WO2015141444A1 - Tube à demeure d'organe tubulaire biologique et dispositif d'insertion de tube - Google Patents

Tube à demeure d'organe tubulaire biologique et dispositif d'insertion de tube Download PDF

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Publication number
WO2015141444A1
WO2015141444A1 PCT/JP2015/055861 JP2015055861W WO2015141444A1 WO 2015141444 A1 WO2015141444 A1 WO 2015141444A1 JP 2015055861 W JP2015055861 W JP 2015055861W WO 2015141444 A1 WO2015141444 A1 WO 2015141444A1
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WO
WIPO (PCT)
Prior art keywords
tube
biological
insertion device
tube body
region
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Application number
PCT/JP2015/055861
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English (en)
Japanese (ja)
Inventor
康之 本間
美雪 小山
祐亮 百貫
杏梨 藤城
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テルモ株式会社
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Priority to JP2016508644A priority Critical patent/JPWO2015141444A1/ja
Publication of WO2015141444A1 publication Critical patent/WO2015141444A1/fr

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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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • 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
    • A61M16/0434—Cuffs
    • A61M16/0445—Special cuff forms, e.g. undulated
    • 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
    • A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
    • 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
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/025—Helium
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0266—Nitrogen (N)

Definitions

  • the present invention relates to a biological tube indwelling tube and a tube insertion device.
  • a tracheostomy tube is a medical device that is generally used for the purpose of securing a patient's airway and breathing management.
  • the tracheostomy tube cuts through the trachea to form a puncture hole, and is inserted into the trachea through the puncture hole.
  • Such tracheostomy and tracheostomy tube insertion methods are classified as surgical incision and percutaneous tracheostomy.
  • the percutaneous tracheostomy method is further classified into a forceps method and a dilator method depending on a medical instrument for expanding the puncture hole.
  • Cook's Ble Rhino registered trademark
  • Blue Dolphin trademark
  • Patent Documents 2 and 3 various devices for expanding a hole formed in a tissue with an expansion body have been studied for the purpose of forming a percutaneous channel and accessing the inside of a blood vessel.
  • the puncture hole forming technique and the tracheostomy tube insertion technique are performed separately. It needs to be done separately. Therefore, the percutaneous tracheostomy method using such a conventional device is complicated and there is a risk of bleeding when the device forming the puncture hole is removed, which is separate from the tracheostomy tube. Since the puncture hole is formed using this device, there is a problem that the insertion resistance of the tracheostomy tube is increased.
  • an object of the present invention is to form a puncture hole and insert a biological tube indwelling tube only with a relatively simple procedure and to have a relatively low risk of bleeding and the like, a tube insertion device, a biological tube indwelling tube and a transfusion.
  • the object is to provide a method for skin-inserting a living tube placement tube.
  • the puncture hole can be expanded by folding a part of the biological tube indwelling tube and expanding the folded portion at the puncture hole, thereby completing the present invention. It came.
  • a biological tube indwelling tube having a tubular tube body and an expandable / shrinkable expansion portion provided on the outer peripheral surface of the tube body;
  • a catheter having a pressing member that can be inserted into the lumen of the tube main body and can be pressed in the circumferential direction;
  • the tube body has a region folded in a longitudinal direction at a position including at least an arrangement portion of the extension portion, When the expansion portion is contracted, the expansion portion is housed in a groove of the tube body formed in a folded region,
  • the tube insertion device wherein the folded region is configured to be expandable by a pressing member when the catheter is inserted into the lumen of the tube body.
  • the tube body has a region folded in a longitudinal direction at a position including at least an arrangement portion of the extension portion, The expansion part is housed in a groove of the tube body formed in the folded region at the time of contraction, The biological tube indwelling tube is configured such that the folded region can be expanded by being pressed from the lumen of the tube main body.
