WO2015067234A2

WO2015067234A2 - Set for adhesively attaching over a tracheostoma of a laryngectomized patient

Info

Publication number: WO2015067234A2
Application number: PCT/DE2014/000567
Authority: WO
Inventors: Harry Leibitzki; Steffen SÜSS
Original assignee: Primed Halberstadt Medizintechnik Gmbh
Priority date: 2013-11-07
Filing date: 2014-10-28
Publication date: 2015-05-14
Also published as: WO2015067234A3; DE102013018905A1

Abstract

The invention relates to a set for adhesively attaching over a tracheostoma of a laryngectomized patient. The problem addressed by the invention is that of specifying a set for adhesively attaching over a tracheostoma of a laryngectomized patient, which set is economical in production and use, is very light, has good breathing activity with simultaneous filtering of the breathed air, very good sealing behavior when properly adhesively attached over a tracheostoma in the neck of a patient, and ensures easy filter replacement while also being easy to use and comfortable to wear. This problem is solved in that the set comprises a neck patch (1), a housing (2), a cover (4) having four variants of the design of the cover, and a sponge-like breathing filter (3) for cover variants one to three, the neck patch (1) is a thin, planar, flexible film, which is adhesive on the proximal side of said film and which has a centrally arranged passage hole (11), the passage hole (11) is surrounded on the distal side of the film at the edge of the passage hole by a housing (2) having a central hole (21), the housing (2) has a bottom (22), the housing (2) has at least one first coupling element (23) in the region of the outer edge of the distal opening of the housing, the first coupling element (23) retains the cover (4) having the breathing filter (3), the breathing filter (3) having a rotationally symmetric shape, which is supported in the housing (2), the cover (4) has an edge, which partially surrounds the housing (2) and which has at least one second coupling element (41) on the side of the edge of the cover facing the housing (2), by means of which at least one second coupling element the cover (4) is connected to the housing (2), the bottom (22) of the housing (2) being designed as an ventilation structure that leaves 70-80% of the passage hole (11) of the film free, the ventilation structure is designed in the form of through-holes (221) in the bottom (22), the breathing filter (3) is supported in the housing (2) on the ventilation structure of the bottom (22) on the proximal side of the breathing filter and is retained by the cover (4) on the distal side of the breathing filter, and the cover (4) is connected to the distal side of the breathing filter (3) and has a passage hole (11), which partially leaves the breathing filter (3) free, provided the breathing filter is used in the set.

Description

Set for sticking over a tracheostoma of a laryngectomized patient

The present invention relates to a set for adhering via a tracheostomy of a laryngectomized patient comprising a neck patch, a housing, a ventilation filter and a lid.

Tracheostomy prostheses (also called tracheal cannulas or tracheostoma tubes) for the treatment of laryngectomized patients with opened throat (known as tracheostoma) have been known for decades. These prostheses are available as versions with and without speaking valve, and in recent years the various embodiments with speaking valve have become increasingly important in the rehabilitation of the laryngectomized patients, since they allow speaker success in patients.

The tracheostoma prostheses are inserted and fixed in a tracheostoma.

As an external attachment to the patient u.a. Straps and patches.

From DE 10 2010 049 895 AI a Halspflaster for sticking to a tracheostoma is known, which consists of a flat part having a support frame which surrounds the outer edge of the flat part, and which is provided with an opening and a mounting surface which a having sticky functionality, wherein the flat part is a thin, planar, flexible film having a thickness between 5 and 30μηι, which is adhesive on one side on its proximal side, and the opening of the flat part as a centrally disposed hole through which a tracheal cannula hindurchfuhrbar trained is around which on the distal side of the film, a hard circular plastic disc is arranged with a central recess, wherein the flat part is about 5 to 10 times thicker than the film, so that a positioning of the neck plaster without rolling possible and by means of the plastic disc a Tracheal cannula or an artificial nose is halterbar. The disadvantage of these technical solutions is that even tiny particles can enter the tracheostoma through the opening of the flat part, even if a housing with respiratory filter is coupled via the plastic disc.

