Catheter and method of manufacturing the same

Abstract

A catheter comprises: a shaft (10) having a distal end and a proximal end in a longitudinal direction (x), the shaft (10) having a first side hole (31) and a second side hole (32) in a wall (12); an insert component (20) located in an inner cavity (11) of the shaft; a first electrode (41) located outside the first side hole (31); and a first wire (51) connected to the first electrode (41) and extending from the first side hole (31) to the inner cavity (11) outside the insert component (20); the first wire (51) having a first position (61) in the shaft (10) which is the same as the first side hole (31) and a second position (62) which is the same as the second side hole (32) in the longitudinal direction (x), and in the circumferential direction of the insert component (20), the second position (62) is offset by more than 45 degrees relative to the first position (61).

Description

Technical Field

[0001] The present invention relates to an electrode catheter used for measuring the potential of an internal organ, mainly a heart, and for cauterizing internal tissue, and a method for manufacturing the electrode catheter. Background Art

[0002] The electrode catheter, which is a catheter having electrodes on the shaft, is mainly used as a medical device for diagnosing arrhythmia by measuring the potential of the heart, or for causing a high-frequency current to flow and burn the tissue in the body in order to treat arrhythmia. In the electrode catheter, a plurality of electrodes are arranged on the outside of the shaft having an inner cavity. The wire electrically connected to the inner surface of the electrode extends to the electrocardiograph through the inner cavity of the shaft. The connector is used to connect the wire to the electrocardiograph. Therefore, for example, by inserting the electrode catheter into the patient's heart and connecting the connector to the electrocardiograph, the electrocardiogram near the electrode part can be measured, and the condition of the myocardium that causes the arrhythmia can be accurately grasped. For example, Patent Document 1 discloses that the direction of the distal end of the electrode catheter inserted into the heart can be changed.

[0003] Patent Document 1: Japanese Patent Application Publication No. 2012-176163

[0004] like Fig.11 As shown in FIG. 1 , in the above-mentioned conventional catheter 101, the wire 150 connected to the electrode 140 is introduced into the shaft 110 through the side hole 130 provided on the wall of the shaft 110. In the shaft 110, the wire 150 is arranged to extend linearly along the long axis direction x of the shaft 110. However, the wire 150 is made of metal and is difficult to stretch. Therefore, if the distal end of the catheter 101 is to be bent, the wire 150 is supported, and there is a concern that the flexibility of the distal end of the catheter 101 is impaired. In particular, when an inserting member 120 is provided in the lumen of the shaft 110 for the purpose of maintaining the shape of the distal end of the shaft 110 during surgery or bending the distal end of the shaft 110 during surgery, the lumen of the shaft 110 becomes narrower, so that the movement of the wire 150 is further restricted, and thus the wire 150 is easily supported. Therefore, an object of the present invention is to provide a catheter and a manufacturing method thereof that can ensure the flexibility of the distal end. Summary of the invention

[0005] One embodiment of the catheter of the present invention capable of solving the above-mentioned problems is characterized in that it comprises: a shaft having a distal end and a proximal end in the longitudinal direction, the shaft having a first side hole and a second side hole provided in a wall of the shaft adjacent to each other in order from the distal side, and an inner cavity extending in the longitudinal direction; an inserting member arranged in the inner cavity of the shaft; a first electrode provided outside the first side hole; and a first guide wire electrically connected to the first electrode and extending through the first side hole in the inner cavity of the shaft and outside the inserting member, the first guide wire having a first position in the longitudinal direction of the shaft that is the same as the first side hole and a second position in the longitudinal direction of the shaft that is the same as the second side hole, the first guide wire being located at the second position offset by more than 45 degrees in the circumferential direction of the inserting member relative to the first position. According to the above-mentioned catheter, the first guide wire is arranged at the second position that is offset by more than 45 degrees in the circumferential direction of the inserting member relative to the first position, thereby making it possible to provide a margin for the length of the first guide wire in the inner cavity of the shaft. Therefore, even if the first guide wire is stretched due to the bending of the shaft, the stretch can be absorbed by the excess length, thereby preventing the first guide wire from being supported. Therefore, the flexibility of the distal end portion of the catheter can be ensured.

[0006] Another embodiment of the catheter of the present invention capable of solving the above-mentioned problems is characterized in that it comprises: a shaft having a distal end and a proximal end in the longitudinal direction, the shaft having a first side hole, a second side hole, and a third side hole arranged in a wall of the shaft in order from the distal side and adjacent to each other, and an inner cavity extending in the longitudinal direction; an inserting member arranged in the inner cavity of the shaft; a first electrode arranged outside the first side hole; and a first guide wire electrically connected to the first electrode and extending through the first side hole in the inner cavity of the shaft and outside the inserting member, the first guide wire having a first position in the longitudinal direction of the shaft that is the same as the first side hole, a second position in the longitudinal direction of the shaft that is the same as the second side hole, and a third position in the longitudinal direction of the shaft that is the same as the third side hole, the first guide wire being located at a position offset by more than 90 degrees in the circumferential direction of the inserting member relative to the first position. According to the above-mentioned catheter, the first guide wire is arranged at a position offset by more than 90 degrees in the circumferential direction of the inserting member relative to the first position at the third position, thereby making it possible to provide a margin for the length of the first guide wire in the inner cavity of the shaft. Therefore, even if the first guide wire is stretched due to the bending of the shaft, the stretch can be absorbed by the excess length, thereby preventing the first guide wire from being supported. Therefore, the flexibility of the distal end portion of the catheter can be ensured.

[0007] In the above-mentioned catheter, it is preferable that the first guide wire is looped around the outside of the insertion member from the first position toward the second position.

[0008] Preferably, the catheter further comprises a second electrode disposed on the outside of the second side hole and a second wire electrically connected to the second electrode and extending through the second side hole in the inner cavity of the shaft and on the outside of the insertion component. A third side hole is disposed in the wall of the shaft and on the side closer to the second side hole. The second wire has a second position in the shaft in the direction of the long axis of the shaft which is the same as that of the second side hole and a third position in the direction of the long axis of the shaft which is the same as that of the third side hole. The second wire is located at the third position which is offset by more than 45 degrees in the circumferential direction of the insertion component relative to the second position.

[0009] In the above catheter, preferably, a direction in which the first guide wire is looped around the outer side of the insertion member from the first position toward the second position is the same as a direction in which the second guide wire is looped around the outer side of the insertion member from the second position toward the third position.

[0010] In the above catheter, preferably, a direction in which the first guide wire is looped around the outer side of the insertion member from the first position toward the second position is opposite to a direction in which the second guide wire is looped around the outer side of the insertion member from the second position toward the third position.

[0011] In the above-mentioned catheter, it is preferable that the first side hole and the second side hole are located at positions overlapping each other in the circumferential direction of the shaft.

[0012] In the above-mentioned catheter, it is preferable that the first side hole and the second side hole are located at positions that do not overlap each other in the circumferential direction of the shaft.

[0013] In the above-mentioned catheter, preferably, the shaft, the insertion member, and the first guide wire are fixed to each other at a position closer to the second side hole.

[0014] Still another embodiment of the catheter of the present invention capable of solving the above-mentioned problems is characterized in that it comprises: a shaft having a distal end and a proximal end in the longitudinal direction, the shaft having a fourth side hole provided on the wall of the shaft and an inner cavity extending in the longitudinal direction; an inserting member arranged in the inner cavity of the shaft; a fourth electrode provided outside the fourth side hole; and a fourth wire electrically connected to the fourth electrode and extending through the fourth side hole in the inner cavity of the shaft and outside the inserting member, the catheter having a fixing portion fixing the shaft, the inserting member and the fourth wire to each other on the side closer to the fourth side hole, the fourth wire having a fourth position in the longitudinal direction of the shaft that is the same as the fourth side hole and a fifth position in the longitudinal direction of the shaft that is the same as the fixing portion, and the fourth wire is located at the fifth position at a position offset by more than 90 degrees in the circumferential direction of the inserting member relative to the fourth position. According to the catheter, the fourth wire is arranged at the fifth position at a position offset by more than 90 degrees in the circumferential direction of the inserting member relative to the fourth position, thereby making it possible to allow a margin for the length of the fourth wire in the inner cavity of the shaft. Therefore, even if the fourth guide wire is stretched due to the bending of the shaft, the stretch can be absorbed by the excess length, thereby preventing the fourth guide wire from being supported. Therefore, the flexibility of the distal end portion of the catheter can be ensured.

[0015] In the above catheter, the fourth side hole is preferably located on the side closer to the longitudinal side than the center of the length from the distal end of the shaft to the distal end of the fixing portion in the longitudinal direction of the shaft.

