Catheter and manufacturing method for catheter

Abstract

To provide a catheter of a novel structure equipped with a three-dimensional deformation area three-dimensionally curved and deformed by external operation.SOLUTION: In an initial state extending almost straight of a catheter, there is provided a three-dimensional deformation area 30 in which an inserted operation lumen 22 of an operation wire 28 is twisted in a circumferential direction in a longitudinal direction and which three-dimensionally curves and deforms by a pulling operation force given through the operation wire 28.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a catheter that is inserted into the body and is provided with a deformation region that can be curved and deformed by external manipulation. [Background technology]

[0002] BACKGROUND ART Catheters that are inserted into tubular tissues within the body, such as blood vessels, digestive tracts, and bronchial tubes, have been known as a type of medical device used for examining, treating, and the like, tubular tissues within the body.

[0003] During medical procedures using such catheters, it is necessary to insert the catheter into a blood vessel or the like and advance the tip of the catheter until it reaches the target location in the internal tissue. Because blood vessels and the like are curved, it may be necessary to bend and deform the catheter itself to change the direction of the tip in order to insert the catheter along the curve of the blood vessel or the like. Furthermore, when removing a thrombus or the like from the inner surface of a blood vessel wall using an aspiration lumen, it may be necessary to bend and deform the catheter so that the aspiration lumen opening at the tip of the catheter faces the inner surface of the blood vessel wall. Furthermore, when detecting an electric potential or applying an electrical stimulus to a specific location in the internal tissue, it may be necessary to bend and deform the catheter so that the detection site or stimulation site of the catheter abuts the specific location in the internal tissue.

[0004] Therefore, JP 2009-537244 A (Patent Document 1) and JP 6349797 A (Patent Document 2) propose a steerable catheter in which an operating wire is arranged along the outer wall of the catheter in the longitudinal direction, and the tip of the operating wire is fixed to the distal end of the catheter, so that the tip portion of the catheter can be curved and deformed by the tensile operating force exerted from the base end side of the operating wire.

[0005] However, conventional steerable catheters such as those described in Patent Documents 1 and 2 exhibit two-dimensional bending deformation, which can make it difficult to point the catheter tip in a desired direction even when the catheter is deformed by external manipulation, and can also make it difficult to guide a specific part of the catheter to a desired position. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Special Publication No. 2009-537244 [Patent Document 2] Patent No. 6349797 Summary of the Invention [Problem to be solved by the invention]

[0007] An object of the present invention is to provide a catheter with a novel structure that can exhibit three-dimensional deformation in a deformation region that is curved and deformed by external manipulation. [Means for solving the problem]

[0008] A first aspect of the present invention is as follows. A catheter having a catheter main body to be inserted into the body, the catheter main body extending substantially straight in an initial state, a manipulation lumen formed in the catheter main body that is continuous in the longitudinal direction, a manipulation wire inserted into the manipulation lumen with the tip of the manipulation wire fixed to the tip side of the catheter, the manipulation lumen through which the manipulation wire is inserted in the initial state being twisted circumferentially in the longitudinal direction of the catheter main body, and a three-dimensional deformation region that is curved and deformed three-dimensionally by a tensile manipulation force applied from the outside through the manipulation wire is provided in the catheter main body.

[0009] In the catheter according to this embodiment, a tensile force is applied to the operating wire twisted along the operating lumen, causing both a bending force and a circumferential rotational force (torsion force) to act on the catheter main body. In particular, the operating wire to which the tensile force is applied can directly exert a torsional pressing force on the catheter main body by contacting the inner circumferential surface of the operating lumen. As a result, the catheter main body is efficiently curved and deformed in three dimensions. Furthermore, the degree of three-dimensional bending and deformation can be controlled by adjusting the magnitude of the tensile force applied to the operating wire from the outside.

[0010] Therefore, by using the catheter according to this embodiment, it becomes possible to easily perform operations such as pointing the catheter tip in a direction that was difficult with conventional two-dimensional deformation modes, or contacting the catheter with a specific part of body tissue that was difficult with conventional two-dimensional deformation modes. Note that the number, length, and setting position of the three-dimensional deformation regions in the present invention are not limited, and various settings can be made depending on the desired deformation mode.

