Closed cannula system with improved airway access for an inspection device

Abstract

The invention relates to a closed intubation system comprising at least one endotracheal tube adapted to be inserted into the trachea of a patient, a tubular connection to a ventilation device and an adapter device with at least three cylindrical containers, the connection of the ventilation device and at least one further container, wherein the adapter device comprises at least: a) an adapter base body which is designed in a T shape by the arrangement of the containers with at least one closure device designed to open or close the air passage between the further container and the two containers for the ventilation device and the endotracheal tube in an air-tight manner, b) an adapter attachment which can be coupled to the further container, wherein the adapter attachment can be connected to the adapter base body in an air-tight manner via a seal and can be mechanically fixed to the adapter base body by a holding device; c) an elastic tubular sheath which is arranged in an air-tight manner on one end of the adapter attachment; d) an attachment connected to the other end of the elastic tubular sheath in an air-tight manner, the attachment comprising a passage to the tubular sheath, the passage having a sealing device arranged therein, wherein the sealing device is designed for receiving cylindrical devices and guiding these devices in a displaceable and air-tight manner through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube.

Description

Technical Field

[0001] This invention relates to a closed intubation system comprising at least one endotracheal tube adapted for insertion into a patient's trachea, a tubular connector connected to a ventilation device, and an adapter device having at least three cylindrical containers for creating an airtight coupling between the endotracheal tube, the tubular connector of the ventilation device, and at least one additional container, wherein the adapter device comprises at least:

[0002] a) An adapter base, the adapter base being designed in a T-shape by means of the arrangement of the container and at least one closure device, the closure device being designed to open or close in an airtight manner the air passage between the other container and the two containers for the ventilation device and the endotracheal tube.

[0003] b) An adapter accessory that can be coupled to the other container, wherein the adapter accessory can be hermetically connected to the adapter base via a seal and can be mechanically secured to the adapter base via a retaining device;

[0004] c) A flexible tubular sheath, which is airtightly disposed at one end on the adapter accessory;

[0005] d) An accessory that is airtightly connected to the other end of the resilient tubular sheath, wherein the accessory includes a channel leading to the tubular sheath, the channel having a sealing device configured to receive and guide cylindrical devices in a displaceable and airtight manner through the accessory, the tubular sheath, the adapter accessory, the adapter base, and the endotracheal tube. Background Technology

[0006] Today, employees working in the healthcare system face increasing personal stress. This largely applies to hospital staff, particularly nurses and intensive care unit personnel who have direct contact with patients. For the latter, the increasing workload and widespread shortage of nursing staff in recent years have led to a particularly increased potential risk, further exacerbated by outbreaks of Severe Acute Respiratory Syndrome (SARS-CoV-2), which have resulted in a significant increase in ICU cases and patient infectivity. Many mechanically ventilated pneumonia patients suffer from acute respiratory distress syndrome (ARDS), requiring positive end-expiratory pressure (PEEP) ventilation and the use of humidified, temperature-controlled ventilation air. However, in intensive care, life-threatening complications such as severe pulmonary hemorrhage (>200 ml / 24 hours), foreign bodies in the lungs, atelectasis, or similar conditions may require immediate bronchoscopy or bronchoalveolar lavage (BAL) for treatment and sampling. Emergency measures often necessitate opening closed ventilation circuits, releasing aerosols and droplets into the ambient air. This carries a significant risk of exposure to infectious diseases (MERS, influenza, tuberculosis, etc.) for directly involved healthcare personnel. Due to these risks, obtaining samples from the patient's upper respiratory tract may be an option, potentially leading to secondary infections that are either undiagnosed or diagnosed too late. Therefore, even with highly infectious patients, there is a need for technical assistance that allows for safe and simple treatment or sampling of their lungs without posing risks to treatment personnel.

[0007] The patent documents also contain various methods for designing compatible closed intubation systems, bronchoscopes, and aspiration catheters.

[0008] For example, US 4850350 describes a closed system with a combined medical surgical aspiration and ventilation device, the closed system comprising (1) an aspiration catheter; (2) an aspiration control valve positioned distal to the system; (3) a multi-port coupling assembly through which the catheter is passed for aspiration of a patient; (4) a flexible tubular sheath providing sterile protection for the catheter, the distal end of which is connected to the proximal end of the coupling unit; and (5) a sheath release valve. The coupling unit has two separate elements, one of which is axially fitted into the other such that they are rotatable relative to each other about their longitudinal axes to close and open the access route of the catheter from the sheath through the coupling unit to the patient. The aspiration control valve has substantially identical first and second parts positioned along the longitudinal side, which are slidably engaged with each other to move between an open and closed position of the valve. A sheath safety valve prevents contamination of the sheath with air during use of the assembly.

