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WO2014207797A1 - Procédé de fabrication de dispositif médical, et dispositif médical - Google Patents

Procédé de fabrication de dispositif médical, et dispositif médical Download PDF

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Publication number
WO2014207797A1
WO2014207797A1 PCT/JP2013/067211 JP2013067211W WO2014207797A1 WO 2014207797 A1 WO2014207797 A1 WO 2014207797A1 JP 2013067211 W JP2013067211 W JP 2013067211W WO 2014207797 A1 WO2014207797 A1 WO 2014207797A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular body
medical device
welded portion
wire
welded
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/JP2013/067211
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English (en)
Japanese (ja)
Inventor
田中　速雄
兼政　賢一
山口　憲二郎
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Bakelite Co Ltd
Original Assignee
Sumitomo Bakelite Co Ltd
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 Sumitomo Bakelite Co Ltd filed Critical Sumitomo Bakelite Co Ltd
Priority to PCT/JP2013/067211 priority Critical patent/WO2014207797A1/fr
Publication of WO2014207797A1 publication Critical patent/WO2014207797A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires

Definitions

  • the present invention relates to a medical device manufacturing method and a medical device.
  • distal end As a typical example, for example, a catheter is known.
  • Patent Document 1 in order to bend the distal end portion of the catheter, a technique is adopted in which an operation wire is fixed to the distal end portion, and the distal end portion is bent by pushing / pulling the operation wire. Is disclosed.
  • the distal end portion of the catheter is required to be formed flexibly so that it can be easily bent.
  • the intermediate part of the catheter and the rear end part on the operation side (hereinafter referred to as “proximal end part”) require high torque transmission ability in the body cavity and transmission ability of the pushing force. There is a need to form.
  • the catheter of Patent Document 1 has a tubular main body formed by winding a flat wire in a coil shape.
  • the winding pitch of the wire rod at the distal end portion of the tubular body is set wider than the winding pitch of the wire rod at the proximal end portion of the tubular body, thereby improving the flexibility at the distal end portion of the catheter. The technology is described.
  • medical devices such as catheters may be configured to include multi-strand coils.
  • a multi-strand coil is a coiled tubular body configured by spirally winding a plurality of wire rods in a parallel state aligned in the winding axis direction (see Patent Document 2).
  • the present invention has been made in view of the above problems, and provides a method for manufacturing a medical device and a medical device that can easily manufacture a medical device such as a catheter having a long tubular body.
  • each of a plurality of wires constituting the multi-strand coil is partially melted to form a ring-shaped welded portion on the multi-strand coil.
  • Wires are welded and integrated (see FIGS. 19 and 20).
  • the welded portion is not located at the end of the multi-strand coil, the multi-strand coil is cut so that the ring-shaped welded portion is exposed at the end of the multi-strand coil.
  • one end of the other tubular body is connected to the welded portion of the multi-strand coil so that the other tubular body is connected to the multi-strand coil.
  • the other tubular body is also a multi-strip coil
  • a similar welded portion is formed on the other tubular body in advance, and the welded portion is exposed at the end of the other tubular body before connection.
  • the two welds of the multi-strand coils are connected to each other. As described above, a long tubular body can be easily produced.
  • the present inventor conducted various trials in order to suppress this swell and to connect the multi-strip coil to another tubular body while maintaining a straight line shape.
  • the present inventors have conceived the present invention for easily producing a long tubular body.
  • the present invention includes a step of forming a tubular body that is long and flexible and is inserted into a body cavity, Forming the tubular body comprises: Preparing a first tubular body that is a multi-strand coil configured by being spirally wound so that a plurality of wire rods are arranged in parallel in the winding axis direction; A step of welding the plurality of wires by partially melting each of the plurality of wires in a ring-shaped second welding portion that circulates around the first tubular body; Connecting one end of the second tubular body to the second welded portion so that the second tubular body is connected to the first tubular body; A method for manufacturing a medical device is provided.
  • the present invention includes a step of forming a tubular body that is long and flexible and is inserted into a body cavity, Forming the tubular body comprises: Preparing a first tubular body that is a multi-strand coil configured by being spirally wound so that a plurality of wire rods are arranged in parallel in the winding axis direction; In the first welding portion extending in a direction intersecting the circumferential direction of the first tubular body, each of the two or more adjacent wires is partially melted to weld the two or more wires to each other.
  • each of the plurality of wires constituting the first tubular body is partially melted at the ring-shaped second welded portion that circulates around the first tubular body, thereby welding the plurality of wires.
  • one end of the second tubular body is connected to the second welded portion so that the first tubular body and the second tubular body are connected.
  • a long tubular body can be easily produced with a high yield, and as a result, a medical device such as a catheter having such a tubular body can be easily produced with a high yield.
  • the first welded portion that extends in the direction intersecting the circumferential direction of the first tubular body is formed in advance.
  • the wire materials of a 1st tubular body can be welded and it can fix mutually. Therefore, it is possible to suppress the positional deviation between the wires when the second welded portion is subsequently formed, and as a result, it is possible to suppress the occurrence of periodic deflection (that is, swell) in the longitudinal direction of the first tubular body. be able to. That is, it is possible to easily create a long tubular body with good yield while suppressing the occurrence of swell.
  • the present invention has a tubular body that is long and flexible, and is inserted into a body cavity.
  • the tubular body is A first tubular body that is a multi-strand coil configured by being spirally wound so that a plurality of wire rods are arranged in parallel in the winding axis direction; A second tubular body connected to the first tubular body; Have In the first welding portion extending in the direction intersecting the circumferential direction of the first tubular body, two or more adjacent wires are welded, In the ring-shaped second welded portion that goes around one end of the first tubular body, the ends of the plurality of wires are welded together, One end of the second tubular body is connected to the second welded portion, and a medical device is provided.
  • the ends of the plurality of wire members constituting the first tubular body are welded, and the second welded portion is secondly connected. Since one end of the tubular body is connected, a medical device capable of easily creating a long tubular body with a high yield can be provided. Further, since the first welded portion extending in the direction intersecting the circumferential direction of the first tubular body is formed, a long tubular body can be easily created with high yield while suppressing the occurrence of undulation. Equipment can be provided.
  • a medical device such as a catheter having a long tubular body can be easily manufactured.
  • FIG. 1 It is a schematic diagram for demonstrating the process of the manufacturing method of the medical device which concerns on 1st Embodiment. It is a schematic diagram for demonstrating the process of the manufacturing method of the medical device which concerns on 1st Embodiment. It is a schematic diagram which shows the end surface of a ring-shaped 2nd welding part. It is a figure which shows a multi-strand coil. It is a schematic diagram which shows an example of a tubular main body. It is a longitudinal cross-sectional view which shows an example of the catheter manufactured by the manufacturing method of the medical device which concerns on 1st Embodiment. It is II-II sectional drawing of FIG. It is a typical longitudinal cross-sectional view for demonstrating operation
  • FIG. 3 is a diagram for explaining a method for manufacturing the medical device according to the first embodiment.
  • 6 is a diagram for explaining a method of manufacturing a medical device according to Example 2.
  • FIG. 6 is a diagram for explaining a method of manufacturing a medical device according to Example 3.
  • FIG. 6 is a diagram for explaining a method for manufacturing a medical device according to Embodiment 4.
  • FIG. 9 is a diagram for explaining a method for manufacturing a medical device according to a fifth embodiment.
  • 10 is a diagram for explaining a method for manufacturing a medical device according to Embodiment 6.
  • FIG. FIG. 10 is a diagram for explaining a method for manufacturing the medical device according to the seventh embodiment.
