Closed intubation systems with improved airway access for examination devices

Description

[0001] The present invention relates to a closed intubation system comprising at least one endotracheal tube suitable for insertion into the trachea of ​​a patient, a tubular connection to a ventilator and an adapter arrangement with at least three cylindrically designed receptacles for establishing a gas-tight coupling between the endotracheal tube, the connection to the ventilator and at least one further receptacle, wherein the adapter arrangement comprises at least: a) an adapter base body which is T-shaped due to the arrangement of the receptacles and has at least one shut-off device, wherein the shut-off device is designed to open or close the airway between the further receptacle and the two receptacles for the ventilation device and the endotracheal tube in a gas-tight manner, b) an adapter attachment which can be coupled to the further receptacle, wherein the adapter attachment can be connected to the adapter base body in a gas-tight manner via a seal and can be mechanically fixed to the latter via holding means; c) an elastic, tubular sheath with one end arranged on the adapter attachment in a gas-tight manner;d) an attachment connected in a gas-tight manner to the other end of the elastic, tubular sheath, the attachment comprising a passage to the tubular sheath with a sealing device arranged therein, the sealing device being designed to receive cylindrically shaped devices and to guide them displaceably and gas-tightly through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube.

[0002] Healthcare workers are exposed to increasing levels of personal stress today. This applies particularly to hospital staff, especially nurses with direct patient contact and intensive care staff. For these latter groups, the constant intensification of workloads and the general shortage of nurses in recent years have led to a significant increase in their own risk potential, which has been further exacerbated by the pandemic situation triggered by SARS-CoV-2, with significantly rising intensive care caseloads and significantly increased patient infectivity. Many COVID-19 patients requiring mechanical ventilation suffer from acute respiratory distress syndrome (ARDS), the treatment of which requires positive pressure ventilation with positive end-expiratory pressure (PEEP) and the use of humidified, temperature-controlled ventilation air.However, in intensive care, it can often happen that life-threatening complications, such as severe pulmonary hemorrhage (>200 ml / 24 h), foreign bodies in the lung, atelectasis, or similar, require immediate bronchoscopy or bronchoalveolar lavage (BAL) for treatment and sample collection. These emergency measures usually require the closed ventilation circuit to be opened, releasing aerosols and droplets into the ambient air, which poses a significant risk of exposure to infectious diseases (SARS-CoV-2, MERS, influenza, tuberculosis, etc.) for the directly involved medical personnel. Due to the risk described above, samples are obtained from the upper respiratory tract of COVID-19 patients as an alternative, which can lead to secondary infections being diagnosed too late or not at all.In this respect, technical aids would be desirable that enable safe and simple treatment or sampling of the lungs of even highly infectious patients without danger to the treating staff.

[0003] The patent literature also contains a wide variety of approaches to the design of closed intubation systems as well as bronchoscopes and suction catheters compatible with them.

[0004] For example, US 4,850,350 describes a closed system with a combined medical-surgical suction and ventilation tubing device comprising (1) a suction catheter, (2) a suction control valve positioned at the distal end of the system, (3) a multi-port coupling unit through which the catheter passes to be delivered for aspiration of a patient, (4) a flexible tubular sheath providing a sterility protection sheath for the catheter, which is attached at its distal end to the proximal end of the coupling unit, and (5) a sheath relief valve. The coupling units comprise two separate elements, one of which is axially fitted into the other so that they can rotate relative to each other about their longitudinal axes to close and open the access of the catheter from the sheath through the coupling unit into the patient.The suction control valves have first and second substantially identical parts positioned in sliding engagement with each other along a longitudinal side for movement between an open and a closed position of the valves. The jacket relief valves prevent air from contaminating the jacket during use of the assembly.

[0005] US 2010 / 0154799 A1 describes an airway access assembly comprising: a movable connector having at least one opening, the opening in communication with an artificial airway of a patient; a closed suction catheter assembly comprising at least one connecting end having an opening formed thereby, a suction catheter, and a sheath positioned over the suction catheter; a shuttle movable between the opening in the connector and the opening in the connecting end of the closed suction catheter assembly, the shuttle having an opening formed thereby and being configured to move into a locked and an unlocked position relative to the connector; an actuator for moving the shuttle into the locked position and the unlocked position;and a flap positioned adjacent to the shuttle and the closed suction catheter assembly, the flap movable to an open position allowing passage of the suction catheter into an artificial airway when the shuttle is in a locked position, and the flap movable to a closed position preventing passage of the suction catheter through the shuttle when the shuttle is in an unlocked position;

[0006] The possibilities and importance of protecting intensive care physicians from unwanted infections caused by the release of infectious particles during ventilation of COVID-19 patients was demonstrated, for example, by Koehler P., Cornely OA, Kochanek M., "Bronchoscopy safety precautions for diagnosing COVID-19 associated pulmonary aspergillosis - a simulation study" in Mycoses, 2020.

