Systems and methods for avoiding leaks in single or double cuffed endotracheal tubes

Abstract

The present invention relates to an improved intubation condition of a patient based on the application of a new type of endotracheal (ET) tube with one or two cuffs. The present invention relates in particular to a cuff configuration for a single or double cuff ET tube. The cuff is especially configured to achieve an improved seal with the tracheal wall of the patient, thus avoiding air and / or liquid leakage. Although tight and efficient, the improved seal is soft and gentle (making the minimum necessary contact between the cuff and the tracheal wall) and no longer causes severe reversible or permanent damage to the tracheal region of the patient. The special cuff configuration comprises multiple inflatable sections (because the cuff is inflatable), which may possibly be determined as separate balloons, and may further comprise one or more one-way valves, all of which may or may not be inflatable. [Reference figure] Figure 1

Description

[Technical field]

[0001] The present invention relates to a special design or configuration of a cuff, e.g., a single or double cuff, for an endotracheal (ET) tube, which achieves improved sealing of the cuff with the patient's tracheal wall, thus avoiding air or fluid leakage. The improved sealing is not only better performing, but also more comfortable and less harmful for the patient, and does not pose the risk of permanent damage to the patient's internal body. The special cuff configuration comprises a multi-section cloud shape, and may further comprise one or more one-direction valves, all or none of which are inflatable.

[0002] The present invention further relates to sensing means in an ET tube double cuff configuration, and in particular to detecting and / or determining whether the cuff is making a good seal with the patient's tracheal wall, i.e., whether a leak has occurred therebetween.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority (under 35 U.S.C. §119(a)-(d)) to Belgian Patent Application No. 2022 / 5098, filed February 15, 2022, which is incorporated herein by reference in its entirety. [Background technology]

[0004] Traditionally, a single cuff is inflated with air after inserting an ET tube into a human trachea to achieve airtight sealing of the cavity between the tube and the surrounding tracheal wall. Alternative tubes with double cuffs also exist and were introduced as a possible solution to some deficiencies in traditional single cuff endotracheal tubes. One of these deficiencies is leakage on the cuff, for example due to insufficient cuff pressure or due to maneuvers that change the patient's condition. Thus, secretions may pass and subsequently accumulate in the upper trachea. Furthermore, because the single cuff has a leak-free seal, high sidewall cuff pressures may be applied, which may cause severe (possibly permanent) damage to the tracheal wall. However, in practice, the double cuff has not always been experienced as the most efficient and appropriate solution, and the deficiencies, although they could be partially reduced, continued to exist.

[0005] Thus, cuffed endotracheal tubes have been used routinely for decades to prevent upper airway obstruction or to facilitate artificial ventilation in unconscious or anesthetized patients. Three basic problems can arise with ET tubes with single or double cuffs. For each of these problems, solutions have been proposed in the past, sometimes exacerbating another problem or creating new ones. The first basic problem is related to air leaking from the trachea during inspiration. For this reason, increasing the cuff pressure helps, but it is necessary to know if and when to reach a dangerous pressure that would prevent perfusion or cause tissue necrosis. Not knowing when the loaded cuff is giving the required airtight seal will probably result in a higher cuff pressure than is needed. The second basic problem is the opposite and mostly concerns fluid leaking into the trachea during expiration, also called silent aspiration. Higher cuff pressures have limited effect here, whereas cuff material and / or shape as well as subglottic aspiration are more important but can be very complicated and therefore not useful for short interventions. A third fundamental problem is that mucosal ischemia becomes more of a problem when higher cuff pressures are applied.

[0006] Recent studies have shown that the currently available ET tubes, whether single-cuff or double-cuff, still have some deficiencies. To improve ET tubes, certain cuff designs have been introduced, among which, for example, the microcuff. (登録商標) The Taperguard TM features an advanced micro-thin polyurethane cuff and is specifically designed for the pediatric airway. TM The cuff is characterized by a tapered conical cuff. A major drawback of certain current cuff designs is their level of complexity and difficulty to fabricate, and therefore, are generally quite expensive compared to standard cuffs. Summary of the Invention [Problem to be solved by the invention]

[0007] The challenge we still face is to search for each individual patient and for each mode of ventilation and airway management the lowest possible cuff pressure, while clarifying if / when / where leakage still occurs in order to avoid air and / or fluid leakage and to react quickly and appropriately. Furthermore, if pressure needs to be increased, this should be controlled and kept as short as possible. A simple response to full and frequent use in the ventilation system is required.

[0008] An object of an embodiment of the present invention is to ensure a gas-tight and fluid-tight fitting seal between the cuff of the endotracheal tube and the tracheal wall of the patient, with the lowest possible cuff pressure, optionally automatically adjusted. A gas-tight and fluid-tight fitting seal with the lowest possible cuff pressure minimizes any possible damage caused to the tracheal wall due to minimal inflation of the cuff, ensures leak-free or leak-free ventilation, and avoids asymptomatic aspiration of oral fluids and the passage of any secretions therethrough. In particular, an object of the present invention is to provide a gas-tight and fluid-tight fitting seal even during high positive pressure ventilation, such as during lung recruitment and active aspiration.

[0009] It is also an object of embodiments of the present invention to detect and / or determine whether the cuff is making a good seal with the patient's tracheal wall, i.e., whether a leak has occurred therebetween. [Means for solving the problem]

[0010] According to a first aspect, the present invention provides a cloud cuff for an endotracheal tube (ETT) system comprising a ventilation tube and one or more cuff inflation lumens (also referred to as cuff inflation lumens or cuff inflation lines, or elongated channels through which the cuff can be inflated). For example, in the case of a cuff inflation lumen or line, such lumen or line may be in fluid or fluidic communication with an interior portion of the cuff and may be used to inflate and / or deflate the cuff. The name Cloud Cuff comes from the special cloud shape that the cuff has. Instead of Cloud Cuff, one may refer to a stepped, lobed, or ribbed cuff, but the cloud shape is similar to stepped, lobed, or ribbed. The Cloud Cuff is attached or attachable to the ventilation tube of the ETT system and can be described as a continuous multi-section (or multi-chamber) envelope that is inflated when the ETT system is intubated into the patient. An inflatable multi-section cloud cuff comprises two or more sections that are connected (and therefore inflatable). The sections can be considered to be physically connected, i.e., a new section starts from one end or the other of the previous one, while each section has two ends, one of the ends of a section being connected to one of the ends of another (adjacent) section. The sections can also be viewed as being pneumatically connected (due to the hollow shape of the cuff when inflated).

[0011] In a standard cylindrical cuff that has a constant diameter along most of its length when fully inflated, the diameter may vary or change (along the length of the cuff) from cuff section to cuff section, and the diameter may reach a local maximum in each section. The cloud cuff can be viewed as comprising different diameters when inflated. At least two sections have different (local) maximum diameters. Adjacent sections may have a common diameter where they join or touch. The difference in this maximum diameter is generally fairly small. At least one section acts as a sealing portion and may, for example, have a maximum diameter, but may also have a smaller diameter. When a typical cylindrical cuff (known in the art) is inserted into a patient's trachea and inflated, the cylindrical cuff wall may not be able to expand to its maximum diameter and may fold back on itself in order to fit within the trachea, creating wrinkles and leak paths. The sealing portion or section according to the present invention is adapted to form a wrinkle-free band against the patient's tracheal wall when inflated, wherein the wrinkle-free sealing band or section is configured to prevent leakage of fluid or air through the wrinkle-free sealing band when inflated. As an example, have a cloud-like cuff with three sections, when inflated, one section may contact the non-wrinkled portion of the tracheal wall, while a larger section (i.e., having a larger diameter) may contact the wrinkled wall, and a smaller section (i.e., having a smaller diameter) may not contact the tracheal wall at all.

[0012] The sections can be prepared as stepped, lobed or ribbed sections, each of which can have a graduated or varying diameter in that each section (having two ends) can have a first end with a first diameter, a second end with a second diameter, and an intermediate portion determined by a (local) maximum diameter, and thus larger than both the first and second diameters. This is a direct result or consequence of the fact that the sections herein all have convex surfaces when expanded. The first and second diameters may be different, i.e., the first diameter may be smaller or larger than the second diameter. In some cases, the first and second diameters are the same. When inflated, the cloud cuff can have a frusto-conical shape if the cuff includes at least two sections, or the cloud cuff can have a double taper (stepped) shape if the cuff includes at least three sections. The Cloud Cuff may comprise polyethylene terephthalate (PETP), low density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU). The ETT system may include a distal end adapted to be inserted into a patient's trachea and a proximal end adapted to be connected to a ventilator.

[0013] According to one embodiment, the Cloud Cuff is configured to be inflated to a cuff pressure of 5-30 cm H2O, exceptionally up to a cuff pressure of 100 cm H2O.

[0014] According to one embodiment, the cloud cuff is configured such that one or more sections make minimal respective contact with the tracheal mucosa such that ischemic phenomena are reduced. The cuff must be small and narrow so as to compress the mucosa (membrane) along a ring that is narrower than the tracheal cartilage ring. The contact that a standard cuff makes with the tracheal mucosa generally occurs over a ring distance of approximately 3 cm along the length of the cuff. The cloud cuff may be configured such that each section makes slight contact with the tracheal mucosa over a ring distance of less than 2 cm, preferably less than 1 cm, along the length of the cuff, thereby allowing perfusion between the different sections. In other words, the sections can be designed to be small enough to achieve this slight contact, but with sufficient space in the transitions between adjacent sections due to their different diameters and / or their gradually changing diameters.

[0015] According to one embodiment, two or more sections are defined as separate (or individual) balloons stacked together (eg, like the weights in a dumbbell). If the section is expandable, then the balloon is also expandable. The balloons may be physically connected by stacking them, but may also be pneumatically connected by having only one cuff inflation lumen (or cuff inflation line) for inflating each of them, or through openings provided between adjacent balloons. Each of the balloons may be separately connected to a respective corresponding intramural channel in the ventilation tube that allows for independent inflation of the balloons, for example these intramural channels being cuff inflation lumens. A balloon should be understood to be the result of inflating an essentially 2D surface material configured to enclose a volume. Typically, a balloon has one input port for inflation, however the balloon concept is not so limited as multiple inputs are also possible, as outlined above.

[0016] According to one embodiment, one or more one-way valves (which may or may not be inflatable) are provided near the cloud cuff. The valve, possibly even suddenly and / or briefly, comes into contact with the patient's tracheal wall in the event of underpressure (also called underpressure or negative pressure) or overpressure (also called overpressure), so that additional sealing is achieved, in other words the contact is made stronger so that additional sealing is achieved. This under- or over-pressure occurs during inspiration or expiration (eg, 0.5-3 seconds) and then drops / levels off back to zero and is typically temporary. Regardless of the cuff pressure (e.g. 20 mbar), a good seal with or against the tracheal wall is ensured by a temporary overpressure of the ventilator (e.g. 40 mbar, 50 mbar) or an underpressure of the suction device (e.g. 20 mbar, 30 mbar, 50 mbar or even 100 mbar).

