WO2018025865A1 - Suction catheter, and method for manufacturing suction catheter - Google Patents

Suction catheter, and method for manufacturing suction catheter Download PDF

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Publication number
WO2018025865A1
WO2018025865A1 PCT/JP2017/027906 JP2017027906W WO2018025865A1 WO 2018025865 A1 WO2018025865 A1 WO 2018025865A1 JP 2017027906 W JP2017027906 W JP 2017027906W WO 2018025865 A1 WO2018025865 A1 WO 2018025865A1
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WO
WIPO (PCT)
Prior art keywords
tube
suction
cross
section
suction port
Prior art date
Application number
PCT/JP2017/027906
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French (fr)
Japanese (ja)
Inventor
翠翠 李
陽平 黒瀬
Original Assignee
株式会社カネカ
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 株式会社カネカ filed Critical 株式会社カネカ
Priority to CN201780032062.2A priority Critical patent/CN109152911B/en
Priority to JP2018531926A priority patent/JP7061069B2/en
Publication of WO2018025865A1 publication Critical patent/WO2018025865A1/en

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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

Definitions

  • One aspect of the present invention relates to a suction catheter for sucking and removing substances in the body outside the body and a method for manufacturing the suction catheter.
  • Patent Document 1 discloses a thrombus suction catheter that introduces a tube having a suction port on the distal side into a blood vessel to reach a lesion site, and sucks and removes a thrombus from the suction port. Is disclosed.
  • Such a catheter is required to suppress lumen blockage due to aspirated thrombus. Therefore, a catheter with a larger lumen inner diameter has been proposed. It is conceivable that a catheter having a large inner diameter of the lumen has high suction performance and can prevent the lumen from being blocked. However, further improvement is required in view of the peripheral reachability of the suction port of the catheter.
  • an object of one aspect of the present invention is to provide a suction catheter and a method for manufacturing the suction catheter that can improve suction efficiency.
  • a suction catheter includes a tube having a lumen extending from a proximal side to a distal side and a suction port formed on a distal side of the lumen, and the suction port extends from the lumen.
  • the tube has a portion formed to be inclined with respect to a plane perpendicular to the first direction, and the tube has a distal end at the suction port on the upper side in the vertical direction and a proximal end at the suction port on the lower side in the vertical direction.
  • the first cross section when the cross section perpendicular to the first direction of the lumen at the first position where the proximal end of the suction port is located in the first direction is the first cross section, the first cross section is The bottom portion extends in the width direction perpendicular to the first direction, and the bottom portion has a length that is not less than 0.3 times and not more than 1.0 times the maximum length in the width direction.
  • a substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from the proximal portion in the first direction of the suction port.
  • the tube arranged as described above when the tube arranged as described above is viewed from the side perpendicular to the first direction, the substance sucked by the suction catheter is sucked into the lumen from the lower portion of the suction port of the tube.
  • the bottom that is the lower end in the vertical direction of the first cross section is orthogonal to the vertical direction in the first cross section.
  • the orthogonal here includes substantially orthogonal.
  • the maximum length in the vertical direction of the first cross section may be 0.4 times or more and 0.9 times or less of the maximum length in the width direction.
  • the lumen has a so-called horizontally long shape. For this reason, since the lower side part in which a substance is suck
  • the shape of the first cross section may be a polygon.
  • the suction catheter having such a configuration it becomes easy to form a cross section at the time of manufacturing, and it is easy to maintain the shape even after manufacturing.
  • a suction catheter is a suction catheter including a tube having a lumen extending from a proximal side to a distal side and a suction port formed on a distal side of the lumen, Has a portion formed to be inclined with respect to a plane perpendicular to the first direction in which the lumen extends, with the distal end of the suction port being vertically upward and the proximal end of the suction port being vertically downward
  • the first cross section Has a bottom portion extending in the width direction perpendicular to the vertical direction and the first direction at the lower end in the vertical direction, and the shape of the first cross section is a polygon.
  • a substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from the proximal portion in the first direction of the suction port.
  • the substance sucked by the suction catheter is sucked into the lumen from the lower portion of the suction port of the tube.
  • the suction catheter according to one aspect of the present invention since the bottom portion extending in the width direction is formed at the lower end in the vertical direction of the first cross section when the tube arranged as described above is viewed from the first direction, The part that is sucked into the lumen is wide. For this reason, the substance does not get caught in the portion of the suction port where the substance is first sucked into the lumen. As a result, the suction efficiency can be improved.
  • the orthogonal here includes substantially orthogonal.
  • the lumen may have the first cross-sectional shape at the first position continuing a predetermined distance toward the proximal side.
  • the tube changes the cross section from the first cross section to the second cross section whose shape is different from the first cross section at a position proximal to the first position in the first direction.
  • the suction catheter having this configuration the sucked suction substance easily collides with the inner surface of the tube, and vibration due to the collision of the suction substance with the shaft becomes strong. For this reason, the operator of the suction catheter can sense the vibration. As a result, the operator can grasp the suction state of the substance.
  • the cross-section switching unit may change the cross section from the first cross section to the second cross section having a shape and a cross-sectional area different from the first cross section.
  • the end side of the cross-section switching unit may be located within 20 mm from the first position in the first direction. In the suction catheter having this configuration, it is possible to more reliably suppress the blockage in the vicinity of the suction port, and it is possible to more reliably apply vibration to the tube.
  • the cross-section switching portion may be a taper formed on at least a part of the inner surface forming the lumen.
  • the cross-section switching part can be easily formed.
  • the shape of the cross section perpendicular to the first direction of the lumen at the proximal end of the cross section switching portion may be circular.
  • the orthogonal here includes substantially orthogonal.
  • the cross-section switching unit changes the cross-sectional shape of the lumen along the first direction from a shape in the first cross-section to a circle.
  • the fluid of the substance flowing through the lumen makes it possible to aspirate a larger sized thrombus with a change in the lumen channel shape. Vibration is generated by sucking a large-sized thrombus, and the operator of the suction catheter can sense the vibration. As a result, the operator can grasp the suction state of the substance.
  • the length from the proximal end to the distal end of the suction port may be 2.0 mm or more and 10 mm or less.
  • the suction catheter having this configuration is excellent in peripheral reachability.
  • a method of manufacturing a suction catheter includes a first cutting step of cutting one end of a tube extending in a first direction so as to be inclined with respect to a plane perpendicular to the first direction in which a lumen extends, A deformation step of deforming the lumen of the tube cut by the cutting step, and a second portion of the proximal side including the proximal end of the tube opening formed by the first cutting step and deformed by the deformation step.
  • Cutting step includes a first cutting step of cutting one end of a tube extending in a first direction so as to be inclined with respect to a plane perpendicular to the first direction in which a lumen extends.
  • the end portion between the inner surface of the tube and the outer surface of the tube on one of the upper side and the lower side in the vertical direction of the suction port is concave or convex with respect to the suction surface forming the suction port. It may be.
  • a substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from the proximal portion in the first direction of the suction port.
  • the substance sucked by the suction catheter is sucked into the lumen from the lower portion of the suction port of the tube.
  • an end portion between the inner surface of the tube and the outer surface of the tube on one of the upper side and the lower side of the suction port forms a suction port. It is concave or convex with respect to the suction surface.
  • the shape of a portion that is concave or convex with respect to the suction surface that forms the suction port may be defined by a curved surface.
  • the end portion between the inner surface of the tube and the outer surface of the tube in the vertical direction below the suction port may be convex with respect to the suction surface forming the suction port. .
  • the thrombus easily enters the lumen.
  • the end between the inner surface of the tube and the outer surface of the tube in the vertical direction above the suction port may be recessed with respect to the suction surface forming the suction port. .
  • the suction catheter having this configuration since the thrombus contacting the edge of the tube is cut, the thrombus can be easily sucked.
  • the straight line on the suction surface is a reference line that connects the upper end of the tube and the lower end of the tube
  • the upper end portion in the vertical direction above the suction port is a reference It is concave in line symmetry with respect to the line
  • the lower end of the suction port in the vertical direction may be convex in line symmetry with respect to the reference line.
  • the first proximal end on the outer surface side of the end portion in the vertical direction of the lumen is the first proximal end on the inner surface side of the end portion.
  • a straight line that is located proximal to the one distal end and connects the first proximal end and the first distal end is inclined in a range of 2 ° to 60 ° with respect to the first direction
  • the second distal end on the outer surface side of the end portion in the vertically upper direction is positioned more distally than the second proximal end on the inner surface side of the end portion, and the second distal end and the second proximal end May be inclined in a range of 2 ° to 60 ° with respect to the first direction.
  • the suction catheter having such a configuration has a sharp shape in the direction in which the substance is sucked.
  • the substance sucked into the suction port is shredded by the sharply pointed end. As a result, the lumen is prevented from being blocked by a large substance caught in the vicinity of the suction port.
  • the first proximal end on the outer surface side of the end portion in the vertical direction of the lumen is the first proximal end on the inner surface side of the end portion.
  • the second distal end located on the proximal side of the distal end and on the outer surface side of the end vertically above the lumen is located on the distal side of the second proximal end on the inner surface side of the end portion.
  • the end between the inner surface of the tube and the outer surface of the tube in the vertical direction below the suction port is concave or convex
  • the end between the inner surface of the tube and the outer surface of the tube in the vertical direction above the suction port may be concave or convex with respect to the straight line connecting the second distal end and the second proximal end.
  • the curvature at the proximal end of the suction port when the suction port is viewed from below in the vertical direction, the curvature at the proximal end of the suction port may be smaller than the curvature at the distal end.
  • the curvature (degree of bending) at the proximal end of the suction port when the suction port is viewed from below in the vertical direction, the curvature (degree of bending) at the proximal end of the suction port is smaller than the curvature at the distal end, that is, suction.
  • the radius of curvature at the proximal end of the mouth is greater than the radius of curvature at the distal end.
  • the curvature includes the case where the curvature is 0, that is, the case where the curvature is a straight line. As a result, the blockage of the lumen by the suction substance can be suppressed.
  • the proximal end of the suction port when the suction port is viewed from below in the vertical direction, the proximal end of the suction port is linear in the width direction orthogonal to both the first direction and the vertical direction. It may extend to.
  • the proximal end of the suction port extends linearly in the width direction, so that the thrombus can be easily cut. As a result, the blockage of the lumen by the suction substance can be suppressed.
  • the orthogonal here includes substantially orthogonal.
  • the vertical direction and the first direction It is possible to easily form a bottom portion extending in the width direction orthogonal to the width direction.
  • the suction catheter having a tube having a bottom formed at the lower end in the vertical direction in the first cross section a portion where the substance is sucked into the lumen is widened.
  • the suction efficiency can be improved.
  • FIG. 1 is a cross-sectional view of a suction catheter according to an embodiment when cut along a first direction.
  • FIG. 2 is a diagram showing a cross-sectional configuration along the line AA in FIG.
  • FIG. 4B is a diagram showing a cross-sectional configuration along the line BB in FIG.
  • FIG. 5 is a bottom view of the suction port in the suction lumen according to the embodiment as viewed from below in the vertical direction.
  • Drawing 6 is a bottom view which looked at a suction mouth in a suction lumen concerning a different embodiment from the perpendicular direction lower part.
  • 7 (a) to 7 (c) are diagrams for explaining an example of the steps of the suction catheter manufacturing method of FIG.
  • FIG. 8 is a perspective view showing a distal end face of the suction port of the second tube of the suction catheter according to the first modification.
  • 9A is a cross-sectional view in the first direction showing the distal end face of the suction port of the second tube of the suction catheter according to the first modification
  • FIG. 9B is an enlarged cross-sectional view of the upper end portion.
  • FIG. 9C is an enlarged cross-sectional view of the lower end portion.
  • FIG. 10A to FIG. 10D are examples of cross-sectional views of the suction lumen in the suction catheter according to the first modification.
  • FIGS. 11A to 11H are examples of cross-sectional views of the suction lumen in the suction catheter according
  • the suction catheter 1 is introduced into the body and used to suck and remove the thrombus generated in the blood vessel from the body by negative pressure applied from the proximal side of the suction catheter 1.
  • the same elements may be denoted by the same reference numerals, and redundant descriptions may be omitted.
  • the operation side (left side in FIG. 1) of the suction catheter 1 is defined as the proximal side, and the opposite side to the operation side of the suction catheter 1
  • the side (right side in FIG. 1) to be introduced into the head is defined as the distal side. 1 to 6,
  • the first direction in which the suction catheter 1 extends is the X-axis direction
  • the vertical direction is the Z-axis direction
  • the width of the suction lumen 10 is the direction perpendicular to the first direction and the vertical direction.
  • the direction may be indicated as the Y-axis direction.
  • the first direction in which the suction catheter 1 extends is also the longitudinal direction when the suction catheter 1 is viewed from the side.
  • the suction catheter 1 has a suction lumen 10 extending from the proximal end to the distal end, and a guide wire lumen 20 extending along the suction lumen 10 on the distal side of the suction lumen 10. is doing.
  • the suction lumen 10 serves as a flow path for a thrombus or the like sucked from a suction port 11 provided at the distal end of the suction lumen.
  • the guide wire lumen 20 is a lumen through which a guide wire (not shown) for guiding the suction port 11 of the suction lumen 10 to the target site is passed.
  • the portion where the suction lumen 10 extends alone is referred to as the first shaft 3
  • the portion where the suction lumen 10 and the guide wire lumen 20 extend side by side is referred to as the second shaft 5.
  • the first shaft 3 includes a first tube 31 that forms the suction lumen 10.
  • the first tube 31 is a hollow member extending in one direction, and a cross section perpendicular to the longitudinal direction (hereinafter simply referred to as “cross section”) is an annular member.
  • the inner surface 31a of the first tube 31 forms the suction lumen 10, and the suction lumen 10 extends from the proximal side to the distal side.
  • the first tube 31 is formed of a resin material. Examples of the resin material include at least one selected from polyamide resin, polyamide elastomer, polyurethane resin, polyether resin, polyester resin, polyimide resin, and polyethylene resin.
  • the first tube 31 may be a member including an inner layer and an outer layer.
  • the material forming the inner layer include polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), and tetrafluoroethylene.
  • -Fluorine resins such as ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), high-density polyethylene and the like are included.
  • the material forming the outer layer include elastomers such as polyamide elastomer, polyester elastomer, and polyolefin elastomer.
  • a braided tube may be used as the first tube 31.
  • the braided tube is a tube including a braided structure made of resin or metal in a tube formed of resin or the like.
  • the braided structure is, for example, a structure formed by a knitted linear object provided around the lumen of the tube.
  • the braided structure may be a structure in which one wire is wound or a structure arranged along a lumen. Since the material or structure of the braid constituting the braided tube does not limit the effect of one aspect of the present invention, various materials or structures can be used.
  • Metal can be used as the material of the braid.
  • Stainless steel such as SUS304 and SUS316, spring steel, piano wire, oil temper wire, Co-Cr alloy, Ni-Ti alloy, etc. It is possible to use a metal that has been processed into a braid with one or more metal wires processed into a shape.
  • the first shaft 3 may have a double tube structure in which another tube is disposed inside or outside the first tube 31.
  • a hub 35 is provided at the proximal end 3 b of the first shaft 3.
  • a suction device such as a syringe is connected to the hub 35 via, for example, a Y-shaped connector (not shown).
  • the negative pressure suction force by the suction device is applied to the suction lumen 10 of the first tube 31 through the hub 35.
  • the hub 35 is made of, for example, a styrene-butadiene copolymer.
  • the proximal end 31 b of the first tube 31 is bonded to the hub 35 with an adhesive 37.
  • the adhesive 37 is, for example, a urethane adhesive.
  • the suction lumen 10 of the first tube 31 communicates with the opening 35 a of the hub 35.
  • the second shaft 5 is formed by a second tube (tube) 41 and a third tube 61.
  • the second tube 41 has a suction lumen 10 extending in the first direction from the proximal side to the distal side
  • the third tube 61 has a guide wire lumen 20 extending in the first direction from the proximal side to the distal side.
  • the second tube 41 and the third tube 61 are shown in a state different from the main body resin 71 as shown in FIG.
  • the outer shape of the three tubes 61 may not be the shape shown in FIG. That is, the boundary between the second tube 41, the third tube 61, and the main body resin 71 may be indefinite.
  • the second tube 41 is a hollow member extending in the first direction and is formed of a resin material.
  • the suction lumen 10 is formed by the inner surface 41 a of the second tube 41.
  • the example of the resin material which forms the 2nd tube 41 is the same as the example of the material which forms the 1st tube 31 demonstrated in the upper stage.
  • the second tube 41 may be a member including an inner layer and an outer layer, and the material thereof may be the same as that of the first tube 31.
  • a braided tube may be used as the second tube 41, and an example of the material may be the same as that of the first tube 31.
  • the distal end (not shown) of the first tube 31 and the proximal end (not shown) of the second tube 41 are connected to each other, and the suction lumen 10 of the first tube 31 and the suction lumen of the second tube 41 are connected. 10 communicate with each other.
  • the same tube may be disposed through the first shaft 3 and the second shaft 5.
  • the second tube 41 may extend from the first shaft 3 to the second shaft 5.
  • the first tube 31 and the second tube 41 may be integrally formed as a single tube, or a plurality of different tubes may be connected on the way.
  • the first tube 31 and the second tube 41 may be formed of the same resin material.
  • tubes formed of the same resin material may be connected, or tubes formed of different resin materials may be connected.
  • the connecting portion may connect the tubes using an adhesive or a connecting member, or may melt and connect the tubes.
  • the distal end surface 41b of the second tube 41 is inclined. Specifically, the distal end surface 41b of the second tube 41 is inclined at a predetermined angle with respect to the direction (first direction) in which the second tube 41 extends. Specifically, as shown in FIG. 1, the distal end surface 41 b of the second tube 41 extends from the distal side to the proximal side so that the upper end is the distal side and the lower end is the proximal side. Inclined continuously. The end surface 41 b is open and communicates with the suction lumen 10. A configuration in which a part of the end surface 41b is closed may be employed. The inclination may be linear as viewed from the side, or may be curved.
  • the end surface 41b may have any shape as long as the upper end is on the distal side and the lower end is on the proximal side.
  • the end surface 41b may change in a staircase shape by providing a step or the like. There may be.
  • the suction port 11 is provided at the distal end of the second tube 41.
  • the suction port 11 is formed including part or all of the end face 41b.
  • the suction port 11 is provided along the longitudinal direction of the second tube 41, and one end is disposed on the distal side and the other end is disposed on the proximal side.
  • length L0 (refer FIG. 1) in the 1st direction from the proximal end 11b to the distal end 11a in the suction port 11 can be 2.0 mm or more and 10 mm or less, for example.
  • the suction port 11 provided in the end surface is inclined with respect to the surface orthogonal to the first direction of the suction lumen 10.
  • the distal end 11 a of the suction port 11 is on the upper side in the vertical direction and the proximal end 11 b of the suction port 11 is on the lower side in the vertical direction when viewed from the side.