[0007] Furthermore, US 2014 / 121607 A1 shows a switchable device for a closed suction catheter, which comprises a device body and a two-way switching valve. The device body consists of a valve sleeve, a patient tube adapter, a side port, and a catheter adapter. A cavity is formed in the valve sleeve, which allows corresponding rotation of the two-way switching valve relative to the device body. The catheter adapter and the patient tube adapter are formed at opposite ends of the valve sleeve and can therefore create an unobstructed path between them. The side port is shaped at an angle and extends from the patient tube adapter to ensure unobstructed flow between them. A groove is formed at one end of the patient tube adapter as a coupling element that can rotate freely through 360 degrees.

[0008] Such state-of-the-art solutions may offer further potential for improvement, particularly with regard to their suitability for reducing exposure to ambient air in intensive care procedures under closed ventilation circuits.

[0009] It is therefore the object of the present invention to at least partially overcome the disadvantages known from the prior art. In particular, the object of the present invention is to provide a closed intubation system that enables safe ventilation of a patient and simple conduct of intensive care examinations without the unwanted release of aerosol particles or droplets into the ambient air.

[0010] The object is achieved by the features of the independent claim directed to the device according to the invention. Preferred embodiments of the invention are specified in the subclaims, in the description, or in the figures. Further features described or shown in the subclaims, in the description, or in the figures may constitute a subject matter of the invention, individually or in any combination, unless the context clearly indicates otherwise.

[0011] According to the invention, a closed intubation system is therefore at least comprising an endotracheal tube suitable for insertion into the trachea of ​​a patient, a tubular connection to a ventilation device and an adapter arrangement with at least three cylindrically designed receptacles for establishing a gas-tight coupling between the endotracheal tube, the connection of the ventilation device and at least one further receptacle, wherein the adapter arrangement comprises at least: a) an adapter base body configured in a T-shape due to the arrangement of the receptacles, with at least one shut-off device, wherein the shut-off device is designed to open or close the airway between the further receptacle and the two receptacles for the ventilation device and the endotracheal tube in a gas-tight manner, b) an adapter attachment which can be coupled to the further receptacle, wherein the adapter attachment can be connected to the adapter base body in a gas-tight manner via a seal and can be mechanically fixed to the latter via holding means; c) an elastic, tubular sheath with one end arranged on the adapter attachment in a gas-tight manner;d) an attachment connected in a gas-tight manner to the other end of the elastic, tubular sheath, the attachment comprising a passage to the tubular sheath with a sealing device arranged therein, the sealing device being designed to receive cylindrically shaped devices and to guide them displaceably and gas-tightly through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube.

[0012] Surprisingly, it has been shown that the closed intubation system with the adapter structure described above can ensure simple, rapid, and safe treatment and sampling of the respiratory tract, even in highly infectious patients, without allowing droplets or aerosols to escape from the closed circuit into the ambient air. Potentially released particles are safely contained within the adapter assembly or tubular sheath, and the insertion and handling of an examination device, such as a bronchoscope, to the examination site in the patient's lungs is only negligibly restricted. This reliably prevents exposure of the environment and the treating personnel to potentially infectious particles.In addition to protecting against contamination, the adapter arrangement also ensures rapid operation, which is particularly important for invasive emergency medical procedures. Furthermore, the inventive design, contrary to the properties of prior art designs, enables sterile handling of bronchoscopes or other examination instruments. The adapter arrangement is also flexible enough to allow for a range of different procedures, such as bronchoscopy or lung lavage. The special design of the arrangement also ensures rapid and safe removal and isolation of samples. This can facilitate safe treatment and occupational safety as such, as well as simplify the subsequent examination process.

[0013] The system considered here is a closed intubation system. Endotracheal intubation is generally used when patients require mechanical respiratory support. Another possible application is to create a secure ventilation path when protective reflexes are absent. Intubation prevents obstruction of the upper airway and offers protection against aspiration. During intubation, a cuff (block cuff, small balloon at the end of the endotracheal tube) is inflated while the tube is in position, thus sealing the trachea. This seal prevents stomach contents, blood, or foreign bodies from entering the lungs, or only allows minimal amounts of them to enter. In endotracheal intubation, an endotracheal tube is inserted into the trachea through the mouth (orotracheal), nose (nasotracheal), or a tracheostomy.Intubation is considered the standard method of airway management and is used in anesthesia, intensive care, and emergency medicine, in anesthetized or unconscious patients, or generally in cases of acute respiratory distress. The inserted tube can be a single-lumen or double-lumen tube, allowing separate ventilation of the lungs. The system is considered a closed system in cases where, apart from the ventilator, no significant air exchange with the unprotected ambient air occurs during forced ventilation through the intubation system.

