WO2020071084A1 - Electrode catheter - Google Patents

Abstract

Provided is an electrode catheter which is easy to manufacture, and in which an end part of an electrode is less likely to be caught by an introducer, a sheath, the internal wall of a blood vessel or the heart, or the like. This electrode catheter comprises: a catheter shaft (10) having a distal-proximal direction and having a lumen (11) extending in the distal-proximal direction; an electrode (20) provided on the catheter shaft (10); a conductive wire (30) connected to the electrode (20); and a protective body (40) disposed outward of the electrode (20). The electrode catheter satisfies one or both of the following conditions (1) and (2): (1) a part of a distal end part of the electrode (20) is covered with the protective body (40), and the remaining part is not covered with the protective body (40); and (2) a part of a proximal end part of the electrode (20) is covered with the protective body (40), and the remaining part is not covered with the protective body (40).

Description

Electrode catheter

The present invention relates to an electrode catheter in which the catheter shaft has an electrode.

カ テ ー テ ル A catheter with electrodes may be used in the examination and treatment of arrhythmias such as atrial fibrillation. At the time of the examination, an electrode catheter is inserted into the heart cavity, and an intracardiac potential is measured to identify an abnormal part of the heart that causes arrhythmia. During treatment, a high-frequency current is passed from a catheter electrode to the myocardium causing the arrhythmia, and the source of the arrhythmia is cauterized to be electrically separated from the heart (ablation surgery). If atrial fibrillation occurs spontaneously during these examinations or treatments, or if atrial fibrillation occurs to identify abnormal parts of the heart, electrical stimulation is given to the heart from the electrodes of the catheter. Defibrillation.

In an electrode catheter, a catheter in which the end of the electrode is coated so that the end of the electrode does not damage the blood vessel or the inner wall of the heart (see, for example, Patent Documents 1 to 3), and energy loss due to the electrode coming into contact with blood can be reduced. There is a catheter in which a portion of an electrode on the side that comes into contact with blood without contacting heart tissue is coated to reduce the amount (for example, see Patent Document 4).

JP-A-2017-159056 JP 2012-34852 A JP 2014-83171 A Japanese Patent Publication No. 11-507270

When an electrode catheter is inserted into a blood vessel from a sheath placed in a femoral vein or the like, an introducer may be used. Specifically, the tip of the electrode catheter is pulled into the introducer, the tip of the introducer is inserted into the rear end of the sheath, and the electrode catheter is pushed into the blood vessel.

In the electrode catheters disclosed in Patent Documents 1 to 4, when the tip of the electrode catheter is pulled into the introducer or when the electrode catheter is withdrawn from the sheath, the end of the electrode of the electrode catheter is caught on the tip of the introducer or the sheath, There have been problems such as damage to the tip of the introducer or the sheath, or dropping of the electrode of the electrode catheter. Further, in the manufacture of the electrode catheter as disclosed in Patent Documents 1 to 4, it is difficult to cover the end of the electrode and the production cost is high, and the degree of covering of the end of the electrode is not uniform. Therefore, there was also a problem that the variation in quality was large. Further, in the electrode catheters disclosed in Patent Documents 1 to 4, the effect of preventing the ends of the electrodes from damaging blood vessels and the inner wall of the heart is not sufficient, and there is room for improvement.

The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an electrode catheter in which an end of an electrode is hardly caught on an introducer or a sheath, an inner wall of a blood vessel or a heart, and is easy to manufacture. To provide.

