WO1986006970A3

WO1986006970A3 - Tracheotomy closure

Info

Publication number: WO1986006970A3
Application number: PCT/EP1986/000274
Authority: WO
Inventors: Walter Koss; Ingo F. Herrmann
Original assignee: Walter Koss; Herrmann Ingo F
Priority date: 1985-05-21
Filing date: 1986-05-10
Publication date: 1987-04-23
Also published as: WO1986006970A2; DE3673328D1; EP0221973A1; JPS62502875A; EP0221973B1; DE8514859U1; JPH0798062B2

Abstract

A tracheotomy closure comprises a valve (18, 23) which is voluntarily actuable during expiration, thereby enabling the person to talk. An open tube part (10) insertable in the trachea opening comprises a cannula stub (7) which traverses the opening and opens to the outside, and carries on its front end a housing (9) for the valve. An adjustable flange ring (8) surrounds the cannula stub (7) and seals the trachea opening. The valve is formed of a non-return valve (18) which is pivotably arranged within the housing (9) of the valve so as to open during inspiration and close during expiration when a predetermined flow speed is exceeded.

Description

Tracheostoma closure

The invention relates to a tracheostoma closure according to the preamble of claim 1. Such a closure is known from DE-GM 83 29 888 and the same DE-OS 34 36 777. After a total operation of the larynx, patients with a tracheostoma, ie an artificial opening leading into the airway in the neck area, can speak in a known manner with the help of a speech or voice prosthesis, which is operative as a connection between the airway and the foodway is used. The tracheostoma must then be closed to speak. For this purpose, patients usually use a finger, which is placed on the opening and prevents the air from escaping at this point. For simplicity of speech, it is already known to bring anzu¬ a diaphragm valve ^'on the Öff clothes, and using an adhesive film. However, there are difficulties with regard to durability and sealing. In addition, such valves are sensitive to dirt with regard to their function.

The above-mentioned from the documents known tracheostomy closure provides a proven solution for the ^'explained issues. It enables a simple and secure attachment and easy handling by the patient ten.Es are but improvements desirable. The invention is accordingly based on the object of further developing the known tracheostoma closure in such a way that a greater air throughput with a lower overall height and further improved attachment and handling is made possible. The solution to the problem is specified in claim 1. The valve flap enables a large passage cross-section with good and reproducible sensitivity.

Numerous further training courses are possible. So the valve flap and / or its seat made of resilient material, such that the flap after

Closing can pass through its seat if the specified dynamic pressure is exceeded. This special training ensures the necessary safety, because a sudden breath, for example when coughing, must always be possible. The valve flap, once it has passed through its seat, can be pushed back into its normal position by hand without removing the closure.

However, the security feature can also be implemented in a manner known per se in that the valve housing is plugged onto the cannula stub and can then be coughed up or removed if necessary.

The valve flap can be mounted in the lower region of the valve housing in the operating position and can be held in the open position by an additional weight. The valve flap only fulfills its non-return function when a certain flow rate is exceeded during breathing, i.e. the patient wants to close the valve flap arbitrarily by a sudden breath in order to speak. In order to avoid the positional dependence of the closing point, for example when bending over, the valve flap can have a magnet which interacts with a further magnet on or in the wall of the valve housing and holds the valve flap in the open state. Magnet should be understood to mean that at least one component of the interacting pair is a permanent magnet. The other component can consist of soft magnetic material, for example an iron plate. A further possibility of keeping the valve flap in the open state up to a certain outflow speed is to urge the flap into the open position by spring force. The spring force can be achieved by mounting the flap itself, for example in the form of a film hinge, or by a separate spring.

To adapt to the respective patient and their lifestyle and speaking habits, it is advantageous if the force with which the valve flap is kept open can be easily adjusted. To this end, a development of the invention provides that the bearing point of the valve flap can be displaced in the circumferential direction of the cannula stub. In the case of an additional weight, the effective gravity component can then be changed, and in the case of magnets, the displacement of the bearing position changes the magnetic force by changing the opposing effective surfaces of the magnets. However, it is also possible to set the distance between the magnets when the valve flap is open in order to adjust the response sensitivity, for example with the aid of a stop screw.

