Filter element for respiratory gas conditioning with speech function

Abstract

The object of the invention, which relates to a filter element (1) for respiratory gas conditioning with a speech function, is to provide a filter element (1) for use with a tracheostomy patient or a laryngectomy patient, wherein the filter element (1) is robust, easy to operate, and can be produced cost-effectively. The object is achieved in that the housing (2) comprises a first housing part (5) and a second housing part (6) connected to the first housing part (5), in that the first opening (3) is arranged in the second housing part (6), in that the first housing part (5) is designed as a single piece and comprises an outer ring (7), a central upper part (8) and elastically deformable connecting pieces (9), which are arranged between the outer ring (7) and the upper part (8), and in that a second annular nonwoven filter material (23) is arranged with its inner clamping region, clamped between the second retaining ring (12) and the second housing part (6), in a region of a third annular clamping point (24) and with its outer clamping region, clamped between the outer ring (7) of the first housing part (5) and the second housing part (6), in the region of the second annular clamping point (22).

Description

[0001] Filter element for respiratory gas conditioning with speech function

[0002] The invention relates to a filter element for respiratory gas conditioning with speech function, comprising a housing, a first opening for connection with a tracheostomy tube, a second, closable opening for air inlet or air outlet, a foam and a first filter fleece.

[0003] In particular, the filter element according to the invention is intended to be suitable for conditioning respiratory gases. This means that the filter element has a means which facilitates heat and moisture exchange between exhaled air flowing through the filter element and inhaled air.

[0004] The filter element according to the invention is further intended to have a speech function, meaning that a person using the filter element has the option of setting the filter element to an operating mode that prevents exhalation through the filter element. In this way, during exhalation, for example by a tracheotomized person, the airflow is directed over the larynx and the upper airways of the person, thus enabling speech through the use of the vocal cords.

[0005] For example, in cases requiring long-term ventilation after an accident or surgery, a neurological condition with impaired swallowing reflex, radiation therapy to the head or neck, or laryngeal paralysis, a surgical procedure may be necessary to create an opening in the trachea, also known as a tracheostomy, through the soft tissues of the neck. This procedure, colloquially referred to as a tracheotomy, is also performed as a last resort in cases of upper airway obstruction to prevent suffocation. A tracheostomy is also common in individuals who have undergone a complete laryngectomy.

[0006] It is also known from the prior art to insert and secure a so-called tracheostomy tube through a tracheostoma into the trachea, keeping the tracheostoma open with this tube. Such a tracheostomy tube is usually a flexible to rigid, short, curved tube through which breathing is enabled or facilitated by means of a primary lumen. If such treatment with a tracheostomy tube is continued over a longer period, it is also common practice to change the tracheostomy tube regularly.

[0007] For the purposes of this description, a tracheotomized person is a person who has a tracheotomy and still has the larynx (voice cords) as a connecting piece between the pharynx and the trachea.

[0008] A person with such a tracheostomy is unable to speak when the tracheostomy is open because at least some air escapes through the tracheostomy when the person exhales. Therefore, the airflow reaching the vocal cords is insufficient to enable speech using the vocal cords.

[0009] It is known that a tracheotomized person is enabled to use their vocal cords and speak by at least partially closing the tracheotomy.

[0010] To make this possible, the tracheotomy must be temporarily closed, for example, by placing a finger on the outer end of a tracheostomy tube. A more convenient option is the use of a speaking valve, which, positioned at the outer end of the tracheostomy tube, influences or controls the connection between the trachea and the surrounding environment.

[0011] It is known that a speaking valve enables tracheotomized individuals or patients to use their natural airway through the mouth and nose when exhaling. The person inhales through the speaking valve and exhales through the upper airways. To make this possible, after inhalation (inspiration), an air inlet of the speaking valve closes, allowing exhalation (expiration) through the existing larynx and enabling voice production.

[0012] In one embodiment, such speaking valves have an air inlet opening to which a silicone membrane is attached. This silicone membrane has a rest position in which the air inlet opening is closed by the silicone membrane.

[0013] When a person inhales, the silicone membrane is deformed by the resulting suction effect and moved from its resting position. This opens the air inlet opening during inhalation. Once inhalation is complete, the silicone membrane automatically returns to its resting position, sealing the air inlet opening. No airflow is required for this sealing of the air inlet opening by the silicone membrane, unlike the airflow generated during exhalation.

[0014] When the person exhales, the air inlet opening in the speaking valve remains closed by the tightly fitting silicone membrane, so that the person's airflow is completely directed over the larynx and upper airways.

[0015] It is also known to equip the speaking valve with an air outlet that can be opened and closed. Thus, with the air outlet closed, the process described above of directing the airflow during exhalation over the larynx and upper airways for the purpose of speaking can be achieved. Furthermore, with the air outlet open, the airflow during exhalation can be directed through the air outlet, which can facilitate breathing. Speaking is not possible for the person with the air outlet open.

[0016] Various tracheostomy valves or speaking valves are known from the state of the art, which can be used in conjunction with a tracheotomized person who still has vocal cords.

