GB2517680A

GB2517680A - Tracheostomal plaster

Info

Publication number: GB2517680A
Application number: GB201313147A
Authority: GB
Inventors: Graham Steer
Original assignee: Prosys International Ltd
Current assignee: Prosys International Ltd
Priority date: 2013-07-23
Filing date: 2013-07-23
Publication date: 2015-03-04
Anticipated expiration: 2033-07-23
Also published as: GB2517680B; GB201313147D0

Abstract

A tracheostomal plaster 21 comprises a flexible web of material 23 provided with an adhesive layer and an aperture 25 and is fastened, for example by welding or adhesion, to a resiliently flexible tracheostomal device coupler 1, also having an aperture 11, with their respective apertures aligned. The device coupler has a dished base member 3 with a convex surface 9 which abuts the web 23 and a concave surface 7 which defines a recess in which a peripheral wall 13 extends around the coupler aperture 11 and away from the web 23. A bracing structure 15, located in the recess and surrounding the peripheral wall 13 and extending between the peripheral wall 13 and the concave surface 7, may comprise a network of walls 17 to provide a consistent diametrical resistance to flexure. Tabs 27 on different removable release layers (27,29 Figures 5 & 6) may selectively be pulled away from the web adhesive layer to enable alignment with a stoma prior to final attachment of the remainder of the plaster to the surrounding skin.

Description

TRACHEOSTOMAL PLASTER

Field of the Invention

This invention relates to tracheostomal plasters.

Background to the Invention

A tracheostomy is a surgical procedure in which an opening, known as a tracheostoma, is formed through a patient's neck into the trachea.

A laryngectomy is another surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and the creation of a tracheostoma. Some patients have the two vertical sternocleidomastoid muscles cut during the laryngectomy procedure, but for those who don't it is commonplace for the stoma to be sunk into the throat of the patient so that the stoma sits at the bottom of a pit in the neck of the patient.

One consequence of the laryngectomy procedure is that the trachea is no longer connected to the pharynx but is diverted to the tracheostoma. As a result the patient's normal nasal Junction is often compromised. In a subject whose breathing functions normally, the nose and the mucous membrane lining of the nasal cavity perform important functions in conditioning inhaled air. The convoluted passages and rich blood supply serve to increase both the temperature and humidity of the inhaled air to reduce the differential in these parameters with those of the surface of the lungs. Normally some heat and moisture is also captured from exhaled air prior to its release to atmosphere.

The mucous lining of the nasal passages also serves to remove particulate matter, such as fine dust particles, pollutants and microorganisms, from the inhaled air, and the action of cilia transports mucous and any particles away from the lungs.

For patient's who have had a laryngectomy performed on them, all inhaled air enters the lungs via the tracheostoma, and the nose tends not to be involved in the inhalation process. Exhaled air may pass through the tracheostoma or if a voice prosthesis has been fitted, the stoma can be occluded so that the exhaled air is diverted through the voice prosthesis into the pharynx and the mouth, thereby enabling the patient to speak. It is desirable for the flow of the exhaled air be controlled by means of a tracheostoma valve, and in these situations, the valve can be arranged to remain open during breathing but, with a small additional increase in exhaled air flow, to be closed to divert the airflow.

Tracheostoma devices, such as filter devices, HME, breathing protectors, and speech valves, have been developed to moisturise inhaled air, to remove small particles and bacteriological substances in the inhaled air, and to provide the patient with the ability to speak by manually closing the air passage through the trachestoma. These tracheostoma devices couple to a tracheostomal plaster that is attached to the neck of the patient above the tracheostoma. The tracheostomal plaster includes a tracheostomal device coupling, and a web of material that has an adhesive surface at least on that side of the web that faces the patient in use. Typically the tracheostoma device holder is welded or adhered to the web of material.

US 7,025,784 discloses a tracheostomal plaster wherein a circular web of material, adhesive on both sides, is used to adhere a tracheostoma device coupling, above the tracheostoma of the patient. However, as the web of material is adhesive on both sides, it can only be as large as the tracheostoma device coupling, as otherwise that portion of the web extending beyond the device coupling could inadvertently adhere to clothing worn by the patient. Furthermore, as the individual attaching the plaster to the patient has to grip the device coupling, it can be difficult to adhere this plaster to patients with sunken stomas as the adhesive web tends to adhere to the walls of the pit before the central portion of the adhesive web has attached to the patient.

