Speaking valve and method for using the speaking valve on a tracheotomy patient

Abstract

The object of the invention, which relates to a speaking valve (1) and to a method for using the speaking valve (1) on a tracheotomy patient, is to provide a solution in which the speaking valve (1) is robust and can be produced easily and cost-effectively. In addition, the speaking valve (1) is intended to make it possible to control an air flow during exhalation through the upper respiratory tract. Furthermore, the dead space volume inside the speaking valve (1) is to be minimized. This object is achieved by the arrangement in that at least one air outflow opening (8) which can be sealingly closed by means of a closure element is arranged in a wall of the housing (2) of the speaking valve (1), in that the closure element is a separate hollow truncated cone (9) mounted rotatably within the housing (2) of the speaking valve (1), and in that at least one opening (16) corresponding to the air outflow opening (8) is arranged in the hollow truncated cone (9).

Description

[0001] Speaking valve and procedure for using the speaking valve on a tracheotomized person

[0002] The invention relates to a speaking valve comprising a housing with a first connection for connecting to a tracheostomy tube and a closable air inlet opening on which a flexible membrane is arranged.

[0003] The invention also relates to a method for using a speaking valve on a tracheotomized person, in which the speaking valve is provided connected to a tracheostomy tube, in which an air inlet opening which can be closed by means of a flexible membrane is provided in a wall of a housing of the speaking valve, and in which a first airflow is guided through the air inlet opening which opens during inhalation when the person inhales.

[0004] 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.

[0005] It is also known from the prior art to insert and secure a so-called tracheostomy tube into the trachea through a tracheostoma, 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. For the purposes of this description, a tracheotomized person is a person who has a tracheotomy and still possesses the larynx, the connecting structure between the pharynx and the trachea, with its vocal cords.

[0006] 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.

[0007] It is known that a tracheotomized person is enabled to use their vocal cords and speak by at least partially closing the tracheotomy.

[0008] 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 comfortable option is the use of a speaking valve, which is positioned at the outer end of the tracheostomy tube and influences or controls the connection between the trachea and the surrounding environment.

[0009] 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.

[0010] These types of speaking valves typically have an air inlet opening with a silicone membrane attached. This silicone membrane has a resting position in which the air inlet opening is closed by the silicone membrane.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] Various tracheostomy valves or speaking valves are known from the state of the art, which can be used on a tracheotomized person who still has vocal cords.

[0015] 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 way for the user to speak normally using the vocal cords without having to change the device.

[0016] To solve this problem, a speaking valve is described 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 is disclosed that, for this purpose, flexible membranes made of rubber or the like are provided on the inner surface of the circular wall of the speaking valve housing, the membranes being dimensioned such that they each cover a side opening in the housing of the speaking valve. In a first 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 of appropriate devices such as cylindrical pins, whereby the side openings remain open during both inhalation and exhalation. This facilitates breathing for the tracheotomized person, although speaking is not possible.

[0017] German patent DE 10 2012 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.

[0018] 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.

[0019] 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 attachment unit. This is preferably achieved by a threaded engagement between the attachment unit and the valve unit. Furthermore, a speaking valve from Atos Medical GmbH, designated ProTrach DualCare, is known, which provides a combination of a speaking valve and a heat and moisture exchanger (HME) and is intended for spontaneously breathing tracheotomized patients.

[0020] The speaking valve has two modes: speaking mode and HME mode.

[0021] In speaking mode, a flexible membrane is positioned in an airflow opening, acting as an effective one-way valve. The flexible membrane, covering the airflow opening in the speaking valve's lid, opens during inhalation, allowing the patient to breathe in through the airflow opening. During exhalation, the membrane remains closed, and the air is redirected through the upper airways and vocal cords, enabling the patient to speak. In speaking mode, the inhaled air is not conditioned, as the exhaled air escapes through the upper airways.

[0022] In HME mode, the membrane is turned away from the airflow, allowing the patient to both inhale and exhale through the device. The inhaled air is conditioned by the heat and moisture retained from the exhaled air in the impregnated medium of the HME. Speaking is not possible in HME mode.

[0023] The product is switched to HME mode by turning the lid of the speaking valve until it clicks into the desired position. In this position, the flexible diaphragm does not cover the airflow opening in the lid of the speaking valve.

[0024] A disadvantage of the current state of the art is that existing speaking valves are sometimes mechanically complex and expensive to manufacture and assemble. Furthermore, existing speaking valves have sizes that are considered disadvantageous for use on patients. Additionally, a large speaking valve size is associated with a large dead space volume inside the valve, which negatively impacts the patient's breathing. Therefore, there is a need for an improved speaking valve and an improved method for its use on tracheotomized individuals.

[0025] The object of the invention is to provide a speaking valve and a method for using the speaking valve in a tracheotomized person, wherein the speaking valve is robust and can be manufactured simply and cost-effectively. Furthermore, the speaking valve should enable the regulation of airflow during exhalation through the upper airways. Additionally, the dead space volume inside the speaking valve should be minimized.

[0026] The problem is solved by a speaking valve with the features according to claim 1 of the independent patent claims. Further developments are specified in the dependent patent claims.

[0027] The invention relates to a speaking valve comprising a housing with a first connection for connecting to a tracheostomy tube and a closable air inlet opening on which a flexible membrane is arranged.

[0028] To connect the speaking valve to a tracheostomy tube of a tracheotomized person, the speaking valve has its first connection on its housing. This connection is designed to allow a tight seal with standard tracheostomy tubes that typically have a 15 mm connector.

[0029] The speaking valve housing also features a closable air inlet. A flexible membrane is positioned at this air inlet, sealing it tightly in its resting position. When the person inhales, the airflow (suction) deforms the flexible membrane, opening the air inlet. This allows the person to inhale through the air inlet. Once inhalation is complete, the flexible membrane automatically returns to its resting position, sealing the air inlet tightly. The flexible membrane and the air inlet thus form a known one-way valve within the speaking valve. This sealing of the air inlet directs the airflow over the larynx and upper airways of the person, enabling speech through the use of the vocal cords.

[0030] Such a flexible membrane consists, for example, of a synthetic polymer such as polysiloxane or silicone.

