WO2013122056A1 - Cathéter de dilatation - Google Patents

Cathéter de dilatation Download PDF

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Publication number
WO2013122056A1
WO2013122056A1 PCT/JP2013/053284 JP2013053284W WO2013122056A1 WO 2013122056 A1 WO2013122056 A1 WO 2013122056A1 JP 2013053284 W JP2013053284 W JP 2013053284W WO 2013122056 A1 WO2013122056 A1 WO 2013122056A1
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WO
WIPO (PCT)
Prior art keywords
long
elongated body
lumen
elongate
elongated
Prior art date
Application number
PCT/JP2013/053284
Other languages
English (en)
Japanese (ja)
Inventor
リヤー アラスト
賢一 雲山
達 末原
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2013122056A1 publication Critical patent/WO2013122056A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00082—Balloons
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Definitions

  • the present invention relates to an expansion catheter used for expansion of a stenosis portion formed in a living body.
  • body organs such as the thoracic cavity, abdominal cavity, and nasal cavity
  • tubular organs such as digestive organs and ureteral lumens
  • oxygen and various nutrients are delivered to various parts of the body through these tubular organs.
  • the circulation of oxygen, nutrients, and the like is hindered by a narrowed portion generated in a body cavity or a lumen, each function of the living body is remarkably lowered, and various diseases are caused.
  • sinusitis is known which is caused by a stenosis formed in the natural mouth leading to the nasal cavity.
  • Patent Literature 1 discloses an expansion method in which a balloon catheter is operated under an endoscope and the balloon is aligned with a natural mouth to perform expansion.
  • Patent Document 1 also discloses a method of guiding a balloon catheter to a natural mouth using a plurality of guide members that are curved and bent.
  • an object of the present invention is an dilatation catheter used for dilatation of a stenosis part, and is used for differences in introduction routes for introducing an dilator that dilates the stenosis part in a living body and individual differences in anatomical structures for each patient. Nevertheless, it is an object of the present invention to provide an dilatation catheter that can accurately and easily guide an expansion body to a stenosis.
  • a first elongated body that is flexible and can be introduced into a living body in which a lumen extending in the axial direction is formed;
  • the outer shape of the first elongated body is provided in the first elongated body, and the outer shape of the first elongated body is bent in a direction in which at least a part of the first elongated body intersects the axial direction in the living body. Holding part to hold;
  • a second elongate body comprising an expandable extension body and an imaging unit for acquiring an image, the second elongate body being movable in the lumen of the first elongate body whose outer shape is held by the holding unit;
  • a dilatation catheter comprising an expandable extension body and an imaging unit for acquiring an image, the second elongate body being movable in the lumen of the first elongate body whose outer shape is held by the holding unit.
  • the second long body has a long main body portion in which a plurality of bent portions serving as starting points of bending in a direction crossing the axial direction are provided at different positions in the axial direction. ) Or the dilatation catheter according to (2) above.
  • a movement operation unit for operating movement of the second elongated body in the lumen of the first elongated body; Any one of the above (1) to (4), further comprising: an adjustment unit that adjusts a protruding length of the second elongated body projecting from a tip opening communicating with the lumen of the first elongated body.
  • the first elongated body included in the dilatation catheter can be shaped when introduced into the living body.
  • the 2nd elongate body to which the expansion body was attached can be movably inserted in the lumen of the 1st elongate body, maintaining the external shape of the 1st elongate body in the living body. .
  • the expansion body can be accurately and easily guided to the stenosis part regardless of the difference in the introduction route to the stenosis part for each living organ and the individual difference of the anatomical structure for each patient.
  • the first long body When a long metal member and / or a long resin member is used as a holding portion for holding the outer shape of the first long body, the first long body having flexibility is used. A function capable of maintaining the outer shape can be easily and inexpensively added. Further, when a long metal member and / or a long resin member is used as the holding portion, the first long body has a three-dimensionally curved or bent shape in a direction crossing the axial direction. The outer shape can be maintained. In particular, when a long resin member is used as the holding portion, it is possible to reduce the weight of the first long body as compared with a case where a metal member is used.
  • the second elongated body When a movement operation unit for operating the movement of the second elongated body is provided, the second elongated body can be easily moved manually within the insertion lumen of the first elongated body. Can do.
  • the tip of the second long body is Since excessive protrusion is prevented, a dilatation catheter with improved safety can be provided.
