WO2016209192A2

WO2016209192A2 - Improved endotracheal tube and tracheostomy tube

Info

Publication number: WO2016209192A2
Application number: PCT/TR2016/050198
Authority: WO
Inventors: Mehmet Rusen DÜNDARÖZ; Ahmet Koyun; Ufuk ERENBERK; Fatih AYGÜN
Original assignee: Kristal Gida Dagitim Ve Pazarlama Sanayi Ve Ticaret Anonim Sirketi
Priority date: 2015-06-26
Filing date: 2016-06-27
Publication date: 2016-12-29
Also published as: WO2016209192A3

Abstract

Endotracheal tubes and tracheostomy tubes are medical devices with crucial significance frequently used in various medical and surgical cases on both humans and animals. Their main function is to ensure safe and controlled transportation of oxygen and other gases to the patient. In this patent application, various novelties and modifications are provided in order to reduce some side effects encountered during use of these tubes, make operations easier, and achieve some advantages. Some of these novelties and modifications are obtained with arrangements in the anatomy-shape of the tubes, some with additions and changes in the production method, and some via coating techniques. These novelties and modifications are made by considering various factors such as the age, disease, medical condition, and equipment, facilities, and preferences of the intervening staff. Various characteristics required by these factors are provided. While each one of these novelties and modifications can be used alone for some clinical cases, some of their characteristics can be combined with each other to provide more significant and synergistic advantages. In rare clinical situations, all of the novelties and modifications disclosed in this application may be required to be collected and used in one single tube. In most cases, use of only some of these would be sufficient.

Description

DESCRIPTION

IMPROVED ENDOTRACHEAL TUBE AND TRACHEOSTOMY TUBE

Estimation of cuff pressure;

There is at least one cuff in the structure of these tubes. The pressures of the cuff/cuffs must be optimal in order to function better and cause fewer complications. To ensure this, they must be inflated with the required pressure, according to the circumstance. While various factors may cause changes in pressure, they must also be monitored during use. The methods used for pressure control still remain subjective or is time- consuming and demanding. Some studies indicate that circulation is broken down at 30 cm H2O pressure, it stops completely at 45 cm H2O, and damage can be inflicted depending on high pressure in a short time such as 15 minutes.

Optimal in-cuff pressure is recommended to be below around 30 cm H2O which is the perfusion pressure in tracheal mucosa. It is argued that this pressure is required to be below 25, 20, 18, 15, or even 14 cm H2O as it varies individually under the influence of various factors such as the patient's blood pressure, hydration, medications, etc. Some recommend that the safe, optimal pressure range to be 15 - 25 cm H2O.

As is known, in routine application, the cuff/cuffs remaining in the body is/are inflated after the endotracheal and tracheostomy tubes are placed in larynx or trachea at desired distance. It is pretty difficult to measure the pressure therein directly. The pilot balloons that remain outside the body and that are connected to the cuffs, give an idea about the pressure in routine embodiments. Pressure of the pilot balloon is balanced with and comparable to the in-cuff pressure and is same. The most practical way to have an idea about the cuff pressure is to assess pressure of the pilot balloons.

In this system, pilot balloon/balloons and/or the tube/tubes providing connection to applicable cuff/cuffs change/changes colour depending on its/their internal pressure, and thus provide information on pressures of the cuff/cuffs to which they are connected (1 , 21 ). This colour change provides information on both the pilot balloon and in-cuff pressure value. It can be understood both if it is at a sufficient level and if it has reached to dangerous levels. In the same time, it gives warning for readjustment if it diverges from the desired value during use. This colour change depending on pressure is provided in all or a part of pilot balloon/balloons and/or tube/tubes providing connection to applicable cuff/cuffs. In a more improved form of application, different colours such as white, orange, yellow, blue, purple, red, green, or combination or tones of these colours for colour change in order to increase recognisability.

As a more improved model, shape of the part indicating colour change is modified in a manner to provide information on pressure. In this context, colours indicate numbers of pressure values planned at production phase (25, 20, 18, 15, 14 etc. cm H2O) and/or sign, colour, number, letter, emblem, or symbol that correspond to a certain pressure. This colour change can be ensured by numerous methods. A method employed for this purpose is coating technique. It is based on colour change of semi-conductive sensor consisting of improved thin film polymer. A more improved alternative or additional method to make colour change is to obtain conductive or different polymers by chemical means.

In another alternative or additional method for colour change that we develop to estimate cuff pressure, visible signs or figures composed to indicate the pressure in pilot balloon/balloons and/or tube/tubes providing connection to applicable cuff/cuffs, thus cuff pressure, become visible when the cuff/cuffs is/are inflated. These are indicators/markers that correspond to a certain pressure such as sign, colour, number, letter, emblem, or symbol. In a method employed for these embodiments, balloons are bendable like an accordion when deflated, and the said markers become visible when they are inflated under certain pressures.

In an alternative method to estimate pressure, the pilot balloon/balloons and/or the tube/tubes providing connection to applicable cuff/cuffs takes/take a palbable shape according to the pressure inside them, thus the cuff pressure. These shapes are markers that correspond to a certain pressure such as sign, colour, number, letter, emblem, or symbol.

All colour changes and/or visible and/or palbable shapes and/or markers that form according to pressure can be used together and functions comparably when gases and liquids apart from air are used to inflate the cuffs. Enhancing visibility;

There are markers, particularly vocal cord line, some length or distance lines etc. to make it easy to understand the position on tubes, especially during placement. Visibility of these lines and markers in the beginning of procedure depends on the light that can reach the area by means of laryngoscope and similar devices. Use of this light is not possible all the time in every area. Furthermore, it is mostly required to enhance visibility of these signs even during use of these devices. All or at least certain places of the tube and/or cuff/cuffs and/or sign lines on the tube and/or at least one of the markers are made visible in absence or lack of light in order to provide or increase visibility of the tube and the area for a while during intubation procedure. For this purpose, light producing and/or emitting and/or light storing and emitting and/or reflecting substances are used or covered or painted on the tubes and cuffs in production. These procedures may provide light for a time to verify the tube is in the trachea through inspection shortly after the intubation beside their visibility advantages in the beginning of intubation procedure. This depends on anatomical suitability of patients. To detect an image, applicable area may need to be faded out. In this context, light emission feature is also provided on the front of tube and/or cuff/cuffs.

These places are phosphorous as an efficient method to ensure visibility. Phosphor colour may be in any colour, arbitrarily. As a different method of embodiment, different colours such as white, orange, yellow, blue, purple, red, green, or combination or tones of these colours are used at least in a part of the tube or to make the markers on it more apparent. The phosphorous which are used in all these procedures absorbs various sources of light, particularly laryngoscope light that is used during intubation. They are sensitive to all wavelengths.

An alternative and/or additional method to ensure visibility is the use of reflective materials, e.g. mirror, in applicable places. Injection and/or co-injection and/or extrusion and/or co-extrusion and making a reflective surface are among the most important methods to be used within this scope. All features that we bring in order to ensure/increase visibility for endotracheal tubes are also applied to tracheostomy tubes.

Prevention of occlusion; Non-adhesiveness of interior or exterior surfaces or cuff/cuffs of endotracheal and tracheostomy tubes provides advantages such as reduction in infection risk, or prevention of constriction or occlusion. As an alternative form of embodiment for providing these advantages, all of the tubes or cuff/cuffs are produced or covered by using teflon or carbon-teflon. As an alternative form of embodiment for decreasing image prevention effect of the teflon structure or for some cases where transparency is in the forefront, parts of the tubes where there are great risk of occlusion or the areas which are estimated to contact particularly vocal cords, (distal or proximal part, places of the endotracheal tubes that contact vocal cords, the places close to the cuffs, areas of cuffs that contact mucosa, etc.) are produced or covered by using teflon or carbon-teflon. As an alternative form of embodiment for similar purposes, a part of the tube and cuff/cuffs are made of or covered with teflon or carbon-teflon in various sizes and shapes (longitudinal, transverse, oblique or diagonal strips, round, polygonal, oval areas, etc.). This embodiment provides adequately dispersed transparency in addition to dispersed fragmented non-adhesive structure.

In prior embodiments, the whole tube or cuff is made non-adhesive in order to overcome adhesion problem. Such an embodiment leads to increase in complications that non- adhesive structure may cause. As an alternative embodiment for decreasing this side effect, non-adhesiveness is only kept limited to the parts where there are great risk of adhesion or the areas which are estimated to contact particularly vocal cords, (distal or proximal part, places of the endotracheal tubes that contact vocal cords, the places close to the cuffs, areas of cuffs that contact mucosa, etc.). In a new alternative embodiment, the structures added to these structures or only non-adhesive structures are dispersed on all over the tube and cuff/cuffs in various sizes and shapes (longitudinal, transverse, oblique or diagonal strips, round, polygonal, oval areas, etc.). This embodiment partially brings negative effect (constriction effect) of the normal (non- adhesive) structure under control while minimizing the complications that may be caused by non-adhesive structure.

