SIGN FOR TRACHEOSTOMY CANNULATING

Description

[0001] The present disclosure relates to a shield for attachment to the cannula tube of a tracheostomy tube, optionally via an annular connector arranged on the cannula tube, wherein the shield has a central area and two side parts that adjoin two opposite sides of the central area and extend from there in a radial direction to the respective end of the side part, each of the two side parts having an eyelet for passing a retaining strap through it. Furthermore, the present disclosure relates to a tracheostomy tube for insertion into a tracheostoma, comprising a cannula tube and a shield of the disclosed type arranged on the cannula.

[0002] Tracheostomy tubes, often also called tracheostomy cannulas, are usually equipped with a neck plate, also known as a cannula shield, to prevent the tube or cannula from penetrating deeper into the trachea than desired. Commercially available cannula shields are typically flat and have a loop on each of two sides through which the cannula strap can be threaded. These loops are typically simple, continuous cutouts in the flat shield.

[0003] The cannula strap is necessary to secure the cannula to the patient's neck, preventing it from accidentally slipping out of the tracheostomy. For this purpose, the cannula strap is placed around the patient's neck and attached to the eyelets located at the ends of the left and right side sections of the cannula shield.

[0004] The cannula strap can be attached to the eyelet by forming a loop with the strap, securing it to itself with a hook-and-loop fastener. Alternatively, hooks for attaching the cannula strap to the eyelet may be provided at the ends. Some cannula straps are simply knotted to the eyelet of the cannula shield. Some users also utilize the eyelets to sew cannula shields to the patient's neck.

[0005] Cannula straps threaded through eyelets at the end of the side panels of a cannula shield often cause skin irritation. This is because, on many cannula shields, the eyelet is positioned in such a way that part of the cannula strap runs between the shield surface facing the patient's neck and the patient's neck, constantly rubbing against the patient's skin when the patient moves.

[0006] US Patent 8,522,788 B2 discloses a cannula shield in which a stepped thickening is provided at the ends of the shield, in which an eyelet for attaching a retaining strap is formed. In some embodiments, the eyelet is designed such that the retaining strap can be guided so that it does not run between the shield and the patient's neck.

[0007] German patent DE 10 2011 006 064 describes a cannula shield in which the shield is convex at its outermost ends, away from the patient's neck, and retaining loops are embedded in the shield material in this convex end area. Due to the convexity at the ends of the side parts, the loop is not at the level of the patient's neck, so that the retaining strap can be positioned so that it does not run between the shield and the patient's neck.

[0008] The two aforementioned prior art publications only partially solve the problem of skin irritation by guiding the cannula strap through the eyelet slightly above skin level. However, particularly in obese patients, the cannula strap often presses the cannula shield so deeply into the soft tissue that the strap still makes contact with the skin. Furthermore, the cannula eyelet is not always positioned freely enough to thread a new cannula strap without slightly lifting the shield. This latter point is usually very uncomfortable for the patient and leads to coughing or even gagging. In addition, it has been observed that when the cannula strap is attached to lateral eyelets above skin level, certain leverage and tilting effects can occur under unilateral lateral stress and with certain patient anatomies. These effects can cause the shield to tilt, which can be quite uncomfortable for the patient.This is particularly noticeable in very slim patients when the cannula band is subjected to unilateral stress.

[0009] The following documents also reveal labels for tracheostomy tubes, namely US 5 975 080 A and US 5 398 679 A.

[0010] Against this background, the object of the present invention was to seek a solution that ensures that the cannula band does not come into contact with the skin where it is threaded into the eyelet, without causing undesirable lever and tilting effects when putting on and fastening the shield.

[0011] This problem is solved according to the invention by the features of claim 1.

[0012] The terms "distal" and "proximal" are used within the meaning of the present invention from the perspective of a physician using the ventilation device, i.e., the proximal end is the end of the ventilation device that remains outside the patient's body after insertion into the trachea, while the distal end is inserted into the patient's trachea.

[0013] In the present disclosure, the eyelet on each side part of the shield is formed by a bridge-like fastening element, the pillar sections of which are arranged on the proximal surface of the shield at a distance from the end of the respective side part, preventing a part of the cannula band attached to the eyelet from being pinched between the shield and the skin and thus causing skin irritation.

[0014] Furthermore, when applying, inserting, and securing the cannula strap in this manner, unfavorable leverage and tilting effects, which can lead to the shield tilting on the patient's neck, are significantly less likely to occur. In any case, the

[0015] The tendency to tip is significantly lower due to the arrangement of a bridge-like fastening element at a distance from the end of the side parts, as proposed in the disclosure, compared to shields where the eyelets for the retaining strap are located at the outermost end of the side parts of the shield.

