EXPIRATION VALVE ASSEMBLY AND BREATHING GAS PIPE ASSEMBLY WITH SUCH A

Description

[0001] The present invention relates to an expiratory valve assembly for a ventilator for artificially respirating a patient, comprising an expiratory channel having at one end an expiratory inlet for introducing an expiratory respiratory gas flow into the expiratory channel and an inlet connection formation designed for connection to an expiratory respiratory gas line leading to the patient, and having at its other end an expiratory outlet for discharging expiratory respiratory gas, wherein the expiratory channel has an expiratory valve which is movable by an expiratory respiratory gas flow in the expiration direction from the expiratory inlet to the expiratory outlet into a passage position allowing the expiratory respiratory gas flow to pass through, an inspiratory channel having at one end an inspiration inlet for introducing an inspiratory respiratory gas flow into the inspiration channel and an inlet connection formation designed for connection to a respiratory gas source supplying inspiratory respiratory gas,and which has at its other end an inspiration outlet for discharging inspiratory breathing gas and an outlet connection formation which is designed for connection to an inspiration breathing gas line leading to the patient, a control channel which branches off from the inspiration channel at a branching point and leads to the expiration valve in such a way that the expiration valve can be loaded by inspiratory breathing gas into a blocking position blocking the expiratory breathing gas flow.

[0002] Such an expiratory valve assembly, which is designed to direct both an expiratory and an inspiratory respiratory gas flow, is known, for example, from WO 2021 / 018902 A1.

[0003] The expiratory valve assembly known from WO 2021 / 018902 A1 is part of a breathing gas line assembly, with a hose as a line component connected to the expiratory valve assembly. This hose is designed as a bi-lumen hose such that it contains both the expiratory breathing gas line and the inspiratory breathing gas line within its outermost hose sheath. At its distal longitudinal end, i.e., the end furthest from the patient during operation, the known bi-lumen hose is connected to the expiratory valve assembly. At its proximal longitudinal end, i.e., the end closer to the patient during operation, a Y-connector with a check valve assembly is arranged on the hose.The Y-connector element combines the distally connected breathing gas lines: expiratory and inspiratory breathing gas lines, into a common bidirectional breathing gas line between its distal longitudinal end with two legs and its proximal longitudinal end with one leg.

[0004] The non-return valve assembly is designed to decouple the respiratory gas columns present in the area distal to the non-return valve assembly of the currently inactive breathing gas line, consisting of the inspiratory and expiratory breathing gas lines, from the other, active breathing gas line. This ensures that breathing gas flows only through the active breathing gas line required during the respective ventilation phase.

[0005] However, the Y-connector requires a relatively large amount of space due to the inclusion of the check valve assembly and becomes bulky. This is particularly disadvantageous for the Y-connector, which is always positioned close to the patient.

[0006] The known expiratory valve located in the expiratory channel ensures that the expiratory channel is blocked. When inspiratory gas flows through the expiratory channel in the direction of inspiration during an inspiration phase, the expiratory valve is loaded into the blocked position by diverted inspiratory gas. During spontaneous inspiration, the negative pressure generated by the patient during spontaneous inspiration loads the expiratory valve into the blocked position. In both of the two cases mentioned, a pressure gradient exists between the upstream and downstream sides of the expiratory valve during an inspiration phase, which loads the expiratory valve into the blocked position.

[0007] In the breathing gas line assembly known from WO 2021 / 018902 A1, a check valve in the Y-connector ensures a similar blocking of the inspiratory breathing gas line during expiration. It prevents breathing gas flow in the inspiratory breathing gas line in the expiration direction opposite to the inspiration direction.

[0008] For further background information on the prior art, reference is made to EP 2 663 354 B1.

[0009] The object of the present invention is to provide a technical teaching which makes it possible to block the breathing gas line, which is temporarily inactive during the respective ventilation phase of inspiration and expiration, from flow in the wrong direction for the respective inactive breathing gas line, without having to permanently arrange bulky medical-technical components close to the patient.

[0010] The present invention solves this problem by arranging a one-way valve in the inspiration channel of an expiratory valve assembly of the type mentioned above, which valve allows an inspiratory respiratory gas flow in the inspiration direction from the inspiration inlet to the inspiration outlet and prevents a respiratory gas flow in the opposite direction.

[0011] Advantageously, the expiratory valve assembly, always positioned remotely from the patient on the distal side of a ventilation tube or similar device, ensures that the expiratory breathing gas line is blocked during inspiration and the inspiratory breathing gas line is blocked during expiration. The one-way valve required for this can therefore be arranged in a relatively compact assembly and at a distance from the ventilated patient. Even if the expiratory valve assembly were to increase in volume compared to the expiratory valve assembly known from the prior art due to the inclusion of the one-way valve, this would occur at such a great distance from the ventilated patient that the patient would not be restricted.

[0012] The one-way valve is preferably a simple check valve with a valve seat and a valve body, which, in its closed position closing the inspiratory breathing gas line, physically rests against the valve seat and can be removed from the valve seat to allow flow through the inspiratory breathing gas line. To ensure that flow through the inspiratory breathing gas line is only possible in the inspiration direction, the valve body, at its mounting location in the expiratory valve assembly, can only be lifted off the valve seat along the local inspiration direction. This allows the one-way valve to be moved by the inspiratory breathing gas flow itself into its open position, lifted off the valve seat and thus allowing flow through, while a breathing gas flow in the opposite direction forces the valve body back onto its valve seat and thus into the closed position.

[0013] The valve body can be prestressed into the closed position by an elastic force, for example by a prestressing means such as a prestressing spring or an elastic polymer prestressing element. An advantageous simplification through the smallest possible number of components can be achieved by having the valve body act as its own prestressing element. Therefore, the valve body is preferably deformable between a closed shape and an open shape by the inspiratory respiratory gas flow. In the closed shape, the valve body rests against the valve seat and closes the inspiration channel. In the opening shape, the valve body is at least partially lifted from the valve seat and allows flow through the inspiration channel in the inspiration direction. An additional prestressing component can therefore be omitted.

[0014] According to the present invention, the valve body can be designed as a pivotable flap, wherein in order to realize the above-mentioned deformability between the closed shape and the open shape, a hinge which allows the pivoting movement of the flap-like valve body is preferably designed as a film hinge.