  • the curved shape of the proximal end portion 11 d including the proximal end 11 b on the proximal side when viewed from the vertically downward direction is a distal end including the distal end 11 a. It may be different from the curved shape of the side end portion 11c. Specifically, the curve radius in the curved shape of the proximal end portion 11d may be larger than the curve radius in the curved shape of the distal end portion 11c. That is, the degree of curvature (curvature) in the curved shape of the proximal end 11d may be smaller than the degree of curvature (curvature) in the curved shape of the distal end 11c.
  • the effective portion for cutting the thrombus at the suction port 11 is increased, and the thrombus is easily cut.
  • the suction lumen 10 can be prevented from being blocked by a suction substance such as a thrombus.
  • the curvature of the proximal end portion 11d of the suction port 11 may be 1.74 ⁇ 10 3 rad / m or less.
  • occlusion suppression effect can be heightened more.
  • rad / m is a unit of curvature and indicates degree (angle) / perimeter (length).
  • the curved shape of the proximal end portion 111 d including the proximal end 11 b on the proximal side when viewed from the vertically downward direction is the width direction (Y-axis direction). ) May be formed along a straight line. This is also an example when the curvature on the proximal side is made smaller (curvature 0).
  • curvature 0 the curvature on the proximal side is made smaller.
  • the third tube 61 is a hollow member extending in one direction, and is formed of a resin material.
  • the guide wire lumen 20 is formed by the inner surface 61 a of the third tube 61.
  • An opening 21 and an opening 22 are provided at the distal end and the proximal end of the third tube 61, respectively.
  • the opening 21 and the opening 22 are formed along a plane orthogonal to the first direction of the suction lumen 10.
  • the third tube 61 is made of a resin material.
  • the example of the resin material which forms the 3rd tube 61 is the same as the example of the material which forms the 1st tube 31 demonstrated in the upper stage.
  • the third tube 61 may be a member including an inner layer and an outer layer, and the material thereof may be the same as that of the first tube 31.
  • a braided tube may be used as the third tube 61, and the example of the material may be the same as that of the first tube 31.
  • the first tube 31, the shaft and the second tube 41, and the third tube 61 may have a multilayer structure including a plurality of resin materials and other materials.
  • the resin materials may be the same or different from each other.
  • a metal ring or plate may be arranged in a portion facing the lumen of the tube or other portion.
  • a resin or metal wire can be wound around the tube.
  • the third tube 61 may be provided with a marker (not shown) formed of a material that is opaque to X-rays (radiation).
  • the marker is, for example, an annular member formed of an alloy containing gold, platinum, tungsten, platinum (Pt), and indium (Ir).
  • the marker is attached to the third tube 61 so as to surround the third tube 61 in the circumferential direction. Accordingly, the operator can grasp the position of the distal end of the second shaft 5 based on the X-ray transmission image.
  • the second tube 41 and the third tube 61 are integrally formed.
  • the third tube 61 is integrated with a main body resin 71 formed of a resin material in a state where the third tube 61 is arranged above the second tube 41 in the vertical direction.
  • the main body resin 71 is formed of a thermoplastic resin, for example, a polyamide elastomer (PAE) or a polyamide elastomer.
  • PAE polyamide elastomer
  • the main body resin 71 is formed, for example, by heating a shrink tube placed on the second tube 41 and the third tube 61. Thereby, the outer surface (outer shape) 71a of the second shaft 5 is formed.
  • the integration may be a state in which the boundaries of the second tube 41, the third tube 61, and the main body resin 71 are unclear, and even if the respective boundaries are clear as shown in FIG. Good.
  • the second tube 41, the third tube 61, and three members of different tube materials may be integrated, or two lumens may be formed in one member and the three members may be integrated. Only the second tube 41 and the third tube 61 may be integrated. In this case, the main body resin 71 is formed by the dissolved second tube 41 and third tube 61.
  • the cross section of the suction lumen 10 formed by the inner surface 41a of the second tube 41 may change from the proximal side to the distal side.
  • the cross section of the suction lumen 10 at the first position P1 where the proximal end 11b of the suction port 11 is present is defined as a first cross section.
  • the first cross section includes a pair of arc-shaped side portions 42 and 42, and a bottom portion 43 extending linearly in the width direction (Y-axis direction) at the lower end in the vertical direction (Z-axis direction). And an upper portion 44 that faces the bottom 43 and extends linearly in the width direction (Y-axis direction).
  • the first cross section has a shape in which a circular lower part and an upper part are cut off by a bottom part 43 and an upper part 44, respectively.
  • the length W in the width direction (Y-axis direction) of the bottom 43 in the first cross section is 0.3 to 1.0 times the maximum length W max in the width direction in the first cross section. It is. That is, a portion where the thrombus is sucked into the suction lumen 10 is widely formed. For this reason, the thrombus does not get caught in the portion of the suction port 11 where the thrombus is first sucked into the suction lumen 110. As a result, the suction efficiency can be improved.
  • the first cross section has a predetermined shape, so that the thrombus (suction substance) is easily cut at the proximal end side of the suction port, and the large thrombus blocks the suction lumen 10. Can be suppressed.
  • the maximum length h in the vertical direction of the first cross section is shorter than the maximum length W max in the width direction.
  • the first cross section of the present embodiment may have a horizontally long shape, and the maximum length h in the vertical direction may be 0.4 to 0.9 times the maximum length W max in the width direction.
  • the second tube 41 having such a cross section for example, by inserting a stainless steel core material having a cross section substantially the same shape as the first cross section into a tube having a substantially circular cross section manufactured by extrusion molding, It can be manufactured by heating the tube.
  • the maximum length h in the vertical direction of the first cross section may be equal to or greater than the maximum length w in the width direction.
  • the shape of the first cross section of the suction lumen 10 may continue from the first position P1 to the proximal side by a predetermined distance L1. Thereby, a substance can be inhaled more smoothly.
  • the cross-section switching unit 15 that switches from the first cross section to a second cross section (see FIG. 4B) having a shape different from the first cross section at a position closer to the first position P1 in the first direction is It may be formed starting from a second position P2 that is a predetermined distance L1 away from the first position P1 in the direction.
  • the distance L1 between the first position P1 and the second position P2 can be set to 2 mm to 20 mm, for example. Moreover, the lower limit value of the distance L1 can be 2 mm or more, and the upper limit value of the distance can be 10 mm or less.
  • the cross-section switching unit 15 is arranged starting from a second position P2 that is 20 mm from the first position P1 in the first direction. This makes it possible to more reliably suppress clogging due to a thrombus in the vicinity of the suction port 11 and more reliably impart vibration to the second tube 41. The reason why the vibration is more reliably applied is that the sucked suction substance easily collides with the inner surface of the tube, and the vibration due to the collision of the suction substance with the shaft becomes stronger.
  • the cross-section switching unit 15 changes the cross-sectional shape of the suction lumen 10 from the first cross-section (see FIG. 3) to the second cross-section (see FIG. 4B) having a different shape and cross-sectional area from the first cross-section. It may be changed.
  • the cross-section switching unit 15 may be a taper formed on at least a part of the inner surface 41 a of the second tube 41 that forms the suction lumen 10.
  • the cross-section switching unit 15 is formed from the second position P2 to the third position P3 of the second tube 41.
  • Such a shape change makes it easier for the thrombus to be cut.
  • Such a shape change also has an effect of promoting the efficiency of sucking the thrombus and suppressing the thrombus in the second tube 41, that is, the suction lumen 10 from being blocked.
  • the cross-section switching unit 15 may change the cross-sectional shape of the suction lumen 10 gently by a taper provided on the inner surface (inner wall) of the suction lumen 10, or may change it by a step provided in place of the taper. Good.
  • the cross-section switching part 15 which is such a taper or a level
  • the area of the cross-sectional shape at the second position P2 that is 5 mm away from the first position P1 may be 0.8 to 1.3 times the area of the first cross section at the first position P1.
  • the change in the shape of the suction lumen may be not only a change in cross-sectional area from the distal side to the proximal side but also a change in which the cross-sectional area becomes larger.
  • the vibration generated by the change in the flow channel shape is detected by the operator of the suction catheter 1, and the operator can grasp the suction state of the thrombus.
  • the cross-sectional shape of the suction lumen 10 formed by the inner surface 41a of the second tube 41 is substantially circular.
  • the suction lumen 10 has the shape of the second cross section extending to the proximal end 3 b of the first shaft 3, that is, the hub 35.
  • the dashed-two dotted line shown by Fig.4 (a) and FIG.4 (b) has shown the bottom part 43 which is a part of the inner surface 41a in a 1st cross section.
  • the shape or cross-sectional area (size) of the suction lumen 10 may change one or more times between the third position P3 and the hub 35.
  • the cross-sectional shape or cross-sectional area of the suction lumen 10 changes, the sucked suction substance easily collides with the inner surface of the tube, and it is possible to grasp the thrombus suction state.
  • the change in cross-sectional shape or cross-sectional area may be a change in which the distal side is small and the proximal side is large.
  • the suction catheter 1 of this embodiment can be more smoothly introduced into the blood vessel.
  • the length from the proximal end 11b to the distal end 11a in the suction port 11 is 2.0 mm or more and 10 mm or less, it is excellent in peripheral reachability. If the length from the proximal end 11b to the distal end 11a in the suction port 11 is shorter than 2.0 mm, the thrombus tends to clog the suction port, and if it is longer than 10 mm, the suction force becomes very weak.
  • the suction catheter 1 In manufacturing the suction catheter 1, first, the first tube 31, the second tube 41, and the third tube 61 are prepared. Each tube is formed of the above material by extrusion. Subsequently, a marker is attached to the third tube 61. The marker is fixed to the third tube 61 by caulking.
  • one end of the second tube 41 extending in the first direction is cut.
  • the cut end is a distal end, and the cut surface is a suction port.
  • the cutting surface of the second tube 41 is formed so as to be inclined with respect to the surface orthogonal to the first direction of the suction lumen 10 (cutting line C1: first cutting step).
  • FIG. 7C a part of the proximal side including the proximal end of the suction port 11 is cut (cutting line C2: second cutting step).
  • a stainless steel core material 80 may be inserted into the second tube 41, or a resinous core material may be inserted.
  • the core material may be hollow or solid.
  • the cross-sectional shape of the core member 80 is selected in accordance with the desired cross-sectional shape of the suction port.
  • the suction lumen 10 of the second tube 41 may be deformed by pressurization, fixation, or the like from the core material or the outside.
  • the suction port is formed through the first cutting step, the deformation step, and the second cutting step in this order. The order of the suction lumen deformation process and the second cutting process described later may be reversed.
  • the distal end of the first tube 31 is connected to the proximal end of the second tube 41 (first connection step).
  • the second tube 41 and the third tube 61 to which the first tube 31 is connected are arranged in parallel.
  • the third tube 61 is arranged so that the distal end of the third tube 61 protrudes distally with respect to the distal end of the second tube 41.
  • the method of connecting the first tube and the second tube can be appropriately selected such as bonding with an adhesive or heating and welding the tube.
  • a stainless steel core material is inserted into the second tube 41 and the third tube 61.
  • the cross section of the core material is circular.
  • As the cross-sectional shape of the core material a shape other than a circle can be selected as necessary.
  • the second tube 41 and the third tube 61 are covered with a shrink tube and heated.
  • the shrink tube may be formed of a heat resistant resin. For example, an olefin resin is mentioned. Thereby, the 2nd tube 41 and the 3rd tube 61 are welded and integrated. Thereby, the main body resin 71 is formed (second connection step).
  • a stainless steel core material is inserted into the second tube 41.
  • the cross section of the core material has substantially the same cross-sectional shape as the first cross section formed by the inner surface 41a of the second tube 41 as shown in FIG.
  • Examples of the cross-sectional shape of the core material that can be selected include the shapes shown in FIGS. 10 and 11, which will be described in detail later.
  • a stainless steel core material is inserted into the third tube 61. You may use the core material used at the above-mentioned heating process as it is. When the shrink tube is covered and heated, the second tube 41 is also heated, and the shape of the inner surface 41a of the second tube 41 is formed into the shape of the inserted core material. Thereby, the suction lumen 10 having the first cross section shown in FIG. 3 is formed (suction lumen deformation step).
  • the core material having substantially the same cross-sectional shape as the first cross-section is inserted only on the distal side of the second tube 41.
  • the heat generated by inserting and heating the core material is transmitted to the portion of the second tube 41 where the core material is not inserted, whereby the tapered cross-section switching unit 15 is formed.
  • the circular section formed first by the core material has substantially the same cross-sectional shape as the first cross section.
  • the taper-shaped cross-section switching portion 15 is formed by continuously deforming into the first cross-section portion formed by the core material.
  • the hub 35 is connected to the proximal end of the first tube 31 with an adhesive 37 (third connection step).
  • the suction catheter 1 is manufactured through the above steps.
  • a suction catheter 1 according to a modification will be described mainly with reference to FIGS. 8 to 9C.
  • the suction catheter 1 according to the modified example is the same as the suction catheter 1 of the above-described embodiment, in which the inner surface 41a of the second tube (tube) 41 and the outer surface 41c of the second tube 41 on the upper side or the lower side of the suction port 11 are The upper end portion 45a and the lower end portion 45b are concave or convex with respect to the suction surface F that forms the suction port 11. 8 to 9C, the third tube 61 that forms the guide wire lumen 20 is not shown.
  • the distal end face 41b of the second tube 41 is a portion including the end face of the second tube 41 and the end face of the suction lumen 10.
  • the upper side in the vertical direction is the upper end portion 45a
  • the lower side in the vertical direction is the lower end portion 45b.
  • the upper end 45a and the lower end 45b between the inner surface 41a of the second tube 41 and the outer surface 41c of the second tube 41 on one of the upper and lower sides in the vertical direction on the distal side of the second tube 41 are arranged in the width direction (Y axis In the cross section orthogonal to the direction), the second tube 41 is concave or convex with respect to a straight line connecting the most distal point and the closest point of the cross section of the second tube 41. That is, the upper end portion 45a and the lower end portion 45b of the second tube 41 in the suction port 11 are formed by a plurality of flat surfaces or curved surfaces instead of a single flat surface. Thereby, unevenness
  • the convex portions make it easier for blood clots to enter and damage the blood vessels, and in the concave portions, the thrombus contacting the edge of the second tube 41 Since it is cut, thrombus can be sucked easily.
  • the concave or convex of the upper end 45 a or the lower end 45 b of the second tube 41 is also a concave or convex with respect to the suction port 11.
  • the suction surface F is a flat surface or a curved surface formed by the suction port 11, and is formed by the distal end portion 11 c and the proximal end portion 11 d of the suction port 11.
  • the suction port 11 is formed by cutting a part of the second tube 41 with a razor or cutting with a scissors. In that case, the suction port 11 is formed by cutting at a time from the proximal end to the distal end of the thick portion of the second tube 41.
  • the concave or convex shape of the upper end 45a or the lower end 45b of the second tube 41 can be a curved surface.
  • the curved surface is the end of the second tube 41, that is, the thick portion of the second tube 41 that forms the suction port 11 (the upper end 45a that is the portion between the inner surface 41a and the outer surface 41c of the second tube 41).
  • the lower end 45b) is, for example, a dome-shaped projection or depression, a semi-cylindrical convex or concave shape.
  • the upper end 45 a between the inner surface 41 a of the second tube 41 and the outer surface 41 c of the second tube 41 above the suction port 11 in the vertical direction (Z-axis direction) forms the suction port 11.
  • the lower end 45b between the inner surface 41a of the second tube 41 and the outer surface 41c of the second tube 41 below the suction port 11 is recessed with respect to the suction surface F. It may be convex. Moreover, it is a straight line on the suction surface F, and the second distal end 46 a on the outer surface side of the upper end portion 45 a of the end surface 41 b of the second tube 41 and the first outer surface side of the lower end portion 45 b of the end surface 41 b of the second tube 41.
  • an upper end portion 45a in the upper vertical direction of the suction port 11 is concave in line symmetry with respect to the reference line BL, and is lower than the suction port 11 in the vertical direction.
  • the lower end 45b may be convex in line symmetry with respect to the reference line BL.
  • FIGS. 9A, 9B, and 9C in the cross section when the second tube 41 is cut in the first direction (X-axis direction).
  • the second distal end 46a on the outer surface side of the upper end portion 45a of the end surface 41b of the second tube 41 is farther from the second proximal end 46c on the inner surface side of the upper end portion 45a (the distal end 11a of the suction port 11).
  • the first proximal end 46b on the outer surface side of the lower end portion 45b of the end surface 41b of the second tube 41 is located on the rear side, and the first distal end 46d on the inner surface side of the lower end portion 45b (the proximal end of the suction port 11). It is located more proximal than 11b).
  • the upper end portion 45a of the end face 41b of the second tube 41 may be inclined in a range (angle ⁇ ) of 2 ° or more and 60 ° or less with respect to the first direction (X-axis direction).
  • the angle ⁇ is an angle formed by the straight line BL1 connecting the second distal end 46a and the second proximal end 46c and the inner surface 41a of the second tube 41.
  • the lower limit value of the angle ⁇ is, for example, 10 ° or more, and the upper limit value is, for example, 30 ° or less.
  • the lower end portion 45b of the end surface 41b of the second tube 41 may be inclined within a range (angle ⁇ ) of 2 ° or more and 60 ° or less with respect to the first direction (X-axis direction).
  • the angle ⁇ is an angle formed by the straight line BL2 connecting the first proximal end 46b and the first distal end 46d and the inner surface 41a of the second tube 41.
  • the lower limit value of the angle ⁇ is, for example, 10 ° or more, and the upper limit value is, for example, 30 ° or less.
  • the upper end portion 45a between the vertically upper inner surface of the suction port 11 and the outer surface 41c of the second tube 41 is concave or convex. It may be.
  • the straight line BL2 connecting the first distal end 46d and the first proximal end 46b the lower end 45b between the vertically lower inner surface of the suction port 11 and the outer surface 41c of the second tube 41 is concave or It may be convex.
  • the straight line BL1 connecting the second distal end 46a and the second proximal end 46c and the straight line BL2 connecting the first proximal end 46b and the first distal end 46d are in the first direction. That is, the example in which the inner surface 41a of the second tube 41 is inclined in the range extending from 2 ° to 60 ° with respect to the extending direction has been described, but the inclination is inclined in a range different from the above range. There may be.
  • the core member 80 is inserted into the second tube 41 extending in the first direction with respect to the suction catheter 1 manufactured by the manufacturing method of the above embodiment (insertion step).
  • the core material to be inserted is preferably a deformable material and an outer diameter smaller than the suction lumen 10 of the second tube.
  • the second tube 41 into which the core member 80 is inserted is deformed (deformation process). For example, the second tube can be deformed so as to be crushed.
  • one end of the second tube 41 deformed in the deformation process is cut so as to be inclined with respect to a surface orthogonal to the first direction of the suction lumen 10.
  • the second tube 41 is released from the deformation.
  • the upper end 45 a in the vertical direction of the suction port 11 becomes concave with respect to the suction surface F that forms the suction port 11, and the vertical direction of the suction port 11.
  • a second tube 41 in which a lower end 45b in the lower direction is convex with respect to the suction surface F is formed. Only one of the upper end portion 45a and the lower end portion 45b may be cut so as to be concave or convex with respect to the suction surface F.
  • the end of the second tube may be formed to be concave or convex after all the tubes of the first tube, the second tube, and the third tube are connected and integrated. It may be before the second tube 41 and the first tube 31 are connected before the three tubes 61 are connected.
