WO2024038595A1 - Corps allongé à usage médical et cathéter - Google Patents

Corps allongé à usage médical et cathéter Download PDF

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Publication number
WO2024038595A1
WO2024038595A1 PCT/JP2022/031425 JP2022031425W WO2024038595A1 WO 2024038595 A1 WO2024038595 A1 WO 2024038595A1 JP 2022031425 W JP2022031425 W JP 2022031425W WO 2024038595 A1 WO2024038595 A1 WO 2024038595A1
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WIPO (PCT)
Prior art keywords
tip
curved
distal
medical elongated
distal end
Prior art date
Application number
PCT/JP2022/031425
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English (en)
Japanese (ja)
Inventor
佑軌 加藤
直人 浅野
Original Assignee
朝日インテック株式会社
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 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Priority to PCT/JP2022/031425 priority Critical patent/WO2024038595A1/fr
Publication of WO2024038595A1 publication Critical patent/WO2024038595A1/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
    • 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
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a medical elongate body and a catheter.
  • Patent Document 1 discloses a guide wire in which the rigidity of the distal end side can be changed by moving a cylindrical body provided on the outside of the core shaft relative to the core shaft.
  • Patent Document 2 discloses a catheter having a pre-shaped distal end portion.
  • the present invention has been made to solve at least part of the above-mentioned problems, and is a technology that enables a medical elongated body and catheter, which are a type of medical device, to move smoothly inside a blood vessel.
  • the purpose is to provide.
  • the present invention has been made to solve at least part of the above-mentioned problems, and can be realized as the following forms.
  • a medical elongate body includes an inner guide wire and a hollow exterior body surrounding the outer peripheral surface of the inner guide wire, and the exterior body is provided at the distal end of the exterior body body and the exterior body body. and a hollow distal tip, wherein the exterior body main body includes a reinforcing body and a resin layer covering the reinforcing body, and the distal tip is located closer to the distal end than the distal end of the reinforcing body.
  • the exterior body main body includes a curved portion that is curved with respect to the axial direction of the exterior body main body, and the tip of the curved portion is inclined at an angle within a range of 15 degrees or more and 30 degrees or less with respect to the axial direction of the exterior body body. are doing.
  • the distal tip of the sheath that surrounds the outer peripheral surface of the inner guide wire includes a curved portion that is curved with respect to the axial direction of the sheath body, and the tip of the curved portion is connected to the sheath. It is inclined at an angle within a range of 15 degrees or more and 30 degrees or less with respect to the axial direction of the main body. For this reason, when a medical long body is pushed through a curved blood vessel, it is easy to align the outside part of the curved part with the outside part of the curved shape of the blood vessel. The medical elongated body can be pushed forward while rotating the exterior body.
  • a point of the tip of the curved portion located inside the curved shape is defined as a first position
  • an imaginary line is defined by virtually extending a line located on the opposite side to the side of the first position among the lines defining the outer periphery of the exterior body body toward the tip side.
  • the distance from the first position to the second position is within the range of 1.5 mm or more and 4 mm or less, when the medical elongated body is pushed through the curved blood vessel, This makes it easier to align the curved portion with the outer portion of the curved shape of the blood vessel.
  • the outer diameter of the distal tip may gradually become smaller from the proximal end toward the distal end. According to this configuration, the flexibility of the distal end side of the distal tip can be increased while reducing the rigidity gap between the distal end portion of the exterior body main body and the proximal end portion of the distal tip.
  • the distal tip may be formed of resin kneaded with an impermeable material. According to this configuration, since a relatively hard impermeable material is kneaded into the entire resin forming the distal tip, it is possible to prevent the distal tip from hardening and to prevent medical use when inserted into a blood vessel, etc. It becomes possible to grasp the position of the distal tip in the elongated body.
  • the distal tip is formed of resin, and the length of the distal tip along the axial direction of the exterior body body is within a range of 2 mm or more and 8 mm or less. It may be the length of According to this configuration, since the length of the distal tip is relatively long, the curved portion included in the distal tip can also be provided relatively long. Therefore, when the medical elongated body is pushed through a curved blood vessel, it is possible to make the curved part more easily follow the curved outer part of the blood vessel, and it is possible to branch out from the curved outer part of the blood vessel. It is possible to prevent the curved portion from getting caught at the branch point of the blood vessel.
  • a catheter is provided.
  • This catheter includes a hollow shaft having a lumen through which a guide wire can be inserted, and a distal tip provided on the distal side of the hollow shaft and having a distal lumen connected to the lumen, and the distal tip has a distal lumen connected to the lumen.
  • a curved portion curved with respect to the axial direction of the hollow shaft is included on the distal end side of the distal end portion of the hollow shaft.
