JP2023091620A - Guiding catheter and method for manufacturing guiding catheter - Google Patents

Abstract

To take out a wire from a wire lumen in a reliable manner when manufacturing a guiding catheter.SOLUTION: A guiding catheter includes a shaft, a grip part, an operation part, and a wire. The shaft includes a recessed part formed on an outer peripheral surface of the shaft and formed so as to reach a wire lumen. The recessed part includes a first side face provided on a distal side in a longitudinal direction, on which a proximal side opening of the wire lumen is formed. The wire extends from the proximal side opening of the wire lumen to the operation part. The first side face is inclined on a proximal side in the longitudinal direction from the outer peripheral surface to the inside.SELECTED DRAWING: Figure 6

Description

The present disclosure relates to guiding catheters and methods of manufacturing guiding catheters.

BACKGROUND ART Catheters are medical instruments that are inserted into body cavities such as the abdominal cavity and urethra, lumens, or blood vessels to relieve the burden on patients by discharging bodily fluids and delivering medical fluids to treatment sites. In recent years, as the range of applications for catheter treatment increases, there is a demand for a catheter that can perform more complicated procedures and reach the target site more accurately. For this reason, guiding catheters with operable mechanisms are known, such as those found in US Pat.

Such a guiding catheter has a structure in which a wire is passed through the wire lumen of the shaft, one end of the wire is connected to the distal portion of the shaft, and the other end of the wire is connected to the operating portion. . This guiding catheter is configured such that the shaft is bent by a pulling operation of the wire by the operation section.

In the manufacturing method of such a guiding catheter, generally, a wire is inserted through a distal opening of the shaft, and the wire is pulled out from the outer peripheral surface of the shaft at the proximal portion of the shaft in order to connect the wire to the operating section. . For this reason, removal processing is performed on the outer peripheral surface of the shaft at the proximal portion of the shaft to expose a portion of the wire lumen of the shaft. Patent Literature 2 discloses a technique for removing the shaft of a catheter.

U.S. Pat. No. 4,960,134 JP 2013-111191 A

In order to take out the wire from the outer peripheral surface of the shaft, the outer peripheral surface of the shaft is subjected to removal processing to form a recess. It is important to However, the opening of the wire lumen is blocked due to the heat generated during removal processing (for example, heat generated by friction with the cutting tool during cutting and heat generated during laser processing) and burrs on the shaft caused by removal processing. , it may not be possible to remove the wire. The blockage can be eliminated by performing additional removal processing, but if the amount of removal processing increases, the recessed portion may reach the main lumen, and the main lumen and the wire lumen may communicate with each other. In this case, the manufacturing yield of the guiding catheter decreases, and the manufacturing cost of the guiding catheter increases.

The present disclosure has been made in consideration of such points, and provides a guiding catheter and a manufacturing method of the guiding catheter that can reliably remove the wire from the wire lumen during manufacturing of the guiding catheter. aim.

A first aspect of the present disclosure includes a shaft extending longitudinally and having a main lumen and a wire lumen, a grip provided at a proximal portion of the shaft, an operation portion provided at the grip, and the a wire inserted through a wire lumen, one end of which is connected to the distal portion of the shaft, and the other end of which is connected to the operation portion; the shaft is formed on the outer peripheral surface of the shaft; It has a recess formed to reach the wire lumen, the recess being provided on the distal side in the longitudinal direction and having a first side surface in which a proximal opening of the wire lumen is formed. The wire extends from the proximal opening of the wire lumen toward the operating portion, and the first side surface extends inwardly from the outer peripheral surface to the proximal side in the longitudinal direction. It is a guiding catheter that is slanted.

A second aspect of the present disclosure is the guiding catheter according to the first aspect described above, wherein the recessed portion may have a second side surface provided on the proximal side in the longitudinal direction, The two side surfaces may be slanted distally in the longitudinal direction inwardly from the outer peripheral surface.

A third aspect of the present disclosure is the guiding catheter according to the above-described first aspect and the above-described second aspect, wherein the depth of the recess is from the outer peripheral surface in the radial direction of the shaft to the wire lumen. greater than the sum of the length and the diameter of the wire, and greater than the sum of the length from the outer peripheral surface to the wire lumen in the radial direction and half the length of the wire lumen in the radial direction It can be small.

A fourth aspect of the present disclosure is the guiding catheter according to each of the above-described first to third aspects, wherein the recessed portion may be formed along the entire circumference of the shaft in the circumferential direction. .

A fifth aspect of the present disclosure is the guiding catheter according to each of the above-described first to third aspects, wherein the recess may be formed in a part of the shaft in the circumferential direction. .

A sixth aspect of the present disclosure provides a preparatory step of preparing a shaft extending in the longitudinal direction and having a main lumen and a wire lumen, and removing the outer peripheral surface of the shaft after the preparatory step. a forming step of forming a recess on the outer peripheral surface to reach the wire lumen; an inserting step of inserting a wire into the wire lumen from a distal opening of the wire lumen after the forming step; and a removing step of removing the wire from the proximal opening of the wire lumen after the step, wherein in the forming step, the first side surface provided on the distal side of the recess in the longitudinal direction is the outer peripheral surface. The manufacturing method of the guiding catheter, wherein the proximal side opening of the wire lumen is formed on the first side surface so as to be inclined from the inner side toward the proximal side in the longitudinal direction.