From US 5 000 741 A, a transparent wound dressing for wounds is known, which is used for the complete sealing of openings on the neck of a patient.

This association consists of a flat part, which is provided with an opening and a mounting surface, which has a sticky functionality, wherein the opening in the flat part is arranged centrally, the flat part on its proximal side is adhesive on one side and the opening of the flat part, a transparent, thin , planar, flexible film surrounds, so that the flat part forms a support frame around the outer edge of the distal side of the film, which is thicker than the film, so that a positioning of the transparent sealing dressing without rolling is possible.

This dressing closes the opening in the throat of the patient by means of the transparent foil, which is designed as a membrane which is permeable only in one direction for gas and vapor.

The disadvantage of these technical solutions is that a tracheal cannula can not be coupled directly to the flat part via the opening, but can only be placed over the membrane-closed tracheostoma by a housing held by retaining straps. This type of holder does not guarantee particularly good handling.

From DE 10 2010 048 317 AI an artificial nose with speaking valve is known which can be used in a tracheostoma prosthesis or a tracheostoma patch.

This artificial nose comprises a rotationally symmetrical housing, the contour curves of which are considered to be circular along the axis of symmetry, and a rotationally symmetrical valve element whose contour curves are circular as viewed along the axis of symmetry. In this case, the housing has a first opening for connection to the stoma of the patient and at least one second opening on the opposite side, wherein the valve element is provided in the second opening of the housing for closing the second opening. This valve member is adapted to be manually closed by a finger and opened by resilient return, the housing enclosing the valve member and the valve member receiving a moisture and heat exchanging filter. In this case, a spring element is arranged between the housing and the valve element, wherein said spring element consists of an upper spring ring and a lower spring ring and these two spring rings are interconnected by elastic spring arms. The housing has an upper guide ring and a lower guide ring, wherein between the two rings in pairs guide webs are located with intermediate recesses and between the paired guide webs lateral openings are formed.

The valve element has a cover and a wall with lateral recesses, said recesses corresponding in position and shape with the lateral openings of the housing by these come together in the open state of the valve with each other.

On the wall under the cover at least two guide tabs are provided which engage in the recesses of the guide webs of the housing, wherein the guide tabs are movable in the recesses of the guide webs between two end positions.

The filter is positioned between the cover and the wall of the valve element, wherein the spring element is disposed below the filter between the housing and the valve element, and arms extend radially in the opening, these arms form the stop for the lower spring ring and the filter stop forms for the upper spring ring.

The disadvantage of this can be coupled to a tracheostoma patch artificial nose is that it is very complex composed of intricately designed elements and thus can not be easily and inexpensively manufactured. In addition, although the filter is interchangeable, this, however, the entire artificial nose must be dismantled to remove the filter, or just this entire artificial nose must be replaced and disposed of, which is quite expensive for prolonged wearing and multiple filter changes.

From DE 10 2010 048 316 AI a holder for speaking valves or heat-moisture exchanger without cannula attachment for placement on a tracheostomy of a patient is known. This holder consists of a housing which is rotationally symmetrical and its contour curve viewed along the axis of symmetry is circular, from an annular housing holder, a Tracheostomapflaster with sealing and adhesive function and central hole, a filter or a speaking valve and a cover.

The housing contains the filter or the speaking valve and can be detachably connected to the tracheostoma. After making this connection, it then communicates with the tracheostoma, in which the housing with the proximal opening engages tightly and releasably in the housing holder, which is supported by the tracheostoma patch above the central hole and above the tracheostoma. The case holder is firmly and sealingly welded or glued to the tracheostoma patches.

The housing has in its wall a plurality of recesses for the introduction and removal of breathing air. At the proximal opening, it has an outer edge consisting of at least three outer-walled edge segments and at least three peripheral recesses. At its distal opening, it carries the end cap and encloses the filter or the speaking valve, with holder webs on the proximal opening carrying the filter.

