Tracheal tube and application thereof

Abstract

The invention provides a tracheal cannula which at least comprises a cannula body and a cannula shield. The cannula body comprises a distal end portion and a trachea end portion, the cannula shield is located at the distal end portion, and the trachea end portion can be arranged in the trachea. The cannula body includes a cannula lumen continuous from a distal end to a tracheal tip and having a constant inner diameter. At least the tube wall at the end of the trachea includes a first wall thickness connected to the distal end and a second wall thickness at the end of the trachea, wherein the first wall thickness is greater than the second wall thickness. And the wall thickness of the air pipe end part is continuously reduced towards the tail end of the air pipe.

Description

Technical Field

[0001] This invention relates to tracheostomy tubes and their applications. Background Technology

[0002] Tracheostomy tubes are generally known from the prior art. Therefore, DE202017002009U1 discloses a system including a tracheostomy tube and an insertion aid, wherein the insertion aid and the tracheostomy tube can be connected in a form-fit manner.

[0003] A disadvantage of existing technology is that tracheostomy cannula insertion is typically performed invasively. Therefore, known tracheostomy cannulas have a shoulder between the obturator tip and the end of the tracheostomy cannula. Furthermore, it is disadvantageous that the cannula wall and / or the tube applied to the cannula wall are obstructive during insertion. A cannula shield that does not adequately adapt to the user's anatomy is also a disadvantage. Summary of the Invention

[0004] The purpose of this invention is to provide an improved tracheostomy cannula.

[0005] According to the present invention, this problem is solved by a tracheostomy cannula comprising at least a cannula body and a cannula sheath, wherein the cannula body includes a distal end (where the cannula sheath is located) and a tracheal end that can be disposed in the trachea, wherein the cannula body includes a cannula lumen that is continuous from the distal end to the tracheal end and has a constant inner diameter, wherein the wall of at least the tracheal end includes a first wall thickness connected to the distal end and a second wall thickness connected to the tracheal end, wherein the first wall thickness is greater than the second wall thickness, and the wall thickness of the tracheal end continuously decreases toward the tracheal end.

[0006] According to the present invention, this problem is further solved by using the above-described tracheostomy tube for non-invasive placement in the trachea.

[0007] A tracheostomy cannula is proposed, comprising at least a cannula body and a cannula sheath. The cannula body includes a distal end (where the cannula sheath is located) and a tracheal end (which can be disposed within the trachea). The cannula body includes a continuous cannula lumen with a constant inner diameter from the distal end to the tracheal end. The wall of at least the tracheal end includes a first wall thickness connected to the distal end and a second wall thickness at the tracheal end, wherein the first wall thickness is greater than the second wall thickness. The wall thickness of the tracheal end decreases toward the tracheal end, preferably decreasing over the entire length of the tracheal end. The wall thickness of the tracheal end decreases toward the tracheal end, preferably continuously.

[0008] In one configuration, the cannula body includes a wall comprising at least a first conduit guide, wherein at least a first conduit is disposed, wherein at least a portion of the first conduit guide is formed as a groove in the wall, the groove comprising at least a depth greater than or at least approximately equal to the outer diameter of the first conduit.

[0009] When the term “about” is used in connection with values ​​or ranges of values ​​in this invention, it is therefore understood to be what experts in the art consider to be the usual tolerance range; in particular, a tolerance range of ±20%, preferably ±10%, and more preferably ±5% is provided.

[0010] As long as various value ranges are indicated in this invention, such as preferred value ranges and further preferred value ranges, the lower and upper limits of the various value ranges can be combined with each other. The term "depth" of the first catheter guide and / or the second catheter guide describes the distance from the edge of the first catheter guide and / or the second catheter guide that connects to the peripheral surface of the cannula to the deepest point of the first catheter guide and / or the second catheter guide, or to the bottom of the groove of the corresponding catheter guide.

[0011] The term “basically” indicates the range of tolerances that are acceptable to experts from an economic and technical perspective, and therefore the corresponding features are still to be identified or achieved.

[0012] The exemplary examples should not be regarded as conclusive examples in the sense of this invention, but can be supplemented within the scope of general technical knowledge.

[0013] The terms "continuous" and "constant" in the context of this invention should be understood as, for example, the continuity of a surface, preferably uninterrupted. For example, a continuous decrease in wall thickness should be understood as meaning that the wall thickness decreases progressively along the longitudinal direction of the cannula body (preferably the cannula body at the tracheal end). In particular, there is no significant interruption in the reduction along the longitudinal direction. Specifically, "continuous" and "constant" should be understood as meaning that gaps or offsets cannot be detected visually and / or tactilely in the surface or surface cross-section. For example, there is substantially no joint or gap between the outer peripheral surface of the cannula body and the first and / or second catheters. For example, the wall of the tracheal end, which continuously decreases towards the tracheal end, does not include offsets or gaps, preferably not offsets or gaps along its entire length.

[0014] The term "cross section" should be understood as a cross-sectional view perpendicular to the longitudinal extension direction of the cut portion. Preferably, the vector in the horizontal direction of the cross-sectional view is parallel to the vector in the longitudinal extension direction at the interface.

[0015] In the context of this invention, the term "flush" is understood to mean that two parts are directly connected to each other and their surfaces are substantially complementary. For example, a conduit may be constructed to be flush with the outer peripheral surface of a cannula body, wherein at least a portion of the conduit surface and a portion of the outer peripheral surface are without gaps between them. Preferably, components arranged flush have an appearance in which at least a portion of their surfaces are complementary to each other.

[0016] In one embodiment, the cannula body includes a tracheal end and a distal end. The distal end is formed such that it has an upper surface and a lower surface disposed opposite to the upper surface. The cannula guard has a cannula body cutout in which the distal end of the cannula body can be disposed. The cannula guard has a straight first portion defining the cannula body cutout, the first portion being disposed on the upper surface of the distal end, and a straight second portion defining the cannula body cutout, the second portion being disposed on the lower surface of the distal end. The cannula guard is arranged tiltably about an inner-outer axis via a pivot bearing at the distal end.

[0017] The medial-lateral axis is defined as an axis that is substantially perpendicular to the midline plane of the user's body or their respective mirror plane during routine use of the tracheostomy tube. Preferably, the medial-lateral axis extends from the medial side in the lateral direction.

[0018] The tracheostomy tube consists of a tube body. The tube body includes a distal first end and a proximal second end.

[0019] When directional information is used in the description of this invention, it will be understood in relation to the conventional use of the tracheostomy cannula. The use of directional names follows anatomical convention. With respect to the features of the device of the invention, the term "distal" is understood in the sense of the invention to refer to an arrangement or manner of use that is away from or opposite to the tracheostomy cannula or opposite to the tracheostomy cannula, and more generally, to refer to a location away from the skin surface of the person specifically carrying the device of the invention. Preferably, "distal" is understood as a direction away from the patient's body. With respect to the features of the device of the invention, the term "proximal" is understood in the sense of the invention to refer to the skin surface of the person whose arrangement or use is close to or also faces the fixation device of the person specifically carrying the device of the invention. Preferably, "proximal" is understood as a direction pointing towards the patient's body. Preferably, "lateral" is understood as a direction laterally to the right and / or left from the midline or corresponding median line. Preferably, "above" is understood as a direction indicating a direction along or parallel to the longitudinal axis of the body above the reference position. Preferably, "below" is understood as a direction indicating a direction along or parallel to the longitudinal axis of the body below the reference position. "Tracheal" should be understood as referring to the relative direction of the direction of the trachea in normal use.

[0020] The cannula body includes a cannula lumen, which is particularly continuous from a distal first end to a tracheal second end. Specifically, the cannula lumen has an inner diameter. In one configuration, the continuous cannula lumen from the distal end to the tracheal distal end preferably has a constant inner diameter throughout its longitudinal extension, and more preferably has a constant inner diameter in the longitudinal extension direction at the tracheal distal end.

[0021] In the context of this invention, a constant inner diameter should be understood as meaning that the inner diameter is substantially the same along the entire longitudinal direction of the tracheostomy tube or at least the end of the trachea. A tolerance deviation of about 0.5 mm to about 2.5 mm (preferably about 1 mm) should also be understood as “constant”.

