JP7613951B2 - catheter - Google Patents

Description

The present invention relates to an electrode catheter used for defibrillation, cauterization of internal tissue, measuring electrical potentials 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 can achieve 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 on the outside of the first side hole, a second electrode disposed on the outside of the second side hole, a first conducting wire electrically connected to the first electrode and extending through the first side hole into the inner lumen of the shaft, a second conducting wire electrically connected to the second electrode and extending through the second side hole into the inner lumen of the shaft, and a second conducting wire electrically connected to the second electrode and extending through the second side hole into the inner lumen of the shaft. and an inner member disposed in the first lumen region, wherein at least one of the shaft and the inner member has at least one partition portion that divides the lumen of the shaft into at least a first lumen region and a second lumen region, the first lumen region and the second lumen region each extending along the longitudinal axis, the shaft has a gap between the shaft and the inner member, a portion of the gap being smaller than the diameter of the first conductor and smaller than the diameter of the second conductor, the first conductor is disposed in the first lumen region, and the second conductor is disposed in the second lumen region. In the catheter according to the present invention, the lumen of the shaft is divided by the partition portion, and the size of the portion of the gap between the shaft and the inner member is set as described above, so that the first conductor disposed in the first lumen region is less likely to move to the second lumen region, and the second conductor disposed in the second lumen region is also less likely to move to the first lumen region. As a result, the first conductor is less likely to come into contact with the second conductor, and a short circuit between the conductors can be prevented. In addition, the first and second lumen regions are more easily connected through the gap, making it easier to distribute fluids such as sterilizing gas through the lumen of the shaft.

Only one of the shaft and the inner member may have at least one partition, and the other may not have a partition. At least one partition may extend from the center side of the longitudinal axis of the shaft to the inner wall side of the shaft. At least one partition may extend in the radial direction of the shaft, or in the longitudinal direction of the shaft. In addition, the entire inner member may be at least one partition.

At least one partition section may have multiple partition sections, and the multiple partition sections may be aligned in the circumferential direction of the shaft.

At least one of the partitions may be a part of the inner wall of the shaft. In that case, at least one of the partitions of the shaft may be fixed to the inner member.

At least one of the multiple partitions may be a part of the inner member. At least one of the multiple partitions of the inner member may be fixed to the inner wall of the shaft. At least one of the multiple partitions of the inner member may extend in the longitudinal direction of the shaft, and the at least one partition may not be in contact with the inner wall of the shaft over a portion of the longitudinal direction. The inner member may have a cylindrical portion extending in the longitudinal direction of the shaft, and multiple partitions may be arranged on the outer periphery of the cylindrical portion.

At least one partition section of at least one of the shaft and the inner member divides the inner cavity of the shaft into at least a first inner cavity region, a second inner cavity region, and a third inner cavity region, and no conductor wires may be arranged in the third inner cavity region. At least one partition section of at least one of the shaft and the inner member divides the inner cavity of the shaft into at least a first inner cavity region, a second inner cavity region, a third inner cavity region, and a fourth inner cavity region, and the first inner cavity region, the third inner cavity region, the second inner cavity region, and the fourth inner cavity region are arranged in this order in the circumferential direction of the shaft, and no conductor wires may be arranged in the third inner cavity region and the fourth inner cavity region.

The length of the first conductor may be longer than the length of the lumen of the shaft. The inner member may be rotatable relative to the shaft. In the catheter, when performing defibrillation, a voltage of a different polarity than the first electrode may be applied to the second electrode.

In the catheter according to 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 more likely to communicate with each other through the gap, 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) taken along line III-III of the catheter shown in FIG. 1. FIG. 4 is a cross-sectional view of the catheter shown in FIG. 3 taken along line IV-IV. FIG. 5 is a perspective view of an inner member of the catheter shown in FIGS. 1 to 4. 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. 8 is a perspective view of an inner member of the catheter shown in FIG. 7. FIG. 5 is a cross-sectional view showing another modified example of the catheter shown in FIG. 4. 10 is a perspective view of an inner member of the catheter shown in FIG. 9. FIG. 5 is a cross-sectional view showing another modified example of the catheter shown in FIG. 4. FIG. 12 is a cross-sectional view showing a modification of the catheter shown in FIG. 11. FIG. 5 is a cross-sectional view showing another modified example of the catheter shown in FIG. 4. FIG. 4 is a cross-sectional view showing a modification of the shaft and the inner member shown in FIG. 3 . 15 is a cross-sectional view of the shaft and inner member shown in FIG. 14 along line XV-XV.

