Tracheostomy tube

Abstract

Tracheostomy tube (10) for laryngectomized and / or tracheotomized patients comprising a cannula tube section (20), a connector section (40), and at least two support wings (42, 44) for attaching a carrying strap, wherein the support wings (42, 44) are arranged on the connector section (40), wherein the connector section (40) comprises a first conical section (60) and a second conical section (70), wherein the first conical section (60) is arranged on the cannula tube section (20) and widens away from the cannula tube section (20), and wherein the second conical section (70) is arranged on the first conical section (60) and widens towards the first conical section (60), wherein the support wings (42, 44) extend distally (d) and laterally (I) from a connection point (95) on the connector section (40) and are connected to the Connector part (40) are materially bonded.

Description

[0001] The invention relates to a tracheostomy tube for laryngectomized and / or tracheotomized patients comprising a tube part, a connector part and at least two support wings for attaching a carrying strap.

[0002] Tracheostomy tubes are generally known from the prior art. For example, DE 10 2009 013 424 A1 describes a tracheostomy tube with a horizontal perforated screen.

[0003] DE 20 2005 010 223 U1 discloses a tracheostomy tube with a movable cannula shield, wherein the cannula shield is designed as a socket joint and a connector part as a ball joint.

[0004] DE 10 2018 123 562 A1 discloses a tracheostomy tube with a cuff in which a cannula shield is movably arranged at a distal end of a cannula neck.

[0005] DE 10 2017 106 750 A1 discloses a tracheostomy tube with an integrated tube.

[0006] Further examples of state of the art include: US 2004 / 0 226 564 A1 and GB 2 329 340 A.

[0007] Tracheostomy tubes known from the prior art have the disadvantage that they do not seal adequately, especially in certain tracheostomy shapes.

[0008] The object of the invention is therefore to provide an improved tracheostomy tube that overcomes the disadvantages known from the prior art. In particular, the object of the invention is to provide a tracheostomy tube with improved wearing comfort. In particular, the object of the invention is to provide a tracheostomy tube with an improved seal against the tissue surrounding the tracheostoma.

[0009] The object is achieved according to the invention by means of a tracheostomy cannula for laryngectomized and / or tracheotomized patients comprising a cannula tube part, a connector part and at least two support wings for attaching a carrying strap, wherein the support wings are arranged on the connector part, wherein the connector part comprises a first conical part and a second conical part, wherein the first conical part is arranged on the cannula tube part and widens away from the cannula tube part, and wherein the second conical part is arranged on the first conical part and widens towards the first conical part, wherein the support wings extend distally and laterally from a connection point on the connector part and are materially bonded to the connector part.

[0010] A tracheostomy tube for laryngectomized and / or tracheotomized patients is proposed. This tube comprises a cannula tube section, a connector section, and at least two support wings for attaching a carrying strap. The support wings are arranged on the connector section, which includes a first conical section and a second conical section. The first conical section is attached to the cannula tube section and widens away from it. The second conical section is attached to the first conical section and widens towards it.

[0011] Preferably, the first conical section tapers towards the cannula tube section. Furthermore, preferably, the smallest diameter of the first conical section is approximately equal to the diameter of the tracheostomy tube, preferably the diameter of the tracheostomy tube at its end facing the first conical section.

[0012] When the term “approximately” is used in connection with values ​​or ranges of values ​​within the scope of the invention, it is to be understood as a tolerance range which the person skilled in the art considers to be customary in this field, in particular a tolerance range of ±20%, preferably ±10%, and more preferably ±5% is provided.

[0013] Insofar as different value ranges, for example preferred and further preferred value ranges, are specified in the present invention, the lower limits and the upper limits of the different value ranges can be combined with each other.

[0014] Preferably, the second conical section tapers away from the first. Furthermore, preferably, the largest diameter of the second conical section is approximately equal to the largest diameter of the first conical section, which is further preferably directly adjacent to the second conical section.

[0015] For the purposes of the invention, a diameter is an inner diameter and / or an outer diameter, particularly preferably an outer diameter. Preferably, the smallest outer diameter of the first conical part is approximately equal to the outer diameter of the tracheostomy tube, preferably the outer diameter of the tracheostomy tube at its end facing the first conical part. More preferably, the largest outer diameter of the second conical part is approximately equal to the largest outer diameter of the first conical part, which is further preferably directly adjacent to the second conical part.

[0016] The tracheostomy tube comprises a cannula tube section. In one embodiment, the cannula tube section is fenestrated or sieved. In another embodiment, the cannula tube section includes a horizontal sieve. In a further embodiment, the cannula tube section is unfenestrated and unsieved.