[0014] The intubation system comprises the following components: an endotracheal tube suitable for insertion into a patient's trachea and a tubular connection to a ventilation device. The intubation system therefore comprises at least one connection to an air source for ventilating the patient. In addition to the necessary pressure generator, this device can also have other components, such as a humidifier and a temperature control unit for the breathing air. The ventilation device also has a suitable connection by means of which the breathing air is directed from the ventilation device to the patient. This can be done via a tubular or hose-shaped connection, which ensures both the supply and discharge of the breathing air directly or indirectly to the endotracheal tube. As a further component, the system comprises an endotracheal tube, which can be inserted into the patient's lungs.Endotracheal tubes of different designs can be used in conjunction with the other components of the system.

[0015] The intubation system also includes an adapter assembly with at least three cylindrical receptacles for establishing a gas-tight coupling between the endotracheal tube, the ventilation device connection, and at least one additional receptacle. The adapter assembly serves as a mechanical and gas-tight connecting or coupling piece, in which the supply line from the ventilation device and the endotracheal tube connection are brought together. Due to the tubular design of the endotracheal tube and the usual connection of the ventilation device as a tube connection, the adapter assembly has cylindrical receptacles to which the two tube ends can be fixed in a gas-tight manner. The mechanical connection of the tubes to the receptacles can be achieved using connection types known to those skilled in the art, for example, mechanical plug-in or screw connections.However, it is also possible for the receptacles to be designed independently of one another as coupling pieces, which, with one or more sealing means, enable a simple plug-in connection between the adapter assembly and the hoses. In addition to the receptacles toward the ventilator and toward the endotracheal tube, the adapter assembly also has at least one further connection option, which is mechanically independent of the other two receptacles. Therefore, the presence of only two attachment pieces or receptacles, with the airway between one or more of the components—the ventilator, the endotracheal tube, and the further connection—being at least partially converged before entering the adapter assembly, would not be in accordance with the invention.

[0016] The adapter arrangement comprises at least a) an adapter base body which is T-shaped due to the arrangement of the receptacles and has at least one shut-off device, wherein the shut-off device is designed to open or close the airway between the further receptacle and the two receptacles for the ventilation device and the endotracheal tube in a gas-tight manner. The airway via the further receptacle can be decoupled from the receptacles or connections of the endotracheal tube and the ventilation device, so that no air flow occurs between the further receptacle and the two other receptacles. The shut-off device does not influence or impede the air flow from the ventilation device to the endotracheal tube. The shut-off device can be designed in the form of a mechanically or electrically actuated valve or closure.However, it may also be one or more reversibly closable and openable membranes, provided that the shut-off device can withstand a pressure difference of, for example, more than 100 Pa, furthermore more than 500 Pa and furthermore preferably more than 2.5 kPa between the different ventilation phases of the forced ventilation and the further intake.

[0017] Furthermore, the adapter arrangement b) comprises an adapter attachment that can be coupled to the additional receptacle, wherein the adapter attachment can be connected to the adapter base body in a gas-tight manner via a seal and can be mechanically fixed to the adapter base body via holding means. An adapter attachment can therefore be attached to the additional receptacle of the adapter arrangement in a gas-tight manner, which can be mechanically coupled to the additional receptacle of the adapter arrangement, for example via a plug-in connection. The gas-tight connection can also be established via a coupling connection. The connectability of the adapter attachment ensures that the other parts of the adapter arrangement are only connected to the system when they are actually needed. If pure ventilation of the patient is desired without further examinations, the additional receptacle can be hygienically sealed from the environment via a simple mechanical closure.The adapter attachment can, for example, have a cylindrical or conical symmetry and an extension along its axis of symmetry of, for example, 1 cm up to 10 cm.