[0016] In the above-mentioned catheter, it is preferable that the fourth guide wire is looped around the outside of the insertion member from the fourth position toward the fifth position.

[0017] In the above-mentioned catheter, the inserted component preferably comprises: a tube component having a distal end and a proximal end in the long axis direction and an inner cavity extending along its long axis direction; and an elastic component, which is arranged in the inner cavity of the tube component, and the outer shape of the cross section of the tube component perpendicular to the long axis direction is an ellipse with a long axis and a short axis, and the first side hole or the fourth side hole is arranged to be opposite to the short axis portion of the ellipse of the tube component.

[0018] In the above catheter, it is preferable that the axis is bendable in two directions: a normal direction to the first side hole or the fourth side hole and a direction opposite to the normal direction.

[0019] The present invention also provides a method for manufacturing a catheter. One embodiment of the method for manufacturing a catheter of the present invention that can solve the above-mentioned problems is characterized in that it sequentially comprises: a step of preparing a shaft, wherein the shaft has a distal end and a proximal end in the longitudinal direction, a first side hole is provided on the wall of the shaft, and the shaft has an inner cavity extending in the longitudinal direction; a step of inserting a first guide wire into the inner cavity of the shaft from the first side hole and exposing the first guide wire from the proximal end of the shaft; a step of inserting an insert component into the inner cavity of the shaft; a step of pulling the first guide wire in a state where the shaft is bent; and a step of releasing the bending of the shaft. The method for manufacturing the catheter sequentially comprises a step of pulling the first guide wire in a state where the shaft is bent and a step of releasing the bending of the shaft, so that the length of the first guide wire in the inner cavity of the shaft can have a margin. Therefore, even if the first guide wire is stretched due to the bending of the shaft during surgery, it can be absorbed by the excess length, thereby preventing the first guide wire from being supported. Therefore, the flexibility of the distal end of the catheter can be ensured.

[0020] The manufacturing method of the above-mentioned catheter is preferably such that in the shaft preparation process, the shaft is constructed such that a second side hole is provided in the wall of the shaft and on the side closer to the first side hole, and the first side hole and the second side hole are located at positions overlapping each other in the circumferential direction of the shaft, and in the process of pulling the first guide wire, the first side hole and the second side hole are arranged on the outer side of the bend.

[0021] The manufacturing method of the above-mentioned catheter preferably comprises, in a shaft preparation step, a shaft structure in which a second side hole is provided in the wall of the shaft and on a side closer to the first side hole, and the manufacturing method of the above-mentioned catheter further comprises, before the step of inserting the insertion component into the inner cavity of the shaft, a step of inserting the second guide wire into the inner cavity of the shaft from the second side hole and exposing the second guide wire from the proximal end of the shaft, and in the step of pulling the first guide wire, the second guide wire is also pulled.

[0022] The above-mentioned method for manufacturing a catheter preferably further comprises, after the step of releasing the bend of the shaft, a step of fixing the shaft, the first guide wire, and the insertion member to each other at a position closer to the first side hole.

[0023] The catheter manufacturing method described above preferably further comprises a step of fixing the shaft, the first guide wire, and the insertion member to each other at a position closer to the first side hole before the step of releasing the bend of the shaft and after the step of pulling the first guide wire.

[0024] According to the catheter and the manufacturing method thereof, the length of the guide wire in the inner cavity of the shaft can have an excess. Therefore, even if the guide wire is stretched due to the bending of the shaft, it can be absorbed by the excess length, thereby preventing the guide wire from being supported. Therefore, the flexibility of the distal end of the catheter can be ensured. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 A side view showing a catheter according to an embodiment of the present invention.

[0026] Figure 2 Indicates along Figure 1 Side cross-sectional view of the II-II line catheter.

[0027] Figure 3 Indicates along Figure 1 Side cross-sectional view of the III-III line catheter.

[0028] Figure 4 Indicates along Figure 2 Cross-sectional view of the catheter of an IV-IV line.

[0029] Figure 5 Indicates along Figure 2 Cross-sectional view of the V-V line catheter.

[0030] Figure 6 Indicates along Figure 2 Cross-sectional view of the catheter of line VI-VI.

[0031] Figure 7 Shown Figure 4 A cross-sectional view of a catheter of a modified example.

[0032] Figure 8 Shown Figure 2 A side cross-sectional view of a variation of the catheter shown.

[0033] Fig. 9 express Figure 1 A perspective view of the distal end of the shaft is shown.

[0034] Fig.10 Shown Fig. 9A stereoscopic view of a shaft of a modified example.

[0035] Fig.11 A side cross-sectional view along the longitudinal direction of a conventional catheter is shown. DETAILED DESCRIPTION

[0036] The present invention will be described in more detail below based on the following embodiments, but the present invention is not limited to the following embodiments and can be implemented by appropriately changing the above and the following purports, which are all included in the technical scope of the present invention. In addition, in each of the drawings, for convenience, hatching, component reference numerals, etc. may be omitted. In this case, refer to the specification and other drawings. In addition, the dimensions of the various components in the drawings are based on the premise of facilitating the understanding of the features of the present invention, and therefore may be different from the actual dimensions.

[0037] 1. Catheter

[0038] Catheters are used, for example, for the diagnosis and treatment of arrhythmias. In the diagnosis of arrhythmias, a catheter is inserted into a patient's body, electrodes are placed on or near the target tissue of the heart, and the potential of the tissue is measured, thereby obtaining an electrocardiogram. In addition, in the treatment of arrhythmias, for example, a high-frequency current can be passed through the electrodes of the catheter to cauterize the tissue in the body.

[0039] One embodiment of the catheter of the present invention is characterized in that it has: a shaft having a distal end and a proximal end in the longitudinal direction, the shaft having a first side hole and a second side hole arranged adjacent to each other in sequence from the distal side on the wall of the shaft, and an inner cavity extending in the longitudinal direction; an inserting member arranged in the inner cavity of the shaft; a first electrode arranged outside the first side hole; and a first wire electrically connected to the first electrode and extending outside the inserting member through the first side hole in the inner cavity of the shaft, the first wire having a first position in the longitudinal direction of the shaft that is the same as the first side hole and a second position in the longitudinal direction of the shaft that is the same as the second side hole, the first wire being located at a position where the second position is offset by more than 45 degrees in the circumferential direction of the inserting member relative to the first position. According to the above-mentioned catheter, the first wire is arranged at a position where the second position is offset by more than 45 degrees in the circumferential direction of the inserting member relative to the first position, thereby allowing the length of the first wire in the inner cavity of the shaft to have a margin. Therefore, even if the first wire is stretched due to the bending of the shaft, it can be absorbed by the excess length, thereby preventing the first wire from being supported. Therefore, the flexibility of the distal end portion of the catheter can be ensured. In the following description, this aspect is referred to as Embodiment 1.

[0040] The following problems exist in the existing catheters. When a straight catheter formed of a soft material is turned in a curved state, the length of the path of the catheter shaft wall is shortened on the inner side of the bend, and the length of the path is extended on the outer side of the bend. The catheter is bent in the case of a bending mechanism and following the bend in the body cavity. The shaft wall of the soft catheter has elasticity, so it can change its shape to follow the change of the shape of the catheter. On the other hand, the wire is made of metal and has no elasticity, so it cannot follow the change of the shape of the catheter. In the case of arranging the wire near the inner wall surface of the catheter shaft, if the inner wall surface is arranged on the outside of the bend, the wire cannot stretch and will want to move toward the inner side of the bend, so that the curved shape of the catheter does not become a predetermined shape or does not bend. In order to prevent such an undesirable situation, it is necessary to make the wire have a margin. However, the size of the inner cavity of the catheter shaft is limited, and due to manufacturing difficulties, it is difficult to arrange a wire longer than the length of the inner cavity of the straight catheter in the inner cavity. On the other hand, in the catheter of the first embodiment of the present invention in which the first guide wire is located at a position offset by 45 degrees or more in the circumferential direction from the first position to the second position, the length of the guide wire arranged between the first position and the second position is longer than that of the catheter in which the first guide wire is arranged linearly from the first position to the second position. Therefore, the length of the first guide wire in the inner cavity of the shaft can have a margin.