[0016] In certain embodiments, the pier sections of the bridge-like fastening element rest on the proximal surface of the shield at the same distance from the outermost end of the respective side panel. In alternative embodiments, the pier sections of the bridge-like fastening element rest on the outermost end of the respective side panel at different distances. The distance to the end of the respective side panel depends, among other things, on the geometric design of the shield. With respect to a projection of the central longitudinal axis of the side panel onto its proximal surface, the pier sections of a fastening element can rest on a line that runs along or parallel to the longitudinal axis. Here, the central longitudinal axis is understood to be the central axis of the shield running longitudinally from the outer end of one side panel to the outer end of the other side panel.In alternative embodiments, the pillar sections of a fastening element are positioned on the proximal surface of the side part on a line which intersects the projection of the central longitudinal axis of the side part onto its proximal surface at an angle of 45 to 90°.

[0017] In some embodiments, the two pillar sections of the bridge-like fastening element arranged on a side panel can be arranged symmetrically with respect to the projection of the central longitudinal axis of the side panel onto its proximal surface. Depending on the embodiment, this form of symmetry can also be deviated from. In certain embodiments, the two fastening elements arranged on the two side panels of the shield are arranged symmetrically with respect to a projection of the central transverse axis of the shield.

[0018] The two pillar sections of the bridge-like fastening element and the bridging section extending between them, together with the proximal surface of the side piece, form an eyelet through which a retaining strap can be threaded and / or to which the collar can be attached. In certain embodiments, the distance between the inner surfaces of the pillar sections of a bridge-like fastening element is 3 to 12 mm. The clear height between the proximal surface of the side piece and the inner surface of the bridging section is preferably in the range of 2 to 5 mm. These dimensions form an eyelet through which most commercially available retaining straps can be easily threaded.

[0019] To minimize the height by which the bridge-like fastening element protrudes above the proximal surface of the shield, some embodiments include a recess in the proximal surface beneath the bridge-like fastening element. In some embodiments, this recess is trough-shaped. In other embodiments, this recess is groove-shaped and extends to the end of the side panel. In embodiments with such recesses, the clear height between the proximal surface of the side panel and the inside of the bridging section is measured to the deepest point of the groove-shaped or trough-shaped recess.

[0020] At the end of the groove-like recess facing the central area, the groove floor rises to the level of the proximal surface in certain designs. A retaining strap inserted in this direction is thus guided proximally and can therefore be gripped more easily by the user.

[0021] To effectively reduce the risk of tilting under unilateral tension on the cannula band, the minimum distance between the pillar sections and the end of the respective side piece is at least 2 mm in a preferred embodiment. Even better results can be achieved with certain embodiments where the minimum distance is at least 4 mm. In particular embodiments, the minimum distance between the pillar sections and the end of the respective side piece is at least 6 mm.

[0022] The geometry of the bridge-like fastening element is relatively variable. In particular, the present invention encompasses bridge-like fastening elements in which the two pier sections of the respective fastening element form an angle of between 90° and 135° with the bridging section extending between the two pier sections, or in which the two pier sections of the respective fastening element describe a rounded arch with the bridging section extending between the two pier sections. Also included are embodiments in which the upper surface of the bridge-like fastening element is angular and the inner surface facing the eyelet opening is rounded, and vice versa. The term "angular" here is to be understood as also including embodiments with corners that are rounded or chamfered to avoid sharp edges or corners.

[0023] In certain embodiments, the two pillar sections of the respective fastening element have a rectangular or rounded rectangular cross-section. In alternative embodiments, the pillar sections have an oval or circular cross-section.

[0024] In certain embodiments, the bridging section extending between the two pier sections has a rectangular or rounded rectangular cross-section. In alternative embodiments, the bridging section has an oval or circular cross-section.

[0025] In general, rounded edges and corners offer advantages from a hygienic point of view. More angular designs may offer advantages in terms of fastening and holding function, depending on the fastening technique used for the retaining strap.

[0026] To ensure that the end of the retaining strap can be easily gripped after threading it through the eyelet, certain embodiments feature a lifting element on the proximal surface between the eyelet and the central area. This lifting element provides a surface that is essentially flush with the proximal surface on the side facing the eyelet and rises by 1 to 5 mm or 1 to 3 mm towards the central area. This slightly lifts the end of a retaining strap, which is guided through the eyelet from the direction of the side panel end towards the central area, away from the proximal surface of the side panel, making it easier to grip.

[0027] In certain embodiments, the two pillar sections of the respective fastening element are positioned at a right angle to the proximal surface of the shield. In alternative embodiments, the pillar sections are positioned at an angle that deviates from a right angle by ±45°. The deviation from a right angle is either absolute or at least equal in magnitude for the two pillar sections of a fastening element in certain embodiments. Furthermore, the two pillar sections of a fastening element can also deviate from the central longitudinal axis of the central area, either radially or tangentially.

[0028] The bridge-like fastening element provided on the side plates according to the disclosure provides an eyelet through which the retaining strap can be threaded and to which it can be attached. However, since there are also users who wish to have the option of threading the cannula strap through a conventional eyelet as an alternative, depending on the circumstances, certain embodiments of the present disclosure provide, in addition to the eyelet formed by the bridge-like fastening element, a conventional eyelet in the shield surface in the area spanned by the bridge-like fastening element. At this point, the side plates thus have continuous recesses from the proximal surface to the distal surface, which can be, for example, rectangular, circular, oval, or elongated.In embodiments with such recesses, the clear height between the proximal surface of the side part and the inside of the bridging section is referred to the plane of the proximal surface in the edge region of the recess.