[0011] A second aspect of the present invention is the catheter according to the first aspect, wherein the three-dimensional deformation region of the catheter body is flexible compared to a region that maintains a substantially straight shape even when a pulling operating force is applied through the operating wire.

[0012] In this type of catheter, even when an external operating force is applied, it is possible to more efficiently bend and deform the three-dimensional deformation region while suppressing unnecessary deformation in areas of the catheter body where bending and deformation are not intended.

[0013] A third aspect of the present invention is the catheter according to the first or second aspect, wherein the three-dimensional deformation region is located at a tip end portion of the catheter body.

[0014] The catheter of this embodiment can be advantageously applied, for example, in procedures such as inserting the catheter tip into a lumen that opens in a different direction within a body cavity, or in procedures in which a sensor unit provided at the catheter tip is brought into contact with a specific site on the inner surface of a body cavity.

[0015] A fourth aspect of the present invention is a catheter according to any one of the first to third aspects, wherein the catheter body is formed with a functional lumen that extends longitudinally at a circumferential position different from that of the operating lumen, and both the operating lumen and the functional lumen are formed offset from the central axis of the catheter body and are twisted in phase circumferentially along the length of the catheter body.

[0016] In the catheter of this embodiment, when a functional lumen used in the three-dimensional deformation region for suctioning blood or the like, for supplying saline or the like, or for wiring, is formed together with an operating lumen to have, for example, a double lumen structure, it is possible to realize the present invention while ensuring that the effective cross-sectional areas of the two lumens are large.

[0017] A fifth aspect of the present invention is a catheter according to the fourth aspect, wherein a common lumen is formed in the base end portion of the catheter body, and the operating lumen and the functional lumen are formed extending from the common lumen toward the tip end.

[0018] In the catheter of this embodiment, for example, the three-dimensional deformation region set in the distal portion of the catheter body can have a double lumen structure, constituting a manipulation lumen and a functional lumen, while the proximal portion of the catheter body can have a single lumen with a common lumen. This allows the manipulation lumen to be offset from the center of the catheter in the three-dimensional deformation region, allowing for efficient three-dimensional bending deformation of the catheter body due to the tensile force of the manipulation wire, while at the proximal end of the catheter body, moving the manipulation wire closer to the center of the catheter can prevent unnecessary deformation of the catheter body due to the tensile force of the manipulation wire. Furthermore, the common lumen allows for a larger lumen diameter than the manipulation lumen, thereby reducing insertion resistance of the manipulation lumen and improving the ease of assembly of the manipulation lumen.

[0019] A sixth aspect of the present invention is a catheter according to any one of the first to fifth aspects, wherein in the three-dimensional deformation region, the circumferential twisting of the operating lumen in the initial state is less than one revolution around the central axis of the catheter body.

[0020] In this embodiment, the catheter can efficiently generate three-dimensional bending deformation by applying a tensile force externally through the operating wire while suppressing the generation of axial compressive stress in the catheter body, and can generate deformation in the three-dimensional deformation region without requiring an excessively large tensile force.

[0021] Although it depends on the type of deformation required in the three-dimensional deformation region, the circumferential twist of the operating lumen in the initial state in the three-dimensional deformation region is set to 45 degrees or more in the circumferential direction.

[0022] A seventh aspect of the present invention is a catheter according to any one of the first to sixth aspects, wherein the three-dimensional deformation region is provided in the distal end portion of the catheter body, and the circumferential twist of the operating lumen in the initial state is 90 degrees ± 45 degrees around the central axis of the catheter body, and the catheter is capable of being inserted into the heart.

[0023] The catheter of this embodiment can be used advantageously, for example, when performing a procedure in which the catheter tip is inserted from the inferior vena cava through the right atrium into the coronary sinus (CS), making it possible to produce a novel three-dimensional curved shape at the catheter tip.

[0024] An eighth aspect of the present invention is as follows. A catheter having a catheter body to be inserted into the body, wherein an operating wire is inserted through the catheter body to form an operating lumen extending in the longitudinal direction of the catheter body, the tip of the operating wire is fixed to the tip side of the catheter, and in the initial state when no operating force is applied from the outside, the circumferential positions of the operating lumen on the base end side and the tip end side are relatively different, and the operating lumen on the base end side and the operating lumen on the tip end side are continuous.