[0022] The casing body preferably includes a wall. The wall preferably surrounds the casing lumen. The wall preferably has an outer peripheral surface. The outer peripheral surface is preferably the outer surface of the casing body wall. In one configuration, the outer peripheral surface or the corresponding wall configuration is a screen type, a window type, or a non-window type. Preferably, the outer peripheral surface has no gaps in the longitudinal direction of the casing body. More preferably, the outer peripheral surface has a continuous orientation in the longitudinal direction of the casing body.

[0023] In one configuration, the outer circumference of the tracheostomy cannula is at least partially elliptical in cross-section perpendicular to the cannula body.

[0024] The tube wall preferably includes a first catheter guide. In one configuration, the tracheostomy cannula includes at least a first catheter guide, which preferably extends distally from the cannula sheath, more preferably distally from the distal end of the cannula body, extending at least to the cuff located at the tracheal distal end. The catheter guide preferably extends to the tracheal distal end of the cannula body. Preferably, the first catheter guide is configured to receive the first catheter. In one configuration, the first catheter guide is laterally arranged in the tube wall. Preferably, the first catheter guide is configured as a groove in the tube wall. The catheter groove preferably extends in the longitudinal direction of the cannula body, preferably in the longitudinal direction of the cannula body at the tracheal distal end. In one configuration, at least the first catheter guide is at least partially configured as a groove in the outer peripheral surface of the tube wall. Preferably, the first catheter guide has a constant depth along the groove length or a constant material thickness from the bottom of the groove to the inner wall of the cannula. In another configuration, the depth gradually varies distally in the tracheal direction. Preferably, the depth continuously decreases laterally from the distal end.

[0025] In one configuration, the wall of the cannula (at least at the tracheal end) has a material buildup on at least one side of a cross-section perpendicular to the longitudinal extension direction of the cannula. The material buildup thickens the cannula at least on one side, preferably laterally. Preferably, the cannula includes material buildups on both sides of the cross-section perpendicular to the longitudinal extension direction of the cannula, at least partially at the tracheal end. Preferably, no material buildup is provided in the tracheal end region of the cannula, or correspondingly at the tracheal end of the cannula. Preferably, the thickened region of the cannula includes the material buildup. Preferably, the thickened region of the wall or the corresponding material buildup extends laterally along the longitudinal direction of the cannula, preferably laterally along the tracheal end of the cannula. In one configuration, the wall thickness of the thickened region or the wall thickness of the material-reinforced region decreases in the longitudinal direction of the cannula. Preferably, the wall thickness of the thickened region or, more preferably, the wall thickness of the laterally reinforced region, decreases continuously in the longitudinal direction of the casing body. Preferably, the wall thickness of the thickened region or, more preferably, the wall thickness of the laterally reinforced region, decreases continuously in the longitudinal direction of the casing body. Preferably, the wall thickness of the thickened region or, more preferably, the wall thickness of the laterally reinforced region decreases in the longitudinal direction of the casing body to the same extent as the wall thickness of the lower and / or upper regions. Preferably, the wall thickness of the thickened region or, more preferably, the wall thickness of the laterally reinforced region decreases more rapidly in the longitudinal direction of the casing body than the wall thickness of the lower and / or upper regions. In one configuration, at least a first conduit guide is formed in the thickened region of the casing wall or correspondingly in the material reinforcement portion. More preferably, at least a second conduit guide is formed in the thickened region of the casing wall or correspondingly in the material reinforcement portion. Preferably, the conduit guide in the material reinforcement portion is formed as a groove.

[0026] The first catheter guide is preferably rectangular, elliptical, lenticular, curved, or circular in the cross-section of the cannula body. In one configuration, the cross-section of the first catheter guide is similar to an elliptical bow. In another configuration, the first catheter guide is U-shaped in the cross-section perpendicular to the longitudinal extension direction of the cannula body.

[0027] In one configuration, the first catheter guide is configured in a circular-segment-shaped cross-section perpendicular to the longitudinal extension direction of the cannula body. The cross-section of the first catheter guide is preferably adapted to the cross-section of the first catheter. The first catheter guide is preferably adapted to receive the first catheter. Particularly preferably, the first catheter inserted into the first catheter guide forms or complements the outer peripheral surface. Preferably, the first catheter inserted into the first catheter guide forms or complements the outer peripheral surface in such a constant manner. Particularly preferably, the first catheter guide is configured such that the first catheter is formed flush with the outer peripheral surface of the cannula body.

[0028] The tube wall preferably includes a second catheter guide. The second catheter guide is preferably configured to receive the second catheter. In one configuration, the tracheostomy cannula includes at least a second catheter guide extending distal to the cannula sheath at least to the cuff and guiding the second catheter therein. In one configuration, the second catheter guide extends to the second tracheal distal end of the cannula body. In one configuration, the second catheter guide is laterally disposed in the tube wall. Preferably, the second catheter guide is laterally disposed opposite to a first catheter guide. Preferably, the second catheter guide is configured as a groove in the tube wall. In one configuration, the second catheter guide is configured as a tube. In one configuration, at least the second catheter guide is at least partially formed as a groove in the outer peripheral surface of the tube wall. Preferably, the second catheter guide has a constant groove depth along the groove length or a constant material thickness from the bottom of the groove to the inner wall of the cannula. In another configuration, the groove depth gradually changes distally in the tracheal direction. Preferably, the groove depth decreases continuously and consistently distally in the tracheal direction. Preferably, by continuously reducing the wall thickness of the thickened region or, more preferably, the wall thickness of the lateral material-reinforced region in the longitudinal direction of the cannula body, the groove depth preferably decreases continuously and constantly from the distal end in the tracheal direction.

[0029] The second catheter guide is preferably rectangular, elliptical, lenticular, arc-shaped, or circular in the cross-section of the cannula body. In one configuration, the cross-section of the second catheter guide is similar to an elliptical arc. In another configuration, the second catheter guide is U-shaped in the cross-section perpendicular to the longitudinal extension direction of the cannula body. In another configuration, the first catheter guide is arc-shaped or arc-shaped in the cross-section perpendicular to the longitudinal extension direction of the cannula body. Preferably, the cross-section of the second catheter guide is adapted to the cross-section of the second catheter. Preferably, the second catheter guide is adapted to receive the second catheter. Particularly preferably, the second catheter inserted into the second catheter guide forms or complements the outer peripheral surface. Preferably, the second catheter inserted into the second catheter guide forms or complements the outer peripheral surface in such a substantially constant manner. Particularly preferably, the second catheter guide is configured such that the second catheter is formed therein flush with the outer peripheral surface of the cannula body.

[0030] In one embodiment, the first and / or second catheter guides are configured such that they become flatter towards the tracheal distality as the cannula narrows along its length. In one embodiment, the first and / or second catheters have substantially the same outer diameter, inner diameter, and / or cross-section along their length or a portion thereof. In one embodiment, the first and / or second catheters vary their outer diameter, inner diameter, and / or cross-section along their length. Preferably, the outer diameter, inner diameter, and / or cross-section of the first and / or second catheters are adapted along their length to the first and / or second catheter guides. In one embodiment, the portion of the first and / or second catheter connected to the distal end is received substantially entirely by the first and / or second catheter recesses in the tracheal distality, or terminates substantially flush with the outer peripheral surface. In one embodiment, the first and / or second catheters in the tracheal distality are received substantially entirely by the first and / or second catheter recesses along their entire length, or terminate substantially flush with the outer peripheral surface. Advantageously, the first and / or second catheters are fully received along the entire length of the catheter recess in the tracheostomy cannula, avoiding tissue trauma during insertion and removal of the tracheostomy cannula from the trachea. In one embodiment, the first and / or second catheters, in the direction of extension of the first and / or second catheter guides, protrude further beyond the outer peripheral surface of the cannula body in the direction of the tracheal distal end. In one embodiment, the first and / or second catheters are present, respectively arranged in the first and / or second catheter guides of the cannula body. The depth of the catheter guides and / or the diameter of the catheters may vary along their respective lengths in the radial direction of the cannula body. The first and / or second catheters preferably protrude further from the catheter guides in the direction of extension. In the direction of the tracheal distal end, the first and / or second catheters are preferably raised further from the catheter guides than the distal catheter, or correspondingly raised more beyond the outer peripheral surface of the cannula body. Preferably, the first and / or second catheters are continuously raised beyond the outer peripheral surface of the cannula body along their length. Advantageously, by continuously elevating the catheter on the peripheral surface, tissue trauma is avoided when removing the tracheostomy tube from the trachea.