  • FIG. 1 It is a figure for demonstrating the usage example of a dilatation catheter, (A) is a figure which shows the state which introduce
  • FIGS. 8A and 8B are diagrams showing another modification of the second elongated body.
  • FIG. 1 is a block diagram showing the overall configuration of the medical system 10.
  • the medical system 10 used for expanding a stenosis portion formed in a living body is a first elongated body that can be introduced into a living body. 110 (see FIG. 2) and a balloon catheter 100 (corresponding to a dilatation catheter) comprising a second elongated body 120 (see FIG. 3) used with the first elongated body 110.
  • the second elongate body 120 includes a balloon 130 as an expansion body and an imaging unit 140 that can acquire an in-vivo image.
  • the balloon catheter 100 is provided with a hand operating unit 101 disposed on the proximal end side of the first elongated body 110 and the second elongated body 120.
  • the hand operating unit 101 can be used as a gripping unit that is gripped when the practitioner uses the balloon catheter 100.
  • the medical system 10 further includes a pressure supply device 20, a liquid feeding device 30, a suction device 40, a light source device 50, and a display device 60 connected to the balloon catheter 100.
  • the pressure supply device 20 is, for example, an indeflator, a syringe, or a pump.
  • the pressure supply device 20 is liquid-tight and air-tightly connected to a balloon 130 provided in the second elongated body 120.
  • the pressure supply device 20 and the balloon 130 are connected via a known fluid tube 21 (see FIG. 3).
  • the pressure supply device 20 supplies a pressurized medium such as physiological saline or a contrast medium to the inside of the balloon 130 to expand the balloon 130 into a predetermined shape. Further, the pressure supply device 20 discharges the pressurized medium from the inside of the balloon 130 and contracts the balloon 130.
  • the liquid feeding device 30 is, for example, an inflator, a syringe, or a pump.
  • the liquid feeding device 30 sends a fluid such as physiological saline to the front side of the second elongated body 120. This makes it possible to acquire a clear image by cleaning the imaging surface (not shown) located at the tip of the imaging unit 140.
  • the liquid feeding device 30 is connected in a liquid-tight and air-tight manner to a liquid feeding / suction lumen 113 provided in the first elongated body 110.
  • the liquid feeding device 30 and the liquid feeding / suction lumen 113 are connected via a known fluid tube 31 (see FIG. 2).
  • the fluid tube 31 coupled to the liquid feeding device 30 is branched by the connector 32 and coupled to the suction device 40.
  • the suction device 40 is, for example, a deflator, a syringe, or a pump.
  • the suction device 40 sucks bodily fluids, secretory fluids, and the like in the living body via the liquid feeding / suction lumen 113 provided in the first elongated body 110.
  • the imaging surface of the imaging unit 140 included in the second elongated body 120 together with the liquid feeding device 30 is washed, and a clear image can be acquired.
  • it is also possible to perform cleaning of each part of the living body by alternately performing the supply of the cleaning fluid by the liquid feeding device 30 and the suction of the cleaning fluid by the suction device 40.
  • the light source device 50 is used for generating light emitted from the distal end side of the second elongated body 120.
  • the light source device 50 is connected to an optical fiber 51 disposed inside the second long body 120, and the light generated by the light source device 50 passes through the second long body 120 via the optical fiber 51. (See FIG. 3).
  • the display device 60 is used to display an image acquired by the imaging unit 140 included in the second elongated body 120.
  • the display device 60 is configured by, for example, a PC (personal computer) display.
  • the imaging unit 140 and the display device 60 are connected to each other via an electric cable 61 for transmitting and receiving an electric signal (see FIG. 3).
  • FIG. 2 is a cross-sectional view showing a main part of the first elongated body 110 provided in the balloon catheter 100. As shown in FIG.
  • the first elongated body 110 has a lumen 111 (hereinafter simply referred to as an insertion lumen) that extends in the axial direction and can be inserted through the second elongated body 120, and a liquid feed A suction lumen 113 is provided.
  • a lumen 111 hereinafter simply referred to as an insertion lumen
  • the distal end opening 115 provided at the distal end of the insertion lumen 111 can be formed in a shape that gradually increases in diameter toward the distal end side as shown in the figure.
  • the tip opening provided at the tip of the liquid feeding / suction lumen 113 can also be formed in a shape that gradually increases in diameter toward the tip.