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 as appropriate 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. In addition, 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 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 lead wire electrically connected to the first electrode and extending into the inner cavity of the shaft through the first side hole, a second lead wire electrically connected to the second electrode and extending into the inner cavity of the shaft through the second side hole, and a second lead wire disposed in the inner cavity of the shaft. and an inner member having a first lumen region and a second lumen region, at least one of the shaft and the inner member having at least one partition portion that divides the lumen of the shaft into at least a first lumen region and a second lumen region, the first lumen region and the second lumen region each extending along the longitudinal axis direction, the shaft having a gap between the shaft and the inner member, a portion of the gap being smaller than the diameter of the first conductor and smaller than the diameter of the second conductor, the first conductor being disposed in the first lumen region and the second conductor being disposed in the second lumen region. In the catheter according to the present invention, the lumen of the shaft is divided by the partition portion, and the size of the portion of the gap between the shaft and the inner member is set as described above, so that the first conductor disposed in the first lumen region is less likely to move to the second lumen region, and the second conductor disposed in the second lumen region is also less likely to move to the first lumen region. As a result, the first conductor is less likely to come into contact with the second conductor, and a short circuit between the conductors can be prevented. In addition, the first and second lumen regions are more easily connected through the gap, making it easier to distribute fluids such as sterilizing gas through the lumen of the shaft.

An example of the catheter configuration will be described with reference to Figures 1 to 15. 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 perspective view of the inner member of the catheter shown in Figures 1 to 4. Figures 6 to 7, 9, 11, and 13 are cross-sectional views showing modified examples of the catheter shown in Figure 4. Figure 8 is a perspective view of the inner member of the catheter shown in Figure 7. Figure 10 is a perspective view of the inner member of the catheter shown in Figure 9. Figure 12 is a cross-sectional view showing a modified example of the catheter shown in Figure 11. Figure 14 is a cross-sectional view showing a modified example of the shaft and inner member shown in Figure 3. Figure 15 is a XV-XV cross-sectional view of the shaft and inner member shown in Figure 14. 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 an inner member 50.

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 progression 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, 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, 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, this 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, 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-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 conductors electrically connect the electrodes to external devices of the catheter 1, such as a defibrillation power supply, a cauterization power supply, an electrocardiograph, etc. The conductors are electrically connected to the electrodes and extend through the side holes into the lumen 20. It is preferable that the conductors are arranged outside the inner member 50 in the shaft 2. In other words, it is preferable that the conductors are not arranged so as to be contained in the inner member 50. In FIG. 2, the first conductor 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 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 is connected to one electrode. For simplicity, only the first conductor 41 and the second conductor 42 are shown in FIG. 3 and FIG. 4, but conductors 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 length of the conductors is not particularly limited, but the length of each conductor may be longer or shorter than the length of the inner cavity 20 of the shaft 2. For example, the length of the first conductor 41 may be longer than the length of the inner cavity 20 of the shaft 2. Also, the length of the second conductor 42 may be longer than the length of the inner cavity 20 of the shaft 2. Even if the conductors are longer than the inner cavity 20 of the shaft 2 and therefore tend to bend in the inner cavity 20, the partition section can prevent short circuits between the conductors.

The inner member 50 is disposed in the inner cavity 20 of the shaft 2. The inner member 50 may function as a partition member that divides the inner cavity 20. Alternatively, the inner member 50 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 inner member 50 has a distal end 51 and a proximal end 52. The shape of the inner member 50 is not particularly limited, but it is preferably a long member extending in the longitudinal axis direction x of the shaft 2. The inner member 50 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 5 show an example in which the inner member is a long, thin plate shape.

It is preferable that the inner member 50 is disposed only in a portion of the longitudinal axis direction x of the shaft 2. It is also preferable that the inner member 50 is not disposed over the entire longitudinal axis direction x of the shaft 2.

The distal end 51 of the inner member 50 may coincide with the distal end of the shaft 2. Also, as shown in FIG. 2, the distal end 51 of the inner member 50 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 inner member 50 may be disposed inside the distal tip 72.

