Intracardiac defibrillation catheter

Abstract

To provide an intracardiac defibrillation catheter which has excellent operability in an inferior vena cava approach and makes it easy for a manipulator to place a defibrillation electrode at a desired position.SOLUTION: The intracardiac defibrillation catheter comprises: a catheter shaft with an electrode placed on its surface; and an operating part connected to a proximal end side of the catheter shaft. The catheter shaft has: a tube structure area which is placed in a longitudinally first section of the catheter shaft and has a lumen structure constituted of a plurality of tubes separated from each other; a multi-lumen structure area which is placed in a second section being on a longitudinally distal end side of the first section of the catheter shaft and has a lumen structure having a plurality lumens formed in a single core; a lead wire group which extends continuously over both a lumen in the tube structure area and a lumen in the multi-lumen structure area and whose one end is connected to the electrode; and a rope-like member which extends continuously over both the lumen in the tube structure area and the lumen in the multi-lumen structure area and whose one end is connected to the operating part.SELECTED DRAWING: Figure 26

Description

[Technical Field]

[0001] The present disclosure relates to intracardiac defibrillation catheters. [Background technology]

[0002] BACKGROUND ART Intracardiac defibrillation catheters have been widely used as medical devices for treating atrial fibrillation, atrial tachycardia, and the like.

[0003] Intracardiac defibrillation catheters have multiple wide defibrillation electrodes positioned on the right atrium (RA) or left atrium (CS) for the purpose of treating atrial fibrillation, atrial tachycardia, etc. When performing treatment such as intracardiac defibrillation, electrical energy is supplied using the multiple defibrillation electrodes on the right atrium (RA) or left atrium (CS). Furthermore, regardless of whether a tachycardia attack is occurring, the multiple electrodes are used to measure intracardiac potentials within the heart.

[0004] This type of intracardiac defibrillation catheter is described in, for example, Patent Documents 1 and 2. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-63708 [Patent Document 2] Japanese Patent Application Publication No. 2019-150526 Summary of the Invention [Problem to be solved by the invention]

[0006] To perform intracardiac defibrillation via the inferior vena cava approach, an intracardiac defibrillation catheter with multiple defibrillation electrodes must be positioned appropriately. Therefore, the intracardiac defibrillation catheter must be highly maneuverable, allowing the operator to position the defibrillation electrodes at the desired locations. However, conventional intracardiac defibrillation catheters are time-consuming and unsatisfactory in terms of maneuverability.

[0007] The present disclosure has been made in consideration of the above points, and provides an intracardiac defibrillation catheter that is easy to operate and allows the operator to easily place defibrillation electrodes at desired positions. [Means for solving the problem]

[0008] One aspect of the intracardiac defibrillation catheter of the present disclosure comprises: An intracardiac defibrillation catheter having a catheter shaft with electrodes arranged on its surface and an operation unit connected to a proximal end side of the catheter shaft, The catheter shaft a tube structure region disposed in a first section in the longitudinal direction of the catheter shaft and having a tubular structure formed by a plurality of tubes separate from one another; a multi-lumen structure region that is disposed in a second section of the catheter shaft that is located on the distal side of the first section in the longitudinal direction, and has a tubular structure in which multiple lumens are formed in one core; a group of lead wires extending continuously through both the lumen of the tube structure region and the lumen of the multi-lumen structure region, one end of which is connected to the electrode; a cord-like member that extends continuously across both the lumen of the tube structure region and the lumen of the multi-lumen structure region, and one end of which is connected to the operation unit; Equipped with. [Effects of the Invention]

[0009] According to the present invention, an intracardiac defibrillation catheter can be realized that is easy to operate and allows the operator to easily place the defibrillation electrodes at the desired positions. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a diagram illustrating placement of a catheter in a cardiac cavity in the first embodiment. [Figure 2] FIG. 1 is an external view showing the overall configuration of an intracardiac defibrillation catheter on the right atrium side (for RA) in embodiment 1. [Figure 3] FIG. 1 is an external view showing the overall configuration of an intracardiac defibrillation catheter on the left atrium side (for CS) in the first embodiment. [Figure 4] Cross-sectional view of the tube structure region in Configuration Example 1 [Figure 5A] Cross-sectional view of the multi-lumen structure region in configuration example 1 [Figure 5B] Cross-sectional view of the multi-lumen structure region in configuration example 1 [Figure 6] 4 and 5A (or FIG. 5B) is a cross-sectional view of the catheter shaft in Configuration Example 1, taken along a plane including EE. [Figure 7] Cross-sectional view of the tube structure region in configuration example 2 [Figure 8] Cross-sectional view of the multi-lumen structure region in configuration example 2 [Figure 9] 9 is a cross-sectional view of the catheter shaft in Configuration Example 2 taken along a plane including EE in FIGS. 7 and 8. [Figure 10] Cross-sectional view of the multi-lumen structure region in configuration example 3 [Figure 11] Cross-sectional view of the tube structure region in Configuration Example 4 [Figure 12] Cross-sectional view of the multi-lumen structure region in configuration example 4 [Figure 13] 13 is a cross-sectional view of the catheter shaft in Configuration Example 4 taken along a plane including EE in FIGS. 11 and 12. [Figure 14] Cross-sectional view of the tube structure region in Configuration Example 5 [Figure 15] Cross-sectional view of the multi-lumen structure region in configuration example 5 [Figure 16] 14 and 15. A cross-sectional view of the catheter shaft in Configuration Example 5 taken along a plane including EE in FIGS. [Figure 17] Cross-sectional view of the tube structure region in Configuration Example 6 [Figure 18] Cross-sectional view of the multi-lumen structure region in Configuration Example 6 [Figure 19] 17 and 18. A cross-sectional view of the catheter shaft in Configuration Example 6 taken along a plane including EE in FIGS. [Figure 20] Cross-sectional view of the tube structure region in Configuration Example 7 [Figure 21] Cross-sectional view of the multi-lumen structure region in Configuration Example 7 [Figure 22] 20 and 21 are cross-sectional views of the catheter shaft in Configuration Example 7 taken along a plane including EE in FIGS. [Figure 23] FIG. 10 shows an example in which a reinforcing body is provided. [Figure 24] FIG. 10 shows an example in which a reinforcing body is provided. [Figure 25] FIG. 10 is a diagram illustrating placement of a catheter into a cardiac cavity in the second embodiment. [Figure 26] FIG. 10 is an external view showing the overall configuration of an intracardiac defibrillation catheter according to a second embodiment. [Figure 27] Cross-sectional view of the tube structure region in Configuration Example 1 [Figure 28] Cross-sectional view of the tube structure region in Configuration Example 1 [Figure 29] Cross-sectional view of the multi-lumen structure region in configuration example 1 [Figure 30] 27, 28, and 29 are cross-sectional views of the catheter shaft in Configuration Example 1 taken along a plane including LL. [Figure 31] Cross-sectional view of the tube structure region in configuration example 2 [Figure 32] Cross-sectional view of the tube structure region in configuration example 2 [Figure 33] Cross-sectional view of the multi-lumen structure region in configuration example 2 [Figure 34] 34 is a cross-sectional view of the catheter shaft in Configuration Example 2 taken along a plane including LL in FIGS. 31, 32, and 33. [Figure 35] 10 is a cross-sectional view of a multi-lumen structure region in configuration example 1 of embodiment 3. [Figure 36] 10 is a cross-sectional view of a tube structure region in configuration example 1 of embodiment 3. [Figure 37] 35 and 36. FIG. 36 is a cross-sectional view of a catheter shaft in Configuration Example 1 of Embodiment 3. [Figure 38]10 is a cross-sectional view of a multi-lumen structure region in configuration example 2 of embodiment 3. [Figure 39] 10 is a cross-sectional view of a multi-lumen structure region in configuration example 2 of embodiment 3. [Figure 40] 10 is a cross-sectional view of a tube structure region in configuration example 2 of embodiment 3. [Figure 41] 41 is a cross-sectional view of a catheter shaft in Configuration Example 2 of Embodiment 3, cut by a plane including EE in FIGS. 38 to 40. [Figure 42] FIG. 10 is a diagram illustrating the cross-sectional position of the third embodiment. [Figure 43] 10 is a cross-sectional view of a multi-lumen structure region in configuration example 3 of embodiment 3. [Figure 44] 10 is a cross-sectional view of a multi-lumen structure region in configuration example 3 of embodiment 3. [Figure 45] 10 is a cross-sectional view of a tube structure region in configuration example 3 of embodiment 3. [Figure 46] 43 to 45. A cross-sectional view of a catheter shaft in Configuration Example 3 of Embodiment 3, taken along a plane including EE in FIGS. DETAILED DESCRIPTION OF THE INVENTION

