WO1991005579A1

WO1991005579A1 - Arrangement for protecting the breathing passages of laryngectomees

Info

Publication number: WO1991005579A1
Application number: PCT/SE1990/000670
Authority: WO
Inventors: Curt Danielsson
Original assignee: Pharma Systems Ps Ab
Priority date: 1989-10-20
Filing date: 1990-10-18
Publication date: 1991-05-02
Also published as: SE8903479L; SE466990B; SE8903479D0; AU6618890A

Abstract

An arrangement for protecting the breathing passages of laryngectomees comprises a flexible, apertured mounting element (1) adapted to be sealingly applied to the throat of the laryngectomee and connected to a projecting socket-shaped holder (3) accommodating an exchangeable filter means (5) through which the air passes during inhalation and exhalation through a throat stoma (2). The holder is adapted to contain the filter means substantially within a space defined by the holder wall, and has means ensuring that the filter means is held in place and preventing it from being ejected from the holder.

Description

ARRANGEMENT FOR PROTECTING THE BREATHING PASSAGES OF

LARYNGECTOMEES

The present invention relates to an arrangement for protecting the breathing passages of laryngectomees, i.e. people with a throat stoma for the passage of inhaled and exhaled air, said arrangement comprising a flexible, aper- tured mounting element adapted to be sealingly applied to the throat of the laryngectomee in such manner that the aperture is positioned over the stoma, and connected to a projecting socket-shaped holder accommodating an exchange¬ able filter means through which the air passes during inhalation and exhalation through the stoma. Background of the Invention To make it possible for laryngectomees, i.e. people who have had their larynx removed by surgery because of illness, to breathe without risking suffocation, the trachea is made to communicate with an open hole on the outside of the throat, a so-called stoma. Naturally, sur- gery of this type entails considerable inconveniences for the patient. Inter alia, the inhaled air will often be too dry or cold, or contain too many particles, because the temperature-regulating and filtering effect of the oral and nasal cavities no longer exists. This involves health hazards to the laryngectomees whose bronchi often become infected.

SE 7307882 discloses a so-called stoma dressing meant to obviate the inconveniences described above. The dress¬ ing mainly consists of a mounting element, preferably a tape or an adhesive plastic film, a filter being arranged over a hole in the centre of the mounting element. The intention is that the mounting element should be arranged over the stoma in such manner that the filter is centered over it. Thus, the filter should, at least partly, take over the function of the oral and nasal cavities by retaining some of the heat and moisture of the exhaled air to facilitate inhalation. Furthermore, the filter pre- vents the ingress of particles to the respiratory pas¬ sages. For reasons of hygiene, such filters must be exchanged at least once or twice a day, which often causes the skin around the stoma to become irritated and sore since the tape must be removed every time the filter is exchanged. An obvious solution would be to use a mount¬ ing element which is fixed without tape or adhesive, e.g. with ribbons tied around the neck. However, since it is of the utmost importance that the dressing is sealingly applied around the stoma to ensure that all the inhaled air passes through the filter, an adhesive dressing is preferred. Summary of the Invention

One object of the present invention is to obviate the above inconveniences by providing an arrangement in which the filter means is reliably kept in place and can be expediently exchanged. Another ob ect of the invention is to provide an arrangement which is easy to handle, does not take up much space, and has an aesthetic appear- ance. These and other objects are achieved in that the holder is adapted to contain the filter means substan¬ tially within a space defined by the holder wall, and that the holder has means ensuring that the filter means is held in place and preventing it from being ejected from the holder, e.g. in a fit of coughing or the like. Further Description of the Prior Art