  • the distal tip includes a curved portion that is curved with respect to the axial direction of the hollow shaft. For this reason, when a catheter is pushed through a curved blood vessel, it is easy to align the outside part of the curved part with the outside part of the curved shape of the blood vessel, so the catheter is rotated so that it follows the outside part of the curved shape of the blood vessel. You can push forward while doing so.
  • the guide wire since a long member inserted into a curved tube is generally pressed against the outer side of the inner peripheral surface of the curved tube, the guide wire is inserted into the distal lumen of the catheter of this configuration. Even when inserted, the guidewire is pressed against the outer portion of the inner peripheral surface of the distal lumen.
  • the clearance between the outer circumferential surface of the guide wire and the inner circumferential surface of the distal end lumen can be reduced at the outer portion of the distal end of the curved portion. Therefore, when a catheter of this configuration with a guide wire inserted therein is pushed through a curved blood vessel, even if there is a blood vessel that branches from the outside of the curved blood vessel, the curve will appear at the branch point of the branched blood vessel. Since the outer part of the distal end of the catheter can be suppressed from getting caught, the catheter of this configuration, through which the guide wire is inserted, can be smoothly pushed through the blood vessel.
  • the present invention can be realized in various forms, for example, in the form of a medical device including a medical elongated body and a catheter, a method for manufacturing a medical elongated body and a catheter, etc. can.
  • FIG. 1 is an explanatory diagram illustrating a cross-sectional configuration of a medical elongated body 1 according to a first embodiment. It is an explanatory view of details of a composite coil body.
  • FIG. 2 is an enlarged explanatory diagram of the distal end portion of the medical elongated body 1.
  • FIG. FIG. 2 is an enlarged explanatory view of the appearance of the distal end of the medical elongated body.
  • FIG. 2 is an explanatory diagram showing the behavior of a medical elongated body being pushed through a blood vessel.
  • FIG. 2 is an explanatory diagram showing the behavior of a medical elongated body being pushed through a blood vessel.
  • FIG. 2 is an explanatory diagram showing the behavior of a medical elongated body being pushed through a blood vessel.
  • FIG. 7 is an enlarged explanatory diagram of the distal end portion of the medical elongated body of the second embodiment. It is an explanatory view which expanded a tip part of a medical elongate body of a 3rd embodiment. It is an explanatory view which expanded a tip part of a medical elongate body of a 4th embodiment.
  • FIG. 7 is an explanatory diagram illustrating a cross-sectional configuration of a catheter according to a fifth embodiment.
  • FIG. 1 is an explanatory diagram illustrating a cross-sectional configuration of a medical elongated body 1 according to the first embodiment.
  • the connector 46 of the medical elongated body 1 is shown externally, and other members other than the connector 46 are shown in longitudinal section.
  • the medical elongated body 1 of this embodiment is a medical device that is inserted into a blood vessel and used when a catheter is inserted into a living body lumen such as a blood vessel.
  • the medical elongated body 1 includes blood vessels such as cardiovascular and cerebrovascular vessels, as well as biological ducts such as lymphatic system, biliary tract system, urinary tract system, respiratory tract system, digestive system, secretory glands and reproductive organs. It can be configured as a medical device used when inserting a catheter into a cavity.
  • the axis line O (dotted chain line) shown in FIG. 1 is an axis that passes through the center of a portion closer to the proximal end than a curved portion 26R (see FIG. 1), which will be described later, among the axis passing through the center of the medical elongated body 1. , an axis passing through the center of the curved portion 26R and the portion on the tip side from the curved portion 26R is not shown.
  • FIG. 1 shows a longitudinal section including an axis passing through the center of the medical elongated body 1 and the tip of the curved portion 26R. In the example of FIG.
  • FIG. 1 shows XYZ axes that are orthogonal to each other.
  • the X axis corresponds to the axial direction of the medical long body 1 (the insertion direction of the medical long body 1)
  • the Y axis corresponds to the width direction of the medical long body 1
  • the Z axis corresponds to the medical long body 1. It corresponds to the height direction of the body 1.
  • FIG. 1 (+X-axis direction) is called the "tip side” of the medical long body 1 and each component, and the right side of FIG. 1 (-X-axis direction) is the “tip side” of the medical long body 1 and each component. This is called the "proximal side.”
  • the end located on the distal side and the vicinity thereof is referred to as the “distal end” or simply “the tip”
  • the end located on the proximal side and the vicinity thereof is referred to as the "distal end” or simply "tip”.
  • ⁇ proximal end'' or simply ⁇ proximal end.''
  • the distal end of the medical elongated body 1 is a part that is inserted into a living body, and the proximal end is a part that is operated by an operator such as a doctor.
  • the medical elongated body 1 includes an inner guide wire 10, an exterior body 20, a proximal engaging portion 34, and a grip portion 40.
  • the inner guide wire 10 includes a core wire 12 , a distal end coil body 14 , a distal end joint portion 16 , and an inner joint portion 18 .