[0011] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings.

[0012] <1> Embodiment 1 In this embodiment, as shown in FIG. 1, a configuration of an intracardiac defibrillation catheter will be described when intracardiac defibrillation is performed using two intracardiac defibrillation catheters 1 and 2.

[0013] Intracardiac defibrillation catheter 1 is a right atrial (RA) electrode catheter, and intracardiac defibrillation catheter 2 is a left atrial, coronary sinus (CS) electrode catheter.

[0014] An intracardiac defibrillation catheter 1 is inserted into the right atrium 3 from the patient's inferior vena cava and left in place on the inner wall of the right atrium 3. An intracardiac defibrillation catheter 2 is inserted into the coronary sinus 4 in the right atrium from the patient's inferior vena cava and left in place.

[0015] Figure 2 is an external view showing the overall configuration of an intracardiac defibrillation catheter 1 in the right atrium (RA), and Figure 3 is an external view showing the overall configuration of an intracardiac defibrillation catheter 2 in the coronary sinus (CS). Intracardiac defibrillation catheter 1 and intracardiac defibrillation catheter 2 have the same basic configuration, with the only difference being the placement of the electrodes.

[0016] The intracardiac defibrillation catheters 1 and 2 each have a catheter shaft 100, a handle portion 200, and connectors 301 and 302.

[0017] The catheter shaft 100 of the intracardiac defibrillation catheter 1 in the right atrium (RA) is provided with an RA electrode group 110 and an inspection electrode group 130. The RA electrode group 110 consists of a plurality of (eight in this embodiment) wide ring-shaped electrodes 111 arranged at a predetermined distance from each other, and the inspection electrode group 130 consists of a plurality of ring-shaped electrodes arranged at a predetermined distance from each other.

[0018] The catheter shaft 100 of the coronary sinus (CS) intracardiac defibrillation catheter 2 is provided with a CS electrode group 120 and an inspection electrode group 130. The CS electrode group 120 consists of a plurality of (eight in this embodiment) wide ring-shaped electrodes 121 arranged at a predetermined distance from each other, and the inspection electrode group 130 consists of a plurality of ring-shaped electrodes arranged at a predetermined distance from each other.

[0019] In this embodiment, intracardiac defibrillation is performed using two intracardiac defibrillation catheters 1 and 2, so that the position of the intracardiac defibrillation catheter 1 on the right atrium (RA) side of the coronary sinus (CS) can be changed independently of the intracardiac defibrillation catheter 2 on the left atrium side, thereby enabling atrial defibrillation to be performed efficiently.

[0020] In other words, the intracardiac defibrillation catheters described in Patent Documents 1 and 2 are inserted into the cardiac cavity through the jugular vein or subclavian vein, which limits the placement position of the right atrium (RA) electrode, and if the defibrillation threshold is high, there is a risk that atrial fibrillation and atrial tachycardia may not be stopped. Use of intracardiac defibrillation catheters 1 and 2 as in the present embodiment does not cause such problems.

[0021] <1-1> Configuration example 1 of catheter shaft 100 The catheter shaft 100 has a tube structure region 100a and a multi-lumen structure region 100b. The tube structure region 100a is arranged in a first section in the longitudinal direction of the catheter shaft 100, and has a luminal structure composed of one or more tubes. The multi-lumen structure region 100b is arranged in a second section in the longitudinal direction of the catheter shaft 100, which is different from the first section, and has a luminal structure in which multiple lumens are formed.

[0022] In this embodiment, the length of the catheter shaft 100 is 1000 to 1200 mm, the length of the multi-lumen structure region 100b (that is, the length of the second section) is 100 to 200 mm, and the diameter of the catheter shaft 100 is 2 mm.

[0023] Figures 4 and 5A (or Figure 5B) are cross sections taken along lines AA and BB, respectively, in Figure 2. Figure 6 is a cross section taken along line EE in Figures 4 and 5A (or Figure 5B).

[0024] Figure 4 is a cross-sectional view of the tube structure region 100a. As can be seen from Figure 4, the catheter shaft 100 has multiple tubes 101, 102, and 103 in the tube structure region 100a. The tube 101 is a tube that forms the outer shell of the catheter shaft 100, the tube 102 is a tube that houses lead wires 140 that are connected to the RA electrode group, the CS electrode group, or the testing electrode group, and the tube 103 is a tube that houses the pull wire 150. An insulating film is formed on the surface of each lead wire 140, and each lead wire 140 is also insulated by this insulating film.

[0025] Each of the tubes 101, 102, and 103 is made of a resin with insulating properties. Specifically, each of the tubes 101, 102, and 103 is made of, for example, polyvinyl chloride, polyurethane, polyamide, fluorine-based resin, or polyimide. Of the multiple tubes 101, 102, and 103, the tube 101 that forms the outer shell of the catheter shaft 100 is thicker than the other tubes 102 and 103. This reliably prevents blood from entering the interior of the tube 101.

