Padding for tracheostomy tube

Abstract

Padding (10) for a tracheostomy cannula shield (11) with a proximal (1') and a distal (1) surface and a central through-opening (3) penetrating the surfaces, wherein the padding is shaped as a shield in which at least two fastening tabs (2) are attached on either side of the central through-opening (3), which extend from the padding in opposite directions and can be passed through openings (12) of the tracheostomy cannula shield (11) used for fastening, characterized in that the fastening tabs are each provided with at least one eyelet (4) for fastening with a cannula strap (13).

Description

[0001] The present invention relates to a padding for a tracheostomy tube shield having a proximal and a distal surface and a central through-opening penetrating the surface.

[0002] Tracheostomy tubes are used for ventilation or to facilitate breathing and are inserted into the trachea through an artificially created airway, the tracheostomy. Among other components, tracheostomy tubes consist of a tube and a shield. The shield prevents the tracheostomy tube from being inserted too far into the trachea or even slipping into it. Furthermore, the shield, together with a neck strap, secures the tracheostomy tube to the patient's neck.

[0003] To increase patient comfort, tracheostomy tubes are available with a movable shield suspension. For example, some commercially available tube types allow the tube to be pivoted upwards or downwards. Other tube types use a gimbal suspension to allow the shield to be pivoted in two spatial axes. Such a tube is described in EP 0 822 842.

[0004] Despite the use of compresses, which essentially serve to absorb fluids, patients may experience pressure sores on their neck caused by the cannula shield and suffer from skin irritation at the stoma. This may be due, on the one hand, to the fact that the shield material is often very rigid. Another cause of pressure sores could be that the cannula tube attached to the neck lacks the flexibility to deflect any pressure perpendicular to the neck. A further disadvantage of existing cannula shields is that their size and shape cannot be individually adjusted to the patient's anatomy.

[0005] Particularly in patients with very wide stomas or severely distorted stomas, air can escape between the stoma and the cannula when using conventional cannula shields with a compress. When using so-called speaking valves, this has the disadvantage that the flow resistance of these valves causes more air to escape from the sides, which cannot be used for voice production. Furthermore, leaks between the stoma and the tracheostomy tube also have disruptive effects when using so-called moist nasal or moist-heat exchangers (HMEs). Due to the leak, only a portion of the inhaled air is pre-tempered or humidified, which can lead to serious impairments in lung function.

[0006] US Pat. No. 5,918,599 discloses a neck cuff for securing a tracheostomy tube. The neck cuff is made of a washable, reusable, and bidirectionally elastic material. Two fastening tabs are positioned opposite a through-hole and can be secured to the neck cuff with a hook-and-loop fastener.

[0007] In contrast, the object of the present invention was to provide a padding for tracheostomy cannula shields which prevents pressure points caused by the cannula shield and the cannula strap and enables the cannula shield to be adapted to the anatomical conditions of the patient's neck.

[0008] This object is achieved according to the invention by a padding which is shaped as a shield, in which at least two fastening tabs are attached on either side of a central through-opening, which extend from the padding in opposite directions and can be passed through openings of the tracheostomy cannula shield which serve for fastening, wherein the fastening tabs are each provided with at least one eyelet for fastening to a cannula strap.

[0009] The padding is essentially flat, with the proximal surface being the surface adjacent to the patient's neck and the distal surface facing away from the patient. The distal surface of the padding therefore rests against the cannula shield.

[0010] The central opening of the padding extends perpendicular to and through the distal and proximal surfaces and serves to accommodate or pass through the cannula tube of a tracheostomy tube. The opening has a diameter of approximately 0.5 cm to 2 cm, preferably 1 cm to 1.5 cm. The diameter of the central opening is naturally adapted to the cannula tube and is at most slightly larger than its outer diameter, or sized so that it rests against the outer surface of the cannula with slight elastic tension.

[0011] The padding is preferably made of a very soft material so that it conforms to the patient's neck and, in particular, cushions the edges of the harder cannula shield. It is preferably larger than the shield so that the edges of the shield are covered on all or almost all sides by the padding.

[0012] The padding is preferably made of silicone or a thermoplastic elastomer. Thermoplastic elastomers are materials that exhibit the elasticity, softness, and toughness of a thermosetting rubber and the processability of a thermoplastic polymer. Elastomeric foams are also conceivable materials.