  • a method of inserting a living tube placement tube percutaneously into a target living tube Providing a tube insertion device, wherein the tube insertion device is inserted into a tubular tube body and a living body indwelling tube having an expandable / contractable expansion portion provided on an outer peripheral surface of the tube body, and the lumen of the tube body And a catheter having a pressing member that can be pressed in the circumferential direction, and the tube body has a region folded in the longitudinal direction at a position including at least a portion where the expansion portion is disposed, and contraction of the expansion portion
  • the expansion part is housed in a groove in the tube body formed in the folded region, and the folded region can be expanded by the pressing member when inserted into the lumen of the tube body of the catheter Forming a hole communicating with the living body from the side of the living body; and Inserting the tube body of the tube insertion device into the biological tube through the hole, and placing the folded region of the tube body in contact with the hole of the biological tube; Pressing the tube body body
  • the present invention it is possible to form a puncture hole and insert a biological tube indwelling tube only with a relatively simple procedure, and to relatively reduce the risk of bleeding and the like, a tube insertion device, a biological tube indwelling tube, and a percutaneous It is possible to provide a method for inserting a living tube placement tube. That is, according to the present invention, it is not necessary to prepare a separate device for the expansion of the puncture hole and perform the procedure by using the biological tube indwelling tube for expansion (formation) of the puncture hole. For this reason, it is possible to prevent bleeding associated with the removal or attachment of the device used for expanding the puncture hole.
  • the biological tube indwelling tube used for expanding the puncture hole is inserted into the biological tube as it is, an increase in insertion resistance when the biological tube indwelling tube is inserted can be prevented. Furthermore, since the biological tube indwelling tube also serves as an expansion function of the puncture hole, the procedure for placing the biological tube indwelling tube becomes simple and easy.
  • FIG. 1 is a schematic view of a tube insertion device according to a preferred embodiment of the present invention.
  • FIG. 2 is a schematic view of a biological tube indwelling tube provided in the tube insertion device shown in FIG.
  • FIG. 3 is a schematic view of a catheter provided in the tube insertion device shown in FIG.
  • FIG. 4 is a schematic diagram showing the operation of the tube insertion device shown in FIG.
  • FIG. 5 is a schematic diagram showing the operation of the tube insertion device shown in FIG. 6 (a) to 6 (c) are cross-sectional views taken along line xx of the tube insertion device shown in FIGS.
  • FIGS. 7A to 7C are partially enlarged cross-sectional views of a tube insertion device according to another aspect of the present invention.
  • FIG. 1 is a schematic view of a tube insertion device according to a preferred embodiment of the present invention.
  • FIG. 2 is a schematic view of a biological tube indwelling tube provided in the tube insertion device shown in FIG.
  • FIG. 8 is a schematic diagram illustrating a preferred embodiment of the method of the present invention.
  • FIG. 9 is a schematic diagram illustrating a preferred embodiment of the method of the present invention.
  • FIG. 10 is a schematic diagram illustrating a preferred embodiment of the method of the present invention.
  • FIG. 1 is a schematic diagram of a tube insertion device according to a preferred embodiment of the present invention
  • FIG. 2 is a schematic diagram of a biological tube placement tube provided in the tube insertion device shown in FIG. 1
  • FIG. 3 is a tube shown in FIG.
  • FIG. 4 is a schematic diagram showing the operation of the tube insertion device shown in FIG. 1
  • FIG. 5 is a schematic diagram showing the operation of the tube insertion device shown in FIG. 1
  • FIGS. 1C to 1C are sectional views taken along line xx of the tube insertion device shown in FIGS.
  • the size of each member is emphasized as appropriate, and the illustrated members do not indicate actual sizes.
  • a tube insertion device 1 shown in FIG. 1 is an assembly formed by combining a biological tube indwelling tube 2 shown in FIG. 2 and a catheter 3 shown in FIG.
  • the tube insertion device 1 is used to form a puncture hole for a percutaneous biological tube, and is used to insert a provided biological tube indwelling tube 2 into the biological tube via the puncture hole.
  • the biological tube is not particularly limited, but refers to the trachea, bronchus, nasal cavity, oral cavity, pharynx, esophagus, digestive tract, epidural space, blood vessel and the like. Moreover, in this embodiment, the biological tube is a trachea. Therefore, the biological tube indwelling tube 2 is a tracheostomy tube (cannula).
  • the biological tube indwelling tube 2 shown in FIG. 2 has a tube main body 21, an expansion part 22, an injection part 23, a suction part 24, and a fixing member 25.
  • the tube body 21 is a tubular body having a lumen 211 that penetrates from the distal end (distal end) side to the proximal end (proximal end) side, and is appropriate from the viewpoint of securing the airway. Is curved.
  • the tube body 21 can store the shaft 31 of the catheter 3 in the lumen 211, and the lumen 211 is used to secure an airway when the biological tube indwelling tube 2 is placed in the biological tube.
