WO2018092386A1 - Cathéter et procédé de production de cathéter - Google Patents

Cathéter et procédé de production de cathéter Download PDF

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Publication number
WO2018092386A1
WO2018092386A1 PCT/JP2017/031134 JP2017031134W WO2018092386A1 WO 2018092386 A1 WO2018092386 A1 WO 2018092386A1 JP 2017031134 W JP2017031134 W JP 2017031134W WO 2018092386 A1 WO2018092386 A1 WO 2018092386A1
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WIPO (PCT)
Prior art keywords
catheter
distal
proximal
tubular
tubular body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2017/031134
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English (en)
Japanese (ja)
Inventor
安永光輝
大嶽祐八
丸山真理子
羽室皓太
犬飼太輝人
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Terumo Corp
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Terumo Corp
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Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2018551043A priority Critical patent/JPWO2018092386A1/ja
Publication of WO2018092386A1 publication Critical patent/WO2018092386A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • 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

Definitions

  • the present invention relates to a catheter and a method for manufacturing the catheter.
  • the outer diameter of the guiding catheter is inevitably thinner.
  • a treatment catheter inserted into a guiding catheter is required to have a larger outer diameter in order to exert a sufficient effect at a target site such as a treatment site. Therefore, the guiding catheter into which the treatment catheter is inserted is required to have a larger inner diameter. Therefore, the guiding catheter becomes thin and has insufficient rigidity, so that there is a possibility that the target catheter cannot be reached.
  • a thin guiding catheter is easy to bend, it is likely to be kinked at a bent portion of a blood vessel.
  • the proximal portion of the catheter is formed of a relatively hard resin in order to reach the target position.
  • the distal portion of the catheter is formed of a soft resin so as to advance to a target position without damaging the blood vessel wall.
  • Patent Document 1 describes a catheter in which a soft resin is bonded to the distal side of a hard resin.
  • the bond is not stable due to the difference in melting point due to the difference in hardness of the resin, and if a tensile load is applied in the axial direction, the strength to break And the elongation at break is not stable. Further, if the joint is insufficient, the joint may be broken when it is folded. If the catheter is broken in the living body, the catheter cannot be used, and foreign substances may remain in the body.
  • the present invention has been made in order to solve the above-described problems, and it is possible to satisfactorily maintain the bonding strength of resin materials having different hardnesses on the distal side and the proximal side, and to effectively suppress peeling of the bonded portion. It aims at providing a catheter and a manufacturing method of a catheter.
  • a catheter according to the present invention that achieves the above-mentioned object is a catheter that is used in conjunction with the guiding catheter and is detachably disposed in the lumen of the guiding catheter, and is a distal end made of a resin material located on the distal side.
  • a tubular portion and a proximal tubular portion made of a resin having a hardness higher than that of the distal tubular portion, and having a distal end connected to a proximal end of the distal tubular portion.
  • the distal end of the proximal tubular portion has a taper portion that gradually decreases in outer diameter toward the distal side and is located radially inward of the distal tubular portion; and A covering portion that protrudes from the proximal portion toward the distal side and surrounds the radially outer side of the proximal end portion of the distal tubular portion, and the distal tubular portion includes the tapered portion. And a wedge portion sandwiched between the covering portions.
  • the catheter configured as described above has a taper portion and a covering portion formed in the proximal tubular portion, the contact area between the distal tubular portion and the proximal tubular portion is increased. For this reason, the tensile strength and breaking elongation of the joint are improved, and the joint strength is improved and stabilized. For this reason, the joint strength of the joint part can be maintained well, and peeling of the joint part can be effectively suppressed.
  • the wedge portion of the distal tubular portion having low hardness is surrounded by the coating portion having high hardness, it is effective that the wedge portion having low hardness disposed on the radially outer side of the tapered portion is peeled off from the tapered portion. Can be suppressed.
  • the distance from the proximal apex that is the proximal end of the wedge portion to the inner peripheral surface of the catheter may be greater than the distance from the proximal apex to the outer peripheral surface of the catheter.
  • the ratio of the high hardness covering portion that covers the distal tubular portion having low hardness does not become excessively large with respect to the tapered portion, and it is possible to suppress the concentration of tensile force between the distal tubular portion and the covering portion. .
  • the ratio of the taper part located inside the distal tubular part having low hardness is larger than the covering part, the distal tubular part is smoothly bent along the taper part on the radially outer side of the taper part. Can do. For this reason, generation
  • the covering portion may have a protruding portion protruding radially inward at the distal end portion.
  • a protrusion part bites toward a radial inside with respect to a distal tubular part. For this reason, a distal tubular part and a proximal tubular part are connected firmly, and generation
  • a catheter manufacturing method that achieves the above-described object is a method for manufacturing a catheter that is used in conjunction with the guiding catheter and is detachably disposed in the lumen of the guiding catheter.
  • the tapered portion of the second tubular body having a high melting point is partially inserted into the first tubular body having a low melting point.
  • the material of the 1st pipe body which is easy to flow moves, a movement range being regulated by the heat shrinkable tube, and presses and deforms a taper part.