3, the proximal end 52 of the inner member 50 may be located proximal to the proximal end of the most proximal side hole. The proximal end 52 of the inner member 50 may be located distal to the proximal end of the shaft 2. Alternatively, the inner member 50 may extend from the proximal end of the shaft 2, and the proximal end 52 of the inner member 50 may be located proximal to the proximal end of the shaft 2. In this case, a portion of the inner member 50 is disposed inside the handle 70.

The inner member 50 preferably bends in accordance with the bending of the shaft 2. For this reason, the inner member 50 is preferably flexible. The inner member 50 may also be elastic. The inner member 50 may be made of the materials listed as the preferred materials for the shaft 2. The material for the inner member 50 may be the same as or different from the material for the shaft 2.

In the catheter 1, at least one of the shaft 2 and the inner member 50 has at least one partition that divides the lumen 20 of the shaft 2 into at least a first lumen region 21 and a second lumen region 22. The first lumen region 21 and the second lumen region 22 each extend along the longitudinal axis direction x. The shaft 2 has a gap between the inner member 50, and a part of the gap is smaller than the diameter of the first conductor 41 and smaller than the diameter of the second conductor 42. The first conductor 41 is disposed in the first lumen region 21, and the second conductor 42 is disposed in the second lumen region 22. Here, a part of the gap means at least one of the multiple gaps when multiple gaps exist. For example, in FIG. 4, the shaft 2 has at least gaps 181 and 182. The size 181D of the gap 181 is smaller than the diameter of the first conductor 41 and smaller than the diameter of the second conductor 42. The size 182D of the gap 182 is also smaller than the diameter of the first conductor 41 and smaller than the diameter of the second conductor 42. The first conductor 41 arranged in the first lumen region 21 is difficult to move to the second lumen region 22 because it cannot pass through the gaps 181 and 182, and the second conductor 42 arranged in the second lumen region 22 is also difficult to move to the first lumen region 21 because it cannot pass through the gaps 181 and 182. Therefore, the first conductor 41 and the second conductor 42 are difficult to contact each other, and a short circuit between the conductors can be prevented. Furthermore, since the first lumen region 21 and the second lumen region 22 are connected through the gaps 181 and 182, it is easy to distribute a fluid such as a sterilization gas through the lumen 20 of the shaft 2.

At least one of the shaft 2 and the inner member 50 may have at least one partition, and at least one of the shaft 2 and the inner member 50 may have multiple partitions. In Figs. 2 to 10 and Figs. 14 to 15, the inner member 50 has a partition, in Figs. 11 to 12, the shaft 2 has a partition, and in Fig. 13, the shaft 2 and the inner member 50 each have a partition.

As shown in Figures 2 to 12 and 14 to 15, it is preferable that only one of the shaft 2 and the inner member 50 has at least one partition, and the other does not have a partition. This makes it easier to adjust the size of the gap between the shaft 2 and the inner member 50, since the inner cavity 20 is partitioned only by either the shaft 2 or the inner member 50.

The number of lumen regions formed by the partitions may be 2 or more, 3 or more, 4 or more, or 8 or less, 7 or less. It is preferable that the multiple lumen regions are aligned in the circumferential direction p of the shaft. It is preferable that the multiple lumen regions are in communication with each other via gaps.

When at least one partition 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 disposed in the first lumen region 21, the second conductor 42 is disposed in the second lumen region 22, and no conductor is disposed in the third lumen region 23. This allows a member other than the first conductor 41 and the second conductor 42 to be disposed in the third lumen region 23. In Figs. 7-8, the inner member 50 has a first partition 531, a second partition 532, and a third partition 533. The first partition 531 divides the lumen 20 into a first lumen region 21 and a second lumen region 22, the second partition 532 divides the lumen 20 into a second lumen region 22 and a third lumen region 23, and the third partition 533 divides the lumen 20 into a third lumen region 23 and the first lumen region 21.