  • the core wire 12 is a long (tapered) member configured such that its outer diameter decreases from the proximal end toward the distal end.
  • the core wire 12 can be made of materials such as stainless steel alloys (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, piano wire, nickel-chromium alloys, cobalt alloys, tungsten, and the like.
  • the core wire 12 may be made of known materials other than those mentioned above.
  • the distal end coil body 14 is a substantially cylindrical coil body having a substantially constant outer diameter from the proximal end side to the distal end side.
  • the tip coil body 14 is wound around the core wire 12 so as to cover the outer periphery of the tip side of the core wire 12.
  • the tip coil body 14 is a single coil formed by winding one strand into a single thread.
  • the tip coil body 14 may be a multi-filament coil formed by winding a plurality of wires into multiple threads, or may be formed by winding a stranded wire obtained by twisting a plurality of wires together into a single thread.
  • It may be a single stranded wire coil, or a multi-stranded wire coil formed by using a plurality of stranded wires made by twisting a plurality of strands together and winding each stranded wire into multiple threads.
  • the tip joint portion 16 joins the core wire 12 and the tip of the tip coil body 14.
  • the inner joint portion 18 joins the core wire 12 and the base end of the distal end coil body 14 .
  • the tip joint portion 16 and the inner joint portion 18 are formed of any bonding agent, for example, metal solder such as silver solder, gold solder, zinc, Sn--Ag alloy, Au--Sn alloy, or the like.
  • the tip joint portion 16 and the inner joint portion 18 may be formed of an adhesive such as an epoxy adhesive.
  • the exterior body 20 is a hollow member that surrounds the outer peripheral surface of the inner guide wire 10.
  • the exterior body 20 is not fixed to the inner guide wire 10 and is configured to be able to reciprocate along the inner guide wire 10.
  • the exterior body 20 is configured to be rotatable about the inner guide wire 10 as a rotation axis.
  • the exterior body 20 has an exterior body body 22 and a distal tip 26.
  • the exterior body main body 22 has a lumen 22L through which the inner guide wire 10 is inserted.
  • the exterior body main body 22 includes a reinforcing body 23 and a resin layer 25.
  • the reinforcing body 23 is a composite coil body in which a proximal end coil body 23r and a distal end coil body 23f are engaged and joined.
  • FIG. 2 is a detailed explanatory diagram of the composite coil body.
  • FIG. 2(A) shows a longitudinal section of a multi-thread coil body MT1 formed by winding a plurality of wires into multiple threads.
  • FIG. 2(B) shows a longitudinal section of the coil body TH1 after thinning out some of the wires forming the multi-filament coil body MT1. The positions of the thinned out strands are indicated by dashed circles and diagonal dashed lines connecting the dashed circles.
  • FIG. 2C shows an example of the cross section of the thinned-out coil body TH1, in which six strands of wire are thinned out from a multi-thread coil formed by winding 12 strands of wire into multiple strips. It shows a cross section of the body. In FIG. 2(C) as well, the positions of the thinned out wires are indicated by broken-line circles, similarly to FIG. 2(B).
  • FIG. 2(D) shows a longitudinal section of a composite coil body CC in which a thinned-out coil body TH2, which will be described later, is inserted into a thinned-out coil body TH1.
  • the thinned-out coil body TH2 is wedged in the thinned-out strand position of the thinned-out coil body TH1 (see FIG. 2(B)).
  • the thinned-out coil body TH2 is made of strands of the same diameter as the strands forming the multi-strand coil body MT1, the same number of strands as the multi-strand coil body MT1, the same outer diameter and the same as the multi-strand coil body MT1.
  • the same number of threads as the number of threads thinned out from the multi-thread coil body MT1 is used to produce the thinned-out coil body TH1.
  • This is a thinned-out coil body produced by thinning out the multi-thread coil body MT2. That is, the thinned-out coil body TH1 and the thinned-out coil body TH2 correspond to coil bodies in which the same number of wires are thinned out from a multi-strand coil having the same outer diameter and the same pitch.
  • the wire forming the multi-thread coil body MT1 is a stranded wire
  • the strand diameter and twist angle of the stranded wire used for producing the multi-thread coil body MT2 are the same as those forming the multi-thread coil body MT1.
  • the strands are twisted together so that the strand diameter and twist angle are the same as those of the stranded wires.
  • FIG. 2(E) shows a coil body after thinning out 6 strands from a multi-strand coil formed by winding 12 strands of strands into multiple strands.
  • a cross section of a composite coil body in which another similar coil body is inserted is shown.
  • the proximal end coil body 23r is a coil body in which the wires are thinned out only at the distal end portion.
  • the tip side coil body 23f is a coil body in which strands are thinned out throughout.