[0029] The continuous recesses, if they have a larger extent in a first dimension on the plane of the proximal surface of the side panel than in a second dimension, can be oriented similarly to how the bridge-like fastening elements have already been described. In the longitudinal direction of the recess, these recesses can, for example, extend along a line that is parallel to a projection of the central longitudinal axis of the side panel onto its proximal surface. Alternatively, the longitudinal direction of the recess can also lie along a line that intersects the projection of the central longitudinal axis of the side panel onto its proximal surface at an angle of 45 to 90°.

[0030] In a preferred embodiment, the continuous cutouts through the cannula shield extend approximately 1 to 3 mm beyond the area spanned by the bridge-like fastening element towards the end of the side part. This facilitates the threading of the cannula strap and, if necessary, its suturing to the patient's neck.

[0031] The line along which an elongated recess extends longitudinally on the proximal surface lies either on the line on which the pillar sections of the respective fastening element stand on the proximal surface, or it runs parallel to it, or it intersects it on the radially outer side of the fastening element at an angle of 5 to 60°, preferably at an angle of 15 to 45°. With respect to the central transverse axis of the shield, the two continuous recesses of the shield can be arranged symmetrically or not symmetrically.

[0032] In certain embodiments, the side surface extending between the distal and proximal surfaces of a side panel runs along an arc-shaped path across the width of the shield at the end of the side panel, resulting in rounded ends. In some embodiments, the ends of the side panel are also curved upwards in a proximal direction, so that there is no edge at the end of the side panel that could come into contact with the patient's neck.

[0033] In order to avoid any edges that could come into contact with the patient's neck, in certain embodiments of the disclosure the side surfaces extending between the distal surface and the proximal surface of a side part transition smoothly into the distal surface and optionally also into the proximal surface of the respective side part without forming an edge.

[0034] The shield as disclosed typically consists of a plastic material. In certain embodiments, the shield consists of a soft, elastically deformable material, such as soft PVC, polyurethane, SEBS, or another thermoplastic elastomer, or silicone. In alternative embodiments, the shield consists of a hard, dimensionally stable material, such as polystyrene, polycarbonate, ABS, polyamide, or polyester. In special embodiments, the shield consists partly of a hard, dimensionally stable material and partly of a soft, elastically deformable material.

[0035] In embodiments where the shield consists partly of a dimensionally stable and partly of a soft, elastically deformable material, the distribution of the different materials is preferably as follows. The bridge-like fastening element and the area of ​​the shield on which the bridge-like fastening element rests, and optionally at least partially also the area surrounding any continuous recess in the side part of the shield, are preferably made of a hard, dimensionally stable material, while the remaining areas of the shield consist of a soft, elastically deformable material. In this way, the stability required for attaching the retaining strap is ensured in this area, while at the same time the majority of the surfaces in contact with the patient's neck consist of a softer, elastically deformable material that is more comfortable for the patient.

[0036] In order to give the shield greater stiffness and stability, especially in the central area, in certain embodiments the areas of the two shield parts which consist of hard material in the area of ​​the fastening elements are connected by a "stabilizing bridge" made of the same hard material, with this stabilizing bridge extending over the central area of ​​the shield.

[0037] For the purposes of this text, "hard materials" refers to plastics with a Shore A hardness ≥90, and "soft plastics" refers to those with a Shore A hardness of 30 to 85. In embodiments where the shield is made of a single plastic material, the Shore A hardness of this material is preferably ≥40 to ensure a certain minimum stability of the entire shield.

[0038] The side panels of the shield are typically flat and preferably have a material thickness in the range of 1.5 to 4 mm. From the central area to the end of the side panels, the material thickness can be either uniform or decrease uniformly or in steps. However, in certain embodiments of the disclosure, the thickness of the side panels can also vary from the central area to the end of the respective side panel in other ways. In embodiments with side panels of uniform thickness, the distal surface of the side panels runs essentially parallel to the proximal surface of the respective side panel.

[0039] In certain embodiments, the distal surface of the disclosed shield has a section in the central region that is curved in a proximal concave direction along the longitudinal direction of the shield. In some embodiments, the distal surface of the disclosed shield has a section in the central region that is curved perpendicular to the longitudinal direction of the shield in a proximal concave direction. In particular embodiments of the disclosed shield, the distal surface in the central region is curved both in the longitudinal direction of the shield and in a direction perpendicular to the longitudinal direction of the shield in a proximal concave direction.

[0040] The maximum distance between the distal surface and a tangential surface passing through the vertices, caused by the concave curvature of a section of the central area, is between 4 mm and 20 mm. Preferably, the maximum distance is between 6 mm and 12 mm. This ensures that pressure sores do not form on the patient's neck from shield sections resting on it.