The housing holder consists of an annular flange with at least three inner-walled retaining lugs and an annular, outer-walled base, wherein the retaining lugs form a receiving area,

The housing holder holds the housing with filter or speaking valve, in which the edge segments can be inserted accurately by turning the housing in the housing holder in the retaining lugs and in the receiving areas can be latched.

The annular flange has a maximum height of 2 mm and the distance between the end cover and the flat part is a maximum of 6 mm, wherein the housing holder made of a soft, dimensionally stable plastic, the housing made of a hard plastic and the end cover of a soft thermoplastic elastomer and the tracheostoma patches a thin, oval film with a thickness in the range of 30 μηι to 0.9 mm which is made of silicone or an elastomer and has an adhesive function on the proximal side.

The housing can be solved in accordance with DE 10 2010 048 316 AI well from the housing holder of Tracheostoma plaster or connected to this, so that an easy change of filters or speaking valves is possible.

The disadvantage of this technical solution, however, is that it is elaborately composed of quite complicated designed elements and thus can not be easily and inexpensively manufactured.

The invention has for its object to provide an inexpensive for production and application kit for sticking on a tracheostomy of a laryngectomized patient, which is very easy, good breathability with simultaneous filtering of the breath, a very good Abdichtverhalten with proper sticking on a tracheostoma in the neck Having a patient and thereby ensures a slight filter change with good handling and comfortable fit.

This object is achieved by a set according to the first or the second claim. Advantageous embodiments of the invention are specified in the subordinate claims.

The essence of the invention is to provide a specifically designed set comprising a neck patch, a housing, a ventilation filter with speech function and a lid.

The Halspflaster is in the form of a thin, planar, flexible film whose thickness is, for example. Between 5 and 30μπι configured. On its proximal side (the patient-facing side), the film is designed adhesive. The geometric shape of the film can be, for example, round, rectangular or oval and can be fixed according to the application.

This film has a centrally arranged passage hole. This hole is circular, but can also have other geometric shapes.

On the distal side (the side facing away from the patient), the through hole of the film is surrounded at its edge by a housing (connector) with a central recess.

The film may have a support frame, wherein the support frame surrounds the outer edge of the film and is about 5 to 10 times thicker than the film, so that positioning of the Halspflasters without rolling is possible. In the event that the film is designed thicker than 30μπι, this support frame does not have to be present.

The film is advantageously designed as an elastomeric film, for example. TPU (thermoplastic Uretan) or TPE (thermoplastic polyethylene).

The film and the support frame can be configured in one or two pieces.

The housing is designed as a rotationally symmetrical, on the distal side open cylinder with a bottom on its proximal side, consists of a relative to the film much harder plastic material (such as. Silicon, PVU, PET, PU or PE) or metallic material and is firmly welded or glued to the foil. As an alternative to the cylindrical shape but other geometric shapes are possible.

The bottom of the housing is formed as a ventilation structure, which leaves 70-80% of the through hole of the film free.

This ventilation structure is formed by through recesses in the bottom of the housing, which is a slot or hole-shaped Have shape. In principle, however, other geometric shapes of the recesses are possible.

The housing has the function in the region of the outer edge of its distal opening at least one coupling element, for example in the form of a thread of a screw cap or in the form of holding elements of a bayonet closure. In principle, the coupling element can also be designed as a clamp-closure component. By means of this coupling element of the cover with respiratory filter, but also other components, such as. Tracheal cannulas, artificial noses, valves, etc. halterbar on the housing.

The ventilation filter with speech function is sponge-like made of foam and has a rotationally symmetrical shape, which is accurately mounted in the housing.

The respiratory filter is based on its proximal side on the ventilation structure of the soil in the housing and is supported on its distal side by the lid. The lid consists of a plastic material which is substantially harder than the film (such as, for example, silicone, PVU, PET, PU or PE) or metallic material, has an edge which partially encloses the housing and points to the side facing the housing its edge a coupling element, for example. In the form of a thread of a screw cap or in the form of holding elements of a bayonet lock on. In principle, the coupling element can also be designed as a clamp-closure component. By means of this coupling element, the lid is connected to the housing.

