JP5913856B2 - Catheter and method for manufacturing catheter - Google Patents

Description

  The present invention relates to a catheter and a manufacturing method thereof.

  A medical catheter is a hollow medical instrument that is inserted into a body cavity, blood vessel, etc. to suck a thrombus and secure a passage of a blood vessel in a closed state. It has a lumen (passage) that extends. Some catheters have a plurality of such lumens. Such a catheter is generally formed by joining a plurality of tubes having one lumen by welding or adhesion.

  For example, in a suction catheter used for sucking and removing foreign substances in the body, a suction tube having a suction lumen and a guide wire tube having a guide wire lumen through which a guide wire can be inserted are joined by welding. (For example, refer to Patent Document 1). In this type of catheter, for example, a guide wire tube is welded to the outer peripheral surface of the suction tube.

  By the way, in the suction catheter, for the purpose of reinforcing the suction tube, a braided layer may be provided by embedding a braided body in a peripheral wall portion surrounding the suction lumen in the suction tube. In this case, the braided layer may be provided in the proximal portion of the suction tube to increase the rigidity, and the distal portion of the tube may be secured without providing the braided layer. In such a configuration, the guide wire tube may be provided across the braided region where the braided layer is present and the non-braided region where the braided layer is not present with respect to the suction tube.

JP 2008-86476 A

  By the way, in the above-described configuration, when the guide wire tube is welded to the braided region and when it is welded to the non-braided region, conditions (welding conditions) suitable for performing the respective welds are different. Conceivable. Specifically, in the braided region of the suction tube, a braided body is embedded in the peripheral wall, and the amount of resin required for welding is less than that of the non-braided region because of the braided body. When the wire tube is welded across the braided region and the non-braided region in the suction tube, the welding conditions for the braided region and the welding conditions for the non-braided region are different. Therefore, when welding the guide wire tube to the suction tube, if the welding condition is set to a condition suitable for either the braided region or the non-braided region, there is a risk of causing poor welding to the other. In such a case, there is a concern that inconvenience such as a decrease in welding strength may occur.

  Such a problem can occur not only when the guide wire tube is bonded to the suction tube by welding but also when bonded by other bonding methods such as adhesion. For example, when the guide wire tube is bonded to the suction tube using a solvent, the same problem may occur because there is a difference in the amount of resin that can be dissolved by the solvent in the braided region and the non-braided region.

  The present invention has been made in view of the above circumstances, and in a catheter in which two tubes are joined, the main object is to provide a catheter capable of suitably joining the tubes and a method for manufacturing the catheter. To do.

  In order to solve the above problems, a catheter of a first invention includes a first tube having a first lumen, and a second tube having a second lumen extending in the same direction as the first lumen, the first tube The tube is formed by joining a first proximal tube portion and a first distal tube portion provided on a more distal side than the first proximal tube portion, the lumen of the first proximal tube portion and the first distal tube portion. The first lumen is formed by communicating with the lumen of the tube portion, and the second tube is provided to extend over the first proximal tube portion and the first distal tube portion. The second tube is formed by joining a second proximal tube portion and a second distal tube portion provided more distally than the second proximal tube portion to each other. A distal tube portion is joined to the first proximal tube portion, and the second distal tube portion is joined to the first distal tube portion. Characterized in that it is.

  According to the present invention, the second tube is divided into a second proximal tube portion and a second distal tube portion, and each of these tube portions is a first proximal tube portion of the first tube. And the first distal tube portion are individually joined to each other. Therefore, in the joining of the first proximal tube portion and the second proximal tube portion, and the joining of the first distal tube portion and the second distal tube portion, one of the joining conditions for joining to be performed. The other joining conditions are not limited by the conditions, and the joining conditions suitable for each joining can be obtained. Therefore, joining of the 1st proximal tube part and the 2nd proximal tube part, and joining of the 1st distal tube part and the 2nd distal tube part can be performed suitably, respectively. Thereby, a 1st tube and a 2nd tube can be joined suitably.

  The catheter according to a second aspect of the present invention is the catheter according to the first aspect, wherein in the first tube, either one of the first proximal tube portion and the first distal tube portion surrounds a lumen thereof. A reinforcing layer formed by using a reinforcing body is provided on the other side, and on the other side, the reinforcing layer is not provided on the peripheral wall portion surrounding the inner cavity.

  According to the present invention, in the first proximal tube portion and the first distal tube portion on the side where the reinforcing layer is provided (hereinafter referred to as the reinforcing tube portion), the reinforcing body is present on the peripheral wall portion. Therefore, it is conceivable that the amount of resin is smaller than that of the tube portion on which the reinforcing layer is not provided (hereinafter referred to as a non-reinforcing tube portion). Therefore, for example, when the second tube is joined to the first tube by welding, when the second tube is welded to the first proximal tube portion, and when the second tube is welded to the first distal tube portion, It is assumed that the welding conditions suitable for each welding are different. In this regard, in the present invention, first, the reinforcing tube portion (of the first tube) and the second proximal tube portion (or the second distal tube portion) are joined by welding, and the non-reinforcing tube portion and the second distal portion are joined. Since a pipe part (or 2nd proximal pipe part) can be joined by welding, these welding can be implemented on the welding conditions suitable for each welding, respectively. Therefore, in such a configuration, it is possible to suitably join the two tubes.

  According to a third aspect of the present invention, in the first or second aspect, at least one of the first proximal tube portion and the first distal tube portion is disposed in the lumen of the first tube. The second tube is disposed in a state in which the portion protrudes, and the second tube is disposed in a state in which the portion does not protrude into the inner cavity on the other side.

  As a catheter formed by joining the first tube and the second tube, there is one in which the arrangement mode of the second tube with respect to the first tube is switched in the middle of the axial direction of the first tube. For example, at least a part of the second tube protrudes into the lumen of one of the first proximal tube portion and the first distal tube portion (hereinafter referred to as a protruding tube portion) of the first tube. It is possible to adopt a configuration in which it is arranged in a state in which it is arranged, and the other (hereinafter referred to as a non-protruding side tube part) is arranged in a state in which it does not protrude into its lumen. Here, when arranging the second tube as in the former, it is necessary to join the second tube in a state of being arranged in the first lumen of the first tube, whereas in arranging the second tube as in the latter. Needs to be joined in a state where the second tube is disposed outside the first lumen. Therefore, in such a configuration, it is considered difficult to join the second tube across the first proximal tube portion and the first distal tube portion with respect to the first tube. In this regard, according to the present invention, first, in the state where the second proximal tube portion (or the second distal tube portion) is arranged in the lumen of the protruding side tube portion (of the first tube), the respective tube portions are joined. And each of the tubes can be joined in a state where the second distal tube (or the second proximal tube) is disposed outside the lumen of the non-projecting tube. It can manufacture suitably about a catheter.

  A catheter of a fourth invention is the catheter according to the third invention, wherein the second tube of the first tube does not protrude into the lumen of the first proximal tube portion and the first distal tube portion. A second tube placement portion that is disposed in a state in which the second tube extends in the axial direction of the first tube and is in contact with the second tube is set on the outer circumference of the tube portion that is disposed. The tube placement portion is characterized in that the second proximal tube portion and the second distal tube portion are coaxially joined to each other with their end faces abutting each other.