[0017] According to one embodiment, between the two sections, one of the one-way valves is provided (at the proximal end of the cuff), which in the event of negative pressure comes into contact with the patient's tracheal wall, thereby achieving additional sealing at a proximal position, and / or between the (other) two sections, another one of the one-way valves is provided (at the distal end of the cuff), which in the event of overpressure comes into contact with the patient's tracheal wall, thereby achieving additional sealing at a distal position. Providing the valve between the two sections of the cuff may be an option to achieve easier folding / deployment of the valve. Where an overpressure valve provides additional sealing at a proximal location, the valve is typically oriented in a direction toward the patient's mouth, and where a negative pressure valve (typically a separate valve from the overpressure valve) provides additional sealing at a distal location, the valve is typically oriented in the opposite direction toward the patient's lungs. A one-way valve may be designed or constructed to function in one direction or the other (opposite). According to one embodiment, the valve may be designed or constructed to act or function in two opposing directions, and thus may be a two-way valve.

[0018] According to one embodiment, an inflatable one-way valve is placed proximate (also referred to as adjacent) to the cloud cuff, preferably adjacent two or more sections thereof, which when inflated will come into contact with the patient's tracheal wall, thereby achieving additional sealing. For a cuff having two ends (proximal and distal), the inflatable one-way valves may be placed adjacent to both end sections, one proximally and one distally. The inflatable one-way valve can be incorporated into the Cloud Cuff, for example, to have one inflatable valve(s) and entire cuff section. These configurations, where the one-way valve is placed on or near (also referred to as adjacent to) the cuff for an endotracheal tube (ETT) system, define valve-cuff configurations within the different embodiments provided herein.

[0019] It should be noted that a one-way valve may also be applicable to a standard single cuff (or double cuff). The valve may be inflatable but provide a standard fit / closure. A one-way valve, particularly an inflatable valve, may be interpreted as a cuff with a particular form or shape that is not only intended to close but also functions as a one-way valve for overpressure or negative pressure.

[0020] According to a second aspect, the present invention provides an ETT system for ventilating a patient, the system comprising a ventilation tube, one or more cuff inflation lumens (also referred to as cuff inflation lumens) or cuff inflation lines (also referred to as cuff inflation lines), and a cloud cuff comprising two or more sections attached or attachable to the ventilation tube as in the first aspect. At least two sections having a (slight) difference in (local) maximum diameter so as to be connected, wherein at least one section is adapted to form a wrinkle-free band against the patient's tracheal wall when inflated and acts as a sealing part, wherein the wrinkle-free sealing band is configured to prevent leakage of fluid or air through the wrinkle-free sealing band when inflated. An ETT system for ventilating a patient may comprise one or more one-way valves in the vicinity of the cloud cuff, e.g., a one-way valve between its two sections, which in the event of negative pressure contacts the patient's tracheal wall to achieve additional sealing at a proximal location, and / or another one-way valve between (the other) two sections, which in the event of overpressure contacts the patient's tracheal wall to achieve additional sealing at a distal location.

[0021] According to a third aspect, the present invention provides an ETT system for ventilating a patient, comprising: Two cloud cuffs according to a first aspect, comprising a primary cloud cuff and a secondary cloud cuff distal to the primary cloud cuff, the two cloud cuffs comprising one or more cuff inflation lumens or lines for inflating and / or deflating the two cuffs, and an inter-cuff region connecting the primary and secondary cloud cuffs. For example, in the case of one cuff inflation lumen, such lumen may be in fluid communication with the interior of each cuff and may be used to inflate and / or deflate each cuff. The cuffs are then connected serially via the cuff inflation lumen. The inter-cuff region may comprise a means for sensing and / or measuring airflow parameters (e.g., amount of airflow, airway pressure, or air leak). The cuff pressure can be controlled or adjusted to achieve the lowest possible pressure without having a leak as measured in the inter-cuff area. By measuring whether there is a leak (air or fluid) in the inter-cuff area, it is automatically detected what the minimum pressure needed to get a good seal is. A one-way valve (all-or-not inflatable) may include a primary cloud cuff that contacts the patient's tracheal wall in the event of negative pressure, thereby achieving additional sealing at a proximal location, while another one-way valve (all-or-not inflatable) may include a secondary cloud cuff that contacts the patient's tracheal wall in the event of overpressure, thereby achieving additional sealing at a distal location.

[0022] According to a fourth aspect, the present invention provides a method for ventilating a patient, comprising: (i) providing an ETT system as in the third aspect; (ii) orally inserting the ETT system into the patient such that the two Cloud Cuffs are positioned within the patient's trachea; (iii) inflating the two cloud cuffs including the inter-cuff regions; (iv) sensing and / or measuring one or more airflow parameters in the inter-cuff region; and (v) further / additionally inflating the two cloud cuffs in the event of a (sudden / significant) change (e.g., decrease or drop) in the one or more airflow parameters such that a constant pressure in the inter-cuff area (and / or the two cloud cuffs) is achieved.

[0023] In addition to the above, the present invention can be summarized according to the following numbered embodiments: 1. A one-way valve for an endotracheal tube (ETT) system, the one-way valve being placed on or in the vicinity of a cuff, the cuff being attachable to a ventilation tube of the ETT system, the ETT system having one or more cuff inflation lumens, the one-way valve being configured such that under-pressure or over-pressure the valve is in contact with a patient's tracheal wall, thereby providing a sealing with the patient's tracheal wall. 2. A one-way valve as described in embodiment 1, wherein the one-way valve is located at a proximal position (on or near the cuff) and in the event of negative pressure in contact with the patient's tracheal wall, the valve achieves sealing at the proximal position. 3. A one-way valve according to embodiment 1, wherein the one-way valve is provided at a distal location (on or near the cuff) such that in the event of overpressure contacting the patient's tracheal wall, the valve thereby achieves sealing at the distal location. 4. A one-way valve as described in any one of embodiments 1 to 3, having an expandable volume. 5. A Cloud Cuff for an endotracheal tube (ETT) system, said Cloud Cuff attachable to a ventilation tube of said ETT system; The cloud cuff comprises: (i) an inflatable cuff body having a cloud shape with at least two sections having a difference in maximum diameter, at least one section acting as a sealing portion adapted to form a wrinkle-free sealing band against a patient's tracheal wall when said cloud cuff is inflated, thereby preventing leakage of fluid or air through said wrinkle-free sealing band when said cloud cuff is inflated; (ii) a first cylindrical portion disposed at a proximal end of the inflatable cuff body; and (iii) a second cylindrical portion disposed at a distal end of the inflatable cuff body; A cloud cuff, wherein the first and second cylindrical portions have surfaces that match the cylindrical shape of the ventilation tube upon which the cloud cuff is disposed. 6. The cloud cuff of embodiment 5, wherein each of the two or more sections has a diameter that varies gradually along the length of the ventilation tube. 7. The cloud cuff of embodiment 6, wherein the cloud cuff is configured by selecting its shape, in particular the gradually varying diameter of two or more sections, such that the sections of the cloud cuff make slight contact with the patient's tracheal mucosa when attached to a ventilation tube and inserted into the patient's trachea. 8. The cloud cuff of any one of embodiments 5 to 7, wherein the cloud cuff has a substantially uniform thickness. 9. The cloud cuff of embodiment 8, wherein the substantially uniform thickness is achieved by (blow) molding the cloud cuff during its manufacture, the thickness being in the range of 0.05mm to 0.2mm, with uniformity in the range of ±5% (mainly manufacturing operating margins). 10. The cloud cuff of any one of embodiments 5 to 9, wherein the cloud cuff is configured to be inflated to a cuff pressure of 5 cm H2O to 30 cm H2O or up to 100 cm H2O by selecting the material used and / or its thickness. 11. The cloud cuff of any one of embodiments 5 to 10, wherein the cloud cuff is made from polyethylene terephthalate (PETP), low density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU). 12. A cloud cuff according to any one of embodiments 5 to 11, wherein the cloud cuff has one or more one-way valves (as in embodiments 1 to 4) on or near it (possibly between two sections of the cloud cuff), which are in contact with the patient's tracheal wall in the event of negative or overpressure, such that sealing is achieved. 13. (i) an electronic device for inputting sensed parameters and calculating one or more conditioned air flows therefrom; (ii) one or more first mechanical means (e.g., a ventilator) for providing said flow of conditioned air; A cuff controller suitable for controlling a cuff (preferably a cloud cuff according to any one of embodiments 5 to 12). 14.(iii) A cuff controller as described in embodiment 13, further comprising one or more second mechanical means (e.g., pumps) for providing suction operations, and the electronic device also determines and / or calculates (from the input sensed parameters) the one or more suction operations. 15. A computer program product operable on a processing engine to perform any of the computing steps of embodiments 13 and / or 14. 16. A non-transitory machine-readable storage medium storing the computer program product of embodiment 15. 17. An endotracheal tube (ETT) system for ventilating a patient, said ETT system comprising: *Ventilation tube, *One or more cuff inflation lumens (also called cuff inflation lumens), and *A cloud cuff described in any one of embodiments 5 to 12. 18. The ETT system of embodiment 17, wherein the cloud cuff is defined as a primary cloud cuff, and the ETT system comprises: An additional cloud cuff according to any one of embodiments 5 to 12, defined as a secondary cloud cuff distal to the primary cloud cuff, wherein the two cloud cuffs are provided with one or more cuff inflation lumens for inflating and / or deflating the two cuffs, and *The inter-cuff area that connects the primary cloud cuff to the secondary cloud cuff. 19. An ETT system as described in embodiment 18, wherein the inter-cuff area includes means for sensing and / or measuring airflow parameters (using a cuff controller as described in any one of embodiments 13 and 14).

[0024] These and other features, aspects, and advantages will become better understood with reference to the following description and appended claims.

[0025] Additional features and advantages of the embodiments described herein will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from that description, or will be learned by practicing the embodiments described herein, including the following detailed description, the claims, and the accompanying drawings.

[0026] It should be understood that both the foregoing general description and the following detailed description are intended to describe various embodiments and provide an overview or framework for understanding the nature and features of the claimed subject matter, and should not be considered in isolation, but may be combined independently. The accompanying drawings are included to provide a further understanding of the various embodiments, and are incorporated in and constitute a part of this specification. The drawings illustrate various embodiments described herein, and together with the description, serve to explain the principles and operation of the claimed subject matter. [Brief description of the drawings]

[0027] [Figure 1] Figures 1a and 1b show endotracheal tubes according to the state of the art, with Figure 1a shown intubated in a patient and Figure 1b shown with either an inflated or uninflated cuff.

[0028] [Diagram 2] 2a, 2b and 2c show an embodiment of a single cuff ET tube cuff configuration in an inflated state, and FIG. 2d shows an embodiment of a single cuff configuration in a non-inflated state.

