WO2016052340A1 - Tube trachéal pouvant être inséré dans la trachée - Google Patents

Tube trachéal pouvant être inséré dans la trachée Download PDF

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Publication number
WO2016052340A1
WO2016052340A1 PCT/JP2015/077122 JP2015077122W WO2016052340A1 WO 2016052340 A1 WO2016052340 A1 WO 2016052340A1 JP 2015077122 W JP2015077122 W JP 2015077122W WO 2016052340 A1 WO2016052340 A1 WO 2016052340A1
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WIPO (PCT)
Prior art keywords
tube
trachea
lumen
tracheal
end portion
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PCT/JP2015/077122
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English (en)
Japanese (ja)
Inventor
秀彬 柴田
祐亮 百貫
杏梨 藤城
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2016551979A priority Critical patent/JP6573896B2/ja
Publication of WO2016052340A1 publication Critical patent/WO2016052340A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes

Definitions

  • the present invention relates to a tracheal tube that can be inserted into a trachea. More particularly, the present invention relates to a tracheostomy tube, a multi-tube tracheostomy tube, an inner cylinder thereof, an endotracheal tube, and a tracheal cannula for annular thyroid puncture and incision.
  • tracheal intubation which is a method of inserting a tracheal tube called an endotracheal tube into the trachea from the mouth or nose through the pharynx to the trachea
  • Tracheostomy is a method in which tracheostomy tubes called tracheostomy tubes are inserted into the trachea from the incision through the skin of the trachea and the upper part of the trachea when the intubation is prolonged or when tracheal intubation is impossible Incision
  • annular thyroid incision is a method of inserting the tracheal cannula by incising the annular thyroid (annular thyroid ligament), and inserting the tracheal cannula by puncturing the annular thyroid
  • An example is a ring-shaped thyroid puncture.
  • tracheal tube that can be inserted into the trachea
  • the amount of secretions such as sputum increases. This may cause stenosis / occlusion of the tracheal tube and may cause dyspnea / suffocation.
  • wrinkles are normally discharged by ciliary movement of the trachea, wrinkles are likely to adhere because the tracheal tube has no cilia. Therefore, the sputum in the tracheal tube must be periodically sucked to prevent the tracheal tube from becoming constricted and not blocked.
  • the salmon is mainly composed of water and glycoprotein (mucin), and the viscosity is as wide as several hundred to several hundred thousand cP.
  • the soot left behind in the tracheal tube may dry out and become more likely to adhere.
  • the removal of sputum from the tracheal tube must be performed frequently and must be carefully aspirated so that it is left as little as possible, so the burden on the nurse / caregiver is great. Therefore, there is a demand for a tracheal tube that does not easily adhere soot.
  • Patent Document 1 discloses that an anhydrous maleic vinyl maleate is formed on the surface of a tracheostomy tube made of any one of polyvinyl chloride, polyurethane, nylon, and nylon elastomer and on the inner surface that forms a lumen for securing the airway of the lumen.
  • a mixture of an acid copolymer and a polyether block amide was applied by immersing a tracheostomy tube in a solution of a 2-propanol / tetrahydrofuran mixture having a weight ratio of 70:30, and the applied mixture was added with water.
  • a tracheostomy tube is described that has been treated with an aqueous sodium oxide solution to form a coating that exhibits surface lubricity when wet.
  • This tracheostomy tube describes that if the inner surface of the luminal body is moistened by breathing or brim when the patient breathes, surface lubricity is exhibited and it is difficult for wrinkles or the like to adhere to the inner surface of the luminal body. Has been.
  • an object of the present invention is to provide a tube for trachea to which soot hardly adheres.
  • the inventors have made a distal end portion disposed on the lung side in the trachea, a proximal end portion provided on the opposite side of the distal end portion, and a distal end from the proximal end portion.
  • a tracheal tube that can be inserted into the trachea, including a lumen body having an airway securing lumen that penetrates through the portion, at least part of the inner surface that forms the lumen for securing the airway of the lumen body has a concavo-convex size of several tens of ⁇ m It has been found that the arrangement of a microstructure region having a surface on which can be provided can provide a tube for trachea to which soot does not easily adhere, and the present invention has been completed.
  • the present invention provides the following (1) to (13).
  • a microstructure region is disposed on at least a portion of the inner surface forming the lumen for securing the airway of the lumen body;
  • the tracheal tube that can be inserted into the trachea according to (4) which is a tracheostomy tube.
  • the tracheal tube insertable into the trachea according to (4) which is a double-tube tracheotomy tube.
  • the tracheal tube that can be inserted into the trachea according to (4) which is an inner tube of a double-tube tracheostomy tube.
  • the tracheal tube which can be inserted into the trachea according to (4) which is a tracheal cannula which can be inserted into the trachea through a puncture hole or an incision hole in a ring-shaped thyroid membrane.
  • the tracheal tube can be inserted into the trachea according to (9), which is a tracheal cannula that can puncture the annular thyroid membrane.
  • intersection point K The intersection point intersecting with the inner surface of the tube wall located outside the curve is the intersection point K
  • the reference line perpendicular to the plane P at the intersection point K is the reference line S
  • the tangent line tangent to the inner peripheral surface of the lumen body is the tangent line T
  • the tangent line T When the angle formed by the reference line S is the angle ⁇ , the microstructure region is disposed at a position on the inner peripheral surface of the lumen body where the angle ⁇ is 30 ° or more.
  • the angle ⁇ is an acute angle or a right angle formed by the reference line S and the tangent line T.
  • the tube for tracheas which a wrinkle cannot adhere easily can be provided.