  According to the present invention, the two tube portions (the second proximal tube portion and the second distal tube portion) of the second tube are both disposed in contact with the second tube arrangement portion of the first tube. In the configuration in which the first proximal tube portion and the second proximal tube portion are joined and the first distal tube portion and the second distal tube portion are joined as described above, for example, A part of the second distal tube portion can be arranged so as to overlap the outer peripheral portion of the 1 proximal tube portion. That is, the two tube portions (the first proximal tube portion and the first distal tube) of each of the two tube portions (the second proximal tube portion and the second distal tube portion) of the second tube. Part) can be used as a reference part for installation. In this case, one of the second proximal tube portion and the second distal tube portion of the second tube is joined to one of the first proximal tube portion and the first distal tube portion of the first tube. On the other hand, the other can be configured to be joined to both the first proximal tube portion and the first distal tube portion of the first tube.

  And according to the said structure, the outer peripheral part of the pipe | tube part (non-projection side pipe | tube part) by which the 2nd tube is arrange | positioned in the state which does not protrude in a lumen | bore among the 1st proximal tube part and the 1st distal tube part. Then, since the second proximal tube portion and the second distal tube portion are both arranged in the second tube placement portion, the two tube portions of the second tube ( The work of arranging the second proximal tube portion and the second distal tube portion coaxially can be facilitated.

  A catheter according to a fifth aspect of the present invention is the suction catheter used for sucking and removing foreign substances in any of the first to fourth aspects of the invention, wherein the first tube has the suction lumen as the first lumen. The second tube is a guide wire tube having a guide wire lumen through which the guide wire is inserted as the second lumen.

  In the suction catheter, the configuration of the tube may be different between the proximal side and the distal side of the suction tube. For example, the thickness of the peripheral wall (resin layer) may be different between the proximal side and the distal side, or materials having different melting temperatures may be used. When a guide wire tube is arranged and joined to such a suction tube so as to extend over the proximal side and the distal side, the joining condition of the guide wire tube to the suction tube is the proximal side of the suction tube. It is conceivable that there is a difference between the distal side and the distal side, and in that case, there is a possibility that a bonding failure may occur on either the proximal side or the distal side. In this regard, in the present invention, since the first invention is applied to the suction catheter, the guide wire tube can be suitably joined to the suction tube. In particular, in the case of a guide wire tube, when the guide wire is inserted into the guide wire lumen and used, a load in a direction perpendicular to the axial direction is applied to the tube, and a part of the tube is peeled off from the suction tube. In view of this point, it can be said that the effect of the present invention is great.

  In general, the guide wire tube has a smaller diameter than the suction tube, and the thickness of the peripheral wall portion is smaller than that of the suction tube. Therefore, when joining the guide wire tube to the suction tube, for example, by thermal welding, when performing thermal welding under conditions different from the predetermined welding conditions set in advance, for example, under conditions where the thermal load is greater than the predetermined welding conditions, The guide wire tube may be thermally deteriorated and cracks may be generated in the tube. In this regard, the above configuration in which the guide wire tube can be welded to the first proximal tube portion and the first distal tube portion of the suction tube under appropriate welding conditions also has an advantage of avoiding such inconvenience.

  According to a sixth aspect of the present invention, there is provided a catheter manufacturing method comprising: a first tube having a first lumen; and a second tube having a second lumen, wherein the first tube has a first proximal tube portion and a first tube. A first distal tube portion provided on the distal side is joined to each other, and the second tube includes a second proximal tube portion and a second distal tube portion provided more distally than the second proximal tube portion. And is applied to a catheter provided to extend across the first proximal tube portion and the first distal tube portion, and the first proximal tube portion and the first A proximal tube manufacturing process for manufacturing a proximal tube by bonding two proximal tubes, and a distal side by bonding the first distal tube and the second distal tube A distal tube manufacturing process for manufacturing a tube, and the first proximal tube portion and the first distal tube portion. And a tube joining step for joining the proximal tube and the distal tube by joining the second proximal tube portion and the second distal tube portion. And

  According to the present invention, the proximal tube is first manufactured by joining the first proximal tube portion and the second proximal tube portion, and the first distal tube portion and the second distal tube portion are joined. To produce a distal tube. In this case, since the joining conditions can be different between the joining at the time of manufacturing the proximal tube and the joining at the time of manufacturing the distal side tube, each of the conditions (joining conditions) suitable for each joining can be used. Bonding can be performed. Thereafter, the proximal tube and the distal tube are joined by joining the first proximal tube portion and the first distal tube portion, and joining the second proximal tube portion and the second distal tube portion. Join. Thereby, the 1st tube and the 2nd tube can be joined suitably like the 1st invention.

  In the catheter manufacturing method according to a seventh aspect of the present invention, in the distal tube manufacturing step, the second distal tube portion is disposed in the lumen of the first distal tube portion constituting a part of the first lumen. In this state, by joining the first distal tube portion and the second distal tube portion, at least a part of the second distal tube portion protrudes into the lumen of the first distal tube portion. The distal tube is manufactured, and in the proximal tube manufacturing process, the second proximal tube portion is disposed outside the first proximal tube portion constituting a part of the first lumen. In this state, by joining the first proximal tube portion and the second proximal tube portion, the second proximal tube portion does not protrude into the lumen of the first proximal tube portion. Producing a proximal tube.

According to the present invention, the distal tube can be manufactured by joining each of the tubes in a state where the second distal tube is disposed in the lumen of the first distal tube, and the first proximal tube A proximal tube can be manufactured by joining each of the tube portions with the second proximal tube portion disposed outside the tube. That is, in a catheter in which the arrangement mode of the second tube relative to the first tube is different between the distal side and the proximal side of the first tube, the distal portion (distal tube) and the proximal portion (proximal) of the catheter Side tube) can be manufactured separately, and then the distal tube and the proximal tube can be joined to manufacture the catheter. Therefore, the catheter having such a configuration can be preferably manufactured.
Here, the catheter according to the first aspect of the present invention is basically the catheter according to the first aspect added with the configurations of the third aspect and the fourth aspect. Specifically, the catheter of the invention described in claim 1 includes a first tube having a first lumen and a second tube having a second lumen extending in the same direction as the first lumen, The tube is formed by joining a first proximal tube portion and a first distal tube portion provided on a more distal side than the first proximal tube portion, the lumen of the first proximal tube portion and the first distal tube portion. The first lumen is formed by communicating with the lumen of the tube portion, and the second tube is provided to extend over the first proximal tube portion and the first distal tube portion. The second tube is formed by joining a second proximal tube portion and a second distal tube portion provided more distally than the second proximal tube portion to each other. A distal tube portion is bonded to the first proximal tube portion, and the second distal tube portion is bonded to the first distal tube portion. In the first tube, at least a part of the first proximal tube portion and the first distal tube portion protrudes into the lumen of the second tube. And the second tube portion is disposed in the other tube portion so as not to protrude into the lumen thereof, and the other tube portion extends in the axial direction of the first tube on the outer periphery thereof, and A second tube placement portion is set in which the second tube is placed in contact with the outer peripheral surface thereof. The second tube placement portion includes the second proximal tube portion and the second far end. It is characterized in that it is joined with the position pipe part coaxially and in a state where the end faces of each other are butted.
A catheter manufacturing method according to a fourth aspect of the invention basically includes the seventh invention added to the catheter manufacturing method of the sixth invention. Specifically, the method for manufacturing a catheter according to claim 4 includes a first tube having a first lumen and a second tube having a second lumen, wherein the first tube is a first proximal tube. And a first distal tube portion provided on the distal side of the first tube portion are joined to each other, and the second tube has a second proximal tube portion and a first distal tube portion provided on the distal side of the second proximal tube portion. Two distal tube portions joined to each other and applied to a catheter provided to extend over the first proximal tube portion and the first distal tube portion, and the first proximal tube portion A proximal tube manufacturing step of manufacturing a proximal tube by bonding a tube portion and the second proximal tube portion, and bonding the first distal tube portion and the second distal tube portion; A distal tube manufacturing process for manufacturing a distal tube, the first proximal tube portion and the first tube A tube joining step for joining the proximal tube and the distal tube by joining the distal tube portion and joining the second proximal tube portion and the second distal tube portion; In the distal tube manufacturing step, the first distal tube portion is disposed in the lumen of the first distal tube portion constituting a part of the first lumen, By joining the distal tube portion and the second distal tube portion, the distal side so that at least a portion of the second distal tube portion projects into the lumen of the first distal tube portion. The tube is manufactured, and in the proximal tube manufacturing step, the second tube extends in an axial direction of the first tube on an outer peripheral portion of the first proximal tube portion constituting a part of the first lumen. Sets the second tube placement portion to be placed with its outer peripheral surface in contact with the second tube. With the second proximal tube portion disposed in the placement portion, the second proximal tube portion is joined to the first proximal tube portion by joining the first proximal tube portion and the second proximal tube portion. The proximal tube is manufactured so as not to protrude into the lumen of the position tube portion, and in the tube joining step, the second proximal tube portion and the second distal tube portion are provided in the second tube placement portion. It arrange | positions in the state which mutually faced each other coaxially, and the said 2nd proximal tube part and the said 2nd distal tube part are joined in the arrangement | positioning state, It is characterized by the above-mentioned.