  • a core material or a cover for protecting the third tube may be used. Thereby, the suction catheter 1 which concerns on a modification is manufactured.
  • the upper end 45a and the lower end 45b are processed by cutting or melting the upper end 45a and the lower end 45b. You may form in a concave or convex. Even with such a method, the suction catheter 1 according to the modification can be manufactured.
  • a 1st cross section is a pair of circular arc-shaped side parts 42 and 42, the bottom part 43 extended linearly along the width direction in the perpendicular direction lower end, and the bottom part 43
  • the first cross section of the suction lumen 10 has a bottom portion 143A, 143B, 143C, 143D of 0.3 times or more of the maximum length in the width direction as shown in FIGS. 10 (a) to 10 (d).
  • the shape may be 1.0 times or less in length.
  • the first cross section includes a pair of arc-shaped side portions 142A and 142A, a bottom portion 143A extending linearly along the width direction at the lower end in the vertical direction, and a bottom portion 143A. It may be formed by an upper portion 144A that faces and extends linearly along the width direction.
  • the first cross section has a shape in which the lower part and the upper part of the ellipse are cut off by the bottom part 143A and the upper part 144A, respectively.
  • the length of the bottom portion 143B may be shorter than that of the upper portion 144B.
  • the first cross section has a shape in which a circular lower portion and an upper portion are cut off by a bottom portion 143B and an upper portion 144B, respectively.
  • the length of the bottom portion 143C may be longer than that of the upper portion 144C.
  • the first cross section may have a straight side portion.
  • the shape of the first cross section is a polygon, and the first cross section has a bottom portion extending in the width direction perpendicular to the vertical direction and the first direction at the lower end in the vertical direction. You may do it.
  • the polygon includes the polygon formed by the polygonal cross-sectional shape in the direction perpendicular to the longitudinal direction of the core material in the example of the manufacturing method.
  • the suction catheter of this embodiment is formed with resin, it is a soft tube, and each vertex of a polygon may not appear clearly.
  • the polygon may be a regular polygon in which each side has the same length, or may be a polygon in which each side has an arbitrary length.
  • the shape of the first cross section may be various polygons having bottoms 243A, 243B, 243C, 243D, 243E, 243F, 243G, and 243H, as shown in FIG. Even if the first cross section has such a polygonal shape, the thrombus is easily sucked into the suction lumen 10 from the suction port 11, and the blockage of the suction lumen 10 in the vicinity of the suction port 11 can be suppressed. Moreover, in the suction catheter according to the modified example in which the shape of the first cross section is a polygon, it becomes easy to form a cross section at the time of manufacturing, and it is easy to maintain the shape even after manufacturing.

Abstract

This suction catheter 1 comprises a second tube 41 having a suction lumen 10 that extends from the proximal side towards the distal side, and a suction port 11 that is formed at the distal side of the suction lumen. The suction port comprises a section formed inclined relative to a plane orthogonal to a first direction in which a first lumen extends. When the second tube is positioned such that a distal end 11a of the suction port is vertically upwards and a proximal end 11b of the suction port is vertically downwards, and a cross section of the suction lumen in a direction orthogonal to the first direction and at a first position P1 possessed by the proximal end 11b of the suction port in the first direction serves as a first cross section, the first cross section comprises, at the lower end in the vertical direction, a bottom part 43 that extends in a widthwise direction orthogonal to the vertical direction and the first direction, the bottom part having a length 0.3-1.0 times the maximum length in the widthwise direction.

Description

吸引カテーテル及び吸引カテーテルの製造方法Suction catheter and method for manufacturing suction catheter
　本発明の一側面は、体内の物質を体外に吸引除去する吸引カテーテル及び吸引カテーテルの製造方法に関する。 One aspect of the present invention relates to a suction catheter for sucking and removing substances in the body outside the body and a method for manufacturing the suction catheter.
　体内に導入され、カテーテル手元端から加える陰圧によって、体内の物質を体外に吸引除去する吸引カテーテルが知られている。このような吸引カテーテルとして、例えば、特許文献１には、遠位側に吸引口を有するチューブを血管内に導入して病変部位にまで到達させ、当該吸引口から血栓を吸引除去する血栓吸引カテーテルが開示されている。 A suction catheter that is introduced into the body and sucks and removes the substance inside the body by negative pressure applied from the proximal end of the catheter is known. As such a suction catheter, for example, Patent Document 1 discloses a thrombus suction catheter that introduces a tube having a suction port on the distal side into a blood vessel to reach a lesion site, and sucks and removes a thrombus from the suction port. Is disclosed.
特開２００７－２３６６３３号公報JP 2007-236633 A
　このようなカテーテルでは、吸引された血栓によるルーメンの閉塞を抑制することが求められている。そこで、ルーメンの内径を大きくしたカテーテルが提案されている。ルーメンの内径が大きいカテーテルは、吸引性能が高く、ルーメンの閉塞が抑制されることが考えられる。しかし、カテーテルの吸引口の末梢到達性を考慮すると、更なる改良が必要となる。 Such a catheter is required to suppress lumen blockage due to aspirated thrombus. Therefore, a catheter with a larger lumen inner diameter has been proposed. It is conceivable that a catheter having a large inner diameter of the lumen has high suction performance and can prevent the lumen from being blocked. However, further improvement is required in view of the peripheral reachability of the suction port of the catheter.
　そこで、本発明の一側面の目的は、吸引効率を向上させることができる吸引カテーテル及び吸引カテーテルの製造方法を提供することにある。 Therefore, an object of one aspect of the present invention is to provide a suction catheter and a method for manufacturing the suction catheter that can improve suction efficiency.
　本発明の一側面に係る吸引カテーテルは、近位側から遠位側に延びるルーメンと、ルーメンにおける遠位側に形成された吸引口と、を有するチューブ、を備え、吸引口は、ルーメンが延びる第一方向に直交する面に対して傾いた状態に形成された部分を有しており、吸引口における遠位端を鉛直方向上側、吸引口における近位端を鉛直方向下側となるチューブの配置において、第一方向において吸引口の近位端が有る第一位置でのルーメンの第一方向に直交する断面を第一断面としたとき、第一断面は、鉛直方向下端に、鉛直方向と第一方向とに直交する幅方向に延びる底部を有しており、底部は、幅方向における最大長さの０．３倍以上１．０倍以下の長さである。 A suction catheter according to one aspect of the present invention includes a tube having a lumen extending from a proximal side to a distal side and a suction port formed on a distal side of the lumen, and the suction port extends from the lumen. The tube has a portion formed to be inclined with respect to a plane perpendicular to the first direction, and the tube has a distal end at the suction port on the upper side in the vertical direction and a proximal end at the suction port on the lower side in the vertical direction. In the arrangement, when the cross section perpendicular to the first direction of the lumen at the first position where the proximal end of the suction port is located in the first direction is the first cross section, the first cross section is The bottom portion extends in the width direction perpendicular to the first direction, and the bottom portion has a length that is not less than 0.3 times and not more than 1.0 times the maximum length in the width direction.
　上記吸引カテーテルによって吸引される血栓又は異物等の物質は、吸引口の第一方向における近位側部分からルーメンに吸い込まれる。言い換えれば、上記のように配置されたチューブを第一方向に直交する側方から見たときに、上記吸引カテーテルによって吸引される物質は、チューブの吸引口における下側部分からルーメンに吸い込まれる。本発明の一側面に係る吸引カテーテルでは、上記のように配置されたチューブを第一方向から見たときに、第一断面の鉛直方向下端である底部が、第一断面における鉛直方向に直交する幅方向における最大長さの０．３倍以上１．０倍以下の長さに形成されているので、物質がルーメンに吸い込まれる部分が広い。このため、吸引口の中でも物質が最初にルーメンに吸い込まれる部分で物質が引っ掛かることが無くなる。この結果、吸引効率を向上させることができる。なお、ここでいう直交には、略直交も含む。 A substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from the proximal portion in the first direction of the suction port. In other words, when the tube arranged as described above is viewed from the side perpendicular to the first direction, the substance sucked by the suction catheter is sucked into the lumen from the lower portion of the suction port of the tube. In the suction catheter according to one aspect of the present invention, when the tube arranged as described above is viewed from the first direction, the bottom that is the lower end in the vertical direction of the first cross section is orthogonal to the vertical direction in the first cross section. Since the length is 0.3 times or more and 1.0 times or less the maximum length in the width direction, a portion where the substance is sucked into the lumen is wide. For this reason, the substance does not get caught in the portion of the suction port where the substance is first sucked into the lumen. As a result, the suction efficiency can be improved. Note that the orthogonal here includes substantially orthogonal.
　本発明の一側面に係る吸引カテーテルでは、第一断面は、鉛直方向における最大長さが、幅方向における最大長さの０．４倍以上０．９倍以下としてもよい。上記ルーメンは、いわゆる横長形状である。このため、吸引口において物質が吸い込まれる下側部を広げることができるので、より効果的に吸引口から物質を吸引することができる。 In the suction catheter according to one aspect of the present invention, the maximum length in the vertical direction of the first cross section may be 0.4 times or more and 0.9 times or less of the maximum length in the width direction. The lumen has a so-called horizontally long shape. For this reason, since the lower side part in which a substance is suck | inhaled in a suction opening can be expanded, a substance can be attracted | sucked from a suction opening more effectively.
　本発明の一側面に係る吸引カテーテルでは、第一断面の形状は、多角形としてもよい。このような構成の吸引カテーテルでは、製造時に断面を形成し易くなり、製造後においても形状を維持し易い。 In the suction catheter according to one aspect of the present invention, the shape of the first cross section may be a polygon. In the suction catheter having such a configuration, it becomes easy to form a cross section at the time of manufacturing, and it is easy to maintain the shape even after manufacturing.
　本発明の一側面に係る吸引カテーテルは、近位側から遠位側に延びるルーメンと、ルーメンにおける遠位側に形成された吸引口と、を有するチューブ、を備える吸引カテーテルであって、吸引口は、ルーメンが延びる第一方向に直交する面に対して傾いた状態に形成された部分を有しており、吸引口における遠位端を鉛直方向上側、吸引口における近位端を鉛直方向下側となるようにチューブが配置された状態において、第一方向において吸引口の近位端が有る第一位置でのルーメンの第一方向に直交する断面を第一断面としたとき、第一断面は、鉛直方向下端に、鉛直方向と第一方向とに直交する幅方向に延びる底部を有しており、第一断面の形状は、多角形である。 A suction catheter according to one aspect of the present invention is a suction catheter including a tube having a lumen extending from a proximal side to a distal side and a suction port formed on a distal side of the lumen, Has a portion formed to be inclined with respect to a plane perpendicular to the first direction in which the lumen extends, with the distal end of the suction port being vertically upward and the proximal end of the suction port being vertically downward In a state where the tube is arranged so as to be on the side, when the cross section perpendicular to the first direction of the lumen at the first position where the proximal end of the suction port is present in the first direction is the first cross section, the first cross section Has a bottom portion extending in the width direction perpendicular to the vertical direction and the first direction at the lower end in the vertical direction, and the shape of the first cross section is a polygon.
　上記吸引カテーテルによって吸引される血栓又は異物等の物質は、吸引口の第一方向における近位側部分からルーメンに吸い込まれる。言い換えれば、上記のように配置されたチューブを第一方向に直交する側方から見たときに、上記吸引カテーテルによって吸引される物質は、チューブの吸引口における下側部分からルーメンに吸い込まれる。本発明の一側面に係る吸引カテーテルでは、上記のように配置されたチューブを第一方向から見たときに、第一断面の鉛直方向下端に幅方向に延びる底部が形成されているので、物質がルーメンに吸い込まれる部分が広い。このため、吸引口の中でも物質が最初にルーメンに吸い込まれる部分で物質が引っ掛かることが無くなる。この結果、吸引効率を向上させることができる。なお、ここでいう直交には、略直交も含む。 A substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from the proximal portion in the first direction of the suction port. In other words, when the tube arranged as described above is viewed from the side perpendicular to the first direction, the substance sucked by the suction catheter is sucked into the lumen from the lower portion of the suction port of the tube. In the suction catheter according to one aspect of the present invention, since the bottom portion extending in the width direction is formed at the lower end in the vertical direction of the first cross section when the tube arranged as described above is viewed from the first direction, The part that is sucked into the lumen is wide. For this reason, the substance does not get caught in the portion of the suction port where the substance is first sucked into the lumen. As a result, the suction efficiency can be improved. Note that the orthogonal here includes substantially orthogonal.
　本発明の一側面に係る吸引カテーテルでは、ルーメンは、第一位置における第一断面形状が近位側へ所定距離続いていてもよい。上記構成の吸引カテーテルでは、よりスムーズに物質を吸い込むことができる。 In the suction catheter according to one aspect of the present invention, the lumen may have the first cross-sectional shape at the first position continuing a predetermined distance toward the proximal side. With the suction catheter configured as described above, the substance can be sucked more smoothly.
　本発明の一側面に係る吸引カテーテルでは、チューブは、第一方向における第一位置よりも近位側の位置において、第一断面から第一断面とは形状が異なる第二断面へ断面を変化させる断面切替部を更に有していてもよい。この構成の吸引カテーテルでは、吸引された吸引物質がチューブの内面に衝突しやすくなり、吸引物質のシャフトへの衝突による振動が強くなる。このため、吸引カテーテルの操作者は、当該振動を感知することができる。この結果、操作者は、物質の吸引状況の把握が可能になる。 In the suction catheter according to one aspect of the present invention, the tube changes the cross section from the first cross section to the second cross section whose shape is different from the first cross section at a position proximal to the first position in the first direction. You may further have a cross-section switching part. In the suction catheter having this configuration, the sucked suction substance easily collides with the inner surface of the tube, and vibration due to the collision of the suction substance with the shaft becomes strong. For this reason, the operator of the suction catheter can sense the vibration. As a result, the operator can grasp the suction state of the substance.
　本発明の一側面に係る吸引カテーテルでは、断面切替部は、第一断面から第一断面とは形状及び断面積が異なる第二断面へ断面を変化させてもよい。この構成の吸引カテーテルでは、操作者は、物質の吸引状況の把握が可能になる。 In the suction catheter according to one aspect of the present invention, the cross-section switching unit may change the cross section from the first cross section to the second cross section having a shape and a cross-sectional area different from the first cross section. With the suction catheter having this configuration, the operator can grasp the suction state of the substance.
　本発明の一側面に係る吸引カテーテルでは、断面切替部の端側は、第一方向において第一位置から２０ｍｍ以内に位置してもよい。この構成の吸引カテーテルでは、吸引口近傍での閉塞をより確実に抑制することが可能になると共にチューブへの振動付与が、より確実になる。 In the suction catheter according to one aspect of the present invention, the end side of the cross-section switching unit may be located within 20 mm from the first position in the first direction. In the suction catheter having this configuration, it is possible to more reliably suppress the blockage in the vicinity of the suction port, and it is possible to more reliably apply vibration to the tube.
　本発明の一側面に係る吸引カテーテルでは、断面切替部は、ルーメンを形成する内面の少なくとも一部に形成されるテーパであってもよい。この構成の吸引カテーテルでは、断面切替部を容易に形成することができる。 In the suction catheter according to one aspect of the present invention, the cross-section switching portion may be a taper formed on at least a part of the inner surface forming the lumen. In the suction catheter having this configuration, the cross-section switching part can be easily formed.
　本発明の一側面に係る吸引カテーテルでは、断面切替部の近位端でのルーメンの第一方向に直交する断面の形状は、円形としてもよい。なお、ここでいう直交には、略直交も含む。断面切替部は、第一方向に沿ってルーメンの断面形状を、上記第一断面における形状から円形に変化させる。ルーメンを流れる物質の流体は、ルーメンの流路形状に変化により大きいサイズの血栓を吸引することが可能となる。大きいサイズの血栓の吸引により振動が発生し、吸引カテーテルの操作者は、当該振動を感知することができる。この結果、操作者は、物質の吸引状況の把握が可能になる。 In the suction catheter according to one aspect of the present invention, the shape of the cross section perpendicular to the first direction of the lumen at the proximal end of the cross section switching portion may be circular. Note that the orthogonal here includes substantially orthogonal. The cross-section switching unit changes the cross-sectional shape of the lumen along the first direction from a shape in the first cross-section to a circle. The fluid of the substance flowing through the lumen makes it possible to aspirate a larger sized thrombus with a change in the lumen channel shape. Vibration is generated by sucking a large-sized thrombus, and the operator of the suction catheter can sense the vibration. As a result, the operator can grasp the suction state of the substance.
　吸引口における近位端から遠位端までの長さを２．０ｍｍ以上１０ｍｍ以下としてもよい。この構成の吸引カテーテルは、末梢到達性に優れる。 The length from the proximal end to the distal end of the suction port may be 2.0 mm or more and 10 mm or less. The suction catheter having this configuration is excellent in peripheral reachability.
　本発明の一側面に係る吸引カテーテルの製造方法は、第一方向に延びるチューブの一端を、ルーメンが延びる第一方向に直交する面に対して傾くように切断する第一切断工程と、第一切断工程により切断されたチューブのルーメンを変形させる変形工程と、変形工程により変形され、第一切断工程により形成されたチューブの開口における近位端を含む近位側の一部を切断する第二切断工程と、を含む。 A method of manufacturing a suction catheter according to one aspect of the present invention includes a first cutting step of cutting one end of a tube extending in a first direction so as to be inclined with respect to a plane perpendicular to the first direction in which a lumen extends, A deformation step of deforming the lumen of the tube cut by the cutting step, and a second portion of the proximal side including the proximal end of the tube opening formed by the first cutting step and deformed by the deformation step. Cutting step.
　本発明の一側面に係る吸引カテーテルでは、吸引口の鉛直方向上方又は下方の一方におけるチューブの内面とチューブの外面との間の端部が、吸引口を形成する吸引面に対して凹又は凸となっていてもよい。 In the suction catheter according to one aspect of the present invention, the end portion between the inner surface of the tube and the outer surface of the tube on one of the upper side and the lower side in the vertical direction of the suction port is concave or convex with respect to the suction surface forming the suction port. It may be.
　上記吸引カテーテルによって吸引される血栓又は異物等の物質は、吸引口の第一方向における近位側部分からルーメンに吸い込まれる。言い換えれば、上記のように配置されたチューブを第一方向に直交する側方から見たときに、上記吸引カテーテルによって吸引される物質は、チューブの吸引口における下側部分からルーメンに吸い込まれる。本発明の一側面に係る吸引カテーテルでは、上記のようなチューブの配置において、吸引口の鉛直方向上方又は下方の一方におけるチューブの内面とチューブの外面との間の端部が、吸引口を形成する吸引面に対して凹又は凸となっている。このため、凸となっている部分では血栓が入り易くなり、凹となっている部分では、チューブのエッジに接触した血栓が切断されるので、血栓の吸引が容易になる。この結果、吸引物質によるルーメンの閉塞を抑制することができる。 A substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from the proximal portion in the first direction of the suction port. In other words, when the tube arranged as described above is viewed from the side perpendicular to the first direction, the substance sucked by the suction catheter is sucked into the lumen from the lower portion of the suction port of the tube. In the suction catheter according to one aspect of the present invention, in the arrangement of the tube as described above, an end portion between the inner surface of the tube and the outer surface of the tube on one of the upper side and the lower side of the suction port forms a suction port. It is concave or convex with respect to the suction surface. For this reason, it becomes easy for a thrombus to enter in the convex portion, and in the concave portion, the thrombus in contact with the edge of the tube is cut, thereby facilitating the suction of the thrombus. As a result, the blockage of the lumen by the suction substance can be suppressed.
