JP7555850B2 - catheter - Google Patents

Description

The present invention relates to an electrode catheter used for defibrillation, cauterization of internal tissue, measuring the electrical potential of internal organs, etc.

Electrode catheters with electrodes on their shafts are primarily used as medical devices to apply electrical stimulation or cauterize body tissue to treat arrhythmias such as atrial fibrillation and ventricular fibrillation, or to measure the electrical potential of organs such as the heart. In an electrode catheter, multiple electrodes are disposed on the outside of a shaft having an internal cavity. Conductors electrically connected to the inner surfaces of the electrodes extend through the internal cavity of the shaft to an external device, such as a defibrillation power supply or an electrocardiograph. Patent documents 1 and 2 disclose examples of devices with electrodes.

JP 2014-97084 A Special Publication No. 2006-506195

Multiple conductors are placed inside the shaft lumen, but because the lumen of the shaft is narrow, there is a possibility that the conductors may short-circuit. Therefore, the present invention aims to provide a catheter that is less likely to cause short-circuits between the conductors.

One embodiment of the catheter of the present invention that has achieved the above object is a shaft extending in the longitudinal direction from the distal end to the proximal end, the shaft having an inner lumen, a first side hole communicating with the inner lumen, and a second side hole proximal to the first side hole, a first electrode disposed outside the first side hole, a second electrode disposed outside the second side hole, a first lead wire electrically connected to the first electrode and extending into the inner lumen of the shaft through the first side hole, a second lead wire electrically connected to the second electrode and extending into the inner lumen of the shaft through the second side hole, and a partition member disposed in the inner lumen of the shaft and dividing the inner lumen into at least a first lumen region and a second lumen region, the partition member having at least one through hole, the first lead wire disposed in the first lumen region, and the second lead wire disposed in the second lumen region. In the catheter according to the present invention, the inner cavity of the shaft is divided by a partition member, so that the first conductor arranged in the first inner cavity region is less likely to move to the second inner cavity region, and the second conductor arranged in the second inner cavity region is also less likely to move to the first inner cavity region. As a result, the first conductor and the second conductor are less likely to come into contact with each other, and short circuits between the conductors can be prevented. In addition, the first inner cavity region and the second inner cavity region are connected through the through hole, so that it is easier to distribute a fluid such as a sterilization gas through the inner cavity of the shaft.

At least one through hole may pass through the partition member in a direction perpendicular to the longitudinal axis of the shaft. At least one through hole may extend in the radial direction of the shaft or in the longitudinal direction of the shaft.

At least one of the through holes may have a plurality of through holes, and the plurality of through holes may be aligned in the longitudinal direction of the shaft. At least one of the through holes may have a plurality of through holes, and the plurality of through holes may be aligned in the radial direction of the shaft.

The partition member may have at least one partition section extending from the center side of the longitudinal axis of the shaft toward the inner wall side of the shaft, and at least one through hole may be arranged in the at least one partition section. The at least one partition section may extend in the radial direction of the shaft, or in the longitudinal direction of the shaft. The at least one partition section may have multiple partition sections, and the multiple partition sections may be arranged in the circumferential direction of the shaft.

The partition member may have a cylindrical portion extending in the longitudinal direction of the shaft, and multiple partition portions may be arranged on the outer periphery of the cylindrical portion.

At least one partition may be fixed to an inner wall of the shaft.

The shaft has a gap between its inner wall and the partition member, and the gap may be smaller than the diameter of the first conductor and smaller than the diameter of the second conductor.

When performing defibrillation in a catheter, a voltage of a different polarity than the first electrode may be applied to the second electrode.

According to the catheter of the present invention, the first conductor disposed in the first lumen region is less likely to move into the second lumen region, and the second conductor disposed in the second lumen region is also less likely to move into the first lumen region. As a result, the first conductor and the second conductor are less likely to come into contact with each other, and short circuits between the conductors can be prevented. In addition, the first lumen region and the second lumen region are connected via the through hole, making it easier to distribute a fluid such as a sterilizing gas through the lumen of the shaft.

FIG. 1 is a side view of a catheter according to one embodiment of the present invention. FIG. 2 is a cross-sectional view (partial side view) taken along line II-II of the catheter shown in FIG. 1. FIG. 2 is a cross-sectional view (partial side view) of the catheter shown in FIG. 1 taken along line III-III. FIG. 4 is a cross-sectional view of the catheter shown in FIG. 3 taken along line IV-IV. FIG. 5 is a plan view of the partition member shown in FIGS. 2 to 4. 6 is a plan view showing a modified example of the partition member shown in FIG. 5 . 6 is a plan view showing another modified example of the partition member shown in FIG. 5 . FIG. 5 is a cross-sectional view showing a modification of the catheter shown in FIG. 4. FIG. 5 is a cross-sectional view showing another modified example of the catheter shown in FIG. 4. FIG. 5 is a cross-sectional view showing another modified example of the catheter shown in FIG. 4. FIG. 5 is a cross-sectional view (partial plan view) showing a modification of the catheter shown in FIG. 4 . 12 is a cross-sectional view of the catheter shown in FIG. 11 along line XII-XII.

The present invention will be described in more detail below based on the following embodiment, but the present invention is not limited to the following embodiment, and can of course be modified appropriately within the scope of the above and below, all of which are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to contributing to an understanding of the features of the present invention.

Catheters are used, for example, in the treatment and diagnosis of arrhythmias such as atrial fibrillation and ventricular fibrillation. In the treatment of arrhythmias, for example, defibrillation or cauterization of body tissue can be performed by passing a high-frequency current through the electrodes of the catheter. In the diagnosis of arrhythmias, an electrocardiogram can be obtained by inserting a catheter into the patient's body and placing electrodes on or near the tissue to be diagnosed in the heart, and measuring the electrical potential of the tissue. The catheter may be an intracardiac defibrillation catheter.