[0029] [Diagram 3] FIG. 3 shows another embodiment of a cuff configuration for a single-cuff ET tube.

[0030] [Figure 4] 4a, 4b, and 4c show one embodiment of a cuff configuration for a double-cuff ET tube.

[0031] [Diagram 5] 5a and 5b illustrate another embodiment of a cuff configuration for a double-cuff ET tube.

[0032] [Figure 6] 6a and 6b show yet another embodiment of a cuff configuration for a double-cuff ET tube.

[0033] [Figure 7] 7a and 7b illustrate a further embodiment of a cuff configuration for a double-cuff ET tube.

[0034] [Figure 8] One embodiment of a double-cuff ET tube with a double-cuff configuration is shown in FIG. 8a, where the tube includes sensing and / or measuring means for detecting if a leak occurs between the cuff and the patient's tracheal wall, and FIG. 8b includes a cuff controller connected thereto.

[0035] [Figure 9] A photographic embodiment of a cuff configuration for a single cuff ET tube is shown in FIG. 9a, where the single cuff is shown in an uninflated state, and FIG. 9b includes a photographic embodiment of the same single cuff configuration, now shown in a fully inflated state.

[0036] [Figure 10] A photographic embodiment of the cuff configuration of a single-cuff ET tube inserted into a patient's trachea is shown in FIG. 10a, where the single cuff is shown in a very lightly inflated state, and FIG. 10b includes a photographic embodiment of the same single-cuff ET tube within a patient's trachea, where the single cuff is now shown in a fully inflated state.

[0037] [Figure 11]FIG. 11 shows a pictorial embodiment of the same single-cuff ET tube of FIGS. 10a and 10b inserted into a patient's trachea, with the single-cuff shown fully inflated to inhibit or prevent secretions from traveling further within the trachea. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] The present invention relates to an improved intubation condition of a patient based on the application of a new type of endotracheal (ET) tube with one or two cuffs. The present invention relates in particular to a cuff configuration for a single or double cuff ET tube. The cuff is especially configured to achieve an improved seal with the tracheal wall of the patient, thus avoiding air and / or liquid leakage. Although tight and efficient, the improved seal is soft and gentle (making the minimum necessary contact between the cuff and the tracheal wall) and no longer causes severe reversible or permanent damage to the tracheal region of the patient. The special cuff configuration comprises multiple inflatable sections (because the cuff is inflatable), which may possibly be determined as separate balloons, and may further comprise one or more one-way valves, all of which may or may not be inflatable.

[0039] The invention further relates to a sensing and / or measuring means, in particular with a double-cuff ET tube, for detecting if a leak occurs between the cuff and the patient's tracheal wall, which may be connected to a cuff controller for controlling the pressure and flow in the cuffs or here in between, in the inter-cuff region, such that if a leak occurs it is detected in the inter-cuff region, which connects the cuffs together along the ventilation tube.

[0040] According to the art, to ensure proper mechanical ventilation, a patient is intubated, for example, by using an endotracheal (ET) tube as shown in Figures 1a and 1b. To avoid any leakage between the patient's tracheal wall and the ET tube, a single or double cuff is placed on the tube and inflated to a certain low estimated pressure. By way of example, Figures 1a and 1b represent a single-cuff ET tube known in the art.

[0041] In Fig. 1a, a patient 9 is shown with an intubated endotracheal tube 10 used to maintain an airway. The endotracheal tube 10 comprises a ventilation tube 100 having an oral end 140 and a patient body end, the latter having a distal tip including a bevel and an opening called the Murphy eye. At its oral end 140, which includes a universal adaptor, the tube 100 can be connected to an oxygen source. The tube 100 comprises an elongated channel 105 through which a cuff can be inflated, which is therefore also referred to as the cuff inflation line 105.

[0042] At some level, a cuff inflation line 105 mates with, and is specifically integrated into, the tube 100. A single cuff 110 is disposed at the distal end of the tube 100 and, when inflated, creates a seal between the trachea 8 and the cuff 110, thereby preventing aspiration and ensuring delivery of a set tidal volume when mechanical ventilation is used. The inflated cuff 110 also prevents air from passing to the vocal cords, nose, or mouth.

[0043] In FIG. 1b, the ET tube 100 is depicted with a single uninflated cuff 111 and an inflated cuff 110, respectively. In the case of the ET tube 100 with the inflated cuff 110, a syringe 120 for inflation is also shown. The cuff inflation line 105 comprises a pilot balloon 130 connected to the syringe 120 that allows inflation. The pilot balloon 130 allows air to flow into the cuff 110, prevents air from escaping, and can be used as a guideline to determine the presence or absence of air in the cuff 110. A universal adapter at the mouth end 140 allows the tube 100 to be attached to a mechanical ventilation tube or other type of oxygen delivery system. When ventilation of the patient 9 is started and, for example, a sudden leak is detected, in order to immediately solve the leak problem, the applied cuff pressure can be increased by (further) inflating the cuff 110 using the syringe 120 connected to the pilot balloon (a balloon that measures the air flow) 130.

[0044] Experience has shown that the use of conventional ET tubes as currently known in the art can lead to different problems: frequent leaks can occur due to incorrectly placed tubes, due to patient movement, or due to the movement of the ET tube, etc. Furthermore, constant or too high pressure applied to the cuff can cause tissue damage.

[0045] The aim of the present invention, which is particularly a new type of endotracheal tube with a specially constructed cuff, is to ensure leak-free ventilation by air-tight and liquid-tight sealing of the ET tube, particularly by sealing of the single or double cuff with the patient's tracheal wall, where minimal pressure is applied to avoid reversible or irreversible damage.

[0046] Figures 2a, 2b and 2c show an embodiment of a cuff configuration for a single cuff ET tube in different development views, where an xyz coordinate system is provided to facilitate the description of the cuff configuration. Figures 2a, 2b and 2c all show an inflated state, while an embodiment of a single cloud cuff configuration in a non-inflated state is shown in Figure 2d.

[0047] In FIG. 2a, a single cuff 210 is shown to be provided on the ventilation tube 200 (having a longitudinal axis L) of the ET tube 20, and a cuff inflation line 205 is marked. At the distal end 230 of the tube 200, a bevel 231 and a Murphy eye opening 232 are clearly visible. The cuff 210 comprises several sections 211, 212, 213, 214, 215, here, by way of example, five sections above each other, having a cloud-shaped appearance. Although a specific number of five sections is shown here by way of example, other embodiments are also included in which a different amount of sections (e.g., more or less than five) are envisaged. Thus, the single cuff 210 is also referred to as a cloud cuff 210. With this configuration, the present invention has several sections at different heights (along the z-axis) and with different or varying widths or diameters (along the xy plane). Cloud cuffs are specifically designed or have a specific shape to prevent wrinkling of the cuff (as a common problem with ET tubes today). In general, a cloud cuff is considered as soon as the cuff contains two sections. In other words, a cloud cuff comprises at least two sections. The cuff is inflatable, but the sections (contained in the cuff) are also inflatable and are shown here inflated. A cloud cuff 210 containing two or more sections is attached to a ventilation tube 200. The sections are connected both physically and via the air. At least two sections have a (slight) difference in diameter with at least one section (e.g., having a maximum diameter) to act as a sealing portion 270 adapted to form a wrinkle-free band against the patient's tracheal wall upon inflation, where the wrinkle-free sealing band is configured to prevent leakage of fluid or air through the wrinkle-free sealing band upon inflation.

[0048] Figure 2b zooms in on the cuff 210 itself, but in cross-sectional (along the vertical yz plane) and semi-transparent view the different sections (including the inside) become visible and therefore all can be distinguished. A single cuff 210 is shown, again placed on top of each other on the ventilation tube 200 of the ET tube 20, which is marked with a cuff inflation line 205. The sections 211, 212, 213, 214, 215 appear overlapping as bands, lobes or ribbons and can therefore be referred to as band-like. The strip has a circular cross-section along the (horizontal) xy plane. However, for each zone, the diameter of the circular cross-section varies along the (vertical) z-axis to produce a particular zone. Such circular symmetry need not be perfect as shown here, but is approached as close as possible so that the cuff containing the sections, when inflated, more or less conforms to the tubular cylindrical shape of the patient's trachea.

[0049] In particular, for each strip section along the z-axis (following the z-axis in an upward or downward direction), the diameter of the section, which starts out at a particular size (at the beginning of the section), initially increases until it reaches a larger maximum diameter size. Further following the z-axis in the same direction (up or down), the diameter size decreases again towards the particular size it had at the beginning of the section. Alternatively, at the end of the section, the diameter size may be slightly smaller or larger than the particular size at the beginning of the section. By way of example, this is shown for sections 212, 213, 214. In particular, section 213 has a minimum diameter d1 that increases to a maximum diameter d2 to produce a band-like shape. Immediately below section 213, adjacent section 214 begins at a diameter d1, increases to a diameter d3, and then decreases again to a diameter d4. Immediately above section 213, the adjacent section 212 begins at a diameter d1, increases to a diameter d5, and then decreases again to a diameter d6. Thus, not only does the diameter per section vary, but it also varies between different sections. Cloud cuff 210 is designed such that the maximum diameter of the sections, here along the z-axis, first increases gradually in space (but not in time) until it reaches a maximum diameter d2, and then decreases gradually again.

[0050] Here, a symmetrical geometry is chosen for the cuff 210, which starts and ends with the same minimum diameter d7 at the open end 216 in the form of a cylindrical or tubular section, and at the closed end 217 also in the form of a cylindrical or tubular section. The diameter d7 is comparable (or approximately the same) as the diameter of the tube 200, so that the ends 216, 217 fit nicely and close to the surface of the tube 200. Due to the symmetry here, the diameters d3, d5 and the diameters d4, d6 are of the same size, respectively. Cloud cuff 210 has an open end 216 and a closed end 217, both of which fit tightly over the surface of tube 200 so that their connection is sealed and therefore no air or fluid can leak between them. Here, the open and closed ends 216, 217 have a diameter d7 to achieve this intimate connection with the tube 200. As shown, the cloud cuff 210 having five sections 211, 212, 213, 214, 215 has a generally spherical or ovoid cloud shape or volume in the inflated state. Additionally, due to the symmetry of the multiple sections and volumes, a (double) tapered shape in the inflated state is also discernible. For example, if the cloud cuff includes only two sections, given that the sections are different sizes, i.e., one has a smaller maximum diameter than the other, the overall shape or volume is more of a cone or frusto-cone in the inflated state. For example, if the Cloud Cuff includes three sections, the central section (or band) having a larger (largest) diameter than the outer sections (or distal and proximal bands) exhibits a double taper shape. The cloud cuff with different sections can be made from polyethylene terephthalate (PETP), low density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU) as materials. According to one embodiment, the cloud cuff material can be selected from materials such as PVC, siliconized PVC or silicone, or another physiologically compatible material. According to one embodiment, the cloud cuff material is styrene-ethylene-butylene-styrene (SEBS) or another suitable thermoplastic elastomer or polymer. According to one embodiment of the invention, the thickness of the cloud cuff is selected to be very thin, about 0.1 mm ± 25%. The cloud cuff can be made from one piece, for example, by a (blow) molding process, leading to an approximately uniform thickness of, for example, 0.1 mm, with a thickness range, i.e., a difference in thickness uniformity of about 5% over the entire cuff. According to one embodiment, the cloud cuff material is suitable for (blow) molding. According to the invention, the cloud cuff material is inflatable and biocompatible.