  • the tube main body 21 has a region 212 that is folded along the longitudinal direction from the distal end to a position beyond the arrangement portion of the extended portion 22. .
  • the part in the region 212 of the tube main body 21 is configured to have a smaller outer diameter compared to other parts, while the folded part is expanded as shown in FIGS. 4 and 6B.
  • the outer diameter of the tube body 21 is almost the same as that of other portions of the tube body 21.
  • the tube body 21 in the region 212, has a groove 213 formed therein.
  • the tube main body 21 is accommodated by nipping a part of the extended portion 22 in the groove 213.
  • the groove 213 disappears to expose the storage portion of the expansion portion 22 on the outer surface.
  • the region 212 also extends closer to the proximal end side than the position where the expansion portion 22 of the tube body 21 is arranged. Thereby, at the time of expansion of the puncture hole as will be described later, the puncture hole can be pressed and expanded at the region 212 where the expansion portion 22 of the tube body 21 does not exist.
  • the vicinity of the proximal end of the tube main body 21 is configured to be connectable to the connection member 34 of the catheter 3.
  • the inner wall near the proximal end of the tube main body 21 can be screwed with the connection member 34.
  • the tube body 21 has flexibility and moderate flexibility. Thereby, the tube main body 21 can follow the shape of the catheter 3 when the catheter 3 is inserted, and the tube main body 21 is in contact with the biological tube when the biological tube indwelling tube 2 is indwelled. Even if it exists, it is prevented that a biological tube is damaged.
  • the outer diameter of the tube body 21 is not particularly limited, but may be, for example, 2.2 to 25 mm, preferably 5 to 15 mm.
  • the outer diameter of the folded region 212 of the tube body 21 is not particularly limited, but may be, for example, 2 to 10 mm, preferably 2 to 8 mm.
  • the inner diameter of the tube body 21 is not particularly limited, but may be 2 to 20 mm, preferably 3 to 15 mm, for example.
  • the inner diameter of the tube body 21 in the folded state 212 is not particularly limited, but may be, for example, 1 to 9.5 mm, preferably 2 to 8 mm.
  • the thickness of the wall portion of the tube body 21 is not particularly limited, but may be, for example, 0.1 to 2.5 mm, preferably 0.5 to 2 mm. Note that the thickness of the wall portion of the tube main body 21 in the region 212 can be relatively thin. In this case, the outer diameter of the region 212 in the folded state can be reduced. Thus, even when the wall portion of the tube main body 21 is formed relatively thin, the inner tube (not shown) having rigidity is appropriately inserted into the tube main body 21 as necessary, so that the tube main body 21 It is possible to maintain the shape and secure the airway.
  • the length of the tube body 21 is not particularly limited, but can be, for example, 25 to 350 mm, preferably 30 to 100 mm.
  • the material constituting the tube body 21 is not particularly limited, and various known materials can be used alone or in combination. Examples of such materials include soft vinyl chloride resin, polyurethane resin, silicone rubber, natural rubber, synthetic rubber, styrene-ethylene-butylene-styrene copolymer (SEBS), and styrene-ethylene-propylene-styrene copolymer. (SEPS), ethylene vinyl acetate copolymer (EVA), polyamide resins and polyamide elastomers such as nylon, polyester resins and polyester elastomers such as polyethylene terephthalate (PET), olefinic resins such as polyethylene, fluororubber, fluororesins, etc. 1 type or 2 types or more of them can be used in combination. Unless otherwise specified, various other known materials as described above can be used singly or in combination for other members.
  • SEBS styrene-ethylene-butylene-styrene copolymer
  • SEBS
  • the extension portion 22 is disposed so as to cover the outer peripheral surface of the tube main body 21 in the region 212 near the distal end side of the tube main body 21.
  • the expansion part 22 can be expanded and contracted, and is a balloon in this embodiment. As shown in FIGS. 5 and 6 (c), the expansion portion 22 expands when the living tube placement tube 2 is placed, and fixes and supports the tube body 21 in the living tube and prevents reflux aspiration. Used as a cuff.
  • the expanded portion 22 is partially folded and stored in the groove 213 when contracted. Thereby, when the tube main body 21 is folded in the area 212, the expansion portion 22 is prevented from forming wrinkles or wrinkles on the outer peripheral surface of the tube main body 21. As a result, even when the small-diameter puncture hole is passed, the extension portion 22 can easily pass through the puncture hole.