A related problem is that as the tracheostomal device coupling has to be relatively stiff in order to withstand flipping over at high speech pressures, the circular shape of the device coupling makes it difficult to fit the plaster to patients with sunken stomas.

To address some of these issues, European Patent No. 1513575 proposed a tracheostomal plaster which comprises a circular device coupling and a larger rectangular web of material that is welded to the circular device coupling. Since the web is welded to the device coupling, only one side of the web of material (the side that faces the patient in use) needs to be adhesive. This plaster has a greater area of adhesive than that proposed in the aforementioned US patent and hence can more firmly be adhered to the patient, without the danger of inadvertently attaching the plaster to the patient's clothing. However, this device is still difficult to fit to patients with a sunken stoma.

To facilitate the adhesion of plaster to patients with sunken stomas, European Patent Publication No. 2358420 discloses a tracheostomal plaster with a device coupling comprised of a generally rectangular dished plate that has a central aperture for alignment with the stoma. Two pairs of bracing walls extend in opposite directions along the longer axis of the rectangular plate from an upstanding wall that surrounds the periphery of the aperture. The bracing walls are configured so that the device coupling has a greater resistance to flexure in the direction of the long axis of the plate, than in the direction of the short axis of the plate.

Whilst this device addresses some of the problems associated with the devices disclosed in EP1513575 and US7025784, the fact that the bracing extends substantially the entire length of the rectangular plate can make the plaster uncomfortable to wear -particularly for patients with a relatively short neck. Furthermore, whilst the device is braced against flipping along the long axis of the plate, it is not braced along the short axis and thus is still susceptible to flipping.

Aspects of the present invention have been devised with the foregoing problems in mind.

Summary of the Invention

In accordance with a presently preferred embodiment of the present invention, there is provided a tracheostomal plaster comprising: a resiliently flexible tracheostomal device coupler having an aperture; and a flexible web of material having an aperture, the web of material being fastened to said device coupler so that the web aperture aligns with said coupler aperture; wherein said device coupler comprises: a dished base member that is longer in a first dimension than in a second perpendicular dimension; said dished base member including a convex surface that abuts said web of material and a concave surface facing away from said web of material to define a recess; a peripheral wall extending from said concave surface in a direction away from said web and surrounding said coupler aperture; and a bracing structure located in said recess and extending between said peripheral wall and said concave surface, said bracing structure surrounding said peripheral wall.

In one implementation the bracing structure comprises a network of walls extending from said convex surface in a direction away from said web. Preferably the network of walls cooperate to define a plurality of depressions.

The peripheral wall may, in one implementation, be generally circular. The bracing structure may define a circular periphery at its radially outermost point from the peripheral wall. In one arrangement the circular periphery of the bracing structure may be concentric with said peripheral wall. Preferably the bracing structure is wholly within the recess defined by said dished base member. In one implementation the periphery of the bracing structure radially outermost from said peripheral wall may be spaced from the periphery of said dished base member.

Preferably the flexible web extends beyond the periphery of said dished base member. In one arrangement a side of said flexible web that is configured to lie against a subject's skin in use may be at least partly covered by a layer of adhesive. The plaster may comprise one or more removable release layers overlying said adhesive layer.

In one implementation the plaster may comprise a first release layer configured to cover a part of said adhesive layer in the vicinity of said web aperture and said coupling aperture, said first release layer being removable separately from one or more remaining release layers. In a preferred arrangement the plaster comprises one remaining release layer partly surrounding said first release layer.

In another implementation the plaster may comprise a single release layer, said release layer including two lines of perforations that define a first portion configured to cover a part of said adhesive layer in the vicinity of said web aperture and said coupling aperture, and second and third portions located to either side of said first portion and together covering the remainder of said adhesive layer; wherein said first, second and third portions of said one release layer are separately removable.

Preferably said one or more release layers each include a grippable tab projecting beyond the periphery of said web of material.

In one envisaged arrangement the flexible web may be adhered to said concave surface (preferably to substantially all of said concave surface). The flexible web may (alternatively or additionally) be welded to the base plate of said device coupler.

Preferably the device coupler is formed of a plastics material, for example an EVA co-polymer.

In one implementation the bracing structure may be generally annular and be configured to have the same resistance to flexure in any diametrical direction.

These and other representative aspects embodying the teachings of the present invention, and advantages thereof, are set out hereafter.