[0017] From DE 600 07 993 T2, a speaking valve for attachment to the neck of a tracheotomized person is known. The problem to be solved is to create a speaking valve for inhalation and exhalation in a manner that is comfortable for the user of the device. Furthermore, it should provide a means of speaking in the normal way using the vocal cords without having to change the device. To solve this problem, a speaking valve is provided which, by means of a normally closed shut-off valve element arranged in the air passage, allows inhalation through the air passage, and which, by means of a manually adjustable element for generating a free airflow through the air passage, enables both inhalation and exhalation.It has been revealed that flexible membranes made of rubber or similar material are provided on the inner surface of the circular wall of the speaking valve housing, with these membranes being dimensioned to each cover a side opening in the valve housing. In one operating mode, inhalation is permitted via the flexible membranes and exhalation via the larynx and upper airways, allowing the patient to speak. In a second operating mode, the membranes are spread apart from the side openings by means such as cylindrical pins, with the side openings remaining open during both inhalation and exhalation. This facilitates breathing for the tracheotomized person, but prevents speech.

[0018] German patent DE 102012 109 916 A1 discloses a speaking valve for attachment to a tracheostomy tube. The problem to be solved is to provide an alternative to known speaking valves where, despite using a speaking valve, it is possible, if desired, to exhale through the tracheostoma by bypassing the valve function.

[0019] To solve this problem, a valve unit is designed and arranged such that in a first position it seals the housing of the plug-in unit airtight at least with respect to one flow direction and in at least a second position allows an airflow into or out of the housing, wherein the valve unit can be moved from the first to the at least one second position by a movement parallel to the direction of the longitudinal axis of the tubular housing.

[0020] An embodiment is disclosed in which the valve unit can be continuously moved from the first to a second position by a movement parallel to the direction of the longitudinal axis of the tubular housing, wherein any number of positions can be set between the first and second positions in which the valve unit is spaced apart from the housing of the mounting unit. This is preferably achieved by a threaded engagement between the mounting unit and the valve unit.

[0021] Ventilation filters are also known from the prior art and are used, for example, in anesthesia, intensive care, and emergency medical services. Such ventilation filters, also known as HME (Heat and Moisture Exchangers), function as both heat and moisture exchangers. In the present invention, such a ventilation filter (HME) is implemented using a foam or foam filter.

[0022] It is also known that respiratory filters (HME) are operated together with a further filter that provides protection against viruses and bacteria. In this embodiment, such filters, which offer heat exchange, moisture exchange, and protection against viruses and bacteria, are also referred to as HMEFs. In the present invention, such a further filter for protection against viruses and bacteria is implemented by at least one filter fleece.

[0023] State-of-the-art ventilation filters are used in tracheotomized individuals where the speaking valve is connected to a tracheostomy tube. The speaking valve, and therefore also the ventilation filter (HME) or the ventilation filter with an additional filter (HMEF), is exposed to both the exhaled and inhaled air of the tracheotomized individual.

[0024] A disadvantage of the known state of the art is that known speaking valves are sometimes mechanically complex and expensive to manufacture or assemble.

[0025] Therefore, there is a need for an improved speaking valve.

[0026] The object of the invention is to provide a filter element for respiratory gas conditioning with a speech function for use with a tracheotomized or laryngectomized person, in order to overcome the disadvantages of speaking valves known from the prior art, wherein the filter element is robust, easy to operate, and inexpensive to manufacture. This object is achieved by a filter element with the features according to claim 1 of the independent claims. Further developments are specified in the dependent claims.

[0027] According to the invention, the filter element for respiratory gas conditioning with speech function, having the features according to claim 1, can be combined arbitrarily with one or more features of dependent claims 2 to 10 to advantageously further develop the subject matter of the invention.

[0028] The invention relates to a filter element for respiratory gas conditioning with speech function, comprising a housing with a first opening for connection to a tracheostomy tube, a second closable opening for air inlet or outlet, a foam and a first filter fleece.

[0029] To connect the inventive filter element for respiratory gas conditioning with speech function to a tracheostomy tube of a tracheotomized person, the inventive filter element for respiratory gas conditioning with speech function has a first opening on its housing, which is also referred to as the tube connection. This first opening is designed such that it can be sealedly connected to tracheostomy tubes with a connection or connector of typically 15 mm. Alternatively, the first opening is designed such that it can be sealedly connected to tracheostomy tubes with a connection or connector of 22 mm.

[0030] In the following, the filter element according to the invention for respiratory gas conditioning with speech function will only be referred to as the filter element.

[0031] The filter element also features a closable second opening, also known as the air inlet or outlet. This second closable opening can be opened and closed, for example, by the tracheotomized person. Speaking is only possible when the second closable opening is closed. The filter element is also intended for use with a laryngectomized person.

[0032] Inside the filter element housing is a cylindrical foam element that acts as a heat and moisture exchanger and is typically exposed to the exhaled and inhaled air of the tracheotomized person. Such a foam element, or foam filter, is also known as an HME (Heat and Moisture Exchanger).

[0033] According to the invention, the housing comprises a first housing part and a second housing part connected to the first housing part, the first opening is arranged in the second housing part, the first housing part is made in one piece and comprises an outer ring, a central upper part and webs, wherein the webs are elastically deformable and wherein the elastically deformable webs are arranged between the outer ring and the upper part.

[0034] The housing of the filter element comprises a first housing part and a second housing part, which are connected to each other and mechanically fixed, for example, by means of a snap connection.