One embodiment of the catheter of the present invention is a shaft extending in a longitudinal direction from a distal end to a proximal end, the shaft having an inner lumen, a first side hole communicating with the inner lumen, and a second side hole proximal to the first side hole, a first electrode disposed outside the first side hole, a second electrode disposed outside the second side hole, a first lead wire electrically connected to the first electrode and extending into the inner lumen of the shaft through the first side hole, a second lead wire electrically connected to the second electrode and extending into the inner lumen of the shaft through the second side hole, and a partition member disposed in the inner lumen of the shaft and dividing the inner lumen into at least a first lumen region and a second lumen region, the partition member having at least one through hole, the first lead wire disposed in the first lumen region, and the second lead wire disposed in the second lumen region. In the catheter according to the present invention, the inner cavity of the shaft is divided by a partition member, so that the first conductor arranged in the first inner cavity region is less likely to move to the second inner cavity region, and the second conductor arranged in the second inner cavity region is also less likely to move to the first inner cavity region. As a result, the first conductor and the second conductor are less likely to come into contact with each other, and short circuits between the conductors can be prevented. In addition, the first inner cavity region and the second inner cavity region are connected through the through hole, so that it is easier to distribute a fluid such as a sterilizing gas through the inner cavity of the shaft.

An example of the catheter configuration will be described with reference to Figures 1 to 12. Figure 1 is a side view of a catheter according to one embodiment of the present invention. Figure 2 is a II-II cross-sectional view (partial side view) of the catheter shown in Figure 1. Figure 3 is a III-III cross-sectional view (partial side view) of the catheter shown in Figure 1. Figure 4 is a IV-IV cross-sectional view of the catheter shown in Figure 3. Figure 5 is a plan view of the partition member shown in Figures 2 to 4. Figures 6 to 7 are plan views showing other modified examples of the partition member shown in Figure 5. Figures 8 to 10 are cross-sectional views showing other modified examples of the catheter shown in Figure 4. Figure 11 is a cross-sectional view (partial plan view) showing a modified example of the catheter shown in Figure 4. Figure 12 is a XII-XII cross-sectional view of the catheter shown in Figure 11. The catheter 1 has a shaft 2, a first electrode 31, a second electrode 32, a first conducting wire 41, a second conducting wire 42, and a partition member 60.

The distal side of the catheter 1 refers to the distal end side of the shaft 2 in the longitudinal axis direction x, which is the side to be treated. The proximal side of the catheter 1 refers to the proximal end side of the shaft 2 in the longitudinal axis direction x, which is the side closest to the user. When each component is divided in half along its longitudinal axis, the proximal side is sometimes referred to as the proximal portion, and the distal side is sometimes referred to as the distal portion.

The shaft 2 is a long member having a longitudinal axis direction x, a radial direction, and a circumferential direction p. The shaft 2 extends in the longitudinal axis direction x from the distal end to the proximal end. The catheter 1 is inserted into the patient's body from the distal end side of the shaft 2. A handle 70 that is held by the surgeon is preferably connected to the proximal portion of the shaft 2. The shaft 2 may have a passage therein for a guide wire that guides the advancement of the shaft 2. The catheter 1 may include a guide wire extending in the longitudinal axis direction x.

The shaft 2 has an inner lumen 20. The inner lumen 20 extends in the longitudinal axis direction x. A single shaft 2 may have multiple inner lumens 20, but it is preferable that only one lumen 20 is provided. The shaft 2 preferably has a cylindrical structure in order to place a conductor in the inner lumen 20. The inner lumen 20 of the shaft 2 is disposed throughout the entire longitudinal axis direction x of the shaft 2, and it is preferable that an opening is provided at each of the distal end side and the proximal end side of the shaft 2.

A tip 72 may be provided at the distal end of the shaft 2. The tip 72 may be made of a conductive material or an insulating material. The tip 72 may cover a part or all of the opening at the distal end of the shaft 2.

The shaft 2 is preferably flexible. This allows the shaft 2 to be deformed according to the shape of the body cavity. In order to maintain the shape, the shaft 2 is preferably elastic. The shaft 2 is preferably made of resin, metal, or a combination of resin and metal. Examples of the shaft 2 include a resin tube, a metal tube, a hollow body formed by arranging wires in a predetermined pattern, a hollow body in which at least one of the inner and outer surfaces is coated with resin, or a combination of these, for example, a combination of these, such as a combination of these connected in the longitudinal direction. The resin tube can be manufactured by, for example, extrusion molding. Examples of hollow bodies in which wires are arranged in a predetermined pattern include a cylindrical body having a mesh structure formed by simply crossing or weaving wires, and a coil in which wires are wound. The wires may be one or more solid wires, or one or more twisted wires. The cross-sectional shape of the wires may be, for example, a circle, an oval, a polygon, or a combination of these. The oval shape includes an ellipse, an egg, and a rounded rectangle, and the same applies in the following explanation. The type of mesh structure is not particularly limited, and the number of turns and density of the coil are also not particularly limited. The mesh structure and coil may be formed with a constant density over the entire longitudinal direction of the shaft 2, or may be formed so that the density varies depending on the longitudinal position of the shaft 2. In order to increase the flexibility of the metal tube, cuts or grooves may be formed on the outer surface of the metal tube. The shape of the cuts or grooves may be linear, arc-shaped, annular, spiral, or a combination of these. When the shaft 2 is a cylindrical resin tube, the shaft 2 may be composed of a single layer or multiple layers, and a part in the longitudinal axis direction x or circumferential direction p may be composed of a single layer, and the other part may be composed of multiple layers.

