WO2018025860A1 - 吸引カテーテル及び吸引カテーテルの製造方法 - Google Patents

吸引カテーテル及び吸引カテーテルの製造方法 Download PDF

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Publication number
WO2018025860A1
WO2018025860A1 PCT/JP2017/027898 JP2017027898W WO2018025860A1 WO 2018025860 A1 WO2018025860 A1 WO 2018025860A1 JP 2017027898 W JP2017027898 W JP 2017027898W WO 2018025860 A1 WO2018025860 A1 WO 2018025860A1
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WIPO (PCT)
Prior art keywords
tube
suction
cross
section
suction port
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Application number
PCT/JP2017/027898
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English (en)
French (fr)
Japanese (ja)
Inventor
翠翠 李
陽平 黒瀬
Original Assignee
株式会社カネカ
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Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Priority to JP2018531922A priority Critical patent/JP7009368B2/ja
Priority to CN201780032364.XA priority patent/CN109414529B/zh
Publication of WO2018025860A1 publication Critical patent/WO2018025860A1/ja

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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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems

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 distal end of the suction port is vertically upward, and the proximal end of the suction port is vertically downward.
  • 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 maximum width portion in the first cross section is lower than the vertical center position in the first cross section. Since it is formed so as to be located on the side, the 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.
  • the orthogonal here includes substantially orthogonal.
  • the first cross section may have a bottom portion extending in the width direction at the lower end in the vertical direction.
  • the maximum length in the vertical direction of the first cross section may be shorter than the maximum length in the width direction.
  • the first cross section of the lumen has a so-called horizontally long shape. For this reason, since the shape balance is better than the circular lumen having the same circumferential length, the resistance at the time of insertion of the catheter is reduced, and the performance of reaching the distal end of the catheter is improved.
  • 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 substance that is sucked easily collides with the inner surface of the tube, and the vibration caused by the collision of the sucked substance with the shaft becomes stronger. 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 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.
  • a method of manufacturing a suction catheter is a method of manufacturing a suction catheter including a tube having a substance suction port on a distal side, and an insertion step of inserting a core material into the tube, and an insertion step A deformation step for deforming the tube in which the core material is inserted, a cutting step for cutting one end of the tube deformed in the deformation step so as to be inclined with respect to a plane orthogonal to the first direction in which the lumen extends, and a cutting step And a removing step of removing the core material from the tube.
  • the tube manufactured by the above-described suction catheter manufacturing method is such that, in the tube arrangement as described above, the end portion between the inner surface of the tube and the outer surface of the tube on the upper side or the lower side of the suction port is the suction port.
  • 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 of the suction catheter according to the embodiment as viewed from below in the vertical direction.
  • FIG. 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.
  • FIG. 7 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.
  • FIG. 8A 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. 8B is an enlarged cross-sectional view of the upper end portion.
  • FIG. 8C is an enlarged cross-sectional view of the lower end portion.
  • FIG. 9A to FIG. 9C are diagrams for explaining an example of the steps of the suction catheter manufacturing method according to the first modification.
  • FIGS. 10A to 10F are examples of cross-sectional views of a suction lumen in a catheter according to a modification.
  • 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 is formed by an arc-shaped first inner surface 42 and a second inner surface (bottom) 43 having a smaller curvature than the first inner surface 42.
  • the maximum width portion 13 having the maximum length w in the width direction (Y-axis direction) in the first cross section is located below the vertical center position M in the first cross section. 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 10. As a result, the suction efficiency can be improved.
  • the maximum length h in the vertical direction of the first cross section may be shorter than the maximum length w in the width direction.
  • the first cross section may have a horizontally long shape.
  • 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 imparted more reliably 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 thrombus suction 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.
  • a plurality of cross-section switching portions 15 having such a taper or a step may be provided.
  • 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 2nd inner surface 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 the thrombus suction state can be grasped.
  • 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 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. The distal end of the first tube 31 is connected to the proximal end of the second tube 41. Subsequently, the second tube 41 and the third tube 61 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 selected as appropriate, such as bonding with an adhesive or heating and welding the tube.
  • a stainless steel core material (not shown) 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. Examples of heat resistant resins include olefin resins. Thereby, the 2nd tube 41 and the 3rd tube 61 are welded and integrated. Thereby, the main body resin 71 is formed.
  • 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.
  • the cross-sectional shape of the core material there is a shape shown in FIG.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. 7 to 9, illustration of the third tube 61 forming the guide wire lumen 20 is omitted.
  • the distal end surface 41b of the second tube 41 is a portion including the end surface of the second tube 41 and the end surface 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. 8A, 8B, and 8C 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.
  • FIG. 9 (c) As an example of a method of forming the upper end portion 45a and the lower end portion 45b to be concave or convex, an example of a method of forming the upper end portion 45a to be concave and forming the lower end portion 45b to be convex is mainly shown in FIG. ) To FIG. 9 (c).
  • 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.
  • the core member 80 is inserted into the second tube 41 extending in the first direction as shown in FIG. 9A (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.
  • 9B 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 (cut line).
  • C1 cutting step).
  • the second tube 41 is released from the deformation as shown in FIG.
  • the upper end portion 45 a in the upper vertical direction of the suction port 11 becomes concave with respect to the suction surface F forming 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.
  • suction catheter 1 according to the modified example is manufactured through the same manufacturing process as in the above 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.
  • the 1st cross section is formed by the arc-shaped 1st inner surface 42 and the 2nd inner surface 43 with a curvature smaller than the 1st inner surface 42.
  • the first cross section may have bottoms 143A, 143B, 143C, 143D, 143E, and 143F at the lower end thereof.
  • the bottom portions 143A, 143B, 143C, 143D, 143E, and 143F are substantially linear portions extending in the width direction.
  • the maximum width portions 13A, 13B, 13C, 13D, 13E, and 13F having the maximum length w in the width direction in the first cross section are located below the vertical center position M in the first cross section.
  • the bottom portions 143A, 143B, 143C, 143D, 143E, and 143F, which are the portions where the thrombus is most sucked in the suction port 11, are compared to the other portions. Since it is spread out, the thrombus can be sucked more effectively.
  • the 2nd tube 41 which has such a 1st cross section can also be manufactured by the method similar to the method demonstrated in the said embodiment.
  • the lower side portion into which the thrombus is sucked in the suction port 11 can be expanded, so that it is more effective. A thrombus can be sucked from the suction port 11.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • External Artificial Organs (AREA)
PCT/JP2017/027898 2016-08-04 2017-08-01 吸引カテーテル及び吸引カテーテルの製造方法 WO2018025860A1 (ja)

