WO2018151204A1 - Corps allongé médical - Google Patents

Corps allongé médical Download PDF

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Publication number
WO2018151204A1
WO2018151204A1 PCT/JP2018/005228 JP2018005228W WO2018151204A1 WO 2018151204 A1 WO2018151204 A1 WO 2018151204A1 JP 2018005228 W JP2018005228 W JP 2018005228W WO 2018151204 A1 WO2018151204 A1 WO 2018151204A1
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WO
WIPO (PCT)
Prior art keywords
balloon
groove
intermediate region
layer
groove portion
Prior art date
Application number
PCT/JP2018/005228
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English (en)
Japanese (ja)
Inventor
鈴木　健太
Original Assignee
テルモ株式会社
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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 WO2018151204A1 publication Critical patent/WO2018151204A1/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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a medical long body.
  • a balloon catheter (medical long body) is known as a medical instrument used to expand a lesion (stenosis, etc.) formed in a body lumen such as a blood vessel or to place a stent or the like in a lesion.
  • the balloon catheter has a shaft (catheter body) and a balloon that is provided on the distal end side of the shaft and expands in the radial direction of the shaft when fluid is injected through the lumen of the shaft.
  • the balloon in an expanded state, has an intermediate region that contacts the living body lumen wall, a distal-side inclined region that extends from the distal end of the intermediate region to the distal side, and a proximal-side inclined region that extends from the proximal end to the proximal side of the intermediate region And having.
  • the balloon catheter is introduced from the puncture site into the living body lumen via the introducer sheath, guiding catheter, etc., and delivered to the lesioned part.
  • the balloon catheter preferably has a smaller frictional resistance between the outer surface of the balloon and the living body lumen wall.
  • the frictional resistance between the outer surface of the balloon and the living body lumen wall is large in order to suppress displacement in the axial direction of the balloon. .
  • the surface of the tip side inclined region and the base end side inclined region of the balloon is given lubricity
  • a balloon catheter that is not lubricated on the surface of the intermediate region of the balloon that contacts the lumen wall is known (see, for example, Patent Document 1).
  • the present invention has been made in view of the above-described problems, and when the balloon is expanded at the lesion, the occurrence of slippage between the outer surface of the balloon and the body lumen wall is suppressed, and the axial direction of the balloon
  • An object of the present invention is to provide a medical elongate body that can prevent a positional shift to the position.
  • a medical elongated body of the present invention is provided on the distal end side of a catheter body and the catheter body, and fluid is injected through the lumen of the catheter body, A balloon that expands radially.
  • the balloon has an outer surface formed of a hydrophobic resin and an intermediate region in contact with a living body lumen wall in a state where the balloon is expanded, and a distal end side extending from the distal end of the intermediate region to the distal end side An inclined region, and a proximal-side inclined region extending from the proximal end of the intermediate region to the proximal end side.
  • the intermediate region includes a groove portion in which the outer surface of the balloon is recessed.
  • the groove portion has a hydrophilic coating formed on the surface forming the groove portion.
  • the medical elongated body according to the present invention when the balloon is expanded and the middle region of the balloon comes into contact with the living body lumen wall, the water present between the outer surface of the balloon and the living body lumen wall is It is guided from the outer surface of the balloon formed of a hydrophobic resin having a low affinity for moisture toward the groove where the hydrophilic coating having a high affinity for moisture is formed. Therefore, the medical elongate body according to the present invention can reduce the amount of moisture existing between the outer surface of the balloon and the living body lumen wall when the balloon is expanded. Therefore, the medical elongated body according to the present invention suppresses the occurrence of slipping between the outer surface of the balloon and the living body lumen wall when the balloon is expanded at the lesion, Misalignment can be prevented.
  • FIG. 1A is a view showing a balloon catheter according to an embodiment of the present invention
  • FIG. 1B is an enlarged cross-sectional view of a portion indicated by a broken line portion 1B in FIG. 1A
  • 2A is a plan view of the balloon of the balloon catheter according to the embodiment
  • FIG. 2B is an enlarged cross-sectional view of a portion indicated by a broken line portion 2B in FIG. 1A
  • FIG. 3A is a cross-sectional view of a balloon of the balloon catheter according to the embodiment
  • FIG. 3A is a cross-sectional view of the balloon in a deflated state
  • FIG. 3B is a cross-sectional view of the balloon in an expanded state. .