[0017] Preferably, the length of the cannula tube section is approximately 36 mm to approximately 55 mm. Preferably, the length of the cannula tube section is the distance from the connector section to the proximal end opposite the connector section.

[0018] When directional terms are used in the description of the invention, they are to be understood in relation to the usual use of the tracheostomy tube. Directional terms are used as is customary in anatomy. In particular, medical directional terms can also be used when the tracheostomy tube is not being worn by a user. In this case, the usual use of the tracheostomy tube is assumed to determine the direction. For the purposes of the present invention, the term "distal" with respect to a feature of the device according to the invention is understood to mean an arrangement or use of the same far from, or even away from, or opposite the tracheostomy tube, or more generally, a skin surface of a person who is wearing the tracheostomy tube. "Distal" preferably refers to a direction away from the user's body when the tracheostomy tube is used as intended.In the context of the present invention, the term "proximal" refers to a feature of the device according to the invention that is arranged or used close to, or even adjacent to, a tracheostomy tube, or more generally, towards the center of the body of a person wearing the tracheostomy tube. "Proximal" preferably refers to a direction towards the user's center of the body, as intended with the tracheostomy tube in use. For example, the cannula tube section extends distally and caudally from the connector section – towards the buttocks. The connector section is, for example, arranged distally to the cannula tube section.

[0019] Preferably, the outer diameter of the cannula tube part is approximately 8 to approximately 12 mm, preferably approximately 8 mm, more preferably approximately 9 mm, more preferably approximately 10 mm, more preferably approximately 12 mm.

[0020] In one embodiment, the cannula tube section is made of a material selected from a group comprising at least silicone and / or TPE. In a further embodiment, it is provided that at least the cannula tube section (20) has a hardness of approximately 60 Shore A to approximately 80 Shore A according to DIN ISO 7619-1 (2012-02). Preferably, the cannula tube section has a hardness of approximately 70 Shore A.

[0021] The tracheostomy tube further comprises a connector. In one embodiment, the connector is made of a material selected from a group comprising at least silicone and / or TPE. In one embodiment, the connector is made of the same material as the tube section. In another embodiment, the connector is made of a different material than the tube section. Preferably, the connector and tube sections are formed in one piece, and more preferably, injection-molded in a single production step.

[0022] In a further embodiment, at least the connector part is provided that it has a hardness of approximately 60 Shore A to approximately 80 Shore A according to DIN ISO 7619-1 (2012-02). Preferably, the connector part has a hardness of approximately 70 Shore A. In one embodiment, the connector part has a different hardness than the cannula tube part, in particular, a harder hardness than the cannula tube part. In a further embodiment, the cannula tube part and the connector part have approximately the same hardness.

[0023] The connector part comprises the first conical part. In one embodiment, the first conical part comprises a first half-opening angle. The first half-opening angle is preferably about 20° to about 45°, more preferably about 38°.

[0024] Preferably, the first conical part comprises a continuous recess, particularly from proximal to distal, and more preferably from the side facing the first cannula tube part to the opposite side facing the second conical part. More preferably, the first conical part is connected to the cannula tube part in a communicative manner. In one embodiment, the recess is bounded by a preferably substantially conical inner wall of the first conical part.

[0025] The term "essentially" indicates a tolerance range that is acceptable to a person skilled in the art from an economic and technical point of view, so that the corresponding feature is still recognizable as such or is realized.

[0026] In one embodiment, the first conical section has a first material thickness. Preferably, the first material thickness is at least partially approximately equal to the material thickness of the cannula tube section. More preferably, the material thickness of the cannula tube section is approximately 1 mm to approximately 1.5 mm. Even more preferably, the material thickness of the first conical section is at least partially approximately 1 mm to approximately 1.5 mm.

[0027] The connector part comprises the second conical part. In one embodiment, the second conical part comprises a second half-opening angle. The second half-opening angle is preferably about 10° to about 45°, more preferably about 16°.

[0028] Preferably, the second conical part comprises a continuous recess, preferably from proximal to distal, and more preferably from the side facing the first conical part to the opposite side. More preferably, the second conical part is connected to the first conical part in a communicative manner. In one embodiment, the recess is bounded by a preferably substantially conical inner wall of the second conical part. In a further embodiment, the inner wall of the second conical part has a connector profile for a tracheostomy device. Preferably, the connector profile has a connector opening diameter of approximately 22 mm. Preferably, the second conical part forms a standard receptacle for tracheostomy devices. More preferably, the connector profile is designed to receive a tracheostomy device with a diameter of approximately 22 mm.Examples of tracheostomy aids include heat and moisture exchangers, speaking valves and / or ventilators.

