JP5890979B2 - Suction catheter - Google Patents

Description

  The present invention relates to a suction catheter for removing a foreign substance such as a thrombus in a blood vessel.

  Conventionally, an aspiration catheter for aspirating and removing a foreign substance such as a thrombus existing in a blood vessel is known (for example, see Patent Document 1). The suction catheter includes a suction tube having a suction lumen for sucking foreign matter inside. When using this type of aspiration catheter, for example, when aspirating a thrombus in a blood vessel, for example, a treatment person first inserts the aspiration catheter into the blood vessel and moves it to form the distal end of the aspiration tube. The suction port is made to reach the treatment target site where the thrombus exists. Then, by using the suction tool attached to the proximal end of the suction tube, the suction lumen is set to a negative pressure, whereby the thrombus is sucked and removed through the lumen.

  By the way, when the suction catheter is transported to a treatment target site in the body, it is transported along a guide wire previously inserted into the body. Specifically, in addition to the suction tube, the suction catheter is provided with a guide wire tube having a guide wire lumen therein. The guide wire is inserted into the guide wire lumen to reach the treatment target site. Be transported. In addition, the guide wire tube is joined and provided, for example on the outer peripheral side of the suction tube.

JP 2004-222946 A

  By the way, in the above-described suction catheter in which the guide wire tube is disposed on the outer peripheral side of the suction tube, the suction tube and the guide wire tube are disposed side by side in a direction orthogonal to the axial direction. A width dimension becomes large, and there exists a possibility that the insertion property in the body of the catheter may fall. In particular, when the guide wire tube extends to the distal end side of the suction tube, the width dimension in the arrangement direction is increased on the distal end side of the suction catheter, and the insertability may be significantly reduced. There is.

  Therefore, as a countermeasure against this problem, it is conceivable to arrange a guide wire tube in the suction lumen of the suction tube, thereby suppressing a decrease in the insertion property of the suction catheter. However, in this case, since the passage area of the suction lumen is reduced by the guide wire tube, there is a concern about a reduction in suction performance.

  This invention is made | formed in view of the said situation, and it aims at providing the suction catheter which suppresses the fall of a suction performance while suppressing the fall of the insertion property to a body.

  In order to solve the above-described problems, a suction catheter according to a first aspect of the present invention is a suction catheter including a catheter tube having a suction lumen for sucking a foreign substance and a guide wire lumen through which the guide wire is inserted. In the distal portion of the distal portion including the distal end portion in the axial direction and the proximal portion that is more proximal than the distal portion, a lumen partition wall that partitions the suction lumen and the guidewire lumen is It is provided to protrude toward the center of the suction lumen, and at the proximal portion, the lumen partition wall is provided without protruding toward the center of the suction lumen. To do.

  According to the present invention, in the distal portion of the catheter tube, the lumen partition wall portion is provided so as to protrude toward the center portion of the suction lumen, so that the lumen partition wall portion does not protrude toward the center portion of the suction lumen. Compared with the case where it is provided, the width dimension of the catheter tube in the direction in which the suction lumen and the guide wire lumen are arranged, that is, the maximum width dimension can be reduced. Thereby, the fall of the insertion property in the body in a catheter tube can be suppressed. On the other hand, in the proximal portion of the catheter tube, since the lumen partition wall portion does not protrude toward the center portion of the suction lumen, the opening area of the suction lumen is not reduced by the lumen partition wall portion. For this reason, a decrease in suction performance is suppressed. Therefore, in this case, it is possible to suppress a decrease in the insertion performance into the body and to suppress a decrease in the suction performance.

  In addition, when comparing the distal and proximal parts of a suction catheter, the distal part is more demanding for insertability into the body, while the proximal part is more demanding for insertability than the distal part. Not. Therefore, in the above configuration, paying attention to this point, the proximal portion satisfies the requirement for the suction performance. This makes it possible to satisfy both conflicting requirements of insertability into the body and suction performance.

  The suction catheter of the second invention is the suction catheter according to the first invention, wherein a reinforcing layer is formed by embedding a reinforcing body in a peripheral wall portion surrounding the suction lumen in the proximal portion of the catheter tube, In the distal portion, the reinforcing layer is not formed on the peripheral wall portion, and in the proximal portion, the guide wire lumen is provided outside the reinforcing layer.