  • the tracheal tube of the present invention it is possible to reduce the frequency of sucking and removing wrinkles adhering to the tracheal tube, so that the burden on the patient and caregiver can be reduced.
  • FIG. 1 is a view showing a state in which a tracheostomy tube according to a first embodiment of the present invention is attached to a patient.
  • FIG. 2A is a cross-sectional view showing the main part of the tracheostomy tube according to the first embodiment of the present invention shown in FIG.
  • FIG. 2B is a cross-sectional view taken along the line AA shown in FIG.
  • FIG. 2C is a partially enlarged cross-sectional view of the fine structure region.
  • FIG. 2D is a cross-sectional view showing a state in which wrinkles adhering to the inside of the tracheostomy tube according to the first embodiment of the present invention are sucked.
  • FIG. 2A is a cross-sectional view showing the main part of the tracheostomy tube according to the first embodiment of the present invention shown in FIG.
  • FIG. 2B is a cross-sectional view taken along the line AA shown in FIG.
  • FIG. 2C is a partially enlarged cross
  • FIG. 2E is a partially enlarged cross-sectional view of another embodiment of the microstructure region.
  • FIG. 3A is a cross-sectional view showing a modification of the tracheostomy tube according to the first embodiment.
  • 3B and 3C are cross-sectional views taken along line BB shown in FIG. 3A.
  • FIG. 4A is a cross-sectional view showing a main part of a tracheostomy tube according to the second embodiment of the present invention.
  • FIG. 4B is a cross-sectional view taken along the line CC shown in FIG.
  • FIG. 4C is a cross-sectional view showing a modification of the tracheostomy tube according to the second embodiment.
  • FIG. 5A is a cross-sectional view showing the main part of a tracheostomy tube according to the third embodiment of the present invention.
  • FIG. 5B is a cross-sectional view taken along the line DD shown in FIG.
  • FIG. 5C is a cross-sectional view showing a modified example of the tracheostomy tube according to the third embodiment.
  • FIG. 6A is a cross-sectional view showing the main part of a tracheostomy tube according to the fourth embodiment of the present invention.
  • FIG. 6B is a cross-sectional view taken along the line EE shown in FIG.
  • FIG. 7 is a view showing a state in which an endotracheal tube according to a fifth embodiment of the present invention is attached to a patient.
  • FIG. 8A is a perspective view showing a configuration example of an endotracheal tube according to the fifth embodiment of the present invention shown in FIG.
  • FIG. 8B is a cross-sectional view taken along the line FF shown in FIG.
  • FIG. 9 is a view showing a state in which a tracheal cannula according to a sixth embodiment of the present invention is attached to a patient.
  • FIG. 10 is a view showing a state in which a tracheal cannula according to a seventh embodiment of the present invention is attached to a patient.
  • a sputum is a type of mucus that is a viscous fluid that is secreted from the mucous membranes of the trachea and has a slimy nature. Pulling properties) and viscoelasticity (like rubber, it stretches when it is grabbed and lifted, returns to its original shape when released, and breaks when stretched more than a certain amount). Examples of the main components of koji include water and glycoproteins such as mucin.
  • the repellency refers to the property of repelling wrinkles. As a result of repelling wrinkles, wrinkles are less likely to adhere to the inside of the tracheal tube (the inner peripheral surface of the lumen body). Moreover, the stringing property of the cocoon can be suppressed.
  • the repellency surface is a surface on which the wrinkle moves when an inclination angle is set to 30 ° and 100 ⁇ L of the wrinkle is dropped on the surface.
  • the tracheal tube shown in FIGS. 1 and 2 is a so-called tracheostomy tube.
  • a tracheostomy tube 101 shown in FIG. 1 is an instrument for performing respiratory management of a patient, and is used in a state where it is directly inserted into the trachea 7 through an incision hole formed by incising the trachea.
  • the tracheostomy tube 101 includes a lumen body 102 that constitutes a main part of the tracheostomy tube 101, and a fixing portion 127 for fixing the lumen body 102 to a patient. As shown in FIGS.
  • a microstructure region 150 is arranged on the inner surface (inner peripheral surface) forming the lumen for securing the airway of the lumen body 102.
  • the fine structure region 150 is disposed on the inner peripheral surface of the lumen body 102.
  • the microstructure region 150 may be a coating 250 including a particle layer 154 and an adhesive layer 152.
  • the lumen body 102 is formed in a cylindrical shape that is open at both ends and has a uniform outer diameter and inner diameter along the length direction. Inside the lumen body 102, an airway securing lumen 102a that is a space through which exhalation passes along the length direction of the lumen body 102 is formed.
  • the lumen body 102 includes a distal end portion 122, a proximal end portion 121 disposed on the opposite side of the distal end portion 122, and a curved portion 123 positioned between the proximal end portion 121 and the distal end portion 122.
  • the curved portion 123 is curved so that the central axis of the distal end portion 122 and the central axis of the proximal end portion 121 intersect at an angle ⁇ , and in this first embodiment, the lumen body 102 is formed in a substantially L shape. Is done. That is, the angle ⁇ is about 90 °.
  • the lumen body 102 has such flexibility that the ⁇ can be changed in a range from about 90 ° to about 120 ° in accordance with a change in the posture of the patient. Even if the ⁇ changes within this range, the microstructure region 150 does not peel off or fall off from the lumen body 102.
  • the material of the lumen body 102 include synthetic resins such as silicone, polycarbonate, polypropylene, polyethylene, and polyvinyl chloride.
  • a tracheostomy hole formed by incising the wall of the trachea 7 and the skin 5 on the upper part of the trachea 7 in a patient lying on his back (the supine position).