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JP2018531922A JP7009368B2 (ja) 2016-08-04 2017-08-01 吸引カテーテル及び吸引カテーテルの製造方法
CN201780032364.XA CN109414529B (zh) 2016-08-04 2017-08-01 抽吸导管及抽吸导管的制造方法

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CN109152911B (zh) * 2016-08-04 2021-04-27 株式会社钟化 抽吸导管及抽吸导管的制造方法

Citations (3)

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US5556390A (en) * 1995-03-07 1996-09-17 Quinton Instrument Company Catheter with oval or elliptical lumens
JP2007244757A (ja) * 2006-03-17 2007-09-27 Nippon Sherwood Medical Industries Ltd 医療用チューブ
US20130261605A1 (en) * 2011-02-10 2013-10-03 C. R. Bard, Inc. Multi-Lumen Catheter with Enhanced Flow Features

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US6146354A (en) * 1996-05-24 2000-11-14 Horizon Medical Products Asymmetrical multi-lumen apheresis catheter with balanced flow rates
WO2000048525A2 (en) * 1999-02-19 2000-08-24 Scimed Life Systems, Inc. Laser lithotripsy device with suction
KR100972463B1 (ko) * 2003-03-28 2010-07-27 코비디엔 아게 폐색 저항성 선단을 구비한 카테터
US8298210B2 (en) * 2005-10-26 2012-10-30 Medtronic Vascular, Inc. Catheter having oval aspiration lumen and method of making
BRPI0809858A2 (pt) * 2007-04-03 2014-09-30 Nipro Corp Cateter de aspiração de trombo
JP5777936B2 (ja) * 2010-07-16 2015-09-09 テルモ株式会社 吸引カテーテル
JP5643024B2 (ja) * 2010-08-06 2014-12-17 テルモ株式会社 吸引カテーテル及び該吸引カテーテルの製造方法
JP5713732B2 (ja) * 2011-03-08 2015-05-07 日本コヴィディエン株式会社 弁付きカテーテル
JP2012187351A (ja) * 2011-03-14 2012-10-04 Goodman Co Ltd 吸引カテーテル
JP5913856B2 (ja) * 2011-08-01 2016-04-27 株式会社グッドマン カテーテル及びカテーテルの製造方法
JP5890979B2 (ja) * 2011-08-01 2016-03-22 株式会社グッドマン 吸引カテーテル
JP6391910B2 (ja) * 2012-12-14 2018-09-19 株式会社グッドマン 吸引カテーテル

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5556390A (en) * 1995-03-07 1996-09-17 Quinton Instrument Company Catheter with oval or elliptical lumens
JP2007244757A (ja) * 2006-03-17 2007-09-27 Nippon Sherwood Medical Industries Ltd 医療用チューブ
US20130261605A1 (en) * 2011-02-10 2013-10-03 C. R. Bard, Inc. Multi-Lumen Catheter with Enhanced Flow Features

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