  • the tip opening 115 of the first elongate body 110 and the tip opening provided at the tip of the liquid feeding / suction lumen 113 may have a shape other than the enlarged shape as illustrated, for example, a straight shape. It can also be formed.
  • the first elongate body 110 is preferably made of a material having a predetermined flexibility in consideration of operability in the living body.
  • materials include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, soft polyvinyl chloride resin, polyamide, Polyamide elastomer, polyester, polyester elastomer, polyurethane, thermoplastic resin such as fluororesin, silicone rubber, latex rubber, etc. can be used.
  • the first long body 110 is provided with a holding portion 150 for holding the outer shape of the first long body 110 in a predetermined shape in the living body.
  • the holding part 150 is configured by a long metal member and / or a long resin member included in the first long body 110.
  • a metal member and / or the long resin member for example, a hollow tubular member or the like can be used in addition to a solid bar as illustrated.
  • a plurality of long members can be juxtaposed in the axial direction or in a direction intersecting with the shaft to form one long member as a whole.
  • the long metal member constituting the holding unit 150 for example, a bar made of a soft metal such as copper, brass, or brass can be used.
  • polyethylene can be used as the long resin member constituting the holding unit 150.
  • a known resin member made of polyethylene to which plastic deformability is added can be used for the holding portion 150.
  • the holding part 150 can be entirely constituted by only a metal member or a resin member, or a material in which a part in the longitudinal direction and a part in the circumferential direction are partially different by using the metal member and the resin member together. It can also consist of things.
  • the rigidity of the holding unit 150 is such that the first elongated body 110 introduced into the living body is bent into a predetermined curved shape (an outer shape in which at least a part of the first elongated body intersects the axial direction). ) Is set to such a size that it can be held. Accordingly, the rigidity of the holding portion 150 is set to be at least larger than the rigidity of the first long body 110. In addition to this, it is preferable that the first elongate body 110 has a rigidity that allows the first elongate body 110 to be shaped by a simple manual operation. For example, the rigidity of the holding portion 150 is set to about 50 to 150 Hv. .
  • the rigidity of the first elongate body 110 can be set in a range having rigidity smaller than the rigidity included in the holding unit 150.
  • the tip of the holding part 150 may be formed in a tapered shape, or the diameter of the holding part 150 may be partially thinned or thickened.
  • the “long shape” included in the holding unit 150 in the present embodiment is a shape that extends in the direction in which the first long body 110 extends.
  • the first long body 110 can be deformed into a bent shape in an arbitrary direction that intersects the axial direction and can be held in that shape.
  • the holding unit 150 prevents the first long body 110 from being excessively bent when the first long body 110 is bent. For this reason, it can prevent that the 1st elongate body 110 fractures
  • the holding portion is included in the first long body
  • the holding portion 150 is disposed in a predetermined lumen formed inside the first long body 110.
  • buried in the wall of the 1st elongate body 110 is contained. In other words, it means that the holding unit 150 is covered with the first elongated body 110 without being exposed to the outside.
  • the first elongate body 110 includes a hand portion 151 made of a metal bar made of a material having a rigidity higher than that of the holding portion 150.
  • the proximal portion 151 is disposed on the proximal end side with respect to the holding portion 150 and improves the pushability of the balloon catheter 100 and prevents the holding portion 150 from being kinked.
  • the hand portion 151 is made of, for example, iron, stainless steel, a hard resin material, or the like that has rigidity greater than the rigidity of the holding portion 150. As shown in the drawing, it is possible to integrally form the holding portion 150 and the hand portion 151 by joining two metal rods having different rigidity.
  • FIG. 3 is a cross-sectional view showing a main part of the second elongated body 120 provided in the balloon catheter 100.
  • the second elongate body 120 is disposed so as to cover a main body portion 121 constituted by a long coil, a cover material 122 disposed so as to cover the main body portion 121, and a part of the cover material 122.
  • the outer tube 123, the balloon 130 attached so as to partition the inner space 131 into which the pressurized medium is introduced between the cover member 122 and the outer tube 123, and the fluid tube 21 in the inner space 131 of the balloon 130.
  • a port 124 provided for communicating the imaging unit 140 and the optical fiber 51 fixed to the tip chip 126.