[0031] According to the invention, at least one air outlet opening which can be sealed by means of a sealing element is arranged in a wall of the housing of the speaking valve, the sealing element is a separate hollow cone truncated cone rotatably mounted within the housing of the speaking valve, and at least one opening corresponding to the air outlet opening is arranged in the hollow cone truncated cone.

[0032] The speaking valve has a housing in the wall of which at least one air outlet opening is arranged. This air outlet opening can be sealed by means of a sealing element. According to the invention, the sealing element is formed by a separate, rotatably mounted, hollow truncated cone within the housing of the speaking valve. This separate hollow truncated cone has at least one opening, which is designed and arranged such that the opening in the hollow truncated cone corresponds to the air outlet opening.This means that the rotatably mounted hollow cone truncated cone in the housing can assume a position in which the position of the opening in the hollow cone truncated cone essentially coincides with the position of the air outlet opening in the housing of the speaking valve, so that an airflow emanating from the person when the person exhales is allowed to pass through the tracheostomy tube, the opening in the hollow cone truncated cone and the air outlet opening from the speaking valve into the ambient air.

[0033] It is provided that the first connection on the housing of the speaking valve is aligned in one direction along an imaginary longitudinal axis of the speaking valve. Furthermore, it is provided that an opening in the truncated hollow cone and a corresponding air outlet opening in the housing of the speaking valve are aligned along a second axis, with the opening in the truncated hollow cone and the corresponding air outlet opening in the housing of the speaking valve being positioned concurrently. This second axis is aligned with the longitudinal axis of the speaking valve at an angle between 70 degrees and 110 degrees, and in particular at an angle of 90 degrees.

[0034] While the airflow from the person exhaling through the tracheostomy tube into the speaking valve is directed via the first port of the speaking valve in the direction of the imaginary longitudinal axis of the speaking valve, the exhaled air flows out of the speaking valve in a direction radial to the imaginary longitudinal axis of the speaking valve, essentially perpendicular to the speaking valve.

[0035] Furthermore, according to the invention, the opening in the truncated hollow cone and the air outlet opening have approximately the same or identical shape and size. If several openings in the truncated hollow cone and several air outlet openings are arranged in the wall of the housing of the speaking valve, then each of these openings in the truncated hollow cone and each of the air outlet openings has a substantially identical shape and size. Even though some embodiments or examples with only one air outlet opening and one opening in the truncated hollow cone are described below, this does not limit the invention, since it is always possible for someone skilled in the art to transfer this embodiment or example to configurations with several air outlet openings and several openings in the truncated hollow cone.

[0036] Additionally, the rotatably mounted hollow cone within the speaking valve housing is designed to assume a position in which the positions of the multiple openings in the hollow cone align with the positions of the multiple air outlet openings in the speaking valve housing. Thus, when the person exhales, the airflow is directed through the tracheostomy tube, the multiple openings in the hollow cone, and the multiple air outlet openings of the speaking valve.

[0037] Because the hollow cone is rotatably mounted in the speaking valve housing, its position within the housing can be changed. Changing the position of the hollow cone within the housing alters the position of an opening in the hollow cone relative to the corresponding air outlet opening in the housing. This change in the relative positions of the openings alters the cross-section through which the airflow passes from the speaking valve into the surrounding air when the person exhales.

[0038] If the openings are positioned identically, the resulting cross-sectional area for the airflow during exhalation is maximized. The exhaled airflow is completely directed through the openings of the speaking valve into the surrounding air, preventing the person from speaking.

[0039] If the openings are only partially aligned due to a twisting of the hollow cone, the resulting cross-sectional area for airflow during exhalation is reduced. Part of the exhaled air escapes through the openings of the speaking valve into the surrounding air. Another portion of the airflow is directed through the larynx and upper airways. This allows the person to speak if the amount of air passing through the larynx and upper airways is sufficient for speech.

[0040] If the openings become misaligned due to twisting of the hollow cone, there is no longer a cross-section through which air can escape from the speaking valve when the person exhales. In this case, the air outlet opening in the speaking valve housing is sealed by the hollow cone, and the exhaled air is directed entirely through the larynx and upper airways, thus enabling the person to speak.

[0041] According to the invention, it is further provided that the housing of the speaking valve has a lower part and a cover, that the closable air inlet opening is arranged in the cover, that the closable air outlet opening is arranged in the lower part, and that the hollow cone truncated cone is rotatably and fixedly arranged between the lower part and the cover.

[0042] The speaking valve consists of a base and a cover that snap together to form the entire housing of the speaking valve. To connect the base to the cover, both components have corresponding circumferential locking elements that securely fix the components in place after assembly.

[0043] In one embodiment, such locking elements are formed by a ring-shaped projection arranged on the outside of the lower part and a ring-shaped notch arranged on the inside of the cover.

[0044] The cover houses the closable air inlet opening. In one version of the speaking valve, the flexible diaphragm, which closes the air inlet opening, is fixed between the base and the cover. For this purpose, the base, for example, has a cylindrical cavity with a first annular surface. The cover also has a pin corresponding to the cavity and a second annular surface. The centers of the two annular surfaces lie on the longitudinal axis of the speaking valve. When assembling the components to form a speaking valve, the pin is inserted into the cylindrical cavity until the first and second annular surfaces are as close together as possible, securely fixing the ring-shaped flexible diaphragm located between them.This flexible membrane is designed in the shape of a circular ring, with the membrane having a central opening which essentially corresponds to the diameter of the pin.

[0045] In this position, fixed between the first and second annular surfaces, the flexible membrane rests against an annular recess in the cover, thus closing the air inlet opening. For this purpose, the flexible membrane has an outer diameter larger than the diameter of the annular recess in the cover.

[0046] For secure positioning of the hollow cone truncated cone within the speaking valve, the lower part and the cover feature corresponding guide elements, at least partially annular, such as grooves and / or projections. These guide elements position the hollow cone truncated cone according to the invention in its intended installation position after the components have been assembled, with the hollow cone truncated cone being rotatably arranged within the speaking valve. In one embodiment, the hollow cone truncated cone is positioned within the speaking valve between a first guide element in the lower part and a second guide element in the cover. In this installation position of the hollow cone truncated cone within the speaking valve, the at least one opening in the hollow cone truncated cone can be rotated into a position in which the at least one air outlet opening is located in the wall of the lower part.The positions of the openings are therefore identical, and an airflow from the speaking valve when the person exhales can escape into the surrounding air through these openings.