[0013] The material should be both skin-friendly and flexible and elastic. The elasticity of the tabs, in particular, allows a certain degree of mobility of the cannula perpendicular to the neck, which also helps minimize pressure points. Furthermore, the padding can be removed and replaced without removing the cannula from the stoma. Especially with very elastic materials, the central opening of the padding can be pulled over the smaller cannula shield.

[0014] It is particularly useful if the material can be cut to size so that the padding can be adjusted to both the cannula shield and the patient's neck by the patient or the doctor.

[0015] The padding material can also have a surface texture or perforation to inhibit excessive sweating of the skin covered by the padding. The material should be both skin-friendly and flexible and elastic.

[0016] In particular, it is also conceivable that the material of the fastening tabs has different properties, for example with regard to elasticity, structure or thickness, than the material of the ultimately cushioning area of ​​the padding.

[0017] A further preferred embodiment of the padding is one in which the material has a thickness of between 0.5 mm and 20 mm, preferably between 2 mm and 8 mm. To achieve sufficient padding, the padding material should not be less than the minimum thickness specified above. On the other hand, excessive thickness could increase the distance between the neck and the cannula shield to such an extent that the cannula is pressed against the anterior tracheal wall. This is not only painful for the patient, but also poses the risk of injury or stenosis of the trachea.

[0018] Particularly preferably, the material in the area of ​​the central opening is thicker than the outer edge of the padding. Particularly in the stoma area, where the edges of the central opening of the padding directly abut, particularly good padding must be provided against the shield. This padding not only protects the sensitive stoma but also creates a seal between the cannula tube and the stoma. This prevents air from entering or escaping from the sides of the cannula tube.

[0019] Of course, the padding can also be curved, alternatively or additionally, with the hypothetical apex of the curve located at the central opening on the distal side of the padding. This curve ensures a good fit of the padding to the patient's neck while simultaneously providing a seal.

[0020] In a further preferred embodiment of the invention, the proximal and distal surfaces are elongated and have a lateral dimension of between 3 cm and 10 cm, preferably between 4 cm and 8 cm, and a height of between 4 cm and 7 cm, preferably between 3 cm and 6 cm. The padding is thus excessive compared to known and commercially available tracheostomy tube shields, which are thus completely covered by the padding according to the invention.

[0021] Of course, the padding may also have cuts and wedge-shaped notches, provided that, despite the cuts or notches, it is ensured that a large portion of the edge of the tracheostomy tube shield with which the padding is intended to be used is covered by the padding opposite the patient's neck. A large portion is understood to mean at least 75%, preferably at least 85%.

[0022] Preferably, the proximal and distal surfaces are oval or elliptical. A rectangular shape of the surfaces is also conceivable, with the shape essentially depending on the shape of the cannula shield used and any anatomical features of the patient.

[0023] Furthermore, it is preferred that the two fastening tabs are attached to the distal surface on either side of the central through-opening. In this embodiment, the fastening tabs can be guided through the fastening openings of the tracheostomy tube shield, while simultaneously providing seamless padding of the neck opposite the tube shield. In particular, this embodiment allows the fastening tabs to be formed from a different material than the proximal or distal surface, allowing, for example, a different degree of elasticity to be achieved compared to the cushioning area of ​​the padding.

[0024] Particularly preferably, the fastening tabs are located at a distance of between 0.5 cm and 1.5 cm from the central opening. The distance of the fastening tabs from the central opening preferably corresponds to the distance between the cannula tube and the fastening openings of the tracheostomy tube shield.

[0025] The fastening tabs, unless designed as a cannula strap, have a preferred length of between 1 cm and 5 cm. At the free end of the fastening tabs remote from the distal surface there are one or more, preferably two or three, eyelets. Too many eyelets would possibly reduce the tensile stability of the fastening tabs. The two or three eyelets are spaced apart from one another in the longitudinal direction of the fastening tabs so that the pressure of the shield on the neck can be adjusted by attaching the cannula strap to different eyelets of the fastening tabs, whereby the length of the fastening tabs to which a tensile load is exerted is changed. The fastening tabs can be designed so that they can yield under a stretch of between 10 mm and 30 mm before they tear.