  • the expansion part 22 is a fluid, for example, liquids, such as a physiological saline, a buffer solution, a sterilized water, air, nitrogen, oxygen, through the injection
  • the material constituting the expanded portion 22 is not particularly limited, but materials having appropriate elasticity and stretchability are preferable.
  • polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer examples include polyolefins such as ionomers, soft polyvinyl chloride, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, thermoplastic resins such as fluororesins, silicone rubbers, latex rubbers, and the like. They can be used in combination.
  • the injection unit 23 includes a tube 231, a bag body 232, and an injection port 233.
  • the tube 231 communicates with the expansion part 22 via a lumen provided in the tube main body 21 separately from the lumen, and the fluid injected from the injection port 233 can be transferred to the expansion part 22. it can.
  • the bag body 232 is configured to be expandable so as to have the same expansion compliance as the expansion portion 22 and communicates with the tube 231. Thereby, the bag body 232 can be expanded together with the expansion of the expansion part 22, and the surgeon can grasp the expansion state of the expansion part 22 more accurately.
  • the injection port 233 has a check valve inside thereof, and can insert and discharge gas through the connector by inserting a connector such as a syringe.
  • a connector such as a syringe.
  • the check valve at the injection port functions to restrict the injection and discharge of the fluid, so that the expanded portion 22 is kept contracted or expanded.
  • the suction unit 24 includes a tube 241, a suction port 242, and a lid 243.
  • the tube 241 communicates with an opening (not shown) provided on the outer surface of the tube body 21 in the vicinity of the proximal end of the expansion portion 22 via a lumen provided in the tube body 21 separately from the lumen.
  • a suction device (not shown) can be connected to the suction port 242, and liquid or the like in the vicinity of the opening can be sucked through the tube 241 by the suction device.
  • the suction port 242 can be appropriately sealed with a lid 243 when not in use.
  • the fixing member 25 has a plate shape and supports the tube body 21 in the vicinity of the center thereof. On the other hand, a pair of through holes 251 are provided in the vicinity of the end in the longitudinal direction.
  • the catheter 3 includes a shaft 31, a pressing member 32 provided on the outer peripheral surface of the shaft 31, a hub 33 connected to the proximal end side of the shaft 31, and a connecting member 34.
  • the shaft 31 is a tubular member having an inner tube 311 and an outer tube 312 covering the vicinity of the proximal end side of the inner tube 311, and the proximal end side is connected to the hub 33.
  • the distal end side exposed from the outer tube 312 of the inner tube 311 is inserted into the tube main body 21 and used.
  • the inner tube 311 penetrates the tube main body 21 in a state where the catheter 3 and the biological tube indwelling tube 2 are assembled, and the distal end of the inner tube 311 extends from the distal end of the tube main body 21. Exposed.
  • the inner tube 311 of the catheter 3 can guide the tube body 21 when the tube insertion device 1 is inserted into the living body tube.
  • the vicinity of the tip of the inner tube 311 forms an acute angle toward the tip, and is made of a soft material. This facilitates insertion of the inner tube 311 into a puncture hole or the like before expansion, and prevents unintentional damage to living tissue.
  • the inner tube 311 has a lumen 35 penetrating in the axial direction from the distal end to the proximal end to the first port 331 of the hub 33.
  • an instrument such as a guide wire can be inserted.
  • the inner tube 311 includes a lumen (not shown) that penetrates from the second port 332 to the side surface corresponding to the installation position of the pressing member 32.
  • the outer diameter of the inner tube 311 is not particularly limited as long as it can be inserted into the inner cavity 211 of the tube main body 21, but can be set to 1 to 10 mm, for example.
  • the length of the inner tube 311 from the distal end portion of the outer tube 312 is not particularly limited, but is preferably larger than the length of the tube main body 21 and can be, for example, 30 to 400 mm.
  • the length of the inner tube 311 from the distal end portion of the tube main body 21 is not particularly limited, but may be, for example, 1 to 10 mm.
  • the material constituting the shaft 31 is not particularly limited, but a material having moderate flexibility is preferable.
  • examples of the material constituting the shaft 31 include metals and resins.
  • the metal include pseudoelastic alloys (including superelastic alloys) such as Ni—Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt-based alloys, noble metals such as gold and platinum, tungsten-based alloys, carbon-based materials (including Viano wires), and the like.