  • FIG. 4A is an enlarged cross-sectional view of a portion indicated by a broken line portion 4A in FIG. 3B
  • FIG. 4B is an enlarged view of a portion indicated by a broken line portion 4B in FIG. 2A.
  • FIG. 5 (A) is a view for explaining the action of the balloon catheter according to the embodiment
  • FIG. 5 (B) is an enlarged view of a portion indicated by a broken line portion 5B in FIG. 5 (A).
  • It is an expanded sectional view corresponding to Drawing 4 (A) of a balloon catheter concerning a modification.
  • It is an expanded sectional view of the balloon along the direction perpendicular to the axial direction of the balloon catheter concerning another modification, and is an expanded sectional view showing a part of the balloon in the contracted state.
  • FIGS. 8A and 8B are enlarged cross-sectional views corresponding to FIG. 4A of a balloon catheter according to still another modified example.
  • FIG 1 to 4 are diagrams showing the configuration of each part of the balloon catheter 10 according to the embodiment.
  • the balloon catheter 10 allows the shaft 20 to be inserted into the living body lumen V and narrows the balloon 30 disposed on the distal end side of the shaft 20.
  • the part N (lesioned part)
  • it is configured as a medical instrument for expanding and treating the stenotic part N.
  • the stenosis N is a place where the living body lumen V surrounded by the living body lumen wall Vw is narrow.
  • the balloon catheter 10 can be configured, for example, as a PTCA dilatation balloon catheter used to widen the stenosis N of the coronary artery.
  • the balloon catheter 10 is intended for the treatment and improvement of stenosis N formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, other digestive tract, urethra, ear nasal lumen, and other organs. It can also be configured as used.
  • the balloon catheter 10 (corresponding to a medical long body) according to this embodiment is The shaft 20 (corresponding to the catheter body), a balloon 30 provided on the distal end side of the shaft 20, and a hub 40 disposed on the proximal end side of the shaft 20.
  • the balloon 30 expands in the radial direction of the shaft 20 by injecting fluid through the lumen 21 u of the shaft 20.
  • the outer surface 30S1 of the balloon 30 is formed of a hydrophobic resin.
  • the balloon 30 In the expanded state, the balloon 30 includes an intermediate region 31 that contacts the living body lumen wall Vw, a distal-side inclined region 32 that extends from the distal end 31a of the intermediate region 31 to the distal side, and a proximal end from the proximal end 31b of the intermediate region 31. And a proximal-side inclined region 33 extending to the side.
  • the intermediate region 31 includes a groove 100 in which the outer surface 30S1 of the balloon 30 is recessed. In the groove portion 100, a hydrophilic coating 110 is formed on the surface 101 that forms the groove portion 100.
  • the side of the balloon catheter 10 that is inserted into the living body lumen V (the side on which the balloon 30 is disposed) is referred to as the distal end side, and the side that is operated on the side opposite to the distal end side (hub)
  • the side on which 40 is disposed) is referred to as the proximal side
  • the direction in which the balloon extends is referred to as the axial direction of the balloon.
  • the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof
  • the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof. Means range.
  • the shaft 20 is disposed in the outer shaft 21 having a lumen 21u (corresponding to the lumen of the catheter body) and the lumen 21u of the outer shaft 21, And an inner shaft 25 that forms a guide wire lumen 25u through which the guide wire can be inserted.
  • the shaft 20 has a guide wire port P communicating with the guide wire lumen 25u of the inner shaft 25.
  • the guide wire port P is formed at the proximal end portion of the inner shaft 25.
  • the balloon catheter 10 is configured as a so-called rapid exchange type catheter in which a guide wire port P through which a guide wire can enter and exit is formed near the tip of the shaft 20.
  • the proximal end side of the guide wire lumen 25u communicates with the guide wire port P.