The lid is connected to the distal side of the ventilation filter and has a through-hole, for example in the range of 13 to 15 mm, which leaves the ventilation filter to a part free, so that an air flow through the through hole into the ventilation filter through the housing and the Bottom of the housing is formed therethrough. The advantage of this design of the set is that the ventilation filter is exchangeable very quickly and inexpensively together with the lid and the respiratory filter optimally holds back particles of the air.

In addition to this inexpensive form of a lid with a ventilation filter, the kit according to the invention as an alternative as follows with lid and ventilation filter and disc: The cover with through hole has in its edge next to the at least one coupling element Luftdruchtrittsöffnungen, the lid a first and the housing a form a second valve seat for a disc, which is connected to the ventilation filter and is movable between the first and the second valve seat.

By the clamped between the bottom and the lid ventilation filter, the through hole is closed by means of the disc in the first valve seat.

By a pressure (eg by means of a finger) on the lid, this is pressed onto the second valve seat of the housing and the housing is closed.

The advantage of this embodiment of the set is that the ventilation filter is exchangeable very quickly and inexpensively together with the lid and the disc, the respiratory filter optimally holds back particles of the air and the passage of air through the housing is controlled manually by the respiratory function of the patient.

In addition to this form of a lid with a ventilation filter and disc, the set according to the invention can be equipped, as a further alternative, with a membrane and respiratory filter as follows:

The cover with through-hole has two cross-shaped webs, which is provided at its intersection with a holder oriented in the proximal direction for a membrane and leave 80 to 90% of the through hole free. By means of this holder, a movable membrane, which is spaced from the lid by an air-permeable spacer, is held between the lid and the distal side of the ventilation filter.

By this arrangement of lid, movable membrane with air-permeable spacer and breathing filter, a speech function of the set according to the invention is generated in such a way that the ventilation filter between the bottom and the air-permeable spacer and the otherwise open through-hole in the lid is apparently closed by the membrane, so that a speech function is generated with simultaneous filter function.

This opening of the through hole is made in the intended use of the set by a negative pressure of the air inside the housing, which is generated by the active inhalation of the patient and thereby opens the movable membrane.

The advantage of this embodiment of the set is that the ventilation filter is exchangeable very quickly and inexpensively together with the lid, the respiratory filter optimally holds back particles of the air and the air passage through the housing is automatically controlled by the patient's respiratory function, so that a speech function consists.

Alternatively, the ventilation filter and the air-permeable spacer can also be omitted, since in the lid variant with diaphragm for the speech function, the through hole of the lid is usually closed and controlled only by respiratory function of the patient shortly to generate the speech function is opened, so that the probability of Inhalation of particles in the air in this variant is kept very low compared to the variant with ventilation filter.

Further advantages of the four embodiments of the set are the good breathability and the very good sealing behavior when using the gluing of the very thin film over a tracheostoma in the neck of a patient as intended good support of the components on the plastic disc / the connector of the plaster.

Particularly advantageous is the fact that in the invention Halspflaster a hard plastic disc with foam padding, as it is known from the prior art, is not used, whereby the overall height (inventive Halspflaster + further component, such as. A very flat lateral Nose with 5 mm height) can be kept very low, which in addition to the good breathability significantly improves the comfort for the patient.

The invention will be explained in more detail below with reference to four embodiments of the set and the figures. Showing:

1 a shows a schematic 3 D representation of a first embodiment of the set according to the invention,

Fig. Lb: a schematic detail view of the lid with

Respiratory filter according to FIG. 1 a,

Fig. Lc: a schematic detail view of a Halspflasters with

Housing according to Figure la,

Fig. Ld: a sectional view of the embodiment according to

Fig. 1a,

2a shows a schematic 3-D representation of the second embodiment of the set according to the invention,

2b shows a sectional view of the embodiment according to FIG. 2a in the opened state, FIG.