As a more improved method of embodiment for making prevention of occlusion more effective, all or a part of the tube and cuff/cuffs are produced or covered in the manner hydrophilic and hidrophobic structures in various dimensions and shapes are side by side on the same face for use in cases of great risk considering that the materials leading to occlusion are mixed in terms of their chemical and physical features. This new approach is more effective in prevention of adhesion as large biological molecules of the material causing adhesion have various physical-chemical features.

Ease of use;

In most patients, it is possible to both prevent the tube from moving and determine a movement, if any, thanks to simple embodiments. Today, cloth-like material or plaster, etc. adhesive bands are used mostly to fix the tube. As exterior surface of the present tubes are flat, they move or slide especially when being wet. Exterior surface of the tube is made in the manner these tools hold it more tightly, easily and safely and make it difficult to slide. In this context, particularly proximal part of the tube is made clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shapes, directions, depths and lengths, thus it provide convenience by both grabbing the tube and preventing sliding in various fixation procedures of the tube. In this embodiment, in patient who having the teeth and can close their jaws, anti-slide feature provided on exterior surface of the tube contributes to prevent undesirable displacement even if it is minimal by fixing it. For some situations, these structures are marked with markers such as colour, number, figure, symbol, etc. to enable to understand the amount and direction of sliding, if any. These markers we put on this area of the tubes enable to realize any undesirable movement-sliding and know the amount and direction.

An alternative embodiment in this regard, similar facility is provided by sticking and/or fixing the special structure that provides the features mentioned in the paragraph above (making the tube clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shapes, directions, depths and lengths to make fixing easy, and markers such as colour, number, figure, symbol, etc. to enable to understand the amount and direction of sliding) to exterior surface of the tubes.

In presently used intubation tubes, connection is made by inserting the tip of distal part of the connectors in proximal opening of the tube body. There is a slight expansion in proximal opening terminal of the tube. Despite the expansion, loss of lumen still occurs. This case causes turbulence and increase in air resistance. After the intubation the tube body must be shortened and it must be reconnected to the connector for distance calibration. In this case, connection may be very difficult. In order to overcome these problems, distal tip of the connectors are expanded in a way to contain proximal tip of the tube body (2). To make connection easily, structure of the connector therein is made wider and more elastic, and it is made capable of expanding in a way to contain the tip of the tube. And/or structure of proximal part of the tube is made more stable-resistant, connection to the connector is made in the manner there is no loss of lumen while inserting it in the distal tip. And/or both sides of the connection (exterior surface of proximal tip of the tube body-interior surface of distal tip of the connector) are made easier to join tightly by making them clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shapes, directions, depths and lengths in the manner the connection is compatible for cases where connection is desired to be safer. In cases where connection is required to be more stable, a model that can utilize vacuum system is also developed. After the intubation tube is inserted, it is often shortened. As an alternative to provide convenience and more reliable connection, a screw system is developed that combines exterior surface of proximal of the tube in adequate length with interior surface of distal tip of the connector in a compatible and stable way (10). The connector is fixed to the tube by rotating it in a controlled manner thanks to the screw mechanism that is developed for connection between these two surfaces. The connecting parts are made in the manner they are not weakened by factors such as temperature, humidity, etc. As is known, tube lumen is typically narrower than device terminals. Interior design of these connectors have gradual narrowing feature to prevent any potential turbulence. In this model that is developed in the manner distal tip of the connectors contain proximal tip of the tube body, an alternative method is also developed to utilize present tubes with less modification. In this context, exterior surface of proximal part of the tube body and/or interior surface of distal tip of the connector is made easier to join by sticking and/or fixing the structure that is made clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shape, direction, depth and length to ensure the connection is safer and/or screw system and/or the structure that can utilize the vacuum system to proximal surface of the tube body and/or interior surface of distal tip of the connectors in a compatible manner.

Size of the intubation tubes are selected according to age and body size of patient. In this assessment made by taking account of the diameter, even if right choice is made for tube diameter, this length is not always ideal due to anatomical differences of the case. As length of the present tubes is fixed to diameter, there is not any chance of making a separate choice as to the size. Sometimes, the values apart from the tube length are also desired according to the type of medical intervention to a case. Both the length of the tube and the direction of the proximal lumen need to be changed during connection to ventilator or when additional medical interventions such as manual respirator are required. Due to the fixed structure in the production, plastic material resistance is encountered in direction efforts and tube displacement risk arises in the body. In order to overcome these problems, at least one bendable structure is provided along the tube. While this structure makes it easy to move the tube to a further distance, resistance of the plastic structure stops being a problem in changes in direction of the lumen opening and enables it to be fixed in the appropriate position during intervention. In addition, such bendable structures also function as shock absorber to prevent external movements from affecting the tube. The bendable structure is preferably placed close to the proximal lumen (4). As an alternative method, a structure to facilitate fixation after placement of the tube is added to distal of the bendable structure. Thus, body of the tube that functions within the body remains fixed more safely while the bendable structure is used. This structure also provides advantage in manipulation. The bendable structure can be locked when not in use (5). Thus, integrity of the tube is protected. As an alternative form of embodiment, the curves are made on the exterior surface-in a position not to constrict the lumen in order not to cause turbulence or any constriction in the lumen. All these features that are provided in endotracheal tubes through the bendable structure are also applied to tracheostomy tubes (22, 23).

In another alternative form of embodiment for similar purposes (changing direction and/or access-distance of the tube tip), direction and/or length changing feature is also provided in the component called adaptor or connector that is found on the proximal tip of endotracheal and tracheostomy tubes that enables their connection to other medical intervention devices. In this context, a bendable structure is made in at least one place of this part (6, 24). By means of this bendable structure, both their connection to other devices becomes easier and movement of the tubes within the body when connected is minimized. In addition, this bendable structure functions as a shock absorber to absorb undesirable movements of the devices toward the tubes when they are connected to other devices. The bendable structure therein can also be locked when not in use (7, 25). As an alternative form of embodiment, curves are made on the exterior surface-in a position not to constrict the lumen in order not to cause turbulence or any constriction in the lumen. In order for the connectors to be useful for similar purposes, an alternative form of embodiment is to make the connection divertible to any direction by adding at least one piston rod bearing mechanism that structurally consists of at least two components (8, 26). These components that are similar to piston rod enable terminal of the tubes that connect them to other devices to be rotated toward a desired direction. Thus, undesired movements of the tubes in trachea are minimized. A more improved embodiment is addition of bendable structure to each of these components. The bendable structures therein can also be locked when not in use. As an alternative form of embodiment, the curves are made on the exterior surface-in a position not to constrict the lumen in order not to cause turbulence or any constriction in the lumen. Thus, the connector is enabled to reach a farther distance. Terminals of these adaptors or connectors are compatible with all present tubes and devices in routine use. These adaptors are also made more compatible with outlet of tracheostomy tubes. Their outlets are suitable for modification for connection. They are made sterilizable for reuse. These connectors can also be utilized in other tubes with their reusable feature. As a further addition to essential function of these connecting part/parts (adaptors- connectors), they are capable of holding or fixing the rods-pipes, etc. components and apparatus that are used to inflate the cuff/cuffs and/or for aspiration (suction) around the tube for use in some cases.

It ensures the blurriness and visual pollution in the area are reduced. In an embodiment in this context, appropriate areas are provided around the connector in directions such as up, down, sideways, oblique, etc. taking ergodynamics into consideration, and at least one handle is provided on the connectors in various directions using these areas. An alternative and/or additional embodiment is equipped with paper clips and similar function tools (velcro mechanism, press stud mechanism, vacuum system, magnet system, hook, clasp, latch, clips, etc.) in various directions of the connectors. As an alternative and/or additional embodiment, slots in the form of indent and/or protrusion where rods-pipes of the tubes can be fixed tightly are made on various places of the connectors. While these slots that are in various sizes and/or found in various directions according to the needs have inlet that is wide enough to be placed easily to be more useful, and it becomes narrow to allow fixation after the placement or provides rotation to prevent displacement. Such various structures that are contained within these connectors and enable rods-pipes of the tubes to be fixed stably are also made on the fixation part placed on distal of the bellows in bendable tubes. Terminals of these adaptors or connectors are compatible with all present tubes and the devices in routine use. These adaptors are also made more compatible with outlets of the tracheostomy tubes. Their outlets are suitable for modification for connection. They are made sterilizable for reuse. These connectors can also be utilized in other tubes with its reusable feature.