  • FIG. 10 is a diagram for explaining a method for manufacturing the medical device according to the eighth embodiment.
  • FIG. 10 is a diagram for explaining a method for manufacturing the medical device according to the ninth embodiment.
  • FIG. 10 is a diagram for explaining a manufacturing method of the medical device according to Example 10.
  • 10 is a diagram for explaining a method for manufacturing a medical device according to Example 11.
  • FIG. 10 is a diagram for explaining a manufacturing method of a medical device according to Example 12.
  • FIG. It is a schematic diagram for demonstrating the mechanism of the manufacturing method of the medical device which concerns on embodiment. It is a schematic diagram for demonstrating the mechanism of the manufacturing method of the medical device which concerns on embodiment. It is a schematic diagram for demonstrating the mechanism of the manufacturing method of the medical device which concerns on Example 11 and 12.
  • FIG. 10 is a diagram for explaining a method for manufacturing the medical device according to the ninth embodiment.
  • FIG. 10 is a diagram for explaining a manufacturing method of the medical device according to Example 10.
  • 10 is a diagram for explaining a method for manufacturing a medical device according to Example 11.
  • FIG. 10 is a diagram for explaining a manufacturing
  • FIG. 1 is a schematic view (schematic front view) showing an end face of the ring-shaped second welded portion 313.
  • 4A and 4B are diagrams showing the multi-strip coil 310, in which (a) shows an image obtained by imaging the multi-strip coil 310 from the side, and (b) is a schematic side view of the multi-strip coil 310.
  • FIG. 5 is a schematic diagram showing an example of the tubular main body 300, in which (a) shows a state in which the tubular main body 300 is not bent and the axial direction of the tubular main body 300 is in a straight line. A state where the tubular body 300 is bent is shown.
  • 6 is a longitudinal sectional view showing an example of the catheter 10 manufactured by the method for manufacturing a medical device according to the first embodiment
  • FIG. 7 is a sectional view taken along the line II-II in FIG.
  • FIG. 8 is a schematic longitudinal sectional view for explaining the operation of the catheter 10, in which (a) shows the catheter 10 in a natural state (the state where the bending operation is not performed), and (b) shows the bending operation.
  • FIG. 9 to FIG. 18 are diagrams for explaining methods of manufacturing medical devices according to the first to tenth embodiments.
  • (a) is a schematic view in which a multi-strand coil 310 as a first tubular body is developed in the circumferential direction, and a first weld portion 312 and a second weld portion 313 are attached to the multi-strand coil 310. And the scanning direction of the laser beam for forming the first welded portion 312 and the second welded portion 313 are shown.
  • (b) shows an image obtained by imaging from the side the multi-strip coil 310 on which the first welded portion 312 and the second welded portion 313 are formed.
  • the method for manufacturing a medical device includes a step of forming a tubular main body 300 (FIGS. 2C and 5) that is long and flexible and is inserted into a body cavity.
  • the step of forming the tubular body 300 includes the following steps. (1) A plurality of wire rods 311 (for example, twelve wire rods W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12 (FIG. 4)) arranged in parallel in the winding axis direction (1) First welding extending in a direction intersecting the circumferential direction of the first tubular body is prepared.
  • wire rods 311 for example, twelve wire rods W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12 (FIG. 4)
  • two or more adjacent wires 311 are partially melted to partially melt the two or more wires 311.
  • Step of welding (3) After the step of (2), each of the plurality of wires 311 (wires W1 to W12) is partially melted in the ring-shaped second welded portion 313 that goes around the first tubular body.
  • the second tubular body for example, the multi-row coil 320 (FIG. 2 (c), FIG. 5)
  • the structure of the multi-strand coil (first tubular body) 310 will be described.
  • the multi-strand coil 310 is configured by winding a plurality of wire rods 311 together in a spiral manner in a parallel state in which a plurality of wire rods 311 are arranged in parallel in the winding axis direction (that is, the axial center direction of the multi-strand coil 310).
  • the plurality of wires 311 are wound around the axis of the multi-strip coil 310 so as to translate in a spiral.
  • multiple winding such a method of winding the wire 311 is referred to as “multiple winding”. That is, the multi-strand coil 310 is configured by winding a plurality of wire rods 311 in a multi-strand manner.
  • the wire 311 is made of an elastic body.
  • the wire 311 is preferably made of metal.
  • the metal constituting the wire 311 include stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy.
  • the wire 311 may be comprised with materials (for example, resin material etc.) which have elasticity other than a metal.
  • the cross-sectional shape of the wire 311 is not specifically limited, For example, rectangular shape or circular shape can be mentioned.
  • FIG. 4 shows an example in which the number of wires 311 (the number of strips) is 12 (12 strips). That is, the multi-strand coil 310 shown in FIG. 4 includes a total of 12 (12 strips) of wire rods 311 (wire rods W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12). It is configured by winding.
  • FIG. 4A an auxiliary line schematically showing the path of the wire W1 is added.
  • the wire rods W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, and W12 are in the direction of their winding axes (multiple strands).
  • the multi-strand coil 310 is configured by winding a plurality of wire rods 311 (wire rods W1 to W12) around a core wire 315. That is, the core wire 315 is arranged at the center of the multi-strand coil 310. The core wire 315 is pulled out from the multi-strand coil 310 in the process of manufacturing the catheter 10 using the multi-strand coil 310 (details will be described later).
  • the 1st welding part 312 is formed in the multi-strand coil 310 (the process of said (2) is performed).
  • laser light is applied to the multi-strip coil 310 and the laser beam is scanned in a direction intersecting the circumferential direction of the multi-strip coil 310. That is, the laser beam is scanned in a direction intersecting with a plane orthogonal to the axial direction of the multi-strip coil 310.
  • any two or more adjacent wires 311 are adjacent.
  • Each of the wire rods 311) can be partially melted, and the two or more wire rods 311 can be welded and integrated. That is, by forming the first welded portion 312 in the multi-strand coil 310, two or more wire rods 311 can be integrated.
  • the 1st welding part 312 can be formed so that it may extend along the axial direction of the multi-strand coil 310 (FIG. 1 (a), FIG. 9, FIG. 10, FIG. 11, FIG. 12, FIG. 15). FIG. 16, FIG. 17, FIG. 18).
  • the laser beam is scanned along a direction intersecting the axial direction of the multi-strip coil 310 so that the first welded portion 312 extends along a direction intersecting the axial direction of the multi-strip coil 310. (See FIGS. 13 and 14).
  • the first welded portion 312 is formed to extend linearly by scanning the laser beam linearly. That is, the first welded portion 312 has a shape in which the dimension in the extending direction is larger than the dimension (width) in the direction orthogonal to the extending direction. In this case, the width (thickness) of the first welded portion 312 is, for example, a width (thickness) equivalent to the diameter of the laser spot. In this case, it is a preferable example that the first welded portion 312 is formed to extend linearly by scanning the laser beam linearly.
  • the portion where the first welded portion 312 is formed has higher rigidity than the other portions. For this reason, by forming the first welded portion 312 as narrow as possible, the rigidity of the multi-strand coil 310 can be made uniform in the longitudinal direction as much as possible.
  • the first welded portion 312 is an example that is preferably formed in a continuous manner, for example.
  • the 1st welding part 312 can be formed in one chain by scanning a laser beam in a single stroke (FIG. 1 (a), FIG. 9, FIG. 10, FIG. 11, FIG. 12, FIG. 14 and 18).
  • the first welded portion 312 can be easily formed, and the integrity of the plurality of wires 311 by the first welded portion 312 can be enhanced.