  • pseudoelastic alloys including superelastic alloys
  • Ni—Ti alloys such as Ni—Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L
  • the resin examples include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, Examples thereof include polymer materials such as polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins or mixtures thereof, or two or more of the above polymer materials.
  • the shaft 31 may be a composite of these metals and resins (for example, a multilayer tube in which a metal and a resin are laminated).
  • the pressing member 32 is disposed so as to cover the outer peripheral surface of the inner tube 311 of the shaft 31.
  • the pressing member 32 is disposed in a region corresponding to the region 212 where the tube body 21 of the biological tube indwelling tube 2 is folded in a state where the catheter 3 and the biological tube indwelling tube 2 are assembled. And as shown to Fig.6 (a), (b), the press member 32 can cancel
  • the pressing member 32 is an expansion body (balloon) that can be expanded and contracted. Then, the pressing member 32 is supplied from a second port 332 of the hub 33 through a lumen (not shown), a fluid such as a liquid such as physiological saline, buffer solution, sterilized water, air, nitrogen, oxygen, carbon dioxide. It expands by injecting gas, such as helium, and can press tube body 21 from the inside.
  • a fluid such as a liquid such as physiological saline, buffer solution, sterilized water, air, nitrogen, oxygen, carbon dioxide. It expands by injecting gas, such as helium, and can press tube body 21 from the inside.
  • the hub 33 is connected to the proximal end side of the shaft 31, and includes a first port 331 provided on the proximal end side and a second port 332 provided on the proximal end side of the second cylindrical member. Have.
  • the first port 331 is a member that communicates with the lumen 35, and a member such as a guide wire can be inserted through the lumen 35 via the first port 331.
  • the second port 332 is a member that communicates with the lumen of the pressing member 32 via a lumen, and a fluid can be introduced into the pressing member 32 via the second port 332.
  • the connecting member 34 is connected to the distal end side of the outer tube 312 of the shaft 31 so as to be rotatable about the longitudinal direction as a rotation axis.
  • the connecting member 34 can be screwed with the tube main body 21, thereby connecting the living tube placement tube 2 and the catheter 3 and fixing the positional relationship. Thereby, also when inserting the tube insertion device 1 into a puncture hole, the positional relationship of the biological tube indwelling tube 2 and the catheter 3 is maintained.
  • thermoplastic resin such as a methacrylate-butylene-styrene copolymer or the like can be used singly or in combination of two or more.
  • the tube insertion device 1 configured to include such a biological tube indwelling tube 2 and the catheter 3 has a region 212 of the tube main body 21 when the puncture hole is inserted. Can be inserted in a folded state. Thereby, even if it is a puncture hole with a comparatively small diameter, the vicinity of the front-end
  • the puncture hole is expanded, by pressing the region 212 of the tube body 21 from the inside by the pressing member 32, the tube body 21 can be expanded and the puncture hole can be expanded simultaneously. Furthermore, the tube body 21 once expanded can be further inserted into the puncture hole as it is, and can be placed in the living tube as the living tube placing tube 2.
  • Such a tube insertion device 1 does not perform a procedure by preparing a separate device for expanding the puncture hole by using the biological tube indwelling tube 2 for expansion (formation) of the puncture hole. For this reason, it is possible to prevent bleeding associated with the removal or attachment of the device used for expanding the puncture hole.
  • the biological tube indwelling tube 2 used for expanding the puncture hole is inserted into the biological tube as it is, an increase in insertion resistance when the biological tube indwelling tube 2 is inserted can be prevented.
  • the biological tube indwelling tube 2 also serves as an expansion function of the puncture hole, a procedure for placing the biological tube indwelling tube 2 becomes simple and easy.
  • tube insertion device 1 mentioned above was demonstrated in detail as an example of the tube insertion device which concerns on the suitable embodiment of this invention, the tube insertion device of this invention is not limited to this, Various deformation
  • FIGS. 7A to 7C are cross-sectional views of a tube insertion device according to another embodiment of the present invention.
  • symbol is attached
  • FIG. Hereinafter, it demonstrates centering around difference with the tube insertion device 1 of 1 A of tube insertion devices, and abbreviate
  • a plurality of folded regions 212A are arranged in the circumferential direction along the longitudinal direction of the tube main body 21A (four regions in this embodiment). Further, a plurality of (four in the present embodiment) extended portions 22A are provided along the circumferential direction in a part of the outer peripheral surface of the tube body 21 in the longitudinal direction. These are housed in the grooves 213A of the tube body 21A formed in the folded regions 212A.