Undesirable movement of intubation tubes after placement, or sometimes sliding into bronchus are among the frequently encountered complications. Sometimes, even X-ray may need to be used to check for displacement. It is desired that it does not move in the body after ideal placement. It is also important for tracheostomy tubes to be fixed after placement. Various devices are developed to keep these tubes in place. Use of these devices is inconvenient and time-consuming. They cause visual pollution due to occupying too much space in mouth and throat area. It makes evaluation of patient and intervention difficult. The connectors that connect the tubes with other devices are developed to function in overcoming this problem, and they are made to serve tube fixation function. As a form of embodiment within this scope, appropriate areas are added around the connector in directions such as up, down, sideways, oblique, etc. for some cases, and structures are made that enable to place and use at least one apparatus such as velcro mechanism, press stud mechanism, vacuum system, magnet system, hook, clasp, latch, clips, etc. in various directions on the connectors by using these areas and/or indents, protrusions, slots, holes are added. In the most practical model, wing-shaped structures that are typically found on both sides of the connectors of many tubes are extended a bit more, and at least one hole (preferably 2 holes) are made symmetrically on each of them. These holes and/or other fixation apparatus function as application point/points of pulling forces (via rubber-like structures) as an easy and safe holder to keep the tube in place and/or ensures fixation via apparatus such as rope, etc. These forces are applied to the tube via holes and/other fixation apparatus, so they do not occupy too much space in intervention and observation area. There are also structures such as tape, belt, strap, etc. that are developed and can be easily connected to fix to head and neck of a patient by using the holes and/or other fixation apparatus that are added to the connectors. These structures are prepared as connector-specific or additional component-apparatus. Features such as flexibility, softness, elasticity, transparency, non-adhesiveness, anti-infectiveness, non- allergenicity, etc. are added to these structures for some cases. These structures that are in various widths and lengths and length of which can be adjusted to patient have the risk of applying pulling force backwards even if they are connected on the sides, thus pushing the tube toward the distal unintentionally when the tubes are fixed toward the rear of head or neck in cases where tubes are used for a long time. To overcome this problem, inflatable airbags are added to the body of the structures such as tape, strap, etc. that are developed as a component of the connectors, preferably to the part contacting the patient. Inflating them both reduces pressure in contact areas of the patient and enables to adjust the power and direction of fixation. These airbags have at least two compartments for substitutional use in order to prevent pressure damage on skin and subcutaneous tissue in long-term use. Another method to prevent backsliding is to adjust the tube size by shortening. Thus, the additional area formed around the connector contacts the teeth and/or circumoral area and/or various areas of the body, so it prevents movement toward the distal. A solution that is developed to help overcome this problem is to place airbag on the rear of these connectors (the area that contacts the patient). This airbag prevents trauma on the teeth and/or circumoral area and enables to adjust the distance partially. The model having at least two compartments is also developed for substitutional use to prevent complications due to pressure. Terminals of these adaptors or connectors are compatible with all present tubes and devices in routine use. These adaptors are also made compatible with outlets of tracheostomy tubes and/or proximal part of the tracheostomy tube is also modified for these purposes and made to serve similar functions. Their outlets are suitable for modification for connection. They are made sterilizable for reuse. These connectors can also be utilized in other tubes with their reusable feature.

They are made capable of utilizing healthy teeth and/or gums and/or palate structures using additional alternative methods for use of these components (connectors-adaptors) in fixation of the tubes. The fixation structures that are developed in this context, placed on the teeth and/or gums and/or palates, and connected to the connectors are additional apparatus-components specific to the connectors. They are in various sizes to fit for upper and/or lower teeth and/or gums and/or palates. A number of embodiments are developed to fix these apparatus that are a type of endotracheal tube fixator to the teeth. They grasp the teeth and/or gums from the outside and hold them on the foreground- background with the structures similar to biting apparatus. They can be locked after placement. In another form of embodiment, there are screws that can compress the teeth and/or gums manually in a controlled manner. Alternatively, a form (similar to latch) is also developed that can be closed directly. Thin structures that can get in between upper and/or lower teeth are added to the component that is developed for the teeth for some patients. They are only preferred in cases where the teeth are very healthy and the tube must be held tightly. These extensions are prepared by taking the size of teeth into account because of the tube size. A form that contains airbag that can grab the upper and/or lower teeth and/or gums and/or palates with air pressure when inflated is also developed for more sensitive cases. Formal structure of these airbags enables the fixation part to fit the anatomy of the teeth and/or gums better, hold them more tightly and prevent trauma when inflated. They are suitable for addition of all pressure control systems that are developed in pilot balloons. For some cases, they have multiple compartments for substitutional use. For some cases, these structures that are similar to biting apparatus are suitable for use of biological-natural adhesive to hold onto the upper and/or lower teeth and/or gums and/or palates more tightly. These auxiliary-additional apparatus (additional structures for fixation) that are developed as a component of the connectors can be connected to the connectors easily and safely. In this context, at least one velcro mechanism and/or press stud mechanism and/or magnet system and/or vacuum system and/or hook and/or clasp and/or latch and/or clips and/or indent and/or protrusion and/or slot and/or screwing system, etc. formations that are mutually adaptable are added in various numbers and directions. The most practical model for durableness and controllability is to fix them to the recipient structure on the fixation apparatus by means of the screw that are passed through the additional areas around the connector. Screw mechanism can be controlled manually and easily, so it is possible to adjust position of the connector (thus the tube) in the body. Thus, undesirable movements of the tube that is placed by using the screw system are minimized considerably.

All terminals of this/these connecting part/parts (adaptors-connectors) and/or additional apparatus-components are in various sizes that are compatible with all present tubes (endotracheal and tracheostomy tubes) and other devices in routine use. Terminals are suitable for modification when needed. There are also sterilizable versions of all these connectors and/or additional apparatus-components for reuse. They can also be utilized in other tubes with this reusable feature. These connectors that allow many multi- directional embodiments can also be connected to the fixation structures in bendable tubes as well as connectors.

A more improved alternative model for fixation of the tube is screw fixator (3). This additional tube apparatus is placed by rotating it by using the screw mechanism (10) in adequate length in proximal part of the tube body. It is moved along the tube by rotating after the intubation is made, its place is verified, and then the tube is shortened by cutting it. While this screw socket groove structure can be formed on the tube in production, it can also be formed by sticking or fixing a structure having these features to a smooth-surfaced tube later. Depending on the patient's condition, it is enabled to contact the lips or teeth. In this case, the tube is prevented from moving toward the distal. If it moves to the proximal, its divergence from the mouth can be detected immediately. Softness, elasticity, transparency, non-adhesiveness, anti-infectiveness, non-allergenicity features are also provided on the applicable surface to prevent the screw fixator from harming the body by contact. Inflatable airbags are added to this surface for more sensitive patients. Inflating them both reduces pressure in contact areas of the patient and enables to adjust the power and direction of fixation. These airbags have at least two compartments for substitutional use in order to prevent pressure damage on skin and subcutaneous tissue in long-term use. To ensure better fixation of the screw fixator that is developed as an additional component of the tube for active patients, structures that allow placement and use of at least one velcro mechanism, press stud mechanism, magnet system, hook, clasp, latch, clips, etc. apparatus in various numbers and directions to fix it to head or neck by using strap-like apparatus and/or indents, protrusions, slots, holes are added. In cases where observation of patient is crucial, at least one hole (preferably 2 holes on each) are formed on lateral sides in order for it not to occupy too much space (20). These holes function as application point/points of pulling forces (via rubber-like structures) as an easy and safe holder to keep the tube in place. And/or they ensure fixation by means of rope, etc. apparatus. This structure prevents sliding toward the proximal. The wings contact the lips in lower and/or upper direction to prevent moving toward the distal. This structure is in minimal size to avoid disruption of observation of patient. Considering ergodynamics and space occupation, the most practical model is the four-wing model of the screw fixator (the two are in horizontal position for connection to the strap, the two for preventing moving toward the distal in vertical position). One-, two-, three-, or multi- winged versions are also developed for cases where patient intervention is frequent. There are also holes on these wings for connection. In addition to their essential function, they are capable of holding or fixing the rods-pipes, etc. components and apparatus that are used to inflate the cuff/cuffs and/or for aspiration (suction) around the tube for use in some cases. In this context, the apparatus that are made for connection to strap-like apparatus are utilized.

An alternative embodiment is also developed for the purpose of applying the screw fixator that is developed as an additional tube apparatus for fixation of the tube to present tubes with less modification. In this context, this is achieved by sticking and/or fixing the special structure (having the feature of placing by using the screw mechanism and/or containing groove and set) that can utilize the screw system to exterior surface of proximal part of the tube body in adequate length.