[0026] The ability to adjust the elasticity of the fastening tabs prevents the cannula shield from being pressed against the neck due to certain patient movements. In particular, this could cause the cannula tube to be pressed against the trachea and rub against it, which could lead to stenosis.

[0027] Since the eyelets for the cannula strap are easily accessible on the movable fastening tabs, this invention also simplifies the changing of the cannula strap.

[0028] The fastening tabs for attaching the shield and padding can be pulled through corresponding fastening openings in the cannula shield and are preferably between 0.3 cm and 2 cm wide, more preferably between 0.7 cm and 1.2 cm wide. This width is well suited to absorbing and distributing the tensile load on the fastening tabs when a cannula strap is attached to them, or when the straps themselves serve as a cannula strap. Particularly when the fastening tabs are designed as a cannula strap, a sufficiently wide strap prevents the strap from rubbing or cutting into the neck.

[0029] In a further preferred embodiment, one or more, in particular four, slits radiate from the central opening, extending from the distal surface to the proximal surface through the padding and preferably having a length of between 0.5 cm and 1.5 cm. These slits facilitate the attachment of the padding, whereby the central opening of the padding is stretched or widened by folding over the areas between the slits so that it can be pulled over the smaller cannula shield. With this type of padding attachment, the tracheostomy tube can remain in the trachea while the padding is being attached or replaced.

[0030] Due to the material's stretchability, the application or replacement of the padding can also be facilitated by locally reduced wall thicknesses, e.g., by grooves molded or incorporated into the distal surface. These grooves do not extend through the padding and can be wider than the slits described above. They have a width of between 0.3 mm and 3 mm, preferably between 1 mm and 2 mm. These grooves make the material thinner at this point and therefore easier to stretch. However, thanks to the smooth proximal surface, it lies flat against the skin and has no edges that could irritate the skin.

[0031] In a particularly preferred embodiment of the invention, an annular, fillable fluid cushion is located on the proximal surface around the central opening. The covering of this fluid cushion is preferably so flexible and elastic that, when the fluid cushion is filled after the padding has been applied, it adapts particularly well to the stoma and the cannula tube, thus achieving a good seal of the stoma.

[0032] The fluid cushion can be filled with fluid using a filling tube and an attached valve. In addition to various types of liquids, such as water, gases, and especially air, can be used as fluid. The filling tube is attached to the padding and the fluid cushion in such a way that no additional pressure is exerted on the stoma or the neck.

[0033] However, the fluid cushion could also be pre-filled with a predetermined amount of fluid and completely sealed, eliminating the need for a filling tube. This would provide comfortable cushioning of the stoma while simultaneously ensuring a sufficient seal, particularly for patients with average anatomy and a largely round stoma.

[0034] It is possible for the fluid cushion to be formed integrally with the rest of the padding. The entire padding, or at least the entire cushioning area, can also be designed as a fluid cushion. Of course, much thinner wall thicknesses for the cushioning area are initially conceivable, but in use, by filling the fluid cushion, these correspond to the aforementioned thicknesses for the padding.

[0035] When filled, the fluid cushion preferably extends into the central opening. This design of the fluid cushion allows for a good seal, particularly in patients with very large stomas or a distorted stoma. This effect is further enhanced by individually filling the fluid cushion.

[0036] Particularly preferably, the fluid cushion can be filled to a thickness of up to 2 cm, preferably 1.5 cm. Selecting a suitable pressure should prevent the formation of pressure sores at the stoma. An excessively thick fluid cushion would cause the cannula tube to be displaced forward perpendicular to the neck, potentially causing damage due to friction against the anterior tracheal wall.

[0037] Of course, the invention also encompasses cannula shields with an embodiment of the padding described above. Such a cannula shield could be designed specifically for use with the padding according to the invention and, for example, could itself have only a slight curvature; in this case, adaptation to the patient's neck would be achieved solely through the varying thicknesses of the padding.

[0038] The cannula shield and padding can also be adjusted to each other so that the surface of the padding extends beyond the surface of the shield on all sides.

[0039] The invention also relates to a tracheostomy tube with a shield and padding according to the preceding embodiments.

[0040] Further advantages, features, and possible applications of the present invention will become clear from the following descriptions of preferred embodiments and the accompanying figures. They show: Fig. 1 a plan view of the distal side of a padding according to the invention, Fig. 2 a plan view of the distal side of another embodiment of a padding according to the invention, Fig. 3 a schematic representation of a tracheostomy cannula with shield and cannula strap as well as a further embodiment of a padding according to the invention and Fig. 4 a plan view of the distal side of another embodiment of a padding with a shield according to the invention.