[0009] US 2010 / 0154779A1 describes an airway access assembly comprising: a movable connector having at least one opening communicating with a patient's artificial airway; a closed suction catheter assembly including at least one connector end, a suction catheter, and a sheath located above the suction catheter, the connector end having an opening formed therethrough; a shuttle movable between an opening in the connector of the closed suction catheter assembly and an opening in the connector end, the shuttle having an opening formed therethrough and configured to move relative to the connector to a locked position and an unlocked position; an actuator for moving the shuttle to the locked position and the unlocked position; and a flap positioned adjacent to the shuttle and the closed suction catheter assembly, the flap being movable to an open position, wherein when the shuttle is in the locked position, the suction catheter is allowed to enter the artificial airway, and the flap being movable to a closed position, wherein when the shuttle is in the unlocked position, the suction catheter is prevented from passing through the shuttle.

[0010] For example, Koehler P., Cornely OA, and Kochanek M., in their "Bronchoscopic Safety Precautions for Diagnosing Pneumonia-Associated Periarthritis - A Simulation Study" published in Mycology 2020, demonstrated the possibility and importance of protecting intensive care physicians from unnecessary infections caused by the escape of infectious particles during ventilation of pneumonia patients.

[0011] Such solutions, known from existing technologies, can offer potential for further improvements, particularly regarding their applicability in reducing ambient air exposure during intensive care interventions with closed ventilation circuits. Summary of the Invention

[0012] Therefore, the object of the present invention is to at least partially overcome the disadvantages known in the prior art. In particular, the object of the present invention is to provide a closed intubation system that enables patients to be safely ventilated and to undergo enhanced medical examinations simply without unintentionally releasing aerosol particles or droplets into the ambient air.

[0013] This problem is solved by addressing the features of the independent claims relating to the device according to the invention. Preferred embodiments of the invention are indicated in the dependent claims, description, or drawings, whereby further features described or shown in the dependent claims, description, or drawings may individually or in any combination constitute the purpose of the invention, provided that no explicit indication to the contrary is given herein.

[0014] According to the invention, the closed intubation system therefore includes at least one endotracheal tube adapted for insertion into a patient's trachea, a tubular connector connected to a ventilation device, and an adapter device having at least three cylindrical containers for creating an airtight coupling between the endotracheal tube, the tubular connector of the ventilation device, and at least one additional container, wherein the adapter device includes at least:

[0015] a) An adapter base, the adapter base being designed in a T-shape by means of the arrangement of the container and at least one closure device, the closure device being designed to open or close the air passage between the other container and the two containers for the ventilation device and the endotracheal tube in an airtight manner.

[0016] b) An adapter accessory that can be coupled to the other container, wherein the adapter accessory can be hermetically connected to the adapter base by a seal and can be mechanically secured to the adapter base by a retaining device;

[0017] c) A flexible tubular sheath, one end of which is airtightly attached to the adapter accessory;

[0018] d) An accessory that is airtightly connected to the other end of the resilient tubular sheath, the accessory including a channel leading to the tubular sheath, the channel having a sealing device configured to receive and guide cylindrical devices in a displaceable and airtight manner through the accessory, the tubular sheath, the adapter accessory, the adapter base, and the endotracheal tube.

[0019] Surprisingly, it has been shown that closed-loop intubation systems with the aforementioned adapter structure can be used to ensure simple, rapid, and safe treatment and sampling of the airways of even highly infectious patients, without any droplets or aerosols escaping from the closed loop into the surrounding air. Potentially released particles are securely contained within the adapter device or tubular sheath, and the insertion and handling of examination devices (e.g., bronchoscopes) into the patient's lungs is limited to negligible levels. In this way, exposure of potentially infectious particles to the environment and the treated population can be reliably prevented. In addition to contamination safety, the adapter device ensures rapid operability, which is particularly important in emergency medical and invasive procedures. Furthermore, unlike the characteristics of structures known in the prior art, the structure according to the invention enables aseptic handling of bronchoscopes or other examination instruments. The adapter device is also highly flexible, allowing for a range of different procedures, such as bronchoscopy or lung lavage. The special design of the adapter device also ensures rapid and safe sample removal and isolation. Besides safe treatment and occupational safety, this also simplifies further examination procedures.