　本発明の一側面に係る吸引カテーテルでは、吸引口を形成する吸引面に対して凹又は凸である部分の形状が、曲面で定義されていてもよい。これにより、吸引口に近づいた血栓を吸引し易くなる。また、血管の損傷を抑制することもできる。 In the suction catheter according to one aspect of the present invention, the shape of a portion that is concave or convex with respect to the suction surface that forms the suction port may be defined by a curved surface. Thereby, it becomes easy to suck the thrombus approaching the suction port. In addition, damage to blood vessels can be suppressed.
　本発明の一側面に係る吸引カテーテルでは、吸引口の鉛直方向下方におけるチューブの内面とチューブの外面との間の端部が、吸引口を形成する吸引面に対して凸となっていてもよい。この構成の吸引カテーテルでは、血栓がルーメンに入り易くなる。 In the suction catheter according to one aspect of the present invention, the end portion between the inner surface of the tube and the outer surface of the tube in the vertical direction below the suction port may be convex with respect to the suction surface forming the suction port. . In the suction catheter having this configuration, the thrombus easily enters the lumen.
　本発明の一側面に係る吸引カテーテルでは、吸引口の鉛直方向上方におけるチューブの内面とチューブの外面との間の端部が、吸引口を形成する吸引面に対して凹となっていてもよい。この構成の吸引カテーテルでは、チューブのエッジに接触した血栓が切断されるので、血栓の吸引が容易になる。 In the suction catheter according to one aspect of the present invention, the end between the inner surface of the tube and the outer surface of the tube in the vertical direction above the suction port may be recessed with respect to the suction surface forming the suction port. . In the suction catheter having this configuration, since the thrombus contacting the edge of the tube is cut, the thrombus can be easily sucked.
　本発明の一側面に係る吸引カテーテルでは、吸引面上の直線であり、チューブの上端と前記チューブの下端とを繋ぐ直線を基準線としたとき、吸引口の鉛直方向上方における上端部は、基準線に対し線対称に凹となっており、吸引口の鉛直方向下方における下端部は、基準線に対し線対称に凸となっていてもよい。 In the suction catheter according to one aspect of the present invention, when the straight line on the suction surface is a reference line that connects the upper end of the tube and the lower end of the tube, the upper end portion in the vertical direction above the suction port is a reference It is concave in line symmetry with respect to the line, and the lower end of the suction port in the vertical direction may be convex in line symmetry with respect to the reference line.
　本発明の一側面に係る吸引カテーテルでは、チューブを第一方向に切断した際の断面において、ルーメンの鉛直方向下方における端部の外面側の第一近位端は、端部の内面側の第一遠位端よりも近位側に位置し、当該第一近位端及び第一遠位端を繋ぐ直線は、第一方向に対して２°以上６０°以下の範囲で傾いており、ルーメンの鉛直方向上方における端部の外面側の第二遠位端は、端部の内面側の第二近位端よりも遠位側に位置し、当該第二遠位端及び第二近位端を繋ぐ直線は、第一方向に対して２°以上６０°以下の範囲で傾いていてもよい。このような構成の吸引カテーテルでは、物質の吸い込まれる方向に鋭利に尖った形状となっている。吸引口に吸い込まれる物質は、このように鋭利に尖った端部によって細断される。この結果、吸引口の近傍に大きな物質が引っ掛かることによってルーメンが閉塞されることが抑制される。 In the suction catheter according to one aspect of the present invention, in the cross section when the tube is cut in the first direction, the first proximal end on the outer surface side of the end portion in the vertical direction of the lumen is the first proximal end on the inner surface side of the end portion. A straight line that is located proximal to the one distal end and connects the first proximal end and the first distal end is inclined in a range of 2 ° to 60 ° with respect to the first direction, The second distal end on the outer surface side of the end portion in the vertically upper direction is positioned more distally than the second proximal end on the inner surface side of the end portion, and the second distal end and the second proximal end May be inclined in a range of 2 ° to 60 ° with respect to the first direction. The suction catheter having such a configuration has a sharp shape in the direction in which the substance is sucked. The substance sucked into the suction port is shredded by the sharply pointed end. As a result, the lumen is prevented from being blocked by a large substance caught in the vicinity of the suction port.
　本発明の一側面に係る吸引カテーテルでは、チューブを第一方向に切断した際の断面において、ルーメンの鉛直方向下方における端部の外面側の第一近位端は、端部の内面側の第一遠位端よりも近位側に位置し、ルーメンの鉛直方向上方における端部の外面側の第二遠位端は、端部の内面側の第二近位端よりも遠位側に位置し、第一近位端と第一遠位端とを繋ぐ直線に対し、吸引口の鉛直方向下方におけるチューブの内面とチューブの外面との間の端部が、凹又は凸となっており、第二遠位端と第二近位端とを繋ぐ直線に対し、吸引口の鉛直方向上方におけるチューブの内面とチューブの外面との間の端部が、凹又は凸となっていてもよい。これにより、吸引口に近づいた血栓をより吸引し易くなる。 In the suction catheter according to one aspect of the present invention, in the cross section when the tube is cut in the first direction, the first proximal end on the outer surface side of the end portion in the vertical direction of the lumen is the first proximal end on the inner surface side of the end portion. The second distal end located on the proximal side of the distal end and on the outer surface side of the end vertically above the lumen is located on the distal side of the second proximal end on the inner surface side of the end portion. And, with respect to the straight line connecting the first proximal end and the first distal end, the end between the inner surface of the tube and the outer surface of the tube in the vertical direction below the suction port is concave or convex, The end between the inner surface of the tube and the outer surface of the tube in the vertical direction above the suction port may be concave or convex with respect to the straight line connecting the second distal end and the second proximal end. Thereby, it becomes easier to suck the thrombus approaching the suction port.
　本発明の一側面に係る吸引カテーテルでは、吸引口を鉛直方向下方から見た場合に、吸引口の近位側端部における曲率が、遠位側端部における曲率よりも小さくてもよい。このような構成の吸引カテーテルでは、吸引口を鉛直方向下方から見た場合に、吸引口の近位側端部における曲率（曲がり度合）が遠位側端部における曲率よりも小さい、すなわち、吸引口の近位側端部における曲率半径が遠位側端部における曲率半径よりも大きい。このため、吸引口において血栓を切断する有効部分が大きくなるので、血栓を切断し易い。なお、ここでいう曲率には、曲率が０の場合、すなわち、直線である場合も含む。この結果、吸引物質によるルーメンの閉塞を抑制することができる。 In the suction catheter according to one aspect of the present invention, when the suction port is viewed from below in the vertical direction, the curvature at the proximal end of the suction port may be smaller than the curvature at the distal end. In the suction catheter having such a configuration, when the suction port is viewed from below in the vertical direction, the curvature (degree of bending) at the proximal end of the suction port is smaller than the curvature at the distal end, that is, suction. The radius of curvature at the proximal end of the mouth is greater than the radius of curvature at the distal end. For this reason, since the effective part which cut | disconnects the thrombus in a suction port becomes large, it is easy to cut | disconnect a thrombus. Here, the curvature includes the case where the curvature is 0, that is, the case where the curvature is a straight line. As a result, the blockage of the lumen by the suction substance can be suppressed.
　本発明の一側面に係る吸引カテーテルでは、吸引口を鉛直方向下方から見た場合に、吸引口の近位側端部は、第一方向と鉛直方向との両方に直交する幅方向に直線状に延びていてもよい。この吸引カテーテルの構成では、吸引口の近位側端部は、幅方向に直線状に延びているので、血栓を切断し易い。この結果、吸引物質によるルーメンの閉塞を抑制することができる。ここでいう直交には、略直交も含む。 In the suction catheter according to one aspect of the present invention, when the suction port is viewed from below in the vertical direction, the proximal end of the suction port is linear in the width direction orthogonal to both the first direction and the vertical direction. It may extend to. In this suction catheter configuration, the proximal end of the suction port extends linearly in the width direction, so that the thrombus can be easily cut. As a result, the blockage of the lumen by the suction substance can be suppressed. The orthogonal here includes substantially orthogonal.
　上記吸引カテーテルの製造方法では、第一方向において吸引口の近位端が有る第一位置でのルーメンの第一方向に直交する第一断面において、鉛直方向下端に、鉛直方向と第一方向とに直交する幅方向に延びる底部を容易に形成することができる。第一断面において鉛直方向下端に底部が形成されたチューブを有する吸引カテーテルでは、物質がルーメンに吸い込まれる部分が広くなる。 In the suction catheter manufacturing method, in the first cross section orthogonal to the first direction of the lumen at the first position where the proximal end of the suction port is in the first direction, the vertical direction and the first direction It is possible to easily form a bottom portion extending in the width direction orthogonal to the width direction. In the suction catheter having a tube having a bottom formed at the lower end in the vertical direction in the first cross section, a portion where the substance is sucked into the lumen is widened.
　本発明の一側面によれば、吸引効率を向上させることができる。 According to one aspect of the present invention, the suction efficiency can be improved.
図１は、一実施形態に係る吸引カテーテルを第一方向に沿って切断したときの断面図である。FIG. 1 is a cross-sectional view of a suction catheter according to an embodiment when cut along a first direction. 図２は、図１におけるＡ－Ａ線に沿った断面構成を示す図である。FIG. 2 is a diagram showing a cross-sectional configuration along the line AA in FIG. 図３は、図１におけるＤ－Ｄ線に沿った断面構成を示す図である。FIG. 3 is a diagram showing a cross-sectional configuration along the line DD in FIG. 図４（ａ）は、図１におけるＣ－Ｃ線に沿った断面構成を示す図であり、図４（ｂ）は、図１におけるＢ－Ｂ線に沿った断面構成を示す図である。4A is a diagram showing a cross-sectional configuration along the line CC in FIG. 1, and FIG. 4B is a diagram showing a cross-sectional configuration along the line BB in FIG. 図５は、一実施形態に係る吸引ルーメンにおける吸引口を鉛直方向下方から見た底面図である。FIG. 5 is a bottom view of the suction port in the suction lumen according to the embodiment as viewed from below in the vertical direction. 図６は、異なる実施形態に係る吸引ルーメンにおける吸引口を鉛直方向下方から見た底面図である。Drawing 6 is a bottom view which looked at a suction mouth in a suction lumen concerning a different embodiment from the perpendicular direction lower part. 図７（ａ）～図７（ｃ）は、図１の吸引カテーテルの製造方法の工程の一例を説明する図である。7 (a) to 7 (c) are diagrams for explaining an example of the steps of the suction catheter manufacturing method of FIG. 図８は、変形例１に係る吸引カテーテルの第二チューブの吸引口における遠位側端面を示した斜視図である。FIG. 8 is a perspective view showing a distal end face of the suction port of the second tube of the suction catheter according to the first modification. 図９（ａ）は、変形例１に係る吸引カテーテルの第二チューブの吸引口における遠位側端面を示した第一方向の断面図であり、図９（ｂ）は、上端部の拡大断面図であり、図９（ｃ）は、下端部の拡大断面図である。9A is a cross-sectional view in the first direction showing the distal end face of the suction port of the second tube of the suction catheter according to the first modification, and FIG. 9B is an enlarged cross-sectional view of the upper end portion. FIG. 9C is an enlarged cross-sectional view of the lower end portion. 図１０（ａ）～図１０（ｄ）は、変形例１に係る吸引カテーテルにおける吸引ルーメンの断面図の一例である。FIG. 10A to FIG. 10D are examples of cross-sectional views of the suction lumen in the suction catheter according to the first modification. 図１１（ａ）～図１１（ｈ）は、変形例２に係る吸引カテーテルにおける吸引ルーメンの断面図の一例である。FIGS. 11A to 11H are examples of cross-sectional views of the suction lumen in the suction catheter according to the second modification.
　以下、図面を参照して一実施形態の吸引カテーテル１について説明する。吸引カテーテル１は、体内に導入されて、血管内に生成した血栓を吸引カテーテル１の手元側（近位側）から加える陰圧により体外に吸引除去するために用いられる。なお、図面の説明において、同一要素には同一符号を付し、重複する説明を省略する場合がある。 Hereinafter, an aspiration catheter 1 according to an embodiment will be described with reference to the drawings. The suction catheter 1 is introduced into the body and used to suck and remove the thrombus generated in the blood vessel from the body by negative pressure applied from the proximal side of the suction catheter 1. In the description of the drawings, the same elements may be denoted by the same reference numerals, and redundant descriptions may be omitted.
　以下の説明においては、吸引カテーテル１が延びる第一方向において、吸引カテーテル１の操作側（図１左側）を近位側と定義し、吸引カテーテル１の操作側とは反対側であって、人体に導入される側（図１右側）を遠位側と定義する。また、図１～図６では、吸引カテーテル１が延びる第一方向をＸ軸方向として、鉛直方向をＺ軸方向として、上記第一方向及び上記鉛直方向に直交する方向である吸引ルーメン１０の幅方向をＹ軸方向として示す場合がある。吸引カテーテル１が延びる第一方向とは、吸引カテーテル１を側面視した場合の長手方向でもある。 In the following description, in the first direction in which the suction catheter 1 extends, the operation side (left side in FIG. 1) of the suction catheter 1 is defined as the proximal side, and the opposite side to the operation side of the suction catheter 1 The side (right side in FIG. 1) to be introduced into the head is defined as the distal side. 1 to 6, the first direction in which the suction catheter 1 extends is the X-axis direction, the vertical direction is the Z-axis direction, and the width of the suction lumen 10 is the direction perpendicular to the first direction and the vertical direction. The direction may be indicated as the Y-axis direction. The first direction in which the suction catheter 1 extends is also the longitudinal direction when the suction catheter 1 is viewed from the side.
　図１に示されるように、吸引カテーテル１は、近位端から遠位端まで延びる吸引ルーメン１０と、吸引ルーメン１０の遠位側において吸引ルーメン１０に沿って延びるガイドワイヤールーメン２０と、を有している。吸引ルーメン１０は、吸引ルーメンの遠位端に設けられた吸引口１１から吸引される血栓等の流路となる。ガイドワイヤールーメン２０は、吸引ルーメン１０の吸引口１１を対象部位にまで案内するためのガイドワイヤ（図示せず）を通過させるルーメンとなる。以下、吸引ルーメン１０が単独で延びる部分を第一シャフト３と称し、吸引ルーメン１０とガイドワイヤールーメン２０とが並んで延びる部分を第二シャフト５と称する。 As shown in FIG. 1, the suction catheter 1 has a suction lumen 10 extending from the proximal end to the distal end, and a guide wire lumen 20 extending along the suction lumen 10 on the distal side of the suction lumen 10. is doing. The suction lumen 10 serves as a flow path for a thrombus or the like sucked from a suction port 11 provided at the distal end of the suction lumen. The guide wire lumen 20 is a lumen through which a guide wire (not shown) for guiding the suction port 11 of the suction lumen 10 to the target site is passed. Hereinafter, the portion where the suction lumen 10 extends alone is referred to as the first shaft 3, and the portion where the suction lumen 10 and the guide wire lumen 20 extend side by side is referred to as the second shaft 5.
　第一シャフト３は、吸引ルーメン１０を形成する第一チューブ３１から成る。図２に示されるように、第一チューブ３１は、一方向に延びる中空部材であり、長手方向に直交する断面（以下、単に「断面」と称する）が円環状の部材である。第一チューブ３１の内面３１ａは、上記吸引ルーメン１０を形成し、上記吸引ルーメン１０は、近位側から遠位側に延びる。第一チューブ３１は、樹脂材料により形成されている。樹脂材料の例には、ポリアミド樹脂、ポリアミドエラストマー、ポリウレタン樹脂、ポリエーテル樹脂、ポリエステル樹脂、ポリイミド樹脂、及びポリエチレン樹脂から選択される少なくとも一つが含まれる。 The first shaft 3 includes a first tube 31 that forms the suction lumen 10. As shown in FIG. 2, the first tube 31 is a hollow member extending in one direction, and a cross section perpendicular to the longitudinal direction (hereinafter simply referred to as “cross section”) is an annular member. The inner surface 31a of the first tube 31 forms the suction lumen 10, and the suction lumen 10 extends from the proximal side to the distal side. The first tube 31 is formed of a resin material. Examples of the resin material include at least one selected from polyamide resin, polyamide elastomer, polyurethane resin, polyether resin, polyester resin, polyimide resin, and polyethylene resin.
　第一チューブ３１は、内層及び外層を含む部材であってもよい。内層を形成する材料の例には、ポリテトラフルオロエチレン（ＰＴＦＥ）、テトラフルオロエチレン・パーフルオロアルキルビニルエーテル共重合体（ＰＦＡ）、テトラフルオロエチレン・ヘキサフルオロプロピレン共重合体（ＦＥＰ）、テトラフルオロエチレン・エチレン共重合体（ＥＴＦＥ）、ポリビニリデンフルオライド（ＰＶＤＦ）、ポリクロロトリフルオロエチレン（ＰＣＴＦＥ）等のフッ素樹脂、高密度ポリエチレン等が含まれる。外層を形成する材料の例には、ポリアミドエラストマー、ポリエステルエラストマー、ポリオレフィンエラストマー等のエラストマーが含まれる。 The first tube 31 may be a member including an inner layer and an outer layer. Examples of the material forming the inner layer include polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), and tetrafluoroethylene. -Fluorine resins such as ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), high-density polyethylene and the like are included. Examples of the material forming the outer layer include elastomers such as polyamide elastomer, polyester elastomer, and polyolefin elastomer.
　第一チューブ３１として、編組チューブを用いてもよい。編組チューブは、樹脂等で形成されたチューブに樹脂又は金属による編組構造を含むチューブである。編組構造とは、例えばチューブのルーメンの周囲に設けられる編まれた線状物による構造である。編組構造は、１本の線材が巻き付けられた構造又はルーメンに沿って配置された構造であってもよい。編組チューブを構成する編組の材質又は構造は本発明の一側面の効果を制限しないので、様々な材質又は構造が利用可能である。編組の材質として金属を使用することができ、ＳＵＳ３０４、ＳＵＳ３１６等のステンレス鋼、バネ鋼、ピアノ線、オイルテンパー線、Ｃｏ－Ｃｒ合金、Ｎｉ－Ｔｉ合金等を円、楕円、四角形等各種の断面形状に加工した金属素線を１本持あるいは複数本持で編組に加工した金属を使用することができる。 A braided tube may be used as the first tube 31. The braided tube is a tube including a braided structure made of resin or metal in a tube formed of resin or the like. The braided structure is, for example, a structure formed by a knitted linear object provided around the lumen of the tube. The braided structure may be a structure in which one wire is wound or a structure arranged along a lumen. Since the material or structure of the braid constituting the braided tube does not limit the effect of one aspect of the present invention, various materials or structures can be used. Metal can be used as the material of the braid. Stainless steel such as SUS304 and SUS316, spring steel, piano wire, oil temper wire, Co-Cr alloy, Ni-Ti alloy, etc. It is possible to use a metal that has been processed into a braid with one or more metal wires processed into a shape.