  • the distal end portion 122 of the lumen body 102 is inserted into the trachea 7.
  • the distal end portion 122 of the luminal body 102 is tracheal toward the lung side so as to be spaced apart from the mucous membranes (skin-side tracheal mucosa 7a, inner tracheal mucosa 7b) constituting the tube wall of the trachea 7. 7.
  • proximal end portion 121 of the lumen body 102 is exposed to the outside through the tracheostomy hole, and a ventilator (not shown) is attached to the proximal end portion 121.
  • a ventilator (not shown) is attached to the proximal end portion 121.
  • exhaled air passes through the airway securing lumen 102a.
  • respiratory management is performed.
  • the fixing portion 127 is attached to the proximal end portion 121 of the lumen body 102.
  • the fixing portion 127 fixes the distal end portion 122 to an appropriate position in the trachea 7 by contacting the skin 5 when the luminal body 102 is attached to the patient.
  • the fixed plate 128 is a flat plate member, and a storage hole 131 that penetrates the fixed plate 128 is formed at the center.
  • An adhesive portion 129 is attached to the front surface of the fixing plate 128, and the back surface of the fixing plate 128 is brought into contact with the patient's skin 5.
  • the bonding portion 129 is for bonding the lumen body 102 to the fixing portion 127, and has a ring shape in which a substantially circular through hole 130 is formed at the center.
  • the through hole 130 of the bonding portion 129 communicates with the storage hole 131 of the fixing plate 128, and the size of the through hole 130 is set according to the outer diameter of the lumen body 102.
  • the lumen body 102 passes through the accommodation hole 131 of the fixing plate 128 and the through hole 130 of the bonding portion 129, and is fixed by, for example, an adhesive.
  • fixing with an adhesive is given as an example, but various fixing methods such as fixing by welding can be employed.
  • the fine structure region 150 includes a particle layer 154 and is disposed on the entire inner surface of the lumen body 102 forming the lumen for securing the airway.
  • the particle layer 154 is located on the surface side (innermost side) of the microstructure region 150 disposed on the inner surface forming the airway securing lumen 102a of the lumen body 102, and the surface 24 thereof faces the airway securing lumen 102a. It is an (exposed) layer that prevents soot from accumulating inside the lumen body 102. That is, the airway securing lumen 102a functions so as not to be blocked.
  • the particle layer 154 is a layer that includes the microparticles 21 and has a surface on which unevenness of a size of several tens of ⁇ m is formed. In other words, it is a layer having a surface in which microparticles 21 adhere to the luminal body 102 and unevenness of several tens of ⁇ m is formed.
  • an adhesive layer 152 described later is interposed between the particle layer 154 and the luminal body 102, the particle layer 154 has microparticles 21 attached to the adhesive layer 152, and unevenness of a size of several tens of ⁇ m is formed. A layer having a rough surface.
  • the microparticle 21 is not particularly limited as long as the average primary particle diameter is several tens of ⁇ m, but is preferably 10 to 70 ⁇ m, and more preferably 10 to 40 ⁇ m.
  • the average primary particle diameter of the microparticles can be measured using a transmission electron microscope or a scanning electron microscope. Specifically, when the particle shape is spherical, the diameter is considered as the diameter, and when the particle shape is non-spherical, the average value of the longest diameter and the shortest diameter is regarded as the diameter, and 20 arbitrarily selected by observation with a scanning electron microscope or the like. The average diameter of the particles is defined as the average primary particle diameter.
  • the microparticles 21 are not particularly limited, but are preferably hydrophobic fine particles.
  • hydrophobic oxide fine particles, metal oxide composite particles, fluororesin fine particles, and the like can be used.
  • the hydrophobic oxide used for the hydrophobic oxide particles is not particularly limited as long as it is a hydrophobic oxide, and for example, at least one of silica (silicon dioxide), alumina, titania and the like can be used. Further, the hydrophobicity may be imparted by surface treatment. For example, fine particles in which hydrophilic oxide fine particles are subjected to surface treatment with a silane coupling agent or the like to make the surface state hydrophobic can be used. . These can be known or commercially available.
  • the metal oxide composite particles include metal oxide particles as a core and a coating layer formed on the surface thereof.
  • the metal oxide particles serving as the core form an aggregate structure (aggregate porous structure) in which a plurality of metal oxide particles (primary particles) are three-dimensionally connected.
  • the covering layer is formed inside and outside the aggregate structure.
  • fluorine-containing metal oxide composite particles are preferable.
  • the fluorine-containing metal oxide composite particles are not particularly limited as long as they include metal oxide particles and a coating layer containing a polyfluoroalkyl methacrylate resin formed on the surface thereof.
  • the metal oxide particles are not limited as long as they can be the core of the metal oxide composite particles.
  • At least one kind of particles (powder) such as silicon oxide, titanium oxide, aluminum oxide, and zinc oxide may be used.
  • the polyfluoroalkyl methacrylate resin include a copolymer obtained by copolymerizing polyfluorooctyl methacrylate, 2-N, N-diethylaminoethyl methacrylate, 2-hydroxyethyl methacrylate, and 2,2′-ethylenedioxydiethyl dimethacrylate. It can be used suitably.
  • the fluororesin fine particles are not particularly limited as long as they are mainly composed of a fluororesin.
  • the fluororesin include polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE, CTFE), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), perfluoroalkoxy fluororesin (PFA), tetrafluoroethylene.