A seventh aspect of the present disclosure is the method for manufacturing a guiding catheter according to the sixth aspect described above, wherein in the forming step, the second side surface provided on the proximal side of the recess in the longitudinal direction is the outer peripheral surface. may be formed to slope distally in the longitudinal direction inwardly from the .

An eighth aspect of the present disclosure is the manufacturing method of the guiding catheter according to the above-described sixth aspect and the above-described seventh aspect, wherein in the forming step, the depth of the recessed portion is A length that is greater than the sum of the length from the outer peripheral surface to the wire lumen and the diameter of the wire and is half the length from the outer peripheral surface to the wire lumen in the radial direction and the length of the wire lumen in the radial direction The recess may be formed so as to be smaller than the sum of .

A ninth aspect of the present disclosure is the manufacturing method of the guiding catheter according to each of the above-described sixth aspect to the above-described eighth aspect, wherein in the forming step, the recessed portion extends along the entire circumference of the shaft in the circumferential direction. may be formed over

A tenth aspect of the present disclosure is the manufacturing method of the guiding catheter according to each of the above-described sixth to eighth aspects, wherein in the forming step, the recessed portion is a part of the shaft in the circumferential direction. may be formed in

According to the present disclosure, the wire can be reliably removed from the wire lumen during manufacturing of the guiding catheter.

FIG. 1 is a schematic diagram of a guiding catheter according to a first embodiment. 2 is a partially enlarged cross-sectional view of the distal side of the guiding catheter of FIG. 1; FIG. 3 is a partially enlarged cross-sectional view of FIG. 2 with the wires and pull wiring removed; FIG. 4 is a partially enlarged cross-sectional view of the proximal side of the guiding catheter of FIG. 1; FIG. FIG. 5 is a diagram for explaining a traction operation for bending the distal portion of the shaft of FIG. 1; 6 is an enlarged partial perspective view of the proximal portion of the shaft of FIG. 4; FIG. 7 is a top view of FIG. 6. FIG. FIG. 8 is a partially enlarged cross-sectional view of the proximal side of a guiding catheter according to a comparative example. 9 is an enlarged partial perspective view of the proximal portion of the shaft of FIG. 8; FIG. 10 is a top view of FIG. 9. FIG. FIG. 11 is a partially enlarged perspective view showing the proximal portion of the shaft of the guiding catheter according to the second embodiment. 12 is a top view of FIG. 11. FIG.

An embodiment of the present disclosure will be described below with reference to the drawings. In addition, in the drawings attached to this specification, for the convenience of easy understanding, the scale, the ratio of vertical and horizontal dimensions, etc. are appropriately changed from those of the real thing and exaggerated.

(First embodiment)
First, a guiding catheter according to a first embodiment will be described with reference to FIGS. 1 to 7. FIG.

FIG. 1 is a schematic diagram of a guiding catheter 1 according to this embodiment. As shown in FIG. 1, the guiding catheter 1 includes a shaft 10, a grasping portion 20, and an operating portion 30. As shown in FIG. The guiding catheter 1 may be used for purposes such as expansion of occluded or constricted tissue, stent delivery, tissue cauterization, and tissue electrical activity monitoring by attaching a balloon or electrodes to the shaft 10 . Also, the guiding catheter 1 may be used as a sheath or a parent catheter, and another catheter may be inserted into the lumen of the shaft 10 for use in almost all catheter applications.

First, the shaft 10 will be explained. The shaft 10 is the part that is inserted into the patient's internal organs when the guiding catheter 1 is used. The shaft 10 is formed in a tubular shape. For example, shaft 10 may be cylindrical. As shown in FIG. 1, the shaft 10 extends in the longitudinal direction X. As shown in FIG. In other words, the longitudinal direction X is specified as the direction in which the shaft 10 extends. The shaft 10 is configured to bend when a wire 40 is pulled by an operation section 30, which will be described later (see FIG. 5). Examples of materials for the shaft 10 include, but are not limited to, resin materials such as polyamide resin, polyvinyl chloride resin, polyimide resin, fluororesin, and polyurethane resin. The length of the shaft 10 (or the length of the guiding catheter 1) in the longitudinal direction X may be, for example, 200 mm or more and 1500 mm or less. The length of the shaft 10 in the radial direction Y, that is, the outer diameter of the shaft 10 may be, for example, 2 mm or more and 20 mm or less. Here, the radial direction Y of the shaft 10 is a direction orthogonal to the longitudinal direction X and indicates the vertical direction in FIG.

FIG. 2 is a partially enlarged cross-sectional view of the distal side Xa of the guiding catheter 1 of FIG. Distal portion 12 of shaft 10 is shown in FIG. In this specification, the “distal” side used for each configuration of the guiding catheter 1 and the shaft 10 means a distance along the longitudinal direction X of the shaft 10 from the operator (operator) of the guiding catheter 1. side, or in other words the tip side. In addition, the "proximal" side used for each configuration of the guiding catheter 1 and the shaft 10 means the side of the guiding catheter 1 that is close to the operator (operator) along the longitudinal direction X of the shaft 10, in other words, means proximal.