  • the second elongate body 120 When the constriction is expanded by the balloon catheter 100, a predetermined portion on the distal end side of the second elongate body 120 is inserted into the insertion lumen 111 of the first elongate body 110 (see FIG. 2).
  • the second elongate body 120 is configured to be movable in the lumen 111 of the first elongate body 110 shaped by the holding portion 150. Therefore, the practitioner can position and arrange the balloon 130 included in the second elongated body 120 by the first elongated body 110 in the stenosis (see FIG. 6A).
  • the first elongate body 110 has a function as a guide member that guides the second elongate body 120 to the stenosis part, and the second elongate body 120 serves as an expansion device for expanding the stenosis part. It has a function.
  • the coil constituting the main body 121 of the second elongated body 120 is formed by winding a metal wire.
  • the coil is compressed in the axial direction in accordance with the pushing and pulling. Elongate.
  • the insertion lumen 111 is caused by the pushability generated by the elasticity of the coil.
  • the second elongate body 120 can be pushed into the curved part.
  • a part of the main body 121 of the second elongated body 120 is closely attached to the inner surface of the insertion lumen 111, and a part of the main body 121 of the second elongated body 120 is It is separated from the inner surface of the insertion lumen 111.
  • the second elongated body 120 is further pushed in this state, the second elongated body 120 is compressed in a state in which a part of the main body 121 of the second elongated body 120 is in close contact with the inner surface of the insertion lumen 111. Or it moves in the lumen 111 of the first elongate body 110 while extending.
  • the second elongated body 120 is made to follow the shape of the insertion lumen 111 of the first elongated body 110.
  • the body 120 can be moved. Therefore, good pushability can be obtained by using a coil for the main body 121 of the second long body 120, and the insertion lumen 111 of the first long body 110 whose shape is held by the holding portion 150.
  • the second elongate body 120 can be smoothly moved inside.
  • the 2nd elongate body 120 can also move the inside of the insertion lumen
  • the main body 121 of the second long body 120 has a lumen 127 formed in the axial direction.
  • an imaging unit 140 an electric cable 61 connected to the imaging unit 140, and an optical fiber 51 that emits light that illuminates the front of the second elongated body 120 during imaging by the imaging unit 140 are arranged. .
  • the imaging unit 140 is provided for acquiring an image at an arbitrary position in the living body, and for example, a CCD camera is used.
  • the imaging unit 140 includes precision devices such as an optical system element such as a camera lens and a light receiving element, and a circuit element for generating and transmitting and receiving various signals during imaging. Moreover, a metal protective member for preventing breakage of these elements and the like is appropriately provided.
  • the imaging unit 140 is not limited to a CCD camera, but a digital video camera using another imaging element such as a CMOS image sensor, an image fiber that acquires an image and transmits an image using an optical fiber. It may be an imaging system that performs image transmission using a fiberscope, an objective lens, and a plurality of relay lens optical systems.
  • the arrangement form of the image fiber and the relay lens optical system, the installation position of the eyepiece provided with the eyepiece and the eyepiece, and the like are not particularly limited as long as imaging is possible.
  • it can be incorporated into the second elongate body 120 after changing according to each specification.
  • the distal tip 126 seals the lumen 127 of the main body 121 of the second elongated body 120 on the distal end side, and further connects the imaging unit 140 and the optical fiber 51 to the main body 121 of the second elongated body 120.
  • Provided to fix for the tip chip 126, for example, hard rubber or the like is used.
  • the cover material 122 is used to form the internal space 131 of the balloon 130 attached to the outer peripheral portion of the second elongated body 120. By covering the coil with the cover material 122, the flow of the pressurized medium into the lumen 127 of the coil is prevented.
  • the cover material 122 for example, a tubular member made of a resin material formed relatively thin can be used.
  • the port 124 has an insertion port 125 for inserting the fluid tube 21.
  • the fluid tube 21 is drawn into the port 124 through the insertion port 125 and communicates with the internal space 131 defined between the cover member 122 and the balloon 130.
  • the port 124 is for partially sealing the lumen 127 of the main body 121 of the second elongated body 120 to partition a sealed space that prevents leakage of the pressurized medium.
  • the port 124 is made of, for example, hard plastic.
  • the balloon 130 is provided so as to be expandable by injecting a pressurized medium into the internal space 131.
