One-way diaphragm valve, in particular as an exhalation valve for a respiratory device

Abstract

An exhalation valve for a respiratory device comprises a valve housing (12) with a fluid line (20, 22) and with a valve diaphragm (14) held by a holding portion (42) of the valve housing (12), wherein the fluid line (20, 22) has a first line portion (20) with a valve seat (26) and a second line portion (22) which differs from the first line portion (20), a valve body (36) formed with the involvement of the valve diaphragm (14) rests on the valve seat (26) in a closed position of the diaphragm valve (10) and interrupts a flow path between the first line portion (20) and the second line portion (22), the valve body (36) of the valve diaphragm (14) can be lifted from the valve seat (26) along an extended imaginary virtual lifting path which serves as a virtual reference path (Z), and at least one region of the valve housing (12) is designed as a thermal deformation region (78, 80, 82, 84) made of a polymer which has a dimensional stability temperature of less than 115°C, measured according to ASTM D648 at a test load of 66 psi, and / or a dimensional stability temperature of less than 100°C, measured according to ASTM D648 at a test load of 264 psi, the thermal deformation region (78, 80, 82, 84) being a shell-shaped region with a wall thickness of less than 0.9 mm.

Description

[0001] 68724P WO Hamilton Medical AG

[0002] - 1 -

[0003] One-way diaphragm valve, especially as an expiratory valve for a ventilator.

[0004] Description

[0005] The present invention relates to a diaphragm valve comprising a valve housing with a fluid line and a valve diaphragm held by a mounting section of the valve housing, wherein the fluid line has a first line section with a valve seat and a second line section distinct from the first, wherein a valve body formed with the participation of the valve diaphragm rests on the valve seat in a closed position of the diaphragm valve and interrupts a flow path between the first and the second line section. To open the diaphragm valve, the valve body of the valve diaphragm can be lifted from the closed position from the valve seat along an extended virtual lift-off path, which subsequently serves as a virtual reference path. The diaphragm valve is intended in particular as an expiratory valve for use on or in a ventilation device.

[0006] Such a diaphragm valve as an expiratory valve is known from US 2021 / 0275763 A1. Diaphragm valves as expiratory valves are also known from CN 109908449 A, TW 201143828 A1, EP 3 318 296 A1, EP 3 318 297 A1, EP 3 318 298 A1, WO 2018 / 077618 A1, WO 2018 / 210956 A1 and WO 2018 / 210958 A1.

[0007] In medical applications of such diaphragm valves, as is generally the case in medical technology, the hygiene of the diaphragm valve throughout its service life plays a crucial role in the health of the treated patient. Expiratory valves, or valves on ventilators in general, are particularly sensitive to hygiene because, firstly, they are used for extended periods; secondly, they operate in a temperature range approximately at human body temperature, which promotes the growth of microorganisms; and thirdly, the treated patient may themselves be a carrier of microorganisms that, during treatment, especially ventilation, enter the area of ​​the diaphragm valve. 68724P WO Hamilton Medical AG

[0008] - 2 - can enter the valve and multiply there, and fourthly, the respiratory gas enters the patient's body directly.

[0009] In medical technology, objects that are or may be part of a diagnostic or therapeutic procedure are frequently thermally sterilized by autoclaving. Depending on the sterilization method, specific temperature-time profiles must be observed. As a general rule, the higher the temperature, the shorter the time an object must be held at a certain temperature. For example, a component can be sterilized by holding it at 121 °C for at least 15 minutes, at 126 °C for at least 10 minutes, or at 134 °C for at least 3 minutes. The selection of the appropriate temperature-time profile for thermal sterilization depends, among other things, on the temperature resistance of the component to be sterilized.

[0010] Commonly used expiratory valves are often made of polycarbonate, a particularly temperature-stable material. Within the scope of the present application, a material is considered more temperature-stable than another material if a test component made of one material deforms less at a given temperature than the same test component made of the other material, or if a test component made of one material exhibits the same deformation at a higher temperature as a test component made of the other material exhibits at a lower temperature.

[0011] For medical hygiene reasons, diaphragm valves that carry breathing gas should not be reused to avoid contamination of a patient by a previously used valve. However, available diaphragm valves, especially those made of polycarbonate, are readily suitable for thermal sterilization after use due to their temperature stability. The high price of medical diaphragm valves (68724P WO Hamilton Medical AG) is intended to cover the costs of extensive mandatory approval procedures for the authorization of diaphragm valves for use in medical applications.

[0012] - 3 - leads some users to reuse membrane valves multiple times, contrary to medical doctrine and common sense, with intermediate sterilization.

[0013] One risk of performing a thermal sterilization process on a diaphragm valve is that, for whatever reason – for example, because emergency medical measures urgently require a diaphragm valve – the necessary holding time is not reached, or / and that, for whatever reason – for example, because the diaphragm valve is placed in the autoclave at too low an initial temperature – the diaphragm valve as a component is not heated homogeneously and thus the desired temperature level is at least locally undershot, which in each case can lead to incomplete sterilization with residual contamination of the diaphragm valve by microorganisms.

[0014] It is therefore an object of the present invention to ensure that sterile membrane valves are used only once and then disposed of for the benefit of the patients.

[0015] The present invention solves this problem in a diaphragm valve mentioned above by forming at least one region of the valve body as a heat-deforming region from a polymer with a dimensional stability temperature of less than 115 °C, measured according to ASTM D648 at a test load of 66 psi, and / or with a dimensional stability temperature of less than 100 °C, measured according to ASTM D648 at a test load of 264 psi, wherein the heat-deforming region is a shell-shaped region with a wall thickness of less than 0.9 mm. Even more preferred, because it is sufficiently dimensionally stable in intended operation, but thermal distortion sets in even earlier at the same temperature, is a wall thickness in the shell-shaped heat-deforming region of 0.7 mm or less.

[0016] The test load of 66 psi is expressed differently in SI units in the literature, for example as 0.45 MPa, 0.455 MPa, or 0.46 MPa. Similarly, the test load of 264 psi is expressed differently in SI units in the literature as 1.80 MPa, 1.8 MPa, or 1.82 MPa. To avoid this ambiguity, 68724P WO Hamilton Medical AG

[0017] - 4 - in the claims and in the explanation of the present invention, the test load specified in the relevant standard ASTM D648 is given in the unit psi.

[0018] The present invention therefore takes a different approach than that of the previously described diaphragm valves with a polycarbonate valve housing: the aim is not to provide a valve housing that is as easily thermally sterilizable as possible, and consequently a diaphragm valve that is easily thermally sterilizable. Rather, the aim is to ensure that the diaphragm valve is unusable due to thermal distortion after an attempt at proper thermal sterilization.

[0019] Tests have shown that the combination of the aforementioned material-dependent dimensional stability temperatures and the stated maximum wall thicknesses of shell-shaped component areas of the valve housing leads to thermal deformation after only a short time when the housing is heated to one of the aforementioned recognized sterilization temperatures for autoclaving. This deformation renders the entire diaphragm valve leaky and therefore unusable. The temperature-time relationship described above for autoclaving also applies to thermal distortion: the higher the temperature to which the valve housing of the diaphragm valve according to the invention is heated, the shorter the time it takes for the valve housing to deform to the point of being unusable. During normal operation, the sterilization temperatures are not reached or are significantly lower, thus ensuring the reliable operation of the diaphragm valve.

[0020] Preferably, the fluid line is arranged at least partially, more preferably over most of its length, and most preferably over its entire length within the valve housing. This allows for a compact design of the diaphragm valve.