Reducing infection risk;

The material that comes from proximal of the cuff-upper respiratory tract from above and via reflux is accumulated between exterior wall of the tube proximal to the cuffs and trachea-larynx mucosa and causes irritation and infection. The humidity in this area is very high. In addition, it is a very limited and closed environment for aspiration. The humidity and lack of ventilation make the material riskier in terms of infection and irritation. This is also the case in distal of the cuff and the spaces between cuffs in the tubes having multiple cuffs. Dehydration or partial drying of the material via ventilation of these areas reduces the microorganism load and infection risk. For this purpose, the wall of the tube in trachea and larynx has air (gas) permeable feature. Thus, airflow is ensured between the tube wall and mucosa to a degree not to disrupt normal ventilation. This airflow leads to reduction in the amount of liquid that forms a basis for infection in the area. So far, no recommendation is found that aims to ventilate or dehydrate these areas. As a method of embodiment for this purpose, at least one hole or a thin incision is made on the tube wall and tiny passage/passages is/are made. This/these passage/passages ensure/ensures ventilation but do/does not disrupt ventilation and do/does not cause turbulence (12, 27). As a safer method of embodiment, this/these passage/passages have/has liquid (including water) tight and air (gas) permeable feature through its/their tightness. To improve this feature, the passage/passages is/are adjusted in the manner it/they do/does not allow airflow under pressures in expirium while allowing airflow under pressures in inspirium. Thus, a structure and opening that enable clean and oxygen-rich air inflow is provided. Adequate flexibility and opening is provided for this feature. It is possible to use many different methods (sound wave, heat, etc.) while making such passages. Mechanical systems and/or laser technology can also be utilized. As an alternative system, a opening cap-valve system is added to the passage/passages in inspirium or expirium to control air passage better. As an alternative method, wall of the tubes are made of air-permeable and liquid tight (including water) materials to achieve the same purposes (ventilation-drying). These materials constitute the tube surface at various rates depending on the purpose. While they are kept limited in certain areas (proximal or distal to the cuff, between the cuffs, etc.) for some indications, they are used in the whole tube in some cases. Such materials are also found in the structure of the cuff/cuffs in some cases. They are particularly preferred on surfaces that contact mucosa when inflated. The materials that are used within this scope are those that have low surface tension and/or hydrophobic and/or porous and/or diffusive characteristics. They are used at different rates and amounts depending on the clinical condition.

Another solution that is considered for ventilating-drying the areas in order to reduce microorganism load and infection risk is to make at least one capillary passage on the tube wall that passes through the wall as well as providing connection between the interior and exterior surface of the tube (13, 28). This/these passage/passages go/goes up to the proximal to prevent the material therein from reaching the lumen while going down to the cuff and especially while conducting air to the area on the cuff in the inspirium. Diameter and length of the capillary channels and their position in the tube (anterior, posterior, oblique, diagonal, lateral, etc.) vary by age and clinical condition of the patient and tube size. There is little risk for any material to go down the lumen (for patients lying in supine position) in positions apart from the posterior position. In more improved models, the opening of capillary passages is open in the inspirium and closed in the expirium and/or they have at least one opening valve (cap-pressure relief valve system) in inspirium or expirium.

All the features regarding ventilation and drying that are provided for endotracheal tubes are also added to tracheostomy tubes. Manipulation of tubes;

Elasticity of the endotracheal tube makes intubation difficult in some cases. A part of the tube wall is made of metal to manipulate the tube better. Alternatively, the metal structure is positioned in the rubber constituting the tube wall. Thus, it makes manipulation of the tube easy while not contacting the tissue. Some desired changes (curvature angle, etc.) can be made in overall shape of the tube. It prevents clinking of the tube and reduces obstruction risk. It also reduces the need for stylet. As the metal is radiopaque, it eliminates the need for radiopaque structure. It provides advantage in determining the position of the tube in radiographic or ultrasound examination. While it can be found throughout the tube, its width, thickness, and length are kept limited to a certain part for some indications considering age and clinical condition of the patient. The structure that lies beginning from proximal of the tube to tip of the cuff is mostly sufficient. In the tubes that comprise a bendable structure at least in one place to enable to change the length and direction, this metal structure preferably begins from the distal part where the bendable structure tips. Its most preferable position is the right hand side of the tube wall as the tube is placed by using the right hand in intubation. The models that are placed on different areas of the wall (left front, rear, oblique, diagonal, lateral, etc.) are also developed for some special cases. The metal can be any element, alloy, or a compound at various rates. It withstands bending or shaping many times. It is resistant to cracking or breaking. MR-compatible versions are also developed for some clinical conditions. Rigid plastic is also used together with metal for some rare special cases. An alternative embodiment for similar functions is to use spring wire or plastic wire separately or additionally. Carbon and metal powder at various rates are added to plastic wire depending on the need. The metal and/or plastic covered metal and/or rigid plastic and/or spring wire and/or plastic wire, etc. materials in all these embodiments can be cut by using scissors and similar tools. All features provided for endotracheal tubes by using metal and/or plastic covered metal and/or rigid plastic and/or spring wire and/or plastic wire are also applied to tracheostomy tubes. Reducing some complications;

The cuff/cuffs of the present intubation and tracheostomy tubes can enlarge-expand toward every direction equally when inflated. However, they are not suitable for lumen structure when anatomical structure of larynx or trachea that are planned to contact the tubes are examined. They increase the possibility of problem on the areas where the cuff/cuffs contact/contacts mucosa. To eliminate this potential problem, the cuffs are made compatible with lumen of the area where the cuffs are planned to contact when inflated. That is, the cuffs take the shape identical to anatomy-lumen of larynx or trachea when inflated. In general terms, this shape is roughly similar to a slight flat-rear elliptical form on the front-rear diameter along with slight loss of area on the rear (14, 29). This feature reduces the risk of problems due to pressure on contact areas of the mucosa.

Concavity of the currently used endotracheal tubes faces across (upwards). This concavity (curvature) comes over the tongue on the mouth floor of the patient during intubation. In this position, the hole called Murphy eye is found on the right hand side distal to the tube (1 1 ). On the left hand side, the tube is given a shape that is cut in oblique form from above right after the tip of the cuff, becomes thin gradually and has pointed tip, and the air outlet surface faces the left hand side of the patient (15). That is, right hand side of the tube tip is longer than the left hand side. As is known, the possibility of the endotracheal tube to get into the right main bronchus is higher than the left main bronchus when it is moved too much or when it slides forwards during use as the right main bronchus is more vertical than the left main bronchus according to anatomic structure of the lungs. In this case, the possibility of endotracheal tubes to move and slide toward the right main bronchus is higher due to the fact that Murphy eye is found on the right hand side while concavity of the endotracheal tubes are on the front, and the right tip of the tubes are longer; furthermore, it is not possible for Murphy eye to ventilate the left lung areas when it slides towards the right.

In an alternative endotracheal tube model that is developed for use in specific cases, localization of the oblique shape and Murphy eye is quite the opposite of the present structure symmetrically. That is, while concavity (curvature) of the tubes faces across (upwards), Murphy eye is found on the left hand side (32). The opening on the tip of the tubes faces towards the right hand side of the patient (33). Left hand side of the tube tip is longer than the right hand side as the oblique incision is found on the quite opposite side. The incision is made after the end of the cuff. Value of the incision slope and concavity angle is selected according to age and condition of the patient. As a form of embodiment, the incision slope is selected as 45 degrees. This new structure makes the tubes difficult to get into the right main bronchus and increases the possibility of getting stuck on the midline in the trachea. Moreover, Murphy eye can ensure ventilation of the left main bronchus even if it is placed in the right main bronchus.

To make this structure more advantageous, at least one additional hole is made as a substitute of Murphy eye between the starting point of the incision that is preferably on the opposite side (on the right hand side where the short tip is found) and the tube while Murphy eye is found on the left hand side. These holes are made in various sizes and shapes (triangle, rectangle, oval, polygon, round, angular, etc.) by taking account of age and condition of the patient (35).

Another solution that is developed to prevent the tube from getting into the right main bronchus is that the cuffs of the tubes that are produced according to classic system (Murphy eye on the right hand side) are produced in the manner they inflate more on the right hand side compared to the left under the same pressure (18). Thus, the possibility of getting into the right bronchus reduces in case of sliding toward the distal as the tip on the long side is made to slide slightly toward the left. The feature of inflating more is improved in the cuffs on the left hand side in cases of sliding toward the left due to certain anatomic differences. In other words, they are tubes with cuffs that inflate more under the same pressure on the right to prevent them getting into the right main bronchus and on the left to prevent them from getting into the left main bronchus by taking account of anatomic differences. In an alternative system to prevent the tube from getting into bronchia by taking account of anatomic differences, it is ensured that the cuff/cuffs inflate/inflates more in anterior, posterior, oblique, diagonal, etc. directions under the same pressure. In this case, distal tips of the tubes are prevented from getting into the main bronchus. Such a risk is very low in the models where Murphy eye is on the left hand side. Nevertheless, they are made in a way to ensure that the cuff/cuffs on the long part having Murphy eye (the left hand side) inflate/inflates more under the same pressure. The feature of inflating more under the same pressure is developed in the tubes with cuff/cuffs on the right (the tubes having Murphy eye on the left) for cases where there is a risk of getting into the left side due to certain anatomic differences.

In one of the methods employed to inflate the cuff/cuffs more under the same pressure to prevent the tip of the tube from getting into the main bronchia, the number of curves in cuffs of the tubes where the cuff wall is made curved inwards and/or outwards in deflated position is higher on the side that is desired to be inflated more to ensure there is more plastic texture therein (19). And/or resistance of the plastic texture is lower on the inflated side. And/or there are more and thicker plastic textures. All these changes enable the cuff/cuffs to inflate more. Rotation around the long axis of these tubes may change contact areas of the cuffs and put their function in jeopardy, so front, rear, or lateral side is marked clearly to detect any potential rotation. These markers are also applied to all other tubes.