  • the balloon 130 includes an expansion effective part 132 that is pressed against the stenosis part to expand the stenosis part formed in the living body, a taper part 133 that is continuous with the distal end side of the expansion effective part 132, and a taper part that is continuous with the base end side. 134.
  • the taper portion 134 on the proximal end side is formed in a taper shape that is inclined to the same extent as the taper portion 133 on the distal end side, or a taper shape that is more gently inclined than the taper portion 133 on the distal end side as shown in FIG. can do.
  • the balloon into the insertion lumen 111 through the distal end opening 115 of the first elongated body 110. 130 can be smoothly pulled in (see FIG. 4B).
  • Balloon 130 preferably has a high pressure resistance so as not to burst when inflated, and can be formed of, for example, polyamide, polyethylene terephthalate, high-density polyethylene, nylon elastomer, polyether elastomer, or the like.
  • the portion of the second elongated body 120 where the balloon 130 is disposed is partially increased in rigidity by the balloon 130 and the cover material 122.
  • the rigidity at the portion is, for example, the holding portion of the first elongated body 110. If the rigidity is greater than 150, the portion where the balloon 130 of the second elongated body 120 is disposed may not be smoothly moved within the lumen 111 of the first elongated body 110. . In order to prevent this, the rigidity of the second elongated body 120 can be partially adjusted.
  • the winding interval of the coil in the portion where the balloon 130 of the second elongated body 120 is disposed is formed in a relatively large sparse state, and the other portion is the coil winding.
  • a method of forming the gap in a relatively narrow space, a method of partially varying the outer diameter of the coil, a method of partially varying the diameter of the coil wire itself, and the like can be employed.
  • the outer tube 123 can be formed to have flexibility.
  • the outer tube 123 is made of, for example, polyolefin such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, soft polyvinyl chloride resin, polyamide, Polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin, acrylic resin and other thermoplastic resins, silicone rubber, latex rubber and the like can be used.
  • polyolefin such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof
  • soft polyvinyl chloride resin polyamide, Polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin, acrylic resin and other
  • the first elongated body 110 and the second elongated body 120 are assembled by inserting the distal end side of the second elongated body 120 into the insertion lumen 111 of the first elongated body 110.
  • the insertion is performed, and the proximal end side of the first elongated body 110 and the proximal end side of the second elongated body 120 are accommodated in the hand operation unit 101.
  • tip part of the 2nd elongate body 120 is formed in the dimension of 3 mm or less, for example, in consideration of the introductory property in the living body.
  • the balloon catheter 100 includes a movement operation unit 160 for operating the movement of the second elongated body 120 in the insertion lumen 111 of the first elongated body 110, and the insertion lumen 111 of the first elongated body 110. It further has an adjustment portion 170 that adjusts the protruding length by which the second elongated body 120 protrudes from the communicating tip opening 115.
  • the movement operation part 160 is connected to the base part 161 via the base part 161 attached to the coil constituting the main body part 121 of the second elongated body 120, the connection part 162 extending from the base part 161, and the connection part 162. And a grip portion 163.
  • the second elongated body 120 can be moved in conjunction with the movement of the gripping portion 163 by moving the gripping portion 163 in the front-rear direction (indicated by an arrow in FIG. 4B).
  • the adjustment part 170 can be comprised by the edge part 103 of the front end side of the opening part 102 provided in the hand operation part 101, and the edge part 104 of a base end side so that it may show in figure.
  • the opening 102 is provided to position the grip 163 of the movement operation unit 160 outside the hand operation unit 160.
  • the connecting portion 162 connected to the grip portion 163 is connected to the end portion 103 on the distal end side or the proximal end side of the opening portion 102. It abuts against the end 104. Thereby, the movement of the 2nd elongate body 120 can be controlled. By restricting the movement of the long body 120, it is possible to adjust the protruding length of the second long body 120 protruding from the tip opening 115 of the first long body 110.
  • the display function of the movement amount may be added to the balloon catheter 100 by attaching a scale indicating the movement amount of the second elongated body 120 in the vicinity of the opening 102 of the hand operation unit 101.
  • a scale indicating the movement amount of the second elongated body 120 in the vicinity of the opening 102 of the hand operation unit 101.
  • the movement operation part 160 is rotated and the first is accompanied by this rotation. It is also possible to adopt a configuration in which the two long bodies 120 are moved. In this case, a gear or the like that converts the rotation of the movement operation unit 160 into the forward / backward movement of the second elongated body 120 is appropriately used.