  • the first welding portion 312 may be divided into a plurality of divided portions 316 by scanning the laser beam in a plurality of times, and different combinations of the wire rods 311 may be welded by the divided portions 316. (See FIGS. 15, 16, and 17).
  • the plurality of divided portions 316 are preferably formed at positions shifted from each other in the circumferential direction of the multi-strip coil 310 (see FIGS. 15, 16, and 17). ).
  • the range which forms the 1st welding part 312 in the longitudinal direction of the multi-strand coil 310 can be made small, the location (section) where rigidity is locally large in the longitudinal direction of the multi-strand coil 310 is made as small as possible. be able to.
  • scanning with laser light means that the position of the laser spot irradiated to the multi-strip coil 310 is moved on the surface of the multi-strip coil 310.
  • the laser beam and the multi-strip coil 310 may be relatively moved. That is, the laser irradiation device that irradiates laser light may be moved while the multi-strip coil 310 is fixed, the multi-strip coil 310 may be moved while the laser irradiation device is fixed, or Both the strip coil 310 and the laser irradiation device may be moved.
  • the laser beam irradiation to the multi-strip coil 310 may be performed intermittently by irradiating the laser beam in a pulsed manner, or may be performed continuously.
  • the first welded portion 312 and the second welded portion 313 are formed by an aggregate of spot-like welding spots 341 (FIGS. 1C and 1D) formed by laser irradiation. (To be described later).
  • the wire rods 311 constituting the first welded portion 312 are fixed to each other, and the wire rods 311 are connected to each other. Misalignment can be suppressed.
  • the 2nd welding part 313 is formed in the multi-strand coil 310 (the process of said (3) is performed).
  • laser light is applied to the multi-strip coil 310 and the laser light is scanned in the circumferential direction of the multi-strip coil 310.
  • the locus of the laser beam irradiation position on the multi-strip coil 310 has a ring shape.
  • the ring-shaped second welded portion 313 that circulates in the vicinity of one end of the multi-strip coil 310 the vicinity of each end of the plurality of wire rods 311 (wire rods W1 to W12) is partially melted.
  • a plurality of wire rods W1 to W12 can be welded and integrated. That is, by forming the second welded portion 313 in the multi-strand coil 310, all the wire materials 311 constituting the multi-strand coil 310 can be integrated.
  • the second welded portion 313 is formed by sequentially shifting the laser light in the axial direction of the multi-strip coil 310 and scanning the laser beam so as to circulate a plurality of times in the circumferential direction of the multi-strip coil 310.
  • the width dimension of the second welded portion 313 (the width dimension in the axial direction of the multi-strip coil 310) is made larger than the diameter of the laser spot (for example, twice or three times the diameter of the laser spot). Can do.
  • the second welded portion 313 is configured by a plurality of ring-shaped portions that circulate around the multi-strip coil 310 in the circumferential direction (for example, the first portion 313a and Constituted by the second portion 313b).
  • a plurality of second welds are formed at positions shifted from each other in the axial direction of the multi-strip coil 310.
  • the laser beam is moved to another position as indicated by an arrow 332 shown in FIG.
  • a plurality of second welded portions (for example, the first portion 313a and the second portion 313b) are obtained by scanning the laser light with a separate stroke for each turn, such as scanning the laser light in the circumferential direction of the multi-strip coil 310. ).
  • a plurality of second weldings are performed by scanning the laser light in a zigzag or zigzag manner along the circumferential direction of the multi-strip coil 310.
  • the portions (for example, the first portion 313a and the second portion 313b) may be formed in parallel.
  • the second welded portion 313 is formed so that the first welded portion 312 and the second welded portion 313 are connected to each other (the positions where the first and second welded portions 312 and 313 are formed are respectively set.
  • the first and second welded portions 312 and 313 are formed so that one end of the first welded portion 312 is connected to the second welded portion 313 (FIG. 1B, FIG. 9, FIG. 10, (Refer FIG. 11, FIG. 13).
  • first and second welded portions 312 and 313 may be formed so that the first welded portion 312 and the second welded portion 313 are separated from each other in the axial direction of the multi-strip coil 310 (FIGS. 12 and 14). FIG. 16, FIG. 17).
  • the 1st welding part 312 and the 2nd welding part 313 are separated too much, the suppression effect of the wave
  • the 1st welding part 312 and the 2nd welding part 313 are adjoined so that the frequency
  • the winding number of each wire 311 between the 1st welding part 312 and the 2nd welding part 313 is less than 2/12 (1/6).
  • the multi-strand coil 310 is formed with reference to the formation position of the second welded portion 313. Welding one of the N wires 311 to at least one of the adjacent wires 311 on the one side by the first welded portion 312 on one side in the axial direction (usually, the side far from the end of the multi-row coil 310). Is preferable (see FIGS. 9 to 17).
  • the first welded portion 312 causes all of the wire rods 311 to be at least of the adjacent wire rods 311. Weld to one side. Thereby, the integrity of the plurality of wires 311 by the first welded portion 312 can be enhanced.
  • a part of the wire 311 is not integrated with any other wire 311 by welding on one side in the axial direction of the multi-strip coil 310 on the basis of the formation position of the second welded portion 313. That is, even if the number of the wire 311 to be welded to the adjacent wire 311 is less than N on one side in the axial direction of the multi-strip coil 310 with reference to the formation planned position of the second welded portion 313, the first Compared with the case where the 1 welding part 312 is not formed (FIG. 19, FIG. 20), generation
  • the N wires 311 are welded and integrated by the welded portion 312. That is, for example, as shown in FIG.
  • a group of wire rods 311 in which a plurality of wire rods 311 are integrated by a certain divided portion 316, and a group of wire rods 311 in which a plurality of wire rods 311 are integrated by another divided portion 316 In the case where all the wire members 311 constituting the multi-strip coil 310 are integrated together by one continuous first welded portion 312 or a plurality of divided portions 316, compared to the case where there is a cut 314 between them. Is preferred. For example, in the example of FIG. 17, the wire 311 is integrated by four divided portions 316, but there is no portion like the cut 314 in FIG. 15, and all the wires 311 of the multi-strip coil 310 are integrated together. Has been.
  • the second welded portion 313 is formed at a position separated from the end of the multi-strand coil 310.
  • the second welded portion 313 is preferably formed in the vicinity of the end of the multi-strand coil 310.
  • the multi-strand coil 310 is cut so that the second welded portion 313 is exposed at the end of the multi-strand coil 310. That is, before the step (3), the step of exposing the second welded portion 313 to the end portion of the multi-strand coil 310 is performed by cutting the multi-strand coil 310.
  • the multi-strand coil 310 is cut at the second welded portion 313 by cutting the multi-strand coil 310 at the cutting position 317 shown in FIG.
  • a plurality of second welded portions for example, the first portion 313a and the second portion 313b
  • positions between the plurality of second welded portions for example, the first portion 313a and the second portion 313b
  • the second welded portion 313 is exposed at the end of the multi-strand coil 310 by cutting the multi-strand coil 310 at a position between the two portions 313b.
  • the multi-strip coil 310 By cutting the multi-strip coil 310 at such a position, the multi-strip coil 310 can be prevented from being crushed at the time of cutting, and can be easily cut. This is because there are second welded portions on both sides of the cut portion that have become highly rigid by welding.
  • the multi-strand coil 310 may be cut at the interface between the second welded portion 313 and the adjacent portion.
  • the cutting and removing portion 319 located on the end side of the multi-strip coil 310 with respect to the multi-strip coil 310 is not left in the tubular body 300 because it is removed.
  • the second welded portion 313 is exposed at the end of the multi-strand coil 310 as shown in FIG.