  • a part of the second tubular body flows so as to cover the radially outer side of the first tubular body, and a covering portion that covers the wedge portion positioned on the radially outer side of the tapered portion can be formed.
  • this manufacturing method can stably manufacture the distal tubular portion and the proximal tubular portion, which have a large difference in melting point and are difficult to obtain high bonding strength, with high bonding strength and reproducibility.
  • proximal side of the inner catheter is referred to as “proximal side”
  • distal side the side inserted into the living body
  • the inner catheter 30 (catheter) according to the embodiment of the present invention is used as the catheter assembly 10 in combination with the guiding catheter 20.
  • the catheter assembly 10 is percutaneously percutaneously as shown in FIG. 8 with the inner catheter 30 inserted into the lumen of the guiding catheter 20. Inserted into artery V1.
  • the catheter assembly 10 passes through the descending aorta V2 (the thoracic aorta and the abdominal aorta) and is pushed into the lower limb artery V3. After the distal portion of the catheter assembly 10 reaches the target site of the lower limb artery V3, the inner catheter 30 is removed from the guiding catheter 20.
  • treatment catheters such as balloon catheters, various liquids such as contrast media, medicinal solutions, and physiological saline can be introduced into the target site.
  • the inner catheter 30 compensates for the gap between the guiding catheter 20 and the guide wire 120, improves the kink resistance, pushability, operability, etc. of the catheter assembly 10, and the distal end of the guiding catheter 20 And the guide wire 120 are restrained from causing a step, thereby reducing blood vessel damage.
  • the guiding catheter 20 includes a tubular guiding catheter main body 40, a guiding catheter hub 50 fixed to the proximal end of the guiding catheter main body 40, and a kink protector 60.
  • the inner catheter 30 includes an inner catheter body 70 that can be inserted into the guiding catheter body 40, and an inner catheter hub 80 that is disposed at the proximal end of the inner catheter body 70.
  • the inner catheter main body 70 When the inner catheter main body 70 is inserted into the proximal end side of the guiding catheter hub 50 and the guiding catheter hub 50 and the inner catheter hub 80 are brought into contact with each other and fixed by a locking mechanism described later, as shown in FIG.
  • the guiding catheter 20 and the inner catheter 30 are assembled (assembled state). Note that the locking mechanism may not be provided.
  • the guiding catheter body 40 of the guiding catheter 20 is formed of a flexible tubular body.
  • the guiding catheter body 40 has a substantially central portion extending over the entire length of the guiding catheter body 40.
  • a guiding catheter lumen 41 is formed.
  • the guiding catheter body 40 includes an inner layer 42 that forms an inner surface within a guiding catheter lumen 41, an outer layer 43 that forms an outer surface, a reinforcing layer 44 positioned between the inner layer 42 and the outer layer 43, and an outer layer. 43, and a flexible tip 45 provided on the tip side of 43.
  • the inner layer 42 may extend to the tip end 45.
  • constituent material of the outer layer 43 examples include various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. , One or a combination of two or more of these (polymer alloy, polymer blend, laminate, etc.) can be mentioned.
  • the constituent material of the inner layer 42 is made of a material that, when a device such as a treatment catheter or a guide wire is inserted into the guiding catheter lumen 41, at least a portion in contact with these devices has low friction. It is preferable. Thereby, the device inserted with respect to the guiding catheter main body 40 can be moved to an axial direction with a smaller sliding resistance, and operativity improves.
  • the entire inner layer 42 may be made of a low friction material. Examples of the low friction material include fluorine resin materials such as polytetrafluoroethylene (PTFE).
  • the reinforcing layer 44 is for reinforcing the guiding catheter body 40 and has a reinforcing material composed of a plurality of reinforcing wires.
  • the material of the outer layer 43 or the inner layer 42 enters the gaps between the plurality of reinforcing wires in the reinforcing layer 44.
  • Examples of the reinforcing material include those in which a reinforcing wire is formed in a spiral shape or a net shape.
  • the reinforcing wire is made of a metal such as stainless steel or NiTi.
  • the tip 45 is formed more flexibly than the outer layer 43. Thereby, the damage of the blood vessel by the front-end
  • the constituent material of the tip 45 is, for example, various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene-butadiene rubber, styrene, polyolefin, polyurethane, and polyester. And various thermoplastic elastomers such as polyamide, polybutadiene, trans polyisoprene, fluororubber, and chlorinated polyethylene.
  • the outer diameter of the guiding catheter body 40 is, for example, 1.7 to 2.6 mm, preferably 2.2 mm to 2.5 mm, more preferably 2.3 mm to 2.4 mm. If the outer diameter is too large, the operability when the guiding catheter body 40 is inserted into the artery and traveled is lowered, and the burden on the patient may be increased.
  • the inner diameter of the guiding catheter body 40 is, for example, 1.5 to 2.4 mm, preferably 2.0 mm to 2.3 mm, more preferably 2.15 mm to 2.25 mm. If the inner diameter is too small, the treatment catheter or the like that can be inserted into the guiding catheter body 40 has a small outer diameter accordingly, and the range of selection of treatment devices to be inserted is limited, which is not preferable. .