  In the suction catheter, a reinforcing layer is formed in the proximal portion of the catheter tube in which a reinforcing body is embedded in the peripheral wall portion to increase the rigidity of the tube, while the flexibility of the tube is ensured in the distal portion. Therefore, the reinforcing layer on the peripheral wall portion may not be formed as much as possible. In such a configuration, since the reinforcing body is embedded in the peripheral wall portion in the proximal portion, it is considered difficult to have a configuration in which the lumen partition wall portion projects toward the central portion of the suction lumen. In this regard, in the present invention, in the proximal portion, the guide wire lumen is disposed outside the reinforcing layer, and the lumen partition wall portion projects toward the central portion of the suction lumen in the distal portion having no reinforcing layer. Yes. In this case, the effect of the first aspect of the invention can be suitably achieved even for a catheter tube having a reinforcing layer.

  The suction catheter according to a third aspect is the first direction according to the first or second aspect, wherein the suction lumen and the guide wire lumen are arranged in a cross section that is a cross section perpendicular to the axial direction of the catheter tube. When the width dimension of the catheter tube at W1 is W1 and the width dimension of the catheter tube in the direction orthogonal to the first direction is W2, the dimensional ratio W1 / W2 at the distal portion is The size ratio is smaller than W1 / W2.

  By the way, when the width dimensions W1 and W2 in two directions orthogonal to each other in the cross section of the catheter tube are different, that is, when the cross section has an elliptical shape, the flexibility of the catheter tube is relative to that of the tube. It is conceivable that there is a difference between when the bending force in the first direction is applied and when the bending force in the second direction is applied. This is not preferable from the viewpoint of insertion of the catheter tube into the body. In particular, if such a difference in bendability occurs in the distal portion where the catheter tube is inserted into the body, the insertability of the tube may be greatly reduced. Accordingly, in the present invention, in view of this point, the distal portion is made smaller than the proximal portion with respect to the dimensional ratio W1 / W2 in the width dimension of the catheter tube. The distal portion has a shape close to a perfect circle. In this case, the insertion property into the body of the catheter tube having the two lumens of the suction lumen and the guide wire lumen can be enhanced.

  For example, when the width W2 of the catheter tube is the same in the proximal portion and the distal portion, the width W1 of the catheter tube, in other words, the maximum width of the tube is farther from the proximal portion. The position portion can be made smaller. In this case, it can be said that this is a preferable configuration in terms of the insertion property of the catheter tube into the body.

  A suction catheter according to a fourth aspect of the present invention is the suction catheter according to any one of the first to third aspects, wherein the catheter tube has a guide wire tube partially embedded in a peripheral wall portion surrounding the suction lumen. The guide wire lumen is formed by the lumen of the wire tube, the guide wire tube protrudes inside the suction lumen at the distal portion, and the guide wire tube is the suction portion at the proximal portion. It does not protrude inside the lumen.

  According to the present invention, since the guide wire tube is at least partially embedded in the peripheral wall portion surrounding the suction lumen, compared to the case where the guide wire tube is disposed in the suction lumen without being embedded in the peripheral wall portion, Bonding strength of the guide wire tube to the peripheral wall portion can be increased. Thereby, even when an excessive load is applied to the guide wire tube at the time of inserting the guide wire into the guide wire tube, it is possible to suppress the inconvenience that the tube peels off from the peripheral wall portion.

  A suction catheter according to a fifth aspect of the present invention is the suction catheter according to any one of the first to fourth aspects, wherein the lumen partition wall portion projects toward the central portion of the suction lumen, and the lumen partition wall. The catheter tube is configured to include a proximal tube provided without protruding toward the central portion of the suction lumen, and the distal tube and the proximal tube The proximal end of the distal tube and the distal end of the proximal tube are heat-welded to each other in a joined state.

  In the catheter tube described above, the lumen partition wall portion protrudes into the suction lumen at the distal portion, while the lumen partition wall portion is provided without protruding at the proximal portion. The tube configuration is different. In this regard, in manufacturing the catheter tube, first, the distal tube constituting the distal portion and the proximal tube constituting the proximal portion are separately manufactured, and then the distal tube and the proximal tube A catheter tube can be manufactured by joining the side tube by heat welding. Therefore, the above-mentioned catheter tube in which the tube configuration is different between the proximal portion and the distal portion can be preferably manufactured.

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. The cross-sectional view which shows the catheter main body in other embodiment. 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 located on the proximal side. 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.

