JP2018019976A - Suction catheter and manufacturing method of suction catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a suction catheter capable of suppressing obstruction of a lumen by a sucked material and a manufacturing method thereof.SOLUTION: A suction catheter 1 includes a second tube 41 having a suction lumen 10 extending from a proximal side to a distal side, and a suction port 11 formed at the distal side in the suction lumen. The suction port has a portion inclined to a surface that is orthogonal to a first direction in which a first lumen is extended. In the arrangement of the second tube in which a distal end 11a in the suction port is arranged in a vertically upper side and a proximal end 11b in the suction port is arranged on a vertically lower side, an upper end portion 45a and a lower end portion 45b between an inner surface 41a of the second tube and an outer surface 41c of the second tube in one of the vertically upper or lower sides of the suction port are recessed or projected with respect to a suction surface F forming the suction port.SELECTED DRAWING: Figure 7

Description

  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.

  2. Description of the Related Art A suction catheter is known that introduces a substance in the body to the outside of the body by a negative pressure that is introduced into the body and applied from the proximal end of the catheter. 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.

JP 2007-236633 A

  Such a catheter is required to suppress lumen occlusion 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.

  Therefore, an object of the present invention is to provide a suction catheter and a suction catheter manufacturing method capable of suppressing lumen blockage by a suction substance.

  The suction catheter of the present invention includes 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, and the suction port extends in a first direction in which the lumen extends. In the arrangement of the tube, which has a portion inclined with respect to the orthogonal plane, the distal end of the suction port is the upper side in the vertical direction, and the proximal end of the suction port is the lower side in the vertical direction. Alternatively, an end portion between the inner surface of the tube and the outer surface of the tube on one side below is concave or convex with respect to the suction surface forming the suction port.

  A substance such as a thrombus or a foreign substance sucked by the suction catheter is sucked into the lumen from a 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 of the present invention, in the arrangement of the tubes 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 is a suction surface that forms the suction port. On the other hand, it is concave or convex. For this reason, the thrombus easily enters the convex portion, and the thrombus contacting the edge of the tube is cut in the concave portion, so that the thrombus can be easily sucked. As a result, the blockage of the lumen by the suction substance can be suppressed.

  The shape of the 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.

  The end between the inner surface of the tube and the outer surface of the tube below the suction port in the vertical direction may be convex with respect to the suction surface forming the suction port. In the suction catheter having this configuration, a thrombus easily enters.

  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 may be concave 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.

  When the straight line connecting the upper end of the tube and the lower end of the tube is a reference line, the upper end of the suction port in the vertical direction is recessed symmetrically with respect to the reference line. The lower end of the suction port in the lower vertical direction may be convex in line symmetry with respect to the reference line.

  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 proximal side than the first distal end on the inner surface side of the end portion. The straight line connecting the first proximal end and the first distal end is inclined in a range of 2 ° to 60 ° with respect to the first direction, and is on the outer surface side of the end portion in the vertical direction of the lumen. The second distal end is located more distally than the second proximal end on the inner surface side of the end portion, and the straight line connecting the second distal end and the second proximal end is in the first direction. You may incline in the range of 2 degrees or more and 60 degrees or less. 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.

  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 proximal side than the first distal end on the inner surface side of the end portion. The second distal end on the outer surface side of the end portion in the vertical direction of the lumen is located more distally than the second proximal end on the inner surface side of the end portion, and is connected to the first proximal end and the first far end. The end between the inner surface of the tube and the outer surface of the tube below the suction port in the vertical direction with respect to the straight line connecting the distal end is concave or convex, and the second distal end and the second proximal end 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 two. Thereby, it becomes easier to suck the thrombus approaching 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. 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 a 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.

  When the suction port is viewed from below in the vertical direction, the proximal end of the suction port may extend linearly in the width direction orthogonal to both the first direction and the vertical direction. In the configuration of the suction catheter, 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 manufacturing method of the suction catheter of the present invention is a manufacturing method of a suction catheter including a tube having a substance suction port on the distal side, and an insertion step of inserting a core material into the tube, and a core material is inserted in the insertion step A deforming step of deforming the formed tube, a cutting step of cutting one end of the tube deformed in the deforming step so as to be inclined with respect to a plane orthogonal to the first direction in which the lumen extends, and after the cutting step, from the tube Removing the core material.