[0047] In this installation position of the hollow cone truncated cone in the speaking valve, the at least one opening in the hollow cone truncated cone can be rotated into a position where it does not coincide with the position of the at least one air outlet opening in the wall of the lower part. Because the positions of the openings do not coincide, an airflow cannot escape from the speaking valve into the ambient air when the person exhales, as the air outlet opening in the wall of the lower part is sealed by a section of the hollow cone truncated cone that has no opening. In this position of the hollow cone truncated cone, the airflow during the person's exhalation is directed over the upper airways, thus enabling voice production.

[0048] It has proven advantageous that the cover of the speaking valve has openings. The cover protects the flexible diaphragm from external mechanical stresses, such as contact with the diaphragm, which could impair its proper functioning. The cover also features openings that allow ambient air to enter the speaking valve through the closable air inlet. These openings are designed with a total cross-section equal to, or in particular larger than, the inner cross-section of the tracheostomy tube connected to the speaking valve. This ensures that sufficient air can flow into the speaking valve through the openings and the closable air inlet. The openings in the cover do not increase resistance when the person breathes through the speaking valve.

[0049] A sealing effect when closing one or more air outlet openings in the wall of the lower part of the speaking valve housing with the hollow cone is achieved by the hollow cone's outer surface abutting against one or more air outlet openings in the wall of the lower part. This is achieved by the outer surface of the hollow cone being designed to correspond to a surface on the inner side of the lower part, at least in the area of ​​the air outlet openings. When the hollow cone is rotated within the lower part of the speaking valve housing, the two surfaces slide against each other. Furthermore, the material of the hollow cone is designed to be more elastic than the material of the lower part.

[0050] According to the invention, the air outlet opening and the corresponding opening of the truncated hollow cone are designed to be circular, oval or rectangular.

[0051] The air outlet opening in the wall of the lower part of the speaking valve housing and the opening of the hollow cone are, for example, circular, oval, or rectangular, although other embodiments are conceivable. It is important that the air outlet opening in the wall of the lower part and the opening of the hollow cone have identical, corresponding shapes. This applies to both their shape and their dimensions, such as diameter, length, or width.

[0052] It is also intended that the hollow conical truncated cone is rotatably arranged within the housing of the speaking valve in a range between 0 degrees and 90 degrees, in particular in a range between 0 degrees and 60 degrees.

[0053] The hollow cone is positioned and fixed within the housing of the speaking valve, specifically between the lower part and the housing cover, such that it can be rotated within the housing. For this purpose, a handle is attached to the hollow cone, projecting from the lower part. The handle is positioned so that it protrudes from the housing in the area of ​​an air outlet. In this case, at least one of the air outlets penetrated by the handle is larger than its corresponding opening in the hollow cone. The cross-section permeable to an airflow during exhalation, formed by an air outlet in conjunction with a corresponding opening in the hollow cone, is not affected by the handle and remains unchanged.

[0054] In one version of the speaking valve, the hollow cone truncated section in the speaking valve is rotatably arranged in a range between 0 degrees and 90 degrees.

[0055] In an alternative design of the speaking valve, the hollow cone truncated cone in the speaking valve is rotatably arranged in a range between 0 degrees and 60 degrees.

[0056] For example, when the truncated cone in the speaking valve is at 0 degrees, the air outlet is sealed by the outer surface of the truncated cone, and when it is at approximately 60 degrees, it is fully open. At positions of the truncated cone in the speaking valve greater than 0 degrees and less than approximately 60 degrees, various states occur in which the air outlet is more or less partially closed.

[0057] It has proven particularly advantageous that the hollow cone truncated cone is made of polypropylene and the housing of acrylonitrile butadiene styrene copolymer.

[0058] As described above, the sealing of the air outlet opening in the lower part of the speaking valve housing is to be improved by using a more elastic material for the hollow cone than for the housing. In one embodiment, a semi-crystalline thermoplastic such as polypropylene (PP) is used for the hollow cone, and an amorphous thermoplastic such as acrylonitrile butadiene styrene copolymer (ABS) is used for the housing.

[0059] It has also proven advantageous that a second connection for connecting to an additional oxygen supply is provided on the cover of the speaking valve.

[0060] A second connection is provided on the housing of the speaking valve, specifically on the cover. This second connection is used for connecting to an additional oxygen supply. The second connection has a shape and diameter that allows it to connect to standard, prior art supplemental oxygen tubing. The second connection is positioned within the speaking valve such that the supplemental oxygen, for example, continuously supplied, is directed into a section of the closable air inlet opening outside the speaking valve. When the user inhales, the flexible membrane opens the air inlet opening, and the supplemental oxygen is carried to the user by the airflow.

[0061] The flexible membrane at the air inlet opening is designed in such a way that it does not open due to the flow of additionally supplied oxygen.

[0062] It is particularly advantageous that the truncated hollow cone has a diameter of less than 23 mm and a height of 6 mm or less.

[0063] Due to the inventive design of the speaking valve's closure element as a hollow truncated cone and its small dimensions of less than 23 mm in maximum diameter and a height of 6 mm or less at its greatest extent, the speaking valve according to the invention can have a very small size. In one embodiment of the hollow truncated cone, the maximum first outer diameter is 22.31 mm and the minimum second outer diameter is 16.82 mm. The wall thickness of the hollow truncated cone is between 0.6 mm and 1.2 mm. The housing of the speaking valve is designed to have a diameter of less than 26 mm and a height of less than 21 mm.

[0064] Thus, the speaking valve according to the invention has a particularly small design and size. This small size also results in a reduction in the weight of the speaking valve, thereby improving the wearing comfort of the person using the speaking valve in conjunction with a tracheostomy tube.

[0065] In addition to the compact design of the speaking valve, the dead space volume inside the valve is reduced, resulting in improved oxygen supply to the patient. This is because less exhaled air remains inside the valve during exhalation, which is then inhaled first through the tracheostomy tube. In one embodiment of the speaking valve according to the invention, the dead space volume inside the valve is equal to or less than 1700 mm³. 3 .

