Medical intubation product and method for producing a medical intubation product

Abstract

The present invention relates to a medical intubation product (10), comprising a tube (12), which can be fed by a user to a trachea of a patient in order to carry out ventilation, a spatula (14), which is designed to assist the user during said feeding and which has a contour (16) along which the tube (12) can be guided during said feeding, 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. The invention also relates to a method for producing a medical intubation product (10).

Description

[0001] Medical intubation product and method for producing a medical intubation product

[0002] The invention relates to a medical intubation product and a method for producing a medical intubation product.

[0003] Airway management refers to all measures that serve to secure the airway and ensure ventilation and optimal oxygen supply to a patient. Airway management is always necessary when a patient's spontaneous breathing is critically impaired due to illness or accident, or when it is not functioning or is not functioning sufficiently due to medications used during anesthesia.

[0004] The gold standard for airway management is endotracheal intubation. During endotracheal intubation, a user typically inserts a tube through the oral cavity, 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 block cuff is placed over the distal end of the tube and inflated 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 enable ventilation of the patient.

[0005] A common tool used in intubation is the laryngoscope. It allows the larynx to be visualized to facilitate intubation. The laryngoscope typically consists of a handle and a blade. The blade allows the user to compress soft structures in the floor of the mouth, depress the lower jaw, and push the tongue aside. This allows the user to gain direct insight into the larynx and view, for example, the vocal folds and cords. This allows the user to more easily position the tube between the vocal cords.

[0006] When inserting the tube into the patient's trachea, the user guides the tube along the blade and / or past the blade. However, the inventors recognized that the shape of the tube can complicate insertion. In particular, it can be problematic if a curvature of the tube deviates from the shape of the blade. This can lead to critical time losses, particularly in emergency situations or during difficult intubation. Typically, tubes have at least a substantially straight shape when removed from their outer packaging. However, the user usually bends the tube before intubation to facilitate intubation. The inventors recognized that this costs valuable time.

[0007] The inventors also recognized that blades and tubes are generally available in different sizes, which are used depending on the patient's anatomy. This means that, for example, an ambulance must be stocked with many different blades and / or tubes, each individually packaged. In an emergency situation, the user must select the appropriate combination for the patient from the various blades and tubes, unpack them individually, and prepare them. This can also lead to further critical time losses.

[0008] Based on the prior art, the invention is based on the object of assisting a user in performing an intubation.

[0009] The object is achieved according to the invention by a medical intubation product and a method for producing a medical intubation product as described herein and defined in the claims.

[0010] The present invention provides a medical intubation product. The medical intubation product comprises a tube that can be inserted into a patient's trachea by a user to perform ventilation, a blade configured to assist the user during insertion and having a contour along which the tube can be guided during insertion, and an outer packaging, wherein the tube and the blade are packaged, in particular together, in the outer packaging. In particular, the tube and the blade touch each other in the outer packaging.

[0011] The tube can be preconditioned to the contour of the blade by being packaged. Alternatively or additionally, the outer packaging can be designed to effect and / or bring about preconditioning of the tube. Furthermore, the tube can be and / or become preconditioned to the contour of the blade in the outer packaging. Furthermore, the outer packaging can be designed to precondition the tube to the contour of the blade while the tube is packaged in the outer packaging. Alternatively or additionally, the blade can be preconditioned by being packaged for a predetermined minimum period of time and / or the preconditioning can be effected and / or brought about by being packaged for a predetermined minimum period of time. Furthermore, the tube can be preconditioned for intubation using the blade by being packaged, in particular for the minimum period of time.

[0012] Furthermore, the present invention provides a method for producing a medical intubation product. The medical intubation product comprises a tube that can be inserted into a patient's trachea by a user to perform ventilation, and a spatula that is configured to assist the user during insertion and that has a contour along which the tube can be guided during insertion. The method comprises the step of packaging the tube and the spatula, in particular jointly, in an outer package, wherein the packaging creates a packaged state, in particular jointly.

[0013] Furthermore, the method may comprise a step of preconditioning the tube to the contour of the spatula by maintaining the packaged state for a predetermined minimum period of time. Alternatively or additionally, the method may comprise the step of preconditioning by means of the outer packaging, wherein the outer packaging is configured to effect and / or induce preconditioning of the tube. Again alternatively or additionally, the method may comprise a step of preconditioning by maintaining the tube and spatula in the packaged state, in particular for a predetermined minimum period of time, wherein the tube is preconditioned for intubation using the spatula.

