WO2000066208A2

WO2000066208A2 - Tracheostoma button

Info

Publication number: WO2000066208A2
Application number: PCT/GB2000/001681
Authority: WO
Inventors: Eric Hinkles
Original assignee: Eric Hinkles
Priority date: 1999-04-29
Filing date: 2000-05-02
Publication date: 2000-11-09
Also published as: WO2000066208A3; AU4588700A

Abstract

A tracheostoma button (1) comprises a tube (2) for insertion through the stoma into the trachea. The tube (2) has a retaining flange (3) around the free end thereof to provide a small degree of resistance to removal from the stoma. An enlarged head portion (4) at the other end and integrally formed therewith carries an air filter means (7) in sealing engagement therewith.

Description

TRACHEOSTOMA BUTTON Field of the Invention

This invention relates to a tracheostoma button. Background to the Invention The surgical procedure in which an opening is created through the neck and into the trachea, for example to provide a by-pass to an obstruction in an upper airway, is called a tracheostomy, and the resulting opening a tracheostoma, or simply stoma.

In the immediate post-operative period, a relatively complex tube arrangement is fitted in the stoma, but while some people are obliged to use a tube long-term, most will quickly progress to the use of a tracheostoma button, which is a small resiliently- deformable device which is inserted into the stoma to protect the opening and to facilitate the diversion of exhaled air to the larynx for speaking, by simply covering the opening therein with the user's finger. The button has a short tube with an enlarged head at one end and a retaining flange at the other to prevent the button from being involuntarily ejected from the stoma, in use. The button is small and discreet in appearance.

A problem with such buttons is that they do not provide a filtering function. A filter is important as a substitute for the filtering and warming effect of the nasal passages. Without some form of filter, there is a risk of solid particles being drawn direct into the trachea and the lungs through the stoma, which could give rise to irritation or infection, while the possible introduction of cold air and/or excessively dry air through the stoma is also detrimental. It has been found that use of tracheostoma breathing devices not incorporating filters leads to increased secretion of mucous and a greater incidence of chest infections. A number of proposals have been made for filter arrangements. For example,

EP-A-649321 discloses a tracheostoma tube assembly having a filter arrangement which can clip on to the end of the tube. The construction of the filter is disclosed in WO-A- 94/01 199. These devices are associated with the type of tube assembly generally intended for immediate post-operative use. A filter mounting device for use by people who have passed the initial post-operative stage and who use only a stoma button is dis- closed in GB-A-2 303 553. It comprises a housing in which the replaceable filter element is fitted. The housing comprises a plate which is attached to the user's throat over the stoma. A problem with this arrangement is that it is not readily removable, for example when the user wishes to cough to eject mucous. In addition, some users feel that its appearance is obtrusive in comparison with the simple stoma button, and they therefore prefer not to use the filter. Lady users in particular would prefer a device with a more discreet appearance. Summary of the Invention

According to the invention, there is provided a tracheostoma button comprising a tube for insertion through the stoma into the trachea, the tube having a retaining flange around the free end thereof to provide a small degree of resistance to removal from the stoma, and an enlarged head portion at the other end thereof, the tube, the flange and the head portion being integrally formed, wherein the head portion carries an air filter means in sealing engagement therewith. The filter may be permanently sealed on to the head portion over the inlet/outlet face of the button, so that the complete button and filter are simply replaced when the filter life is ended, the spent assembly being thrown away. Preferably, however, the filter may be arranged to clip in to the head portion of the button, and to be replaceable at the end of its life independently of the button. The filter may comprise one or more layers of filter fabric, for example a woven or non-woven polyester fabric which may, if desired, be impregnated with active carbon to enhance the filtration and purification action. The filter could incorporate an indicator substance which changes colour to indicate the need to discard the filter in favour of a new one. The fabric is suitably held in a rigid plastics annular frame. The button body may be formed as a one-piece elastomeric moulding in which the filter can be received. Its design is preferably such that the external inlet/outlet thereto can be sealed by a user's finger or thumb when the user wishes to speak.

The device of the invention provides the small size, convenience of use and discreet appearance of a stoma button with the health and comfort advantages of an air filter. Brief Description of the Drawings

In the drawings, which illustrate an exemplary embodiment of the tracheostoma button of the invention;

Figure 1 is a perspective view of the button according to one embodiment of the invention, with the filter attached;

Figure 2 is a cross-sectional elevation of the button of Figure 1 ; and

Figure 3 is an enlarged cross-sectional view of the filter fitted to the button shown in Figures 1 and 2.

Detailed Description of the Illustrated Embodiment The stoma button 1 comprises, in conventional manner, a short tube 2 having an angled flange 3 around one end to help retain the button in position in the stoma in use, and an enlarged head portion 4 at the other end. The head portion 4 has a rim 5 surrounding the inlet/outlet aperture 6. The button is typically a one-piece elastomeric moulding, for example of silicone rubber, and is resiliently deformable to assist in inser- tion and to improve comfort in use.

The rim 5 has an annular inwardly-facing recess 8 therearound into which the periphery of the filter 7 is inserted, by resilient deformation of the material of the rim. The filter 7 comprises an annular frame 9 in which the edge of a circular pad 10 of filter material is moulded to hold it flat and to seal the edges to prevent air by-passing the fil- ter. The filter 7 can be snapped in to the stoma button by stretching/distortion of its rim, and then readily removed for disposal when at the end of its life. For example, daily or more frequent replacement may be simply undertaken. The sealing of the filter material 10 in the annular frame 9 may be seen more clearly in Figure 3.

Claims

1 . A tracheostoma button comprising a tube for insertion through the stoma into the trachea, the tube having a retaining flange around the free end thereof to provide a small degree of resistance to removal from the stoma, and an enlarged head portion at the other end thereof, the tube, the flange and the head portion being integrally formed, wherein the head portion carries an air filter means in sealing engagement therewith.

2. A tracheostoma button according to Claim 1 , wherein the filter is re- movably mounted in or on the head portion.

3. A tracheostoma button according to Claim 2, wherein the head portion is provided with a resiliently deformable rim having an inwardly facing recess therearound to receive the peripheral edge of the filter therein.

4. A tracheostoma button according to Claim 1 , 2 or 3, wherein the filter comprises a rigid plastics frame supporting one or more layers of a filter material.

5. A tracheostoma button according to Claim 4, wherein the filter is circular in plan.

6. A tracheostoma button according to Claim 4 or 5, wherein the filter material is a woven or non-woven fabric.

7. A tracheostoma button according to any preceding claim, wherein the filter incorporates active carbon.

8. A tracheostoma button according to any preceding claim, wherein the filter incorporates a bactericidal material.

9. A tracheostoma button according to any preceding claim, wherein the filter incorporates an indicator substance which changes colour to indicate the need to change the filter after use.

10. A tracheostoma button according to any preceding claim, wherein the body of the button is formed of an elastomeric material so as to be resiliently deformable.

1 1 . A tracheostoma button according to Claim 10, wherein the elastomeric material is silicone rubber.

12. A kit of parts, comprising a tracheostoma button according to any preceding claim, and a plurality of replacement filters therefor.