  • PTFE polytetrafluoroethylene
  • PCTFE polychlorotrifluoroethylene
  • CTFE polyvinylidene fluoride
  • PVDF polyvinyl fluoride
  • PFA perfluoroalkoxy fluororesin
  • tetrafluoroethylene tetrafluoroethylene
  • FEP ethylene / hexafluoropropylene copolymer
  • ETFE ethylene / tetrafluoroethylene copolymer
  • ECTFE ethylene / chlorotrifluoro
  • Hydrophobic fine particles are preferably hydrophobic metal oxide fine particles, more preferably hydrophobic silica fine particles.
  • hydrophobic silica fine particles having a silyl group, preferably a trimethylsilyl group on the surface, or metal oxide particles having a surface coated with a polyfluoroalkyl methacrylate resin are preferred because they are more excellent in preventing soot adhesion.
  • the total adhesion amount (weight after drying) of the microparticles 21 is not limited, but is usually preferably 0.01 to 10 g / m 2 , more preferably 0.2 to 1.5 g / m 2. 0.3 to 1 g / m 2 is more preferable, and 0.5 to 1 g / m 2 is particularly preferable. By setting within the above range, more excellent repellency can be obtained over a long period of time, and it is further advantageous in terms of suppression of dropout of the microparticles 21 and cost.
  • the particle layer 154 is disposed on the entire inner surface of the lumen body 102 that forms the airway securing lumen 102a.
  • the present invention is not limited to this aspect, and the particle layer 154 is disposed in at least a partial region. It only has to be done.
  • the microstructure region 150 may include an adhesive layer 152 that is interposed between the lumen body 102 and the particle layer 154 and improves the adhesion between them.
  • the adhesive layer 152 and the particle layer 154 constitute a coating 250.
  • the particle layer 154 is disposed on the entire surface of the adhesive layer 152 disposed on the entire inner surface of the lumen 102a for securing the airway of the lumen 102.
  • the present invention is not limited to this mode, and the region where the particle layer 154 is disposed. May be disposed in at least a partial region of the adhesive layer 152.
  • the thickness of the adhesive layer 152 is not particularly limited, but is preferably about 2 to 150 ⁇ m from the viewpoint of adhesion, productivity, manufacturing cost, and the like.
  • the adhesive layer 152 a known material can be used.
  • a layer formed of an adhesive such as a lacquer type adhesive, an easy peel adhesive, or a hot melt adhesive can be employed.
  • a lacquer type adhesive or a sealant film it is preferable to employ a lacquer type adhesive or a sealant film, and particularly an adhesive layer formed of a lacquer type adhesive can be suitably employed.
  • the lacquer type adhesive means an adhesive that is dried and cured by volatilization of the solvent.
  • a method for producing the microstructure region 150 of the tracheostomy tube 101 of the present embodiment is not particularly limited.
  • the particle layer 154 is formed by attaching the microparticles 21 to the inner surface of the lumen 102 forming the lumen 102a for securing the airway.
  • an adhesive layer 152 is arranged on the inner surface of the lumen 102 to form the airway securing lumen 102a, and the surface of the adhesive layer 152 (the surface exposed to the airway securing lumen 102a) is microscopic.
  • the particle layer 154 is disposed on the adhesive layer 152 by attaching the particle 21.
  • Examples of the method for arranging the adhesive layer 152 include known methods such as a dry laminating method, an extrusion laminating method, a wet laminating method, and a heat laminating method.
  • a method of arranging the particle layer 154 for example, a known method such as roll coating, gravure coating, bar coating, doctor blade coating, brush coating, powder electrostatic method or the like can be employed.
  • roll coating or the like it can be carried out by a method of drying after forming a coating film on the adhesive layer 152 using a dispersion in which the microparticles 21 are dispersed in a solvent.
  • the solvent in this case is not limited, and in addition to water, for example, alcohol (ethanol), cyclohexane, toluene, acetone, IPA, propylene glycol, hexylene glycol, butyl diglycol, pentamethylene glycol, normal pentane, normal hexane, hexyl alcohol
  • An organic solvent such as can be selected as appropriate.
  • a very small amount of a dispersant, a colorant, an anti-settling agent, a viscosity modifier and the like can be used in combination.
  • the dispersion amount of the microparticles 21 with respect to the solvent is usually about 10 to 100 g / L in total.
  • the drying temperature is not limited as long as it does not affect the luminal substrate, but it is usually 150 ° C. or less, and preferably 80 to 120 ° C.
  • the heating temperature in this case can be appropriately set according to the type of the adhesive layer 152 and the like, and is usually from (Tm ⁇ 50) ° C. to (Tm + 50) with respect to the melting point Tm (melting start temperature) ° C. of the adhesive layer 152 used. ) It is preferable to be within the range of ° C.
  • FIG. 1 A case where the eyelid in the tracheostomy tube 101 is sucked using a suction catheter will be described with reference to FIG.
  • the suction catheter 601 is inserted into the lumen body 102 from the proximal end 121 side of the lumen body 102, and the tip of the suction catheter 601 is advanced to the vicinity of the tip section 122 along the inner surface of the lumen body 102, Aspirate Z.
  • the fine structure region 150 is arranged on the inner surface of the lumen 102a of the lumen 102 for airway securing lumen 102a.
  • a method of forming unevenness in size may be used.
  • examples of the method for forming the unevenness of several tens of ⁇ m include extrusion molding, injection molding, cutting, laser processing, and surface processing using a core rod.
  • corrugation of a several tens micrometer size may be newly formed, you may use the commercial item which has such an unevenness
  • the microstructure region 150 exists over the entire circumference of the inner peripheral surface of the lumen body 102, but is not limited to this form. As shown in 3 (A) to (C), it may be arranged only on a part of the inner peripheral surface of the lumen body 102.