2c is a sectional view of a sectional view of

Embodiment according to FIG. 2a in the closed,

3a shows a schematic 3-D representation of a third embodiment of the set according to the invention,

3b is a sectional view of the embodiment of FIG 3a in the open state, 3c is a sectional view of a sectional view of the embodiment of FIG. 3a in the closed state,

Fig. 4a: a schematic 3-D representation of a fourth

Embodiment of the kit according to the invention,

4b is a sectional view of the embodiment of FIG. 4a in the open state and

4c is a sectional view of a sectional view of

Embodiment according to FIG. 4a in the closed state.

The first embodiment of the kit for gluing over a tracheostoma of a laryngectomized patient shown in FIG. 1 comprises a neck flap (1), a rotationally symmetrical housing (2), a sponge-like ventilation filter (3) and a lid (4).

The neck flap (1) is a thin, planar, flexible film which adheres on its proximal side and has a centrally arranged through hole (1 1).

This through hole (11) is surrounded on the distal side of the film at its edge by the rotationally symmetrical housing (2) with a central recess (21).

The housing (2), as shown in Figure lc, at its proximal opening connected to the film on a bottom (22) and is provided in the region of the outer edge of its distal opening with at least one first coupling element (23).

This first coupling element (23) releasably supports the cover (4), in which the cover (4) has an edge which partially surrounds the housing (2) and at least one second side of its edge facing the housing (2) Coupling element (41), by means of which the cover (4) with the first coupling element (23) of the housing (2) is detachably connected (see Figure ld).

The respiration filter (3) also has a rotationally symmetrical shape and is mounted in the rotationally symmetrical housing (2). Essential in this first embodiment of the set is that the bottom (22) of the housing (2) is formed as a ventilation structure in the form of through recesses (221) in the bottom (22), which 70-80% of the through hole (11) of the film leaves free and the ventilation filter (3) is supported on its proximal side to the ventilation structure of the bottom (22) in the housing (2).

It is advantageous that the continuous recesses (221) have a slot or hole-shaped form.

Further, as shown in FIG. 1b, in this first embodiment, it is essential that the lid (4) is connected to the distal side of the breathing filter (3) and has a through hole (42) which leaves part of the breathing filter (3) ,

The neck flap (1) with housing (2) of a second embodiment shown in FIG. 2a corresponds to the neck flap (1) shown in FIG. 1c with housing (2) of the first embodiment.

However, it is essential in this second, alternative embodiment that the cover (4) in its edge Luftdruchtrittsöffnungen (43), wherein the cover (4) form a first and the housing (2) a second valve seat for a disc (5), which is connected to the respiratory filter (3), and the disc (5) is movable between the first and the second valve seat, wherein the passage between the bottom (22) and the lid (4) strained ventilation filter (3) ( 42) is closed or opened by means of the disc (5) in the first valve seat (see FIGS. 2b and 2c).

The neck flap (1) with housing (2) of a third embodiment shown in FIG. 3a corresponds to the neck flap (1) shown in FIG. 1c with housing (2) of the first embodiment. However, it is essential in this third, further alternative embodiment, that the cover (4) in its through hole (42) has two cross-shaped extending webs (6), which at its intersection with a aligned in the proximal direction holder (61) for a movable Membrane (7) are provided, the webs (6) 80 to 90% of the through hole (42) free and the movable membrane (7) through the holder (61) between the lid (4) and the distal side of the ventilation filter (3 ) and the ventilation filter (3) is thereby spaced from the cover (4) and the membrane (7) by an air-permeable spacer (8), so that the through-hole (42) of the cover (4) by means of the membrane (7) closed or opened (see Fig. 3b and 3 c).

The neck flap (1) with housing (2) of a fourth embodiment shown in FIG. 4a corresponds to the neck flap (1) shown in FIG. 1c with housing (2) of the first embodiment.

However, it is essential in this fourth, further alternative embodiment that compared to the third embodiment, the set next to the Halspflaster (1), the rotationally symmetrical housing (3) and the lid (4) has no sponge-like ventilation filter.