As shown in FIG. 2, shaft 10 has main lumen 14 and wire lumen 16 . The main lumen 14 is a portion through which body fluids, medical fluids, and the like flow. The main lumen 14 forms the interior space of the shaft 10 and extends along the longitudinal direction X from the distal end 12a of the shaft 10 to the proximal end 13a (see FIG. 4). The main lumen 14 may be cylindrically formed around the central axis O<b>1 of the shaft 10 . The diameter (inner diameter) of the main lumen 14 may be, for example, 1 mm or more and 10 mm or less.

The wire lumen 16 is a portion through which the wire 40 is inserted. A wire lumen 16 forms the interior space of the shaft 10 and extends along the longitudinal direction X from the distal portion 12 of the shaft 10 to the proximal portion 13 (see FIG. 4). The wire lumen 16 may be cylindrically formed around a central axis O2 parallel to the central axis O1 of the shaft 10 . The center axis O2 may be located on one side (upper side in FIG. 2) in the radial direction Y of the center axis O1 of the shaft 10 . The diameter (inner diameter) of the wire lumen 16 may be large enough to allow the wire 40 to pass therethrough, and may be smaller than the diameter of the main lumen 14 . The diameter of the wire lumen 16 may be, for example, 0.1 mm or more and 1 mm or less. A wire 40 inserted through the wire lumen 16 has one end 40a connected to the distal portion 12 of the shaft 10 via a pull wire ring 42, and the other end 40b connected to the operation portion 30 via a wire connection portion 32, which will be described later. (see FIG. 4).

FIG. 3 is a partially enlarged cross-sectional view of FIG. 2 with the wire 40 and pull wire ring 42 removed. As shown in FIG. 3, the shaft 10 has a notch 18. As shown in FIG. The notch portion 18 is a portion cut inward from the outer peripheral surface 10S of the shaft 10 in a region including the distal end 12a of the shaft 10 . The notch 18 may be formed along the entire circumference of the shaft 10 . The notch 18 is formed to reach the wire lumen 16 . On the other hand, the notch 18 is formed so as not to reach the main lumen 14 . The notch 18 forms a distal opening 16 a of the wire lumen 16 on the proximal side Xb in the longitudinal direction X of the distal end 12 a of the shaft 10 . The cutout portion 18 may be formed by removing the outer peripheral surface 10</b>S of the shaft 10 . For example, the notch 18 may be formed by cutting or laser processing the outer peripheral surface 10S of the shaft 10 .

A pull wire ring 42 is provided near the distal end 12a of the shaft 10, as shown in FIG. A pull wire ring 42 is provided to engage the notch 18 . The pull wire ring 42 may be cylindrically shaped to engage the notch 18 . For example, pull wire ring 42 may be formed in a cylindrical shape having the same outer diameter as shaft 10 . The pull wire ring 42 may be provided to block the distal opening 16a of the wire lumen 16, and may be connected to one end 40a of the wire 40 near the distal opening 16a. A wire 40 may be provided to extend out of the pull wire ring 42 and into the wire lumen 16 .

FIG. 4 is a partially enlarged cross-sectional view of the proximal side Xb of the guiding catheter 1 of FIG. The proximal portion 13 of the shaft 10 is shown in FIG. The proximal portion 13 of the shaft 10 is formed with a recess portion 50, which will be described later. A proximal side opening 16b of the wire lumen 16 is formed in a first side surface 51 of the recess 50, which will be described later. The wire 40 extends from the proximal side opening 16b toward the operating section 30, and the other end 40b of the wire 40 extending from the proximal side opening 16b is operated through the wire connecting section 32. It is connected to the section 30 .

Next, the grip portion 20 will be described. The grasping portion 20 is a portion grasped by an operator (surgeon) when using the guiding catheter 1 . As shown in FIGS. 1 and 4 , gripper 20 is provided on proximal portion 13 of shaft 10 . The grasping part 20 may have any shape that can be easily grasped by the operator (surgeon). As shown in FIG. 4, the grip part 20 may have an internal space through which the shaft 10 and the wire 40 can pass.

Next, the operating section 30 will be described. The operating portion 30 is a portion that is operated by an operator (surgeon) with a finger or the like when using the guiding catheter 1 . As shown in FIGS. 1 and 4 , the operating section 30 is provided on the grip section 20 . The operation unit 30 is configured to be movable in the longitudinal direction X by an operator's operation. As shown in FIG. 4 , the operation section 30 has a wire connection section 32 . The wire connecting portion 32 is a portion connected to the wire 40 . The wire connecting portion 32 is connected to the other end 40 b of the wire 40 . That is, the operation section 30 is connected to the other end 40 b of the wire 40 via the wire connection section 32 . The operating portion 30 is configured to bend the distal portion 12 of the shaft 10 by being operated by an operator.