[0035] In the filter element, the first opening, through which the filter element is connected to a tracheostomy tube, is located in the second part of the housing.

[0036] The filter element comprises a single-unit or one-piece housing component. This one-piece housing component includes an annular outer ring, a central upper section, and several elastically deformable webs. These elastically deformable webs are arranged, for example, radially between the annular outer ring and the central upper section. For instance, four or six elastically deformable webs are provided.

[0037] This design of the first housing part allows for simple and time-saving assembly of the filter element. Furthermore, this design of the first housing part allows movement of the central upper section within the first housing part. When the central upper section is moved, its position within the first housing part changes by a distance of approximately 3 mm to 6 mm, particularly 4.1 mm. The central upper section of the first housing part will subsequently be referred to simply as the upper section.

[0038] In addition, according to the invention, a second annular filter fleece is provided with its inner clamping area, clamped between the second retaining ring and the second housing part, in an area of ​​a third annular clamping point and with its outer clamping area, clamped between the outer ring of the first housing part and the second housing part, in the area of ​​the second annular clamping point.

[0039] A third ring-shaped clamping point is formed between the second retaining ring and the second housing part.

[0040] The second ring-shaped filter fleece of the filter element also has, viewed from the inside out, an inner ring-shaped clamping area, a ring-shaped effective area, and an outer ring-shaped clamping area. While the two clamping areas serve to fix the second ring-shaped filter fleece in the filter element, the effective area can be permeated by the exhaled and inhaled air of the tracheotomized person, thus preventing the penetration of foreign bodies, such as dirt or insects, as well as bacteria and viruses, into the filter element.

[0041] In one embodiment of the invention, the second annular filter fleece is oval in shape. In this case, both the annular clamping points and the annular effective area are oval in shape.

[0042] The second ring-shaped filter fleece is clamped to the third ring-shaped clamping point with its inner ring-shaped clamping area and is thus mechanically fixed.

[0043] Furthermore, the second ring-shaped filter fleece is clamped at the second ring-shaped clamping point with its outer ring-shaped clamping area and is thus also mechanically fixed within the filter element. The outer ring-shaped clamping areas of both the first and second filter fleeces are therefore clamped at the second ring-shaped clamping point.

[0044] The inventive arrangement of the second annular filter fleece, utilizing a common clamping point, achieves a secure mechanical fixation of the second annular filter fleece within the filter element without the need for any additional fastening elements. In addition to this advantageous fastening method, the use of the second annular filter fleece alongside the first annular filter fleece further improves the protection of the tracheotomized person from foreign bodies such as dirt or insects, as well as from bacteria and viruses.

[0045] It is further planned that a first retaining ring is arranged on the upper part, which has a ring-shaped first sealing surface.

[0046] In the filter element according to the invention, a first retaining ring is arranged on the upper part. This first retaining ring has a circumferential annular first sealing surface, which in one embodiment is designed as a circular ring. The first retaining ring is, for example, mechanically connected to the upper part. The first retaining ring is, for example, arranged on a cylindrical protrusion of the upper part and held in this position by the foam. Alternatively, the mechanical connection can be effected by a snap-fit ​​connection or by bonding.

[0047] It is advantageous if the first sealing surface is flat. The first sealing surface is one of two components arranged in the filter element for closing the second, closable opening.

[0048] Furthermore, it is provided that a second retaining ring is arranged on the second housing part, which has a ring-shaped second sealing surface.

[0049] In the filter element according to the invention, a second retaining ring is arranged on the second housing part. This second retaining ring has a circumferential annular second sealing surface, which in one embodiment is designed to be circular. The second retaining ring is mechanically connected to the second housing part, for example, by means of a snap-fit ​​connection.

[0050] It is advantageous if the second sealing surface is also flat. The second sealing surface is the second component for closing the second, closable opening. It is essential that the surface of the first sealing surface and the surface of the second sealing surface are identical. For example, both surfaces are flat, with the annular sealing surfaces having the same dimensions. This means that both the inner and outer radii of the first and second annular sealing surfaces are nearly the same. Thus, the first sealing surface can be placed fluid-tight on the second sealing surface.According to the invention, the foam or foam filter is cylindrical and arranged in the housing with a top surface on the first retaining ring and on the upper part and with a base surface on the second housing part, wherein a part of a lateral surface of the cylindrical foam is surrounded by the second retaining ring.

[0051] The filter element has a foam which is cylindrical in shape and has a top surface, a base surface and a lateral surface.

[0052] The foam is arranged within the filter element housing such that its top surface faces the first retaining ring and the central upper section. The base of the foam faces the second housing section. Furthermore, one longitudinal axis of the cylindrical foam is aligned with a longitudinal axis of the filter element.

[0053] A first portion of the foam's outer surface is surrounded by the second retaining ring. A second portion of the foam's outer surface is located in the area of ​​the second closable opening, and thus between the first and second sealing surfaces. Inhaled air flows through this second portion of the foam's outer surface to the tracheostomy patient. Exhaled air from the tracheostomy patient can also flow through this portion of the foam's outer surface when the filter element is not in speech mode.

[0054] A small third part of the foam's surface area is arranged around the first retaining ring.

