Medical intubation product and method for manufacturing a medical intubation product

Abstract

The present invention relates to a medical intubation product (10) comprising a tube (12) that can be inserted into a patient's trachea by a user for the purpose of ventilation, a spatula (14) that is designed to assist the user in the insertion and that has a contour (16) along which the tube (12) can be guided during insertion, and an outer packaging (18) wherein the tube (12) and the spatula (14) are packaged in the outer packaging (18), wherein the tube (12) is preconditioned to the contour (16) of the spatula (14) by being packaged. Furthermore, the present invention relates to a method for manufacturing a medical intubation product (10).

Description

[0001] The invention relates to a medical intubation product and a method for manufacturing a medical intubation product.

[0002] Airway management encompasses all measures taken to secure the airway and ensure ventilation and optimal oxygenation of a patient. Airway management is always necessary when a patient's spontaneous breathing is dangerously impaired due to illness or accident, or when it is ineffective or insufficient due to medication during anesthesia.

[0003] The gold standard for securing the airway is endotracheal intubation. In endotracheal intubation, the operator typically inserts a tube through the mouth, then between the vocal cords of the larynx, and finally into the patient's trachea. The distal end of the tube is then positioned at the desired location within the trachea and secured in place. A cuff is inflated over the distal end of the tube to secure it. This cuff not only secures the tube but also seals the trachea, reducing the risk of aspiration. A ventilator is then attached to the proximal end of the tube to provide ventilation.

[0004] A common tool used in intubation is the laryngoscope. The laryngoscope allows visualization of the larynx to facilitate intubation. It typically consists of a handle and a blade. The blade allows the user to compress soft tissues in the floor of the mouth, depress the lower jaw, and move the tongue aside. This provides a direct view into the larynx, allowing the user to see, for example, the vocal cords and ligaments. This makes it easier to position the endotracheal tube between the vocal cords.

[0005] When inserting the endotracheal tube into the patient's trachea, the user guides the tube along and / or around the blade. However, the inventors recognized that the shape of the tube can complicate insertion. In particular, it can be problematic if the tube's curvature deviates from the shape of the blade. This can lead to a critical loss of time, especially in emergency situations or during difficult intubation. Endotracheal tubes are typically at least substantially straight when removed from their packaging. However, users usually bend the tube before intubation to facilitate the procedure. The inventors recognized that this wastes valuable time.

[0006] The inventors also recognized that spatulas and tubes come in various sizes, each requiring a different patient's anatomy. This means that, for example, an ambulance must carry many different spatulas and / or tubes, each individually packaged. In an emergency, the user must select the appropriate combination for the patient from these various spatulas and tubes, unpack them individually, and prepare them for use. This can lead to further critical delays.

[0007] US Patent 2022 / 0118207A1 discloses a handheld system for use with an endotracheal tube to assist intubation. The system includes at least a bougie with a light source, an intubation channel, and a handle.

[0008] US 2018 / 0318537A1 discloses an emergency cricothyrotomy kit packaged in a sealed outer package.

[0009] Furthermore, a jointly packaged intubation set from HangZhou Trifanz Medical Device Co., Ltd is known (URL: http: / / www.trifanz.com / Pdetail / b_22_p_1_c_65.html).

[0010] Based on the prior art, the invention aims to assist a user in performing an intubation.

[0011] The object is solved according to the invention by a medical intubation product and a method for manufacturing a medical intubation product as described herein and defined in the claims.

[0012] The present invention provides for a medical intubation product. The medical intubation product comprises a tube that can be inserted into a patient's trachea by a user for the purpose of ventilation, a blade designed to assist the user during insertion and which has a contour along which the tube can be guided during insertion, and an outer packaging, wherein the tube and the blade, in particular together, are packaged in the outer packaging. In particular, the tube and the blade are in contact within the outer packaging.

[0013] The tube may be preconditioned to the contour of the larynx by being packaged. Alternatively or additionally, the outer packaging may be designed to effect and / or induce preconditioning of the tube. Furthermore, the tube may be preconditioned to the contour of the larynx within the outer packaging. Additionally, the outer packaging may be designed to precondition the tube to the contour of the larynx while the tube is packaged within the outer packaging. Alternatively or additionally, the larynx may be preconditioned by being packaged for a predetermined minimum period, and / or the preconditioning may be effected and / or induced by being packaged for a predetermined minimum period. Furthermore, the tube may be preconditioned for intubation using the larynx by being packaged, particularly for the minimum period.

[0014] Furthermore, the present invention provides a method for manufacturing a medical intubation product. The medical intubation product comprises a tube that can be inserted into a patient's trachea by a user for the purpose of ventilation, and a blade designed to assist the user during insertion and having a contour along which the tube can be guided during insertion. The method includes the step of packaging the tube and the blade together in an outer package, whereby the packaging creates a packaged state, particularly a combined package.

[0015] Furthermore, the method can include a step of preconditioning the tube to the contour of the blade by maintaining the packaged state for a predetermined minimum period. Alternatively or additionally, the method can include a step of preconditioning by the outer packaging, wherein the outer packaging is configured to effect and / or induce preconditioning of the tube. Again, alternatively or additionally, the method can include a step of preconditioning by maintaining the tube and blade in the packaged state, in particular for a predetermined minimum period, whereby the tube is preconditioned for intubation using the blade.