  • the end surface of the ring-shaped second welded portion 313 is the end surface of the multi-strand coil 310. Further, the end surface of the second welded portion 313 is polished and flattened.
  • the first welded portion 312 is formed on the multi-strand coil 320 as in the case of the multi-strand coil 310 (see FIG. 1 (a)), formation of the second welded portion 313 (FIG. 1 (b)), and cutting for exposing the second welded portion 313 to the end of the multi-strip coil 320 (FIG. 2 (a) to FIG. 2 (b)) and polishing of the end face of the second welded portion 313.
  • one end of the multi-strand coil 320 is connected to the second welding portion 313 so that the multi-strand coil (second tubular body) 320 is connected to the multi-strand coil 310.
  • Connect perform step (4) above).
  • the multi-strand coil 310 and the multi-strand coil 320 are connected by, for example, laser welding.
  • one end (end face) of the multi-strip coil 320 can be easily placed on the end face of the multi-strip coil 310. It can be joined with sufficient strength.
  • tubular body 300 can be created.
  • the tubular main body 300 includes a first tubular body that is a multi-strip coil 310 configured by spirally winding a plurality of wire rods 311 in a parallel state aligned in the winding axis direction, and a first tubular body.
  • a second tubular body (for example, multi-strip coil 320) connected to the body.
  • the first welded portion 312 extending in the direction intersecting the circumferential direction of the first tubular body, two or more adjacent wire rods 311 are welded together, and the ring-shaped second welded around the one end portion of the first tubular body.
  • end portions of the plurality of wires 311 are welded together, and one end of the second tubular body is connected to the second welded portion 313.
  • the multi-strand coil 310 and the multi-strand coil 320 constitute a series of tubular bodies (tubular body 300).
  • the wire 311 is made of metal, for example. However, the wire 311 may be made of an elastic body (resin or the like) other than metal.
  • the first welded portion 312 preferably extends linearly. Moreover, it is mentioned that the 1st welding part 312 is extended in the axial direction of the multi-strand coil 310. FIG.
  • each of the N wire rods 311 is welded to the wire rod 311 adjacent to at least one side thereof by the first welded portion 312. It is preferable. More preferably, the N wires 311 are welded and integrated by the first welding portion 312.
  • the 1st welding part 312 is formed in one chain, for example.
  • the 1st welding part 312 may consist of several division parts 316, and the wire rod 311 of a mutually different combination may be welded by each division part 316.
  • FIG. it is a preferable example that the plurality of divided portions 316 are formed at positions shifted from each other in the circumferential direction of the multi-row coil 310.
  • first welded portion 312 and the second welded portion 313 are connected to each other.
  • first welded portion 312 and the second welded portion 313 may be separated from each other in the axial direction of the multi-strip coil 310. In this case, it is preferable that the number of windings of the wire 311 between the first welded portion 312 and the second welded portion 313 is less than one.
  • the first tubular body (multi-row coil 310) and the second tubular body may be similar to each other, but the first tubular body (multi-row coil 310) and the second tubular body will be described below. As such, they may be different from each other.
  • the second tubular body is not limited to the multi-strand coil 320, and may be configured by spirally winding one (one strip) wire. Alternatively, the second tubular body may be configured by knitting a plurality of wires into a mesh shape (referred to as a blade).
  • the bending rigidity of the multi-strand coil 310 in the direction intersecting the axis of the multi-strand coil 310 and the bending rigidity of the second tubular body in the direction intersecting the axis of the second tubular body are different from each other. It is done. Since the distal end portion of the catheter 10 (described later) is required to be flexible so that it can be easily bent, for example, the multi-coil 310 and the second tubular body are provided on the distal end side of the catheter. One having a lower bending rigidity is disposed, and the one having a larger bending rigidity is disposed on the proximal end portion side of the catheter among the multiple coils 310 and the second tubular body.
  • the multi-strand coil 320 is a multi-strand coil 320 configured by spirally winding a plurality of wire rods 311 aligned in the winding axis direction
  • the multi-strand coil 320 is It can be mentioned that the number of the wire rods 311 (the number of strands) constituting the wire rod 311 and the number of the wire rods 311 constituting the multi-strand coil 310 are different from each other. As the number of the multi-strip coils increases, the torque transmission property and the bending rigidity increase as the number of the multi-strip coils increases. It is possible to arrange the one having the smaller number of lines, and arrange the one having the larger number of lines among the multiple coils 310 and the multiple coils 320 on the proximal end portion side of the catheter 10.
  • the second tubular body is a coil (including a case of a multi-strand coil) formed by winding the wire in a spiral shape
  • the diameter (wire diameter) of the wire constituting the second tubular body is mentioned mutually different.
  • the coil (including a multi-strand coil) has a greater torque transmission and bending rigidity as the wire diameter of the wire constituting the coil is larger, for example, a multi-strand coil 310 and Of the second tubular body, the one with the smaller wire diameter is disposed, and the proximal end portion side of the catheter 10 has the larger wire diameter between the multi-strip coil 310 and the second tubular body. Arrangement may be mentioned.
  • the second tubular body is a coil (including a case of a multi-strand coil) formed by winding the wire in a spiral shape
  • the winding diameter of the wire constituting the second tubular body It is mentioned that the winding diameter of the wire 311 constituting the strip coil 310 is different from each other. Since the coil (including the multi-strand coil) can reduce the outer diameter of the catheter itself as the winding diameter of the wire constituting the coil decreases, for example, the multi-strand coil 310 and the first coil are disposed on the distal end side of the catheter.
  • the one with the smaller winding diameter of the wire is disposed, and the proximal end portion side of the catheter has the one with the larger winding diameter of the wire rod of the multi-strip coil 310 and the second tubular body.
  • the winding diameter of the wire mentioned here is an outer diameter.
  • the winding diameter of the wire mentioned here may be an outer diameter and an inner diameter.
  • the tubular main body 300 is not limited to a configuration in which two tubular bodies are connected, and for example, a configuration in which three tubular bodies are connected as shown in FIG. 5 may be used.
  • the distal end portion of the tubular main body 300 is configured by a blade 360 as a third tubular body.
  • the tubular body 300 may have a configuration in which three or more tubular bodies are connected.
  • the medical device for example, the catheter 10) according to the present embodiment has a tubular body 300 that is long and flexible and is inserted into a body cavity.
  • the tubular body 300 is configured as described above. Details will be described below.
  • the catheter 10 is a suitable example that is an intravascular catheter used by being inserted into a blood vessel. As shown in FIG. 6, the catheter 10 has a sheath 16 as a long main body.
  • the sheath 16 includes a tubular main body 300.
  • the predetermined length region including the distal end (tip) DE of the catheter 10 (and the sheath 16) is referred to as the distal end portion 15 of the catheter 10 (and the sheath 16).
  • the predetermined length region including the proximal end (proximal end) PE of the catheter 10 (and the sheath 16) is referred to as the proximal end (proximal end) 17 of the catheter 10 (and the sheath 16) (see FIG. 8).
  • a main lumen 20 and a sub-lumen 30 are formed inside the sheath 16.
  • the main lumen 20 and the sub-lumen 30 extend along the longitudinal direction (the left-right direction in FIG. 6) of the sheath 16 (the catheter 10).
  • the main lumen 20 is disposed at the center of the transverse cross section (cross section orthogonal to the longitudinal direction) of the sheath 16, and the sub lumen 30 is disposed around the main lumen 20. More specifically, in the cross section, the sub-lumens 30 are arranged at rotationally symmetric positions with respect to the center of the main lumen 20.