The present inventors have conducted intensive studies to solve the above problems, and as a result, have completed the present invention. That is, the gist of the present invention is as follows.
[1] A catheter shaft having a perspective direction and a lumen extending in the perspective direction, an electrode disposed on the catheter shaft, a lead wire connected to the electrode, and disposed outside the electrode. An electrode catheter having a protective object, and satisfying at least one of the following conditions (1) and (2).
(1) A part of the distal edge portion of the electrode is covered with the protective material, and the remaining portion is not covered with the protective material.
(2) A part of the proximal edge of the electrode is covered with the protective material, and the remaining part is not covered with the protective material.
[2] The protective object is preferably in contact with the electrode.
[3] The protective object is preferably an insulator.
[4] It is preferable to satisfy both the condition (1) and the condition (2).
[5] It is preferable that the protection covering part of the distal edge of the electrode and the protection covering part of the proximal edge of the electrode are integral.
[6] Preferably, the protective object extends from a distal side of the distal end of the electrode and extends from a proximal side of the proximal end of the electrode.
[7] It is preferable that the protective object has a long shape and extends in the direction near or far from the catheter shaft.
[8] The electrode has a first electrode and a second electrode, wherein the first electrode is disposed more distally than the second electrode, and the protection object is the first electrode. Is preferably provided over at least a part of the second electrode and at least a part of the second electrode.
[9] Among the electrodes arranged on the catheter shaft, the first electrode is arranged on the most distal side, the second electrode is arranged on the most proximal side, and the protective material is , From the distal edge of the first electrode to the proximal edge of the second electrode.
[10] The catheter shaft preferably has a bent portion at a distal portion, and at least one electrode is preferably disposed at the bent portion.
[11] The protection object is preferably arranged outside the catheter shaft and inside the bent portion.
[12] The catheter shaft has a straight section closer to the bending section than the bending section, and the bending section is a section 1 cm from the distal end of the bending section and a boundary between the bending section and the straight section. It is preferable to have a second section which is a section of 1 cm, and that the position of the protective object in the circumferential direction of the catheter shaft be different between the first section and the second section.
[13] A connector connected to the catheter shaft, the catheter shaft having a hole communicating the lumen with the outside of the catheter shaft, and a lead extending from the electrode to the connector through the hole. Preferably, the hole and the guard are opposite to the axial center of the catheter shaft.

According to the electrode catheter of the present invention, the end of the electrode is hardly caught by the introducer, the sheath, and the inner wall of the blood vessel or the heart. Can be. In addition, the protection object can be easily arranged, and the manufacture of the electrode catheter is easy.

1 shows a plan view of an entire electrode catheter according to an embodiment of the present invention. FIG. 2 shows a plan view of the distal end of the electrode catheter shown in FIG. 1 as viewed from the proximal side. 1 shows a plan view of the distal end of an electrode catheter according to one embodiment of the present invention. FIG. 4 shows a sectional view of the electrode catheter shown in FIG. 3 along a perspective direction. FIG. 5 is a sectional view taken along line VV of the electrode catheter shown in FIG. 4. FIG. 9 is a cross-sectional view of an electrode catheter according to another embodiment of the present invention, taken along a perspective direction.

Hereinafter, the present invention will be described more specifically based on the following embodiments. However, the present invention is not limited to the following embodiments, and appropriate changes may be made within a range that can conform to the purpose of the preceding and the following. In addition, it is of course possible to implement them, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, hatching, reference numerals, and the like may be omitted, but in such a case, the specification and other drawings are referred to. In addition, dimensions of various members in the drawings are different from actual dimensions because priority is given to contributing to understanding of features of the present invention.

FIG. 1 is an overall plan view of an electrode catheter according to an embodiment of the present invention, FIGS. 2 and 3 are plan views of a distal end portion of the electrode catheter, and FIG. 4 is a perspective view of the electrode catheter along a perspective direction. FIG. 5 is a sectional view of the electrode catheter perpendicular to the perspective direction, and FIG. 6 is a sectional view of the electrode catheter according to another embodiment of the present invention along the perspective direction. FIG. 2 shows an electrode catheter having a configuration in which the catheter shaft has a bent portion at the distal portion, and FIG. 3 shows that the catheter shaft has no bent portion at the distal portion, or the bent portion has a linear shape. 2 shows the electrode catheter in the state shown in FIG.

The electrode catheter 1 of the present invention has a catheter shaft 10 having a perspective direction and a lumen 11 extending in the perspective direction, an electrode 20 disposed on the catheter shaft 10, and a lead wire connected to the electrode 20. 30 and a protective object 40 disposed outside the electrode 20, wherein at least one of the following conditions (1) and (2) is satisfied.
(1) A part 20x of the distal edge portion of the electrode 20 is covered with the protection object 40, and the remaining part 20y is not covered with the protection object 40.
(2) A part of the proximal edge portion of the electrode 20 is covered with the protector 40, and the remaining part is not covered with the protector 40.

The electrode catheter 1 is, for example, allowed to reach the heart from the distal side of the electrode catheter 1 through the blood vessel of the patient, and is used for examination, treatment, and defibrillation of arrhythmia in the heart.