　第一シャフト３は、第一チューブ３１の内側又は外側に別のチューブが配置される二重管構造であってもよい。 The first shaft 3 may have a double tube structure in which another tube is disposed inside or outside the first tube 31.
　図１に示されるように、第一シャフト３の近位端３ｂには、ハブ３５が設けられている。ハブ３５には、例えばＹ字コネクタ（図示せず）を介して、シリンジ等の吸引装置（図示せず）が接続されている。吸引装置による負圧吸引力は、ハブ３５を通じて、第一チューブ３１の吸引ルーメン１０に及ぼされる。ハブ３５は、例えば、スチレン－ブタジエン共重合体により形成されている。第一チューブ３１の近位端３１ｂは、接着剤３７によりハブ３５に接着されている。接着剤３７は、例えば、ウレタン接着剤である。第一チューブ３１の吸引ルーメン１０は、ハブ３５の開口部３５ａと連通している。 As shown in FIG. 1, a hub 35 is provided at the proximal end 3 b of the first shaft 3. A suction device (not shown) such as a syringe is connected to the hub 35 via, for example, a Y-shaped connector (not shown). The negative pressure suction force by the suction device is applied to the suction lumen 10 of the first tube 31 through the hub 35. The hub 35 is made of, for example, a styrene-butadiene copolymer. The proximal end 31 b of the first tube 31 is bonded to the hub 35 with an adhesive 37. The adhesive 37 is, for example, a urethane adhesive. The suction lumen 10 of the first tube 31 communicates with the opening 35 a of the hub 35.
　第二シャフト５は、第二チューブ（チューブ）４１と第三チューブ６１によって形成される。第二チューブ４１は、近位側から遠位側に第一方向に延びる吸引ルーメン１０を有し、第三チューブ６１は、近位側から遠位側に第一方向に延びるガイドワイヤールーメン２０を有している。なお、説明の便宜のため、第二チューブ４１及び第三チューブ６１は、図３等に示されるように、本体樹脂７１と別の部分である状態で示しているが、第二チューブ４１及び第三チューブ６１の外形は、図３に示される形状を留めていなくてもよい。すなわち、第二チューブ４１、第三チューブ６１、及び本体樹脂７１の境界が不明確な状態であってもよい。 The second shaft 5 is formed by a second tube (tube) 41 and a third tube 61. The second tube 41 has a suction lumen 10 extending in the first direction from the proximal side to the distal side, and the third tube 61 has a guide wire lumen 20 extending in the first direction from the proximal side to the distal side. Have. For convenience of explanation, the second tube 41 and the third tube 61 are shown in a state different from the main body resin 71 as shown in FIG. The outer shape of the three tubes 61 may not be the shape shown in FIG. That is, the boundary between the second tube 41, the third tube 61, and the main body resin 71 may be indefinite.
　第二チューブ４１は、第一方向に延びる中空部材であり、樹脂材料により形成されている。吸引ルーメン１０は、第二チューブ４１の内面４１ａによって形成される。第二チューブ４１を形成する樹脂材料の例は、上段にて説明した第一チューブ３１を形成する材料の例と同じである。同様に、第二チューブ４１は、内層及び外層を含む部材であってもよく、その材料も第一チューブ３１の例と同じであってもよい。また、同様に、第二チューブ４１として、編組チューブを用いてもよく、その材料の例も第一チューブ３１と同じであってもよい。 The second tube 41 is a hollow member extending in the first direction and is formed of a resin material. The suction lumen 10 is formed by the inner surface 41 a of the second tube 41. The example of the resin material which forms the 2nd tube 41 is the same as the example of the material which forms the 1st tube 31 demonstrated in the upper stage. Similarly, the second tube 41 may be a member including an inner layer and an outer layer, and the material thereof may be the same as that of the first tube 31. Similarly, a braided tube may be used as the second tube 41, and an example of the material may be the same as that of the first tube 31.
　第一チューブ３１の遠位端（図示せず）と第二チューブ４１の近位端（図示せず）とは、互いに接続され、第一チューブ３１の吸引ルーメン１０と第二チューブ４１の吸引ルーメン１０とは互いに連通している。なお、第一シャフト３と第二シャフト５とを通して、同一のチューブが配置されていてもよく、例えば、第二チューブ４１が、第一シャフト３から第二シャフト５にまで延びていてもよい。 The distal end (not shown) of the first tube 31 and the proximal end (not shown) of the second tube 41 are connected to each other, and the suction lumen 10 of the first tube 31 and the suction lumen of the second tube 41 are connected. 10 communicate with each other. The same tube may be disposed through the first shaft 3 and the second shaft 5. For example, the second tube 41 may extend from the first shaft 3 to the second shaft 5.
　第一チューブ３１と第二チューブ４１とは、一本のチューブとして一体的に形成されていてもよく、途中で異なる複数のチューブが接続されていてもよい。一体的に形成されている場合、第一チューブ３１と第二チューブ４１とは、同じ樹脂材料で形成されていてもよい。接続されている場合、同じ樹脂材料で形成されたチューブ同士を接続してもよく、異なる樹脂材料により形成されたチューブ同士を接続してもよい。接続部分は、接着剤又は接続用部材を用いてチューブ同士を接続してもよく、チューブを溶融して接続してもよい。 The first tube 31 and the second tube 41 may be integrally formed as a single tube, or a plurality of different tubes may be connected on the way. When formed integrally, the first tube 31 and the second tube 41 may be formed of the same resin material. When connected, tubes formed of the same resin material may be connected, or tubes formed of different resin materials may be connected. The connecting portion may connect the tubes using an adhesive or a connecting member, or may melt and connect the tubes.
　図１に示されるように、第二チューブ４１の遠位側の端面４１ｂは、傾斜している。具体的には、第二チューブ４１の遠位側の端面４１ｂは、第二チューブ４１が延びる方向（第一方向）に対して、所定の角度を成して傾斜している。詳細には、図１に示されるように、第二チューブ４１の遠位側の端面４１ｂは、上端が遠位側でかつ下端が近位側となるように、遠位側から近位側に向かって連続して傾斜している。端面４１ｂは、開口しており、吸引ルーメン１０に連通する。端面４１ｂの一部が、閉じている構成であってもよい。上記傾斜は、側面視、直線状であってもよく、湾曲していてもよい。直線と曲線の組み合わせであってもよい。端面４１ｂは、上端が遠位側でかつ下端が近位側である形状であればよく、段差が設けられるなどして階段状に形状が変化してもよく、直線と曲線との組み合わせ形状であってもよい。 As shown in FIG. 1, the distal end surface 41b of the second tube 41 is inclined. Specifically, the distal end surface 41b of the second tube 41 is inclined at a predetermined angle with respect to the direction (first direction) in which the second tube 41 extends. Specifically, as shown in FIG. 1, the distal end surface 41 b of the second tube 41 extends from the distal side to the proximal side so that the upper end is the distal side and the lower end is the proximal side. Inclined continuously. The end surface 41 b is open and communicates with the suction lumen 10. A configuration in which a part of the end surface 41b is closed may be employed. The inclination may be linear as viewed from the side, or may be curved. It may be a combination of straight lines and curves. The end surface 41b may have any shape as long as the upper end is on the distal side and the lower end is on the proximal side. The end surface 41b may change in a staircase shape by providing a step or the like. There may be.
　第二チューブ４１の遠位端には、吸引口１１が設けられている。上記吸引口１１は上記端面４１ｂの一部又は全部を含んで形成される。吸引口１１は、第二チューブ４１の長手方向に沿って設けられ、一方端が遠位側に、他方端が近位側に配置される。なお、吸引口１１における近位端１１ｂから遠位端１１ａまでの第一方向における長さＬ０（図１参照）は、例えば、２．０ｍｍ以上１０ｍｍ以下とすることができる。上記のとおり、第二チューブ４１の遠位端の端面４１ｂは傾斜しているので、当該端面に設けられる吸引口１１は、吸引ルーメン１０の第一方向に直交する面に対して傾いた状態に形成されている。第二チューブ４１は、側面視において、吸引口１１における遠位端１１ａが鉛直方向上側、吸引口１１における近位端１１ｂが鉛直方向下側となる。 The suction port 11 is provided at the distal end of the second tube 41. The suction port 11 is formed including part or all of the end face 41b. The suction port 11 is provided along the longitudinal direction of the second tube 41, and one end is disposed on the distal side and the other end is disposed on the proximal side. In addition, length L0 (refer FIG. 1) in the 1st direction from the proximal end 11b to the distal end 11a in the suction port 11 can be 2.0 mm or more and 10 mm or less, for example. As described above, since the end surface 41b at the distal end of the second tube 41 is inclined, the suction port 11 provided in the end surface is inclined with respect to the surface orthogonal to the first direction of the suction lumen 10. Is formed. In the second tube 41, the distal end 11 a of the suction port 11 is on the upper side in the vertical direction and the proximal end 11 b of the suction port 11 is on the lower side in the vertical direction when viewed from the side.
　図５に示されるように、吸引口１１では、鉛直下方向から見たときの近位側の近位端１１ｂを含む近位側端部１１ｄの曲線形状が、遠位端１１ａを含む遠位側端部１１ｃの曲線形状と異なっていてもよい。具体的には、近位側端部１１ｄの曲線形状における曲線半径が、遠位側端部１１ｃの曲線形状における曲線半径よりも大きくてもよい。すなわち、近位側端部１１ｄの曲線形状における曲がり具合（曲率）が、遠位側端部１１ｃの曲線形状における曲がり具合（曲率）よりも小さくてもよい。この構成により、吸引口１１において血栓を切断する有効部分が大きくなり、血栓が切断され易くなる。この結果、血栓等の吸引物質による吸引ルーメン１０の閉塞を抑制することができる。例えば、吸引口１１の近位側端部１１ｄの曲率を、１．７４×１０３ｒａｄ／ｍ以下としてもよい。これにより、閉塞抑制効果をより高めることができる。ｒａｄ／ｍは、曲率の単位であり、度（角度）／周長（長さ）を示す。 As shown in FIG. 5, in the suction port 11, the curved shape of the proximal end portion 11 d including the proximal end 11 b on the proximal side when viewed from the vertically downward direction is a distal end including the distal end 11 a. It may be different from the curved shape of the side end portion 11c. Specifically, the curve radius in the curved shape of the proximal end portion 11d may be larger than the curve radius in the curved shape of the distal end portion 11c. That is, the degree of curvature (curvature) in the curved shape of the proximal end 11d may be smaller than the degree of curvature (curvature) in the curved shape of the distal end 11c. With this configuration, the effective portion for cutting the thrombus at the suction port 11 is increased, and the thrombus is easily cut. As a result, the suction lumen 10 can be prevented from being blocked by a suction substance such as a thrombus. For example, the curvature of the proximal end portion 11d of the suction port 11 may be 1.74 × 10 3 rad / m or less. Thereby, the obstruction | occlusion suppression effect can be heightened more. rad / m is a unit of curvature and indicates degree (angle) / perimeter (length).
　異なる実施形態の一例として、図６に示されるように、鉛直下方向から見たときの近位側の近位端１１ｂを含む近位側端部１１１ｄの曲線形状を、幅方向（Ｙ軸方向）に沿って直線状に形成してもよい。これは、近位側の曲率をより小さくした場合（曲率０）の例でもある。この構成により、血栓が吸引口１１により引っかかり易くなると共に、吸引口１１において血栓を切断する有効部分が大きくなり、血栓が切断され易くなる。この結果、血栓等の吸引物質による吸引ルーメン１０の閉塞を抑制することができる。 As an example of a different embodiment, as shown in FIG. 6, the curved shape of the proximal end portion 111 d including the proximal end 11 b on the proximal side when viewed from the vertically downward direction is the width direction (Y-axis direction). ) May be formed along a straight line. This is also an example when the curvature on the proximal side is made smaller (curvature 0). With this configuration, the thrombus is easily caught by the suction port 11, and an effective portion for cutting the thrombus at the suction port 11 is increased, so that the thrombus is easily cut. As a result, the suction lumen 10 can be prevented from being blocked by a suction substance such as a thrombus.
　図１に示されるように、第三チューブ６１は、一方向に延びる中空部材であり、樹脂材料により形成されている。ガイドワイヤールーメン２０は、第三チューブ６１の内面６１ａによって形成される。第三チューブ６１における遠位端及び近位端のそれぞれには、開口２１及び開口２２が設けられている。開口２１及び開口２２は、吸引ルーメン１０の第一方向に直交する面に沿って形成されている。第三チューブ６１は、樹脂材料により形成されている。第三チューブ６１を形成する樹脂材料の例は、上段にて説明した第一チューブ３１を形成する材料の例と同じである。同様に、第三チューブ６１は、内層及び外層を含む部材であってもよく、その材料も第一チューブ３１の例と同じであってもよい。また、同様に、第三チューブ６１として、編組チューブを用いてもよく、その材料の例も第一チューブ３１と同じであってもよい。 As shown in FIG. 1, the third tube 61 is a hollow member extending in one direction, and is formed of a resin material. The guide wire lumen 20 is formed by the inner surface 61 a of the third tube 61. An opening 21 and an opening 22 are provided at the distal end and the proximal end of the third tube 61, respectively. The opening 21 and the opening 22 are formed along a plane orthogonal to the first direction of the suction lumen 10. The third tube 61 is made of a resin material. The example of the resin material which forms the 3rd tube 61 is the same as the example of the material which forms the 1st tube 31 demonstrated in the upper stage. Similarly, the third tube 61 may be a member including an inner layer and an outer layer, and the material thereof may be the same as that of the first tube 31. Similarly, a braided tube may be used as the third tube 61, and the example of the material may be the same as that of the first tube 31.
　第一チューブ３１、シャフトと第二チューブ４１、及び第三チューブ６１は、複数の樹脂材料や他の材料を含む複層構造であってもよい。複数の樹脂材料を用いる場合、樹脂材料は同じであってもよく、互いに異なってもよい。また、例えば金属製のリング又はプレートなどをチューブのルーメンに面する部分又はそれ以外の部分に配置してもよい。樹脂製又は金属製のワイヤをチューブに巻き付けることもできる。 The first tube 31, the shaft and the second tube 41, and the third tube 61 may have a multilayer structure including a plurality of resin materials and other materials. When using a plurality of resin materials, the resin materials may be the same or different from each other. Further, for example, a metal ring or plate may be arranged in a portion facing the lumen of the tube or other portion. A resin or metal wire can be wound around the tube.
　第三チューブ６１には、Ｘ線（放射線）が不透過である材料により形成されるマーカー（図示せず）が設けられてもよい。マーカーは、例えば、金、白金、タングステン、白金（Ｐｔ）及びインジウム（Ｉｒ）を含む合金で形成される環状の部材である。マーカーは、第三チューブ６１を周方向に囲うように第三チューブ６１に取り付けられる。これにより、操作者は、Ｘ線透過画像に基づいて第二シャフト５の遠位端の位置を把握することができるようになる。 The third tube 61 may be provided with a marker (not shown) formed of a material that is opaque to X-rays (radiation). The marker is, for example, an annular member formed of an alloy containing gold, platinum, tungsten, platinum (Pt), and indium (Ir). The marker is attached to the third tube 61 so as to surround the third tube 61 in the circumferential direction. Accordingly, the operator can grasp the position of the distal end of the second shaft 5 based on the X-ray transmission image.
　第二シャフト５において第二チューブ４１と第三チューブ６１とは一体的に形成されている。具体的には、第三チューブ６１が第二チューブ４１の鉛直方向上方に配列された状態で、樹脂材料により形成される本体樹脂７１により一体化されている。本実施形態では、本体樹脂７１は熱可塑性樹脂、例えば、ポリアミドエラストマー（ＰＡＥ）、又はポリアミドエラストマーにより形成されている。本体樹脂７１は、例えば、第二チューブ４１及び第三チューブ６１に被せられたシュリンクチューブを加熱することによって形成される。これにより、第二シャフト５の外面（外形）７１ａが形成される。ここで一体化とは、第二チューブ４１、第三チューブ６１、及び本体樹脂７１の境界が不明確な状態であってもよく、図３に示されるようにそれぞれの境界が明確であってもよい。第二チューブ４１、第三チューブ６１、及びチューブ材料の異なる３つの部材を一体化していてもよく、１の部材に２つのルーメンを形成して三者が一体化していてもよい。第二チューブ４１、第三チューブ６１のみを一体化してもよい。この場合、溶解した第二チューブ４１、第三チューブ６１によって、本体樹脂７１が形成される。 In the second shaft 5, the second tube 41 and the third tube 61 are integrally formed. Specifically, the third tube 61 is integrated with a main body resin 71 formed of a resin material in a state where the third tube 61 is arranged above the second tube 41 in the vertical direction. In the present embodiment, the main body resin 71 is formed of a thermoplastic resin, for example, a polyamide elastomer (PAE) or a polyamide elastomer. The main body resin 71 is formed, for example, by heating a shrink tube placed on the second tube 41 and the third tube 61. Thereby, the outer surface (outer shape) 71a of the second shaft 5 is formed. Here, the integration may be a state in which the boundaries of the second tube 41, the third tube 61, and the main body resin 71 are unclear, and even if the respective boundaries are clear as shown in FIG. Good. The second tube 41, the third tube 61, and three members of different tube materials may be integrated, or two lumens may be formed in one member and the three members may be integrated. Only the second tube 41 and the third tube 61 may be integrated. In this case, the main body resin 71 is formed by the dissolved second tube 41 and third tube 61.
　図１、図３及び図４に示されるように、第二チューブ４１の内面４１ａによって形成される吸引ルーメン１０は、近位側から遠位側に沿って断面が変化してもよい。第二チューブ４１の第一方向において、吸引口１１の近位端１１ｂが有る第一位置Ｐ１での吸引ルーメン１０の断面を第一断面とする。図３に示されるように、上記第一断面は、一対の円弧状の側部４２，４２と、鉛直方向（Ｚ軸方向）下端に幅方向（Ｙ軸方向）に直線状に延びる底部４３と、底部４３に対向すると共に幅方向（Ｙ軸方向）に直線状に延びる上部４４と、により形成されている。第一断面は、円形の下部と上部とが底部４３と上部４４とによってそれぞれ切り取られたような形状となっている。 As shown in FIGS. 1, 3 and 4, the cross section of the suction lumen 10 formed by the inner surface 41a of the second tube 41 may change from the proximal side to the distal side. In the first direction of the second tube 41, the cross section of the suction lumen 10 at the first position P1 where the proximal end 11b of the suction port 11 is present is defined as a first cross section. As shown in FIG. 3, the first cross section includes a pair of arc-shaped side portions 42 and 42, and a bottom portion 43 extending linearly in the width direction (Y-axis direction) at the lower end in the vertical direction (Z-axis direction). And an upper portion 44 that faces the bottom 43 and extends linearly in the width direction (Y-axis direction). The first cross section has a shape in which a circular lower part and an upper part are cut off by a bottom part 43 and an upper part 44, respectively.