[0014] The features according to the invention can be used to support a user in performing intubation. The user can perform the intubation safely and time-efficiently. Valuable time can be saved, particularly in time-critical situations such as emergencies. Furthermore, the risk of selecting an unsuitable blade-tube combination is reduced or eliminated. Because the blade and tube are packaged together, the user does not have to search for a suitable combination of tube and blade. These can be pre-packaged for typical patient physiologies and / or anatomies. This increases clarity, for example, in an ambulance. Due to the preconditioning, the tube takes on a shape tailored to the blade. The tube can be used for intubation immediately after unpacking. The tube does not need to be bent for intubation.This reduces the risk of contamination because the tube does not have to be touched at a distal end. In addition, the preconditioning ensures that the tube does not obstruct the view of the patient's larynx and / or vocal cords when intubation is performed. Thanks to the features according to the invention, the user does not have to open separate outer packaging for the tube and blade. Overall, fewer hands are needed to prepare the tube and blade. This means that the user can carry out the preparation alone. With a separately packaged tube and blade, on the other hand, two people are generally required and / or an already unpacked, particularly sterile, tube and / or blade must be set aside in order to open another outer packaging.

[0015] The medical intubation product can be provided and / or used in ambulances, hospitals, emergency kits, doctor's offices, and / or the like. For example, an emergency physician can carry an intubation product according to the invention with them during deployment and use it at the scene of an accident, in particular for emergency medical first aid. The intubation product can have various embodiments, which are designed according to patient needs. For example, larger patients require a larger tube and a larger blade. Smaller patients, on the other hand, require a smaller tube and blade. Depending on the patient's anatomy or the degree of difficulty of intubation, a different blade shape may be necessary and / or more suitable. In principle, the medical intubation product can be one for emergency medical care of a patient.Emergency medical use can specifically mean that the medical device is intended for the initial treatment of a patient, for example, in an ambulance and / or helicopter after an accident.

[0016] The tube can be any common tube. In principle, the tube can be configured and / or intended to provide an airway for a patient. In particular, the tube can be an endotracheal tube. Furthermore, the tube can be a laryngeal tube. A tube can be designed in various sizes and be intended for the intubation of patients of any age. Furthermore, the tube can comprise a blocking cuff at the distal end portion and / or near a distal end of the tube. The tube can be made of a plastic, in particular polyvinyl chloride (PVC). According to some embodiments, the tube can comprise a shaping element that extends along at least one portion, in particular a distal end portion, of the tube. The shaping element can be configured to assist preconditioning.For example, the shaping element can comprise 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 provided in a patient- and / or application-specific manner.

[0017] The spatula can be an auxiliary instrument to assist intubation. The spatula can be intended for use in the patient's oral cavity. Using a spatula, the patient's epiglottis can be charged in such a way that the user can and / or becomes exposed to the patient's glottis. A spatula can be shaped to adapt to the tongue anatomy and / or pharyngeal anatomy. The spatula can be curved and / or straight. Furthermore, the spatula can be a hyperangulated spatula. This can mean that the spatula can have a greater bend than a conventional curved spatula. The spatula can also have a tube guide section. The tube guide section can, for example, provide a lateral stop for guiding the tube. It can be provided that the tube contacts the tube guide section when the tube is inserted.The tube guide section can, for example, comprise a step recessed into the side of 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 a plastic and / or a metal. The blade can also be disinfectable, in particular wipe-disinfectable, 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 a handle and / or connected to a handle. The blade can be operated and / or handled using the handle.

[0018] When performing intubation with a 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. They can then guide the tube, particularly an endotracheal tube, 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 the tube. In other embodiments, the user guides the tube along the blade without any contact between the tube and the blade. The blade can then define a path along which the blade can be guided. Contact between the blade and the tube can occur in such cases, but is 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 blade, particularly the section along which the tube is guided. On the one hand, the tube slightly obstructs the view of the patient's vocal cords. On the other hand, the available space within the patient's oral cavity for positioning the tube is limited. The inventors therefore recognized that this space can be utilized effectively if the tube is matched to the blade.

[0019] The contour of the blade can refer to a section of an outline that is visible in a side view of the blade. In particular, the contour can refer to the outline of a side, in particular a top, of the blade. For example, a curved blade in a side view has an outline that has a bend. The tube is guided along this bend during intubation. In particular, a curved blade bends in a main direction of extension of the blade. “Bend” does not mean a movement, but rather describes a shape. Alternatively, “bend” can mean “curve” and / or the like.A "main extension direction" of an object should be understood in particular as a direction which runs parallel to the longest edge of the smallest imaginary cuboid which just completely encloses the object and which preferably runs through a geometric center and / or through a center of mass of the component. With one side, in particular a bottom side, of the spatula, the base of the tongue can be compressed or compressible, 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 contour along which the tube can be guided during feeding.