To achieve the displacement in the circumferential direction it can be provided that the valve housing is plugged onto the cannula stub and can be rotated against it. In order to keep the forces exerted on the cannula stump and thus the stoma and the trachea small when rotating the valve housing against the cannula stub in order to adjust the sensitivity, it can be provided that the cannula stub unites in the area of its contact surface with the valve housing has surrounding web. The inner edge of the valve housing then slides on the narrow web instead of on the entire contact surface. So that the valve housing cannot fall off too easily, a circumferential web can also be arranged in the area of its contact surface with the cannula stub, which snaps behind the web when the valve housing is pressed onto the cannula stub. One of the circumferential webs can also have interruptions without impairing the tightness.

In a further development of the invention, the valve housing can also be in one piece part of the cannula stub. In this case, but also when the valve housing is separate, this can be useful the valve flap is in the form of a thin disc which is connected via a film hinge to a radial extension which is sealingly inserted through a slot in the wall of the valve housing and preferably has a stop which defines and limits the insertion depth. To achieve the adjustability with regard to the air speed required for closing when the cannula stub and valve housing are formed in one piece, the slot in the circumferential direction of the valve housing can be so wide that the extension of the valve flap can be adjusted in its angular position.

In some cases it has been shown that a bulge or depression occurs in the lower area of the tracheostoma, which makes sealing more difficult. For this purpose, a further development of the invention provides that the displaceable flange ring in this area has a recess on part of its circumference. In addition or instead of this, the flange ring can also be made of differently hard material in such a way that soft, well-fitting material is present in the region of the arch. Furthermore, an individual shape adaptation of the flange ring to the anatomical conditions is possible. In addition, the flange ring can be provided with a radially projecting tab with a bore, which enables the attachment of a band leading to the removable valve housing. The valve housing is then secured against loss. Instead, the valve housing can also be fastened to a radially projecting tab of the cannula stub with a band.

The flange rings can then be formed symmetrically so that they are easier to handle by the patient.

In the known tracheostoma closure explained at the outset, the closure member consists of a flange. In a further development of the invention, it is provided that the closing member is a piece of pipe attached to the inner end of the cannula stub and open towards the cannula stub. This presupposes that the trachea is not in the otherwise is usually guided under bending to the stoma, but that the trachea receives a cover after the larynx has been removed and the stoma is guided laterally into the trachea. This also enables a large-lumen stoma with a correspondingly large cross-section of the closure. '

The ends of the pipe section are expediently set off at an angle such that the pipe section is shorter on the side opposite the cannula stub. To insert a voice prosthesis into the tracheostoma closure, the pipe section advantageously has an opening on the wall opposite the cannula stub.

The voice prosthesis can then pass through this opening and the wall of the trachea into the esophagus. Another possibility is to open the tube piece completely on the side opposite the cannula stem, so that a channel-shaped structure is formed instead of the tube.

The tracheostoma closure according to the invention is advantageously made of an elastomeric plastic, preferably silicone rubber. To avoid irritation in the area of its ends, the piece of pipe is made of soft material. The sealing washer with its radial extension and the film hinge can also be made from a resilient plastic, in particular a polyacetate resin (POM).

The invention is described below using exemplary embodiments in conjunction with the drawing. 1 shows schematically and in section the neck and head region of a patient with a tracheostoma, into which a valve closure according to an embodiment of the invention is inserted; Fig. 2 is a front view of a composite

Closure according to the invention; 3 shows the partially sectioned side view of the closure according to FIG. 2; 4 shows a sectional side view of the closure according to FIGS. 2 and 3 with the flange ring and valve body removed; 5 shows a sectional side view of the valve body with the valve flap inserted for the valve body

Closure according to Fig. 2 to 4; FIG. 6 is an enlarged view of the valve flap for the closure according to FIGS. 2 to 5; 7 is a view of the flange ring for the closure according to FIGS. 2 to 5; .