[0016] The features according to the invention enable the user to be supported during intubation. The user can perform intubation safely and efficiently. Particularly in time-critical situations such as emergencies, valuable time savings can be achieved. Furthermore, the risk of selecting an unsuitable blade-tube combination is reduced or eliminated. Since the blade and tube are packaged together, the user does not have to search for a suitable combination. These can be pre-packaged for typical patient physiologies and / or anatomies. This improves clarity, for example, in an ambulance. Due to pre-conditioning, the tube assumes a shape adapted to the blade. The tube can be used for intubation immediately after unpacking. The tube does not need to be bent into shape for intubation.This reduces the risk of contamination, as the tube does not need to be touched at its distal end. Furthermore, preconditioning ensures that the tube does not obstruct the view of the patient's larynx and / or vocal cords during intubation. Thanks to the features of the invention, the user does not need to open separate outer packaging for the tube and laryngoscope blade. Fewer hands are required overall for preparing the tube and blade. This means the user can perform the preparation alone. In contrast, separately packaged tubes and blades typically require two people and / or the removal of an already unpacked, especially sterile, tube and / or blade to open another outer package.

[0017] The medical intubation product can be provided and / or used in ambulances, hospitals, emergency kits, doctors' offices, and / or similar settings. For example, an emergency physician can carry an intubation product according to the invention with them during operations and use it at an accident scene, particularly for emergency medical first aid. The intubation product can have various embodiments, designed according to patient needs. For example, larger patients require a larger tube and blade. Smaller patients, on the other hand, require a smaller tube and blade. Depending on the patient's anatomy or the difficulty of intubation, a different blade shape may also be necessary and / or more suitable. In principle, the medical intubation product can be used for the emergency medical care of a patient.The term "emergency medical" can specifically refer to a medical product intended for the initial treatment of a patient, for example, in an ambulance and / or helicopter after an accident.

[0018] The tube can be any standard tube. In principle, the tube can be designed and / or intended to provide an airway for a patient. In particular, the tube can be an endotracheal tube. It can also be a laryngeal tube. A tube can be of various sizes and intended for the intubation of patients of any age. Furthermore, the tube can include a cuff at or near the distal end of the tube. The tube can be made of a plastic material, in particular polyvinyl chloride (PVC). According to some embodiments, the tube can include a shaping element that extends along at least one section, in particular a distal end, of the tube. The shaping element can be designed to assist in preconditioning.For example, the shaping element may include a wire, in particular a metal wire, a splint, in particular a metal and / or plastic splint, and / or the like. In particular, the tube can be patient- and / or application-specific. The blade may be an auxiliary instrument to assist intubation. The blade may be intended for use in the patient's oral cavity. A blade may be used to retract the patient's epiglottis in such a way as to provide the user with a view of the patient's glottis. A blade may be shaped to conform to the anatomy of the tongue and / or pharynx. The blade may be curved and / or straight. Furthermore, the blade may be hyperangulated. This may mean that the blade has a greater curvature than a conventional curved blade.The blade can also include a tube guide section. This tube guide section can, for example, provide a lateral stop for guiding the tube. The tube can be designed to contact the tube guide section during insertion. The tube guide section can, for example, include a step recessed laterally into the blade. In general, the intubation product according to the invention is not limited to specific blade geometries. The features described herein can be combined with any blade. The blade can be made of plastic and / or metal. The blade can also be disinfectable, in particular by wipe disinfection, and / or autoclavable. For example, the blade can be prepared for use by cleaning it with a cloth. Furthermore, the blade can be attached to and / or connected to a handle.The handle allows the spatula to be operated and / or handled.

[0019] When performing intubation with a laryngoscope blade, the patient is often positioned supine. The user can carefully guide the blade into the patient's oral cavity and lift the base of the tongue. The endotracheal tube, in particular, can then be inserted into the trachea to secure the airway. In some embodiments, the user guides the tube directly along the blade into the trachea, i.e., with contact between the blade and tube. In other embodiments, the user guides the tube along the blade without contact between the tube and blade. The blade can then define a path along which it can be guided. Contact between the blade and tube is possible in such cases, but not mandatory.The inventors recognized that in both cases it is advantageous to adjust the bend of the tube to mimic the shape of the larynx, particularly the section along which the tube is guided. Firstly, this minimizes the obstruction of the patient's view of the vocal cords. Secondly, available space within the patient's oral cavity for positioning the tube is limited. The inventors therefore recognized that this space can be utilized more effectively if the tube is shaped to fit the larynx.

[0020] The contour of the blade can refer to a section of an outline visible in a side view of the blade. In particular, the contour can refer to the outline of one side, especially the top, of the blade. For example, a curved blade has a side view with an outline that exhibits a bend. The endotracheal tube is guided along this bend during intubation. Specifically, a curved blade bends in one of its main directions of extension. "Bending" here does not imply movement, but rather describes a shape. Alternatively, "bending" can mean "curving" or similar.The term "principal extension direction" of an object is understood to mean, in particular, a direction that runs parallel to the longest edge of the smallest imaginary cuboid that just completely encloses the object and that preferably passes through a geometric center and / or a center of mass of the component. The tongue base can be compressed, or be compressible, with one side, in particular a bottom side, of the spatula, while the tube is guided, or can be guided, along the opposite side, in particular the top side, and / or is guided, or can be guided, past this side, in particular the top side. The contour of the opposite side, in particular the top side, is the one along which the tube can be guided during insertion.