  • the outer shaft 21 has a distal end side shaft 22 and a proximal end side shaft 23 connected to the proximal end side of the distal end side shaft 22.
  • the distal end side shaft 22 and the proximal end side shaft 23 are integrally connected (fused) with the inner shaft 25 in the vicinity of the guide wire port P of the shaft 20.
  • the lumen (not shown) of the distal shaft 22 and the lumen (not shown) of the proximal shaft 23 are expanded in the expansion space 34 of the balloon 30 when the distal shaft 22 and the proximal shaft 23 are connected.
  • a lumen 21u of the outer shaft 21 communicating with is formed.
  • the balloon 30 is provided on the distal end side of the shaft 20.
  • the distal end portion 30 a of the balloon 30 is connected to the distal end portion of the inner shaft 25.
  • the proximal end portion 30 b of the balloon 30 is connected to the distal end portion of the outer shaft 21.
  • the inner shaft 25 is provided with an X-ray contrast marker 26 indicating a substantially center position in the axial direction of an intermediate region 31 to be described later of the balloon 30.
  • the X-ray contrast marker 26 can be made of, for example, a metal such as platinum, gold, silver, iridium, titanium, tungsten, or an alloy thereof.
  • the balloon 30 is expanded in the radial direction of the shaft 20 by injecting a fluid through the inner lumen 21u (expansion lumen) of the outer shaft 21.
  • the hub 40 has a port 41 that can be connected in a liquid-tight and air-tight manner with a supply device (not shown) such as an indeflator for supplying a fluid (pressurized medium).
  • a supply device such as an indeflator for supplying a fluid (pressurized medium).
  • the port 41 of the hub 40 can be configured by, for example, a well-known luer taper configured such that a fluid tube or the like can be connected / separated.
  • the shaft 20 is connected to the hub 40 with the lumen 21u of the outer shaft 21 communicating with the flow path in the hub 40.
  • a fluid for example, contrast medium or physiological saline
  • used to expand the balloon 30 is supplied to the lumen 21 u of the outer shaft 21 through the port 41 of the hub 40.
  • the balloon 30 will be described in detail with reference to FIGS.
  • the outer surface 30S1 of the balloon 30 is formed of a hydrophobic resin.
  • the balloon 30 includes a middle region 31 that is in contact with the living body lumen wall Vw in a state in which the balloon 30 is expanded, and a distal side from the distal end 31 a of the middle region 31. And a proximal-side inclined region 33 extending from the proximal end 31b of the intermediate region 31 toward the proximal end side.
  • the middle region 31 of the balloon 30 includes a groove 100 in which the outer surface 30S1 of the balloon 30 is recessed.
  • the groove portion 100 has a hydrophilic coating 110 formed on the surface 101 forming the groove portion 100. More specifically, in the intermediate region 31, the hydrophilic coating 110 is formed only on the surface 101 that forms the groove 100. In the groove part 100, at least a hydrophilic coating 110 is formed on the side surface 102 that forms the groove part 100.
  • the side surface 102 that forms the groove 100 is a portion of the surface 101 that forms the groove 100 that faces each other across the groove 100 in a cross section perpendicular to the axial direction of the balloon 30.
  • the surface 101 which forms the groove part 100 is formed by a curved surface. More specifically, the surface 101 that forms the groove 100 is a curved surface in a cross section perpendicular to the axial direction of the balloon 30.
  • the hydrophilic coating 110 is disposed along the shape of the surface 101 that forms the groove 100. Specifically, the hydrophilic coating 110 has a shape that is recessed from the outer surface 30S1 side of the balloon 30 toward the expansion space 34 side along the surface 101 that forms the groove 100 in a state where the balloon 30 is expanded. .
  • the material constituting the hydrophilic coating 110 is not particularly limited as long as it has hydrophilicity, and a known material can be used.