FIG. 2 is a schematic overall side view showing a configuration of a suction catheter. (A) is a longitudinal cross-sectional view which shows the structure of a catheter main body, (b) is a side view which shows the structure. It is a cross-sectional view which shows the structure of a catheter main body, (a) is the AA line cross section of Fig.2 (a), (b) is a BB line cross section, (c) is a CC line cross section, (d ) Shows a cross section taken along the line DD. Explanatory drawing for demonstrating the manufacture procedure of a suction catheter. The cross-sectional view which shows the catheter main body in other embodiment.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the present embodiment, a suction catheter for sucking a thrombus is embodied. FIG. 1 is a schematic overall side view showing the configuration of a suction catheter.

  As shown in FIG. 1, the suction catheter 10 has a length of 1 to 2 m, and includes a catheter body 11 and a hub 12 attached to a proximal end portion (base end portion) of the catheter body 11. It has. The catheter body 11 includes a suction tube 14 and a guide wire tube 15 provided on the distal end side of the suction tube 14 and is formed by joining the tubes 14 and 15 by welding. The suction tube 14 has a suction lumen 17 therein, and the guide wire tube 15 has a guide wire lumen 18 (see FIGS. 2 and 3) into which the guide wire is inserted.

  The hub 12 has a fluid passage 12 a communicating with the suction lumen 17 of the suction tube 14 inside thereof. A syringe S is connected to the hub 12 as a suction tool. By using the syringe S to apply a negative pressure to the suction lumen 17, a thrombus can be sucked through the lumen 17. Incidentally, as the suction tool, an electric vacuum pump or the like is used in addition to the syringe S.

  Next, the configuration of the catheter body 11 will be described in detail with reference to FIGS. 2A is a longitudinal sectional view showing the configuration of the catheter body 11, and FIG. 2B is a side view showing the configuration. 3A and 3B are cross-sectional views showing the configuration of the catheter body 11, wherein FIG. 3A is a cross-sectional view taken along line AA in FIG. 2A, FIG. 3B is a cross-sectional view taken along line BB, and FIG. A line section and (d) show a DD line section. Incidentally, the longitudinal section is a section parallel to the longitudinal direction (axial direction) of the catheter body 11, and the transverse section is a section orthogonal to the longitudinal direction.

  As shown in FIGS. 2 and 3, the catheter body 11 is formed by welding the suction tube 14 and the guide wire tube 15 as described above. The suction tube 14 includes a proximal suction tube 21 and a distal suction tube 22 provided at a more distal side than the proximal suction tube 21, and the tubes 21 and 22 are joined to each other by welding. ing. Here, the suction tube 14 corresponds to the first tube, and the guide wire tube 15 corresponds to the second tube. The proximal suction tube 21 corresponds to the first proximal tube portion, and the distal suction tube 22 corresponds to the first distal tube portion.

  In this specification, “welding” means not only the case where the materials of the respective members to be joined are joined (fused) by melting, but also the respective members to be joined are formed by heat shrinkable tubes. By covering and heating, etc., it means that one member of each member melts and is joined to the other member.

  The proximal suction tube 21 forms a predetermined range from the proximal end portion to the distal side of the suction tube 14. The proximal suction tube 21 has a tubular shape, and has a lumen 21a extending continuously over the entire longitudinal direction. The proximal suction tube 21 has a multilayer structure in which a plurality of types of materials including a synthetic resin are laminated. Specifically, the proximal suction tube 21 constitutes a predetermined range from its distal end portion toward the proximal side, and a guide tube arrangement region 24 in which the guide wire tube 15 is arranged on the outer peripheral side thereof; It has a guide tube non-arrangement region 25 in which the guide wire tube 15 is not disposed on the outer peripheral side of the region 24 that is more proximal than the region 24. In the proximal suction tube 21, in the guide tube non-arranged region 25, the inner layer 27 is a fluorine-based resin such as Teflon (registered trademark), the outer layer 28 is a polyamide elastomer, and the intermediate layer 29 (corresponding to a reinforcing layer) is a metal braid. It has a three-layer structure (see FIG. 3 (d)) composed of the body 31.

  The braided body 31 is a reinforcing body for reinforcing the proximal suction tube 21, and an intermediate layer 29 formed using the braided body 31 is a braided layer. As shown in FIG. 2B, the braided body 31 is formed by braiding stainless steel wire into a mesh shape. The resin of the outer layer 28 enters between the plurality of wires in the braided body 31 and is welded to the inner layer 27 at the portion where the resin enters. 2A and 3, for the sake of convenience, the intermediate layer 29 is shown in a state in which the gaps between the wires of the braided body 31 are filled.

  On the other hand, in the guide tube arrangement region 24, the outer layer 28 is not provided among the above layers 27 to 29 and has a two-layer structure including the inner layer 27 and the intermediate layer 29 (see FIG. 3C). In this case, the outer layer 45 described later is provided on the outer peripheral side of the intermediate layer 29 of the proximal suction tube 21, so that the resin of the outer layer 45 enters between the plurality of wires in the braided body 31, and the inner layer in the portion where the resin enters 27 is welded.

  The distal suction tube 22 is formed in a tubular shape by a polyamide elastomer, and has a single layer structure (see FIG. 3A). That is, unlike the proximal suction tube 21, the distal suction tube 22 does not have the braided body 31 and is therefore formed with lower rigidity than the proximal suction tube 21. The distal suction tube 22 has a lumen 22a extending continuously over the entire length in the inside thereof. The lumen 22a communicates with the lumen 21a of the proximal suction tube 21 on the proximal end side, and the suction lumen 17 is formed by the lumens 21a and 22a. In the present embodiment, the diameters of the lumens 21a and 22a are substantially the same, and therefore the diameter of the suction lumen 17 (lumen diameter) is substantially constant throughout the longitudinal direction of the suction tube 14. However, the diameters of the lumens 21a and 22a may be different, that is, the diameter of the lumen 21a may be larger or smaller than the diameter of the lumen 22a.

