluids such as blood, aqueous solutions, etc. and / or for the addition of medicinal substances and drugs. Such a medical fluid line system, for example an infusion set, is usually (but not necessarily always) a hose line system with a hose that is at least partially flexible, for example an infusion hose, one of the proximal (ieaway from the patient's body) end, particularly in the case of an infusion set with a coupling, for example in the form of a Luer Lock, a medical 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 whose other distal end (i.e. 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] A person skilled in the art understands a medical spike to be a rigid tube (piercing spike) tapered at one free end, preferably with a handle formed thereon, wherein at the opposite end of the rigid tube either a fluid line system as defined above is permanently connected or a connection coupling such as a lock is formed, to which, for example, a fluid line system as defined above can be connected. In some cases, such a spike can also be designed with a so-called injection port and / or vent port. In some cases, such an injection / vent port is intended and designed 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 designed with couplings, in particular according to the Luer principle, in order to connect a syringe or the like directly to them.

[0007] Medical spike designs with a so-called dry connection (also known as a vial-to-vein closed system drug-transfer device (CSTD system)) already exist. This is often used to safely transfer potentially dangerous / toxic medications, for example, from a syringe into an infusion bag / infusion bottle without allowing moisture / liquid to escape. In addition, the medical spike / spike is used to transport an infusion solution filled in an infusion container from the infusion container to the patient via an infusion set / infusion equipment as described above. To connect such an infusion set to the medical spike, connectors based on the Luer principle, for example, or the CSTD systems mentioned above, can be used.However, when using the spike as a fluid withdrawal port on an infusion container, venting is required to equalize the pressure on non-collapsible / collapsible containers, i.e., non-bag-shaped containers but, for example, bottle-shaped ones (rigid containers), as otherwise fluid withdrawal would come to a standstill. For this purpose, the spike is equipped with an (additional) vent port, which is connected to the spike tip and thus to the already connected infusion container either via the fluid withdrawal channel in the spike or via an air duct running parallel to it in the spike. Alternatively, it is also possible to use the aforementioned injection port as a vent port. For this purpose, a filter is inserted into it, through which ambient air can be sucked in, particularly when drawing from the rigid infusion container.

[0008] Infusion fluid is withdrawn and the infusion container does not have its own flow equalization device.

[0009] Commonly known in the field of medical technology are the above-mentioned “Vial-to-Vein Closed System Drug-transfer Devices” (CSTD systems), i.e. closed / self-sealing vial liquid withdrawal devices.

[0010] / Transmission devices, for example, from WO 2022 232405 A1 , the basic functioning of which is shown in the attached Fig. 1 and 2 and the content of which is expressly made the subject of this application.

[0011] According to 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 agent or to a fluid line system leading to the patient at a location provided for this purpose (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, wherein this proximal opening is closed by means of a membrane or similar seal. Furthermore, the housing of the first coupling adapter part preferably forms an undercut on the inside.

[0012] The CSTD system cited as an example from this prior art further comprises a second coupling adapter part (also referred to as a dry-break syringe component) consisting of a housing forming an inner undercut, in which a piston with an inner channel is mounted for axial movement. A hollow needle is mounted for relatively axial movement in the inner channel, the proximal end of which, remote from the needle tip, is held by an anchor sleeve that rests against the housing or is inserted into a proximal central housing socket. At the distal end of the piston, the inner channel is closed by a membrane or similar seal, with the needle tip initially covered by this seal. Finally, elastic locking arms extending longitudinally in the distal and proximal directions are provided on the piston of the second coupling adapter part, the proximal and distal end sections of which are shaped into locking hooks.In addition, the anchor sleeve forms a connection, for example for a syringe, at its proximal end region facing away from the needle, which is not shown in Figures 1 and 2.

[0013] According to Fig. 2, to achieve an outwardly closed / self-sealing fluid connection with, for example, a vial or a fluid line system, the distal Luer Lock connection is coupled to the vial or the fluid line system. The first coupling adapter part is thus connected to the vial / fluid line system in a fluid-tight manner. The syringe mentioned as an example is then coupled to the proximal connection of the second coupling adapter part in a fluid-tight manner. Finally, the second coupling adapter part or the piston mounted therein is placed onto the membrane 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 are engaged in the undercuts of the first and second coupling adapter parts.During this sliding movement, the needle pierces the membranes of the first and second coupling adapter parts that are already adjacent to each other and establishes a fluid connection between the vial / fluid line system and the syringe.