[0021] The phrase "along which the tube can be guided during insertion" does not necessarily mean that the tube touches the blade during insertion. It can be understood, for example, as meaning that the tube can be guided parallel to the top surface of the blade and / or parallel to the blade's contour during insertion. In general, this can mean that the tube can be guided and / or advanced parallel to a surface of the blade along the blade's main direction of extension.

[0022] The outer packaging can define a single-compartment receiving space into which the blade and the endotracheal tube are contained, particularly directly and / or together. For example, the blade and endotracheal tube may not have any further, separate outer packaging. This can mean that the user can remove the blade and endotracheal tube from the outer packaging after opening it and use them immediately. The endotracheal tube and blade are thus made available to the user directly for use or intubation within the outer packaging. The outer packaging may comprise a blister pack, a sterile package, a sterile container, a paper-plastic package, a Tyvek package, a vacuum package, and / or the like. According to some embodiments, the outer packaging may have such high rigidity that the endotracheal tube can be preconditioned and / or deformed using the outer packaging. The endotracheal tube and blade may be contained together in the outer packaging.The tube and the blade can be specifically aligned with each other. For example, a distal end of the tube can be specifically aligned with the blade, particularly its upper surface and / or contour. When packaged, and / or during packaging, the tube and blade can make targeted contact. This contact can be intentionally designed for preconditioning purposes.

[0023] "Preconditioned" can mean that the endotracheal tube is prepared for use. The tube can be specifically adjusted for intubation. This can mean that the user can use the tube immediately after removing it from its packaging, with the tube having a specific shape resulting from the preconditioning. This shape can be specifically designed for the blade packaged together. This can be understood, for example, as "contour-preconditioned." The tube's shape can thus be modified to specifically accommodate the blade. Preconditioning can involve flow and / or relaxation of the tube, and / or partial flow and / or relaxation. Preconditioning can also include plastic deformation of the tube.However, preconditioning can also be achieved through a combination of plastic and elastic deformation. After removal from its outer packaging, the tube can at least slightly return to its pre-preconditioning shape and / or approximate it.

[0024] "Preconditioning through packaging" can be understood to mean that the tube undergoes a significant change in its properties during packaging, such that it may exhibit an altered shape for a minimum period after removal. This preconditioning is achieved precisely because the tube and blade can be packaged together, allowing them to touch. The minimum duration can be approximately 1 minute, 2 minutes, 5 minutes, 10 minutes, or 1 hour. The tube is therefore not preconditioned by any deformation or similar action prior to packaging. It is understood, however, that the tube may already be deformed, bent, or otherwise altered before packaging.

[0025] "Co-packing" can be understood as placing and / or aligning the tube and spatula within the outer packaging, and then sealing the outer packaging and / or preparing it for storage and / or further transport. Packaging is generally carried out in a factory.

[0026] The term "to the contour" can be understood to mean that, for example, the contour of the tube closely approximates the contour of the blade. It is understood that the tube does not need to precisely replicate the contour of the blade's upper surface with respect to its longitudinal axis. Rather, it can refer to an approximation of the tube's longitudinal axis to the surface contour of the blade. If the blade generally exhibits a contour, particularly on its upper surface, this can be described by its course along the blade's main direction of extension, along which the tube is guided or can be guided. Preconditioning allows the longitudinal axis of the tube, especially along a distal end section of the tube that is initially inserted into the trachea, to be approximated and / or adapted to the contour. This allows at least some of the advantages of the invention to be achieved.

[0027] The specified minimum duration of packaging and / or maintaining the packaged state can be, for example, at least 1 hour, 1 day, or 1 week. In particular, the minimum duration can include the period between the packaging of the tube and blade in a factory and the typical use of the tube for intubation. In this case, the user may be, in particular, an emergency physician and / or similar professional.

[0028] The term "maintain" can mean at least essentially maintaining the original shape. After unpacking the tube from its outer packaging, it may deviate, at least slightly, from the shape it assumed while packaged. For example, the amplitude of a bend relative to a straight line and / or the radius of curvature may change, and in particular decrease, by up to 1 cm, up to 2 cm, and / or up to 3 cm relative to the shape it assumed while packaged. The deviation may depend on the type and size of the tube. Different tubes may deviate from their preconditioned shape to varying degrees. In this context, the values ​​given should be understood as examples. Generally, preconditioning may involve deformation of the tube with an elastic component.

[0029] In principle, it may be provided that a distal end section of the tube is preconditioned. This can mean that a distal end section of the tube, whose length may approximately correspond to the length of the blade, particularly along its main direction of extension, is preconditioned and / or becomes preconditioned through packaging. Within the outer packaging, the tube and blade may be arranged and / or be arranged, particularly during packaging, such that the distal end section of the tube contacts the blade, particularly on the upper side of the blade, and especially at least substantially along the blade's main direction of extension.