  • the length of the guiding catheter body 40 is 1200 mm or more, preferably 1300 mm to 1600 mm, more preferably 1500 mm so that it can be inserted from the radial artery V1 and reach the lower limb artery V3.
  • the guiding catheter hub 50 is fixed to the proximal end of the guiding catheter body 40.
  • the guiding catheter hub 50 has a guiding catheter hub lumen 54 that communicates with the guiding catheter lumen 41.
  • the guiding catheter hub lumen 54 opens at the proximal guiding catheter hub opening 55.
  • a male threaded portion 53 is formed on the outer peripheral surface of the proximal portion of the guiding catheter hub 50.
  • the male screw portion 53 can be screwed with a female screw portion 82 formed in a screwing portion 81 (described later) provided rotatably on the inner catheter hub 80.
  • the male screw portion 53 and the female screw portion 82 constitute a lock mechanism that holds the guiding catheter hub 50 and the inner catheter hub 80 in a connected state.
  • the constituent material of the guiding catheter hub 50 is, for example, various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. And combinations thereof (polymer alloys, polymer blends, laminates, etc.).
  • the inner catheter 30 is inserted from the guiding catheter hub opening 55 in the assembled state.
  • a guide wire catheters (for example, Insertion or removal of long objects (linear bodies) such as balloon catheters or stent placement catheters, endoscopes, ultrasonic probes, temperature sensors, contrast media (X-ray contrast media), drug solutions, physiological saline
  • catheters for example, Insertion or removal of long objects (linear bodies) such as balloon catheters or stent placement catheters, endoscopes, ultrasonic probes, temperature sensors, contrast media (X-ray contrast media), drug solutions, physiological saline
  • contrast media X-ray contrast media
  • the kink protector 60 is attached so as to cover a portion connecting the guiding catheter body 40 and the guiding catheter hub 50, and suppresses kinking of the guiding catheter 20 in the portion.
  • the inner catheter main body 70 provided in the inner catheter 30 includes a distal tubular portion 71 located on the distal side and a proximal tubular portion located on the proximal side of the distal tubular portion 71. 72.
  • An inner catheter lumen 74 penetrating from the distal end to the proximal end along the axis is formed at the central portion of the inner catheter body 70.
  • the outer diameter of the inner catheter body 70 substantially matches the inner diameter of the guiding catheter body 40.
  • the outer diameter of the inner catheter body 70 does not have to match the inner diameter of the guiding catheter body 40 as long as the inner catheter body 70 can be inserted into and removed from the guiding catheter body 40. Then, the inner catheter body 70 is arranged in the guiding catheter body 40, so that the outer surface of the inner catheter body 70 is in contact with the inner surface of the guiding catheter body 40 without a gap or through a minute gap. Adjacent.
  • the distal portion of the distal tubular portion 71 protrudes from the guiding catheter body 40 to the distal side. Accordingly, the distal tubular portion 71 is located on the most distal side when the catheter assembly 10 is pushed forward in the blood vessel, and easily contacts the blood vessel wall.
  • the distal tubular portion 71 has lower Shore D hardness and bending rigidity than the proximal tubular portion 72. Shore D hardness is a hardness by a durometer test measured according to ISO868. Since the distal tubular portion 71 is more flexible than the proximal tubular portion 72 and has a lower bending rigidity, the distal tubular portion 71 is prevented from being damaged.
  • the outer peripheral surface of the distal end portion of the distal tubular portion 71 is smoothly formed with a curvature so that the living tissue that comes into contact with it is not damaged.
  • the proximal tubular portion 72 has higher bending rigidity and Shore D hardness than the distal tubular portion 71.
  • the proximal tubular portion 72 is preferably somewhat rigid so that it can pass through the thick and linear descending aorta V2 and transmit the pushing force to the distal tubular portion 71. If the proximal tubular portion 72 is too soft, the proximal tubular portion 72 is deflected inside a thick blood vessel such as the descending aorta V2, the direction is not fixed, and the pushing force cannot be transmitted effectively.
  • the distal tubular portion 71 and the proximal tubular portion 72 having greatly different hardness are fused adjacently. Since the proximal tubular portion 72 exhibiting high pushability is directly connected to the distal tubular portion 71 exhibiting high followability, the proximal tubular portion 72 is located at the tip of the long and straight descending aorta V2. The pushing force can be effectively transmitted to the distal tubular portion that moves through the serpentine iliac artery located.
  • the distal end of the proximal tubular portion 72 includes a tapered portion 75 whose outer diameter gradually decreases toward the distal side, and a covering portion that protrudes from the proximal side of the tapered portion 75 toward the distal side. 76.
  • the tapered portion 75 is located on the radially inner side of the proximal end portion of the distal tubular portion 71.
  • the covering portion 76 surrounds the radially outer side of the proximal end portion of the distal tubular portion 71.
  • a wedge portion 77 is formed which is sandwiched between the taper portion 75 and the covering portion 76 and protrudes to the proximal side.
  • a distance D1 from the proximal apex 78 that is the proximal end of the wedge 77 to the inner peripheral surface of the inner catheter 30 is larger than a distance D2 from the proximal apex 78 to the outer peripheral surface of the inner catheter 30.