8 shows a modified flange ring for the closure according to FIGS. 2 to 5; 9 shows the side view of a further exemplary embodiment of a closure according to the invention;

10 shows an enlarged section of the closure according to FIG. 9 in the region of the valve body; 11 is an enlarged front view of the valve flap for the closure according to FIGS. 9 and 10; FIG. 12 shows an enlarged side view of the valve flap according to FIG. 11 in the angled state; 13 shows a perspective view of the closure according to FIGS. 9 and 10; 14 shows a perspective view of the closure according to FIGS. 2 to 5 with a modified end member. *

1 shows schematically how a tracheostomy closure is arranged according to the invention. After total operation of the larynx, the airway (trachea) 1 is connected to the outside air via a front opening cut using a template and a stoma 2. A lid 3 made of muscle tissue closes the trachea at the opposite end. Through an operatively established connection between the airway 1 and the feedway 4, a so-called speech or voice prosthesis 5 leads into the feedway, which enables speech even without a larynx. Such prostheses are known. So that the patient can now speak over the speaking prosthesis 5 while breathing out air, the stoma 2 must be closed. This takes place either by placing a finger on it or by means of a valve connection 6. Exemplary embodiments of valve closures 6 according to the invention are described in more detail below. In the embodiment according to FIGS. 2 to 7, a cannula stub 7 with a pushed-on flange ring 8 and a cup-shaped valve housing 9 is provided. At the rear (proximal) end of the cannula stub 7 there is a pipe section 10 with inclined end faces 11 '. As shown in FIG. 1, the pipe section 10 later lies in the airway 1, and the cannula stub 7 leads through the stoma 2 to the outside. Since the closure is made entirely of soft elastic material, for example silicone rubber, with a quality approved for medical purposes, the tube piece 10 can also be inserted subsequently into the airway 1 by the stoma 2. But there is also the possibility of the closure during the

Operation as a placeholder. The sliding one

Flange ring 8 is pressed tightly against the patient's skin. A recess 12 (FIG. 8) can be provided in the lower region of the flange ring 8, which enables better adaptation to the anatomical conditions in the lower region of the stoma 2.

The rotatable valve housing 9, which is placed on the cannula stub 7, is connected to the flange ring 8 via a band 13, which leads to a bore 14 (FIGS. 7 and 8) in a radial tab 15, so that it also after the Ab¬ pulling from the cannula stub 7 cannot be lost. Instead, the band 13 can also be connected to a radial extension 24 of the cannula stub 7 (not shown), so that the flange ring 8 remains free and can be replaced more easily. If the flange ring 8 is rounded symmetrically on both sides (cf. FIG. 9), then it can be placed on the cannula stub as desired in both directions. An easier turn of the

Valve housing 9 on the cannula stub 7 is reached by means of a circumferential web 31 in the front area of the cannula stub. The valve housing 9 then slides in 1 essentially on this web 31. A corresponding web 32 on the inside of the valve housing 9 snaps over the web 31 after being plugged in and prevents it from falling off unintentionally.

5 The valve housing is located in the lower front area

9 has a slot 16 through which the radial extension 17 of a disk-shaped valve flap 18 (see also FIG. 6) leads. The radial extension 17 has a stop in

Form of a web 19, which is drawn through the slot 16

10 until it just comes out and on the bottom wall of the

Valve housing 9 is present. The valve flap 18 then has the correct position in the valve housing 9. The "hinge" of the valve flap 18 is a so-called film hinge in

Form of a material thinning 20 at the transition of the extension

^• --5 17 to the disc-shaped valve flap 18.

The valve flap 18 carries a small and flat magnet 21 in the upper region, which lies for example in a thin-skinned pocket (not shown) and with _ «

Plastic is covered. Another magner 22 (FIG. 4) is embedded in the inner wall of the cannula 20. If the valve housing 9 is in the fully extended angular position in FIG. 2 and the valve flap is pushed downwards when inhaled, there is a magnetic adhesive effect between the two magnets 21 and 22.

