Pneumatically controlled exhalation valve for a ventilator

WO2026190553A1PCT designated stage Publication Date: 2026-09-17IMT INNOVATIONS AG
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Patent Information

Application Number
PCT/IB2026/051409
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2025-03-13
Filing Date
2026-02-13
Publication Date
2026-09-17

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Abstract

The invention relates to a pneumatically controlled exhalation valve (1) for fastening to a ventilator (7) for humans and animals, comprising an exhalation valve body (10) having a front section (2) and a rear section (4), wherein the exhalation valve body (10) can be detachably fastened to a valve receiving section (70) via a loose control membrane (5) in such a way that, by way of an inner contour (52) and a lip (51) of the control membrane (5), a controlled release and a closure of a rear air chamber (401) in the rear section (4) is achieved by means of pressurisation in a control pressure chamber (710) by means of a control line (740). The aim is to make it possible to attach the exhalation valve to the valve receiving section (70) quickly and in an uncomplicated manner. This is achieved by the use of a multifunctional control membrane (5) having a positioning cutout (50), a tab (53) and at least two through-holes.
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Description

[0001] Pneumatically controlled exhalation valve for a ventilator

[0002] Technical field

[0003] The present invention describes a pneumatically controlled exhalation valve for attachment to a ventilator for humans and animals, comprising an exhalation valve body with a front section and a rear section, wherein the exhalation valve body can be detachably attached to a valve receiving section via a loose control diaphragm in such a way that an inner contour and a lip of the control diaphragm achieve a controlled release and closure of a rear air chamber in the rear section by means of pressurization in a control pressure chamber via a control line.

[0004] State of the art

[0005] Respiratory systems, especially ventilators for humans and animals, have been known for a long time. One of the most important components is an exhalation valve, which is connected to the patient via various tubing systems.

[0006] Exhalation valves, also called expiratory valves, are important components of ventilation systems because they control the patient's exhalation process and release pressure after inhalation. There are various types of exhalation valves, which are used depending on the ventilator, patient needs, and ventilation mode.

[0007] Mechanical exhalation valves are among the simplest of their kind. They function by opening and closing depending on a manually set pressure. This pressure is typically generated by a spring-operated valve: as soon as the force acting on a diaphragm – calculated as the product of its area and the pressure – exceeds the spring force, the valve opens.

[0008] Since the expiratory pressure is determined directly by the user, the ventilator cannot regulate it automatically. This has the disadvantage that the expiratory pressure corresponds exclusively to the preset value and cannot be flexibly adjusted.

[0009] The exhalation valves, their components, and their connection to a ventilator that are of interest here are pneumatically controlled exhalation valves. Pneumatically controlled exhalation valves are preferred by many device manufacturers because they have a simple design and are inexpensive to manufacture. They consist of a diaphragm that is pressed against an outlet opening by a control force, sealing it airtight. The control force is the product of the control pressure and the diaphragm area. Only when the force exerted on the outlet area by the pressure in front of the outlet becomes greater than the control force does the diaphragm open, allowing air to escape.

[0010] Typically, the ratio between the diaphragm area and the outlet area is 2:1. This means that the control pressure must be at least half the outlet pressure to keep the valve closed. Additionally, pneumatic vent valves can be equipped with a flow meter. For this purpose, a resistance element is inserted before or after the outlet, creating a differential pressure. This pressure can be measured and converted into a flow rate.

[0011] Most exhalation valves are designed for single use and are completely replaced after use. However, there are also reusable models that can be cleaned and used multiple times.

[0012] P2510626C An example of a reusable solution is the AV0022 model from Galemed. This valve is autoclavable; the diaphragm is removed and disposed of, while the upper part of the valve can be unscrewed and sterilized. A new diaphragm is then inserted.

[0013] Another example is an exhalation valve from GE. It is based on the same operating principle, but additionally features a water trap to collect condensed water, as well as integrated flow measurement and a mounting option for the ventilator.