[0021] A "shell-shaped area" refers to a typical area for fluid lines in which the housing extends as a planar component that has significantly larger dimensions in two mutually orthogonal local spatial directions than in the area orthogonal to those mutually orthogonal spatial directions. 68724P WO Hamilton Medical AG

[0022] - 5 -

[0023] Thickness direction of the component area. Due to component curvature, the thickness direction of the shell-shaped area can be oriented differently locally.

[0024] In the present application, an extended virtual lift-off path serves as one axis of a reference coordinate system. Along this path, a valve body, formed with the participation of the valve diaphragm, can be lifted from the valve seat starting from the closed position. Such a lift-off path is necessarily present in every diaphragm valve. Due to the relatively small stroke of a diaphragm valve, the lift-off path can be considered a straight lift-off axis, which, if there is any doubt, runs orthogonally to the surface enclosed by the valve seat. The virtual lift-off path or virtual lift-off axis, extended beyond its longitudinal ends, is the virtual reference path or virtual reference axis for describing the present diaphragm valve. The virtual reference path defines an axial direction running along its extension.

[0025] The shell-shaped heat deformation area with the maximum wall thickness specified above preferably has an extent of at least 1 cm. 2 , more strongly preferred at least 2 cm 2 This is to ensure that, through the largest possible heat deformation zone, the deformations occurring in this area can be transferred to other, thicker and therefore stiffer, component areas as deformations and not just as stresses. Thus, starting from a sufficiently large, albeit locally formed, heat deformation zone, a sufficiently large component section—larger than the heat deformation zone itself—can be deformed to such an extent that the valve housing, and therefore the entire diaphragm valve, becomes unusable.

[0026] On the other hand, to ensure that the diaphragm valve is usable as such and fulfills its expected function over the expected service life, particularly as an expiratory valve, it is preferably provided that the polymer of the heat deformation area has a dimensional stability temperature of over 90 °C, more preferably over 100 °C, measured according to ASTM D648 at a test load of 66 psi, and / or with a dimensional stability temperature of over 78 °C, more preferably 68724P WO Hamilton Medical AG

[0027] - 6 - preferably above 88 °C, as measured according to ASTM D648 at a test load of 264 psi.

[0028] One polymer exhibiting the aforementioned thermal shape resistance properties is, for example, a copolymer, more precisely a copolyester, offered by Eastman under the brand name "Tritan™". The advertised primary application of this polymer is the manufacture of drinking bottles. In previous tests, the "MX811" type of Tritan™ polymer from Eastman, or rather the Eastman Chemical Company, has proven particularly suitable for use as a polymer in creating the heat-deformable zone.

[0029] Ensuring the expected function of the diaphragm valve over its expected service life is also facilitated by the advantageous further development of the diaphragm valve with a wall thickness of more than 0.3 mm, ideally more than 0.5 mm, in the shell-shaped heat-deformation zone. A wall thickness of more than 0.3 mm, and even more than 0.5 mm, ensures sufficient mechanical and thermal stability in the heat-deformation zone.

[0030] In principle, it may suffice to form only the heat-deforming area from the aforementioned polymer with the required dimensional stability properties. Preferably, the valve housing is an injection-molded component, which is accordingly manufactured from a thermoplastic polymer. For reasons of simple and efficient manufacturing of the valve housing, a one-piece component section, which includes the heat-deforming area, is preferably manufactured entirely from the polymer defined above, particularly the thermoplastic polymer. If the entire valve housing can be manufactured in a single injection molding process, the entire valve housing is formed from the polymer, preferably in a single piece without joints, to avoid the use of multi-component injection molding processes.

[0031] The valve diaphragm of the diaphragm valve is usually made of silicone or a silicone compound and as such is extremely thermoformable. 68724P WO Hamilton Medical AG

[0032] - 7 - constantly. The advantageous effect of the present invention is therefore only achieved with a valve housing for a diaphragm valve with a heat deformation zone described above, wherein the valve housing has a fluid line, preferably arranged at least partially in the valve housing, and a support section for supporting a valve diaphragm, wherein the fluid line of the valve housing has a first line section with a valve seat and a second line section different from the first, wherein a flow path running through the valve housing between the first and the second line section runs in or on the valve housing. The preceding and subsequent advantageous embodiments of the diaphragm valve are therefore also embodiments of this valve housing.

[0033] In a diaphragm valve, the valve seat is often formed as the longitudinal end of the first pipe section. A tubular channel, which is preferably a cylindrical tube but need not be, preferably terminates in a valve seat that forms an end edge of the tubular channel. The valve body, formed by the valve diaphragm, rests on this end edge, which serves as the valve seat, when the diaphragm valve is closed.

[0034] Since, firstly, the first pipe section in the area of ​​the valve seat is preferably designed as a shell-shaped component area, and since, secondly, the thermally induced deformation of the valve seat leads to the desired unusability of the diaphragm valve or its valve housing in the case of an attempted thermal sterilization, the heat deformation area is preferably designed in a longitudinal end area of ​​the first pipe section having the valve seat.

[0035] The valve seat, which for reasons of advantageous sealing has a preferably planar shape in the closed position of the diaphragm valve, encloses a seat cross-sectional area A and has a length, or circumference, U, running around the seat cross-sectional area A. For the present application, a characteristic clear width of the valve seat is to be used as a characteristic dimension of the valve seat for a largely shape-independent description of the valve seat. 68724P WO Hamilton Medical AG

[0036] - 8 - be drawn. The characteristic clear width cIW used here corresponds to four times an opening quotient, formed by dividing the seat cross-sectional area A by the circumferential length U. Therefore:

[0037] As can easily be seen, for example the characteristic clear width for a circular valve seat is its diameter and for a square cross-section it is an edge length of the square shape.

[0038] Preferably, the longitudinal end region comprising the heat-deforming zone extends from the valve seat along the first pipe section containing the valve seat in the direction away from the valve body over a length corresponding to the characteristic clear width. According to a preferred embodiment of the present invention, the heat-deforming zone can be configured within this longitudinal end region. In this case, a particularly advantageous deformation of the valve seat by a thermal sterilization test is more likely the closer the heat-deforming zone is to the valve seat. Therefore, the longitudinal end region extending from the valve seat preferably covers only two-thirds of the characteristic clear width, and more preferably only half of the characteristic clear width. For this reason, the valve seat is preferably located within the heat-deforming zone or is formed by the heat-deforming zone.

[0039] In principle, to solve the aforementioned problem, it is sufficient if only a portion of the longitudinal end section is designed as the heat deformation zone. As explained above, the thermal deformation caused during the thermal sterilization of the valve housing is more pronounced the larger the heat deformation zone is. Therefore, according to a preferred embodiment of the present invention, at least half of the longitudinal end section, and even more preferably the entire longitudinal end section, is designed as the heat deformation zone. 68724P WO Hamilton Medical AG

[0040] - 9 -

[0041] In addition to or as an alternative to the first pipe section with the valve seat, the heat deformation zone can be formed in the mounting section of the valve housing in which the valve diaphragm is held to the valve housing, or the mounting section itself can be formed within the heat deformation zone. Thermal deformation of the mounting section can also cause leakage leading to the unusability of the diaphragm valve. Deformation of the mounting section can deform the valve diaphragm held to it, preventing it from sealing properly against the valve seat.

[0042] Even when the retaining section is located in the heat-deformation zone, the heat-deformation zone comprising the retaining section preferably extends transversely to the extent of the valve diaphragm over a length corresponding to the characteristic clear width of the valve seat defined above. Since, here too, a closer proximity of the heat-deformation zone to the location of the valve diaphragm's retention on the valve housing leads to a greater probability of deformation of at least one retaining element on the retaining section intended for holding the valve diaphragm, and thus to deformation of the valve diaphragm during operation, the heat-deformation zone comprising the retaining section preferably extends only over a length corresponding to two-thirds of the characteristic clear width of the valve seat, and particularly preferably only to half the characteristic clear width.