[0041] In Fig. Figure 1 shows a flat embodiment of a padding, designated overall by 10. The distal surface 1 faces the viewer; it is interrupted by the central through-opening 3, which also penetrates the proximal surface 1', which is parallel to the viewing plane. Attachment tabs 2 are attached to the sides, each having three eyelets 4. A cannula shield 11 is indicated in dashed lines, which can be used together with the padding embodiment; it is largely covered by the cushioning area 9 of the padding 10 opposite the patient's neck.

[0042] The padding is made of a soft material, and by attaching a cannula strap to different eyelets, a softer or firmer suspension of the cannula suspension can be adjusted. For this purpose, the fastening tabs are designed so that they can each yield up to 30 mm. This prevents excessive tension in the cannula strap, which would otherwise result in excessive pressure from the cannula shield on the neck and thus cause damage or skin irritation.

[0043] In this embodiment, the fastening tabs engage laterally in indentations on the edges of the padding. These indentations are sized such that the spacing of the attachment tabs corresponds to or is slightly smaller than the spacing of the openings 12 for the passage of the fastening tabs 2 in the associated cannula shield 11. This guarantees that, after the tabs 2 have been passed through the openings 12, the padding rests smoothly and without wrinkles on both the shield and the patient's neck. Although the edge sections of the cannula shield located beyond the openings 12 used for fastening are then not covered by the padding, the protrusions provided on both sides of the indentations in the padding ensure that the edges of the shield immediately above and below the fastening openings are covered.If the padding is thick enough, the edge sections not covered by the padding will not come into contact with the patient's neck.

[0044] This embodiment is particularly easy to manufacture since it is a single piece and completely flat and the tabs 2 are positioned at the edges in the plane of the cushioning area 9 of the padding.

[0045] Another possible embodiment of a padding according to the invention is shown in Fig. 2. To ensure complete padding of the neck against the edges of the cannula shield, the fastening tabs 2 are arranged laterally of the central opening 3 on the distal surface 1 at a corresponding distance so that they can be passed through corresponding fastening openings 12 of the tracheostomy tube shield 11 without causing deformation of the distal 1 or proximal 1' surface. In the illustrated embodiment, the fastening tabs each have two eyelets that can be used for connection to a cannula strap. In the area of ​​the two eyelets 4 in each fastening tab 2, bulges 8 are provided which stabilize the eyelets and thereby increase the tear resistance of the tabs 2.At the same time, the tabs are sufficiently deformable, especially in the area of ​​the eyelets 4, so that they can be pulled through the openings 12 of a cannula shield 11 indicated by dashed lines, even if the tabs in the area of ​​the eyelets 4 are wider than the corresponding openings 12.

[0046] For special pressure relief in the stoma area, the padding material can be thicker at the edge 5 of the central opening 3 than at the outer edge 6 of the padding. The edge 5 lies directly against the stoma. It serves primarily as padding, as the stoma is a very sensitive area that may still be healing or is sore. Incisions 7 are provided in the edge 5 of the central opening, extending from the distal surface 1 to the proximal surface 1'. They serve to facilitate the attachment of the padding 10, with the central opening of the padding being pulled over a cannula shield 11.

[0047] Instead of the incisions, grooves could also be provided that do not extend all the way to the proximal surface 1' of the padding 10, so that the proximal side of the padding has no edges. These grooves lead to a reduced thickness of the padding in some places and thus to better stretchability and deformability. Point-like depressions in the distal surface 1 in place of the grooves or at other locations in the padding area 9 of the padding are also conceivable, which would have the same effect.

[0048] In Fig. Figure 3 shows a perspective view of another embodiment of a padding according to the invention, as used in conjunction with a cannula with a shield 11 and a cannula strap 13. The distal surface 1 of the padding lies directly against the proximal surface of the shield 11 facing the patient.