US 4,325,366 discloses a device for protecting the breathing passages of so-called tracheostomees. This device comprises a valve insert which is introduced into a smooth, cylindrical holder. It would seem obvious that also laryngectomees should be able to use a device of the type carried by tracheostomees. It is, however, out of the question that the device in US 4,325,366 could be successfully used by a laryngectomee, because the natural respiratory passages of a tracheostomee are still open, and all the inhaled air therefore need not pass through the stoma. A laryngectomee, on the other hand, has had his larynx removed, and it would consequently be fatal to let the trachea open in the pharynx, considering that food and liquid may enter the lungs when there is no closing larynx. For this reason, the natural respiratory passages through the pharynx are completely closed, and all the inhaled air must compulsorily pass through the stoma. This entails that, e.g. in a fit of coughing, a large amount of air will pass through the stoma in a short time, resulting in that devices which, like the arrangement of the present invention, are applied in front the stoma, are subjected to high air pressures. Thus, the valve insert forming part of the device in US 4,325,366 would undoubtedly be ejected in a fit of cough¬ ing, since the insert is only introduced into a complete- ly smooth cylindrical holder with no means whatsoever for holding it in place. Neither are there any means for maintaining in place the filter holder adapted to be com¬ bined with the valve device. US 4,325,366 also shows how a breathing filter can be combined with the holder of the device. However, no means for maintaining the breathing filter on the holder are stated. A further inconvenience of this device is that the filter is mounted in its entirety outside the holder, and the user will thus find the device both cumbersome and bulky. Brief Description of the Drawings In the drawings, FIG. 1 is a perspective view illustrating how an inventive arrangement, with various acces¬ sories, is to be applied to the throat of a laryngectomee,

FIG. 2 is an exploded perspective view of a carrier and a breathing filter, and FIGS 3 and 4 are perspective views of alternative embodi¬ ments of the carrier as seen from behind. Detailed Description of Preferred Embodiments

Preferred embodiments of the invention will be described below with reference to the accompanying draw¬ ings. Fig. 1 illustrates how the inventive arrangement is to be fixed to the throat of a laryngectomee, and how various accessories may be connected to the holder of the arrangement. A mounting element or carrier 1 consists of a self-adhesive, flexible tape which is to be sealingly attached to the throat around the stoma 2 of the laryn- gectomee. The tape also carries a holder 3 projecting from the tape and having a wall 3' which defines a space 26. This holder is adapted to accommodate a releasable accessory member. Fig. 1 illustrates preferred embodi¬ ments of such accessories, the function and construction of which will be described in more detail below.

Fig. 2 shows a first embodiment of the carrier with the holder and an accessory member in the form of a fil¬ ter. In this case, the carrier consists of a double-adhe¬ sive piece of tape 8, i.e. a tape with adhesive on both sides. In the centre of the tape, there is an aperture over which the holder 3 is centered and fixed in such manner that a rear flange 9 of the holder is attached to the front of the tape. Here and hereinafter, the front is the side which is to be placed so as to face away from the throat of the laryngectomee, and the back is the side which is to face the throat. In order to conceal that part of the tape not covered by the flange of the holder, a flexible fibre cloth or fabric 10 is applied to the front of the carrier. This cloth or fabric is formed with an aperture 11 through which the projecting part of the holder extends. To hold the cloth in position around the holder, the latter has a circumferential bead 12, the edge of the cloth being positioned in a groove between the bead and the flange. Suitably, the cloth is of non- woven type. The back of the carrier is covered by a release paper 14 to protect the tape before this is attached to the skin. The cylindrical holder 3 is preferably made of an at least to some extent resilient material, such as silicone rubber and silicone plastic. At the rear of the holder, the material is in the form of a grid 15 for preventing various objects from being sucked into the respiratory passages. Furthermore, the front of the holder has an inwardly bent or inwardly projecting annular edge portion 16 ensuring that the accessories introduced into the holder are held in place. One aim of the present invention is that the carrier with the holder should be allowed to remain on the throat of the laryngectomee for up to a week before it is necessary to replace it. Thus, the skin around the stoma is not exposed to unnecessary strain, as is the case when the tape has to be removed frequently. In order to make it possible to exchange e.g. a filter, which, for reasons of hygiene, might be necessary once or twice every day, the filter is in the form of an exchangeable accessory member 5 forming part of a complete set of accessories suited for different purposes.