[0020] “Along which the tube can be guided during insertion” does not necessarily mean that the tube touches the spatula during insertion. This can be understood, for example, to mean that the tube can be guided parallel to the top side of the spatula and / or parallel to the contour of the spatula during insertion. In principle, this can mean that the tube can be guided and / or advanced parallel to a surface of the spatula along the main direction of extension of the spatula. The outer packaging can define a single-chamber receiving space into which the spatula and the tube are received, in particular directly and / or together. For example, the spatula and tube do not have any further, separate outer packaging. This can mean that the user can remove the spatula and the tube from the outer packaging after opening it and insert them immediately.The tube and spatula are provided to the user in the outer packaging, for example, for immediate use or intubation. The outer packaging can comprise blister packaging, sterile packaging, a sterile container, paper-plastic packaging, Tyvek packaging, vacuum packaging, and / or the like. According to some embodiments, the outer packaging can have such a high rigidity that the tube can be preconditioned and / or deformed by means of the outer packaging. The tube and spatula can be accommodated together in the outer packaging. The tube and spatula can be arranged in a targeted manner relative to one another. For example, a distal end section of the tube can be specifically aligned with respect to the spatula, in particular the upper side and / or contour of the spatula. In a packaged state and / or while being packaged, the tube and spatula can touch in a targeted manner.Touch can be intentionally used for preconditioning.

[0021] “Preconditioned” can mean that the tube is prepared for use. The tube can be specifically adjusted for intubation. This can mean that the user can use it immediately after removing it from the outer packaging, with the tube having a specific shape resulting from the preconditioning. This shape can be specifically intended for the blade that is packaged with it. This can be understood as “preconditioned to the contour,” for example. The tube’s shape can therefore be influenced in such a way that it is specifically intended for the blade. Preconditioning can be based on flow and / or relaxation of the tube and / or section-by-section flow and / or relaxation can cause the preconditioning. Preconditioning can include plastic deformation of the tube.Furthermore, however, a combination of plastic and elastic deformation can also bring about preconditioning. After removal from the outer packaging, the tube can at least slightly return to the shape it had before preconditioning and / or approach this shape. “Preconditioning through packaging” can be understood to mean that the tube changes significantly in its properties while it is packaged in such a way that it can have an altered shape for a minimum period after removal. Preconditioning can be brought about precisely because the tube and the spatula can be packaged together, whereby they can touch each other. The minimum period can be at least 1 minute, 2 minutes, 5 minutes, 10 minutes or 1 hour. The tube is therefore not preconditioned by any deformation and / or the like carried out before packaging.However, it is understood that the tube may be deformed and / or have a bend and / or the like prior to packaging.

[0022] "Combined packaging" can be understood as the placement and / or alignment of the tube and blade in the outer packaging, and the outer packaging is then sealed and / or prepared for storage and / or further transport. Packaging is typically performed in a factory.

[0023] “To the contour” can be understood to mean that a contour of the tube at least substantially matches the contour of the spatula. It is understood that the tube does not have to exactly replicate a contour of the top side of the spatula, for example with reference to its longitudinal axis. Rather, an approximation of a course of the longitudinal axis of the tube to the course of the surface contour of the spatula can be meant. If the spatula generally has the contour, in particular on the top side, this can be described by means of a course along the main extension direction of the spatula, along which the tube is guided or can be guided. By preconditioning, the course of the longitudinal axis of the tube, in particular along a distal end section of the tube, which is initially guided into the trachea, can be approximated to the course of the contour and / or adapted. In this way, at least some of the advantages of the invention can be achieved.

[0024] The specified minimum duration of packaging and / or maintaining the packaged state can, for example, be at least 1 hour, 1 day, or 1 week. In particular, the minimum duration can comprise the period of time that normally lies between packaging the tube and blade in a factory and use of the tube to perform intubation. In this case, the user can, in particular, be an emergency physician and / or the like. “Maintaining” can mean at least substantially maintaining. After unpacking the tube from the outer packaging, the tube can deviate at least slightly from the shape it assumed while packaged. For example, an amplitude of a bend relative to a rectilinear shape and / or a radius of curvature can change, 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.In particular, the deviation can depend on the type and size of the tube. Different tubes can deviate from the preconditioned shape to varying degrees. In this context, the values ​​given are to be understood as examples. In general, preconditioning can involve deformation of the tube with an elastic component.