[0055] It is particularly advantageous that the second, closable opening of the filter element is arranged in an area of ​​the outer surface of the cylindrical foam and between the first sealing surface and the second sealing surface.

[0056] The second, closable opening of the filter element is formed in a region of the cylindrical foam's outer surface that is not surrounded by either the first or the second retaining ring. This second closable opening is located between the first and second sealing surfaces and can therefore be closed by at least one movement of one sealing surface against the other, oppositely arranged sealing surface.

[0057] For this purpose, the first sealing surface is arranged parallel to, opposite, the second sealing surface in the filter element.

[0058] As a result of a force acting, at least indirectly, on the first sealing surface, the first sealing surface in the filter element is moved or shifted onto the second sealing surface. When the surfaces of the sealing surfaces reach each other, the second, closable opening is closed.

[0059] It has proven advantageous that the first ring-shaped filter fleece is arranged with its inner clamping area, clamped between the upper part and the first retaining ring of the first housing part, in an area of ​​a first ring-shaped clamping point, and with its outer clamping area, clamped between the outer ring of the first housing part and the second housing part, in an area of ​​a second ring-shaped clamping point.

[0060] A first annular clamping point is formed between the upper part and the first retaining ring of the first housing part. Furthermore, a second annular clamping point is formed between the outer ring of the first housing part and the second housing part.

[0061] The first ring-shaped filter fleece of the filter element has, viewed from the inside out, an inner ring-shaped clamping area, a ring-shaped effective area, and an outer ring-shaped clamping area. While the two clamping areas serve to fix the first ring-shaped filter fleece in the filter element, the effective area can be permeated by the exhaled and inhaled air of the tracheotomized person, thus preventing the penetration of foreign bodies, such as dirt or insects, as well as bacteria and viruses, into the filter element.

[0062] The first ring-shaped filter fleece is clamped at the first ring-shaped clamping point with its inner ring-shaped clamping area and thus mechanically fixed in place. Furthermore, the first ring-shaped filter fleece is clamped at the second ring-shaped clamping point with its outer ring-shaped clamping area and thus also mechanically fixed within the filter element.

[0063] The first and second ring-shaped filter fleeces are preferably designed as a polypropylene-acrylic fiber filter.

[0064] The filter material for such a filter fleece is an electrostatic medium consisting of permanently charged, bipolar, rectangular split fibers. This allows the filter fleece to trap airborne particles, bacteria, and viruses. Patients can be protected from cross-infection, for example, when using such filter fleeces.

[0065] Furthermore, it is also planned that the first housing part will be made of a semi-elastic material such as polypropylene (PP) or polyethylene (PE).

[0066] According to the invention, it is also provided that the elastically deformable webs are s-shaped.

[0067] The elastically deformable webs, which are arranged between the central upper part and the outer ring, have an S-shape. These elastically deformable S-shaped webs are attached to an inner mounting point on the upper part and to an outer mounting point on the outer ring. The webs are S-shaped in the area between the inner and outer mounting points.

[0068] The outer attachment points of the elastically deformable S-shaped struts on the outer ring lie in an imaginary plane that is oriented perpendicular to the longitudinal axis of the filter element. This imaginary plane thus extends radially outwards from the longitudinal axis of the filter element.

[0069] In the case that the filter element is open, with the first sealing surface spaced apart from the second sealing surface, the inner attachment points on the upper part are located on a first side of the imaginary plane. In the case that the filter element is closed, with the first sealing surface sealing against the second sealing surface, the inner attachment points on the upper part are located on a second side of the imaginary plane opposite the first side. In each case, the elastically deformable S-shaped webs essentially have an S-shaped profile, with the radii of the bends of the elastically deformable S-shaped webs changing under the influence of a force on the upper part when the filter element is closed.

[0070] The design specifies that the elastically deformable S-shaped webs should have a modulus of elasticity or tensile modulus in the range between 1200 MPa and 1600 MPa. In a particular embodiment, the elastically deformable S-shaped webs are made of polypropylene with a modulus of elasticity or tensile modulus of 1450 MPa.

[0071] According to the invention, it is also advantageous that when the filter element is actuated, a force acts on the central upper part and, as a result of the acting force, the first sealing surface is arranged on the second sealing surface and thus the second, closable opening of the filter element is closed.

[0072] Since the central upper part of the first housing section is connected to the outer ring of the first housing section by means of elastically deformable S-shaped ribs, movement or a change in position of the upper part within the first housing section, and thus within the filter element, is permitted. This movement or change in position of the upper part also moves the first retaining ring, which is rigidly connected to the upper part, and its first sealing surface.

[0073] For example, if a person with a tracheostomy presses a finger on the central upper part of the filter element, a force acts on the upper part, directed essentially along one of the filter element's longitudinal axes. This force causes the central upper part, together with the first retaining ring, to move in the direction of the applied force within the filter element. The elastically deformable, S-shaped ribs located between the central and outer rings deform elastically to allow this movement of the upper part. When the force is applied, the central upper part, together with the first retaining ring, moves toward the second housing part. Consequently, the first sealing surface also moves in the direction of the applied force within the filter element, reaching the second sealing surface and thus closing the second, closable opening.For this purpose, the first sealing surface and the second sealing surface have, for example, flat surfaces. This ensures a fluid-tight seal of the second, closable opening.