This set may further include a high-efficiency breathing filter 4 having an extra thick layer of filter medium 17, which gives it a high capacity for storing moisture and heat, and, optionally, a layer filtering off bacteria. A breathing filter of this type is used e.g. when the laryngectomee is risking an infection in the respiratory passages, or in polluted surroundings. Since the filter layer is thick, the breathing resistance will be comparatively high. To compensate for this, the flow area of the filter has been enlarged by providing the filter medium in a part which in its entirety is to be located outside the holder and which is much larger than the part of an insert introduced into the holder 3.

Normally, a breathing filter 5 which is much smaller than the one described above, is perfectly adequate. The details of such a filter are apparent from Fig. 2. The entire filter is to be contained in the holder 3, so that the arrangement in its entirety will take up a minimum of space and not be too conspicuous. The filter is made up of an outer sleeve 18 which encloses the filter medium 17 and in the circumferential surface of which are formed a number of slots 19. Every other slot ends at a given, short distance 20 from the rear end of the sleeve, while the other slots end at a corresponding distance from the front end of the sleeve. Thus, the filter member is given a radial deformability which facilitates introduction into the holder. To hold the filter member securely in place in the holder, the front end of the member is formed with an inwardly bent edge portion or groove 21 which the corresponding inwardly bent edge portion 16 of the front portion of the holder is intended to engage. This should eliminate the risk of the filter member being ejected, e.g. in a coughing fit. For this very reason, the front portion of the filter member is provided with a cross-shaped stop 22 preventing the filter medium from being pressed out. Furthermore, the filter member is equipped with a pulling band 23 to facilitate exchange thereof.

The accessory set may further comprise an extension piece 6 comprising an angular tube 6' and a flexible tube 6". This extension piece is especially suited for use in cold weather, when the inlet opening thereof is kept under a coat lapel or the like to preheat the inhalation air.

An angular tube 7 is made up of a member 7' which can be inserted in the holder 3, and a member 7" extend- ing perpendicularly from the member 7' . This tube is especially adapted for use when taking a shower, and pre¬ vents water from entering the lungs through the stoma when the member 7" is directed downwards.

Figs. 3 and 4 are rear views of alternative embodi- ments of the carrier. The embodiment in Fig. 3 is for people who are especially sensitive in the area imme¬ diately around the stoma. To make things easier for such people, the flange 9 of the holder is located at the back of the tape, so that an area immediately adjacent to the aperture is free from adhesive agents, which makes it extra kind to the skin. In the area around the aperture, the embodiment in Fig. 4 is provided with a liquid-absorbing ring 24 which may consist of foam plastic or a felt material. This ring serves to absorb liquid or phlegm from the respiratory passages of people for whom this is a problem. Fig. 3 illustrates a detail intended to facilitate removal of the carrier from the skin. In this case, a part of one corner of the piece of tape has been cut off, resulting in that a corner 25 of the fibre cloth is com¬ pletely free from adhesive agents. Thus is obtained a tearing aid which makes it easier for the user to grip the carrier for removal.