　ここで、上記第一断面において底部４３の幅方向（Ｙ軸方向）における長さＷは、第一断面において幅方向における最大長さＷｍａｘの０．３倍以上１．０倍以下の長さである。すなわち、血栓が吸引ルーメン１０に吸い込まれる部分が広く形成されている。このため、吸引口１１の中でも血栓が最初に吸引ルーメン１１０に吸い込まれる部分において血栓が引っ掛かることが無くなる。この結果、吸引効率を向上させることができる。 Here, the length W in the width direction (Y-axis direction) of the bottom 43 in the first cross section is 0.3 to 1.0 times the maximum length W max in the width direction in the first cross section. It is. That is, a portion where the thrombus is sucked into the suction lumen 10 is widely formed. For this reason, the thrombus does not get caught in the portion of the suction port 11 where the thrombus is first sucked into the suction lumen 110. As a result, the suction efficiency can be improved.
　本実施形態の吸引カテーテル１では、第一断面を所定の形状とすることにより、血栓（吸引物質）が吸引口の近位端側において、切断されやすくなり、大型の血栓が吸引ルーメン１０を閉塞することを抑制することができる。 In the suction catheter 1 of the present embodiment, the first cross section has a predetermined shape, so that the thrombus (suction substance) is easily cut at the proximal end side of the suction port, and the large thrombus blocks the suction lumen 10. Can be suppressed.
　また、第一断面の鉛直方向における最大長さｈは、幅方向における最大長さＷｍａｘよりも短い。更に、本実施形態の第一断面は、横長形状としてもよく、鉛直方向における最大長さｈが、幅方向における最大長さＷｍａｘの０．４倍以上０．９倍以下としてもよい。これにより、吸引口１１において血栓が吸い込まれる下側部を広げることができるので、より効果的に吸引口１１から血栓を吸引することができる。このような断面を有する第二チューブ４１は、例えば、押出成形によって製造される断面形状が略円環状のチューブに、断面形状が第一断面と略同形状のステンレス製の芯材を挿入し、当該チューブを加熱することによって製造することができる。なお、第一断面の鉛直方向における最大長さｈは、幅方向における最大長さｗ以上であってもよい。 Moreover, the maximum length h in the vertical direction of the first cross section is shorter than the maximum length W max in the width direction. Furthermore, the first cross section of the present embodiment may have a horizontally long shape, and the maximum length h in the vertical direction may be 0.4 to 0.9 times the maximum length W max in the width direction. Thereby, since the lower side part in which the thrombus is sucked in the suction port 11 can be expanded, the thrombus can be sucked from the suction port 11 more effectively. The second tube 41 having such a cross section, for example, by inserting a stainless steel core material having a cross section substantially the same shape as the first cross section into a tube having a substantially circular cross section manufactured by extrusion molding, It can be manufactured by heating the tube. The maximum length h in the vertical direction of the first cross section may be equal to or greater than the maximum length w in the width direction.
　図１に示されるように、吸引ルーメン１０における第一断面の形状は、第一位置Ｐ１から近位側へ所定距離Ｌ１続いていてもよい。これにより、よりスムーズに物質を吸い込むことができる。第一方向における第一位置Ｐ１よりも近位側の位置において、第一断面から第一断面とは形状が異なる第二断面（図４（ｂ）参照）へ切り替わる断面切替部１５が、第一方向において第一位置Ｐ１から所定距離Ｌ１離れた第二位置Ｐ２を起点に形成されていてもよい。 As shown in FIG. 1, the shape of the first cross section of the suction lumen 10 may continue from the first position P1 to the proximal side by a predetermined distance L1. Thereby, a substance can be inhaled more smoothly. The cross-section switching unit 15 that switches from the first cross section to a second cross section (see FIG. 4B) having a shape different from the first cross section at a position closer to the first position P1 in the first direction is It may be formed starting from a second position P2 that is a predetermined distance L1 away from the first position P1 in the direction.
　第一位置Ｐ１と第二位置Ｐ２との距離Ｌ１は、例えば、２ｍｍ～２０ｍｍとすることができる。また、当該距離Ｌ１の下限値は、２ｍｍ以上とすることができ、当該距離の上限値は、１０ｍｍ以下とすることができる。本実施形態では、断面切替部１５は、第一方向において第一位置Ｐ１から２０ｍｍの第二位置Ｐ２を起点として配置されている。これにより、吸引口１１近傍での血栓による閉塞を、より確実に抑制することが可能になると共に、第二チューブ４１への振動付与が、より確実になる。振動付与がより確実になるのは、吸引された吸引物質がチューブの内面に衝突しやすくなり、吸引物質のシャフトへの衝突による振動が強くなるためである。 The distance L1 between the first position P1 and the second position P2 can be set to 2 mm to 20 mm, for example. Moreover, the lower limit value of the distance L1 can be 2 mm or more, and the upper limit value of the distance can be 10 mm or less. In the present embodiment, the cross-section switching unit 15 is arranged starting from a second position P2 that is 20 mm from the first position P1 in the first direction. This makes it possible to more reliably suppress clogging due to a thrombus in the vicinity of the suction port 11 and more reliably impart vibration to the second tube 41. The reason why the vibration is more reliably applied is that the sucked suction substance easily collides with the inner surface of the tube, and the vibration due to the collision of the suction substance with the shaft becomes stronger.
　本実施形態において断面切替部１５は、吸引ルーメン１０の断面形状を、第一断面（図３参照）から第一断面とは形状及び断面積が異なる第二断面（図４（ｂ）参照）へと変化させてもよい。断面切替部１５は、吸引ルーメン１０を形成する第二チューブ４１の内面４１ａの少なくとも一部に形成されるテーパであってもよい。断面切替部１５は、第二チューブ４１の第二位置Ｐ２から第三位置Ｐ３にかけて形成されている。このような形状変化により、血栓が切断され易くなる。また、このような形状変化は、血栓吸引の効率を促進し、また第二チューブ４１の中で血栓がつまり、吸引ルーメン１０が閉塞してしまうことを抑制する効果もある。 In the present embodiment, the cross-section switching unit 15 changes the cross-sectional shape of the suction lumen 10 from the first cross-section (see FIG. 3) to the second cross-section (see FIG. 4B) having a different shape and cross-sectional area from the first cross-section. It may be changed. The cross-section switching unit 15 may be a taper formed on at least a part of the inner surface 41 a of the second tube 41 that forms the suction lumen 10. The cross-section switching unit 15 is formed from the second position P2 to the third position P3 of the second tube 41. Such a shape change makes it easier for the thrombus to be cut. Such a shape change also has an effect of promoting the efficiency of sucking the thrombus and suppressing the thrombus in the second tube 41, that is, the suction lumen 10 from being blocked.
　断面切替部１５は、吸引ルーメン１０の断面形状を、吸引ルーメン１０の内面（内壁）に設けられたテーパによってなだらかに変化させてもよく、テーパの代わりに設けられた段差などによって変化させてもよい。このようなテーパ又は段差である断面切替部１５は、設けられていてもよい。第一位置Ｐ１から５ｍｍ離れた第二位置Ｐ２における断面形状の面積は、第一位置Ｐ１における第一断面の面積の０．８倍以上１．３倍以下であってもよい。吸引ルーメンの形状の変化は、遠位側から近位側にかけて断面積が小さくなる変化だけでなく、大きくなる変化であってもよい。流路形状の変化により発生する振動が吸引カテーテル１の操作者に感知され、操作者は、血栓の吸引状況を把握することができる。第三位置Ｐ３において、第二チューブ４１の内面４１ａによって形成される吸引ルーメン１０の断面形状は、略円形である。吸引ルーメン１０は、当該第二断面の形状が、第一シャフト３の近位端３ｂ、すなわち、ハブ３５にまで延びている。なお、図４（ａ）及び図４（ｂ）に示される二点鎖線は、第一断面における内面４１ａの一部である底部４３を示している。 The cross-section switching unit 15 may change the cross-sectional shape of the suction lumen 10 gently by a taper provided on the inner surface (inner wall) of the suction lumen 10, or may change it by a step provided in place of the taper. Good. The cross-section switching part 15 which is such a taper or a level | step difference may be provided. The area of the cross-sectional shape at the second position P2 that is 5 mm away from the first position P1 may be 0.8 to 1.3 times the area of the first cross section at the first position P1. The change in the shape of the suction lumen may be not only a change in cross-sectional area from the distal side to the proximal side but also a change in which the cross-sectional area becomes larger. The vibration generated by the change in the flow channel shape is detected by the operator of the suction catheter 1, and the operator can grasp the suction state of the thrombus. In the third position P3, the cross-sectional shape of the suction lumen 10 formed by the inner surface 41a of the second tube 41 is substantially circular. The suction lumen 10 has the shape of the second cross section extending to the proximal end 3 b of the first shaft 3, that is, the hub 35. In addition, the dashed-two dotted line shown by Fig.4 (a) and FIG.4 (b) has shown the bottom part 43 which is a part of the inner surface 41a in a 1st cross section.
　異なる実施形態として、第三位置Ｐ３とハブ３５との間に、吸引ルーメン１０の形状又は断面積（サイズ）の変化が、一又は複数回あってもよい。本実施形態の吸引カテーテル１は、吸引ルーメン１０の断面形状又は断面積が変化するため、吸引された吸引物質がチューブの内面に衝突しやすく、血栓の吸引状況の把握が可能である。断面形状又は断面積の変化は、遠位側が小さく近位側が大きくなる変化であってもよい。用途に応じて、遠位側が小さく近位側が大きくなる変化、及び近位側が小さく遠位側が大きくなるような変化を適宜組み合わせることができる。これにより、本実施形態の吸引カテーテル１は、よりスムーズに血管内に導入することができる。 As a different embodiment, the shape or cross-sectional area (size) of the suction lumen 10 may change one or more times between the third position P3 and the hub 35. In the suction catheter 1 of the present embodiment, since the cross-sectional shape or cross-sectional area of the suction lumen 10 changes, the sucked suction substance easily collides with the inner surface of the tube, and it is possible to grasp the thrombus suction state. The change in cross-sectional shape or cross-sectional area may be a change in which the distal side is small and the proximal side is large. Depending on the application, a change in which the distal side is small and the proximal side is large, and a change in which the proximal side is small and the distal side is large can be appropriately combined. Thereby, the suction catheter 1 of this embodiment can be more smoothly introduced into the blood vessel.
　また、本実施形態では、吸引口１１における近位端１１ｂから遠位端１１ａまでの長さが２．０ｍｍ以上１０ｍｍ以下であるので末梢到達性に優れる。吸引口１１における近位端１１ｂから遠位端１１ａまでの長さが２．０ｍｍよりも短いと、血栓が吸引口に詰まりやすくなり、１０ｍｍより長いと、吸引力が非常に弱くなる。 Moreover, in this embodiment, since the length from the proximal end 11b to the distal end 11a in the suction port 11 is 2.0 mm or more and 10 mm or less, it is excellent in peripheral reachability. If the length from the proximal end 11b to the distal end 11a in the suction port 11 is shorter than 2.0 mm, the thrombus tends to clog the suction port, and if it is longer than 10 mm, the suction force becomes very weak.
　続いて、吸引カテーテル１の製造方法の一例について説明する。吸引カテーテル１の製造では、最初に、第一チューブ３１、第二チューブ４１、及び第三チューブ６１が準備される。各チューブは、上記材料によって、押出成形により形成される。続いて、第三チューブ６１に、マーカーが取り付けられる。マーカーは、第三チューブ６１にかしめて固定される。 Subsequently, an example of a method for manufacturing the suction catheter 1 will be described. In manufacturing the suction catheter 1, first, the first tube 31, the second tube 41, and the third tube 61 are prepared. Each tube is formed of the above material by extrusion. Subsequently, a marker is attached to the third tube 61. The marker is fixed to the third tube 61 by caulking.
　次に、図７（ａ）に示されるように、第一方向に延びる第二チューブ４１の一端が切断される。切断された一端は遠位端であり、切断面は吸引口となる。この切断により、第二チューブ４１の切断面は、吸引ルーメン１０の第一方向に直交する面に対して傾くように形成される（切断線Ｃ１：第一切断工程）。次に、図７（ｃ）に示されるように、吸引口１１の近位端を含む近位側の一部が切断される（切断線Ｃ２：第二切断工程）。このとき、図７（ｂ）に示されるように、第二チューブ４１には、ステンレス製の芯材８０が挿入されてもよいし又は樹脂性の芯材が挿入されてもよい。芯材は、中空であってもよいし、中実であってもよい。当該芯材８０は、所望の吸引口の断面形状に合わせて、断面の形状が選択される。このとき、第二チューブ４１の吸引ルーメン１０は、芯材又は外部からの加圧、固定等によって変形されてもよい。吸引ルーメンを変形して吸引口を形成する場合は、吸引口は、第一切断工程、変形工程、及び第二切断工程を順次経て形成される。後述する吸引ルーメン変形工程と、第二切断工程とは、順序が逆であってもよい。 Next, as shown in FIG. 7A, one end of the second tube 41 extending in the first direction is cut. The cut end is a distal end, and the cut surface is a suction port. By this cutting, the cutting surface of the second tube 41 is formed so as to be inclined with respect to the surface orthogonal to the first direction of the suction lumen 10 (cutting line C1: first cutting step). Next, as shown in FIG. 7C, a part of the proximal side including the proximal end of the suction port 11 is cut (cutting line C2: second cutting step). At this time, as shown in FIG. 7B, a stainless steel core material 80 may be inserted into the second tube 41, or a resinous core material may be inserted. The core material may be hollow or solid. The cross-sectional shape of the core member 80 is selected in accordance with the desired cross-sectional shape of the suction port. At this time, the suction lumen 10 of the second tube 41 may be deformed by pressurization, fixation, or the like from the core material or the outside. When the suction lumen is formed by deforming the suction lumen, the suction port is formed through the first cutting step, the deformation step, and the second cutting step in this order. The order of the suction lumen deformation process and the second cutting process described later may be reversed.
　次に、第二チューブ４１の近位端に、第一チューブ３１の遠位端が接続される（第一接続工程）。続いて、第一チューブ３１が接続された第二チューブ４１と第三チューブ６１とが平行に並べられる。具体的には、第二チューブ４１の遠位端に対し第三チューブ６１の遠位端が遠位側に突出するように並べられる。第一チューブと第二チューブとを接続する方法は、接着剤により接着する、チューブを加熱し溶着するなど適宜選択することができる。 Next, the distal end of the first tube 31 is connected to the proximal end of the second tube 41 (first connection step). Subsequently, the second tube 41 and the third tube 61 to which the first tube 31 is connected are arranged in parallel. Specifically, the third tube 61 is arranged so that the distal end of the third tube 61 protrudes distally with respect to the distal end of the second tube 41. The method of connecting the first tube and the second tube can be appropriately selected such as bonding with an adhesive or heating and welding the tube.
　次に、第二チューブ４１及び第三チューブ６１に、ステンレス製の芯材が挿入される。当該芯材の断面は、円形である。芯材の断面形状は、必要に応じて円形以外の形状を選択することもできる。第二チューブ４１及び第三チューブ６１にシュリンクチューブを被せられ加熱される。シュリンクチューブは、耐熱性樹脂により形成されてもよい。例えば、オレフィン系樹脂が挙げられる。これにより、第二チューブ４１及び第三チューブ６１を溶着されて一体化される。これにより、本体樹脂７１が形成される（第二接続工程）。次に、第二チューブ４１に、ステンレス製の芯材が挿入される。当該芯材の断面は、図３に示されるような、第二チューブ４１の内面４１ａによって形成される第一断面と略同一の断面形状を有している。選択可能な芯材の断面形状の例として、後段にて詳述する図１０及び図１１に示される形状がある。第三チューブ６１に、ステンレス製の芯材が挿入される。前述の加熱工程で用いた芯材をそのまま使用してもよい。シュリンクチューブを被せて加熱したときに、第二チューブ４１も加熱され、第二チューブ４１の内面４１ａの形状が、挿入された芯材の形状に成形される。これにより、図３に示される第一断面を有する吸引ルーメン１０が形成される（吸引ルーメン変形工程）。 Next, a stainless steel core material is inserted into the second tube 41 and the third tube 61. The cross section of the core material is circular. As the cross-sectional shape of the core material, a shape other than a circle can be selected as necessary. The second tube 41 and the third tube 61 are covered with a shrink tube and heated. The shrink tube may be formed of a heat resistant resin. For example, an olefin resin is mentioned. Thereby, the 2nd tube 41 and the 3rd tube 61 are welded and integrated. Thereby, the main body resin 71 is formed (second connection step). Next, a stainless steel core material is inserted into the second tube 41. The cross section of the core material has substantially the same cross-sectional shape as the first cross section formed by the inner surface 41a of the second tube 41 as shown in FIG. Examples of the cross-sectional shape of the core material that can be selected include the shapes shown in FIGS. 10 and 11, which will be described in detail later. A stainless steel core material is inserted into the third tube 61. You may use the core material used at the above-mentioned heating process as it is. When the shrink tube is covered and heated, the second tube 41 is also heated, and the shape of the inner surface 41a of the second tube 41 is formed into the shape of the inserted core material. Thereby, the suction lumen 10 having the first cross section shown in FIG. 3 is formed (suction lumen deformation step).
　上記第一断面と略同一の断面形状を有している芯材は、第二チューブ４１の遠位側にのみ挿入される。当該芯材を挿入して加熱した熱が、第二チューブ４１の当該芯材を挿入していない部分に伝わることにより、テーパ形状の断面切替部１５が形成される。上記第一断面と略同一の断面形状を有している芯材からの熱が伝わることにより、最初に芯材により形成した断面円形の部分が、上記第一断面と略同一の断面形状を有している芯材により形成される第一断面部分へと連続的に変形して、テーパ形状の断面切替部１５が形成される。 The core material having substantially the same cross-sectional shape as the first cross-section is inserted only on the distal side of the second tube 41. The heat generated by inserting and heating the core material is transmitted to the portion of the second tube 41 where the core material is not inserted, whereby the tapered cross-section switching unit 15 is formed. When heat from the core material having substantially the same cross-sectional shape as the first cross section is transmitted, the circular section formed first by the core material has substantially the same cross-sectional shape as the first cross section. The taper-shaped cross-section switching portion 15 is formed by continuously deforming into the first cross-section portion formed by the core material.
　最後に、第一チューブ３１の近位端に、ハブ３５を接着剤３７により接続される（第三接続工程）。以上の工程により、吸引カテーテル１が製造される。 Finally, the hub 35 is connected to the proximal end of the first tube 31 with an adhesive 37 (third connection step). The suction catheter 1 is manufactured through the above steps.
　以上、一実施形態について説明したが、本発明の一側面は上記実施形態に限定されない。 Although one embodiment has been described above, one aspect of the present invention is not limited to the above embodiment.