At least one partition divides the inner cavity 20 of the shaft 2 into at least the first inner cavity region 21, the second inner cavity region 22, the third inner cavity region 23, and the fourth inner cavity region 24. The first inner cavity region 21, the third inner cavity region 23, the second inner cavity region 22, and the fourth inner cavity 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 inner cavity region 23 and the fourth inner cavity region 24. The third inner cavity region 23 and the fourth inner cavity region 24 can separate the first inner cavity region 21 and the second inner cavity 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 inner cavity region 23 and the fourth inner cavity region 24. In Figures 9 and 10, the inner member 50 has a first partition 531, a second partition 532, a third partition 533, and a fourth partition 534. These partitions 531 to 534 divide the inner cavity 20 into four regions, the first lumen region 21 to the fourth lumen region 24, as shown in Figure 9. The first partition 531 provides a gap 181 between the inner wall 5 of the shaft 2 and the inner member 50. Similarly, the second partition 532, the third partition 533, and the fourth partition 534 provide gaps 182, 183, and 184, respectively.

For example, as shown in Figures 7, 9, 11 and 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 a partition portion so that a gap is formed in this manner, it is possible to prevent short circuits between the conductors connected to electrodes to which voltages of different polarities are applied.

The inner member 50 may be movable relative to the shaft 2. The movement of the inner member 50 allows the conductors to move appropriately, preventing tension on the conductors due to bending of the shaft 2 or the inner member 50. The inner member 50 may be slidable in the longitudinal axis direction x relative to the shaft 2, and the inner member 50 may be rotatable relative to the shaft 2.

The inner member 50 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 inner member 50 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 inner member 50 relative to the shaft 2 may be 5° or more, 10° or more, or 20° or more.

The inner member 50 may be fixed to the shaft 2 so as to be movable. The inner member 50 may be fixed to the shaft 2 so as to be rotatable. For example, the inner member 50 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 inner member 50, the inner member 50 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 inner member 50 may be fixed to the shaft 2 so as not to rotate relative to the shaft 2.

The following describes the configuration common to the partitions arranged on the shaft 2 and the inner member 50. It is preferable that at least one partition extends 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 area has an appropriate size while preventing an increase in the profile of the shaft 2. For example, in FIG. 6, the two partitions 531, 532 of the inner member 50 extend so as to protrude from the center side of the longitudinal axis of the shaft 2 toward the inner wall 5 side. In FIG. 11, the four partitions 161 to 164 of the shaft 2 extend so as to protrude from the inner wall 5 of the shaft 2 toward the center side of the longitudinal axis.

In a cross section perpendicular to the longitudinal axis direction x of the shaft 2, the partition portion may extend linearly or curvedly. In addition, in a cross section perpendicular to the longitudinal axis direction x of the shaft 2, the partition portion may extend so as to curve in the circumferential direction p of the shaft 2. For example, the partition portion 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 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 53 extends in the radial direction of the shaft 2. The inner member 50 is disposed within the shaft 2 so that the partition 53 passes through the center of the longitudinal axis of the shaft 2.

For example, as shown in Figures 2 to 3, 5, 8, and 10, it is preferable that at least one partition portion 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.

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

It is preferable that at least a portion of the partition is disposed proximally of the most proximal side hole. For example, in FIG. 3, the partition 53 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. The proximal end of the partition may be disposed distal to the proximal end of the most proximal side hole.

At least a portion of the partition 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 53 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 is preferably disposed in the proximal portion of the shaft 2. The partition 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 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.

For example, as shown in Figures 6, 7, and 9, at least one partition section may have multiple partition sections. 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 arranged in the inner cavity 20 of the shaft 2 may be one or more, and is preferably two or more, and may be three or more, four or more, and may also be eight or less, seven or less.

It is preferable that at least one of the partition sections 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 of the partition sections extend from the distal end of the most distal side hole to the proximal end of the most proximal side hole.

The multiple partitions 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 may be aligned at equal intervals in the circumferential direction p of the shaft 2. For example, in FIG. 6, the centers of two partitions 531, 532 are offset by 180° in the circumferential direction p, in FIG. 7, the centers of three partitions 531 to 533 are offset by 120°, and in FIG. 9, the centers of four partitions 531 to 534 are offset by 90°.

The multiple partitions may be arranged in a circular pattern from the distal end to the proximal end of the shaft 2. For example, the multiple partitions 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 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 may each have the same shape, or may have different shapes.