[0043] For the additional or alternative design of the mounting section in the heat deformation area, and with reference to the advantages already explained above, it is also the case that preferably at least half of the mounting section, and especially preferably the entire mounting section, is designed as a heat deformation area.

[0044] Since the valve seat is formed on the first line section and this is to be closed or opened by the valve body, which is formed with the participation of the valve diaphragm, for a flow of fluid, in particular with breathing gas, the mounting section is preferably on a section separated from the first line section with Ab- 68724P WO Hamilton Medical AG

[0045] - 10 - The mounting section is formed on the wall, in particular the outer wall, of the valve housing. The mounting section is particularly preferably formed on the second pipe section. The aforementioned distance is preferably at least a radial distance of a virtual reference path, which is conceived as centrally penetrating the seat cross-sectional area enclosed by the valve seat. To ensure the functionality of the diaphragm valve while maintaining a compact design, it has proven extremely advantageous if a longitudinal region of the second pipe section surrounds the first pipe section. Preferably, the second pipe section runs concentrically and coaxially to the course of the first pipe section in the area, in particular the longitudinal end region, of the valve seat in the area of ​​the mounting section.

[0046] Preferably, a conduit wall that radially delimits the first conduit section forms a shell-shaped region of the first conduit section. Its radially inner side faces the flow space of the first conduit section, in which the first conduit section carries a fluid flow, and its radially outer side faces, at least partially, a flow space of the second conduit section, in which the second conduit section carries a fluid flow. In this respect, the conduit wall of the first conduit section can also form a conduit wall of the second conduit section.

[0047] A radially inner side of the pipe wall forming the second pipe section preferably faces the flow space of the second pipe section and / or the first pipe section surrounded by the second pipe section. Conversely, the opposite radially outer side of the pipe wall forming the second pipe section faces away from the flow space of the second pipe section and / or away from the first pipe section.

[0048] Preferably, a retaining element for holding the valve diaphragm on the retaining section is arranged or formed on an externally accessible, radially outer side of a wall of the valve housing for easy mounting of the valve diaphragm. Preferably, this wall is a section forming the second conduit section. 68724P WO Hamilton Medical AG

[0049] - 11 - tungswand. A fluid flow in the second pipe section is then not disturbed by the holding formation.

[0050] In a preferred, because simple, case of a valve diaphragm being held in place by the holding section, the holding section, as the holding element described above, can have a first rib projecting from a wall of the valve housing, in particular from the conduit wall of the second conduit section. Preferably, the first rib extends transversely to the reference path. Preferably, the first rib, which can be formed from several sub-ribs, extends orthogonally to the reference path. If the holding section is formed on a conduit wall of the second conduit section, the first rib can preferably extend orthogonally to the local course of the virtual conduit path of the second conduit section at the point where the first rib projects.

[0051] The first rib preferably serves not only to hold the valve diaphragm to the valve housing, particularly on the second pipe section, but also to provide local stiffening of the heat-deformation zone in the area of ​​the holding section. This allows the holding section to be designed with an advantageously thin wall thickness of between 0.3 mm and 0.9 mm, preferably between 0.3 mm and 0.7 mm, while still being sufficiently stiff locally to securely hold the valve diaphragm. The first rib also preferably has a thickness of less than 0.9 mm, particularly less than 0.7 mm, measured perpendicular to its path. Since the first rib preferably extends in the heat-deformation zone, particularly of the second pipe section, the comparatively thin rib thickness of less than 0.9 mm provides sufficient stiffening of the holding section.However, in the event of thermal deformation of the heat-deforming area, the first rib can deform along with the heat-deforming area itself, so that the housing-side retaining element for holding the valve diaphragm to the valve housing also tends to deform thermally along with the first rib. This can render the valve housing, and thus the entire diaphragm valve, unusable during an attempt at unwanted thermal sterilization. 68724P WO Hamilton Medical AG.

[0052] - 12 -

[0053] Preferably, the valve diaphragm has a retaining counterform which, in the operational state of the diaphragm valve, engages in a positive-locking manner with the retaining form of the retaining section to hold the valve diaphragm to the valve housing. Preferably, a retaining form and a retaining counterform engage behind each other. Particularly preferably, the retaining counterform surrounds the retaining form on the valve housing, especially on the second pipe section, radially outward with respect to the reference path imagined to pass centrally through the valve seat.

[0054] The retaining element is preferably formed integrally with the valve diaphragm, and the valve diaphragm itself is particularly preferably a one-piece component, for example made of silicone. However, it should not be excluded that the valve diaphragm has a separate retaining element, made of a different material than the diaphragm, for securing the valve diaphragm to the valve housing.

[0055] The valve diaphragm can have a reinforcing component, preferably in the area of ​​the valve body or a valve body section formed integrally with the valve diaphragm, such as a disc, in particular an annular disc with a central opening, made of a material with a higher modulus of elasticity than the material of the valve diaphragm. Preferably, the reinforcing component is a metal component, in particular an annular metal disc with a central opening. The reinforcing component in the area of ​​the valve body or valve body section ensures a defined shape of the contact surface of the valve body for contact with the valve seat.

[0056] The reinforcement component is preferably rotationally symmetrical. Likewise, the valve body or the valve body section of the valve diaphragm is preferably rotationally symmetrical. The valve diaphragm as a whole is preferably non-rotationally symmetrical. It has a cover or diaphragm section containing the valve body, from which a skirt projects, preferably completely circumferentially, in one direction, which has the retaining counter-formation. The skirt is shape-invariant only over a larger part of its circumference with respect to rotation about a virtual diaphragm axis that centrally penetrates the skirt. [At a circumferential section 68724P WO Hamilton Medical AG]

[0057] - 13 - The skirt may have a circumferential anomaly, for example, a bulge and / or a recess, which must be physically aligned with the valve housing when the valve diaphragm is attached to the second pipe section. This ensures that even if the valve diaphragm detaches from the valve housing, it can be reattached in a defined orientation relative to the valve housing. Thus, the valve diaphragm can be factory-positioned in a defined orientation on the valve housing, and the resulting diaphragm valve can be factory-calibrated. Even if the valve diaphragm detaches from and is subsequently reattached to the valve housing, the calibration of the diaphragm valve, once established, would not be lost.The physical circumference anomaly means that the valve diaphragm can only be attached to the valve housing in a defined orientation; otherwise, the valve diaphragm, especially its skirt, physically collides with the fit of the valve housing and prevents any arrangement.

[0058] The valve diaphragm with the retaining element preferably surrounds a longitudinal end of the valve housing, in particular of the second pipe section, in a hood-like manner. If the retaining element is formed on the second pipe section, it is preferred that the first pipe section extends at least in the region of the valve seat and the second pipe section extends at least in the region of the retaining element along respective parallel or collinear virtual pipe paths, preferably straight virtual pipe axes.

[0059] To ensure the most secure possible retention of the valve diaphragm on the valve housing, particularly on the second conduit section, the first rib can extend around the reference track by at least half the circumference of the valve housing, especially the second conduit section. Although the first rib, as already explained above, can be formed from several spaced-apart partial ribs, the first rib is preferably a continuous first rib extending along its circumference around the reference track, and preferably also around the virtual conduit track of the second conduit section. To further increase the stiffness of the retention section on the one hand, and to provide 68724P WO Hamilton Medical AG

[0060] - 14 - to ensure a holding force that is as uniform as possible for holding the valve diaphragm on the valve housing, in particular on the second pipe section, in the circumferential direction around the reference track, the first rib more preferably runs around at least three quarters of the circumference, particularly preferably around the entire circumference of the valve housing, in particular of the second pipe section.