  • the proximal coil body 23r and the distal coil body 23f are joined by the distal end of the proximal coil body 23r and the proximal end of the distal coil body 23f biting into each other. Note that the proximal end coil body 23r and the distal end coil body 23f are fused together by YAG welding at a position where they are bitten into each other.
  • a resin layer 25 included in the exterior body main body 22 is formed of a resin material such as urethane, and is a layer that covers the reinforcing body 23 . Further, the outer surface of the resin layer 25 may be coated with a hydrophilic or hydrophobic resin.
  • the distal tip 26 is a hollow member made of resin and provided at the distal end of the exterior body main body 22.
  • the distal tip 26 has a lumen 26L through which the inner guide wire 10 is inserted.
  • the distal tip 26 includes a curved portion 26R that is curved with respect to the axial direction of the exterior body main body 22 on the distal end side of the distal end portion of the reinforcing body 23.
  • the curved portion 26R is a portion of the distal tip 26 from a position on the proximal side of the center in the X-axis direction to the tip (see FIG. 1), and the entire curved portion 26R is curved in an arc shape. .
  • curved includes not only the gently curved shape shown in FIG. Also included.
  • the distal tip 26 has an outer diameter that gradually decreases from the proximal end toward the distal end, and is made of resin kneaded with an impermeable material. Details of the curved portion 26R will be described later using FIG. 3.
  • the grip portion 40 is joined to the base end portion of the exterior body 20.
  • the inner guide wire 10 is inserted inside the gripping portion 40 .
  • the gripping portion 40 is not fixed to the inner guide wire 10, and is capable of reciprocating along the inner guide wire 10 together with the exterior body 20. It is configured to be rotatable.
  • the grip section 40 includes a protector 42, a main body section 44, and a connector 46.
  • the protector 42 has a tapered shape whose outer diameter increases toward the proximal end.
  • a distal opening 42o formed on the distal side of the protector 42 is an opening through which the inner guide wire 10 is inserted.
  • the main body part 44 is a member that connects the protector 42 and the connector 46 and is a part that is held by a technician such as a doctor.
  • the narrowed portion 44o formed inside the main body portion 44 is a portion of the inner diameter of the main body portion 44 that is narrowed.
  • the connector 46 is threaded on the inner peripheral side and can be connected to other medical equipment such as a syringe (not shown).
  • the proximal end engaging portion 34 is an annular (ring-shaped) member fixed to the outer periphery of the proximal end of the core wire 12.
  • the proximal engaging portion 34 is a protrusion protruding from the outer periphery of the core wire 12 .
  • the outer diameter of the proximal engaging portion 34 is smaller than the inner diameter of the distal tip 26 (the diameter of the lumen 26L) and larger than the inner diameter of the narrowed portion 44o. Therefore, when the exterior body 20 and the gripping part 40 move in the distal direction (+X-axis direction in FIG. 1) relative to the inner guide wire 10, the proximal engaging part 34 engages with the narrowing part 44o. engage (contact).
  • the proximal engaging portion 34 restricts movement of the sheath 20 and the gripping portion 40 along the inner guide wire 10. Further, when the exterior body 20 and the gripping part 40 move in the proximal direction (-X axis direction in FIG. 1) relative to the inner guide wire 10, the proximal engaging part 34 moves through the lumen 26L. Since the inner guide wire 10 can pass through the inside of the inner guide wire 10, movement of the outer sheath 20 and the grip part 40 along the inner guide wire 10 is not restricted.
  • FIG. 3 is an enlarged explanatory view of the distal end portion of the medical elongated body 1 shown in FIG. 1.
  • FIG. 1 shows a longitudinal section including the axis passing through the center of the medical elongated body 1 (that is, the axis of the exterior body body 22) and the tip of the curved part 26R
  • FIG. 3 also shows a similar longitudinal section.
  • the tip of the curved portion 26R is within a range of 15 degrees or more and 30 degrees or less with respect to the axial direction of the outer body main body 22. It is designed to be inclined at an angle ⁇ within.
  • the axis of the exterior body 22 coincides with the axis passing through the center of the medical elongated body 1, so the axial direction of the exterior body 22 coincides with the direction in which the axis O extends.
  • the axis O is an axis passing through the center of the medical elongated body 1, and passing through the center of the portion closer to the proximal end than the curved portion 26R.
  • the angle ⁇ is represented by the angle formed by this axis O and a tangent line TL shown by a broken line in FIG.
  • the tangent TL is a tangent at a position P0 in the longitudinal section of FIG.
  • the outside of the curved shape is the side of the curved shape that is convex.
  • the inside of the curved shape is the concave side of the curved shape.
  • the inside of the curved shape is the side where the center of curvature of the curve is located when viewed from the curved shape (the side marked with the symbol "26R" in FIG. 3)
  • the outside of the curved shape is the side where the center of curvature is located when viewed from the curved shape. This is the opposite side to the side where the center of curvature of the curve is located.