  • FIG. 5A is a view showing a state in which the balloon catheter 100 travels in the nasal cavity
  • FIG. 5B is a view showing a state in which the balloon 130 of the balloon catheter 100 is guided to the vicinity of the natural mouth E
  • FIG. FIG. 6B is a diagram showing a state in which the dilation effective portion 132 of the balloon 130 is aligned with the constriction S of the natural mouth E
  • FIG. 6B is a diagram showing a state in which the constriction S of the natural mouth E is pushed and expanded by the balloon 130. It is.
  • the balloon catheter 100 Prior to introducing the balloon catheter 100 into the living body, the balloon catheter 100 is shaped.
  • the shaping can be performed, for example, manually by an operator.
  • the shaping is performed by deforming the first elongated body 110 into an arbitrary shape according to the anatomical shape up to the sinus A.
  • the holding portion 150 is constituted by a long metal member and / or a long resin member, for example, the balloon catheter 100 has a three-dimensionally curved or bent shape in a direction intersecting the axial direction.
  • the overall shape can be changed.
  • shaping is performed in a state where the second elongated body 120 is inserted into the insertion lumen 111 of the first elongated body 110, according to the deformation of the outer shape of the first elongated body 110
  • the outer shape of the second elongated body 120 is also temporarily deformed.
  • the balloon catheter 100 is introduced into the nasal cavity N while maintaining the shaped outer shape.
  • the introduction route and introduction position of the balloon catheter 100 in the living body can be confirmed at any time based on the image taken by the imaging unit 140 arranged in the distal end opening 115 of the second elongated body 110.
  • a suction operation by the suction device 40 can be performed. By performing suction, it is possible to prevent body fluid and secretions from adhering to the tip of the imaging unit 140, so that a clearer image can be acquired.
  • the distal end side of balloon catheter 100 is introduced to the vicinity of natural mouth E while performing suction by suction device 40.
  • the second elongated body 120 is projected from the first elongated body 110, and the second elongated body 120 is projected.
  • the expansion effective part 132 of the balloon 130 provided on the stenosis part S is positioned.
  • the alignment is performed, for example, by confirming the entrance of the sinus A located in front of the natural mouth E by an image captured by the imaging unit 140.
  • the balloon 130 is expanded.
  • the constriction S formed in the natural mouth E can be pushed and expanded.
  • the balloon catheter 100 is taken out from the living body.
  • the outer shape of the balloon catheter 100 can be returned to the original shape before the shaping, or can be transformed into a different outer shape.
  • the balloon catheter 100 can be shaped into an outer shape corresponding to the introduction route and the introduction angle each time. .
  • the first elongated body 110 provided in the balloon catheter 100 can be shaped.
  • the second elongated body 120 to which the balloon 130 is attached can be moved into the insertion lumen 111 of the first elongated body 110 while holding the outer shape of the first elongated body 110 in the living body. It can be inserted.
  • the balloon 130 can be accurately and easily guided to the stenosis part regardless of the difference in the introduction route to the stenosis part for each living organ and the individual difference of the anatomical structure for each patient.
  • the first long member and / or a long resin member When a long metal member and / or a long resin member is used as the holding portion 150 for holding the outer shape of the first long body 110, the first long member having flexibility is used. A function capable of retaining the outer shape of the scale body 110 can be easily and inexpensively added. Further, when a long metal member and / or a long resin member is used as the holding portion 150, the first long shape is curved or bent three-dimensionally in a direction crossing the axial direction. The outer shape of the body 110 can be held. In particular, when a long resin member is used as the holding portion 150, the first long body 110 can be reduced in weight compared to a case where a metal member is used.
  • the main body 121 of the second elongate body 120 When a coil is used for the main body 121 of the second elongate body 120, good pushability can be obtained, and the insertion lumen 111 of the first elongate body 110 whose shape is held by the holding portion 150.
  • the second elongate body 120 can be smoothly moved inside.
  • the movement operation unit 160 for operating the movement of the second long body 120 When the movement operation unit 160 for operating the movement of the second long body 120 is provided, the movement of the second long body 120 in the insertion lumen 111 of the first long body 110 is manually performed. It can be done easily. Moreover, when providing the adjustment part 170 which adjusts the protrusion length which the 2nd elongate body 120 protrudes from the front-end
  • ⁇ Modification> 7 and 8 are diagrams showing modifications of the second elongated body.