Another method developed for similar purposes is that the cuff/cuffs have/has multiple compartments. The cuff/cuffs have/has at least two compartments to manipulate the tip of the tube in desired direction. The tip of the tube is manipulated and prevented from getting into the bronchia by providing these compartments with the feature of inflating in different volumes under different pressures and/or more or less under the same pressure.

Also, at least one hole is made in distal part of the tracheostomy tubes in order to reduce the possibility of obstruction and to create an alternative passage. These holes are in various shapes such as triangle, rectangular, polygon, oval, round, angular, etc. (34). Considering anatomical differences, the cuff/cuffs that inflate/inflates more under the same pressure on the right to prevent them getting into the right main bronchus and on the left to prevent them from getting into the left or alternatively in anterior, posterior, diagonal, or oblique direction is/are also applied to tracheostomy tubes, and thus they are made safer.

It is observed that both intubation and tracheostomy tubes cause tracheitis in long-term use and this is encountered more frequently on the front. As a reason, it is stated that the tubes contact the anterior mucosa of the trachea due to undesired movements toward the front and cause a type of trauma. It is thought that tip of the tube contacts mucosa of the trachea due to the opening of the curvature facing the front that is made for convenience in placement of intubation tubes. Similar problem is encountered in tracheostomy tubes even if they do not have such a structure. To overcome these problems, it is ensured that tip of the tube gets away from the front side because of inflation of the cuff/cuffs more in the anterior part under the same pressure. This structure enables to reduce tracheitis complication. In cuffless tubes, the oblique incision is prepared by making a loss on the front of the tube. In other words, short part of the tubes is found on the front, and the long part is found on the rear (9). This new shape provided in tracheostomy tubes (30) also provides advantage in passing their tips through the incision for placement in trachea. This specific structure is also applied to cuffed tubes. Murphy eye is found on the rear in such endotracheal tubes (16). It should be preferred in long-term use and the cases where there is a higher risk of undesired movements-thus trauma. At least one additional hole is made on the front of such cuffed or cuffless tubes where Murphy eye is found on the rear. These holes are in different sizes and shapes (triangle, rectangular, oval, round, angular, etc.) taking account of age and condition of the patient (17). The models where the cuff/cuffs inflate/inflates more in front-right and/or front-left direction more in cases where it is desired to reduce the possibility of getting into the main bronchia are developed in addition to the feature of inflating more on the front of the trachea to avoid trauma. The loss on the front (the incision on the tip of the tube) that is made to avoid tracheitis in the tubes is slided towards the right or left hand side in various distances in order for it not to cause problem in placement in some medical conditions, and oblique incisions are made in various sizes. In this case, the holes that are substitutes of Murphy eye are thus slided toward the right or left hand side. Sliding toward the right (placing the long part of the tube tip in oblique position on the right-rear) also reduces the possibility of getting into the right main bronchus.

Only the relevant area (the area that contacts the mucosa on the top) is made curved in order to minimize contact area of the cuff/cuffs that move/moves away when inflated more. The area of the cuff that contacts the mucosa is reduced by means of the curved structure. This curved structure can increasingly inflate (rise towards the distal), thus provide gradual divergence considering an embodiment.

Another method to prevent contact of the tip of cuffless tube with mucosa of the trachea is to add small airbags that creates distance via inflation with inspirium air. While they are placed on the front, they are also positioned in posterior, lateral, diagonal, oblique, etc. directions for some patients.

Forms of this/these cuff/cuffs that enable(s) to manipulate the tube tip to prevent some complications and are compatible with anatomic structure of larynx or trachea (more inflation in the desired direction, with at least two compartments, etc.) are also developed for cases where protection of larynx or trachea mucosa from trauma is crucial.

An alternative and/or additional method to prevent the tubes placed in the trachea from harming the mucosa is to make the tube tips curved-dished and/or create a radius inwards. This also prevents endotracheal tubes from harming vocal cords during intubation. These features are provided by making an inward-radius outlet during production of the tubes. This solution is developed within the scope of injection and/or co-injection method. An inward radius is made by additional operation-intervention in cases where extrusion and/or co-extrusion method is applied.

All novelties that are presented in this reference and mentioned above can be applied or adapted to all tubes (single, double, multiple, grooved, corrugated, non-adhesive, water- swellable, accordion, curved) that are used on humans and all similar cuff types, and in addition, all tubes that have aspiration (suction) or monitorisation facilities, the tubes that are spiral, ringed, double-lumen and the like, the tubes that allow to administer medications, and the tubes that are used in veterinary medicine individually or in combination. In addition, they are also sterilizable, washable, and reusable as well as being disposable.

Description of the Figures

Figure 1 : is the side view of the improved endotracheal tube. Figure 2: is the front view of the endotracheal tube distal wherein the Murphy eye is found on the right hand side.

Figure 3: Is the front view of the improved endotracheal tube wherein the Murphy eye is found on the left hand side.

Figure 4: is the front top view of the proximal part of the developed endotracheal tube.

Figure 5: is the side view of the improved tracheostomy tube.

Description of reference numbers given in the figures

I . Improved pilot balloon of the endotracheal tube

2. Improved connector of the endotracheal tube

3. Screwed fixator of the endotracheal tube

4. Bendable structure proximal to the endotracheal tube

5. Locking apparatus for the bendable structure proximal to the endotracheal tube

6. Bendable structure found on the improved connector of the endotracheal tube

7. Locking apparatus for the bendable structure found on the improved connector of the endotracheal tube

8. Rotatable piston rod bearing apparatus that can be connected to the improved connector of the endotracheal tube

9. Distal tip structure having endotracheal tube opening facing forward

10. Screw mechanism bearing found on the endotracheal tube

I I . Right hand side localization of the Murphy eye in the endotracheal tube

12. Small ventilation hole found on the endotracheal tube cuff

13. Capillary passage found at the endotracheal tube wall

14. Anatomically compatible flat-back cuff structure of endotracheal tube

15. Distal tip structure having endotracheal tube opening facing left 16. Structure having Murphy eye at the rear part of the endotracheal tube

17. Perforated structure found in front of the endotracheal tube distal tip

18. Extra-inflatable cuff structure of the endotracheal tube

19. Extra-curly cuff structure of the endotracheal tube

20. Endotracheal tube screw fixator hole

21 . Pilot balloon of the improved tracheostomy tube

22. Bendable structure proximal to the tracheostomy tube

23. Locking apparatus for locking the bendable structure proximal to the tracheostomy tube

24. Bendable structure found on the improved connector of the tracheostomy tube

25. Locking apparatus for the bendable structure found on the improved connector of the tracheostomy tube

26. Rotatable piston rod bearing apparatus of the improved connector of the tracheostomy tube

27. Small ventilation hole found on the tracheostomy tube cuff

28. Capillary passage found at the tracheostomy tube wall

29. Anatomically compatible flat-back cuff structure of tracheostomy tube

30. Distal tip structure having tracheostomy tube opening facing forward

31 . Structure having Murphy eye at the rear part of the tracheostomy tube

32. Structure having Murphy eye at the left part of the endotracheal tube

33. Distal tip structure having opening facing towards the right hand side distal to the endotracheal tube

34. Perforated structure found in front of the tracheostomy tube distal part

35. Perforated structure found at the right hand side of the endotracheal tube distal part

Claims

1 . The invention relates to tube/tubes providing connection with pilot balloon/balloons and/or cuff/cuffs found outside the body or connected the cuff/cuffs found inside the body in order to provide control and information for inflation of endotracheal and tracheostomy tubes, and it is characterized in that; all or some of these structures have a metachromatic structure (1 , 21 ) in order to provide information about the pressure values of the cuff/cuffs.

2. Metachromatic structures according to claim 1 , characterized in that; it comprises structures on which various colours such as white, orange, yellow, blue, purple, red, green etc. and combinations thereof or tones thereof are used for increasing recognisability.

3. Metachromatic structures according to claim 1 , characterized in that; these colours indicate numbers of pressure values planned at production phase and/or sign, colour, number, letter, emblem, or symbol that correspond to a certain pressure.

4. Metachromatic structures according to claim 1 , characterized in that; the method employed for colour change is coating technique, and the method is based on colour change of semi-conductive sensor consisting of improved thin film polymer and/or has a structure in which chemical ways are used in obtaining conductive and/or different polymers for colour change.

5. The invention relates to tube/tubes providing connection with pilot balloon/balloons and/or cuff/cuffs found outside the body or connected the cuff/cuffs found inside the body in order to provide control and information for inflation of endotracheal and tracheostomy tubes, and it is characterized in that; the visible signs or symbols formed thereon in order to show the inner pressure, and therefore the cuff pressure become visible when the cuff/cuffs is/are inflated and they have indicators in the form of signs, colours, numbers, letters, emblems, or symbols corresponding to certain pressure values.