  • the expansion portion 22A is all housed in the groove 213A of the tube main body 21A, so that the insertion resistance when the tube main body 21A is inserted into the living body can be reduced (FIG. 7). (A)).
  • FIG. 7B when the tube main body 21A is expanded, each expansion portion 22A can be exposed to the outer surface of the tube main body 21A.
  • FIG.7 (c) when extending the expansion part 22A, each expansion part 22A functions as one cuff, respectively.
  • each expansion part 22A may be inject
  • the number of the expanded portions and the folded regions in the biological tube indwelling tube can be appropriately changed according to, for example, the shape and size of the biological tube.
  • the folded region of the tube main body only needs to be arranged at a position including at least the arrangement portion of the extended portion. For example, if the vicinity of the distal end of the tube body is sufficiently thin, the tube insertion device can be inserted into a biological tube.
  • FIGS. 8-10 are schematic diagrams illustrating preferred embodiments of the method of the present invention.
  • the method of the present invention is a method of percutaneously inserting a biological tube indwelling tube into a target biological tube, Providing a tube insertion device, wherein the tube insertion device is inserted into a tubular tube body and a living body indwelling tube having an expandable / contractable expansion portion provided on an outer peripheral surface of the tube body, and the lumen of the tube body And a catheter having a pressing member that can be pressed in the circumferential direction, and the tube body has a region folded in the longitudinal direction at a position including at least a portion where the expansion portion is disposed, and contraction of the expansion portion
  • the expansion part is housed in a groove in the tube body formed in the folded region, and the folded region can be expanded by the pressing member when inserted into the lumen of the tube body of the catheter Forming a hole communicating with the living body from the side of the living body; and Inserting the tube body of the tube insertion device into the biological tube through the hole, and placing the folded region of the tube body in contact with the hole
  • the method of the present invention can be applied to any biological tube 100, in the present embodiment, the biological tube 100 will be described as a trachea.
  • the tube insertion device is not particularly limited as long as it is within the scope of the present invention, but in the present embodiment, the tube insertion device 1 described above will be used.
  • a tube insertion device 1 as shown in FIG. 1 is provided.
  • the provided tube insertion device 1 may be appropriately washed and sterilized by a known method.
  • the tube insertion device 1 is preferably coated with a lubricant at a site that comes into contact with the biological tube 100.
  • lubricants include, but are not limited to, gels containing an anesthetic such as lidocaine, mepivacaine, bupivacaine, and ropivacaine, silicone, and the like. Can be used.
  • a hole 101 is formed on the side surface of the biological tube 100 (FIGS. 8A and 8B).
  • This step can be performed, for example, by specifying a position where the hole 101 is to be formed from above the skin by palpation and forming the hole 101 with, for example, a syringe needle.
  • the position where the hole 101 of the living body (trachea) 100 should be formed is, for example, between the tracheal cartilage, preferably between the first tracheal cartilage 102 and the second tracheal cartilage 103 or the second tracheal cartilage 103 and the third. It can be between the tracheal cartilage 104. In this case, the position can be specified by palpating anatomical landmarks such as cricoid cartilage and / or thyroid notches.
  • a hole 101 is formed between the first tracheal cartilage 102 and the second tracheal cartilage 103.
  • the skin is incised.
  • the hole 101 is formed by piercing the side surface of the biological tube 100 with the needle 201 of the syringe 200 as shown in FIG.
  • a liquid such as water
  • the gas leaking from the biological tube 100 can be confirmed as bubbles in the syringe body 202, and the needle 201 has reached the biological tube 100.
  • local anesthesia is appropriately performed using an anesthetic such as lidocaine, mepivacaine, bupivacaine, and ropivacaine.
  • the tube main body 21 of the tube insertion device 1 is inserted into the biological tube 100 through the hole 101, and the folded region 212 of the tube main body 21 is arranged so as to be in contact with the hole 101 of the biological tube 100 (FIG. 8). (B), (c) and FIG. 9 (a)).