[0026] Fig. 5A (or Fig. 5B) is a cross-sectional view of the multi-lumen structure region 100b. As can be seen from Fig. 5A and Fig. 5B, the catheter shaft 100 has multiple lumens 161, 162, and 163 formed in the multi-lumen structure region 100b. The lumens 161, 162, and 163 are formed by drilling a cylindrical core 170 of the catheter shaft 100 in the longitudinal direction of the catheter shaft 100. Note that the core 170 may be covered with a shell 171 as shown in Fig. 5B, or may not be covered with the shell 171 as shown in Fig. 5A.

[0027] 5A and 5B, core 170 is made of, for example, a low-hardness nylon elastomer. In the configuration of Fig. 5B, the outer periphery of core 170 may be covered with shell 171 made of a high-hardness nylon elastomer. Core 170 and lumens 161, 162, and 163 are partitioned by fluororesin layers 161a, 162a, and 163a.

[0028] The configuration of the multi-lumen structure region 100b is not limited to this. The multi-lumen structure region 100b may have at least a core 170 and a plurality of lumens drilled in the longitudinal direction of the core 170.

[0029] The hollow portions of the lumens 162 and 163 are perfectly circular. In contrast, the hollow portion of the lumen 161 is not perfectly circular. Specifically, the lumen 161 is shaped like an oval coin. Alternatively, the lumen 161 may be said to have a shape with two opposing straight lines and two opposing curved lines. The hollow portion of the lumen 161 may be elliptical or approximately elliptical, oval (racetrack), or other shapes. For example, the cross-sectional shape of the lumen 161 may be shaped like glasses or a gourd, so that the cross-sectional shape of the lumen 161 has a depression (constriction). By employing such a shape and positioning the lumens 162 and 163 near the depression (constriction), the positions of the lumens 162 and 163 can be more stabilized. Stabilizing the positions of the lumens 162 and 163 leads to improved operation accuracy. Furthermore, the hollow portion of lumen 161 may have a shape that is a composite combination of different shapes, such as a perfect circle, a rectangle, etc. Lumen 161 is formed along the diameter of core 170, and lumens 162 and 163 are formed on both sides of lumen 161.

[0030] A lead wire 140 is inserted through the lumen 161, and a pull wire 150 is inserted through the lumen 162. In the example of Fig. 5A (or Fig. 5B), nothing is inserted through the lumen 162. Therefore, the lumen 162 does not have to be formed.

[0031] The proximal end of the pull wire 150 is connected to a dial 201 of the handle portion 200. The distal end of the pull wire 150 is connected to the distal end or near the distal end of the catheter shaft 100. As can be seen in FIG. 5A (or FIG. 5B), the pull wire 150 passes through a position eccentric from the center of the catheter shaft 100. As a result, when a user operates the dial 201, the pull wire 150 is pulled by the dial 201, and the distal end portion of the catheter shaft 100 is bent, for example, downward (in the -a direction) in FIG. 5A (or FIG. 5B), allowing the catheter shaft 100 to be advanced in a desired direction within a blood vessel and the heart.

[0032] The configuration of the catheter shaft 100 of this embodiment will be described in more detail with reference to Figure 6. Figure 6 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figure 4 and Figure 5A (or Figure 5B).

[0033] Each lead wire 140 is connected to each electrode 111 (121, 131) of the RA electrode group 110 (or the CS electrode group 120, or the testing electrode group 130). Here, each lead wire 140 is connected to each electrode 111 (121, 131) in the multi-lumen structure region 100b. The electrodes 111 (121, 131) and the lead wire 140 are connected by, for example, welding.

[0034] As described above, according to the configuration shown in FIGS. 2 to 6, the catheter shaft 100 has a tube structure region 100a arranged in a first section in the longitudinal direction of the catheter shaft 100 and having a tubular structure composed of a plurality of tubes 101, 102, 103 that are separate from one another, and a tube structure region 100b arranged in a second section in the longitudinal direction of the catheter shaft 100 that is different from the first section and has a tubular structure in which a plurality of lumens 161, 162, 163 are formed in one core 170. The device has a multi-lumen structure region 100b, a group of lead wires (lead wires 140) that extend continuously through both the lumen of the tube structure region 100a and the lumen of the multi-lumen structure region 100b, one end of which is connected to the electrode 111 (121, 131), and a pull wire 150 that extends continuously through both the lumen of the tube structure region 100a and the lumen of the multi-lumen structure region 100b, one end of which is connected to the operating portion (handle portion 200).

[0035] <1-2> Configuration example 2 of catheter shaft 100 In the above item <1-1>, a unidirectional type catheter shaft 100 was described, that is, a catheter shaft 100 whose tip can be bent in only one direction (-a direction) by one pull wire 150. In this configuration example 2, the configuration of a bidirectional type catheter shaft 100 will be described.

[0036] 7 to 9, in which the same reference numerals are used to denote parts corresponding to those in Figures 4 to 6, show the configuration of a bidirectional catheter shaft 100. Figure 7 is a cross-sectional view of the tube structure region 100a, Figure 8 is a cross-sectional view of the multi-lumen structure region 100b, and Figure 9 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 7 and 8.

[0037] Compared to the configuration of the unidirectional catheter shaft 100, the bidirectional catheter shaft 100 of Configuration Example 2 has two pull wires 150, 151. As can be seen from Fig. 7, the tube structure region 100a is provided with a tube 104 that houses the pull wire 151.

[0038] The two pull wires 150, 151 are wound in opposite directions around the dial 201. This allows the tip of the catheter shaft 100 to be selectively bent in one of two directions (-a direction, +a direction) depending on the direction of rotation of the dial 201.

[0039] <1-3> Configuration example 3 of catheter shaft 100 The catheter shaft 100 of Configuration Example 3 differs from the catheter shaft 100 of Configuration Example 2 in the configuration of the multi-lumen structure region 100b.

[0040] Figure 10, in which the same reference numerals are assigned to parts corresponding to those in Figure 8, is a cross-sectional view of the catheter shaft 100 of Configuration Example 3. Compared to the configuration in Figure 8, the catheter shaft 100 of Configuration Example 3 has a reinforcing plate 180. Of the lumens 161, 162, and 163 in the multi-lumen structure region 100b, the reinforcing plate 180 is disposed in the lumen 161 in which the lead wire 140 is disposed.

[0041] The reinforcing plate 180 is a long, thin plate extending in the longitudinal direction of the catheter shaft 100 within the lumen 161. The reinforcing plate 180 is made of an insulating material and has a higher hardness than the main material (core 170) that constitutes the multi-lumen structure region 100b. In this example, the reinforcing plate 180 is made of resin. Note that the reinforcing plate 180 does not have to be insulating.