6. The invention relates to indicators showing the pressures of the cuff/cuffs of the endotracheal and tracheostomy tubes according to Claim 5, and it is characterized in that; when the pilot balloons are deflated, they are foldable like an accordion and they have a structure that makes the indicators visible when the pilot balloons are opened under certain pressures.

7. The invention relates to tube/tubes providing connection with pilot balloon/balloons and/or cuff/cuffs found outside the body or connected the cuff/cuffs found inside the body in order to provide control and information for inflation of endotracheal and tracheostomy tubes, and it is characterized in that; they take a certain palpable shape according to the pressure found therein, and therefore in the cuff, and they have indicators in the form of signs, colours, numbers, letters, emblems, or symbols corresponding to certain pressure values.

8. A pilot balloon according to Claim 1 , 5, or 7, and it is characterized in that; all colour changes and/or visible and/or palpable shapes and/or markers that form according to pressure can be used together and they have a structure which functions similarly when gases and liquids apart from air are used to inflate the cuffs.

9. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; all or at least certain places of the tubes and/or cuff/cuffs and/or sign lines on the tubes and/or at least one of the indicators are made visible in absence or lack of light in order to provide or increase visibility of the tubes and the area for a while during intubation procedure.

10. The invention relates to making the endotracheal and tracheostomy tubes according to claim 9 visible in case of absence or scarcity of light, and it is characterized in that; light producing and/or emitting and/or light storing and emitting and/or reflecting substances are used or covered or painted on the tubes and cuffs during their production.

1 1 . An endotracheal tube or tracheostomy tube according to claim 9 or 10, and it is characterized in that; the visibility characteristic provided to the tubes is also found at the front side of the tubes and/or cuff/cuffs in order to ensure that the presence of the tube in trachea can be confirmed by visual inspection.

12. An endotracheal tube or tracheostomy tube according to claim 9, 10 or 1 1 , and it is characterized in that; its relevant parts have phosphorous structure and the phosphorus can be any colour according to preference.

13. The invention relates to the phosphorus according to claim 12, and it is characterized in that; various colours such as white, orange, yellow, blue, purple, red, green etc. and combinations thereof or tones thereof are used for improving visibility, and the phosphorus in all these applications have a structure that makes use of various sources of light, particularly laryngoscope light that is used during intubation, and it is also sensitive to all wavelengths.

14. An endotracheal tube or tracheostomy tube according to claim 9 or 10, and it is characterized in that; it has a structure formed by using materials that reflect light such as mirror at certain places.

15. The invention relates to said materials reflecting light according to claim 14, and it is characterized in that; the most significant methods used in production of these structures have a reflective surface structure formed by injection and/or co-injection and/or extrusion and/or co-extrusion.

16. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; at least certain parts or all parts of the tubes have a structure that is made of or coated by teflon or carbon-teflon in order to ensure that the tubes and cuff/cuffs are non-adhesive.

17. The invention relates to the tubes and cuff/cuffs according to claim 16, and it is characterized in that; it has a structure made of or coated by teflon or carbon-teflon in various dimensions and shapes (longitudinal, transverse, diagonal or oblique strips, circles, polygons, oval areas) such that it would provide adequate transparency and non-adhesiveness distributed all along.

18. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; non-adhesiveness is only limited to the parts where there are great risk of adhesion or the areas which are estimated to be contacted, particularly the vocal cords (distal or proximal part, places of the endotracheal tubes that contact vocal cords, the places close to the cuffs, areas of cuffs that contact mucosa etc.), and/or the non- adhesive structures are dispersed on all over the tube and cuff/cuffs in various sizes and shapes (longitudinal, transverse, oblique or diagonal strips, round, polygonal, oval areas, etc.).

19. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; all or a part of the tubes and cuff/cuffs have a structure that is manufactured or coated such that hydrophilic and hydrophobic structures will be placed side by side in various sizes and shapes in order to ensure non-adhesiveness.

20. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; the proximal part of the tube is made clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shapes, directions, depths and lengths so as to provide convenience in both grabbing/handling of the tube and preventing it from sliding, and these structures are marked with indicators such as colour, number, figure, symbol, etc. to enable understanding of the amount and direction of sliding, if any.

21 .The invention relates to the structure that prevents sliding according to claim 20, and it is characterized in that; endotracheal and tracheostomy tubes are made clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shapes, directions, depths and lengths so as to provide convenience fixing their outer surfaces, and these structures are marked with indicators such as colour, number, figure, symbol, etc. to enable understanding of the amount and direction of the distance and/or have a mounted structure.

22. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; in order to ensure easier and stronger connection, the distal tip of the connectors are have a structure (2) that would accommodate the proximal tip of the tube body.

23. The endotracheal tube and tracheostomy tube connector according to claim 22, and it is characterized in that; to make connection easily, structure of the connector therein is made wider and more elastic, and it is made capable of expanding in a way to contain the tip of the tube.

24. The endotracheal tube and tracheostomy tube connector according to claim 22, and it is characterized in that; in order to ensure easier connection, the structure of the tube proximal part is made more stable/resistant such that there would be no loss of lumen while entering into the distal tip during connection to the connector.

25. The endotracheal tube and tracheostomy tube connector according to claim 22, and it is characterized in that; both sides of the connection are made easier to join tightly by making them clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched, etc. in various shapes, directions, depths and lengths in the manner that the connection is compatible to be safer, and for cases where connection is required to be more stable, a model that can utilize vacuum system is also developed.

26. The endotracheal tube and tracheostomy tube connector according to claim 22, and it is characterized in that; it has a structure comprising a screw system-mechanism at both sides for performing the connection in a more controlled manner.

27. The endotracheal tube and tracheostomy tube connector according to claim 22, 23, 24, 25, or 26, and it is characterized in that; the parts providing the connection have characteristics that would not be weakened due to heat, moisture etc. factors, and/or its interior design has gradual narrowing feature to prevent any potential turbulence while passing to the tube lumen that is narrower than the device connection ports.

28. The endotracheal tube and tracheostomy tube connector according to claim 22, 23, 24, 25, 26, or 27, and it is characterized in that; in order to ensure that the prior art tubes can be applied by less modification, it has a structure that is formed by sticking the structure that is made clawed, rough, saw-toothed, grooved, knurled, serrated, indented, protruding, or notched etc. in various shapes, directions, depths and lengths on the exterior surface of proximal part of the tube body and/or interior surface of distal tip of the connector.

29. The invention relates to an endotracheal tube, and it is characterized in that; it has a structure that is bendable at least on one part such that it would enable changing the length and direction (4).

30. The invention relates to the bendable structure according to claim 29, and it is characterized in that; the bendable structures can be locked when they are not used and/or the curves are made on the exterior surface-in a position not to constrict the lumen in order not to cause turbulence or any constriction in the lumen.

31 . The invention relates to an endotracheal tube, and it is characterized in that; it has a structure distal to the bendable structure that provides advantage in manipulation of the tube and making fixation easier.

32. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; pieces are called adaptors or connector that enables their connection to other medical intervention devices, is found on the proximal tip of endotracheal and tracheostomy tubes, have the direction and/or length changing structure.

33. The invention relates to the adapter or connector according to claim 32, and it is characterized in that; it has a structure that is bendable at least on one position (6, 24) such that it would enable changing the length and direction and/or act as a damper to prevent external movements from effecting the tube, and the bendable structure therein can also be locked when not in use (7, 25), and/or the curves are made on the exterior surface-in a position not to constrict the lumen in order not to cause turbulence or any constriction in the lumen.

34. The invention relates to the adapter or connector according to claim 32, and it is characterized in that; it has a partially mobile structure (8, 26) that is formed of at least two pieces formed by using piston rod like components and/or bearing mechanisms in order to ensure that the connection port can be rotated at the desired direction.

35. The invention relates to the adapter or connector according to claim 32, and it is characterized in that; bendable structures with damper characteristics are added to the piece or each one of the pieces for access to farther distances and/or to prevent the external movements from affecting the tube, and these bendable structures can be locked when they are not in use and/or the curves are made on the exterior surface-in a position not to constrict the lumen in order not to cause turbulence or any constriction in the lumen.

36. The endotracheal tube and tracheostomy tube adapter and connector according to claim 32, 33, 34, or 35, and it is characterized in that; the connectors are compatible with all present tubes and devices used in the state of the art, these adaptors are also compatible with the outlets of tracheostomy tubes, and their outlets are suitable for modification for connection, when needed.

37. The invention relates to the adapter and connector in the endotracheal tube and tracheostomy tube according to claim 32, 33, 34, 35, or 36, and it is characterized in that; it has a sterilizable structure for reuse, and these connectors can also be utilized in other tubes with their reusable characteristics.

38. The invention relates to adapters and connectors found in endotracheal tubes and tracheostomy tubes, and it is characterized in that; in addition to their essential function, they have the required structure for holding or fixing the rods-pipes, etc. components and apparatus that are used to inflate the cuff/cuffs and/or for aspiration (suction) around the tube.