In the following, an example in which the shaft 2 has at least one partition will be described. It is preferable that at least one partition is arranged on the inner wall 5 of the shaft 2, and it is more preferable that multiple partitions are arranged on the inner wall 5 of the shaft 2. It is also more preferable that at least one of the multiple partitions of the shaft 2 is a part of the inner wall 5 of the shaft 2. With this configuration, the size of the gap between the shaft 2 and the inner member 50 can be adjusted by changing the structure of the shaft 2. In Figures 11 and 12, four partitions 161 to 164 are arranged on the inner wall 5 of the shaft 2. In Figure 11, a gap 181 is arranged between the partition 161 and the inner member 50 by the partition 161. Similarly, gaps 182, 183, and 184 are arranged by the partitions 162, 163, and 164, respectively. In FIG. 12, gaps 181, 182, and 183 are provided by partitions 161, 162, and 163, respectively.

The partition of the shaft 2 is preferably a convex portion that protrudes from the inner wall 5 side of the shaft 2 toward the center of the longitudinal axis of the shaft 2. The convex portion may be a projection or a ridge that extends 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 of the shaft 2 may have a shape that tapers toward the center of the longitudinal axis of the shaft 2.

It is preferable that the gap between the partition of the shaft 2 and the inner member 50 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 partitions of the shaft 2 and the inner member 50 are smaller than the diameters of all the conducting wires.

As shown in FIG. 11, it is preferable that the gap between the outer end of the partition portion in the radial direction of the shaft 2 and the outer surface of the inner member 50 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 of the shaft 2, the gap between the outer end of the partition portion in the radial direction of the shaft 2 and the outer surface of the inner member 50 is smaller than the diameter of all of the conducting wires.

At least one partition part of the shaft 2 may be in contact with the inner member 50. For example, at least one partition part of the shaft 2 may be fixed to the inner member 50, or at least one of the partition parts of the shaft 2 may be fixed to the inner member 50. Since the inner member 50 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. In FIG. 12, four partition parts 161 to 164 are arranged on the inner wall 5 of the shaft 2 as in FIG. 11, but the partition part 164 is fixed to the outer surface of the inner member 50, and there is no gap between the partition part 164 and the inner member 50, which is different from the embodiment in FIG. 11.

At least one of the multiple partitions of the shaft 2 may be fixed to the inner member 50, and the rest may not be fixed to the inner member 50. The partitions of the shaft 2 fixed to the inner member 50 may be fixed to the inner member 50 in such a manner that only a portion of the partition in the longitudinal direction of the partition is fixed to the inner member 50, or the entire partition in the longitudinal direction of the partition may be fixed to the inner member 50.

At least one of the multiple partitions of the shaft 2 preferably extends in the longitudinal axis direction x, and at least one of the partitions does not contact the inner member 50 in a portion of the longitudinal axis direction x. A gap can be formed between the inner wall 5 of the shaft 2 and the partition that is not in contact with the inner member 50.

The entire longitudinal axis direction x of at least one of the multiple partitions that the shaft 2 has may be fixed to the inner member 50. In that case, it is preferable that the number of partitions fixed to the inner member 50 is smaller than the number of partitions that are not fixed to the inner member 50. This makes it easier to position the inner member 50 within the shaft 2 so that the inner member 50 does not move relative to the shaft 2, while communicating the first lumen region 21 and the second lumen region 22 through the gap.

All of the partitions of the shaft 2 may be fixed to the inner member 50. In that case, it is preferable that at least one partition of the shaft 2 is fixed to the inner member 50 only in a portion of its longitudinal axis direction x. In other words, it is preferable that there is a gap between at least one partition and the inner member 50.

Below, an example will be described in which the inner member 50 has at least one partition. It is more preferable that multiple partitions are arranged on the inner member 50 as shown in Figures 2 to 10 and 14 to 15. It is even more preferable that at least one of the multiple partitions is a part of the inner member 50. By changing the configuration of the inner member 50, the size of the gap between the shaft 2 and the inner member 50 can be adjusted.

When the inner member 50 has a partition, the partition may be disposed only in a portion of the inner member 50 in the longitudinal direction, or the partition may be disposed over the entire longitudinal direction of the inner member 50 as shown in Figures 5, 8, and 10.

The partition of the inner member 50 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 of the inner member 50 may have a shape that tapers toward the inner wall 5 of the shaft 2.

At least a part of the inner member 50 may be at least one partition section. Also, the entire inner member 50 may be at least one partition section. This configuration allows the space inside the shaft 2 to be used effectively. For example, in Figures 2 to 5, the inner member 50 has one partition section 53 in the shape of a long flat plate. By disposing the inner member 50 in the lumen 20, one side of the partition section 53 can be divided into the first lumen region 21, and the other side of the partition section 53 can be divided into the second lumen region 22.