  • the catheter 10 has, for example, a plurality of sublumens 30.
  • Each sub-lumen 30 has a smaller diameter than the main lumen 20. That is, in the case of this embodiment, the main lumen 20 having a diameter larger than that of the sub-lumen 30 is formed in the sheath 16 along the longitudinal direction of the sheath 16.
  • the sub-lumens 30 and the main lumen 20 and the sub-lumen 30 are arranged separately from each other.
  • the plurality of sub-lumens 30 are distributed around the main lumen 20.
  • the number of sub-lumens 30 is two, and the sub-lumens 30 are arranged around the main lumen 20 at intervals of 180 degrees.
  • the operation lines 40 are accommodated in the sub-lumens 30 respectively. That is, the operation line 40 is inserted through each sub-lumen 30.
  • the operation line 40 can move in the longitudinal direction of the sub-lumen 30 relative to the sub-lumen 30 by sliding (sliding) with respect to the peripheral wall of the sub-lumen 30. That is, the operation line 40 can slide (slide) in the longitudinal direction of the sub-lumen 30.
  • the operation wire 40 may be formed of a single wire, but may be a stranded wire formed by twisting a plurality of thin wires.
  • the number of fine wires constituting one stranded wire is not particularly limited, but is preferably 3 or more.
  • a suitable example of the number of thin wires is three or seven.
  • the number of fine lines is 3, the three fine lines are arranged point-symmetrically in the cross section.
  • the number of fine lines is seven, the seven fine lines are arranged point-symmetrically in a honeycomb shape in the cross section.
  • the material of the wire constituting the operation wire 40 (or the fine wire constituting the stranded wire)
  • Poly paraphenylene benzobisoxazole
  • PBO polyether ether ketone
  • PES polyphenylene sulfide
  • PBT polybutylene terephthalate
  • PI polyimide
  • PTFE polytetrafluoroethylene
  • Polymer fibers can be used.
  • examples of the structure of the sublumen 30 include the following two structures.
  • a hollow tube 32 formed in advance is embedded in an outer layer 60 (described later) along the longitudinal direction of the sheath 16.
  • the lumen is sublumen 30. That is, in these examples, the sub-lumen 30 is constituted by the lumen of the hollow tube 32 embedded in the sheath 16.
  • the hollow tube 32 can be made of, for example, a thermoplastic resin.
  • thermoplastic resin include low friction resins such as polytetrafluoroethylene (PTFE) and polyetheretherketone (PEEK).
  • the sub-lumen 30 is formed by forming a long hollow along the longitudinal direction of the sheath 16 in the outer layer 60 (described later).
  • the sheath 16 includes, for example, an inner layer 21, an outer layer 60 formed around the inner layer 21, and a coat layer 64 formed around the outer layer 60.
  • the inner layer 21 is made of a tubular resin material.
  • a main lumen 20 is formed at the center of the inner layer 21.
  • the outer layer 60 is made of the same or different resin material as the inner layer 21.
  • the sub-lumen 30 is formed inside the outer layer 60.
  • the coat layer 64 constitutes the outermost layer of the catheter 10 and is made of a hydrophilic material.
  • the coat layer 64 may be formed only in a region extending over a part of the distal end portion 15 of the sheath 16, or may be formed over the entire length of the sheath 16.
  • the material of the inner layer 21 examples include a fluorine-based thermoplastic polymer material.
  • the fluorine-based thermoplastic polymer material is, for example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or perfluoroalkoxy fluororesin (PFA).
  • PTFE polytetrafluoroethylene
  • PVDF polyvinylidene fluoride
  • PFA perfluoroalkoxy fluororesin
  • the material of the outer layer 60 is, for example, a thermoplastic polymer.
  • a thermoplastic polymer polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA) And polyvinyl chloride (PVC) or polypropylene (PP).
  • the coat layer 64 is made hydrophilic by molding it with a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone.
  • the coat layer 64 may be formed by subjecting the outer surface of the outer layer 60 to lubrication so that at least the outer surface of the outer layer 60 is hydrophilic.
  • the sheath 16 is made of, for example, a resin material. That is, the sheath 16 includes the outer layer 60 and the inner layer 21 made of a resin material.
  • the sheath 16 has a hollow resin layer including the outer layer 60 and the inner layer 21.
  • the resin layer is disposed coaxially with the tubular main body 300 and covers the tubular main body 300. That is, the tubular main body 300 is embedded in this resin layer.
  • the multi-strip coil 310 (first tubular body) and the second tubular body of the tubular body 300 are located in the same layer.
  • the resin material constituting the sheath 16 may contain an inorganic filler.
  • an inorganic filler for example, as the resin material constituting the outer layer 60 that occupies most of the thickness of the sheath 16, a material containing an inorganic filler can be used.
  • the inorganic filler is, for example, barium sulfate or bismuth carbonate.
  • the tubular body 300 is disposed around the inner layer 21.
  • the tubular body 300 is enclosed in the outer layer 60.
  • the sublumen 30 is formed outside the tubular body 300 inside the outer layer 60.
  • the first welded portion 312 is preferably arranged at a position shifted from the path of the operation line 40 in the circumferential direction of the multi-strip coil 310 (see FIGS. 9 to 18). That is, an operation line 40 for performing an operation of bending the catheter 10 (the sheath 16 of the catheter 10) is embedded in the resin layer along the longitudinal direction of the tubular body 300, and the first welded portion 312 is The multi-strand coil 310 is disposed at a position shifted from the operation line path in the circumferential direction. Thereby, it can suppress that the bending operativity of the catheter 10 resulting from the rigidity of the 1st welding part 312 will be inhibited.
  • a ring-shaped marker 66 made of a material that does not transmit radiation such as X-rays is provided.
  • the marker 66 is made of a metal material such as platinum.
  • the marker 66 is provided around the main lumen 20 and inside the outer layer 60.
  • the radius of the main lumen 20 is about 200 to 300 ⁇ m
  • the thickness of the inner layer 21 is about 10 to 30 ⁇ m
  • the thickness of the outer layer 60 is about 50 to 150 ⁇ m
  • the outer diameter of the tubular body 300 is 500 to 860 ⁇ m
  • the inner diameter of the tubular body 300 Can have a diameter of 420 to 660 ⁇ m.
  • the radius (distance) from the axial center of the catheter 10 to the center of the sublumen 30 is about 300 to 450 ⁇ m
  • the inner diameter (diameter) of the sublumen 30 is 40 to 100 ⁇ m.
  • the thickness of the operation line 40 is about 30 to 60 ⁇ m.
  • the outermost diameter (radius) of the catheter 10 is about 350 to 490 ⁇ m, that is, the outer diameter is less than 1 mm in diameter.
  • FIG. 8 only one of the two operation lines 40 of the catheter 10 is illustrated.
  • the distal end portion 41 of the operation line 40 is fixed to the distal end portion 15 of the sheath 16.
  • a mode in which the tip 41 of the operation line 40 is fixed to the distal end 15 is not particularly limited.
  • the tip 41 of the operating line 40 may be welded or fastened to the marker 66, welded to the distal end 15 of the sheath 16, or the distal end of the marker 66 or the sheath 16 with an adhesive. 15 may be adhered and fixed.
  • the sublumen 30 is open at least on the proximal end PE side of the catheter 10.
  • the base end portion 42 of the operation line 40 protrudes from the opening of the sub-lumen 30 toward the proximal end PE.
  • the base end portion 42 is connected to an operation portion 70 provided on the proximal end PE side of the sheath 16.