[0020] The system considered here is a closed intubation system. Endotracheal tubes are typically used when a patient requires mechanical ventilation support. Another possible application is creating a safe ventilation route in the absence of protective reflexes. Intubation prevents upper airway obstruction and provides protection against aspiration. During intubation, a cuff (an occlusion cuff, a small balloon at the end of the endotracheal tube) is inflated at the tube location to seal the trachea. This seal prevents stomach contents, blood, or foreign bodies from entering the lungs, or allows only small amounts to enter. In an endotracheal tube, the endotracheal tube is inserted into the trachea through the mouth (orotrachea), nose (nasotrachea), or tracheostomy. Intubation is the standard method for airway fixation, used in anesthesia, intensive care, and emergency medicine, for anesthetized or comatose patients, or generally for acute respiratory disturbances. The inserted tube can be a single-lumen or double-lumen tube, which allows for lateral separation ventilation of the lungs. During forced ventilation outside of a ventilator using an intubation system, where there is no significant air exchange with unprotected ambient air, the system is a closed system.

[0021] As components, the intubation system includes an endotracheal tube adapted for insertion into a patient's trachea and a tubular connector to a ventilation device. The intubation system therefore includes at least one connection to an air source for ventilating the patient. In addition to the necessary pressure generator, the device may also have other components such as a humidifier and a temperature control unit for the breathing air. The ventilation device also has suitable connections through which breathing air is supplied from the ventilation device to the patient. This can be done via a tubular or tubular connector, ensuring that breathing air is supplied and removed directly or indirectly to the endotracheal tube. Another component of the system is the endotracheal tube, which can be inserted into the patient's lungs. Endotracheal tubes of different designs can be used in combination with other components of the system.

[0022] The intubation system also includes an adapter assembly with at least three cylindrical containers for forming an airtight coupling between the endotracheal tube, the ventilation device, and at least one additional container. The adapter assembly, in which the supply line from the ventilation device and the connector of the endotracheal tube are joined together, serves as a mechanical and airtight connection or coupling element. Due to the tubular design of the endotracheal tube and its typical connection to the ventilation device, the adapter assembly therefore has a cylindrical container to which the two tube ends can be airtightly secured. The mechanical connection between the tube and the container can be made using connection types known to those skilled in the art, such as mechanical insertion or threaded connections. However, the containers can also be designed independently of each other as coupling elements, allowing for a simple insertion connection between the adapter assembly and the tubing using one or more sealants. In addition to the containers in the direction of the ventilation device and the endotracheal tube, the adapter assembly has at least one additional connection option that is mechanically independent of the other two containers. Therefore, if there are only two attachments or containers, and the air paths between one or more of the ventilator, endotracheal tube, and other connecting components are at least partially combined before entering the adapter device, this would not conform to the present invention.

[0023] The adapter device includes at least a) an adapter base designed in a T-shape by means of a container arrangement having at least one closure device, the closure device being designed to open or close in an airtight manner the air passage between the additional container and the two containers of the ventilation device and the endotracheal tube. The air passage can be decoupled from the containers or connectors of the endotracheal tube and the ventilation device via the additional container, so that there is no airflow between the additional container and the other two containers. The closure device does not affect or impede airflow from the ventilation device to the endotracheal tube. The closure device can take the form of a mechanically or electrically operated valve or closure. However, it can also be one or more reversibly closable and openable diaphragms, provided that the closure device can withstand, for example, a pressure difference greater than 100 Pa, greater than 500 Pa, and preferably greater than 2.5 kPa, between different ventilation stages of forced ventilation and further entry.

[0024] Furthermore, adapter device b) includes an adapter accessory that can be coupled to the other container, wherein the adapter accessory can be hermetically connected to the adapter base via a seal and can be mechanically secured to the latter by a retaining device. Thus, the adapter accessory can be hermetically attached to another container of the adapter device, for example, mechanically coupled to the other container of the adapter device via an insert connection. A hermetically tight connection can also be achieved via a coupling connection. The connectability of the adapter accessory ensures that other parts of the adapter device are connected to the system only when actually needed. If pure ventilation of the patient is required without further examination, a further adapter can be hygienically sealed to the environment with a simple mechanical seal. The adapter accessory can, for example, have cylindrical or conical symmetry, and its extension along its axis of symmetry is, for example, 1 cm to 10 cm.