[0030] Furthermore, preconditioning allows the tube to retain the contour of the spatula, at least temporarily, after removal from its outer packaging. Advantageously, a standard tube can be used. An elastic component of deformation due to packaging and / or being packaged may occur, but the tube is still preconditioned. Regarding the phrase "retain the spatula's contour," reference can be made to the explanations above. It is understood that two adjacent curved bodies will not have the same bend and / or degree of curvature. Accordingly, it could mean that the tube rests against the outside of the spatula during preconditioning and therefore has a lower degree of curvature. This can still be interpreted as preconditioning to the contour.

[0031] Furthermore, the endotracheal tube and blade can have a coordinated shape and size, allowing for their combined use during intubation. Advantageously, endotracheal tubes and blades can be provided in pre-packaged sets of matching sizes and shapes. This eliminates the need for the user to select suitable combinations in an emergency situation and search through various containers for the desired size and shape. This can save the user critical time, which can be crucial in emergencies.

[0032] Even a small gain in time can be crucial to saving a patient's life or protecting them from permanent damage.

[0033] A cost-effective and simple method of preconditioning can be achieved by vacuum-sealing the outer packaging. Packaging can involve vacuum-sealing the outer packaging after the tube and spatula have been carefully positioned inside. Vacuum sealing can involve removing air from the outer packaging.

[0034] Furthermore, a vacuum can exist within the outer packaging, causing the tube to press against the spatula, at least in sections. An increased ambient pressure can be deliberately used for shaping and / or preconditioning the tube. Due to the increased ambient pressure compared to the interior of the outer packaging, the tube can be pressed against the spatula, particularly its upper surface, and / or fixed to it, at least in sections. As described above, the tube can, at least in part, essentially assume the contour of the spatula. The outer packaging can be sealed, at least in part, airtight.

[0035] Furthermore, the contour can have a curve. Intubation can be particularly easy using a tube and blade with a curve. Preconditioning can also be especially advantageous in this case. A blade with a curved contour can refer to a bent blade or a hyperangulated blade.

[0036] Furthermore, the medical intubation product may include a preconditioning element designed to precondition the tube. This preconditioning element can assist the preconditioning process, ensuring that the tube is indeed preconditioned.

[0037] For example, it can prevent the endotracheal tube from moving or shifting within the outer packaging during transport of the intubation product. Essentially, it ensures that the endotracheal tube is reliably preconditioned. The preconditioning element can comprise an insert, a liner, a rail, a slide, a contour element, a guide rail, and / or the like. The preconditioning element can be, for instance, a flat insert that is enclosed within the outer packaging along with the endotracheal tube and blade. In particular, the preconditioning element can be in contact with the endotracheal tube and / or blade while packaged. The preconditioning element can be a single, integral component.For example, the preconditioning element can be an injection-molded part, an additively manufactured component, a stamped part, a molded fiber part, a folded paper and / or cardboard part, and / or the like. In particular, the preconditioning element can be inexpensive to manufacture and intended for single use. The preconditioning element can have a greater bending stiffness than the tube, especially perpendicular to its main direction of extension, and particularly perpendicular to its longitudinal axis. During packaging, the preconditioning element can be positioned in the outer packaging together with the spatula and the tube. The preconditioning element can be configured to guide the tube, especially during packaging, such that the tube is brought close to the spatula and / or the tube is deformed between the preconditioning element and the spatula.If, for example, the outer packaging is vacuum-sealed, the tube can be influenced in a predetermined and / or targeted manner by the pre-conditioning element.

[0038] According to some embodiments, the preconditioning element can be formed by the outer packaging. An outer packaging can be provided, and preconditioning can be achieved without vacuuming. The preconditioning element can be designed, for example, as a projection on an inner surface or on a side facing the interior of the outer packaging.

[0039] Furthermore, the preconditioning element can be designed separately from the outer packaging. Such a preconditioning element can be easy to manufacture.

[0040] A particularly effective preconditioning element can be provided if the preconditioning element has a shape that at least partially replicates the contour of the spatula. "Replicates" can mean that the preconditioning element approximates the contour of the spatula. As explained above, the degree of curvature of the preconditioning element can be greater than the degree of curvature of the spatula. In particular, "replicates" can mean that the preconditioning element closely resembles the contour.

[0041] Preconditioning can be achieved with high reliability and / or the risk of malfunction, for example during transport or storage, can be reduced if the preconditioning element is designed to press the tube against the spatula within the outer packaging, particularly during packaging. This ensures that the tube conforms to the contour of the spatula. The tube, especially a distal section of the tube, can be positioned, at least partially, between the preconditioning element and the spatula during packaging.

[0042] In some embodiments, the intubation product includes a handle which, together with the blade, forms a laryngoscope. Advantageously, the user can perform intubation immediately after unpacking the tube and laryngoscope. The user does not need to connect the blade to a separately provided handle.