In the present invention, the proximal side refers to the user's hand side with respect to the extending direction of the catheter shaft 10, and the distal side refers to the opposite side of the proximal side, that is, the treatment target side. Further, the extending direction of the catheter shaft 10 is referred to as a near-far direction. The radial direction refers to the radial direction of the catheter shaft 10, the radially inward direction refers to a direction toward the axial center of the catheter shaft 10, and the radially outward direction refers to a direction toward the opposite side to the inward direction. . In FIGS. 1, 3, 4, and 6, the right side of the figure is the proximal side, and the left side of the figure is the distal side. In FIG. 2, the lower side of the figure is the proximal side, and the upper side is the distal side.

As shown in FIG. 1, the electrode catheter 1 may have a handle 2 on the proximal side. As shown in FIG. 4, one end of the wire 3 may be fixed to the distal end of the catheter shaft 10. Further, although not shown, the other end of the wire 3 may be fixed to the handle 2. Electrode catheter 1 has handle 2 on the proximal side, one end of wire 3 is fixed to the distal end of catheter shaft 10, and the other end of wire 3 is fixed to handle 2 By operating the handle 2 to move the wire 3 in the near and far directions, the distal end of the catheter shaft 10 fixed to the wire 3 is linked to the movement of the wire 3, and the distal side of the catheter shaft 10 is Bend to one side. Therefore, by operating the handle 2, the distal end of the electrode catheter 1 can be curved, and the electrode 20 of the electrode catheter 1 can be easily brought into contact with a target portion in the heart chamber.

The catheter shaft 10 has a perspective direction, and has a lumen 11 extending in the perspective direction. In the lumen 11 of the catheter shaft 10, for example, a conducting wire 30 connected to the electrode 20, a wire 3, and the like are arranged. The catheter shaft 10 may have a single lumen structure having one lumen 11 or a multi-lumen structure having a plurality of lumens 11. If the number of the lumens 11 included in the catheter shaft 10 is one, there is no partition partitioning the lumens 11 inside the catheter shaft 10, so that the flexibility of the catheter shaft 10 can be enhanced, and the electrode catheter 1 can be improved. If the catheter shaft 10 has a plurality of lumens 11, a plurality of conductors 30, wires 3, and the like arranged in the lumen 11 are respectively arranged in different lumens 11, so that the conductors 30 are different from each other. It is possible to prevent the electrode catheter 1 from being damaged, such as the conductive wire 30 being disconnected, by preventing the electrode catheter 1 from coming into contact with the wire 30 or the wire 3.

The catheter shaft 10 is made of, for example, a polyolefin resin such as polyethylene or polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, a polyether polyamide resin, or a polyurethane resin. , A polyimide resin, a fluorinated resin such as PTFE, PFA, and ETFE, and a synthetic resin such as a polyvinyl chloride resin. The catheter shaft 10 may have a single-layer structure or a multi-layer structure. When the catheter shaft 10 has a multi-layer structure, for example, a structure using a metal braid such as stainless steel, carbon steel, or a nickel titanium alloy can be used as the intermediate layer of the resin tube constituting the catheter shaft 10. The material constituting the catheter shaft 10 is preferably a fluororesin, and more preferably PTFE. Since the material constituting the catheter shaft 10 is a fluorocarbon resin, the outer surface of the catheter shaft 10 has good slipperiness, and the catheter shaft 10 has appropriate rigidity, so that the electrode catheter has good penetrability into blood vessels. It can be 1.

遠 The length of the catheter shaft 10 in the distance direction can be selected to be appropriate for the treatment. For example, the length of the catheter shaft 10 in the distance direction can be 500 mm or more and 1500 mm or less.

外 The outer diameter of the catheter shaft 10 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1 mm or more. By setting the lower limit of the outer diameter of the catheter shaft 10 within the above range, the catheter shaft 10 can be given appropriate rigidity, and the electrode catheter 1 having high penetrability into blood vessels can be obtained. The outer diameter of the catheter shaft 10 is preferably 3 mm or less, more preferably 2.8 mm or less, and further preferably 2.5 mm or less. By setting the upper limit of the outer diameter of the catheter shaft 10 to the above range, when the electrode catheter 1 is inserted into a blood vessel using an introducer or a sheath, the catheter shaft 10 is inserted into the introducer, the sheath, the inner wall of the blood vessel, or the like. It becomes difficult to contact, and it is possible to make it difficult to damage the introducer, the sheath, the inner wall of the blood vessel, and the like.