[0025] Furthermore, the adapter device c) includes a resilient tubular sheath, one end of which is arranged in an airtight manner on the adapter accessory. The adapter accessory may be connected to the adapter device at one end and to the sheath at the other end. For example, the sheath may be externally connected to the adapter accessory. For example, a cap may surround the entire adapter accessory and be externally glued or clamped to it. However, it is also possible that the tubular cap is attached or fastened to the inner edge of the adapter accessory. Importantly, the tubular cap is airtightly connected to the adapter accessory. The tubular sleeve is a mechanically flexible and movable accessory, which may be achieved, for example, by means of a thin plastic tube or sleeve. The sleeve is resilient in that it can be reversibly compressed and restretched. For example, a resilient sleeve is produced when the sleeve can be compressed to 1 / 10 of its original length and then stretched several times. Preferably, the resilient sleeve may be made of PE or PVC, or include these polymers. The diameter of the resilient sheath is preferably greater than or equal to 0.5 cm and less than or equal to 5 cm, more preferably greater than or equal to 1.0 cm and less than or equal to 2.5 cm. The length of the elastic sleeve is preferably greater than or equal to 15 cm and less than or equal to 100 cm, more preferably greater than or equal to 50 cm and less than or equal to 90 cm. When not in use, for storage, the elastic sleeve can be attached to the adapter attachment, for example, in a compressed form.

[0026] Finally, adapter device d) includes an accessory that is hermetically attached to the other end of the resilient tubular sheath, wherein the accessory includes a channel leading to the tubular sheath, and a sealing device is disposed therein, wherein the sealing device is designed to receive cylindrical devices and guide these devices in a displaceable and hermetically sealed manner through the accessory, the tubular sheath, the adapter accessory, the adapter base, and the endotracheal tube. Another accessory is coupled to the other end of the tubular sheath, which may be attached to the tubular sheath, for example, by adhesive or clamp. This accessory has a channel leading to the interior of the tubular sheath, in which at least one additional sealant is fitted. The sealant of this sealing device may, for example, be an O-ring. However, a seal may also be achieved by a flap device. When mechanical force is applied, for example by inserting a bronchoscope, the flap device can open, allowing the bronchoscope to pass through the sealing device of the accessory into the interior of the sheath. Thus, the bronchoscope can be pushed through the sealing device in the direction of the examination site, hermetically sealed to the environment. The sealing device acts as a final seal to the environment, preventing the unintentional escape of potentially infectious particles or aerosols. Infectious particles or aerosols are retained in the tubular sheath at the latest. The attachment may also have means for reversibly securing the attachment to the adapter attachment or adapter device. For example, the attachment may be held to these components by magnetic interaction. Thus, if desired, the attachment can be coupled to the sheath, and examination and / or treatment can be initiated by inserting an examination device through the seal and tubular sheath of the attachment. The attachment may, for example, be cylindrical, wherein the inner diameter of the cylinder may, for example, be greater than or equal to 0.5 cm and less than or equal to 5 cm, and more preferably greater than or equal to 1 cm and less than or less than 3.0 cm.

[0027] In a preferred embodiment of the intubation system, the closure device may include a rotatable closure mechanism consisting of a substantially cylindrical base with a substantially centrally arranged channel, wherein at least two sealing devices spaced apart along an axis of symmetry may be arranged within the channel. For safe mechanical guidance and improved operation of the bronchoscope or aspiration device, the use of two sealing devices within the opening of the cylindrical base of the closure mechanism has proven particularly suitable. Within this critical part of the adapter device, the inserted examination object is mechanically held in a particularly safe manner. Furthermore, the double-seal design helps improve the seal against other adapter devices located away from the patient. The use of a double seal at this point is not obvious, as those skilled in the art would have to assume that a double seal would prevent free movement of the bronchoscope, thus unduly impairing critical handling performance. It could also be assumed that removing biological samples from the lungs would become more difficult, since there would now be two constrictions through the sealed channel. Unexpectedly, neither is true, thus the improved sealing effect remains between the closed breathing air circuit and the container for the examination device. For example, the two seals could be designed in the form of O-rings.

[0028] In another preferred embodiment of the intubation system, the cylindrical design of the rotatable closure device may include a tapered recess in a centrally arranged channel in the direction of another container, whereby the cone angle may be greater than or equal to 20° and less than or equal to 90°. Connecting the tapered recess to a locking mechanism can significantly improve operability, for example, in bronchoscopes used for examining the lungs. On the one hand, inserting the bronchoscope and passing it through the opening becomes much easier. On the other hand, the tapering can increase the lateral mobility of the bronchoscope, which contributes to better maneuverability of the cylindrical suction device or bronchoscope. These improved properties, in particular, combine with a double seal within the opening, thereby particularly contributing to improved sealing, even under conditions of high pressure differentials or rapid pressure changes. In another preferred embodiment, the cone angle may be greater than or equal to 30° and less than or equal to 85°, more preferably greater than or equal to 45° and less than or equal to 75°.