[0042] The reinforcing plate 180 increases the rigidity of the multi-lumen structure region 100b in a direction perpendicular to the longitudinal direction, thereby suppressing buckling of the multi-lumen structure region 100b. In particular, as can be seen from Fig. 10, the reinforcing plate 180 is arranged so that its main surface is perpendicular to the direction (±a direction) in which the catheter tip is deflected by the pull wires 150, 151. This allows the catheter shaft 100 to bend in the deflection direction (±a direction) by the pull wires 150, 151 in the multi-lumen structure region 100b, but is difficult to bend in other directions. Therefore, a catheter shaft 100 can be realized that bends in the desired direction (±a direction) but is difficult to bend in other directions.

[0043] Furthermore, the lumen 161 in which the reinforcing plate 180 is disposed has a shape including a flat hollow cross section when the catheter shaft 100 is cut along a plane perpendicular to the longitudinal direction. In the example of FIG. 10, the hollow cross section forming the lumen 161 is oval. The width of the reinforcing plate 180 is equal to or slightly shorter than the longitudinal length of the oval shape. At least, the width of the reinforcing plate 180 is longer than the shorter width of the oval shape. This prevents the reinforcing plate 180 from rotating about its axis within the lumen 161. As a result, operation in the deflection directions (±a directions) by the pull wires 150, 151 is stabilized, and bending of the catheter shaft 100 in directions other than the desired direction can be prevented.

[0044] The cross-sectional shape of lumen 161 in which reinforcing plate 180 is disposed is not limited to the oval shape shown in Fig. 10 etc. The cross-sectional shape of lumen 161 may be, for example, an ellipse, or any other shape. The cross-sectional shape of lumen 153 in which reinforcing plate 180 is disposed does not have to be a perfect circle, and may be any shape that can suppress rotation of reinforcing plate 180 around the axis within lumen 161.

[0045] <1-4> Configuration example 4 of catheter shaft 100 The catheter shaft 100 of Configuration Example 4 differs from the catheter shaft 100 of Configuration Example 1 in the configuration of the multi-lumen structure region 100b.

[0046] 11 to 13, in which the same reference numerals are assigned to parts corresponding to those in Figures 4 to 6, are cross-sectional views of the catheter shaft 100 of Configuration Example 4. Figure 11 is a cross-sectional view of the tube structure region 100a, Figure 12 is a cross-sectional view of the multi-lumen structure region 100b, and Figure 13 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 11 and 12.

[0047] As can be seen from FIG. 12, two lumens 161-1 and 161-2 are formed as lumens for accommodating the lead wires 140 in the multi-lumen structure region 100b of the catheter shaft 100 of this fourth configuration example.

[0048] The plurality of lead wires 140 housed in the tube 102 in the tube structure region 100a are distributed to either of the two lumens 161-1, 161-2 in the multi-lumen structure region 100b.

[0049] <1-5> Configuration example 5 of catheter shaft 100 The catheter shaft 100 of Configuration Example 5 differs from the catheter shaft 100 of Configuration Example 4 in that while Configuration Example 4 is a unidirectional type catheter shaft 100, Configuration Example 5 is a bidirectional type catheter shaft 100.

[0050] 14 to 16, in which the same reference numerals are assigned to parts corresponding to those in Figures 11 to 13, are cross-sectional views of the catheter shaft 100 of Configuration Example 5. Figure 14 is a cross-sectional view of the tube structure region 100a, Figure 15 is a cross-sectional view of the multi-lumen structure region 100b, and Figure 16 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 14 and 15.

[0051] The bidirectional catheter shaft 100 of Configuration Example 5 has two pull wires 150, 151, as compared with the configuration of the unidirectional catheter shaft 100. As can be seen from Fig. 14, the tube structure region 100a is provided with a tube 104 that houses the pull wire 151.

[0052] <1-6> Configuration example 6 of catheter shaft 100 17 to 19, in which the same reference numerals are assigned to parts corresponding to those in Figures 11 to 13, are cross-sectional views of the catheter shaft 100 of Configuration Example 6. Figure 17 is a cross-sectional view of the tube structure region 100a, Figure 18 is a cross-sectional view of the multi-lumen structure region 100b, and Figure 19 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 17 and 18.

[0053] 11 to 13, the catheter shaft 100 of Configuration Example 6 has an additional lumen 164 formed in the multi-lumen structure region 100b, as can be seen from Figure 18. That is, in Configuration Example 6, five lumens 161-1, 161-2, 162, 163, and 164 are formed in the multi-lumen structure region 100b. Of these five lumens 161-1, 161-2, 162, 163, and 164, the lead wire 140 is disposed in the lumen 161-1 and 161-2, the pull wire 150 is disposed in the lumen 162, and the lumens 163 and 164 are empty lumens.

[0054] <1-7> Configuration example 7 of catheter shaft 100 The catheter shaft 100 of Configuration Example 7 differs from the catheter shaft 100 of Configuration Example 6 in that while Configuration Example 6 is a unidirectional type catheter shaft 100, Configuration Example 7 is a bidirectional type catheter shaft 100.

[0055] 20 to 22, in which the same reference numerals are assigned to parts corresponding to those in Figures 17 to 19, are cross-sectional views of the catheter shaft 100 of Configuration Example 7. Figure 20 is a cross-sectional view of the tube structure region 100a, Figure 21 is a cross-sectional view of the multi-lumen structure region 100b, and Figure 22 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 20 and 21.

[0056] The bidirectional catheter shaft 100 of Configuration Example 7 has two pull wires 150 and 151, as compared to the configuration of the unidirectional catheter shaft 100.

[0057] <1-7> Summary of the first embodiment As described above, according to this embodiment, intracardiac defibrillation is performed using two intracardiac defibrillation catheters 1 and 2, which allows the position of the intracardiac defibrillation catheter 1 on the right atrium (RA) side to be changed independently of the intracardiac defibrillation catheter 2 on the left atrium (CS) side, thereby making it possible to lower the defibrillation threshold.

[0058] Furthermore, the catheter shafts 100 of the two intracardiac defibrillation catheters 1 and 2 have a tube structure region 100a arranged in a first longitudinal section of the catheter shaft 100 and having a luminal structure composed of multiple tubes 101, 102, 103, and 104, a multi-lumen structure region 100b arranged in a second longitudinal section different from the first longitudinal section of the catheter shaft 100 and having a luminal structure in which multiple lumens 161, 162, 163, and 164 are formed, a lead wire 140 extending into the lumen of the tube structure region 100a and the lumen of the multi-lumen structure region 100b and having one end connected to the electrodes 111, 121, and 131, and a pull wire 151 extending continuously through both the lumen of the tube structure region 100a and the lumen of the multi-lumen structure region 100b.