い な い Although not shown, the introducer is a tubular member that has been inserted through the catheter shaft in advance. When the electrode catheter is inserted into the sheath placed in the blood vessel, the introducer is moved to the tip of the electrode catheter, the introducer is inserted into the sheath, and the introducer is used to introduce the electrode catheter into the sheath. When the electrode catheter has a bent portion at the distal end portion, the length of the introducer in the long axis direction is preferably such that the straight bent portion is disposed in the introducer.

The thickness of the catheter shaft 10 is preferably 50 μm or more, more preferably 100 μm or more, and even more preferably 150 μm or more. By setting the lower limit of the thickness of the catheter shaft 10 within the above range, the rigidity of the catheter shaft 10 can be increased, and the electrode catheter 1 having good penetrability into blood vessels can be obtained. The thickness of the catheter shaft 10 is preferably 350 μm or less, more preferably 300 μm or less, and further preferably 250 μm or less. By setting the upper limit of the thickness of the catheter shaft 10 within the above range, the lumen 11 of the catheter shaft 10 can be widened, and the electrodes 20 of the electrode catheter 1 can be multipolar.

The catheter shaft 10 may have the tip 5 at the distal end. For the tip 5, a hemispherical electrode or a lid-like member that prevents the distal end of the catheter shaft 10 from opening can be used. Since the catheter shaft 10 has the distal end tip 5, when the electrode catheter 1 is used, moisture such as blood enters the lumen 11 of the catheter shaft 10, and the moisture at the connection between the electrode 20 and the conductive wire 30. The contact can prevent the insulation between the plurality of conductive wires 30 from being reduced, and prevent the occurrence of a drift phenomenon in which the baseline potential of the electrocardiogram becomes unstable when measuring the intracardiac potential. In addition, the distal tip 5 serves as a guide for the distal end of the electrode catheter 1, and it is possible to improve the insertability of the electrode catheter 1. When the electrode catheter 1 has the wire 3, the distal tip 5 can be a fixed portion of the wire 3 in the lumen 11 of the catheter shaft 10. Since the distal end tip 5 has a fixed end of the wire 3, the electrode catheter 1 can be effectively bent by operating the wire 3.

材料 A material constituting the distal tip 5 is not particularly limited. For example, a material constituting the catheter shaft 10 described above, a material constituting the electrode 20 described later, or the like can be used. The distal tip 5 can also serve as the electrode 20 by forming the distal tip 5 from a conductive material such as a material constituting the electrode 20 described later and connecting the distal tip 5 to the conductive wire 30.

Note that the distal end of the catheter shaft 10 is not provided with the tip 5 and the distal end of the catheter shaft 10 is heat-sealed or the like, so that the opening at the distal end of the catheter shaft 10 is closed. Is also good.

The electrode 20 is disposed on the catheter shaft 10. The electrode 20 is preferably disposed on the outer surface of the catheter shaft 10. Since the electrode 20 is disposed on the catheter shaft 10, the electrode 20 is brought into close proximity to or in contact with the inner wall of the heart to measure an intracardiac potential to identify an abnormal part of the heart causing arrhythmia, It becomes possible to perform defibrillation in the heart chamber.

The electrode 20 may be a ring-shaped electrode or a plate electrode having a rectangular or square shape formed independently on the catheter shaft 10 in an island shape. When the electrode 20 is a flat electrode, at least one of the back surface (inside surface) and the front surface (outside surface) of the flat electrode may be curved so as to easily follow the curved surface of the catheter shaft 10. Especially, it is preferable that the electrode 20 is ring-shaped. When the electrode 20 is a ring-shaped electrode, the area of the electrode 20 on the circumference of the catheter shaft 10 can be increased, and the electrode 20 can be easily brought into contact with a target site on the inner wall of the heart.