[0074] The applied force causes the foam in the filter element to compress along its longitudinal axis, allowing the first sealing surface to reach the second sealing surface.

[0075] By closing the second, closable opening according to the invention, the airflow of the tracheotomized person is directed over the larynx and upper airways of the person during exhalation, thus enabling speech by using the person's vocal cords.

[0076] When the tracheotomized person no longer presses on the central upper part of the filter element, the force causing the elastic deformation of the elastically deformable S-shaped struts is released, and the elastically deformable S-shaped struts return to their original position. This also causes the central upper part and the first retaining ring with its first sealing surface to return to their original position. The distance between the first sealing surface and the second sealing surface increases, and the second, closable opening reopens. Furthermore, the foam decompresses and returns to its original dimensions.

[0077] It is also provided according to the invention that the first housing part is arranged on the second housing part by means of a snap connection.

[0078] The connection between the first and second housing parts is ensured, for example, by means of a snap-fit ​​connection. To mechanically fix the two housing parts together in the filter element, the first housing part is pressed onto the second housing part and snapped into place in a single assembly step. The design of such circumferential or ring-shaped snap-fit ​​connections is known from the prior art. The features and advantages of this invention, as explained above, can be better understood and evaluated after careful study of the following detailed description of the preferred, non-limiting exemplary embodiments of the invention, along with the accompanying drawings, which show:

[0079] Fig. 1 : a filter element according to the invention in a sectional view,

[0080] Fig. 2: a filter element according to the invention in a view from a first side,

[0081] Fig. 3: a filter element according to the invention in a top view,

[0082] Fig. 4: a filter element according to the invention in a view from below,

[0083] Fig. 5: a filter element according to the invention in a view rotated by 90 degrees compared to the representation in Figure 2,

[0084] Fig. 6: the filter element according to the invention in a speech function with a closed second, closable opening,

[0085] Fig. 7 shows a filter element according to the invention in the open state and

[0086] Fig. 8 shows a filter element according to the invention in the closed state.

[0087] Figure 1 shows a filter element 1 according to the invention in a sectional view.

[0088] The filter element 1 according to the invention has a housing 2 with a first opening 3. By means of this first opening 3, which is designed as a cannula connection, the filter element 1 is connected to a tracheostomy cannula (not shown) of a tracheotomized person.

[0089] The filter element 1 also has a second, closable opening 4. This second, closable opening 4 forms the air inlet and air outlet of the filter element 1. When the filter element 1 is not in its speech function, the tracheotomized person breathes in and out through this second, closable opening 4. Closing the second, closable opening 4 in the speech function of the filter element 1 directs an exhaled airflow over the larynx and upper airways of the person, enabling speech by using the vocal cords. The housing of the filter element 1 comprises an upper first housing part 5 and a lower second housing part 6 mechanically connected to the first housing part 5.Since the housing parts 5 and 6 partially overlap in an area where they are mechanically connected, the clamps representing the areas of the housing parts 5 and 6 only substantially encompass the housing parts 5 and 6.

[0090] The first opening 3 is located in the lower second housing part 6.

[0091] The essential feature of the invention is that the first housing part 5 is made in one piece and comprises an outer ring 7, a central upper part 8, and several elastically deformable webs 9. The elastically deformable webs 9 are not visible in the sectional view of Figure 1.

[0092] The elastically deformable webs 9 are arranged, for example, radially between the upper part 8 and the outer ring 7. For example, four elastically deformable webs 9 are arranged. The four elastically deformable webs 9 thus extend in a straight line and radially from the central upper part 8 to the outer ring 7.

[0093] A first retaining ring 10, which has an annular first sealing surface 11, is arranged on the central upper part 8 of the filter element 1. The first retaining ring 10 is mechanically fastened to the central upper part 8, for example by means of a snap-fit ​​connection.

[0094] Furthermore, a second retaining ring 12 is arranged on the second housing part 6, which has an annular second sealing surface 13. The second retaining ring 12 is also mechanically fastened to the second housing part 6.

[0095] The filter element 1 comprises a foam 14 as HME, which is cylindrically shaped. The foam 14 has a top surface 15, a base surface 16 and a lateral surface 17.

[0096] The foam 14 is arranged in the housing 2 of the filter element 1 such that its top surface 15 faces the first retaining ring 10 and the central upper part 8, and its base surface 16 faces the second housing part 6. A first portion of the outer surface 17 of the foam 14 is surrounded by the second retaining ring 12. A second portion of the outer surface 17 of the foam 14 is located in the area of ​​the second, closable opening 4 between the first sealing surface 11 and the second sealing surface 13. The inhaled air flows to the tracheotomized person through this second portion of the outer surface 17 of the foam 14. The exhaled air from the tracheotomized person can flow through this second portion of the outer surface 17 when the filter element 1 is not in speech mode. A small third portion of the outer surface of the foam 14 is surrounded by the first retaining ring 10.

[0097] The second sealing surface 13 is aligned parallel to and opposite the first sealing surface 11. In Figure 1, the filter element 1 is not shown in speech mode. An airflow during exhalation can leave the filter element 1 via the second, closable opening 4, so that the tracheotomized person can exhale but not speak.