[0066] The problem is also solved by a method for using the speaking valve on a tracheotomized person with the features according to claim 10 of the independent patent claims. Further developments are specified in the dependent patent claims.

[0067] In the present method for using a speaking valve on a tracheotomized person, the speaking valve is connected to a tracheostomy tube. This type of speaking valve incorporates a closable air inlet opening in one wall of its housing. This air inlet opening is closed by a flexible membrane in the form of a one-way valve, such that when the person inhales, the flexible membrane opens the air inlet, allowing an initial airflow to pass through the now-open air inlet.

[0068] The plan is to provide an air outlet opening in a wall of the speaking valve housing and a closing element in the form of a rotatably mounted, separate hollow cone truncated cone inside the speaking valve housing, and to control a second airflow between a maximum and a minimum by means of this hollow cone truncated cone when the person exhales through the air outlet opening.

[0069] According to the invention, a closure element, with which the air outlet of the speaking valve can be opened or closed, is provided in the form of a rotatably mounted, separate hollow cone, which has at least one opening corresponding to the air outlet. The opening and closing of the air outlet of the speaking valve is effected by rotating the hollow cone within the speaking valve. In this way, the positions of the openings, i.e., the air outlet and the opening in the hollow cone, are changed relative to each other. If the positions of the openings coincide, the air outlet of the speaking valve is fully open. If the positions of the openings do not coincide, the air outlet of the speaking valve is sealed by an outer wall of the hollow cone.

[0070] The hollow cone inside the speaking valve can also be rotated so that the air outlet is only partially open or partially closed. This controls a secondary airflow through the outlet during exhalation, adjusting the flow between a maximum and a minimum. This control automatically influences the secondary airflow routed through the upper airways during exhalation. The greater the proportion of the secondary airflow escaping from the speaking valve via the outlet, the smaller the proportion delivered through the upper airways, and vice versa. Thus, by controlling the distribution of the secondary airflow, particularly the portion delivered through the upper airways, the person's ability to produce speech is affected.

[0071] In one embodiment of the invention, the airflow through the air outlet opening is continuously adjustable between a fully closed and a maximally open cross-section. Thus, by partially reducing the cross-section of the air outlet opening, a specific back pressure can be set, enabling the person to speak, since the exhaled airflow is at least partially directed over the person's upper airways and vocal cords. Conversely, at least part of the inhaled airflow can reach the person through the remaining, reduced cross-section of the air outlet opening, facilitating inhalation for the patient.

[0072] In a particular embodiment, it is provided that the speaking valve according to the invention is arranged and operated in conjunction with a heat and moisture exchanger (HME).

[0073] In a particularly advantageous embodiment of the present invention, it is further provided that an oval or rectangular and longitudinally extended air outlet opening has two inner surfaces that are at least partially parallel to each other, that several positioning elements are arranged on the first inner surface or on the second inner surface in such a way that a detent position is formed between each pair of adjacent positioning elements, and that the inner dimensions of the detent positions correspond to an outer dimension of the handle in the area of ​​the air outlet opening, so that the handle can be selectively arranged to engage in one of the detent positions.

[0074] In this embodiment of the invention, the airflow is controlled in stages by the cross-section of the air outlet opening, ranging from a completely closed cross-section to a maximally open cross-section. This cross-section is the cross-section that forms for the airflow when the person exhales.

[0075] In one embodiment, the multiple positioning elements projecting into a space between the opposing inner surfaces are designed in the shape of a circular arc or, in particular, semicircular or triangular shapes.

[0076] The multiple positioning elements each locally reduce the gap or space between the handle and the opposite inner surface, for example, by being arranged on a first inner surface. This local reduction of the distance lies within an area smaller than the outer dimension of the handle in the region of the air outlet opening and thus prevents the handle from moving from its current detent position to another detent position without the application of an external force.

[0077] In one example, the handle is cylindrical in the area of ​​the air outlet, with an outer diameter of 5 mm in this area. A first gap between the parallel inner surfaces is also 5 mm at the points where no positioning elements are located, i.e., at the detent positions. At the points where the positioning elements, for example, circular arc-shaped ones, are located on the first inner surface, a second gap of 3.5 mm is created locally between each positioning element and the opposite inner surface due to the dimensions of the positioning elements (1.5 mm). Therefore, the handle, with its 5 mm diameter, cannot move from its current detent position without the application of an external force.By applying force to the handle by a user of the speaking valve, the handle can be moved from its current detent position via a positioning element to an adjacent detent position, where it is securely held when the external force is released. This is possible because both the handle in the area of ​​the air outlet and the lower part, at least in the area of ​​the air outlet, are made of an elastic material such as plastic, which can be elastically deformed when the handle is moved from its current detent position via the positioning element to an adjacent detent position.

[0078] The handle can be locked into place in one of the detent positions between two adjacent positioning elements. Additionally, it can be provided that the handle can optionally be locked into place at the edge of, for example, the oval, elongated air outlet next to the first or last positioning element in an outer detent position. These positions are those positions of the handle, and thus of the hollow cone truncated section, in which the resulting cross-section for the airflow during exhalation through the air outlet is either completely closed or maximally open.

[0079] The features and advantages of this invention explained above can be better understood and evaluated after careful study of the following detailed description of the preferred, non-restrictive exemplary embodiments of the invention with the accompanying drawings, which show:

[0080] Figs. 1 to 4: several views of an embodiment of the speaking valve according to the invention from the outside,

[0081] Figs. 5 and 6: Sectional views of the speaking valve according to the invention,

[0082] Fig. 7: a first view of an embodiment of the hollow conical truncated cone according to the invention as a closure element,

[0083] Fig. 8: a second view of the truncated hollow cone according to the invention as shown in Figure 7,

[0084] Fig. 9: another view of the truncated hollow cone,

[0085] Fig. 10: a sectional view of the truncated hollow cone according to the invention along the section line AA shown in Figure 9,

[0086] Fig. 11: a top view of the speaking valve according to the invention,

[0087] Fig. 12: a view of the speaking valve according to the invention from below,

[0088] Fig. 13: a perspective view of the speaking valve according to the invention and

[0089] Figs. 14 and 15: each shows the lower part of the speaking valve in different views.