[0018] In addition, the adapter arrangement c) comprises an elastic, tubular sleeve arranged at one end on the adapter attachment in a gas-tight manner. The adapter attachment can be connected to the adapter arrangement at one side and is connected to a sleeve at its other end. The sleeve can, for example, be connected to the adapter attachment from the outside. The sleeve can, for example, encompass the entire adapter attachment and be glued or clamped to it from the outside. However, it is also possible for the tubular sleeve to be attached or fastened to the inner edge of the adapter attachment. It is important that the tubular sleeve is connected to the adapter attachment in a gas-tight manner. A tubular sleeve represents a mechanically flexible and movable attachment, which can be realized, for example, using a thin plastic tube or sleeve. The sleeve is elastic in cases where the sleeve can be reversibly compressed and stretched again.For example, an elastic sleeve results in cases where the sleeve can be compressed several times to 1 / 10 of its original length and then pulled apart again. The elastic sleeve can preferably be made of PE or PVC or comprise these polymers. The elastic sleeve can preferably have a diameter of greater than or equal to 0.5 cm and less than or equal to 5 cm, further preferably of greater than or equal to 1.0 cm and less than or equal to 2.5 cm. The elastic sleeve can preferably have a longitudinal extent of greater than or equal to 15 cm and less than or equal to 100 cm, further preferably of greater than or equal to 50 cm and less than or equal to 90 cm. The elastic sleeve can, for example, be fastened to the adapter attachment in a compressed form for storage when not in use.

[0019] Finally, the adapter arrangement d) comprises an attachment which is connected in a gas-tight manner to the other end of the elastic, tubular sheath, the attachment comprising a passage to the tubular sheath with a sealing device arranged therein, the sealing device being designed to receive cylindrically shaped devices and to guide them displaceably and gas-tightly through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube. At the other end of the tubular sheath, a further attachment is attached, which can be connected to the tubular sheath, for example, by means of an adhesive or a clamp. This attachment has a passage to the interior of the tubular sheath, with at least one further sealing means arranged in the passage. The sealing means of this sealing device can be, for example, an O-ring.It is also possible, however, for the seal to be implemented using a flap arrangement. The flap arrangement can open when subjected to mechanical force, for example by inserting a bronchoscope, and allow the bronchoscope to pass through the sealing device of the attachment into the interior of the sheath. The bronchoscope can then be pushed through the sealing device towards the examination site in a gas-tight manner with respect to the environment. The sealing device, as the final seal against the environment, prevents any unwanted escape of potentially infectious particles or aerosols. The infectious particles or aerosols are contained, at the very latest, in the tubular sheath. The attachment can also have means for reversibly fixing the attachment to the adapter attachment or to the adapter arrangement. The attachment can, for example, be held to these components by a magnetic interaction.Accordingly, the attachment can be coupled to the sheath as needed, and the examination and / or treatment can be initiated by inserting the examination devices through the seal of the attachment and through the tubular sheath. The attachment can, for example, be cylindrical, with the inner diameter of the cylinder being, for example, greater than or equal to 0.5 cm and less than or equal to 5 cm, and further preferably greater than or equal to 1 cm and less than or equal to 3.0 cm.

[0020] In a preferred embodiment of the intubation system, the shut-off device can comprise a rotatable closure mechanism consisting of a substantially cylindrically designed base body with a substantially centrally arranged passage, wherein at least two sealing means spaced apart along the axis of symmetry can be arranged in the passage. For secure mechanical guidance and improved handling of a bronchoscope or a suction device, the use of two sealing means within the opening of the cylindrically designed base body of the shut-off device has proven particularly suitable. Within this critical section of the adapter arrangement, the inserted examination object is thus held particularly securely mechanically. In addition, the double seal design contributes to improved sealing with respect to the further adapter arrangement remote from the patient.The use of a double seal at this point is not obvious, as a specialist would assume that a double seal would restrict the bronchoscope's freedom of movement and thus severely impair critical handling characteristics. Furthermore, one might assume that the removal of biological samples from the lungs would be made more difficult, as the passage through the seals now has two constrictions. Surprisingly, neither of these is the case, and thus the improved sealing effect between the closed breathing air circuit and the receptacle for the examination device remains. The two seals can be designed, for example, in the form of O-rings.

[0021] Within a further preferred embodiment of the intubation system, the cylindrically designed base body of the rotatable closure mechanism can comprise a conical recess in the centrally arranged passage in the direction of the further receptacle, wherein the cone angle can be greater than or equal to 20° and less than or equal to 90°. The provision of a conical recess on the closure mechanism can significantly improve the handling properties, for example of bronchoscopes for examining the lungs. On the one hand, inserting and passing the bronchoscope through the opening can be made significantly easier. On the other hand, the cone can increase the lateral mobility of the bronchoscope, which contributes to better maneuverability of cylindrical suction devices or bronchoscopes.These improved properties are particularly achieved in conjunction with a double seal within the opening, whereby the double seal can also contribute to improved sealing even with higher pressure differences or rapid pressure changes. In a further preferred embodiment, the cone angle can be greater than or equal to 30° and less than or equal to 85°, further preferably greater than or equal to 45° and less than or equal to 75°.

