WO2016209192A2 - Tube endotrachéal et tube de trachéotomie améliorés - Google Patents

Tube endotrachéal et tube de trachéotomie améliorés Download PDF

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Publication number
WO2016209192A2
WO2016209192A2 PCT/TR2016/050198 TR2016050198W WO2016209192A2 WO 2016209192 A2 WO2016209192 A2 WO 2016209192A2 TR 2016050198 W TR2016050198 W TR 2016050198W WO 2016209192 A2 WO2016209192 A2 WO 2016209192A2
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WIPO (PCT)
Prior art keywords
tube
tubes
endotracheal
tracheostomy
relates
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/TR2016/050198
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English (en)
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WO2016209192A3 (fr
Inventor
Mehmet Rusen DÜNDARÖZ
Ahmet Koyun
Ufuk ERENBERK
Fatih AYGÜN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kristal Gida Dagitim Ve Pazarlama Sanayi Ve Ticaret AS
Original Assignee
Kristal Gida Dagitim Ve Pazarlama Sanayi Ve Ticaret AS
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Publication of WO2016209192A2 publication Critical patent/WO2016209192A2/fr
Publication of WO2016209192A3 publication Critical patent/WO2016209192A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0418—Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0425—Metal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/044—External cuff pressure control or supply, e.g. synchronisation with respiration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A61M16/049—Mouthpieces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/0497—Tube stabilizer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L7/00—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements
    • G01L7/02—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0404—Special features for tracheal tubes not otherwise provided for with means for selective or partial lung respiration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0436—Special fillings therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
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    • A61M16/0438—Liquid-filled
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0227—Materials having sensing or indicating function, e.g. indicating a pressure increase
    • A—HUMAN NECESSITIES
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    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
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    • A61M2205/3331—Pressure; Flow
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    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
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    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
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    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • cuff 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • indicators/markers that correspond to a certain pressure such as sign, colour, number, letter, emblem, or symbol.
  • balloons are bendable like an accordion when deflated, and the said markers become visible when they are inflated under certain pressures.
  • 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.
  • 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.
  • 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.
  • light emission feature is also provided on the front of tube and/or cuff/cuffs.
  • Phosphor colour may be in any colour, arbitrarily.
  • 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.
  • 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.
  • all of the tubes or cuff/cuffs are produced or covered by using teflon or carbon-teflon.
  • parts of the tubes where there are great risk of occlusion or the areas which are estimated to contact particularly vocal cords are produced or covered by using teflon or carbon-teflon.
  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • anti-slide feature provided on exterior surface of the tube contributes to prevent undesirable displacement even if it is minimal by fixing it.
  • 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.
  • 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.
  • distal tip of the connectors are expanded in a way to contain proximal tip of the tube body (2).
  • 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.
  • connection to the connector is made in the manner there is no loss of lumen while inserting it in the distal tip.
  • 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 the connection is compatible for cases where connection is desired to be safer.
  • a model that can utilize vacuum system is also developed.
  • 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.
  • tube lumen is typically narrower than device terminals. Interior design of these connectors have gradual narrowing feature to prevent any potential turbulence.
  • 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.
  • 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).
  • a structure to facilitate fixation after placement of the tube is added to distal of the bendable structure.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • velcro mechanism press stud mechanism
  • vacuum system vacuum system
  • magnet 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.
  • 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.
  • 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.
  • 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.
  • inflatable airbags 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.
  • 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.
  • 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.
  • 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.
  • screws that can compress the teeth and/or gums manually in a controlled manner.
  • 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.
  • auxiliary-additional apparatus additional structures for fixation
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the wall of the tube in trachea and larynx has air (gas) permeable 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.
  • 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.
  • a opening cap-valve system is added to the passage/passages in inspirium or expirium to control air passage better.
  • 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 vary by age and clinical condition of the patient and tube size.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • the tube 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.
  • 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 are also developed for some special cases.
  • the metal can be any element, alloy, or a compound at various rates.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • This structure enables to reduce tracheitis complication.
  • 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.
  • 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.
  • 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.
  • 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.
  • Distal tip structure having endotracheal tube opening facing forward
  • Distal tip structure having endotracheal tube opening facing left 16.
  • Distal tip structure having tracheostomy tube opening facing forward
  • Distal tip structure having opening facing towards the right hand side distal to the endotracheal tube