[0041] In order to optimally adapt the shield to the specific anatomy of the respective patient when attaching it to the patient's neck, certain designs of the shield have a suspension device in the central area for gimbal mounting on the cannula tube or on a connector of a tracheostomy cannula.

[0042] In addition or alternatively, for the purpose of adapting to the particular anatomy of the respective patient, a separate flat padding element made of a soft, elastically deformable material is provided in certain embodiments, adjoining the distal surface of the shield, wherein the outer circumference of the flat padding element extends beyond the outer circumference of the distal surface of the shield by at least 1 mm on all sides.

[0043] The shield according to the invention is connected to the cannula or connector, and the cushioning element can be attached beforehand or afterwards, if required. Ideally, the shield fulfills its function with the properties described above even without the variant with a cushioning element described here. The cushioning element serves either to further improve the properties of the shield according to the invention or to individualize it to the specific requirements of a particular patient.

[0044] The cushioning element can be provided for a standard sign according to the invention either individually or in the form of a kind of adapter set in various shapes and sizes, in order to then attach the sign over the selected cushioning element. in situ to be able to adapt to the specific anatomy and individual needs of each patient.

[0045] In some designs, the distal surface of the padding element, in the area that rests against the central part of the shield, features a conical connector that can be inserted into the patient's stoma to improve the seal. The outer diameter, height, and slope can vary depending on the size of the patient's stoma.

[0046] The material of the cushioning element preferably has a thickness of at least 0.2 mm to achieve the best possible cushioning effect. The cushioning element can also be used to ensure that a cannula that is slightly too long for a particular patient is inserted less deeply into the trachea. Therefore, in some embodiments, the material of the cushioning element has a thickness of up to 12 mm. In certain embodiments, the thickness is in the range of 0.2 mm to 8 mm or in the range of 0.2 mm to 4 mm.

[0047] Examples of soft elastomeric materials that can be used for the padding element have already been mentioned above in connection with soft shield components.

[0048] In certain embodiments, the material of the cushioning element forms an elastic hollow body, allowing the thickness of the cushioning element to be varied by filling the hollow body with different volumes of a filling fluid. In embodiments with a conical connector, this connector can also be provided with a hollow body, allowing the expansion of the connector to be optimally adapted to the size of the stoma by filling the hollow body with different volumes of a filling fluid. The more fluid is added, the larger the diameter of the conical seal becomes.

[0049] In some embodiments, the shield and the padding element are bonded together. In alternative embodiments, the padding element is held to the shield by a positive-locking or friction-locking connection, such as a snap fastener. In certain embodiments, the shield and padding element are joined together by a two-component injection molding process.

[0050] A particular embodiment of this variant is characterized in that the shield is made of a hard material and continuous recesses are provided in the side parts of the shield from the proximal surface to the distal surface, extending at least over the area adjacent to the area spanned by the bridge-like fastening elements. The separate, flat padding element abutting the distal surface of the shield is made of a soft, elastically deformable material, with the outer circumference of the flat padding element projecting at least 1 mm beyond the outer circumference of the proximal surface of the shield on all sides.

[0051] In the embodiment described here, the separate padding element has two eyelets for attaching a retaining strap, each eyelet being formed by a bridge-like fastening element comprising two pillar sections arranged on the proximal surface of the padding element and a bridging section extending between the two pillar sections. The two bridge-like fastening elements of the padding element are designed to project through the continuous recesses in the side panels of the shield and are thus positioned adjacent to the bridge-like fastening elements of the shield such that the eyelets of the padding element substantially coincide with the eyelets of the shield. Preferably, in the assembled state, the pillars of the fastening elements of the padding element are also located at a distance from the end of the respective side panel of the shield.

[0052] In this embodiment, the fastening elements of the shield and the padding element are arranged side by side, allowing the retaining strap to be guided through both fastening elements. This prevents the components from separating and thus prevents the padding element from accidentally slipping into the trachea.

[0053] The present invention relates to a shield for attachment to the cannula tube of a tracheostomy tube or to an annular connector arranged proximally to the cannula tube. The present invention also encompasses tracheostomy tubes for insertion into a tracheostoma, comprising a cannula tube and a shield of the type described above according to the invention.

[0054] For the purposes of the original disclosure, it is pointed out that all features as they can be deduced by a person skilled in the art from the present description, the drawings, and the claims, even if they are specifically described only in connection with certain other features, can be combined individually or in any combination with other features or groups of features disclosed herein, unless this has been expressly excluded or technical circumstances render such combinations impossible or pointless. A comprehensive, explicit description of all conceivable combinations of features is omitted here solely for the sake of brevity and readability.

[0055] Furthermore, it should be noted that it is self-evident to those skilled in the art that the following exemplary embodiments serve only to illustrate the possible embodiments of the present invention presented as examples. Those skilled in the art will therefore readily understand that, in addition, all other embodiments exhibiting the features or combinations of features of the invention mentioned in the claims also fall within the scope of protection of the invention. A comprehensive, explicit description of all conceivable embodiments is omitted here solely for the sake of brevity and readability.