  • an epoxy group-containing monomer such as glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, ⁇ -methylglycidyl methacrylate, allyl glycidyl ether, N- Copolymers with hydrophilic monomers such as methylacrylamide, N, N-dimethylacrylamide and acrylamide; (Co) polymers composed of the above hydrophilic monomers; Cellulose systems such as hydroxypropylcellulose and carboxymethylcellulose High molecular substances: polysaccharides, polyvinyl alcohol, methyl vinyl ether-maleic anhydride copolymer, water-soluble polyamide, poly (2-hydroxyethyl (meth) acrylate), polyethylene glycol, polyacryl
  • the width B of the groove portion 100 is not particularly limited, but may be, for example, 0.001 mm to 0.2 mm.
  • the width B of the groove part 100 is the length of the opening part 105 of the groove part 100 in a state where the balloon 30 is expanded by the nominal pressure.
  • the height H of the groove 100 is not particularly limited, but may be, for example, 0.001 mm to 0.2 mm.
  • the height H of the groove 100 is a distance from the bottom 103 of the groove 100 to the outer surface 30S1 of the balloon 30 where the groove 100 is not formed.
  • the balloon 30 has a first layer 30L1 and a second layer 30L2 disposed on the surface of the first layer 30L1. And the groove part 100 is formed in the second layer 30L2.
  • the constituent material of the first layer 30L1 is preferably harder than the constituent material of the second layer 30L2.
  • the magnitude relationship between the hardness (flexibility) of the constituent material of the first layer 30L1 and the constituent material of the second layer 30L2 can be defined based on the Shore hardness D (conforming to JIS 6253).
  • the constituent material of the first layer L1 and the second layer 30L2 is such that the constituent material of the first layer 30L1 is harder than the constituent material of the second layer 30L2, and the material constituting the second layer 30L2 is hydrophobic.
  • the constituent material of the first layer 30L1 may be formed of a material different from the constituent material of the second layer 30L2, or may be formed of the same material as the constituent material of the second layer 30L2.
  • the first layer 30L1 or the second layer 30L2 is such that the constituent material of the first layer 30L1 is harder than the constituent material of the second layer 30L2. Adjust the hardness with additives.
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or two or more kinds thereof
  • a polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or the above-described two or more polymer materials can be used.
  • the groove 100 extends between the distal end 31a and the proximal end 31b of the intermediate region 31.
  • the groove portion 100 has a distal end 31a of the intermediate region 31 so as to form a discharge port 106, which will be described later, in order to efficiently reduce the amount of moisture existing between the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw. It is preferably formed continuously with the base end 31b.
  • the groove part 100 may be formed over the whole region between the front-end
  • the groove portion 100 includes a plurality of first inclined groove portions 121 inclined with respect to the axial direction of the balloon 30, a plurality of second inclined groove portions 122 intersecting with the first inclined groove portion 121, and Have
  • the groove part 100 has a discharge port 106 for discharging the moisture induced in the groove part 100.
  • the discharge port 106 discharges the moisture guided to the groove part 100 from the groove part 100 in the axial direction of the balloon 30.
  • the discharge port 106 is disposed at the distal end 31a and the proximal end 31b of the intermediate region 31.
  • the discharge port 106 disposed at the tip 31a of the intermediate region 31 is open on the tip side inclined region side. Further, the discharge port 106 arranged at the base end 31b is opened on the base end side inclined region side. Thereby, when the balloon 30 is expanded, the moisture guided to the groove part 100 is discharged to the outside of the intermediate region 31 (the tip inclined region side and the base end inclined region side).
  • the balloon 30 is folded so that the groove portion 100 is not exposed to the outer surface 30S1 of the balloon 30 in the contracted state.
  • the “shrinked state” means a state in which the balloon 30 is wound around the inner shaft 25, more specifically, a state in which the balloon 30 is directly wound around the inner shaft 25. Note that “directly” means that no other member is interposed between the balloon 30 and the inner shaft 25 in a state where the balloon 30 is wound around the inner shaft 25.
  • the balloon 30 has a blade portion 35 in a contracted state.
  • the blade portion 35 is wound around the inner shaft 25 in a state where the balloon 30 is folded. Therefore, in a state where the balloon 30 is folded, the blade portion 35 forms a non-exposed surface 35S1 that is not exposed to the outside and an exposed surface 35S2 that is exposed to the outside on the outer surface 30S1 of the balloon 30.