When the electrode 20 is a ring-shaped electrode, it is preferable that the inner diameter of the electrode 20 is smaller than the outer diameter of the catheter shaft 10 as shown in FIG. When the electrode 20 is configured in this manner, the end of the electrode 20 is less likely to be caught by another object, and the electrode 20 is less likely to damage the introducer, the sheath, the blood vessel, the inner wall of the heart, and the like. In order to make the inner diameter of the electrode 20 smaller than the outer diameter of the catheter shaft 10, for example, the inner diameter of the electrode 20 is formed larger than the outer diameter of the catheter shaft 10, and the electrode 20 is passed through the catheter shaft 10 to form the electrode 20. A method of caulking from the outside to reduce the inner diameter of the electrode 20, or forming the catheter shaft 10 having an outer diameter smaller than the inner diameter of the electrode 20 with a thermally expandable resin, passing the electrode 20 through the catheter shaft 10, A method of increasing the outer diameter of the catheter shaft 10 by heating is used.

材料 The material forming the electrode 20 is, for example, a metal material such as copper, gold, platinum, aluminum, iron, or an alloy thereof. In particular, the material constituting the electrode 20 is preferably platinum or an alloy thereof. Since the material constituting the electrode 20 is platinum or an alloy thereof, the contrast of the electrode 20 with respect to X-rays can be enhanced, and the position of the electrode 20 can be easily confirmed by using X-rays when the electrode catheter 1 is used. can do.

The conducting wire 30 is connected to the electrode 20. The conducting wire 30 electrically connects the electrode 20 to an external device (not shown) such as a power supply device of the electrode catheter 1, and is disposed in the lumen 11 of the catheter shaft 10. By connecting the conducting wire 30 to the external device of the electrode catheter 1, the electrode 20 and the external device of the electrode catheter 1 are electrically connected. Further, a connector 4 is provided on the proximal side of the electrode catheter 1, and the lead wire 30 is connected to the connector 4. By connecting the connector 4 to an external device of the electrode catheter 1, the electrode 20 is connected. And an external device.

導 Although not shown, the conductive wire 30 has a core and a coating. The material constituting the core of the conductive wire 30 may be a conductive material, and examples thereof include metal materials such as iron, copper, silver, stainless steel, tungsten, nickel, titanium, and alloys thereof. In particular, the material constituting the core of the conductive wire 30 is preferably stainless steel. Since stainless steel has straightness and rigidity, since the material constituting the core of the lead wire 30 is stainless steel, the lead wire 30 can be easily passed through the lumen 11 of the catheter shaft 10 in the manufacture of the electrode catheter 1, and Disconnection of the conductive wire 30 at a connection portion or the like is less likely to occur.

(4) The conductive wire 30 has a coating on portions other than both ends connected to other objects such as the electrode 20. Specifically, for example, the coating on one end of the conductive wire 30 is partially removed, and one end of the conductive wire 30 is connected to the electrode 20 by welding this portion to the electrode 20 or the like. By partially removing the coating on the other end and connecting to the external device of the electrode catheter 1 or the connector 4 of the handle 2, the conductive wire 30 can be configured to have a coating on portions other than both ends.

As a method of connecting the conductive wire 30 to the electrode 20, for example, welding, brazing of solder or the like, connection by caulking, or the like can be used. The method of connecting the conductive wire 30 to the electrode 20 is preferably welding. Since the conductor 30 is connected to the electrode 20 by welding, the connection strength between the conductor 30 and the electrode 20 can be easily increased. Although not shown, the conductive wire 30 and the electrode 20 may be connected with a conductive member having conductivity between the conductive wire 30 and the electrode 20.

(4) The connection between the conductive wire 30 and the electrode 20 is preferably coated with a resin or the like in order to prevent oxidation deterioration due to moisture or the like contained in the air. Examples of the resin used for this coating include a polyurethane resin and an epoxy resin.

The covering of the conductive wire 30 may be any insulating material, for example, a polyolefin resin such as polyethylene and polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, Polyether polyamide resin, polyurethane resin, polyimide resin, fluorine resin such as PTFE, PFA and ETFE, and synthetic resin such as polyvinyl chloride resin are exemplified. The material constituting the coating of the conductive wire 30 is preferably a fluorine-based resin, and more preferably PFA. Since the coating of the conductive wire 30 is configured as described above, the insulating property of the conductive wire 30 can be enhanced, and further, in the lumen 11 of the catheter shaft 10, the conductive wire 30 and the wire connected to another electrode 20 can be provided. The slidability with other objects such as 3 can be improved, and breakage of the coating due to contact between the coating of the conductive wire 30 and another object can be prevented.