By using a resin as the constituent material of the shaft 2, it becomes easier to impart flexibility and elasticity to the shaft 2. By using a metal as the constituent material of the shaft 2, it is possible to improve the deliverability of the catheter 1. Examples of resins constituting the shaft 2 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, fluororesins (e.g., PTFE, PFA, ETFE), vinyl chloride resins, and silicone resins, as well as natural rubber and synthetic rubber. Examples of metals constituting the shaft 2 include stainless steels such as SUS304 and SUS316, carbon steel, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, or combinations thereof. These may be used alone or in combination of two or more types. The shaft 2 may have a laminated structure made of different materials or the same material.

The shaft 2 is configured to be bendable. The shaft 2 may be curved in a plane or in a three-dimensional manner. When the shaft 2 is curved in a plane, it means that the distal end and proximal end of the curved portion of the shaft 2 are on approximately the same plane before and after bending. When the shaft 2 is curved in a three-dimensional manner, it means that the plane on which the distal end and proximal end of the curved portion of the shaft 2 are located before bending is different from the plane on which they are located after bending. In other words, it means that the shaft 2 is twisted by bending.

The shaft 2 has multiple side holes. The side holes are arranged in the wall of the shaft 2, more specifically, in the peripheral wall. The side holes are arranged so as to penetrate from the outside of the shaft 2 to the inner cavity 20. A conductor connected to an electrode can be inserted into the inner cavity 20 through the side holes. In FIG. 2, the shaft 2 has at least a first side hole 11 and a second side hole 12, and the second side hole 12 is located proximally of the first side hole 11. The first side hole 11 and the second side hole 12 communicate with the inner cavity 20 of the shaft 2. The number of side holes arranged in one shaft 2 may be two or more, and can be set according to the number of electrodes. In the catheter 1 shown in FIG. 1 to FIG. 2, the shaft 2 has six side holes proximal to the second side hole 12, although not shown, and an electrode is arranged in each of these side holes.

The first side hole 11 and the second side hole 12 may be aligned in the longitudinal axis direction x of the shaft 2. In order to easily place the first conducting wire 41 in the first lumen region 21 and the second conducting wire 42 in the second lumen region 22, it is preferable that the first side hole 11 and the second side hole 12 are arranged at different positions in the circumferential direction p of the shaft 2. For example, in the circumferential direction p, the center of the first side hole 11 and the center of the second side hole 12 are preferably shifted by 45° or more, more preferably by 60° or more, and even more preferably by 90° or more, and may be shifted by 180° or less, 140° or less, or 120° or less. In FIG. 2, the center of the first side hole 11 and the center of the second side hole 12 in the circumferential direction p are shifted by 180°.

The shape of the side hole when the shaft 2 is viewed in a direction perpendicular to the longitudinal axis direction x can be a circle, an oval, a polygon, or a combination of these. The side hole may have a central axis that coincides with the radial direction of the shaft 2, or may be arranged such that the central axis extends from the outer side to the inner side in the radial direction from the distal side to the proximal side of the shaft 2.

An electrode is disposed on the outside of the side hole of the shaft 2. The electrode can have at least one of the following functions: defibrillation, cauterization, potential measurement, and reference during potential measurement. The reference electrode is, for example, a ground electrode. In FIG. 2, the first electrode 31 is disposed on the outside of the first side hole 11, and the second electrode 32 is disposed on the outside of the second side hole 12. In FIGS. 1 and 2, the first electrode 31 is the most distal electrode, but it is not essential that it is the most distal electrode. In FIGS. 1 and 2, the second electrode 32 is an electrode one electrode closer to the proximal side than the first electrode 31, but another electrode may be disposed between the first electrode 31 and the second electrode 32.

In addition to the first electrode 31 and the second electrode 32, the catheter 1 may have one or more electrodes. In FIG. 1, the third electrode 33, the fourth electrode 34, the fifth electrode 35, the sixth electrode 36, the seventh electrode 37, and the eighth electrode 38 are arranged in this order proximally from the second electrode 32 toward the proximal side. The eighth electrode 38 is the most proximal electrode. It is preferable that one electrode is arranged on the outside of each of the side holes of the shaft 2.

The electrode may be, for example, in the shape of a ring, in the shape of a C-shaped cross section with a notch in the ring, or in the shape of a coil made of wound wire. The electrode can be attached to the shaft 2 by crimping the electrode from the outside of the shaft 2. The electrode may be a sheet, thin plate, or chip of any shape disposed on the shaft 2.

The electrodes may be made of any conductive material, such as metal or a mixture containing a resin and a metal. In particular, the electrodes may be made of conductive resin, platinum, platinum-iridium alloy, stainless steel, tungsten, or other metals. When the electrodes are made of conductive resin, they may be mixed with a contrast agent such as barium sulfate or bismuth oxide.

The conductor wire electrically connects the electrode to an external device of the catheter 1, such as a defibrillation power supply, a cauterization power supply, an electrocardiograph, etc. The conductor wire is electrically connected to the electrode and extends through the side hole into the lumen 20. It is preferable that the conductor wire is arranged outside the partition member 60 in the shaft 2. In other words, it is preferable that the conductor wire is not arranged so as to be enclosed in the partition member 60. In FIG. 2, the first conductor wire 41 is electrically connected to the first electrode 31 and extends through the first side hole 11 into the lumen 20 of the shaft 2. The second conductor wire 42 is electrically connected to the second electrode 32 and extends through the second side hole 12 into the lumen 20 of the shaft 2. In this way, it is preferable that one conductor wire is connected to one electrode. For simplicity, only the first conductor wire 41 and the second conductor wire 42 are shown in FIG. 3 and FIG. 4, but conductor wires are also connected to the third electrode 33 to the eighth electrode 38.