[0015] Alternatively, and preferred due to the possibility of symmetrical flow, the valve body can be designed as a disc, which is held in a central disc region located away from its disc edge, so that the disc edge can move relative to the held central disc region by deformation of the disc transversely to the disc surface. The valve seat can then be formed by an annular surface on which a disc edge region located radially outside the central disc region rests in the closed position of the one-way valve, and from which the disc edge region can be lifted into the open position by deformation of the disc-shaped valve body.

[0016] To hold the valve body, it can have an opening in the central disc area through which a support component passes. The support component preferably has a larger cross-section on both sides of the opening than the opening itself, so that the valve body can be held very effectively in a form-fitting manner by the support component.

[0017] The valve seat and the retaining component of the valve body are preferably formed as a single-piece component. The one-way valve is preferably insertable into the inspiratory channel as a preassembled assembly, comprising the base component with the valve seat and the retaining component. Preferably, the component, particularly preferably as a single-piece component, with the valve seat and retaining component, can be secured in the inspiratory channel after insertion into the latter, either by gluing, welding, such as ultrasonic or friction welding, or simply by frictional engagement between an outer surface of a component wall facing the inner surface of the inspiratory channel wall and the inner surface.To facilitate insertion, the mounting component can be designed to be rotationally symmetrical, at least with its securing section that can be secured to the inspiratory channel, or with repeating sections along the circumferential direction, if the section of the inspiratory channel into which the base component with the one-way valve is inserted is also rotationally symmetrical. In this case, the orientation of the base component relative to the insertion axis is advantageously not important during assembly.

[0018] To facilitate thermal bonding by melting opposing interfaces, such as during welding, at least the securing portion of the base component and the portion of the inspiratory channel that receives it are made of compatible thermoplastics, at least on the opposing and contacting surfaces. Preferably, to simplify manufacturing, the entire base component, including the valve seat and retaining component, and / or the entire inspiratory channel, are formed from compatible thermoplastic materials.

[0019] The valve body, in particular the disc-shaped valve body, can be made of a thermoplastic elastomer or, more generally, of an elastomer, such as silicone. The material of the valve body does not need to be compatible with the material of the valve seat and / or the support component and / or the material forming the inspiratory channel wall. Preferably, it is not compatible in order to avoid undesirable random connections between the valve body and the valve seat and / or the inspiratory channel wall.

[0020] The inspiration direction and the expiration direction are functionally opposite directions, however, this does not mean that the inspiratory respiratory gas flow and the expiratory respiratory gas flow flow in opposite directions at every location in the expiratory valve assembly. The expiratory channel and the inspiration channel may run parallel in sections, but typically do not run parallel along their entire common extension. For example, the expiratory outlet, preferably located in the expiratory valve assembly location, opens into the external environment of the expiratory valve assembly, while the inspiration inlet is connected to a respiratory gas source, such as a pressurized respiratory gas supply and / or a blower or the like.As far as the expiratory channel and the inspiratory channel extend locally parallel on or in the expiratory valve assembly, the expiratory and inspiratory respiratory gas flow in this parallel area usually actually flow in opposite flow directions.

[0021] The inlet connection formation, the inlet connection formation, and the outlet connection formation can have any shape that allows for the connection of another line or another channel. These formations can each be part of a pneumatic quick-release coupling or can simply be formed by either a channel nozzle or a channel bushing. Experts generally know how to connect breathing gas lines to an inlet connection formation and an outlet connection formation. Experts are also aware of how an inlet connection formation can be effectively fluidically connected to a breathing gas supply, such as a container containing pressurized breathing gas or a ventilator with a blower.

[0022] To ensure that the expiratory valve can be loaded into the blocking position by inspiratory breathing gas, regardless of the functionality of the one-way valve, the branch point is preferably located upstream of the one-way valve in the inspiration direction.

[0023] The expiratory valve is preferably designed as a membrane valve known per se, with a membrane that can be deflected orthogonally to its main extension surface as a valve body and with a frontal longitudinal end of a section of the expiratory channel as an annular valve seat on which the valve body rests in the blocking position.

[0024] Preferably, the expiratory valve comprises, in a manner known per se, a radially inner inlet-side expiratory channel section with a valve seat, comprising the expiratory inlet, and an outlet-side expiratory channel section, comprising the expiratory outlet, located radially outside the inlet-side expiratory channel section. Expiratory respiratory gas can only flow from the inlet-side expiratory channel section into the outlet-side expiratory channel section in the flow-through position, i.e., with the valve body lifted from the valve seat. Due to the relatively large diaphragm surface, a chamber can be formed on the side of the preferred diaphragm valve body facing away from the valve seat, which chamber communicates with the control channel, so that inspiratory respiratory gas can flow through the control channel into the chamber and there load the diaphragm valve body toward the valve seat, i.e., into its blocking position.

[0025] The diaphragm valve body preferably has an inspiratory membrane surface which faces the chamber and which can be wetted by inspiratory respiratory gas. On the opposite side, which faces the expiratory inlet, the diaphragm valve body preferably has an expiratory membrane surface which can be flowed against by expiratory respiratory gas from the inlet-side expiratory channel section. When the expiratory valve is viewed in the closed state as a reference state, the expiratory membrane surface is located within the valve seat. The inspiratory membrane surface of the diaphragm valve body which can be wetted by inspiratory respiratory gas is preferably larger than the expiratory membrane surface which can be flowed against by expiratory respiratory gas in order to be able to keep the expiratory valve securely closed by inspiratory respiratory gas during an inspiration process.An advantageous area ratio of inspiratory to expiratory membrane area is in the range of 1.5 to 2. More preferably, the area ratio is in the range of 1.7 to 1.9. The area ratio is particularly preferably 1.8.

[0026] In principle, the inspiratory channel and the expiratory channel can have any desired course between their respective inlets and outlets. However, to avoid unnecessary turbulence and flow resistance, it is preferred that an inspiratory inlet section of the inspiratory channel located closer to the inspiratory inlet than the inspiratory outlet runs along an inspiratory inlet axis. The inspiratory inlet section preferably includes the inspiratory inlet and extends from it.

[0027] For the sake of clarity, it is noted that in the present application, the term "axis" refers to a straight path.