[0014] Currently, the reusability or cleaning of pneumatic exhalation valves is not widespread, which is why one-way valves are most commonly used. Even though the plastic components of conventional exhalation valves are inexpensive, there are applications where reuse is desired. Since a commonly used diaphragm is often unavailable, difficult to install, or can be installed incorrectly, replacement and reuse of the exhalation valves are frequently avoided altogether.

[0015] Description of the invention

[0016] The present invention aims to create a pneumatically controlled exhalation valve that can be quickly and easily attached to and removed from a valve receiving section of a ventilator, wherein the various elements of a diaphragm are always precisely aligned and measurements in measuring channels are always possible.

[0017] Additionally, a multi-part version of the pneumatic exhalation valve has been created, which is cleanable, with individual

[0018] P2510626CH Sections are designed to be quickly separable from each other with a cleaning mechanism.

[0019] Variations in feature combinations or minor adjustments to the invention can be found in the detailed description, illustrated in the figures, and included in the dependent patent claims.

[0020] Brief description of the drawings

[0021] The subject matter of the invention is described in detail below in connection with the accompanying drawings.

[0022] Further features, details, and advantages of the invention will also become apparent from the following description of slightly modified embodiments of the invention, some of which will be clear to a person skilled in the art simply from the drawings. These are illustrated in

[0023] Figure 1 is a schematic perspective view of a ventilator and a pneumatic exhalation valve before the exhalation valve is inserted. Figure 2 is a schematic sectional view through an exhalation valve coupled to a quick-release exhalation valve coupling of a ventilator.

[0024] Figure 3 shows a schematic exploded view of the exhalation valve in a disassemblable variant of an exhalation valve body, wherein the front section, sealing section and a rear section can be separated from each other, while

[0025] Figure 4 shows an exploded rear view of an exhalation valve body before connection with a

[0026] P2510626CH shows the control diaphragm and the coupling with the quick-release expiratory valve on the ventilator. P2510626CH Description

[0027] This document describes a pneumatically controlled exhalation valve 1 for use in a corresponding recess in a ventilator 7. Compared to the prior art, the exhalation valve 1 incorporates several technical modifications and improvements, including changes to the channel design, the use of a special multifunctional diaphragm as the control diaphragm 5 (see Figure 2), and the possibility of cleaning and reuse. The exhalation valve 1 can be connected to the ventilator 7 more easily and quickly. The exhalation valve 1 is connected to an expiratory tube, which is usually connected via a Y-connector to an inspiratory tube and an outlet port of the ventilator. Typically, either an HME filter is used between the Y-connector and the patient interface, or a humidifier is placed between the ventilator and the inspiratory tube.Since the features of the exhalation valve 1 are of interest, other hoses and connectors have been omitted from the illustrations.

[0028] The exhalation valve 1 is multi-part, comprising at least three parts, and includes at least one one-piece exhalation valve body 10, to which the multifunctional control diaphragm 5 can be detachably attached. This simple version is intended as a non-disassemblable, single-use version of the exhalation valve 1. The exhalation valve 1 can be easily attached to a valve receptacle 70 on the ventilator 7 using a quick-release exhalation valve coupling.

[0029] This valve receiving section 70, which is described in more detail below, allows the ventilator 7 itself to be designed without protruding parts, while the insertion and coupling of the exhalation valve 1 is easily and quickly accessible, with the multifunctional control diaphragm 5 controlling the opening of at least one outlet chamber 407, depending on the pressure applied.

[0030] P2510626CH serves as a control line 740 to the back of the multifunctional control membrane 5 and provides a seal for two measuring channels 404 and 405.

[0031] Figure 2 shows, for further explanation, a detachable and thus cleanable variant of the pneumatic exhalation valve 1 or the exhalation valve body 10, comprising a front section 2, a sealing section 3 and a rear section 4, wherein the individual parts 2, 3, 4 of the exhalation valve body 10 can be separated from each other.

[0032] In the non-disassemblable version of the exhalation valve body 10 (not shown), the sealing section 3 is not required, and the front section 2 and the rear section 4 are fused together to form a single component with corresponding air chambers, channels, openings, and measuring channels. The slide section 6 is not required in this version. However, the channel layout in the exhalation valve body 10 and the control diaphragm 5 correspond to the disassemblable version, as shown in the figures and description.