The conductor wire may be any wire that is conductive, such as copper wire, iron wire, stainless steel wire, piano wire, tungsten wire, or nickel titanium wire. To prevent short circuits with adjacent members, the conductor wire may be covered with a covering material such as a covering tube except for both ends in the longitudinal direction. The covering material may be made of an insulating material. The electrodes and conductor wires may be connected by laser welding, resistance welding, or bonding with an adhesive.

The partition member 60 is disposed in the lumen 20 of the shaft 2 and divides the lumen 20 into at least a first lumen region 21 and a second lumen region 22. The partition member 60 has at least one through hole 64. A first conductor 41 is disposed in the first lumen region 21, and a second conductor 42 is disposed in the second lumen region 22. In the catheter 1, since the lumen 20 of the shaft 2 is divided by the partition member 60, the first conductor 41 disposed in the first lumen region 21 is less likely to move to the second lumen region 22, and the second conductor 42 disposed in the second lumen region 22 is also less likely to move to the first lumen region 21. As a result, the first conductor 41 and the second conductor 42 are less likely to come into contact with each other, and a short circuit between the conductors can be prevented. In addition, the first lumen region 21 and the second lumen region 22 are connected via the through hole 64, making it easier to distribute fluids such as sterilization gas throughout the lumen of the shaft.

The partition member 60 may function as a housing member that houses an operating wire or elastic member for bending the shaft 2, or a guide wire that guides the advancement of the shaft 2.

As shown in Figures 2 and 3, the partition member 60 has a distal end 61 and a proximal end 62. The shape of the partition member 60 is not particularly limited, but it is preferably a long member extending in the longitudinal axis direction x of the shaft 2. The partition member 60 as a whole may have, for example, a cylindrical shape, a plate shape, a shape in which a part of the plate is bent, a coil shape, a shape having a longitudinal direction and a width direction perpendicular to the longitudinal direction and the width size varies depending on the position in the longitudinal direction (e.g., a fishbone shape), or a combination of these shapes. Figures 2 to 7 show an example in which the partition member 60 is a long, thin plate shape.

It is preferable that the partition member 60 is disposed only in a portion of the longitudinal axis direction x of the shaft 2. It is also preferable that the partition member 60 is not disposed over the entire longitudinal axis direction x of the shaft 2.

The distal end 61 of the partition member 60 may coincide with the distal end of the shaft 2. Also, as shown in FIG. 2, the distal end 61 of the partition member 60 may be located proximal to the distal end of the shaft 2, or may be located distal to the distal end of the most distal side hole (first side hole 11 in FIG. 2). Also, the partition member 60 may be disposed inside the distal tip 72.

As shown in FIG. 3, the proximal end 62 of the partition member 60 may be located proximal to the proximal end of the most proximal side hole. The proximal end 62 of the partition member 60 may be located distal to the proximal end of the shaft 2. The partition member 60 may also extend from the proximal end of the shaft 2, and the proximal end 62 of the partition member 60 may be located proximal to the proximal end of the shaft 2. In this case, a portion of the partition member 60 is disposed inside the handle 70.

It is preferable that the partition member 60 bends in accordance with the bending of the shaft 2. For this reason, it is preferable that the partition member 60 has flexibility. The partition member 60 may also have elasticity. The partition member 60 may be made of the materials listed as the preferred constituent materials of the shaft 2. The constituent material of the partition member 60 may be the same as or different from the constituent material of the shaft 2.

It is preferable that the partition member 60 has at least one partition portion 63 extending from the center side of the longitudinal axis of the shaft 2 toward the inner wall 5 side of the shaft 2. This configuration makes it possible to partition the inner cavity 20 so that each lumen region has an appropriate size while preventing an increase in the profile of the shaft 2.

In a cross section perpendicular to the longitudinal axis direction x of the shaft 2, the partition portion 63 may extend in a straight line or in a curved line. In addition, in a cross section perpendicular to the longitudinal axis direction x of the shaft 2, the partition portion 63 may extend so as to curve in the circumferential direction p of the shaft 2. For example, the partition portion 63 may extend so that its position in the circumferential direction p changes from the longitudinal axis center side of the shaft 2 to the inner wall 5 side of the shaft 2.

At least one partition 63 preferably extends in the radial direction of the shaft 2. This configuration allows the lumen 20 to be partitioned so that each lumen area has an appropriate size while preventing an increase in the profile of the shaft 2. For example, in FIG. 4, the partition 63 extends in the radial direction of the shaft 2. The partition member 60 is disposed within the shaft 2 so that the partition 63 passes through the center of the longitudinal axis of the shaft 2.

As shown in Figures 2 to 3 and 5 to 7, it is preferable that at least one partition portion 63 extends in the longitudinal axis direction x of the shaft 2. This makes it easier to prevent short circuits between the conductors over a wide range in the longitudinal axis direction x of the shaft 2.

The partition 63 is preferably a convex portion extending from the center side of the longitudinal axis of the shaft 2 toward the inner wall 5 side of the shaft 2. The convex portion may be a projection or a ridge extending in the longitudinal axis direction x of the shaft 2.

In a cross section perpendicular to the longitudinal axis direction x of the shaft 2, the partition portion 63 may have a shape that tapers toward the inner wall 5 of the shaft 2.

At least one partition section 63 may constitute at least a part of the partition member 60. At least one partition section 63 may also constitute the entire partition member 60. This configuration allows the space inside the shaft 2 to be used effectively. For example, in Figures 2 to 4, the partition member 60 has one partition section 63 in the shape of a long flat plate. By disposing the partition member 60 in the lumen 20, one side of the partition section 63 can be divided into the first lumen region 21, and the other side of the partition section 63 can be divided into the second lumen region 22.