[0028] In WO 2021 / 018902 A1, the valve movement path along which the valve body of the expiratory valve can be lifted from its valve seat runs orthogonally to the inspiration inlet axis. The known valve movement path also runs parallel to an inspiration outlet section, which is closer to the inspiration outlet than to the inspiration inlet. The known inspiration outlet section runs along an inspiration outlet axis. Furthermore, the known valve movement path runs parallel to an expiratory inlet section running along an expiratory inlet axis, which is closer to the expiratory inlet than to the expiratory outlet. With this kinematics of the valve body, gravity can have an adverse effect on the expiratory valve in some operating situations, or at least no beneficial effect on it.

[0029] In principle, the valve body of the expiratory valve is preloaded into the blocking position, usually by the material elasticity of the preferred diaphragm valve body. In order to additionally ensure that gravity forces the expiratory valve into the blocking position in most operating situations and thus increases the functional reliability of the expiratory valve, the expiratory valve assembly discussed here is preferably provided with a valve movement path along which a valve body, in particular the aforementioned diaphragm valve body, of the expiratory valve can be lifted from a valve seat, in particular the aforementioned valve seat, of the expiratory valve from its blocking position and can be brought closer to the valve seat, is inclined relative to the inspiration inlet axis by an angle of incidence in the range of 10° to 45°, preferably in the range of 15° to 35°.The expiratory valve assembly discussed here is preferably used on an emergency ventilator that is carried in medical or accident emergency transport vehicles, such as ambulances, rescue helicopters, etc. Accordingly, the orientation of the expiratory valve assembly during emergency use is unpredictable. The specified positioning of the expiratory valve with respect to the valve movement path has shown that in most operating situations, the expiratory valve assembly is used in such a way that at least a portion of the gravity acting on the valve body forces it into the closed position.

[0030] An advantageously compact expiratory valve assembly in the application situation with additional lines connected to the connection and connecting formations of the expiratory valve assembly can be achieved by having an expiratory inlet section of the expiratory channel located closer to the expiratory inlet than the expiratory outlet run along an expiratory inlet axis. Preferably, the valve movement path is inclined relative to the inspiratory inlet axis about a line parallel to the expiratory inlet axis.

[0031] Preferably, the expiratory inlet axis and the inspiratory inlet axis are oriented orthogonally to each other. The two inlet axes, conceived as passing centrally through the respective channel section, do not need to intersect but can pass each other at a distance.

[0032] Preferably, the valve seat is flat or has a valve seat surface located in a single plane. If the valve seat surface extends along the valve movement path, for example because it is conical or negatively conical, the above-mentioned plane of the valve seat surface is not to be understood as a mathematical plane, but rather as a technical plane with a small extension along the valve movement path.

[0033] If the valve movement path is inclined relative to the inspiration inlet axis as explained above, the valve seat or the plane of extension of the flat valve seat surface is preferably also inclined relative to a plane orthogonal to the inspiration inlet axis. In this case, the valve seat, even a theoretically possible non-flat valve seat, has an approximate approach section inclined toward the inspiration inlet section and a distance section inclined away from the inspiration inlet section and located further away. In order to keep the control channel as short and thus as loss-free as possible, the control channel preferably runs closer to the approach section than to the distance section from the branch point to the expiratory valve.

[0034] The control channel can be designed, at least in sections, as a channel component or channel component section arranged at a spatial distance from the inspiratory channel and / or the expiratory channel. This allows each of these channels to be provided with the smallest possible cross-section, thus enabling the expiratory valve assembly to be provided with the smallest possible construction volume, in contrast to the integrated design of the control channel with at least one channel consisting of the inspiratory channel and the expiratory channel.

[0035] Preferably, the present expiratory valve assembly also envisions allowing any necessary signal lines to run at least partially through the expiratory valve assembly, in particular through at least one channel comprising the inspiration channel and the expiration channel. To ensure that such at least one signal line routed in a channel can be safely routed out of the channel and connected to its communicating device, according to a preferred development of the present invention, at least one passage opening can be formed in a region between the inspiration inlet section and the expiration inlet section and / or in a region between the inspiration inlet section and an inspiration outlet section located closer to the inspiration outlet than the inspiration inlet. This at least one passage opening passes through a channel wall delimiting the inspiration channel and / or the expiration channel.

[0036] The at least one through-opening can be simply penetrated by the at least one signal line. Alternatively, a signal line can physically terminate on the inner side of the channel wall facing the respective channel. To securely position the longitudinal end of the signal line, a receiving formation, such as a plug-in socket, a plug-in collar, or a ring of leaf springs projecting in the same direction from the peripheral edge region of the through-opening, onto or into which the longitudinal end of the signal line can be inserted, can be arranged on the inner side of the channel wall to create a positive receiving engagement with the longitudinal end of the signal line.

[0037] Likewise, a further receiving formation can be arranged on the outside of the respective channel, which is designed in an analogous manner for positioning a longitudinal end of a further signal line that continues the signal line outside the channel carrying the signal line. The further receiving formation can also be, for example, a plug-on socket, a plug-in collar, or a ring of leaf springs projecting in the same direction from the peripheral edge region of the through-opening. The at least one receiving formation can be formed on a separate feedthrough component, which can be inserted and secured in a through-opening.

[0038] If several through-openings are formed, the through-openings are preferably of the same type, as is any plurality of feed-through components.

[0039] To avoid the need for unnecessary curvature of the at least one signal line, the at least one passage opening is arranged, if possible, such that the signal line section adjoining the passage opening or the adjoining further signal line does not have to be routed around channel components. This can be achieved by locating the at least one passage opening downstream of a reference plane in the expiration direction, which is oriented orthogonally to the expiration inlet axis and divides an opening area enclosed by the valve seat into equal surface areas.

[0040] Furthermore, an unnecessary curvature of the signal line can be avoided in that the at least one passage opening and / or a feed-through component optionally inserted into the passage opening runs along a passage axis which is parallel to the expiration inlet axis and / or to an inspiration outlet axis along which the inspiration outlet section extends.