25 Only one of the two magnets needs to be a permanent magnet. The other can consist of a simple piece of iron with appropriate corrosion protection. The magnetic adhesive force between the magnets 21 and 22 is dimensioned such that only at a ratio

30 excessively high flow rate when breathing out the ^• flap 18 with its magnet 21 is lifted from the magnet 22 and defines a sealing manner under fulfillment of its non-return function against its seat 23rd The patient can arbitrarily bring about the closing of the valve by exhaling briefly in the form of a shock. After closing the flap 18, the patient can then speak using the voice prosthesis 5. In order to adjust the magnetic holding force between the magnets 21 and 22, the valve housing 9 can be rotated to both sides, expediently by gripping a handle 24, in an angular range indicated in FIG. 2 of 50 ", for example. The two magnets 21, 22 then lie in the open state of the valve flap 18 no longer over one another over the entire surface, as a result of which the holding force is reduced , The valve flap 18 is made of a flexible material and is dimensioned such that, when a certain dynamic pressure occurs, it overcomes its seat 23 and emerges from the valve housing 9. Instead, the valve housing 9 can be designed so that it automatically presses off when coughing becomes.

Instead of the magnetic holding force between .the magnet 21 and 22, the valve flap 18 may be also ^'provided with ^* an additional weight, which has, for example, similar in shape to the magnetic 21st The weight and the hinge formation must then be such that the flap 18 rests on the bottom of the cannula stub in the idle state, ie without air flowing through it, and only closes at higher exhalation speeds. Here, too, a rotation of the valve housing 9 leads to a setting for the air speed at which the closing takes place.

The tube piece 10 has an opening 25 in its wall opposite the cannula stub 7, through which the voice prosthesis 5 (see FIG. 1) leads into the closure 6. Instead of the opening 25, the pipe section 10 can also be completely opened, as the perspective view in FIG. 14 shows. The embodiment of FIG. 9 differs from the embodiment described above in that the valve housing 29 is now integrally formed on the cannula stub 7. Otherwise corresponds the valve with its flap 18 and the magnets 21, 22 of the embodiment according to FIGS. 2 to 5. The same applies to the flange ring 8 and the pipe section 10.

Similar to the exemplary embodiment according to FIGS. 2 to 5, the valve flap 18 is fastened with its radial extension 17 in the valve housing 29 in that the extension 17 is inserted through a slot 30. 6, the radial extension has two webs 19 as stops, one of which lies outside of the valve housing 29 after the plugging in, and the other lies inside the valve housing 29. 10, the slot 30 is widened in the circumferential direction so that the radial extension 17 in the slot 30 can be displaced in the circumferential direction. This allows the same adjustment as when turning the valve housing 9 in the embodiment according to FIGS. 2 to 5 to achieve. The slot 30 is different .gestaltet from the illustration in Fig. 10 so that ^"its edges Where the Fortsa tz-19 is not sealingly other place anein-.

FIG. 12 shows the valve flap 18 according to FIG. 1 in a side view. 12 shows the rest position, ie the position in which the flap 18 with its extension 17 has been manufactured. As a result, a spring force can additionally be generated via the hinge 20, which urges the valve disk 18 into the rest position according to FIG. 12.

FIG. 13 shows the exemplary embodiment according to FIG. 9 again in perspective. Instead of the pipe section 10 with an opening 25, the pipe section 10 cut open in a channel-shaped manner according to FIG. 14 can also be used here. In the dash-dotted end regions 33, the tube piece 10 is advantageously made of a soft material so that irritation or even injury to the patient is avoided.

While in the embodiment according to FIGS. 2 to 5 the overall height of the closure and in particular that dimension with which the closure emerges from the stoma is, compared to the prior art has been significantly reduced, the embodiment of FIG. 9 enables a further improvement in this direction by the integrated valve housing 29. Such a reduction in overall height is particularly important for the patient for aesthetic reasons.