The neck flap (1) likewise has a thin, planar, flexible film which is adhesive on its proximal side and has a centrally arranged through hole (11).

Similarly, the through hole (1 1) on the distal side of the film is surrounded at its edge by the rotationally symmetrical housing (2) with a central recess (21) and the housing (2) also has at its connected to the film proximal opening a bottom (22).

It is also the case that the housing (2) has at least one first coupling element (23) in the region of the outer edge of its distal opening, wherein the first coupling element (23) releasably supports the cover (4), in which the cover (4) over has an edge which the Housing (2) partially encloses and on the housing (2) facing side of its edge at least a second coupling element (41), by means of which the lid (4) with the first coupling element (21) of the housing (2) is detachably connected ,

Essential in the fourth alternative embodiment is that the bottom (22) of the housing (2) is also formed as a ventilation structure in the form of through recesses (221) in the bottom (22) leaving 70-80% of the through-hole of the film, and the lid (2), as shown in FIG. 4a, has in its through-hole (42) two cross-shaped webs (6) which, at their point of intersection, have a proximal-directional support (61) for a movable membrane (FIG. 7), the webs 80 to 90% of the through hole (42) free and the through hole (42) of the lid (4) by means of the membrane (7) is closed or opened (see Fig. 4b and 4c).

It is advantageous for all four embodiments of the set that the film has a thickness of 5 to 30 μm.

The film may have a support frame, wherein the support frame surrounds the outer edge of the film and is about 5 to 10 times thicker than the film.

Further advantageous for all four embodiments of the set is that the film is an elastomeric film of TPU or TPE, the housing (2) is designed as a cylinder open on the distal side and both the housing (2) and the lid (4) of a Compared to the film substantially harder plastic material made of silicone, PVU, PET, PU or PE or metallic material.

The housing (2) can be firmly welded or glued to the film.

In addition, it is advantageous for all four embodiments of the set that the first and the second coupling element (21, 41) take the form of a Threaded a screw cap or in the form of holding elements of a bayonet closure is executed, the through hole (42) in the lid (4) has a diameter in the range of 13 to 15 mm and the through recesses (221) have a slot or hole-shaped.

The advantage of the four embodiments described above with reference to the figures la to 4c of the inventive set for sticking on a tracheostomy of a laryngectomized patients is that the production of the set is inexpensive, as to the same Halspflaster with housing the four different housing various embodiments (first and second cover variant with ventilation and filter function and third and fourth cover variant with ventilation and speech function with and without filter function) can be arbitrarily and optionally combined.

A further advantage is that the use of the set for sticking on a tracheostomy of a laryngectomized patient is very easy for the patient, in which the four different cover variants can be changed without the same time also the neck plaster with housing has to be changed.

Due to the design of the coupling element as a screw or bayonet this change the lid variants is very simple.

Geleichzeitig the set is very light, has due to its material composition a good breathability with simultaneous filtering of the breath (in the lid variants one to three), a very good sealing behavior with proper sticking on a tracheostomy in the neck of a patient and guaranteed in the lid variants one to three a light filter change with good handling and pleasant wearing comfort.

All features described in the description, the exemplary embodiments and the following claims may be essential to the invention both individually and in any combination with one another. LIST OF REFERENCE NUMBERS

1 throat patch

1 1 through hole

2 housings

21 recess

22 floor

23 first coupling element

221 recesses

3 ventilation filters

4 lids

41 second coupling element

42 through hole

43 air passage openings

5 disc

6 bridges

61 bracket

7 membrane

8 spacers

Claims

claims

A set for sticking over a tracheostomy of a laryngectomized patient comprising a neck flap (1), a rotationally symmetrical housing (2), a sponge-like ventilation filter (3) and a

Lid (4), where

The neck flap (1) is a thin, planar, flexible film which is adhesive on its proximal side and has a centrally arranged through-hole (11),

The through-hole (11) on the distal side of the foil is surrounded at its edge by the rotationally symmetrical housing (2) with a centric recess (21),