[0049] In this embodiment, the fastening tabs 2 are attached to the distal surface 1 of the padding and are passed through the openings 12 of the cannula shield. The cannula strap 13 is pulled through the eyelets 4 of the fastening tabs 2 and is thereby secured to the padding. The cannula strap 13 also has a padding 14 underneath. The Fig. The embodiment of a padding shown in Figure 4 represents a modification of the embodiment in Fig. 1. The dashed lines represent parts that are not visible in the top view. For reasons of clarity, a central opening in the cannula shield and the cannula mounted therein have been omitted.

[0050] In this embodiment, an incision 7' ​​extends from the central opening 3 penetrating the padding 10 to one of the two fastening tabs, dividing the fastening tab into two parts 2' and 2". The parts 2' and 2" are shaped such that they lie on top of one another in the area of ​​the eyelets 4, whereby the eyelets 4 present in both parts 2' and 2" coincide. At the end of the tab parts 2' and 2" connected to the padded area of ​​the padding 9, these parts lie next to one another such that the incision 7' ​​is completely closed. In this area, the parts 2' and 2" of the fastening tab are located within the opening 12 of the shield 11, whereby the edges of the incision 7' ​​are pressed together at this point and, despite the incision, a smooth distal and proximal surface is created in the padded area 9 of the padding 10.

[0051] The advantage of this embodiment is that the padding does not have to be pulled over the cannula shield 11 during attachment or replacement, and, for example, during artificial respiration via the cannula, a ventilation tube does not have to be removed, because the padding can be spread open at the incision 7' ​​and pushed laterally behind the cannula shield. A similar construction, in which an incision extends from the central opening 3 to the edge of the padding area or into a fastening tab and divides the latter into two parts, is of course also conceivable for padding in which the fastening tabs are attached to the distal surface 1.

[0052] It goes without saying that the Fig. 4 shown embodiment in contrast to the one in Fig. 1 does not have to be completely flat, and the thickness of the padding and possibly also the fastening straps may vary. The padding should be designed in such a way that it can be seen from the top view of the Fig. 1 shown embodiment.

Claims

[1] Padding (10) for a tracheostomy tube shield (11) with a proximal (1') and a distal (1) surface and a central through-opening (3) penetrating the surfaces, wherein the padding is shaped as a shield in which at least two fastening tabs (2) are attached on either side of the central through-opening (3), which extend from the padding in opposite directions and can be passed through openings (12) of the tracheostomy tube shield (11) serving for fastening, characterized by that the fastening tabs are each provided with at least one eyelet (4) for fastening with a cannula strap (13). [2] Upholstery according to claim 1, characterized by that the material is silicone, a thermoplastic elastomer or an elastomeric foam. [3] Upholstery according to claim 1 or 2, characterized bythat the padding (10) consists of a material with a thickness of between 0.2 mm and 7 mm, preferably 0.5 mm to 4 mm. [4] Upholstery according to claim 1, 2 or 3, characterized by that the material in the region of the central opening (3) has a greater thickness than an outer edge (6). [5] Upholstery according to one of the preceding claims, characterized by that the proximal (1') and the distal (1) surfaces are elongated and have a lateral extent of between 3 cm and 10 cm, preferably between 4 cm and 8 cm, and a height of between 4 and 7 cm, preferably between 3 and 6 cm. [6] Upholstery according to one of the preceding claims, characterized by that the proximal (1') and distal (1) surfaces are oval or elliptical. [7] Upholstery according to one of the preceding claims, characterized bythat the two fastening tabs (2) are attached to the distal surface (1) on both sides of the central through-opening (3). [8] Upholstery according to one of the preceding claims, characterized by that the fastening tabs (2) are positioned at a distance of between 0.5 and 1.5 cm from the central opening (3). [9] Upholstery according to one of the preceding claims, characterized by that several, preferably four, slits (7) radiate from the central opening (3), which extend from the distal (1) surface to the proximal (1') surface and preferably have a length of between 0.5 cm and 1.5 cm. [10] Upholstery according to one of the preceding claims, characterized by that an annular, fillable fluid cushion is attached to the proximal surface (1') around the central opening (3). [11] Upholstery according to claim 10, characterized by that the fluid cushion extends into the central opening (3). [12] Upholstery according to one of claims 10 or 11, characterized by that the fluid cushion can be filled up to a thickness of 2 cm, preferably up to 1.5 cm. [13] Cannula shield (11) with a padding (10) according to claims 1 to 12. [14] Tracheostomy cannula with a cannula shield (11) and a padding (10) according to claims 1 to 12.

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