The partition member 60 may be formed by combining at least one plate-shaped partition section 63. The thickness of the partition section 63 of the partition member 60 may be constant as shown in FIG. 4, or may have a portion that becomes thinner from the center side of the longitudinal axis of the shaft 2 toward the inner wall 5 side of the shaft 2 as shown in FIG. 8. All of the partition sections 63 may become thinner toward the inner wall 5 side of the shaft 2. At least one of the multiple partition sections 63 may have a constant thickness, and the rest may have a portion that becomes thinner toward the inner wall 5 side of the shaft 2.

It is preferable that the partition portion 63 is disposed only in a portion of the longitudinal axis direction x of the shaft 2. It is also preferable that the partition portion 63 is not disposed over the entire longitudinal axis direction x of the shaft 2.

The partition section 63 may be disposed only in a portion of the partition member 60 in the longitudinal direction, or the partition section 63 may be disposed over the entire longitudinal direction of the partition member 60.

It is preferable that at least a portion of the partition 63 is disposed proximally of the most proximal side hole. For example, in FIG. 3, the partition 63 is disposed at a position proximal to the most proximal side hole. This makes it possible to prevent a short circuit between the conductors in the proximal portion of the shaft 2. Note that the proximal end of the partition 63 may be located distal to the proximal end of the most proximal side hole.

At least a portion of the partition 63 may be disposed distal to the most proximal side hole, or distal to the most distal side hole. For example, in FIG. 2, the distal end of the partition 63 is distal to the distal end of the most distal first side hole 11. This configuration makes it possible to prevent short circuits between the conductors over a wide area of the shaft 2.

The number of conductors in the shaft 2 increases toward the proximal end of the shaft 2, so the partition 63 is preferably disposed in the proximal portion of the shaft 2. The partition 63 does not have to be disposed distal to the proximal end of the most proximal side hole. In addition, if the catheter 1 has one or more electrodes other than the first electrode 31 and the second electrode 32, the partition 63 does not have to be disposed distal to the proximal end of the side hole on the inside of the electrode to which a voltage of the same polarity as the first electrode 31 is applied.

At least one partition section 63 may have multiple partition sections 63. This configuration makes it easier to divide the inner cavity 20 of the shaft 2 into multiple inner cavity regions. The number of partition sections 63 arranged in the inner cavity 20 of the shaft 2 may be 1 or more, is preferably 2 or more, may be 3 or more, 4 or more, and may also be 8 or less, 7 or less.

The multiple partitions 63 are preferably aligned in the circumferential direction p of the shaft 2. This configuration makes it easier to divide the inner cavity 20 of the shaft 2 into multiple inner cavity regions. The multiple partitions 63 may be aligned at equal intervals in the circumferential direction p of the shaft 2. For example, in FIG. 8, the centers of two partitions 63 are offset by 180° in the circumferential direction p, in FIG. 9, the centers of three partitions 63 are offset by 120°, and in FIG. 10, the centers of four partitions 63 are offset by 90°.

The multiple partitions 63 may be arranged in a circular pattern from the distal end side to the proximal end side of the shaft 2. For example, the multiple partitions 63 may be arranged in a spiral shape. In this case, each lumen region also extends in a spiral shape.

When viewed from the longitudinal axis direction x of the shaft 2, the multiple partitions 63 may have a rotationally symmetric shape, or may have a linearly symmetric shape with respect to a line passing through the center of the longitudinal axis of the shaft 2. The multiple partitions 63 may each have the same shape, or may have different shapes.

When the partition member 60 has multiple partition sections 63, it is preferable that at least one partition section 63 extends from the distal end of the most distal side hole to the proximal end of the most proximal side hole. It is more preferable that all partition sections 63 extend from the distal end of the most distal side hole to the proximal end of the most proximal side hole.

The partition member 60 preferably has a cylindrical portion 65 extending in the longitudinal axis direction x of the shaft 2, and a plurality of partitions 63 are arranged on the outer periphery of the cylindrical portion 65. In FIG. 10, four partitions 631-634 are arranged around the cylindrical portion 65. Each partition is a protrusion extending in the longitudinal axis direction x. With this configuration, a member such as a guide wire can be passed through the inner cavity 66 of the cylindrical portion 65, and the partitions 631-634 make it difficult for the first conducting wire 41 and the second conducting wire 42 to come into contact with each other.

The number of lumen regions formed by the partition member 60 may be 2 or more, 3 or more, 4 or more, or 8 or less, 7 or less. The multiple lumen regions are preferably aligned in the circumferential direction p of the shaft 2. The multiple lumen regions are preferably connected via the through holes 64.

When the partition member 60 divides the lumen 20 of the shaft 2 into at least the first lumen region 21, the second lumen region 22, and the third lumen region 23, it is preferable that the first conductor 41 is arranged in the first lumen region 21, the second conductor 42 is arranged in the second lumen region 22, and no conductor is arranged in the third lumen region 23. This allows a member other than the first conductor 41 and the second conductor 42 to be arranged in the third lumen region 23. In FIG. 9, the partition member 60 has partition portions 631, 632, and 633. Each partition portion has a plurality of through holes 64. The partition 631 divides the lumen 20 into a first lumen region 21 and a second lumen region 22, the partition 632 divides the lumen 20 into a second lumen region 22 and a third lumen region 23, and the partition 633 divides the lumen 20 into a third lumen region 23 and a first lumen region 21.

In the circumferential direction p of the shaft 2, it is preferable that the first lumen region 21, the second lumen region 22, and the third lumen region 23 are arranged in this order. By forming the third lumen region 23 with the partition portion 63, it becomes even more difficult for the first conducting wire 41 to move into the second lumen region 22, or for the second conducting wire 42 to move into the first lumen region 21.