[0029] Exemplary lists are not to be considered exhaustive within the meaning of the invention, but can be supplemented within the scope of general technical knowledge.

[0030] In one embodiment, the second cone section has a second material thickness. Preferably, the second material thickness is at least partially equal to the material thickness of the first cone section. More preferably, the material thickness of the second cone section is at least partially approximately 1 mm to approximately 2.5 mm, and even more preferably approximately 1.5 mm to approximately 2.5 mm.

[0031] For the purposes of the invention, a cone is a geometric body in which all points of a base are connected in a straight line to a vertex or a point in a plane in which the base is not located. The base can be circular, rectangular, oval, or any other shape, particularly with rounded corners. Furthermore, for the purposes of the invention, the recess of the first and / or second cone part preferably has a circular cone shape. For the purposes of the invention, a cone can also be understood to be a truncated cone. In particular, it is provided that the recess overlaps the first and / or second cone part in such a way that the first and / or second cone part is formed as a truncated cone.In one embodiment, a longitudinal axis of the recess is preferably congruent with a vertical axis of the first and / or second conical part, which is a perpendicular from a theoretical, undeveloped tip to the base of the conical shape of the first and / or second conical part.

[0032] In one embodiment, the first conical part and the second conical part adjoin each other via a transition area. Preferably, a radius, preferably on an outer surface of the connector part, is formed in the transition area between the first and second conical parts. More preferably, the transition area has a transition point. The transition point is preferably formed as an inflection point on the outer surface of the transition area, as seen in a longitudinal section through the tracheostomy tube. In an embodiment in which the first and second conical parts adjoin each other directly, and preferably the connector has no transition area, the transition point is the essentially discontinuous point on the outer surface where the first and second conical parts adjoin each other.Preferably, the transition area on the outer surface has a radius of approximately 3 mm to approximately 10 mm, more preferably approximately 5 mm. In one embodiment, the connector part has a maximum diameter, in particular a maximum outer diameter, at the transition point.

[0033] Preferably, the transition point is arranged on a frontal plane. The frontal plane is preferably the plane that is expected to at least touch a skin surface of a user of the tracheostomy tube when the tracheostomy tube is positioned in the user's tracheostoma.

[0034] The tracheostomy tube includes support wings. These support wings advantageously replace a cannula shield that completely surrounds the connector and are therefore significantly more comfortable and visually appealing than those found in tracheostomy tubes known from the prior art. In one embodiment, the support wings are arranged essentially in the transition area. Preferably, the support wings are arranged laterally on the connector. More preferably, the connector preferably includes a connection point in the transition area where the support wings are arranged. According to the invention, the support wings are materially bonded to the connector. In a further embodiment, the connector has a greater material thickness, at least in the area of ​​the connection point, than in other areas of the connector. In a further embodiment, the material thickness of the second conical part is greater than that of the first conical part.In a further embodiment, the connection point or the support wings are arranged only on the second conical part. Preferably, the connection point is arranged distal to the transition point.

[0035] The support wings are designed to accommodate a carrying strap, which secures the tracheostomy tube to the neck. In one preferred embodiment, each support wings has at least one strap recess. In a further preferred embodiment, the strap recesses preferably extend completely through the support wings. Preferably, the width of the strap recess is adapted to the carrying strap expected to be used, ideally such that the carrying strap has essentially no play. This advantageously prevents movement of the carrying strap, particularly to prevent chafing on the skin.

[0036] In one embodiment, the support wings are curved. Preferably, they are curved or, more preferably, have a radius. The support wings are preferably curved in the direction of the cannula tube section.

[0037] In a further embodiment, it is provided that the radius of curvature of the wing can be arranged essentially in a transverse plane. The transverse plane corresponds to the horizontal plane of a standing user.

[0038] According to the invention, the support wings extend distally and laterally from a connection point on the connector part. Preferably, the support wings are directed more laterally in the region of the connection point and more distally in the region of a laterally located end of the support wings. More preferably, along the length of the support wing extending from the connection point, a distal extension vector increases. Even more preferably, along the length of the support wing extending from the connection point, a lateral extension vector decreases.