[0061] Preferably, at least the area of ​​the valve housing supporting the mounting section is formed as an injection-molded component, such that the first rib is preferably formed monolithically as a single piece with the section of the valve housing wall, in particular with the pipe wall of the second pipe section, from which it projects. The first rib is preferably a planar structure and further preferably extends in a plane that is oriented orthogonally to the aforementioned membrane axis and / or orthogonally to the reference path in the area of ​​the mounting section.

[0062] The term "first rib," like any mention of a rib with an ordinal number, is not to be understood in the present application as meaning that a second or further rib can only exist if a first rib is also present. Rather, the term is to be understood as meaning that the first rib is the first rib mentioned in the present application. Unless logical contextual factors dictate otherwise, a second or further rib, as described below, may well be formed on the valve housing without a first or preceding rib being present.

[0063] To further stiffen the mounting section, the mounting section can have a second rib that projects from a wall of the valve housing, in particular from a conduit wall of the second conduit section, and which extends along the reference path. Preferably, the second rib extends parallel to the reference path. In this case, the second rib preferably runs orthogonally to the first rib. Preferably, a plurality of second ribs are distributed around the circumference of the reference path, in particular equidistantly distributed, on the mounting section. The at least one second rib is also preferably formed integrally with the valve housing wall from which it projects, using injection molding. 68724P WO Hamilton Medical AG

[0064] - 15 -

[0065] Preferably, the first and second ribs project to the same side, and more preferably from the same wall of the valve housing.

[0066] The second rib, or each of the plurality of second ribs, is preferably shorter than the first rib. More preferably, the second rib, or the plurality of second ribs, extends exclusively in a region between the first rib and a longitudinal end of the valve housing, particularly the second pipe section, which is preferably covered by the valve diaphragm in a hood-like fashion. This ensures that the at least one second rib does not impede the first rib's engagement by a retaining counter-formation of the valve diaphragm.

[0067] To further stiffen the valve housing wall, which simultaneously allows for an increasingly thinner design and consequently facilitates easier and / or faster deformation of the heat-deforming area containing the mounting section by heating, the mounting section can have a third rib that runs essentially parallel to the first rib and projects from a valve housing wall, preferably from the same valve housing wall as the first and / or second rib, and particularly preferably from the pipe wall of the second pipe section. The third rib is also preferably formed integrally with the valve housing wall from which it projects, using an injection molding process.

[0068] The third rib also preferably extends around at least half the circumference, more preferably around at least three-quarters of the circumference, and most preferably around the entire circumference of the valve housing around the reference track.

[0069] The second rib can connect the first and third ribs, forming a truss-like partial ring or ring structure that stiffens the support section on the second conduit section. The second rib is then preferably integral with the first and third ribs. 68724P WO Hamilton Medical AG

[0070] - 16 -

[0071] The valve diaphragm, which preferably spans a longitudinal end of the valve housing, in particular of the second pipe section, and especially preferably also the longitudinal end of the first pipe section supporting the valve seat, is exposed and vulnerable to attack from the outside and is therefore, according to an advantageous embodiment of the present invention, protected in the transport state of the diaphragm valve by a protective cap spanning the valve diaphragm in a hood-like manner.

[0072] The protective cap is therefore preferably hood-shaped and comprises a cover section spanning the diaphragm section of the valve diaphragm in the transport state of the diaphragm valve, and a collar section projecting outwards from the cover section on one side. In the transport state of the diaphragm valve, the collar section covers at least a large part of the valve diaphragm's skirt. Preferably, in the transport state, the collar section extends in the direction of projection from the cover section—that is, an axial direction with respect to a virtual cap axis passing centrally through the cover section and the collar section—over the entire axial extent of the valve diaphragm's skirt, so that the collar section completely covers a large part of its circumference in the transport state of the diaphragm valve.The cover section may also exhibit a circumferential anomaly in the area of ​​the valve diaphragm's circumferential anomaly, such as a bulge or a recess. In the case of a recess, the valve diaphragm is not, or not completely, covered by the protective cap along the circumference of the recess in the collar section.

[0073] On the side of the protective cap's cover section facing the valve diaphragm, a locking mechanism can be arranged which, during transport, presses the valve body against the valve seat, thus immobilizing the valve body, at least in the direction of lift-off from the valve seat, and preferably completely. Transport movements with accelerations atypically high for conventional operation of the diaphragm valve then do not lead to undesirable abrupt movements of the valve body and ensure the integrity of the valve diaphragm during transport. 68724P WO Hamilton Medical AG

[0074] - 17 -

[0075] The closing element can be a projection which, preferably integrally, extends from the cover section along the cap axis. The projection can have the shape of a cylinder, particularly a hollow cylinder for reasons of weight and material savings, to ensure the most uniform possible contact of the valve body with the valve seat along its circumferential length during transport.

[0076] In the transport state, the cap axis is therefore preferably parallel or even coaxial with the reference track or reference axis.

[0077] In a preferred embodiment of the present invention, the protective cap is removed from the diaphragm valve for its intended operation. Preferably, during intended operation of the diaphragm valve, a surface of the valve body facing away from the valve seat is accessible from the outside, for example, to allow a travel limiter to approach it, to limit the stroke of the valve body along the reference path, and / or to set a PEEP (Positive End-Expiratory Pressure) when using the diaphragm valve as an expiratory valve.

[0078] The applicant expressly reserves the right to seek separate legal protection only for the protective cap described in the present application.

[0079] Preferably, the protective cap is held in the transport state on the valve housing, particularly on the second tube section, by a positive locking mechanism that can be overcome. For this purpose, the protective cap preferably has a locking feature on the collar section, especially on its axial end region furthest from the cover section, which is designed to positively lock against a corresponding locking feature on the valve housing, particularly on the second tube section. The locking feature can be a recess or a projection. Preferably, it is a locking projection that extends radially inwards from the collar section surrounding the virtual collar axis at a radial distance towards the collar axis. 68724P WO Hamilton Medical AG

[0080] - 18 -

[0081] The locking projection preferably comprises a plurality of partial locking projections arranged circumferentially around the collar axis at intervals to achieve the most uniform possible distribution of holding force in the circumferential direction, without this holding force becoming excessively large and causing problems when attaching and / or removing the protective cap. Preferably, the distance between two adjacent partial locking projections circumferentially around the collar axis is greater than the circumferential extent of a partial locking projection. Further preferably, at least a plurality of partial locking projections are arranged equidistantly around the collar axis.

[0082] To facilitate the attachment and removal of the protective cap from the valve housing, the locking projection, and in particular all its partial locking projections, have no radii smaller than 0.9 mm, preferably smaller than 1.2 mm. This applies both to radii of concave curvature at the transition between the collar section and the locking projection or a partial locking projection, and to radii of convex curvature on the locking projection or the partial locking projection itself. Preferably, the locking projection, especially as a plurality of partial locking projections, is a planar structure located in a plane that is orthogonal to the cap axis.

[0083] In the present application, "extension plane" does not refer to an infinitely thin plane in the mathematical sense, but rather to a plane to be understood in engineering terms, which has a certain thickness in order to provide space for the formation arranged in the respective extension plane.