  • the guide wire 300 is inserted into the living body tube 100 through the hole 101, and then the tube insertion device 1 is placed along the guide wire 300 along the living body. You may carry out by inserting in the pipe
  • the guide wire 300 may be inserted by any method. With the needle 201 of the syringe 202 inserted into the side surface of the biological tube 100, the syringe body 202 is removed from the needle 201, and the guide wire 300 is inserted into the needle 201. This can be done. After insertion of the guide wire 300, the needle 201 is removed from the biological tube 100.
  • the tube insertion device 1 in which the biological tube indwelling tube 2 and the catheter 3 are combined is inserted into the hole 101 along the guide wire 300. Since the catheter 3 has the lumen 35 in the tube insertion device 1, the tube insertion device 1 can be placed along the guide wire 300 by inserting the guide wire 300 through the lumen 35. In addition, since the inner tube 311 of the catheter 3 having a relatively small diameter is exposed from the distal end side of the tube body 21 near the distal end of the tube insertion device 1, insertion into the hole 101 is relatively easy. In addition, the tube body 21 is folded in the region 212, and the outer diameter is sufficiently small, so that the insertion into the hole 101 is relatively easy.
  • the folded region 212 of the tube body 21 is arranged so as to be in contact with the hole 101 of the biological tube 100.
  • the region 212 that is in contact with the hole 101 is preferably a portion where the expansion portion 22 is not disposed. Thereby, in the step of expanding the hole 101 described later, the expanded portion 22 is prevented from being unintentionally damaged.
  • the tube body 21 is pressed by the pressing member 32 to expand the folded region 212 of the tube body 21 (FIG. 9B).
  • the pressing of the tube body 21 by the pressing member 32 can be performed by expanding the pressing member 32. More specifically, the pressing member 32 is expanded by injecting a fluid into the pressing member 32 from the second port 332 of the catheter 3, thereby expanding the region 212 from the inside of the tube main body 21. Thereby, the folding of the region 212 is canceled, and the region 212 of the tube main body 21 is expanded. And by the diameter expansion of the area
  • the fluid for expanding the hole 101 can be injected, for example, at a pressure of 5 to 15 atm, preferably 8 to 13 atm, for 5 seconds to 1 minute, preferably 8 to 30 seconds.
  • the method of this embodiment changes the position of the tube insertion device 1, and moves the biological tube indwelling tube 2 to the target indwelling position. May further be included.
  • connects the puncture hole 101a of the biological tube 100 is parts other than the area
  • the expansion unit 22 is expanded at a predetermined position in the biological tube 100 (FIG. 10A).
  • the expanded expansion part 22 fixes and supports the tube body 21 in the biological tube 100 as a so-called cuff and prevents reflux aspiration.
  • the said predetermined position means the position where the expansion part 22 should be arrange
  • the expansion of the expansion part 22 can be performed by injecting a fluid from the injection of the injection part 23.
  • the catheter 3 is removed from the biological tube 100 (FIG. 10B). Since the catheter 3 is not in contact with the living body tube 100, the risk of bleeding at the time of removal is low.
  • the removal of the catheter 3 can be performed by releasing the screwing of the connection member 34 with the living body indwelling tube 2 and withdrawing the catheter 3.
  • the removal of the catheter 3 is preferably performed after the pressing member 32 is contracted. Thereby, when the pressing member 32 contracts, the catheter 3 and the biological tube indwelling tube 2 do not come into close contact with each other, and the catheter 3 can be easily removed.
  • treatment such as suturing and disinfection of the incision site is performed as necessary. As described above, it is possible to form the puncture hole 101a in the biological tube 100 and place the biological tube indwelling tube 2 in the biological tube 100 through the puncture hole 101a.
  • a rigid inner tube (not shown) may be inserted into the lumen 211 of the tube body 21 for the purpose of maintaining the shape. Since the wall portion of the tube body 21 is relatively thin, the lumen of the inner tube can be made large enough to secure an airway even when a further inner tube is inserted.
  • the living tube placement tube 2 is used for the expansion (formation) of the puncture hole 101a, so that a separate device is not prepared for the expansion of the puncture hole 101a. For this reason, it is possible to prevent bleeding associated with the removal and removal of the device used for expanding the puncture hole 101a. Moreover, since the biological tube indwelling tube 2 used for the expansion of the puncture hole 101a is inserted into the biological tube 100 as it is, an increase in insertion resistance when the biological tube indwelling tube 2 is inserted can be prevented. Furthermore, since the biological tube indwelling tube 2 also serves as an expansion function of the puncture hole 101a, a procedure for placing the biological tube indwelling tube 2 becomes simple and easy.