[0033] Through air chambers or air channels, exhaled air A coming from the patient is guided from the front section 2 through the sealing section 3 to the rear section 4 in the direction of the control membrane 5, deflected in the rear section 4 and discharged to the outside.

[0034] The front section 2 has a clearly visible cylindrical interface 21 to which a breathing tube can be attached. Additionally, the front section 2 has a first pressure tap 22, a front air chamber 23, and a first measuring channel 24.

[0035] The exhaled air A flows from the front section 2, passes through the sealing section 3, which is essentially a one-piece sealing wall, and passes through a pneumatic resistance 400. The pneumatic

[0036] The resistance 400 is preferably between 0.5 mbar and 20 mbar at an airflow of 60 L / min, more preferably below 5 mbar at 60 L / min, and ideally at 2.5 mbar at 60 L / min. Here, the pneumatic resistance 400 is formed by a partial reduction in the cross-section of a rear air chamber 401. The pneumatic resistance 400 could also be designed as a component of the front section 2, i.e., as part of a channel in the front section 2. In the non-disassemblable embodiment of the exhalation valve 1 with a one-piece exhalation valve body 10, these arrangements are no longer important; what is crucial is the arrangement of the pneumatic resistance 400 in the path between the front air chamber 23 and the rear air chamber 401.

[0037] The rear air chamber 401 and the pneumatic resistance 400 are components of the rear section 4, and the pneumatic resistance 400 generates a pressure difference between the first pressure tap 22 and a subsequent second pressure tap 402. The first pressure tap 22 connects the front air chamber 23 to the first measuring channel 24, and the second pressure tap 402 connects the rear air chamber 401 to a third measuring channel 403 in the rear section 4.

[0038] The sealing section 3 is located between the front section 2 and the rear section 4 and establishes a tight connection between the front air chamber 23 and the rear air chamber 401. It also seals the connection between the first measuring channel 24 and the second measuring channel 405, as well as the connection between the third measuring channel 403 and the fourth measuring channel 404. The sealing section 3 must be shaped from an elastomer to seal the channels and chambers described above. A dome 30 projecting from the sealing section 3 allows for precise alignment of the sealing section 3 relative to the front section 2 and easy removal of the sealing section 3.

[0039] P2510626CHThe control membrane 5 seals the one or more part exhalation valve body 10, more precisely the rear section 4 of the exhalation valve body 10 against the valve receiving section 70 on the ventilator 7.

[0040] The control membrane 5 is manufactured in one piece from an elastic material, preferably an elastomer, preferably silicone, in a sufficient thickness.

[0041] The control diaphragm 5 comprises several positioning cutouts 50 and a circumferential sealing lip 51, with an inner contour 52 framed by the sealing lip 51. The control diaphragm 5 is easily positioned and held in place on the rear section 4 via the positioning cutouts 50 and positioning domes 410. The control diaphragm 5 can thus be arranged with the exhalation valve body 10 on its rear section 4, so that the exhalation valve 1 is attached to the valve mounting section 70. The control pressure, indicated by the double arrow in Figure 2, acts on the inner contour 52 of the control diaphragm 5 through the control line 740. At lower pressure in the control line 740, the inner contour 52 opens the outlet chamber 407, allowing exhaled air A to escape.

[0042] Several tabs 53 are arranged along the control diaphragm 5, which allow for easy assembly of the control diaphragm 5. The control diaphragm 5 ensures the distance between the rear section 4 of the exhalation valve body 10 and the valve receiving section 70 and seals the connection between the second measuring channel 405 and the fifth measuring channel 760 as well as the connection between the fourth measuring channel 404 and the sixth measuring channel 750.

[0043] P2510626CHThe valve receiving section 70 on the ventilator 7 includes, in addition to the control line 740, a control pressure chamber 710, positioning cutouts 720, a fifth measuring channel 760 and a sixth measuring channel 750.