[0025] In the catheter according to this aspect, when a pulling force is applied to the operating wire, the proximal and distal operating lumens, which are located at relatively different circumferential positions of the catheter body, are twisted in a direction toward each other in the circumferential direction, thereby producing a three-dimensional curved deformation of the catheter body. As a result, for example, procedures requiring catheter manipulation that were difficult with conventional two-dimensional deformation modes can be easily performed.

[0026] In the catheter according to this aspect, a three-dimensional deformation region capable of three-dimensional bending deformation can be formed by a longitudinal region in which the circumferential position of the manipulation lumen is relatively different. For example, a proximal lumen extending substantially along the central axis of the catheter main body may be provided further proximal to the three-dimensional deformation region in the longitudinal direction of the catheter main body, and a manipulation wire may be routed through the proximal lumen. In this case, the proximal lumen may be used as the common lumen according to the fifth aspect, and the manipulation lumen and functional lumen may be formed by extending from the common lumen toward the catheter tip.

[0027] A ninth aspect of the present invention is as follows. A method for manufacturing a catheter body with an operating lumen that is twisted circumferentially in the longitudinal direction, the method comprising the steps of: preparing a catheter body having an operating lumen that is linearly formed in the longitudinal direction and through which an operating wire is inserted; and twisting both longitudinal sides of a twisted region set in a longitudinal intermediate portion of the catheter body in the circumferential direction while heating the twisted region.

[0028] According to the method of the present invention, it is possible to easily manufacture a catheter body having a specially shaped operating lumen that can be used in, for example, the catheters according to the first to eighth aspects described above, by utilizing a catheter body having a simple shape with an operating lumen extending linearly in the longitudinal direction, which is manufactured by, for example, extrusion molding or pultrusion molding. [Effects of the Invention]

[0029] According to the present invention, by applying a pulling force to the operating wire, a bending force and a circumferential rotational force (torsion force) act together on the catheter body, effectively bending and deforming the catheter body in three dimensions. This makes it easy to perform catheter manipulations, such as pointing the catheter tip in a direction that was difficult with conventional two-dimensional deformation. [Brief explanation of the drawings]

[0030] [Figure 1] 1A and 1B are diagrams showing a catheter according to an embodiment of the present invention, in which (a) is a schematic overall view and (b) is an enlarged view of a distal end portion. [Figure 2] FIG. 2 is an explanatory diagram illustrating the operation lumen and operation catheter in the distal end portion of the catheter shown in FIG. 1. [Figure 3] [a], [b], and [c] are cross-sectional views corresponding to the cross sections IIIa-IIIa, IIIb-IIIb, and IIIc-IIIc in Figure 2. [Figure 4] FIG. 2 is a perspective view showing the distal end portion of the catheter shown in FIG. 1 in a three-dimensionally curved and deformed state due to a pulling force. [Figure 5] 2A and 2B are explanatory diagrams showing an example of application of the catheter shown in FIG. 1, in which (a) is a diagram of a heart model before catheter insertion, and (b) is a diagram of a heart model after catheter insertion. [Figure 6] FIG. 2 is an explanatory diagram for explaining a manufacturing process of the catheter shown in FIG. 1. [Figure 7] FIG. 10 is a cross-sectional view illustrating another embodiment of the catheter body according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0031] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0032] First, Fig. 1 shows the overall appearance from the side of a schematic configuration of a catheter 10 according to one embodiment of the present invention. This catheter 10 is an example of an electrode catheter for the heart, and includes a long catheter body 12. The distal end (left side in Fig. 1) of the catheter body 12 is provided with a plurality of electrodes 14 required for detecting myocardial action potentials, applying electrical stimulation, and the like. Meanwhile, the proximal end (right side in Fig. 1) of the catheter body 12 is provided with a hub 16 that is held by a practitioner during treatment. The hub 16 is also provided with a connector 20 for external connection that is connected to the electrodes 14 by an electric wire 18.