  • the operation unit 70 is a mechanism that bends the distal end portion 15 of the catheter 10 by the operator pulling the two operation lines 40 individually or by simultaneously pulling the two operation lines 40. Detailed illustration and description regarding the structure of the operation unit 70 are omitted.
  • the bending of the sheath 16 includes an aspect in which the sheath 16 is bent in an “L” shape and an aspect in which the sheath 16 is bent in an “U” shape.
  • the distal end 15 of the catheter 10 is bent in a first direction and a second direction which is the opposite direction by selectively pulling the two operation lines 40 by an operation on the operation unit 70. Can be made.
  • the first direction and the second direction are included in the same plane. Therefore, the direction of the distal end DE of the catheter 10 can be freely controlled by combining the torque operation for axially rotating the entire catheter 10 inserted into the endoscope with the traction operation. Furthermore, the amount of bending of the distal end DE of the catheter 10 can be adjusted by adjusting the pulling amount of the operation line 40. For this reason, the catheter 10 of this embodiment can be made to approach in a desired direction, for example with respect to body cavities, such as a branching blood vessel.
  • the catheter 10 is manufactured by separately creating each part of the catheter 10 and combining them.
  • the outer layer 60 is formed by, for example, extruding a resin material as a molding material with an extrusion molding apparatus (not shown). At the time of this extrusion molding, a core material (mandrel) is extruded together with the resin material, thereby adhering the resin material to be the outer layer 60 around the core wire.
  • a core material manufacturedrel
  • a release treatment may optionally be performed on the surface of the core wire.
  • optical or chemical surface treatment may be performed in addition to the application of a release agent such as fluorine or silicon.
  • gas is supplied to each position where the hollow tube 32 is embedded in the outer layer 60 to form a long hollow along the longitudinal direction at each position where the sub-lumen 30 is formed. While extruding.
  • the hollow inner diameter is larger than the outer diameter of the hollow tube 32. This is to facilitate the process of later inserting the hollow tube 32 into the hollow.
  • the hollow outer layer 60 can be formed by drawing the core wire. Note that the wire diameter of the core wire used for forming the outer layer 60 is larger than the outer diameter of the tubular body 300. This is to facilitate the process of covering the outer layer 60 around the tubular body 300 (and the inner layer 21) later.
  • the inner layer 21 is formed by extruding a resin material by an extrusion apparatus (not shown) different from the extrusion apparatus for forming the outer layer 60. At the time of this extrusion molding, the resin material to be the inner layer 21 is adhered around the core wire by extruding the core wire together with the resin material.
  • the diameter of the core wire corresponds to the diameter of the main lumen 20.
  • the inner layer 21 may be formed by a dispersion forming apparatus.
  • the tubular main body 300 is created by the process described above. As described above, the core wire 315 is disposed in the multi-strand coil 320, and the same core wire is also disposed in the multi-strand coil 320 and the blade 360. After the production of the tubular body 300, these core wires (including the core wire 315) are pulled out from the tubular body 300.
  • the tubular body 300 is placed around the inner layer 21 with the core wire. Accordingly, at this stage, the core wire is still inserted into the inner layer 21.
  • the hollow tube 32 is formed by extruding a resin material with an extrusion molding apparatus (not shown) separate from the extrusion molding apparatus for creating the inner layer 21 and the extrusion molding apparatus for creating the outer layer 60. create.
  • a hollow is formed at the center of the hollow tube 32 by performing extrusion molding while discharging a fluid such as gas from a discharge tube disposed at the center of the extrusion port (nozzle) of the extrusion molding apparatus.
  • a dummy core wire inserted into the hollow tube 32 is separately prepared, and the dummy core wire is inserted into the hollow tube 32.
  • the outer layer 60 After forming the outer layer 60 and covering the tubular body 300 around the inner layer 21, the outer layer 60 is covered around the tubular body 300. Accordingly, the core wire (used for forming the inner layer 21), the inner layer 21, the tubular main body 300, and the outer layer 60 are arranged concentrically in order from the center side. Next, a hollow tube 32 (with a dummy core wire) is inserted into each hollow of the outer layer 60.
  • a heat shrinkable tube (not shown) is placed around the outer layer 60.
  • the heat shrinkable tube is contracted by heating, and the outer layer 60 is tightened from the surroundings, and the outer layer 60 is melted.
  • the heating temperature is higher than the melting temperature of the outer layer 60 and lower than the melting temperature of the inner layer 21.
  • the outer layer 60 and the inner layer 21 are joined by welding.
  • the resin material constituting the outer layer 60 encloses the tubular body 300, and the resin material impregnates the tubular body 300. Further, the outer layer 60 and the hollow tube 32 are joined by welding.
  • the heat shrinkable tube is removed from the outer layer 60 by cutting the heat shrinkable tube and tearing the heat shrinkable tube.
  • the operation wire 40 is inserted into the hollow tube 32.
  • a marker 66 which is an annular metal member, is prepared separately.
  • a member (not shown) serving as an inlet for a chemical solution or the like is connected to the proximal end portion of the main lumen 20.
  • the core wire in the inner layer 21 is pulled out.
  • the core wire is pulled out in a state where the core wire is reduced in diameter by pulling both ends in the longitudinal direction of the core wire.
  • a hollow serving as the main lumen 20 is formed at the center of the inner layer 21.
  • the base end portion of the operation line 40 is connected to the operation unit 70 created separately.
  • the coat layer 64 is formed.
  • the catheter 10 having a structure having the hollow tube 32 as shown in FIGS. 6 and 7 can be produced.
  • the wire rod 311 of the multi-strand coil 310 used in each example has a wire diameter of 50 ⁇ m.
  • the number of wires 311 (the number of strips) is 12 (strips).
  • the inner diameter of the multi-strip coil 310 is 0.50 mm.
  • a linear piano wire having a wire diameter of 0.49 mm was used as the core wire 315.
  • Both the 1st welding part 312 and the 2nd welding part 313 were formed by scanning a laser beam. In any of the examples, the first welded portion 312 was formed by scanning the laser beam linearly.
  • Example 1 As shown in FIG. 9A, first, in the direction of the arrow 351 (that is, along the axial direction of the multi-strip coil 310), laser light is scanned linearly toward the tip of the multi-strip coil 310. Thus, the first welded portion 312 was formed. The length of the first welded portion 312 (the dimension in the axial direction of the multi-strand coil 310) was 1.00 mm. As a result, all (that is, twelve) wire rods 311 constituting the multi-strand coil 310 were welded and integrated with each other at the first welded portion 312. Then, the 2nd welding part 313 was formed by scanning a laser beam in the direction of the arrow 352 (namely, circumferential direction of the multi-strand coil 310).
  • the laser beam was sequentially shifted in the axial direction of the multi-strip coil 310 and scanned so as to go around twice in the circumferential direction of the multi-strip coil 310.
  • the first round of scanning was performed at substantially the same position as one end of the first welded portion 312 (the end portion side of the multi-strip coil 310).
  • the first portion 313a of the second welded portion 313 was formed integrally with the first welded portion 312 by scanning the first round.
  • the scanning of the second round was performed at a position shifted from the scanning position when forming the first portion 313 a by 0.05 mm toward one end side of the multi-strand coil 310 in the axial direction of the multi-strand coil 310.
  • the second portion 313b of the second welded portion 313 was formed integrally with the first portion 313a by scanning the second round.
  • the laser beam scanning direction (the direction of the arrow 352) when forming the second welded portion 313 is a clockwise direction when viewed from the end of the multi-row coil 310 (FIG. 9). (A) from top to bottom).
  • the undulation (the multi-strand coil 310 of the multi-strand coil 310 is formed) as shown in FIG. It can be seen that the occurrence of deflection that is periodically repeated in the axial direction is suppressed.