FIG. 5 is a diagram for explaining a pulling operation for bending the distal portion 12 of the shaft 10 of FIG. When the operating portion 30 is moved from the distal side Xa to the proximal side Xb in the longitudinal direction X by the operator's operation, tension is applied to the wire 40 and the pull wire ring 42 is moved proximally in the longitudinal direction X via the wire 40 . Pulled to side Xb. As shown in FIGS. 2 and 4, the wire 40 is located on one side (upper side in the drawing) of the central axis O1 of the shaft 10 in the radial direction Y. As shown in FIG. Therefore, the distal portion 12 of the shaft 10 receives a force directed toward the proximal side Xb in the longitudinal direction X on one side in the radial direction Y. As shown in FIG. As a result, the distal portion 12 of the shaft 10 curves toward one side in the radial direction Y, as indicated by the dashed line in FIG. The mechanism for bending the distal portion 12 of the shaft 10 described here is merely an example, and the operating portion 30 may have any other mechanism as long as the distal portion 12 of the shaft 10 can be bent. may

Wire 40 may be constructed of a highly rigid material so that it does not easily break during a pulling operation. Examples of materials for such wires 40 include, but are not limited to, metal materials such as iron, copper, and SUS, and aramid fibers. The cross-sectional shape of the wire 40 may be circular. In this case, the diameter (outer diameter) of the wire 40 may be, for example, 0.05 mm or more and 1 mm or less. Also, the cross-sectional shape of the wire 40 is not limited to a circular shape, and may be, for example, a flat wire or a stranded wire.

Moreover, as described above, the shaft 10 has the recessed portion 50 . The recessed portion 50 will be described below.

6 is a partially enlarged perspective view showing the proximal portion 13 of the shaft 10 of FIG. 4. FIG. 7 is a top view of FIG. 6. FIG. In FIGS. 6 and 7, illustration of elements other than the shaft 10, that is, the grasping portion 20, the operating portion 30, and the wire 40 is omitted. As shown in FIGS. 6 and 7, the recessed portion 50 is formed on the outer peripheral surface 10S of the shaft 10. As shown in FIGS. In the present embodiment, recessed portion 50 is formed over the entire circumference of shaft 10 in the circumferential direction. The recessed portion 50 is formed to reach the wire lumen 16 . On the other hand, the recessed portion 50 is formed so as not to reach the main lumen 14 . The recessed portion 50 may be formed by removing the outer peripheral surface 10</b>S of the shaft 10 . For example, the recessed portion 50 may be formed by cutting or laser processing the outer peripheral surface 10S of the shaft 10 .

As shown in FIGS. 6 and 7, the recessed portion 50 has a first side surface 51, a second side surface 52, and a bottom surface 53. As shown in FIGS. The first side surface 51 is a side surface of the recessed portion 50 provided on the distal side Xa in the longitudinal direction X. As shown in FIG. The second side surface 52 is a side surface of the recessed portion 50 provided on the proximal side Xb in the longitudinal direction X. As shown in FIG. The bottom surface 53 is the bottom surface of the recessed portion 50 provided between the first side surface 51 and the second side surface 52 and is the bottom surface of the recessed portion 50 at a position where the wire lumen 16 is not provided. The bottom surface 53 may extend linearly along the axial direction X and connect the first side surface 51 and the second side surface 52 .

As shown in FIGS. 6 and 7, the first side surface 51 is formed with a proximal opening 16b of the wire lumen 16. As shown in FIGS. That is, a part of the wire lumen 16 is exposed by forming the recessed portion 50 on the outer peripheral surface 10S of the shaft 10 . As shown in FIG. 4, the wire 40 extends from the proximal opening 16b toward the operating portion 30. As shown in FIG. Similarly, the opening 16c of the wire lumen 16 may be formed on the second side surface 52 as well.

Further, in the present embodiment, the first side surface 51 is inclined toward the proximal side Xb in the longitudinal direction X inward from the outer peripheral surface 10S. As shown in FIG. 4, the first side surface 51 may extend linearly inward from the outer peripheral surface 10S, or may extend curvedly. Due to this inclination of the first side surface 51, the proximal opening 16b of the wire lumen 16 formed in the first side surface 51 has a substantially elliptical shape when viewed from the radial direction Y, as shown in FIG. ing.

In addition, the second side surface 52 is inclined toward the distal side Xa in the longitudinal direction X inward from the outer peripheral surface 10S. The second side surface 52 may also extend linearly inward from the outer peripheral surface 10S as shown in FIG. 4, or may extend curvedly. Due to this inclination of the second side surface 52, the opening 16c of the wire lumen 16 formed in the second side surface 52 also has a substantially elliptical shape when viewed from the radial direction Y, as shown in FIG. In addition, the second side surface 52 does not have to be inclined inward from the outer peripheral surface 10S. That is, the second side surface 52 may be formed in a planar shape perpendicular to the axial direction X. As shown in FIG.

The first side surface 51 is inclined toward the proximal side Xb in the longitudinal direction X inward from the outer peripheral surface 10S, and the second side surface 52 is the distal side in the longitudinal direction X inward from the outer peripheral surface 10S. When inclined to Xa, it can be said that the recessed portion 50 is tapered inward from the outer peripheral surface 10S.