[0033] More specifically, the catheter body 12 constituting the catheter 10 of this embodiment is a long member that is small in diameter and flexible enough to be inserted into a body cavity such as a blood vessel from outside the body, and is made of a synthetic resin that is resistant to the liquids (including medicinal solutions) used and is biocompatible. The specific material of the catheter body 12 is not limited, and, taking into account the required characteristics, etc., a fluorine-based or olefin-based thermoplastic polymer resin or the like may be used in accordance with various conventionally known catheters, and various surface treatments or multilayer structures may be used as appropriate to impart hydrophilicity, hydrophobicity, low friction, etc.

[0034] In this embodiment, which illustrates an electrode catheter, multiple electrodes 14 are provided in the distal portion of the catheter body 12. Specifically, a tip electrode 14a is provided at the very tip of the catheter body 12. In addition, multiple outer peripheral surface electrodes 14b (a total of nine in FIG. 1 ) extending annularly in the circumferential direction with a predetermined width are provided exposed on the outer peripheral surface of the distal portion of the catheter body 12 and spaced apart from one another along the catheter length. Note that the number, positions, and sizes of these electrodes 14 are not limited. For example, only outer peripheral surface electrodes 14b may be provided without the tip electrode 14a, or the tip electrode 14a may be ring-shaped.

[0035] Each of these multiple electrodes 14 is formed from an electrically conductive material (metal) and exposed on the surface of the catheter, and is capable of, for example, detecting the electrical potential of body tissue by contacting the surface of the body tissue, or of providing electrical stimulation to the body tissue by supplying power from an external source.

[0036] The catheter body 12, which is equipped with such an electrode 14 at its distal end, is shaped like a hollow pipe having a lumen extending in the longitudinal direction. The outer circumferential shape of the catheter body 12 is not limited, but suitable outer circumferential cross-sectional shapes include a perfect circle, an ellipse, and a polygon with arc-shaped corners. The number and size of the lumens in the catheter body 12 are also not limited, and an appropriate number of lumens, each with an appropriate size and shape, can be provided depending on the application and required functions of the catheter 10.

[0037] In this embodiment, which illustrates an electrode catheter, at least one operating lumen 22 and at least one wiring lumen 24 are formed with a luminal structure that extends independently over the entire length. In this embodiment, the wiring lumen 24 is a functional lumen, and current-carrying wires 18 connected to each electrode 14 are wired through the wiring lumen 24. Each current-carrying wire 18 is connected to one electrode 14 at its distal end, while its proximal end extends from the proximal end of the wiring lumen 24 and is connected to the connector 20 via the hub 16.

[0038] More specifically, in this embodiment, as shown in Figure 3, one operation lumen 22 and one wiring lumen 24 are formed. The operation lumen 22 is formed eccentrically toward the outer periphery with respect to the catheter central axis 26. Preferably, in the cross section shown in Figure 3, the entire operation lumen 22 is formed at a position that does not include the catheter central axis 26. The shape of the inner peripheral surface of the operation lumen 22 is not particularly limited, but a perfect circle or an ellipse is preferable.

[0039] The wiring lumen 24 can be formed on the same central axis as the catheter central axis 26, or can be formed with an eccentric central axis. For example, as shown in Figure 3, when one operating lumen 22 and one wiring lumen 24 are provided, by forming the wiring lumen 24 with a central axis that is eccentric in a different direction from the central axis of the operating lumen 22 with respect to the catheter central axis 26 (in the opposite radial direction in the illustrated example), it becomes possible to form the operating lumen 22 and the wiring lumen 24 with approximately circular cross sections and as large a cross-sectional area as possible.

[0040] An operation wire 28 is inserted through the operation lumen 22. The tip of the operation wire 28 is fixed to the tip side of the catheter 10, and in this embodiment, the tip of the operation wire 28 is fixed to the tip electrode 14a. The base end of the operation wire 28 extends from the proximal end of the catheter main body 12 and is connected to the operation section of the hub 16. The practitioner can apply or release a pulling force to the operation wire 28 by rotating or otherwise operating the operation section 16a of the hub 16.

[0041] The specific mechanism that applies a tensile force to the operating wire 28 in the hub 16 is not limited, and various mechanisms can be used, such as a winding-type rotation mechanism, a tension-type slide mechanism, or a composite mechanism such as a rack and pinion that combines a rotating member and a slide member.A stopper mechanism that maintains the tensile force applied to the operating wire 28 can also be used as appropriate.