  • Example 2 In the second embodiment shown in FIG. 10, the scanning direction of the laser beam (the direction of the arrow 351 (FIG. 10A)) when forming the first welded portion 312 is opposite to that in the first embodiment (FIG. 9). It differs from the first embodiment only in certain points, and the other points are the same as in the first embodiment.
  • Example 2 when the multi-strand coil 310 after the first and second welds 312 and 313 are formed is observed, as shown in FIG. It turns out that it is suppressed similarly.
  • Example 3 In Example 3 shown in FIG. 11, the scanning direction of the laser light (direction of arrow 352 (FIG. 11A)) when forming the second welded portion 313 is opposite to that in Example 1 (FIG. 9). It differs from the first embodiment only in certain points, and the other points are the same as in the first embodiment. In Example 3, when the multi-strip coil 310 after the first and second welds 312 and 313 are formed is observed, as shown in FIG. It turns out that it is suppressed similarly.
  • Example 4 shown in FIG. 12 differs from Example 3 (FIG. 11) only in that the first welded portion 312 and the second welded portion 313 are separated in the axial direction of the multi-strip coil 310. The point is the same as in Example 3. In the interval between the first welded portion 312 and the second welded portion 313, one boundary between the wire rods 311 exists. In Example 4, when the multi-strand coil 310 after the first and second welds 312 and 313 are formed is observed, as shown in FIG. It turns out that it is suppressed similarly.
  • Example 5 shown in FIG. 13 is different from Example 3 (FIG. 11) only in the direction in which the first welded portion 312 extends and the length of the first welded portion 312, and other points are the same as in Example 3. It is the same.
  • the direction in which the first welded portion 312 extends is a crossing direction with respect to the circumferential direction of the multi-strand coil 310, but is also a direction that intersects with the axial direction of the multi-strand coil 310.
  • the extending direction of the first welded portion 312 was set so that the first welded portion 312 intersects each wire 311 at an angle close to a right angle.
  • the extending direction of the first welded portion 312 is such a direction, all the wire rods 311 constituting the multi-strip coil 310 can be welded and integrated with each other by the first welded portion 312 shorter than the third embodiment. It was.
  • the length of the first welded portion 312 extending in the axial direction of the multi-strip coil 310 was 0.85 mm.
  • the angle range in which the first welded portion 312 is formed in the circumferential direction of the multi-row coil 310 is about 150 ° (for example, a range from 200 ° to 350 ° as shown in FIG. 13A).
  • the fifth embodiment when the multi-strand coil 310 after the first and second welded portions 312 and 313 are formed is observed, as shown in FIG. It turns out that it is suppressed similarly.
  • Example 6 shown in FIG. 14 differs from Example 5 (FIG. 13) only in that the first welded portion 312 and the second welded portion 313 are separated in the axial direction of the multi-row coil 310. The point is the same as in the fifth embodiment. In the interval between the first welded portion 312 and the second welded portion 313, one boundary between the wire rods 311 exists. In Example 6, when the multi-strand coil 310 after the first and second welds 312 and 313 are formed is observed, as shown in FIG. It turns out that it is suppressed similarly.
  • Example 7 shown in FIG. 15 differs from Example 3 (FIG. 11) in the points described below.
  • the 1st welding part 312 was divided
  • the extending direction of each divided portion 316 was set to a direction along the axial direction of the multi-strip coil 310.
  • the two divided portions 316 were formed at positions shifted from each other in the circumferential direction of the multi-row coil 310. In the circumferential direction of the multi-strand coil 310, the two divided portions 316 are arranged at intervals of 180 °. Two divided portions 316 were formed by scanning the laser beam in two steps. The first divided portion 316 was formed by performing the first scan in the direction of the arrow 351a, and the second divided portion 316 was formed by performing the second scan in the direction of the arrow 351b. The length of each divided portion 316 (the dimension in the axial direction of the multi-strand coil 310) was 0.50 mm. One end of both divided parts 316 is connected to the second welded part 313.
  • Example 7 when the multi-strand coil 310 after the first and second welds 312 and 313 are formed is observed, the occurrence of undulation in the multi-strand coil 310 is suppressed as shown in FIG. I understand that. However, in Example 7, slight undulation was observed.
  • Example 8 In Example 8 shown in FIG. 16, each of the two divided portions 316 of the first welded portion 312 and the second welded portion 313 are separated from each other in the axial direction of the multi-strip coil 310 only in Example 7 (FIG. 15) and the other points are the same as in the seventh embodiment. In the interval between each of the divided portions 316 and the second welded portion 313, one boundary between the wire rods 311 exists.
  • Example 8 when the multi-strand coil 310 after the first and second welds 312 and 313 are formed is observed, the occurrence of undulation in the multi-strand coil 310 is shown in FIG. (In other words, even in Example 8, a slight swell was observed).
  • Example 9 The ninth embodiment shown in FIG. 17 is different from the third embodiment (FIG. 11) in the points described below.
  • the 1st welding part 312 was divided
  • FIG. With each divided portion 316 four adjacent wires 311 were welded and integrated.
  • the extending direction of each divided portion 316 was set to a direction along the axial direction of the multi-strip coil 310. Further, the four divided portions 316 were formed at positions shifted from each other in the circumferential direction of the multi-strip coil 310.
  • the four divided portions 316 were arranged at 90 ° intervals. By scanning the laser beam in four times, four divided portions 316 were formed. By performing the first scan in the direction of the arrow 351a, the first divided portion 316 is formed, and by performing the second scan in the direction of the arrow 351b, the second divided portion 316 is formed. The third divided portion 316 was formed by performing the third scan in the direction of the arrow 351c, and the fourth divided portion 316 was formed by performing the fourth scan in the direction of the arrow 351d. The length of each divided portion 316 (the dimension in the axial direction of the multi-row coil 310) was 0.25 mm.
  • Each of the divided portions 316 and the second welded portion 313 are separated from each other in the axial direction of the multi-strand coil 310. In the interval between each of the divided portions 316 and the second welded portion 313, one boundary between the wire rods 311 exists.
  • Example 9 when the multi-strand coil 310 after forming the first and second welds 312 and 313 is observed, the occurrence of undulation in the multi-strand coil 310 is suppressed as shown in FIG. I understand that. However, in Example 9, swells slightly larger than those in Examples 7 and 8 were observed.
  • Example 10 shown in FIG. 18 differs from Example 3 (FIG. 11) only in that the first welded portion 312 and the second welded portion 313 intersect, and the other points are the same as in Example 3. It is the same. Specifically, the first welded portion 312 and the second welded portion 313 are crossed at the central portion in the longitudinal direction of the first welded portion 312. In Example 10, when the multi-strand coil 310 after the first and second welded portions 312 and 313 are formed is observed, as shown in FIG. It can be seen that it is suppressed (in the vicinity of the two welds 313). However, in Example 10, a larger swell than in Example 9 was observed.
  • FIG. 19 is a diagram for explaining a method for manufacturing a medical device according to Example 11
  • FIG. 20 is a diagram for explaining a method for manufacturing a medical device according to Example 12.
  • (a) is the schematic diagram which expand
  • (b) shows the image obtained by imaging the multi-strand coil 310 in which the 2nd welding part 313 was formed from the side.
  • Example 11 shown in FIG. 19 is different from Examples 1 and 2 (FIGS. 9 and 10) only in that the first welded portion 312 is not formed, and the other points are the same as those in Examples 1 and 2. is there.
  • Example 11 undulation was observed in the multi-strand coil 310 after the second welded portion 313 was formed, as shown in FIG.