[0025] In principle, it can be provided that a distal end section of the tube is preconditioned. This can mean that a distal end section of the tube, which in its length can correspond approximately to the length of the spatula, in particular along its main extension direction, is and / or will be preconditioned by the packaging. In the outer packaging, the tube and the spatula can be arranged and / or can be arranged accordingly, in particular during packaging, such that the distal end section of the tube touches the spatula, in particular on the upper side of the spatula, in particular at least substantially along the extension of the spatula along the main extension direction of the spatula.

[0026] Furthermore, as a result of the preconditioning, the tube can at least temporarily at least substantially retain the contour of the spatula after being removed from the outer packaging. Advantageously, a standard tube can be used. An elastic component of a deformation due to packaging and / or being packaged can occur, whereby the tube is nevertheless preconditioned. With regard to the phrase "maintaining the contour of the spatula", reference can be made to the above explanations. It is understood that two adjacent curved bodies do not have the same bend and / or the same degree of curvature. Accordingly, this can mean that the tube rests against the outside of the spatula during preconditioning and accordingly has a lower degree of curvature. This can nevertheless mean preconditioning to the contour.

[0027] In addition, the tube and blade can have a coordinated shape and size, allowing them to be used together during intubation. Advantageously, tubes and blades can be packaged together in coordinated sizes and shapes. The user does not have to select suitable combinations in an emergency situation and search through various tube and blade containers for the desired size / shape. This can save the user critical time, which can be crucial in emergencies.

[0028] In principle, even a small gain in time can be important in saving a patient's life or protecting them from permanent damage.

[0029] A cost-effective and simple method for preconditioning can be achieved by vacuum-sealing the outer packaging. Packaging may involve vacuuming the outer packaging after the tube and spatula have been positioned within the outer packaging. Vacuuming may involve extracting air from the outer packaging.

[0030] Furthermore, a negative pressure can prevail within the outer packaging, and the tube can rest against the spatula at least in sections as a result of the negative pressure. An increased ambient pressure can be deliberately exploited for deformation and / or preconditioning of the tube. Due to the increased ambient pressure compared to the interior of the outer packaging, the tube can be pressed and / or fixed to the spatula, in particular to the upper side of the spatula, at least in sections. According to the above explanations, the tube can at least substantially assume the contour of the spatula in sections. The outer packaging can be at least substantially hermetically sealed.

[0031] Furthermore, the contour can have a curve. Using a tube and a blade with a curve, intubation can be particularly easy. Furthermore, preconditioning can be particularly advantageous in this case. A blade with a curved contour can be understood as a bent blade. It can also be understood as a hyperangulated blade.

[0032] Furthermore, the medical intubation product can comprise a preconditioning element configured to precondition the tube. The preconditioning can be assisted by the preconditioning element. It can be ensured that the tube is actually preconditioned. For example, it can be prevented that the tube moves in the outer packaging during transport of the intubation product and / or that the tube shifts. In principle, it can be ensured that the tube is reliably preconditioned. The preconditioning element can comprise an insert, an inlay, a rail, an insert, a contour element, a guide rail, and / or the like. The preconditioning element can be, for example, a flat insert that is accommodated by the outer packaging together with the tube and the blade.In particular, the preconditioning element can contact the tube and / or the spatula during packaging. The preconditioning element can be a one-piece component or be formed in one piece. For example, the preconditioning element can be an injection-molded part, an additively manufactured component, a stamped part, a fiber-molded 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 greater flexural rigidity, in particular perpendicular to its main extension direction, than the tube, in particular perpendicular to its longitudinal axis. During packaging, the preconditioning element can be positioned together with the spatula and the tube in the outer packaging.The preconditioning element can be configured to guide the tube, particularly during packaging, in such a way that the tube is brought closer 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 preconditioning element can influence the tube in a predetermined and / or targeted manner.

[0033] 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 formed, for example, as a projection on an inner side of the outer packaging, or on a side facing the interior of the outer packaging.

[0034] Furthermore, the preconditioning element can be formed separately from the outer packaging. Such a preconditioning element can be easy to manufacture. 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 approximately has the contour of the spatula. According to the above explanations, a degree of curvature of the preconditioning element can be greater than a degree of curvature of the spatula. In particular, "replicates" can mean that the preconditioning element resembles the contour.

[0035] 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 configured to press the tube against the spatula within the outer packaging, particularly during packaging. This ensures that the tube takes on the contour of the spatula. The tube, particularly a distal portion of the tube, can be arranged at least partially between the preconditioning element and the spatula during packaging.

[0036] According to some embodiments, the intubation product comprises a handle that, 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.