[0039] In one embodiment, the end of the support wings facing away from the connection point is spaced apart from a frontal plane on which a transition point is located in the transition area. This design advantageously prevents the support wings from touching the user's skin. In a further, and preferably, it is proposed that the space corresponds approximately to the width of at least one band recess arranged in the support wings. More preferably, the space is equal to the thickness of a support band. This ensures that the support band, with its side facing the cannula tube section, and more preferably with its proximal side, is at least partially congruent with the frontal plane. This further preferably ensures that the support band lies flat on the user's skin and does not cause pressure points.

[0040] Preferably, the distance between the connection point and the frontal plane of the transition point or the turning area of ​​the transition point is approximately equal to the width of the band recess, or more preferably, of a provided support band that can be used with the tracheostomy tube. In one embodiment, the distance is approximately equal to the width of at least one band recess arranged in the wings. A further preferred distance between the connection point and the frontal plane of the transition point or the turning area of ​​the transition point is approximately 1 mm to approximately 5 mm, preferably approximately 2 mm.

[0041] Preferably, the belt recess is arranged in the area of ​​a turning point of the respective wing.

[0042] In a further embodiment, the tracheostomy tube is provided with a marking. In a further embodiment, the marking indicates the size and / or length of the tracheostomy tube. Preferably, the marking is arranged on the outer surface of a connector part. More preferably, the marking is arranged on the second conical part. Arranging the marking on the second conical part has the advantage that, under normal storage conditions, the tracheostomy tube does not need to be handled to determine its size. In particular, due to the conical shape of the second conical part, the marking is also visible in the packaging, as it is not obscured by surrounding packaging material.

[0043] An exemplary design of the tracheostomy tube comprises a cannula tube section and a connector section. The connector section is materially bonded to the cannula tube section. The cannula tube section includes a first conical section and a second conical section. Two support wings are also arranged on the connector section, extending essentially laterally from a connection point. Each support wing has a groove through which a support strap can be threaded. The width of each groove is designed to correspond approximately to the thickness of the support strap. The width of the support strap is also designed to correspond approximately to its width.

[0044] The second conical section has a continuous second recess that communicates with a first recess of the first conical section, which in turn communicates with the cannula tube section. Furthermore, the second conical section has an inner wall that includes a connector profile. A tracheostomy device (not shown here), such as a wet-heat exchanger, can be attached to the tracheostomy tube by means of the connector profile. The second conical section has a marking, clearly visible from the front due to its conical shape, which preferably indicates at least one size of the tracheostomy tube.

[0045] The connector part, specifically the first and second conical sections, as well as the cannula tube section, are, in this exemplary embodiment, made of a single, composite material. In particular, the tracheostomy tube is made of silicone with a hardness of approximately 70 Shore A. A transition zone with an exemplary radius is formed between the first and second conical sections. A turning point in this transition zone marks the interface between the first and second conical sections, which also preferably represents the maximum insertion depth of the tracheostomy tube into the user's tracheostoma. The frontal plane on which the interface is located is preferably at least partially the plane of the user's skin surface when the tracheostomy tube is inserted into the tracheostoma.The wings are essentially positioned distal to the frontal plane, so that skin irritations and pressure sores caused by the wings can be avoided.

[0046] The first cone section, for example, has a first half-opening angle of approximately 38°. The second cone section, whose base corresponds to the base of the first cone section, has a second half-opening angle of approximately 16°. This arrangement of the cone sections is visually appealing and particularly comfortable when wearing the tracheostomy tube.

[0047] The second conical section includes, for example, a second material thickness that is greater than the first material thickness of the first conical section. This second conical section includes a connector profile and is advantageously reinforced to hold the support wings without significant deformation of the connector during use. In contrast, the first material thickness is designed to allow slight deformation to adapt to the tissue surrounding the tracheostoma.

[0048] Further advantageous embodiments are shown in the following drawings. However, the developments shown there are not to be interpreted as limiting; rather, the features described therein can be combined with each other and with the features described above to form further embodiments. Furthermore, it should be noted that the reference numerals given in the figure description do not limit the scope of protection of the present invention, but merely refer to the exemplary embodiments shown in the drawings. Identical parts or parts with the same function are referred to by the same reference numerals in the following. The figures show: Fig. 1. A tracheostomy tube in a first view; and Fig. 2. The tracheostomy tube in a side view.

[0049] Fig. Figure 1 shows a tracheostomy tube 10 comprising a tube section 20 and a connector section 40. The connector section 40 is materially bonded to the tube section 20. The tube section 40 comprises a first conical section 60 and a second conical section 70. Two support wings 42, 44 are also arranged on the connector section 40, extending essentially laterally from a connection point 95. The support wings 42, 44 each have a strap recess 46, 48 through which a support strap (not shown) can be guided. The width 52 of the strap recesses 46, 48 is designed such that it corresponds approximately to the thickness of the support strap. The width 50 of the support strap is also designed such that it corresponds approximately to the width of the support strap.