[0029] In another preferred aspect of the intubation system, the closure device in the adapter body may include at least one locking device, which can be configured to hold the closure device in a closed position. For the security of the closed ventilation circuit, it has proven advantageous for the closure device of the adapter assembly to initially remain in the closed position. In this position, there is no air exchange between the other adapter and the components of the ventilation circuit. In this position, the examination instrument cannot be inserted into the endotracheal tube. The locking device may be, for example, a spring or other mechanical locking device that prevents the locking device from being accidentally opened without significant and intentional force. Only after a minimal amount of force is applied can the spring force be overcome and the passage for inserting the examination instrument into the endotracheal tube be released. In the open position, for example, a bronchoscope can be inserted into the endotracheal tube. This design also prevents accidental opening of the ventilation circuit under busy conditions. In addition to the spring, a spring lock may be installed, which, for example, can mechanically hold the spring in a corresponding recess. Advantageously, the closure device is designed to actively indicate whether the opening is closed or open. The closure device may also be made of a transparent material that, in addition to allowing visual inspection of the open / closed position, allows operation to check for possible obstructions.

[0030] According to preferred features of the intubation system, the closure device in the adapter base may include at least one detection device for detecting an object within the channel of the closure device. For improved safety, it has proven particularly advantageous for the closure device in the adapter base to have a detector capable of detecting an object within the channel of the closure device. The detection device may be a simple mechanical switch, for example, triggered upon mechanical contact with the bronchoscope. However, the detection device may also be of the electrical or optical type, in which case the electrical or optical signal also indicates the presence of an object in the channel of the closure device. If the detection device is triggered, the closure of the closure device may, for example, be blocked. Furthermore, the detection device may indicate the earliest possible time when the closure device can be safely closed. This prevents biological materials from unintentionally becoming lodged in the opening of the closure device. The detection device also ensures that the closure device closes safely under all circumstances.

[0031] In another preferred embodiment of the intubation system, the connection between the elastic sheath and the adapter accessory, as well as the connection between the elastic sheath and the accessory, can each be designed to be independently rotatable. It is helpful that critical locations in the intubation system where there is a tight seal for the inserted object are designed to be rotatable, for particularly easy handling of the aspiration device or bronchoscope. This facilitates the manipulation of the aspiration catheter, for example, because there is no fixed relationship between the intubation system and the catheter at these locations. This results in a greater degree of mechanical freedom, particularly preventing unintentional twisting of the elastic sheath. Furthermore, it reduces the mechanical forces acting on the adapter accessory. By reducing mechanical forces, surgeons can also manipulate the aspiration catheter or bronchoscope more precisely and easily.

[0032] In a preferred aspect of the cannulation system, at least a portion of the adapter substrate may be made of a transparent material. For better control of processing and a simple initial assessment of the removed biological material, the adapter substrate has been found particularly suitable to be at least partially composed of an optically transparent material. Suitable materials may be selected, for example, from the group of plastics, from which those skilled in the art are familiar with materials of sufficient mechanical strength. In this embodiment, the entire adapter substrate, or only a portion thereof, such as half, may be made of or have a transparent material.

[0033] In a preferred embodiment of the intubation system, the adapter base includes means for detecting the applied pressure and means for controlling the closure device, whereby the opening or closing of the closure device can be controlled as a function of the applied pressure. To optimize the opening time of the closure device, it has proven advantageous to equip the adapter base with means that detect the pressure currently applied to the ventilation device and allow the closure device to be controlled as a function of the applied pressure. For example, it is conceivable that if a pressure peak is present, the closure device cannot open. For example, the closure device can only be released when the current pressure is low during a ventilation cycle. This reduces pressure loss when the closure device opens and, in particular, helps to ensure that as little aerosol or droplet as possible escapes through the opening of the closure device when it is opened. Suitable means may be, for example, an electronic pressure sensor with integrated or external electronic control of the closure device. However, in principle, the closure device can also be locked by a mechanical switch that moves as a function of the current pressure cycle present in the adapter device and only allows the closure device to be released at lower pressures. In a particularly advantageous case, the adapter device may also be electrically coupled to the ventilation device. In addition to these basic controls, additional mechanical or electrical devices can be provided that can override these basic pressure-related controls in emergency situations. In these cases, the operator can intervene immediately in an emergency, regardless of the current stage of the ventilation cycle.