[0042] Furthermore, it is desirable that the operation wire 28 be disposed slidably without being adhered to the inner circumferential surface of the operation lumen 22, and it is preferable that the operation wire 28 have an outer diameter smaller than the inner diameter of the operation lumen 22. There are no limitations on the material of the operation wire 28, and various wire materials (including twisted wires) such as metals and resins that have sufficient strength resistance and tensile strength characteristics in consideration of the tensile operating force to be applied can be used. Furthermore, a low-friction coating layer or the like may be provided on the outer circumferential surface of the operation wire 28 for the purpose of improving slidability with the operation lumen 22, etc.

[0043] 2 and 3, the operating lumen 22, through which the operating wire 28 is inserted, has a circumferentially twisted shape in a predetermined region, twisted circumferentially in the longitudinal direction of the catheter main body 12. In order to clearly show the twisted shape of the operating lumen 22, Fig. 2 shows the operating lumen 22 and the operating wire 28 in a see-through side view, with hatching applied to the portion excluding the operating lumen 22, the wiring lumen 24 is shown imaginarily by a dashed line in the figure, and the outer peripheral surface electrode 14b is not shown.

[0044] In this embodiment, a region where the operating lumen 22 has a circumferentially twisted shape is set in the distal end portion of the catheter main body 12, and this region serves as a three-dimensional deformation region 30 that undergoes three-dimensional curvature deformation due to a tensile operating force applied from the outside through the operating wire 28. Furthermore, in the electrode catheter of this embodiment, the three-dimensional deformation region 30 includes the regions where the multiple electrodes 14 are arranged, and is set as a region that extends a predetermined length from the regions where these electrodes 14 are arranged toward the base end.

[0045] As a result, when the practitioner applies an external pulling force to the manipulation wire 28, an axial pulling force (a compressive force on the catheter body 12) acts at an eccentric position on the distal end of the catheter body 12 via the tip electrode 14a, and a bending moment corresponding to the pulling force and the amount of eccentricity is applied to the three-dimensional deformation region 30 of the catheter body 12. At the same time, the pulling force on the manipulation wire 28 also generates a component force in a direction that straightens the manipulation wire 28, so that a torsional force corresponding to the pulling force and the twist of the manipulation wire 28 (twist of the manipulation lumen 22) is applied to the three-dimensional deformation region 30 of the catheter body 12. As a result, a three-dimensional deformation occurs in the three-dimensional deformation region 30 of the catheter body 12 as a result of the resultant force of the bending moment and the torsional force.

[0046] A specific example of a modified form of this embodiment is shown in Figure 4. Because of this three-dimensional deformation occurring at the distal end portion of the catheter 10, for example, as shown in Figures 5(a) and (b), when the distal end portion of the catheter 10 is inserted from the femoral region of a human body through the inferior vena cava 36 and from the right atrium 38 to the coronary sinus 40 to detect human tissue potentials using the electrodes 14, it is necessary to first extend the distal end of the catheter 10 inserted from the inferior vena cava 36 to the right atrium 38 toward the left front of the body and then turn it toward the rear of the body to guide it into the coronary sinus 40. This procedure for introducing the distal end of the catheter 10 can be more easily performed with the catheter 10 of this embodiment, which has the above-described three-dimensional deformation region 30 at its distal end portion.

[0047] The overall circumferential twist amount and axial length of the operating lumen 22 in the three-dimensional deformation region 30, the twist angle (inclination angle relative to a line parallel to the axial direction) of the twisted portion, and other such parameters are not limited and can be set appropriately taking into consideration the required deformation form and the strength characteristics of the catheter main body 12. For example, the circumferential twist of the operating lumen 22 is desirably set to one revolution or less around the central axis of the catheter main body 12, more preferably within the range of 180°±90°, and even more preferably 90°±45° as in this embodiment. Furthermore, the maximum twist angle of the operating lumen 22 is desirably set within the range of 1 to 45°, and more preferably within the range of 5 to 15° as in this embodiment. By setting the circumferential twist of the operating lumen 22 within this range, it becomes possible to more efficiently generate three-dimensional bending deformation in the three-dimensional deformation region 30 by, for example, suppressing the action of axial compressive force on the catheter main body 12 in the three-dimensional deformation region 30 when a tensile operating force is applied by the operating wire 28. Furthermore, the axial length of the three-dimensional deformation region 30 can be set within a range of, for example, 5 to 30 cm, and more specifically, considering application to a cardiac electrode catheter, an axial length of 5 to 15 cm is desirable.