  • a point located inside the curved shape among the tips of the curved portions 26R is defined as a first position P1
  • a point located at the first position P1 among the lines defining the outer periphery of the exterior body body 22 is defined as a first position P1.
  • a virtual line VL is defined by virtually extending a line located on the opposite side (i.e., the outside of the curved shape) toward the tip side, and from the virtual line VL and the first position P1 to the virtual line VL.
  • the distance D from the first position P1 to the second position P2 is within the range of 1.5 mm or more and 4 mm or less.
  • the length of the distal tip 26 along the axial direction (axis O) of the exterior body main body 22 is within a range of 2 mm or more and 8 mm or less.
  • FIG. 4(A) is an explanatory diagram showing an enlarged appearance of the distal end portion of the medical elongated body 1.
  • the portion of the inner guide wire 10 of the ulnar body 1 that is inserted through the curved portion 26R is also pressed against the outer side of the inner circumferential surface of the curved portion 26R (corresponding to the lumen 26L in FIGS. 1 and 3).
  • FIG. 4(B) is an explanatory diagram enlarging the appearance of the distal end portion of the medical elongated body 1P of the comparative example.
  • the configuration of the medical elongate body 1P is the same as that of the medical elongate body 1 of this embodiment, except that the distal tip 26 does not include the curved portion 26R.
  • the distal tip 26 does not include the curved portion 26R, so that the portion of the inner guide wire 10 that is inserted through the distal tip 26 is attached to the inner circumferential surface of the distal tip 26 (see FIG. , 3 (equivalent to 26L of lumen). Therefore, a large clearance CL is likely to occur between the outer circumferential surface of the inner guide wire 10 and the inner circumferential surface of the distal tip 26 at the outer portion of the distal end of the distal tip 26.
  • FIG. 5(A) is an explanatory diagram showing the behavior of the medical elongated body 1 being pushed through the curved blood vessel VE.
  • the medical elongate body 1 supports delivery of the catheter CA.
  • the outer part of the curved portion 26R is easily aligned with the curved outer part of the blood vessel VE.
  • the medical elongated body 1 can be pushed forward while rotating the body 20.
  • the inner guide wire 10 is connected to the outer portion of the distal end of the curved portion 26R, as explained in FIG. 4(A). Since the clearance CL between the outer circumferential surface and the inner circumferential surface of the curved portion 26R (corresponding to the lumen 26L in FIGS. 1 and 3) can be reduced, the curved portion 26R is placed at the branch point BP of the blood vessel VE and the blood vessel BR. This can prevent the outer part of the tip from getting caught.
  • FIG. 5(B) is an explanatory diagram showing the behavior of the medical elongated body 1P of the comparative example that is pushed through the curved blood vessel VE.
  • the medical elongated body 1P supports delivery of the catheter CA.
  • the medical elongated body 1P is pushed through the blood vessel VE, as explained in FIG. Since a large clearance CL is likely to occur between the tip and the surface (corresponding to the lumen 26L in FIGS. 1 and 3), there is a possibility that the outer portion of the tip of the distal tip 26 may get caught in the branch point BP.
  • the distal end of the curved portion 26R is prevented from getting caught in the branch point BP.
  • the body 1 can be smoothly pushed forward within the blood vessel VE.
  • FIG. 6 is an explanatory diagram showing the behavior of the medical elongated body 1 being pushed through the meandering blood vessel ME.
  • the medical elongated body 1 In the vicinity of the curved portions CP1 to CP3 of the blood vessel ME, the medical elongated body 1 is shown enlarged as it is pushed through the curved portions CP1 to CP3.
  • the medical elongated body 1 rotates and pushes toward the back side of the blood vessel ME so that the outer part of the tip follows the medical elongated body 1.
  • a marker MK is attached to the tip of each long medical body 1, but this is done to make it easier to visually recognize the rotation of the long medical body 1. It is assumed that the marker MK is not attached to the actual medical long body 1.
  • the medical elongated body 1 of the first embodiment when the medical elongated body 1 is pushed through a curved blood vessel, as explained in FIGS. Since the outer portion of the curved portion 26R can be easily aligned with the outer portion of the curved shape, the medical elongated body 1 can be pushed forward while rotating the exterior body 20 so as to follow the outer portion of the curved shape of the blood vessel.
  • the curved portion 26R of the medical long body 1 since a long member inserted into a curved tube is generally pressed against the outer side of the inner circumferential surface of the curved tube, the curved portion 26R of the medical long body 1 The portion of the inner guide wire 10 that is inserted through the inner guide wire 10 is also pressed against the outer portion of the inner circumferential surface of the curved portion 26R (corresponding to the lumen 26L in FIGS. 1 and 3). Therefore, the clearance CL (see FIG. 4(B)) between the outer circumferential surface of the inner guide wire 10 and the inner circumferential surface of the curved portion 26R can be reduced in the outer portion of the distal end of the curved portion 26R. Therefore, as explained in FIG.