[0031] In one configuration, at least a first catheter guide and / or a second catheter guide are formed in a material-reinforced region of the tube wall. In another configuration, at least one (preferably two) catheter guides are arranged in a region of the tracheostomy tube having a material reinforcement. Preferably, the tracheostomy tube includes two material reinforcements, preferably located in substantially opposite positions, each comprising a catheter guide. Preferably, at least one material reinforcement includes a groove serving as either the first or second catheter guide. At least one material reinforcement preferably extends in the longitudinal direction of the tracheostomy tube. In the tracheal distal region of the first and / or second catheter guides, the tracheostomy tube preferably has a material reinforcement that substantially protrudes beyond the wall thickness of the enclosed region. The wall thickness between the tracheal distal end and the distal ends of the first and second catheter guides is preferably configured to be thinner than the wall thickness in the catheter guide region and has a smaller or no material reinforcement. The wall thickness relative to the tracheostomy tube preferably increases distally. The wall thickness of the material-reinforced region along the longitudinal extension direction of the tracheostomy tube preferably remains constant along the length of the catheter guide. In another embodiment, the wall thickness of the material-reinforced region increases distally along the longitudinal extension direction of the tracheostomy cannula, at least within the length of the catheter guide. Advantageously, the first and / or second catheter guides can be embedded in the material reinforcement at the same depth along the longitudinal extension direction of the tracheostomy cannula.

[0032] In one configuration, the wall of the cannula body has a first outer diameter. Preferably, a portion of the wall, more preferably a portion of the cannula body, and even more preferably the tracheal end of the cannula body has the first outer diameter. Preferably, the tracheal end of the cannula body, more preferably, has the first outer diameter at the end facing the cannula shield. Preferably, the first outer diameter is the maximum outer diameter of the cannula body, more preferably the maximum outer diameter of the tracheal end of the cannula body.

[0033] In another configuration, the cannula body has a second outer diameter. Preferably, a portion of the cannula wall, more preferably a portion of the cannula body, and even more preferably the tracheal end of the cannula body has a second outer diameter. Preferably, the tracheal end of the cannula body, more preferably in the tracheal terminal region, more preferably at the tracheal terminal, and even more preferably at the cuff, has a second outer diameter.

[0034] Preferably, the tracheostomy cannula includes a continuous lumen with a constant inner diameter from the distal end to the tracheal distal end. More preferably, the first outer diameter is larger than the second outer diameter. More preferably, the outer peripheral surface of the cannula wall is formed in a tapered manner. In one configuration, the cannula wall narrows at least from the tracheal distal end to the tracheal distal end. In one configuration, the cannula wall includes a first outer diameter located at the cannula sheath and a second outer diameter located at the cannula or correspondingly at the tracheal distal end, wherein the first outer diameter is larger than the second outer diameter. In another configuration, at least the cannula wall at the tracheal distal end includes a first wall thickness connected to the distal end and a second wall thickness adjacent to the tracheal distal end, wherein the first wall thickness is larger than the second wall thickness. In yet another configuration, the wall thickness at the tracheal distal end decreases continuously or discontinuously towards the tracheal distal end.

[0035] In one configuration, the second outer diameter is the minimum outer diameter of the tracheostomy tube. More preferably, the second outer diameter is the outer diameter of the tracheostomy tube, which is selected by the operator during insertion of the tracheostomy tube based on the size of the tracheostomy opening. Preferably, the first outer diameter is about 1 mm, preferably 1 mm larger than the standard size of the tracheostomy tube, which indicates the nominal width, i.e., the inner diameter of the tracheostomy tube. Advantageously, the operator does not need to measure the outer diameter of the tracheostomy tube, but can select the proposed tracheostomy tube by means of the standard size marking of the corresponding open tracheostomy opening. Here, he only needs to consider that the first outer diameter of the tracheostomy tube is about 1 mm larger than the standard size marking.

[0036] In one configuration, the tracheal end of the tube wall located at the tracheal terminal is thinner than the distal end of the tube wall located in the cannula sheath. In another configuration, a first wall thickness at a first outer diameter of the cannula body is greater than a second wall thickness at a second outer diameter of the cannula body, wherein the second outer diameter is closer to the tracheal terminal than the first outer diameter. Preferably, the tracheal end is configured to narrow in the trachea, thus facing the tracheal terminal. More preferably, a portion of the tracheal end located in the cannula sheath is configured with a thicker tube wall than a portion of the tracheal end located at the tracheal terminal. In one configuration, the wall thickness at the tracheal end or the second outer diameter is approximately 0.4 mm to approximately 0.6 mm, preferably approximately 0.5 mm.

[0037] Advantageously, the first catheter and / or the second catheter do not protrude at least partially from the outer peripheral surface of the cannula, with the first outer diameter and / or the second outer diameter not protruding.

[0038] In one configuration, the tracheostomy tube comprises at least one material selected from the group consisting of at least silicone, thermoplastic elastomer, polyvinyl chloride and / or polycarbonate.

[0039] In one configuration, the cannula body includes a tracheal end and a distal end. The distal end is preferably located within the cannula sheath. More preferably, the distal end can be disposed outside the trachea. More preferably, the tracheal end can be disposed within the trachea. More preferably, the distal end and the tracheal end are geometrically different from each other. In one configuration, the distal end is substantially box-shaped or correspondingly cubic. For example, the distal end is substantially box-shaped, while the tracheal end is substantially tubular. More preferably, the distal end is connected distally to the tracheal end. In one embodiment, the distal end is configured as two parts, wherein the first part is integrally connected to the tracheal end in terms of material. The second part is preferably integrally connected to the first part in terms of material in a form-fitting manner and / or in an integral manner.

[0040] In one configuration, the distal end includes a shape formed from the proximal end in a distal direction. In another configuration, the distal end has a lateral shaping, preferably larger than the lateral shaping of the tracheal end. In another configuration, the distal end includes a bottom-to-top shaping, preferably larger than the bottom-to-top shaping of the tracheal end. In one configuration, the degree of bottom-to-top of the distal end substantially corresponds to the degree of bottom-to-top contact of the tracheal end with the distal end. In one configuration, the distal end of the cannula body extends laterally, bottom-to-top, and / or top-to-top beyond a first outer diameter of the tracheal end.

[0041] Preferably, the distal end includes an upper surface, preferably defined by an edge. Preferably, the upper surface is configured to be substantially flat.

[0042] More preferably, the upper surface is constructed to be substantially rectangular, particularly in a view from above.

[0043] Preferably, the distal end includes a lower surface, preferably defined by an edge. Preferably, the lower surface is configured to be substantially flat. More preferably, the lower surface is configured to be substantially rectangular, particularly in a view from below. Preferably, the lower surface is substantially parallel to the upper surface.

[0044] Preferably, the distal end includes a side surface. Preferably, the side surface is flat, curved, rounded, or convex laterally. Preferably, the side surface is rectangular, preferably when viewed from the side. The side surface is preferably defined by an upper surface and a lower surface, as well as a proximal surface and a distal surface.

[0045] Preferably, the distal end includes a distal face. When using a tracheostomy cannula, the distal face is preferably substantially parallel to the user's front. The distal face is preferably defined by side surfaces and upper and lower surfaces. Preferably, the distal face is constructed to be flat. More preferably, the distal face includes at least one opening. In one configuration, at least the distal end has an opening that leads into the tracheal end. Preferably, the opening leads into the lumen of the cannula.

[0046] In one configuration, the distal end, starting from the edge of the opening, extends upward and / or downward by about 1 mm to about 5 mm, preferably about 1 mm to about 2 mm.

[0047] In one configuration, the distal end has at least a first catheter groove for a first catheter. Preferably, in a view from the distal end, the catheter groove is configured to be circular, lenticular, or elliptical. Preferably, the first catheter groove is adapted to the cross-section of the first catheter.