[0022] Within a further preferred aspect of the intubation system, the shut-off device in the adapter base body can comprise at least one locking means, wherein the locking means can be configured to hold the shut-off device in a closed position. For the safety of the closed ventilation circuit, it has proven advantageous for the shut-off device of the adapter arrangement to initially be held in a closed position. In this orientation, no air exchange of the further receptacle with the components of the ventilation circuit is possible. In this position, an examination instrument cannot be inserted into the endotracheal tube. The locking means can, for example, be a spring or another mechanical locking means which prevents accidental opening of the shut-off device without significant and deliberate application of force.Only after minimal force is applied can the spring force be overcome, allowing access to the examination instrument to be inserted into the endotracheal tube. In the open position, a bronchoscope, for example, can be inserted into the endotracheal tube. This design can prevent accidental opening of the ventilation circuit, even in hectic situations. In addition to the spring, a spring lock can also be installed, which can, for example, mechanically hold the spring in a corresponding groove. Advantageously, the design of the shut-off device can actively indicate whether the opening is closed or open. The shut-off device can also be made of a transparent material, which not only allows visual control of the open / closed position but also allows monitoring of the procedure for possible blockages.

[0023] According to a preferred characteristic of the intubation system, the shut-off device in the adapter base body can comprise at least one detection means for detecting an object inside the passage of the shut-off device. To increase application safety, it has proven particularly advantageous for the shut-off device in the adapter base body to have a detector that can detect an object in the passage of the shut-off device. The detection means can, for example, be a simple mechanical switch that is triggered upon mechanical contact, for example with a bronchoscope. The detection means can also be electrical or optical, in which case the electrical or optical signal also indicates the presence of an object in the passage of the shut-off device. If the detection means is triggered, for example, the closing of the shut-off device can be blocked.In addition, the detection device can indicate the earliest possible time at which the shut-off device can be safely closed. This can prevent biological material from accidentally becoming trapped in the opening of the shut-off device. Furthermore, the detection device can ensure that the shut-off device closes safely under all circumstances.

[0024] In a further preferred embodiment of the intubation system, the connection of the elastic sheath to the adapter attachment and the connection of the elastic sheath to the attachment can each be individually rotatable. For particularly easy handling of a suction device or a bronchoscope, it can be helpful if those points on the intubation system where a tight seal with the inserted object is important are designed to be rotatable. This can, for example, facilitate the handling of a suction catheter, since no fixed relationships are established between the intubation system and the catheter at these points. This results in greater mechanical freedom and, in particular, prevents unintentional twisting of the elastic sheath. Furthermore, the mechanical forces acting on the adapter arrangement are reduced.By reducing mechanical forces, the surgeon can also manipulate the suction catheter or bronchoscope more precisely and easily.

[0025] Within a preferred aspect of the intubation system, at least part of the adapter base body can be made of a transparent material. For better control during handling and for simple initial assessment of removed biological material, it has proven particularly suitable for the adapter base body to be made at least partially of an optically transparent material. Suitable materials can be selected, for example, from the group of plastics, with sufficiently mechanically strong materials from this group being known to those skilled in the art. In this embodiment, either the entire adapter base body or just a partial area, for example one half, can consist of or comprise the transparent material.

[0026] In a preferred embodiment of the intubation system, the adapter base body can have means for detecting the applied pressure and means for controlling the shut-off device, wherein the opening or closing of the shut-off device can be controlled as a function of the applied pressure. To optimize the opening time of the shut-off device, it has proven advantageous for the adapter base body to be equipped to detect the currently applied pressure of the ventilation device and to enable control of the shut-off device as a function of the applied pressure. For example, it is conceivable that the shut-off device cannot be opened when pressure peaks are currently occurring. The shut-off device can, for example, only be released when a low pressure is currently present during the ventilation cycle.This can reduce the pressure loss when opening the shut-off device and, in particular, also help ensure that the smallest possible amount of aerosols or droplets can escape through the opening of the shut-off device at the moment the device is opened. Suitable means can be, for example, an electronic pressure sensor with integrated or external, electronic control of the shut-off device. In principle, however, it is also possible for the shut-off device to be blocked via a mechanical switch which moves in the adapter arrangement as a function of the current pressure cycle and only allows the shut-off device to be released at lower pressures. In particularly advantageous cases, the adapter arrangement can also be electrically coupled to the ventilation device.In addition to this basic control, other mechanical or electrical means may be present that can override this basic pressure-dependent control in emergencies. In these cases, the surgeon can intervene immediately in an emergency, regardless of the current stage of the ventilation cycle.