  The distal end opening of the lumen 22a serves as a suction port 33 for taking a foreign substance such as a thrombus into the suction lumen 17. The distal end face of the distal suction tube 22 is inclined with respect to the axial direction, and a suction port 33 is formed along the inclination. In this case, compared with the case where the suction port 33 is formed along a direction orthogonal to the axial direction, the opening area of the suction port 33 can be increased, and the foreign matter suction performance can be improved.

  As shown in FIG. 3A, the peripheral wall portion 37 (resin layer made of polyamide elastomer) surrounding the lumen 22a in the distal suction tube 22 has a different thickness in the circumferential direction. Specifically, the peripheral wall portion 37 is a thick portion 37a formed thick at a portion where the guide wire tube 15 is disposed as will be described later, whereas the peripheral wall portion 37 has a thick portion 37a sandwiching the lumen 22a. A thin portion 37b is formed at a portion opposite to the thick portion 37a.

  The proximal end of the distal suction tube 22 is welded to the distal end of the proximal suction tube 21. The proximal end side of the distal suction tube 22 is a diameter-expanded portion 35 whose diameter is expanded with respect to other portions, and a proximal-side suction is provided inside the diameter-expanded portion 35 (inner lumen 22a). The distal end side of the tube 21 is inserted. Hereinafter, the inserted portion is referred to as an insertion portion 39. And in this insertion state, the proximal suction tube 21 and the distal suction tube 22 are joined by welding.

  Here, the enlarged diameter in the enlarged diameter portion 35 is based on the stretchability of the distal suction tube 22, and the enlarged diameter portion 35 is formed by extending the distal suction tube 22 in the radial direction. Yes. In the enlarged diameter portion 35, the thin portion 37b of the peripheral wall portion 37 is displaced radially outward with respect to the axis of the lumen 22a, while the thick portion 37a is radial with respect to the axis of the lumen 22a. There is no displacement. Therefore, in the peripheral wall portion 37 of the distal suction tube 22, a stepped portion 38 is formed on the thin portion 37 b side at the boundary portion between the enlarged diameter portion 35 and the other portion, and on the thick portion 37 a side. The step portion is not formed.

  The guide wire tube 15 is formed in a tubular shape with nylon resin, and has a guide wire lumen 18 extending over the entire length in the inside thereof. The guide wire tube 15 is provided so as to extend over both the proximal suction tube 21 and the distal suction tube 22 in the axial direction of the suction tube 14. Further, the guide wire tube 15 is provided in a state in which a part thereof extends more distally than the suction tube 14 (distal suction tube 22).

  The guide wire tube 15 is disposed on the outer peripheral side with respect to the proximal suction tube 21, and is disposed on the inner side (specifically, on the inner side of the outer peripheral surface) with respect to the distal suction tube 22. ing. Specifically, the guide wire tube 15 is provided so as to penetrate through the thick part 37a of the tube 22 in the axial direction with respect to the distal suction tube 22 (see FIG. 3A). . In the arrangement state of the guide wire tube 15, the guide wire lumen 18 of the tube 15 extends in the same direction as the suction lumen 17 of the suction tube 14. Therefore, the lumens 17 and 18 are orthogonal to the axial direction. It is lined up in the direction. Hereinafter, the arrangement direction of the lumens 17 and 18 is referred to as a first direction X, and a direction orthogonal to the first direction X and the axial direction is referred to as a second direction Y.

  The guide wire tube 15 includes a proximal guide tube 41 and a distal guide tube 42 that are divided in the axial direction. Each of these tubes 41 and 42 has inner cavities 41a and 42a extending continuously in the entire longitudinal direction inside thereof, and the respective inner cavities 41a and 42a communicate with each other. A guide wire lumen 18 is formed by the lumens 41a and 42a. Further, the proximal guide tube 41 and the distal guide tube 42 have the same cross section. The guide tubes 41 and 42 are arranged so that their axis lines are located on the same straight line and in a state where the end faces of each other are abutted with each other. In the arrangement state, the end faces are joined by welding. Yes. Here, the proximal guide tube 41 corresponds to the second proximal tube portion, and the distal guide tube 42 corresponds to the second distal tube portion.

  The proximal guide tube 41 is joined to the proximal suction tube 21 by welding. The proximal guide tube 41 is disposed on the outer peripheral surface (the outer peripheral surface of the intermediate layer 29) in the guide tube arrangement region 24 of the proximal suction tube 21 in a direction extending in the same direction as the suction tube 21. Here, the outer peripheral surface of the guide tube arrangement region 24 corresponds to the second tube arrangement portion.

  The proximal guide tube 41 has an axial length (full length) shorter than the length in the same direction of the guide tube placement region 24, and the proximal end of the proximal guide tube 41 is the proximal end of the guide tube placement region 24. It is arranged in alignment with the part. In this case, a part of the proximal suction tube 21 (guide tube arrangement region 24) extends distally with respect to the proximal guide tube 41, and the extended part is the distal suction tube 22. The insertion portion 39 is inserted into the enlarged diameter portion 35.

  As shown in FIG. 3C, the proximal suction tube 21 and the proximal guide tube 41 are covered with an outer layer 45 in the guide tube arrangement region 24. The outer layer 45 is made of polyamide resin, and is welded to the proximal guide tube 41 and the proximal suction tube 21. Thereby, the proximal suction tube 21 and the proximal guide tube 41 are welded to each other through the outer layer 45.

  The outer layer 45 is formed along the outer peripheral surface of the proximal suction tube 21 and forms a layer surrounding the tube 21 from the outside. The outer layer 45 has a different thickness in the circumferential direction. Specifically, the outer layer 45 has a thick portion 45a formed thick at a portion on the side where the proximal guide tube 41 is disposed. The thin portion 45b is formed thin at a portion opposite to the thick portion 45a with the proximal suction tube 21 interposed therebetween. The proximal guide tube 41 is embedded in the thick portion 45 a in the outer layer 45.

  On the proximal end side of the outer layer 45, the portion on the side where the proximal guide tube 41 is disposed in the circumferential direction extends to the outer layer 28 in the guide tube non-arranged region 25 and is welded to the outer layer 28. And the opening part 56 penetrated to an axial direction is formed in the said site | part. The opening 56 is formed at a position corresponding to the proximal end opening of the proximal guide tube 41 (and thus the guide wire tube 15), and the guide wire is pulled out from the guide wire lumen 18 of the guide wire tube 15 through the opening 56. It is possible.

  The insertion portion 39 in the guide tube arrangement region 24 of the proximal suction tube 21 is not covered with the outer layer 45, and the distal suction tube 22 is arranged and welded to the outer peripheral side as described above. ing. And the proximal end part of the distal suction tube 22 and the distal end part of the outer layer 45 are welded in a state in which the end faces are abutted with each other.

  The distal guide tube 42 is joined to the distal suction tube 22 by welding. As shown in FIG. 3A, a part of the distal guide tube 42 is embedded in a thick portion 37a in the peripheral wall portion 37 of the distal suction tube 22, and the distal side guide tube 42 is distant from the distal side in the embedded state. It is welded to the suction tube 22. In this case, the distal guide tube 42, specifically, the peripheral wall portion 47 surrounding the lumen 42a in the tube 42, a part thereof is not embedded in the distal suction tube 22, but is a non-embedded portion 47a. A non-embedded portion 47 a is provided so as to partially protrude in the lumen 22 a of the distal suction tube 22. The non-embedded portion 47a partitions the lumen 22a of the distal suction tube 22 and the lumen 42a of the distal guide tube 42. In such a configuration, in the first direction X, the distance from the center portion P1 (axial position) of the lumen 22a to the distal guide tube 42 is such that the center wall P1 of the lumen 22a and the peripheral wall portion 37 (thin wall portion 37b). ) Is smaller than the separation distance. The distal guide tube 42 is disposed on the inner side of the outer peripheral surface of the distal suction tube 22 and does not protrude from the outer peripheral surface.