  • the waviness in the eleventh embodiment is larger than that in the tenth embodiment, and the waviness is generated in the vicinity of the second welded portion 313.
  • Example 12 shown in FIG. 20 is different from Example 3 (FIG. 11) only in that the first welded portion 312 is not formed, and the other points are the same as Example 3.
  • Example 12 undulation was observed in the multi-strand coil 310 after the second welded portion 313 was formed, as shown in FIG.
  • the waviness in the twelfth embodiment is equivalent to that in the eleventh embodiment.
  • 21 and 22 are schematic views for explaining the mechanism of the method for manufacturing a medical device according to the embodiment.
  • the first welded portion 312 extending in the direction intersecting the circumferential direction of the multi-strip coil 310 is formed.
  • each winding portion for example, between the winding portions 501 and 502 of the adjacent wire 311 (for example, the wire W1 and the wire W2) of the multi-strip coil 310. It is considered that the winding portions 501 and 502 are locally (partially) melted when they are welded to each other by irradiation, and the winding portions 501 and 502 come close to each other due to the surface tension of the molten metal.
  • Reference numeral 401 in FIG. 21A indicates molten metal generated by melting a part of the winding portions 501 and 502.
  • the direction in which one winding portion 502 of the wire W2 approaches the winding portion 501 of the wire W1 adjacent thereto when observed from the side of the multi-strand coil 310 is the winding direction of the winding portion 502. It is considered that the direction is orthogonal to the direction. That is, it is considered that the force in the direction of the arrow 402 in FIGS. 21A and 21B acts on the wound portion 502. For this reason, as shown in FIG.21 (b), the winding part 502 inclines so that it may approach the winding part 501 side in the formation location of the molten metal 401. FIG. At this time, it is considered that a force in the direction opposite to the arrow 402 acts on the winding portion 501 and the winding portion 501 approaches the winding portion 502 side.
  • Reference numeral 411 in FIG. 22A indicates molten metal generated by melting a part of the winding portions 502 and 503.
  • FIG. 23 is a schematic diagram for explaining the mechanism of the method for manufacturing a medical device according to Examples 11 and 12.
  • the second welded portion 313 is formed without forming the first welded portion 312.
  • the molten metals 401 and 411 are formed at different positions in the circumferential direction.
  • the arrow 402 and the arrow 412 are largely shifted in the circumferential direction. Therefore, after the winding portion 502 is tilted toward the winding portion 501, the amount of offset between the tilts when the winding portion 502 is tilted toward the winding portion 503 is smaller than that in the embodiment. Become.
  • the direction in which the winding portion 502 tilts toward the winding portion 501 (the circumferential position where the tilt occurs) and the direction where the winding portion 503 tilts toward the winding portion 502 (the circumferential position where the tilt occurs). ) Is deviated in the circumferential direction.
  • the direction of tilt of each winding portion (the circumferential position where the tilt occurs) is sequentially shifted in the circumferential direction.
  • FIG. 23C when the second welded portion 313 is formed by scanning the laser light in the circumferential direction of the multifilament coil 310 without forming the first welded portion 312, Swelling occurs in the coil 310.
  • each of the plurality of wire members 311 constituting the multi-strand coil 310 is partially melted, thereby After welding the plurality of wire rods 311, one end of the second tubular body is connected to the second welding portion 313 so that the multi-strand coil 310 and the second tubular body are connected.
  • the long tubular main body 300 can be easily produced with a good yield. Therefore, a medical device such as the catheter 10 having such a tubular body 300 can be easily manufactured with a high yield.
  • the first welded portion 312 extending in the direction intersecting the circumferential direction of the multi-strip coil 310 is formed in advance.
  • the wire 311 of the multi-strand coil 310 can be welded and it can fix mutually. Therefore, it is possible to suppress the positional deviation between the wire rods 311 when the second welded portion 313 is subsequently formed.
  • the occurrence of periodic deflection (that is, swell) in the longitudinal direction of the multi-strip coil 310 is prevented. Can be suppressed. Therefore, the multi-strip coil 310 can be connected to the second tubular body while maintaining the linear shape. That is, the long tubular body 300 can be easily produced with high yield while suppressing the occurrence of undulation.
  • the multi-strand coil 310 and the second tubular body may have the same characteristics as each other, or may have different characteristics such as mechanical characteristics.
  • the example in which the number (the number of strips) of the wire 311 constituting the multi-strand coil 310 as the first tubular body is twelve is described. It can be.
  • the 2nd welding part 313 may be formed in the edge part of the multi-row coil 310, and such a cutting process may be abbreviate
  • the example in which the multi-strip coil 310 as the first tubular body and the second tubular body are directly connected has been described.
  • the multi-strip coil 310 and the second tubular body as the first tubular body are provided.
  • connection may be made via a ring-shaped joining member.
  • An example of this joining member is metal wax.

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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)
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Abstract

La présente invention vise à relier facilement une bobine à multiples extrémités à un autre corps tubulaire. L'invention concerne un procédé pour fabriquer un dispositif médical, qui comprend une étape consistant à former un corps principal tubulaire souple long qui est introduit dans une cavité corporelle. L'étape consistant à former le corps principal tubulaire comprend les étapes suivantes : une étape consistant à préparer un premier corps tubulaire (bobine à multiples extrémités (310)) constituée de multiples fils (311) enroulés en spirale de façon juxtaposée, de multiples fils (60) étant alignés dans une direction d'axe d'enroulement ; une étape consistant à fondre partiellement chacun de deux ou plusieurs fils adjacents (60) pour souder les deux ou plusieurs fils adjacents (311) l'un à l'autre dans une première partie de soudage (312) qui s'étend dans une direction transversale par rapport à une direction circonférentielle du premier corps tubulaire ; une étape consistant à fondre partiellement chacun des multiples fils (311) pour souder les multiples fils (60) l'un à l'autre dans une seconde partie de soudage annulaire (313) qui entoure le premier corps tubulaire ; et une étape consistant à fixer une première extrémité d'un second corps tubulaire à la seconde partie de soudage (313) de telle sorte que le second corps tubulaire est relié au premier corps tubulaire.
PCT/JP2013/067211 2013-06-24 2013-06-24 Procédé de fabrication de dispositif médical, et dispositif médical Ceased WO2014207797A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220152355A1 (en) * 2020-11-18 2022-05-19 Inari Medical, Inc. Catheters having steerable distal portions, and associated systems and methods
WO2024243114A1 (fr) * 2023-05-19 2024-11-28 Legacy Ventures LLC Cathéter à réglage automatique

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012147956A (ja) * 2011-01-19 2012-08-09 Sumitomo Bakelite Co Ltd 医療機器
JP2012192177A (ja) * 2011-02-28 2012-10-11 Sumitomo Bakelite Co Ltd 医療機器および医療機器の製造方法
JP2012213507A (ja) * 2011-03-31 2012-11-08 Sumitomo Bakelite Co Ltd 医療機器

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012147956A (ja) * 2011-01-19 2012-08-09 Sumitomo Bakelite Co Ltd 医療機器
JP2012192177A (ja) * 2011-02-28 2012-10-11 Sumitomo Bakelite Co Ltd 医療機器および医療機器の製造方法
JP2012213507A (ja) * 2011-03-31 2012-11-08 Sumitomo Bakelite Co Ltd 医療機器

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220152355A1 (en) * 2020-11-18 2022-05-19 Inari Medical, Inc. Catheters having steerable distal portions, and associated systems and methods
WO2024243114A1 (fr) * 2023-05-19 2024-11-28 Legacy Ventures LLC Cathéter à réglage automatique

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