[0027] In a further embodiment of the intubation system, a closure cap with a sealing device can be arranged on the adapter base body via a mechanical connecting means, wherein the closure cap can be configured to mechanically close the further receptacle of the adapter base body when the adapter attachment is not coupled. In everyday clinical practice, it has proven particularly advantageous for the further receptacle to be arranged on the adapter base body via a further closure cap, which does not allow the insertion of an examination instrument, and with a corresponding sealing device. In these cases, the actual adapter attachment with the insertion option is only attached directly before the upcoming examination and opening of the shut-off device. The closure cap with the sealing device hygienically protects the adapter base body.A suitable mechanical connection between the closure cap and the adapter base body is, for example, a cord or a polymer strip that flexibly connects the closure cap and adapter base body. After the examination, for example, after removing the suction device, the closure cap with the sealing device can be replaced on the adapter base body.

[0028] In a further preferred embodiment of the intubation system, the elastic, tubular sheath can comprise means for isolating a biological sample. During a patient examination using a bronchoscope or during suctioning, it may be part of clinical routine to take biological samples from the lung cavity. Currently, these samples require cumbersome handling, and the biological samples are usually briefly exposed to the ambient air. To eliminate this source of contamination, it has proven advantageous to use the tubular sheath as a sample container after the examination.For this purpose, the entire tubular sheath or only a part of the tubular sheath can be designed to be detachable, so that after the biological sample from the lung has been introduced into the tubular sheath, this area of ​​the tubular sheath can be isolated from the environment. In this respect, the tubular sheath can have at least two, preferably three, further preferably four individual spaced-apart elements which can locally close the tubular sheath. In this embodiment, one closure can serve to prevent the adapter arrangement from being exposed to the ambient air. The second and third closure options can serve to isolate the biological sample. The fourth closure option can be used to insulate the tubular sheath in the direction of the suction catheter or bronchoscope.These four closure options for the tubular sheath protect the entire system from uncontrolled contact with the ambient air, while also allowing a biological sample to be isolated and collected separately. One possible design for the isolation could be the arrangement of several clips capable of sealing the tubular sheath gas-tight at different points. One or more of the clips could also have cutting devices, for example, allowing the central section containing the biological sample to be severed. This sample can then be passed on while isolated from the ambient air.

[0029] Further advantages and advantageous embodiments of the inventive objects are illustrated by the drawings and explained in the following description. It should be noted that the drawings are for descriptive purposes only and are not intended to limit the invention.

[0030] They show: Fig. 1 schematically shows the structure of the closed intubation system according to the invention; Fig. 2 schematically shows the structure of the adapter arrangement according to the invention; Fig. 3 schematically shows the structure of the adapter base body according to the invention with a connectable adapter attachment; Fig. 4 schematically shows the structure of the adapter base body according to the invention; Fig. 5 schematically shows the structure of the adapter attachment that can be connected according to the invention with an elastic, tubular sheath and a gas-tight connected attachment.

[0031] The Figure 1shows the structure of the closed intubation system 1 according to the invention. The closed intubation system 1 comprises a connection to a ventilation device 2, an endotracheal tube 3, and the adapter arrangement 4 according to the invention. The ventilation device 2 is configured to supply a patient with optionally tempered and humidified breathing air and, in particular, oxygen. For this purpose, air or a specifically composed air mixture is fed into the patient through the closed intubation system 1 via a regulated pressure cycle. The connection of the ventilation device 2 to the adapter arrangement 4 according to the invention is expediently achieved via one or more tubes, wherein the tube of the ventilation device 2 is connected to a receptacle of the adapter arrangement 4.An endotracheal tube 3 can be connected to the second receptacle of the adapter assembly 4, wherein the tube can be inserted into the patient's lungs for ventilation. The adapter assembly 4 also has a further receptacle to which an examination instrument can be connected via the adapter assembly 4. The examination instrument can be, for example, a bronchoscope or a suction device, wherein the examination instruments are designed to be inserted at least partially into the patient's lungs. The examination instrument is inserted into the patient's lungs via the receptacle of the adapter assembly 4, through the endotracheal tube 3.In particular, the design of the adapter attachment 10 of the adapter assembly 4 allows the examination instrument to be guided flexibly and safely, while in particular preventing potentially contaminated aerosols, particles, or droplets from escaping into the environment during the examination. This closed intubation system 1 provides particularly efficient protection for medical personnel from infection during an examination. The closed intubation system 1 is flexible in use and can be handled safely even under hectic examination conditions.