[0048] Preferably, the conduit groove comprises a lenticular, circular, or elliptical cross-section. "Lens-shaped" in the context of this invention should be understood as a shape constructed as convex on one or both sides. In particular, the shape on one side can be flat. More preferably, the two halves of the lenticular shape can have different radii. In one configuration, the lenticular shape consists of two circular cross-sections. Preferably, the lenticular or elliptical shape includes a lenticular axis and two poles, defined by the contact point of the radii of the respective halves of the lenticular shape or the respective halves of the elliptical shape. Preferably, when using the tracheostomy cannula, the axis of the lenticular shape is substantially parallel to the user's midline plane.

[0049] Preferably, the first catheter recess is centrally located, i.e., clearly outside the central axis of the tracheostomy cannula. More preferably, the first catheter recess is laterally arranged for connection to the inner cannula. Advantageously, the first catheter recess is thus located sufficiently far externally to not obstruct the connection of the inner cannula. More advantageously, the catheter recess is substantially aligned with the first catheter guide at the end of the trachea. More preferably, the first catheter recess is arranged at or below the lateral diameter of the opening. Preferably, the first catheter recess is arranged approximately halfway between the lateral diameter of the opening and the lower edge of the distal face. Advantageously, in this way, the radius of curvature of the first catheter guide or the corresponding first catheter is large enough that it does not substantially impede flow.

[0050] Preferably, the first catheter groove extends into or continuously into the first catheter guide. More preferably, the first catheter groove extends through the distal end in a straight or curved manner.

[0051] In one configuration, the distal end has at least a second catheter groove for a second catheter. Preferably, in a view from the distal end, the catheter groove is configured to be circular, lenticular, or elliptical. Preferably, the second catheter groove is adapted to the cross-section of the second catheter.

[0052] Preferably, the catheter groove has a lenticular, circular, or elliptical cross-section. Preferably, when using a tracheostomy cannula, the lenticular axis of the second catheter groove is substantially parallel to the user's midline plane.

[0053] Preferably, the second catheter groove is arranged relative to the midline of the distal end opposite the first catheter groove. Preferably, the second catheter groove is arranged centrally, i.e., clearly outside the central axis of the tracheostomy cannula. More preferably, the second catheter groove is laterally arranged for a connection device to the inner cannula. Advantageously, the second catheter groove is thus located sufficiently far externally to not obstruct the connection of the inner cannula. Furthermore, advantageously, the catheter groove is substantially aligned with the second catheter guide at the tracheal end. More preferably, the second catheter groove is arranged at or below the lateral diameter of the opening. Preferably, the second catheter groove is arranged approximately halfway between the lateral diameter of the opening and the lower edge of the distal end face. Advantageously, in this way, the radius of curvature of the second catheter guide or the second catheter is sufficiently large, which substantially does not impede flow.

[0054] Preferably, the second catheter groove extends into or is correspondingly connected to the second catheter guide. More preferably, the second catheter groove extends through the distal end in a straight or curved manner.

[0055] In another configuration, the distal end includes a connecting device. Preferably, the connecting device is configured to connect the tracheostomy cannula to the inner cannula. Preferably, the connecting device is located at the opening. More preferably, the connecting device is arranged at least partially circumferentially around the opening. Preferably, the connecting device is a bayonet closure portion, which is further preferably capable of interacting with a bayonet closure portion of the inner cannula. Preferably, the connecting device is arranged on the distal end face. More preferably, the connecting device extends from the distal end face in a distal direction.

[0056] Furthermore, a catheter suitable for use with the tracheostomy cannula is proposed. In one configuration, the catheter is constructed as elliptical, lenticular, or circular in cross-section perpendicular to the longitudinal extension direction of the first catheter. Preferably, the catheter comprises a thermoplastic material.

[0057] In a preferred configuration, the conduit is elliptical or lenticular. Preferably, the conduit is made of a circular tube, which is preferably longitudinally separated and preferably rejoined after heat deformation. In a preferred configuration of the first and / or second conduit, the latter is lenticular in cross-section. Preferably, the cross-section of the conduit, particularly the cross-section of the outer peripheral surface of the conduit, is lenticular, and more preferably convex on both sides.

[0058] Furthermore, a catheter is proposed that is particularly suitable for use with a tracheostomy cannula, comprising two protruding catheter portions in a cross-section perpendicular to the longitudinal extension direction, extending in the longitudinal extension direction of a first catheter and / or a second catheter, wherein the first catheter portion has a first radius R1 in the cross-section and the second catheter portion has a second radius R2 in the cross-section, wherein the first radius R1 is smaller than the second radius R2.

[0059] In one configuration, the catheter is a first catheter and / or a second catheter as described above.

[0060] In one configuration, the conduit has two conduit portions. The conduit portions are preferably protruding portions extending in the longitudinal direction of the conduit, extending in cross-section, or correspondingly extending in an end-face view. Preferably, the two conduit portions are longitudinally connected, preferably by material connection, and more preferably by welding. In one configuration, the protruding conduit portions are formed differently. The first conduit portion preferably has a first radius R1 in cross-section. The second conduit portion preferably has a second radius R2 in cross-section. Preferably, the first radius R1 is smaller than the second radius R2. Preferably, the first conduit portion is located at the bottom of the corresponding conduit groove. In one configuration, the outer periphery of the first conduit portion and / or the second conduit portion has a radius substantially the same as the outer periphery of the cannula body, preferably substantially the same radius at the distal boundary of the cannula body.

[0061] In one configuration, the outer periphery of the first conduit portion and / or the second conduit portion has a radius approximately the same as the material reinforcement portion of the sleeve body, preferably approximately the same as the material reinforcement portion of the conduit groove providing the conduit. In another configuration, the conduit is made of a circular tube, preferably longitudinally separated and preferably rejoined after heat deformation.

[0062] In one configuration, the tracheostomy cannula includes a first catheter. Preferably, the first catheter can be used as a suction tube. In one configuration, the first catheter is a suction tube with its end above the cuff. In one configuration, the first catheter is at least partially disposed within a first catheter guide. Preferably, the first catheter extends from its distal end through a first catheter recess into the first catheter guide. More preferably, the first catheter extends from its distal end in a distal direction and more preferably has a connector for a suction device. In one configuration, the first catheter is configured in cross-section as elliptical, lenticular, or circular. Preferably, the first catheter is configured in cross-section as lenticular. Preferably, the first catheter is adapted to the first catheter guide such that there is substantially no joint between the outer peripheral surface of the tracheal end and the first catheter. Advantageously, this achieves non-invasive (i.e., tissue-protected) insertion and comfortable use of the tracheostomy cannula. Preferably, the first catheter is disposed within the first catheter guide such that a portion of the surface of the first catheter protruding from the first catheter guide complements the encasing of the outer peripheral surface. In one configuration, the covering that encloses the outer peripheral surface and the first conduit in the first conduit guide is substantially circular or elliptical in cross-section. In another configuration, the covering that encloses the outer peripheral surface of the tube wall and the first conduit in the first conduit guide is substantially constant in cross-section. In yet another configuration, the covering that encloses the outer peripheral surface of the tube wall and the second conduit in the second conduit guide is substantially constant in cross-section. In one embodiment, the outer peripheral edge of the first conduit protrudes beyond the circular or elliptical shape of the outer peripheral surface, or correspondingly forms a vertical surface within the circular or elliptical shape of the covering. In particular, the outer peripheral edge of the first conduit protrudes from about 0.01 mm to about 1 mm beyond the circular or elliptical shape. Preferably, the first conduit and the outer peripheral surface form a constant surface.

[0063] In one configuration, the outer diameter of the first conduit in the radial extension direction of the cannula body is smaller or approximately equal to the depth of the first conduit guide.