  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 in the vertical direction of the suction port is the suction port. Are concave or convex with respect to the suction surface. For this reason, the thrombus easily enters the convex portion, and the thrombus contacting the edge of the tube is cut in the concave portion, so that the thrombus can be easily sucked. As a result, the blockage of the lumen by the suction substance can be suppressed.

  According to the present invention, the lumen can be prevented from being blocked by the suction substance.

It is sectional drawing when the suction catheter which concerns on one Embodiment is cut | disconnected along a 1st direction. It is a figure which shows the cross-sectional structure along the AA in FIG. It is a figure which shows the cross-sectional structure along the DD line | wire in FIG. (A) is a figure which shows the cross-sectional structure along CC line in FIG. 1, (b) is a figure which shows the cross-sectional structure along BB line in FIG. It is the bottom view which looked at the suction opening in the suction lumen in Drawing 1 from the perpendicular direction lower part. It is the perspective view which showed the distal end surface in the suction port of the 2nd tube in FIG. (A) is sectional drawing of the 1st direction which showed the distal end surface in the suction opening of the 2nd tube in FIG. 1, (b) is an expanded sectional view of an upper end part, (c) is It is an expanded sectional view of a lower end part. (A)-(c) is a figure explaining an example of the process of the manufacturing method of the suction catheter of FIG. It is the bottom view which looked at the suction port in the suction lumen concerning a different embodiment from the perpendicular direction lower part. (A)-(d) is an example of sectional drawing of the suction lumen | rumen in the catheter which concerns on a modification. (A)-(h) is an example of sectional drawing of the suction lumen | rumen in the catheter which concerns on a modification.

  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.

  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 width of the suction lumen 10 is a direction perpendicular to the first direction and the vertical direction, where the first direction in which the suction catheter 1 extends is the X-axis direction and the vertical direction is the Z-axis 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.

  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. doing. The suction lumen 10 is a flow path such as a thrombus 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.

  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.

  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.

  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. A structure in which one wire is wound or a structure arranged along a lumen may be used. The material and structure of the braid constituting the braided tube do not limit the effects of the present invention, and various materials and structures can be used. Metal is preferable as the material of the braid, and stainless steel such as SUS304 and SUS316, spring steel, piano wire, oil temper wire, Co—Cr alloy, Ni—Ti alloy, etc. are processed into various cross-sectional shapes such as circle, ellipse, and rectangle. It is possible to use a metal wire that has been processed into a braid with one or more metal wires.

  The first shaft 3 may have a double tube structure in which another tube is disposed inside or outside the first tube 31.

  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.

  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.

  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.

  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.

  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.

  As shown in FIG. 1, the distal end surface 41 b 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 stepped manner by providing a step or the like. May be.

  A suction port 11 is provided at the distal end of the second tube 41. The suction port 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, 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 a side view, the distal end 11a of the suction port 11 is on the upper side in the vertical direction, and the proximal end 11b of the suction port 11 is on the lower side in the vertical direction.

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, since the effective portion for cutting the thrombus at the suction port 11 is increased, 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).

  As an example of a different embodiment, as shown in FIG. 9, the curved shape of the proximal end 111d including the proximal end 11b on the proximal side when viewed from the vertically downward direction is shown in the width direction (Y-axis direction). ) May be formed linearly. This is an example when the curvature on the proximal side is made smaller. With this configuration, the thrombus is easily caught by the suction port 11, and the 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.

  As shown in FIGS. 6 and 7A to 7C, the distal end surface 41 b 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. 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 portion 45a and the lower end portion 45b between the inner surface 41a of the second tube 41 and the outer surface 41c of the tube on one of the upper and lower sides in the vertical direction on the distal side of the second tube 41 are in a cross section parallel to the major axis direction. It is concave or convex with respect to a straight line connecting the most distal point and the nearest point of the cross section of the tube. 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. As described above, it is easy for blood clots to enter in the convex part, and it is difficult to damage the blood vessel, and in the concave part, the thrombus in contact with the edge of the second tube 41 is cut, Thrombus can be easily aspirated.