[0056] Some of the above-mentioned features or combinations of features are clarified in the attached figures in the form of exemplary embodiments, without the present invention being limited in any way to any of the embodiments shown here. Figure 1 shows an embodiment of a shield according to the disclosure, attached to the cannula tube of a tracheostomy cannula, with a square, bridge-like fastening element. Figure 2 shows a comparison with a conventional shield from the prior art, which has fastening lugs provided in the form of through-holes in the shield surface ( Figure 2a ), with a shield as disclosed, wherein the eyelets are provided by a bridge-like fastening element arranged on the proximal surface of the shield ( Figure 2bFigure 3 shows an embodiment of a shield according to the disclosure attached to the cannula tube of a tracheostomy cannula, with a rounded, bridge-like fastening element. Figure 4 shows an embodiment of a shield according to the disclosure with lifting elements for the retention strap. Figure 5 shows an embodiment of a shield according to the disclosure with groove-shaped recesses in the shield surface through which the retention strap can be guided. Figure 6 shows an embodiment of a shield according to the disclosure in which continuous recesses are provided in the shield surface under the bridge-like fastening elements through which the retention strap can be guided. Figure 7 shows an alternative embodiment of a shield according to the disclosure in which, compared to the embodiment of Figure 6Figure 8 shows an embodiment of a shield according to the disclosure with a combination of groove-shaped recesses and continuous recesses in the area of ​​the bridge-like fastening elements. Figure 9 shows an embodiment of a shield according to the disclosure in which the material of the shield is formed section by section from a harder plastic material and section by section from a softer plastic material. Figure 10 shows, in comparison to Figure 9An alternative embodiment of a shield according to the disclosure with areas made of plastic materials of varying hardness. Figure 11 shows an embodiment of a shield according to the disclosure with convex shield surfaces. Figure 12 shows a tracheostomy tube with a shield according to the disclosure gimbal mounted on it. Figure 13 shows an embodiment of a shield according to the disclosure with a cushioning element, wherein the shield and cushioning element are shown once separately (top) and once in the assembled state (bottom). Figure 14 shows a particular variant of the cushioning element of a shield according to the disclosure with a snap fastener provided on the shield, once in a top view from the side (left) and once a detail of the cushioning element in the cutaway state. Figure 15 shows an embodiment of a shield according to the disclosure with a cushioning element that has a conical connector on the underside.

[0057] In Figure 1a Figure 1 is a perspective top view of a tracheostomy cannula 3 with a shield 1 as disclosed attached to it. At the proximal end of the cannula tube 2 is a connector 4, which is guided through a corresponding recess in the central area 5 of the shield 1. In this view, the proximal surface 8 of the shield 1 is visible, extending over the central area 5 and the two side parts 7, 7', which are attached to two opposite sides of the central area 5 and extend from there in a radial direction to the respective end of the side part 7, 7'. In the end region of the side parts 7, 7' a bridge-like fastening element 11, 11' is arranged, which has two pillar sections 12, 12' standing on the proximal surface 8 of the shield and a bridging section 13 extending between the two pillar sections 12, 12' (cf. Figure 1bThe pier sections 12, 12' are arranged at a distance from the end of the respective side part, such that the bridge-like fastening elements 11, 11' are arranged at a distance from the respective end of the side part 7, 7', in order to form an eyelet 10, 10' there in each case. This eyelet 10, 10' extends over the area that lies above the area spanned by the bridge-like fastening element 11, 11' above the proximal surface 8 of the shield 1.

[0058] In the embodiment shown here, the bridge-like fastening element 11, 11' is angular in design, with the edges and corners of the bridge-like fastening element 11, 11' being rounded in order to minimize the potential risk of injury at these corners and edges.

[0059] Figure 1b ) shows the proximal area of ​​the in Figure 1aThe tracheostomy cannula 3 shown in Figure 1 is greatly enlarged and shown from a different perspective to more clearly depict the pillar sections 12, 12' and the bridging section 13 of the fastening elements 11, 11'. Furthermore, the eyelet 10, 10' formed by the bridge-like element 11, 11' in conjunction with the proximal surface 8 of the shield 1 is also more easily visible in this illustration.

[0060] In Figure 2a Figure 1 shows a conventional sign 1, as known from the prior art. In this conventional sign 1, the eyelets 10 and 10 lines for the retaining strap 20 are provided in the form of continuous recesses in the sign 1. In the left figure of Figure 2a Figure 1 shows a top view of the conventional shield 1 with the retaining strap 20 attached to it. The figure shows the shield 1 fixed to the neck of a patient using the retaining strap 20.

[0061] In the right-hand image of Figure 2a ) the section along line DD is shown to show that in this conventional solution the retaining strap 20 is partially guided under shield 1, i.e. between shield 1 and the patient's neck (hatched area).

[0062] In Figure 2b ) is a shield as disclosed, with fastening elements 11, 11' and a retaining strap 20 attached thereto, also shown in the state attached to the patient's neck. On the left side of Figure 2b Figure 1 shows a top view of shield 1, while the right-hand figure shows a section along line DD. This illustration clearly shows that, according to the present disclosure, the retaining strap 20 is not positioned between the shield and the patient's neck, thus preventing the undesirable friction effects.

