Intubationstubusstabilisator

Abstract

Disclosed is an intubation tube stabilizer comprising a fastening element 2, an intubation tube, and a base 1 in the form of an elongated plate, wherein the base 1 and the fastening element 2 are made of an elastic material and form a single element of the stabilizer. The fastening element 2 is an annular element connected to a long edge of the base 1 substantially halfway along the length of the base. Within a plane extending along the connection of the base 1 to the fastening element 2, the base has a transverse notch 6 defining two lateral base parts 7 that are flared relative to one another, wherein the fastening element 2 has a radial interruption 8 in its outline, and the direction of the radial interruption 8 in the outline of the fastening element 2 coincides with the direction of the notch 6 in the base 1.

Description

[0001] The invention provides an intubation tube stabilizer intended to be used by paramedics and also under hospital conditions, particularly in intensive care and thoracic surgery departments.

[0002] Endotracheal intubation is currently the best, most efficient, and, most importantly, the safest instrumental method for restoring airway patency. It is also one of the most challenging methods for performing advanced respiratory support. This technique requires the insertion of a tube into the trachea, provided visual guidance is available with a laryngoscope. Once the intubation tube is correctly positioned to ensure proper ventilation of the patient, the next priority is to establish and secure the tube's position, which can be achieved using a bandage, a plaster, or a special stabilizer.

[0003] There are numerous types of ready-to-use solutions on the market designed to stabilize intubation tubes, such as adhesive tapes, fixation bandages, multi-piece or single-piece stabilizers, among others. To perform intubation quickly, so-called "pre-hospital" stabilizers are used, such as the Thomas stabilizer, which consists of a strap with a hook-and-loop fastener that is applied to the patient's head. The strap ends in a fastener for securing the intubation tube with a fixation screw, thus fixing it in a predetermined position. These solutions are most commonly used by paramedics in emergency situations due to their simple design, availability, and ease of use. They are then replaced in a first aid room or hospital setting with other, more precise solutions for securing the intubation tube and for backup ventilation.

[0004] For intubation stabilizers used in perioperative settings and hospitals, a holder for securing an endotracheal tube is disclosed, for example, in US Pat. No. 6,526,978 B2. The holder comprises three elements: a submental element that complementarily adapts to the shape of the face, a pair of straps attached to openings in the submental element, and an extension element attached to the submental portion and extending perpendicular to and spaced from the patient's face. The extension element is used to secure an endotracheal tube and comprises a vertical element located at the end of the extension element opposite the patient, at a constant distance from the patient's lips.

[0005] US 2021 / 0 008 315 A1 also discloses a device for securing a tube, comprising a support splint positioned over the patient's lips. The splint comprises an outer portion, an inner portion, and two opposite ends, each of which is connected to the corresponding buccal support. Additionally, an auxiliary clamp is connected to the support splint, which clamp is slidable along the support splint to hold the auxiliary device for securing the intubation tube relative to the patient's face. A similar device is known from US 2011 / 0 126 839 A1.

[0006] The stabilization systems described above are characterized by a stable, yet highly complex construction for both securing the device relative to the patient's face and securing the position of the intubation tube. A system of a one-piece holder for positioning an endotracheal tube, as proposed in US 2009 / 0 255 538 A1, is simpler in terms of construction and use. According to the disclosure, the holder comprises a monolithic elastic support structure comprising an integrated base collar and extraoral and intraoral peripheral housings for inserting an intubation tube. The holder is provided with a base collar extending perpendicular to the peripheral housings and secured to clamping plates by means of a fixation strap, thus holding the endotracheal tube holder in a predetermined position and orientation on the patient.Despite a significant simplification of the designs and limitation of the number of components, this solution still does not provide a firm fixation of an endotracheal tube, which depends on an appropriate tension of the fixation strap on the patient's head.

[0007] From US 6 408 850 B1 an intubation tube stabilizer according to the preamble of claim 1 is known.