[0064] In one configuration, the tracheostomy cannula includes a second catheter. Preferably, the second catheter can be used as a filling tube. In one configuration, the second catheter is a filling tube for the cuff, extending into the cuff. Preferably, air can be filled into the cuff through the second catheter. In one configuration, the second catheter is at least partially disposed within a second catheter guide. Preferably, the second catheter extends from its distal end through a second catheter recess into the second catheter guide. More preferably, the second catheter extends from its distal end in a distal direction, and more preferably has a connector for a suction device. In one configuration, the second catheter is configured in cross-section as elliptical, lenticular, or circular. Preferably, the second catheter is formed substantially circularly in cross-section. Preferably, the second catheter is adapted to the second catheter guide such that there is substantially no joint between the outer peripheral surface of the tracheal end and the second catheter. Advantageously, this achieves non-invasive insertion and comfortable use of the tracheostomy cannula. Preferably, the second catheter is disposed within the second catheter guide such that a portion of the surface of the second catheter protruding from the second catheter guide complements the coverage of the outer peripheral surface. In one configuration, the covering that encloses the second conduit within the outer peripheral surface and the second conduit guide is substantially circular or elliptical in cross-section. In one embodiment, the outer peripheral edge of the second conduit protrudes beyond the circular or elliptical shape of the outer peripheral surface, or correspondingly forms a facade within the circular or elliptical covering. Specifically, the outer peripheral edge of the second conduit protrudes from about 0.01 mm to about 1 mm beyond the circular or elliptical shape. Preferably, the second conduit and the outer peripheral surface form a constant surface.

[0065] In one configuration, the outer diameter of the second conduit is smaller or approximately equal to the depth of the first conduit guide in the radial extension direction of the cannula body.

[0066] In one configuration, the tracheostomy cannula includes a cannula sheath. Preferably, the cannula sheath includes a cannula body socket. More preferably, the cannula socket extends entirely from the proximal end through the cannula sheath toward the distal end. In a top view from the distal end, the cannula body socket is preferably rectangular. More preferably, the cannula body socket includes upper and / or lower straight edges, which are further preferably arranged parallel to each other. More preferably, the cannula body socket includes opposing lateral straight edges, which are preferably arranged parallel to each other. More preferably, the cannula body socket includes opposing curved sides, which are preferably laterally curved in a convex manner. The cannula body socket is preferably defined by at least a first outer portion, a second outer portion, and more preferably by a first upper portion and a first lower portion. The cannula body is preferably adapted to receive the distal end of the cannula body. Preferably, the cannula body is mounted via a pivot bearing in the cannula body socket.

[0067] In one configuration, the cannula shield has an outer portion defining a cannula body socket, with a pivot bearing disposed between the outer portion of the cannula body socket and a side of the cannula body end. In one embodiment, the outer portion has a bearing groove or bearing pin that mates with a bearing pin or bearing groove disposed at the distal end. Preferably, the bearing pin is disposed on the side of the end, or introduced into the bearing groove. Preferably, the cannula shield and the cannula body are capable of extending laterally about a bearing axis that is inclined relative to each other. More preferably, in a top view from the distal end, the bearing axis is the same as the axis of the end opening diameter. Advantageously, the cannula shield is tiltable relative to the cannula body, preferably about a transverse axis. Thus, the angles at which the cannula shield, capable of being disposed on the neck surface, and the cannula body, capable of being disposed in the trachea, achieve a comfortable fit. Surprisingly, the construction of a straight trailing edge and lower edge is particularly advantageous. With this construction, the cannula shield can be tilted relative to the cannula body at a greater angle than in the prior art. In one configuration, by tilting motion, at least one lower and / or upper gap between the distal end of the casing body and the casing shroud is at least partially closed or reduced. Preferably, the gap between the wall of the casing body socket and the surface of the end is reduced. More preferably, the tilting motion is defined. Preferably, the tilting motion is defined such that the casing shroud, preferably the rear or lower portion of the casing body socket, is close to the casing body.

[0068] In one configuration, the tracheostomy tube includes an inner sleeve. The inner sleeve is configured to be either fenestrated or non-fenestrated. Preferably, the inner sleeve can be secured to the tracheostomy tube by a snap-fit ​​mechanism.

[0069] In one configuration, the tracheostomy cannula includes a cuff. Preferably, the cuff is located at the end of the trachea. More preferably, a second catheter extends into the cuff. More preferably, the cuff is inflated through the second catheter and / or air can be extracted from the cuff through the second catheter.

[0070] In an exemplary embodiment, the tracheostomy cannula includes a first catheter for subglottic suction and a second catheter for filling the cuff. The cannula body includes an opening at its distal end, around the edge of which a connecting device is arranged for connection to an inner cannula. Furthermore, the cannula body includes, for example, a screen at the tracheal end. The distal end of the cannula body is disposed in a cannula body fitting hole and is installed there in a tiltable manner.

[0071] On the side of the exemplary inner cannula, a first catheter is arranged for filling the cuff at the distal end of the cannula body. The exemplary inner cannula is secured to the cannula body by a connecting device. The inner cannula includes a fenestrated portion arranged in the screen area of ​​the tracheostomy cannula.

[0072] The distal end of an exemplary cannula body is disposed in a cannula body socket and mounted there in a tiltable manner. The exemplary box-shaped distal end includes an upper surface and a lower surface arranged opposite each other. An exemplary cannula sheath has a cannula body socket that is continuous from the distal side to the proximal side, and the distal end can be disposed therein. For example, the cannula sheath includes a straight first portion defining the cannula body socket, the first portion being disposed on the upper surface of the distal end. Furthermore, as an example, the cannula sheath includes a straight second portion defining the cannula body socket, the second portion being disposed on the lower surface of the distal end. As an example, the cannula sheath is arranged in a tiltable manner around an inner-outer axis of the distal end via a pivot bearing. The exemplary cannula sheath includes an outer portion defining the cannula body socket, wherein the pivot bearing is disposed between the outer portion of the cannula body socket and the side surface of the end. When the distal end and the casing sheath are tilted relative to each other, the gap between them decreases.

[0073] An exemplary tracheostomy cannula is divided into a distal end and a tracheal end, which are connected to each other at a contact point. For example, the distal end includes a connection device for the inner cannula. An exemplary tracheostomy cannula includes a continuous cannula lumen from the distal end to the tracheal end, having a constant inner diameter. For example, the cannula lumen is surrounded by a wall forming the cannula body, which has a first outer diameter that mates with a cannula sheath. For example, the wall or correspondingly the cannula body has a second outer diameter that mates with the tracheal end. The first outer diameter is larger than the second outer diameter, and the outer peripheral surface of the wall extends taperedly from the first outer diameter to the second outer diameter. For example, a first wall thickness at the first outer diameter is greater than a second wall thickness at the second outer diameter. Because the inner diameter is configured to be constant, the tracheal end tapers in the tracheal direction. The wall thickness of the upper and lower regions of the cannula body, or the wall thickness of the upper and lower regions of the cannula body at the tracheal end, continuously decreases from the distal end along the tracheal direction. Similarly, the wall thickness of the outer region of the cannula body, or the wall thickness of the outer region of the cannula body at the tracheal end, decreases continuously from the distal end along the tracheal direction. For example, the distal end of the cannula body extends from below to above beyond the first outer diameter of the tracheal end.

[0074] For example, the distal end is constructed in two parts, where the first part is integrally connected to the tracheal end in terms of material. The second part may be connected to the first part in a form-fitting manner and / or materially. For example, the tube wall has a first catheter guide and a second catheter guide arranged on opposite sides of the cannula body. The first catheter is arranged in the first catheter guide, and the second catheter is arranged in the second catheter guide. For example, the first and / or second catheters are constructed in a lens shape in cross-section, wherein the two halves of the lens shape have different radii. The first catheter guide opens into a first catheter recess in the distal end. The second catheter guide opens into a second catheter recess in the distal end. For example, the exemplary overlay directly against the tube wall is substantially constant, wrapping the outer peripheral surface of the tube wall and the first catheter in the first catheter guide and the second catheter in the second catheter guide. For example, there are substantially no joints or gaps between the outer peripheral surface and the first and second catheters.