[0051] According to the embodiment shown in Figures 2a and 2b, the cloud cuff 210 further comprises one-way valves 220, 225 proximate either end 216, 217 of the cuff 210, i.e. one-way valve 220 proximate the open end (or proximal end relative to the tube 200) and one-way valve 225 proximate the closed end 217 (or distal end relative to the tube 200). Both valves 220, 225 are depicted here as mirror images of each other, although this does not necessarily have to be the case. Here, the valves 220, 225 are designed to have a concave surface. In particular, here the concave surface of the valve 220 at the proximal end is directed towards the centre of the cuff and the concave surface of the valve 225 at the distal end is directed towards the centre of the cuff, so that the concave surfaces 220, 225 face each other and therefore appear as their mirror images. According to one embodiment, the valves have different shapes, e.g., with symmetry, to look the same at both the proximal and distal ends of the tube 200. The valves 220, 225 can, for example, be made from the same material as the cuff 210 and its sections 211, 212, 213, 214, 215, and the valves can be integral with the rest of the cuff. However, according to an embodiment, different materials for the valves can be used and the valves can be placed or designed on the cuff as separate parts. In an unused state, the valves 200 (or is it 220?), 225 appear as flaps or skirts placed on (overlapping) the cloud cuff 210. The valves 220, 225 are provided to control high positive and negative pressures (HPNP) and are specifically configured to avoid leakage during high ventilation or negative suction pressures, due to which the valves expand and their (concave) surfaces adhere to the tracheal wall to form a seal. Conventional ET tube cuff sealing does not protect against ventilation at such high ventilation pressures or during aspiration (when high negative pressure is applied).

[0052] Using valves 220, 225 (or at least one of them, i.e., when having only one valve, even better sealing is provided, but when having both, further improvements are achieved) provides a solution for further sealing even during higher ventilation pressures or during suction, at low cuff pressures. According to the state of the art, positive pressure is defined as the working pressure of the ventilator used to ventilate a patient with an inserted ET tube. This positive pressure, also called overpressure, is generally up to about 100 mbar (legally permitted), but typically, according to the art, the pressure in the cuff is up to about 20-30 mbar during ventilation of the patient. The pressure in the cuff, or cuff pressure, may be higher than this 20-30 mbar, but only for a very short time, for example up to 1-2 minutes. The working pressure of the ventilator is a maximum of approximately 100 mbar, but the pressure in the lungs can be increased to approximately 100 mbar, which is possible but considered high. Negative pressure, also called underpressure, is caused by pulmonary aspiration and thus occurs during aspiration in (or into) the lungs. In the use or inflated state, when pressure (e.g. positive / overpressure or negative / underpressure) is applied, the valve acquires the shape as shown in Figures 2a and 2b. The applied pressure causes the valve to open such that the respective edges 221, 226 contact and thus seal with the patient's tracheal wall, e.g. at the respective sealing portions 272, 275 shown. For example, in the case of positive or overpressure, the operating pressure of the ventilator determines the pressure in the lungs, and here, with the configuration of the cloud cuff 210 with valve 225 of Figures 2a and 2b, the lung pressure (and directed therefrom as shown by arrow P) presses against the valve 225, and in particular its shell-like surface, against the patient's tracheal wall, as shown in Figure 10b. In addition to the arrow P in Fig. 10b, dashed arrows Sp are also shown to show how the valve 1025 unfolds due to overpressure, i.e. how the surface of the valve 1025 (and its expansion volume) moves towards the tracheal wall 1007 of the patient 1009. Positive pressure arrows P are also shown in Figs. 2a and 2b. Inhalation with overpressure can last up to several seconds per cycle. For example, in the case of negative or underpressure, suction of the lungs (and directed towards the lungs as indicated by arrow N) aspirates the valve 220, particularly at its shell-like surface, as shown in FIG. 10 and against the patient's tracheal wall. In addition to the arrow N in Fig. 10b, dashed arrows Sn are also drawn to show how negative pressure causes the valve 1020 to unfold, i.e., how the surface of the valve 1020 (and its expansion volume) moves towards the tracheal wall 1007 of the patient 1009. The arrow N for negative pressure is also shown in Figs. 2a and 2b. 2a and 2b, as indicated by their respective shapes, each valve faces in an opposite direction, with valve 220 facing upward (meaning toward the patient's mouth) and the other valve 225 facing downward (meaning toward the patient's lungs). More specifically, the one-way valve comes into contact with the patient's tracheal wall in the event of a (sudden and / or short, but high) negative or overpressure, so that additional sealing is achieved. The one-way valve 220 contacts the patient's tracheal wall in the event of negative pressure, thereby achieving additional sealing at a proximal location (towards the patient's mouth). When suction is being applied, leakage around the cuff can result in air and secretions being "sucked" into or towards the lungs etc., leading to VAP (ventilator associated pneumonia) and other complications. A one-way valve 220 located at or adjacent to the upper or open end 216 of the cuff 210 creates a leak-free cuff closure even during suction. The force or power of suction pulls the valve against the tracheal wall, thereby achieving a good seal. The one-way valve 225, in case of overpressure, comes into contact with the patient's tracheal wall, thus achieving further sealing at the distal location (towards the patient's lungs). To further improve the sealing protection and avoid the ventilator having a large leak during ventilation, the one-way valve 225 is provided near the lower or closed end 217 of the cuff 210, also called the distal end in view of the tube 200. This valve 225 creates a perfect seal by receiving the pressure of the ventilator. According to one embodiment of the present invention, it is preferable to provide at least the one-way valve 225 with a cloud cuff to avoid interference with the ventilator.

[0053] It is noted that the valves 220, 225 in Fig. 2a and 2b are provided between two sections, which allows easier folding / unfolding of the valves compared to the situation shown in Fig. 2c. In particular, in Fig. 2a and 2b, the valve 220 is provided between the sections 211, 212 close to the tube cuff proximal or open end 216 of the cuff 210. The valve 225 is provided between the sections 214, 215 close to the tube cuff distal or open end 216 of the cuff 210. Generally, according to an embodiment, a distal valve (meaning a valve near the distal end) and a proximal valve (meaning a valve near the proximal end) may be provided. More specifically, according to an embodiment, the valves (also referred to as valves) may be provided above and / or below the sections and / or the valves may be provided between the sections.

[0054] The zoom shown on the cuff 230 in Figure 2c shows a slightly different embodiment in that the one-way valves 240, 245 are not provided between the two sections, but rather near the respective open or closed ends 216, 217 of the cuff 230. A single cuff 230 is shown, again provided on the ventilation tube 200 of the ET tube 20 with an integrated cuff inflation line 205. Here an opening 206 is shown provided for inflating the cuff 230 via the cuff inflation line 205. It is understood that such an opening is also present in Figures 2a and 2b, but is not shown here.

[0055] With today's standard ET tubes, leakage can occur due to cuff wrinkling. In the cloud cuff according to the embodiment, by forming a cloud shape with different sections, cuff wrinkling and therefore leakage is avoided. As mentioned above, the sections are usually zonular and possibly stepped, meaning that they appear on top of each other (overlapping) from smaller to larger size and / or vice versa (see Figs. 2a-2c). In contrast to the typical cylindrical cuff (known in the art) that is inserted into a patient's trachea and inflated, the outer surface of the cuff is no longer cylindrical, but rather cloud-shaped, which may also be defined as a generally spherical or ovoid shape (see, for example, dashed circle / oval 290 shown in FIG. 2b). In the present invention, the cuff walls, defined by different maximum diameters, can expand to their maximum (local) diameters to fit the trachea without them folding in on themselves. Thus, wrinkles or wrinkling are avoided and, as a result, leak paths formed are also eliminated. Current ET tubes in the art that exhibit leakage problems make it difficult or even impossible to maintain proper ventilation. The one-way valve according to the embodiment avoids any leakage even when the ventilation pressure is (much) higher than the cuff pressure (defined here as 5 mbar or higher) at or near the distal end of the cuff. Furthermore, the one-way valve according to the embodiment avoids any leakage even when suction is applied (defined as 5 mbar or higher) at or near the proximal end of the cuff, in contrast to standard ET tubes which cannot protect against suction.

[0056] In FIG. 2d, a single Cloud Cuff 210' is shown in an uninflated state and is placed on the ventilation tube 200 of the ET tube 20. Due to its uninflated state, the sections are not distinguishable here, but the appearance of the flaps or skirts of the one-way valves 220', 225' in the uninflated state is clearly visible (see hatched areas). The edges 221', 226' of the valves 220', 225', respectively, in the uninflated state are shown. The open end 216 and closed end 217 of the single cuff 210' in the uninflated state are shown, both having a cylindrical or tubular shape, and are firmly connected to and sealed by the tube 200.

[0057] Figures 9a and 9b include a photographic embodiment of a cuff configuration for a single cuff ET tube in Figure 9a, where the single cuff is shown in an uninflated state, and in Figure 9b, a photographic embodiment of the same single cuff configuration, now shown in a fully inflated state. In Figure 9a, a single cuff 910' is shown in an uninflated state, with a cuff inflation line 905 provided on the ventilation tube 900 of the ET tube 90 marked. At the distal end 930 of the tube 900, a bevel 931 and a Murphy eye opening 932 are clearly visible. Due to its uninflated state, the cuff appears as a flat cylindrical shape, but due to its volume that it can take up when inflated, it exhibits wrinkles 960, as shown in Figure 9b. When the cuff 910 is in an inflated state, two one-way (double-walled) valves 920, 925 are clearly visible in its sections 911, 912, 913, near the proximal, cylindrical or tubular open end 916 of the cuff 910, and near the distal, cylindrical or tubular closed end 917 of the cuff 910, respectively.