[0043] According to some embodiments, the spatula and handle are formed as a single piece. This can mean that the spatula and handle are made from one piece of material and / or have no joints. For example, the spatula and handle can be manufactured together as a single injection-molded part. Furthermore, the spatula and handle can be formed as a single piece. This can mean that the spatula and handle can be manufactured separately and then permanently joined. In this case, the spatula and handle may have a joint.

[0044] The blade, together with an imaging device and / or the handle, can form a video laryngoscope if the blade and / or the handle has a recess into which the imaging device can be inserted. The blade and / or the handle together can define a video laryngoscope housing that can at least partially accommodate the imaging device. After unpacking, the user simply needs to insert the imaging device into the blade and / or the handle, specifically into the recess. The recess can extend along the blade such that, when inserted into the recess, an optical axis of the imaging device extends distally from a distal end of the blade. The imaging device can be configured to image a region of the object and generate image data.The imaging device can include optics, in particular imaging optics comprising at least one lens, and / or an image sensor, for example a CCD sensor or CMOS sensor. The optics and / or the image sensor can define the optical axis. The imaging device can include an energy storage device and / or a control unit. Furthermore, in some embodiments, the imaging device can have a cable connection by means of which image data can be transmitted to an external processing unit and / or display device, control commands can be transmitted to the control unit, and / or electrical energy can be transmitted. The image data can also be transmitted wirelessly. A display based on the image data of the imaging device can be generated on the display device, in particular at least substantially in real time.The user can observe a representation of the larynx on the display device while performing intubation. "Real-time" can mean that the image data is acquired and displayed within a maximum time of 1 second, 0.5 seconds, 0.1 seconds, 0.01 seconds, or even 0.001 seconds. In some embodiments, the imaging device may have a main body, in which at least the energy storage device may be located, and an extension, which in some embodiments is flexible and which may include at least the optics and / or the image sensor. In some embodiments, the imaging device further includes a lighting unit by means of which an area of ​​the object to be imaged, for example, the patient's larynx, can be illuminated. The lighting unit may also be located in the extension.The extension can extend along the spatula in a state arranged in the recess, with the main body being arranged at least substantially within the handle.

[0045] Furthermore, at least the spatula can be designed for single use. This reduces the risk of spatula contamination. Treatment costs can also be lowered, as the spatula does not require extensive reprocessing.

[0046] Furthermore, the tube and spatula can be sterilized while still packaged in the outer packaging. This advantageously reduces production costs. The outer packaging, for example, can be sterilized in an autoclave along with the tube and spatula inside. The outer packaging can be at least partially gas-permeable, water vapor-permeable, gamma-ray-permeable, plasma-permeable, and / or similar, depending on the intended sterilization process.

[0047] The present invention is described below by way of example with reference to the accompanying figures. The drawing, the description, and the claims contain numerous features in combination. A person skilled in the art will expediently consider the features individually and use them meaningfully in combination within the scope of the claims.

[0048] If more than one instance of a particular object exists, only one of them may be identified with a reference symbol in the figures and description. The description of this instance can then be applied to the other instances of the object. If objects are named using numerical terms, such as first, second, third object, etc., these serve to identify and / or classify objects. Thus, for example, a first object and a third object, but not a second object, may be included. However, numerical terms could also indicate a number and / or sequence of objects.

[0049] They show: Fig. 1 a schematic representation of an outer packaging; Fig. 2 a schematic representation of a spatula; Fig. 3 a schematic representation of the spatula in a view of a top surface; Fig. 4 a schematic representation of a tube; Fig. 5 a schematic representation of a preconditioning element; Fig. 6 a schematic representation of the preconditioning element in another view; Fig. 7 a schematic representation of a medical intubation product, wherein the tube and blade are shown in a state packed in the outer packaging; Fig. 8 a schematic representation of the tube and spatula after preconditioning; Fig. 9 a schematic representation of another medical intubation product; Fig. 10 a sectional view of an outer packaging; Fig. 11 a schematic representation of another embodiment of a tube; Fig. 12 a schematic representation of another embodiment of a spatula; and Fig. 13 a schematic representation of another embodiment of a spatula.

[0050] Fig. 1 to Fig. Figure 6 shows schematic representations of individual components of a medical intubation product 10 before preconditioning. It is understood that the components shown are not to scale. Fig. Figure 1 shows a schematic representation of an outer packaging 18. The outer packaging 18 has a receiving space 36, in particular a single-chambered one, in which a tube 12 and a spatula 14 can be arranged (see Figure 1). Fig. 2, Fig. 3 and Fig. 4) The outer packaging 18 can directly accommodate at least the tube 12 and the spatula 14. Furthermore, a preconditioning element 22 can be added if required (see Fig. 5 and Fig. 6) are arranged in the receiving chamber 36. The tube 12 and the blade 14 have a coordinated shape and size that allows the combined use of the tube 12 and blade 14 during intubation.