[0090] Figures 1 to 4 show several external views of an embodiment of the speaking valve 1 according to the invention. Figures 1 to 4 each show external views of the speaking valve 1 according to the invention rotated by 90 degrees.

[0091] The speaking valve 1 has a two-part housing 2. The two-part housing 2 consists of a lower part 3 and a cover 4, which, when the speaking valve 1 is assembled, snap into one another, thus forming the entire housing 2 of the speaking valve 1. To connect the lower part 3 to the cover 4, both components, lower part 3 and cover 4, have corresponding circumferential locking elements, which are not shown in Figures 1 to 4 and which securely fix the components to form a speaking valve 1 after assembly.

[0092] The speaking valve 1 has a first port 5 for connecting to a tracheostomy tube 6 of a person or patient (not shown in Figures 1 to 4). This first port 5 is designed to allow a tight seal with standard tracheostomy tubes 6 with a diameter of 15 mm.

[0093] Also visible from the outside is a second connection 7 located on the cover 4, which is intended for connection to an additional oxygen source not shown.

[0094] Furthermore, depending on the orientation of the speaking valve 1, up to two closable air outlet openings 8 are visible. These air outlet openings 8 can be closed by a hollow conical truncated cone 9, which is only partially visible inside the lower part 3 in Figures 2 and 4. For this purpose, a handle 10 is arranged on the hollow conical truncated cone 9 located inside the lower part 3. This handle 10 is positioned such that it protrudes from the lower part 3 of the housing 2 of the speaking valve 1 in the area of ​​an air outlet opening 8, as shown in Figures 2, 3, and 4. The handle 10 can be moved in the directions indicated by a double arrow in Figure 3, thereby closing or opening the two air outlet openings 8 of the speaking valve 1.

[0095] Figures 1 to 4 further show openings 11 arranged in the cover 4. Through these openings 11, when the closable air inlet opening 12 (not visible in Figures 1 to 4) is opened, an airflow can pass from the ambient air to the person when they inhale, via the openings 11, the air inlet opening 12, the first connection 5, and the tracheostomy tube 6.

[0096] Figures 1, 3, and 4 also show a fastening element 13. The speaking valve 1 can be attached using this fastening element 13, for example, with a special retaining strap. Figures 5 and 6 each show a sectional view of the speaking valve 1 according to the invention along a longitudinal axis. The lower part 3 and the cover 4 of the housing 2 are also visible in the sectional views of Figures 5 and 6. In the illustrated embodiment of the speaking valve 1, the two components, lower part 3 and cover 4, have corresponding circumferential locking elements that securely fix the components after they have been assembled to form a speaking valve 1.

[0097] In the illustrated embodiment, these locking elements are formed by an annular projection 14 arranged on the outside of the lower part 3 and an annular notch 15 arranged on the inside of the cover 4. The elements 14 and 15 can only be partially, i.e., not completely, annular in order to securely fix the components after assembly.

[0098] Figure 5 shows the first connection 5 and the second connection 7 for a connection to an additional oxygen source.

[0099] In Figure 6, a part of a tracheostomy tube 6 is indicated by means of a dash-dash line at the first connection 5 as an example.

[0100] In the sectional views of Figures 5 and 6, the hollow conical truncated cone 9 according to the invention can also be seen, which is arranged in the speaking valve 1 in abutting an inner wall of the lower part 3. This hollow conical truncated cone 9, which is rotatably arranged in the lower part 3, is a separate component in the speaking valve 1. Changing the position of the hollow conical truncated cone 9 in the lower part 3, i.e., rotating the hollow conical truncated cone 9 relative to the lower part 3, is made possible by the handle 10 protruding from the lower part. In one embodiment, the hollow conical truncated cone 9 and the handle 10 are made of the same material, which is, for example, polypropylene. A component comprising the hollow conical truncated cone 9 and the handle 10 is manufactured, for example, by an injection molding process. This component is simply inserted into the lower part 3 during assembly of the speaking valve 1 before the cover 4 is snapped into place with the lower part 3 to form the finished speaking valve 1.This locking action is made possible by the ring-shaped design 14 in conjunction with the ring-shaped notch 15.

[0101] The truncated hollow cone 9 has at least one, and in the example of the figures shown in this description two, openings 16. In Figure 6, the two openings 16 of the truncated hollow cone 9 can be seen in the left and right areas of the depicted speaking valve 1.

[0102] In the illustration of Figure 6, the openings 16 of the truncated cone 9 are positioned such that they correspond to the positions of the two air outlet openings 8 arranged in the lower part 3. The openings 16 of the truncated cone 9 and the air outlet openings 8 are designed to correspond to each other, meaning that the openings have both the same shape and the same dimensions. When the openings are in the positions shown in Figure 6, which is achieved by rotating the truncated cone 9 accordingly within the lower part 3, the air outlet openings 8 are not closed by the truncated cone 9, i.e., they are fully open. A cross-section formed by the two openings 8 and 16, through which air flows, for example, is maximized in this orientation of the openings 8 and 16 relative to each other.

[0103] With openings 8 and 16 aligned in this way, a second airflow 19, when the person exhales, enters the interior of the speaking valve 1 via the tracheostomy tube 6 and the first connection 5, and then flows through the openings 16 of the hollow conical truncated cone 9 and the air outlet openings 8 into the ambient air. This airflow 19 is illustrated in Figure 6 by several arrows.

[0104] If the truncated cone 9 is rotated in the lower part 3, the positions of the openings 16 in the truncated cone 9 change relative to the air outlet openings 8. For example, by rotating the truncated cone 9 by an angle of 30 degrees, the cross-section formed by the two openings 8 and 16, through which air flows, changes and is, for example, only 50% of the maximum cross-section. If the truncated cone 9 is rotated further in the lower part 3, the positions of the openings 16 in the truncated cone 9 relative to the air outlet openings 8 change further. For example, by rotating the truncated cone 9 by an angle of 60 degrees, the cross-section formed by the two openings 8 and 16 changes such that no cross-section remains and the air outlet openings 8 are completely closed.In this case, not shown in Figures 5 and 6, a first airflow 17 as depicted in Figure 6 is no longer possible. In this case, the first airflow 17 is directed over the upper airways and the vocal cords, thus enabling the person to speak.