[0041] Another embodiment of the catheter of the present invention is characterized in that it comprises: a shaft having a distal end and a proximal end in the longitudinal direction, the shaft having a first side hole, a second side hole, and a third side hole which are arranged adjacent to each other in order from the distal side on the wall of the shaft, and an inner cavity extending in the longitudinal direction; an inserting member arranged in the inner cavity of the shaft; a first electrode arranged outside the first side hole; and a first guide wire which is electrically connected to the first electrode and extends through the first side hole in the inner cavity of the shaft and outside the inserting member, the first guide wire having a first position in the longitudinal direction of the shaft which is the same as the first side hole, a second position in the longitudinal direction of the shaft which is the same as the second side hole, and a third position in the longitudinal direction of the shaft which is the same as the third side hole, the first guide wire being located at a position which is offset by more than 90 degrees in the circumferential direction of the inserting member relative to the first position. According to the above-mentioned catheter, the first guide wire is arranged at a position which is offset by more than 90 degrees in the circumferential direction of the inserting member relative to the first position at the third position, thereby making it possible to allow a margin for the length of the first guide wire in the inner cavity of the shaft. Therefore, even if the first guide wire is stretched due to the bending of the shaft, it can be absorbed by the excess length, thereby preventing the first guide wire from being supported. Therefore, the flexibility of the distal end of the catheter can be ensured. In the following description, this mode is referred to as embodiment 2.

[0042] Still another embodiment of the catheter of the present invention is characterized in that it comprises: a shaft having a distal end and a proximal end in the longitudinal direction, the shaft having a fourth side hole provided on the wall of the shaft and an inner cavity extending in the longitudinal direction; an inserting member arranged in the inner cavity of the shaft; a fourth electrode arranged outside the fourth side hole; and a fourth wire electrically connected to the fourth electrode and extending through the fourth side hole in the inner cavity of the shaft and outside the inserting member, the catheter having a fixing portion fixing the shaft, the inserting member and the fourth wire to each other on the side closer to the fourth side hole, the fourth wire having a fourth position in the longitudinal direction of the shaft that is the same as the fourth side hole and a fifth position in the longitudinal direction of the shaft that is the same as the fixing portion, and the fourth wire is located at the fifth position at a position offset by more than 90 degrees in the circumferential direction of the inserting member relative to the fourth position. According to the catheter, the fourth wire is arranged at the fifth position at a position offset by more than 90 degrees in the circumferential direction of the inserting member relative to the fourth position, thereby making it possible to allow a margin for the length of the fourth wire in the inner cavity of the shaft. Therefore, even if the fourth guide wire is stretched due to the bending of the shaft, it can be absorbed by the excess length, thereby preventing the fourth guide wire from being supported. Therefore, the flexibility of the distal end of the catheter can be ensured. In the following description, this mode is referred to as embodiment 3.

[0043] Reference Figures 1 to 8 A structural example of a catheter will be described. Figure 1 A side view showing a catheter according to an embodiment of the present invention, Figure 2-Figure 3 Respectively indicate along Figure 1 Side sectional view of the II-II line and III-III line catheter. Figures 4 to 6 Respectively indicate along Figure 2 A cross-sectional view of the catheters of the IV-IV line, V-V line, and VI-VI line. Figure 7 Shown Figure 4 A cross-sectional view of a catheter of a modified example. Figure 8 Shown Figure 2 In addition, in order to facilitate the understanding of the present invention, in Figures 4 to 7 , only the first conductive wire 51 of the conductive wire 50 is shown, and the second conductive wire 52 and the third conductive wire 53 are omitted.

[0044] The distal side of the catheter 1 refers to the distal end side of the long axis direction x of the shaft 10, i.e., the side to be treated. In addition, the proximal side refers to the proximal end side of the long axis direction x of the shaft 10, i.e., the hand side of the user (operator). The proximal side of each component when it is divided in half in the long axis direction is often called the proximal part, and the distal side is called the distal part. Figure 1 The inside of the catheter 1 refers to the direction toward the center of the long axis of the shaft 10 in the radial direction of the shaft 10, and the outside refers to the radial direction opposite to the inside.

[0045] The shaft 10 is a component having a distal end and a proximal end in the longitudinal direction, and the distal end side is inserted into the patient's body. The shaft 10 has an inner cavity 11 extending in the longitudinal direction x. The shaft 10 preferably has a cylindrical structure in order to configure the guide wire 50 in its inner cavity 11. In addition, the shaft 10 is inserted into the body, so it is preferably flexible. Examples of the shaft 10 having a cylindrical structure include a hollow coil formed by spirally winding one or more metal wires, a structure in which a resin is coated on at least one of the inner surface or outer surface of the hollow coil or the hollow body, a cylindrical resin tube, or a structure in which they are connected in the longitudinal direction x. In the case where the shaft 10 is a cylindrical resin tube, the shaft 10 can be composed of a single layer or multiple layers. The shaft 10 may also be composed of a single layer in a portion in the longitudinal direction x or in the circumferential direction, and a multilayer in the other portion. Although not shown in the figure, the inner cavity 11 of the shaft 10 may also be provided in plurality. As Figure 1 As shown, the operation portion 70 held by the operator is preferably connected to the proximal portion of the shaft 10. In addition, a front blade material 17 is preferably arranged at the distal end of the shaft 10. The front blade material 17 may be an electrode or a resin material for closing the opening on the distal side of the shaft 10. As the constituent material of the front blade material 17, reference can be made to the description of the constituent material of the shaft 10 described later.

[0046] The shaft 10 can be made of, for example, synthetic resins such as polyolefin resins (e.g., polyethylene, polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, fluororesins (e.g., PTFE, PFA, ETFE), or metals such as stainless steel, carbon steel, and nickel-titanium alloys. These can be used alone or in combination of two or more.

[0047] Although not shown in the figure, a reinforcing material made of metal may be arranged on the shaft 10. The reinforcing material may be formed in layers, or may be a material in which single wires or twisted wires are arranged or woven in a specific pattern. In this way, the strength and torque characteristics of the shaft 10 can be improved. The cross-sectional shape of the wire may be, for example, circular, oblong, polygonal, or a combination thereof. Oblong includes elliptical, egg-shaped, and rounded rectangular. The same applies to the following description. In addition, the material constituting the reinforcing material can refer to the description of the metal constituting the shaft 10. The reinforcing material can be arranged on the outer surface, inner surface, or inside the wall 12 of the shaft 10.

[0048] The shaft 10 is bendable. The shaft 10 is preferably bendable in a plane, but may be bendable in a three-dimensional manner. Here, the shaft 10 being bendable in a plane means that the distal end and the proximal end of the bending portion of the shaft are located in substantially the same plane before and after the bending. Figure 1, an example is shown in which the distal portion of the shaft 10 can be bent in two directions, direction A and direction B opposite to direction A. Three-dimensional bending means that the plane where the distal end and the proximal end of the bent portion of the shaft are located before bending is different from the plane where they are located after bending. In other words, it means that the shaft is twisted due to bending.

[0049] The wall 12 (preferably the peripheral wall) of the shaft 10 is provided with a side hole 30. Thus, the guide wire 50 can be inserted into the inner cavity 11 of the shaft 10 through the side hole 30. The side hole 30 is provided to pass through from the outside of the shaft 10 to the inner cavity 11. Figure 2 As shown in FIG. 1 , the wall 12 of the shaft 10 of the catheter 1 of the first embodiment is provided with a first side hole 31 and a second side hole 32 adjacent to each other in order from the distal side. Figure 2 As shown in FIG. 1 , the wall 12 of the shaft 10 of the catheter 1 of the second embodiment is provided with a first side hole 31, a second side hole 32, and a third side hole 33 in order from the distal side. Figure 3 As shown, a fourth side hole 34 is provided in the wall 12 of the shaft 10 of the catheter 1 of the third embodiment.

[0050] In each embodiment, one or more side holes 30 other than the first to third side holes 31 to 33 can be provided in the wall 12 of the shaft 10. The total number of the side holes 30 of the shaft 10 is not particularly limited, but is preferably 2 or more, more preferably 3 or more, further preferably 5 or more, further preferably 10 or more, and may be 30 or less, 25 or less, or 20 or less. Figure 3 In the embodiment, a fifth side hole 35 is provided on the side closer to the fourth side hole 34 .

[0051] The side hole 30 can be circular, oblong, polygonal or a combination thereof. The side hole 30 can be configured such that its central axis is consistent with the radial direction of the shaft 10, or can be configured such that its central axis extends from the distal side of the shaft 10 toward the proximal side from the radial outside to the inside.

[0052] An electrode 40 is provided outside the side hole 30 of the shaft 10. The electrode 40 functions as a measuring electrode or a reference electrode (e.g., a grounding electrode) when measuring potential. In the catheter 1 of Embodiments 1 and 2, a first electrode 41 is provided outside the first side hole 31. In addition, in the catheter 1 of Embodiment 3, a fourth electrode 44 is provided outside the fourth side hole 34. In addition to the above, Figure 2 In the embodiment, a second electrode 42 is disposed on the outer side of the second side hole 32, a third electrode 43 is disposed on the outer side of the third side hole 33, and Figure 3 In the embodiment, a fifth electrode 45 is provided outside the fifth side hole 35 (the side hole 30 located closest to the side hole 30 ).