[0075] For example, two catheter guides are arranged in the region of a tracheostomy cannula with material reinforcement. In the tracheal distal region of each respective catheter guide, the tracheostomy cannula has a material reinforcement that protrudes substantially beyond the wall thickness of the surrounding region. The catheter guides are arranged within the material reinforcement. The wall thickness in the surrounding region of the material reinforcement of the first and second catheter guides is constructed to be thinner, particularly in the tracheal distal region of the catheter guides. The wall thickness of the exemplary tracheostomy cannula increases distally. On the other hand, the wall thickness of the material reinforcement region remains constant in the longitudinal extension direction of the tracheostomy cannula. Therefore, the exemplary catheter guides can be embedded in the material of the tracheostomy cannula in the longitudinal extension direction in the same depth. In one configuration, the material reinforcement has at least a partial radius, preferably the radius of the outer peripheral surface, which is approximately the same as the radius of the cannula body, for example, the radius of the cannula body at the distal boundary.

[0076] For example, the first catheter guide resembles an elliptical arc in cross-section. Furthermore, as an example, the second catheter guide is constructed in a U-shape in cross-section perpendicular to the longitudinal extension direction of the cannula body.

[0077] In an exemplary configuration of the first and / or second catheter, it is lenticular in cross-section. For example, the cross-section of the catheter, particularly the cross-section of the outer peripheral surface of the catheter, is convex on both sides. For example, the catheter has two catheter portions by a division in the extension direction, each of which is convex in cross-section and longitudinally connected. For example, the convex catheter portions have different shapes. For example, the first catheter portion has a first radius R1 in cross-section, and the second catheter portion has a second radius R2 in cross-section, wherein, for example, the first radius R1 is smaller than the second radius R2. The outer periphery of the second catheter portion has a radius R2 that is substantially the same as the outer periphery of the cannula body, for example, the outer periphery of the cannula body at the distal boundary has a radius R2 that is substantially the same as the outer periphery of the cannula body.

[0078] In one configuration, a endotracheal cannula occluder includes a guide rod, a non-invasive endotracheal tip, a distal clamp, and a sleeve, wherein the clamp is disposed at the distal end of the guide rod, and a portion of the clamp facing the guide rod includes threads into which the sleeve can be screwed.

[0079] The obturator allows for non-invasive insertion of the tracheostomy tube into the user's trachea. Advantageously, the obturator is adapted to the tracheostomy tube. Preferably, at least the tip (preferably the maximum diameter of the tip) of the obturator is adapted to the inner and / or outer diameter of the tracheostomy tube body. Preferably, the tip is clampingly positioned at least in the tracheal end of the tracheostomy tube. In one configuration, the tip comprises a rubber-elastic material. For example, the tip comprises a maximum diameter approximately equal to or greater than the inner diameter of the tracheostomy tube body providing the obturator. Advantageously, the obturator can be at least partially removed from the tracheostomy tube body via a sleeve. In one configuration, the sleeve is movable by translating about its longitudinal axis on a clamping element. When introduced into the tracheostomy tube, the sleeve can apply a force to the tracheostomy tube to move the obturator and the tracheostomy tube relative to each other. Preferably, the force acts on the tracheostomy tube body, more preferably on the distal end of the tracheostomy tube body. More preferably, the force acts only on the tracheostomy tube body and preferably not on the tracheostomy tube sheath. Advantageously, this ensures that the casing and the casing body do not tilt relative to each other when the end cap is pulled out of the casing.

[0080] Preferably, the guide rod and the clamping member are integrally formed or constructed separately as a single unit. More preferably, the tip is held on the guide rod in an engaged manner or in a form-fit manner. More preferably, the sleeve is arranged on the clamping member with a gap. In one configuration, the maximum tip diameter of the tip is greater than the maximum rod diameter of the guide rod.

[0081] In one configuration, a bayonet closure portion is preferably arranged on the clamping member of the closure device. Preferably, the bayonet closure portion can be connected to the bayonet closure portion of the tracheal cannula.

[0082] In one configuration, the threaded portion on the clamping element is interrupted. Therefore, the friction between the sleeve and the thread is minimized. Preferably, about two to about four threaded portions are arranged per thread pitch on the clamping element, more preferably precisely two threaded portions. Preferably, the threaded portions are complementary to each other or arranged separately on the clamping element, such that the internal thread of the sleeve can be screwed onto them. Preferably, the clamping element is constructed to be substantially smooth between the threaded portions. In one configuration, the thread is a flat thread, a trapezoidal thread, or a round thread.

[0083] In one configuration, the obturator has a bayonet closure portion, preferably corresponding to a clamping element. Preferably, the bayonet closure portion can engage with a bayonet closure portion of the tracheostomy cannula (preferably a cannula guard). Advantageously, the obturator can be securely held in the tracheostomy cannula in such a manner that it is preferably held in a fixed position. Preferably, the bayonet closure is detachable from both the obturator and the tracheostomy cannula to allow removal of the obturator from the tracheostomy cannula.

[0084] In one configuration, the obturator includes a distal plate. The distal plate is preferably disposed at the distal end of the guide rod. Preferably, the distal plate and the guide rod are integrally formed. The distal plate advantageously prevents over-insertion of the obturator into the inlet endotracheal cannula. Preferably, a clamping element is capable of being secured to the distal plate.

[0085] In an exemplary configuration of a endotracheal cannula obturator for non-invasive insertion, a guide rod, a non-invasive endotracheal tip made of rubber-elastic material, and a distal clamping member are included. For example, the clamping member is disposed at the distal end of the guide rod. For example, a portion of the clamping member facing the guide rod includes threads onto which a sleeve can be screwed. For example, the thread is configured as a flat thread and is only partially formed or partially interrupted. For example, the tip is connected to the guide rod in a form-fit manner. For example, the tip has a maximum tip diameter greater than the maximum rod diameter.

[0086] In another exemplary configuration, the obturator includes a guide rod, a non-invasive tracheal tip made of rubber-elastic material, and a distal plate. The distal plate is disposed at the distal end of the guide rod and integrally formed therewith.

[0087] In one configuration, a kit is provided comprising at least a tracheostomy tube, preferably the aforementioned tracheostomy tube, and the aforementioned obturator, wherein the length of the guide rod of the obturator is adapted to the length of the tracheostomy tube body. The kit of the tracheostomy tube and obturator is advantageously adjustable to each other, wherein, for example, the maximum tip diameter and / or outer diameter of the guide rod is less than or equal to the maximum inner diameter of the tracheostomy tube body. Furthermore, the radius of curvature of the guide rod is approximately equal to the radius of curvature of the tracheostomy tube body.

[0088] In one configuration, the tip of the obturator has an outer diameter or maximum tip diameter that is larger than the inner diameter of the tracheostomy tube at the tracheal end. In another configuration, the tip of the obturator has a maximum tip diameter that is substantially the same as or larger than the inner diameter of the tracheostomy tube, preferably substantially equal to or greater than the outer diameter of the tracheostomy tube at the tracheal end. Particularly preferably, the tip of the obturator or its surface in the inserted state is flush with the tracheostomy tube or its outer peripheral surface.

[0089] Preferably, the obturator is inserted into the tracheostomy cannula in such a manner that the tip protrudes at least partially at the tracheal end of the tracheostomy cannula. More preferably, the tip is adapted to the tracheal end of the tracheostomy cannula such that its maximum diameter is about 0.1 mm to about 1 mm larger than the inner diameter of the tracheostomy cannula. More preferably, the maximum diameter of the tip is approximately equal to the outer diameter of the tracheostomy cannula at the tracheal end. Advantageously, the tracheostomy cannula into which the obturator is inserted can be inserted into the tracheostomy non-invasively.

[0090] Specifically, the tip of the obturator clamps or engages the tracheal end of the tracheostomy cannula. Preferably, the rubber elastic material of the tip relaxes as it extends from the distal end, thus providing a form fit between the obturator and the tracheostomy cannula. Preferably, the surface of the tip is connected to the outer peripheral surface of the tracheostomy cannula. Preferably, the tip does not overlap with the outer peripheral surface. In one configuration, when the obturator is introduced into the tracheostomy cannula, a sleeve can be screwed onto the clamping member, which applies a force to the distal end of the tracheostomy cannula. This force can pull the tip into the tracheostomy cannula, wherein the tip preferably deforms. Therefore, removing the obturator becomes safer and more comfortable compared to manually removing it from the tracheostomy cannula.

[0091] In one configuration, the kit includes an inner sleeve. Preferably, the inner sleeve is removed from the tracheostomy tube while the tracheostomy tube is being placed through the obturator.