It goes without saying that the inventive arrange¬ ment may be modified in many ways within the scope of the appended claims. Thus, many other types of accessories may form part of the accessory set, the shape of the car¬ rier may of course be varied, and the holder need not be cylindrical, although this is preferred in actual prac¬ tice. Furthermore, the means for holding the filter hol¬ der in place may be otherwise designed, e.g. the inwardly protecting portion of the holder may be in the form of a bead and need not necessarily engage a corresponding, inwardly projecting portion or groove on the filter accessory member, but may also grip about the outer end edges thereof. The inwardly projecting portions of both the socket-shaped holder and the accessory member need not extend around their entire peripheries, but may consist of a number of spaced-apart portions. Neither need the inwardly projecting portions be located at the outer end portion of the holder. As mentioned above, the holder and the mounting ele¬ ment are to remain on the throat of the laryngectomee for up to a week. One reason for this is that, owing to the strong adhesion necessary to ensure that the mounting element remains in place despite the high air pressure that may arise, the mounting element cannot be torn off too often since this may irritate or hurt the skin around the stoma. It is, therefore, desirable to have a holder that can serve different purposes so that the mounting element may remain on the laryngectomee for longer periods of time. Thus, the inventive holder is made of a soft and yielding material enabling other types of acces- sory members, not adapted to be contained in their entirety in the holder, to be introduced and held in place therein. Such alternative accessories include the short bent tube 7 used when taking showers, the long flexible tube 6 used in cold weather to preheat the inhalation air, or the large filter 4 suited for use in highly polluted air. All these accessories are to be used for specific occasions only, and need not therefore be held in place as securely as the small filter 5 which is the one normally used, in the daytime as well as at night. Since the breathing resistance of these acces¬ sories is not as high as that of the small filter 5, the air pressure on the accessories will be lower in a fit of coughing. The holder being made of a soft flexible mate¬ rial, it is possible to insert such accessories with sub- stantially smooth cylindrical tube connections, despite the presence of the inwardly projecting annular portion. Furthermore, the latter will increase the force with which the accessories are maintained in place, owing to it being compressed about the tube connections. In prac- tice, it is preferred that the holder is in the form of a tight-fitting collar preventing the breathing air from bypassing any of the filters or the other accessories.

Although it is preferred that the small filter 5, as stated in the foregoing description, is contained in its entirety in the space defined by the holder wall, it is, of course, perfectly conceivable that the front end of the filter projects somewhat beyond the boundary wall of the holder. However, the projecting portion of the filter should not have a length exceeding about 1/4 of the length of the filter, as measured from its front to its rear end.

Claims

1. An arrangement for protecting the breathing pas- sages of laryngectomees, i.e. people with a throat stoma

(2) for the passage of inhaled and exhaled air, comprising a flexible, apertured mounting element (1) adapted to be sealingly applied to the throat of the laryngectomee in such manner that the aperture is positioned over the stoma, and connected to a projecting socket-shaped holder

(3) accommodating an exchangeable filter means (5) through which the air passes during an inhalation and exhalation through the stoma (2), c h a r a c t e r i s e d in that the holder (3) is adapted to contain the filter means (5) substantially within a space (26) defined by the holder wall (3'), and that the holder has means (16) ensuring that the filter means is held in place and preventing it from being ejected from the holder, e.g. in a fit of coughing or the like.

2. The arrangement of claim 1, c h a r a c t e r ¬ i s e in that the holder (3) is made of a resilient material, such as silicone rubber and silicone plastic.

3. The arrangement of claim 1 or 2, c h a r a c ¬ t e r i s e d in that the holder has an inwardly pro- jecting portion (16) adapted to grip about or engage in the corresponding inwardly projecting portion (21) of the filter means (5).

4. The arrangement of claims 1-3, c h a r a c ¬ t e r i s e d in that the mounting element (1) comprises a double-adhesive tape, i.e. a tape with adhesive on both sides, which is attached to the skin around the stoma (2) and to which the holder (3) is applied, the front of said tape which faces away from the skin being covered by a fibre cloth or fabric (10) applied around the holder.

5. The arrangement of claim 4, c h a r a c t e r ¬ i s e d in that the rear portion of the holder (3) is provided with a flange (9) extending radially outwards and adapted to be fixed to the mounting element (1).

6. The arrangement of claim 4 or 5, c h a r a c ¬ t e r i s e d in that the back of the mounting element (1) is completely free from adhesive agents in the area around the aperture, so as to be kind to the skin around the stoma (2).

7. The arrangement of any one of the preceding claims, c h a r a c t e r i s e d in that the back of the mounting element (1) is equipped with a liquid-absorb¬ ing annular member (24) in the area around the aperture.

8. The arrangement of any one of the preceding claims, c h a r a c t e r i s e d in that the filter means is formed in its circumferential surface with slots (19) allowing radial deformation of said filter means.