  • the distance D1 to the inner peripheral surface of the inner catheter 30 may be equal to or less than the distance D2 from the proximal apex 78 to the outer peripheral surface of the inner catheter 30.
  • the proximal tubular portion 72 has a higher melting point than the distal tubular portion 71.
  • the resin material that can be fused usually has a close structure, and the higher the melting point, the higher the hardness. For this reason, it is easy to set the material so that the melting point of the proximal tubular portion 72 having high hardness is higher than the melting point of the distal tubular portion 71 having low hardness.
  • the melting point difference is not particularly limited, it is preferably 35 ° C. or higher and 50 ° C. or lower.
  • resin materials that can be fused include, but are not limited to, urethane and polyester, nylon and polyester elastomer, nylon and urethane, high-density polyethylene and low-density polyethylene, and the like.
  • the fusible resin materials having different melting points and hardnesses may be the same type of resin materials having different grades depending on the type of additive. Further, by applying a surface treatment to the surface of the resin material, resin materials having different melting points and hardnesses can be fused.
  • the length in the axial direction of the joint 73 which is a region where the distal tubular portion 71 and the proximal tubular portion 72 overlap in the radial direction, is not particularly limited, but is, for example, 2.5 to 10 mm, preferably 3 to 8 mm, and more preferably. Is 3-5 mm. If the length of the joining portion 73 in the axial direction is too long, the angle of the tapered portion 75 with respect to the axial direction becomes too acute, and the joining surface is liable to peel off. On the other hand, if the axial length of the joint portion 73 is too short, the angle of the taper portion 75 with respect to the axial direction approaches a right angle, the area of the joint surface decreases, and peeling easily occurs.
  • the joint 73 is located inside the guiding catheter body 40. Since the joint portion 73 is located inside the guiding catheter body 40, even if the inner catheter body 70 tries to bend excessively at the joint portion 73 between the distal tubular portion 71 and the proximal tubular portion 72, the guiding catheter body 40. Due to this, bending is suppressed. For this reason, the excessive bending of the catheter assembly 10 is suppressed, and the inside of the blood vessel can be favorably advanced. Further, since the joint portion 73 is located inside the guiding catheter body 40, the proximal portion of the distal tubular portion 71 is located inside the distal portion of the guiding catheter body 40. For this reason, the distal portion of the guiding catheter body 40 is guided to the distal tubular portion 71 that flexibly moves in the meandering artery, and can smoothly pass through the meandering artery.
  • the length in the axial direction from the distal end of the distal tubular portion 71 to the joint 73 is not particularly limited, but is, for example, 100 to 120 mm.
  • the protruding length from the distal end of the guiding catheter body 40 to the distal end of the distal tubular portion 71 is not particularly limited, but is, for example, 10 to 50 mm.
  • the outer diameter of the inner catheter body 70 substantially matches the inner diameter of the guiding catheter body 40.
  • the outer diameter of the inner catheter body 70 is, for example, 1.5 mm to 2.4 mm, preferably 1.5 mm to 2.2 mm, and more preferably 2.0 mm to 2.2 mm.
  • the inner diameter of the inner catheter body 70 is substantially the same as or somewhat larger than the outer diameter of the guide wire 120 to be used.
  • the inner diameter of the inner catheter body 70 is, for example, 0.9 mm to 1.3 mm, preferably 1.0 mm to 1.2 mm.
  • the length of the inner catheter main body 70 is longer than the guiding catheter main body 40, and is 1200 mm or more, preferably 1400 mm to 1700 mm, more preferably so that it can be inserted from the radial artery V1 and reach the lower limb artery V3. Is 1600 mm.
  • the constituent materials of the distal tubular portion 71 and the proximal tubular portion 72 are, for example, styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, chlorinated polyethylene-based, etc. These include various thermoplastic elastomers and the like, and one or a combination of two or more of these may be mentioned.
  • the constituent materials of the distal tubular portion 71 and the proximal tubular portion 72 (particularly, the distal tubular portion 71) It is preferable that a radiopaque material (X-ray contrast agent) is blended therein.
  • a radiopaque material for example, barium sulfate, bismuth oxide, tungsten, or the like can be used.
  • the inner catheter hub 80 is fixed to the proximal end of the inner catheter body 70 as shown in FIGS.
  • the inner catheter hub 80 has an inner catheter hub lumen 84 that communicates with the inner catheter lumen 74.
  • the inner catheter hub lumen 84 opens at the proximal inner catheter hub opening 85.
  • a rotatable threaded portion 81 is provided on the outer surface of the inner catheter hub 80.
  • On the inner peripheral surface of the screwing portion 81 a female screw portion 82 that can be screwed with the male screw portion 53 of the guiding catheter hub 50 is formed.
  • a cylindrical portion 86 that can be inserted into the guiding catheter hub opening 55 of the guiding catheter hub 50 is formed at the distal side of the inner catheter hub 80.
  • the tubular portion 86 is inserted into the guiding catheter hub opening 55 so as to be in close contact with the guiding catheter hub lumen 54.