[0084] To secure the protective cap to the valve housing during transport of the diaphragm valve, the valve housing, along the reference path, and in particular the second conductor section along its virtual conductor path, can have the aforementioned counter-locking feature at a distance from the retaining element for the valve diaphragm holder, particularly in the form of the first rib described above, and at a distance from the valve diaphragm. This counter-locking feature preferably projects from a wall of the valve housing. The wall from which the counter-locking feature projects can be the same wall from which at least one [68724P WO Hamilton Medical AG]

[0085] - 19 -

[0086] The counter-locking element projects from the first, second, and third ribs. For easier access to the formations, the counter-locking element preferably projects in the same direction, preferably radially away from the reference path, in which at least one rib from the first, second, and third ribs also projects. Particularly preferably, the first, second, and third ribs and the counter-locking element all project in the same direction. To achieve a compact diaphragm valve, the wall from which the counter-locking element projects is preferably a pipe wall of the second pipe section. Particularly preferably, the counter-locking element is formed integrally with the supporting wall, for example, by injection molding. The counter-locking element is designed for positive engagement with the locking element of the protective cap spanning the valve diaphragm in a transport state of the diaphragm valve.

[0087] According to the preferred arrangement of the locking element on the protective cap, the counter-locking element extends transversely to the reference track, and in particular transversely to the local course of the virtual conductor track of the second conductor section at the point where the counter-locking element projects, to ensure the longest possible spatial engagement. Preferably, the counter-locking element extends around at least half the circumference, and preferably around at least two-thirds of the circumference of the valve housing around the reference track. Although the counter-locking element can be formed by spaced-apart partial counter-locking elements, for easier attachment of the protective cap to the valve housing, the counter-locking element preferably extends continuously around the reference track, and in particular around the virtual conductor track of the second conductor section.The counter-stave formation is also preferably a planar formation and is even more preferably arranged parallel to the first rib.

[0088] According to a preferred embodiment of the present invention, the counter-locking formation is a fourth rib, wherein the valve housing, in particular the second conduit section, more preferably has a plurality of fifth ribs in a region between the first and the fourth rib, which project from a wall of the valve housing, in particular from the same wall from which the fourth rib also projects, and more preferably from the conduit wall of the second conduit section. 68724P WO Hamilton Medical AG

[0089] - 20 -

[0090] The fifth ribs extend along the reference path, projecting from the fourth rib. Preferably, they extend towards the valve diaphragm without reaching it. Therefore, they preferably terminate at a distance before the valve diaphragm and before the first rib, if present.

[0091] The fifth ribs can form a recess with the first rib, into which the retaining counterform of the valve diaphragm engages and is preferably clamped from two opposite sides. For this purpose, the distance between the fifth ribs and the first rib is preferably smaller than a dimension of the retaining counterform extending in the direction of this distance.

[0092] The fifth ribs can develop a particularly advantageous, stronger stiffening effect if they not only project radially from the conductor wall of the second conductor section, but also axially from the fourth rib with respect to the reference path, in particular with respect to the virtual conductor path of the second conductor section.

[0093] Preferably, the radial projection of the fifth ribs from the pipe wall of the second pipe section decreases with increasing distance from the fourth rib towards the valve diaphragm. This allows the fifth ribs not only to stiffen the valve housing, particularly a heat-deformation area, in the region where the protective cap is anchored to the valve housing, especially to the second pipe section, but also to serve as an engagement aid. When the protective cap is slid onto the second pipe section, this aid widens the engagement formation or the multiple partial engagement formations, thus facilitating the overcoming of the opposing engagement formation to create a locking connection with the protective cap.

[0094] Preferably, the counter-locking formation, in particular as a fourth rib, ends further away in the radial direction from the reference path, in particular from the virtual conduction path of the second conduction section, than the retaining formation, in particular in the form of the first rib, for anchoring the valve diaphragm to the 68724P WO Hamilton Medical AG

[0095] - 21 -

[0096] Valve housing. This ensures that the protective cap, properly positioned on the valve housing, at least largely surrounds and protects the valve diaphragm without physically impacting it. In particular, when the protective cap is removed before the diaphragm valve is put into operation, any mechanical impact of the protective cap on the valve diaphragm can be avoided or at least reduced. This prevents, in particular, the valve diaphragm from being unintentionally stripped from the valve housing when the protective cap is removed.

[0097] The present invention will be explained in more detail below with reference to the accompanying drawings. It illustrates:

[0098] Fig. 1 shows a schematic exploded view of an embodiment of a diaphragm valve according to the invention of the present application,

[0099] Fig. 2 is a schematic longitudinal sectional view of the diaphragm valve of Fig. 1, with protective cap, along a section plane 11-11 in Fig. 3 containing the virtual conduit of the first conduit section and the outlet-side virtual conduit of the second conduit section.

[0100] Fig. 3 is a schematic longitudinal sectional view of the diaphragm valve of Fig. 1, with protective cap, along a section plane Ill-Ill in Fig. 2 that is orthogonal to the section plane of Fig. 2.

[0101] Fig. 4 shows a bottom view of the protective cap of Figs. 2 and 3,

[0102] Fig. 5 shows a longitudinal sectional view of the protective cap from Fig. 4.

[0103] Fig. 6 shows a bottom view of the valve diaphragm of Figs. 1 to 3 and

[0104] Fig. 7 shows a longitudinal sectional view of the valve diaphragm from Fig. 6. 68724P WO Hamilton Medical AG

[0105] - 22 - In the schematic exploded view of Fig. 1, an embodiment of a diaphragm valve according to the invention of the present application is generally designated by 10. The diaphragm valve 10, which in the illustrated embodiment is an expiratory valve of a ventilation device, comprises a valve housing 12, at one longitudinal end 12a of which a valve diaphragm 14 is arranged and at the opposite longitudinal end 12b of which a retaining ring 16 can be attached, in particular screwed on, for securing a connection of the diaphragm valve 10 with a fluid line not shown.

[0106] A roughly cylindrical main section 18 of the valve housing 12 extends along a cylinder axis Z, which, in the sense of the introductory description, is virtual conduction path LB1 of a first conduction section 20, inlet-side virtual conduction path LB2e of a second conduction section 22, diaphragm axis MA and cap axis KA.

[0107] A line stub 24 extends substantially orthogonally from the main section 18 of the valve housing 12, forming an outlet-side portion of the second line section 22. This outlet-side portion of the second line section 22 runs along an outlet-side virtual line path LB2a. In this example, the outlet-side virtual line path LB2a runs transversely, and in particular orthogonally, to the inlet-side virtual line path LB2e.

[0108] In the illustrated embodiment, the first line section 20 runs essentially straight through the main body 18 of the valve housing 12 and has an annular valve seat 26 at its longitudinal end 20a, which points towards the valve diaphragm 14. The valve seat 26 has a circumferential length U and encloses a seat cross-sectional area A. Due to the circular shape of the valve seat 26, its characteristic clear width cIW is equal to its diameter.

[0109] In the illustrated embodiment, the cylinder axis Z is a lifting path along which a valve body section 36 of the valve diaphragm 14, forming a valve body, can be lifted from the valve seat 26 and placed back onto it. The cylinder axis Z is a virtual reference path of the diaphragm valve 10. Since in the present 68724P WO Hamilton Medical AG

[0110] - 23 -

[0111] In an exemplary embodiment, where the virtual conductor tracks LB1 and LB2e are oriented coaxially with the reference track, a subsequent reference to at least one of the virtual conductor tracks LB1 and LB2 is also a reference to the virtual reference track Z.