[0059] When inserting a catheter shaft into a patient's blood vessels and cardiac chambers, kinking is more likely to occur mechanically toward the distal end, so it is desirable for the catheter shaft to be configured so that kinking is less likely toward the distal end.On the other hand, when inserting a catheter shaft into a patient's blood vessels and cardiac chambers, it is desirable for the catheter shaft to be configured so that torque transmission is higher (in other words, the pushing force is stronger) toward the proximal end.

[0060] Taking this into consideration, in this embodiment, the multi-lumen structure region 100b is arranged on the distal end side, and the tube structure region 100a is arranged on the proximal end side.

[0061] The reason for this will be explained below.

[0062] In other words, the tube structure region 100a is a hollow structure that is prone to kinking, making it disadvantageous as a distal end configuration. In contrast, the multi-lumen structure region 100b has a large amount of resin, is less likely to kink, and has high viscosity and followability, making it advantageous as a distal end configuration. Therefore, the multi-lumen structure region 100b was adopted as the distal end configuration.

[0063] Here, it is possible to construct the entire catheter shaft from the base end to the tip end using a multi-lumen structure, but we thought that a multi-lumen structure would be less advantageous than a tube structure in terms of improving the torque transmission required for the base end structure.

[0064] The inventors have noticed that tube structures offer a high degree of freedom in design and are easy to process. Because a large proportion of a tube structure is hollow, it is easy to provide a reinforcing member in that portion, thereby improving torque transmission.

[0065] 23, in which the same reference numerals are assigned to parts corresponding to those in FIG. 20, and FIG. 24, in which the same reference numerals are assigned to parts corresponding to those in FIG. 22, are views showing an example in which a coil K1 is provided as a reinforcing body. As can be seen from FIGS. 23 and 24, the coil K1 is provided in the tube structure region 100a. In the example shown, the coil K1 is arranged along the inner circumferential surface of the tube 101. This allows the coil K1 to improve the torque transmission performance of the tube structure region 100a.

[0066] In this embodiment, the coil K1 is used as a reinforcing body in the tube structure region 100a, but the reinforcing body may be, for example, a metal tube or a wire. The configuration in which a reinforcing body is provided in the tube structure region 100a to enhance torque transmission is preferably also applied to other embodiments described below.

[0067] In this way, the configuration of this embodiment takes into consideration the characteristics of the tube structure and the multi-lumen structure, and by arranging the multi-lumen structure region 100b on the tip side and the tube structure region 100a on the base end side, it is possible to realize a catheter shaft 100 that is less likely to kink and has high viscosity and tracking ability on the tip side, and high torque transmission ability on the base end side.

[0068] This makes it possible to realize an intracardiac defibrillation catheter that is easy to operate and allows the operator to easily place the defibrillation electrodes at the desired positions.

[0069] <2> Embodiment 2 In this embodiment, as shown in Fig. 25, a description will be given of the configuration of an intracardiac defibrillation catheter when intracardiac defibrillation is performed using a single intracardiac defibrillation catheter 10. The intracardiac defibrillation catheter 10 is a catheter having both RA and CS electrodes.

[0070] The catheter shaft of the intracardiac defibrillation catheter 10 is inserted through the inferior vena cava into the right atrium 3 and the coronary sinus 4. At this time, the RA electrode group is placed in the right atrium (RA) 3, and the CS electrode group is placed in the coronary sinus (CS) 4.

[0071] 26 is an external view showing the overall configuration of the intracardiac defibrillation catheter 10 of this embodiment. The intracardiac defibrillation catheter 10 has a catheter shaft 1100, a handle portion 1200, and connectors 1301 and 1302.

[0072] The catheter shaft 1100 is provided with an RA electrode group 1110, a CS electrode group 1120, and an inspection electrode group 1130. The RA electrode group 1110 consists of a plurality of (eight in this embodiment) ring-shaped electrodes 20 arranged at a predetermined distance apart, the CS electrode group 1120 consists of a plurality of (eight in this embodiment) ring-shaped electrodes 1121 arranged at a predetermined distance apart, and the inspection electrode group 1130 consists of a plurality of (four in this embodiment) ring-shaped electrodes 1131 arranged at a predetermined distance apart.

[0073] The catheter shaft 1100 has a tube structure region 1100a and a multi-lumen structure region 1100b. The tube structure region 1100a is arranged in a first section in the longitudinal direction of the catheter shaft 100, and has a luminal structure composed of one or more tubes. The multi-lumen structure region 1100b is arranged in a second section in the longitudinal direction of the catheter shaft 1100, which is different from the first section, and has a luminal structure in which multiple lumens are formed. The tube structure region 1100a and the multi-lumen structure region 1100b will be described in detail later.

[0074] The connectors 1301 and 1302 are connected to a defibrillator (not shown).

[0075] When performing treatment such as intracardiac defibrillation, the defibrillator supplies electrical energy to the RA electrode group 1110 and the CS electrode group 1120. On the other hand, when measuring an intracardiac electrocardiogram, the defibrillator obtains the intracardiac electrocardiogram using the potentials of the RA electrode group 1110, the CS electrode group 1120, and the testing electrode group 1130.

[0076] <2-1> Configuration example 1 of catheter shaft 1100 Next, the configuration of the catheter shaft 1100 of this embodiment will be described in detail. Figures 27, 28, 29, and 30 are cross-sectional views showing the AA, BB, CC, and LL cross sections of Figure 26 (LL cross sections of Figures 27, 28, and 29), respectively.

[0077] 27 and 28 are cross-sectional views of the tube structure region 1100a. As can be seen from Figures 27 and 28, the catheter shaft 1100 has multiple tubes 1101, 1102, and 1103 arranged concentrically in the tube structure region 1100a. Specifically, the tubes 1101, 1102, and 1103 have different diameters, and the tube 1102 is arranged in the hollow portion of the tube 1101, the tube 1103 is arranged in the hollow portion of the tube 1102, and the tube 1104 is arranged in the hollow portion of the tube 1103.

[0078] Each of the tubes 1101, 1102, 1103, and 1104 is made of a resin having insulating properties. Specifically, each of the tubes 1101, 1102, 1103, and 1104 is made of, for example, polyvinyl chloride, polyurethane, polyamide, fluorine-based resin, or polyimide. Of the multiple tubes 1101, 1102, 1103, and 1104, the outermost tube 1101 is thicker than the other tubes 1102, 1103, and 1104. This reliably prevents blood from entering the interior of the tube 1101 and increases the reliability of the fixation of the electrodes 1111, 1121, and 1131 to the tube 1101.

[0079] Lead wires 1132 connected to electrodes 1131 of the inspection electrode group 1130 are arranged in the gap between the tubes 1101 and 1102. In the example of the present embodiment, the inspection electrode group 1130 has four electrodes 1131, and therefore four lead wires 1132 are provided to connect to the respective electrodes 1131. Furthermore, a pull wire 1140 is provided inside the tube 1101.