  • 3A to 3C show a tracheostomy tube 201 according to a modification of the first embodiment. The difference from the tracheostomy tube 101 of the first embodiment shown in FIG. The position where the structure area 150 exists is mentioned.
  • 3B and 3C are cross-sectional views taken along line BB shown in FIG. 3A.
  • a plane P passing through the center J of each luminal body 102 at the proximal end 121, the distal end 122, and the bending portion 123 is a luminal body.
  • the tangent line T is the reference.
  • the microstructure region 150 is present at a position on the inner peripheral surface of the lumen 102 where the angle ⁇ formed with the line S is 30 ° or more.
  • FIG. 4 A second embodiment of the tracheal tube of the present invention will be described with reference to FIG.
  • the tracheal tube shown in FIG. 4 is a so-called tracheostomy tube.
  • the difference between the tracheostomy tube 301 of the second embodiment shown in FIG. 4 and the tracheostomy tube 101 of the first embodiment shown in FIG. 2 described above is mainly that the tracheostomy tube 301 includes the cuff 106 and the cuff.
  • the point which has the adjustment part 108 is mentioned.
  • a cuff 106 is attached to the distal end portion 122 of the lumen body 102.
  • the cuff 106 is fixed so as to cover the outer peripheral surface of the lumen body 102 in the vicinity of the distal end portion 122.
  • the cuff 106 is connected to the cuff adjusting unit 108.
  • the cuff adjusting unit 108 includes a pilot balloon 126 and an air injection tube 125 that connects the cuff 106 and the pilot balloon 126.
  • the pilot balloon 126 is formed to have a substantially flat hexagonal cross section.
  • the cross-sectional shape of the pilot balloon 126 is described as a hexagon, but the present invention is not limited to this.
  • the cross-sectional shape of the pilot balloon 126 can be formed in a substantially square shape or a circular shape, and may be formed in various other shapes.
  • An air injection hole 126 a is provided at one end of the pilot balloon 126, and a discharge port 126 b is provided at the other end of the pilot balloon 126.
  • a check valve is attached to the air injection hole 126a. Then, air is sent into the cuff 106 through the pilot balloon 126 and the air injection tube 125 from the air injection hole 126a. The air sent in does not leak from the air injection hole 126a by the check valve. Further, the pressure applied to the cuff 106 can be sensed tactilely by pressing the pilot balloon 126 with a finger.
  • the air injection tube 125 communicates with the internal space of the cuff 106 through the cuff side opening 111 formed once.
  • a storage hole 231 is formed at the center of the fixed plate 128.
  • the adhesive portion 129 has a substantially circular through hole 130 and a groove formed from the outer periphery toward the through hole 130.
  • the through hole 130 communicates with the storage hole 231.
  • the lumen body 102 and the air injection tube 125 pass through the storage hole 231. That is, the air injection tube 125 passes through the groove portion of the bonding portion 129 and the accommodation hole 131 of the fixing plate 128. 4B, the air injection tube 125 is disposed along the inside of the curved portion 123 of the lumen body 102, and is fixed to the outer peripheral surface 102c of the lumen body 102.
  • the cuff 106 When the air sent from the air injection hole 126a through the pilot balloon 126 and the air injection tube 125 enters the cuff 106, the cuff 106 swells and the mucous membrane of the trachea 7 (skin-side tracheal mucosa 7a, body inner tracheal mucosa 7b). ). Thereby, the clearance gap formed between the lumen body 102 and the trachea 7 can be closed.
  • the cuff 106 blocks the gap formed between the luminal body 102 and the trachea 7, thereby preventing oxygen sent from the ventilator from leaking to the larynx side, and saliva flowing from the larynx side, etc. Can be prevented from entering the lungs.
  • FIG. 4B the configuration in which the air injection tube 125 is fixed to the outer peripheral surface 102c of the lumen body 102 has been described.
  • the present invention is not limited to this configuration, and for example, as shown in FIG.
  • an air injection lumen 125 a may be provided in the tube wall of the lumen 302, and air may be sent from the pilot balloon 126 to the cuff 106.
  • FIG. 5 A third embodiment of the tracheal tube of the present invention will be described with reference to FIG.
  • the tracheal tube shown in FIG. 5 is a so-called tracheostomy tube.
  • the difference between the tracheostomy tube 401 of the third embodiment shown in FIG. 5 and the tracheostomy tube 301 of the second embodiment shown in FIG. 4 is mainly that the tracheostomy tube 401 is a cuff-side suction part.
  • the point which has 138 is mentioned.
  • a cuff-side suction unit 138 is disposed on the opposite side of the cuff adjusting unit 108 with the lumen body 102 interposed therebetween.
  • the cuff side suction part 138 includes a cuff side suction connector 139 and a cuff side suction tube 140.
  • a storage hole 331 is formed at the center of the fixed plate 128.
  • the cuff side suction tube 140 passes through the groove portion of the bonding portion 129 and the accommodation hole 331 of the fixing plate 128, similarly to the air injection tube 125.
  • the cuff-side suction tube 140 is disposed along the outside of the curved portion 123 of the lumen body 102 and is fixed to the outer peripheral surface 102 c of the lumen body 102.
  • One end of the cuff side suction tube 140 extends to the vicinity of the cuff 106 and opens, and the cuff side suction port 140a is formed by this opening.
  • a cuff side suction connector 139 is attached to the other end of the cuff side suction tube 140.
  • a suction device (not shown) is attached to the cuff side suction connector 139.
  • Saliva or the like flowing from the larynx side flows through the mucous membrane of the trachea 7 (skin-side tracheal mucosa 7a, internal tracheal mucosa 7b) and flows to the lung side.