[0105] For clarity, only a portion of the air inlet opening 12 in the cover 4 is shown in Figure 5 by means of a curved bracket. A flexible membrane 18 is arranged at the closable air inlet opening 12, which seals the air inlet opening 12 in its resting position. When a person inhales, an initial airflow 17 is created. The resulting suction deforms the flexible membrane 18 and thus opens the air inlet opening 12, which is not shown in Figures 5 and 6. Figures 5 and 6 each show the flexible membrane 18 in its resting position. Once inhalation is complete, the flexible membrane 18 automatically returns to the depicted resting position and seals the air inlet opening 12. The flexible membrane 18 and the air inlet opening 12 thus form a known one-way valve in the speaking valve 1.

[0106] The first airflow 17 during the person's inhalation leads from the ambient air through the air inlet opening 12 into the interior of the speaking valve 1 and then via the first connection 5 and the tracheostomy tube 6 to the person. This first airflow 17 is also illustrated in Figure 6 by means of several arrows.

[0107] The flexible membrane 18, which closes the air inlet opening 12 in its rest position within the speaking valve 1, is fixedly arranged between the lower part 3 and the cover 4. For this purpose, the lower part 3 has, for example, a cylindrical cavity 20 with a first annular surface 21. The cover 4 also has a pin 22 corresponding to the cavity 20 and a second annular surface 23. The centers of the two annular surfaces 21 and 23 lie on the first longitudinal axis 24 of the speaking valve 1, as shown in Figure 5.

[0108] When assembling the components to form a speaking valve, the pin 22 is inserted into the cylindrical cavity 20 until the first annular surface 21 and the second annular surface 23 are as close together as possible and securely fix the ring-shaped flexible diaphragm 18 located between these annular surfaces 21 and 23. The flexible diaphragm 18 is in the shape of an annulus, with a central opening that essentially corresponds to the diameter of the pin 22.

[0109] In this position of the flexible membrane 18, fixed between the annular surfaces 21 and 23, the annular membrane 18, in its rest position, rests against an annular projection 25 arranged in the cover 4 in the region of its outer circumference and thus closes the air inlet opening 12. For this purpose, the membrane 18 has an outer diameter which is larger than the diameter of the annular projection 25 in the cover 4.

[0110] For secure positioning of the hollow cone 9 in the speaking valve 1, the lower part 3 and the cover 4 have corresponding guide means 26 and 27, at least partially annular in shape, such as grooves and / or projections. These guide means 26 and 27 position the hollow cone 9 according to the invention in the intended installation position of the hollow cone 9 after the components 3 and 4 have been joined, wherein the hollow cone 9 is rotatably arranged within the lower part 3 of the speaking valve 1.

[0111] In one embodiment, the hollow cone 9 is arranged between a first guide 26 in the lower part 3 and a second guide 27 in the cover 4. In this installation position of the hollow cone 9 in the speaking valve 1, the separate hollow cone 9 is rotatable. Thus, the at least one opening 16 in the hollow cone 9 can be moved into or away from a position in which the at least one air outlet opening 8 is located in the wall of the lower part 3 by rotating the hollow cone 9. Therefore, by rotating the hollow cone 9, it is possible to open or partially or completely close the air outlet opening 8.

[0112] For the sake of clarity, not all of the reference symbols described above are shown in each of Figures 5 and 6.

[0113] Figure 7 shows a first view of an embodiment of the truncated hollow cone 9 according to the invention as a closing element of the speaking valve 1. As is known from geometry, the truncated hollow cone 9 is created by cutting a smaller hollow cone off a straight hollow cone parallel to its base.

[0114] Figure 7 shows a view looking into the hollow cone 9, which is a straight hollow cone 9. From the perspective of a viewer of Figure 7, the hollow cone 9 extends from a maximum outer diameter to a minimum inner diameter. In the outer surface of the hollow cone 9, which can also be referred to as the side wall, two openings 16 are visible in the illustration shown in Figure 7. These openings 16 are arranged opposite each other within the hollow cone 9. When such a hollow cone 9 is used in a speaking valve 1 according to the invention, the air outlet openings 8 arranged in the wall of the lower part 3 must also be arranged opposite each other, which is not shown in Figure 7.

[0115] The openings 16 in the example of Figure 7 are designed in the form of an elongated bore or groove, which is also referred to as a slotted hole.

[0116] Figure 7 also shows the handle 10 connected to the hollow conical truncated cone 9. The unit, consisting of the hollow conical truncated cone 9 and the handle 10, is manufactured using an injection molding process and is made of polypropylene.

[0117] In the lower part 3 of the speaking valve 1, the truncated hollow cone 9 is arranged such that the center point 28 of the truncated hollow cone 9 coincides with the longitudinal axis 24 of the speaking valve 1. With this arrangement, the truncated hollow cone 9 is rotatable about its center point 28, or longitudinal axis 24, in the lower part 3 of the speaking valve 1.

[0118] Figure 8 shows a second view of the hollow truncated cone 9 according to the invention, as shown in Figure 7. Figure 8 depicts the hollow truncated cone 9 from one side. Visible are the handle 10 connected to the hollow truncated cone 9 and the two opposing openings 16. Also shown is the longitudinal axis 24 passing through the center point 28 of the hollow truncated cone 9. The hollow truncated cone 9 has a surface 29 on its outer surface. After the hollow truncated cone 9 is inserted into the lower part 3 of the speaking valve 1, this surface 29 rests against the inner surface of the lower part 3. The surface 29 of the outer surface of the hollow truncated cone 9 corresponds to the surface of the inner surface of the lower part 3, or vice versa.Thus, at least in the area of ​​surface 29 of the outside of the truncated cone 9, the two surfaces run parallel to each other and slide against each other in the lower part 3 when the truncated cone 9 is rotated.

[0119] This design of the two components 3 and 9 makes it possible to seal the air outlet openings 8 by means of the surface 29 of the outer surface of the truncated cone 9. This sealing of the air outlet openings 8 only occurs, of course, if the openings 16 arranged in the truncated cone 9 are not located in the area of ​​the air outlet openings 8.