The protection object 40 is arranged outside the electrode 20. As shown in FIG. 4, the protective object 40 may not be in contact with the electrode 20 and may be disposed outside the electrode 20 with a distance between the protective object 40 and the electrode 20. As shown in FIG. 6, it may be arranged outside the electrode 20 in a state of being in direct contact with the electrode 20.

The electrode catheter 1 of the present invention satisfies at least one of the following condition (1) and the following condition (2).
(1) A part 20x of the distal edge portion of the electrode 20 is covered with the protection object 40, and the remaining part 20y is not covered with the protection object 40.
(2) A part of the proximal edge portion of the electrode 20 is covered with the protector 40, and the remaining part is not covered with the protector 40.

An example of a mode that satisfies the condition (1) will be described with reference to FIGS. As shown in FIGS. 4 and 5, the protector 40 is disposed outside the electrode 20, and a part of the distal end including the distal end 20 a of the electrode 20 is covered by the protector 40. . In the present invention, the phrase “the electrode 20 is covered with the protective object 40” means that the electrode 20 is covered with a space between the protective object 40 and the electrode 20 so that the protective object 40 and the electrode 20 are in direct contact with each other. However, both the form in which the protector 40 indirectly protects the electrode 20 and the form in which the protector 40 is in direct contact with the protector 40 and the protector 40 directly protects the electrode 20 are both included. . In the electrode catheter 1 shown in FIGS. 4 and 5, the protective object 40 indirectly protects the electrode 20, and in the electrode catheter 1 shown in FIG. 6, the protective object 40 directly protects the electrode 20. Here, the term “indirect protection” refers to a state in which the protection object 40 is not directly in contact with the electrode 20, that is, a state in which the protection object 40 covers the electrode 20 with a space.

As shown in FIG. 5, the protection 40 covers a part 20 x of the distal edge of the electrode 20, and the protection 40 does not cover the remaining part 20 y of the distal edge of the electrode 20. By arranging the protector 40 in this manner, the protector 40 protects a portion 20x of the distal edge of the electrode 20 from contact with other objects, so that the end of the electrode 20 is introductory. It becomes difficult to be caught by the inducer or the sheath, the blood vessel, the inner wall of the heart, or the like, and the breakage of the introducer or the sheath can be prevented, and the blood vessel or the inner wall of the heart can be hardly damaged. In addition, since the remaining portion 20y of the distal edge of the electrode 20 is not covered with the protector 40, the remaining portion 20y is unlikely to hinder the examination or treatment by bringing the electrode 20 into contact with the inner wall of the heart. Further, since the protection object 40 is provided so as to cover a part 20x of the distal edge portion, not the entire circumference of the distal edge portion of the electrode 20, the protection object 40 is easily arranged.

The case where the condition of (2) is satisfied is the same as the case of satisfying the condition of (1) above, and the “part 20x of the distal edge portion of the electrode 20” is replaced with the “proximal edge portion of the electrode 20”. , "The remaining portion 20y of the distal edge portion of the electrode 20" may be replaced with "the remaining portion of the proximal edge portion of the electrode 20". That is, the protector 40 covers a portion of the proximal edge of the electrode 20, and the protector 40 does not cover the remaining portion of the proximal edge of the electrode 20. When the electrode catheter 1 satisfies the condition (2), similarly to the case where the electrode catheter 1 satisfies the condition (1), the end of the electrode 20 is less likely to be caught by another object, and the end of the electrode 20 is It is hard to hurt things.

(4) The protective object 40 may not be in direct contact with the electrode 20, but is preferably in contact with the electrode 20. Since the protection object 40 directly protects the electrode 20 because the protection object 40 is in direct contact with the electrode 20, the end of the electrode 20 can be hardly caught by another object. In addition, it becomes easy to dispose the protective object 40 on the catheter shaft 10, and the manufacturing cost is reduced. Further, the variation in quality can be reduced, so that the electrode catheter 1 can be easily manufactured.

The protection object 40 may have a configuration in which a part of the protection object 40 is in contact with the electrode 20 and the remaining part is not in contact with the electrode 20. Specifically, for example, one end of the protective object 40 is in contact with the electrode 20 and the other end is not in contact with the electrode 20, or one end and the other end of the protective object 40 are in contact with the electrode 20. Instead, a configuration in which an intermediate portion is in contact with the electrode 20 is exemplified. Since a part of the protection object 40 is in contact with the electrode 20 and the remaining part is not in contact with the electrode 20, the rigidity of the portion of the catheter shaft 10 where the protection object 40 is arranged varies depending on each part. The degree of bending of the catheter shaft 10 can be adjusted.