[0092] In an exemplary configuration of the kit, it includes a closure device and a tracheostomy tube. For example, a sleeve is screwed onto the threads of a clamping element, the sleeve being connected to the distal end of the tracheostomy tube in the assembled state. For example, a guide rod extends through the tube body, with its tip protruding at the tracheal end of the tracheostomy tube. For instance, the maximum tip diameter is approximately equal to the inner diameter of the tube body at the tracheal end.

[0093] In one configuration, a method is provided for removing the aforementioned obturator from a tracheostomy cannula, comprising the following steps: - Screw the sleeve on the clamping part of the pore closer onto the tracheal tube. - Tighten the sleeve to resist the resistance of the endotracheal cannula, thereby allowing at least the guide rod to move in the distal direction. - Remove the obturator from the tracheostomy tube.

[0094] In one configuration, the obturator is immediately removed from the tracheostomy tube after the tip has been pulled out by at least screwing the sleeve portion into the tracheostomy tube.

[0095] Furthermore, according to the present invention, this problem is solved by using the aforementioned tracheostomy cannula for non-invasive placement in the trachea. In one configuration, at least a catheter guide is used to receive the catheter.

[0096] In one configuration, the tracheostomy cannula is provided for receiving a first catheter, such that the outer diameter of the first catheter is less than or approximately equal to the depth of the first catheter guide in the radial extension direction of the cannula body, or the first catheter at least partially supplements the outer peripheral surface of the cannula body, such that the outer periphery of the outer peripheral surface of the cannula body is further guided, wherein the outer diameter of the first catheter has a radius that is substantially equal to, greater than, or smaller than that of the outer peripheral surface within the region of the first catheter guide. In one embodiment, the first catheter in the catheter guide is used to form a covering over the outer peripheral surface of the cannula body wall of the tracheostomy cannula and the first catheter, which is substantially constant in cross-section.

[0097] In one configuration, the use of the aforementioned tracheostomy cannula is provided. The tracheostomy cannula has a cannula guard with a cannula body fitting hole extending from a proximal end to a distal end. The cannula guard has straight portions at the top and bottom defining the cannula body fitting hole. The cannula guard includes a tiltable pivot bearing for the distal end of the cannula body, which has an upper surface and an opposing lower surface. One advantage of using the cannula guard is increased patient freedom of movement, particularly during head nodding. This significantly improves the comfort of the tracheostomy cannula in daily use. Attached Figure Description

[0098] Further advantageous constructions can be seen from the figures below. However, the further improvements shown should not be construed as limiting; rather, the features described herein can be combined with each other and with the aforementioned features to form further configurations. Furthermore, it should be noted that the reference numerals indicated in the accompanying drawings do not limit the scope of protection of the invention, but only refer to the exemplary embodiments shown in the figures. Identical components or components having the same function are given the same reference numerals below. As shown in the figures: Figure 1 : Tracheostomy tube; Figure 2 Tracheostomy tube with an inner sleeve; Figure 3 : Figure 2 The longitudinal section of the tracheostomy tube; Figure 4 : Exploded view of the tracheostomy tube; Figure 5 Side view of tracheostomy tube 20; Figure 6 : Figure 5 Cross-sectional view VI-VI; Figure 7 : Figure 5 Cross-sectional view VII-VII; Figure 8 : Figure 5 Cross-sectional diagrams VIII-VIII; Figure 9 : A cannula sheath having part of the end of the tracheostomy tube; Figure 10 : Closed-hole device; Figure 11 : The pore-closing device in the tracheal sleeve in the longitudinal section; Figure 12 Another construction of a closed-cell device; Figure 13 : Cross-sectional view of the first catheter. Detailed Implementation

[0099] Figure 1 A tracheostomy cannula 10 with a cannula body 20 and a cannula sheath 88 is shown. The tracheostomy cannula 10 includes a first conduit 40 for subglottic suction and a second conduit 48 for filling the cuff 80. The first conduit 40 has a lenticular cross-section. The second conduit 48 has a circular cross-section. The cannula body 20 includes an opening 32 at its distal end 12, and a connecting device 72 is arranged around an edge 34 through which a device can be connected to, for example... Figure 2 The inner sleeve is shown. Furthermore, the sleeve body 20 includes a screen 74 in the tracheal end 46. The distal end 22 of the sleeve body 20 is arranged in the sleeve body socket 90 and is installed there in a tiltable manner.

[0100] Figure 2 It shows Figure 1 The tracheostomy cannula 10 has a cannula body 20, a cannula shield 88, and an inner cannula 76. A first conduit 40 with a lens-shaped cross-section is arranged on the side of the inner cannula 76 in the distal end 22 of the cannula body 20 for filling the cuff 80. The inner cannula 76 is fixed to the cannula body 20 by a connecting device 72. Furthermore, the cannula body 20 includes a screen 74 in the tracheal end 46. The distal end 22 of the cannula body 20 is arranged in a cannula body fitting hole 90 and is installed there in a tiltable manner.

[0101] Figure 3 It shows Figure 2The cross-section of the tracheostomy cannula 10 is shown. The cannula body 20 is divided into a distal end 22 and a tracheal end 46, which are connected to each other at a contact point 28. The distal end 22 is mounted in a cannula guard 88. When the distal end 22 and the cannula guard 88 are tilted relative to each other, the gap 70 between them decreases. The distal end 22 includes a connecting device 72 for the inner cannula 76. The inner cannula 76 has a window 78 that can correspond to the screen 74 of the tracheostomy cannula 10. The tracheostomy cannula 10 includes a continuous cannula lumen 16 from the distal end 12 to the tracheal end 14, having a constant inner diameter 18. The cannula lumen 16 is surrounded by a tube wall 52 forming the cannula body 20, which has a first outer diameter 62 that mates with the cannula guard 88. The tube wall 52, or correspondingly the cannula body 20, has a second outer diameter 64 that mates with the tracheal end 14. The first outer diameter 62 is larger than the second outer diameter 64, and the outer peripheral surface 54 of the tube wall 52 extends conically from the first outer diameter 62 to the second outer diameter 62. The first wall thickness 66 of the tube wall 52 at the first outer diameter 62 is greater than the second wall thickness 68 of the tube wall 52 at the second outer diameter 64. Since the inner diameter 18 is constructed to be constant, the tracheal end 46 tapers conically in the tracheal direction. The wall thicknesses 66, 68 of the regions above and below the cannula body 20 or the cannula body 20 of the tracheal end 46, which are visible here, continuously decrease from the distal end along the tracheal direction. The distal end 22 of the cannula body 20 extends from below to above beyond the first outer diameter 62 of the tracheal end 46.

[0102] Figure 4 The exploded view shows a cannula body 20 having a first conduit 40 and a second conduit 48. The distal end 22 is constructed in two parts, wherein the first part 82 is integrally connected to the tracheal end 46 in terms of material. The second part 84 (as shown in the exploded view) Figure 7 (As shown) It can be connected to the first portion 82 in a form-fitting manner and / or materially. The tube wall 52 has a first conduit guide 56 and a second conduit guide 58, which are arranged on opposite sides of the sleeve body 20. The first conduit 40 is arranged in the first conduit guide 56, and the second conduit 48 is arranged in the second conduit guide 58. The first conduit guide 58 opens into the first conduit groove 30 of the distal end 22.

[0103] Figure 5 A side view of the cannula body 20 without catheters 40 and 48 is shown. Figure 5 In the diagram, sections VI-VI, VII-VII, and VIII-VIII are marked on different parts of the catheter guide 58, as shown below. Figure 6 , Figure 7 and Figure 8 As shown.

[0104] Figure 6 It shows Figure 5The endotracheal cannula 20 is shown in section VI-VI, viewed along the direction of the screen 74, in the region of the endotracheal end 14 of the second catheter guide 58. It has material reinforcement portions 42 and 44 in the regions of the first catheter guide 56 and the second catheter guide 58, respectively, in which the catheter guides 56 and 58 are disposed. The wall thickness 67 is thinner in the region surrounding the material reinforcement portions 42 and 44 of the first and second catheter guides 56 and 58. The cannula lumen 16 is circular.