[0112] The opposite longitudinal end 20b of the first line section 20 projects axially beyond the longitudinal end 12b of the valve housing 12, or rather beyond its main body 18, with respect to the virtual line path LB1. It serves to connect an expiratory gas line, which supplies exhaled gas from a ventilated patient to the diaphragm valve 10. The retaining ring 16 secures the line connection established at the longitudinal end 20b.

[0113] The expiratory breathing gas can flow out of the diaphragm valve 10 and thus out of the valve body 12 via the line 24 if the valve diaphragm 14 allows the expiratory breathing gas to flow from the first line section 20 over the valve seat 26 into the second line section 22.

[0114] The valve diaphragm 14 comprises a cover or diaphragm section 28, which extends transversely to the diaphragm axis MA and has a skirt 30 projecting from the outer edge of the diaphragm section 28 along the diaphragm axis, preferably in one piece.

[0115] The membrane section 28 is essentially rotationally symmetrical with respect to the membrane axis MA that passes through it centrally. The skirt 30, on the other hand, has a circumferential anomaly 32 in the form of a radial outward projection.

[0116] The circumferential anomaly 32 corresponds to a fitting 34 on the valve housing 12, which, in the illustrated embodiment, extends radially from the main body 18 and axially from the line stub 24 with respect to the virtual conductor paths LB1 and LB2. In the fully assembled state, the circumferential anomaly 32 encompasses the fitting 34. Due to the corresponding arrangement of the fitting 68724P WO Hamilton Medical AG

[0117] - 24 - mation 34 in a receiving space of the circumferential anomaly 32 the valve diaphragm 14 can only be arranged in a single orientation on the valve housing 12, such that it spans the longitudinal end 12a of the valve body 12 in a hood-like manner.

[0118] The diaphragm section 28 has a valve body section 36 with a receiving chamber into which a metal ring 38 is inserted as a reinforcing component. The valve body section 36 and the metal ring 38 are rotationally symmetrical with respect to the diaphragm axis MA, which is conceived as passing centrally through the valve body section 36 and the metal ring 38. The diaphragm section 28 also has a diaphragm membrane 40 extending between the valve body section 36 and the skirt 30, which allows axial movement of the valve body section 36 along the diaphragm axis MA, thus enabling the valve body section 36 to lift off the valve seat 26 and consequently opening the diaphragm valve 10 for the flow of expiratory breathing gas.

[0119] The valve diaphragm 14 is held on a mounting section 42 on the radially outer side 44a of the main body 18, which points away from the virtual conduit paths LB1 and LB2e. The mounting section 42 is formed on a wall 44 of the main body 18, which is also a conduit wall 44 that radially outwards bounds the second conduit section 22.

[0120] The mounting section 42 comprises a first rib 46 running around the virtual conductor tracks LB1 and LB2e as a mounting formation for mounting the valve diaphragm 14 on the valve body 12 or, in the illustrated embodiment, on the second conductor section 22.

[0121] The first rib 46 runs essentially around the entire circumference of the main section 18 around the virtual pathways LB1 and LB2e, interrupted in the region of the pass 34 and formed or continued at the pass 34 at a radial distance from the boundary wall 44 of the second pathway section 22. The first rib 46 lies in a plane of extension that is essentially orthogonal to the pathways LB1 and LB2e and is formed with a ratio- 68724P WO Hamilton Medical AG

[0122] - 25 - moderately thin wall thickness of between 0.3 mm to 0.5 mm on the one hand and 0.7 mm to 0.9 mm on the other.

[0123] Starting from the first rib 46, a plurality of second ribs 48 extend around the circumference of the longitudinal end 12a of the valve body 12, running along the virtual conduction paths LB1 and LB2e, preferably parallel to them. The second ribs 48 stiffen the first rib 46 and the mounting section 42 as a whole.

[0124] Beneath the second ribs 48, there exist ribs 48a, each of which lies in a plane of extension which, if extended towards the conduction pathways LB1 and LB2e, contains the virtual conduction pathways LB1 and LB2e. Furthermore, beneath the second ribs 48, there exist ribs 48b, which, as planar ribs, also lie in a plane of extension which, if extended towards the conduction pathways LB1 and LB2e, is located at a distance from them.

[0125] The second ribs 48 extend axially to a third rib 50, which is parallel to the first rib 46. In the present embodiment, the third rib 50 is essentially identical to the first rib 46 in terms of rib thickness and circumferential shape. The third rib 50 is also interrupted in the region of the pass 34 at the conduit wall 44 and continues in the region of the pass 34. Despite this interruption, the third rib 50, like the first rib 46, extends completely, but not continuously, around the conduit paths LB1 and LB2e. The third rib 50 forms the axial longitudinal end of the valve housing 12 in the longitudinal end region 12a. The second ribs 48 connect the first rib 46 and the third rib 50 to each other.In a preferred embodiment, the first rib 46, the second ribs 48, and the third rib 50 terminate at the same radial distance from at least one of the conduction pathways LB1 and LB2e, and, due to the coaxiality of the conduction pathways LB1 and LB2e, at the same radial distance from both conduction pathways LB1 and LB2e. 68724P WO Hamilton Medical AG.

[0126] - 26 -

[0127] The first ribs 46, the second ribs 48 and the third rib 50 form a truss stiffening the support section 42.

[0128] A fourth rib 52 is located at a slightly greater distance from the third rib 50 than from the first rib 46. In the preferred embodiment shown, the fourth rib 52 is also a substantially planar rib, which runs parallel to the first rib 46 around the virtual conductor tracks LB1 and LB2e. However, the fourth rib 52 does not run completely around the virtual conductor tracks LB1 and LB2e, but has a circumferential gap in which the fitting 34 is located.

[0129] The fourth rib 52 shares with the first rib 46 and the third rib 50 the characteristic that its distance from at least one of the virtual conductor tracks LB1 and LB2e, or in the illustrated preferred embodiment from both virtual conductor tracks LB1 and LB2e, does not change along the circumferential direction about the at least one virtual conductor track consisting of LB1 and LB2e. When using a cylindrical coordinate system with the cylinder axis Z or at least one of the virtual conductor tracks LB1 and LB2e as the axial coordinate axis, the radial distance of the fourth rib 52 is always greater than the radial distance of the first rib 46 and the third rib 50 from the same axial coordinate axis (see Figs. 2 and 3).

[0130] The fourth rib 52 serves, in addition to stiffening the conduit wall 44, to lock a protective cap 54 shown in Figs. 2 and 3 onto the longitudinal end region 12a of the valve housing 12.

[0131] From the fourth rib 52, a plurality of fifth ribs 56 project axially on one side, which also project radially from the conduit wall 44. The fifth ribs 56 are axially short enough that a gap 58 is formed between the longitudinal end furthest from the fourth rib 52 of a plurality of the fifth ribs 56, preferably every fifth rib 56, and the first rib 46. In this gap, a retaining counter-formation 60 engages the first rib 46 behind the valve diaphragm 14, more precisely at the longitudinal end of the skirt 30 furthest axially from the diaphragm section 28. 68724P WO Hamilton Medical AG

[0132] - 27 - engages and thus anchors the valve diaphragm 14 to the valve housing 12 (see Fig. 2 and 3).

[0133] The fourth rib 52 has a material thickness that essentially corresponds to that of the first to third ribs 46, 48 and 50.

[0134] The fifth ribs 56 taper with increasing axial distance from the fourth rib 52. At the point of transition of the fifth ribs 56 into the fourth rib 52, the radial distance of the fifth ribs 56 from the at least one virtual conduction path consisting of LB1 and LB2e is equal to the radial distance of the free edge of the fourth rib 52. This allows the fifth ribs 56 to form partial locking projections 62 on a collar section 64 of the protective cap 54 when the protective cap 54 is placed on and removed from the longitudinal end region 12a.