  • the constituent material of the inner catheter hub 80 is, for example, various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. And a combination of one or more of these.
  • a first tube 90 that becomes the distal tubular portion 71 and a second tube 100 that becomes the proximal tubular portion 72 are prepared.
  • the first tubular body 90 has a lower hardness and a lower melting point than the second tubular body 100.
  • the core metal 110 is placed in the lumen of the second tube 100, and the distal end is inserted into a heated mold. Thereby, the edge part of the 2nd tubular body 100 melts partially, and the taper part 101 is formed.
  • the cored bar 110 is pulled out from the tapered portion 101.
  • the core metal 110 is not completely pulled out from the second tubular body 100.
  • the method for forming the taper portion 101 is not particularly limited, and for example, the taper portion 101 may be formed by cutting, cutting, pulling, deforming, or melting by a method other than a mold.
  • a part of the tapered portion 101 of the second tubular body 100 is inserted into the lumen of the first tubular body 90.
  • the tapered portion 101 enters between the inner peripheral surface of the first tubular body 90 and the cored bar 110.
  • the proximal end of the first tubular body 90 is pushed radially outward to expand the diameter.
  • the first tubular body 90 and the second tubular body 100 are covered with a heat shrinkable tube 111.
  • the heat shrinkable tube 111 is heated, and at the same time, the proximal portion of the first tubular body 90 and the distal portion of the second tubular body 100 are heated. As a result, the first tubular body 90 and the second tubular body 100 are softened or melted. Since the first tube 90 has a lower melting point than the second tube 100, it flows more easily than the second tube 100. For this reason, as shown in FIG. 7B, the softened or melted material of the first tubular body 90 that has been expanded on the diameter of the tapered portion 101 is pushed by the heat-shrinkable tube 111 that is reduced in diameter, It moves proximally along the tapered portion 101 of the second tubular body 100.
  • the first tubular body 90 and the second tubular body 100 cannot be deformed toward the lumen because the cored bar 110 is inserted. Further, the heat-shrinkable tube 111 is in close contact with the outer peripheral surface having a uniform diameter located on the proximal side of the tapered portion 101 of the second tubular body 100 at an early stage when the diameter is reduced. For this reason, the softened or melted first tubular body 90 is restricted from entering the space between the first tubular body 90 and the heat-shrinkable tube 111 beyond the tapered portion 101. The material of the first tubular body 90 pressed by the heat shrinkable tube 111 that reduces the diameter presses the softened or melted tapered portion 101.
  • the tapered portion 101 is depressed, and the material of the first tubular body 90 enters the recessed portion. Therefore, when the heat-shrinkable tube 111 is completely contracted, a covering portion 102 that protrudes to the distal side is formed at a portion on the proximal side of the tapered portion 101 as shown in FIGS. 6C and 7C. Is done. Thereafter, when the heating is stopped and the temperature of the first tubular body 90 and the second tubular body 100 is lowered, the first tubular body 90 and the second tubular body 100 are solidified and fused. As a result, as shown in FIG.
  • a wedge portion 77 made of the first tubular body 90 is formed on the radially outer side of the tapered portion 75 made of the second tubular body 100.
  • the covering portion 76 made of the second tubular body 100 can be formed.
  • the heat-shrinkable tube 111 is removed, and the inner catheter body 70 in which the distal tubular portion 71 and the proximal tubular portion 72 are fused is obtained.
  • the proximal tubular portion 72 having the tapered portion 75 and the covering portion 76 and the distal tubular portion 71 having the wedge portion 77 sandwiched between the tapered portion 75 and the covering portion 76 are fused.
  • the catheter body 70 can be easily manufactured.
  • the joining area of the distal tubular part 71 and the proximal tubular part 72 becomes large, and joining strength becomes high.
  • the tapered portion 101 of the second tubular body 100 having a high melting point is partially inserted into the first tubular body 90 having a low melting point. For this reason, by covering and heating with the heat shrinkable tube 111, the material of the first tubular body 90 that is easy to flow moves while the movement range is regulated by the heat shrinkable tube 111, and presses the tapered portion 101 to be deformed.
  • this manufacturing method can manufacture stably the distal tubular part 71 and the proximal tubular part 72 which are difficult to obtain high joint strength due to a large melting point difference with high joint strength and reproducibility.
  • a structure in which different materials are fused at the tapered portion can be formed by two-layer extrusion molding in which the resin material is switched during the molding.
  • the difference in fluidity increases due to the large difference between the melting points of the two materials. For this reason, it is difficult to mold in a stable shape, and reproducibility is low.
  • the resin material is switched, the axial length of the joint portion where the two materials are fused is increased. Therefore, it is difficult to form a joint with a length of about 2.5 mm to 10 mm as in this embodiment.
  • pipes of different materials can be arranged and fused to a heated mold.
  • the axial length of the joint can be shortened.
  • materials having different melting points are heated at the same time in the heated mold, the difference in melting point is large, and thus the low melting point material flows too much, the taper portion becomes too long, and the bonding strength decreases.
  • the molding temperature is lowered so that the low melting point material does not flow too much, the high melting point material will not flow. For this reason, the low melting point material does not adhere to the high melting point material, the bonding strength is lowered, and peeling of the bonded portion is likely to occur.