  • a coil is used for the main body portion of the second long body, but the configuration of the main body portion of the second long body is the insertion of the shaped first long body. It can be changed as long as the second elongated body can move in the lumen.
  • the main body of the second elongated body is a long body in which a plurality of bent portions serving as starting points for bending in the direction intersecting the axial direction are provided at different positions in the axial direction. It can be constituted by a shaped member.
  • the second long body 220 shown in FIG. 7 (A) has a main body portion 221 formed of a tubular member having a plurality of slits 222 formed in a direction crossing the axial direction.
  • Each of the slits 222 constitutes a bent portion that bends the main body portion 221 in a direction intersecting the axial direction.
  • each slit 222 becomes a starting point of bending.
  • each part of the second elongated body 220 is bent.
  • the entire second long body 220 can be deformed into a curved shape, so that the second long body 220 is moved following the shape of the insertion lumen 111 of the first long body 110. be able to.
  • the hollow portion 223 included in the main body 221 of the second long body 220 can be used as a lumen for arranging the imaging unit 140 and the optical fiber 51.
  • the coil itself is extended when the coil is pulled in the insertion lumen 111, so that the tensile force can be transmitted to the entire coil.
  • the second elongated body 120 may not be smoothly moved in the insertion lumen 111.
  • a long member having a plurality of bent portions shown in the present modification is used for the main body portion 221 of the second long body 220, it does not stretch like a coil even when pulled. The pulling force can be sufficiently transmitted to the entire main body 221.
  • rumen 111 of the 1st elongate body 110 can be performed much more smoothly.
  • the point which can obtain favorable pushability when pushing in the main-body part 221 and moving the inside of the insertion lumen 111 is the same as the case where a coil is used.
  • FIG. 8 shows another modification of the main body of the second elongated body.
  • a tubular member having a groove 224 provided on the outer surface can be used for the main body 221 of the second elongate body 220.
  • Each of the grooves 224 constitutes a bent portion that bends the main body portion 221 in a direction crossing the axial direction.
  • each groove 224 becomes a starting point of bending, so that the entire second elongate body 220 is deformed into a curved shape. To do. Thereby, the 2nd elongate body 220 can be moved following the shape of the insertion lumen
  • channel 224 is formed in the 2nd elongate body 220 are not limited to the form shown in figure.
  • a tubular member constituted by a plurality of tubular members 225 connected to each other so as to be able to swing can be used for the main body 221 of the second elongated body 220.
  • Each of the connection portions 226 that connect the cylindrical members 225 constitutes a bent portion that bends the main body portion 221 in a direction that intersects the axial direction.
  • each cylindrical member 225 swings (indicated by an arrow in the figure) via the connection portion 226, so that the second The entire long body 220 is deformed into a curved shape. Thereby, the 2nd elongate body 220 can be moved following the shape of the insertion lumen
  • FIG. the connection method of each cylindrical member 225 is not specifically limited, For example, the method of connecting each cylindrical member 225 so that rotation is possible, respectively using a well-known member, such as a pin-shaped support member and a rivet, is employ
  • the constituent material of the main body 221 of the second elongate body 220 in each modification shown in FIGS. 7 and 8 is such that the second elongate body 220 moves within the insertion lumen 111 of the first elongate body 110.
  • a metal material, a resin material, or the like can be used.
  • the attachment of the cover material 122 which prevents the leakage of the pressurized medium from the 2nd elongate body 220 is abbreviate
  • the balloon catheter 100 is used for the procedure for expanding the stenosis portion formed in the natural mouth leading to the sinuses, but the target site using the balloon catheter is not limited thereto.
  • the purpose is to expand the constriction formed in the living body, it can be used for each organ of the living body, for example, body cavities such as thoracic cavity, abdominal cavity and nasal cavity, and lumens such as digestive organs and ureters. You may use for.
  • the holding portion provided in the first long body can be changed as long as the outer shape of the first long body can be held.
  • maintenance part is not limited only to such a form.
  • the holding portion can be configured so that the inside and outside of the first long body can be moved by an operation at hand, and a part of the holding portion is exposed from the first long body. It can also be configured as follows.