Brief Description of the Drawings

Various aspects of the teachings of the present invention, and arrangements embodying those teachings, will hereafter be described by way of illustrative example with reference to the accompanying drawings, in which: Fig. 1 is a perspective view of a device coupler of a tracheostomal plaster that embodies the teachings of the present invention; Fig. 2 is a cross-sectional view of the coupler along the line A-A in Fig. 1; Fig. 3 is a cross-sectional view of the coupler along the line B-B in Fig. 1; Fig. 4 is a plan view of one side of a plaster embodying the teachings of the present invention; Fig. 5 is a plan view of the other side of the plaster depicted in Fig. 4 showing one illustrative release layer configuration; and Fig. 6 is a plan view of a plaster depicting an alternative release layer configuration.

Detailed Description of Preferred Embodiments

Referring now to Fig. 1 to 3, there is depicted a schematic perspective view of a device coupling I for a tracheostomal plaster that embodies the teachings of the present invention.

The coupling 1 is resiliently flexible and may be made of a plastics material, for example ethylene vinyl acetate (EVA) -a copolymer made by blending vinyl acetate and low density polythene. The softness of the EVA can be varied, as is known in the art, by increasing the amount of vinyl acetate in the co-polymer. The coupling is affixed to a flexible web of material (not shown in Fig. 1) to form the plaster.

The coupling comprises a dished base member 3 with a generally concave surface 7 on one side and a generally convex surface 9 on the other side (Figs. 3 & 4).

The dished base member is preferably longer in one dimension than the other (to facilitate fitting of the plaster to a patient), and in this particular implementation is generally oval in shape. The base member 3 includes an aperture 11 that is surrounded by a peripheral wall 13. The concave surface 7 of the base member 3 defines a recess in which a bracing structure 15 is located. The bracing structure extends from partway up the peripheral wall towards the periphery of the concave surface 7, and surrounds the peripheral wall 13. As shown in Figs. 2 and 3, in a preferred implementation the bracing structure iSis wholly within the recess defined by the concave surface 7.

The bracing structure is comprised of a network of walls 17 that extend upwardly from the concave surface 7 and cooperate to define a plurality of depressions 19 of varying sizes. The depressions extend down to the concave surface 7, and the bracing structure terminates at a circular periphery 21 that is generally concentric with the aperture 11. In a preferred arrangement the circular periphery 21 is spaced from the periphery of the base member 3 (as shown in Fig. 1).

The walls and depressions of the bracing structure form a pattern where a line drawn through any diameter of the bracing structure crosses the same number of walls and depressions on either side of the aperture Ii. This provides the bracing structure with the same diametrical resistance to flexure, irrespective of which diameter is selected. The depressions can also be tilled with an aromatic paste to mask any noxious odours, or with a medicament (for example, a menthol paste).

Fig. 4 is a plan view of a tracheostomal plaster 21 that comprises the abovedescribed device coupling 1 and a flexible web of material 23. The flexible web of material includes an aperture 25, and is connected to the coupling 1 so that the web aperture 25 aligns with the coupling aperture 11. The convex side 9 of the coupling 1 may be connected to the material web 21 in any of a number of different ways. For example, the coupling 1 could be adhered to the web 21 by means of an adhesive layer surrounding the aperture 25 in the web. Alternatively (or additionally) the coupling may be welded to the web of material 23.

The underside of the web of material is provided with an adhesive layer (preferably over substantially all of the underside of the web) so that the plaster can be adhered to a subject's skin. One or more removable release layers (Figs 5 & 6) cover the adhesive layer, and each release layer is provided with at least one grippable tab 27 that can be pulled away from the web 23 to detach the release layer from the adhesive.

The plaster depicted schematically in Fig. 4 has a generally square web of material 23, but it will be appreciated that this is merely illustrative and that the web can have any desired shape.

Figs. 5 and 6 are schematic representations of illustrative release layer configurations. In the arrangement depicted in Fig. 5, the plaster 21 is provided with two release layers 29, 31. The first release layer 29 covers a part of the adhesive layer on the underside of the web 23 in the vicinity of the aligned web aperture 25 and coupling aperture 11 (the position of those apertures being indicated by the dashed circle). The second release layer 31 covers the remainder of the adhesive layer and, the first and second release layers are separately detachable from the web of material 23. This configuration allows a user to remove the first release layer 29, position the plaster 21 so that the web and coupling apertures 25, 11 are aligned with the stoma of a patient, and then remove the second release layer 31. Once the second release layer has been removed, the remainder of the plaster can be firmly attached to the patient.