[0051] The outer packaging 18 is designed as a sterilization pouch made of at least partially transparent material. The contents of the outer packaging 18 are therefore visible. At one end, the outer packaging 18 has, for example, a closure section 19 which can be sealed, particularly airtight, by welding after the tube 12, spatula 14, and / or preconditioning element 22 have been inserted during packaging. The outer packaging 18 is made of polyamide / polyethylene (PA / PE) as an example. Furthermore, the outer packaging 18 is suitable for sterilizing its contents, in particular the tube 12 and the spatula 14, while packaged in the outer packaging 18. For example, the contents can be sterilized by gamma sterilization after being packaged in the outer packaging 18. Other outer packaging materials and / or sterilization methods are also conceivable. These can be coordinated with each other.Furthermore, the tube 12 and spatula 14 can also be inserted into the outer packaging 18 in an already sterilized state.

[0052] Furthermore, the outer packaging 18 has a vacuum opening 34. During the packaging of the tube 12 and spatula 14 in the outer packaging 18, the outer packaging 18 can be vacuum-sealed to initiate preconditioning of the tube 12. For this purpose, air is extracted from the outer packaging 18 via the vacuum opening 34, creating a vacuum inside the outer packaging 18. The outer packaging 18 is then hermetically sealed. The vacuum opening 34 can be welded shut. The degree and / or amount of vacuum can be specifically selected. It is understood that a complete vacuum in the sense of an airless environment does not need to be achieved. When the tube 12 and spatula 14 are packaged in a state brought about by the packaging process, the outer packaging 18 is vacuum-sealed.The outer packaging 18 is made of such a material and has such a material thickness that the tube 12 can be deformed during packaging, in particular by the outer packaging 18.

[0053] Fig. Figure 2 shows a schematic side view of the spatula 14. The outline of the spatula 14, designed to assist a user in inserting the endotracheal tube 12 into a patient's trachea, is visible. The spatula 14 has a handle attachment 42 to which a handle (not shown) can be attached. Furthermore, the spatula 14 has a bottom surface 38. The user loads the patient's tongue floor with the bottom surface 38 of the spatula 14. This allows the user to compress soft structures of the floor of the mouth, depress the mandible, and move the tongue laterally, thereby exposing the patient's vocal cords. A top surface 40 opposite the bottom surface 38 has a contour 16 along which the endotracheal tube 12 can be guided during insertion. More precisely, the endotracheal tube 12 can be guided approximately along a path 44 toward a distal end 46 of the spatula 14.Path 44 extends along a principal direction of extension of the spatula 14. It is understood that the tube 12 can also be guided along the spatula 14 without contact. The tube 12 can therefore be advanced parallel to the upper surface 40. However, contact can occur. It can be seen that the spatula 14 is a curved spatula 14. This means that the contour 16 has a curvature 20, or that the surface 40 has a bend along path 44 and / or the principal direction of extension. The spatula 14 is made of metal and is intended for multiple uses. For example, the spatula can be reprocessed by autoclaving.

[0054] Fig. Figure 3 shows a schematic representation of the spatula 14 in a view of the top surface 40. A width 48 of the spatula 14 can be seen. The width can be approximately between 1 cm and 6 cm.

[0055] Fig. Figure 4 shows a schematic representation of the tube 12. The tube 12 is an endotracheal tube, is hollow and cylindrical, and extends along its longitudinal axis 52. Near and / or at a distal section 54, the tube 12 has a cuff 56. This cuff can be inflatable to fix the tube 12 within the patient's trachea. Instead of an endotracheal tube, a laryngeal tube, for example, can also be used. The tube 12 is made of PVC. For patient ventilation, the tube 12 has a channel 50, in particular an air channel. During intubation, the distal section 54 is inflated by the user along at least one section of the path 44 ( Fig. 2) guided, passed between the patient's vocal cords, introduced into the trachea, and positioned there. A proximal end segment of the tube 12 remains outside the patient, and a ventilator (not shown) is connected to this proximal end segment. The tube 12 can be flexible, particularly elastic and / or elastic-plastic. Furthermore, the tube can be viscoelastic, meaning it can exhibit flow and / or relaxation behavior. By selecting a suitable material for the tube 12, the viscoelastic behavior can be specifically controlled. This viscoelastic behavior can be used for preconditioning. The tube 12 also has a diameter 57, which can range from approximately 0.3 cm to 2 cm. These values ​​are for general guidance only. Common endotracheal tube and / or laryngeal tube diameters can be incorporated. In particular, the diameter 57 can be smaller than the width 48.Tube 12 is shown before preconditioning. The longitudinal axis 52 can be seen, exhibiting only a slight curvature.

[0056] Fig. 5 and Fig. Figure 6 shows schematic representations of the preconditioning element 22 in a top view ( Fig. 5) and one side ( Fig. 6) The preconditioning element 22 is formed separately from the outer packaging 18. In particular, the preconditioning element 22 is formed in one piece; it is, for example, an injection-molded part. The preconditioning element 22 is a plastic rail that can be added to the outer packaging 18 during packaging as needed. The shape of the preconditioning element 22 is approximately modeled on the contour 16 of the spatula 14. It therefore also has a bend and / or curvature. Consequently, the preconditioning element 22 has a shape that at least partially replicates the contour 16 of the spatula 14. For preconditioning, the tube 12 can, for example, be pressed between the preconditioning element 22 and the spatula 14 and / or positioned between them. This allows the longitudinal axis 52 of the tube 12 to be changed and, in particular, adapted to the contour 16.By packaging the tube 12 and spatula 14 in this arrangement, it can be ensured that the tube 12, after being removed from the outer packaging 18, retains at least this shape, in particular the contour 16, at least temporarily. This pre-conditions the tube 12.