  In the axial direction (longitudinal direction) of the catheter body 11, the distal tube 51 has a lumen partition wall (specifically, a peripheral wall 47 of the distal guide tube 42) that partitions the suction lumen 17 and the guide wire lumen 18. Since the tube 51 is provided so as to protrude toward the central portion P <b> 1 of the suction lumen 17, the suction lumen 17 is provided in the tube 51 as compared with the case where the lumen partition wall portion is provided without protruding toward the central portion P <b> 1 of the suction lumen 17. And the width dimension W1 in the first direction X in which the guide wire lumen 18 is arranged, that is, the maximum width dimension can be reduced. Therefore, it is possible to suppress a decrease in insertability into the body. On the other hand, in the proximal tube 52, the lumen partition wall portion (specifically, the peripheral wall portion 48 of the proximal guide tube 41 and the proximal suction tube 21 (inner layer 27 and intermediate layer 29)) is connected to the suction lumen 17. Since the tube 52 is provided without protruding toward the center portion P1, the opening area of the suction lumen 17 is not narrowed by the lumen partition wall portion in the tube 52. For this reason, a decrease in suction performance is suppressed. Therefore, in this case, it is possible to suppress a decrease in the insertion performance into the body and to suppress a decrease in the suction performance.

  In the proximal tube 52 of the catheter body 11, the braided body 31 is embedded in the peripheral wall portion (proximal suction tube 21 (inner layer 27 and intermediate layer 29) and outer layer 45) surrounding the suction lumen 17, whereby the intermediate layer 29 ( The distal tube 51 is configured such that the braided layer is not formed on the peripheral wall portion 37 surrounding the suction lumen 17. In this case, rigidity can be increased on the proximal side of the catheter body 11, while flexibility can be secured on the distal side. In this configuration, since the braided body 31 is embedded in the peripheral wall portion surrounding the suction lumen 17 in the proximal tube 52, the lumen partition wall portion protrudes toward the central portion P1 of the suction lumen 17. Is considered difficult. In this regard, in the above-described configuration, the guide wire lumen 18 is disposed outside the braided layer in the proximal tube 52, and the lumen partition wall portion is arranged at the central portion P1 of the suction lumen 17 in the distal tube 51 having no braided layer. It is configured to project toward. In this case, in the catheter body 11 having the braided layer, the above-described effect of suppressing the deterioration of the insertion performance into the body and suppressing the decrease of the suction performance can be suitably obtained.

  Regarding the dimension ratio W1 / W2 of the width dimension in the cross section of the catheter body 11, the dimension ratio W1 / W2 in the distal tube 51 is smaller than the dimension ratio W1 / W2 in the proximal tube 52. The cross-sectional shape of the distal tube 51 is closer to a perfect circle than the proximal tube 52. In this case, regarding the bendability of the catheter body 11 on the distal side of the catheter body 11, the bendability when the bending force in the first direction X is applied to the body 11 and the bending force in the second direction Y. It is possible to reduce the difference from the flexibility when acting. Therefore, the insertion property into the body of the catheter body 11 having the two lumens of the suction lumen 17 and the guide wire lumen 18 can be improved.

  In the distal tube 51 of the catheter body 11, the distal guide tube 42 is embedded in the peripheral wall portion 37 of the suction tube 14 (distal suction tube 22), and the distal guide tube 42 is sucked into the suction lumen in the embedded state. 17 was projected inside. In this case, as compared with the case where the distal guide tube 42 is not embedded in the peripheral wall portion 37 and disposed in the suction lumen 17, the bonding strength of the distal guide tube 42 (and thus the guide wire tube 15) with respect to the peripheral wall portion 37. Can be increased. Thereby, even when an excessive load is applied to the guide wire tube 15 when the guide wire is inserted into the guide wire tube 15, it is possible to suppress the inconvenience that the tube 15 is peeled off from the peripheral wall portion 37.

  The catheter body 11 includes a distal tube 51 having a lumen partition wall protruding toward the center portion P1 of the suction lumen 17, and a lumen partition wall portion not protruding toward the center portion P1 of the suction lumen 17. The proximal tube 52 is provided, and each of the tubes 51 and 52 is joined by heat-welding each other. In this case, when the catheter body 11 is manufactured, first, the distal side tube 51 and the proximal side tube 52 are individually manufactured, and then the distal side tube 51 and the proximal side tube 52 are joined by heat welding. The catheter body 11 can be manufactured. Thereby, the above-mentioned catheter main body 11 from which a structure differs in a proximal part and a distal part can be manufactured suitably.