  • the distance to the second position P2 is within a range of 1.5 mm or more and 4 mm or less. Therefore, when the medical elongated body 1 is pushed through the curved blood vessel, the curved portion 26R can be more easily aligned with the outside portion of the curved shape of the blood vessel.
  • the outer diameter of the distal tip 26 gradually decreases from the proximal end toward the distal end. Therefore, the flexibility of the distal end side of the distal tip 26 can be increased while reducing the rigidity gap between the distal end of the exterior body body 22 and the proximal end of the distal tip 26.
  • the distal tip 26 is formed of resin mixed with an impermeable material. For this reason, since a relatively hard impermeable material is kneaded into the entire resin forming the distal tip 26, the hardening of the distal tip 26 is suppressed and the medical length is maintained when inserted into a blood vessel or the like. It becomes possible to grasp the position of the distal tip 26 in the ulnar body 1.
  • the length of the distal tip 26 along the axial direction of the exterior body main body 22 is within the range of 2 mm or more and 8 mm or less. . Therefore, since the length of the distal tip 26 is relatively long (existing distal tips are approximately 0.5 to 1.0 mm), the curved portion 26R included in such a distal tip 26 should also be provided relatively long. Can be done. Therefore, when the medical elongated body 1 is pushed through the curved blood vessel, the curved portion 26R can be more easily aligned with the curved outer portion of the blood vessel, and the curved outer portion of the blood vessel can be more easily aligned. It is possible to prevent the curved portion 26R from getting caught at a branch point of a blood vessel (see FIG. 6) branching from the tube.
  • FIG. 7 is an enlarged explanatory view of the distal end portion of the medical elongated body 1A of the second embodiment.
  • the medical elongated body 1A of the second embodiment is different from the medical elongated body 1 (FIG. 1) of the first embodiment in that it includes a distal tip 26a different from the distal tip 26 of the first embodiment. different.
  • the curved portion 26Ra included in the distal tip 26a of the second embodiment is a portion from the bending position of the distal tip 26a to the tip. As shown in FIGS. 1 and 3, the curved portion 26R included in the distal tip 26 of the first embodiment was entirely curved in an arc shape, but the curved portion 26Ra included in the distal tip 26a of the second embodiment is From the bent position, the tip side is not curved in an arc but extends in a straight line. Further, the outer diameter of the distal tip 26a gradually decreases from the proximal end toward the distal end, similarly to the distal tip 26 of the first embodiment.
  • the medical elongated body 1A of the second embodiment as described above can also provide the same effects as those of the first embodiment.
  • FIG. 8 is an enlarged explanatory diagram of the distal end portion of the medical elongated body 1B of the third embodiment.
  • the medical elongated body 1B of the third embodiment is different from the medical elongated body 1 (FIG. 1) of the first embodiment in that it includes a distal tip 26b different from the distal tip 26 of the first embodiment. different.
  • the curved portion 26Rb included in the distal tip 26b of the third embodiment is located at a position on the proximal side of the distal tip 26b from the center in the X-axis direction. It is the part from the tip to the tip, and the whole is curved in an arc shape.
  • the curved portion 26R of the first embodiment has an outer diameter that gradually decreases from the proximal end to the distal end, but the curved portion 26Rb of the third embodiment , the outer diameter is approximately constant from the proximal end to the distal end.
  • FIG. 9 is an enlarged explanatory diagram of the distal end portion of the medical elongated body 1C of the fourth embodiment.
  • the medical elongated body 1C of the fourth embodiment is different from the medical elongated body 1B (FIG. 7) of the second embodiment in that it includes a distal tip 26c that is different from the distal tip 26a of the second embodiment. different.
  • the curved portion 26Rc included in the distal tip 26c of the fourth embodiment is a portion from the position where the distal tip 26c is bent to the tip.
  • the curved portion 26Ra of the second embodiment has an outer diameter that gradually decreases from the proximal end to the distal end, but the curved portion 26Rc of the fourth embodiment has an outer diameter that gradually decreases from the proximal end to the distal end. The outer diameter is approximately constant from the end side to the tip side.
  • the medical elongated body 1C of the fourth embodiment as described above can also provide the same effects as those of the first embodiment.
  • FIG. 10 is an explanatory diagram illustrating a cross-sectional configuration of a catheter 50 of the fifth embodiment.
  • FIG. 10 shows a longitudinal section including an axis passing through the center of the catheter 50 and a tip of a curved portion 70R, which will be described later.
  • the connector 86 of the catheter 50 is shown externally, and other members other than the connector 86 are shown in longitudinal cross section.
  • the axis O (dotted chain line) shown in FIG. 10 is an axis passing through the center of the catheter 50 and passing through the center of a portion closer to the proximal end than a curved portion 70R, which will be described later.