  • the second elongate body can be changed as long as it can move within the insertion lumen of the first elongate body, for example, a spring material that ensures followability in the insertion lumen, You may comprise by the resin-made tubes etc. with which the metal braid
  • the expansion body is not limited to the balloon, but can be changed as long as it can be expanded and deformed in the living body to apply a pressing force to the stenosis.
  • a stent-type expansion body having a shape memory that expands and deforms as it protrudes from the distal end opening of the first long body may be used.

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Abstract

　L'invention concerne un cathéter de dilatation permettant, indépendamment des différences individuelles dans la structure anatomiques des patients et des disparités des voies d'introduction, d'insérer un corps de dilatation destiné à dilater une partie rétrécie dans un organisme vivant, ainsi que de guider facilement et de façon précise le corps de dilatation vers la partie rétrécie. Pour ceci, un cathéter à ballonnet (100) flexible comporte: un premier corps allongé (110) pouvant être introduit à l'intérieur d'un organisme vivant et dans lequel un conduit d'insertion (111) s'étendant en direction radiale a été formé; une partie de maintien (150) située à l'intérieur du premier corps allongé, qui maintient la forme extérieure du premier corps allongé (110) à l'intérieur d'un organisme vivant, au moins une partie de ce premier corps allongé (110) étant incurvée dans une direction croisant la direction axiale; un deuxième corps allongé (120) possédant un ballonnet (130) et une partie de capture d'images (140), et pouvant se déplacer à l'intérieur du conduit d'insertion (111) du premier corps allongé (110) dont la forme extérieure est maintenue par la partie de soutient (150).
PCT/JP2013/053284 2012-02-13 2013-02-12 Cathéter de dilatation WO2013122056A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012028851A JP2015083021A (ja) 2012-02-13 2012-02-13 拡張カテーテル
JP2012-028851 2012-02-13

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WO2013122056A1 true WO2013122056A1 (fr) 2013-08-22

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016160815A1 (fr) * 2015-03-30 2016-10-06 Acclarent, Inc. Cathéter à ballonnet doté de caractéristiques de capture d'image et d'émission de lumière
CN106999302A (zh) * 2014-09-11 2017-08-01 阿克拉伦特公司 小外型咽鼓管扩张系统
US9955852B2 (en) 2015-03-30 2018-05-01 Acclarent, Inc. Guide catheter with image capture and light emission features

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101802317B1 (ko) 2016-11-25 2017-11-29 (의료)길의료재단 굽힘각과 풍선 위치 조절이 가능한 부비동용 풍선 카테터

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005056100A1 (fr) * 2003-12-15 2005-06-23 Terumo Kabushiki Kaisha Ensemble de catheter
WO2011033938A1 (fr) * 2009-09-15 2011-03-24 テルモ株式会社 Cathéter

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005056100A1 (fr) * 2003-12-15 2005-06-23 Terumo Kabushiki Kaisha Ensemble de catheter
WO2011033938A1 (fr) * 2009-09-15 2011-03-24 テルモ株式会社 Cathéter

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106999302A (zh) * 2014-09-11 2017-08-01 阿克拉伦特公司 小外型咽鼓管扩张系统
WO2016160815A1 (fr) * 2015-03-30 2016-10-06 Acclarent, Inc. Cathéter à ballonnet doté de caractéristiques de capture d'image et d'émission de lumière
US20160287059A1 (en) * 2015-03-30 2016-10-06 Acclarent, Inc. Balloon catheter with image capture and light emission features
CN107708519A (zh) * 2015-03-30 2018-02-16 阿克拉伦特公司 具有图像捕获和发光特征的球囊导管
US9931026B2 (en) 2015-03-30 2018-04-03 Acclarent, Inc. Balloon catheter with image capture and light emission features
JP2018510018A (ja) * 2015-03-30 2018-04-12 アクラレント インコーポレイテッドＡｃｃｌａｒｅｎｔ， Ｉｎｃ． 画像取り込み機構及び発光機構を備えるバルーンカテーテル
US9955852B2 (en) 2015-03-30 2018-05-01 Acclarent, Inc. Guide catheter with image capture and light emission features
US10687690B2 (en) 2015-03-30 2020-06-23 Acclarent, Inc. Guide catheter with image capture and light emission features
CN107708519B (zh) * 2015-03-30 2020-08-07 阿克拉伦特公司 具有图像捕获和发光特征的球囊导管

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