[0041] It should be noted that the signal line typically runs from a sensor located closer to the patient than the expiratory valve assembly, particularly a flow sensor, to the expiratory valve assembly. The signal line can be an electrical signal line that transmits electrical signals. In this case, its curvature is generally uncritical. Especially with frequently used proximal differential pressure flow sensors, two signal lines are provided, each of which, as a hollow pressure line, transmits a respiratory gas pressure upstream of a flow resistance in the flow sensor and a respiratory gas pressure downstream of the flow resistance. Avoiding bends and kinks is helpful for the most precise pressure transmission.

[0042] In principle, it is possible to design the expiratory inlet section and the inspiratory outlet section, both of which functionally face the patient to be ventilated, spatially separate from each other. However, particularly in emergency medicine, the fastest possible setup of a ventilator, and thus also of the expiratory valve assembly, is of decisive advantage. Therefore, it is preferably provided that the expiratory inlet section and the inspiratory outlet section are formed in a common multi-lumen end section. Accordingly, the inlet connection formation and the outlet connection formation can advantageously be formed as a common, preferably one-piece, connection formation.A multi-lumen tube can be connected to this with a single connection process so that both the expiratory breathing gas line is connected to the expiratory channel and the inspiratory breathing gas line is connected to the inspiratory channel at the same time and with only one actuation process, if possible.

[0043] The expiratory valve assembly can be provided as compactly as possible by embodying the inspiratory inlet section, the expiratory inlet section, and the inspiratory outlet section as a single-piece channel component. The single-piece channel component is preferably manufactured using a plastic injection molding process. The single-piece channel component has, preferably also integrally formed thereon, the inlet connection formation, the inlet connection formation, and the outlet connection formation, preferably each as a connecting piece and / or connecting bushing.

[0044] The present invention also relates to a breathing gas line assembly comprising an expiratory valve assembly as described and further developed above, an expiratory breathing gas line, an inspiratory breathing gas line and a flow sensor.

[0045] The expiratory breathing gas line preferably has, at its distal longitudinal end, a distal expiratory coupling formation configured to establish a connection, conducting an expiratory breathing gas flow, with the inlet connection formation of the expiratory channel of the expiratory valve assembly. Likewise, the expiratory breathing gas line has, at its proximal longitudinal end, a proximal expiratory coupling formation configured to establish a connection, conducting an expiratory breathing gas flow, with an expiratory output connection formation at the distal longitudinal end of the flow sensor. Furthermore, the inspiratory breathing gas line has, at its distal longitudinal end, a distal inspiratory coupling formation configured to establish a connection, conducting an inspiratory breathing gas flow, with the outlet connection formation of the inspiratory channel of the expiratory valve assembly.Finally, the inspiratory breathing gas line has a proximal inspiratory coupling formation at its proximal longitudinal end, which is designed to establish a connection conducting an inspiratory breathing gas flow with an inspiratory input connection formation at the distal longitudinal end of the flow sensor.

[0046] To avoid an unnecessarily large number of different lines or hoses that could entangle rescue or medical personnel during an operation, at least one breathing gas line comprising the expiratory and inspiratory breathing gas lines preferably contains at least one signal line, which is designed to transmit detection information from the flow sensor from the proximal to the distal longitudinal end of the at least one breathing gas line. This is the at least one signal line already mentioned above.

[0047] In such a breathing gas line assembly, the one-way valve described above in the inspiratory channel of the expiratory valve assembly is preferably the only one-way valve in the inspiratory breathing gas flow from the inspiratory inlet to the proximal end of the flow sensor. A further valve arrangement in the inspiratory channel or in the entire inspiratory breathing gas line is not functionally necessary.

[0048] Likewise, the expiratory valve is preferably the only valve arrangement in the expiratory channel or particularly preferably in the entire expiratory breathing gas line.

[0049] As already explained above, at least one of the at least one signal line can pass through at least one of the at least one through-openings or can terminate in a receiving recess of a receiving formation for receiving the distal end of the at least one signal line. Possible receiving formations have already been mentioned above.

[0050] To further avoid an unnecessarily large number of lines, especially hoses, which increases the risk of personnel working in the operating area of ​​the breathing gas line assembly becoming entangled and endangering or even interrupting patient ventilation, the expiratory breathing gas line and the inspiratory breathing gas line are preferably formed on a common multi-lumen line component. While the multi-lumen line component, such as a multi-lumen breathing gas hose, can also be connected to spatially separate formations consisting of an inlet connection formation and an outlet connection formation, the multi-lumen line component is preferably connected to the aforementioned multi-lumen end section of the expiratory valve assembly.

[0051] Although the multi-lumen line component can comprise two coaxial, preferably concentric, tubes as a bi-lumen line component, it is preferred that the expiratory and inspiratory gas lines be separated from one another by a septum in the line component that runs along the line component and along its inner diameter, in order to provide approximately equal cross-sectional areas in the inspiratory and expiratory gas lines with approximately equal wall areas per unit length. The line component is preferably a tube.

[0052] In order to load the two breathing gas lines consisting of the expiratory and inspiratory breathing gas lines as evenly as possible by accommodating signal lines, the same number of signal lines are preferably accommodated in the expiratory lumen and the inspiratory lumen, preferably exactly one in each.

[0053] At its proximal longitudinal end, the respiratory gas line assembly, in particular the line component, particularly preferably the multi-lumen line component, can have a proximal coupling component to which the line component, in particular the multi-lumen line component, is connected. The coupling component preferably has, at its distal longitudinal end, an expiratory connection formation for establishing a connection, conducting an expiratory respiratory gas flow, with the expiratory respiratory gas line, in particular with the expiratory lumen of the multi-lumen line component, and an inspiratory connection formation for establishing a connection, conducting an inspiratory respiratory gas flow, with the inspiratory respiratory gas line, in particular with the inspiratory lumen of the multi-lumen line component.The coupling component preferably has a coupling formation at its proximal longitudinal end, which serves as both the proximal expiratory coupling formation and the proximal inspiratory coupling formation. DE102019121712 A1 discloses a breathing gas valve assembly for a ventilation line arrangement of a ventilation device for at least supporting artificial ventilation of a patient.