[0008] Based on the above, the starting point for the present invention was the task of providing a novel and structurally simple stabilizer solution that ensures quick, uncomplicated, yet safe and reliable attachment of an intubation tube in the patient's mouth. The aim of the invention is to limit the number of additional stabilizer elements and to enable its use by minimizing the number of operations necessary to position and secure an endotracheal tube, thus ensuring correct and safe emergency ventilation for the patient. A further goal was to develop a stabilizer with bactericidal properties and to ensure greater sterility in the intubation tube positioning area.

[0009] An intubation tube stabilizer according to the invention, which is configured to be positioned in the mouth region of a patient and fastened to the patient's head via a strap element, comprises an intubation tube fastening element and a base in the form of an elongated plate. The base and the fastening element are made of an elastic material and form a single stabilizer element. The intubation tube stabilizer is characterized in that the fastening element is an annular element connected to the long edge of the base substantially halfway along the length of the base. Within a plane extending along the connection of the base to the fastening element, the base has a transverse incision defining two lateral portions of the base, which can be flared with respect to one another.In addition, the fastening element has a radial interruption in its outline, wherein the direction of the radial interruption in the outline of the fastening element coincides with the direction of the cut in the base, wherein the fastening element is connected to the base via connecting arms.

[0010] Preferably, the base has an arcuate curved shape in a plane perpendicular to the notch.

[0011] Likewise, the radial interruption is preferably provided in an upper portion of the contour of the fastening element.

[0012] Furthermore, the base, at the transition of the two flared lateral parts, is preferably provided with a catching element through which the incision runs.

[0013] Preferably, the base has recesses for a guide band and locking projections in the region of its short edges.

[0014] According to another preferred solution, the fastening element is detachably connected to at least one additional annular element, wherein the average inner diameter of the additional annular element is different from the inner diameter of the fastening element. Thus, within the scope of the present invention, the additional annular elements preferably represent reducers of the inner diameter of the main opening of the fastening element, which should enable precise attachment of numerous sizes of intubation tubes. Assuming that the diameter of the opening in the fastening element is, for example, 10 mm, the openings in the additional annular elements can be selected such that their diameters are 9, 8, and 7 mm, respectively.

[0015] Preferably, the detachable connection of the additional annular element to the fastening element is realized via a detachable radial arm.

[0016] Likewise, the outline of the additional annular element preferably has a radial interruption which corresponds in shape to the radial interruption in the outline of the fastening element.

[0017] In a preferred solution, the intubation tube stabilizer consists of a material whose chemical composition includes silver. Plastic products treated with antibacterial silver are known, for example, from Dr. Oliver Rohling's "Plastics in Medicine - Protection through Silver," PLASTVERARBEITER, 53rd year, 2002, 3, 54 et seq.

[0018] Likewise, the stabilizer is preferably manufactured by injection molding of plastic.

[0019] The design of an intubation tube stabilizer according to the invention is based on an elastic clamp, allowing for quick and easy assembly without the need for additional adhesive tape or plasters to secure the position of the endotracheal tube. Due to the fact that the stabilizer consists entirely of a single element and a simplified design, manufacturing costs are reduced. The stabilizer does not need to be connected to a band element at the factory—it is therefore conceivable to use independent band elements at the factory, including a type of bandage that is readily available in the outpatient clinic setting.The use of smooth surfaces and the elimination of the commonly used adhesive tape (with a porous surface) to secure an endotracheal tube stabilizer ensure greater sterility and, as a result of the possible addition of silver to the material's chemical composition, bacteriostatic properties. The stabilizer material itself, in the form of a soft plastic, increases patient comfort and, thanks to its elasticity, including the curved curvature of the base profile, adapts more easily to the patient's facial profile. Furthermore, the selection of an environmentally friendly plastic as the material of the stabilizer and its design, which allows for automatic and rapid release of the strap element, are particularly relevant from the perspective of waste separation.

[0020] The subject matter of the invention is illustrated in embodiments in the drawings, wherein Fig. 1 shows a top perspective view of an intubation tube stabilizer according to an embodiment; Fig. 2 a front plan view of the stabilizer according to the embodiment of Fig. 1 shows; Fig. 3 a side view of the stabilizer according to the embodiment of Fig. 1 shows; and Fig. 4 a perspective bottom view of the stabilizer according to the embodiment of Fig. 1 shows.