[0058] 10a and 10b include photographic embodiments of a cuff configuration for a single-cuff ET tube inserted into a patient's trachea in FIG. 10a, where the single cuff is shown in a very lightly inflated state, and FIG. 10b, where the same single-cuff ET tube is shown in a fully inflated state. In FIG. 10a, a single cuff 1010" is shown in a very lightly inflated (almost uninflated) state placed on a ventilation tube 1000 of an ET tube inserted into the trachea 1008 of a patient 1009. At the distal end 1030 of the tube 1000, the bevel 1031 and Murphy eye opening 1032 are clearly visible. Due to the very lightly inflated (almost uninflated) state, the cuff appears as a nearly flat cylindrical shape. However, in contrast to the uninflated state shown in FIG. 9a, the view in FIG. 10a shows that the presence of valves 1020", 1025" and cuff section 1014" are beginning to become visible due to very slight inflation. As shown in Fig. 10b, in the fully inflated state of the cuff 1010, its sections 1011, 1012, 1013 as well as its two one-way (double-walled) valves 1020, 1025 are clearly visible near the proximal, cylindrical or tubular open end 1016 of the cuff 1010 and near the distal, cylindrical or tubular closed end 1017 of the cuff 1010, respectively. Furthermore, in Fig. 10b, an arrow P is shown to indicate a positive or overpressure, as indicated by the dashed arrow Sp, which moves the valve 1025, in particular its surface (and its inflated volume), towards the tracheal wall 1007 of the patient 1009. Furthermore, an arrow N is shown to indicate a negative or underpressure, as indicated by the dashed arrow Sn, which moves the valve 1020, in particular its surface (and its inflated volume), towards the tracheal wall 1007 of the patient 1009. The illustration in Fig. 10b clearly shows that not only the cloud cuff 1010 but also the two valves 1020, 1025 ensure a good seal for this cuff configuration. An example of a sealing portion is shown in Fig. 10b by the dashed circle / oval 1070. This good sealing, especially at the proximal end of the cuff, is further illustrated in Figure 11, which illustrates a pictorial embodiment of the same single-cuff ET tube 1100 (as in Figures 10a and 10b) in a patient's trachea 1108, shown with the single cuff 1110 in a fully inflated state. And here, the secretions 1180 are blocked or prevented from traveling further within the trachea 1108, particularly by sealing by the valve 1120 at the proximal end 1116, avoiding passing through the cuff configuration 1100 such that the secretions 1180 cannot reach and / or enter the patient's lungs (indicated by arrows, but not shown).

[0059] Switching to specially coated ET tubes or the like to avoid VAP would mean paying significantly more (i.e., a much higher price) per ET tube and is not a complete solution. Strong leakage does not prevent VAP and antimicrobial coatings are only active for a limited time. Overinflation of the cuff can result in tissue ischemia, ulceration, and necrosis of the tracheal wall, while slight inflation can result in leakage of air and oropharyngeal secretions around the cuff, which predisposes the patient to, for example, inadequate ventilation, derecruitment, and aspiration pneumonia.

[0060] FIG. 3 shows another embodiment of the cuff configuration for a single cuff ET tube according to the present invention. A single cuff 310 is again shown on the ventilation tube 300 of the ET tube 30, with an integrated cuff inflation line 305. A small opening 306 is provided in the tube 300 to inflate the cuff 310 via the cuff inflation line 305. Air travels down the line 305 and out into the volume defined between the tube 300 and the inner wall of the cuff 310. The cloud cuff 310 comprises two sections 311, 312 above or on top of each other. The sections 311, 312 are inflatable and are shown here in an inflated state. Again, the sections are connected here either physically or through air. The two sections have a difference in maximum diameter such that there is a smaller section 311 and a larger section 312. The difference in maximum diameter thus avoids folding and thus achieves a sealing portion 370 adapted to form a wrinkle-free band against the patient's tracheal wall when the cuff is inflated, wherein the wrinkle-free sealing band is configured to prevent leakage of fluid or air therethrough when the cuff is inflated.

[0061] The cloud cuff 310 has an open end 316 in the form of a cylindrical or tubular section and a closed end 317 also in the form of a cylindrical or tubular section, both ends 316, 317 being tightly connected to the tube 300. Adjacent to the two sections 311, 312, and in particular adjacent to the smaller section 311, an inflatable one-way valve 320 is provided which, when inflated, comes into contact with the patient's tracheal wall, so that additional sealing is achieved. Unlike the previous embodiment discussed in Figures 2a-c, where the valve is single-walled, the one-way valve 320 in Figure 3 is double-walled, so that the valve can also be inflated until a bowl, cup or boat-like shape is created. From a practical point of view, both embodiments are applicable for use, respectively with an inflatable one-way valve (see FIG. 3) or with a single flap or skirt (see FIGS. 2a-2c, see also FIG. 2d). The double-walled valve 320 comprises an inner wall 322 and an outer wall 321. The valve 320 is in an inflated state as shown with a sealing portion 372 (for sealing against the tracheal wall). As an extension of this embodiment (not shown), a second (mirror) double wall, and therefore inflatable one-way valve, can be provided just below larger portion 312. For completeness, it is noted that according to one embodiment, one single wall valve is used; or according to one embodiment, two single wall valves are used; or according to one embodiment, one double wall valve is used; or according to one embodiment, two double wall valves are used; or according to one embodiment, a combination of single wall and double wall valves are used. When such a combination of single-walled and double-walled valves are used, the location where the single-walled and double-walled valves are placed (i.e., proximal or distal ends) can be selected depending on, for example, the application, need, patient anatomy, and / or other circumstances.

[0062] 4a, 4b, and 4c show one embodiment of a cuff configuration for a double-cuff ET tube.

[0063] As shown in Fig. 4a, the double-cuff ET tube 40 comprises two cuffs 410, 450 placed on the ventilation tube 400 of the ET tube 40 and marked with cuff inflation lines 405. The two cuffs 410, 450 are both cloud cuffs, each here including three sections (i.e., the present invention also contemplates cases with fewer or more sections, and even asymmetric cases are not excluded, where one cuff may have more sections than the other). According to one embodiment, the double cuff configuration is made in one piece (e.g., by a (blow) molding process), and the two cuffs 410, 450 are connected by a cylindrical or tubular section. Thus, the cuffs 410, 450 are at a certain distance from each other. The space between the two cloud cuffs 410, 450 may be referred to as the inter-cuff area 440, where the cylindrical or tubular connection is placed, connecting the upper cloud cuff 410 with the lower cloud cuff 450 (which would otherwise be separated). According to the present invention, the double cloud cuff does not have a significantly different impact (no mechanical effect) in terms of sealing behavior compared to the single cloud cuff. However, the double cuff configuration with the inter-cuff region has advantages from a measurement point of view. The inter-cuff region has the functional advantage of facilitating pressure or flow related measurements in this particular region, for example using an additional measuring device called a cuff controller (which not only measures but also controls). At the double cuff proximal end 418, adjacent the upper cloud cuff 410, is an open end 416 in the form of another cylindrical or tubular section tightly connected to the tube 400. Figure 4b is a perspective view and Figure 4c is a top view, cross-section (along the vertical yz plane) and semi-transparent display zooming in on the cuffs 410, 450.

[0064] In Figure 4b, the upper cloud cuff 410 is shown in an inflated state with three overlapping sections 411, 412, 413. The lower cloud cuff 450 at the distal end 419 includes three overlapping sections 451, 452, 453, also shown in an inflated state. The three sections per cuff have differences in maximum diameter such that for each cuff 410, 450 there is a smaller section 411, 453, a middle section 412, 452, and a larger section 413, 451. Both cloud cuffs 410, 450 are depicted as mirror images of each other, each having a frustro-conical shape. For each cuff, a sealing portion 470 (only shown for upper cuff 410) is provided that is adapted to form a wrinkle-free band against the patient's tracheal wall when inflated, the wrinkle-free sealing band being configured to prevent leakage of fluid or air past the wrinkle-free sealing band when inflated.

[0065] As shown in Figures 4b and 4c, at the double cuff distal end 419, adjacent the lower cloud cuff 450, there is a closed end 417 in the form of a further cylindrical or tubular section tightly connected to the tube 400. Openings 406, 407 are provided for inflating the cuffs 410, 450 via a cuff inflation line 405. In the case of cuff 410, sections 411, 412, 413 are physically and pneumatically connected. In the case of cuff 450, sections 451, 452, 453 are physically and pneumatically connected.

[0066] 4a-4c, cloud cuff 450 is provided with a one-way valve 425 disposed near closed end 417. In an unused state, valve 425 appears as a flap or skirt disposed on cloud cuff 450, specifically disposed between two sections 452, 453 for easy folding / deployment of valve 425. Valve 425 is in an inflated state such that sealing portion 475 (for sealing against the tracheal wall) is shown. Both the cloud cuffs 410, 450, each containing three sections, and the one-way valve 425 can be made from the same material, such as, for example, polyethylene terephthalate (PETP), low density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU). In practice, a single Cloud Cuff may be installed as a stand-alone to replace a standard cuff on an ET tube, but a double Cloud Cuff will generally be installed integrally with the ET tube, with a cuff controller also being connected or connectable for measurement and control purposes.

[0067] Also, with the Cloud Cuff, double cuff ET tube configuration, the formation of cuff creases along the contact with the tracheal wall is no longer an issue.

[0068] Modern cuffs are made of very thin materials and can overcome some of the limitations of previous generation cuffs. Very thin cuff walls form smaller folds and therefore allow for less leakage. Mucus leakage through the cuff, a clinically significant risk, can be prevented with very thin cuffs made of highly expansive elastomers.

[0069] The Cloud Cuff comprises multiple sections at different heights and with varying maximum diameters (due to their configuration), the sections connected together are configured to avoid folding and therefore possible leakage of the ET tube cuff and ensure a good seal and tight fit.

[0070] Figures 5a and 5b illustrate another embodiment of a cuff configuration for a double-cuff ET tube. Two one-way valves are installed in the double-cuff configuration. Figure 5a shows a cross section (along the vertical yz plane) and Figure 5b shows a full perspective zoom-in on the cuffs 510, 550. The double-cuff ET tube comprises two cuffs 510, 550 provided on the ventilation tube 500 of the ET tube 50, marked with cuff inflation lines 505. The two cuffs 510, 550 are both cloud cuffs, each containing three sections.

[0071] Between the two cloud cuffs 510, 550 is shown an inter-cuff region 540 that connects the upper cloud cuff 510 to the lower cloud cuff 550. At the double cuff proximal end, an open end 516 in the form of a cylindrical or tubular section is adjacent to the upper cloud cuff 510 and is intimately connected to the tube 500. At the double cuff distal end, a closed end 517 also in the form of a cylindrical or tubular section is adjacent to the lower cloud cuff 550 and is intimately jointed or connected to the tube 500. Both cloud cuffs 510, 550 are equipped with one-way valves 520, 525 proximate their respective ends 516, 517. In the unused state, both valves 520, 525 appear as flaps or skirts placed on their corresponding cloud cuffs 510, 550, especially placed between the two sections for easy folding / deployment of the valves. Again, the valves come into contact with the patient's tracheal wall in case of negative or overpressure (sudden and / or short, but high), thus providing additional sealing (see e.g. sealing portions 572, 575). Thus, the embodiment provides good (against leakage) protection even during suction and higher pressure ventilation.

[0072] As known in the art, leakage can be caused by higher ventilation pressures than those provided by the ventilator or by high suction: cuffs from the art are filled with / at 25 mbar for example, but when the ventilation pressure is 40 mbar, the cuff does not have a sufficient seal and therefore has leakage and ventilator capacity limitations.