  The concave or convex of the upper end 45 a or the lower end 45 b of the second tube 41 is 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 defined by the distal end, the proximal end, and the tube side wall of the suction port 11. The distal end and the proximal end of the suction port 11 include a distal end 11c and a proximal end 11d of the suction port 11. When 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.

  The shape of the end of the second tube 41 that forms the suction port 11 and that is concave or convex with respect to the suction surface F that forms the suction port 11 is preferably a curved surface. The curved surface is the end of the second tube 41, that is, the thick part of the second tube 41 that forms the suction port 11 (the part between the inner surface 41a and the outer surface 41c of the second tube 41), for example, This is the case of a dome-shaped protrusion or depression, a semi-cylindrical convex shape or a concave shape. Thereby, it becomes easy to suck the thrombus approaching the suction port 11, and damage to blood vessels can be suppressed.

  As shown in FIG. 6, 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.

  In the present embodiment, as shown in FIGS. 7A, 7B, and 7C, 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 located more distally than the second proximal end 46c on the inner surface side of the upper end portion 45a. The first proximal end 46b on the outer surface side of the lower end portion 45b of the end surface 41b is positioned closer to the proximal side than the first distal end 46d on the inner surface side of the lower end portion 45b.

  The upper end portion 45a of the end surface 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 preferably 10 ° or more, and the upper limit value is preferably 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 preferably 10 ° or more, and the upper limit value is preferably 30 ° or less.

  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 is preferable that 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 is preferably convex. Particularly, it is concave or 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. As a result, the suction efficiency can be further improved.

  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.

  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. 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.

  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. Accordingly, the operator can grasp the position of the distal end of the second shaft 5 based on the X-ray transmission image.

  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.

  As shown in FIGS. 1, 3 and 4, the suction lumen 10 formed by the inner surface 41a of the second tube 41 may change in cross section 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 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.

  Here, the maximum width portion 13 having the maximum length w in the width direction (Y-axis direction) in the first cross section may be located below the vertical center position M in the first cross section. Further, 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. In other words, 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.

  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 is 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. A preferable value of the lower limit value of the distance L1 is 2 mm or more, and a preferable value of the lower limit value of the distance is 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. This is because 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.

  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. Thereby, the efficiency of thrombus suction is promoted, and the thrombus in the second tube 41, that is, the suction lumen 10 is prevented 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 having such a taper or a step may be provided. 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 2nd inner surface 43 which is a part of the inner surface 41a in a 1st cross section.

  As a different embodiment, the shape or cross-sectional area (size) of the suction lumen 10 may be changed 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 is preferably 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, or 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.

  Then, an example of the manufacturing method of the suction catheter 1 is demonstrated. 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.

  Next, the core member 80 is inserted into the second tube 41 extending in the first direction as shown in FIG. 8A (insertion step). Next, as shown in FIG. 8B, the second tube 41 into which the core member 80 is inserted is deformed (deformation step). And the end of the 2nd tube 41 deform | transformed in the deformation | transformation process is cut | disconnected so that it may incline with respect to the surface orthogonal to the 1st direction of the suction lumen 10 (cutting line C1: cutting process). After the cutting step, the core member 80 is removed from the second tube 41 and released from the deformation as shown in FIG. As a result, as shown in FIGS. 6 and 7A, 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 that forms the suction port 11. A lower end 45b in the lower direction is convex with respect to the suction surface F.

  Next, 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 to which the first tube 31 is connected are arranged in parallel. Specifically, the second tube 41 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.

  Next, a stainless steel core material is inserted into the second tube 41. The cross section of the core material is circular. The second tube 41 and the third tube 61 are covered with a shrink tube and heated. The shrink tube is preferably 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. 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. When the shrink tube is 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 member 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.

  Finally, 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.