[0021] According to the principle of the invention, an intubation tube stabilizer is manufactured as a one-piece structure, meaning its components are molded into a single mold using a manufacturing process such as plastic injection molding. The material used for this purpose should have high elasticity; for example, the material can be a soft silicone suitable for direct contact with skin or another elastomeric material. To ensure bacteriostatic parameters during the manufacturing process, silver is added to the chemical composition of the material from which the stabilizer is to be made.

[0022] As can be seen from the embodiment shown in the drawings, an intubation tube stabilizer comprises a base 1 connected to a fastening element 2 and an intubation tube (the intubation tube is not shown in the drawings). In one embodiment, an intubation tube stabilizer according to the invention is positioned in a conventional manner above the patient's upper lip (i.e., below the nose) and fastened to the patient's head in a known manner by means of a strap element (e.g., a strip band with a fastener or even a bandage). The strap element is positioned in a releasable connection with the stabilizer base 1 and then wrapped around the patient's head (not shown in the drawings) to secure the stabilizer in a fixed position near the patient's mouth.

[0023] As particularly in Fig. 1 and Fig. As shown in Figure 2, the base 1 of the stabilizer is an elongated plate with an arcuate and curved cross-section. This shape of the base 1 allows for easier adjustment of the stabilizer to the patient's face.

[0024] According to the embodiment shown, the base 1 has symmetrical recesses 3 near the short edges of the plate, through which the strap element (not shown in the drawing) passes. The recesses 3 have a height that is variable and decreases towards the short edges relative to the thickness of the profile of the base 1. In addition, above the recesses 3, along the longitudinal edge of the plate, locking projections 4 are formed, projecting beyond the recesses 3, against which the strap element is intended to rest when guided within the recesses 3. The combined use of the recesses 3 and the locking projections 4 ensures protection against unintentional movement of the strap element from the base 1 in both the horizontal and vertical planes.

[0025] As shown in the drawing, the fastening element 2 is an annular element with a specific diameter of its inner opening for guiding the intubation tube. The fastening element 2 is connected to the long edge of the base 1 via connecting arms 5, which are long enough to ensure the desired distance from the edge of the base 1, so that an intubation tube can be inserted into the patient's mouth. The fastening element 2 is connected halfway along its length to the stabilizer base 1, and within a plane extending along the junction of the base 1 with the fastening element 2, the base 1 has a transverse incision 6 running across the entire width of the base 1. The incision 6 in the base 1 defines two lateral sections 7 of the base 1, which are flared relative to one another.

[0026] Below the transverse incision 6 in the base, along the plane connecting the base 1 to the fastening element 2, the fastening element is provided with a radial interruption 8 defined in the upper section of its contour. The direction of the radial interruption 8 in the contour of the fastening element 2 coincides with the direction of the incision 6 in the base 1 and represents a sort of extension thereof. When using the stabilizer, thanks to the incision 6 in the base 1 and the interruption 8 in the fastening element 2, it is possible to deflect the base 1 and expose it within the area of ​​the lateral sections 7 defined by the incision 6, to enable extremely simple and rapid attachment of the stabilizer to the intubation tube.The closing of the lateral sections 7 of the base simultaneously causes the closure of the outline of the inner opening of the fixing element 2 at the periphery of the intubation tube and therefore fixes its position within the stabilizer by elastic closure.

[0027] According to the embodiment shown in the drawing, the stabilizer base 1 is equipped with a mushroom-shaped retaining element 9 in the area of ​​the transverse incision 6. The function of the mushroom-shaped element 9 is to additionally close the stabilizer to the intubation tube by means of a strap element attached to the base 1 in order to fix the stabilizer to the patient's head. In addition to the recesses formed in the base and the locking projections 4, the mushroom 9 represents a further guide element for the strap elements within the base 1.