[0098] To operate the filter element 1 in its speech mode, the tracheotomized person presses, for example, a finger on the central upper part 8 of the filter element 1. This generates a force 18 on the upper part 8, which is directed essentially in one direction along a longitudinal axis 19 of the filter element 1. This force 18 causes the upper part 8, together with the first retaining ring 10, to move into the filter element 1 in the direction of the acting force 18, whereby the elastically deformable webs 9, which are arranged between the central upper part 8 and the outer ring 7, deform elastically to allow this movement of the upper part 8 within the filter element 1.

[0099] As a result, the first sealing surface 11 is also moved in the direction of the acting force 18 in the filter element 1. When the first sealing surface 11 reaches the second sealing surface 13, the second, closable opening 4 is closed. The first sealing surface 11 and the second sealing surface 13 have flat surfaces and thus enable a fluid-tight closure of the second, closable opening 4.

[0100] Alternatively, the sealing surfaces 11 and 13 can correspond to each other.

[0101] The surface structures, such as a wave pattern, also enable a fluid-tight seal of the second, closable opening 4. In one embodiment, the sealing surfaces 11 and 13 are annular in shape. By closing the second, closable opening 4, an airflow during exhalation is directed over the larynx and upper airways of the person, thus enabling speech by using the vocal cords of the tracheotomized person.

[0102] Figure 1 further shows a first annular filter fleece 20. The first annular filter fleece 20 is arranged with its inner annular clamping area, clamped between the upper part 8 and the first retaining ring 10, in a region of a first annular clamping point 21.

[0103] The first ring-shaped filter fleece 20 is arranged with its outer ring-shaped clamping area, clamped between the outer ring 7 of the first housing part 5 and the second housing part 6, in an area of ​​a second ring-shaped clamping point 22.

[0104] The filter element 1 also has a second annular filter fleece 23. The second annular filter fleece 23 is arranged with its inner annular clamping area, clamped between the second retaining ring 12 and the second housing part 6, in an area of ​​a third annular clamping point 24.

[0105] The second ring-shaped filter fleece 23 is arranged with its outer ring-shaped clamping area, also clamped between the outer ring 7 of the first housing part 5 and the second housing part 6, in the area of ​​the second ring-shaped clamping point 22.

[0106] The second annular filter fleece 23 is thus securely mechanically fixed using a clamping point 22 shared with the first annular filter fleece 20, without the need for any additional fastening elements. In addition to this advantageous fastening method, the use of the second annular filter fleece, in addition to the first filter fleece, further improves the protection of the tracheotomized person from foreign bodies such as dirt or insects, as well as from bacteria and viruses. In one embodiment, the first annular filter fleece and / or the second annular filter fleece have an oval shape. The first annular filter fleece 20 and the second annular filter fleece 23 prevent the penetration of foreign bodies, such as dirt or insects, into the filter element 1 and thus ensure the protection of the tracheotomized person, especially during inhalation.In addition, the first ring-shaped filter fleece 20 and the second ring-shaped filter fleece 23 also retain bacteria and viruses or keep them away from the person during inhalation.

[0107] For the first housing part 5 with its elastically deformable webs 9 or only for the area of ​​the elastically deformable webs 9, semi-elastic materials such as polypropylene or polyethylene are provided.

[0108] As can also be seen in Figure 1, the first housing part 5 is mechanically fastened to the second housing part 6 by means of a snap-fit ​​connection 25. The area of ​​the snap-fit ​​connection 25 is outlined with a dash-dash line in Figure 1.

[0109] Figure 1 shows at least part of another fastening device 27. For the mechanical fixing of the foam 14 in the filter element 1, the base 16 of the foam 14 rests on this further fastening device 27.

[0110] Figure 2 shows the filter element 1 according to the invention in a view from a first side.

[0111] The external view of the filter element 1 shows the housing 2 with the first housing part 5 and the second housing part 6 of the filter element 1. The first housing part 5 is shown with the outer ring 7, the central upper part 8, and the elastically deformable webs 9 arranged between these elements 7 and 8. In the illustration of Figure 2, two of the four elastically deformable webs 9 of the filter element 1 can be seen.

[0112] The first ring-shaped filter fleece 20 can be seen in the area of ​​the upper first housing part 5. The area of ​​the snap connection 25 is also shown outlined in Figure 2 by means of a dash-dash line. Furthermore, the longitudinal axis 19 of the filter element 1 can also be seen in Figure 2.

[0113] On the lower second housing part 6 of the filter element 1, two first stop means 26 can be seen, which are arranged on the cylindrical part or on the cannula connection of the filter element 1 and are used when connecting the filter element 1, for example with a 22 mm connector not shown.

[0114] Figure 3 shows the filter element 1 according to the invention in a top view.

[0115] In the top view of the filter element 1, the first housing part 5 with the elements outer ring 7, central upper part 8, and four elastically deformable webs 9 can be seen. Figure 3 shows all four elastically deformable webs 9 of the filter element 1, arranged radially between the upper part 8 and the outer ring 7. The longitudinal axis 19 of the filter element 1 is also visible. Sections of the first annular filter fleece 20 can be seen between the elastically deformable webs 9 of the filter element 1. In particular, the effective area of ​​the first annular filter fleece 20 is visible.

[0116] Figure 4 shows the filter element 1 according to the invention in a view from below.