[0048] Furthermore, from the viewpoint of more efficiently and stably generating deformation in the three-dimensional deformation region 30, it is desirable that the catheter main body 12 be capable of flexibly deforming in the three-dimensional deformation region 30. That is, it is desirable that the three-dimensional deformation region 30 be more flexibly deformable than a region of the catheter main body 12 that should maintain a substantially straight shape even when a pulling operating force is applied through the operating wire (a region outside the three-dimensional deformation region 30).

[0049] To make the three-dimensional deformation region 30 more flexible than other regions, the catheter body 12 can be made of a different material or the radial thickness (outer diameter) of the catheter body 12 can be made different. Alternatively, flexibility can be adjusted by disposing a reinforcing material such as a braid in the region excluding the three-dimensional deformation region 30. Specifically, in this embodiment, the region of the catheter body 12 excluding the distal end portion that constitutes the three-dimensional deformation region 30, i.e., the region from the proximal end of the catheter body 12 to the three-dimensional deformation region 30, can be made of a braided tube, and the three-dimensional deformation region 30 can be made of a tube without a braid, thereby stabilizing and facilitating bending deformation in the three-dimensional deformation region 30.

[0050] The catheter 10 of this embodiment as described above can be manufactured, for example, as follows.

[0051] First, a catheter main body 12' is prepared using a thermoplastic resin, with an operating lumen 22 formed linearly in the longitudinal direction, through which an operating wire 28 is inserted (see FIG. 6). Such a catheter main body 12' can be easily manufactured by cutting a tubular molded product, which is manufactured by extrusion molding, pultrusion molding, or the like, using a thermoplastic resin as the molding material, to a predetermined length. Although not shown in FIG. 6, other functional lumens, such as the wiring lumen 24 of this embodiment, can also be formed simultaneously with the operating lumen 22.

[0052] Next, after the electrodes 14 are provided on the catheter main body 12' having a linearly extending lumen or after the operating wire 28 is inserted and provided therethrough, or before the electrodes 14 and / or the operating wire 28 are provided, the catheter main body 12' is subjected to a twisting process. This twisting process can be performed, for example, by applying heat using a mold or the like to a portion (twisting region) in the catheter main body 12' that is to be set as the three-dimensional deformation region 30 and where the operating lumen 22 is to be twisted in the circumferential direction, while applying an external force to twist both longitudinal ends of the twisting region relative to each other in the circumferential direction.

[0053] Then, by forming the desired twisted shape and performing a cooling treatment as necessary to fix the twisted shape, it is possible to obtain a catheter main body 12 equipped with a three-dimensional deformation region 30 having an operating lumen 22 twisted in the circumferential direction, as shown in Figures 2 and 3. That is, in the initial state when no external operating force is applied, the circumferential positions of the operating lumen 22 on the base end side and the tip end side of the catheter main body 12 are relatively different, and the operating lumen 22 on the base end side and the operating lumen 22 on the tip end side of the catheter main body 12 are continuous, thereby obtaining the catheter of this embodiment as described above.

[0054] According to this manufacturing method, it is possible to easily and efficiently manufacture catheter bodies 12 in which the operating lumen 22 is provided with various arbitrary twisted configurations in arbitrary regions in the longitudinal direction, using a catheter body 12' that is easy to manufacture because the operating lumen 22 is formed linearly in the longitudinal direction.

[0055] Although one embodiment of the catheter 10 according to the present invention has been described in detail above, the present invention should not be construed as being limited by such an embodiment or the specific or exemplary descriptions in this specification.

[0056] For example, although the above embodiment shows an example of application to an electrode catheter, the present invention can be applied to various catheters that are inserted into biological lumens such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs, and are used for diagnosing or treating the inside of biological lumens.