  • this manufacturing method uses the heat-shrinkable tube 111, the first tube 90 and a part of the second tube 100 are partially heated and fused while allowing the material to flow to some extent. . Therefore, according to the present manufacturing method, the distal tubular portion 71 and the proximal tubular portion 72 having greatly different melting points have the joint portion 73 having a length of about 2.5 mm to 10 mm and have reproducibility. It is possible to join stably. Moreover, according to this manufacturing method, even if it is the structure where the junction part 73 is provided in the relatively distant position about 100 mm from the most distal part, it can manufacture easily by covering the heat contraction tube 111.
  • the guiding catheter 20 and the inner catheter 30 are assembled as shown in FIGS.
  • the inner catheter 30 is inserted into the guiding catheter hub opening 55 from the inner catheter main body 70 side, and the inner catheter 30 is pushed forward until the tubular portion 86 is inserted into the guiding catheter hub opening 55.
  • the threaded portion 81 is rotated after the tubular portion 86 is inserted into the guiding catheter hub opening 55, the male threaded portion 53 is threadedly engaged with the female threaded portion 82 as shown in FIG.
  • the catheter assembly 10 when the catheter assembly 10 is inserted into the blood vessel, the guiding catheter 20 and the inner catheter 30 can be operated integrally, so that the operation becomes easy and the guiding catheter 20 and the inner catheter 30 can be expected.
  • the safety is improved by suppressing the disconnection.
  • the operator punctures the radial artery V1 by a known method and inserts a short guide wire.
  • a catheter introducer 130 having a dilator inserted into the lumen of the sheath 131 is inserted into the puncture site of the radial artery V1 along the short guide wire.
  • the distal end of the catheter introducer 130 is advanced by a predetermined amount toward the central side, the short guide wire and the dilator are removed from the catheter introducer 130.
  • the operator can introduce the catheter assembly 10 into the radial artery V1 via the sheath 131.
  • the surgeon inserts the catheter assembly 10 with the guide wire 120 inserted into the inner catheter lumen 74 and the inner catheter hub lumen 84 into the radial artery V1 through the sheath 131.
  • the catheter assembly 10 is pushed through the descending aorta V2 to the lower limb artery V3 while the guide wire 120 is advanced.
  • the inner catheter body 70 is disposed inside the guiding catheter body 40, and the inner catheter is placed in a gap between the outer surface of the guide wire 120 and the inner surface of the guiding catheter body 40.
  • the main body 70 is located.
  • the distal tubular portion 71 of the inner catheter 30 protrudes more distally than the guiding catheter body 40.
  • the distal end part of the guiding catheter main body 40 while being able to reduce the damage of the blood vessel by the distal end part of the guiding catheter main body 40, it can suppress that the distal end part of the guiding catheter main body 40 turns up by receiving resistance from the blood vessel. Moreover, since the outer peripheral surface of the distal end portion of the distal tubular portion 71 has a curvature and is smooth, it can smoothly contact the blood vessel and reduce the damage to the blood vessel.
  • the catheter assembly 10 passes through the thick and linear descending aorta V2 before reaching the lower limb artery V3. At this time, since the proximal tubular portion 72 has a certain degree of hardness, the proximal tubular portion 72 can be pushed forward with a direction of travel determined within a thick blood vessel.
  • the pushing of the catheter assembly 10 is stopped.
  • the screwing portion 81 is rotated to release the screwing between the male screw portion 53 and the female screw portion 82 (see FIG. 3).
  • the inner catheter 30 is removed from the guiding catheter 20 while leaving the guiding catheter 20 and the guide wire 120 in the blood vessel.
  • the balloon catheter can be inserted into the stenosis using the lumen of the guiding catheter 20 and the stenosis can be expanded.
  • a catheter other than a balloon catheter, an endoscope, an ultrasonic probe, a temperature sensor or the like is inserted or removed through the guiding catheter 20, or a contrast medium (X-ray contrast medium), a drug solution, a physiological Various liquids such as saline can be injected.
  • the guiding catheter 20 is withdrawn from the sheath 131, the sheath 131 is withdrawn from the radial artery V1, and the puncture site by the sheath 131 is hemostatic, thereby completing the procedure.
  • the inner catheter 30 in which the distal tubular portion 71 and the proximal tubular portion 72 having different hardness and melting point are fused repeatedly bends. Therefore, a force for causing separation acts on the joint portion 73 between the distal tubular portion 71 and the proximal tubular portion 72.
  • the proximal tubular portion 72 has a taper portion 75 that is located on the radially inner side of the distal tubular portion 71 with the outer diameter gradually decreasing toward the distal side at the distal end portion, and the tapered portion 75.
  • the distal tubular portion 71 has a covering portion 76 that protrudes from the proximal portion toward the distal side and surrounds the radially outer side of the proximal end portion of the distal tubular portion 71.
  • the distal tubular portion 71 has a wedge portion 77 sandwiched between the tapered portion 75 and the covering portion 76.