The housing (2) has a bottom (22) at its proximal opening connected to the film,

· The housing (2) in the area of the outer edge of its distal

Opening has at least one first coupling element (23),

• the first coupling element (23) releasably supports the cover (4), in which the cover (4) has an edge which partially surrounds the housing (2) and at least one side of its edge facing the housing (2) second

Coupling element (41), by means of which the cover (4) with the first coupling element (23) of the housing (2) is detachably connected, and

The respiration filter (3) has a rotationally symmetrical shape and is stored in the housing (2),

characterized in that

• the bottom (22) of the housing (2) is formed as a ventilation structure in the form of through slot or hole-shaped recesses (221) in the bottom (22), which leaves 70-80% of the through hole (1 1) of the film free , and

• the first and the second coupling element (21, 41) are designed in the form of a thread of a screw cap or in the form of holding elements of a bayonet closure, so that different types of the lid (4) can be coupled to one another.

The laryngectomy patient tracheostomy set of claim 1, wherein the lid (4) is connected to the distal side of the respiratory filter (3) and has a through hole (42) exposing the respiratory filter (3) to a portion and wherein the respiratory filter (3) is supported on its proximal side on the ventilation structure of the bottom (22) in the housing (2).

A laryngectomized patient adhering set according to claim 1, wherein the lid (4) has air passage openings (43) in its periphery, the lid (4) having a first and the housing (2) a second valve seat for a disc (5), which is connected to the respiratory filter (3), and the disc (5) is movable between the first and the second valve seat, wherein by the between the bottom (22) and the lid (4) strained ventilation filter ( 3) the through hole (42) is closed or opened by means of the disc (5) in the first valve seat and wherein the respiratory filter (3) is supported on its proximal side on the ventilation structure of the bottom (22) in the housing (2).

4. A set for sticking over a tracheostoma of a laryngectomized patient according to claim 1, wherein the cover (4) in its through hole (42) has two cross-shaped extending webs (6), which at its point of intersection with a proximally oriented holder (61 ) are provided for a movable diaphragm (7), the webs (6) 80 to 90% of the through hole (42) leave free and the movable membrane (7) through the holder (61) between the lid (4) and the distal side the ventilation filter (3) is held and the ventilation filter (3) is thereby spaced from the cover (4) and the membrane (7) by an air-permeable spacer (8), so that the through hole (42) of the cover (4) by means of Membrane (7) is closed or opened and wherein the respiratory filter (3) is supported on its proximal side to the ventilation structure of the bottom (22) in the housing (2).

5. A set for gluing over a tracheostomy of a laryngectomized patient according to claim 1, wherein the cover (4) in its through hole (42) has two cross-shaped extending webs (6) which at its point of intersection with a proximally oriented holder (61 ) are provided for a movable membrane (7), the webs 80 to 90% of the through hole (42) free and the through hole (42) of the lid (4) by means of the membrane (7) is closed or opened and wherein the respiratory filter ( 3) on its proximal side to the ventilation structure of the bottom (22) in the housing (2) is supported.

6. Set for sticking on a tracheostomy according to one of claims 1 to 5, characterized in that the film has a thickness of 5 to 30 μπι and the through hole (42) in the lid (4) has a diameter in the range of 13 to 15 mm has.

A kit for adhering via a tracheostomy according to any one of claims 1 to 6, characterized in that the foil has a support frame, wherein the support frame surrounds the outer edge of the foil and is about 5 to 10 times thicker than the foil.

8. Set for sticking on a tracheostoma according to one of claims 1 to 7, characterized in that the film is an elastomeric film of TPU or TPE.

9. set for sticking on a tracheostomy according to one of claims 1 to 8, characterized in that the housing (2) and the cover (4) made of a relative to the film much harder plastic material made of silicone, PVU, PET, PU or PE or of metallic material.

10. set for sticking on a tracheostomy according to one of claims 1 to 9, characterized in that the housing (2) is firmly welded or glued to the film.