[0054] The present invention is explained in more detail below with reference to the accompanying drawings. It shows: Fig. 1A is an exploded side view of a distal end of an embodiment of a breathing gas line assembly according to the invention with an embodiment of an expiratory valve assembly according to the invention, Fig. 1B is an exploded side view of a proximal end of the breathing gas line assembly of Figure 1A , Fig. 2A a side view of the distal end of the breathing gas line assembly of Figure 1Ain assembled condition when viewed along arrow IIA in the Figure 3A and 4 , Fig. 2B Side view of the proximal end of the breathing gas line assembly of Figure 1B in assembled condition when viewed along arrow IIB in Figure 3B , Fig. 3A a bottom view of the proximal end of the breathing gas line assembly of Figure 2A along the arrow IIIA into the Figure 2A and 4 , Fig. 3B Bottom view of the distal end of the breathing gas line assembly of Figure 2B along the arrow IIIB in Figure 2B , Fig. 4 an elevation view of the breathing gas line assembly when viewed along arrow IV in the Figure 2B and 3B , Fig. 5 a longitudinal sectional view of a one-piece channel component of the expiratory valve assembly of Figure 4 along the section plane VV of Figure 4 .

[0055] In the Figures 1A to 3BAn embodiment of a breathing gas line assembly according to the invention is generally designated 10. In the Figure 1A , 2A and 3A the distal longitudinal end region 12 of the breathing gas line assembly 10 is shown, in the Figure 1B , 2B and 3B whose proximal longitudinal end region 14.

[0056] The distal longitudinal end 12 of the breathing gas line assembly 10, i.e. the end further away from the ventilated patient, comprises an expiration valve assembly 16 with a channel component 18 which is injection-molded in one piece from plastic. The channel component 18 in isolation is shown in longitudinal section in Figure 5 shown.

[0057] The channel component 18 comprises a multi-lumen end section 20, which in its Figure 1Ahas an expiratory inlet 22 in its upper region and an inspiration outlet 24 in its lower region. Adjacent to the expiratory inlet 22 in the expiration direction E is a linear expiratory inlet section 26, which extends along an expiratory inlet axis EEA. Adjacent to the inspiration outlet 24, opposite to the inspiration direction I, is a linear inspiration outlet section 28, which extends along an inspiration outlet axis IAA. In the illustrated embodiment, the expiratory inlet axis EEA and the inspiration outlet axis IAA are parallel to one another, as are the expiratory inlet section 26 and the inspiration outlet section 28.

[0058] The multi-lumen end section 20 has a common terminal connection formation 30, which in its Figure 1A upper area as inlet connection formation 30a and in its Figure 1Alower region acts as an outlet connection formation 30b. Radial projections 32a and 32b, which act as end stops for a cooperating connection mating formation 34 of the multi-lumen hose as the multi-lumen line component 36 of the breathing gas line assembly 10, indicate the longitudinal end of the inlet connection formation 30a and the outlet connection formation 30b.

[0059] The multi-lumen tube 36, with its connecting counter-formation 34, can be pushed onto the connecting counter-formation 30 of the multi-lumen end section 20 to establish a flow connection between the multi-lumen tube 36 and the channel component 18. The connecting counter-formation 34 can be releasably held on the connecting counter-formation 30 by frictional engagement or positive engagement, for example, by a bayonet lock or by a spring-loaded latch or by other locking means.

[0060] An expiratory channel 38 is formed in the expiratory valve assembly, which extends from the expiratory inlet 22 to an expiratory outlet 40. The expiratory inlet section 26 is part of the expiratory channel 38.

[0061] In the expiration channel 38, an expiration valve 42 in the form of a diaphragm valve is arranged in the expiration direction E between the expiration inlet 22 and the expiration outlet 40. In Figure 1AThe annular, flat, yet inclined valve seat 44 can be seen, at which an inlet-side expiratory channel section 38a ends in the expiration direction E, and from which an outlet-side expiratory channel section 38b extends in the expiration direction E. The expiratory channel sections 38a and 38b are separated from one another by the expiratory valve 42. For this purpose, the expiratory valve 42 has a valve body 46 in the form of a membrane, which is held on the channel wall 48 of the outlet-side expiratory channel section 38b by a cover component 50. The diaphragm valve body 46 can be clamped between the channel wall 48 and the cover component 50.

[0062] If expiratory breathing gas flows in the expiration direction E through the inlet-side expiration channel section 38a to the diaphragm valve body 46, the latter is lifted from the annular valve seat 44 by the pressure building up, counter to the prestressing force caused by the material elasticity of the diaphragm valve body 46, and the expiratory breathing gas can flow from the inlet-side expiration channel section 38a into the outlet-side expiration channel 38b surrounding it radially on the outside.

[0063] In the expiration valve assembly 16, in particular in the one-piece channel component 18, an inspiration channel 52 is formed, which is most clearly visible in Figure 5 can be seen. This extends in inspiration direction I from an inspiration inlet 54 to the inspiration outlet 24.

[0064] Adjoining the inspiration inlet 54 in the inspiration direction I is a linear inspiration inlet section 56 as part of the inspiration channel 52, which runs along an inspiration inlet axis IEA, which in the example shown forms an angle of 90° with the inspiration outlet axis IAA. A region of the inspiration inlet section 56 comprising the inspiration inlet 54 is designed as an inlet connection formation 58, which serves to create a connection conducting inspiratory respiratory gas in the inspiration direction I, with which the inspiratory respiratory gas can be introduced into the inspiration channel 52 from a respiratory gas source not shown in the figures, for example from a ventilator. The inlet connection formation 58 can be designed as a plug-in socket, which can be plugged onto a connection piece on the respiratory gas source, surrounding it radially on the outside.Alternatively, the inlet connection formation 58 can be designed as a connection piece which can be inserted into a socket on the breathing gas source.

[0065] A one-way valve 60 is inserted into the inspiration inlet section 56, which has a base component 62 and an elastomeric disc-shaped valve body 64 held thereon. The one-way valve 60 is provided with an inner wall 52a (see Figure 5) of the inspiration channel 52 is welded to the inner wall 52a, preferably by ultrasonic welding of fastening tabs 62a of the base component 62, and thus secured in position. The valve body 64 is held in a form-fitting manner on the base component 62 in a central region and, when flow occurs in the inspiration direction I, can be lifted with its peripheral edge region from a valve seat 62b formed on the base component 62. When flow occurs opposite to the inspiration direction I, the valve body 64 is pressed against the valve seat 62b, thus closing the inspiration channel 52.