[0080] Lead wires 1112 connected to electrodes 1111 of RA electrode group 1110 are arranged in the gap between tube 1102 and tube 1103. In this embodiment, since there are eight electrodes 1111 in RA electrode group 1110, eight lead wires 1112 connected to the respective electrodes 1111 are provided.

[0081] Lead wires 1122 connected to electrodes 1121 of CS electrode group 1120 are arranged in the internal space of tube 1103. In the example of the present embodiment, there are eight electrodes 1121 in CS electrode group 1120, and therefore eight lead wires 1122 connected to the respective electrodes 1121 are provided.

[0082] As a result, the lead wires 1112, 1122, and 1132 are separated by the tubes 1102 and 1103, and are electrically insulated from each other. Note that an insulating film is formed on the surface of each of the lead wires 1112, 1122, and 1132, and the lead wires 1112, 1122, and 1132 are also insulated from each other by this insulating film.

[0083] Here, lead wires connected to the same electrode group have approximately the same potential during intracardiac defibrillation, but large potential differences occur between lead wires connected to different electrode groups during intracardiac defibrillation, so insulation by an insulating film on the surface of the lead wire alone is insufficient. Therefore, in this embodiment, multiple tubes 1102 and 1103 arranged concentrically provide insulation between lead wires 1132, 1112, and 1122 connected to different electrode groups 1130, 1110, and 1120.

[0084] The leads 1112, 1122, 1132 pass through the handle portion 1200 and are connected to the defibrillator via connectors 1301, 1302.

[0085] Figure 29 is a cross-sectional view of the multi-lumen structure region 1100b. As can be seen from Figure 29, the catheter shaft 1100 has multiple lumens 1151, 1152, and 1153 formed in the multi-lumen structure region 1100b. The lumens 1151, 1152, and 1153 are formed by drilling a cylindrical core 1160 of the catheter shaft 1100 in the longitudinal direction of the catheter shaft 1100.

[0086] Core 1160 is made of, for example, a low-hardness nylon elastomer. The outer periphery of core 1160 may be covered with an outer shell made of a high-hardness nylon elastomer. Core 1160 and lumens 1151, 1152, and 1153 are partitioned by fluororesin layers 1151a, 1152a, and 1153a.

[0087] The configuration of the multi-lumen structure region 1100b is not limited to this. The multi-lumen structure region 1100b may have at least a core 1160 and a plurality of lumens drilled in the core 1160 in the longitudinal direction.

[0088] The hollow portions of the lumens 1151 and 1152 are perfectly circular. In contrast, the hollow portion of the lumen 1153 is not perfectly circular. Specifically, the lumen 1153 is shaped like an oval coin. Alternatively, the lumen 1153 may be said to have a shape having two opposing straight lines and two opposing curved lines. The hollow portion of the lumen 1153 may be elliptical or approximately elliptical, oval (racetrack), or other shapes. For example, the cross-sectional shape of the lumen 1153 may be shaped like glasses or a gourd, so that the cross-sectional shape of the lumen 1153 has a depression (constriction). By adopting such a shape and positioning the lumens 1151 and 1152 near the depression (constriction), the positions of the lumens 1151 and 1152 can be more stabilized. Stabilizing the positions of lumens 1151 and 1152 leads to improved operation accuracy. Furthermore, lumen 1153 may have a hollow portion having a shape that is a composite combination of different shapes, such as a perfect circle or a rectangle. Lumen 1153 is formed along the diameter of core 1160, and lumens 1162 and 1163 are formed on both sides of lumen 1161, sandwiching it therebetween.

[0089] A pull wire 1140 is inserted through the lumen 1151. A lead wire 1122 connected to an electrode 1121 of the CS electrode group 1120 is inserted through the lumen 1153. In this embodiment, nothing is inserted through the lumen 1152. Therefore, the lumen 1152 does not have to be formed.

[0090] The proximal end of the pull wire 1140 is connected to the dial 1201 of the handle portion 1200. The distal end of the pull wire 1140 is connected to the cap 1150. Alternatively, the distal end of the pull wire 1140 may be connected to the core 1160. As can be seen from FIGS. 27, 28, and 29, the pull wire 1140 passes through a position eccentric from the center toward the outer periphery of the catheter shaft 1100. As a result, when the user rotates the dial 1201, the pull wire 1140 is pulled, and the distal end of the catheter shaft 1100 is bent, for example, downward (in the -a direction) in FIG. 26, allowing the catheter shaft 1100 to be advanced in a desired direction within the blood vessel and the heart.

[0091] The configuration of the catheter shaft 1100 of this embodiment will be described in more detail with reference to Figure 30. Figure 30 is a cross-sectional view of the catheter shaft 1100 cut along a plane including LL in Figures 26 to 29.

[0092] The proximal ends of the tubes 1101 , 1102 , 1103 , and 1104 are joined to a handle portion 1200 .

[0093] A cap 1150 (FIG. 26) is attached to the tip of the tube 1101. The cap 1150 is made of, for example, an X-ray opaque material, and functions as a marker.

[0094] The tube 1102 extends further distally than the electrodes 1131 of the testing electrode group 1130 and terminates further proximally than the electrodes 1111 of the RA electrode group 1110. The tube 1103 extends further distally than the electrodes 1111 of the RA electrode group 1110 and terminates further proximally than the electrodes 1121 of the CS electrode group 1120.

[0095] Each electrode 1131 of the inspection electrode group 1130 is connected to a lead wire 1132 disposed between the tube 1101 and the tube 1102 .

[0096] Each electrode 1111 of the RA electrode group 1110 is connected to a lead wire 1112 arranged between the tube 1102 and the tube 1103. Here, each lead wire 1112 is led out of the tube 1102 from an opening at the tip of the tube 1102 and connected to each electrode 1111.

[0097] Each electrode 1121 of the CS electrode group 1120 is connected to each lead wire 1122 arranged in the internal space of the tube 1103 and in the lumen 1153. Here, each lead wire 1122 is led out of the tube 1103 from an opening at the tip of the tube 1103, passes through the lumen 1153, and is connected to each electrode 1121.

[0098] The electrodes 1111, 1121, 1131 and the lead wires 1112, 1122, 1132 are connected by, for example, welding. Furthermore, the tube 1101 is formed with insertion holes through which the lead wires 1112, 1122, 1132 can be inserted, and after the lead wires 1112, 1122, 1132 are passed through the insertion holes, the ring-shaped electrodes 1111, 1121, 1131 are attached to the tube 1101 by, for example, crimping. The method of attaching the electrodes 1111, 1121, 1131 to the tube 1101 is not limited to this. The key is to attach the electrodes 1111, 1121, 1131 in such a way that blood does not enter the tube 1101 through the insertion holes. Furthermore, in consideration of smooth insertion of the catheter shaft 1100 into the cardiac cavity, it is preferable to attach the electrodes 1111, 1121, 1131 so that the step between the tube 1101 and the electrodes 1111, 1121, 1131 is as small as possible.