  • each step has been described in the description order.
  • the present invention is not limited to this, and the order between steps may be changed as long as no technical contradiction occurs.
  • the step of providing the tube insertion device may be performed after the step of forming the hole, and the step of removing the catheter may be performed prior to the step of expanding the expansion portion. .
  • the device and method of the present invention it is possible to form a puncture hole and insert a biological tube indwelling tube only with a relatively simple procedure, and to perform a biological tube percutaneously with relatively little risk of bleeding or the like.
  • a method of inserting an indwelling tube can be provided.
  • each component can be replaced with any component that can exhibit the same function, or any component can be added.
  • Tube insertion device 2 Biological tube placement tube 21, 21A Tube body 211 Lumen 212, 212A Folded region 213, 213A Groove 22, 22A Expansion part 23 Injection part 231 Tube 232 Bag body 233 Inlet 24 Suction part 241 Tube 242 Suction port 243 Lid 25 Fixing member 251 Through port 3 Catheter 31 Shaft 32 Press member 33 Hub 331 First port 332 Second port 34 Connection member 35 Lumen 100 Biological tube 101 Hole 101a Puncture hole 102 First tracheal cartilage 103 Second tracheal cartilage 104 Third tracheal cartilage 200 Syringe 201 Needle 202 Syringe body 300 Guide wire

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un dispositif d'insertion de tube et un tube à demeure d'organe tubulaire biologique qui présentent un risque relativement faible de provoquer une hémorragie etc., et avec lesquels il est possible de former un trou de ponction et d'insérer ledit tube à demeure d'organe tubulaire biologique simplement au moyen de manipulations relativement simples. Ce dispositif d'insertion de tube (1) comprend les éléments suivants : un tube à demeure d'organe tubulaire biologique (2) incluant un corps de tube tubulaire (21) et une partie d'extension (22) prévue sur la surface périphérique externe du corps de tube (21) ; et un cathéter (3) qui possède un élément de pression (32) et peut être inséré dans la lumière du corps de tube (21). Le corps de tube (21) inclut une région (212) qui est pliée dans la direction longitudinale et qui se trouve dans une position comprenant au moins la section dans laquelle la partie d'extension (22) est située. Tandis que la partie d'extension (22) est contractée, une partie de la partie d'extension (22) est logée à l'intérieur d'une rainure (213) dans le corps de tube (21) qui est formée dans ladite région (212). Ladite région (212) est expansible par le biais de l'élément de pression (32) lorsque le cathéter (3) est inséré dans la lumière du corps de tube (21).
PCT/JP2015/055861 2014-03-20 2015-02-27 Tube à demeure d'organe tubulaire biologique et dispositif d'insertion de tube WO2015141444A1 (fr)

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JP2016508644A JPWO2015141444A1 (ja) 2014-03-20 2015-02-27 生体管留置チューブおよびチューブ挿入デバイス

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JP2014057910 2014-03-20
JP2014-057910 2014-03-20

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0833720A (ja) * 1994-07-22 1996-02-06 Buaayu:Kk 血管内投薬用バルーンカテーテル
JP2008512212A (ja) * 2004-09-09 2008-04-24 オンセット メディカル コーポレイション 拡張可能な経中隔シース
JP2010523222A (ja) * 2007-04-05 2010-07-15 ボストン サイエンティフィック リミテッド バルーンの再折り畳みを促進する内部機構を有するカテーテル

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58108846U (ja) * 1982-01-16 1983-07-25 株式会社　八光電機製作所 カテ−テル固定板
US4701163A (en) * 1984-11-05 1987-10-20 Medical Innovations Corporation Gastrostomy feeding device
JP4119904B2 (ja) * 2005-04-28 2008-07-16 富士システムズ株式会社 医療用カテーテルの固定具

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0833720A (ja) * 1994-07-22 1996-02-06 Buaayu:Kk 血管内投薬用バルーンカテーテル
JP2008512212A (ja) * 2004-09-09 2008-04-24 オンセット メディカル コーポレイション 拡張可能な経中隔シース
JP2010523222A (ja) * 2007-04-05 2010-07-15 ボストン サイエンティフィック リミテッド バルーンの再折り畳みを促進する内部機構を有するカテーテル

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