[0014] To disconnect, the locking arms are brought out of engagement with all undercuts using a button on the second coupling adapter part and the housing of the second coupling adapter part is pulled back with respect to the first coupling adapter part, whereby the needle is simultaneously pulled out of the two sealingly adjacent membranes. Only now do the two membranes lift off from each other without any liquid being able to drip or drip out of the syringe or the vial / fluid line system.

[0015] 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 provide a dry seal after the connection is separated / disconnected, thus protecting the surrounding area from contamination (e.g., through leaks or droplets forming on the surfaces of the coupling partners / coupling adapter parts after the connection is separated). These CSTD coupling adapter parts can be installed on various products, not just a vial and a syringe.Among other things, the above-described first coupling adapter part (dry-break connection component) could also be connected, for example, to a Luer-Lock injection port of an infusion set of the present type, in particular to a medical spike, via the Luer-Lock connector formed thereon, 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 be dry-sealed after disconnection, and that the internal channels of both coupling adapter parts will remain tightly closed.

[0016] State of the art:

[0017] As indicated above, the medical spike is used, for example, to inject medication from a syringe into a bag / bottle (e.g., via the injection port) and to transport 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 usually equipped with a vent hole. The opening to the environment is in turn equipped with a filter through which air can be drawn in, thus equalizing the pressure inside the infusion bag / bottle (infusion container) during a fluid withdrawal process. Such filters serve to block dirt particles from the ambient air from entering the infusion container, thus preventing contamination of the fluid contained therein.

[0018] If the same spike, equipped with a typical standard filter (e.g., a hydrophobic airborne particle filter), is used for specific medical purposes such as the delivery of hazardous / toxic medications, hazardous / toxic air (or aerosols) within the infusion container can escape through the standard filter into the environment and cause harm to physicians, nurses, and pharmacists. The same applies, of course, to those patients who are currently receiving medication from the infusion container and who therefore need to be in close proximity to the respective infusion container.

[0019] In principle, it is possible to install an extraction device or similar device at this point, for example, which can extract dangerous / toxic gases / aerosols escaping from the ventilation hole / opening. However, this is complex and expensive. It is also possible to attach some kind of exhaust line, for example in the form of a hose, to the ventilation hole, through which the dangerous / toxic gases / aerosols can be diverted to a more distant location. Similar solutions can be found, for example, in automotive engineering for the removal of battery gases from the engine compartment. However, this measure is complicated to use continuously and therefore not particularly practical.

[0020] Brief description of the revelation

[0021] In view of this problem, the object of the present disclosure is to provide a medical ventilation device and preferably a medical component (equipped or equippable therewith), in particular a spike, which reduces the risk of contamination of ambient air by gases (aerosols) released via a ventilation bore / opening.

[0022] This object is achieved by a medical venting device and preferably by a medical component, in particular a spike, having 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 or separately from the other aspects.

[0023] The core of the disclosure is therefore to equip the ventilation device with an activated carbon filter or activated carbon material for absorbing dangerous gases instead of or in addition to a standard filter such as

[0024] (hydrophobic air particle filter), which in turn is designed and constructed to retain dirt particles in the ambient air, thereby reducing the overall risk of dangerous / toxic air (aerosols) escaping and at the same time reliably balancing, for example, the internal pressure of a spike or the internal pressure in an (infusion) container connected via the spike.

[0025] The venting device may already be an integral part of the medical component, such as a medical spike, or may be designed as an attachment, insert or similar additional part which is mounted or can be mounted on / in the medical component.

[0026] A preferred design approach to solving the problem of (heavy) leakage of hazardous / toxic air (or aerosols) and also leakage of liquid from the ventilation system (blind plug effect) is the use of an activated carbon filter, which is installed in the following preferred manner: The installation or connection of the activated carbon filter in / on the ventilation system should be designed in such a way that, in addition to the longitudinal air / gas flow through the activated carbon filter, which is inevitably created as a result of a necessary flow path in the longitudinal direction of the ventilation system, the additional possibility is created to superimpose this longitudinal air / gas flow with a transverse air / gas flow through the activated carbon filter. This extends the flow path within the

[0027] Activated carbon filter / activated carbon material, so that a better flow through the activated carbon filter / activated carbon material as a whole and thus a more thorough, more effective filtration is possible if dangerous / toxic air (or aerosol) from the medical component, such as spike / thorn, should escape via the ventilation device.

[0028] More specifically, the venting device forms a gas flow path in the longitudinal direction of the venting device or in extension to a

[0029] Vent hole in the medical component (spike), wherein the gas flow path includes / comprising at least one filter compartment for accommodating 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 one another both in the flow path longitudinal direction and in the transverse direction of the longitudinally extending flow path.