[0099] <2-2> Configuration example 2 of catheter shaft 1100 In the above section <2-1>, we have described a unidirectional type catheter shaft 1100, i.e., a catheter shaft 1100 whose tip can be bent in only one direction (-a direction) by one pull wire 1140. In this configuration example 2, we will describe the configuration of a bidirectional type catheter shaft 1100.

[0100] 31 to 34, in which the same reference numerals are used to denote parts corresponding to those in Figures 27 to 30, show the configuration of a bidirectional type catheter shaft 1100. Figures 31 and 32 are cross-sectional views of the tube structure region 1100a, Figure 33 is a cross-sectional view of the multi-lumen structure region 1100b, and Figure 34 is a cross-sectional view of the catheter shaft 1100 taken along a plane including LL in Figures 31 to 33.

[0101] Compared to the configuration of the unidirectional catheter shaft 1100, the bidirectional catheter shaft 1100 of Configuration Example 2 has two pull wires 1140, 1141. As can be seen from Figures 29 and 34, the tube structure region 1100a is provided with a tube 1105 that houses the pull wire 1141.

[0102] The two pull wires 1140, 1141 are wound in opposite directions around the dial 201. This allows the tip of the catheter shaft 100 to be selectively bent in one of two directions (-a direction, +a direction) depending on the direction in which the dial 201 is rotated.

[0103] <2-3> Summary of the second embodiment As described above, according to this embodiment, the catheter shaft 1100 is configured with a tube structure region 1100a, which is arranged in a first section in the longitudinal direction of the catheter shaft 1100 and has a tubular structure formed by a plurality of tubes 1101, 1102, 1103 arranged concentrically, and a multi-lumen region 1100b, which is arranged in a second section different from the first section in the longitudinal direction of the catheter shaft 1100 and has a tubular structure in which a plurality of lumens 1151, 1152, 1153 are formed. The device has a tube structure region 1100b, a group of lead wires 1112, 1122, 1132 that extend continuously through both the lumen of the tube structure region 1100a and the lumen of the multi-lumen structure region 1100b and have one end connected to electrodes 1111, 1121, 1131, and a pull wire 150 that extends continuously through both the lumen of the tube structure region 1100a and the lumen of the multi-lumen structure region 1100b and have one end connected to the operating portion (handle portion 1200).

[0104] As a result, as in embodiment 1, by arranging a multi-lumen structure region 1100b on the tip side and a tube structure region 1100a on the base end side, it is possible to realize a catheter shaft 100 that is less likely to kink and has high viscosity and tracking ability on the tip side, and high torque transmission ability on the base end side.

[0105] This makes it possible to realize an intracardiac defibrillation catheter that is easy to operate and allows the operator to easily place the defibrillation electrodes at the desired positions.

[0106] <3> Embodiment 3 In this third embodiment, as explained in the above item <1-3>, another configuration example will be described in which a reinforcing plate is provided on the catheter shaft 100. In the drawings used in the following explanation, the same reference numerals are used to designate the same components as those already explained.

[0107] <3-1> Configuration example 1 (when there is one reinforcing plate) Figures 35, 36, and 37 are cross-sectional views of the catheter shaft 100 of Configuration Example 1. Figure 35 is a cross-sectional view of the catheter shaft 100 taken along a plane including BB in Figure 2, and Figure 36 is a cross-sectional view of the catheter shaft 100 taken along a plane including AA in Figure 2. Figure 37 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 35 and 36.

[0108] The catheter shaft 100 of this configuration example differs from the configuration described in item <1-3> in the following respects.

[0109] 35 and 10, in this configuration example, a resin coating 180a is formed on the surface of the metal reinforcing plate 180. This makes it possible to prevent damage to the lead wire 140 due to contact between the lead wire 140 and the reinforcing plate 180, and to protect the lead wire 140.

[0110] 36 and 11, the catheter shaft 100 of this configuration example has a tubular structure at the AA cross section in the longitudinal direction of the shaft, and a coil K1 is disposed along the inner circumferential surface of the tube 101. Two pull wires 150 and 151 are provided in the tubes 103 and 104, respectively. A plurality of lead wires 140 are also disposed in a dispersed manner within the tube 101.

[0111] As can be seen by comparing FIG. 37 with FIG. 24, the catheter shaft 100 of this configuration example is provided with a reinforcing plate 180 in addition to the configuration described in FIG.

[0112] The reinforcing plate 180 extends in the longitudinal direction of the multi-lumen structure region 100b, and a portion of its base end further extends to the tube structure region 100a. A portion of the rear end of the reinforcing plate 180 overlaps a portion of the tip end of the coil K1, which serves as a reinforcing body, in the longitudinal direction.

[0113] <3-2> Configuration example 2 (when there are two reinforcing plates) Figures 38, 39, 40 and 41 are cross-sectional views of the catheter shaft 100 of Configuration Example 2. Figure 42 shows the positions of the cross sections.

[0114] Figure 38 is a cross-sectional view of the catheter shaft 100 taken along a plane including CC in Figure 42, Figure 39 is a cross-sectional view of the catheter shaft 100 taken along a plane including BB in Figure 42, and Figure 40 is a cross-sectional view of the catheter shaft 100 taken along a plane including AA in Figure 42. Figure 41 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 38-40.

[0115] As can be seen from FIGS. 39 and 41, in this configuration example 2, two metallic reinforcing plates 180 are provided, as compared with the configuration described in the configuration example 1 of the above item <3-1>.

[0116] <3-3> Configuration example 3 (when there are three reinforcing plates) 43, 44, 45, and 46 are cross-sectional views of the catheter shaft 100 of Configuration Example 3.

[0117] Figure 43 is a cross-sectional view of the catheter shaft 100 taken along a plane including CC in Figure 42, Figure 44 is a cross-sectional view of the catheter shaft 100 taken along a plane including BB in Figure 42, and Figure 45 is a cross-sectional view of the catheter shaft 100 taken along a plane including AA in Figure 42. Figure 46 is a cross-sectional view of the catheter shaft 100 taken along a plane including EE in Figures 43 to 45.

[0118] As can be seen from FIGS. 44 and 46, in this configuration example 3, three metallic reinforcing plates 180 are provided, as compared to the configuration described in the configuration example 1 of the above item <3-1>.

[0119] <3-4> Summary of the third embodiment The provision of the metal reinforcing plate (flat plate) 180 improves the flatness of the curved catheter shaft 100. In other words, bending in directions other than the desired direction can be suppressed.