[0053] The total number of electrodes 40 is not particularly limited, but it is preferable that electrodes 40 are disposed outside all of the side holes 30 provided in the shaft 10 .

[0054] Examples of the shape of the electrode 40 include a ring shape, a C-shaped cross section obtained by cutting a ring, and a coil shape obtained by winding a wire. The electrode 40 can be arranged on the shaft 10 by riveting the electrode 40 to the shaft 10 .

[0055] The electrode 40 only needs to be conductive and can be made of metal or a mixture of resin and metal. Among them, as the material of the electrode 40, conductive resin, platinum, platinum-iridium alloy, stainless steel, tungsten and other metals are preferably used. In the case where the electrode 40 is made of conductive resin, it is preferably mixed with a contrast agent such as barium sulfate and bismuth oxide in order to be visible under X-ray fluoroscopy.

[0056] The wire 50 electrically connects the electrode 40 to an external device of the catheter 1, such as an electrocardiograph. The wire 50 is electrically connected to the electrode 40 and extends through the side hole 30 into the inner cavity 11 of the shaft 10 and outside the inner insertion member 20. Figure 2 As shown, in the catheter 1 of the first and second embodiments, the first guide wire 51 is electrically connected to the first electrode 41 and extends through the first side hole 31 into the inner cavity 11 of the shaft 10 and outside the insertion member 20. Figure 3 As shown, in the catheter 1 of the third embodiment, the fourth wire 54 is electrically connected to the fourth electrode 44 and extends through the fourth side hole 34 into the inner cavity 11 of the shaft 10 and outside the insertion member 20. Figure 2 In the embodiment, the second wire 52 is electrically connected to the second electrode 42 and extends through the second side hole 32 to the inner cavity 11 of the shaft 10 and outside the insertion component 20. The third wire 53 is electrically connected to the third electrode 43 and extends through the third side hole 33 to the inner cavity 11 of the shaft 10 and outside the insertion component 20. Figure 3 In the embodiment, the fifth wire 55 is electrically connected to the fifth electrode 45 , and extends through the fifth side hole 35 into the inner cavity 11 of the shaft 10 and outside the interposition member 20 .

[0057] The wire 50 only needs to be conductive, and for example, copper wire, iron wire, stainless steel wire, piano wire, tungsten wire, nickel-titanium wire, etc. can be used. Portions other than the two ends in the long axis direction of the wire 50 can also be covered with a coating material such as a coating tube. In this way, a short circuit with adjacent components can be prevented. As the material of the coating material of the wire 50, the description of the resin material constituting the shaft 10 can be referred to.

[0058] The electrode 40 and the lead wire 50 can be connected by laser welding, resistance welding, bonding with an adhesive, or the like.

[0059] The insertion member 20 is a member disposed in the inner cavity 11 of the shaft 10. By disposing the insertion member 20 in the shaft 10, the shape of the distal end portion of the shaft 10 can be maintained during surgery, or the distal end portion of the shaft 10 can be bent during surgery.

[0060] like Figure 4 As shown, the inserting member 20 preferably includes: a tubular member 21 having a distal end and a proximal end in the longitudinal direction and having an inner cavity extending along the longitudinal direction thereof; and an elastic member 22 disposed in the inner cavity of the tubular member 21. Thus, the degree of curvature of the distal portion of the shaft 10 can be finely adjusted, so that surgery can be performed appropriately.

[0061] The barrel component 21 is configured to accommodate the operation wire 25, the elastic component 22, etc. described later, thereby preventing the operation wire 25 and the elastic component 22 from contacting the guide wire 50. The barrel component 21 may also extend along the long axis direction x of the shaft 10. As the barrel component 21, a resin tube, a cylindrical body formed by arranging a single wire or a plurality of wires or twisted wires in a specific pattern, a metal tube, or a structure composed of a combination thereof may be used in the same manner as the shaft 10. The barrel component 21 may be composed of the resin or metal described as the constituent material of the shaft 10. The material of the barrel component 21 may be the same as or different from the material of the shaft 10.

[0062] The outer shape of the cross section of the barrel member 21 perpendicular to the long axis direction is not particularly limited, and can be circular, oblong, polygonal, or a combination thereof. Figure 7 As shown in FIG. 1 , the ellipse preferably has a short axis 21A and a long axis 21B. This makes it easy to secure a space for arranging the guide wire 50 in the lumen 11 of the shaft 10 and outside the portion of the ellipse of the cylindrical member 21 having the short axis 21A.

[0063] like Figure 4 As shown, an operation wire 25 extending along the long axis direction x of the shaft 10 is preferably provided in the inner cavity 11 of the shaft 10. The operation wire 25 provided in the inner cavity 11 of the shaft 10 may be one or more. The operation wire 25 is pulled toward the proximal side, thereby enabling the distal portion of the shaft 10 to be bent. Alternatively, the operation wire 25 may be pushed toward the distal side to bend the distal portion of the shaft 10. The distal portion of the operation wire 25 is fixed to the distal portion of the catheter 1, preferably fixed to the distal portion of the elastic component 22 described later, and the proximal portion of the operation wire 25 is fixed to the operation portion 70.

[0064] The operating wire 25 can be made of, for example, a metal wire such as stainless steel, carbon steel, nickel-titanium alloy, or a wire formed of a synthetic resin such as polyamide resin (e.g., nylon), polyolefin resin (e.g., polyethylene, polypropylene), polyester resin (e.g., PET), aromatic polyether ketone resin (e.g., PEEK), polyimide resin, or fluororesin (e.g., PTFE, PFA, FEP, ETFE).

[0065] The elastic member 22 is provided so as to be able to finely adjust the degree of curvature of the distal portion of the shaft 10. The elastic member 22 preferably extends along the long axis direction of the tube member 21. As the elastic member 22, for example, a leaf spring or a coil spring can be cited. However, if the configuration in the tube member 21 is considered, Figures 4 to 7 The leaf spring is preferably shown. The leaf spring is configured such that its long axis direction is, for example, along the long axis direction of the barrel member 21. In this case, the distal portion of the leaf spring can be fixed to the distal portion of the shaft 10 (preferably the front blade material 17). The method of joining the elastic member 22 to the shaft 10 or the front blade material 17 is not particularly limited, but methods such as soldering, welding, bonding using an adhesive, and riveting can be cited. As the material constituting the elastic member 22, the description of the constituent material of the operating wire 25 can be referred to.

[0066] Preferably, an operation wire 25 is disposed in the inner cavity of the barrel member 21, and a distal end of the operation wire 25 is fixed to a distal portion of the elastic member 22. The insertion member 20 can be bent and released by the operation wire 25 and the elastic member 22, and the shaft 10 can be bent and released accordingly. In addition, the operation wire 25 is preferably disposed eccentrically from the center of the long axis of the barrel member 21. For example, when the elastic member 22 is a leaf spring, the operation wire 25 can be disposed on one main surface side of the leaf spring.

[0067] The catheter of Embodiment 1 is described in detail. Figure 2 As shown, the first guide wire 51 has a first position 61 in the longitudinal direction x of the shaft 10 that is the same as the first side hole 31 and a second position 62 in the longitudinal direction x of the shaft 10 that is the same as the second side hole 32, and the first guide wire 51 is located at the second position 62 at a position offset by more than 45 degrees in the circumferential direction of the insertion member 20 relative to the first position 61. According to the above-mentioned catheter 1, the first guide wire 51 is arranged at the second position 62 at a position offset by more than 45 degrees in the circumferential direction of the insertion member 20 relative to the first position 61, thereby allowing the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 to have a margin. Therefore, even if the first guide wire 51 is stretched due to the bending of the shaft 10, it can be absorbed by the excess length, thereby preventing the first guide wire 51 from being supported. Therefore, the flexibility of the distal end of the catheter 1 can be ensured.

[0068] The first position 61 in the longitudinal direction x of the shaft 10 is the same as the first side hole 31 and is the range from the distal end to the proximal end of the first side hole 31 in the longitudinal direction x of the shaft 10. The second position 62, the third position 63, and the fourth position 64 are also defined in the same manner.

[0069] In order to facilitate the understanding of the present invention, Figure 2In the figure, there is recorded a straight line L1 parallel to the long axis direction x, which represents the position of the farthest position of the long axis center of the first wire 51 in the first position 61 to the position of the circumferential offset of 45 degrees to the inserted component 20, and a straight line L2 parallel to the long axis direction x, which represents the position of the farthest position to the position of the circumferential offset of 90 degrees to the inserted component 20.