[0057] However, preconditioning by packaging can also be carried out without using the preconditioning element 22.

[0058] In the Fig. Figure 6 shows a width of 60 for the preconditioning element 22. This can correspond at least to the diameter 57 of the tube 12. Alternatively, the width 60 can correspond at least substantially to the width of the spatula 14.

[0059] A method for manufacturing the medical intubation product 10 comprises a step of packaging the tube 12 and the blade 14 in the outer packaging 18, whereby the packaging creates a packaged state. This can be done as previously described.

[0060] The procedure further includes a step of preconditioning the tube 12 to the contour 16 of the spatula 14 by maintaining the packaged state for a predetermined minimum duration. According to the [document / section], the minimum duration is [amount] Fig. 7 and Fig. In the embodiment shown in section 8, at least 1 day. In principle, the tube can be packaged in a factory and preconditioned over the period of delivery to a user and / or storage in a hospital and / or the like.

[0061] In the Fig. Figure 7 shows a schematic representation of the tube 12 and the spatula 14 in their packaged state within the outer packaging 18. The tube 12 and the spatula 14 are thus contained within the outer packaging 18 in its receiving space 36. Because the outer packaging 18 has been vacuum-sealed, and in particular sealed airtight, a negative pressure exists within it. Due to this negative pressure, the tube 12 rests against the spatula 14, at least partially. More precisely, the distal section 54 of the tube 12 rests against the upper surface 40 of the spatula 14 and assumes its contour 16. This means that the longitudinal axis 52 of the tube 12 corresponds, at least substantially, to the contour 16 of the upper surface 40. It is understood that the degree of curvature differs, since the tube 12 is located further outward with respect to the bend of the spatula 14. This type of packaging pre-conditions the tube 12. It is thus specifically adapted to the spatula 14.

[0062] If the user wishes to perform intubation, at least partially, using the intubation product 10, he must open the outer packaging 18 and remove the tube 12 and the blade 14. In the Fig. Figure 8 shows a schematic representation of the tube 12 and the spatula 14 after removal from the outer packaging 18 and after preconditioning by being packaged. In comparison to the Fig. Figure 4 shows a clearly visible curvature of the tube 12. The curvature is adapted to or modeled on the contour 16, in particular the upper surface 40, of the spatula 14. Because the tube 12 of the Fig. 4. Having been preconditioned by being packaged, it now exhibits, according to the Fig. 8 a shape adapted to the spatula 14. Such a pre-conditioned tube 12 can be used immediately after removal from the outer packaging 18 and does not need to be bent into shape. Furthermore, the curvature of the tube 12 makes intubation easier and the tube 12 obstructs the user's view of the patient's vocal cords less.

[0063] In the Fig. 9 and Fig. Figure 10 shows another embodiment of a medical system 10'. Due to the significant similarities, the reference numerals are enclosed in single quotes. Furthermore, the differences are primarily discussed. Fig. Figure 9 shows an outer packaging 18', the tube 12, which is at least essentially the same as the tube 12 of the Fig. Figure 1 to 8 corresponds to a blade 14' in a schematic representation. The blade 14' is formed integrally with a handle 24. Together, the blade 14' and the handle 24 define a laryngoscope, in particular a housing of a video laryngoscope. The blade 14' and the handle 24 jointly have a recess 28 into which an imaging device (not shown) can be inserted. The imaging device comprises a camera by means of which the patient's larynx can be imaged during intubation and image data can be generated. This data can be transmitted to a monitor on which the user can view the larynx. The handle 24 and the blade 14' are jointly manufactured from a single piece of plastic. The handle 24 and the blade 14' can, for example, be injection-molded parts. The blade 14' and the handle 24 are intended for single use. They are therefore disposed of after intubation.

[0064] The 18' outer packaging is designed as a sterilization container and is at least partially made of hard plastic. As in the Fig. As can be seen more precisely in Figure 10, the outer packaging 18' has a base tray 66 and a cover 64. The cover may consist of a plastic film, a hard plastic lid and / or the like. In the Fig. Figure 10 is a schematic sectional view along the section axis AA (see Fig. Figure 9) shows a preconditioning element 22' formed by the outer packaging 18'. More precisely, the preconditioning element 22' is formed integrally with the bottom tray 66. A retaining element 62, also formed integrally with the bottom tray 66, is also visible.

[0065] referring again to Fig. Figure 9 shows several additional retaining elements 62. The retaining elements 62 allow the spatula 14' to be positioned in the outer packaging 18' and, in particular, held in place during packaging. Furthermore, the retaining elements 62 allow a proximal section 70 of the tube 12 to be positioned and / or held. The spatula 14' can correspond in shape, particularly with respect to its contour 16, to the spatula 14. The upper surface 40 of the spatula 14' and an inner surface of the preconditioning element 22' together define a preconditioning channel 68. The tube 12 is inserted into this channel for preconditioning during packaging. The preconditioning element 22' thereby presses the tube 12, in particular its distal section 54, against the contour 16 of the spatula 14'. By being packaged, especially for the specified minimum duration, the tube 12 is preconditioned as already described.After the tube 12 and the spatula 14' have been placed in the base tray 66, the outer packaging 18' is closed using the cover 64. Sterilization can now be carried out. After the tube 12 is removed from the outer packaging 18' after the specified minimum time period, the tube retains at least temporarily, at least substantially, the contour 16 of the spatula 14'.