  • the saliva or the like is blocked by the cuff 106 in an inflated state, and accumulates in a space formed by the mucous membrane (skin-side tracheal mucosa 7 a and body inner tracheal mucosa 7 b) and the cuff 106.
  • the saliva etc. which were dammed by the cuff 106 are sucked from the cuff side suction port 140a by the cuff side suction part 138 by operating the suction device.
  • the microstructure region 150 described above may be disposed on the inner peripheral surface of the cuff side suction tube 140.
  • the fine structure region 150 including the repellent layer 154 may be disposed on the inner peripheral surface of the cuff side suction tube 140, it is possible to prevent wrinkles from adhering to the inner peripheral surface of the cuff side suction tube 140 and to absorb the cuff side suction. Occlusion of the tube 140 can be suppressed.
  • a suction line and related components may be further added to suck foreign substances such as sputum attached to the lung side of the cuff 106.
  • the configuration in which the air injection tube 125 and the cuff side suction tube 140 are fixed to the outer peripheral surface 102c of the lumen 102 is not limited to this configuration.
  • an air injection lumen 125b is provided in the tube wall of the lumen body 402 instead of the air injection tube 125, and the tube wall of the lumen body 402 is replaced instead of the cuff side suction tube 140.
  • a cuff-side suction lumen 140b may be provided therein.
  • the tracheostomy tube shown in FIG. 6 is a so-called tracheostomy tube, but is called a double-tube tracheostomy tube or a tracheostomy tube with an inner tube, and a tracheostomy tube body used for the purpose of securing an airway after tracheostomy
  • This is a combination of inner cannula used to remove secretions in the tube and increase the patency of the lumen.
  • the inner cannula (hereinafter sometimes referred to as “inner cylinder”) is used as a tracheostomy tube body (hereinafter referred to as “inner tube”). It is sometimes referred to as an “outer cylinder”).
  • each member constituting the double-tube tracheostomy tube 701 will be described in detail.
  • the lumen body 102 constituting the inner cylinder 701a is formed in a cylindrical shape that is open at both ends and has a uniform outer diameter and inner diameter along the length direction. Inside the lumen body 102, an airway securing lumen 102a that is a space through which exhalation passes along the length direction of the lumen body 102 is formed.
  • the lumen body 102 includes a distal end portion 122 and a proximal end portion 121 disposed on the opposite side of the distal end portion 122, and a curved portion 123 positioned between the proximal end portion 121 and the distal end portion 122 as desired. You may have.
  • the lumen body 102 is preferably made of a flexible material and is preferably deformed along the lumen body 702.
  • the lumen body 102 When the lumen body 102 has the curved portion 123, the lumen body 102 is curved so that the central axis of the distal end portion 122 and the central axis of the base end portion 121 intersect at an angle ⁇ , and the lumen body 102 is formed in an approximately L shape. May be. In the lumen body 102 shown in FIG. 6A, the angle ⁇ is about 90 °.
  • the material of the lumen body 102 include synthetic resins such as silicone, polycarbonate, polypropylene, polyethylene, and polyvinyl chloride.
  • the lumen body 702 constituting the outer cylinder 701b is formed in a cylindrical shape that is open at both ends and has a uniform outer diameter and inner diameter along the length direction. Inside the lumen body 702, an inner cylinder insertion lumen 702a, which is a space for inserting an inner cannula (inner cylinder) along the length direction of the lumen body 702, is formed.
  • the lumen body 702 includes a distal end portion 722, a proximal end portion 721 disposed on the opposite side of the distal end portion 722, and a curved portion 723 positioned between the proximal end portion 721 and the distal end portion 722.
  • the curved portion 723 is curved so that the central axis of the distal end portion 722 and the central axis of the proximal end portion 721 intersect at an angle ⁇ , and in this fourth embodiment, the lumen body 702 is formed in a substantially L shape. Is done. That is, the angle ⁇ is about 90 °.
  • the lumen body 702 has such flexibility that the angle ⁇ can be changed in a range from about 90 ° to about 120 ° in accordance with a change in the posture of the patient.
  • Examples of the material of the lumen body 702 include synthetic resins such as silicone, polycarbonate, polypropylene, polyethylene, and polyvinyl chloride.
  • a fine structure region having the same configuration as the fine structure region 150 may be disposed on the inner surface of the lumen body 702 forming the inner tube insertion lumen.
  • the proximal end 721 of the lumen body 702 is exposed outside the body through the tracheostomy hole, and a ventilator (not shown) is attached to the proximal end 721.
  • a ventilator (not shown) is attached to the proximal end 721.
  • exhaled air passes into the lumen 102a for securing the airway of the inner cylinder.
  • respiratory management is performed.
  • the fixing portion 727 is attached to the proximal end portion 721 of the lumen body 702.
  • the fixing portion 727 fixes the distal end portion 722 to an appropriate position in the trachea 7 by contacting the skin 5 when the lumen body 702 is attached to the patient.
  • the fixing plate 728 is a flat plate member, and a storage hole 731 penetrating the fixing plate 728 is formed at the center.
  • An adhesive portion 729 is attached to the front surface of the fixing plate 728, and the back surface of the fixing plate 728 is brought into contact with the patient's skin 5.
  • the bonding portion 729 is used to bond the lumen body 702 to the fixing portion 727, and has a ring shape in which a substantially circular through hole 730 is formed at the center.
  • the through hole 730 of the bonding portion 729 communicates with the storage hole 731 of the fixing plate 728, and the size of the through hole 730 is set according to the outer diameter of the lumen body 702.
  • the lumen body 702 penetrates through the accommodation hole 731 of the fixing plate 728 and the through-hole 730 of the bonding portion 729, and is fixed by, for example, an adhesive.