[0034] In another embodiment of the cannulation system, a sealing cap with a sealing device can be disposed on the adapter base via a mechanical connection, whereby the sealing cap can be designed to mechanically close another container of the adapter base when the adapter accessory is not coupled. In routine clinical practice, it has proven particularly advantageous that the additional container is, in principle, disposed on the adapter base only by an additional sealing cap that does not allow insertion of an examination instrument with a corresponding sealing device. In these cases, the actual adapter accessory with insertion options is installed directly only before the upcoming examination and opening / closing of the device. The adapter base is sanitarily protected by the sealing cap with the sealing device. A suitable mechanical connection for the connection between the sealing cap and the adapter base is, for example, a rope or polymer strap, which movably connects the sealing cap and the adapter base to each other. After the examination is completed, for example after the aspiration device is removed, the sealing cap with the sealing device can be returned to the adapter base.

[0035] In another preferred embodiment of the intubation system, the resilient tubular sheath may include a device for isolating biological samples. This may be part of a bronchoscopy procedure or an aspiration procedure. Collecting biological samples from the lung cavities is often a routine clinical practice. Currently, these samples are handled in a cumbersome manner, and the biological samples are typically exposed to ambient air for a short period. To eliminate this source of contamination, it has proven advantageous to use the tubular sheath as a sample container at the end of the procedure. For this purpose, the entire tubular sheath, or only a portion thereof, may be designed to be removable, thus isolating that area of ​​the tubular sheath from the environment after the biological sample from the lung has been introduced. In this regard, the tubular sheath may have at least two, preferably three, more preferably four spaced apart individual elements that can partially close the tubular sheath. In this embodiment, the closure may be used to prevent the adapter device from being exposed to ambient air. Second and third closure options may be used to separate the biological sample. A fourth closure option may be used to isolate the tubular sheath in the direction of the aspiration catheter or bronchoscope. Therefore, the entire system can be protected from uncontrolled contact with ambient air, and the four closure options for the tubular sheath can be used to separate and remove biological samples. One possibility for designing the insulation layer is, for example, arranging several clamps that can airtightly seal the tubular cap at different points. For example, one or more clamps could also have a cutting device that can cut off the middle portion containing the biological sample. It can then be transported in isolation from ambient air. Attached Figure Description

[0036] Further advantages and advantageous embodiments of the invention are illustrated by the accompanying drawings and explained in the following description. It should be noted that the drawings are descriptive only and are not intended to limit the invention.

[0037] The attached image shows:

[0038] Figure 1 The structure of the closed-loop cannulation system according to the present invention is schematically shown;

[0039] Figure 2 The structure of the adapter device according to the present invention is schematically shown;

[0040] Figure 3 The structure of a basic adapter body with connectable adapter accessories according to the present invention is illustrated schematically;

[0041] Figure 4 The structure of the adapter base according to the present invention is schematically shown;

[0042] Figure 5The structure of an adapter accessory according to the invention is schematically shown, the adapter accessory being coupled to a resilient tubular cap and an airtight connection accessory. Detailed Implementation

[0043] Figure 1 The structure of a closed intubation system 1 according to the invention is shown. The closed intubation system 1 according to the invention includes connections to a ventilation device 2, an endotracheal tube 3, and an adapter device 4. The ventilation device 2 is configured to provide the patient with breathing air, possibly blended and humidified, particularly oxygen. For this purpose, air or an air mixture of a specific composition is supplied to the patient via a controlled pressure cycle through the closed intubation system 1. The ventilation device 2 is connected to the adapter device 4 according to the invention via one or more tubing, wherein the tubing of the ventilation device 2 is connected to a container of the adapter device 4. The endotracheal tube 3 can be connected to a second container of the adapter device 4, whereby the tube can be inserted into the patient's lungs to ventilate the patient. The adapter device 4 also has a separate container to which an examination instrument can be connected. The examination instrument can be, for example, a bronchoscope or a suction device, whereby the examination instrument is designed to be at least partially inserted into the patient's lungs. The examination instrument is inserted into the patient's lungs through the endotracheal tube 3 via the adapter device 4. In particular, the adapter accessory 10 of the adapter device 4 is designed to allow for flexible and safe guidance of the examination instrument, thereby preventing potentially contaminating aerosols, particles, or droplets from entering the environment during the examination. This closed intubation system 1 provides particularly effective protection for medical personnel against infection during examinations. The closed intubation system 1 is flexible to use and can be safely handled even under busy examination conditions.