[0120] Figure 9 shows another view of the truncated cone 9. For better understanding, the truncated cone 9 is shown again in a side view in Figure 9, rotated 90 degrees compared to Figure 8. Figure 9 shows the first opening 16 in the front part of the truncated cone 9's surface and a second opening 16 in the rear part of the truncated cone 9's surface. The handle 10 connected to the truncated cone 9 is also shown. It can be seen that the maximum outer diameter of the truncated cone 9 is less than 23 mm and its height is approximately 6 mm. In the embodiment shown in Figure 9, the maximum outer diameter of the truncated cone 9 is specified as 22.31 mm and the minimum outer diameter as 16.82 mm. The height of the truncated hollow cone 9 shown in Figure 9 is 6 mm.Thus, the entire truncated hollow cone 9 has very small dimensions, which makes it possible to also design the dimensions of the speaking valve 1 according to the invention to be very small.

[0121] In this example, the maximum outer diameter of the speaking valve 1 is therefore only 26 mm and the height of the speaking valve 1 is only 21 mm.

[0122] Figure 10 shows a sectional view of the hollow truncated cone 9 according to the invention along the section line AA shown in Figure 9. The partially shown openings 16 of the hollow truncated cone 9 and the cut handle 10 connected to the hollow truncated cone 9 are visible. The hollow truncated cone 9 has a thin surface, ranging from 0.6 mm to 1.2 mm, or 0.7 mm in the example shown in Figure 10. The openings 16 have an opening angle 30°, which lies between 45° and 65°. In the example shown in Figure 10, the opening angle 30° is approximately 55°.

[0123] Figure 11 shows a top view of the speaking valve 1 according to the invention. Visible are the cover 4 with the openings 11, the handle 10, and the second connection 7.

[0124] Figure 12 shows a bottom view of the speaking valve 1 according to the invention. Visible are the lower part 3 with the first connection 5 for connection to a tracheostomy tube 6 (not shown), the opposing air outlet openings 8, the second connection 7, and the handle 10 protruding from an air outlet opening 8.

[0125] Figure 13 shows a perspective view of the speaking valve 1 according to the invention. Visible are the lower part 3 with an air outlet opening 8, the first connection 5, the cover 4 with the openings 11 and the second connection 7.

[0126] Figures 14 and 15 each show the lower part 3 of the speaking valve 1. While Figure 14 shows the lower part 3 in a side view, Figure 15 shows the lower part 3 in a perspective view. The speaking valve 1 has a lower part 3 as part of the housing 2, in the wall of which the air outlet opening 8 is arranged. This air outlet opening 8 is sealed by means of the rotatably mounted, separate hollow conical truncated cone 9, which is not shown in Figures 14 and 15.

[0127] The rotatably mounted, separate hollow cone 9 is arranged and fixed within the housing 2 of the speaking valve 1, specifically between the lower part 3 and the cover 4 of the housing 2 (not shown), such that the hollow cone 9 can be rotated within the housing 2. For this purpose, the handle 10 (also not shown) is attached to the hollow cone 9 and projects from the lower part 3 in the area of ​​the air outlet opening 8 in the housing 2. In Figures 14 and 15, however, a position of the handle 10, which has a cylindrical cross-section in the area of ​​the air outlet opening 8, is indicated by a dash-dash line. In the examples in Figures 14 and 15, the handle 10 is in a central detent position 32.

[0128] Preferably, the air outlet opening 8 is oval or rectangular and longitudinally elongated and has two internal surfaces 33a and 33b that are at least partially parallel to each other within the longitudinally elongated air outlet opening 8. In Figure 14, a region 34 in which the internal surfaces 33a and 33b are at least partially parallel to each other is shown with a bracket.

[0129] According to the invention, several positioning elements 31 are arranged on the first inner surface 33a or on the second inner surface 33b. In the example shown in Figures 14 and 15, the several positioning elements 31 are arranged on the inner surface 33a.

[0130] In the illustrated embodiment of the invention, the airflow through the air outlet opening 8 is controlled in stages. For this purpose, the multiple positioning elements 31 are arranged on the inner surface 33a of the air outlet opening 8 such that detent positions 32 for the handle 10 are formed between the positioning elements 31. This means that the handle 10 is securely held in a detent position 32 between two adjacent positioning elements 31 by the positioning elements 31 arranged on the inner surface 33a of the air outlet opening 8.

[0131] This prevents unintentional adjustment of the handle 10 and thus of the cross-section of the air outlet opening 8. Only by applying a corresponding force 35 to the handle 10, such as that applied by a user to intentionally adjust the position of the handle 10 to a different detent position 32 and thus change the cross-section of the air outlet opening 8, can the handle 10 be moved over a positioning element 31 to the next detent position 32. In the example shown in Figure 14, this force 35 is represented by an arrow and acts on the handle 10 from left to right.

[0132] The force 35 applied by the user to the handle 10 allows the handle 10 to be moved over several positioning elements 31 into a further detent position 32.

[0133] The multiple positioning elements 31 are preferably arranged at equal intervals on the inner surface 33a of the air outlet opening 8. In the examples shown in Figures 14 and 15, six positioning elements 31 are arranged at equal intervals, resulting in five detent positions 32 between the positioning elements 31, in which the handle 10 is securely held with its diameter in the area of ​​the air outlet opening 8. Thus, the speaking valve 1 provides five adjustable cross-sections of the air outlet opening 8. A cross-section of the air outlet opening 8 selected in this way cannot change unintentionally.

[0134] In one example, the handle 10 is cylindrical in the area of ​​the air outlet 8, with a diameter of 5 mm in this area. A first distance 36, or gap, between the parallel inner surfaces 33a and 33b is also 5 mm at the points where no positioning elements 31 are arranged, i.e., at the detent positions 32. At the points where the, for example, arc-shaped positioning elements 32 are arranged on the first inner surface 33a, a second distance 37 is formed locally between each positioning element 31 and the opposite second inner surface 33b, due to the dimensions of the positioning elements (1.5 mm), and this second distance has a value of 3.5 mm. The handle 10, with its diameter of 5 mm, therefore cannot move out of the area of ​​the current detent position 32 without the application of an external force 35.Only by means of the force 35 exerted on the handle by a user of the speaking valve 1 can the handle be moved from the area of ​​the current detent position 32 via a positioning element 31 to an area of ​​an adjacent detent position 32, in which the handle is again securely held when the external force 35 is no longer applied. This is possible because both the handle 10 in the area of ​​the air outlet 8 and the lower part 3 with the air outlet 8 are made of an elastic material such as a plastic. When the handle 10 moves from the current detent position 32 via a positioning element 31 to an adjacent detent position 32, the handle 10 and the lower part 3 in the area of ​​the air outlet 8 undergo elastic deformation. These elastic deformations disappear when the handle 10 has reached the adjacent detent position 32.