[0066] The Fig. Figure 11 shows a schematic representation of another embodiment of a tube 12'. The tube 12' can be used instead of the tube 12. Unlike the tube 12, the tube 12' has a shaping element 72. This extends along a longitudinal axis of the tube 12' and, in particular, at least partially along a distal section 54 of the tube 12'. The shaping element 72 is designed to support preconditioning. The preconditioning element 72 influences, for example, the bending stiffness of the tube 12' and / or has certain flow properties that support the retention of the shape obtained by preconditioning. The preconditioning element 72 is incorporated into the tube 12'. For example, the preconditioning element 72 comprises a plastic splint and / or a metal wire.

[0067] The Fig. 12 and Fig.Figures 13 and 14' each show a schematic representation of a further embodiment of a spatula 14' or 14''', respectively. The spatula 1'' or the spatula 14''' can be used instead of one of the spatulas 14 or 14'. Spatula 14'', for example, is a hyperangulated spatula. Spatula 14''' is a straight spatula that has a slight bend at its distal end section 74, particularly compared to the bend or curvature of spatulas 14, 14', or 14". Reference symbol list 10 Medical Intubation Product 12 tube 14 spatulas 16 contour 18 Outer packaging 19 Closure section 20 Curvature 22 Preconditioning element 24 handles 26 Laryngoscope 28 Exclusion 32 Video laryngoscope 34 Vacuum opening 36 Recording room 38 Underside 40 Top 42 Handle connection Path 44 46 distal end 48 width 50-channel 52 Longitudinal axis 54 distal section 56 Block cuff 57 diameter 58 Curvature 60 width 62 retaining element 64 Coverage 66 Base tray 68 Preconditioning channel 70 proximal section 72 Shaping element 74 distal end section

Claims

[1] Medical intubation product (10), comprising: a tube (12) which can be inserted by a user into the trachea of ​​a patient for the purpose of ventilation; a spatula (14) designed to assist the user in the feeding process and having a contour (16) along which the tube (12) can be guided during feeding; and an outer packaging (18) wherein the tube (12) and the spatula (14) are packed in the outer packaging (18), wherein the tube (12) is preconditioned to the contour (16) of the spatula (14) by being packed. [2] Medical intubation product (10) according to claim 1, wherein the tube (12) retains the contour (16) of the spatula (14) at least temporarily, at least substantially, after removal from the outer packaging (18) by preconditioning. [3] Medical intubation product (10) according to claim 1 or 2, wherein the tube (12) and the spatula (14) have a coordinated shape and size that allows the tube (12) and spatula (14) to be used together during intubation. [4] Medical intubation product (10) according to any of the preceding claims, wherein the outer packaging (18) is vacuum-packed. [5] Medical intubation product (10) according to claim 4, wherein a negative pressure prevails within the outer packaging (18), and wherein the tube (12) is held in contact with the spatula (14) at least partially by the negative pressure. [6] Medical intubation product (10) according to one of the preceding claims, wherein the contour (16) has a curvature (20). [7] Medical intubation product (10) according to any of the preceding claims, further comprising a preconditioning element (22) configured to precondition the tube (12). [8] Medical intubation product (10) according to claim 7, wherein the preconditioning element (22) is formed by the outer packaging (18). [9] Medical intubation product (10) according to claim 7, wherein the preconditioning element (22) is formed separately from the outer packaging (18). [10] Medical intubation product (10) according to one of claims 7 to 9, wherein the preconditioning element (22) has a shape that at least partially replicates the contour (16) of the spatula (14). [11] Medical intubation product (10) according to any one of claims 7 to 10, wherein the preconditioning element (22) is configured to press the tube (12) against the spatula (14) inside the outer packaging (18). [12] Medical intubation product (10) according to one of the preceding claims, further comprising a handle (24) which together with the spatula (14) forms a laryngoscope (26). [13] Medical intubation product (10) according to claim 12, wherein the spatula (14) and / or the handle (24) has a recess (28) into which an imaging device can be inserted. [14] Medical intubation product (10) according to any of the preceding claims, wherein at least the spatula (14) is intended for single use. [15] Medical intubation product (10) according to one of the preceding claims, wherein the tube (12) and the spatula (14) are sterilizable in a state packaged in the outer packaging (18). [16] Method for manufacturing a medical intubation product (10) comprising a tube (12) that can be inserted by a user into a patient's trachea for the purpose of ventilation and a spatula (14) designed to assist the user in the insertion and having a contour (16) along which the tube (12) can be guided during insertion, comprising the steps: Packaging the tube (12) and the spatula (14) in an outer packaging (18), whereby the packaging creates a packaged state; and preconditioning the tube (12) onto the spatula (14) to its contour (16) by maintaining the packaged state for a predetermined minimum duration.

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