  • fixing with an adhesive is given as an example, but various fixing methods such as fixing by welding can be employed.
  • the fine structure region 150 installed on the inner surface of the lumen 102a of the lumen 102 constituting the inner cylinder is as described in the first embodiment of the present invention.
  • the multi-tube tracheostomy tube of the present invention has been described.
  • the cuff and the cuff adjusting unit, the suction line, and related configurations are described. Modifications such as adding can be made.
  • the tracheal tube shown in FIGS. 7 and 8 is a so-called endotracheal tube.
  • the endotracheal tube 501 shown in FIGS. 7 and 8 is an instrument for performing respiratory management of a patient, and is inserted into the trachea 7 from the patient's mouth.
  • the endotracheal tube 501 includes a lumen body 202, a cuff 206, and an air injection tube 225.
  • the fine structure region 150 described above is disposed on the inner peripheral surface of the lumen body 202 over the entire periphery.
  • the form of the microstructure region 150 is as described above, and a description thereof is omitted.
  • the endotracheal tube 501 includes a lumen body 202, an air injection lumen 225 b provided along the longitudinal direction of the lumen body 202, and extended to at least the vicinity of the distal end portion 222 of the lumen body 202, and the lumen body 202 is provided in the vicinity of the distal end portion of the lumen body 202 so as to surround the outer peripheral surface of the lumen body 202 and communicates with the other end of the air injection lumen 225b and the inflatable / shrinkable cuff 206 communicating with one end of the air injection lumen 225b.
  • the lumen body 202 is formed in a cylindrical shape having both ends opened.
  • the lumen body 202 includes a distal end portion 222, a proximal end portion 221 provided on the opposite side of the distal end portion 222, and a curved portion 223 positioned between the proximal end portion 221 and the distal end portion 222.
  • the lumen body 202 is made of a flexible material, and has an airway securing lumen 202a that penetrates from the distal end portion 222 to the proximal end portion 221 for introducing anesthetic gas, oxygen gas, and the like.
  • the distal end portion 222 of the lumen body 202 is formed in a smooth bevel shape in order to facilitate insertion into the body. Further, a connector 212 for connecting to the breathing circuit is attached to the proximal end portion 221.
  • an air injection lumen 225b that is thinner than the airway securing lumen 202a is provided on the tube wall forming the lumen body 202 along the longitudinal direction of the lumen body 202.
  • the air injection lumen 225b is an inflation lumen for sending air into a cuff 206 described later.
  • the air injecting lumen 225 b communicates with the internal space of the cuff 206 via a cuff side opening 225 a formed on the outer surface of the tube wall of the lumen 202 in the cuff 206.
  • the air injecting lumen 225b is a tube for injecting air through a notch 207 formed on the outer surface of the tube wall of the lumen 202 at a position in the vicinity of the base end 221. 225 is in communication.
  • connection between the air injection tube 225 and the air injection lumen 225b is performed, for example, by inserting a preheated mandrel into the air injection lumen 225b, and simultaneously removing the mandrel, the air injection tube 225 is inserted into the air injection lumen 225b. It is carried out by a method such as inserting in and fixing using a solvent or an adhesive.
  • a cuff 206 capable of expanding and contracting is provided so as to surround the outer peripheral surface in an annular shape.
  • the cuff 206 is formed on the outer periphery of the lumen body 202 by covering a cuff-side opening 225a of the air injection lumen 225b with a membrane formed in advance having an inner diameter larger than the outer diameter of the lumen body 202.
  • the both ends are attached to the outer peripheral surface of the lumen body 202 with an adhesive or a solvent, or are fused and attached by heat, high frequency, or the like, so that they are attached in an airtight manner.
  • an inflatable / deflatable pilot balloon 226 for recognizing the degree of expansion / contraction of the cuff 206 is installed at the rear end of the air injection tube 225 so as to communicate with the air injection tube 225. .
  • a check valve 226a having a function of preventing gas from flowing into the pilot balloon 226 but preventing gas from flowing into the pilot balloon 226 is installed at the rear end side of the pilot balloon 226. Yes.
  • a syringe or the like is connected to the check valve 226a and a gas such as air is press-fitted, the gas passes through the pilot balloon 226, the air injection tube 225, the air injection lumen 225b, and the cuff side opening 225a.
  • the cuff 206 is fed into the cuff 206 and the cuff 206 expands.
  • a sixth embodiment of the tracheal tube of the present invention will be described with reference to FIG.
  • the tracheal tube shown in FIG. 9 is also called a small tracheostomy tube, a percutaneous tracheal puncture tube, an annular thyroid puncture tracheal cannula, an annular thyroid incision tracheal cannula, or the like.
  • a tracheal cannula 801 shown in FIG. 9 is an instrument for performing respiratory management of a patient who needs emergency respiratory management, and is inserted into the trachea 7 by puncturing the patient's annular thyroid membrane.
  • the tracheal cannula 801 includes a lumen body 102 and a fixing portion 127.
  • the lumen body 102 of the tracheal cannula 801 is also called an outer needle because it punctures the annular thyroid membrane as a set with the inserted inner needle.
  • the fine structure region 150 (not shown) described above is disposed over the entire circumference.
  • the form of the microstructure region 150 (not shown) is as described above, and a description thereof is omitted.
  • the tracheal cannula 801 includes a lumen body 102 into which an inner needle (not shown) is inserted, and a fixing portion 127 that is provided at the proximal end portion of the lumen body 102 and fixes the lumen body 102 to the skin.
  • the lumen body 102 is made of a synthetic resin, and includes a curved portion that is curved at an angle of 15 ° or less with respect to the axial direction of the inner needle at the distal end portion.