[0066] Analogous to the inspiration channel 52, the expiration channel 38 is defined by a channel wall 38c. The channel wall 48 of the outlet-side expiration channel section 38b is part of the channel wall 38c.

[0067] A dashed rectangle 60' shows in Figure 1 the position of the one-way valve 60 in the channel component 18 in the fully assembled state. Figure 1the disc-shaped valve body 64 is oriented such that the extension plane of the valve body disc is orthogonal to the plane of the drawing of Figure 1 is located.

[0068] A control channel 68 branches off from the inspiration channel 52 from a branch point 66, which is located upstream of the installed valve body 64 of the one-way valve 60 in the inspiration direction I. This control channel 68 penetrates the diaphragm valve body 46 via an opening 70 in the diaphragm valve body 46 and ends in a chamber located on the side of the cover component 50 facing away from the valve seat 44 of the expiratory valve 42. Thus, regardless of the operating state of the one-way valve 60, inspiratory respiratory gas can always be directed through the control channel 68 to the side of the diaphragm valve body 46 facing away from the valve seat 44, so that during an inspiration process, the expiratory valve 42 can be securely held in its blocking position by the inspiratory respiratory gas, in which position the diaphragm valve body 46 resting on the valve seat 44 blocks flow through the expiratory channel 38.The control channel 68 is structurally located in sections both outside the inspiration channel 52 and outside the expiration channel 38 and, at least along one section, does not have a wall section in common with the inspiration channel 52 or the expiration channel 38, such that the common wall section would delimit the control channel 68 on one side and a channel consisting of the inspiration channel 52 and the expiration channel 38 on its opposite side. Only in the region of the channel wall 48 of the outlet-side expiration channel section 38b is there a wall section that delimits both a section of the control channel 68 and a section of the outlet-side expiration channel section 38b.

[0069] In order to keep the expiratory valve securely closed during an inspiration process, the inspiratory membrane surface 46a of the diaphragm valve body 46, which is wettable by inspiratory breathing gas, is larger than the opposite expiratory membrane surface 46b, which, when the expiratory valve 46 is closed, is located within the valve seat 44 and is exposed to expiratory breathing gas from the inlet-side expiratory channel section 38a. In the preferred case illustrated, the inspiratory membrane surface 46a is 1.8 times larger than the expiratory membrane surface 46b.

[0070] The channel component 58 has Figure 5recognizable through-openings 72a in the expiratory channel 38 and 72b in the inspiratory channel 52. The through-openings 72a and 72b, each running along a passage axis DA parallel to the expiratory inlet axis EEA and the inspiratory outlet axis IAA, penetrate the channel component wall 58a of the channel component 58, which delimits both the inspiratory channel 52 and the expiratory channel 38.

[0071] In the through holes 72a and 72b Figure 1 , shown and formed separately from the channel component 18, each extending along the associated passage axis DA, are installed. Since the feedthrough components 74a and 74b are identical, it is sufficient to describe only the feedthrough component 74a, which also applies to the other feedthrough component 74b.

[0072] The feedthrough component 74a has, on its side facing into the expiration channel 38, i.e., into the interior of the channel component 18, a receiving formation 76 to which a first signal line 78 guided in the expiration lumen 36a of the multi-lumen tube 36 can be positively connected. The receiving formation 76 can be a collar surrounding the signal line 78, a spring ring, or a plug-in connector onto which the signal line 78 can be plugged.

[0073] On its opposite side, the feedthrough component 74a has a further receiving formation 80, to which a further signal line 82 can be positively connected. The further receiving formation 80 can also be a collar, spring washer, or a plug-in socket.

[0074] In the multi-lumen tube 36, a second signal line 84 is guided in the inspiration lumen 36b, which, analogous to the above-described feedthrough component 74a, can be continued by a further signal line 86 by means of the feedthrough component 74b on the outside of the channel component 18.

[0075] The signal lines 78 and 84 as well as the further signal lines 82 and 86 transmit, as hollow lines, pressure information from a flow sensor 108 described below in the proximal longitudinal end region 14 of the respiratory gas line assembly 10. The further signal lines 82 and 86 can open into a plug 88, with which a connection transmitting the pressure information to a pressure sensor in a ventilator can be established easily and safely.

[0076] In Figure 1BThe proximal longitudinal end 14 of the breathing gas line assembly 10, i.e., the end located closer to the ventilated patient during operation, is shown. The multi-lumen tube 36 is constructed identically at its distal longitudinal end to the proximal longitudinal end described above, so for an explanation of the distal longitudinal end, reference is made to the description of the proximal longitudinal end of the multi-lumen tube 36.

[0077] A proximal coupling component 90, designed as a separate component, is coupled to the proximal longitudinal end of the multi-lumen tube 36, which coupling component has a common connection formation 92 at its distal longitudinal end, which corresponds to the connection formation 30 already described above, to whose description reference is also made for the explanation of the connection formation 92. The common connection formation 92 comprises a Figure 1Bupper expiration connection formation 92a, which corresponds to the inlet connection formation 30a on the channel component 18, and comprises a Figure 1BLower inspiratory connection formation 92b, which corresponds to the outlet connection formation 30b on the channel component 18. The proximal coupling component 90 functions as a Y-connection component, as it combines the expiratory lumen and the inspiratory lumen at its proximal longitudinal end into a common coupling formation 94, which is both a proximal expiratory coupling formation 94a and a proximal inspiratory coupling formation 94b. Therefore, both inspiratory and expiratory respiratory gas flow through the common coupling formation 94, with the aforementioned respiratory gases flowing from the expiratory lumen and the inspiratory lumen into the lumens assigned to them, depending on the positions of the expiratory valve 42 and the one-way valve 60. The common coupling formation 94 is connectable, for example pluggable, to an input connection formation 109 at the distal longitudinal end of a flow sensor 108.