[0120] Furthermore, by providing multiple reinforcing plates (flat plates) 180, the curved shape of the tip of the catheter shaft 100 can be made asymmetric in the +a and -a directions. Furthermore, the more reinforcing plates (flat plates) 180 are used, the more reinforcement can be provided for the curved base end portion of the tip of the catheter shaft 100. Here, the more reinforcing plates (flat plates) 180 are used, the less likely the corresponding portion is to bend. As a result, the way the tip electrode portion bends changes depending on the number of reinforcing plates (flat plates) 180, and the curved shape of the tip changes. In other words, by appropriately selecting the number of reinforcing plates (flat plates) 180, it is possible to increase the variety of curved shapes of the curved tip portion.

[0121] Incidentally, materials such as NiTi and SUS can be used for the reinforcing plate 180. When multiple reinforcing plates 180 are provided, the materials of each reinforcing plate 180 may be different. For example, if a combination of NiTi and SUS is used as the reinforcing plate (flat plate) 180, the hardness characteristics of each material can make the curved shape of the tip electrode portion asymmetric in the +a direction and the -a direction, further increasing the variety of curved shapes. Furthermore, when a single reinforcing plate 180 is provided, the material may be uniform, or may vary, for example, in the longitudinal direction.

[0122] In addition, with regard to the bidirectional type, a reinforcing plate 180 is located within the lumen of the multi-lumen structure, and the reinforcing plate 180 is fixed at the tip and rear of the tube, preventing the reinforcing plate 180 from twisting within the catheter, improving the torque transmission of the entire catheter.

[0123] In the above embodiment, the resin coating 180a is formed on the entire surface of the reinforcing plate 180, but the resin coating 180a may be formed only on a portion of the surface of the reinforcing plate 180, or the resin coating 180a may not be formed at all.

[0124] 41 and 46, in the above-described embodiment, the region where the multiple reinforcing plates 180 are provided overlapping each other is from the end of the base end side of the reinforcing plate 180 to the base end side of the ring-shaped electrode 111 (121, 122), but the region where the multiple reinforcing plates 180 are provided overlapping each other is not limited to this. For example, the multiple reinforcing plates 180 may be provided overlapping each other further up to the tip side.

[0125] In the above-described embodiment, the lead wire 140 and the pull wires 150 and 151 are disposed inside the lumen of the coil K1 serving as the reinforcing body, but this is not limitative and the lead wire 140 and the pull wires 150 and 151 may be disposed outside the coil K1. The reinforcing body is not limited to the coil K1, and may be, for example, a pipe. A resin coating may be formed on the surface of the reinforcing body.

[0126] <4> Other embodiments The above-described first to third embodiments are merely examples of specific embodiments of the present invention, and the technical scope of the present invention should not be construed as being limited by them. In other words, the present invention can be embodied in various forms without departing from the gist or main features thereof.

[0127] The number and arrangement of lumens in the multi-lumen structure region and the number and arrangement of tubes in the tube structure region are not limited to the examples shown in Embodiments 1-3.

[0128] The number and arrangement of the lead wires and pull wires arranged in the multi-lumen structure region and the tube structure region are not limited to those described in the embodiments. Furthermore, the pull wires are not limited to metal wires, and may be wires made of resin or the like. Therefore, the present disclosure can be implemented by replacing the pull wires in this specification with the cord members.

[0129] Furthermore, the configurations described in the above-mentioned embodiments 1 to 3 can be implemented in appropriate combinations. [Industrial Applicability]

[0130] The intracardiac defibrillation catheter of the present disclosure is useful as an intracardiac defibrillation catheter used for treatment such as intracardiac defibrillation. [Explanation of symbols]

[0131] 1, 2, 10 Intracardiac defibrillation catheter 100, 1100 Catheter shaft 100a, 1100a Tube structure area 100b, 1100b Multi-lumen structure area 101~104, 1101~1105 Tubes 110, 1110 RA electrode group 111, 121, 131, 1111, 1121, 1131 electrode 120, 1120 CS electrode group 130, 1130 Test electrode group 140, 1112, 1122, 1132 lead wires 150, 151, 1140, 1141 pull wire 161~164, 1151~1153 lumens 170, 1160 cores 180 Reinforcement plate 180a resin coating 200, 1200 handle

Claims

1. An intracardiac defibrillation catheter having a catheter shaft with electrodes arranged on its surface and an operation unit connected to a proximal end side of the catheter shaft, The catheter shaft a tube structure region disposed in a first section in the longitudinal direction of the catheter shaft and having a tubular structure formed by a plurality of tubes separate from one another; a multi-lumen structure region disposed in a second section of the catheter shaft that is located on the distal end side of the first section in the longitudinal direction, the multi-lumen structure region having a tubular structure in which multiple lumens are formed in one core; a group of lead wires extending continuously through both the lumen of the tube structure region and the lumen of the multi-lumen structure region, one end of which is connected to the electrode; a cord-like member that extends continuously across both the lumen of the tube structure region and the lumen of the multi-lumen structure region, and one end of which is connected to the operation unit; Equipped with Intracardiac defibrillation catheter.

2. The plurality of tubes in the tube structure region include a plurality of tubes arranged concentrically. The intracardiac defibrillation catheter of claim 1 .

3. At least one lumen in the multi-lumen structure region has a hollow cross section that is not a perfect circle when the catheter shaft is cut along a plane perpendicular to the longitudinal direction. The intracardiac defibrillation catheter of claim 1 .

4. The hollow cross section of the at least one lumen that is not a perfect circle is elliptical or approximately elliptical. The intracardiac defibrillation catheter of claim 3 .

5. A reinforcing plate is disposed in the at least one lumen whose hollow cross section is not a perfect circle. The intracardiac defibrillation catheter of claim 3 .

6. The reinforcing plate is restricted in rotation within the lumen around the longitudinal direction of the catheter shaft as a rotation axis.

6. The intracardiac defibrillation catheter of claim 5.

7. the reinforcing plate is made of a material having a higher hardness than the core in the multi-lumen structure region of the catheter shaft.

6. The intracardiac defibrillation catheter of claim 5.

8. A plurality of the reinforcing plates are provided.

6. The intracardiac defibrillation catheter of claim 5.

9. The base end side of the reinforcing plate extends to the tube structure region.

6. The intracardiac defibrillation catheter of claim 5.

10. The number of the reinforcing plates is greater in the base end region than in the tip end region.

9. The intracardiac defibrillation catheter of claim 8.

11. the lead wire group is disposed in a first lumen in the multi-lumen structure region; The cord-like member is disposed in the second lumen in the multi-lumen structure region. The intracardiac defibrillation catheter of claim 1 .

12. the electrodes in the tube structure region are an RA electrode group, The electrodes in the multi-lumen structure region are a CS electrode group. The intracardiac defibrillation catheter of claim 1 .

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