[0030] From a design point of view, the venting device forms a longitudinal / venting duct which contains at least one filter compartment in which an activated carbon filter or activated carbon material is accommodated. The filter compartment is separated from the ambient air by an outer (duct) transverse wall in which an outer through-opening is formed for fluidly connecting the filter compartment to the environment. Alternatively or additionally to this, the filter compartment is separated from the inner venting duct by an inner (duct) transverse wall in which an inner through-opening is also formed for fluidly connecting the filter compartment to the inner venting duct. The outer or inner through-opening is arranged radially / transversely offset with respect to the central longitudinal axis of the venting duct.In the case that both through-openings are arranged radially transversely offset to the longitudinal axis of the channel, both through-openings are additionally offset in the circumferential direction, preferably arranged diametrically opposite each other.

[0031] Further preferably, the venting duct has two filter compartments, viewed in the axial-Z longitudinal direction, which are separated from each other by the inner (duct) transverse wall, in which the inner through-opening is formed decentrally to the central longitudinal axis of the venting duct. The compartment closest to the environment is separated from the environment by the outer (duct) transverse wall, in which the outer through-opening is also formed decentrally to the central axis of the venting duct, which is thus axially offset from the inner through-opening and (essentially) placed diametrically to the inner through-opening, at least at an angular distance from the inner through-opening.

[0032] In this preferred case, the activated carbon filter is housed in the (outer) compartment closest to the environment, and a (standard) air particle filter, preferably of the hydrophobic type, is housed in the other (inner) compartment. Accordingly, air / gas flows from the medical component first through a hydrophobic standard filter / air filter. If liquid is present in the ventilated (vent) channel, it is blocked by the hydrophobic air filter, and the air then passes through the inner passage 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 passage opening.

[0033] Through both alternative measures as described above, in addition to the axial gas-air flow, a cross-flow is also achieved in the compartment closest to the environment due to the offset of the openings relative to the duct's longitudinal axis, thus extending the flow path within the activated carbon filter. Air filtration is more effective with such a system than with a standard air filter or an activated carbon filter with normal (exclusively axial) flow. It should be noted again that both of the aforementioned through-openings in the (duct) cross walls do not necessarily have to be positioned axially offset. Rather, it would be sufficient if only one of the two through-openings in the (duct) cross walls were positioned axially offset relative to the central axis of the ventilation duct.

[0034] In order to obtain two compartments for the individual and separate accommodation of filters, the venting device can have a housing which is 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-mounting side of the first housing part, and the second compartment is formed in the second housing part, which is closed on a flange-mounting side of the second housing part by the inner (channel) transverse wall, so that when the second housing part is flange-mounted to the second housing part, the inner (channel) transverse wall closes the first compartment.

[0035] Preferably, the second compartment in the second housing part is open on the inner (channel) quench wall and is closed when the venting device is attached / inserted to / into the medical component / spike.

[0036] For example, the connection on the housing of the venting device can be a Luer Lock. It is also conceivable to equip the venting device with a hinged cover that can be pivoted onto its housing, allowing the outer opening to be closed, thus effectively enhancing the venting device's function as a blind plug.

[0037] Instead of the above-mentioned spike as a medical component with activated carbon venting, the drip chamber of an infusion set could also be used as the medical component.

[0038] The spike can be connected to an infusion set using a CSTD system, which is preferably located at an end section opposite the spike tip. Instead of using a dry end connection 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. Furthermore, if the activated carbon filter itself is hydrophobic, an additional hydrophobic air filter is optional.

[0039] Short description of the characters

[0040] The disclosure is explained in more detail below using preferred embodiments with reference to the accompanying figures.

[0041] They show:

[0042] Figs. 1 and 2 a CSTD system of known structure and known function,

[0043] Fig. 3 shows a venting device according to a first preferred embodiment in combination with a medical spike,

[0044] Fig. 4 shows a venting device according to a second preferred embodiment and

[0045] Fig. 5 shows a spike with (integrated or directly connected) drip chamber with a venting device according to the disclosure.

[0046] Character description

[0047] Fig. 1 shows a liquid extraction / transmission device 1 (generally known by the abbreviation CSTD system), which belongs to the state of the art mentioned at the beginning, to which reference is hereby expressly made again.

[0048] In summary, 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 on a proximal flange side 7 by 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 line 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.

[0049] The known CSTD system 1 further comprises a second coupling adapter part 13 with a housing 15 which forms a number of locking elements in the form of undercuts 16, a piston 17 which is mounted in the housing 15 so as to be relatively displaceable, a hollow needle 19 which is mounted in the piston 17 so as to be relatively displaceable and 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.