The present invention is not limited to the above embodiment, and may be implemented as follows, for example.
(1) In the above embodiment, the configuration shown in FIG. 3A is used as the configuration in which the lumen partition wall portion is provided so as to protrude toward the center portion of the suction lumen 17, but this may be changed. For example, in the peripheral wall portion 47 of the distal guide tube 42, the ratio of the portion embedded in the distal suction tube 22 and the portion not embedded (non-embedded portion 47a) is different from that in FIG. As shown in FIG. 5A, in the peripheral wall portion 47 of the distal guide tube 42, half or more in the circumferential direction may be set as the non-embedded portion 47a. In this case, the larger the non-embedded portion 47a is, the larger the amount of protrusion that protrudes toward the center portion P1 of the suction lumen 17 is. It becomes smaller and approaches a perfect circle. That is, the dimensional ratio W1 / W2 is close to 1.

  In addition, the lumen partition wall that partitions the suction lumen 17 and the guide wire lumen 18 is not configured only by the peripheral wall 47 of the distal guide tube 42, but as shown in FIG. A lumen partition wall portion may be constituted by the tube 22 (the molten resin of the distal suction tube 22 melted at the time of tube welding) and the peripheral wall portion 47. In this case, the lumen partition wall portion protrudes toward the central portion of the suction lumen 17 while the distal guide tube 42 is entirely embedded in the distal suction tube 22.

  (2) In the above-described embodiment, the distal portion of the catheter body 11 with respect to the width dimension W1 in the first direction X in the region (parallel region) where the suction tube 14 and the guide wire tube 15 are disposed side by side The proximal portion (proximal tube 52) is made smaller than the (distal tube 51), but this may be changed to make the proximal portion smaller than the distal portion, The position portion and the proximal portion may be the same.

  (3) In the above embodiment, the proximal guide tube 41 and the distal guide tube 42 are arranged coaxially in the guide wire tube 15, but this is changed so that the central portion P <b> 2 of each of the tubes 41 and 42 is changed. The tubes 41 and 42 may be arranged so as to be slightly different positions in the first direction X. In the above-described embodiment, in the suction tube 14, the central portion P <b> 1 of the proximal suction tube 21 and the central portion P <b> 1 of the distal suction tube 22 are positioned slightly different in the first direction X. , 22 may be changed, but the tubes 21 and 22 may be arranged coaxially by changing this.

  (4) At least one of the distal tube 51 and the proximal tube 52 may be formed as a single tube having both the suction lumen 17 and the guide wire lumen 18. For example, the distal tube 65 shown in FIG. 6A is formed as a single tube having a suction lumen 17 and a guide wire lumen 18 (specifically, two lumens). Further, the proximal tube 66 shown in FIG. 6B is formed as a single tube having the suction lumen 17 and the guide wire lumen 18 (specifically, two lumens). These tubes 65 and 66 can be formed by extrusion molding, for example.

  (5) 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.

  (6) 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. 7A 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. 7B 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.

  (7) 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.

  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)

In a suction catheter including a catheter tube having a suction lumen for sucking foreign matter and a guide wire lumen through which the guide wire is inserted,
The catheter tube has a distal portion including a distal end in the axial direction and a proximal portion that is more proximal than the distal portion.
The catheter tube comprises a distal tube constituting the distal portion, and a proximal tube joined to the distal tube and constituting the proximal portion,
The suction lumen is formed across the interior of the distal tube and the interior of the proximal tube;
The guide wire lumen is formed across the inside of the distal tube and the inside of the proximal tube,
In the distal tube, a lumen partition wall portion that partitions the suction lumen and the guide wire lumen is provided to protrude toward a center portion of the suction lumen, and in the proximal tube, the lumen partition wall portion is A suction catheter characterized by being provided without protruding toward the center of the suction lumen. In the catheter tube, a reinforcing layer is formed in the proximal portion by embedding a reinforcing body in a peripheral wall portion surrounding the suction lumen, and the reinforcing layer is formed in the peripheral wall portion in the distal portion. Not
The suction catheter according to claim 1, wherein the guide wire lumen is provided outside the reinforcing layer at the proximal portion.   In a cross section that is a cross section in a direction orthogonal to the axial direction of the catheter tube, the width dimension of the catheter tube in the first direction in which the suction lumen and the guide wire lumen are arranged is W1, and is orthogonal to the first direction. The dimension ratio W1 / W2 in the distal portion is smaller than the dimension ratio W1 / W2 in the proximal portion when the width dimension of the catheter tube in the direction is W2. 3. The suction catheter according to 1 or 2. The catheter tube has a guide wire tube partially embedded in a peripheral wall portion surrounding the suction lumen, and the guide wire lumen is formed by a lumen of the guide wire tube,
The guide wire tube protrudes inside the suction lumen at the distal portion, and the guide wire tube does not protrude inside the suction lumen at the proximal portion. 4. The aspiration catheter according to any one of 3 above.

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