The partition member 60 may divide the lumen 20 of the shaft 2 into at least the first lumen region 21, the second lumen region 22, the third lumen region 23, and the fourth lumen region 24. In this case, the first lumen region 21, the third lumen region 23, the second lumen region 22, and the fourth lumen region 24 are arranged in this order in the circumferential direction p of the shaft 2, and it is preferable that no conductor is arranged in the third lumen region 23 and the fourth lumen region 24. The third lumen region 23 and the fourth lumen region 24 can separate the first lumen region 21 and the second lumen region 22, making it difficult for the first conductor 41 and the second conductor 42 to come into contact with each other. In addition, a member other than the conductor can be arranged in the third lumen region 23 and the fourth lumen region 24. In FIG. 10, the partition member 60 has partitions 631 to 634 that divide the lumen 20 into four regions, the first lumen region 21 to the fourth lumen region 24.

At least one through hole 64 is provided in the partition member 60. The through hole 64 is formed so as to penetrate a part of the partition member 60. It is preferable that the opening edge of the through hole 64 is closed. It is preferable that the through hole 64 is disposed inside the outer edge of the partition member 60. In addition to the through hole 64, the partition member 60 may have a notch portion in which a part of the outer edge is cut out. The notch portion can also communicate the first lumen region 21 and the second lumen region 22. An example of the notch portion is a slit.

The number of through holes 64 arranged in one partition member 60 is not particularly limited, but may be 2 or more, 5 or more, 10 or more, or 50 or less, 40 or less, or 30 or less.

The size of the through hole 64 is not particularly limited, but in order to prevent the conductor from passing through the through hole 64, it is preferable that the outer diameter or the length in the short direction of the through hole 64 is smaller than the diameter of the first conductor 41 and the second conductor 42. Note that the outer diameter, the length in the long direction, or the length in the short direction of the through hole 64 may be larger than the diameter of the first conductor 41 and the second conductor 42.

As shown in Figures 4 and 8 to 10, it is preferable that the partition member 60 has at least one partition section 63 extending from the center side of the longitudinal axis of the shaft 2 toward the inner wall 5 side of the shaft 2, and that at least one partition section 63 has at least one through hole 64 arranged therein. By providing the through hole 64 in the partition section 63 in this manner, the first lumen region 21 and the second lumen region 22 can easily communicate with each other via the through hole 64.

As shown in Figures 8 to 10, it is more preferable that the partition member 60 has multiple partition sections 63, and each of the multiple partition sections 63 has at least one through hole 64. This allows all of the lumen areas formed in the shaft 2 to communicate with each other, making it easier to distribute fluids such as sterilization gas over a wide area of the lumen 20.

When the partition member 60 has multiple partition sections 63, at least one of the multiple partition sections 63 may have a through hole 64, and the remaining partition sections 63 may not have a through hole.

When the partition member 60 has a cylindrical portion 65 and at least one partition portion 63 arranged on the outer periphery of the cylindrical portion 65, the through hole 64 may be arranged in at least one partition portion 63, but not in the cylindrical portion 65. Also, when the partition member 60 has a cylindrical portion 65 and at least one partition portion 63 arranged on the outer periphery of the cylindrical portion 65, the through hole 64 may be arranged in the cylindrical portion 65, but not in the partition portion 63.

When the partition member 60 has a cylindrical portion 65 and at least one partition portion 63 arranged on the outer periphery of the cylindrical portion 65, it is preferable that the through hole 64 is arranged in both the cylindrical portion 65 and at least one partition portion 63. This makes it easier for the lumen 66 of the cylindrical portion 65 to communicate with each lumen region, as well as between the lumen regions formed by the partition portion 63, making it even easier to distribute fluids such as sterilization gas through the lumen 20 of the shaft 2.

The direction in which the through holes 64 penetrate the partition member 60 is not particularly limited, but it is preferable that at least one through hole 64 penetrates the partition member 60 in a direction perpendicular to the longitudinal axis direction x of the shaft 2. This configuration makes it easier to form the through holes 64.

When the partition 63 is plate-shaped or wall-shaped, the through hole 64 may penetrate the partition 63 in the thickness direction.

The shape of the through hole 64 is not particularly limited, and can be, for example, a circle, an oval, a polygon, or a combination of these. The shape of the through hole 64 may be a strip or a line. The through hole 64 may have a longitudinal direction and a lateral direction. When the partition member 60 has multiple through holes 64, the shapes of the multiple through holes 64 may be the same or different from each other.

As shown in Figures 5 to 7, it is preferable that at least one through hole 64 extends in the radial direction of the shaft 2. Since the conductor wire generally extends in the longitudinal axis direction x of the shaft 2, extending the through hole 64 in this manner can prevent, for example, a portion of the first conductor wire 41 in the first lumen region 21 from protruding into the second lumen region 22 through the through hole 64.

As shown in Figures 5 to 7, it is preferable that at least one through hole 64 extends in the longitudinal axis direction x of the shaft 2. By extending the through hole 64 in this manner, it becomes easier to form the through hole 64 over a wide area, and it becomes easier to connect the lumen regions to each other.

The difference between the length of the through hole 64 in the radial direction of the shaft 2 and the length in the longitudinal axis direction x may be within ±5%. FIG. 5 shows an example in which the length of the through hole 64 in the radial direction of the shaft and the length in the longitudinal axis direction x are the same. As shown in FIG. 6, the length of the through hole 64 in the radial direction of the shaft 2 may be longer than the length of the through hole 64 in the longitudinal axis direction x of the shaft 2. Also, as shown in FIG. 7, the length of the through hole 64 in the longitudinal axis direction x of the shaft 2 may be longer than the length of the through hole 64 in the radial direction of the shaft 2.