  • the non-exposed surface 35S1 is a portion where the outer surfaces 30S1 of the balloon 30 are in contact with each other in FIG.
  • the groove part 100 is formed in the non-exposed surface 35S1.
  • the blade portion 35 has a first blade portion 36, a second blade portion 37, and a third blade portion 38 that are spaced apart in the circumferential direction of the balloon 30.
  • the groove portion 100 includes a first groove portion 100a formed on the non-exposed surface 35S1 of the first blade portion 36, a second groove portion 100b formed on the non-exposed surface 35S1 of the second blade portion 37, and the third blade portion 38. And a third groove portion 100c formed in the non-exposed surface 35S1.
  • the first groove portion 100a, the second groove portion 100b, and the third groove portion 100c are separated from each other in the circumferential direction of the balloon 30 when the balloon 30 is expanded.
  • the first groove portion 100a, the second groove portion 100b, and the third groove portion 100c have substantially the same length in the circumferential direction of the balloon 30, and are separated by a substantially equal distance in the circumferential direction of the balloon 30. Yes.
  • the balloon 30 can be formed, for example, by processing a parison into a predetermined balloon shape using biaxial stretch blow molding.
  • the first layer It is possible to form a balloon 30 having 30L1 and a second layer 30L2.
  • the groove portion 100 can be formed simultaneously with the processing into a balloon shape by using a mold having a shape obtained by transferring the shape of the groove portion 100 when biaxial stretch blow molding is performed on a parison.
  • a mold having a shape obtained by transferring the shape of the groove 100 the groove 100 is formed by denting the outer surface 30S1 of the balloon 30 in the direction of the expansion space 34 of the balloon 30. It is formed.
  • the groove portion 100 may be formed by pressing a mold having a shape obtained by transferring the shape of the groove portion 100 against the balloon 30 after processing the parison into a predetermined balloon shape.
  • the groove 100 may be formed by laser processing after processing the parison into a predetermined balloon shape.
  • the hydrophilic coating 110 is formed by applying a hydrophilic material constituting the hydrophilic coating 110 to the outer surface 30S1 of the balloon 30 in which the groove portion 100 is formed, and removing the hydrophilic material that has not flowed into the groove portion 100.
  • the outer surface 30S1 can be formed on the surface on which the groove portion 100 is formed.
  • the hydrophilic coating 110 causes the hydrophilic material to flow into the groove portion 100 by applying the hydrophilic material to the outer surface 30S1 of the balloon 30 in which the groove portion 100 is formed.
  • the hydrophilic material that has not flowed into the groove portion 100 is removed, and the hydrophilic material that has flowed into the groove portion 100 is dried and self-crosslinked, whereby the surface of the outer surface 30S1 of the balloon 30 that forms the groove portion 100 can be formed.
  • the hydrophilic material remaining on the outer surface 30S1 of the balloon 30 can be removed by various methods such as wiping with a cloth.
  • the balloon 30 is expanded in a state where the balloon 30 is positioned at the narrowed portion N.
  • the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw forming the narrowed portion N come into contact with each other.
  • the hydrophilic coating 110 is formed by moisture such as blood existing between the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw forming the constriction N.
  • the groove 100 is guided. Thereby, it can suppress that a slip arises between the outer surface 30S1 of the balloon 30, and the biological lumen wall Vw. Therefore, when the balloon catheter 10 expands the stenosis N with the balloon 30, it is possible to prevent the positional displacement of the balloon 30 in the axial direction.
  • the balloon catheter 10 moves the living body lumen V with the balloon 30 deflated. For this reason, when the balloon catheter 10 moves the balloon 30 in the living body lumen V, the balloon 30 has a smaller outer diameter than the expanded state of the balloon 30, and the outer surface 30S1 of the balloon 30 is disposed on the living body tube. A force to press against the cavity wall Vw is not generated. Therefore, when the balloon catheter 10 moves the balloon 30 in the living body lumen V, moisture continues to exist between the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw. Therefore, the balloon catheter 10 does not deteriorate the slip between the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw, and the operability when the balloon 30 is moved in the living body lumen V is not lowered.