[0063] In Figure 3aFigure 1 shows an alternative embodiment of a shield according to the disclosure, which is attached to the cannula tube 2 of a tracheostomy cannula 3 in the region of the connector 4. In the embodiment shown here, the bridge-like fastening elements 11, 11', which are arranged at a distance from the ends of the side parts 7, 7', are rounded, with the pillar sections 12, 12' transitioning smoothly into the bridging section 13.

[0064] Figure 3b ) shows the proximal end of the in Figure 3a ) embodiment shown in the disclosure greatly enlarged and in a different perspective, in which the eyelets 10, 10', which are formed by the fact that the bridge-like fastening elements 11, 11' are arranged on the proximal surface 8 of the shield 1 according to the disclosure, are formed.

[0065] Figure 4Figure 1 shows an embodiment of a shield according to the disclosure, in which lifting elements 16, 16' are provided on the proximal surface 8 between the bridge-like fastening elements 11, 11' and the central area 5. These lifting elements 16, 16' have a lifting surface that rises towards the central area 5 and is substantially flush with the proximal surface 8 of the shield 1 on the side facing the eyelet. The rising end of the lifting surface slightly lifts the end of a retaining strap (not shown) that extends from the side panel end towards the central area 5 through the eyelet, making it easy to grasp.

[0066] In Figure 5An embodiment of a sign 1 according to the disclosure is shown, in which the bridge-like fastening elements 11, 11' are rounded, and the overall height of the bridge-like fastening elements 11, 11' can be kept relatively low because groove-like recesses are provided under the bridge-like fastening elements 11, 11', extending continuously to the end of the side part. In this way, an eyelet with a sufficiently large clear height is achieved so that the retaining strap can be easily inserted. In the embodiment shown here, the groove floor rises towards the central area 5 up to the level of the proximal surface 8. A retaining strap inserted in this direction is thus guided proximally and can therefore be easily grasped by the user.

[0067] In Figure 6An embodiment of a shield 1 according to the disclosure is shown, in which continuous recesses 14, 14' are provided under the bridge-like fastening elements 11, 11' from the proximal surface to the distal surface of the shield. In the embodiment shown here, the continuous recesses 14, 14' are provided in the form of elongated holes extending from the inner surface of one pillar section of a bridge-like fastening element 11, 11' to the inner surface of the other pillar section of the same bridge-like fastening element 11, 11'. These continuous recesses 14, 14' offer the possibility of threading the cannula band alternatively through the continuous recesses, depending on the circumstances, if desired by the user. Figure 6a This particular embodiment is shown in a perspective view. Figure 6b) the same embodiment is shown again in a top view of the proximal surface 8 of the shield 1.

[0068] In Figure 7 An alternative embodiment of a shield 1 according to the disclosure is shown, with continuous recesses 14, 14' arranged under the bridge-like fastening elements 11, 11', wherein the continuous recess is elongated and wherein the longitudinal axis of the recess, unlike that in Figure 6 In the illustrated embodiment, the line lies on a line which intersects the line on which the pillar sections of the fastening element stand on the proximal surface at an angle of approximately 45°.

[0069] In Figure 8An alternative embodiment of the shield 1 according to the disclosure is shown with continuous recesses 14, 14' arranged under the bridge-like fastening elements 11, 11', wherein in this embodiment additionally groove-like recesses 17, 17' are provided which extend continuously to the continuous recesses 14, 14' in the direction of the lateral ends of the shield 1.

[0070] The Figures 9 and 10Figure 1 shows alternative embodiments of the shield according to the disclosure. In the embodiments shown here, continuous recesses 14, 14' are provided in addition to the bridge-like fastening elements 11, 11'. A special feature of the embodiments shown here is that the shield material consists of a harder plastic material in some areas of the shield 1 and a softer plastic material in other areas. The areas with harder plastic material 18 extend at least partially or completely around the bridge-like fastening elements 11, 11', the continuous recesses 14, 14', and the continuous recess arranged in the central area of ​​the shield for the insertion of a cannula or connector. This serves to provide particularly high stability in these areas, as these areas are especially important for fixing the retaining strap and for stabilizing the cannula.The other areas, which are made of a softer plastic material 19, ensure better wearing comfort and less mechanical stress on the patient's neck.

[0071] In Figure 11 Various views of a particular embodiment of a shield 1 according to the disclosure are shown, in which both the proximal surface 8 and the distal surface 9 of the shield are specially curved. The central area 5 is curved in the proximal direction so that it does not come into contact with the patient's neck when the shield 1 is attached to the patient's neck with a retaining strap. In this way, unnecessary friction on the patient's neck is avoided in this area.

[0072] In Figure 12An embodiment of a shield 1 according to the disclosure is shown, which is arranged on the cannula 2 via a gimbal mounting 15. The additional mobility of the shield 1 achieved by the gimbal mounting 15 enables optimal individual adaptation to the given neck anatomy of the respective patient.