[0037] According to some embodiments, the spatula and the handle are formed as a single piece. This may mean that the spatula and handle are made from a single piece of material and / or have no connection points. For example, the spatula and handle can be manufactured together as an injection-molded part. Furthermore, the spatula and handle can be formed as a single piece. This may mean that the spatula and handle can be manufactured separately and then permanently joined. In this case, the spatula and handle can have a connection point.

[0038] The spatula, together with an imaging device and / or the handle, can form a video laryngoscope if the spatula and / or the handle has a recess into which the imaging device can be inserted. The spatula and / or the handle can together define a housing of a video laryngoscope that can at least partially accommodate the imaging device. After unpacking, the user merely has to insert the imaging device into the spatula and / or the handle, in particular into the recess. The recess can extend along the spatula such that an optical axis of the imaging device, when inserted into the recess, extends distally from a distal end of the spatula. The imaging device can be configured to image an object region and generate image data.For this purpose, the imaging device can comprise an optical system, in particular an imaging optical system comprising at least one lens, and / or an image sensor, for example a CCD sensor or CMOS sensor. The optical system and / or the image sensor can define the optical axis. The imaging device can comprise 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 computing unit and / or display device, control commands can be transmitted to the control unit, and / or the electrical energy can be transmitted. Furthermore, the image data can also be transmitted wirelessly. A representation 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 the intubation. In real time can mean that the image data is elapsed between image data generation and representation generation for a maximum of 1 second, 0.5 seconds, 0.1 seconds, 0.01 seconds, or even a maximum of 0.001 seconds. In some embodiments, the imaging device can have a main body in which at least the energy storage device can be arranged, and an extension which, in some embodiments, is flexible, wherein the extension can comprise at least the optics and / or the image sensor. In some embodiments, the imaging device further comprises an illumination unit by means of which an object region to be imaged can be illuminated, for example the patient's larynx. The illumination unit can also be arranged in the extension.The extension can extend along the spatula in a state arranged in the recess, wherein the main body can be arranged at least substantially within the handle.

[0039] Furthermore, at least the spatula can be designed for single use. This can reduce the risk of spatula contamination. Furthermore, treatment costs can be lowered because the spatula does not require complex reprocessing. Furthermore, the tube and spatula can be sterilized while packaged in the outer packaging. This can advantageously reduce production costs. The outer packaging can, for example, be sterilized in an autoclave with the packaged tube and spatula. The outer packaging can, for example, be at least partially gas-permeable, water vapor-permeable, gamma-ray-permeable, plasma-permeable, and / or the like, particularly depending on the intended sterilization process.

[0040] The present invention is described below by way of example with reference to the accompanying figures. The drawings, the description, and the claims contain numerous features in combination. Those skilled in the art will expediently consider the features individually and use them in meaningful combination within the scope of the claims.

[0041] If there is more than one instance of a particular object, only one of them may be provided with a reference symbol in the figures and in the description. The description of this instance can be transferred accordingly to the other instances of the object. If objects are named using numerical terms, such as first, second, third object, etc., these serve to name and / or assign objects. Accordingly, for example, a first object and a third object, but not a second object, may be included. However, a number and / or sequence of objects could also be derived using numerical terms.

[0042] They show:

[0043] Figure 1 is a schematic representation of an outer packaging;

[0044] Figure 2 is a schematic representation of a spatula;

[0045] Figure 3 is a schematic representation of the spatula in a view of a

[0046] top;

[0047] Figure 4 is a schematic representation of a tube;

[0048] Figure 5 shows a schematic representation of a preconditioning element; Figure 6 shows a schematic representation of the preconditioning element in a further view;

[0049] Figure 7 is a schematic representation of a medical intubation product, wherein the tube and the blade are shown in a state packed in the outer packaging;

[0050] Figure 8 is a schematic representation of the tube and the spatula after preconditioning;

[0051] Figure 9 is a schematic representation of another medical intubation product;

[0052] Figure 10 is a sectional view of an outer packaging;

[0053] Figure 11 is a schematic representation of another embodiment of a tube;

[0054] Figure 12 is a schematic representation of another embodiment of a spatula; and

[0055] Figure 13 is a schematic representation of another embodiment of a spatula.

[0056] Fig. 1 to Fig. 6 show schematic representations of individual components of a medical intubation product 10 prior to preconditioning. It is understood that the components shown are not drawn to scale. Fig. 1 shows a schematic representation of an outer packaging 18. The outer packaging 18 has a receiving space 36, in particular a single-chamber one, in which a tube 12 and a spatula 14 can be arranged (see Figs. 2, 3 and 4). The outer packaging 18 can directly accommodate at least the tube 12 and the spatula 14. Furthermore, if required, a preconditioning element 22 (see Figs. 5 and 6) can be arranged in the receiving space 36. The tube 12 and the spatula 14 have a coordinated shape and size, which allow the tube 12 and spatula 14 to be used together during intubation.