  • the balloon catheter 10 when the balloon 30 is expanded and the intermediate region 31 contacts the living body lumen wall Vw, it exists between the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw. Moisture is induced from the outer surface 30S1 formed of a hydrophobic resin having a low affinity for moisture to the groove 100 where the hydrophilic coating 110 having a high affinity for moisture is formed. Therefore, when the balloon 30 is expanded, the groove portion 100 can reduce the amount of moisture existing between the outer surface 30S1 of the balloon 30 and the living body lumen wall Vw. Therefore, when the balloon is expanded, the balloon catheter 10 can suppress slippage between the outer surface of the balloon and the living body lumen wall, and can suppress displacement of the balloon in the axial direction.
  • the balloon 30 includes the first layer 30L1 and the second layer 30L2 in which the groove portion 100 is formed.
  • the balloon 30 can comprise the 1st layer 30L1 in which the groove part 100 is not formed, and the 2nd layer 30L2 in which the groove part 100 is formed with a different material. Therefore, when imparting optimal characteristics to the balloon 30, the physical properties of the first layer 30L1 and the second layer 30L2 can be adjusted independently.
  • the constituent material of the first layer 30L1 is preferably made of a material harder than the constituent material of the second layer 30L2.
  • the first layer 30L1 can suppress the deformation of the groove portion 100 due to the pressure transmitted from the expansion space 34 of the balloon 30. Further, since the first layer 30L1 is made of a material harder than the second layer 30L2, it is possible to prevent the shape of the balloon 30 from being deformed when the balloon is expanded. As described above, the balloon 30 can easily manufacture the balloon 30 having an optimal structure in accordance with various requirements such as the expansion performance of the balloon 30 and the processing performance of the groove portion 100.
  • the groove portion 100 extends between the distal end 31a and the proximal end 31b of the intermediate region 31 in contact with the living body lumen wall Vw.
  • the groove portion 100 includes the plurality of first inclined groove portions 121 inclined with respect to the axial direction of the balloon 30 and the plurality of second inclined portions intersecting the first inclined groove portion 121. Groove portion 122.
  • the groove part 100 inclines with respect to the axial direction of the balloon 30, the 1st inclined groove part 121 and the 2nd inclined groove part 122 form the groove part 100 linearly along the axial direction of the balloon 30.
  • the range of the groove portion 100 in the predetermined range of the outer surface 30S1 of the balloon 30 can be increased.
  • the first inclined groove portion 121 and the second inclined groove portion 122 can disperse the force that expands the groove portion 100 acting on the groove portion 100 in the circumferential direction. Therefore, the balloon catheter 10 can suppress deformation of the groove 100 when the balloon 30 is expanded by applying a large expansion pressure. Therefore, the balloon catheter can prevent the displacement of the balloon even when the balloon is expanded by applying a large expansion pressure.
  • the surface 101 forming the groove 100 is formed by a curved surface.
  • the groove part 100 can guide
  • the surface 101 forming the groove 100 is formed by a curved surface, the groove 100 can be formed more easily.
  • the balloon 30 is folded so that the groove portion 100 is not exposed to the outer surface 30S1 of the balloon 30 in the contracted state.
  • the balloon catheter 10 can prevent the groove part 100 from contacting the living body lumen wall Vw when moving the balloon 30 in the living body lumen V. Therefore, peeling of the hydrophilic coating 110 can be prevented, and the operability of the balloon catheter 10 can be improved.
  • the balloon 30 has the first layer 30L1 and the second layer 30L2.
  • the balloon 30 may be constituted by a single layer 30L. Also according to this modification, the same operation and effect as the above-described embodiment can be obtained.
  • an expansion pressure that can be applied to the balloon 30 by adjusting the distance R1 (thickness) between the inner surface 30S2 of the single layer 30L and the bottom 103 of the groove 100.
  • the size of can be adjusted. That is, when it is desired to apply a large expansion pressure to the balloon 30, the distance R1 (thickness) between the inner surface 30S2 of the single layer 30L and the bottom 103 of the groove may be increased.