[0135] As with the second ribs 48, which run along the virtual pathways LB1 and LB2e, the fifth ribs 56 also include fifth ribs 56a, each of which runs in a plane of extension which, when extended towards the virtual pathways LB1 and LB2e, contains these pathways. Likewise, fifth ribs 56b exist, each of which runs in a plane of extension which, when extended towards the virtual pathways LB1 and LB2e, is located at a distance from them.

[0136] In Figs. 2 and 3, the diaphragm valve 10 is shown not only in longitudinal section in different section planes, but also in its transport state, in which the valve diaphragm 14 is covered on its side facing away from the valve housing 12 by a protective cap 54.

[0137] The protective cap 54 has a cover section 66 that covers the diaphragm section 28 in the transport state of the diaphragm valve 10, from which the collar section 64, covering and surrounding the skirt 30, projects. The cover section 66 runs essentially transversely, in particular orthogonally, to the virtual 68724P WO Hamilton Medical AG

[0138] - 28 - eilen conductor paths LB1 and LB2e, the collar section 64 along the same, in particular parallel to these.

[0139] The protective cap 54 also has a circumferential anomaly 68, which is designed as a bulge with an axially shortened collar section 64 and which, in the transport state of the diaphragm valve 10, surrounds the circumferential anomaly 32 of the valve diaphragm 14, which is anchored to the detent formation 34. Due to the circumferential anomaly 68, the protective cap 54, in conjunction with the detent formation 34, can only be arranged on the valve housing 12 in exactly one circumferential orientation.

[0140] On its inner side, the protective cap 54 has a centrally projecting closing projection 70 with respect to the cap axis KA. In the transport state shown in Figures 2 and 3, this projection rests on the reinforcing component 38 and presses the valve body section 36 against the valve seat 26. The valve body section 36 is thus sufficiently secured during transport of the diaphragm valve 10. The closing projection 70 is hollow-cylindrical to save material and weight while still generating a contact force that is as uniform as possible across the circumference of the valve seat 26.

[0141] Parallel to the longitudinal end region 72 of the first conduit section 20, which extends from the valve seat 26 towards the valve diaphragm 14, a radially projecting annular projection 76 with a serrated free edge extends from the valve body section 36 outside the outer surface of the wall 74 that delimits the first conduit section 20 in the relevant longitudinal end region 72, preferably at a constant radial distance from this wall. This annular projection 76 is closed around the virtual conduit path LB1 of the first conduit section 20 and around the coaxial diaphragm axis MA. This annular projection 76 directs the expiratory air flowing from the first conduit section 20 into the second conduit section 22 when the diaphragm valve 10 is open, i.e., when the valve body section 36 is lifted from the valve seat 26, thus reducing noise occurring at the diaphragm valve 10 during operation. 68724P WO Hamilton Medical AG

[0142] - 29 -

[0143] The valve body 12 is made of a thermoplastic copolyester polymer belonging to the terephthalates. Preferably, it is glycol-modified. Its heat deflection temperature, expressed as a deflection temperature according to ASTM D648, is between 78 °C and 100 °C at a test load of 264 psi and between 90 °C and 115 °C at a test load of 66 psi, both measured according to the aforementioned standard.

[0144] Preferably, the thermoplastic polymer is a polycyclohexylenedimethyl terephthalate. Most preferably, for injection molding the valve housing 12, a copolyester polymer marketed under the trade name "Tritan™" by Eastman Chemical Company as type MX811 and commercially available at the time of filing of the present application is one. It exhibits a dimensional stability temperature of 109 °C, measured according to ASTM D648, at a test load of 66 psi and a dimensional stability temperature of 92 °C, measured according to ASTM D648, at a test load of 264 psi.

[0145] In combination with an adjustment of the wall thickness of the valve housing 12, a valve housing 12 can be created using a polymer with the specified dimensional stability temperatures. This housing is extremely dimensionally stable during intended operation at temperatures typically around normal room temperature or within an exemplary operating temperature range of -20 °C to +60 °C. However, it does not withstand an attempt at thermal sterilization after use, supposedly to restore its usability. This is based on recognized temperature-time profiles, such as those exemplified above in the introductory description for the thermal sterilization of objects and tools in medical applications.

[0146] In the present case, at least three, more precisely four, locations of the valve housing 12 have heat-deforming areas with wall thicknesses of shell-shaped wall sections made of the aforementioned copolyester of less than 0.9 mm, preferably less than 0.7 mm. A first heat-deforming area 78 is formed in the longitudinal end region 72 of the first conduit section 20, extending from the valve seat 26 towards the valve diaphragm 14. This first heat-deforming area 68724P WO Hamilton Medical AG

[0147] - 30 - area 78 has an axial dimension along the virtual conduction path LB1 of approximately 40% of the dimension of the characteristic clear width cIW.

[0148] A second heat deformation zone 80 extends from the longitudinal end of the main body 18 formed by the third rib 50 in the area of ​​the support section 42 parallel to the virtual conduction path LB2e in the direction away from the valve diaphragm 14. The second heat deformation zone 80 has an axial dimension along the virtual conduction path LB2, which is approximately 60% of the dimension of the characteristic clear width cIW.

[0149] A third heat deformation area 82 extends from the longitudinal end 20b of the first conductor section along the virtual conductor path LB1 to the valve diaphragm 14 and has approximately the same axial dimension as the second heat deformation area 80.

[0150] A fourth heat deformation zone 84 extends from the longitudinal end 12b of the valve housing 12 onto the part of the main section 18 that can be coupled to the retaining ring 16. In the illustrated embodiment, the fourth heat deformation zone 84 has the same axial dimensions as the second and third heat deformation zones 80 and 82, respectively.

[0151] If the diaphragm valve 10, or even just its valve body 12, is heated to one of the aforementioned recognized auto-sterilization temperatures of 121 °C, 126 °C, or 134 °C, all heat deformation zones 78, 80, 82, and 84 typically deform unpredictably, so that the valve diaphragm 14 can only be held in a deformed position on the mounting section 42. As a result, the valve seat 26 no longer has a flat shape, and consequently, the valve body section 36, reinforced by the reinforcement component 38, can no longer seal properly on the deformed valve seat 26. Therefore, a connection formation 86 located in the third heat deformation zone for connecting a breathing gas line to the diaphragm valve 10 is no longer suitable as a connection formation, and / or a fixing form located in the fourth heat deformation zone is no longer suitable. 68724P WO Hamilton Medical AG

[0152] - 31 - mation 88 for fixing the retaining ring 16 is no longer ready to fix the retaining ring 16 due to its deformation.

[0153] The thermal distortion due to the selected dimensional stability and wall thicknesses is so great that any single deformation of one of the heat deformation ranges 78, 80, 82 and 84 is sufficient to render the diaphragm valve 10 unusable.

[0154] This ensures that the diaphragm valve 10 is only suitable for one ventilation cycle and therefore for one patient. Thermal sterilization of the diaphragm valve 10 is not possible due to the aforementioned properties. Unless a diaphragm valve 10 is to be used multiple times without sterilization, often through considerable criminal intent, contamination of successively ventilated patients due to a microbial colony in the expiratory valve can thus be reliably avoided.

[0155] Figures 4 and 5 show the protective cap 54 in a bottom view (Figure 4) and a longitudinal section along a section plane containing the cap axis KA (Figure 5). The longitudinal section of the protective cap 54 in Figure 5 corresponds to the longitudinal section of the protective cap 54 in Figure 2. In Figures 4 and 5, essentially the component sections already described above are visible without obstruction from the representation of the valve housing 12, so that for the explanation of Figures 4 and 5, reference is made primarily to the description of the protective cap 54 in Figures 2 and 3.