  Although one embodiment has been described above, the present invention is not limited to the above embodiment.

<Modification 1>
In the above embodiment, as shown in FIG. 3, an example in which the first cross section is formed by the arc-shaped first inner surface 42 and the second inner surface 43 having a smaller curvature than the first inner surface 42 is given. Although described, the present invention is not limited to this. The first cross section may have any shape, but if it is formed so that the maximum width portion 13 in the first cross section is located below the vertical center position M in the first cross section, the thrombus The portion that is sucked into the suction lumen 10 is wider than the other portions. 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.

Instead of the shape of the first cross section, for example, the first cross section of the suction lumen 10 may have a shape as shown in FIGS. 10 (a) to 10 (d). At this time, the bottom 143A, 143B, 143C, and 143D, if the maximum length _W length of 0.3 times to 1.0 times the _max in the width direction, the portion thrombus is drawn into the suction lumen 10 becomes wider . 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. Further, 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. In this case, since the lower side part into 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.

  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 can be various polygons 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. If the first cross section has such a polygonal shape, the suction pressure at the suction port 11 can be increased, so that the thrombus can be easily cut. Thereby, the thrombus is easily 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.

  11A to 11H, the bottoms 243A, 243B, 243C, 243D, 243E, 243F, 243G, and 243H are not less than 0.3 times the maximum length W in the width direction and 1.0. If the length h is less than double, the portion where the thrombus is sucked into the suction lumen 10 can be widened. For this reason, the thrombus is easily sucked from the suction port 11 by the suction lumen 10. Furthermore, if the maximum length h in the vertical direction is a first cross section that is 0.4 to 0.9 times the maximum length W in the width direction, the lower side where the thrombus is sucked in the suction port 11 Since the portion can be expanded, the thrombus can be sucked from the suction port 11 more effectively.

<Modification 2>
In the above embodiment, 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, Although the example in which the inner surface 41a of the second tube 41 is inclined in the range of 2 ° or more and 60 ° or less with respect to the extending direction has been described, the inclination may be inclined in a range different from the above range. Good.

<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.

  Various embodiments and modifications described above may be combined in various ways without departing from the spirit of the present invention.

  DESCRIPTION OF SYMBOLS 1 ... Suction catheter, 3 ... 1st shaft, 5 ... 2nd shaft, 10 ... Suction lumen, 11 ... Suction port, 11a ... Distal end of suction port, 11b ... Proximal end of suction port, 11c ... Distal side End portion, 11d: proximal end portion, 20: guide wire lumen, 31 ... first tube, 41 ... second tube (tube), 41a ... inner surface of second tube, 41b ... end surface of second tube, 41c ... The outer surface of the second tube, 45a ... upper end, 45b ... lower end, 61 ... third tube, 71 ... main body resin, 111d ... proximal end, BL ... reference line, F ... suction surface, P1 ... first position .

Claims (10)

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 inclined with respect to a plane orthogonal to the first direction in which the lumen extends,
In the arrangement of the tube, the distal end of the suction port is on the upper side in the vertical direction, and the proximal end of the suction port is on the lower side in the vertical direction.
An aspiration catheter in which 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 is concave or convex with respect to the suction surface forming the suction port .   The aspiration catheter according to claim 1, wherein the concave or convex shape is defined by a curved surface.   The suction according to claim 1 or 2, wherein an end portion 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.   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. 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 claims 1 to 4. 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 ° or more and 60 ° or less 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 claim 1, wherein the suction catheter is inclined in the following range. 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 suction catheter according to any one of claims 1 to 6.   The suction according to any one of claims 1 to 5, 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.   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 1 to 6. A method of manufacturing a suction catheter comprising a tube having a suction port for a substance on the distal side,
An insertion step of inserting a core material into the tube;
A deformation step of deforming the tube into which the core material is inserted in the insertion step;
A cutting step of cutting one end of the tube deformed in the deformation step so as to be inclined with respect to a plane orthogonal to a first direction in which the lumen extends;
After the cutting step, removing the core material from the tube;
A method for manufacturing a suction catheter.

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