  • the covering portion 76 and the wedge portion 77 are formed, so that the joining area of the distal tubular portion 71 and the proximal tubular portion 72 is increased as compared with the case of only the tapered portion. For this reason, the inner catheter 30 has improved tensile strength and breaking elongation, and improved joint strength and is stable.
  • the inner catheter 30 rubs against the inner wall surface of the guiding catheter 20 when being inserted into and removed from the guiding catheter 20.
  • the wedge part 77 is covered with the covering part 76, the wedge part 77 covering the taper part 75 can be prevented from being peeled off from the taper part 75 due to friction.
  • the inner catheter 30 has the taper part 75 in the connection part 73, a physical property changes gradually along an axial direction in the range comparatively short in an axial direction. For this reason, when the inner catheter 30 curves, the force acting on the joint portion 73 is dispersed, and peeling of the joint portion 73 can be suppressed.
  • the distance D1 from the proximal apex 78 which is the proximal end of the wedge 77 to the inner peripheral surface of the inner catheter 30 is larger than the distance D2 from the proximal apex 78 to the outer peripheral surface of the inner catheter 30. .
  • the ratio of the covering portion 76 that covers the flexible distal tubular portion 71 does not become too large with respect to the tapered portion 75, and it is possible to suppress the separation between the distal tubular portion 71 and the covering portion 76. That is, if the distance D2 is greater than or equal to the distance D1, the covering portion 76 becomes large and the tapered portion 75 existing inside the covering portion 76 becomes short.
  • At least one of the guiding catheter body 40 and the inner catheter body 70 may be configured to be curved.
  • the inner catheter 30 is a second one that covers the inner peripheral surface of the distal tubular portion 141 from the radially inner side with respect to the inner peripheral surface of the proximal tubular portion 142.
  • the covering portion 143 may be formed.
  • the part which has a function common to the above-mentioned embodiment is attached
  • the second covering portion 143 is formed, it is peeled between the distal tubular portion 141 and the proximal tubular portion 142 by friction with a device such as a guide wire or a balloon catheter that passes through the lumen of the inner catheter 140. Can be suppressed.
  • the covering portion 153 may have a protruding portion 154 protruding radially inward at the distal end portion.
  • a first tube and a second tube having an inner diameter of 1.15 mm and an outer diameter of 2.10 mm were prepared.
  • the constituent material of the first tube was a polyester elastomer having a melting point of 182 ° C.
  • the constituent material of the second tubular body was a polyester elastomer having a melting point of 222 ° C.
  • a cored bar was inserted into the second tubular body, and the end of the second tubular body was pushed into the mold to form a tapered portion having an axial length of 3 mm. Thereafter, the taper portion was inserted into the lumen of the first tube, and the first tube and the second tube were covered with a heat-shrinkable tube and heated to prepare the sample of Example 1.
  • Example 2 was manufactured under the same conditions as in Example 1 except that the length of the taper portion in the axial direction was 5 mm.
  • Table 1 shows the conditions of Examples 1 and 2.
  • Example 1 the tensile strength and breaking elongation of the specimens of Example 1 and Example 2 were measured with a tensile tester. The results are shown in FIG. As a result, the tensile strength and breaking elongation are larger in Example 1 in which the length of the tapered portion is 5 mm than in Example 2 in which the length of the tapered portion is 3 mm, and high fusion strength (joining strength) is obtained. It was confirmed that ⁇ Verification of fusion strength>
  • the specimens of Examples 3 and 4 were manufactured with the length of the taper portion in the axial direction being 5 mm.
  • the inner diameters of the specimens of Examples 3 and 4 were 1.15 mm, and the outer diameter was 2.10 mm.
  • the constituent materials of the first tube and the second tube of Examples 3 and 4 were polyester elastomers having melting points and hardnesses shown in Table 1. The polyester elastomer had higher hardness as the grade was different and the melting point was higher.
  • the tapered portion of the second tubular body is inserted into the lumen of the first tubular body, the first tubular body and the second tubular body are covered with a heat-shrinkable tube, and heated. Specimens were prepared. Moreover, specimens of Comparative Examples 1 and 2 were produced under the same conditions as in Examples 3 and 4 except that the tapered portion was not provided.
  • Example 3 having a tapered portion has higher tensile strength and elongation at break, and higher fusion strength can be obtained. It was.
  • Example 4 having a taper portion has a higher tensile strength and elongation at break and a higher fusion strength. .
  • FIG. 13 shows a photograph of the cross section taken by cutting the specimen of Example 4 along the central axis. As shown in FIG. 13, it was confirmed that a wedge portion was formed on the radially outer side of the tapered portion, and a covering portion was formed on the radially outer side of the wedge portion.