[0156] The view shown in Fig. 4 illustrates how a total of seven partial locking projections 62, extending radially inwards from the collar section 64 towards the cap axis KA, are integrally formed with the collar section 64. No radius less than 1 mm is formed on any partial locking projection 62, neither on the convex partial locking projections 62 nor on the concave transitions from the inside of the collar section 64 to the partial locking projections 62. This enables a smooth locking of the protective cap 54 onto the fourth rib 52. The circumferential anomaly 68, which, as shown in Figs. 4 and 5, is not only caused by a bulge, 68724P WO Hamilton Medical AG

[0157] - 32 - but also formed by an axial shortening of the collar section 64, allows the protective cap 54 to be arranged only in a relative position relative to the longitudinal end 12a of the valve housing 12. In this relative position, the locations of the formation of partial locking projections 62 on the inside of the collar section 64 coincide with the locations of the formation of fifth ribs 56 on the valve housing 12.

[0158] Two radially projecting attack tabs 90 on the cover section 68 are intended to facilitate the handling of the protective cap 54, especially when removing it from the valve housing 12 after transporting the diaphragm valve 10.

[0159] Figures 6 and 7 show the valve diaphragm 14 in a bottom view and a longitudinal section view. The longitudinal section view in Figure 7 corresponds to the longitudinal section view in Figure 2. For a description of the valve diaphragm 14, reference is made to the description already given for Figures 2 and 3. The component sections described therein can also be seen in Figures 6 and 7, except that the valve housing 12 is not shown.

Claims

68724P WO Hamilton Medical AG - 33 - Claims 1. Diaphragm valve (10), in particular an expiratory valve for a ventilation device, comprising a valve housing (12) with a fluid line (20, 22) and with a valve diaphragm (14) held by a mounting section (42) of the valve housing (12), wherein the fluid line (20, 22) has a first line section (20) with a valve seat (26) and a second line section (22) different from the first line section (20), wherein a valve body (36) formed with participation of the valve diaphragm (14) rests on the valve seat (26) in a closed position of the diaphragm valve (10) and interrupts a flow path between the first line section (20) and the second line section (22), wherein the valve body (36) of the valve diaphragm (14) is liftable from the valve seat (26) along an extended virtual lift-off path serving as a virtual reference path (Z),wherein at least one region of the valve body (12) is formed as a heat deformation region (78, 80, 82, 84) of a polymer having a dimensional stability temperature of less than 115 °C, measured according to ASTM D648 at a test load of 66 psi, or / and having a dimensional stability temperature of less than 100 °C, measured according to ASTM D648 at a test load of 264 psi, and wherein the heat deformation region (78, 80, 82, 84) is a shell-shaped region with a wall thickness of less than 0.9 mm.

2. Diaphragm valve (10) according to claim 1 , characterized in that the polymer of the heat deformation area (78, 80, 82, 84) has a shape stability temperature of over 90 °C, measured according to ASTM D648 at a test load of 66 psi, or / and with a shape stability temperature of over 78 °C, measured according to ASTM D648 at a test load of 264 psi.

3. Membrane valve (10) according to claim 1 or 2, characterized in that the wall thickness of the shell-shaped heat deformation area (78, 80, 82, 84) is greater than 0.3 mm. 68724P WO Hamilton Medical AG - 34 - 4. Diaphragm valve (10) according to one of the preceding claims, characterized in that the heat deformation region (78, 80, 82, 84) is formed in a longitudinal end region (72) of the first pipe section (20) having the valve seat (26), wherein the valve seat (26) encloses a seat cross-sectional area (A) and has a length (U) running around the seat cross-sectional area (A), wherein a characteristic clear width (cIW) of the valve seat corresponds to four times an opening quotient formed from the seat cross-sectional area (A) divided by the circumferential length (U), wherein the longitudinal end region (72) having the heat deformation region (78) extends from the valve seat (26) along the first pipe section (20) having the valve seat (26) in the direction away from the valve body (36) over a length which corresponds to the characteristic clear width (cIW) corresponds.

5. Membrane valve (10) according to claim 4, characterized in that at least half of the longitudinal end section (72), preferably the entire longitudinal end section (72), is designed as the heat deformation area (78).

6. Diaphragm valve (10) according to one of the preceding claims, characterized in that the retaining section (42) of the valve housing (12), in which the valve diaphragm (14) is retained on the valve housing (12), is formed in the heat deformation area (80), wherein the valve seat (26) encloses a seat cross-sectional area (A) and has a circumferential length (U), wherein a characteristic clear width (cIW) of the valve seat (26) corresponds to four times an opening quotient formed from the seat cross-sectional area (A) divided by the circumferential length (U), wherein the heat deformation area (80) comprising the retaining section (42) extends transversely to the extent of the valve diaphragm (14) over a length which corresponds to the characteristic clear width (cIW). 68724P WO Hamilton Medical AG - 35 - 7. Diaphragm valve (10) according to one of the preceding claims, characterized in that the mounting section (42) is formed on a wall (44) of the valve housing (12) arranged at a distance from the first line section (20), in particular on the second line section (22).

8. Diaphragm valve (10) according to claim 7, characterized in that the mounting section (42) has a first rib (46) which projects from the wall (44) of the valve housing (12), in particular from a conduit wall (44) of the second conduit section (22) and which extends transversely to the virtual reference path (Z) extended into the arrangement area of ​​the first rib (46).

9. Diaphragm valve (10) according to claim 8, characterized in that the first rib (46) runs around at least half the circumference, preferably at least three quarters of the circumference, particularly preferably the entire circumference of the valve housing (12), in particular of the second conduit section (22).

10. Diaphragm valve (10) according to one of claims 7 to 9, characterized in that the mounting section (42) has a second rib (48) which projects from the wall (44) of the valve housing, in particular from a conduit wall (44) of the second conduit section (22) and which extends along the virtual reference path (Z) extended into the arrangement area of ​​the second rib (48).

11. Diaphragm valve (10) according to one of claims 8 to 10, including claim 8, characterized in that the mounting section (42) has a third rib (50) which runs substantially parallel to the first rib (46) and projects from the wall (44) of the valve housing, in particular from the conduit wall (44) of the second conduit section (22). 68724P WO Hamilton Medical AG - 36 - 12. Membrane valve (10) according to claims 10 and 11, including claim 8, characterized in that the second rib (48) connects the first rib (46) and the third rib (50) together.

13. Diaphragm valve (10) according to one of the preceding claims, including claim 8, characterized in that the valve housing (12) has a counter-locking formation (52) along the virtual reference path (Z) at a distance from the first rib (46) and at a distance from the valve diaphragm (14), which projects from a wall (44) of the valve housing (12) and which is designed for positive locking engagement with a locking formation (62) of a protective cap (54) spanning the valve diaphragm (14) in a transport state of the diaphragm valve (10).

14. Membrane valve (10) according to claim 13, characterized in that the counter-locking formation (52) extends transversely to the virtual reference track (Z) at least by half the circumference, preferably by at least two thirds of the circumference around the reference track (Z).

15. Diaphragm valve (10) according to claim 13 or 14, characterized in that the counter-locking formation (52) is a fourth rib (52), wherein the second conduit section (22) has a plurality of fifth ribs (56) in a region between the first rib (46) and the fourth rib (52), which project from the wall (44) of the valve housing (12) and which extend along the virtual reference path (Z).

Images