A height H1 of the first side surface 51 shown in FIG. may be greater than the sum of Here, the height H1 of the first side surface 51 corresponds to the length between the outer peripheral surface 10S and the bottom surface 53 in the radial direction Y. As shown in FIG. Also, the height H1 of the first side surface 51 may be smaller than the sum of the length from the outer peripheral surface 10S to the wire lumen 16 in the radial direction Y and half the length of the wire lumen 16 in the radial direction Y. good. The height H1 of the first side surface 51 may be, for example, 0.1 mm or more and 2 mm or less. The height H2 of the second side surface 52 shown in FIG. 6, that is, the length H2 of the second side surface 52 in the radial direction Y of the shaft 10 may be the same as or different from the height H1 of the first side surface 51. may The height H2 of the second side surface 52 may be, for example, 0.1 mm or more and 2 mm or less. The height H1 of the first side surface 51 and the height H2 of the second side surface 52 can also be referred to as the depth of the recessed portion 50 or the depth of removal processing.

A length L1 of the first side surface 51 in the longitudinal direction X shown in FIG. 7 may be, for example, 1 mm or more and 10 mm or less. The length L2 of the second side surface 52 in the longitudinal direction X shown in FIG. 7 may be the same as the length L1 of the first side surface 51 in the longitudinal direction X, or may be different. A length L2 of the second side surface 52 in the longitudinal direction X may be, for example, 1 mm or more and 10 mm or less. A length L3 of the bottom surface 53 in the longitudinal direction X shown in FIG. 7 may be, for example, 1 mm or more and 20 mm or less.

Next, a method for manufacturing the guiding catheter according to this embodiment will be described.

A manufacturing method of a guiding catheter includes a preparation step, a formation step, an insertion step, a removal step, and a connection step.

First, a preparatory step is performed. In the preparation step, the shaft 10 having the main lumen 14 and the wire lumen 16 described above is prepared. At this stage, the outer peripheral surface 10S of the shaft 10 has not yet been formed with the notch 18 and the recess 50 described above. Also, the wire 40 is not inserted through the wire lumen 16 of the shaft 10 . In this preparation process, the grip part 20, the operation part 30 and the wire 40 may also be prepared.

A formation step is performed after the preparation step. The forming process includes a notch forming process of forming the notch 18 in the outer peripheral surface 10S of the shaft 10 and a recess forming process of forming the recess 50 in the outer peripheral surface 10S of the shaft 10 .

First, in the notch forming step, the notch 18 is formed by removing the outer peripheral surface 10S of the shaft 10 in a region including the distal end 12a of the shaft 10 . For example, the notch 18 is formed by cutting or laser processing the outer peripheral surface 10</b>S of the shaft 10 . The notch 18 is formed along the entire circumference of the shaft 10 in the circumferential direction. The notch 18 is formed to reach the wire lumen 16 . On the other hand, the notch 18 is formed so as not to reach the main lumen 14 . Thereby, the distal opening 16 a of the wire lumen 16 is formed on the proximal side Xb in the longitudinal direction X from the distal end 12 a of the shaft 10 .

Next, in the depression portion forming step, the depression portion 50 is formed by removing the outer peripheral surface 10</b>S of the shaft 10 in the proximal portion 13 of the shaft 10 . For example, the recess 50 is formed by cutting or laser processing the outer peripheral surface 10</b>S of the shaft 10 . The recessed portion 50 is formed along the entire circumference of the shaft 10 in the circumferential direction. The recessed portion 50 is formed to reach the wire lumen 16 . On the other hand, the recessed portion 50 is formed so as not to reach the main lumen 14 .

Further, in the recess forming step, the recess 50 is formed so as to taper inward from the outer peripheral surface 10S. That is, the first side surface 51 provided on the distal side Xa in the longitudinal direction X of the recessed portion 50 is formed so as to incline toward the proximal side Xb in the longitudinal direction X inward from the outer peripheral surface 10S. A distal opening 16 a of the wire lumen 16 is formed in the first side surface 51 . Further, a second side surface 52 provided on the proximal side Xb in the longitudinal direction X of the recessed portion 50 is formed so as to incline toward the distal side Xa in the longitudinal direction X inward from the outer peripheral surface 10S. An opening 16c of the wire lumen 16 is formed in this second side surface 52 .

An inserting step is performed after the forming step. In the inserting step, the wire 40 is inserted into the wire lumen 16 from the distal opening 16a of the wire lumen 16 . Here, a pull wiring 42 may be connected to one end 40 a of the wire 40 . Then, the wire 40 may be inserted into the wire lumen 16 from the distal opening 16a of the wire lumen 16 with the other end 40b of the wire 40 leading. Thereby, the wire 40 can be passed through the wire lumen 16 .

An extraction process is performed after the insertion process. In the extraction step, the wire 40 is extracted from the proximal opening 16b of the wire lumen 16. As shown in FIG. That is, the other end 40b of the wire 40 inserted through the wire lumen 16 is taken out from the proximal side opening 16b of the wire lumen 16. As shown in FIG.

A connecting step is performed after the removing step. The connecting step includes a first connecting step of connecting one end 40 a of the wire 40 to the distal portion 12 of the shaft 10 and a second connecting step of connecting the other end 40 b of the wire 40 to the operating portion 30 .

First, in the first connecting step, the pull wire ring 42 connected to one end 40a of the wire 40 is engaged with the notch 18 formed near the distal end 12a of the shaft 10. As shown in FIG. One end 40 a of wire 40 is thereby connected to distal portion 12 of shaft 10 via pull wire ring 42 .