[0073] Referring again to the embodiment of FIGS. 5a and 5b, the Cloud Cuff includes multiple sections at different heights and with various maximum diameters (due to their construction) that are connected to each other to avoid folding and therefore possible leakage of the ET tube cuff and ensure a good seal and tight fit. Additionally, a flap or valve 525 is placed at the distal end of the ET tube double cuff, which closes itself (against the tracheal wall) at the ventilator pressure. The ventilator pressure opens the valve, creating a tight fitting and avoiding leakage at the cuff. Thus, a cuff with a lower pressure than the ventilator pressure still ensures sealing. In either case, the cuff is under a certain pressure, called the cuff pressure, which differs between the inflated and non-inflated states. In the non-inflated state, the cuff pressure is 0 mbar (or vacuum). Typically, in the inflated state, the cuff pressure is 20-30 mbar, but can peak up to 60-70 mbar for a few minutes, i.e., about 1-2 minutes. The working pressure of the ventilator, and therefore the equivalent pressure in the lungs, is generally quite high, from 50 to 100 mbar. In case of a leak, the ventilator may give an alarm signal and in some cases the ventilator may fail due to a leak at or on the cuff. A one-way valve is provided at the distal end of the ET tube double cuff, such as valve 525 in Fig. 5, but also valve 225 in Fig. 2 and valve 425 in Fig. 4, to avoid leakage and therefore all its possible consequences, such as, for example, a ventilator failure condition. Referring again to the embodiment of Figs. 5a and 5b, for suction, a flap or valve 520 is placed at the proximal end of the ET tube double cuff.

[0074] Figures 6a and 6b show yet another embodiment of a cuff configuration for a double-cuff ET tube. This embodiment can be interpreted as a double-cuff version of the single-cuff configuration shown in Figure 3, but here the cloud cuff with its two sections and inflatable one-way valve is mirrored and duplicated (i.e., one is a mirror image of the other in configuration) to create the double-cuff configuration.

[0075] Figure 6a shows a cross section (along the vertical yz plane) and Figure 6b shows a full perspective zoom-in on the cuffs 610, 650. The cloud cuffs 610, 650 each comprise two sections 611, 612, 651, 652, one above the other (overlapping), shown here in an inflated state. For each cuff, the sections are connected and have a difference in maximum diameter, such that there is a smaller section 611, 652 and a larger section 612, 651. Thus, a sealing portion is achieved that is adapted to form a wrinkle-free band against the patient's tracheal wall when inflated, where the wrinkle-free sealing band is configured to prevent leakage of fluid or air past the wrinkle-free sealing band when inflated. Cloud cuff 610 is adjacent to an open end 616, while cloud cuff 650 is adjacent to a closed end 617 and intimately connects with tube (600). Both open end 616 and closed end 617 are in the form of cylindrical or tubular sections. Located adjacent to the smaller section 611 of cloud cuff 610 is an inflatable one-way valve 620, and located adjacent to the smaller section 652 of cloud cuff 650 is an inflatable (mirrored) one-way valve 625. Both valves 620, 625 come into contact with the patient's tracheal wall when the cuffs are inflated, so that additional sealing is achieved. Inflatable one-way valves are meant to be double-walled so that they can be inflated until a bowl, cup, or boat-like shape is produced. From a practical standpoint, both inflatable one-way valve(s) can be used as well as single flap(s) or skirt(s). As shown in Figure 6a, the double walled valve 620 comprises an inner wall 622 and an outer wall 621. As shown in Figure 6b, the valves 620, 625 are in an inflated state such that their respective sealing portions 672, 675 (for sealing against the tracheal wall) are visible. The dashed line in Figure 6b indicates the position on the ventilation tube 600 where the cuff arrangement will be placed.

[0076] Figures 7a and 7b show a further embodiment of a cuff configuration 710 for a double-cuff ET tube 70. This embodiment differs from that shown in Figures 4a-4c in that the one-way valve does not include a double-cuff configuration. In Figure 7a, the entire double-cuff ET tube 70 is shown with a ventilation tube 700, a cuff inflation lumen or line 705 (with pilot balloon 706), and two cloud cuffs 720, 730. Figure 7b zooms in on the two cloud cuffs attached around the tube. Note that the ribbed shape of the cuffs 720, 730 differs from the rounded shape of Figures 4a-4c. The rounded shape is preferred, but the ribbed shape is not necessarily excluded from the present invention.

[0077] According to one aspect of the invention, in addition to the single or double cloud cuff, and the one or more one-way valves provided with the single or double (standard or cloud) cuff, a cuff controller is also provided. Before describing the embodiment of the cuff controller shown in the attached drawings in Figures 8a and 8b, according to the present invention, a more general description of the cuff controller is first given. A controller (such as a cuff controller) means an (electronic) device that generates control signals for other equipment (by executing a control algorithm based on monitoring or measuring or sensing one or more signals). In the context of the present invention, such a device or appliance is any device suitable for providing a flow of air (such as a ventilator) and thus also determining the pressure when providing such flow to a closed or semi-closed environment (such as a cuff or inter-cuff area). The (electronic) apparatus comprises a storage device (such as a memory) (e.g. for storing user-defined set points) and a computing device (such as a microcontroller or microprocessor) capable of generating control signals and executing measurement and control procedures or protocols.

[0078] In a first embodiment, a cuff controller is provided for automatically controlling the pressure inside the cuff of an endotracheal tube (ETT), such cuff controller receiving measurements of such pressure and generating a control signal (as described above) based on such measurements.

[0079] In a second embodiment, particularly when using an ETT having two cuffs, a cuff controller is provided to measure the pressure in the space between the cuffs (i.e., the inter-cuff area). The cuff controller can also provide detection of leaks around (but not in) the cuff. The cuff controller can automatically increase the pressure inside the cuff if it detects a leak, which may be the result of improper sealing, e.g., due to wrinkles on the cuff surface and / or under-inflating the cuff. Additionally, the cuff controller can aspirate secretions that accumulate on the cuff. Such a cuff controller inputs measurements of the pressure with the cuff and / or the pressure in the space between the cuffs (i.e., the inter-cuff area) and generates a control signal (as described above) based on such measurements. Additionally, it can generate a control signal for the pump to aspirate secretions.

[0080] In a further embodiment of this second embodiment, the cuff controller may temporarily reduce the pressure in the inter-cuff area as part of a measurement procedure or protocol and then measure or monitor the pressure development to check whether the pressure changes as a change in pressure would indicate a leak. Note that the above first and second embodiments may be combined.

[0081] According to one embodiment of the present invention, the cuff controller has multiple functions, which are illustrated by way of example (but not by way of limitation) in the following random order: (1) adjusting the pressure inside the cuff to a user-defined set point between 10 mbar and 50 mbar; (2) detecting cuff leaks due to cuff damage; (3) detecting pericuff tracheal leaks; (4) Having an automatic cuff pressure adjustment mode, i.e., automatically increasing the pressure inside the cuff within a user-defined tolerance range between 5 mbar and 20 mbar to provide a proper seal when a tracheal leak is detected; (5) Having a timed hold mode, i.e., the cuff pressure is temporarily increased to some higher target pressure to provide a better seal during critical situations (e.g., vomiting, repositioning the patient, or ETT, suction, etc.); if a double cuff ETT is used, the negative pressure in the chamber is also increased to keep the cuff flaps closed (even when suction is performed); (6) Aspirating secretions above the cuff, (7) Continuing to function without mains power for some time (battery), and (8) Provide audible and visual alarms (e.g., cuff leak, tracheal leak, battery).

[0082] According to one embodiment of the invention, the cuff controller has different operating modes. When activating the cuff controller, the user must indicate what kind of ETT is being used, i.e. a standard ETT with a single cuff or an ETT with double cuffs. In the case of an ETT with double cuffs, for example, the cuff controller has five modes:

[0083] 1.Controlled cuff pressure mode. The most basic mode (also present in competing devices) is where the cuff is inflated to a constant pressure and this pressure is maintained over time. Setting: Target pressure.

[0084] 2. Controlled cuff pressure mode with tracheal leak detection. Same as previous mode, but while the cuffs are at the target pressure, negative pressure is created in the space between the cuffs to detect tracheal leaks. If a leak is detected (pressure rises in the space too quickly), the user is notified by an audible alarm. Setting: Target pressure.

[0085] 3. Automatic cuff pressure adjustment mode. Same as the previous mode, but if a tracheal leak is detected, the pressure inside the cuff is automatically increased by a fixed amount. The user defines a minimum and maximum target pressure, and this mode attempts to find the minimum pressure that provides a leak-free tracheal seal by starting at the minimum pressure and increasing the pressure stepwise until there is no leak. If the maximum target pressure is reached and a leak is still present, the user is notified by an audible alarm. Setting: Minimum target pressure. Maximum target pressure.

[0086] 4. Time limited hold mode. In this mode, the cuff pressure is temporarily increased to a specified higher target pressure to provide better sealing during critical conditions (e.g. vomiting, repositioning of the patient or ETT, suctioning, etc.). If a double-cuff ETT is used, the negative pressure in the chamber is also increased to keep the cuff flaps closed (even when suction is being performed). This function is time-limited since increased cuff pressure can cause tissue necrosis. After a user-defined time, the controller automatically returns to the configured mode. Settings: Increase target pressure. Hold time.

[0087] 5.Deflate Mode. In this mode, the pressure inside the cuff is reduced to zero so that the patient can be safely extubated. None set.

[0088] When using a single cuff ETT, for example, there are only three modes, all with the same characteristics as above: 1 / Controlled cuff pressure mode, 2 / Time-limited hold mode, and 3 / Deflate Mode.

[0089] According to one embodiment of the present invention, the cuff controller has five functional requirements:

[0090] 1. The cuff controller must regulate the pressure inside the cuff to a user-defined set point between 10mbar and 50mbar. It must automatically inflate the cuff to the set pressure and maintain this pressure over time to provide an adequate seal to prevent back leakage of tidal volume (risk of hypoxia in the operating room and / or anesthetic contamination) or forward leakage of fluid into the lungs (risk of aspiration and / or pneumonia). Reason: Lower pressure (hyperinflation) will not close the trachea, and higher pressure (hyperinflation) can cause tissue necrosis in the tracheal wall by blocking mucosal blood flow. Automatic pressure monitoring and control does not burden the medical professional to do this manually. This is a fundamental feature inherent to the cuff.

[0091] 2. The cuff controller must be able to detect cuff leaks (cuff damage) in all operating modes and notify the user with audible and visual alarms. A leak due to cuff damage can be detected, for example, when pressure inside the cuff cannot be maintained without continuously pumping air into the cuff. The alarm notifies medical personnel of the leak so that they can intervene to avoid the risks associated with an improper cuff seal, as previously described. Reason: This is a basic safety feature that is also present in all cuff controllers in the art.