[0057] The outer packaging 18 is designed as a sterilization bag made of at least partially transparent material. The contents of the outer packaging 18 can therefore be viewed. At one end, the outer packaging 18 has, for example, a closure section 19, which can be closed, in particular hermetically, by welding after insertion of the tube 12, spatula 14, and / or preconditioning element 22 during packaging. For example, the outer packaging 18 is made of polyamide / polyethylene (PA / PE). Furthermore, the outer packaging 18 is suitable for sterilizing the contents of the outer packaging 18, 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 they have been packaged in the outer packaging 18. Other outer packaging materials and / or sterilization methods are also conceivable. These can be coordinated with one another.Furthermore, the tube 12 and spatula 14 can also be inserted into the outer packaging 18 in an already sterilized state.

[0058] Furthermore, the outer packaging 18 has a vacuum opening 34. During packaging of the tube 12 and spatula 14 in the outer packaging 18, the outer packaging 18 can be vacuum-packed or vacuum-sealed to initiate preconditioning of the tube 12. For this purpose, air is sucked out of the outer packaging 18 via the vacuum opening 34, creating a negative pressure in the outer packaging 18. The outer packaging 18 is then sealed hermetically. The vacuum opening 34 can, for example, be welded. The degree and / or amount of the negative pressure can be specifically selected. It is understood that a vacuum in the sense of an air void needs not to be achieved. When the tube 12 and spatula 14 are in the packaged state brought about by the packaging, the outer packaging 18 is vacuum-sealed.The outer packaging 18 is made of a material and has a material thickness such that the tube 12 can be deformed during packaging, in particular by the outer packaging 18.

[0059] Fig. 2 shows a schematic representation of the spatula 14 in a side view. An outline of the spatula 14 can be seen, which is designed to assist a user in inserting the tube 12 into a patient's trachea. The spatula 14 has a handle connection 42 to which a handle (not shown) can be attached. Furthermore, the spatula 14 has a bottom side 38. The user loads the bottom side 38 of the spatula 14 onto the patient's tongue. This allows the user to compress soft structures of the floor of the mouth, press the lower jaw downward, and push the tongue to the side, thereby exposing the patient's vocal cords. An upper side 40 opposite the bottom side 38 has a contour 16 along which the tube 12 can be guided during insertion. More precisely, the tube 12 can be guided approximately along a path 44 toward a distal end 46 of the spatula 14.The path 44 extends along a main extension direction of the spatula 14. It is understood that the tube 12 can also be guided contactlessly along the spatula 14. The tube 12 can therefore be advanced parallel to the upper side 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 the surface 40 has a bend along the path 44 and / or the main extension direction. The spatula 14 is made of metal and intended for multiple use. For example, the spatula can be reprocessed by autoclaving.

[0060] Fig. 3 shows a schematic representation of the spatula 14 in a view of the upper side 40. One can see a width 48 of the spatula 14. The width can be approximately between 1 cm and 6 cm.

[0061] Fig. 4 shows a schematic representation of the tube 12. The tube 12 is an endotracheal tube, is hollow cylindrical in shape and extends along its longitudinal axis 52. Near and / or on a distal section 54, the tube 12 has a block cuff 56. This 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 provided. The tube 12 is made of PVC. For ventilating the patient, the tube 12 has a channel 50, in particular an air channel. During intubation, the distal section 54 is guided by the user along at least a section of the path 44 (Fig. 2), pushed between the patient's vocal cords, guided to the trachea and placed there. A proximal end portion of the tube 12 remains outside the patient and a ventilator (not shown) is connected to the proximal end portion.The tube 12 can be bendable, in particular elastically and / or elastically-plastically. Furthermore, the tube can be viscoelastic, i.e., it can exhibit flow and / or relaxation behavior. By appropriately selecting the material of the tube 12, the viscoelastic behavior can be specifically provided. The viscoelastic behavior can be specifically utilized for preconditioning. Furthermore, the tube 12 has a diameter 57 that can be approximately between 0.3 cm and 2 cm. These values ​​are merely a rough guide. Common endotracheal tube and / or laryngeal tube diameters can be provided. In particular, the diameter 57 can be smaller than the width 48. The tube 12 is shown before preconditioning. A course of the longitudinal axis 52 can be seen, which has at most a slight curvature.