  The distal guide tube 42 has an axial length (full length) longer than the axial length (full length) of the distal suction tube 22. The distal guide tube 42 is disposed with its proximal end aligned with the proximal end of the distal suction tube 22, and in this disposed state, a portion of the distal guide tube 42 is disposed. The distal suction tube 22 extends more distally than the distal end.

  Further, the distal guide tube 42 partially overlaps with the proximal suction tube 21 in the axial direction on the proximal end side, and the outer peripheral surface at the overlapping portion is the proximal suction tube 21 (specifically, It is in contact with the outer peripheral surface of the insertion part 39). In the contact state, the distal guide tube 42 and the proximal suction tube 21 are welded to each other. Specifically, as shown in FIG. 3 (b), in the overlapping portion, both the distal guide tube 42 and the proximal suction tube 21 are covered by the peripheral wall portion 37 of the distal suction tube 22. The distal guide tube 42 and the proximal suction tube 21 are welded to the peripheral wall portion 37, respectively. That is, the distal guide tube 42 and the proximal suction tube 21 are welded via the peripheral wall portion 37.

  Next, the dimensional relationship of the catheter body 11 will be described. In the region where the suction tube 14 and the guide wire tube 15 are arranged side by side in the axial direction (longitudinal direction) of the catheter body 11, the dimension of the cross section (cross section in the direction perpendicular to the axial direction) of the catheter body 11 is the first. The width dimension W1 in the direction X is larger than the width dimension W2 in the second direction Y. Therefore, the catheter main body 11 has an elliptical shape whose cross section is long in the first direction X in the juxtaposed region of the tubes 14 and 15.

  Specifically, in the catheter body 11, a distal portion in which the guide wire tube 15 (specifically, the distal guide tube 42) is partially embedded in the suction tube 14 (specifically, the distal suction tube 22); A proximal portion that is proximal to the distal portion and in which the guide wire tube 15 (specifically, the proximal guide tube 41) is disposed outside the suction tube 14 (specifically, the proximal suction tube 21). When the dimension ratio W1 / W2 of the width dimension is compared, the dimension ratio W1 / W2 in the distal portion is smaller than the dimension ratio W1 / W2 in the proximal portion. Therefore, in this catheter main body 11, the distal portion has an elliptical shape closer to a perfect circle than the proximal portion.

  The catheter body 11 having the above-described configuration is apparent from FIGS. 3A and 3C when a portion where the suction lumen 17 and the guide wire lumen 18 are arranged on the distal side is seen. 3, the portion having the cross section of FIG. 3A is “distal tube 51”, and the portion having the cross section of FIG. 3C is “proximal tube 52”. It has become. In this case, the distal tube 51 is configured to include the distal suction tube 22 and the distal guide tube 42, and the proximal tube 52 is configured to include the proximal suction tube 21 and the proximal guide tube. 41 and an outer layer 45.

  Here, in the distal tube 51, the suction lumen 17 and the guide wire lumen 18 are partitioned by the peripheral wall portion 47 of the distal guide tube 42, and the peripheral wall portion 47 of the distal guide tube 42 is “lumen”. It corresponds to a “partition wall”. The lumen partition wall portion (the peripheral wall portion 47 of the distal guide tube 42) is provided so as to protrude toward the central portion P1 of the suction lumen 17 (inner lumen 22a). In the proximal tube 52, the suction lumen 17 and the guide wire lumen 18 are partitioned by the proximal suction tube 21 (the inner layer 27 and the intermediate layer 29) and the peripheral wall portion 48 of the proximal guide tube 41. The proximal suction tube 21 (the inner layer 27 and the intermediate layer 29) and the peripheral wall portion 48 of the proximal guide tube 41 correspond to a “lumen partition wall portion”. The lumen partition wall (proximal suction tube 21 and the peripheral wall 48 of the proximal guide tube 41) is provided without protruding toward the central portion P1 of the suction lumen 17 (lumen 21a). .

  In such a configuration, the positions of the guide tubes 41 and 42 with respect to the suction lumen 17 are different. That is, since the distal side guide tube 42 and the proximal side guide tube 41 are arranged coaxially, the central portion P2 of the inner cavities 41a and 42a is in the same position in the first direction X. The central portion P1 of the lumen 22a of the distal suction tube 22 (see FIG. 3A) and the central portion P1 of the lumen 21a of the proximal suction tube 21 (see FIGS. 3B to 3D) Is slightly different in position in the first direction X. Specifically, in the first direction X, the center portion P1 of the lumen 22a is closer to the center portion P2 side of the guide wire lumen 18 than the center portion P1 of the lumen 21a. As described above, the positions of the guide tubes 41 and 42 with respect to the suction lumen 17 are different, so that the dimensional ratio W1 / W2 is different between the distal tube 51 and the proximal tube 52 as described above. It has become.

  Next, the manufacturing procedure of the suction catheter 10 will be described with reference to FIG. FIG. 4 is an explanatory diagram for explaining the manufacturing procedure of the suction catheter 10.

  First, as shown in FIG. 4A, a distal tube manufacturing process for manufacturing the distal tube 51 is performed by joining the distal suction tube 22 and the distal guide tube 42 by heat welding. In this step, first, the distal guide tube 42 is disposed in the lumen 22 a of the distal suction tube 22 with its outer peripheral surface being in contact with the inner peripheral surface of the distal suction tube 22. At this time, the entire length of the distal guide tube 42 is longer than that of the distal suction tube 22, and the end surfaces of the proximal ends (right ends in the figure) of these tubes 22 and 42 coincide with each other as illustrated. As a result, a part of the distal guide tube 42 protrudes from the distal end portion of the distal suction tube 22. The distal guide tube 42 is arranged on the side of the lumen 22a of the distal suction tube 22 where the distal end of the tube 22 is pointed.

  In this arrangement state, the distal suction tube 22 and the distal guide tube 42 are joined by heat welding. In this thermal welding, a mandrel is inserted as a core material into the lumen 22a of the distal suction tube 22 and the lumen 42a of the distal guide tube, and a heat shrinkable tube is placed outside each of the tubes 22 and 42. In this state, heat is applied by a heater from the outside of the shrinkable tube. Thereby, the distal side tube 51 is manufactured. The mandrels inserted into the lumens 22a and 42a are made of a metal bar having an outer diameter substantially the same as the diameter of each of the lumens 22a and 42a. More specifically, the mandrel inserted into the lumen 22a is formed with a groove along the longitudinal direction so as to avoid interference with the distal guide tube 42 disposed in the lumen 22a.

  The distal tube 51 having the cross-sectional structure shown in FIG. 3A is obtained by the above distal tube manufacturing process. It supplements about becoming a cross-sectional structure of Fig.3 (a) with said welding operation | work. Before welding, the distal suction tube 22 is a resin tube having the same thickness in the circumferential direction, and the distal suction tube 22 is set with the distal guide tube 42 and the mandrel set in the lumen 22a. As shown in FIG. 3A, the molten resin in the distal suction tube 22 turns around so as to surround the distal guide tube 42. Thereby, the thick part 37a is formed around the distal side guide tube 42, and the distal side guide tube 42 is a peripheral wall part of the distal side suction tube 22 except for a part on the side of the lumen 22a. 37 will be buried.