The length of the through hole 64 in the radial direction of the shaft 2 is preferably shorter than the diameter of the first conducting wire 41 and shorter than the diameter of the second conducting wire 42. This makes it difficult for the first conducting wire 41 and the second conducting wire 42 to protrude from the through hole 64 into other lumen regions. Note that the length of the through hole 64 in the radial direction of the shaft 2 may be longer than the diameter of the first conducting wire 41 and the diameter of the second conducting wire 42.

The following describes examples of the arrangement of the multiple through holes 64. As shown in Figures 5 to 7, the multiple through holes 64 are preferably aligned in the longitudinal axis direction x of the shaft 2. This configuration makes it easier to communicate the first lumen region 21 and the second lumen region 22 over a wide range in the longitudinal axis direction x.

As shown in Figures 5 and 7, it is preferable that the multiple through holes 64 are aligned in the radial direction of the shaft 2. This configuration makes it easier to communicate the first lumen region 21 and the second lumen region 22 over a wide radial range of the shaft 2.

In the longitudinal axis direction x, the distance between two adjacent through holes 64 is preferably longer than the length of each of the two through holes 64. This makes it difficult for the first conducting wire 41 and the second conducting wire 42 to protrude from the through hole 64 into other lumen regions. Note that in the longitudinal axis direction x, the distance between two adjacent through holes 64 may be shorter than the length of each of the two through holes 64.

In the radial direction of the shaft 2, the distance between two adjacent through holes 64 is preferably longer than the length of each of the two through holes 64. This makes it difficult for the first conducting wire 41 and the second conducting wire 42 to protrude from the through hole 64 into other lumen regions. Note that in the radial direction of the shaft 2, the distance between two adjacent through holes 64 may be shorter than the length of each of the two through holes 64.

It is preferable that the distance between two adjacent through holes 64 in the radial direction of the shaft 2 is longer than the diameter of the first conducting wire 41 and longer than the diameter of the second conducting wire 42.

The partition member 60 may be movable relative to the shaft 2. The movable partition member 60 allows the conductor wires to move appropriately, preventing tension on the conductor wires due to bending of the shaft 2 or the partition member 60. The partition member 60 may be slidable in the longitudinal axis direction x relative to the shaft 2, and the partition member 60 may be rotatable relative to the shaft 2.

The partition member 60 may be disposed in the inner cavity 20 so as to rotate around the longitudinal axis of the shaft 2. However, in order to allow the first conducting wire 41 and the second conducting wire 42 to move only within a certain range within the shaft 2, the rotation range of the partition member 60 relative to the shaft 2 is preferably 90° or less, more preferably 60° or less, and even more preferably 45° or less. The rotation range of the partition member 60 relative to the shaft 2 may be 5° or more, 10° or more, or 20° or more.

The partition member 60 may be fixed to the shaft 2 so as to be movable. The partition member 60 may be fixed to the shaft 2 so as to be rotatable. For example, the partition member 60 may have an engaging portion, and the shaft 2 may have an engaged portion that engages with the engaging portion.

To prevent the conductor wire from being crushed due to excessive misalignment of the partition member 60, the partition member 60 may be fixed to the shaft 2 so as not to slide in the longitudinal axis direction x relative to the shaft 2. For the same reason, the partition member 60 may be fixed to the shaft 2 so as not to rotate relative to the shaft 2.

At least one of the partitions 63 may be in contact with the shaft 2. For example, at least one of the partitions 63 may be fixed to the inner wall 5 of the shaft 2. Since the partition member 60 is less likely to move relative to the shaft 2, the size of each lumen area is maintained during use of the catheter 1, and as a result, the first conducting wire 41 and the second conducting wire 42 are less likely to be crushed. For example, in Figures 4 and 8 to 10, the partition member 60 has a partition 63, and the outer end of the partition 63 in the radial direction of the shaft 2 is fixed to the inner wall 5 of the shaft 2.

At least one of the multiple partition sections 63 of the partition member 60 may be fixed to the inner wall 5 of the shaft 2, and the remaining partition sections 63 may not be fixed to the inner wall 5. The partition section 63 fixed to the inner wall 5 of the shaft 2 may have only a portion of its longitudinal direction fixed to the shaft 2, or may have its entire longitudinal direction fixed to the shaft 2. All of the partition sections 63 of the partition member 60 may be fixed to the inner wall 5 of the shaft 2.

The shaft 2 may have a gap between its inner wall 5 and the partition member 60. In that case, it is preferable that the gap is smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42. By providing a gap between the shaft 2 and the partition member 60, the first lumen region 21 and the second lumen region 22 communicate with each other through the gap in addition to the through hole 64, so that a fluid such as a sterilization gas can be more easily distributed through the lumen 20 of the shaft 2. In addition, by setting the gap to such a size, it is possible to prevent the first conducting wire 41 from moving to the second lumen region 22 through the gap and the second conducting wire 42 from moving to the first lumen region 21 through the gap. For example, in FIG. 11, the shaft 2 has gaps 181 and 182. The size of the gap 181 is smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42. The size of the gap 182 is also smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42. The first conducting wire 41 arranged in the first lumen region 21 cannot pass through the gaps 181 and 182, so it is difficult to move to the second lumen region 22, and the second conducting wire 42 arranged in the second lumen region 22 also cannot pass through the gaps 181 and 182, so it is difficult to move to the first lumen region 21.

As shown in Figures 11 and 12, there may be multiple gaps between the inner wall 5 of the shaft 2 and the partition member 60. In this case, it is preferable that the size of at least one of the multiple gaps is smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42, and it is more preferable that the size of the largest gap is smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42.