[0092] 3. When the tracheal leak detection mode is active, the cuff controller (must) detect leaks around the cuff. Leaks around the cuff (tracheal leaks) can be detected, for example, by depressurizing the space between the cuffs and checking for a pressure rise. Why: This feature is unique and does not yet exist on the market, reducing the risks associated with improper sealing of the cuff and reducing burden on medical professionals.

[0093] 4. When the automatic cuff pressure adjustment mode is active and a tracheal leak is detected, the cuff controller shall automatically increase the pressure in the cuff within a user-defined tolerance range between 5mbar and 20mbar to provide an adequate seal. Description: This mode ensures good tracheal sealing without straining the medical professional. Why: This feature is unique and does not yet exist on the market, reducing the risks associated with improper sealing of the cuff and reducing burden on medical professionals.

[0094] 5. When the automatic cuff pressure adjustment mode is active, the cuff controller shall give an audible and visual alarm if the leak is not automatically resolved by increasing the pressure inside the cuff within a user-set tolerance. The alarm notifies medical personnel of the leak so that they can intervene to avoid the risks associated with an improper cuff seal, as previously described. Why: To avoid the risks associated with improper cuff sealing, as mentioned above.

[0095] 8a and 8b show an embodiment of a type of double-cuff ET tube with a double-cuff configuration, with FIG. 8a showing that the tube includes a sensing and / or measurement system for detecting whether a leak has occurred between the cuff and the patient's tracheal wall, and FIG. 8b showing that it includes a cuff controller connected thereto. As shown in Fig. 8a, the double cuff ET tube 80 comprises two cuffs 810, 850 placed on the ventilation tube 800 of the ET tube 80, with the cuff inflation line 805 marked and a pilot balloon 806. The end 804 and distal end 830 of the ET tube are also shown. The two cuffs 410, 450 are both cloud cuffs, each here including three sections. Between the cuffs 810, 850, also called the inter-cuff region 840, the cuffs are connected by a cylindrical or tubular section. At the proximal end of the double cuff there is an open end 816 in the form of another cylindrical or tubular section adjacent to the upper cloud cuff 810 and in close connection with the tube 400 (800). At the distal end of the double cuff there is a closed end 817 in the form of a further cylindrical or tubular section adjacent to the lower cloud cuff 850 and in close connection with the tube 400 (800). The lower cloud cuff 850 is provided with a one-way valve 825 near the closed end 817. The cylindrical or tubular portion located in the inter-cuff area 840 is provided with, for example, a small opening 841 for connecting a thin tube 842, which is also connected to a cuff controller 890 shown in Fig. 8b. Through this thin tube connection, the pressure in the inter-cuff area 840 can be measured and displayed by the cuff controller 890. The type of double-cuff ET tube 80 in Figure 8a is in fact equivalent to the one shown in Figures 4a-4C, but now also refers to allow measurements between the cuffs 810, 850, i.e. in the intercuff area 840, in order to detect leaks and actively correct the pressure. In other words, the possibility is presented to measure the pressure around the cuffs and to detect any possible leaks between the cuff and the tracheal wall. Through the small opening 841 and the connection of the thin tube 842, the inter-cuff space or area can also be connected to a pressure inlet (e.g., a ventilator) so that pressure can be applied and / or adjusted and thus a balanced pressure is created in and between the cuffs. Standard ET tubes may allow for measurement of cuff pressure, but do not necessarily reveal leaks associated with cuff tracheal closure. By measuring around the cuffs, i.e. between the cuffs, leaks can be detected and corrected. For example, the pressure in the inter-cuff area is first measured by connecting it to a long thin tube with a small opening and a cuff controller. The thin tube is also connected to a pump and adjusted to allow air to be sucked from the inter-cuff area (e.g., about 20 mbar) and to create a small vacuum. The pressure development in the inter-cuff area is then monitored with the cuff controller. If the pressure changes, it can be concluded that there is a leak. The thin tube can be connected to a pump or a pressure inlet to adjust and correct the pressure.

[0096] According to one embodiment, a double cuff ET tube with cloud cuffs is provided that is connected between the cloud cuff(s) with detection and / or measurement means to a cuff controller, which is an electro-medical device that can measure and control the cuff pressure and the gas and liquid tight seal leak detection by a feedback mechanism. Thus, the cuff controller not only allows the detection of leaks around the cuffs, but may also allow active automatic correction.

[0097] The cuff controller measures and maintains the cuff pressure, but also detects if the cuff is providing the required protection and seal (leaks on the fittings are immediately detected by measuring the pressure between the two cuffs). It therefore automatically adapts to the required target pressure (within set tolerances) to maintain a leak-free cuffed ET tube. Thus, an active measuring and pressure / flow correcting device is in place that provides optimal leak-free intubation.

[0098] With the cuff controller, a user preset pressure is given to start filling the cuff. With the feedback mechanism, when the pressure between the two cuffs is decreasing or a higher inflow or outflow is needed to keep the pressure constant at a higher or lower value between both cuffs, and thus does not have a hermetically sealed cuff, the cuff controller will increase the cuff pressure until the flow decreases to keep the pressure constant, ensuring a perfect fit at the lowest possible pressure in the cuff.

[0099] This feature of the invention makes the device unique as a guaranteed airtight fit seal, where the lowest possible cuff pressure is applied to avoid tissue necrosis etc. Currently, it is difficult for the user to know what pressure to apply to the cuff to occlude. Therefore, the cuff is usually inflated to 20-30 cm H2O or mbar, i.e. a given patient safety tolerance pressure, temporarily (up to a few minutes), sometimes much higher (e.g. up to 60 or 70 mbar, which is still acceptable for a short time, i.e. only 1 or 2 minutes). Since it measures whether there is (is not) a leak, it also knows what pressure is needed to be leak-free (e.g. pressure development is monitored). In other words, for closure or sealing, only 15 cm H2O or mbar pressure may be needed, whereas today a minimum of 20 cm H2O or mbar is already adopted as standard. The device described in the present invention can also avoid unintended leaks, which avoids other complications such as VAP.

[0100] List of items Embodiments of the present invention include at least the following items, which are not intended to limit the scope of the invention as a whole or to the appended claims.

[0101] Item 1: A cloud cuff for an endotracheal tube (ETT) system, the cloud cuff being attached or attachable to a ventilation tube of the ETT system, the cloud cuff having one or more cuff inflation lumens (also called lines) and two or more sections connected, where at least two sections have a difference in maximum diameter, at least one section acts as a sealing portion and is adapted to form a wrinkle-free band against the patient's tracheal wall upon inflation, the wrinkle-free sealing band configured to prevent leakage of fluid or air through the wrinkle-free sealing band upon inflation.

[0102] Item 2: The cloud cuff of item 1, wherein each of the two or more sections has a gradually varying diameter, each having a first end having a first diameter, a second end having a second diameter, and an intermediate section determined by the maximum diameter.

[0103] Item 3: The cloud cuff according to item 1 or 2, having a truncated cone shape or a double taper shape.

[0104] Item 4: The cloud cuff according to any one of items 1 to 3, comprising polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU).

[0105] Item 5: The cloud cuff of any one of items 1 to 4, configured to be inflated to a cuff pressure of 5 to 30 cm H2O, and in some cases to a cuff pressure of 100 cm H2O.

[0106] Item 6: A cloud cuff according to any one of items 1 to 5, wherein one or more sections are configured to make respective slight contact with the tracheal mucosa so that ischemic phenomena are reduced.

[0107] Item 7: The cloud cuff described in any one of items 1 to 6, wherein the ETT system has a distal end adapted to be inserted into the patient's trachea and a proximal end adapted to be connected to a ventilator.

[0108] Item 8: The cloud cuff of any one of items 1 to 7, wherein the two or more sections are separate balloons.

[0109] Item 9: The cloud cuff of item 8, wherein each of the balloons is separately connected to a respective intramural channel in the ventilation tube, allowing independent inflation of the balloons, e.g., the intramural channels being cuff inflation lumens or lines.

[0110] Item 10: The cloud cuff according to any one of items 1 to 9, wherein one or more one-way valves are provided in the vicinity thereof, each of which contacts the patient's tracheal wall in the event of negative or overpressure, providing additional sealing.

[0111] Item 11: The cloud cuff described in item 10, wherein between the two sections, one of the one or more one-way valves is provided, which in the event of negative or overpressure, comes into contact with the patient's tracheal wall, so that additional sealing is achieved.

[0112] Item 12: The cloud cuff of item 11, wherein the one-way valve is provided between two sections, which will come into contact with the patient's tracheal wall in the event of negative pressure, thereby achieving additional sealing in a proximal position and / or between two (other) sections, and wherein another one of the one or more one-way valves is provided, which will come into contact with the patient's tracheal wall in the event of overpressure, thereby achieving additional sealing in a distal position.

[0113] Item 13: The cloud cuff of any one of items 1 to 9, wherein an inflatable one-way valve is located near, and preferably adjacent to two or more sections, and / or is incorporated into the cloud cuff, which contacts the patient's tracheal wall when inflated, to achieve additional sealing.

[0114] Item 14: An ETT system for ventilating a patient, comprising a ventilation tube, one or more cuff inflation lumens, and the cloud cuff of any one of items 1 to 13.

[0115] Item 15: An ETT system for ventilating a patient, comprising two cloud cuffs according to items 1-13, the ETT system comprising a primary cloud cuff and a secondary cloud cuff distal to the primary cloud cuff, the two cloud cuffs comprising one or more cuff inflation lumens for inflating and / or deflating the two cuffs, and an inter-cuff region connecting the primary and secondary cloud cuffs.

[0116] Item 16: The ETT system of item 15, wherein the inter-cuff region comprises means for sensing and / or measuring airflow parameters.

[0117] Item 17: An ETT system according to item 15 or 16, wherein a one-way valve with a first cloud cuff contacts the patient's tracheal wall in case of negative pressure and achieves additional sealing at a proximal position, while another one-way valve with a second cloud cuff contacts the patient's tracheal wall in case of overpressure and achieves additional sealing at a distal position.

[0118] Item 18: 18. A method for ventilating a patient, comprising: (i) providing an ETT system according to items 15-17; (ii) orally inserting the ETT system into a patient such that the two cloud cuffs are positioned in the patient's trachea; (iii) inflating the two cloud cuffs including the inter-cuff region; (iv) sensing and / or measuring one or more airflow parameters in the inter-cuff region; and (v) further / additionally inflating the two cloud cuffs such that in the event of a change in the one or more airflow parameters, a constant pressure in the inter-cuff region is achieved.

[0119] Item 19: A (cuff) controller comprising an electronic device for inputting sensed parameters and calculating one or more conditioned air flows therefrom, and one or more first mechanical means (e.g., a ventilator) for providing said conditioned air flows.