The inner member 50 may be formed by combining at least one plate-shaped partition. The thickness of the partition of the inner member 50 may be constant as shown in Figs. 4 to 5, 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 of the shaft 2 as shown in Figs. 6 to 10. At least one of the multiple partitions of the inner member 50 may have a constant thickness, and the remaining may have a portion that becomes thinner toward the inner wall 5 of the shaft 2.

The inner member 50 preferably has a cylindrical portion extending in the longitudinal axis direction x of the shaft 2, and a plurality of partitions are arranged on the outer periphery of the cylindrical portion. In Figs. 9 and 10, four partitions 531-534 are arranged around the cylindrical portion 54. Each of the partitions 531-534 is a protrusion extending in the longitudinal axis direction x. With this configuration, a member such as a guidewire can be passed through the inner cavity 55 of the cylindrical portion 54, and the partitions 531-534 make it difficult for the first conducting wire 41 and the second conducting wire 42 to come into contact with each other.

As shown in Figures 4, 6, 7 and 9, it is preferable that the gap between the partition of the inner member 50 and 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 of the inner member 50 and the shaft 2 are smaller than the diameters of all of the conducting wires.

As shown in Figures 4, 6, 7 and 9, it is preferable that the gap between the outer end of the partition of the inner member 50 and the inner wall 5 of the shaft 2 in the radial direction 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 the partitions of the inner member 50, the gap between the outer end of the partition of the inner member 50 and the inner wall 5 of the shaft 2 in the radial direction of the shaft 2 is smaller than the diameter of all the conducting wires.

When the first lumen region 21, the second lumen region 22, and the third lumen region 23 are arranged in this order in the circumferential direction p of the shaft 2 as shown in FIG. 7, it is preferable that the gap 181 between the outer end of the first partition portion 531 and the inner wall 5 of the shaft 2 in the radial direction of the shaft 2 is smaller than the diameters of the first conducting wire 41 and the second conducting wire 42. At least one of the gap 182 between the outer end of the second partition portion 532 and the inner wall 5 of the shaft 2 in the radial direction of the shaft 2 and the gap 183 between the outer end of the third partition portion 533 and the inner wall 5 of the shaft 2 may be larger than the diameters of the first conducting wire 41 and the second conducting wire 42.

At least one partition part of the inner member 50 may be in contact with the shaft 2. For example, at least one partition part of the inner member 50 may be fixed to the inner wall 5 of the shaft 2, or at least one of the partition parts may be fixed to the inner wall 5 of the shaft 2. Since the inner member 50 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 14 to 15, the inner member 50 has partition parts 531 and 532 on the outer periphery of the cylindrical part 54, and in the cross section shown in Figure 15, the partition part 532 is fixed to the inner wall 5 of the shaft 2.

At least one of the multiple partitions of the inner member 50 may be fixed to the shaft 2, and the rest may not be fixed to the shaft 2. The partition of the inner member 50 fixed to the shaft 2 may be fixed to the shaft 2 in such a manner that only a portion of the partition in the longitudinal direction of the partition is fixed to the shaft 2, or the entire partition in the longitudinal direction of the partition may be fixed to the shaft 2.

As shown in FIG. 14, it is preferable that at least one of the partitions of the inner member 50 extends in the longitudinal axis direction x of the shaft 2, and that at least one partition does not contact the inner wall 5 of the shaft 2 in a part of the longitudinal axis direction x. With this configuration, a gap can be formed between the inner member 50 and the partition that is not in contact with the inner wall 5.

The entire longitudinal axis direction x of at least one of the multiple partitions of the inner member 50 may be fixed to the shaft 2. In this case, it is preferable that the number of partitions fixed to the shaft 2 is smaller than the number of partitions not fixed to the shaft 2. This makes it easier to position the inner member 50 within the shaft 2 so that the inner member 50 does not move relative to the shaft 2, while communicating the first lumen region 21 and the second lumen region 22 through the gap.

All of the partitions of the inner member 50 may be fixed to the shaft 2. In that case, it is preferable that at least one partition of the inner member 50 is fixed to the shaft 2 only in a portion of its longitudinal axis direction x. In other words, it is preferable that there is a gap between at least one partition and the shaft 2.