[0073] Figure 13 Figure 1 shows an embodiment of a shield according to the disclosure with a cushioning element. In the upper part, the shield 1 and the cushioning element 24 are shown separately, i.e., in their unassembled state. Below the arrow shown in the figure, the assembled state is then shown, in which the shield 1 is arranged on the cushioning element 24.

[0074] As can be seen particularly in the illustration above, the fastening elements 11, 11' are arranged on the proximal surface of the shield 1 at a distance from the end of the side parts. The continuous recesses 14, 14' are also located there. Furthermore, the padding element 24 with the fastening elements 26, 26' is clearly visible in the illustration above. Like the fastening elements 11, 11' arranged on the shield 1, the fastening elements 26, 26' on the padding element 24 also consist of pillar sections 28, 28' and an intermediate bridging section 29, thus creating a bridge-like fastening element that forms an eyelet through which a retaining strap can be passed.

[0075] Apart from the fastening elements 26, 26' resting on the proximal surface 27, the padding element 24 is essentially planar. In the embodiment shown here, however, a fully circumferential annular bead 30 is also provided, which is designed to hold the shield 1 in the padding element 24. According to the disclosure, the essentially planar padding element consists of a soft, elastically deformable material, and its geometric shape is chosen such that the outer circumference of the planar padding element 24 projects at least 1 mm beyond the outer circumference of the distal surface of the shield 1 on all sides.

[0076] In the composite illustration below the case shown in arrow 13, it is clearly visible that the fastening elements 26, 26' of the padding element 24 are arranged such that they protrude through the continuous recesses 14, 14' in the side parts of the shield 1 and are positioned next to the bridge-like fastening elements 11, 11' of the shield 1 in such a way that the eyelets of the padding element 24 essentially coincide with the eyelets of the shield 1. A retaining strap guided through the eyelets of the fastening elements 11, 11' of the shield 1 can thus also be guided through the eyelets formed by the fastening elements 26, 26' of the padding element 24. Shield 1 and padding element 24 are therefore held in position both relative to each other and on the patient's neck by the same retaining strap.

[0077] In Figure 14 Is the upholstery element 24 of the in Figure 13The illustrated embodiment of the shield 1 according to the disclosure with cushioning element 24 is shown once in a top view from the side (left side of Figure 14 ). On the right side of Figure 14 A sectioned detail view of the upholstery element 24 is located along the section plane DD, as shown in the illustration on the left side of Figure 14 is shown in the diagram. The ring bead 30, which is provided on the proximal surface of the padding element 24, is particularly visible in the sectioned detail. Also visible is the undercut 31, which is designed so that a shield mounted on the padding 24 can slide into the undercut 31 of the ring bead 30, since the ring bead 30, like the entire padding 24, is made of a soft, elastic material. The shield is thus held securely on the padding 24 (see the lower illustration). Figure 13 ).

[0078] In Figure 15A particular embodiment of a cushioning element 24 for the shield according to the disclosure is shown. In the embodiment shown here, a conical connecting piece 33 is located on the distal surface 32 of the cushioning element 24. This piece can serve to provide a better seal, particularly in patients with a relatively large stoma, so that as little air as possible escapes at this point. Depending on the size of the patient's stoma, a cushioning element 24 can be used that has a conical section with a suitably appropriate outer diameter, height, and slope. Reference symbol list

[0079] 1 Shield 2 Cannula tube 3 Tracheostomy cannula 4 Connector 5 Central area 6 Through-hole 7, 7' Side section 8 Proximal surface 9 Distal surface 10, 10' Eyelet 11, 11' Fastening element 12, 12' Pillar sections 13 Bridging section 14, 14' Through-hole 15 Cardan bearing 16, 16' Lifting element 17, 17' Grooved recess 18 Hard plastic area 19 Soft plastic area 20 Retaining strap 21 Cuff 22 Cuff supply line 23 Filling balloon 24 Cushioning element 25, 25' Cushioning element eyelet 26, 26' Cushioning element fastening element 27 Proximal surface of cushioning element 28, 28'Pillar sections 29Bridging section 30Annular bead 31Undercut 32Distal surface of the cushion element 33Conical section

Claims

1. Shield (1) for mounting on a cannula tube (2) of a tracheostomy cannula (3) or on an annular connector (4) arranged proximally on the cannula tube (2), wherein the shield (1) has - a central region (5) comprising a continuous recess (6) through which the cannula tube (2) and / or the connector (4) is guided, and - two side parts (7, 7') which adjoin two opposite sides of the central region (5) and extend radially from there to the respective end of the side part (7, 7'), wherein the shield (1) has a proximal side with a proximal surface (8), which faces away from the patient's neck during use, and has a distal side with a distal surface (9), which faces towards the patient's neck during use, wherein the two side parts each have an eyelet (10, 10') for fastening a retaining strap, wherein the respective eyelet (10, 10') is formed by a bridge-like fastening element (11, 11'), which has two pillar portions (12, 12') arranged on the proximal surface (8) of the shield (1) and a bridging portion (13) which extends between the two pillar portions (12, 12'), wherein both pillar portions (12, 12') are arranged at a distance from the end of the respective side part (7, 7'), characterized in that both side parts (7, 7'), in the region spanned by the fastening element (11, 11'), have a recess (14, 14') which is continuous from the proximal surface (8) to the distal surface (9) and which optionally protrudes in the direction of the end of the side part (7, 7') by about 1 to 3 mm beyond the region that is spanned by the bridge-like fastening element (11, 11').