  • the annular thyroid membrane (annular thyroid ligament) between the cricoid cartilage and the thyroid cartilage is punctured with a metal inner needle (not shown) inserted into the lumen body 102.
  • the inner needle (not shown) is removed, and only the lumen body 102 is left in the trachea.
  • the tracheal cannula 801 is fixed by tying a cotton tape or the like (not shown) inserted through a string hole (not shown) provided in the fixing part 127 to the neck.
  • a seventh embodiment of the tracheal tube of the present invention will be described with reference to FIG.
  • the tracheal tube shown in FIG. 10 is also referred to as an annular thyroid puncture tracheal cannula, an annular thyroid incision tracheal cannula, or the like.
  • the tracheal cannula 901 shown in FIG. 10 is used for the purpose of aspirating and removing the secretory fluid stored in the trachea or bronchus, for the purpose of securing a suction passage leading from the front of the neck to the inside of the trachea.
  • the tracheal cannula 901 includes a lumen body 102 and a fixing portion 127 (in particular, also referred to as a flange portion).
  • the fine structure region 150 (not shown) described above is disposed over the entire circumference.
  • the form of the microstructure region 150 (not shown) is as described above, and a description thereof is omitted.
  • the tracheal cannula 901 includes a lumen body 102 into which an introducer (not shown) is inserted, and a fixing portion 127 (flange) that is provided at the base of the lumen body 102 and fixes the lumen body 102 to the skin. ing.
  • the lumen body 102 is made of a synthetic resin and includes a curved portion that curves from the proximal end portion to the distal end portion.
  • the tracheal cannula 901 expands the puncture hole of the cricoid thyroid membrane by an expansion operation by a dilator (not shown) via a guide wire (not shown) introduced into the trachea 7 using the Seldinger method, for example.
  • the lumen body 102 into which an introducer (not shown) is inserted can be inserted into the trachea 7 through the puncture hole expanded in the thyroid membrane, and the introducer can be removed to place the tracheal cannula 901 in the trachea.
  • the annular thyroid membrane may be incised, the lumen body 102 into which the introducer is inserted from the incision hole may be inserted into the trachea 7, the introducer may be removed, and the tracheal cannula 901 may be placed in the trachea.
  • normal tracheal suction using a suction catheter (not shown) and oxygen or air supply can be performed via the tracheal cannula 901.
  • Test Piece Test piece 1 was made of silicon rubber (size 50 mm ⁇ 50 mm, thickness 3 mm, manufactured by Hoowaki) having a line & space pattern structure having a width of 20 ⁇ m, a height of 60 ⁇ m, and a width between lines of 40 ⁇ m.
  • Example 2 (1) Preparation of test piece Surface treatment was performed on a slide glass (size: 26 mm ⁇ 76 mm, thickness: 1 mm; white edge polished frost slide glass, manufactured by Matsunami Glass Industrial Co., Ltd.) with trimethylsilyl groups having an average primary particle diameter of 20 ⁇ m.
  • Test piece C1 was produced.
  • test piece A test piece C2 was produced from the same PVC sheet as in Comparative Example 1.
  • test piece C3 was produced by cutting a silicon rubber sheet (thickness: 1.5 mm) into a size of 26 mm x 76 mm.
  • Example 1 and Example 2 showed excellent repellency and adhesion suppression for all the soot samples tested. Further, in Example 1 and Example 2, no stringing of the kite was observed after the kite moved.

Abstract

　L'invention concerne un tube trachéal pouvant être inséré dans la trachée, le tube trachéal étant équipé d'un corps de lumière ayant une partie extrémité distale destinée à être agencée du côté poumon à l'intérieur de la trachée, une partie extrémité basale située sur le côté opposé à la partie extrémité distale, et une lumière de maintien de trachée traversant le corps de lumière de la partie extrémité distale à la partie extrémité basale, le tube trachéal pouvant être inséré dans la trachée ayant une région de microstructure agencée dans au moins une partie de la surface intérieure qui forme la lumière de maintien de trachée du corps de lumière, la région de microstructure ayant une surface sur laquelle sont formées des aspérités d'une taille de plusieurs dizaines de µm, rendant difficile l'adhérence des mucosités.
PCT/JP2015/077122 2014-09-30 2015-09-25 Tube trachéal pouvant être inséré dans la trachée WO2016052340A1 (fr)

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JP2016551979A JP6573896B2 (ja) 2014-09-30 2015-09-25 気管に挿入可能な気管用チューブ

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JP2014-201815 2014-09-30
JP2014201815 2014-09-30
JP2015015172 2015-01-29
JP2015-015172 2015-01-29

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117244123A (zh) * 2023-11-14 2023-12-19 北京安吉贝玛健康科技有限公司 一种呼吸道清理装置

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006102099A (ja) * 2004-10-05 2006-04-20 Nippon Sherwood Medical Industries Ltd 気管切開チューブ
JP2012170792A (ja) * 2011-02-24 2012-09-10 Kawasumi Lab Inc 気管カニューレ

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006102099A (ja) * 2004-10-05 2006-04-20 Nippon Sherwood Medical Industries Ltd 気管切開チューブ
JP2012170792A (ja) * 2011-02-24 2012-09-10 Kawasumi Lab Inc 気管カニューレ

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117244123A (zh) * 2023-11-14 2023-12-19 北京安吉贝玛健康科技有限公司 一种呼吸道清理装置
CN117244123B (zh) * 2023-11-14 2024-02-06 北京安吉贝玛健康科技有限公司 一种呼吸道清理装置

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