Fig. 6 illustrates another envisaged release layer configuration. In this implementation there is provided a single release layer 33 that has two (preferably parallel) lines of perforations 35 formed in it -the perforations dividing the release layer into three sections 33a, 33b and 33c. The first 33b of these sections covers the adhesive layer in the vicinity of the web and coupling aperture 25, 11, and the other sections 33b: 33c cover the adhesive layer to either side of the first section. As before, this configuration allows a user to remove the first release layer section 33b, position the plaster 21 so that the web and coupling apertures 25, 11 are aligned with the stoma of a patient, and then remove the second and third release layer sections 33a, 33c. Once the second and third release layer sections have been removed, the remainder of the plaster can be firmly attached to the patient.

It will be appreciated that whilst various aspects and embodiments of the present invention have heretofore been described, the scope of the present invention is not limited to the particular arrangements set out herein and instead extends to encompass all arrangements, and modifications and alterations thereto, which fall within the scope of the appended claims. For example, whilst the flexible web is depicted as being square, it can have any desired shape. Similarly, whilst the base member of an envisaged implementation is generally oval, it could be rectangular or have any other shape.

It should also be noted that whilst the accompanying claims set out particular combinations of features described herein, the scope of the present invention is not limited to the particular combinations hereafter claimed, but instead extends to encompass any combination of features herein disclosed.

Claims

CLAIMS1. A tracheostomal plaster comprising: a resiliently flexible tracheostomal device coupler having an aperture; and a flexible web of material having an aperture, the web of material being fastened to said device coupler so that the web aperture aligns with said coupler aperture; wherein said device coupler comprises: a dished base member; said dished base member including a convex surface that abuts said web of material and a concave surface facing away from said web of material to define a recess; a peripheral wall extending from said concave surface in a direction away from said web and surrounding said coupler aperture; and a bracing structure located in said recess and extending between said peripheral wall and said concave surface, said bracing structure surrounding said peripheral wall.
2. A plaster according to Claim 1, wherein said bracing structure comprises a network of walls extending from said convex surface in a direction away from said web.
3. A plaster according to Claim 2, wherein said network of walls cooperate to define a plurality of depressions.
4. A plaster according to any preceding claim, wherein said peripheral wall is generally circular.
5. A plaster according to any preceding claim, wherein said bracing structure defines a circular periphery at its radially outermost point from the peripheral wall.
6. A plaster according to Claim 4 and Claim 5 wherein the circular periphery is concentric with said peripheral wall.
7. A plaster according to any preceding claim, wherein said bracing structure is wholly within the recess defined by said dished base member.
8. A plaster according to any preceding claim wherein a periphery of the bracing structure radially outermost from said peripheral wall is spaced from the periphery of said dished base member.
9. A plaster according to any preceding claim, wherein said flexible web extends beyond the periphery of said dished base member.
10. A plaster according to any preceding claim, wherein a side of said flexible web that is configured to lie against a subject's skin in use is at least partly covered by a layer of adhesive.
11. A plaster according to Claim 10, further comprising one or more removable release layers overlying said adhesive layer.
12. A plaster according to Claim 11, comprising a first release layer configured to cover a part of said adhesive layer in the vicinity of said web aperture and said coupling aperture, said first release layer being removable separately from one or more remaining release layers.
13. A plaster according to Claim 12, comprising one remaining release layer partly surrounding said first release layer.
14. A plaster according to any of Claims ito 11, comprising a single release layer, said release layer including two lines of perforations that define a first portion configured to cover a part of said adhesive layer in the vicinity of said web aperture and said coupling aperture, and second and third portions located to either side of said first portion and together covering the remainder of said adhesive layer; wherein said first, second and third portions of said one release layer are separately removable.
15. A plaster according to any of Claims 11 to 14, wherein said one or more release layers each include a grippable tab projecting beyond the periphery of said web of material.
16. A plaster according to any preceding claim wherein said flexible web is adhered to said concave surface (preferably to substantially all of said concave surface).
17. A plaster according to any preceding claim, wherein said flexible web is welded to the base plate of said device coupler.
18. A plaster according to any preceding claim, wherein said device coupler is formed of a plastics material, for example an EVA co-polymer.
19. A plaster according to any preceding claim, wherein said bracing structure is generally annular and has the same resistance to flexure in any diametrical direction.
20. A plaster according to any preceding claim wherein said dished base member is longer in a first dimension than in a second perpendicular dimension.
21. A plaster according to Claim 20, wherein said dished base member is oval or rectangular.
22. A tracheostomal plaster substantially as hereinbefore described with reference to the accompanying drawings.