39. The invention relates to the adapters and connectors in the endotracheal tube and tracheostomy tube according to claim 38, and it is characterized in that; appropriate areas are added around the connector in directions such as up, down, sideways, oblique, etc. for some cases, and structures are made that enable to place and use at least one holder or clips and/or one apparatus such as velcro mechanism, press stud mechanism, vacuum system, magnet system, hook, clasp, latch, clips, etc. in various directions on the connectors by using these areas and/or indents, protrusions, slots, holes are added, and all of these structures also have the structure on which the fixation piece positioned distal to the bendable part in bendable tubes.

40. The endotracheal tube and tracheostomy tube adapter and connector according to claim 38 or 39, and it is characterized in that; housing where rods-pipes of the tubes can be fixed tightly are made on various places of the connectors, and while these housing that are in various sizes and/or found in various directions according to the needs have inlet that is wide enough to be placed easily to be more useful, and it becomes narrow to allow fixation after the placement or provides rotation to prevent displacement.

41 . The endotracheal tube and tracheostomy tube adapter and connector according to claim 38, 39, or 40, and it is characterized in that; the connectors are compatible with all present tubes and devices used in the state of the art, their outlets are suitable for modification for connection, when needed.

42. The endotracheal tube and tracheostomy tube adapter and connector according to claim 38, 39, 40, or 41 , and it is characterized in that; they are made sterilizable for reuse, and these connectors and/or additional apparatus pieces can also be utilized in other tubes with their reusable characteristics.

43. The endotracheal tube and tracheostomy tube adapter and connector according to claim 38, 39, 40, 41 , or 42, and it is characterized in that; they can also be connected to the fixation structures developed in bendable tubes.

44. The invention relates to the adapters or connectors of endotracheal tubes, and it is characterized in that; it has a structure that can provide visibility of the fixing function of the tube following intubation.

45. The invention relates to the adapter or connectors according to claim 44, and it is characterized in that; it has a structure in which appropriate areas are added around the connector in directions such as up, down, sideways, oblique, etc. for some cases, and structures are made that enable placing and use of at least one holder or clips and/or one apparatus such as velcro mechanism, press stud mechanism, vacuum system, magnet system, hook, clasp, latch, clips, etc. in various directions on the connectors by using these areas and/or indents, protrusions, slots, holes.

46. The endotracheal tube adapter and connector according to claim 44 or 45, and it is characterized in that; at least one hole (preferably 2 holes) are formed symmetrically on the widened wings, and these holes and/or other fixation apparatus have a structure functioning as application point/points of pulling forces (via rubber-like structures) to keep the tube in place and/or ensures fixation via apparatus such as rope etc.

47. The endotracheal tube adapter and connector according to claim 44, 45, or 46, and it is characterized in that; it has structures such as tape, belt, strip etc. that are developed and can be easily connected to fix to head and neck of a patient by using the holes and/or other fixation apparatus that are added.

48. The invention relates to structures having various sizes developed as an additional apparatus to the adapters and connectors according to claim 47, and it is characterized in that; characteristics such as flexibility, softness, elasticity, transparency, non- adhesiveness, length-adjustability, anti-infectiveness, non-allergenicity etc. are given to these structures in some cases.

49. The invention relates to a structure formed by addition of a suitable area around the adapter or connector according to claim 45, and it is characterized in that; inflatable airbags are added preferably to the part contacting the patient, by using these areas and/or these structures, and/or these airbags have at least two compartments for alternating use, and the connectors are compatible with all present tubes and devices used in the state of the art.

50. The invention relates to the adapter or connectors according to claim 45, and it is characterized in that; it has a structure, which is developed as additional apparatuses- parts specific to the connector, which can be placed on teeth and/or gum and/or pellet, and which can make use of these organs for fixation.

51 . The additional apparatus of the adapter or connector according to claim 50, and it is characterized in that; it has a structure that grasps the teeth and/or gums from the outside and hold them on the foreground-background and that can be locked following placement.

52. The additional apparatus of the adapter or connector according to claim 50, and it is characterized in that; it comprises screws that can compress the teeth and/or gums manually in a controlled manner, and/or a form (similar to latch) that can be closed directly, and/or thin structures that can get in between the upper and/or the lower teeth.

53. The additional apparatus of the adapter or connector according to claim 50, and it is characterized in that; it comprises a form for more sensitive cases, which contains airbag that can grab the upper and/or lower teeth and/or gums and/or palates with air pressure when inflated, these are suitable for addition of all pressure control systems that are developed in pilot balloons, and they have multiple compartments for alternating use.

54. The additional apparatus of the adapter or connector according to claim 50, and it is characterized in that; for some cases, it has a structure that is similar to biting apparatus suitable for use of biological-natural adhesive to hold onto the upper and/or lower teeth and/or gums and/or palates more tightly.

55. The invention relates to an adapter or connectors and additional apparatuses for fixation purposes according to claims 50, 51 , 52, 53, or 54, characterized in that; they can be easily and safely connected to each other, and at least one velcro mechanism and/or press stud mechanism and/or magnet system and/or vacuum system and/or hook and/or clasp and/or latch and/or clips and/or indent and/or protrusion and/or slot and/or screwing system, etc. formations that are mutually adaptable (between adapter- additional apparatus) are added in various numbers and directions.

56. The invention relates to an adapter or connectors and additional apparatuses for fixation purposes according to claims 50, 51 , 52, 53, 54, or 55, characterized in that; it has a structure, in which the connection is provided with the recipient structure on the fixation apparatus by means of the screws that are passed through the additional areas around the connector.

57. The invention relates to an adapter or connectors and additional apparatuses for fixation purposes according to claims 50, 51 , 52, 53, 54, 55, or 56, characterized in that; the connectors are compatible with all present tubes and devices used in the state of the art, and terminals are suitable for modification when needed.

58. The invention relates to an adapter or connectors and additional apparatuses for fixation purposes according to claims 50, 51 , 52, 53, 54, 55, 56, or 57, characterized in that; they are made sterilizable for reuse, and these connectors and/or additional apparatus pieces can also be utilized in other tubes with their reusable characteristics, and they can also be connected to the fixation structures developed in bendable tubes.

59. The invention relates to the connector parts of tracheostomy tubes, and it is characterized in that; these adaptors are also made more compatible with outlet of tracheostomy tubes, and/or the proximal part of the tracheostomy tube is also modified for these purposes, and inflatable airbags are added preferably to the part contacting the patient, and/or these airbags have at least two compartments for alternating use, and the connectors are compatible with all present tubes and devices used in the state of the art.

60. The invention relates to an endotracheal tube, and it is characterized in that; the tube has a customized additional apparatus using screw system for fixing following intubation, and this screw fixator makes use of the screw mechanism (10) formed at adequate length at the proximal part of the tube body so as to provide controlled fixing and has a structure (3) that is inserted via rotation.

61 . The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; in order to ensure application on the state of the art tubes with less modification, it has a structure (10) obtained by sticking and/or fixing the special structure (having the feature of placing by using the screw mechanism and/or containing groove and set) that can utilize the screw system to exterior surface of proximal part of the tube body in adequate length.

62. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; it has softness, elasticity, transparency, non-adhesiveness, anti- infectiveness, non-allergenicity characteristics on the relevant surface (contacting the patient) to prevent the screw fixator from harming the body.

63. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; inflatable airbags are added preferably to the surface contacting the patient, and/or these airbags have at least two compartments for alternating use.

64. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; it has a structure that allows placement and use of at least one velcro mechanism, press stud mechanism, magnet system, hook, clasp, latch, clips, etc. apparatus in various numbers and directions to fix it to head or neck by using strap-like apparatus and/or indents, protrusions, slots, holes.

65. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; at least one hole (preferably 2 holes on each) are formed on lateral sides in order for it not to occupy too much space, and these holes (20) function as application point/points of pulling forces (via rubber-like structures) as an easy and safe holder to keep the tube in place, and/or have a structure enabling fixing with the help of a rope apparatus.

66. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; it has a single- or two- or three- or four-wing (the two are in horizontal position for connection to the strap, the two for preventing moving toward the distal in vertical position) or in some cases multiple-wing structure for ergodynamics and covering less space, and there are also holes on these wings (20) for connections.

67. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; it has a structure making use of apparatuses for the purpose of holding or fixing the rods-pipes etc. components that are used to inflate the cuff/cuffs and/or for aspiration (suction) around the tube, in addition to their essential function.

68. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; all the connectors are compatible with all present tubes and other devices used in the state of the art, and the terminals are suitable for modification when needed.

69. The endotracheal tube-specific screw fixator according to claim 60, and it is characterized in that; they are made sterilizable for reuse, and it has a structure that can also be utilized in other tubes with their reusable characteristics.

70. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; the wall of the tube has permeable structure against air (gases) for the purpose of drying the perimeter of the tube found in the trachea and larynx in order to at least partially reduce the microorganism load and risk of infection.