[0117] In the view of filter element 1 from below, the second housing part 6 with the cylindrical first opening 3, i.e., the cannula connection, can be seen. In the illustration of Figure 4, sections of the second annular filter fleece 23 can be seen in open areas of the lower second housing part 6. In particular, the effective area of ​​the second annular filter fleece 23 can be seen.

[0118] The first two lifting devices 26 are arranged at the first opening 3. A further lifting device 27, arranged in the first opening 3, can also be seen, which forms a star-shaped stop for the foam 14 with three ribs. The base 16 of the foam 14 rests on this further lifting device 27.

[0119] Figure 5 shows the filter element 1 according to the invention in a view rotated by 90 degrees compared to the representation in Figure 2. Figure 5 shows the previously known elements: housing 2 with first housing part 5 and second housing part 6, outer ring 7, central upper part 8, and the elastically deformable webs 9. Figure 5 also shows only two of the four elastically deformable webs 9 of the filter element 1.

[0120] In the area of ​​the first housing part 5, the first ring-shaped filter fleece 20 can again be seen. Furthermore, the longitudinal axis 19 of the filter element 1 is also shown in Figure 5.

[0121] One of the first lifting devices 26 can be seen on the lower second housing part 6 of the filter element 1.

[0122] Figure 6 shows the filter element 1 according to the invention in a speech function with a closed second, closable opening 4.

[0123] According to the invention, when the filter element 1 is actuated, a force 18 acts on the central upper part 8, and as a result of the acting force 18, the first sealing surface 11 is arranged on the second sealing surface 13, thus closing the second, closable opening 4 of the filter element 1. In this state, which is shown in Figure 6, the filter element 1 is operated in its speech function or speech mode with the second opening 4 closed.

[0124] Since the central upper part 8 of the first housing part 5 is connected to the outer ring 7 of the first housing part 5 by means of elastically deformable webs 9, the central upper part 8 can change its position or location within the first housing part 5 when the force 18 is applied.

[0125] With this movement or change in position of the central upper part 8, the first retaining ring 10, which is firmly connected to the central upper part 8, is also moved with its first sealing surface 11. The first sealing surface 11 thus rests fluid-tight on the second sealing surface 13 arranged on the second retaining ring 12, as shown in Figure 6.

[0126] Here, the direction of the force 18 acting on the central upper part 8 of the filter element 1 and the direction of movement of the central upper part 8 are in the same direction and essentially parallel to the longitudinal axis 19 of the filter element 1.

[0127] This change in position of the central upper part 8 in the first housing part 5 or in the filter element is made possible by the elastically deformable webs 9. These elastically deformable webs 9, arranged between the central upper part 8 and the outer ring 7, can be seen in Figure 6 after their elastic deformation.

[0128] The acting force 18 also causes the foam 14 in the filter element 1 to compress along the longitudinal axis 19. This compression leads to a reduction in the distance between the top surface 15 and the base surface 16 in the foam 14, as can also be seen in Figure 6.

[0129] By closing the second, closable opening 4 according to the invention, the airflow of the tracheotomized person is directed over the larynx and the upper airways of the person during exhalation, thus enabling speech by using the person's vocal cords.

[0130] Figure 6 also shows that the first ring-shaped filter fleece 20, which is made of a flexible material, deforms or moves when the central upper part 8 moves within the filter element 1. The first ring-shaped filter fleece 20 remains firmly clamped or fixed at its first clamping point 21 and its second clamping point 22. The second ring-shaped filter fleece 23 remains unchanged in its position when the central upper part 8 moves within the filter element 1.

[0131] Figure 7 shows the filter element according to the invention in an open state and, for comparison, in Figure 8 shows it in a closed state, wherein in the representations of Figures 7 and 8 two of the elastically deformable s-shaped webs 9 are shown in each case.

[0132] The elastically deformable webs 9, which are arranged between the central upper part 8 and the outer ring 7, have an S-shape. The elastically deformable S-shaped webs 9 are arranged at an inner attachment point 28 on the upper part 8 and at an outer attachment point 29 on the outer ring 7. In the area between the inner attachment point 28 and the outer attachment point 29, the webs 9 are S-shaped.

[0133] The outer attachment points 29 of the elastically deformable S-shaped webs 9 on the outer ring 7 lie in an imaginary plane 30, which is oriented perpendicular to the longitudinal axis 19 of the filter element 1. The imaginary plane 30 thus extends radially outwards from the longitudinal axis 19 of the filter element 1.

[0134] In the case that the filter element 1 is open, with the first sealing surface 11 spaced apart from the second sealing surface 13, the inner mounting points 28 on the upper part 8 are arranged on a first side of the imaginary plane 30. Figure 7 shows this state, in which the inner mounting points 28 are arranged on the first side and thus above the imaginary plane 30.

[0135] In the case that the filter element 1 is closed, with the first sealing surface 11 arranged to seal against the second sealing surface 13, the inner mounting points 28 on the upper part 8 are arranged on a second side of the imaginary plane 30 opposite the first side. Figure 8 illustrates this state, in which the inner mounting points 28 are arranged on the second side and thus below the imaginary plane 30.