[0028] Another feature of the invention according to the present embodiment consists in the connection of three radial arms 10 to the fastening element 2, which extend radially therefrom and terminate in additional annular elements 11, 11', 11". The additional annular elements 11, 11', 11" serve to reduce the diameter of the inner opening of the fastening element 2, which means that their inner diameters are different from the inner diameter of the fastening element 2. The outline of each additional annular element 11, 11', 11" has - analogous to the fastening element 2 - a radial interruption 8', the shape of which corresponds to the radial interruption 8 of the outline of the fastening element 2. This solution ensures, in practice, considerable adaptability of the stabilizer to different sizes of intubation tubes.For this reason, for example, if it is necessary to reduce the diameter of the inner opening of the fastening element 2, a suitable additional annular element 11, 11', 11" is selected and positioned within the inner opening of the fastening element 2 such that the radial interruptions 8 and 8' coincide with one another. Finally, a possibility (not shown in the drawings) is provided here to tear off a selected additional annular element 11, 11', 11", which is realized by means of annular tear-off arms 10. As in the FIG. Fig.3, the annular arms have a significantly reduced thickness compared, for example, to the thickness of the connecting arms 5 for the fastening element 2, and this enables them to be easily released, for example by tearing them off. The ability to release the radial arms 2 in a known manner can also be provided by a special profile or a reduction in the thickness of the radial arms 10 in the region of their connection, respectively, to the fastening element 2 and / or the additional annular elements 11, 11', 11". It will be clear to those skilled in the art that the additional annular elements 11, 11', 11" are elements which, if not specifically required (or if there is no need to adapt the diameter of the inner opening of the fastening element 2 to the size of the intubation tube), can remain unused or even be removed during use of the stabilizer.

[0029] As already mentioned, the present invention is not limited to the embodiment described above. Various modifications and further developments are possible within the scope of the appended claims without departing from the subject matter of the invention.

Claims

[1] Intubation tube stabilizer which can be placed in the mouth area of ​​a patient and fastened to the patient's head via a band element, comprising a fastening element (2) and a base (1) in the form of an elongated plate, wherein the base (1) and the fastening element (2) are made of an elastic material and form a single element of the stabilizer, characterized bythat the fastening element (2) is an annular element connected to a long edge of the base (1) substantially halfway along the length of the base, wherein the base (1) has, within a plane extending along the connection of the base (1) to the fastening element (2), a transverse incision (6) defining two lateral base parts (7) that are flared relative to each other, wherein the fastening element (2) has a radial interruption (8) in its outline and the direction of the radial interruption (8) of the outline of the fastening element (2) coincides with the direction of the extension of the incision (6) in the base (1), characterized by that the fastening element (2) is connected to the base (1) via connecting arms (5). [2] Stabilizer according to claim 1, characterized by that the base (1) has an arcuately curved shape in a plane perpendicular to the notch (6). [3] Stabilizer according to claim 1 or 2, characterized by that the radial interruption (8) is provided in a section of the outline of the fastening element (2) facing the base (1). [4] Stabilizer according to one of claims 1 to 3, characterized by that the base (1) is provided with a catching element (9) at the junction of the two flared lateral base parts (7), through which the notch (6) in the base (1) runs. [5] Stabilizer according to claim 1 or 4, characterized by that the base (1) has recesses (3) for the band element and locking projections (4) in the region of its short edges. [6] Stabilizer according to one of claims 1 to 5, characterized bythat the fastening element (2) is detachably connected to at least one additional annular element (11, 11', 11"), wherein the inner diameter of the additional annular element (11, 11', 11") is different from the inner diameter of the fastening element (2). [7] Stabilizer according to claim 6, characterized by that the detachable connection of the additional annular element (11, 11', 11") to the fastening element (2) is provided via a tear-off radial arm (10). [8] Stabilizer according to claim 6 or 7, characterized by that the outline of the additional annular element (11, 11', 11") has a radial interruption (8') which corresponds in shape to the radial interruption (8) of the outline of the fastening element (2). [9] Stabilizer according to one of the preceding claims, characterized by that it is made of a material that includes an addition of silver in its chemical composition. [10] Stabilizer according to claim 9, characterized by that it is made by injection molding of plastic.

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