Next, in the second connecting step, the other end 40b of the wire 40 is connected to the wire connecting portion 32 of the operating portion 30 provided on the grip portion 20 attached to the proximal portion 13 of the shaft 10 . Thereby, the other end 40 b of the wire 40 is connected to the operation section 30 via the wire connection section 32 .

Thus, the guiding catheter 1 according to this embodiment can be obtained.

Next, the effects of this embodiment will be described in comparison with a general guiding catheter.

FIG. 8 is a partially enlarged cross-sectional view of the proximal side of a typical guiding catheter 100. FIG. As shown in FIG. 8, a typical guiding catheter 100 includes a shaft 110 having a main lumen 114 and a wire lumen 116, a gripping portion 120 provided at a proximal portion 113 of the shaft 110, and a and an operation unit 130 that is mounted. A hollow portion 150 is formed in the outer peripheral surface 110S of the shaft 110 so as to reach the wire lumen 116 . A proximal side opening 116b of the wire lumen 116 is formed in the first side surface 151 (see FIG. 9) of the recess 150. As shown in FIG. A wire 140 is inserted through the wire lumen 116 and extends from the proximal side opening 116b toward the operation portion 130 . A wire 140 extending from the proximal opening 116 b is connected to the operation section 130 via a wire connection section 132 .

FIG. 9 is a partially enlarged perspective view showing proximal portion 113 of shaft 110 of FIG. 10 is a top view of FIG. 9. FIG. As shown in FIGS. 9 and 10, the recess 150 has a first side surface 151 provided on the distal side Xa in the longitudinal direction X and a second side surface 152 provided on the proximal side Xb in the longitudinal direction X. , and a bottom surface 153 provided between the first side surface 151 and the second side surface 152 . As shown in FIG. 9, the proximal side opening 116b of the wire lumen 116 is formed in the first side surface 151. As shown in FIG. Similarly, the opening 116c of the wire lumen 116 is formed on the second side surface 152 as well.

Here, in the general guiding catheter 100, as shown in FIGS. 8 to 10, the first side surface 151 is not inclined toward the proximal side Xb in the longitudinal direction X inward from the outer peripheral surface 110S. , are formed in a plane perpendicular to the axial direction X. As shown in FIG. Similarly, the second side surface 152 is not inclined toward the distal side Xa in the longitudinal direction X inward from the outer peripheral surface 10S, and is formed in a planar shape perpendicular to the axial direction X.

As described above, the recessed portion 150 is formed by removing the outer peripheral surface 110S of the shaft 110 in the forming process when the guiding catheter 100 is manufactured. However, due to the effects of heat generated during removal processing (for example, heat generated by friction with a cutting tool during cutting and heat generated during laser processing) and burrs on the shaft 110 generated by the removal processing, the proximal side of the wire lumen 116 The opening 116b may be blocked. In this case, there is a possibility that the wire 140 cannot be removed from the proximal side opening 116b of the wire lumen 116 in the removal process during manufacturing of the guiding catheter 100 . The clogging can be eliminated by performing additional removal processing, but if the amount of removal processing increases, the recessed portion 150 reaches the main lumen 114, and the main lumen 114 and the wire lumen 116 communicate with each other. It is possible. In this case, the manufacturing yield of the guiding catheter 100 is lowered, and the manufacturing cost of the guiding catheter 100 is increased.

In contrast, according to the present embodiment, the first side surface 51 of the recessed portion 50 is inclined toward the proximal side Xb in the longitudinal direction X from the outer peripheral surface 10S of the shaft 10 inward. As a result, the proximal opening 16b of the wire lumen 16 formed in the first side surface 51 can have a substantially elliptical shape when viewed from the radial direction Y, as shown in FIG. Therefore, it is possible to increase the opening area of the proximal opening 16b of the wire lumen 16 more than the opening area of the proximal opening 116b of the wire lumen 116 in the general guiding catheter 100 (see FIG. 9). can. As a result, even if the proximal opening 16b of the wire lumen 16 is partially narrowed due to the heat generated during the removal process and the burrs of the shaft 110 caused by the removal process, the opening area is blocked. Portion proportions can be smaller. In addition, since the thickness of the shaft 10 near the proximal opening 116b of the wire lumen 116 is thin, the burrs of the shaft 110 are also thin, and the wire 40 can open the blocked portion. For this reason, the wire 40 can be reliably removed from the wire lumen 16 in the removing process when manufacturing the guiding catheter 1 .

In addition, it is possible to eliminate the need for additional removal processing to eliminate blockage of the proximal opening 116b of the wire lumen 116, thereby suppressing an increase in the amount of removal processing. As a result, it is possible to prevent the recessed portion 50 from reaching the main lumen 14 and the main lumen 14 and the wire lumen 16 from communicating with each other. For this reason, it is possible to suppress a decrease in manufacturing yield of the guiding catheter 1 and an increase in the manufacturing cost of the guiding catheter 1 .