[0135] Additionally, it can be provided that the grip 10 can optionally engage at the edge of the, for example, oval, elongated air outlet 8 next to the first or last positioning element 31 in an outer locking position. These positions are those positions of the grip 10, and thus of the truncated cone 9, in which the resulting cross-section for the airflow during exhalation through the air outlet 8 is either completely closed or maximally open. For example, this results in one locking position 32 in which the air outlet 8 is completely closed, five locking positions 32 between the positioning elements 31 in which the cross-section of the air outlet 8 is at least partially open, and one locking position 32 in which the air outlet 8 is maximally open. These possibilities are not shown in Figures 14 and 15. List of reference numerals

[0136] 1 speaking valve

[0137] 2 cases

[0138] 3 lower part

[0139] 4 Cover

[0140] 5 first connection

[0141] 6 tracheostomy tubes

[0142] 7 second connection

[0143] 8 Air outlet opening

[0144] 9 Truncated hollow cone

[0145] 10 Handle

[0146] 11 breakthroughs

[0147] 12 Air intake opening

[0148] 13 Fastening element

[0149] 14 ring-shaped shapes

[0150] 15 ring-shaped notch

[0151] 16 openings of the truncated hollow cone

[0152] 17. First airflow during inhalation

[0153] 18 flexible membrane

[0154] 19 second airflow during exhalation

[0155] 20 cylindrical cavity

[0156] 21 first circular ring area

[0157] 22 cones

[0158] 23 second circular ring area

[0159] 24 Longitudinal axis

[0160] 25 ring-shaped shapes

[0161] 26 first management tool

[0162] 27 second command instrument

[0163] 28 Center point

[0164] 29 Surface of the outer surface of the truncated hollow cone

[0165] 30° opening angle, positioning element, detent position, inner surface, area parallel to opposite inner surfaces, force, first distance, second distance

Claims

Patent claims 1. Speaking valve (1), comprising a housing (2) with a first connection (5) for connecting to a tracheostomy tube (6) and a closable air inlet opening (12) on which a flexible membrane (18) is arranged, characterized in that at least one air outlet opening (8) which can be sealed by means of a closure element is arranged in a wall of the housing (2) of the speaking valve (1), that the closure element is a separate hollow cone truncated cone (9) rotatably mounted within the housing (2) of the speaking valve (1), and that at least one opening (16) corresponding to the air outlet opening (8) is arranged in the hollow cone truncated cone (9).

2. Speaking valve (1) according to claim 1 , characterized in that the housing (2) of the speaking valve (1) has a lower part (3) and a cover (4), that the closable air inlet opening (12) is arranged in the cover (4), that the closable air outlet opening (8) is arranged in the lower part (3) and that the hollow conical truncated cone (9) is rotatably and fixedly arranged between the lower part (3) and the cover (4).

3. Speaking valve (1) according to claim 1 or 2, characterized in that the air outlet opening (8) and the corresponding opening (16) of the truncated hollow cone (9) are circular, oval or rectangular.

4. Speaking valve (1) according to one of claims 1 to 3, characterized in that the hollow conical truncated cone (9) is rotatably arranged within the housing (2) of the speaking valve (1) in a range between 0 degrees and 90 degrees, in particular in a range between 0 degrees and 60 degrees.

5. Speaking valve (1) according to one of claims 1 to 4, characterized in that the hollow conical truncated part (9) is made of polypropylene and the housing (2) is made of acrylonitrile butadiene styrene copolymer.

6. Speaking valve (1) according to one of claims 1 to 5, characterized in that a second connection (7) for connecting to an additional oxygen supply is arranged on the cover (4) of the speaking valve (1).

7. Speaking valve (1 ) according to one of claims 1 to 6, characterized in that the hollow conical truncated cone (9) has a diameter less than 23 mm and a height equal to or less than 6 mm.

8. Speaking valve (1) according to one of claims 1 to 7, characterized in that the housing (2) of the speaking valve (1) has a diameter less than 26 mm and a height less than 21 mm.

9. Speaking valve (1) according to one of claims 1 to 8, characterized in that an oval or rectangular and longitudinally extended air outlet opening (8) has two internal surfaces (33a, 33b) that are at least partially parallel to each other, that several positioning elements (31) are arranged on the first internal surface (33a) or on the second internal surface (33b) such that a detent position (32) is formed between each pair of adjacent positioning elements (31) and that the internal dimensions of the detent positions (32) correspond to an external dimension of the handle (10) in the area of ​​the air outlet opening (8), so that the handle (10) can be selectively arranged to engage in one of the detent positions (32).

10. Method for using a speaking valve (1) on a tracheotomized person, in which the speaking valve (1) is provided connected to a tracheostomy tube (6), in which an air inlet opening (12) which can be closed by means of a flexible membrane (18) is provided in a wall of a housing (2) of the speaking valve (1), and in which a first airflow (17) is guided through the air inlet opening (12) which opens during inhalation by the person, characterized in that an air outlet opening (8) is provided in a wall of the housing (2) of the speaking valve (1), and a closure element in the form of a rotatably mounted, sepa- a hollow cone truncated cone (9) is provided and that by means of this hollow cone truncated cone (9) a second airflow (19) is controlled between a maximum and a minimum when the person exhales through the air outlet opening (8).

11. Method according to claim 10, characterized in that the control of the second airflow (19) through the air outlet opening (8) is stepless between a completely closed cross-section and a maximally open cross-section.

12. Method according to claim 10, characterized in that the control of the second airflow (19) through the air outlet opening (8) takes place in stages between a completely closed cross-section and a maximally open cross-section.

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