[0070] like Figure 2 as well as Figure 5 As shown, the second position 62 of the first guide wire 51 only needs to be located at a position offset by more than 45 degrees in the circumferential direction of the insert component 20 relative to the first position 61, preferably at a position offset by more than 60 degrees, more preferably at a position offset by more than 70 degrees, further preferably at a position offset by more than 90 degrees, and further preferably at a position offset by more than 120 degrees. In this way, the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 can be appropriately left with a margin. In addition, Figure 5 In FIG. 6 , the angle θ1 is used to represent the offset of the second position 62 relative to the first position 61 (specifically, the offset of the closest position of the second position 62 relative to the farthest position of the long axis center of the first conductor 51 in the first position 61 ).

[0071] The first guide wire 51 is preferably located at a position where the second position 62 is offset by 270 degrees or less, more preferably by 240 degrees or less, further preferably by 200 degrees or less, and further preferably by 180 degrees or less in the circumferential direction of the insertion member 20 relative to the first position 61. Thus, the guide wires 50 can be prevented from being entangled with each other due to excessive slack in the lumen 11 of the shaft 10.

[0072] Next, the catheter 1 of the second embodiment will be described in detail. The catheter 1 of the second embodiment is used in the same manner as the catheter 1 of the first embodiment. Figure 2 In description, the catheter 1 of the second embodiment may also include the structure of the catheter 1 of the first embodiment, but it is not essential to include this structure.

[0073] like Figure 2As shown, the first guide wire 51 has a first position 61 in the longitudinal direction x of the shaft 10 that is the same as the first side hole 31, a second position 62 in the longitudinal direction x of the shaft 10 that is the same as the second side hole 32, and a third position 63 in the longitudinal direction x of the shaft 10 that is the same as the third side hole 33, and the first guide wire 51 is located at the third position 63 at a position offset by more than 90 degrees in the circumferential direction of the insertion member 20 relative to the first position 61. According to the above-mentioned catheter 1, the first guide wire 51 is arranged at the third position 63 at a position offset by more than 90 degrees in the circumferential direction of the insertion member 20 relative to the first position 61, thereby allowing the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 to have a margin. Therefore, even if the first guide wire 51 is stretched due to the bending of the shaft 10, it can be absorbed by the excess length, so that the first guide wire 51 can be prevented from being supported. Therefore, the flexibility of the distal end of the catheter 1 can be ensured.

[0074] like Figure 2 as well as Figure 6 As shown, the first guide wire 51 only needs to be located at a position that is offset by more than 90 degrees in the circumferential direction of the insert component 20 relative to the first position 61 at the third position 63, preferably at a position that is offset by more than 100 degrees, more preferably at a position that is offset by more than 120 degrees, further preferably at a position that is offset by more than 140 degrees, and further preferably at a position that is offset by more than 160 degrees. In this way, the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 can be appropriately left with a margin. In addition, Figure 6 , the angle θ2 represents the offset of the third position 63 relative to the first position 61 (specifically, the offset of the closest position of the third position 63 relative to the farthest position of the long axis center of the first conductor 51 in the first position 61). In addition, the angle θ2 is preferably larger than the angle θ1.

[0075] The first conductive wire 51 is preferably located at a position where the third position 63 is offset by 270 degrees or less, more preferably by 240 degrees or less, further preferably by 200 degrees or less, and further preferably by 180 degrees or less relative to the first position 61 in the circumferential direction of the insert member 20. Thus, the conductive wires 50 can be prevented from being entangled with each other due to excessive slack in the lumen 11 of the shaft 10.

[0076] Hereinafter, matters common to the catheter 1 of the first and second embodiments will be described.

[0077] In the catheter 1 of the first embodiment, any side hole 30 other than the side hole 30 located at the proximal side may correspond to the first side hole 31. In addition, in the catheter 1 of the second embodiment, any side hole 30 other than the side hole 30 located at the proximal side and the second side hole 30 from the proximal side may correspond to the first side hole 31. That is, the first side hole 31 may be the most distal side hole 30 disposed on the shaft 10, and the first side hole 31 may be the second and subsequent side holes 30 from the distal side of the shaft 10.

[0078] In the long axis direction x of the shaft 10 , the first distance from the proximal end of the first side hole 31 to the distal end of the second side hole 32 is not particularly limited, but is preferably wider than the width of the first electrode 41 to prevent contact between adjacent electrodes 40 .

[0079] In the long axis direction x of the shaft 10, the second distance from the proximal end of the second side hole 32 to the distal end of the third side hole 33 is preferably wider than the first distance from the proximal end of the first side hole 31 to the distal end of the second side hole 32. Thus, the distance between the electrodes 40 can be narrowed toward the distal side of the shaft 10. In addition, the first distance and the second distance may be the same.

[0080] The first guide wire 51 is preferably wound around the outside of the insertion member 20 from the first position 61 toward the second position 62. By winding around the outside of the insertion member 20, it is easy to make the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 have an excess.

[0081] The conductor 50 looping around the outer side of the interposer 20 is not limited to extending over one circle around the outer circumference of the interposer 20 , but may extend less than one circle, for example, less than half a circle or less than a quarter of a circle.

[0082] The first guide wire 51 is preferably wound in a spiral shape, thereby preventing the first guide wire 51 from being tangled and making it easier to provide a margin for the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 .

[0083] Although not shown in the figure, at least a portion of the first conductive wire 51, preferably at least from the first position 61 to the second position 62, may be formed in a corrugated shape. By extending the first conductive wire 51 as described above, the length of the first conductive wire 51 may have a margin. Although not shown in the figure, at least a portion of the first conductive wire 51, preferably at least from the first position 61 to the second position 62, may be in contact with the inner wall of the shaft 10. By extending the first conductive wire 51 along the inner wall of the shaft 10 as described above, the length of the first conductive wire 51 may have a margin.

[0084] The first guide wire 51 is preferably formed to be bent without bending from the first position 61 to the second position 62. In other words, the first guide wire 51 is preferably provided with no bent portion at least from the first position 61 to the second position 62, and more preferably, no bent portion is provided throughout the entire first guide wire 51. Thus, kinking of the first guide wire 51 can be prevented, and the length of the first guide wire 51 in the inner cavity 11 of the shaft 10 has a margin. Specifically, the first guide wire 51 preferably does not have a bent portion that bends at a substantially right angle.

[0085] The catheter 1 may also include a second electrode 42 disposed outside the second side hole 32 and a second guide wire 52 electrically connected to the second electrode 42 and extending through the second side hole 32 in the inner cavity 11 of the shaft 10 and outside the insertion component 20. In this case, it is preferred that a third side hole 33 is disposed on the wall 12 of the shaft 10 and on the side closer to the second side hole 32, and the second guide wire 52 has a second position 62 in the longitudinal direction x of the shaft 10 that is the same as the second side hole 32 and a third position 63 in the longitudinal direction x of the shaft 10 that is the same as the third side hole 33, and the second guide wire 52 is located at the third position 63 at a position offset by more than 45 degrees in the circumferential direction of the insertion component 20 relative to the second position 62. According to the catheter 1 described above, the second guide wire 52 is arranged at the third position 63 at a position offset by more than 45 degrees in the circumferential direction of the insertion component 20 relative to the second position 62, thereby allowing a margin for the length of the second guide wire 52 in the inner cavity 11 of the shaft 10. Therefore, even if the second guide wire 52 is stretched due to the bending of the shaft 10, the stretch can be absorbed by the excess length, thereby preventing the second guide wire 52 from being supported. Therefore, the flexibility of the distal end portion of the catheter 1 can be ensured.

[0086] In the circumferential direction of the interposer 20 , the third position 63 of the second conductive wire 52 relative to the second position 62 can be offset by, for example, 60 degrees or more, 90 degrees or more, 120 degrees or more, or 270 degrees or less, 240 degrees or less, 200 degrees or less, or 180 degrees or less.

[0087] The winding direction of the plurality of guide wires 50 is not particularly limited, and the winding directions of one guide wire 50 and other guide wires 50 may be the same or different. In addition, the winding directions of all guide wires 50 provided in the catheter 1 may be the same.

[0088] like Figure 2 As shown, it is preferred that the direction in which the first wire 51 is wound around the outside of the insert component 20 from the first position 61 to the second position 62 is the same as the direction in which the second wire 52 is wound around the outside of the insert component 20 from the second position 62 to the third position 63. In this way, the arrangement directions of the adjacent wires 50 are made the same, thereby arranging the wires 50 with good accuracy, thereby preventing the wires 50 from being entangled.