Further, according to the present embodiment, the second side surface 52 of the recessed portion 50 is inclined toward the distal side Xa in the longitudinal direction X inward from the outer peripheral surface 10S of the shaft 10 . This prevents the wire 40 extending from the proximal opening 116b of the wire lumen 116 from contacting the second side surface 52 of the recess 50 during the pulling operation. Alternatively, the frictional force generated between the wire 40 and the second side surface 52 upon contact can be reduced. Therefore, it is possible to suppress the load from being applied to the shaft 10 and the wire 40 during the traction operation. As a result, deterioration of the guiding catheter 1 due to use can be suppressed, and the life of the guiding catheter 1 can be extended.

Further, according to the present embodiment, the depth of the recessed portion 50 is greater than the sum of the length from the outer peripheral surface 10S to the wire lumen 16 in the radial direction Y and the diameter of the wire 40, and It is smaller than the sum of the length from the outer peripheral surface 10S to the wire lumen 16 and half the length of the wire lumen 16 in the radial direction Y. According to the recessed portion 50 described above, the wire 40 can be taken out from the proximal side opening 16b of the wire lumen 16 with such a minimum required depth of removal. As a result, it is possible to suppress an increase in the amount of removal processing, and it is possible to suppress that the recessed portion 50 reaches the main lumen 14 and that the main lumen 14 and the wire lumen 16 are communicated with each other. For this reason, it is possible to suppress a decrease in manufacturing yield of the guiding catheter 1 and an increase in the manufacturing cost of the guiding catheter 1 .

Further, according to the present embodiment, the recessed portion 50 is formed over the entire circumference of the shaft 10 in the circumferential direction. Such a recessed portion 50 is cut along the longitudinal direction X with respect to the outer peripheral surface 10S of the shaft 10 while rotating the shaft 10 around the central axis O1 in the forming process of manufacturing the guiding catheter 1. Alternatively, it can be easily formed by performing laser processing. Therefore, the manufacturing of the guiding catheter 1 can be facilitated, and an increase in the manufacturing cost of the guiding catheter 1 can be suppressed.

(Second embodiment)
Next, referring to FIGS. 11 and 12, a guiding catheter and a manufacturing method of the guiding catheter according to the second embodiment will be described.

The second embodiment shown in FIGS. 11 and 12 is mainly different in that the recessed portion is formed in a portion of the shaft in the circumferential direction. It is substantially the same as the first embodiment. 11 and 12, the same parts as in the first embodiment shown in FIGS. 1 to 7 are denoted by the same reference numerals, and detailed description thereof will be omitted.

FIG. 11 is a partially enlarged perspective view showing the proximal portion 13 of the shaft 10 of the guiding catheter 1 according to this embodiment. 12 is a top view of FIG. 11. FIG. In FIGS. 11 and 12, illustration of elements other than the shaft 10, that is, the grasping portion 20, the operating portion 30, and the wire 40 is omitted. As shown in FIGS. 11 and 12, in this embodiment, the recessed portion 50 is formed in a portion of the shaft 10 in the circumferential direction. The width W of the recessed portion 50 shown in FIG. 12, that is, the length W of the recessed portion 50 in the width direction orthogonal to the longitudinal direction X when viewed from the radial direction Y may be, for example, 1 mm or more and 10 mm or less.

According to the present embodiment, recessed portion 50 is formed in a portion of shaft 10 in the circumferential direction. This makes it possible to reduce the amount of removal processing when forming the recessed portion 50 . As a result, it is possible to prevent the recessed portion 50 from reaching the main lumen 14 and allowing the main lumen 14 and the wire lumen 16 to communicate with each other in the formation process of manufacturing the guiding catheter 1 . For this reason, it is possible to suppress a decrease in manufacturing yield of the guiding catheter 1 and an increase in the manufacturing cost of the guiding catheter 1 . Further, reduction in the outer diameter of the shaft 10 can be suppressed in the region where the recessed portion 50 is formed. Therefore, it is possible to suppress a decrease in the strength of the guiding catheter 1 .

According to the embodiment described above, the wire can be reliably taken out from the wire lumen when manufacturing the guiding catheter.

In the above, the embodiments have been described with reference to specific examples, but the specific examples described above are not intended to limit the embodiments. The above-described embodiments can be implemented in various other specific examples, and various omissions, replacements, changes, additions, etc. can be made without departing from the scope of the invention.

Next, an embodiment of the present disclosure will be described in more detail with reference to examples, but the embodiments of the present disclosure are not limited to the description of the following examples as long as they do not exceed the gist thereof.

First, as an example, a guiding catheter 1 having a shaft 10 as shown in FIGS. 11 and 12 was produced.

In such a guiding catheter 1, the length of the guiding catheter 1 in the longitudinal direction X was 818 mm. The outer diameter of the shaft 10 was 5.2 mm, the inner diameter of the main lumen 14 was 4.3 mm, and the inner diameter of the wire lumen 116 was 0.29 mm. The material of the shaft 10 was polyamide resin. The recessed portion 50 was formed by cutting the outer peripheral surface 10S of the shaft 10 using an end mill, which is a cutting tool. The height H1 of the first side surface 51 shown in FIG. 11 and the height H2 of the second side surface 52 shown in FIG. 11, that is, the depth of removal processing was 0.2 mm. The length L1 of the first side surface 51 in the longitudinal direction X shown in FIG. 12 was 4 mm. The length L2 of the second side surface 52 in the longitudinal direction X shown in FIG. 12 was 7 mm. The length L3 of the bottom surface 53 in the longitudinal direction X shown in FIG. 12 was 2 mm. The width W of the recessed portion 50 shown in FIG. 12 was 2 mm. The wire 40 had an outer diameter of 0.26 mm. The material of the wire 40 was SUS.