  The melting temperature of the distal guide tube 42 is higher than the melting temperature of the distal suction tube 22. Although it is preferable that the melting temperatures of the tubes 22 and 42 are the same from the viewpoint of the bonding strength of the heat welding, the distal guide tube 42 is relatively hard to improve the sliding of the guide wire. This is because the melting temperature is high.

  Next, as shown in FIG.4 (b), the proximal suction tube manufacturing process which manufactures the proximal suction tube 21 is performed. In this step, first, a braided body 31 is formed by winding a plurality of wire rods spirally around the outer peripheral surface of the inner tube 61 constituting the inner layer 27. Thereafter, the outer peripheral side of the braided body 31 is covered with an outer tube 62 constituting the outer layer 28. The outer tube 62 is not covered by a predetermined range from the distal end portion toward the proximal side in the inner tube 61. This predetermined range corresponds to the guide tube arrangement region 24 described above. Thereafter, the outer peripheral surface of the inner tube 61 and the inner peripheral surface of the outer tube 62 are joined by heat welding. Thereby, the proximal suction tube 21 in which the braided body 31 (intermediate layer 29) is interposed between the inner layer 27 and the outer layer 28 is manufactured. In the guide tube non-arrangement region 25, the proximal suction tube 21 has a cross-sectional structure shown in FIG.

  Next, as shown in FIG. 4C, a proximal tube manufacturing process for manufacturing the proximal tube 52 by joining the proximal suction tube 21 and the proximal guide tube 41 by thermal welding is performed. Do. In this step, first, the proximal guide tube 41 is disposed on the outer peripheral surface of the guide tube arrangement region 24 of the proximal suction tube 21. At this time, the proximal guide tube 41 is positioned with its proximal end aligned with the proximal end of the guide tube placement region 24 (ie, the distal end of the outer layer 28 of the proximal suction tube 21). Deploy. Here, the total length of the proximal guide tube 41 is shorter than the length of the guide tube arrangement region 24 (the length of the proximal suction tube 21 in the axial direction). Therefore, in a state where the proximal guide tube 41 is disposed outside the guide tube arrangement region 24, a part of the proximal suction tube 21 extends more distally than the proximal guide tube 41, and the extension This portion becomes the insertion portion 39 described above.

  Subsequently, a cover tube 54 made of polyamide elastomer is put on both the proximal suction tube 21 and the proximal guide tube 41 from the outside. Thereby, the proximal suction tube 21 and the proximal guide tube 41 are inserted inside the cover tube 54. Specifically, the cover tube 54 has its distal end aligned with the distal end of the proximal guide tube 41, and its proximal end is slightly closer to the proximal suction tube 21. (For example, about 1 mm) In the state which covers, it covers on each tube 21,41.

  Thereafter, the proximal suction tube 21 and the proximal guide tube 41 are joined by heat welding. In this thermal welding, a mandrel is inserted into each of the lumen 21a of the proximal suction tube 21 and the lumen 41a of the proximal guide tube, and silicon is applied to the outside of the cover tube 54 covered with each tube 21 and 41. This is performed by applying heat from the outside of the shrinkable tube with a heater in a state where it is further covered with a heat-shrinkable tube. As a result, the cover tube 54 is melted and the tubes 21 and 41 are welded to produce the proximal tube 52. The cover tube 54 becomes the outer layer 45 along with this welding.

  Through the above-described proximal tube manufacturing process, the proximal tube 52 having the cross-sectional structure shown in FIG. 3C is obtained. It supplements about becoming sectional structure of FIG.3 (c) with said welding operation | work. Before welding, the cover tube 54 is a resin tube having the same thickness in the circumferential direction, and the cover tube 54 is set with the proximal suction tube 21, the proximal guide tube 41, and the mandrel set in the lumen. As shown in FIG. 3C, the molten resin in the cover tube 54 wraps around the proximal guide tube 41. Thus, after welding, a thick portion 45a is formed around the proximal guide tube 41, and the proximal guide tube 41 is entirely outside the proximal suction tube 21 (the inner layer 27 and the intermediate layer 29). Is embedded in the outer layer 45 (in FIG. 3C, the peripheral wall portion of the proximal suction tube 21).

  The melting temperature of the proximal guide tube 41 is higher than the melting temperature of the cover tube 54. Although it is preferable that the melting temperatures of the tubes 41 and 54 are the same from the viewpoint of the bonding strength of the heat welding, the proximal guide tube 41 is relatively hard in order to improve the sliding of the guide wire. This is because the melting temperature is high.

  Next, as shown in FIG. 4D, a tube joining step for joining the distal side tube 51 and the proximal side tube 52 is performed. In this step, first, the insertion portion 39 of the proximal suction tube 21 in the proximal tube 52 is inserted into the proximal end portion of the distal suction tube 22 in the distal tube 51. In this insertion, first, the proximal end side of the distal suction tube 22 is enlarged using a jig or the like, and the proximal suction tube 21 is inserted inside the enlarged diameter portion (that is, the enlarged diameter portion 35). Part 39 is inserted. In this insertion, the proximal guide tube 41 of the proximal tube 52 and the distal guide tube 42 of the distal tube 51 are coaxial, and the end faces of each other are butted together. To do so.

  Thereafter, the distal tube 51 and the proximal tube 52 are joined by heat welding. In this thermal welding, a mandrel is inserted so as to straddle the lumen 21a of the proximal suction tube 21 and the lumen 22a of the distal suction tube 22, and the lumen 41a and the distal side of the proximal guide tube 41 are inserted. A mandrel was inserted so as to straddle the lumen 42a of the guide tube 42, and a heat-shrinkable tube was covered from the outside on a predetermined portion including at least an overlapping portion of the distal tube 51 and the proximal tube 52 In this state, heat is applied by a heater from the outside of the shrinkable tube. Thereby, while the distal end side (insertion part 39) of the proximal suction tube 21 and the proximal end side (expansion part 35) of the distal suction tube 22 are heat-welded, the distal suction tube The proximal end face 22 and the distal end face of the outer layer 45 are thermally welded to form the suction tube 14. Further, the proximal guide tube 41 and the distal guide tube 42 are thermally welded to form the guide wire tube 15.

  Through the above-described tube joining step, the joint portion between the distal tube 51 and the proximal tube 52, specifically, the distal suction tube 22 of the distal tube 51 is replaced with the proximal suction tube of the proximal tube 52. The cross-sectional structure shown in FIG. At this time, in the overlapping portion, the distal guide tube 42 of the distal tube 51 and the intermediate layer 29 (braid 31) of the proximal tube 52 are in contact with each other at the outer periphery, and in this state, the distal side The guide tube 42 and the intermediate layer 29 (braided body 31) are integrated by the peripheral wall portion 37 of the distal suction tube 22.

  Thereafter, as a post-process, a hub connection process for connecting the hub 12 to the catheter body 11 and the like are performed, thereby completing a series of manufacturing processes.

  As mentioned above, according to the structure of this embodiment explained in full detail, the following outstanding effects are acquired.