  • the axis passing through the center of the catheter 50 coincides with the axis passing through the centers of each member constituting the catheter 50.
  • Catheter 50 includes a hollow shaft 60, a distal tip 70, and a grip portion 80.
  • the hollow shaft 60 has a lumen 60L through which a guide wire can be inserted.
  • Hollow shaft 60 includes an inner layer 62, a reinforcing layer 64, and an outer layer 66.
  • the inner layer 62 is a layer formed of resin, and a guide wire is inserted into the inner layer 62 .
  • the reinforcing layer 64 is a layer formed outside the inner layer 62.
  • the reinforcing layer 64 is a braided body (metal braid layer) in which strands are woven into a mesh shape. Note that the reinforcing layer 64 may be a coil body.
  • the outer layer 66 is a layer formed of resin and covers the inner layer 62 and the reinforcing layer 64.
  • the gripping part 80 is joined to the base end of the hollow shaft 60.
  • the grip portion 80 includes a protector 82, a main body portion 84, and a connector 86. Further, a distal opening 82o is formed at the distal end of the protector 82. Furthermore, a narrowed portion 84o is formed inside the main body portion 84.
  • the configurations of these gripping parts 80 are the same as those of the protector 42 (distal opening 42o), main body part 44 (narrowed part 44o), and connector 46 that the gripping part 40 of the first embodiment had, so the explanation will be omitted. Omitted.
  • the distal tip 70 is made of resin, is provided on the distal end side of the hollow shaft 60, and has a distal lumen 70L connected to the lumen 60L. Further, the distal tip 70 includes a curved portion 70R that is curved with respect to the axial direction of the hollow shaft 60 on the distal side of the distal end of the hollow shaft 60. Note that the angle of inclination of the distal end of the curved portion 70R with respect to the axial direction of the hollow shaft 60 (corresponding to the angle ⁇ in FIG. 3) can be set arbitrarily, but when the guide wire is inserted into the catheter 50, the angle becomes small.
  • the angle of inclination of the distal end of the curved portion 70R is 15 degrees when the guide wire is inserted, the inclination of the distal end of the curved portion 70R when the guide wire is not inserted is preferable.
  • the angle is set to be 15 degrees or more.
  • the distal tip 70 has an outer diameter that gradually decreases from the proximal end to the distal end, and is made of resin mixed with an impermeable material. ing. Furthermore, the length of the distal tip 70 along the axial direction (axis O) of the hollow shaft 60 is within a range of 2 mm or more and 8 mm or less.
  • the catheter 50 of the fifth embodiment described above similar to the medical elongated body 1 described with reference to FIGS. 5 and 6, when the catheter 50 is pushed through the curved blood vessel, Since the outer portion of the curved portion 70R can be easily aligned with the curved portion, the catheter 50 can be rotated and pushed along the outer portion of the curved shape of the blood vessel. Further, similarly to the medical elongated body 1 described in FIG. be forced to. Therefore, when the guide wire is inserted into the distal end lumen 70L, the clearance CL between the outer circumferential surface of the guide wire and the inner circumferential surface of the distal end lumen 70L can be reduced at the outer portion of the distal end of the curved portion 70R. .
  • a curved portion 70R is formed in the distal tip 70 made of resin.
  • a curved tip is provided in the catheter body.
  • the pre-shaped portion of a general catheter is curved when the guide wire is pulled toward the proximal end and the guide wire is not inserted into the distal end of the catheter, and becomes substantially straight when the guide wire is inserted.
  • the distal tip 70 is designed so that the inclination or curved shape at a predetermined angle is maintained even when the guide wire is inserted.
  • the reinforcing body 23 includes the distal end portion of the proximal coil body 23r in which the strands are thinned out only at the distal end portion, and the distal end coil body 23r in which the strands are thinned out in the entirety.
  • 23f is a composite coil body in which the base end portion and the base end portion are interlocked with each other, but the present invention is not limited to this.
  • the reinforcing body 23 includes a distal end portion of a proximal coil body in which strands are thinned out only at the distal end portion, a proximal end portion of a distal end coil body in which strands are thinned out only in the proximal end portion, It may be a composite coil body in which the wires are interdigitated with each other, or the distal end of the proximal coil body from which the strands are thinned out throughout, and the proximal end of the distal end coil body from which the strands are thinned out throughout. It may be a composite coil body in which the parts and part are interlocked with each other. Further, the reinforcing body 23 may be a single coil body instead of a composite coil body including two coil bodies, or may be a cylindrical body such as a tube made of resin or the like.
  • the entire curved portion is curved in an arc shape, or the distal end side extends linearly from the bent position, but the curved portion is not limited to this.
  • the curved portion may be curved in an arc shape, and the tip side of the arc portion may extend linearly.