71 . The endotracheal tube and tracheostomy tube according to claim 70, and it is characterized in that; it has a structure (12, 27) comprising (a) very small passage/passages obtained by forming at least one hole and/or thin slits on the tube wall, which would allow ventilation around the tube found in the trachea and larynx, but will not deteriorate ventilation and cause turbulence.

72. The endotracheal tube and tracheostomy tube according to claim 70, and it is characterized in that; the passage/passages found at the tube wall has/have liquid (including water) tight and air (gas) permeable characteristics through its/their adequate tightness/narrowness.

73. The endotracheal tube and tracheostomy tube according to claim 70, and it is characterized in that; the passage/passages found at the tube wall is/are adjusted in the manner it/they would not allow airflow under pressures found in expirium while allowing airflow under pressures found in inspirium.

74. The invention relates to the passages in the endotracheal tube and tracheostomy tube according to claims 70, 71 , 72, or 73, and it is characterized in that; it is possible to use many different methods (sound wave, heat, etc.) while making such passages, and they have a suitable structure for use of mechanical systems and/or laser technology.

75. The invention relates to an endotracheal tube and tracheostomy tube according to claims 70, 71 , 72, or 73, and it is characterized in that; the passage/passages found at the tube wall have at least one opening valve (cap-pressure relief valve system) in inspirium or expirium.

76. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; the wall of the tube and the cuff/cuffs are made of material that is liquid-tight (including water), but permeable for air (gases), and these substances have a structure that is used in all or a part of the tube and the cuff according to the purpose.

77. The invention relates to substances found at the tube wall and the cuff/cuffs, which are made of material that is liquid-tight (including water), but permeable for air (gases), and it is characterized in that; the materials used are those that have low surface tension and/or hydrophobic and/or porous and/or diffusive characteristics, and they are used at different rates and amounts depending on the clinical condition.

78. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; it has a structure comprising at least one capillary passage (13, 28) extending along the tube wall as well as providing communication between the inside and the outside areas of the tube and providing ventilation-drying around the tube found in the trachea and larynx.

79. The invention relates to capillary passage/passages according to claim 78, characterized in that; the diameter and length of these capillary passages and their position in the tube (anterior, posterior, oblique, diagonal, lateral etc.) may vary according to the age and clinical condition of the patient and tube size, and/or the opening of capillary passages is open in the inspirium and closed in the expirium and/or they have at least one opening valve (cap-pressure relief valve system) in inspirium or expirium.

80. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; some part of the tube wall is made of metal in order to provide advantage in determining its position via radiography or ultrasound, and make its manipulation easier, and/or it has a structure placed into the plastic forming the wall of the metal structure.

81 . The endotracheal tube and tracheostomy tube according to claim 80, and it is characterized in that; the width, thickness, and length of the metal structure placed within the metal and/or plastic wall forming a part of the tube wall may have various values according to the intended use and it can be positioned on the left, right, front, rear, diagonal, oblique, or laterally, and has a structure that starts from the distal part where the bendable part finishes in bendable tubes.

82. The metal structure in endotracheal tube and tracheostomy tube according to claims 80 or 81 , and it is characterized in that; the metal can be any element, alloy, or a compound at various rates, it can withstand bending or shaping many times, it is also resistant to cracking or breaking, and/or MR-compatible, in some special cases and functions, hard plastic and/or spring wire and/or plastic wire with carbon and metal powder at added various rates are used, and the metal and/or plastic covered metal and/or rigid plastic and/or spring wire and/or plastic wire etc. materials used in all these embodiments can be cut easily by using scissors and similar tools.

83. The invention relates to cuff/cuffs of endotracheal and tracheostomy tubes, and it is characterized in that; they take the shape identical to anatomy-lumen of larynx or trachea when inflated, and this shape is roughly similar to a slight flat-rear elliptical form on the front-rear diameter along with slight loss of area on the rear (14, 29).

84. The invention relates to an endotracheal tube, and it is characterized in that; during intubation operation, while its concavity-curvature faces across (above), the oblique incision tube opening faces to the right hand side of the patient (33), while the Murphy eye is at the left hand side (32).

85. The invention relates to the endotracheal tube according to claim 80, and it is characterized in that; at least one hole is added preferably at the opposite side (on the right hand side where the short tip is found) auxiliary to the Murphy eye found on the left hand side, and these holes are in various shapes such as triangular, rectangular, polygonal, oval, circular, and angular etc (35).

86. The invention relates to an endotracheal tube, and it is characterized in that; there are tubes with cuff/cuffs (18) that inflate more under the same pressure at the long side where Murphy eye is found in order to prevent them from getting into the left or right main bronchus.

87. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; there are tubes with cuffs that inflate more under the same pressure on the right to prevent them getting into the right main bronchus and on the left to prevent them from getting into the left main bronchus and/or in some clinical cases in front, rear, diagonal, oblique, or lateral directions, and the front, rear, or lateral sides of these tubes marked clearly to detect any potential rotation, and these indicators are also applied to all other tubes.

88. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; in order to ensure that there are more plastic texture, the curvature/layer amount of the cuff/cuffs is higher at the side that is desired to inflate more, and/or the resistance of the plastic texture is lower on the inflated side, and/or there is more texture here, and therefore, ensures more inflation and also these cuffs have inward and/or outward curved structure (19).

89. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; the cuff/cuffs has/have at least two compartments, and these compartments have a structure that is inflated at different pressures and thus orient the tube tip and prevent it from entering into the bronchia.

90. The invention relates to tracheostomy tubes, and it is characterized in that; at least one hole is found at the distal part in order to prevent occlusion, and these holes have various shapes such as triangular, rectangular, polygonal, oval, circular and angular (34), and found at various directions.

91 . The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; it has a structure that allows the tubes to inflate more at the anterior part of the cuff/cuffs under the same pressure, in order to prevent the tubes from causing tracheitis via contact at the front side.

92. The invention relates to endotracheal and tracheostomy tubes, and it is characterized in that; in order to prevent the tubes from causing tracheitis via contact at the front side, in cuffed or cuffless tubes, the oblique incision is prepared by making a loss on the front of the tube, the short part of the tubes is found at the front, and the long part is found at the rear (9, 30) part, Murphy eye (16, 31 ) is found at the rear side in these tubes, and at least one hole is added preferably at the front side auxiliary to the Murphy eye, and these holes are in various shapes such as triangular, rectangular, oval, circular, and angular etc (17, 34).

93. The invention relates to endotracheal and tracheostomy tubes according to claim 91 , and it is characterized in that; it has a structure where the cuff/cuffs inflate/inflates more in front-right and/or front-left direction more in cases where it is desired to reduce the possibility of getting into the main bronchia are developed in addition to the feature of inflating more on the front of the trachea to avoid trauma.

94. The invention relates to endotracheal and tracheostomy tubes according to claim 92, and it is characterized in that; the loss at the front that is made to avoid tracheitis in the tubes is slided towards the right or left hand side in various distances in order for it not to cause problem in placement in some medical conditions, and oblique incisions are made in various sizes, and in this case, the holes that are auxiliary to the Murphy eye are thus slided toward the right or left hand side.

95. The invention relates to endotracheal and tracheostomy tubes according to claim 91 , and it is characterized in that; only the relevant area is made curved in order to minimize contact area of the cuff/cuffs that move/moves away when inflated more, and this curved structure can increasingly inflate, and thus provide gradual divergence with regard to a curved embodiment.

96. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; to prevent the tubes placed in the trachea from harming the mucosa, the tube tips are made in curved-dished form and/or with an inward-radiused outlet during production of the tubes.

97. The invention relates to the outlet port forming an inward radius according to claim 96, characterized in that; as a solution, injection and/or co-injection method is applied, and it has a structure with an inward radius formed by additional operation-intervention in cases where extrusion and/or co-extrusion method is applied.

98. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; it has a structure where small airbags that create distance via inflation with inspirium air are added to prevent contact of the tip of cuffless tube with mucosa of the trachea, and while they are mostly placed on the front side, they are also positioned in posterior, lateral, diagonal, oblique, etc. directions for some patients.

99. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; this/these cuff/cuffs have a structure that enables manipulating the tube tip to prevent some complications and are compatible with anatomic structure of larynx or trachea (more inflation in the desired direction, with at least two compartments, etc.) for cases where protection of larynx or trachea mucosa from trauma is crucial.

100. The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; the products having all the novelties disclosed within the context of the above given claims can be applied or adapted to all tubes (single, double, multiple, grooved, corrugated, non-adhesive, water-swellable, accordion, curved) that are used on humans and all similar cuff types, and in addition, all tubes that have aspiration (suction) or monitorisation facilities, the tubes that are spiral, ringed, double-lumen and the like, the tubes that allow to administer medications, and the tubes that are used in veterinary medicine individually or in combination.

101 . The invention relates to an endotracheal tube and a tracheostomy tube, and it is characterized in that; in the context of the above given claims, the products having all the described novelties are disposable, in addition to having sterilizable, washable, and reusable structure.