  • the groove portion 100 includes a hydrophilic coating 110a formed on one side surface 102a of the side surfaces 102 constituting the groove portion 100 and a hydrophilic surface formed on the other side surface 102b facing the one side surface 102a.
  • the protective coatings 110b may be configured to contact each other when the balloon 30 is deflated.
  • the groove portion 100 includes a hydrophilic coating 110a formed on one side surface 102a of the side surfaces 102 constituting the groove portion 100 and a hydrophilic coating 110b formed on the other side surface 102b opposite to the one side surface 102a.
  • the balloons 30 are configured to be separated from each other (see FIG. 4A).
  • the configuration in which the hydrophilic coating 110a and the hydrophilic coating 110b contact and separate from each other according to the contraction / expansion of the balloon 30 is, for example, in consideration of the deformation amount in the circumferential direction of the balloon 30 when the balloon 30 is expanded and contracted. This can be realized by selecting a constituent material.
  • the groove portion 100 and the hydrophilic coating 110 are not exposed to the outer surface 30S1 of the balloon 30 in the contracted state of the balloon 30. Therefore, when moving the balloon 30 in the biological lumen V, the balloon catheter 10 can prevent the groove portion 100 and the hydrophilic coating 110 from coming into contact with the biological lumen wall Vw. Therefore, peeling of the hydrophilic coating 110 can be prevented, and the operability of the balloon catheter 10 can be improved.
  • FIG. 7 illustrates the form in which the hydrophilic coating 110a and the hydrophilic coating 110b contact each other in a state in which the balloon 30 is contracted for all the groove parts 100.
  • the shape of the groove part according to the above-described embodiment The form of the groove part according to this modification may coexist. That is, for some of the plurality of grooves 100, as in the present modification, the hydrophilic coating 110 a and the hydrophilic coating 110 b are in contact with each other when the balloon 30 is deflated, and the other grooves 100. As in the above-described embodiment, the hydrophilic coating 110a and the hydrophilic coating 110b may not be in contact with each other in either the expanded state or the contracted state of the balloon 30.
  • the surface 101 forming the groove 100 is formed by a curved surface.
  • the shape of the surface 101 that forms the groove 100 is not limited to a curved surface, and a portion T1 that is angular on the surface 101 that forms the groove 100 may exist.
  • the groove 100 may have a trapezoidal shape in its cross section, or may have a rectangular shape as shown in FIG. 8 (B).
  • the outer surface 30S1 of the balloon 30 and the side surface 102 of the groove portion 100 are smoothly connected.
  • the outer surface 30S1 of the balloon 30 and the side surface 102 of the groove portion 100 are angular.
  • Site T2 may be present.
  • the hydrophilic coating 110 is formed on the entire surface 101 forming the groove 100, but is formed only on the side surface 102 forming the groove 100 as shown in FIG. 8B. May be. That is, the hydrophilic coating 110 may not be formed on the bottom 103 of the groove 100.
  • the hydrophilic coating 110 When the moisture existing between the intermediate region 31 and the living body lumen wall Vw is guided to the groove portion 100, the hydrophilic coating 110 has a side surface of the groove portion 100 that is more than the hydrophilic coating 110 formed on the bottom portion 103 of the groove portion 100.
  • the hydrophilic coating 110 formed on 102 has a larger contribution. Therefore, when expanding the balloon 30, the balloon catheter 10 applies the hydrophilic coating 110 only to the side surface 102 that forms the groove portion 100, thereby removing moisture existing between the intermediate region 31 and the living body lumen wall Vw. 100 can be guided.
  • the balloon catheter 10 has been described through the embodiment and its modifications.
  • the present invention is not limited only to the configuration described in the embodiment and its modifications, and may be changed as appropriate based on the description of the scope of claims. Is possible.
  • the groove 100 is formed in a part of the outer surface 30S1 of the balloon 30 in the circumferential direction.
  • the groove may be formed in the entire circumferential direction on the outer surface of the balloon.