As shown in FIG. 12, it is preferable that a gap smaller than the diameter of all the conductors in the catheter 1 is provided between two adjacent lumen regions in the circumferential direction p. By providing the partition member 60 so that a gap is formed in this manner, it is possible to prevent a short circuit between the conductors connected to electrodes to which voltages of different polarities are applied.

It is preferable that the gap between the partition 63 and the inner wall 5 of the shaft 2 is smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42. It is also more preferable that the gaps between all of the partitions 63 and the inner wall 5 of the shaft 2 are each smaller than the diameter of all of the conducting wires.

As shown in FIG. 12, it is preferable that the gap between the outer end of the partition portion 63 in the radial direction of the shaft 2 and the inner wall 5 of the shaft 2 is smaller than the diameter of the first conducting wire 41 and smaller than the diameter of the second conducting wire 42. It is also more preferable that for all of the partition portions 63 of the partition member 60, the gap between the outer end of the partition portion 63 in the radial direction of the shaft 2 and the inner wall 5 of the shaft 2 is smaller than the diameter of all of the conducting wires.

As shown in FIG. 11, it is preferable that at least one of the partitions 63 extends in the longitudinal axis direction x of the shaft 2, and that at least one partition 63 does not contact the inner wall 5 of the shaft 2 in a portion of the longitudinal axis direction x. With this configuration, a gap can be formed between the inner wall 5 of the shaft 2 and the partition 63 in the portion that does not contact the inner wall 5 of the shaft 2.

All of the partitions 63 may have a portion in the longitudinal axis direction x in contact with the inner wall 5 of the shaft 2, and the remaining portion may not be in contact with the inner wall 5 of the shaft 2. This configuration makes it even easier to communicate the first lumen region 21 and the second lumen region 22.

Defibrillation may be performed using the catheter 1. When performing defibrillation, it is preferable that a voltage of a different polarity from that of the first electrode 31 is applied to the second electrode 32. The partition member 60 makes it difficult for the first conductor 41 and the second conductor 42 to come into contact with each other, and therefore it is possible to prevent a short circuit between the first conductor 41 and the second conductor 42 even if voltages of different polarities are applied to the first electrode 31 and the second electrode 32.

When the catheter 1 has one or more electrodes other than the first electrode 31 and the second electrode 32, it is preferable that a conductor connected to an electrode to which a voltage of the same polarity as the first electrode 31 is applied is arranged in the first lumen region 21, and a conductor connected to an electrode to which a voltage of the same polarity as the second electrode 32 is applied is arranged in the second lumen region 22. This makes it possible to prevent short circuits between the conductors. Multiple conductors may be arranged in each of the first lumen region 21 and the second lumen region 22.

1: Catheter 2: Shaft 5: Inner wall 11: First side hole, 12: Second side hole 181, 182: Gap 20: Lumen 21: First lumen region, 22: Second lumen region, 23: Third lumen region, 24: Fourth lumen region 31: First electrode, 32: Second electrode 41: First conducting wire, 42: Second conducting wire 60: Partition member 63: Partition portion 64: Through hole 65: Cylindrical portion

Claims (14)

a shaft extending in a longitudinal direction from a distal end to a proximal end, the shaft having an inner cavity, a first side hole communicating with the inner cavity, and a second side hole proximal to the first side hole;
a first electrode disposed outside the first side hole;
a second electrode disposed outside the second side hole;
a first conductor electrically connected to the first electrode and extending through the first side hole into the lumen of the shaft;
a second conductor electrically connected to the second electrode and extending through the second side hole into the lumen of the shaft;
a partition member disposed in the lumen of the shaft and partitioning the lumen into at least a first lumen region and a second lumen region;
The partition member has at least one through hole,
the first conductor is disposed in the first lumen region;
A catheter having the second lead disposed in the second lumen region. The catheter according to claim 1, wherein the at least one through hole penetrates the partition member in a direction perpendicular to the longitudinal axis of the shaft. The catheter according to claim 1 or 2, wherein the at least one through hole extends radially of the shaft. The catheter according to any one of claims 1 to 3, wherein the at least one through hole extends in the longitudinal direction of the shaft. the at least one through hole has a plurality of through holes;
The catheter according to any one of claims 1 to 4, wherein the plurality of through holes are aligned in the longitudinal axis direction of the shaft. the at least one through hole has a plurality of through holes;
The catheter according to any one of claims 1 to 5, wherein the plurality of through holes are aligned in a radial direction of the shaft. The partition member has at least one partition portion extending from a center side of the longitudinal axis of the shaft toward an inner wall side of the shaft,
The catheter according to any one of claims 1 to 6, wherein the at least one partition section has the at least one through hole disposed therein. The catheter according to claim 7, wherein the at least one partition portion extends radially of the shaft. The catheter according to claim 7 or 8, wherein the at least one partition portion extends in the longitudinal direction of the shaft. The at least one partition portion has a plurality of partition portions,
The catheter according to any one of claims 7 to 9, wherein the plurality of partition portions are arranged in a circumferential direction of the shaft. The partition member has a cylindrical portion extending in a longitudinal direction of the shaft,
The catheter according to claim 10, wherein the plurality of partitions are disposed on an outer periphery of the tubular portion. The catheter according to any one of claims 7 to 11, wherein the at least one partition is fixed to the inner wall of the shaft. The shaft has a gap between its inner wall and the partition member,
The catheter of any one of claims 1 to 12, wherein the gap is smaller than a diameter of the first conductor and smaller than a diameter of the second conductor. The catheter according to any one of claims 1 to 13, wherein when performing defibrillation, a voltage of a different polarity from that of the first electrode is applied to the second electrode.

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