[0044] The rear section 4 has a sealing edge 406 against which the control diaphragm 5 rests, thus closing the rear air chamber 401 when a sufficiently high control pressure is present in the control pressure chamber 710. The control pressure is applied to the control diaphragm 5 via the control line 740 from the ventilator control unit. When no control pressure is present in the control line 740, the rear air chamber 401 is connected to the exhaust chamber 407. Since, as shown in Figure 2, the control diaphragm 5 closes the sealing edge 406 of the rear section 4, the exhaled air cannot actually escape from the rear air chamber 401 into the exhaust chamber 407 as indicated by the black arrows. The exhaust chamber 407 has an exhaust opening 408, so that in the absence of control pressure, exhaled air A can escape from the exhaust chamber 407 through the exhaust opening 408 in front of the valve receiving section 70.

[0045] The patient's exhaled air A therefore flows from interface 21 and the anterior air chamber 23 in the anterior segment 2:

[0046] - from the first pressure tap 22 via the first measuring channel 24 in the front section 2, completely crossing the sealing section 3, via the second measuring channel 405 in the rear section 4 and the fifth measuring channel 760 into the valve receiving section 70,

[0047] - from the second pressure tap 402 via the third measuring channel 403, the fourth measuring channel 404 in the rear section 4 and the sixth measuring channel 750

[0048] and depending on the application of control pressure through the control line 740 into the valve receiving section 70,

[0049] P2510626CH- from the front air chamber 23 via the rear air chamber 401, the exhaust chamber 407 through the exhaust opening 408 in the rear section 4 in front of the control diaphragm 5 and the valve receiving section 70 to the outside.

[0050] The control diaphragm 5 serves two purposes: firstly, it releases the exhaled air A into the outlet chamber 407, depending on the pressure applied to the control line 740; and secondly, it seals and transmits the pressure of the exhaled air A through the fifth and sixth measuring channels 750 and 760. Corresponding through-holes are provided within the tabs 53 in the control diaphragm, which are shown with dashed double lines in Figure 4. These through-holes create a passage between the second measuring channel 405 in the rear section 4 and the fifth measuring channel 760 in the valve mounting section 70, as well as between the fourth measuring channel 404 and the sixth measuring channel 750. This is predetermined by the design of the control diaphragm 5, ensuring simple and consistently correct placement after cleaning the exhaled valve body 10 and the control diaphragm 5.The measuring channels 404, 405, 750, 760 are thus functional, while the release and closure of the rear air chamber 401 by the lip 51 or inner contour 52 is always ensured, since the insertion of the control diaphragm 5 is additionally secured by the positioning cutouts 50.

[0051] The slide section 6 is arranged here to be linearly movable on the exhalation valve body 10. The movement is indicated by the double arrow, whereby the slide section 6 can detach the front section 2 from the rear section 4. Here, the slide section 6 is guided movably on the front section 2 and / or the rear section 4, or in between.

[0052] P2510626CH When the sliding section 6 is moved, it pulls the front section 2 and the rear section 4 along an inclined plane against the retaining bosses 409 and the sealing section 3. The retaining bosses 409 are attached to the front section 2 and / or the rear section 4. A structure 60 helps to better hold and move the connector 6. The sliding section 6 allows the front section 2 and rear section 4 to be separated from each other. The sealing section 3 can then be easily removed.

[0053] As can be seen in Figure 3, at least the front section 2, sealed via the sealing section 3 with the rear section 4, forms the exhalation valve body 10. The slide section 6 is also movably attached to the exhalation valve body 10 and can effect the separation of the front section 2 and the rear section 4. The sealing section 3 is positioned with the dome 30 in the front section 2, with the front air chamber 23 and the first measuring channel 24 open, while parts of the walls of the third measuring channel 403 are formed by the sealing section 3. The sealing section 3 is formed in one piece from an elastomer.

[0054] The pneumatic resistance 400 is shown here as a partially closed opening, which runs from the rear section 4 through the sealing section 3 into the front section 2 between the front air chamber 23 and the rear air chamber 401.