[0089] like Figure 8 As shown, the direction in which the first wire 51 is wound around the outside of the insertion component 20 from the first position 61 to the second position 62 may be opposite to the direction in which the second wire 52 is wound around the outside of the insertion component 20 from the second position 62 to the third position 63. By changing the arrangement direction of the adjacent wires 50 in this way, the effect of preventing the wires 50 at the distal portion of the shaft 10 from being entangled can be improved.

[0090] When the plurality of electrodes 40 provided on the shaft 10 are divided into a distal electrode group located in the distal part of the shaft 10 and composed of at least two electrodes 40 and a proximal electrode group located in the proximal part of the shaft 10 and composed of at least two electrodes 40, the wires 50 respectively connected to the distal electrode group may be wound in the same direction, and the wires 50 respectively connected to the proximal electrode group may be wound in the same direction. In addition, the winding direction of the wires 50 respectively connected to the distal electrode group and the winding direction of the wires 50 respectively connected to the proximal electrode group may be the same or different.

[0091] The position of the side hole 30 of the shaft 10 is not particularly limited, but can be arranged, for example, as follows. Figure 9-10 The perspective view showing the distal end portion of the shaft 10 shows an example of arrangement of the plurality of side holes 30 .

[0092] like Fig. 9 As shown, the first side hole 31 and the second side hole 32 are preferably located at positions that overlap each other in the circumferential direction of the shaft 10. As a result, it is easy to adjust the extension direction of the guide wire 50 in a manner with a surplus length portion when the catheter 1 is manufactured. When the shaft 10 is viewed from the distal end side, it is preferred that at least a portion of the first side hole 31 and the second side hole 32 are located at positions that overlap each other, and it is preferred that the center position of the first side hole 31 and the center position of the second side hole 32 are consistent in the circumferential direction of the shaft 10.

[0093] All the side holes 30 provided in the shaft 10 may be located at positions overlapping each other in the circumferential direction of the shaft 10. Thus, when manufacturing the catheter 1, the extending directions of all the guide wires 50 can be adjusted so as to have excess length portions.

[0094] like Fig.10 As shown, the first side hole 31 and the second side hole 32 are preferably located at positions that do not overlap each other in the circumferential direction of the shaft 10. Thus, the first conductive wire 51 and the second conductive wire 52 are easily arranged to be offset in the circumferential direction, thereby preventing the conductive wires 50 from being entangled with each other.

[0095] When observing the shaft 10 from the distal side, the center of the second side hole 32 is preferably located at a position that is circumferentially offset by more than 5 degrees relative to the center of the first side hole 31 on the shaft 10, preferably by more than 10 degrees, more preferably by more than 20 degrees, and further preferably by more than 30 degrees. In addition, an offset of less than 90 degrees, less than 80 degrees, or less than 60 degrees is also allowed.

[0096] The shaft 10, the insert component 20, and the first guide wire 51 are preferably fixed to each other at a position closer to the second side hole 32. As a result, the movement direction of the shaft 10 is restricted, so that the shaft 10 can be bent starting from the fixed portion. In addition, by fixing in this way, the shaft 10 that is easy to bend in a plane can be obtained, thereby preventing three-dimensional bending of the shaft 10. The shaft 10, the insert component 20, and the first guide wire 51 are preferably fixed by the fixing portion 15 described later.

[0097] Next, the catheter according to Embodiment 3 will be described in detail. In addition, the catheter according to Embodiment 3 may include at least one of the aspects of Embodiment 1 and Embodiment 2 simultaneously.

[0098] like Figure 3 As shown, the catheter 1 of embodiment 3 comprises: a shaft 10 having a distal end and a proximal end in the longitudinal direction x, the shaft 10 having a fourth side hole 34 provided in the wall 12 of the shaft 10 and an inner cavity 11 extending along the longitudinal direction x; an insert component 20 disposed in the inner cavity 11 of the shaft 10; a fourth electrode 44 disposed outside the fourth side hole 34; and a fourth wire 54 electrically connected to the fourth electrode 44 and extending through the fourth side hole 34 in the inner cavity 11 of the shaft 10 and outside the insert component 20. The catheter 1 includes a fixing portion 15 that fixes the shaft 10, the insertion member 20, and the fourth guide wire 54 to each other on the side closer to the fourth side hole 34. The fourth guide wire 54 has a fourth position 64 in the longitudinal direction x of the shaft 10 that is the same as the fourth side hole 34 and a fifth position 65 in the longitudinal direction x of the shaft 10 that is the same as the fixing portion 15. The fourth guide wire 54 is located at the fifth position 65 at a position that is offset by more than 90 degrees in the circumferential direction of the insertion member 20 relative to the fourth position 64. According to the catheter 1, the fourth guide wire 54 is arranged at the fifth position 65 at a position that is offset by more than 90 degrees in the circumferential direction of the insertion member 20 relative to the fourth position 64, thereby allowing a margin for the length of the fourth guide wire 54 in the inner cavity 11 of the shaft 10. Therefore, even if the fourth guide wire 54 is stretched due to the bending of the shaft 10, it can be absorbed by the excess length, thereby preventing the fourth guide wire 54 from being supported. Therefore, the flexibility of the distal end of the catheter 1 can be ensured.

[0099] The fifth position 65 of the fourth guide wire 54 relative to the fourth position 64 can be located at a position offset by, for example, 100 degrees or more, 120 degrees or more, 140 degrees or more, or 160 degrees or more in the circumferential direction of the interposer 20. Thus, the length of the fourth guide wire 54 in the inner cavity 11 of the shaft 10 can be appropriately left with a margin. In addition, the fifth position 65 of the fourth guide wire 54 relative to the fourth position 64 can also be located at a position offset by less than 270 degrees, less than 240 degrees, less than 200 degrees, or less than 180 degrees in the circumferential direction of the interposer 20.

[0100] The shaft 10, the insertion component 20, and the fourth guide wire 54 are fixed to each other in the fixing portion 15. As a result, the movement direction of the shaft 10 is restricted, so that the shaft 10 can be bent starting from the fixing portion 15. In addition, by providing the fixing portion 15 in this way, the rotation of the insertion component 20 is suppressed, so that the shaft 10 that is easy to bend in a plane can be obtained, thereby preventing the shaft 10 from bending in three dimensions. In addition, in the fixing portion 15, it is preferred that the cylinder member 21 of the insertion component 20 is fixed to the shaft 10 and the fourth guide wire 54.

[0101] The fifth position 65 , which is located at the same position as the fixing portion 15 in the longitudinal direction x of the shaft 10 , refers to the range from the distal end to the proximal end of the fixing portion 15 in the longitudinal direction x.

[0102] In order to facilitate the understanding of the present invention, Figure 3 , a straight line L3 parallel to the long-axis direction x is shown, which indicates a position offset by 90 degrees in the circumferential direction of the interposer 20 from the farthest position of the long-axis center of the fourth conductive wire 54 in the fourth position 64 .

[0103] One or more fixing parts 15 can be provided. Although not shown in the figure, for example, multiple fixing parts 15 can be arranged in the long axis direction x of the shaft 10. In addition, the fifth position 65 when multiple fixing parts 15 are arranged in the long axis direction x of the shaft 10 refers to the range from the distal end of the most distal fixing part 15 to the proximal end of the most proximal fixing part 15.

[0104] The fixing portion 15 is preferably disposed at a position closer to the side hole 30 ( Figure 3 The fifth side hole 35) in is close to the side.

[0105] The length of the fixing portion 15 in the longitudinal direction x of the shaft 10 is not particularly limited, but is preferably fixed within as wide a range as possible to prevent the catheter 1 from being unable to bend during use. Figure 1 as well as Figure 3 As shown, in the long axis direction x of the shaft 10 , the fixing portion 15 is preferably longer than one side hole 30 , and more preferably longer than one electrode 40 .

[0106] As a method for fixing the shaft 10, the interposer 20 and the fourth wire 54 in the fixing portion 15, there can be mentioned methods such as soldering, welding, and bonding with an adhesive. Figure 3 , an example is shown in which the shaft 10 , the interposer 20 , and the fourth conductive wire 54 are bonded together by the adhesive 16 in the fixing portion 15 .

[0107] The fourth side hole 34 is preferably located on the side closer to the center of the length from the distal end of the shaft 10 to the distal end of the fixing portion 15 in the long axis direction x of the shaft 10. Thus, even if the fourth guide wire 54 disposed on the side closer to the center of the length from the distal end of the shaft 10 to the distal end of the fixing portion 15 is stretched due to bending of the shaft 10, the stretch can be absorbed by the excess length.