  The guide wire tube 15 is formed by welding a proximal guide tube 41 and a distal guide tube 42 distal to the proximal guide tube 41, and the proximal guide tube 41 of the respective tubes 41, 42 is formed. The distal suction tube 21 was welded to the proximal suction tube 21, and the distal guide tube 42 was welded to the distal suction tube 22. In this case, when manufacturing the suction catheter 10, first, the proximal guide tube 41 and the proximal suction tube 21 are welded to produce the proximal tube 52, and the distal guide tube 42 and the distal suction tube 21. The distal side tube 51 is manufactured by welding the tube 22. Thereafter, the proximal suction tube 21 and the distal suction tube 22 are welded, and the proximal guide tube 41 and the distal guide tube 42 are welded, whereby the proximal tube 52 and the distal side are welded. The tube 51 is joined. According to this, welding of the proximal guide tube 41 and the proximal suction tube 21 and welding of the distal guide tube 42 and the distal suction tube 22 are performed under welding conditions suitable for each welding. Since it can be implemented, the suction tube 14 and the guide wire tube 15 can be suitably welded.

  Further, in the guide wire tube 15, when the guide wire is inserted into the guide wire lumen 18 and used, a load in a direction orthogonal to the axial direction is applied to the tube 15, and a part of the tube 15 is a suction tube 14. There is a concern that problems such as peeling from the surface may occur. Therefore, even if this point is considered, it can be said that said effect is large.

  In the suction tube 14, an intermediate layer 29 (braided layer) formed by using the braided body 31 is provided on a peripheral wall portion (inner layer 27, outer layer 28, intermediate layer 29) surrounding the lumen 21 a of the proximal suction tube 21, It was set as the structure which does not provide a braided layer in the surrounding wall part 37 surrounding the lumen | bore 22a of the distal suction tube 22. FIG. In such a configuration, since the braided body 31 is present on the peripheral wall portion of the proximal suction tube 21, it is considered that the amount of resin required for welding is insufficient compared to the distal suction tube 22. It is done. Therefore, it is considered that welding conditions suitable for each welding are different between the case where the guide wire tube 15 is welded to the proximal suction tube 21 and the case where the guide wire tube 15 is welded to the distal suction tube 22. In this regard, according to the above configuration, the proximal suction tube 21 having the braid 31 and the proximal guide tube 41 are welded, and the distal suction tube 22 and the distal guide tube having no braid 31 are included. Therefore, the suction tube 14 and the guide wire tube 15 having such a configuration can be suitably welded.

  In the suction tube 14, the guide wire tube 15 is arranged in a state where the distal suction tube 22 partially projects into the lumen 22 a, and the guide wire tube is not projected in the lumen 21 a in the proximal suction tube 21. 15 was placed. Here, when the guide wire tube 15 is disposed in a state in which it partially protrudes into the lumen 22a, it is necessary to perform welding while the tube 15 is disposed in the lumen 22a. When the tube 15 is disposed without protruding into the lumen 21a, it is necessary to perform welding with the tube 15 disposed outside the lumen 21a. Therefore, with such a configuration, it is considered difficult to weld the guide wire tube 15 across the proximal suction tube 21 and the distal suction tube 22. In this respect, according to the above-described configuration, first, the distal guide tube 42 is welded to the proximal guide tube 41 in a state where the distal guide tube 42 is disposed in the lumen 22a of the distal suction tube 22. Since the tubes 21 and 41 can be welded in a state where the tube is disposed outside the lumen 21a of the proximal suction tube 21, the catheter 10 having such a configuration can be preferably manufactured.

  In the suction tube 14, a site where the guide wire tube 15 is placed in contact with the outer peripheral surface of the proximal suction tube 21 (intermediate layer 29) is set, and the proximal guide tube 41 and the distal end are arranged at the site. The side guide tube 42 was welded coaxially and with its end faces butting each other. In this case, a part of the distal guide tube 42 can be disposed so as to overlap the outer peripheral surface of the proximal suction tube 21. That is, for both the proximal guide tube 41 and the distal guide tube 42, the outer peripheral surface of the proximal suction tube 21 can be used as a reference portion for installation. Therefore, it is possible to facilitate the operation of coaxially arranging the proximal guide tube 41 and the distal guide tube 42 on the outer peripheral surface of the proximal suction tube 21.

  The present invention is not limited to the above embodiment, and may be implemented as follows, for example.

  (1) As a configuration of the catheter body 11, the suction tube 14 is the most proximal in the region where the guide wire tubes 15 are juxtaposed, in particular, the three tubes arranged in the axial direction, specifically the juxtaposed region of the guide wire tubes 15 A configuration is considered in which three tubes are welded: a proximal suction tube as a side, an intermediate suction tube provided continuously at the distal side, and a distal suction tube provided continuously at the distal side. It is done. The present invention may be applied to a catheter body having such a configuration. In this case, the guide wire tube 15 is configured by welding each divided tube divided into three in the axial direction. Then, each divided tube is welded to the proximal suction tube, the intermediate suction tube, and the distal suction tube. According to this configuration, when the catheter body 11 is manufactured, the proximal suction tube and the proximal divided tube are welded, the intermediate suction tube and the intermediate divided tube are welded, and the distal suction tube and the distal divided portion. Each welding with the tube can be done individually. Therefore, for example, even if the braided body 31 (braided layer) is provided in each of the proximal suction tube and the distal suction tube, and the braided body 31 is not provided in the intermediate suction tube, the suction tube 14 and The guide wire tube 15 can be suitably welded.

  (2) Contrary to the configuration of the above embodiment, as the configuration of the catheter body 11, the distal suction tube 22 is arranged in a state where the guide wire tube 15 does not protrude into the lumen 22 a, and the proximal suction tube 21 The structure arrange | positioned in the state which the guide wire tube 15 protrudes to the internal cavity 21a can be considered. Therefore, the present invention may be applied to the catheter body 11 having such a configuration. Also in this case, the distal portion (distal tube 51) and the proximal portion (proximal tube 52) of the catheter body 11 having different arrangement modes of the guide wire tube 15 with respect to the suction lumen 17 can be manufactured separately. The manufacture of the catheter body 11 can be suitably performed.

  Further, in both the distal suction tube 22 and the proximal suction tube 21, the catheter body disposed without the guide wire tube 15 projecting into the lumens 21a and 22a, the distal suction tube 22 and the proximal suction tube In both of the side suction tubes 21, the present invention may be applied to the catheter main body in which the guide wire tube 15 is disposed in a state in which the guide wire tube 15 projects at least partially in the lumens 21a and 22a.

  (3) In the above embodiment, a part of the peripheral wall 47 of the distal guide tube 42 is embedded in the distal suction tube 22, but a portion embedded in the distal suction tube 22 in the peripheral wall 47 The ratio of the portion not embedded (non-embedded portion 47a) may be arbitrary. For example, at least half of the circumferential direction in the circumferential wall portion 47 may be the non-buried portion 47a.

  (4) In the embodiment described above, the distal end portion (insertion portion 39) of the proximal suction tube 21 is inserted into the proximal end portion (expanded portion 35) of the distal suction tube 22. Although 21 and 22 were welded, this may be changed and the proximal suction tube 21 and the distal suction tube 22 may be welded in a state where the end surfaces of each other are butted. Moreover, in the said embodiment, although the proximal side guide tube 41 and the distal side guide tube 42 were welded in the state which mutually faced each other, this is changed and either guide tube 41 (or 42) is changed. ) May be welded in a state of being inserted into the other guide tube 42 (or 41).

  (5) For example, in the suction tube 14, a configuration in which both the proximal suction tube 21 and the distal suction tube 22 do not have the braided body 31 is conceivable. Even in such a configuration, when the proximal suction tube 21 and the distal suction tube 22 have different peripheral wall thicknesses or different melting temperatures of materials forming the tubes, the guide It is conceivable that the welding conditions for the proximal suction tube 21 and the welding conditions for the distal suction tube 22 for the wire tube 15 are different. Therefore, the present invention may be applied in such a case.