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  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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Abstract

La présente invention concerne un cathéter et un procédé de production d'un cathéter qui permet de maintenir une force de liaison favorable entre matériaux de résine de duretés différentes sur un côté distal et un côté proximal, ainsi que d'empêcher efficacement le décollement d'une jonction. Un cathéter interne (30) est disposé dans une lumière d'un cathéter de guidage (20) de façon à pouvoir être retiré, et est utilisé conjointement avec le cathéter de guidage (20). Le cathéter interne (30) comprend une section tubulaire distale (71) qui est constituée de résine et située sur un côté distal, et une section tubulaire proximale (72) qui est constituée d'une résine d'une dureté supérieure à celle de la section tubulaire distale (71) et qui a une section d'extrémité côté distal qui est reliée à une section d'extrémité côté proximal de la section tubulaire distale (71). La section d'extrémité côté distal de la section tubulaire proximale (72) comprend : une section conique (75) qui diminue progressivement vers le côté distal vers le côté distal et qui est située sur le côté radial intérieur de la section tubulaire distale (71) ; et une section de couverture (76) qui fait saillie vers le côté distal à partir d'un site côté proximal de la section conique (75) et qui entoure le côté radial extérieur de la section d'extrémité côté proximal de la section tubulaire distale (71). La section tubulaire distale (71) inclut une section de cale (77) encadrée par la section conique (75) et la section de couverture (76).
PCT/JP2017/031134 2016-11-21 2017-08-30 Cathéter et procédé de production de cathéter Ceased WO2018092386A1 (fr)

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CN109173012A (zh) * 2018-11-14 2019-01-11 苏州海维尔医疗器械有限公司 防划伤超滑导丝、其包覆方法及包覆设备
JPWO2020255736A1 (fr) * 2019-06-19 2020-12-24
CN113827842A (zh) * 2021-11-29 2021-12-24 艾柯医疗器械(北京)有限公司 一种医用导管及其制备方法
JP2022522318A (ja) * 2018-06-01 2022-04-18 パットコム メディカル インコーポレイテッド カテーテルおよびチューブイントロデューサ
WO2023176702A1 (fr) * 2022-03-17 2023-09-21 株式会社カネカ Tube, méthode de fabrication de tube, cathéter et appareil de transport à corps tubulaire à usage médical
JP2024502031A (ja) * 2020-12-31 2024-01-17 マイクロポート・ニューロテック（シャンハイ）・カンパニー・リミテッド カテーテルおよびカテーテル遷移構造体を準備する方法
WO2024071118A1 (fr) * 2022-09-29 2024-04-04 テルモ株式会社 Corps allongé médical et cathéter à ballonnet
JP2024538264A (ja) * 2021-10-28 2024-10-18 アビオメド インコーポレイテッド 薄型のアクセスシース
WO2025100516A1 (fr) * 2023-11-10 2025-05-15 テルモ株式会社 Cathéter pour acquisition d'image

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US4636272A (en) * 1985-02-19 1987-01-13 Cordis Corporation Process for thermally bonding plastic tubes
JP2000005319A (ja) * 1988-10-13 2000-01-11 Terumo Corp カテ―テルの製造方法およびカテ―テル
US6436056B1 (en) * 1996-02-28 2002-08-20 Boston Scientific Corporation Polymeric implements for torque transmission
JP2007175440A (ja) * 2005-12-28 2007-07-12 Nipro Corp カテーテルおよびその加工方法
JP2007202979A (ja) * 2006-02-06 2007-08-16 Kaneka Corp 医療用ガイディングカテーテルチューブ
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Publication number Priority date Publication date Assignee Title
JP7412425B2 (ja) 2018-06-01 2024-01-12 パットコム メディカル インコーポレイテッド カテーテルおよびチューブイントロデューサ
JP2022522318A (ja) * 2018-06-01 2022-04-18 パットコム メディカル インコーポレイテッド カテーテルおよびチューブイントロデューサ
US11737656B2 (en) 2018-06-01 2023-08-29 PatCom Medical Inc. Catheter and tube introducer
CN109173012A (zh) * 2018-11-14 2019-01-11 苏州海维尔医疗器械有限公司 防划伤超滑导丝、其包覆方法及包覆设备
JPWO2020255736A1 (fr) * 2019-06-19 2020-12-24
JP7444879B2 (ja) 2019-06-19 2024-03-06 株式会社カネカ カテーテル、及びカテーテルの製造方法
JP2024502031A (ja) * 2020-12-31 2024-01-17 マイクロポート・ニューロテック（シャンハイ）・カンパニー・リミテッド カテーテルおよびカテーテル遷移構造体を準備する方法
JP7741322B2 (ja) 2021-10-28 2025-09-17 アビオメド インコーポレイテッド 薄型のアクセスシース
JP2024538264A (ja) * 2021-10-28 2024-10-18 アビオメド インコーポレイテッド 薄型のアクセスシース
US12589224B2 (en) 2021-10-28 2026-03-31 Abiomed, Inc. Low profile access sheaths
CN113827842A (zh) * 2021-11-29 2021-12-24 艾柯医疗器械(北京)有限公司 一种医用导管及其制备方法
WO2023176702A1 (fr) * 2022-03-17 2023-09-21 株式会社カネカ Tube, méthode de fabrication de tube, cathéter et appareil de transport à corps tubulaire à usage médical
WO2024071118A1 (fr) * 2022-09-29 2024-04-04 テルモ株式会社 Corps allongé médical et cathéter à ballonnet
WO2025100516A1 (fr) * 2023-11-10 2025-05-15 テルモ株式会社 Cathéter pour acquisition d'image

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