[0055] At the level of the pneumatic resistance 400, retaining domes 409 with barb-shaped projections on the rear section 4 towards the front section 2 are arranged on the outside. In the assembled state, the retaining domes 409 lie in corresponding recesses in the front section 2. The front section 2 and rear section 4 are connected by the sliding section 6, preferably by the attached structure 60, by releasing the

[0056] P2510626CHHaltedome 409 separated from each other. This allows for easy disassembly for cleaning the exhalation valve body 10.

[0057] Preferably, the structure 60 is arranged on the side of the sliding part section 6 facing away from the front section 2.

[0058] When the exhalation valve is inserted into the ventilator 7, positioning pins 411 on the rear section 4, which engage in the cutouts 720 on the valve receiving section 70, ensure the precise positioning of the exhalation valve body 10. The valve receiving section 70 is shown as a plate in Figure 4. The control diaphragm 5 is clamped between the rear section 4 and the valve receiving section 70, so that the lip 51 forms a sealed control pressure chamber 710.

[0059] Pressure introduced via the control line 740, which is connected to the control pressure chamber 710, presses the inner contour 52 of the control diaphragm 5 against the sealing edge 406 of the rear section 4, thus closing it. The tabs 53 molded onto the control diaphragm 5 ensure a tight connection between the second measuring channel 405 and the fifth measuring channel 760 of the valve receiving section 70 of the ventilator 7, as well as between the fourth measuring channel 404 and the sixth measuring channel 750 of the valve receiving section 70.

[0060] The retaining mechanism of the exhalation valve body 10, including the control diaphragm 5, on the valve mounting section 70 can be designed in different ways. The arrangement of the positioning pins 411 and the cutouts 720, along with the appropriate positioning of the channels and chambers and the control diaphragm 5, allows for quick and easy airtight mounting of the exhalation valve 1. No additional steps, such as connecting lines, are required when mounting the pneumatic exhalation valve 1.

[0061] P2510626CH To achieve a retention mechanism, the valve receiving section 70 is preferably designed within a surrounding recess in the ventilator 7. This is not shown in Figures 1 to 4. The contour of the recess with valve receiving section 70 corresponds to the outer contour of the exhalation valve 1 or the rear section 4. To additionally ensure the escape of exhaled air A, the recess should be positioned so that it is open on the underside of the ventilator 7. The design of the multifunctional control diaphragm 5, which forms measuring channels 404, 405, 750, 760, the simple mounting on the exhalation valve body 10, and thus the simple contacting and attachment to the valve receiving section 70, facilitate easy cleaning of the pneumatically controlled exhalation valve 1, which is easy to clean and can be quickly and easily connected to the ventilator.

[0062] In practice, the following cross-sectional areas of chambers and channels in the exhalation valve body 10 have proven effective as follows:

[0063] Cross-sectional area of ​​the front air chamber 23:

[0064] Between 100 mm 2 and 500 mm 2 , ideally 175 mm 2 Cross-sectional area of ​​the rear air chamber 401:

[0065] Between 100 mm 2 and 500 mm 2 , ideally 214 mm 2 Cross-sectional area of ​​the outlet chamber 407 :

[0066] Between 100 mm 2 and 1000 mm 2 , ideally 540 mm 2 Cross-sectional area of ​​the outlet opening 408:

[0067] Between 100 mm 2 and 500 mm 2 , ideally 227 mm 2 Cross-sectional area of ​​all measuring channels 24, 403, 404, 405, 750, 760: Between 2 mm 2 and 20 mm 2 , ideally 7 mm 2 .

[0068] The ratio of the cross-sectional area of ​​the sealing edge 406 to the cross-sectional area of ​​the inner contour 52 is ideally 1:2, but possible ratios between 1:1 and 1:10 are conceivable.