[0062] 5 and 6 show schematic representations of the preconditioning element 22 in a view from above (Fig. 5) and a side view (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, for example, it is 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 approximately replicates the contour 16 of the spatula 14. It therefore also has a bend and / or curvature. The preconditioning element 22 therefore has a shape that at least partially replicates the contour 16 of the spatula 14. For preconditioning, the tube 12 can be pressed between the preconditioning element 22 and the spatula 14 and / or arranged between them, for example.This allows the course of the longitudinal axis 52 of the tube 12 to be changed, and in particular, adapted to the contour 16. Packaging the tube 12 and spatula 14 in this arrangement ensures that the tube 12, after being removed from the outer packaging 18, at least temporarily retains at least substantially this shape, in particular the contour 16. The tube 12 is thus preconditioned.

[0063] However, preconditioning by packaging can also be carried out without using the preconditioning element 22.

[0064] Figure 6 shows a width 60 of the preconditioning element 22. This width can correspond at least to the diameter 57 of the tube 12. Alternatively, the width 60 can at least substantially correspond to the width of the spatula 14.

[0065] A method for manufacturing the medical intubation product 10 includes a step of packaging the tube 12 and the blade 14 in the outer package 18, wherein the packaging creates a packaged state. This can be done as already described.

[0066] The method further comprises a step of preconditioning the tube 12 to the contour 16 of the blade 14 by maintaining the packaged state for a predetermined minimum period of time. According to the embodiment shown in Figs. 7 and 8, the minimum period is 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.

[0067] Fig. 7 shows a schematic representation of the tube 12 and the spatula 14 in the state packaged in the outer packaging 18. The tube 12 and the spatula 14 are thus received by the outer packaging 18 in its receiving space 36. Because the outer packaging 18 has been vacuum-sealed and, in particular, has been hermetically sealed, a negative pressure prevails within the outer packaging 18. Due to the negative pressure, the tube 12 rests at least partially against the spatula 14. More precisely, the distal section 54 of the tube 12 rests against the upper side 40 of the spatula 14 and assumes its contour 16. This means that the course of the longitudinal axis 52 of the tube 12 at least substantially corresponds to the course of the contour 16 of the upper side 40. It is understood that the degree of curvature is different because the tube 12 lies further out with respect to the bend of the spatula 14. By being packaged in this way, the tube 12 is preconditioned.It is therefore specifically adapted to the spatula 14.

[0068] If the user wishes to perform intubation at least partially using the intubation product 10, they must open the outer packaging 18 and remove the tube 12 and the blade 14. Fig. 8 shows a schematic representation of the tube 12 and the blade 14 after removal from the outer packaging 18 and after preconditioning by packaging. Compared to Fig. 4, a clearly visible curvature of the tube 12 can be seen. The curvature is adapted to or simulates the contour 16, in particular the upper side 40, of the blade 14. Because the tube 12 of Fig. 4 was preconditioned by packaging, it now has a shape adapted to the blade 14, as shown in Fig. 8. A tube 12 preconditioned in this way can be used immediately after removal from the outer packaging 18 and does not need to be bent.Furthermore, the curvature of the tube 12 makes intubation easier to perform and the tube 12 less obstructs the user's view of the patient's vocal cords.

[0069] 9 and 10 show a further embodiment of a medical system 10'. Due to the significant similarities, the reference numerals are provided with apostrophes. In addition, differences will be discussed primarily. Fig. 9 shows an outer packaging 18', the tube 12, which at least substantially corresponds to the tube 12 of Figs. 1 to 8, and a spatula 14' in a schematic representation. The spatula 14' is formed integrally with a handle 24. Together, the spatula 14' and the handle 24 define a laryngoscope, in particular a housing of a video laryngoscope. The spatula 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. These can be transmitted to a monitor on which the user can view the larynx.The handle 24 and the blade 14' are made of a single plastic. The handle 24 and the blade 14' may be injection-molded parts. The blade 14' and the handle 24 are intended for single use. They are therefore discarded after intubation.

[0070] The outer packaging 18' is designed as a sterilization container and is made at least partially from a hard plastic. As can be seen in more detail in Fig. 10, the outer packaging 18' has a base tray 66 and a cover 64. The cover can comprise a plastic film, a hard plastic lid, and / or the like. Fig. 10 shows a schematic sectional view along the section axis AA (see Fig. 9). A preconditioning element 22' can be seen, which is formed by the outer packaging 18'. More precisely, the preconditioning element 22' is formed integrally with the base tray 66. Furthermore, a holding element 62 can be seen, which is also formed integrally with the base tray 66.