[0057] Furthermore, various lumens may be provided depending on the functions required of the catheter, and depending on the form of the lumen, a single lumen may be provided on the central axis of the catheter. Specifically, as illustrated in Fig. 7, it is also possible to provide a central lumen 44 of an irregular shape that extends in one radial direction (left-right direction in the figure) including the central axis of the catheter, and a first lumen 46 and a second lumen 48 that are independently positioned on both sides in the other radial direction (up-down direction in the figure) perpendicular to the central lumen 44. For example, the first lumen 46 may be an operation lumen through which the operation wire 28 is inserted, and the central lumen 44 and the second lumen 48 may be functional lumens, with the current-carrying wire 18 inserted into the central lumen 44 and the second lumen 48 being a guidewire lumen through which a guidewire 50 is inserted.

[0058] Furthermore, the three-dimensional deformation region 30 in which the operating lumen 22 in which the operating wire 28 is arranged is twisted circumferentially in the longitudinal direction can be set in a plurality of different regions, for example, in the longitudinal direction of the catheter body 12, and the direction of twist (left and right circumferential direction), amount of twist (magnitude of circumferential twist), inclination angle, etc. of the operating lumen 22 can be set separately for each of these different three-dimensional deformation regions.

[0059] Furthermore, even in one three-dimensional deformation region 30, by partially varying the twist angle of the operating lumen 22 along the length of the catheter body 12, it is possible to adjust the three-dimensional deformation shape generated in the three-dimensional deformation region 30 by the tensile operating force of the operating wire 28.

[0060] It is also possible to provide a plurality of operation lumens 22 in which operation wires 28 are arranged, and for example, operation lumens 22 may be provided with different twisting directions in one three-dimensional deformation region 30, and a tensile operation force may be selectively applied to each inserted operation wire, thereby controlling the direction of bending deformation occurring in the three-dimensional deformation region. Alternatively, by providing two or more operation lumens 22 adjacent to each other in the circumferential direction, it is possible to input a large tensile operation force while reducing the diameter of the operation lumen 22 and, therefore, the inserted operation wire 28.

[0061] Furthermore, it is desirable that the operating lumen 22 be formed with a central axis that is eccentric with respect to the central axis (elastic central axis) of the catheter body 12, but for example, in the longitudinal region excluding the three-dimensional deformation region (the region that maintains a substantially straight shape even when a tensile operating force is applied to the operating wire 28), it may be provided on the central axis of the catheter body 12.

[0062] More specifically, for example, in the three-dimensional deformation region 30 set in the distal portion of the catheter main body 12, the manipulation lumen 22 and the functional lumen (wiring lumen) 24 may be formed substantially independently of each other as in the above embodiment, while on the proximal side of the three-dimensional deformation region 30, as shown by the hidden line (dashed line) in Fig. 3(c), a large-diameter common lumen 54 may be formed extending straight along approximately the central axis of the catheter main body 12, with the manipulation lumen 22 and the functional lumen (wiring lumen) 24 extending distally from the common lumen 54. By employing such a common lumen 54, the manipulation wire 28 can be positioned closer to the central axis of the catheter main body 12 on the proximal side of the three-dimensional deformation region 30, making it possible to suppress unnecessary bending deformation of the proximal portion of the catheter main body 12 due to the manipulation force applied through the manipulation wire 28. Furthermore, the cross-sectional area of ​​the lumen through which the operation wire 28 and the like are inserted can be increased, and the workability of inserting the operation wire 28 and the like can be improved.

[0063] In the above embodiment, each lumen at the distal tip of the catheter body 12 is covered with the tip electrode 14a. However, depending on the required characteristics of the catheter to which the present invention is applied, the lumen may be open at the tip of the catheter body 12. Furthermore, when applied to an electrode catheter, the tip of the operation lumen 22 may be fixed to the outer peripheral electrode 14b other than the tip electrode 14a. The specific structure for fixing the tip side of the operation lumen 22 to the catheter body 12 at the tip side of the three-dimensional deformation region is not limited. For example, the tip side of the operation lumen 22 may be fixed directly to the catheter body 12 by adhesive or welding, or by fixing to an anchor member embedded inside the catheter body 12 or a marker provided on the catheter body 12.