＜変形例１＞
　主に図８～図９（ｃ）を用いて、変形例に係る吸引カテーテル１について説明する。変形例に係る吸引カテーテル１は、上記実施形態の吸引カテーテル１において、吸引口１１の鉛直方向上方又は下方の一方における第二チューブ（チューブ）４１の内面４１ａと第二チューブ４１の外面４１ｃとの間の上端部４５ａ及び下端部４５ｂが、吸引口１１を形成する吸引面Ｆに対して凹又は凸となっている。なお、図８～図９（ｃ）では、ガイドワイヤールーメン２０を形成する第三チューブ６１の図示が省略されている。 <Modification 1>
A suction catheter 1 according to a modification will be described mainly with reference to FIGS. 8 to 9C. The suction catheter 1 according to the modified example is the same as the suction catheter 1 of the above-described embodiment, in which the inner surface 41a of the second tube (tube) 41 and the outer surface 41c of the second tube 41 on the upper side or the lower side of the suction port 11 are The upper end portion 45a and the lower end portion 45b are concave or convex with respect to the suction surface F that forms the suction port 11. 8 to 9C, the third tube 61 that forms the guide wire lumen 20 is not shown.
　以下、変形例１について詳細に説明する。図８及び図９（ａ）～（ｃ）に示されるように、第二チューブ４１の遠位側の端面４１ｂは、第二チューブ４１の端面及び吸引ルーメン１０の端面を含む部分である。第二チューブ４１の遠位端４５において、鉛直方向上側が上端部４５ａであり、鉛直方向下側が下端部４５ｂである。第二チューブ４１における遠位側の鉛直方向上方又は下方の一方における第二チューブ４１の内面４１ａと第二チューブ４１の外面４１ｃとの間の上端部４５ａ及び下端部４５ｂは、幅方向（Ｙ軸方向）に直交する断面において、第二チューブ４１の断面の最遠位点と最近位点とを繋ぐ直線に対して凹又は凸となっている。つまり、吸引口１１における第二チューブ４１の上端部４５ａ及び下端部４５ｂは、一の平面ではなく、複数の平面又は曲面により形成される。これにより、上端部４５ａ及び下端部４５ｂには、凸凹が形成される。上端部４５ａ及び下端部４５ｂにおいて、凸となっている部分では、血栓が入り易くなると共に血管へダメージを与えにくくなり、凹となっている部分では、第二チューブ４１のエッジに接触した血栓が切断されるので、血栓の吸引が容易になる。 Hereinafter, Modification 1 will be described in detail. As shown in FIGS. 8 and 9A to 9C, the distal end face 41b of the second tube 41 is a portion including the end face of the second tube 41 and the end face of the suction lumen 10. At the distal end 45 of the second tube 41, the upper side in the vertical direction is the upper end portion 45a, and the lower side in the vertical direction is the lower end portion 45b. The upper end 45a and the lower end 45b between the inner surface 41a of the second tube 41 and the outer surface 41c of the second tube 41 on one of the upper and lower sides in the vertical direction on the distal side of the second tube 41 are arranged in the width direction (Y axis In the cross section orthogonal to the direction), the second tube 41 is concave or convex with respect to a straight line connecting the most distal point and the closest point of the cross section of the second tube 41. That is, the upper end portion 45a and the lower end portion 45b of the second tube 41 in the suction port 11 are formed by a plurality of flat surfaces or curved surfaces instead of a single flat surface. Thereby, unevenness | corrugation is formed in the upper end part 45a and the lower end part 45b. In the upper portion 45a and the lower end portion 45b, the convex portions make it easier for blood clots to enter and damage the blood vessels, and in the concave portions, the thrombus contacting the edge of the second tube 41 Since it is cut, thrombus can be sucked easily.
　第二チューブ４１の上端部４５ａ又は下端部４５ｂの凹又は凸は、吸引口１１に対する凹又は凸でもある。吸引面Ｆとは、吸引口１１の形成する平面又は曲面であり、吸引口１１の遠位側端部１１ｃ及び近位側端部１１ｄにより形成される。第二チューブ４１を側面視した場合において、吸引口１１が直線で表される場合、吸引面Ｆは平面であり、曲線で表される場合、吸引面Ｆは曲面である。一般に、吸引口１１は、第二チューブ４１の一部を剃刀で削げ切ったり、鋏で切り取ったりすることにより形成される。その場合、第二チューブ４１の肉厚部分の近位端から遠位端にわたって一度に切断され、吸引口１１が形成される。 The concave or convex of the upper end 45 a or the lower end 45 b of the second tube 41 is also a concave or convex with respect to the suction port 11. The suction surface F is a flat surface or a curved surface formed by the suction port 11, and is formed by the distal end portion 11 c and the proximal end portion 11 d of the suction port 11. When the second tube 41 is viewed from the side, when the suction port 11 is represented by a straight line, the suction surface F is a plane, and when represented by a curve, the suction surface F is a curved surface. In general, the suction port 11 is formed by cutting a part of the second tube 41 with a razor or cutting with a scissors. In that case, the suction port 11 is formed by cutting at a time from the proximal end to the distal end of the thick portion of the second tube 41.
　第二チューブ４１の上端部４５ａ又は下端部４５ｂの凹又は凸の形状は、曲面状とすることができる。曲面状とは、第二チューブ４１の端部、つまり、吸引口１１を形成する第二チューブ４１の肉厚部分（第二チューブ４１の内面４１ａと外面４１ｃとの間の部分である上端部４５ａ及び下端部４５ｂ）が、例えば、ドーム状の突起又は窪み、半円筒状の凸又は凹の形状である場合をいう。上端部４５ａ又は下端部４５ｂの形状を凹又は凸とすることにより、吸引口１１に近づいた血栓を吸引し易くしたり、血管の損傷を抑制したりすることができる。 The concave or convex shape of the upper end 45a or the lower end 45b of the second tube 41 can be a curved surface. The curved surface is the end of the second tube 41, that is, the thick portion of the second tube 41 that forms the suction port 11 (the upper end 45a that is the portion between the inner surface 41a and the outer surface 41c of the second tube 41). And the lower end 45b) is, for example, a dome-shaped projection or depression, a semi-cylindrical convex or concave shape. By making the shape of the upper end portion 45a or the lower end portion 45b concave or convex, it is possible to easily suck a thrombus approaching the suction port 11 or to suppress damage to blood vessels.
　図８に示されるように、吸引口１１の鉛直方向（Ｚ軸方向）上方における第二チューブ４１の内面４１ａと第二チューブ４１の外面４１ｃとの間の上端部４５ａが、吸引口１１を形成する吸引面Ｆに対して凹となっており、吸引口１１の鉛直方向下方における第二チューブ４１の内面４１ａと第二チューブ４１の外面４１ｃとの間の下端部４５ｂが、吸引面Ｆに対して凸となっていてもよい。また、吸引面Ｆ上の直線であり、第二チューブ４１における端面４１ｂの上端部４５ａにおける外面側の第二遠位端４６ａと第二チューブ４１における端面４１ｂの下端部４５ｂにおける外面側の第一近位端４６ｂとを繋ぐ線を基準線ＢＬとしたとき、吸引口１１の鉛直方向上方における上端部４５ａは、基準線ＢＬに対し線対称に凹となっており、吸引口１１の鉛直方向下方における下端部４５ｂは、基準線ＢＬに対し線対称に凸となっていてもよい。 As shown in FIG. 8, the upper end 45 a between the inner surface 41 a of the second tube 41 and the outer surface 41 c of the second tube 41 above the suction port 11 in the vertical direction (Z-axis direction) forms the suction port 11. The lower end 45b between the inner surface 41a of the second tube 41 and the outer surface 41c of the second tube 41 below the suction port 11 is recessed with respect to the suction surface F. It may be convex. Moreover, it is a straight line on the suction surface F, and the second distal end 46 a on the outer surface side of the upper end portion 45 a of the end surface 41 b of the second tube 41 and the first outer surface side of the lower end portion 45 b of the end surface 41 b of the second tube 41. When a line connecting the proximal end 46b is defined as a reference line BL, an upper end portion 45a in the upper vertical direction of the suction port 11 is concave in line symmetry with respect to the reference line BL, and is lower than the suction port 11 in the vertical direction. The lower end 45b may be convex in line symmetry with respect to the reference line BL.
　また、本実施形態では、図９（ａ）、図９（ｂ）及び図９（ｃ）に示されるように、第二チューブ４１を第一方向（Ｘ軸方向）に切断した際の断面において、第二チューブ４１における端面４１ｂの上端部４５ａにおける外面側の第二遠位端４６ａは、上端部４５ａにおける内面側の第二近位端４６ｃ（吸引口１１の遠位端１１ａ）よりも遠位側に位置し、第二チューブ４１における端面４１ｂの下端部４５ｂにおける外面側の第一近位端４６ｂは、下端部４５ｂにおける内面側の第一遠位端４６ｄ（吸引口１１の近位端１１ｂ）よりも近位側に位置する。 In the present embodiment, as shown in FIGS. 9A, 9B, and 9C, in the cross section when the second tube 41 is cut in the first direction (X-axis direction). The second distal end 46a on the outer surface side of the upper end portion 45a of the end surface 41b of the second tube 41 is farther from the second proximal end 46c on the inner surface side of the upper end portion 45a (the distal end 11a of the suction port 11). The first proximal end 46b on the outer surface side of the lower end portion 45b of the end surface 41b of the second tube 41 is located on the rear side, and the first distal end 46d on the inner surface side of the lower end portion 45b (the proximal end of the suction port 11). It is located more proximal than 11b).
　第二チューブ４１における端面４１ｂの上端部４５ａは、第一方向（Ｘ軸方向）に対して２°以上６０°以下の範囲（角度α）で傾いていてもよい。角度αは、第二遠位端４６ａと第二近位端４６ｃとを繋ぐ直線ＢＬ１と、第二チューブ４１の内面４１ａのなす角である。当該角度αの下限値は、例えば、１０°以上であり、上限値は、例えば、３０°以下である。第二チューブ４１における端面４１ｂの下端部４５ｂは、上端部４５ａと同様に、第一方向（Ｘ軸方向）に対して２°以上６０°以下の範囲（角度α）で傾いていてもよい。角度αは、第一近位端４６ｂと第一遠位端４６ｄとを繋ぐ直線ＢＬ２と、第二チューブ４１の内面４１ａのなす角である。当該角度αの下限値は、例えば、１０°以上であり、上限値は、例えば、３０°以下である。 The upper end portion 45a of the end face 41b of the second tube 41 may be inclined in a range (angle α) of 2 ° or more and 60 ° or less with respect to the first direction (X-axis direction). The angle α is an angle formed by the straight line BL1 connecting the second distal end 46a and the second proximal end 46c and the inner surface 41a of the second tube 41. The lower limit value of the angle α is, for example, 10 ° or more, and the upper limit value is, for example, 30 ° or less. Similarly to the upper end portion 45a, the lower end portion 45b of the end surface 41b of the second tube 41 may be inclined within a range (angle α) of 2 ° or more and 60 ° or less with respect to the first direction (X-axis direction). The angle α is an angle formed by the straight line BL2 connecting the first proximal end 46b and the first distal end 46d and the inner surface 41a of the second tube 41. The lower limit value of the angle α is, for example, 10 ° or more, and the upper limit value is, for example, 30 ° or less.
　第二近位端４６ｃと第二遠位端４６ａとを繋ぐ直線ＢＬ１に対し、吸引口１１の鉛直方向上方内面と第二チューブ４１の外面４１ｃとの間の上端部４５ａが、凹又は凸となっていてもよい。また、第一遠位端４６ｄと第一近位端４６ｂとを繋ぐ直線ＢＬ２に対し、吸引口１１の鉛直方向下方内面と第二チューブ４１の外面４１ｃとの間の下端部４５ｂが、凹又は凸となっていてもよい。第二近位端４６ｃと第二遠位端４６ａとを繋ぐ直線ＢＬ１又は第一遠位端４６ｄと第一近位端４６ｂとを繋ぐ直線ＢＬ２に対し、凹又は凸となっている構成により、吸引効率をより向上させることができる。 With respect to the straight line BL1 connecting the second proximal end 46c and the second distal end 46a, the upper end portion 45a between the vertically upper inner surface of the suction port 11 and the outer surface 41c of the second tube 41 is concave or convex. It may be. Further, with respect to the straight line BL2 connecting the first distal end 46d and the first proximal end 46b, the lower end 45b between the vertically lower inner surface of the suction port 11 and the outer surface 41c of the second tube 41 is concave or It may be convex. With respect to the straight line BL1 connecting the second proximal end 46c and the second distal end 46a or the straight line BL2 connecting the first distal end 46d and the first proximal end 46b, a configuration that is concave or convex, The suction efficiency can be further improved.
　なお、上記変形例１では、第二遠位端４６ａと第二近位端４６ｃとを繋ぐ直線ＢＬ１及び第一近位端４６ｂと第一遠位端４６ｄとを繋ぐ直線ＢＬ２は、第一方向、すなわち、第二チューブ４１の内面４１ａが延びる方向に対して２°以上６０°以下の範囲で傾いている例を挙げて説明したが、当該傾きは、上記範囲とは異なる範囲で傾く構成であってもよい。 In the first modification, the straight line BL1 connecting the second distal end 46a and the second proximal end 46c and the straight line BL2 connecting the first proximal end 46b and the first distal end 46d are in the first direction. That is, the example in which the inner surface 41a of the second tube 41 is inclined in the range extending from 2 ° to 60 ° with respect to the extending direction has been described, but the inclination is inclined in a range different from the above range. There may be.
　次に、上端部４５ａ及び下端部４５ｂを凹又は凸に形成する方法の一例として、上端部４５ａを凹に形成し、下端部４５ｂを凸に形成する方法の一例を説明する。すなわち、上記実施形態の製造方法によって製造された吸引カテーテル１に対し、第一方向に延びる第二チューブ４１に、芯材８０が挿入される（挿入工程）。挿入する芯材は、変形可能な材質、第二チューブの吸引ルーメン１０よりも小さい外径のものが好ましい。次に、芯材８０が挿入された第二チューブ４１が変形させられる（変形工程）。例えば、第二チューブを押しつぶすように変形させることができる。そして、変形工程において変形された第二チューブ４１の一端が、吸引ルーメン１０の第一方向に直交する面に対して傾くように切断される。この切断の後、第二チューブ４１から芯材８０を取り除かれると、第二チューブ４１は上記変形から解放される。これにより、図８及び図９（ａ）に示されるように、吸引口１１の鉛直方向上方における上端部４５ａが、吸引口１１を形成する吸引面Ｆに対して凹となり、吸引口１１の鉛直方向下方における下端部４５ｂが、吸引面Ｆに対して凸となった第二チューブ４１が形成される。上端部４５ａ又は下端部４５ｂのいずれか一方のみを切断し、吸引面Ｆに対して凹又は凸としてもよい。 Next, as an example of a method of forming the upper end 45a and the lower end 45b to be concave or convex, an example of a method of forming the upper end 45a to be concave and forming the lower end 45b to be convex will be described. That is, the core member 80 is inserted into the second tube 41 extending in the first direction with respect to the suction catheter 1 manufactured by the manufacturing method of the above embodiment (insertion step). The core material to be inserted is preferably a deformable material and an outer diameter smaller than the suction lumen 10 of the second tube. Next, the second tube 41 into which the core member 80 is inserted is deformed (deformation process). For example, the second tube can be deformed so as to be crushed. Then, one end of the second tube 41 deformed in the deformation process is cut so as to be inclined with respect to a surface orthogonal to the first direction of the suction lumen 10. After the cutting, when the core member 80 is removed from the second tube 41, the second tube 41 is released from the deformation. As a result, as shown in FIGS. 8 and 9A, the upper end 45 a in the vertical direction of the suction port 11 becomes concave with respect to the suction surface F that forms the suction port 11, and the vertical direction of the suction port 11. A second tube 41 in which a lower end 45b in the lower direction is convex with respect to the suction surface F is formed. Only one of the upper end portion 45a and the lower end portion 45b may be cut so as to be concave or convex with respect to the suction surface F.
　第二チューブの端部を凹又は凸に形成するのは、第一チューブ、第二チューブ、及び第三チューブの全てのチューブが接続され、一体になった後でもよく、第二チューブ４１と第三チューブ６１とが接続される前、第二チューブ４１と第一チューブ３１とが接続される前であってもよい。第二チューブ４１と第三チューブ６１とが接続された後に、第二チューブの端部を凹又は凸に形成する場合は、第三チューブを保護する芯材又はカバーを用いてもよい。これにより、変形例に係る吸引カテーテル１が製造される。 The end of the second tube may be formed to be concave or convex after all the tubes of the first tube, the second tube, and the third tube are connected and integrated. It may be before the second tube 41 and the first tube 31 are connected before the three tubes 61 are connected. When the end of the second tube is formed to be concave or convex after the second tube 41 and the third tube 61 are connected, a core material or a cover for protecting the third tube may be used. Thereby, the suction catheter 1 which concerns on a modification is manufactured.
　また、上記実施形態に係る吸引カテーテル１を上記実施形態に記載のとおり製造した後、上端部４５ａ及び下端部４５ｂを切削、又は溶融等の処理を施すことにより、上端部４５ａ及び下端部４５ｂを凹又は凸に形成してもよい。このような方法であっても、変形例に係る吸引カテーテル１が製造することができる。 Moreover, after manufacturing the suction catheter 1 according to the above-described embodiment as described in the above-described embodiment, the upper end 45a and the lower end 45b are processed by cutting or melting the upper end 45a and the lower end 45b. You may form in a concave or convex. Even with such a method, the suction catheter 1 according to the modification can be manufactured.
＜変形例２＞
　上記実施形態では、図３に示されるように、第一断面が、一対の円弧状の側部４２，４２と、鉛直方向下端において幅方向に沿って直線状に延びる底部４３と、底部４３に対向すると共に幅方向に沿って直線状に延びる上部４４と、により形成されている例を挙げて説明したが、本発明の一側面はこれに限定されない。例えば、吸引ルーメン１０の第一断面は、図１０（ａ）～図１０（ｄ）に示されるような、底部１４３Ａ，１４３Ｂ，１４３Ｃ，１４３Ｄは、幅方向における最大長さの０．３倍以上１．０倍以下の長さとなる形状であってもよい。 <Modification 2>
In the said embodiment, as FIG. 3 shows, a 1st cross section is a pair of circular arc-shaped side parts 42 and 42, the bottom part 43 extended linearly along the width direction in the perpendicular direction lower end, and the bottom part 43 Although the example formed by the upper part 44 that faces and extends linearly along the width direction has been described, one aspect of the present invention is not limited thereto. For example, the first cross section of the suction lumen 10 has a bottom portion 143A, 143B, 143C, 143D of 0.3 times or more of the maximum length in the width direction as shown in FIGS. 10 (a) to 10 (d). The shape may be 1.0 times or less in length.
　すなわち、第一断面は、図１０（ａ）に示されるように、一対の円弧状の側部１４２Ａ，１４２Ａと、鉛直方向下端において幅方向に沿って直線状に延びる底部１４３Ａと、底部１４３Ａに対向すると共に幅方向に沿って直線状に延びる上部１４４Ａと、により形成されていてもよい。第一断面は、楕円の下部と上部とが底部１４３Ａと上部１４４Ａとによってそれぞれ切り取られたような形状となっている。 That is, as shown in FIG. 10 (a), the first cross section includes a pair of arc-shaped side portions 142A and 142A, a bottom portion 143A extending linearly along the width direction at the lower end in the vertical direction, and a bottom portion 143A. It may be formed by an upper portion 144A that faces and extends linearly along the width direction. The first cross section has a shape in which the lower part and the upper part of the ellipse are cut off by the bottom part 143A and the upper part 144A, respectively.