[0032] The Figure 2shows a schematic of the structure of the adapter arrangement 4 according to the invention of the closed intubation system 1. The adapter arrangement 4 comprises a base adapter body 5, which is T-shaped with three receptacles for the tube 3, the ventilation device 2 and the examination instrument. Accordingly, the adapter arrangement 4 has a receptacle 6 for the connection to the ventilation device 2 and a receptacle 7 for the connection to the endotracheal tube 3. These two receptacles 6, 7 can be closed off in a gas-tight manner from the further receptacle 8 by a shut-off device 9. An adapter attachment 10 can be arranged on the further receptacle 8 on the base adapter body 5 in the event that an examination is to be carried out. However, this receptacle 8 can be closed with a cap with a sealing device in cases in which no examination is being carried out.The adapter attachment 10 can therefore only be plugged onto the adapter base body 5 and mechanically secured shortly before an examination is carried out. This figure shows tongue and groove means which can be used for mechanical fixation between the adapter base body 5 and the adapter attachment 10. The adapter attachment 10 can also be connected to the adapter base body 5 in a gas-tight manner via an internal seal. A tubular sheath 11 is arranged on the adapter attachment 10 and connected to it in a gas-tight manner. The tubular sheath 11 serves to flexibly accommodate the front part of the examination instrument and can also accommodate biological samples from the patient. The tubular sheath 11 prevents aerosols or particles from the closed intubation system 1 from being released into the environment when the examination instrument is inserted.Although the aerosols can escape into the area of ​​the adapter base body 5 and possibly through the adapter attachment 10, they are safely contained by the tubular sheath 11 and the attached attachment 12 in conjunction with the examination instrument. Such isolation from aerosols or particles cannot be achieved by simply encapsulating the examination instrument as such in a movable enclosure. It is important to isolate aerosols in an area in which the examination instrument still insulates the environment from the closed intubation system 1. For this purpose, the attachment 12 is connected to the examination instrument in a gas-tight manner via a seal. The insertion of the front part of the examination instrument via the attachment 12, the tubular sheath 11, and the adapter attachment 10 into the essentially closed intubation system 1 is achieved via the shut-off device 9.The shut-off device 9 can, for example, be designed to be rotatable and has an opening for the passage of the examination instrument. After opening the shut-off device 9, the examination instrument can be inserted through the receptacle 7 into the endotracheal tube 3 arranged thereon.

[0033] The Figure 3shows a schematic of the structure of the adapter base body 5 according to the invention with a connectable adapter attachment 10. The adapter base body 5 has a receptacle 6 for the ventilation device and a receptacle 7 for the endotracheal tube 3. These two receptacles can be closed off from the receptacle 8 for the examination instrument by the shut-off device 9. Furthermore, the figure shows the adapter attachment 10, which is designed to be gas-tightly connected to the adapter base body 5 via an internal sealing device. The shut-off device 9 has one or more internal seals (not shown) through which the examination instrument can be pushed during an examination. The shut-off device 9 can also have a locking means in which the shut-off device 9 is locked in the open position (not shown).Furthermore, the shut-off device 9 can be held in the closed position, for example by a spring, whereby the spring force must first be overcome to open the shut-off device 9. This can prevent the shut-off device 9 from opening too easily or accidentally.

[0034] The Figure 4shows a schematic view of the structure of the adapter base body according to the invention, with the receptacle 6 for the ventilation device 2, the receptacle 7 for the endotracheal tube 3, and the further receptacle 8 for connecting the adapter attachment 10 (not shown). The adapter base body 5 can be subdivided by the shut-off device 9. In this case, the shut-off device 9 is cylindrical and has a centrally arranged passage with two internal sealing devices, for example in the form of O-rings or valve leaflets. A cylindrical examination instrument can be guided or pushed through the seals in a gas-tight manner. This figure shows that the centrally arranged passage 13 has a conical recess in the direction of the further receptacle. The cone angle in this case is approximately 20-40°.By creating a conical recess, handling and, in particular, the seamless insertion of the examination instrument into the tube can be made significantly easier. Furthermore, this design allows for faster and more targeted insertion of the examination instrument, even under time pressure. Without being bound by theory, this probably results from the fact that the lower part of suction devices or bronchoscopes can be guided more easily to the actual opening due to their conical design. This can occur, for example, even when the shut-off device 9 is not fully open, which then generates additional force from the examination instrument to open the shut-off device 9.The opening is also more efficiently covered by the examination instrument, which reduces the spread of aerosols or droplets from the patient's lungs towards further imaging 8.