[0108] Although not shown, the fourth side hole 34 may be the nearest side hole 30. This can prevent the lead wire 50 connected to the electrode 40 disposed in the nearest side hole 30 from being supported.

[0109] The fourth guide wire 54 is preferably looped outside the insertion member 20 from the fourth position 64 toward the fifth position 65. By looping outside the insertion member 20 in this way, it is easy to make the length of the fourth guide wire 54 in the inner cavity 11 of the shaft 10 have an excess.

[0110] The fourth conductive line 54 may be wound around or spirally wound like the first conductive line 51, or a portion thereof may have a wave shape.

[0111] Hereinafter, matters common to the catheter 1 of Embodiments 1 to 3 will be described.

[0112] like Figure 7 As shown, the insertion member 20 preferably includes: a barrel member 21 having a distal end and a proximal end in the long axis direction and having an inner cavity 11 extending in the long axis direction thereof; and an elastic member 22, which is arranged in the inner cavity 11 of the barrel member 21, and when the outer shape of the cross section of the barrel member 21 perpendicular to the long axis direction is an ellipse having a long axis 21B and a short axis 21A, the first side hole 31 or the fourth side hole 34 is arranged to be opposite to the part of the short axis 21A of the ellipse of the barrel member 21. When the guide wire 50 is inserted toward the inner cavity 11 of the shaft 10 through the side hole 30, the space for the guide wire 50 is most needed near the side hole 30, but by arranging the side hole 30 to be opposite to the part of the short axis 21A of the ellipse of the barrel member 21, it is possible to ensure the space near the connection part between the guide wire 50 and the electrode 40, so that the arrangement of the guide wire 50 is easy.

[0113] As per Figure 1 As can be understood, the shaft 10 is preferably able to bend in two directions: a normal direction to the first side hole 31 or the fourth side hole 34 and a direction opposite to the normal direction. Figure 1 In the embodiment, the distal portion of the shaft 10 can be bent in two directions: direction A and direction B opposite to direction A. By setting the position of the side hole 30 and the bending direction of the shaft 10 in this way, it is easy to provide a margin for the length of the first guide wire 51 or the fourth guide wire 54 in the inner cavity 11 of the shaft 10, thereby preventing the shaft 10 from bending in three dimensions.

[0114] 2. Method for manufacturing the catheter

[0115] The present invention also provides a method for manufacturing a catheter. Each step will be described below.

[0116] First, a shaft having a distal end and a proximal end in the longitudinal direction, a first side hole provided in the wall of the shaft, and a lumen extending in the longitudinal direction is prepared (step 1). The shaft described in "1. Catheter" can be used as the shaft.

[0117] The first guide wire is inserted into the inner cavity of the shaft from the first side hole and exposed from the proximal end of the shaft (step 2). To facilitate the insertion of the first guide wire into the inner cavity of the shaft, the shaft may be bent when inserting the first guide wire into the inner cavity of the shaft from the first side hole.

[0118] In step 2 of exposing the first guide wire from the proximal end of the shaft, the first electrode is preferably connected to the distal end of the first guide wire. This eliminates the need to connect the first guide wire and the first electrode in a subsequent step, and thus allows the catheter to be manufactured smoothly.

[0119] Insert the insert component into the inner cavity of the shaft (step 3). As the insert component, the insert component described in "1. Catheter" can be used. Specifically, the insert component can be inserted from the proximal end of the shaft. In order to improve the smoothness of the surface of the insert component and facilitate insertion into the shaft, it is preferred to coat at least one of the outer surface of the insert component and the inner surface of the shaft with fluororesin.

[0120] In step 3 of inserting the insertion member into the inner cavity of the shaft, the first guide wire can be arranged outside the insertion member in the inner cavity of the shaft.

[0121] The first guide wire is pulled while the shaft is bent (step 4). Thus, the length of the guide wire required when the shaft is bent can be ensured. In addition, by pulling the guide wire, the extension direction of the guide wire in the inner cavity of the shaft can also be shaped. For example, in the pulling step, the first guide wire can be pulled from the proximal side.

[0122] In step 4 of pulling the first guide wire in a state where the shaft is bent, bending the shaft means that the worker applies an external force to the shaft from a natural state where no external force is applied, or intends to bend the shaft by the shaft's own weight. Therefore, the shaft before bending in step 4 also includes the shaft that is in a natural state and is relaxed from bending.

[0123] For step 4 of pulling the first guide wire while the shaft is bent, the shaft can be bent in a plane or in a three-dimensional manner. The shaft only needs to bend a portion of its long axis direction, and it is particularly preferred to bend the portion of the shaft that is intended to be bent when the catheter is used. For example, when a fixing portion is provided on the shaft to fix the guide wire to the inserted component, it is preferred to bend the shaft from the distal end to the fixing portion. In this way, the excess length of the first guide wire can be further ensured to be longer. The shaft can be bent at one location or at multiple locations. When the shaft is bent at multiple locations, it is preferred that the bending directions of the respective bending portions are the same.

[0124] When the shaft is placed on a horizontal surface such as a workbench, the worker can bend the shaft, or use a bending jig to bend the shaft. In addition, the shaft can be bent by holding the middle part of the long axis direction and applying self-weight or a predetermined weight to both ends of the long axis direction to make them droop.

[0125] The staff can directly hold the proximal portion of the wire to pull it, or connect a traction component for pulling the wire to the proximal portion of the wire and pull the traction component to pull the wire.

[0126] Release the bend of the shaft (step 5). In addition, steps 1 to 5 are performed in sequence. The bend of the shaft is released, thereby releasing the traction of the first guide wire, so that a part of the first guide wire returns to the distal side. As a result, the length of the first guide wire in the state where the catheter is not bent can have a margin. Therefore, even if the shaft of the catheter is bent during the operation to stretch the first guide wire, it can be absorbed by the excess length, thereby preventing the first guide wire from being supported. Therefore, the flexibility of the distal end of the catheter can be ensured.

[0127] In step 5 of releasing the bending of the shaft, it is preferable not to apply external force to the shaft, so that the shaft can easily return to a natural state.

[0128] In the step 5 of releasing the bending of the shaft, the shaft may be stretched in a straight line. In this way, the length of the first guide wire in the state where the catheter is not bent can also have a margin during the operation. As a method for stretching the shaft in a straight line, there can be cited a method of placing the shaft into a mold having a straight groove formed therein, or a method in which a worker grasps both ends of the shaft in the long axis direction to stretch it. In addition, in the step 5 of releasing the bending of the shaft, it is not necessary to completely return the shaft to the state before the bending, and it is sufficient to release the external force applied to the shaft.

[0129] In the step 1 of preparing the shaft, the shaft is preferably configured such that a second side hole is provided in the wall of the shaft and closer to the first side hole, and the first side hole and the second side hole are located at positions overlapping each other in the circumferential direction of the shaft, and in the step of pulling the first guide wire, the first side hole and the second side hole are arranged on the outer side of the bend. By adjusting the position of the side hole during bending, it is easy to make the length of the guide wire in the state where the shaft of the catheter is not bent have an allowance.

[0130] In the step 1 of preparing the shaft, the shaft is preferably configured such that a second side hole is provided in the wall of the shaft and on the proximal side of the first side hole, and before the step of inserting the insert component into the inner cavity of the shaft, there is also a step of inserting the second wire into the inner cavity of the shaft from the second side hole and exposing the second wire from the proximal end of the shaft, and in the step of pulling the first wire, the second wire is also pulled. Thus, not only the first wire but also the second wire can be ensured to have the required length when the shaft is bent. In addition, since it is not necessary to pull each wire separately, the operation process can also be shortened.

[0131] Preferably, after the step 5 of releasing the bending of the shaft, there is also a step of fixing the shaft, the first guide wire and the insert component to each other at the side closer to the first side hole. As a result, the movement direction of the shaft is restricted, so the shaft can be bent starting from the fixed part. In addition, by fixing in this way, a shaft that is easy to bend in a plane can be obtained, thereby preventing the shaft from bending in three dimensions. In addition, for the fixing method of the shaft, the insert component and the first guide wire, the description of the fixing part 15 of "1. Catheter" can be referred to.

[0132] Preferably, before the step 5 of releasing the bending of the shaft and after the step of pulling the first wire, there is a step of fixing the shaft, the first wire and the insert component to each other at a position closer to the first side hole. By fixing the shaft, the first wire and the insert component in this order, the length of the wire required when the shaft is bent can be ensured.

[0133] This application claims the benefit of priority from Japanese Patent Application No. 2019-185879 filed on October 9, 2019. The entire contents of the specification of Japanese Patent Application No. 2019-185879 filed on October 9, 2019 are incorporated herein by reference.