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Abstract

Des tubes endotrachéaux et des tubes de trachéotomie sont des dispositifs médicaux ayant une importance cruciale fréquemment utilisés dans divers cas médicaux et chirurgicaux sur les humains et sur les animaux. Leur fonction principale est d'assurer un transport sans danger et régulé de l'oxygène ou d'autres gaz jusqu'au patient. Dans cette demande de brevet, diverses nouveautés et modifications sont apportées afin de réduire certains effets secondaires rencontrés pendant l'utilisation de ces tubes, de rendre les opérations plus faciles et d'obtenir certains avantages. Certaines de ces modifications et nouveautés sont obtenues avec des agencements dans la forme d'anatomie des tubes, certains avec des ajouts et des changements dans le procédé de production, et certains par l'intermédiaire de techniques de revêtement. Ces nouveautés et modifications sont effectuées en prenant en considération divers facteurs comme l'âge, la maladie, l'état médical ainsi que les équipements, les installations et les préférences de l'équipe d'intervention. Diverses caractéristiques requises par ces facteurs sont obtenues. Tandis que chacune de ces nouveautés et modifications peut être utilisée seule pour certains cas cliniques, certaines de leurs caractéristiques peuvent être combinées les unes avec les autres pour offrir plusieurs avantages importants et synergistes. Dans de rares situations cliniques, il peut être nécessaire que toutes les nouveautés et modifications décrites dans cette demande soient collectées et utilisées dans un seul et même tube. Dans la plupart des cas, l'utilisation de seulement certaines de celles-ci suffirait.
PCT/TR2016/050198 2015-06-26 2016-06-27 Tube endotrachéal et tube de trachéotomie améliorés Ceased WO2016209192A2 (fr)

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CN111526912A (zh) * 2017-12-22 2020-08-11 卡利纳拉姆·安娜塔拉亚南 具有优异通气能力，并具有将支气管内导管准确放置在期望支气管中的系统的气管插管促进器
CN111526912B (zh) * 2017-12-22 2023-08-08 卡利纳拉姆·安娜塔拉亚南 具有优异通气能力，并具有将支气管内导管准确放置在期望支气管中的系统的气管插管促进器
WO2019216858A3 (fr) * 2018-04-05 2020-02-06 Duendaroez Mehmet Rusen Tubes endotrachéal et de trachéostomie sans danger
CN109589478A (zh) * 2018-12-04 2019-04-09 刘玉昌 一种全身麻醉用内置式气管导管喉罩联合通气装置
CN109589478B (zh) * 2018-12-04 2021-04-16 刘玉昌 一种全身麻醉用内置式气管导管喉罩联合通气装置
CN110585543A (zh) * 2019-09-26 2019-12-20 南昌市康华卫材有限公司 一次性使用气管插管
CN112826430B (zh) * 2020-12-31 2022-08-23 湖南省肿瘤医院 一种耳鼻喉科检查用的通气式喉镜及其使用方法
CN112826430A (zh) * 2020-12-31 2021-05-25 郭振东 一种耳鼻喉科检查用的通气式喉镜及其使用方法
CN115025349A (zh) * 2022-06-20 2022-09-09 中国人民解放军西部战区总医院 一种适用于野外急救的气管切开装置
US11744972B1 (en) * 2022-06-23 2023-09-05 Kevin Chong Kim System and method for a tracheostomy tube with a secondary airflow opening and a dual cuff assembly
US11819611B1 (en) 2022-06-23 2023-11-21 Kevin Chong Kim System and method for pressure management and air leak detection of an inflatable cuff in a medical device
EP4543520A4 (fr) * 2022-06-23 2025-11-12 Kevin Chong Kim Système et méthode pour tube de trachéotomie avec ouverture d'écoulement d'air secondaire et ensemble ballonnet double
WO2026005733A1 (fr) * 2024-06-27 2026-01-02 Istanbul Medipol Universitesi Système de canule de trachéotomie comprenant au moins deux orifices de sortie d'air pour distribution d'écoulement d'air équilibré

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