[0069] P2510626CH5

[0070] P2510626CH Reference code list

[0071] 1 exhalation valve (pneumatically controlled, optionally disassemblable) 10 exhalation valve bodies

[0072] 2 Anterior section

[0073] 21 Interface

[0074] 22 First pressure tap

[0075] 23 Front air chamber

[0076] 24 First measuring channel

[0077] 3 Sealing section

[0078] 30 Cathedral

[0079] 4 Rear section

[0080] 400 Pneumatic Resistance

[0081] 401 Rear air chamber

[0082] 402 Second pressure tap

[0083] 403 Third measuring channel

[0084] 404 Fourth measuring channel

[0085] 405 Second measuring channel

[0086] 406 Sealing edge

[0087] 407 Outlet chamber

[0088] 408 Outlet opening

[0089] 409 Holding Dome

[0090] 410 positioning domes

[0091] 411 positioning pins

[0092] 412 Holding niche

[0093] 5 Control membrane

[0094] 50 positioning cutouts

[0095] 51 Lippe

[0096] 52 Inner contour

[0097] 53 tabs

[0098] 6. Slide section

[0099] 60 Structure

[0100] 7 ventilators

[0101] 70 Valve mounting section

[0102] 710 Control pressure chamber

[0103] 720 positioning cutouts

[0104] 740 Control line

[0105] 750 Sixth measuring channel

[0106] 760 Fifth measuring channel

[0107] A exhaled air

[0108] P2510626CH

Claims

Patent claims 1. Pneumatically controlled exhalation valve (1) for attachment to a ventilator (7) for humans and animals, comprising an exhalation valve body (10) with a front section (2) and a rear section (4), wherein the exhalation valve body (10) can be detachably attached to a valve receiving section (70) via a loose control diaphragm (5) such that an inner contour (52) and a lip (51) of the control diaphragm (5) achieves a controlled release and closure of a rear air chamber (401) in the rear section (4) by means of pressurization in a control pressure chamber (710) by means of a control line (740), characterized by the fact that the membrane is formed as a multifunctional control membrane (5) in one piece from an elastomer, which additionally has at least one positioning cutout (50), a tab (53) and at least two through holes, such that when the control membrane (5) is installed a) a first measuring channel (24) is led into a second measuring channel (405) in the rear section (4) and further, surrounded by the first through-hole, is led into a fifth measuring channel (760) in the valve receiving section (70), and b) a third measuring channel (403) is guided after passing through a pneumatic resistance (400) and a fourth measuring channel (404) in the rear section (4) and is further guided, surrounded by the second through-hole, into a sixth measuring channel (750) in the valve receiving section (70), so that an automatically aligned attachment of the multifunctional control diaphragm (5) to the valve receiving section (70) is easily achievable. P2510626CH2. Pneumatically controlled exhalation valve (1) according to claim 1, wherein at least one positioning pin (411) in the rear section (4) engages in at least one positioning recess (720) in the valve receiving section (70).

3. Pneumatically controlled exhalation valve (1) according to claim 2, wherein at least one positioning dome (410) on the rear section (4) engages through the at least one positioning cutout (50) in the control diaphragm (5).

4. Pneumatically controlled exhalation valve (1) according to one of the preceding claims, wherein the front section (2) is separable from the rear section (4), the exhalation valve body (10) has a sealing section (3) detachably positioned between the front section (2) and the rear section (4), and a slide section (6) for separating the front section (2), sealing section (3) and rear section (4) is arranged as part of the exhalation valve body (10).

5. Pneumatically controlled exhalation valve (1) according to claim 4, wherein the slider section (6) comprises a structure (60) on the side of the slider section (6) facing away from the front section (2).

6. Pneumatically controlled exhalation valve (1) according to one of the preceding claims 4 to 5, wherein the sealing section (3) is formed integrally from an elastomer.

7. Pneumatically controlled exhalation valve (1) according to claim 6, wherein a projecting dome (30) is arranged on the sealing section (3) such that when the sealing section (3) is fixed, the P2510626CH front air chamber (23) and the first measuring channel (24) are released, while parts of the walls of the third measuring channel (403) are formed by the sealing section (3).

8. Pneumatically controlled exhalation valve (1) according to one of the preceding claims 4 to 7, wherein two retaining domes (409) with barb form are arranged on the rear section (4) projecting towards the front section (2), which can be detached from the front section (2) by means of a slide section (6). P2510626CH