[0134] Description of Reference Numerals

[0135] 1…catheter; 10…shaft; 11…inner cavity; 12…wall; 15…fixing part; 17…front blade material; 20…insertion part; 21…cylindrical part; 21A…short axis; 21B…long axis; 22…elastic part; 25…operating wire; 30…side hole; 31…first side hole; 32…second side hole; 33…third side hole; 34…fourth side hole; 35…fifth side hole; 40…electrode; 41…first electrode; 42…second electrode; 43…third electrode; 44…fourth electrode; 45…fifth electrode; 50…guide wire; 51…first guide wire; 52…second guide wire; 53…third guide wire; 54…fourth guide wire; 55…fifth guide wire; 61…first position; 62…second position; 63…third position; 64…fourth position; 65…fifth position; 70…operating part; 101…existing catheter; 110…shaft of existing catheter ; 120…an inserted part of an existing catheter; 130…a side hole of an existing catheter; 140…an electrode of an existing catheter; 150…a guide wire of an existing catheter; A, B…directions; L1…represents a straight line parallel to the long axis direction of the axis from the farthest position of the long axis center of the first guide wire in the first position to a position offset 45 degrees in the circumferential direction of the inserted part; L2…represents a straight line parallel to the long axis direction of the axis from the farthest position of the long axis center of the first guide wire in the first position to a position offset 90 degrees in the circumferential direction of the inserted part; L3…represents a straight line parallel to the long axis direction of the axis from the farthest position of the long axis center of the fourth guide wire in the fourth position to a position offset 90 degrees in the circumferential direction of the inserted part; x…long axis direction of the axis; θ1…the circumferential offset angle of the second position relative to the first position; θ2…the circumferential offset angle of the third position relative to the first position.

Claims

1. A catheter, characterized in that: have: A shaft having a distal end and a proximal end in the long axis direction, the shaft having a first side hole and a second side hole arranged adjacent to each other in sequence from the distal side on the wall of the shaft, and an inner cavity extending along the long axis direction; an insert component disposed in the inner cavity of the shaft; a first electrode disposed outside the first side hole; and A first wire is electrically connected to the first electrode and extends through the first side hole in the inner cavity of the shaft and outside the inserting member. The first guide wire has a first position in the shaft that is the same as the first side hole in the long axis direction and a second position in the shaft that is the same as the second side hole in the long axis direction. The first conductive wire is located at a position where the second position is offset by more than 45 degrees in the circumferential direction of the interposer relative to the first position. The first conductive line is looped around the outer side of the interposer from the first position toward the second position.

2. A catheter, characterized in that: have: A shaft having a distal end and a proximal end in the long axis direction, the shaft having a first side hole, a second side hole and a third side hole arranged adjacent to each other in sequence from the distal side on the wall of the shaft, and an inner cavity extending along the long axis direction; an insert component disposed in the inner cavity of the shaft; a first electrode disposed outside the first side hole; and A first wire is electrically connected to the first electrode and extends through the first side hole in the inner cavity of the shaft and outside the inserting member. The first guide wire has a first position in the shaft that is the same as the first side hole in the long axis direction, a second position in the long axis direction that is the same as the second side hole, and a third position in the long axis direction that is the same as the third side hole. The first conductive wire is located at a position where the third position is offset by more than 90 degrees in the circumferential direction of the interposer relative to the first position. The first conductive line is looped around the outer side of the interposer from the first position toward the second position.

3. The catheter according to claim 1 or 2, characterized in that The catheter further comprises a second electrode disposed outside the second side hole and a second guide wire electrically connected to the second electrode and extending through the second side hole in the inner cavity of the shaft and outside the insertion component. A third side hole is provided on the wall of the shaft and closer to the second side hole. The second guide wire has a second position in the shaft that is the same as the second side hole in the long axis direction and a third position in the shaft that is the same as the third side hole in the long axis direction. The second conductive line is located at a position where the third position is offset by more than 45 degrees in the circumferential direction of the interposer relative to the second position.

4. The catheter according to claim 3, characterized in that A direction in which the first conductive line is wound around the outer side of the interposer from the first position toward the second position is the same as a direction in which the second conductive line is wound around the outer side of the interposer from the second position toward the third position.

5. The catheter according to claim 3, characterized in that A direction in which the first conductive line is wound around the outer side of the interposer from the first position toward the second position is opposite to a direction in which the second conductive line is wound around the outer side of the interposer from the second position toward the third position.

6. The catheter according to claim 1 or 2, characterized in that The first side hole and the second side hole are located at positions overlapping each other in the circumferential direction of the shaft.

7. The catheter according to claim 1 or 2, characterized in that The first side hole and the second side hole are located at positions that do not overlap each other in the circumferential direction of the shaft.

8. The catheter according to claim 1 or 2, characterized in that The shaft, the insertion member, and the first guide wire are fixed to each other at a position closer to the second side hole.

9. A catheter, characterized in that: have: A shaft having a distal end and a proximal end in the long axis direction, the shaft having a fourth side hole provided on the wall of the shaft and an inner cavity extending along the long axis direction; an insert component disposed in the inner cavity of the shaft; a fourth electrode, disposed outside the fourth side hole; as well as a fourth wire electrically connected to the fourth electrode and extending through the fourth side hole in the inner cavity of the shaft and outside the inserting member, The catheter includes a fixing portion for fixing the shaft, the insertion member, and the fourth guide wire to each other at a position closer to the fourth side hole. The fourth guide wire has a fourth position in the shaft that is the same as the fourth side hole in the longitudinal direction and a fifth position in the longitudinal direction that is the same as the fixing portion. The fourth conductive line is located at a position where the fifth position is offset by more than 90 degrees in the circumferential direction of the interposer member with respect to the fourth position.

10. The catheter according to claim 9, characterized in that The fourth side hole is located on the side closer to the center of the length from the distal end of the shaft to the distal end of the fixing portion in the long axis direction.

11. The catheter according to claim 9 or 10, characterized in that The fourth conductive line is looped around the outer side of the interposer from the fourth position toward the fifth position.

12. The catheter according to any one of claims 1, 2 and 9, characterized in that: The insert component comprises: a tube component, the tube component having a distal end and a proximal end in the long axis direction, and having an inner cavity extending along the long axis direction; and an elastic component, wherein the elastic component is disposed in the inner cavity of the tube component, The cross-section of the tube member perpendicular to the major axis direction is an ellipse having a major axis and a minor axis. The first side hole or the fourth side hole is arranged to face the minor axis portion of the ellipse of the tube member.

13. The catheter according to any one of claims 1, 2 and 9, characterized in that: The shaft can be bent in two directions: a normal direction to the first side hole or the fourth side hole and a direction opposite to the normal direction.

14. A method for manufacturing a catheter, characterized in that: In turn, they have: A step of preparing a shaft, wherein the shaft has a distal end and a proximal end in a long axis direction, a first side hole is provided on a wall of the shaft, and the shaft has an inner cavity extending along the long axis direction; a step of inserting a first guide wire from the first side hole into the inner cavity of the shaft and allowing the first guide wire to be exposed from the proximal end of the shaft; a step of inserting an insert component into the inner cavity of the shaft; a step of pulling the first guide wire while the shaft is bent; and A step of releasing the bending of the shaft.

15. The method for manufacturing a catheter according to claim 14, characterized in that: In the shaft preparation step, the shaft is configured such that a second side hole is provided on the wall of the shaft and closer to the first side hole, and the first side hole and the second side hole are located at positions overlapping each other in the circumferential direction of the shaft. In the step of pulling the first guide wire, the first side hole and the second side hole are arranged on the outer side of the bend.

16. The method for manufacturing a catheter according to claim 14 or 15, characterized in that: In the shaft preparation step, the shaft is configured such that a second side hole is provided on a wall of the shaft at a position closer to the first side hole. The manufacturing method of the catheter further comprises, before the step of inserting the insert component into the inner cavity of the shaft, the step of inserting a second guide wire from the second side hole into the inner cavity of the shaft and exposing the second guide wire from the proximal end of the shaft. In the step of pulling the first conductive wire, the second conductive wire is also pulled.

17. The method for manufacturing a catheter according to claim 14 or 15, characterized in that: After the step of releasing the bending of the shaft, the method further includes fixing the shaft, the first guide wire, and the interposer to each other at a position closer to the first side hole.

18. The method for manufacturing a catheter according to claim 14 or 15, characterized in that: Before the step of releasing the bending of the shaft and after the step of pulling the first guide wire, there is further included a step of fixing the shaft, the first guide wire, and the interposition member to each other at a position closer to the first side hole.

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