[0136] In any case, the elastically deformable S-shaped webs 9 essentially have an S-shaped profile or an S-shape, whereby the radii of the bends of the elastically deformable S-shaped webs 9 change under the influence of a force 18 on the upper part 8 when the filter element 1 is closed, as can be seen in a comparison between Figure 7 and Figure 8. In the example of Figures 7 and 8, the elastically deformable S-shaped webs 9 are made of polypropylene with a modulus of elasticity or tensile modulus of 1450 MPa. List of reference numerals

[0137] 1 filter element for respiratory gas conditioning with speech function

[0138] 2 cases

[0139] 3 first opening

[0140] 4 second lockable opening

[0141] 5 first housing part

[0142] 6 second housing part

[0143] 7 Outer ring

[0144] 8 central top

[0145] 9 elastically deformable bridge

[0146] 10 first retaining ring

[0147] 11 first sealing surface

[0148] 12 second retaining ring

[0149] 13 second sealing surface

[0150] 14 Foam (HME)

[0151] 15 Cover area

[0152] 16 Base area

[0153] 17 Surface area

[0154] 18 Force

[0155] 19 Longitudinal axis

[0156] 20 first filter fleece

[0157] 21 first clamping point

[0158] 22 second clamping point

[0159] 23 second filter fleece

[0160] 24 third clamping point

[0161] 25 rest connection

[0162] 26 first lifting device

[0163] 27 additional lifting equipment

[0164] 28 inner mounting point

[0165] 29 outer attachment point

[0166] 30 imaginary levels

Claims

AMENDED CLAIMS received by the International Bureau on 10 February 2026 (10.02.2026) 1. Filter element (1) for respiratory gas conditioning with speech function, comprising a housing (2), a first opening (3) for connection to a tracheostomy tube, a second, closable opening (4) for air inlet or outlet, a foam (14) and a first annular filter fleece (20), characterized in that the housing (2) comprises a first housing part (5) and a second housing part (6) connected to the first housing part (5), that the first opening (3) is arranged in the second housing part (6), that the first housing part (5) is made in one piece and comprises an outer ring (7), a central upper part (8) and elastically deformable webs (9) arranged between the outer ring (7) and the upper part (8), that the first annular filter fleece (20) with its inner clamping area is clamped between the upper part (8) and a first retaining ring (10) of the first housing part (5),in an area of ​​a first annular clamping point (21) and with its outer clamping area, clamped between the outer ring (7) of the first housing part (5) and the second housing part (6), in an area of ​​a second annular clamping point (22), that a second annular filter fleece (23) is arranged in the filter element (1), that the second annular filter fleece (23) is arranged with its inner clamping area, clamped between a second retaining ring (12) of the filter element (1) and the second housing part (6), in an area of ​​a third annular clamping point (24) and with its outer clamping area, clamped between the outer ring (7) of the first housing part (5) and the second housing part (6), in the area of ​​the second annular clamping point (22), that a first retaining ring (10) is arranged on the upper part (8) in the filter element (1), which has an annular first sealing surface (11),that a second retaining ring (12) is arranged on the second housing part (6), which has an annular second sealing surface (13), wherein a surface of the first sealing surface (11) and a surface of the second sealing surface (13) are designed to correspond to each other, and that the elastically deformable webs (9) are arranged so that when the filter element (1) is actuated, AMENDED SHEET (ARTICLE 19) force (18) acts on the central upper part (8) and as a result of the acting force (18) the first sealing surface (11 ) is arranged sealingly on the second sealing surface (13) and thus the second, closable opening (4) of the filter element (1 ) is sealed.

2. Filter element (1) according to claim 1, characterized in that the foam (14) is cylindrical and is arranged in the housing (2) with a top surface (15) aligned with the first retaining ring (10) and the upper part (8) and with a base surface (16) aligned with the second housing part (6), wherein a part of a lateral surface (17) of the cylindrical breathing filter (14) is surrounded by the second retaining ring (12).

3. Filter element (1 ) according to claim 2, characterized in that the second, closable opening (4) of the filter element (1) is arranged in a region of the outer surface (17) of the cylindrical foam (14) and between the first sealing surface (11 ) and the second sealing surface (13).

4. Filter element (1 ) according to one of claims 1 to 3, characterized in that the first annular filter fleece (20) is arranged with its inner clamping area, clamped between the upper part (8) and the first retaining ring (10) of the first housing part (3), in a region of a first annular clamping point (21 ) and with its outer clamping area, clamped between the outer ring (7) of the first housing part (5) and the second housing part (6), in a region of a second annular clamping point (22).

5. Filter element (1 ) according to one of claims 1 to 4, characterized in that the first housing part (5) consists of a semi-elastic material such as polypropylene or polyethylene.

6. Filter element (1 ) according to one of claims 1 to 5, characterized in that the elastically deformable webs (9) are s-shaped. AMENDED SHEET (ARTICLE 19) 7. Filter element (1 ) according to one of claims 1 to 6, characterized in that when the filter element (1 ) is actuated, a force (18) acts on the upper part (8) and as a result of the acting force (18) the first sealing surface (11 ) is arranged on the second sealing surface (13) and thus the second, closable opening (4) of the filter element (1 ) is closed.

8. Filter element (1 ) according to one of claims 1 to 7, characterized in that the first housing part (5) is arranged on the second housing part (6) by means of a snap connection (25). AMENDED SHEET (ARTICLE 19)

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