[0078] The first signal line 78 running in the expiration lumen 36a and the second signal line 84 running in the inspiration lumen 36b are in Figure 1Bnot shown. However, they are present and lead again into feedthrough components 96a and 96b, which are identical to the previously described feedthrough components 74a and 74b. The feedthrough components 96a and 96b are each arranged in a through-opening 98a or 98b, respectively, passing through the wall of the proximal coupling component 90. Outside the coupling component 90, the signal lines 78 and 84 are continued by further proximal signal lines 100 and 102, which end at connection pieces 104 or 106 of a differential pressure flow sensor 108. The signal lines 100 and 102 as well as 80 or 84 and further 82 or86 transmit, as hose lines, the pressures on both sides of a flow resistance (not shown in detail but known per se) inside the differential pressure flow sensor 108 to a pressure sensor in the ventilator, which uses the transmitted pressure information to determine the respiratory gas flows flowing bidirectionally through the proximal differential pressure flow sensor 108 during inspiration and expiration.

[0079] In the Figure 2A and 3A The distal longitudinal end of the breathing gas line assembly 10 is shown in the assembled state from the viewing directions mentioned in the above list of figures and shown in the figures. Figure 2B and 3B The same applies to the proximal longitudinal end of the breathing gas line assembly 10.

[0080] In the bottom view of Figure 3Athe structure of the base component 62 with the fastening tabs 62a and the valve seat 62b of the one-way valve 60 as well as the Figure 3A The valve body 64 located behind it can be seen. For the sake of clarity, not all structures of the valve seat 62b are provided with a reference symbol.

[0081] In Figure 4 the breathing gas line assembly 10 is arranged along a plane perpendicular to the drawing plane of Figure 4 orthogonal parallels P to the expiratory inlet axis EEA and the inspiration outlet axis IAA as viewed from the proximal end of the differential pressure flow sensor 108. Apart from the fact that in Figure 4 into the proximal opening of the flow sensor 108 through which both inspiratory and expiratory respiratory gas flows and there an orthogonal to the plane of the drawing of Figure 4 flow guide element 110 and a flow guide element 110 located behind it and facing the plane of the Fig. 4parallel foil-like flow resistance component 112 with flow-dependent variable flow resistance, shows Figure 4 also the inclination of the cover component 50 with respect to the inspiration inlet axis IEA around the parallel P. The angle of inclination α in the example shown is between 20 and 30°, preferably between 22 and 26°, particularly preferably 24° or 25°.

[0082] This design also inclines the valve movement path VBB, along which the diaphragm valve body 46 lifts off the valve seat 44 to move into its open position and moves toward the valve seat 44 to return to its closed position, by the inclination angle α. This results in an expiratory valve assembly 16 in which, even during hectic operation at accident sites and in rescue situations, gravity contributes to the loading of the diaphragm valve body 64 toward the valve seat 44, thus supporting a type of preload of the expiratory valve 42 into the closed position. This loading due to gravity is in addition to the preload of the expiratory valve 42 into the closed position due to the design and material elasticity of the diaphragm valve body 64.

[0083] The control channel 68 preferably runs parallel to the valve movement path VBB.

[0084] Due to the inclination of the valve movement path VBB and thus of the cover component 50, the cover component 50, but especially the expiration valve 42 and in particular the valve seat 44 which is orthogonal to the valve movement path VBB, has a Figure 1 The valve has a proximity section 44a shown, which is located closer to the inspiration inlet 54, and a distance section 44b, which is located farther from the inspiration inlet 54. The distance section 44b and the proximity section 44a are diametrically opposite one another with respect to the valve movement path VBB. In order to be able to realize a particularly short control channel 68, this is located on the side of the proximity section 44a.

[0085] In Figure 5 is a longitudinal section through the channel component 18 along the Figure 4 shown in the section plane VV. The spacer section 44b of the valve seat 44 can also be seen there.

[0086] Figure 5also shows the through-openings 72a and 72b as well as the orthogonal to the plane of the drawing of Figure 5 oriented, essentially flat septum 114, which divides the multi-lumen end section 20 in the channel component 18 into an expiratory lumen 23a and an inspiratory lumen 23b. In the fully assembled state of the breathing gas line assembly 10 in the multi-lumen tube 36, the expiratory lumen 23a and inspiratory lumen 23b continue into the expiratory lumen 36a and the inspiratory lumen 36b, respectively. The multi-lumen tube 36 is also divided into the two lumens 36a and 36b by a substantially flat septum diametrically extending through it. A groove 114a formed in the septum 114 serves to provide a gas-tight connection between the two septa of the multi-lumen end section 20 and the multi-lumen tube 36.

[0087] In Fig. 5 the reference symbol BE marks a plane of the Fig. 5orthogonal reference plane BE, which divides an opening area surrounded by the valve seat 44 into equal-sized surface portions located on either side of the reference plane BE. The passage openings 72a and 72b are located downstream of the reference plane BE in the expiration direction E. This allows the signal lines 78 and 84 to run with as little curvature as possible for as long as possible.

Claims

1. Expiration valve assembly (16) for a respiratory device for artificial ventilation of a patient, comprising - An expiration duct (38) which at one end exhibits an expiration inlet (22) for introducing an expiratory breathing gas flow into the expiration duct (38) and an inlet linkage formation (30a) which is configured for linking to an expiration breathing gas line (36a) leading to the patient, and which at its other end exhibits an expiration outlet (40) for discharging expiratory breathing gas, where the expiration duct (38) exhibits an expiration valve (42) which through an expiratory breathing gas flow in the expiration direction (E) from the expiration inlet (22) to the expiration outlet (40) is moveable into a feed-through position which lets the expiratory breathing gas flow through, - An inspiration duct (52) which exhibits at one end an inspiration inlet (54) for introducing an inspiratory breathing gas flow into the inspiration duct (52) and an inlet connector formation (58) which is configured for connecting with a breathing gas source supplying inspiratory breathing gas, and which at its other end exhibits an inspiration outlet (24) for letting out inspiratory breathing gas and an outlet connector formation (30b) which is configured for connecting with an inspiration breathing gas line (36b) leading to the patient, - A control duct (68) which branches off from the inspiration duct (52) at a branching point (66) and leads to the expiration valve (42) in such a way that the expiration valve (42) can be strained by inspiratory breathing gas into a blocking position which blocks the expiratory breathing gas flow, Characterized in that in the inspiration duct (52) there is arranged a one-way valve (60, 60') which allows inspiratory breathing gas flow in the inspiration direction (I) from the inspiration inlet (54) to the inspiration outlet (24) and prevents breathing gas flow in the opposite direction.