　また、第一断面は、図１０（ｂ）に示されるように、底部１４３Ｂの長さが、上部１４４Ｂよりも短くてもよい。第一断面は、円形の下部と上部とが底部１４３Ｂと上部１４４Ｂとによってそれぞれ切り取られたような形状となっている。また、第一断面は、図１０（ｃ）に示されるように、底部１４３Ｃの長さは、上部１４４Ｃよりも長くてもよい。また、第一断面は、図１０（ｄ）に示されるように、側部が直線状であってもよい。 Further, as shown in FIG. 10B, in the first cross section, the length of the bottom portion 143B may be shorter than that of the upper portion 144B. The first cross section has a shape in which a circular lower portion and an upper portion are cut off by a bottom portion 143B and an upper portion 144B, respectively. In the first cross section, as shown in FIG. 10C, the length of the bottom portion 143C may be longer than that of the upper portion 144C. Further, as shown in FIG. 10D, the first cross section may have a straight side portion.
　このような第一断面であっても、血栓が吸引ルーメン１０に吸い込まれる部分が広い。このため、血栓が吸引口１１から吸引ルーメン１０に吸い込まれ易くなり、吸引口１１近傍における吸引ルーメン１０の閉塞を抑制できる。また、第一断面を線対称な形状としてもよい。これにより、吸引口のサイズをチューブに対して大きく確保することができる。また、必要に応じて第一断面を非対称な形状又は不定形としてもよい。 Even in such a first cross section, the portion where the thrombus is sucked into the suction lumen 10 is wide. For this reason, it becomes easy for a thrombus to be sucked into the suction lumen 10 from the suction port 11, and blockage of the suction lumen 10 in the vicinity of the suction port 11 can be suppressed. Moreover, it is good also considering a 1st cross section as a line symmetrical shape. Thereby, the size of the suction port can be largely ensured with respect to the tube. Moreover, it is good also as an asymmetrical shape or an indefinite shape for a 1st cross section as needed.
＜変形例３＞
　上記実施形態の第一断面の形状に代えて、第一断面の形状を多角形とし、第一断面は、鉛直方向下端において、鉛直方向と第一方向とに直交する幅方向に延びる底部を有していてもよい。ここで多角形とは、上記製造方法の一例における芯材の長手方向に垂直な方向の断面形状が多角形であることにより形成された多角形であることを含む。なお、本実施形態の吸引カテーテルは、樹脂により形成されるため柔らかいチューブであり、多角形の各頂点が明確に現れない場合がある。多角形は、各辺の長さが同一である正多角形でもよく、各辺が任意の長さである多角形であってもよい。例えば、第一断面の形状を、図１１に示されるように、底部２４３Ａ，２４３Ｂ，２４３Ｃ，２４３Ｄ，２４３Ｅ，２４３Ｆ，２４３Ｇ，２４３Ｈを有する、種々の多角形とすることができる。第一断面が、このような多角形の形状であっても、血栓が吸引口１１から吸引ルーメン１０に吸い込まれ易くなり、吸引口１１近傍における吸引ルーメン１０の閉塞を抑制できる。また、第一断面の形状が多角形である変形例に係る吸引カテーテルでは、製造時に断面を形成し易くなり、製造後においてもその形状を維持し易い。 <Modification 3>
Instead of the shape of the first cross section of the above embodiment, the shape of the first cross section is a polygon, and the first cross section has a bottom portion extending in the width direction perpendicular to the vertical direction and the first direction at the lower end in the vertical direction. You may do it. Here, the polygon includes the polygon formed by the polygonal cross-sectional shape in the direction perpendicular to the longitudinal direction of the core material in the example of the manufacturing method. In addition, since the suction catheter of this embodiment is formed with resin, it is a soft tube, and each vertex of a polygon may not appear clearly. The polygon may be a regular polygon in which each side has the same length, or may be a polygon in which each side has an arbitrary length. For example, the shape of the first cross section may be various polygons having bottoms 243A, 243B, 243C, 243D, 243E, 243F, 243G, and 243H, as shown in FIG. Even if the first cross section has such a polygonal shape, the thrombus is easily sucked into the suction lumen 10 from the suction port 11, and the blockage of the suction lumen 10 in the vicinity of the suction port 11 can be suppressed. Moreover, in the suction catheter according to the modified example in which the shape of the first cross section is a polygon, it becomes easy to form a cross section at the time of manufacturing, and it is easy to maintain the shape even after manufacturing.
＜その他の変形例＞
　上記実施形態又は変形例では、図３に示されるように、第二チューブ４１と第三チューブ６１とが本体樹脂７１によって一体的に形成される例を挙げて説明したが、これに限定されない。例えば、第二チューブ４１と第三チューブ６１とが接着剤等によって互いに固定される構成であってもよい。 <Other variations>
In the said embodiment or modification, as FIG. 3 showed, although the 2nd tube 41 and the 3rd tube 61 gave and demonstrated the example integrally formed with the main body resin 71, it is not limited to this. For example, the second tube 41 and the third tube 61 may be fixed to each other with an adhesive or the like.
　以上説明した種々の実施形態及び変形例同士は、本発明の一側面の趣旨を逸脱しない範囲で種々、組み合わせられてもよい。 Various embodiments and modifications described above may be combined in various ways without departing from the spirit of one aspect of the present invention.
　１…吸引カテーテル、３…第一シャフト、５…第二シャフト、１０…吸引ルーメン（ルーメン）、１１…吸引口、１１ａ…遠位端、１１ｂ…近位端、１１ｃ…遠位側端部、１１ｄ…近位側端部、１５…断面切替部、２０…ガイドワイヤールーメン、３１…第一チューブ、４１…第二チューブ（チューブ）、４１ａ…内面、４３…底部、６１…第三チューブ、７１…本体樹脂、１４３Ａ，１４３Ｂ，１４３Ｃ，１４３Ｄ…底部、２４３Ａ，２４３Ｂ，２４３Ｃ，２４３Ｄ，２４３Ｅ，２４３Ｆ，２４３Ｇ，２４３Ｈ…底部、Ｐ１…第一位置。 DESCRIPTION OF SYMBOLS 1 ... Suction catheter, 3 ... 1st shaft, 5 ... 2nd shaft, 10 ... Suction lumen (lumen), 11 ... Suction port, 11a ... Distal end, 11b ... Proximal end, 11c ... Distal end part, 11d ... proximal end, 15 ... cross-section switching part, 20 ... guide wire lumen, 31 ... first tube, 41 ... second tube (tube), 41a ... inner surface, 43 ... bottom, 61 ... third tube, 71 ... body resin, 143A, 143B, 143C, 143D ... bottom, 243A, 243B, 243C, 243D, 243E, 243F, 243G, 243H ... bottom, P1 ... first position.

Claims (21)

  1. 　近位側から遠位側に延びるルーメンと、前記ルーメンにおける遠位側に形成された吸引口と、を有するチューブ、を備え、
    　前記吸引口は、前記ルーメンが延びる第一方向に直交する面に対して傾いた状態に形成された部分を有しており、
    　前記吸引口における遠位端を鉛直方向上側、前記吸引口における近位端を鉛直方向下側となる前記チューブの配置において、前記第一方向において前記吸引口の近位端が有る第一位置での前記ルーメンの前記第一方向に直交する断面を第一断面としたとき、
    　前記第一断面は、鉛直方向下端に、前記鉛直方向と前記第一方向とに直交する幅方向に延びる底部を有しており、
    　前記底部は、前記幅方向における最大長さの０．３倍以上１．０倍以下の長さである、吸引カテーテル。     A tube having a lumen extending from the proximal side to the distal side, and a suction port formed on the distal side of the lumen;
    The suction port has a portion formed in a state inclined with respect to a plane orthogonal to the first direction in which the lumen extends,
    In the arrangement of the tube in which the distal end of the suction port is in the vertical direction upper side and the proximal end of the suction port is in the vertical direction lower side, the first position has the proximal end of the suction port in the first direction. When the cross section perpendicular to the first direction of the lumen is the first cross section,
    The first cross section has a bottom portion extending in a width direction orthogonal to the vertical direction and the first direction at a lower end in a vertical direction,
    The aspiration catheter, wherein the bottom has a length that is not less than 0.3 times and not more than 1.0 times the maximum length in the width direction.
  2. 　前記第一断面は、前記鉛直方向における最大長さが、前記幅方向における最大長さの０．４倍以上０．９倍以下である、請求項１記載の吸引カテーテル。 The suction catheter according to claim 1, wherein the first section has a maximum length in the vertical direction that is not less than 0.4 times and not more than 0.9 times the maximum length in the width direction.
  3. 　前記第一断面の形状は、多角形である、請求項１又は２記載の吸引カテーテル。 The suction catheter according to claim 1 or 2, wherein the shape of the first cross section is a polygon.
  4. 　近位側から遠位側に延びるルーメンと、前記ルーメンにおける遠位側に形成された吸引口と、を有するチューブ、を備える吸引カテーテルであって、
    　前記吸引口は、前記ルーメンが延びる第一方向に直交する面に対して傾いた状態に形成された部分を有しており、
    　前記吸引口における遠位端を鉛直方向上側、前記吸引口における近位端を鉛直方向下側となるように前記チューブが配置された状態において、前記第一方向において前記吸引口の近位端が有る第一位置での前記ルーメンの前記第一方向に直交する断面を第一断面としたとき、
    　前記第一断面は、鉛直方向下端に、前記鉛直方向と前記第一方向とに直交する幅方向に延びる底部を有しており、
    　前記第一断面の形状は、多角形である、吸引カテーテル。     A suction catheter comprising: a lumen having a lumen extending from a proximal side to a distal side; and a suction port formed at a distal side of the lumen;
    The suction port has a portion formed in a state inclined with respect to a plane orthogonal to the first direction in which the lumen extends,
    In the state where the tube is arranged so that the distal end of the suction port is vertically upward and the proximal end of the suction port is vertically lower, the proximal end of the suction port is the first direction. When a cross section perpendicular to the first direction of the lumen at a first position is a first cross section,
    The first cross section has a bottom portion extending in a width direction orthogonal to the vertical direction and the first direction at a lower end in a vertical direction,
    The shape of the said 1st cross section is a polygonal suction catheter.
  5. 　前記ルーメンは、前記第一位置における前記第一断面の形状が近位側へ所定距離続いている、請求項１～４の何れか一項記載の吸引カテーテル。 The aspiration catheter according to any one of claims 1 to 4, wherein the lumen has the shape of the first cross section at the first position continuing a predetermined distance toward the proximal side.
  6. 　前記チューブは、前記第一方向における前記第一位置よりも近位側の位置において、前記第一断面から前記第一断面とは形状が異なる第二断面へ断面を変化させる断面切替部を更に有している、請求項１～５の何れか一項記載の吸引カテーテル。 The tube further includes a cross-section switching unit that changes a cross section from the first cross section to a second cross section having a shape different from the first cross section at a position proximal to the first position in the first direction. The aspiration catheter according to any one of claims 1 to 5, wherein
  7. 　前記断面切替部は、前記第一断面から前記第一断面とは形状及び断面積が異なる第二断面へ断面を変化させる、請求項６記載の吸引カテーテル。 The suction catheter according to claim 6, wherein the cross-section switching unit changes the cross section from the first cross section to a second cross section having a shape and a cross-sectional area different from the first cross section.
  8. 　前記断面切替部の端側は、前記第一方向において前記第一位置から２０ｍｍ以内に位置する、請求項６又は７記載の吸引カテーテル。 The suction catheter according to claim 6 or 7, wherein an end side of the cross-section switching unit is located within 20 mm from the first position in the first direction.
  9. 　前記断面切替部は、前記ルーメンを形成する内面の少なくとも一部に形成されるテーパである、請求項６～８の何れか一項記載の吸引カテーテル。 The suction catheter according to any one of claims 6 to 8, wherein the cross-section switching portion is a taper formed on at least a part of an inner surface forming the lumen.
  10. 　前記断面切替部の近位端での前記ルーメンの前記第一方向に直交する断面の形状は、円形である、請求項６～９の何れか一項記載の吸引カテーテル。 The suction catheter according to any one of claims 6 to 9, wherein a shape of a cross section perpendicular to the first direction of the lumen at a proximal end of the cross section switching portion is a circle.
  11. 　前記吸引口における近位端から遠位端までの長さが２．０ｍｍ以上１０ｍｍ以下である、請求項１～１０の何れか一項記載の吸引カテーテル。 The suction catheter according to any one of claims 1 to 10, wherein a length from a proximal end to a distal end of the suction port is 2.0 mm or more and 10 mm or less.
  12. 　前記吸引口の鉛直方向上方又は下方の一方における前記チューブの内面と前記チューブの外面との間の端部が、前記吸引口を形成する吸引面に対して凹又は凸となっている、請求項１～１１の何れか一項記載の吸引カテーテル。 The end portion between the inner surface of the tube and the outer surface of the tube on one of the upper and lower sides in the vertical direction of the suction port is concave or convex with respect to the suction surface forming the suction port. The aspiration catheter according to any one of 1 to 11.
  13. 　前記凹又は凸の形状が曲面で定義される、請求項１２記載の吸引カテーテル。 The suction catheter according to claim 12, wherein the concave or convex shape is defined by a curved surface.
  14. 　前記吸引口の鉛直方向下方における前記チューブの内面と前記チューブの外面との間の端部が、前記吸引口を形成する吸引面に対して凸となっている、請求項１２又は１３記載の吸引カテーテル。 The suction according to claim 12 or 13, wherein an end between the inner surface of the tube and the outer surface of the tube below the suction port is convex with respect to the suction surface forming the suction port. catheter.
  15. 　前記吸引口の鉛直方向上方における前記チューブの内面と前記チューブの外面との間の端部が、前記吸引口を形成する吸引面に対して凹となっている、請求項１２～１４の何れか一項記載の吸引カテーテル。 The end portion between the inner surface of the tube and the outer surface of the tube above the suction port in the vertical direction is concave with respect to the suction surface forming the suction port. The suction catheter according to one item.
  16. 　前記チューブの外面の上端と前記チューブの外面の下端とを繋ぐ直線を基準線としたとき、
    　前記吸引口の鉛直方向上方における前記端部は、前記基準線に対し凹となっており、前記吸引口の鉛直方向下方における前記端部は、前記基準線に対し凸となっている、請求項１２～１５の何れか一項記載の吸引カテーテル。     When a straight line connecting the upper end of the outer surface of the tube and the lower end of the outer surface of the tube is a reference line,
    The end portion in the vertical direction above the suction port is concave with respect to the reference line, and the end portion in the vertical direction below the suction port is convex with respect to the reference line. The suction catheter according to any one of 12 to 15.
  17. 　前記チューブを前記第一方向に切断した際の断面において、
    　前記ルーメンの鉛直方向下方における前記端部の外面側の第一近位端は、前記端部の内面側の第一遠位端よりも近位側に位置し、当該第一近位端及び第一遠位端を繋ぐ直線は、前記第一方向に対して２°以上６０°以下の範囲で傾いており、前記ルーメンの鉛直方向上方における前記端部の外面側の第二遠位端は、前記端部の内面側の第二近位端よりも遠位側に位置し、当該第二遠位端及び第二近位端を繋ぐ直線は、前記第一方向に対して２°以上６０°以下の範囲で傾いている、請求項１２～１６の何れか一項記載の吸引カテーテル。     In the cross section when the tube is cut in the first direction,
    The first proximal end on the outer surface side of the end portion in the vertically lower direction of the lumen is located closer to the first distal end on the inner surface side of the end portion than the first proximal end and the first proximal end. A straight line connecting one distal end is inclined in a range of 2 ° to 60 ° with respect to the first direction, and a second distal end on the outer surface side of the end portion in the vertical direction of the lumen is A straight line connecting the second distal end and the second proximal end is located at a position distal to the second proximal end on the inner surface side of the end portion, and is 2 ° or more and 60 ° with respect to the first direction. The suction catheter according to any one of claims 12 to 16, wherein the suction catheter is inclined in the following range.
  18. 　前記チューブを前記第一方向に切断した際の断面において、前記ルーメンの鉛直方向下方における前記端部の外面側の第一近位端は、前記端部の内面側の第一遠位端よりも近位側に位置し、前記ルーメンの鉛直方向上方における前記端部の外面側の第二遠位端は、前記端部の内面側の第二近位端よりも遠位側に位置し、
    　前記第一近位端と前記第一遠位端とを繋ぐ直線に対し、前記吸引口の鉛直方向下方における前記チューブの内面と前記チューブの外面との間の端部が、凹又は凸となっており、
    　前記第二遠位端と前記第二近位端とを繋ぐ直線に対し、前記吸引口の鉛直方向上方における前記チューブの内面と前記チューブの外面との間の端部が、凹又は凸となっている、請求項１２～１７の何れか一項記載の吸引カテーテル。     In the cross section when the tube is cut in the first direction, the first proximal end on the outer surface side of the end portion in the vertically lower direction of the lumen is more than the first distal end on the inner surface side of the end portion. A second distal end located on a proximal side and on an outer surface side of the end portion in a vertical direction of the lumen is located on a more distal side than a second proximal end on an inner surface side of the end portion;
    With respect to a straight line connecting the first proximal end and the first distal end, an end portion between the inner surface of the tube and the outer surface of the tube below the suction port is concave or convex. And
    With respect to the straight line connecting the second distal end and the second proximal end, an end portion between the inner surface of the tube and the outer surface of the tube in the vertical direction above the suction port is concave or convex. The aspiration catheter according to any one of claims 12 to 17, wherein
  19. 　前記吸引口を鉛直方向下方から見た場合に、前記吸引口の近位側端部における曲率が、遠位側端部における曲率よりも小さい、請求項１２～１６の何れか一項記載の吸引カテーテル。 The suction according to any one of claims 12 to 16, wherein a curvature at a proximal end portion of the suction port is smaller than a curvature at a distal end portion when the suction port is viewed from below in the vertical direction. catheter.
  20. 　前記吸引口を鉛直方向下方から見た場合に、前記吸引口の近位側端部は、前記第一方向と前記鉛直方向との両方に直交する幅方向に直線状に延びている、請求項１２～１７の何れか一項記載の吸引カテーテル。 The proximal end of the suction port extends linearly in the width direction perpendicular to both the first direction and the vertical direction when the suction port is viewed from below in the vertical direction. The suction catheter according to any one of 12 to 17.
  21. 　一方向に延びるチューブの一端を、ルーメンが延びる第一方向に直交する面に対して傾くように切断する第一切断工程と、
    　前記第一切断工程により切断された前記チューブの前記ルーメンを変形させる変形工程と、
    　前記変形工程により変形され、前記第一切断工程により形成された前記チューブの開口における近位端を含む近位側の一部を切断する第二切断工程と、を含む、吸引カテーテルの製造方法。     A first cutting step of cutting one end of the tube extending in one direction so as to be inclined with respect to a plane orthogonal to the first direction in which the lumen extends;
    A deformation step of deforming the lumen of the tube cut by the first cutting step;
    A second cutting step of cutting a part of the proximal side including the proximal end in the opening of the tube formed by the first cutting step and deformed by the deforming step.
PCT/JP2017/027906 2016-08-04 2017-08-01 Suction catheter, and method for manufacturing suction catheter WO2018025865A1 (en)

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