[0120] Item 20: 20. The (cuff) controller of item 19, further comprising one or more second mechanical means (e.g., pumps) for providing suction action, the electronic device also determining or calculating (from sensed parameters) the one or more suction actions.

[0121] It should be noted that the terms "substantially" and "about" may be utilized herein to express the degree of inherent uncertainty that may result from any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to express the degree to which a quantitative representation may vary from a stated reference without resulting in a change in the basic functionality of the subject matter in question. The term "substantially" is also utilized herein to express the degree to which a quantitative representation may vary from a stated reference without resulting in a change in the basic functionality of the subject matter in question. It is thus utilized to express the degree of inherent uncertainty that may result from any quantitative comparison, value, measurement, or other representation that refers to an arrangement of elements or features that is expected in theory to exhibit an exact correspondence or behavior, but in reality may embody something that is not exact.

[0122] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. The terms used in the description of this specification are only for describing particular embodiments and are not intended to be limiting. As used in this specification and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms unless the context clearly indicates otherwise.

[0123] As used herein, the terms "horizontal" and "vertical" are relative terms only and indicate only a general relative orientation, not necessarily verticality. These terms may also be used for convenience to refer to the orientation used in the figures, which orientation is used as a convention only and is not intended as a feature of the device shown. The invention and its embodiments described herein may be used in any desired orientation. Furthermore, horizontal and vertical walls generally only need to be intersecting walls and not necessarily vertical.

[0124] It should be noted that one or more of the claims below utilize the term "herein" as a transitional phrase. For purposes of defining the present technology, it should be noted that this term is introduced into the claims as an open-ended transitional phrase used to introduce a recitation of a series of features of a structure and should be interpreted in a similar manner to the more commonly used open-ended preamble term "comprising."

[0125] It should be understood that when a first component is described as "comprising" or "including" a second component, in some embodiments, it is contemplated that the first component "consists of" or "consists essentially of" the second component. In addition, the term "consisting essentially of" is used herein to refer to quantitative values ​​that do not materially affect the basic and novel characteristics of the invention.

[0126] It should be understood that any two quantitative values ​​assigned to a property or measurement may constitute a range for that property or measurement, and all combinations of ranges formed from all recited quantitative values ​​for a given property or measurement are contemplated in the present invention.

[0127] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications can be made without departing from the scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter. [Explanation of symbols]

[0128] 10: Endotracheal tube 100: Ventilation tube 1000: Ventilation tube 1007: Tracheal wall 1008: Trachea 1009:Patient 1010: Cuff 1010': Single cuff 1011: Section 1012: Section 1013: Section 1014'':Cuff section 1016: Open end 1017: Closed end 1020:One-way (double-walled) valve 1020: Valve 1020': Valve 1025: One-way (double-walled) valve 1025: Valve 1025': Valve 1030: Distal end of tube 1000 1031: Bevel 1032: Murphy Eye Aperture 105: An elongated channel through which the cuff can be inflated 105: Cuff inflation line (also called cuff inflation lumen or cuff inflation lumen; the same applies below) 1070:Ceiling part 110: Cuff 110: Inflated cuff 110: Inflated single cuff 1100:ET Tube 1100: Cuff configuration 1108: Patient's trachea 111: Uninflated single cuff 1110: Single cuff 1116: Proximal end 1120: Valve 1180: Secretion 120: Syringe 120: Syringe for inflation 130: Pilot Balloon 140: Edge of mouth 20:ET Tube 200: Tube 200: Ventilation tube 200: Pipe (also called tube) 205: Cuff inflation line 206: Aperture (opening) 210: Cuff 210: Cloud Cuff 210: Single cuff 210': Single cuff 210': Single Cloud Cuff 211: Section 212: Section 213: Section 214: Section 215: Section 216: Tube cuff distal end or open end 216: Open end 216: End 217: Lower end or closed end 217: End 217: Closed end 220: One-way valve 220': One-way valve 220': Uninflated bulb 221: Edge of valve 221': Edge 225: One-way valve 225: Valve 225': One-way valve 225': Uninflated bulb 226: Edge of valve 226': Edge 230: Cuff 230: Single cuff 230: Distal end 231: Bevel 232: Murphy eye opening 240: One-way valve 245: One-way valve 270: Sealing part 272: Sealing part 275: Sealing part 290: Cloud Cuff 30:ET tube 300: Ventilation tube 300: tube 305: Cuff inflation line 305: Line 306: Opening 310: Cuff 310: Cloud Cuff 310: Single cuff 311: Section 312: Section 312: Large part 316: Open end 317: Closed end 320: Double wall valve 320: Inflatable one-way valve 321: Exterior wall 322:Inner wall 370: Sealing part 372: Sealing part 40:ET tube 40: Double cuff ET tube 400: Tube 400: Ventilation tube 400: tube 405: Cuff inflation line 406: Opening 407: Opening 410: Cuff 411: Section 412: Section 413: Section 416: Open end 417: Closed end 418: Double cuff proximal end 419: Double cuff distal end 419: Distal end 425: One-way valve 425: Valve 440: Intercuff area 450: Cuff 450: Lower Cloud Cuff 451: Section 452: Section 453: Section 470: Sealing part 475: Sealing part 50:ET tube 500: Ventilation tube 500: tube 505: Cuff inflation line 510: Cuff 516: Open end 517: Closed end 520: Flap or valve 525: One-way valve 525: Valve 540: Intercuff area 550: Cuff 575: Sealing part 600: Ventilation tube 610: Cuff 611: Section 612: Section 616: Open end 617: Closed end 620: Double wall valve 620: Inflatable one-way valve 621: Exterior wall 622:Inner wall 625: Inflatable (mirrored) one-way valve 650: Cuff 651: Section 652: Section 672: Sealing part 675: Sealing part 70: Double cuff ET tube 700: Ventilation tube 705: Cuff inflation lumen or line 706: Pilot Balloon 710: Cuff configuration 720: Cloud Cuff 730: Cloud Cuff 8: Trachea 80: Double cuff ET tube 800: Ventilation tube 804:Terminal 805: Cuff inflation line 806: Pilot Balloon 810: Cuff 816: Open end 817: Closed end 825: One-way valve 830: Distal end 840: Intercuff area 841: Opening 842: Thin tube 850: Cuff 850: Lower Cloud Cuff 890: Cuff controller 9:Patient 90:ET Tube 900: Ventilation tube 905: Cuff inflation line 910: Cuff 910': Single cuff 911: Section Section 912 Section 913 916: Open end 917: Closed end 920:One-way (double-walled) valve 925: One-way (double-walled) valve 930: Distal end of tube 900 931: Bevel 932: Murphy Eye Aperture 960: Wrinkles d1: minimum diameter d2: Maximum diameter d3: diameter d4: diameter d5: diameter d6: diameter d7: diameter N: Arrow for negative pressure N:Arrow P: Arrow Sn: dashed arrow Sp:Arrow

Claims

1. A one-way valve located on or near a cuff for an endotracheal tube (ETT) system, the cuff being attachable to a ventilation tube of the ETT system, the ETT system having one or more cuff inflation lumens, the one-way valve configured such that under negative or overpressure, the valve is in contact with a patient's tracheal wall, thereby achieving a seal with the patient's tracheal wall.

2. 10. The one-way valve of claim 1, wherein the one-way valve is located proximal to the cuff such that in the event of negative pressure in contact with the patient's tracheal wall, the valve thereby achieves sealing at the proximal position.

3. 10. The one-way valve of claim 1, wherein the one-way valve is provided at a distal position of the cuff, such that in the event of overpressure contact with the patient's tracheal wall, the valve thereby achieves sealing at the distal position.

4. 10. The one-way valve of claim 1 having an inflatable volume.

5. 1. A Cloud Cuff for an endotracheal tube (also known as ETT) system, said Cloud Cuff attachable to a ventilation tube of said ETT system, said Cloud Cuff comprising: (i) an inflatable cuff body having a cloud shape with at least two sections having a difference in maximum diameter; (ii) a first cylindrical portion disposed at a proximal end of the inflatable cuff body; and (iii) a second cylindrical portion disposed at a distal end of the inflatable cuff body; wherein the first and second cylindrical portions have surfaces that match the cylindrical shape of the ventilation tube.

6. 6. The cloud cuff of claim 5, wherein each of the two or more sections has a diameter that varies gradually along the length of the ventilation tube.

7. 7. The cloud cuff of claim 6, wherein the cloud cuff is configured by a shape selection, particularly by gradually varying diameters of the two or more sections, such that the sections of the cloud cuff make slight contact with the patient's tracheal mucosa when attached to a ventilation tube and inserted into the patient's trachea.

8. 6. The cloud cuff of claim 5, wherein the cloud cuff has a substantially uniform thickness.

9. 10. The cloud cuff of claim 8, wherein the substantially uniform thickness is achieved by molding (also known as blow molding) the cloud cuff during its manufacture, and the thickness ranges from 0.05 mm to 0.2 mm, with a uniformity of ±5%.

10. 6. The cloud cuff of claim 5, wherein the cloud cuff is configured to be inflated to a cuff pressure of between 5 cm H2O and 30 cm H2O or up to 100 cm H2O by selecting the material used and / or its thickness.

11. 6. The cloud cuff of claim 5, wherein the cloud cuff is made from polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU).

12. 12. The cloud cuff of any one of claims 5 to 11, wherein the cloud cuff has one or more one-way valves according to any one of claims 1 to 4 on or near it, or between two sections of the cloud cuff, which contact the patient's tracheal wall in the event of negative or overpressure, such that a seal is achieved.

13. (i) an electronic device for inputting sensed parameters and calculating one or more conditioned air flows therefrom; (ii) comprising one or more first mechanical means or ventilators for providing said conditioned air flow; Cuff controller suitable for cuff control.

14. 14. The cuff controller of claim 13, further comprising: (iii) one or more second mechanical means or pumps for providing suction, the electronic device also determining and / or processing the one or more suction operations.

15. 15. A computer program product operable on a processing engine to perform any of the computing steps of claims 13 and / or 14.

16. 16. A non-transitory machine-readable storage medium storing the computer program product of claim 15.

17. 1. An endotracheal tube (ETT) system for ventilating a patient, said ETT system comprising: * Ventilation tube, *One or more cuff inflation lumens (also called cuff inflation lumens or lines), and *Cloud cuff as claimed in claim 12.

18. 18. The ETT system of claim 17, wherein the cloud cuff is defined as a primary cloud cuff, and the ETT system includes:

13. The additional cloud cuff of claim 12, defined as a secondary cloud cuff distal to the primary cloud cuff, wherein the two cloud cuffs comprise one or more cuff inflation lumens (also referred to as cuff inflation lumens or lines) for inflating and / or deflating the two cuffs; and *The inter-cuff area connecting the primary cloud cuff to the secondary cloud cuff.

19. 19. The ETT system of claim 18, wherein the inter-cuff region includes means for sensing and / or measuring airflow parameters using a cuff controller according to any one of claims 13 and 14.

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