2. Expiration valve assembly (16) according to Claim 1, Characterized in that the branching point (66) lies upstream of the one-way valve (60, 60') in the inspiration direction (I).

3. Expiration valve assembly (16) according to Claim 1 or 2, Characterized in that an inspiration inlet section (56) of the inspiration duct (52) which lies nearer to the inspiration inlet (54) than to the inspiration outlet (24) proceeds along an inspiration inlet axis (IEA), where a valve movement path (VBB) along which a valve body (46) of the expiration valve (42) can be raised from a valve seat (44) of the expiration valve (42) from its blocking position and made to approach the valve seat (44), is tilted relative to the inspiration inlet axis (IEA) by a setting angle (α) in the range from 10° to 45°, preferably in the range from 15° to 35°.

4. Expiration valve assembly (16) according to Claim 3, Characterized in that an expiration inlet section (26) of the expiration duct which lies nearer to the expiration inlet (22) than to the expiration outlet (40) proceeds along an expiration inlet axis (EEA), where the valve movement path (VBB) is tilted about a parallel (P) to the expiration inlet axis (EAA) with respect to the inspiration inlet axis (IAA).

5. Expiration valve assembly (16) according to Claim 3 or 4, Characterized in that the valve seat (44) exhibits a proximity section (44a) approaching and tilted towards the inspiration inlet section (56) and a distanced section (44b) lying further away and tilted away from the inspiration inlet section (56), where the control duct (68) runs nearer to the proximity section (44a) than to the distanced section (44b) from the branching point (66) to the expiration valve (42).

6. Expiration valve assembly (16) according to Claim 4 or according to Claim 5, by reference to Claim 4, Characterized in that in a region between the inspiration inlet section (56) and the expiration inlet section (30a) and / or in a region between the inspiration inlet section (56) and an inspiration outlet section (28) lying nearer to the inspiration outlet (24) than to the inspiration inlet (54) there is configured at least one feed-through aperture (72a, 72b) which penetrates through a duct wall (52a, 38c) which bounds the inspiration duct (52) and / or the expiration duct (38).

7. Expiration valve assembly (16) according to Claim 6, Characterized in that the at least one feed-through aperture (72a, 72b) is located in the expiration direction (E) downstream of a reference plane (BE) which is oriented orthogonally to the expiration inlet axis (EEA) and subdivides an aperture surface bordered by the valve seat (44) into equal area parts.

8. Expiration valve assembly (16) according to Claim 6 or 7, Characterized in that the at least one feed-through aperture (72a, 72b) runs along a feed-through axis (DA) which is parallel to the expiration inlet axis (EEA) and / or to an inspiration outlet axis (IAA) along which the inspiration outlet section (28) extends.

9. Expiration valve assembly (16) according to one of the preceding Claims, in consideration of Claims 4 and 6, Characterized in that the expiration inlet section (26) and the inspiration outlet section (28) are configured in a common multi-lumen end section (20).

10. Expiration valve assembly (16) according to one of the preceding Claims, in consideration of Claims 4 and 6, Characterized in that the inspiration inlet section (56), the expiration inlet section (26), and the inspiration outlet section (28) are realized through an integral duct component (18).

11. Breathing gas line assembly (10), comprising an expiration valve assembly (16) according to one of the preceding Claims, an expiration breathing gas line (36a), an inspiration breathing gas line (36b), and a flow sensor (108), Where the expiration breathing gas line (36a) exhibits at its distal longitudinal end a distal expiratory coupling formation (34) which is configured to establish a connection which conducts an expiratory breathing gas flow with the inlet linkage formation (26) of the expiration duct (58) of the expiration valve assembly (16), Where the expiration breathing gas line (36a) exhibits at its proximal longitudinal end a proximal expiratory coupling formation (94a) which is configured to establish a connection which conducts an expiratory breathing gas flow with an expiratory output linkage formation (109) at the distal longitudinal end of the flow sensor (108), Where the inspiration breathing gas line (36b) exhibits at its distal longitudinal end a distal inspiratory coupling formation (34) which is configured to establish a connection which conducts an inspiratory breathing gas flow with the outlet connector formation (28) of the inspiration duct (52) of the expiration valve assembly (16), Where the inspiration breathing gas line (36b) exhibits at its proximal longitudinal end a proximal inspiratory coupling formation (94b) which is configured to establish a connection which conducts an inspiratory breathing gas flow with an inspiratory input linkage formation (109) at the distal longitudinal end of the flow sensor (108), Where in at least one breathing gas line (36a, 36b) out of the expiration and inspiration breathing gas line (36a, 36b) there is accommodated at least one signaling line (78, 80) which is configured to transmit information acquired by the flow sensor (108) from the proximal to the distal longitudinal end of the at least one breathing gas line (36a, 36b).

12. Breathing gas line assembly (10) according to Claim 11, in consideration of Claim 6, Characterized in that at least one of the at least one signaling line (78, 80) penetrates through at least one of the at least one feed-through aperture (72a, 72b) or ends in an accommodating engagement of an accommodating formation (76) for accommodating the distal end of the at least one signaling line (78, 80).

13. Breathing gas line assembly (10) according to Claim 11 or 12, Characterized in that the expiration breathing gas line (36a) and the inspiration breathing gas line (36b) are configured at a common multi-lumen line component (36).

14. Breathing gas line assembly (10) according to Claim 13, Characterized in that in the expiration lumen (36a) and in the inspiration lumen (36b) there is a signaling line (78, 80) accommodated in each.

15. Breathing gas line assembly (10) according to one of the Claims 13 to 14, Characterized in that the breathing gas line assembly (10) exhibits a proximal coupling component (90) with which the multi-lumen line component (36) is connected, where the coupling component (90) exhibits at its distal longitudinal end an expiration connector formation (90a) for establishing a connection which conducts an expiratory breathing gas flow with the expiration lumen (36a) and an inspiration connector formation (90b) for establishing a connection which conducts an inspiratory breathing gas flow with the inspiration lumen (36b), and where the coupling component (90) exhibits at its proximal longitudinal end a coupling formation (94) which is both the proximal expiratory coupling formation (94a) and the proximal inspiratory coupling formation (94b).