[0105] Figure 7 The 74 area of ​​the screen is shown. Figure 5 The cross section VII-VII of the tracheostomy tube 20. Here, also in the regions of the duct guides 56 and 58, material reinforcements 42 and 44 are arranged; however, their thickness is less than that of the wall thickness 67, because the wall thickness 67 of the screen region is greater than that of the tracheostomy end region.

[0106] Figure 8 It shows Figure 5 The endotracheal cannula 20 has a cross-section VIII-VIII at the distal end 22 boundary. The wall thickness 67 is approximately equal on the outer periphery 21 of the endotracheal cannula 20. As the wall thickness 67 increases toward the distal end 22, it becomes thicker there to receive catheter guides 56 and 58 or corresponding catheters not shown here.

[0107] exist Figure 6 , Figure 7 and Figure 8 As can be specifically seen, the first catheter guide 56 has a cross-section resembling an elliptical arc. Furthermore, the second catheter guide 58 is constructed in a U-shape. Additionally, from... Figure 6 , Figure 7 and Figure 8 It can be seen that the outer region of the cannula body 20 or the tracheal end 46 (respectively in) Figure 2 and Figure 3 The wall thickness 67 of the outer region of the cannula body 20 (marked in the middle) decreases continuously from the distal end to the trachea.

[0108] Figure 9The exploded view shows the cannula shroud 88 and the second portion 84 of the distal end portion 22. The box-shaped distal end portion 22 includes an upper surface 24 and an opposing lower surface 26. The cannula shroud 88 has a cannula body socket 90 that is continuous from the distal side 102 to the proximal side 103, and the distal end portion 22 can be disposed therein. The cannula shroud 88 includes a straight first portion 91 that defines the cannula body socket 90, which is disposed on the upper surface 24 of the distal end portion 22. Furthermore, the cannula shroud 88 includes a straight second portion 92 that defines the cannula body socket 90, which is disposed on the lower surface 26 of the distal end portion 22. The cannula shroud 88 is arranged in an tiltable manner around an inner-outer axis 100 via pivot bearings 98.1 and 98.2 at the distal end portion 22. The casing cover 88 includes outer portions 94, 96 that define the casing body socket 90, wherein the pivot bearing 98 is arranged between the outer portions 94, 96 of the casing body socket 90 and the sides 36, 38 of the end 22.

[0109] Figure 10 An obturator 104 for non-invasive insertion of a tracheostomy cannula 10 is shown. The obturator 104 includes a guide rod 106, a non-invasive tracheal tip 108 made of rubber-elastic material, and a distal clamp 110. The clamp 110 is disposed at the distal end 112 of the guide rod 106 and is integrally formed therewith. A portion 114 of the clamp 110 facing the guide rod 106 includes threads 116, onto which a sleeve 118 can be screwed, such as... Figure 11 As shown. Thread 116 is constructed as a flat thread and is only partially formed or partially interrupted. Tip 108 is connected to guide rod 106 in a form-fit manner. The maximum tip diameter 122 of tip 108 is greater than the maximum rod diameter 124.

[0110] Figure 11 A set of kits 120 is shown, which includes Figure 10 The closed-cell device 104 and Figure 1 The tracheostomy tubes 10 are assembled in longitudinal section. A sleeve 118 is screwed onto the thread 116 of the clamp 110, and the sleeve is connected to the distal end 22 of the tracheostomy tube 10. A guide rod 106 extends through the tube body 20, with its tip 108 protruding at the tracheal end 14 of the tracheostomy tube 10. The maximum tip diameter 122 is approximately equal to the inner diameter 18 of the tube body 20 at the tracheal end 14.

[0111] The sleeve 118 can be screwed onto the distal end 22, so that a force F can be applied thereon. With the force F, the tracheostomy tube 10 and the obturator 104 move relative to each other, wherein the tip 108 is pulled back into the tube body 20.

[0112] Figure 12Another configuration of the obturator 104 is shown. The obturator 104 includes a guide rod 106, a non-invasive endotracheal tip 108 made of rubber-elastic material, and a distal plate 126. The distal plate 126 is disposed at the distal end 112 of the guide rod 106 and integrally formed therewith. The distal plate 126 prevents the obturator 104 from being inserted into the endotracheal cannula 20 (which can be, for example,...). Figure 1 (Seen from the middle) Too far. Tip 108 is connected to guide rod 106 in a form-fit manner. The maximum tip diameter 122 of tip 108 is greater than the maximum rod diameter 124.

[0113] Figure 13 A cross-section of the first conduit 40 is shown. The first conduit 40 is lenticular in cross-section, with the protruding conduit portions 41 and 43 formed differently. The first conduit portion 41 has a first radius R1 in cross-section, and the second conduit portion 43 has a second radius R2 in cross-section, wherein the first radius R1 is smaller than the second radius R2. The outer periphery 45 of the second conduit portion 45 has a boundary at the distal end 22 that connects with the outer periphery 21 of the cannula body 20 (from...). Figure 8 As you can see, they have roughly the same radius R2.

[0114] Advantageously, the proposed tracheostomy cannula and its obturator allow for insertion in a substantially more tissue-protective manner. The proposed tracheostomy cannula also significantly improves wearing comfort.

Claims

1. A tracheostomy tube (10) comprising at least a tube body (20) and a tube shield (88), wherein the tube body (20) includes a distal end (22) and a tracheal end (46), the tube shield (88) being located at the distal end (22), the tracheal end (46) being arable in a trachea, wherein the tube body (20) includes a tube lumen (16) continuous from the distal end (12) to the tracheal end (14) and having a constant inner diameter (18), wherein at least the wall (52) of the tracheal end (46) includes a first wall thickness (66) connected to the distal end (22) and a second wall thickness (68) at the tracheal end (14), wherein the first wall thickness (66) is greater than the second wall thickness (68), and the wall thickness (66, 68) of the tracheal end (46) decreases toward the tracheal end (14).

2. The tracheostomy cannula (10) according to claim 1, characterized in that, At least at the end of the trachea (46), the wall (52) of the cannula body (20) has a material reinforcement portion (42, 44) on at least one side in a cross section perpendicular to the extension direction of the cannula body (20).

3. The tracheostomy cannula (10) according to one or more of the preceding claims, characterized in that, The outer periphery (21) of the tracheostomy tube (10) is at least partially substantially elliptical in cross-section perpendicular to the extension direction of the tube body (20).

4. The tracheostomy cannula (10) according to one or more of the preceding claims, characterized in that, The tracheostomy cannula (10) includes at least a first catheter guide (56) that extends from the distal side (102) of the cannula shield (88) to a cuff (80) at least at the end of the trachea (12).

5. The tracheostomy cannula (10) according to claim 4, characterized in that, At least the first catheter guide (56) is at least partially formed as a groove in the wall (52) of the tracheal end (46).

6. The tracheostomy tube (10) according to one or more of claims 4 to 5, characterized in that, At least the first catheter guide (56) is formed in the thickened region of the tube wall (52) at the end of the trachea (46).

7. The tracheostomy tube (10) according to one or more of claims 4 to 6, characterized in that, The first catheter (40) is at least partially disposed in the first catheter guide (56).

8. The tracheostomy cannula (10) according to claim 7, characterized in that, The first conduit (40) is configured as an ellipse, a lens, or a circle in cross-section perpendicular to the extension direction of the conduit (40).

9. The tracheostomy tube (10) according to one or more of claims 7 to 8, characterized in that, The outer diameter of the first conduit (40) is less than or approximately equal to the depth of the first conduit guide (56) in the radial extension direction of the cannula body (20).

10. The tracheostomy cannula (10) according to one or more of the preceding claims, characterized in that, The tracheostomy cannula (10) includes at least a second catheter guide (58) that extends distal to the cannula shield (88) at least to the cuff (80) and guides a second catheter (48) within the second catheter guide (58).

11. The tracheostomy cannula (10) according to claim 10, characterized in that, The second catheter (48) is a filling tube for the cuff (80), which extends into the cuff (80).

12. Use of the tracheostomy tube (10) according to one or more of the preceding claims for non-invasive placement of the tracheostomy tube (10) in the trachea.

13. The use according to claim 12, characterized in that, At least one of the first catheter guide (56) and the second catheter guide (58) is used to receive catheters (40, 48).

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