[0035] The Figure 5shows a schematic of the structure of the adapter attachment 10 which can be coupled according to the invention, with an elastic, tubular sheath 11 and a gas-tightly connected attachment 12. The tubular sheath 11 can, for example, have a diameter of greater than or equal to 1.5 cm and less than or equal to 5 cm and a length of greater than or equal to 10 cm and less than or equal to 100 cm. The tubular sheath 11 is connected in a gas-tight manner to both the adapter attachment 10 and the attachment 12 by means of a clamp or an adhesive. The tubular sheath 11 can be pushed together and extended so that the length of the tubular sheath 11 can be changed during the examination. The tubular sheath 11 can also have devices for dividing it into several compartments. The attachment 12 and the adapter attachment 10 each have at least one seal inside them which is or can be adjusted to the diameter of the examination device.Different versions with different seal diameters can also be manufactured. After the examination is completed, for example, a bronchoscope is guided out of the patient's lungs by pulling the bronchoscope towards the attachment 12. The bronchoscope passes through the adapter base body 5 and is guided first through the first and then through the second seal of the shut-off device 9. In this case, any released aerosols are trapped in the adapter base body 5, as the bronchoscope seals against the sealant of the adapter attachment 10. If the bronchoscope is also guided through this seal, any remaining aerosols are trapped in the tubular sheath 11. In this position, or even after the instrument has been passed through the seals of the adapter base body 5, the shut-off device 9 can be closed. This reduces the risk of further aerosols being released from the closed intubation system 1.After partially passing the bronchoscope itself through, the tubular sheath 11 can then be divided into compartments using optional constriction options, allowing any material removed from the lung to be passed for further examination. Finally, the bronchoscope is passed through the sealing attachment 12. The adapter assembly according to the invention can be closed on the attachment 12 with an additional cap and disposed of.

Claims

1. A closed intubation system (1) comprising at least an endotracheal tube (3) suitable for insertion into the trachea of a patient, a tubular connection to a breathing device (2) and an adapter arrangement (4) with at least three cylindrically designed receptacles (6, 7, 8) for establishing a gas-tight coupling between the endotracheal tube (3), the connection of the breathing device (2) and at least one further receptacle (8), wherein the adapter arrangement (4) comprises at least: a) an adapter base body (5) with at least one shut-off device (9), which is configured in a T-shape via the arrangement of the receptacles (6, 7, 8), the shut-off device (9) being designed to open or close the airway between the further receptacle (8) and the two receptacles (6, 7) for the breathing device (2) and the endotracheal tube (3) in a gas-tight manner, b) an adapter attachment (10) that can be coupled to the further receptacle (8), wherein the adapter attachment (10) can be connected in a gas-tight manner to the adapter base body (4) via a seal and is designed to be mechanically fixed to the latter by holding means; c) an elastic, tubular sheath (11) that is arranged in a gas-tight manner at one end on the adapter attachment (10); d) an attachment (12) connected in a gas-tight manner to the other end of the elastic, tubular sheath (11), characterised in that the attachment (12) comprises a passage to the tubular sheath (11) with a sealing device arranged therein, wherein the sealing device is configured to receive cylindrically configured devices and to guide them in a displaceable and gas-tight manner through the attachment (12), the tubular sheath (11), the adapter attachment (10), the adapter base body (5) and the endotracheal tube (3).

2. Intubation system according to claim 1, wherein the shut-off device (9) comprises a rotatable closure mechanism consisting of a substantially cylindrical base body with a substantially centrally arranged passage, wherein at least two sealing means are arranged in the passage, spaced apart from one another along the axis of symmetry.

3. Intubation system according to claim 2, wherein the cylindrically configured base body of the rotatable shut-off mechanism (9) comprises a conical recess (13) in the centrally arranged passage in the direction of the further receptacle, wherein the cone angle is greater than or equal to 20° and less than or equal to 90°.

4. Intubation system according to any one of the preceding claims, wherein the shut-off device (9) in the adapter base body (5) comprises at least one locking means, the locking means being configured to hold the shut-off device (9) in a closed position.

5. Intubation system according to any one of claims 2 to 4, wherein the shut-off device (9) in the adapter base body (5) comprises at least one detection means for detecting an object in the interior of the passage for the shut-off device.

6. Intubation system according to any one of the preceding claims, wherein the connection of the elastic sheath (11) to the adapter attachment (10) and the connection of the elastic sheath (11) to the attachment (12) are each individually rotatable.

7. Intubation system according to any one of the preceding claims, wherein at least a part of the adapter base body (5) is made of a transparent material.

8. Intubation system according to any one of the preceding claims, wherein the adapter base body (5) has means for detecting the applied pressure and means for controlling the shut-off device (9), wherein the opening or closing of the shut-off device (9) can be controlled as a function of the applied pressure.

9. Intubation system according to any one of the preceding claims, wherein a sealing cap with a sealing device is arranged on the adapter base body (5) using a mechanical connecting means, the sealing cap being designed to mechanically seal the further receptacle (8) on the adapter base body when the adapter attachment (10) is not coupled.

10. An intubation system according to any one of the preceding claims, wherein the elastic tubular sheath (11) comprises means for isolating a biological sample.