Claims

.1 2Patent claims

1. Tracheostoma closure with a valve which can be actuated at will to allow the patient to speak when exhaling, a cannula stub (7) which can be inserted into the stoma (2) and which has a closure member (10) which can be inserted into the trachea (1) , a flange ring (8) which can be pushed or latched onto the cannula stub (7) or is firmly connected to the cannula stub, a valve housing (9, 29) which closes off the cannula stub (7) to the outside, and a device which, in the event of over ¬ If a predetermined dynamic pressure renders the valve ineffective, characterized by the fact that a check valve cap (18) is pivotally mounted in the valve housing (9, 29), which opens in the direction of inspiration and closes in the direction of exhalation when a predetermined Flow rate is exceeded.

2. Closure according to claim 1, characterized in that the valve flap (18) and / or its seat (23) consists of flexible material, such that the flap (18) can pass through its seat (23) after closing if the specified dynamic pressure is exceeded. .

3. Closure according to claim 1 or 2, characterized in that the valve flap (18) is mounted in the lower region of the valve housing (9, 29) in the operating position and is held in the opened position by an additional weight (21).

4. Closure according to claim 1, 2 or 3, characterized in that the valve flap (18) has a magnet (21) which with a further magnet (22) on or in the wall of the valve housing (9, 29) zu- interacts and holds the valve flap (18) in the open state.

5. Closure according to one of claims 1 to 4, characterized in that the valve flap (18) is held in the open state by spring force.

6. Closure according to one of claims 1 to 5, characterized in that the force with which the valve flap (18) is held in the open state is adjustable bar.

7. Closure according to claim 6, characterized in that the bearing point of the Ventil¬ flap (18) in the circumferential direction of the cannula stub (7) is displaceable.

8. Closure according to one of claims 1 to 7, characterized in that the valve housing (9) on the cannula stub (7) is plugged and can be rotated against it.

9. Closure according to claim 8, characterized in that the cannula stub (7) has a circumferential web (31) in the area of its contact surface with the valve housing (9).

10. Closure according to claim 9, characterized in that the valve housing (9) in the region of its contact surface with the cannula stub (7) has a circumferential web (32).

11. Closure according to one of claims 1 to 7, characterized in that the valve housing (29) is part of the cannula stub (7).

12. Closure according to one of claims 1 to 11, characterized in that the valve flap has the shape of a thin disc (18) and is connected via a film hinge (20) to a radial extension (17) which seals through a slot (16 , 30) is inserted in the wall of the valve housing (9, 29).

13. Closure according to claim 12, characterized in that the radial extension has at least one stop (19) which defines and limits the insertion depth.

14. Closure according to claim 11 and 12 or 13, characterized in that the slot (30) in the circumferential direction of the valve housing (29) is so wide that the extension (17) of the valve flap (18) is adjustable in its angular position.

15. Closure according to one of claims 1 to 14, characterized in that the flange ring (8) has a recess on a part of its circumference (Fig. 8: 12).

16. Closure according to one of claims 1 to 15, characterized in that the flange ring (8) is provided with a radially projecting tab (15) having a bore (14) and that in the bore one with the valve housing (9th ) connected holding thread (13) is fixed.

17. Closure according to one of claims 1 to 15, characterized in that the cannula stub (7) has a radially projecting tab (24) and that the Ventil¬ housing (9) is connected to the tab via a holding thread. -

18. Closure according to one of claims 1 to 17, characterized in that the closure member is a pipe piece (10) which is attached to the inner end of the cannula stub (7) and is open against the cannula stub (7).

19. Closure according to claim 18, characterized in that the ends of the tube section (10) are offset obliquely (11), such that the tube section (10) on the side opposite the cannula stub (7) is shorter.

20. Closure according to claim 18 or 19, characterized in that the tube piece (10) has an opening (25) on the wall opposite the cannula stub.

21. Closure according to one of claims 18 to 20, characterized in that the tube piece (10) on the side opposite the cannula stub (7) is completely open.

22. Closure according to one of claims 18 to 21, characterized in that the tube piece (10) in the area L of its ends is made of soft material.

23. Closure according to one of claims 1 to 22, characterized by its production from silicone rubber.

5 24. Closure according to one of claims 1 to 23, characterized in that the valve disc (18) with its radial extension (17) and the film hinge (20) is made of a resilient plastic, in particular a polyacetate resin (POM) .