  (6) In the above embodiment, the present invention is applied to the suction catheter in which the suction tube 14 having the suction lumen 17 and the guide wire tube 15 having the guide wire lumen 18 are welded. The present invention may be applied to other catheters in which two tubes having lumens are welded. For example, conventionally, a double-lumen catheter for blood access used for extracorporeal circulation treatment (blood access) such as hemodialysis is known. This type of catheter is known in which a tube having a blood removal lumen for discharging blood out of the body and a tube having a blood supply lumen for returning purified blood to the body are welded together. Yes. In this case, for example, when it is desired to secure flexibility on the distal side while securing rigidity on the proximal side of one of the tubes, the thickness of the tube is made different between the distal side and the proximal side. Alternatively, it may be possible to provide a braided layer on the proximal side but not a braided layer on the distal side. Therefore, the present invention may be applied to a catheter having such a configuration.

  (7) In the proximal suction tube 21, it is possible to use other than the braided body as the reinforcing body provided on the peripheral wall portion surrounding the suction lumen 17. For example, a configuration in which a high-rigidity resin body made of a resin material that is harder (higher rigidity) than the resin material (polyamide elastomer) of the distal-side suction tube 22 is provided on the peripheral wall portion of the proximal-side suction tube 21. Also good. In this case, a reinforcing layer is formed by embedding a highly rigid resin body in the peripheral wall portion of the proximal suction tube 21.

  (8) The cross-sectional shape in the region where the proximal suction tube 21 and the proximal guide tube 41 are juxtaposed in the proximal tube 52, specifically, the cross-sectional shape of the outer layer 45 is not necessarily shown in FIG. The shape is not limited to an elliptical shape as shown in c). For example, the outer layer 45 shown in FIG. 5A has a portion on the proximal guide tube 41 side closer to the proximal suction tube 21 side in the first direction X (the suction lumen 17 and the guide wire lumen 18 are aligned). The distal side guide tube 41 is tapered toward the side. Further, the outer layer 45 shown in FIG. 5B has an outer peripheral surface formed along the outer peripheral surface of the proximal suction tube 21 (intermediate layer 29) and the outer peripheral surface of the proximal guide tube 41 in the outer peripheral direction. Has been. In this case, the thickness of the outer layer 45 is relatively uniform in the outer peripheral direction. In short, as long as the proximal suction tube 21 and the proximal guide tube 41 are covered with the outer layer 45, the cross-sectional shape of the outer layer 45 may be arbitrary.

  (9) In the above embodiment, the proximal suction tube 21 and the distal suction tube 22 are joined, the proximal guide tube 41 and the distal guide tube 42 are joined, and the proximal suction tube 21 and the proximal suction tube 21 are close to each other. The joining of the distal side guide tube 41 and the joining of the distal side suction tube 22 and the distal side guide tube 42 were performed by welding, but these joinings were performed by adhesion using an adhesive or a solvent. Also good. For example, when the guide wire tube 15 is bonded to the suction tube 14 by adhesion using a solvent, the amount of resin dissolved by the solvent differs between the proximal suction tube 21 and the distal suction tube 22. Therefore, it is conceivable that the bonding condition of the guide wire tube 15 to the proximal suction tube 21 and the bonding condition of the guide wire tube 15 to the distal suction tube 22 are different. In this regard, by applying the present invention in which these bondings are individually performed, each bonding can be performed under conditions (bonding conditions) suitable for each bonding, and therefore the suction tube 14 and the guide wire tube 15 can be bonded appropriately.

  DESCRIPTION OF SYMBOLS 10 ... Suction catheter, 11 ... Catheter main body, 14 ... Suction tube, 15 ... Guide wire tube, 17 ... Suction lumen, 18 ... Guide wire lumen, 21 ... Proximal suction tube, 22 ... Distal suction tube, 41 ... Proximal guide tube, 42 ... Distal guide tube, 51 ... Distal tube, 52 ... Proximal tube.

Claims (4)

A first tube having a first lumen;
A second tube having a second lumen extending in the same direction as the first lumen;
The first tube is formed by joining a first proximal tube portion and a first distal tube portion provided on a more distal side than the first proximal tube portion, and the lumen of the first proximal tube portion and the first tube The first lumen is formed by communicating with a lumen of a distal tube portion;
The second tube is a catheter provided so as to extend over the first proximal tube portion and the first distal tube portion,
The second tube is formed by joining a second proximal tube portion and a second distal tube portion provided on a more distal side than the second proximal tube portion, and the second proximal tube portion is the first tube. Joined to one proximal tube, the second distal tube joined to the first distal tube ;
In the first tube, the second tube is disposed in a state in which at least a part of the first proximal tube portion and the first distal tube portion protrudes into the lumen thereof, In the other tube portion, the second tube is arranged in a state where it does not protrude into its lumen,
In the other tube portion, a second tube arrangement portion is set on the outer peripheral portion thereof, which extends in the axial direction of the first tube and is arranged in a state where the outer peripheral surface of the second tube is in contact with the second tube portion. And
The catheter , wherein the second proximal tube portion and the second distal tube portion are coaxially joined to the second tube placement portion in a state in which their end faces are butted together .   In the first tube, any one of the first proximal tube portion and the first distal tube portion is provided with a reinforcing layer formed on a peripheral wall portion surrounding the lumen using a reinforcing body. The catheter according to claim 1, wherein, on the other side, the reinforcing layer is not provided on a peripheral wall portion surrounding the lumen. A suction catheter used to suck and remove foreign matter,
The first tube is a suction tube having a suction lumen as the first lumen;
The catheter according to claim 1 or 2 , wherein the second tube is a guide wire tube having a guide wire lumen through which the guide wire is inserted as the second lumen. A first tube having a first lumen;
A second tube having a second lumen,
The first tube is formed by joining a first proximal tube portion and a first distal tube portion provided more distally than the first proximal tube portion,
The second tube is formed by joining a second proximal tube portion and a second distal tube portion provided more distally than the second proximal tube portion, and the first proximal tube portion and the first far tube. Applied to the catheter provided to extend across the position tube part,
A proximal tube manufacturing step of manufacturing a proximal tube by joining the first proximal tube portion and the second proximal tube portion;
A distal tube manufacturing step of manufacturing a distal tube by joining the first distal tube portion and the second distal tube portion;
By joining the first proximal tube portion and the first distal tube portion and joining the second proximal tube portion and the second distal tube portion, the proximal tube and the far tube are joined. A tube joining step for joining the distal side tube,
Equipped with a,
In the distal tube manufacturing process, the first distal tube portion is disposed in a state where the second distal tube portion is disposed in the lumen of the first distal tube portion constituting a part of the first lumen. And manufacturing the distal tube so that at least a part of the second distal tube portion projects into the lumen of the first distal tube portion. ,
In the proximal tube manufacturing process, an outer peripheral surface of the first proximal tube portion constituting a part of the first lumen extends in an axial direction of the first tube, and the second tube has an outer peripheral surface thereof. In the state which set the 2nd tube arrangement | positioning part arrange | positioned by contact | abutting and has arrange | positioned the said 2nd proximal tube part in the 2nd tube arrangement | positioning part, the said 1st proximal tube part and the said 2nd proximal tube The proximal tube is manufactured so that the second proximal tube portion does not protrude into the lumen of the first proximal tube portion,
In the tube joining step, the second proximal tube portion and the second distal tube portion are arranged coaxially in the second tube placement portion and in a state in which the end faces thereof are abutted with each other. A method for manufacturing a catheter, comprising joining the second proximal tube portion and the second distal tube portion .

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