[0071] Referring again to Fig. 9, several further holding elements 62 can be seen. By means of the holding elements 62, the spatula 14' can be positioned in the outer packaging 18' and held therein, in particular during packaging. Furthermore, a proximal section 70 of the tube 12 can be positioned and / or held by means of the holding elements 62. The spatula 14' can correspond to the spatula 14 in terms of its shape, in particular with regard to the contour 16. The upper side 40 of the spatula 14' and an inner side 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 the distal section 54 of the tube 12, against the contour 16 of the spatula 14'. By being packaged, in particular for the specified minimum period of time, the tube 12 is preconditioned as already described.After the tube 12 and the spatula 14' have been arranged in the base tray 66, the outer packaging 18' is closed using the cover 64. Sterilization can now be performed. After the tube 12 is removed from the outer packaging 18' after the specified minimum period, the tube at least temporarily retains at least substantially the contour 16 of the spatula 14'.

[0072] Fig. 11 shows a schematic representation of another embodiment of a tube 12'. The tube 12' can be used instead of the tube 12. In contrast to 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 portion 54 of the tube 12'. The shaping element 72 is configured to support the preconditioning. The preconditioning element 72 influences, for example, a flexural rigidity of the tube 12' and / or has certain flow properties that support maintaining the shape achieved by preconditioning. The preconditioning element 72 is incorporated into the tube 12'. For example, the preconditioning element 72 comprises a plastic rail and / or a metal wire.

[0073] Figs. 12 and 13 each show a schematic representation of another embodiment of a spatula 14" or 14'", respectively. The spatula 14" 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 portion 74, particularly compared to the bend or curvature of the spatulas 14, 14', or 14".

[0074] List of reference symbols

[0075] 10 Medical intubation product

[0076] 12 tubes

[0077] 14 spatulas

[0078] 16 Contour

[0079] 18 Outer packaging

[0080] 19 Closure section

[0081] 20 Curvature

[0082] 22 Preconditioning element

[0083] 24 Handle

[0084] 26 Laryngoscope

[0085] 28 recess

[0086] 32 Video laryngoscope

[0087] 34 Vacuum opening

[0088] 36 Recording Room

[0089] 38 Bottom

[0090] 40 Top

[0091] 42 Handle connection

[0092] 44 Path

[0093] 46 distal end

[0094] 48 width

[0095] 50 channel

[0096] 52 Longitudinal axis

[0097] 54 distal section

[0098] 56 block cuff

[0099] 57 diameter

[0100] 58 Curvature

[0101] 60 width

[0102] 62 Holding element

[0103] 64 Cover

[0104] 66 floor pan

[0105] 68 Preconditioning channel

[0106] 70 proximal section

[0107] 72 Shaping element

[0108] 74 distal end section

Claims

Claims 1. A medical intubation product (10), comprising: a tube (12) that can be inserted into a patient's trachea by a user to perform ventilation; a blade (14) that is configured to assist the user during 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 blade (14) are packaged in the outer packaging (18), wherein the tube (12) is preconditioned by the packaging to the contour (16) of the blade (14).

2. Medical intubation product (10) according to claim 1, wherein the tube (12) at least temporarily at least substantially retains the contour (16) of the spatula (14) after removal from the outer packaging (18) as a result of the preconditioning.

3. Medical intubation product (10) according to claim 1 or 2, wherein the tube (12) and the blade (14) have a coordinated shape and size which allow the tube (12) and blade (14) to be used together during intubation.

4. Medical intubation product (10) according to one of the preceding claims, wherein the outer packaging (18) is vacuum-sealed.

5. Medical intubation product (10) according to claim 4, wherein a negative pressure prevails within the outer packaging (18), and wherein the tube (12) rests against the spatula (14) at least in sections due to 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 one 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 separate from the outer packaging (18) is formed.

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 one of claims 7 to 10, wherein the preconditioning element (22) is configured to press the tube (12) within the outer packaging (18) against the blade (14).

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 one 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 when packaged in the outer packaging (18).

16. A method for producing a medical intubation product (10) comprising a tube (12) which can be fed by a user into a patient's trachea to perform ventilation, and a spatula (14) which is designed to assist the user in feeding, and which has a contour (16) along which the tube (12) can be guided during feeding, comprising the steps: Packaging the tube (12) and the spatula (14) in an outer package (18), wherein the packaging creates a packaged state; and preconditioning the tube (12) to the contour (16) of the spatula (14) by maintaining the packaged state for a predetermined minimum period of time.

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