2. Shield according to Claim 1, characterized in that the distance between the inner sides of the pillar portions of a bridge-like fastening element is in the range of 3 to 12 mm, and / or the clear height between the proximal surface of the shield and the inner side of the bridging portion is in the range of 2 to 5 mm.

3. Shield according to either of Claims 1 and 2, characterized in that the distance of the pillar portions from the end of the respective side part is at least 4 mm, more preferably at least 6 mm.

4. Shield according to any one of the preceding claims, characterized in that the two pillar portions of the respective fastening element and the bridging portion extending between the two pillar portions have a rectangular, a roundedly rectangular, an oval or circular cross section.

5. Shield according to any one of the preceding claims, characterized in that the two pillar portions of the respective fastening element form, with the bridging portion extending between the two pillar portions, in each case an angle in the range of 90° to 135°, or the two pillar portions of the respective fastening element, together with the bridging portion extending between the two pillar portions, describe a circular arc.

6. Shield according to any one of the preceding claims, characterized in that the two pillar portions of the respective fastening element stand at a right angle on the proximal surface, or at an angle that deviates by + / -45° from the right angle.

7. Shield according to any one of the preceding claims, characterized in that the distal surface of the side parts runs substantially parallel to the proximal surface of the respective side part.

8. Shield according to any one of the preceding claims, characterized in that the side surface which extends between the distal surface and the proximal surface of a side part runs, at the end of the side part, over the width of the shield on an arc-shaped path and / or, without forming an edge, transitions seamlessly into the distal surface and optionally also into the proximal surface of the respective side part.

9. Shield according to any one of the preceding claims, characterized in that the shield is made of a soft, elastically deformable material or of a hard, dimensionally stable material or partly of a soft, elastically deformable material and partly of a hard, dimensionally stable material.

10. Shield according to any one of the preceding claims, characterized in that the side parts of the shield are designed to be flat and preferably have a material thickness in the range of 1.5 mm to 4 mm.

11. Shield according to any one of the preceding claims, characterized in that the distal surface in the central region has a proximally concavely curved portion in the longitudinal direction of the shield and / or a proximally concavely curved portion perpendicular to the longitudinal direction of the shield.

12. Shield according to any one of the preceding claims, characterized in that the shield has at least one of the following: - in the central region, a suspension device (15) for cardanic mounting on the cannula tube or on a connector of a tracheostomy cannula, - on the proximal surface between the eyelet and the central region, a lifting element (16, 16') having a lifting surface which, on the side toward the eyelet, ends substantially flush with the proximal surface and, in the direction of the central region, rises by 1 to 5 mm or 1 to 3 mm, - in the proximal surface, in each case a trough-shaped or groove-like recess (17, 17') in and optionally beyond the region spanned by the bridge-like fastening elements, - in the side parts, recesses (14, 14') which are continuous from the proximal surface to the distal surface and which extend at least over the region spanned by the bridge-like fastening elements, or which extend at least over the region extending adjacent to the region spanned by the bridge-like fastening elements, - a separate flat cushion element (24) made of a soft, elastically deformable material and bearing on the distal surface of the shield, wherein the outer circumference of the flat cushion element protrudes beyond the outer circumference of the distal surface of the shield by at least 1 mm on all sides.

13. Shield according to any one of the preceding claims, characterized in that, in the side parts, recesses (14, 14') are provided which are continuous from the proximal surface to the distal surface and which extend at least over the region extending adjacent to the region spanned by the bridge-like fastening elements, wherein the shield has a separate flat cushion element (24) made of a soft, elastically deformable material and bearing on the distal surface of the shield, wherein the outer circumference of the flat cushion element protrudes beyond the outer circumference of the distal surface of the shield by at least 1 mm on all sides, wherein the separate cushion element (24) has two eyelets (25, 25') for fastening a retaining strap, wherein the respective eyelet (25, 25') is formed by a bridge-like fastening element (26, 26') which has two pillar portions (28, 28') arranged on the proximal surface (27) of the cushion element (24) and a bridging portion (29) extending between the two pillar portions (28, 28'), wherein the two bridge-like fastening elements (26, 26') of the cushion element (24) are provided such that they protrude through continuous recesses (14, 14') arranged in the side parts of the shield (1) and are thus arranged next to the bridge-like fastening elements (11, 11') of the shield such that the eyelets (25, 25') of the cushion element (24) come to be substantially congruent with the eyelets (10, 10') of the shield (1).

14. Tracheostomy cannula for insertion into a tracheostoma, with a cannula tube and a shield according to any one of Claims 1 to 13.