[0064] Furthermore, the method for manufacturing a catheter according to the present invention is not limited to the processes described in the above-described embodiments. For example, when manufacturing a tubular catheter body having an operating lumen by continuous pultrusion or extrusion molding of a synthetic resin material, the molding die and the holding member of the pultrusion or extrusion molded product may be rotated relative to each other about a central axis during molding of the region corresponding to the three-dimensional deformation region, thereby plastically torsionally deforming the operating lumen during resin molding of the catheter body, thereby simultaneously forming a circumferentially twisted shape for the operating lumen. Alternatively, a twisted tube having a lumen that is continuously twisted circumferentially along its length may be cut to a predetermined length to form only the three-dimensional deformation region, and a straight tube having a separately formed straight lumen may be axially connected to the twisted tube to obtain a catheter according to the present invention having a three-dimensional deformation region in a predetermined longitudinal region.

[0065] Although not listed here, the present invention can be implemented in various forms with various changes, modifications, improvements, etc. made based on the knowledge of those skilled in the art, and it goes without saying that all such embodiments are included within the scope of the present invention as long as they do not deviate from the spirit of the present invention. [Explanation of symbols]

[0066] 10 Catheter 12 catheter body 14 electrodes (14a tip electrode, 14b outer surface electrode) 16 Hub (16a operation part) 18 Power Lines 20 Connectors 22 operating lumen 24 wiring lumens (functional lumens) 26 Catheter central shaft 28 Control wire 30 Three-dimensional deformation domain 36 Inferior vena cava 38 Right atrium 40 Coronary sinus 44 central lumens 46 first lumen 48 Second Lumen 50 Guidewire 54 common lumens

Claims

1. A catheter having a catheter body that can be inserted into a body, the catheter body extends substantially straight in an initial state, The catheter body has a continuous operation lumen formed in the longitudinal direction, and an operation wire is inserted through the operation lumen, with the tip of the operation wire fixed to the tip side of the catheter. In the initial state, the operating lumen through which the operating wire is inserted is twisted circumferentially in the longitudinal direction of the catheter body, The catheter has a three-dimensional deformation region in the catheter body that is curved and deformed three-dimensionally by a tensile operating force applied from the outside through the operating wire.

2. 2. The catheter according to claim 1, wherein the three-dimensionally deformable region is more flexible than a region of the catheter body that maintains a substantially straight shape even when a pulling force is applied through the operating wire.

3. 3. The catheter according to claim 1, wherein the three-dimensional deformation region is located at a distal end portion of the catheter body.

4. The catheter body has a functional lumen formed therein, the functional lumen extending in the longitudinal direction at a circumferential position different from that of the operating lumen, 3. The catheter according to claim 1, wherein both the operating lumen and the functional lumen are formed offset from the central axis of the catheter body and twisted in the same phase in the circumferential direction along the length of the catheter body.

5. 5. The catheter according to claim 4, wherein a common lumen is formed in the proximal end portion of the catheter body, and the operating lumen and the functional lumen are formed by extending from the common lumen to the distal end side.

6. In the three-dimensional deformation region, 3. The catheter according to claim 1, wherein the circumferential twist of the operating lumen in the initial state is less than one revolution around the central axis of the catheter body.

7. the three-dimensional deformation region is provided in a distal end portion of the catheter body, a circumferential twist of the operating lumen in the initial state is set to 90°±45° around the central axis of the catheter main body; 3. The catheter according to claim 1, which is inserted into the heart.

8. A catheter having a catheter body that can be inserted into a body, an operating wire is inserted through the catheter body to form an operating lumen extending in the longitudinal direction of the catheter body, and the tip of the operating wire is fixed to the tip side of the catheter; A catheter in which, in an initial state when no external operating force is applied, the circumferential positions of the operating lumen are relatively different on the base end side and the tip end side of the operating lumen, and the operating lumen on the base end side and the operating lumen on the tip end side are continuous.

9. A step of preparing a catheter body having an operating lumen formed linearly in the length direction, through which an operating wire is inserted; a step of heating a twisted region set in a longitudinally intermediate portion of the catheter body and twisting both longitudinal portions of the twisted region in a circumferential direction relative to each other; A method for manufacturing a catheter body having a working lumen that is circumferentially twisted in the longitudinal direction, comprising:

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