  • the curved portion may extend in a straight line from the bent position on the distal end side, and may curve in an arc shape on the distal end side from the distal end portion of the linear portion.
  • the curved shape has an arcuate portion and a straight portion. They may be combined.
  • the outer diameter of the distal tip 70 gradually decreases from the proximal end to the distal end, but the present invention is not limited to this. The outer diameter may be substantially constant from the side toward the tip.
  • the inner guide wire 10 had the tip coil body 14, but the invention is not limited to this, and the inner guide wire 10 may not have the tip coil body 14. .
  • the distance D from the first position P1 to the second position P2 was within the range of 1.5 mm or more and 4 mm or less, but the distance D is not limited to this. , may be shorter than 1.5 mm or may be longer than 4 mm. Further, in the first to fourth embodiments, the length of the distal tip 26 along the axial direction (axis O) of the exterior body body 22 is within the range of 2 mm or more and 8 mm or less, but is not limited to this. However, it may be shorter than 2 mm or longer than 8 mm.
  • the length of the distal tip 26 along the axial direction (axis O) of the hollow shaft 60 may be shorter than 2 mm or longer than 8 mm.
  • the distal tips 26, 26a to 26c are made of resin kneaded with an impermeable material, but are not limited to this, and may be made of any arbitrary material.
  • the distal tip 70 may be formed of any material instead of resin kneaded with an impermeable material.
  • the exterior body main body 22 included the reinforcing body 23 and the resin layer 25, but may further include an inner layer inside the reinforcing body 23. Further, at least one of the reinforcing body 23 and the resin layer 25 may be configured such that the hardness or bending rigidity decreases from the proximal end side to the distal end side.
  • a syringe capable of supplying fluid to the inside of the reinforcing body 23 from the proximal end side of the reinforcing body 23 is attached to one of the gripping parts 40. It may be connected to the part.
  • the fluid supplied from the proximal end to the inside of the reinforcing body 23 is supplied to the medical elongated body 1 through the opening on the distal end side of the distal tip 26. released outside.
  • the inside of the medical elongated body 1 is flushed, and the relative movement and relative rotation of the exterior body 20 (and grip portion 40) is smoothed. It is possible to suppress a decline in sexual performance.
  • Modification 7 The configurations of the medical elongated bodies 1, 1A to C of the first to fourth embodiments and the configurations of the medical elongated bodies of Modifications 1 to 6 may be combined as appropriate. Furthermore, the configuration of the catheter 50 of the fifth embodiment and the configuration of the catheters of the second and fourth modified examples may be combined as appropriate.

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

Abstract

Selon l'invention, un corps allongé à usage médical comporte un fil de guidage interne, et une enveloppe externe creuse qui entoure la surface circonférentielle du fil de guidage interne. L'enveloppe externe possède un corps principal d'enveloppe externe et une pointe d'extrémité avant creuse située au niveau de l'extrémité avant du corps principal d'enveloppe externe. Le corps principal d'enveloppe externe contient un corps renforcé, et une couche de résine qui recouvre le corps renforcé. La pointe d'extrémité avant contient une partie incurvée qui s'incurve par rapport à la direction axiale du corps principal d'enveloppe externe, davantage côté extrémité avant que la partie extrémité avant du corps renforcé. La partie extrémité avant de la partie incurvée est inclinée par rapport à la direction axiale du corps principal d'enveloppe externe, dans un angle compris dans la plage 15 à 30 degrés.
PCT/JP2022/031425 2022-08-19 2022-08-19 Corps allongé à usage médical et cathéter WO2024038595A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2022/031425 WO2024038595A1 (fr) 2022-08-19 2022-08-19 Corps allongé à usage médical et cathéter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2022/031425 WO2024038595A1 (fr) 2022-08-19 2022-08-19 Corps allongé à usage médical et cathéter

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WO2024038595A1 true WO2024038595A1 (fr) 2024-02-22

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007190376A (ja) * 2005-12-27 2007-08-02 Cordis Corp 可変剛性ガイドワイヤ
US20090264980A1 (en) * 2008-04-17 2009-10-22 Mackay Allen B Device delivery catheter having a curved distal tip
WO2020225935A1 (fr) * 2019-05-07 2020-11-12 朝日インテック株式会社 Fil-guide
WO2022070540A1 (fr) * 2020-10-01 2022-04-07 朝日インテック株式会社 Cathéter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007190376A (ja) * 2005-12-27 2007-08-02 Cordis Corp 可変剛性ガイドワイヤ
US20090264980A1 (en) * 2008-04-17 2009-10-22 Mackay Allen B Device delivery catheter having a curved distal tip
WO2020225935A1 (fr) * 2019-05-07 2020-11-12 朝日インテック株式会社 Fil-guide
WO2022070540A1 (fr) * 2020-10-01 2022-04-07 朝日インテック株式会社 Cathéter

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