[0050] The second conical section 70 has a continuous second recess 74 that communicates with a first recess 64 of the first conical section, which in turn communicates with the cannula tube section 20. Furthermore, the second conical section 70 has an inner wall 76 that includes a connector profile 78. A tracheostomy aid (not shown here), for example, a wet-heat exchanger, can be attached to the tracheostomy tube 10 by means of the connector profile 78. A marking 96, preferably indicating at least one size of the tracheostomy tube 10, is clearly visible on the second conical section 70 due to its conical shape when viewed from the front.

[0051] Fig. Figure 2 shows the tracheostomy tube 10 in a side view, with hidden edges indicated by dashed lines. The connector part 40, or rather the first conical part 60 and the second conical part 70, as well as the tube section 20, are made of a single, composite material. In particular, the tracheostomy tube is made of silicone with a hardness of approximately 70 Shore A. A transition area 79 is formed between the first conical part 60 and the second conical part 70, which has a radius not further specified here. An inflection point of the transition area 79 marks a transition point 80, which preferably also represents the maximum insertion depth of the tracheostomy tube 10 into the tracheostoma of a user. The frontal plane 81 on which the transition point 89 is arranged is preferably at least partially the plane of the user's skin surface when the tracheostomy tube 10 is inserted into the tracheostoma.The support wings 46, 48 are arranged essentially distal to the frontal plane, so that skin irritations and pressure sores caused by the support wings 42, 44 can be avoided.

[0052] The first cone section 60 has a first half-opening angle 62 of approximately 38°. The second cone section 70, whose base (not shown here) corresponds to the base (not shown) of the first cone section 60, has a second half-opening angle 72 of approximately 16°. This arrangement of the cone sections 60 and 70 is visually appealing and particularly comfortable when wearing the tracheostomy tube.

[0053] The second conical part 70 comprises a second material thickness 73, which is greater than the first material thickness 63 of the first conical part 60. The second conical part 70 comprises the in Fig.1 designates connector profile 78 and is advantageously reinforced to hold the support wings 42, 44 without significantly deforming the connector part 40 during use. In contrast, the first material thickness 63 is designed to allow slight deformations for adaptation to the tissue surrounding the tracheostoma.

[0054] The proposed tracheostomy tube 10 can be worn comfortably and, due to its geometry, avoids pressure points and skin irritations.

Claims

[1] Tracheostomy tube (10) for laryngectomized and / or tracheotomized patients comprising a cannula tube part (20), a connector part (40) and at least two support wings (42, 44) for attaching a carrying strap, wherein the support wings (42, 44) are arranged on the connector part (40), wherein the connector part (40) comprises a first conical part (60) and a second conical part (70), wherein the first conical part (60) is arranged on the cannula tube part (20) and widens away from the cannula tube part (20), and wherein the second conical part (70) is arranged on the first conical part (60) and widens towards the first conical part (60), wherein the support wings (42, 44) extend distally (d) and laterally (I) from a connection point (95) on the connector part (40) and are connected with are materially bonded to the connector part (40). [2] Tracheostomy tube (10) according to claim 1, characterized by, that the first cone part (60) and the second cone part (70) adjoin each other via a transition area (79). [3] Tracheostomy tube (10) according to claim 2, characterized by , that the airfoils (42, 44) are essentially located in the transition area (79). [4] Tracheostomy tube (10) according to one or more of the preceding claims, characterized by , that the airfoils (42, 44) are curved. [5] Tracheostomy tube (10) according to claim 4, characterized by , that a radius of curvature (92) of the airfoils (42, 44) can be arranged essentially in a transverse plane (93). [6] Tracheostomy tube (10) according to one or more of the preceding claims, characterized by , that an end (45) of the wings (42, 44) facing away from the connection point (95) comprises a distance (90) to a frontal plane (81) on which a transition point (80) arranged in the transition area (79) is arranged. [7] Tracheostomy tube (10) according to claim 6, characterized by , that the distance (90) corresponds approximately to a width (52) of at least one band recess (46, 48) arranged in the wings (42, 44). [8] Tracheostomy tube (10) according to one or more of the preceding claims, characterized by , that at least the cannula tube part (20) has a hardness of approximately 60 Shore A to approximately 80 Shore A according to DIN ISO 7619-1 (2012-02).

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