  • the groove part 100 was formed over the full length between the front-end
  • the groove part 100 may be formed only in a part between the front end 31a and the base end 31b of the intermediate region 31.
  • the groove portion is formed over the entire length between the distal end 31a and the proximal end 31b of the intermediate region 31 in order to efficiently discharge the moisture guided to the groove portion to the outside of the intermediate region 31 when the balloon 30 is expanded. It is preferable.
  • the balloon 30 is folded so that the entire groove portion 100 is not exposed to the outer surface 30S1 of the balloon 30 in the contracted state.
  • the balloon 30 may be folded so that a part of the groove 100 is not exposed to the outer surface 30S1 of the balloon 30 in the contracted state.
  • 10 balloon catheter medical long body
  • 20 shaft catheter body
  • 21u lumen the lumen of the catheter body
  • 30 balloon 30L1 first layer
  • 30L2 second layer The outer surface of the 30S1 balloon, 31 middle region, 31a tip of the middle region, 31b proximal end of the intermediate region, 32 tip side inclined region, 33 proximal slope region, 35 feathers, 40 hubs, 100 groove, 101 surface forming a groove, 110 hydrophilic coating, 121 a first inclined groove, 122 second inclined groove, V biological lumen, Vw Living body lumen wall.

Abstract

Le problème décrit par la présente invention concerne un corps allongé médical qui, lorsqu'un ballonnet est déployé au niveau d'une lésion, empêche le glissement entre la surface extérieure du ballonnet et une paroi de lumière biologique, empêchant ainsi le déplacement du ballonnet dans la direction axiale. La solution selon l'invention porte sur un corps allongé médical qui comprend un corps de cathéter et un ballonnet 30 qui est disposé sur le côté distal du corps de cathéter et qui s'étend dans la direction radiale du corps de cathéter lorsqu'un fluide est introduit en son sein à travers une lumière du corps de cathéter. La surface externe 30S1 du ballonnet est constituée d'une résine hydrophobe. Le ballonnet, dans un état déployé, présente une région intermédiaire 31 qui est en contact avec la paroi de lumière biologique, une région inclinée côté distal s'étendant de l'extrémité distale de la région intermédiaire au côté distal et une région inclinée côté proximal s'étendant de l'extrémité proximale de la région intermédiaire au côté proximal. La région intermédiaire est pourvue d'une rainure 100 qui est un renfoncement sur la surface externe du ballonnet. La rainure présente un revêtement hydrophile 110 sur la surface 101 qui forme la rainure.
PCT/JP2018/005228 2017-02-17 2018-02-15 Corps allongé médical WO2018151204A1 (fr)

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JP2017028036A JP2020062062A (ja) 2017-02-17 2017-02-17 医療用長尺体
JP2017-028036 2017-02-17

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
CN112353519A (zh) * 2020-11-09 2021-02-12 深圳素士科技股份有限公司 按键防水电动牙刷
CN112370638A (zh) * 2020-12-04 2021-02-19 上海康德莱医疗器械股份有限公司 一种药物球囊

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023085112A1 (fr) * 2021-11-09 2023-05-19 株式会社カネカ Cathéter à ballonnet

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Publication number Priority date Publication date Assignee Title
JP2005278684A (ja) * 2004-03-26 2005-10-13 Terumo Corp 拡張体付カテーテル
JP2008529733A (ja) * 2005-02-17 2008-08-07 ボストン サイエンティフィック リミテッド 医療器具

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005278684A (ja) * 2004-03-26 2005-10-13 Terumo Corp 拡張体付カテーテル
JP2008529733A (ja) * 2005-02-17 2008-08-07 ボストン サイエンティフィック リミテッド 医療器具

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112353519A (zh) * 2020-11-09 2021-02-12 深圳素士科技股份有限公司 按键防水电动牙刷
CN112353519B (zh) * 2020-11-09 2022-04-12 深圳素士科技股份有限公司 按键防水电动牙刷
CN112370638A (zh) * 2020-12-04 2021-02-19 上海康德莱医疗器械股份有限公司 一种药物球囊

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