[0044] Figure 2The structure of an adapter device 4 according to the closed intubation system 1 of the present invention is schematically shown. The adapter device 4 includes a basic adapter base 5, which is T-shapedly connected to the tube 3, the ventilation device 2, and the examination instrument via three containers. Thus, the adapter device 4 has a container 6 for connection to the ventilation device 2 and a container 7 for connection to the endotracheal tube 3. These two containers 6 and 7 can be closed airtightly relative to another container 8 via a closing device 9. In the case of an examination, an adapter attachment 10 can be disposed on another container 8 on the adapter base 5. However, when not undergoing an examination, this container 8 can be closed with a cap with a sealing device. Therefore, before an examination, the adapter attachment 10 can simply be placed on the adapter base 5 and mechanically secured. In this figure, tongue-shaped and groove-shaped devices are shown for this purpose, used for mechanical fixation between the adapter base 5 and the adapter attachment 10. The adapter attachment 10 can also be airtightly connected to the adapter base 5 via an internal seal. A tubular sheath 11 is disposed on the adapter attachment 10 and airtightly connected to the adapter attachment 10. The tubular sheath 11 is used to flexibly hold the front of the examination instrument and can also hold biological samples from the patient. When the examination instrument is inserted, the tubular sheath 11 prevents aerosols or particles from being released from the closed cannulation system 1 into the environment. Although aerosols can escape into the area of ​​the adapter base 5 and possibly through the adapter attachment 10, they are securely surrounded by the tubular sheath 11 and the attachment 12 attached thereto with the examination instrument. This isolation from aerosols or particles cannot be achieved if the examination instrument is simply encapsulated in a movable housing. It is important to isolate aerosols in the area where the examination instrument still isolates the environment from the closed cannulation system 1. For this purpose, the attachment 12 is connected to the examination instrument in an airtight manner via a seal. The front of the examination instrument is inserted into the self-closed cannulation system 1 via the attachment 12, the tubular sheath 11, and the adapter attachment 10; this insertion is made via a closure device 9. The closure device 9 can be designed, for example, to be rotatable and has an opening for the passage of the examination instrument. After the closure device 9 is opened, the examination instrument can be inserted into the endotracheal tube 3 placed thereon through the container 7.

[0045] Figure 3The structure of a basic adapter base 5 with a connectable adapter accessory 10 according to the present invention is schematically shown. The basic adapter base 5 has a container 6 for a ventilation device and a container 7 for an endotracheal tube 3. These two containers can be blocked from the container 8 toward the examination instrument by a blocking device 9. The figure also shows the adapter accessory 10, which can be airtightly connected to the adapter base 5 by an internal sealing device. The closing device 9 has one or more seals (not shown) internally through which the examination instrument can be pushed during the examination. The closing device 9 may also have a locking device in which it is locked in the open position (not shown). Furthermore, the closing device 9 can be held in the closed position, for example by a spring, whereby the spring force must first be overcome before the closing device 9 can be opened. This prevents the closing device 9 from being opened too easily or accidentally.

[0046] Figure 4 The structure of the basic adapter body according to the invention is schematically shown, including a container 6 for the ventilation device 2, a container 7 for the endotracheal tube 3, and another container 8 for connecting the adapter accessory 10 (not shown). The basic adapter body 5 can be subdivided by a closure device 9. In this case, the closure device 9 is cylindrical and has a centrally arranged channel with two internal sealing devices, such as O-rings or wing seals. The cylindrical examination instrument can be guided or pushed through the seals in an airtight manner. In this figure, it can be seen that the centrally arranged channel 13 has a conical recess in the direction of the other container. In this case, the cone angle is approximately 20-40°. By forming the conical recess, operation can be significantly facilitated, especially the insertion of the examination instrument into the tube without contact. Furthermore, even under time pressure, this design allows for faster and more targeted insertion of the examination instrument. Without being bound by theory, this may be because the lower shape of the suction device or bronchoscope can be more easily guided to actual opening due to its conical design. For example, this can happen even when the closure device 9 is not fully open, causing the examination instrument to apply additional force to open the closure device 9. The opening is also more effectively covered by the examination instrument, which reduces the propagation of aerosols or droplets from the patient's lungs in the direction of further inhalation 8.