[0050] 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. 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.

[0051] Fig. 2 shows the function of the CSTD system 1 according to Fig. 1.

[0052] 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 and thereby establish 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.As stated above, the hollow needle 19 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 in fluid communication with the fluid channel 5 of the first coupling adapter part 3 via the hollow needle 19.

[0053] Separating / deconnecting both coupling adapter parts 3, 13 takes place in exactly the reverse order, wherein after disengaging the locking arms 21 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.

[0054] Fig. 3 now shows a medical component, preferably in the form of a spike 31, on which a (main) connection is arranged, preferably as a first coupling adapter part 3 according to the CSTD principle described above, for connecting, for example, an infusion set of known construction (not further shown) and a venting device 33 according to the present disclosure.

[0055] The venting device 33 has a housing with a spike connector 35, for example, based on the Luer principle, and a cap 37 integrally formed with the connector 35, forming an outer transverse wall, in which an outer venting bore 39 (outlet of a first compartment 41) is formed. The cap 37 and the connector 35 together form a first compartment 41 fluidly connected to the outer venting bore 39, in which an activated carbon filter 43 and a hydrophobic particle filter 45 are housed 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 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 this venting connection when the device is mounted on a corresponding venting connection on the medical component / spike 31. The venting connection, the first compartment 41, and the outer venting bore 39 together form a venting channel or passage that defines a flow path along which (filtered) gases / aerosols can escape from the medical component / spike 31 into the environment.

[0056] The cap 37 forms on its (underside) side facing the compartment 41 a number of spacer ribs against which the activated carbon filter 43 rests, whereby (air) gaps are formed between the spacer ribs, which ensure a better flow around and through the activated carbon filter 43.

[0057] Finally, Fig. 3 shows a cover 47 hinged to the housing of the venting device 33, with which the venting hole 39 can be temporarily closed.

[0058] Fig. 4 shows a venting device 33 according to a second preferred embodiment.

[0059] In this case, the housing of the venting device 33 consists of two housing parts 33a, 33b, wherein the outer housing part 33a is formed with the outer venting bore 39 and the inner housing part 33b located underneath forms the connection 35. Furthermore, the cover 47, with which the outer venting bore 39 can be closed, is hinged to the outer (upper) housing part 33a.

[0060] According to Fig. 4, the outer (upper) housing part 33a forms the first compartment 41, in which the activated carbon filter 43 is accommodated. In this case, the outer (upper) housing part 33a represents the outer transverse wall, in which the outer vent hole 39 is introduced. The first compartment 41 is arranged centrally with respect to the connection 35, wherein the outer vent hole 39 is placed decentrally, 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) separating or closing wall 49, which represents an inner transverse wall, in which an inner vent hole 51 is formed. Below the separating or closing wall 49, i.e.Between the dividing or closing wall 49 and the vent connection / connection section of the venting device 33, a second, inner compartment 53 is formed, in which the hydrophobic air particle filter 45 is housed, which is fluidly connected to the activated carbon filter 43 via the inner vent bore 51. According to the second exemplary 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 jointly form the vent channel, which defines the flow path.

[0061] As shown in Fig. 4, the inner vent hole 51 is preferably also axially offset from the central axis of the connection or the outer first compartment and more preferably on the side diametrically opposite the outer vent hole 39. In this way, the flow path within the first compartment 41 does not run exactly coaxially with the central axis of the connection or the first compartment 41, but rather the flow path has a component in the transverse or radial direction to connect the two vent holes 39 and 51 to one another.

[0062] Fig. 5 shows an alternative medical component in the form of a spike 31 equipped or formed 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 can optionally be closed by a blind plug 57.

Claims

Patent claims 1. Medical venting device (33), preferably in the form of an attachment or cap, which has a connection 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 incorporated into or placed in the medical venting device (33), characterized in that the filter (43) is an activated carbon filter or contains activated carbon as a filter material.

2. Medical ventilation 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-hole or vent hole (39) which fluidly connects the activated carbon filter (43) to the external environment.

3. Medical venting device (33) according to claim 2, characterized by an 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 ventilation 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 in 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-hole or vent hole (39).

6. Medical ventilation device (33) according to claim 4 and 5, characterized in that the additional air particle filter (51) is accommodated in the second compartment (53).

7. A medical spike set comprising a spike (31) having a tapered piercing tube section forming a fluid supply and / or fluid removal channel and a venting 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 in 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 in 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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