In the removal process during manufacturing of the guiding catheter 1, the other end 40b of the wire 40 inserted through the wire lumen 16 could be removed from the proximal opening 16b of the wire lumen 16 without any problems. In the manufacture of 120 guiding catheters 1, the wire 40 could be taken out from the proximal side opening 16b of the shaft 10 of all the guiding catheters 1. The take-out rate of the wire 40 was 100%.

Next, as a comparative example, a general guiding catheter 100 as shown in FIGS. 8-10 was produced.

In such a guiding catheter 100, the same shaft 110 and wire 140 as in the guiding catheter 1 according to the embodiment were used. The recessed portion 150 is formed by cutting the outer peripheral surface 110S of the shaft 110 using an end mill as a cutting tool. The height H1' of the first side surface 151 shown in FIG. 9 and the height H2' of the second side surface 152 shown in FIG. 9, that is, the depth of removal processing was 0.2 mm. The length L' of the bottom surface 153 in the longitudinal direction X shown in FIG. 10 was 13 mm.

In the removing step during the manufacture of the guiding catheter 100, the proximal opening 116b of the wire lumen 116 is closed, and the other end 140b of the wire 140 inserted through the wire lumen 116 is pulled through the proximal opening 116b. Sometimes it was not possible to remove it from the In manufacturing 120 guiding catheters 100, the wire 140 could not be removed from the proximal opening 116b of the shaft 110 of 10 guiding catheters 100. FIG. The take-out rate of the wire 140 was 91.6%.

DESCRIPTION OF SYMBOLS 1... Guiding catheter, 10... Shaft, 10S: Outer peripheral surface, 13... Proximal part, 14... Main lumen, 16... Wire lumen, 16b... Proximal side opening , 20... Grasping part 30... Operation part 40... Wire 50... Recessed part 51... First side surface 52... Second side surface X... Longitudinal direction

Claims (10)

a longitudinally extending shaft having a main lumen and a wire lumen;
a gripper on the proximal portion of the shaft;
an operation unit provided in the grip;
a wire inserted through the wire lumen, having one end connected to the distal portion of the shaft and the other end connected to the operation portion;
with
The shaft has a recess formed on the outer peripheral surface of the shaft and formed to reach the wire lumen,
The recess has a first side surface provided on the distal side in the longitudinal direction and formed with a proximal side opening of the wire lumen,
the wire extends from the proximal opening of the wire lumen toward the operation section;
Said 1st side surface is a guiding catheter which inclines to the proximal side in the said longitudinal direction inwardly from the said outer peripheral surface. The recess has a second side surface provided on the proximal side in the longitudinal direction,
The guiding catheter according to claim 1, wherein the second side surface is slanted distally in the longitudinal direction inwardly from the outer peripheral surface. The depth of the recessed portion is greater than the sum of the length from the outer peripheral surface to the wire lumen in the radial direction of the shaft and the diameter of the wire, and the depth from the outer peripheral surface to the wire lumen in the radial direction. 3. A guiding catheter according to claim 1 or 2, which is less than the sum of the length of and half the length of the wire lumen in the radial direction. The guiding catheter according to any one of claims 1 to 3, wherein the recessed portion is formed along the entire circumference of the shaft in the circumferential direction. The guiding catheter according to any one of claims 1 to 3, wherein the recessed portion is formed in a portion of the shaft in the circumferential direction. preparing a longitudinally extending shaft having a main lumen and a wire lumen;
a forming step of forming a depression that reaches the wire lumen in the outer peripheral surface of the shaft by removing the outer peripheral surface of the shaft after the preparation step;
an inserting step of inserting a wire into the wire lumen from a distal opening of the wire lumen after the forming step;
a removing step of removing the wire from a proximal opening of the wire lumen after the inserting step;
with
In the forming step, a first side surface provided on a distal side in the longitudinal direction of the recessed portion is formed so as to incline toward the proximal side in the longitudinal direction inward from the outer peripheral surface, and the first side surface a method for manufacturing a guiding catheter, wherein the proximal opening of the wire lumen is formed at . 7. In the forming step, the second side surface provided on the proximal side in the longitudinal direction of the recessed portion is formed so as to incline toward the distal side in the longitudinal direction inwardly from the outer peripheral surface. A method of manufacturing the described guiding catheter. In the forming step, the depth of the recessed portion is greater than the sum of the length from the outer peripheral surface of the shaft in the radial direction to the wire lumen and the diameter of the wire, and 8. The method of manufacturing a guiding catheter according to claim 6, wherein the recess is formed to be smaller than the sum of the length to the lumen and the half length of the wire lumen in the radial direction. The manufacturing method of the guiding catheter according to any one of claims 6 to 8, wherein in the forming step, the recessed portion is formed along the entire circumference of the shaft in the circumferential direction. The manufacturing method of the guiding catheter according to any one of claims 6 to 8, wherein in the forming step, the recessed portion is formed in a part of the shaft in the circumferential direction.

Images