[0047] Figure 5The structure of adapter accessory 10 is schematically shown. According to the invention, adapter accessory 10 can be coupled to a resilient tubular sheath 11 and an airtightly connected accessory 12. The tubular sheath 11 can have, for example, a diameter greater than or equal to 1.5 cm and less than or equal to 5 cm and a length greater than or equal to 10 cm and less than or equal to 100 cm. The tubular sheath 11 is airtightly connected to adapter accessory 10 and accessory 12 by clamping or engaging. The tubular sheath 11 can be pushed together and pulled out, such that the length of the tubular sheath 11 can be changed during the examination. The tubular sheath 11 can also have means for dividing it into several compartments. Accessory 12 and adapter accessory 10 each have at least one seal inside, which is adapted or can be adapted to the diameter of the examination device. Different versions with different seal diameters can also be produced. Once the examination is completed, for example, the bronchoscope is removed from the patient's lung by pulling the bronchoscope toward accessory 12. The bronchoscope passes through adapter body 5, then is guided through the first seal, and then through the second seal of closure device 9. In this configuration, any potentially released aerosols are contained within the adapter base 5 due to the sealant of the bronchoscope-sealed adapter accessory 10. If the bronchoscope also passes through this seal, any residual aerosols are retained within the tubular sheath 11. The closure device 9 can be closed in this position, or after the instrument has passed through the seal of the adapter base 5. This reduces the risk of further aerosol release from the closed intubation system 1. Then, after the bronchoscope itself has been partially passed through, the tubular sheath 11 can be divided into multiple compartments via an optional shrink-off option, whereby any material removed from the lungs can be used for further examination. Finally, the bronchoscope passes through the sealing accessory 12. The adapter device according to the invention can be sealed to accessory 12 with another cap and discarded.

Claims

1. A closed intubation system (1) comprising at least one endotracheal tube (3) adapted for insertion into a patient's trachea, a tubular connector connected to a ventilation device (2), and an adapter device (4) having at least three cylindrical containers (6, 7, 8) for creating an airtight coupling between the endotracheal tube (3), the tubular connector of the ventilation device (2), and at least one additional container (8), characterized in that, The adapter device (4) includes at least: a) An adapter base (5) designed in a T-shape by means of the arrangement of the containers (6, 7, 8) and at least one closing device (9), the closing device (9) being designed to open or close the air passage between the additional container (8) and two of the cylindrical containers (6, 7) for the ventilation device (2) and the endotracheal tube (3) in an airtight manner. b) An adapter attachment (10) that can be coupled to the other container (8), wherein the adapter attachment (10) can be hermetically connected to the adapter base (5) by a seal and can be mechanically secured to the latter by a retaining device; c) An elastic tubular sheath (11), one end of which is airtightly mounted on the adapter accessory (10); d) Attachment (12), which is airtightly connected to the other end of the elastic tubular sheath (11), the attachment (12) including a channel leading to the elastic tubular sheath (11), the channel being provided with a sealing device, wherein the sealing device is designed to receive a cylindrical device and guide it through the attachment (12), the elastic tubular sheath (11), the adapter attachment (10), the adapter base (5) and the endotracheal tube (3) in a displaceable and airtight manner.

2. The cannulation system according to claim 1, wherein, The closing device (9) includes a rotatable closing mechanism consisting of a substantially cylindrical base having a substantially centrally arranged channel in which at least two sealing devices spaced apart along an axis of symmetry are arranged.

3. The cannulation system according to claim 2, wherein, The cylindrical design of the rotatable closure mechanism includes a tapered recess (13) in the centrally arranged channel along the direction of the other container, wherein the cone angle is greater than or equal to 20° and less than or equal to 90°.

4. The cannulation system according to any one of the preceding claims, wherein, The closing device (9) in the adapter base (5) includes at least one locking device, wherein the locking device is arranged to hold the closing device (9) in a closed position.

5. The cannulation system according to any one of claims 2 to 4, wherein, The closing device (9) in the adapter base (5) includes at least one detection device for detecting objects within the channel of the closing device.

6. The cannulation system according to any one of the preceding claims, wherein, The connection between the elastic tubular sheath (11) and the adapter accessory (10), as well as the connection between the elastic tubular sheath (11) and the accessory (12), are all designed to be rotatable independently.

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

8. The cannulation system according to any one of the preceding claims, wherein, The adapter base (5) includes a device for detecting the applied pressure and a device for controlling the closing device (9), wherein the opening or closing of the closing device (9) is controllable as a function of the applied pressure.

9. The cannulation system according to any one of the preceding claims, wherein, A sealing cap with a sealing device is arranged on the adapter base (5) via a mechanical connection, wherein the sealing cap is designed to mechanically close another container (8) of the adapter base when the adapter accessory (10) is not connected.

10. The cannulation system according to any one of the preceding claims, wherein, The elastic tubular sheath (11) includes a device for separating biological samples.

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