All of the partitions of the inner member 50 may be fixed to the shaft 2, but it is preferable that only a portion of each partition of the inner member 50 in the longitudinal axis direction x is fixed to the inner wall 5 of the shaft 2 as shown in FIG. 14. In other words, it is preferable that there are portions between the shaft 2 and all of the partitions of the inner member 50 where there is a gap and portions where there is no gap. Since the first lumen region 21 and the second lumen region 22 are connected through the gap, it becomes easier to distribute a fluid such as a sterilization gas in the lumen 20 of the shaft 2. In addition, the portions where there is no gap, i.e., the fixed portions, can prevent the inner member 50 from shifting position inside the shaft 2.

Figure 13 shows an example in which the shaft 2 has a partition portion 16, and the inner member 50 has a partition portion 53. In Figure 13, the partition portions 16, 53 are arranged so as to be furthest apart in the circumferential direction p, but the partition portions 16, 53 may be arranged so as to face each other. The number of partition portions of the shaft 2 and the inner member 50 may be the same, or one may be greater than the other. For other configurations of the partition portions 16, 53, refer to the explanations of the embodiment in which only the shaft 2 has a partition portion, or the embodiment in which only the inner member 50 has a partition portion, as appropriate.

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 makes it difficult for the first conductor 41 and the second conductor 42 to come into contact with each other, so that even if voltages of different polarities are applied to the first electrode 31 and the second electrode 32, a short circuit between the first conductor 41 and the second conductor 42 can be prevented.

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 16, 161, 162, 163, 164: Partition portion 181, 182, 183, 184: 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 50: Inner member 53, 531, 532, 533, 534: Partition portion 54: Cylindrical portion

Claims (12)

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 conductive wire 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;
an inner member disposed in the lumen of the shaft;
the inner member has a plurality of partitions dividing the lumen of the shaft into at least a first lumen region and a second lumen region;
The first lumen region and the second lumen region each extend along the longitudinal axis;
the partition portion is a portion extending from a center side of a longitudinal axis of the shaft to an inner wall side of the shaft, and in a cross section perpendicular to the longitudinal axis direction of the shaft, the entire partition portion has a shape that tapers from the center side of the longitudinal axis of the shaft to the inner wall side of the shaft,
The shaft has a gap between it and the inner member,
a portion of the gap is smaller than a diameter of the first conductor and smaller than a diameter of the second conductor;
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 partition portion extends in a radial direction of the shaft. The catheter according to claim 1 or 2 , wherein the partition portion extends in a longitudinal axis direction of the shaft. The catheter according to any one of claims 1 to 3 , wherein the plurality of partition portions are arranged in a circumferential direction of the shaft. The inner member has a cylindrical portion extending in a longitudinal direction of the shaft,
The catheter according to any one of claims 1 to 4 , wherein the plurality of partition portions are arranged on an outer periphery of the tubular portion. The catheter according to any one of claims 1 to 5 , wherein at least one of the plurality of partition sections is fixed to an inner wall of the shaft. The catheter according to claim 6 , wherein at least one of the plurality of partition sections extends in the longitudinal direction of the shaft and does not contact the inner wall of the shaft along a portion of the longitudinal direction. The catheter according to any one of claims 1 to 7 , wherein the length of the first conducting wire is longer than the length of the lumen of the shaft. the plurality of partition portions partition the inner cavity of the shaft into at least the first inner cavity region, the second inner cavity region, and a third inner cavity region;
The catheter of any one of claims 1 to 8 , wherein no conductor wires are disposed in the third lumen region. the plurality of partition portions partition the inner cavity of the shaft into at least the first inner cavity region, the second inner cavity region, a third inner cavity region, and a fourth inner cavity region;
the first lumen region, the third lumen region, the second lumen region, and the fourth lumen region are arranged in this order in a circumferential direction of the shaft,
The catheter according to any one of claims 1 to 8 , wherein no conductor wires are disposed in the third lumen region and the fourth lumen region. The catheter of any one of claims 1 to 5 , wherein the inner member is rotatable relative to the shaft. The catheter according to any one of claims 1 to 11 , wherein, when performing defibrillation, a voltage having a polarity different from that of the first electrode is applied to the second electrode.

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