(4) Examples of the material forming the protective object 40 include fluorine-based resins such as PTFE, PFA, and ETFE, epoxy-based resins, urethane-based resins, and the like, silicone-based resins, and synthetic resins of vinyl chloride-based resins. Above all, it is preferable that the material forming the protective object 40 is an insulating material. Since the material forming the protective object 40 is an insulating material, when the electrode 20 is brought into contact with the inner wall of the heart to perform examination or treatment, the protective object 40 may be in contact with the electrode 20 or may be in contact with the electrode 20. Even if the distance to the electrode 20 is short, it is possible to prevent the protective object 40 from hindering the electrode 20 from measuring an intracardiac potential or applying an electrical stimulus to the heart. Further, it is more preferable that the material forming the protection object 40 includes a fluorine-based resin, an epoxy-based resin, or a urethane-based resin. Since the material constituting the protection object 40 includes a fluorine-based resin, an epoxy-based resin, or a urethane-based resin, the electrode catheter 1 having high biocompatibility and being less invasive can be obtained.

When the material forming the protective object 40 is a synthetic resin, a method of disposing the protective object 40 outside the electrode 20 includes, for example, applying an adhesive or a paint containing a synthetic resin on the electrode 20, A wire made of resin is arranged on the electrode 20, and the wire is fixed to the catheter shaft 10 and the electrode 20 using an adhesive. A wire made of synthetic resin is arranged on the electrode 20. A method of arranging another component outside the wire and caulking the other component to physically fix the wire and the like can be given. In particular, when the material forming the protection object 40 is a synthetic resin, as an arrangement method of the protection object 40, it is preferable to apply an adhesive containing a synthetic resin on the electrode 20. By arranging the protection object 40 by applying an adhesive containing a synthetic resin on the electrode 20, the protection object 40 is easily formed, and the electrode catheter 1 is easily manufactured.

When the protector 40 is not in contact with the electrode 20, the material forming the protector 40 may be a metal such as stainless steel, iron, nickel, titanium, or an alloy thereof, in addition to the above-described materials forming the protector 40. Can also be used. Since the material constituting the protective object 40 is a metal, the strength of the protective object 40 can be increased, and even if the electrode catheter 1 is repeatedly inserted into the introducer or the sheath, the protective object 40 is hardly damaged, and the electrode The durability of the catheter 1 increases. When the material forming the protection object 40 is a metal, it is preferable that the protection object 40 has an insulating coating. Even if the distance between the protective object 40 and the electrode 20 becomes short due to the fact that the protective object 40 has the insulating coating, the protective object 40 is pushed by the blood vessel or the inner wall of the heart, etc. It is possible to make it difficult to interfere with examination or treatment such as measurement of the intracardiac potential of the catheter 1 or application of electrical stimulation to the heart.

When the material forming the protection object 40 is metal, as a method of disposing the protection object 40 outside the electrode 20, for example, a metal wire is disposed on the electrode 20, and the metal wire is connected to the catheter shaft 10 or the like. A method of fixing to the electrode 20 with an adhesive or the like, or a method of physically fixing by caulking another component or the like is used. In particular, as a method of arranging the protective object 40 when the material forming the protective object 40 is a metal, it is preferable to arrange a metal wire on the electrode 20 and fix it with an adhesive or the like. By arranging the metal wire on the electrode 20 and fixing it using an adhesive or the like to form the protection object 40, the protection object 40 can be easily arranged, and the manufacture of the electrode catheter 1 is easy. Become.

The electrode catheter 1 may satisfy at least one of the conditions (1) and (2), but preferably satisfies both the conditions (1) and (2). That is, it is preferable that both the distal edge and the proximal edge of the electrode 20 are partially covered with the protection object 40 and the remaining part is not covered with the protection object 40. Since the electrode catheter 1 has a configuration that satisfies both the conditions (1) and (2), it is possible to prevent both the distal end 20a and the proximal end 20b of the electrode 20 from being caught by another object, and The effect of preventing the end portions of 20 from damaging other objects can be further enhanced.

When the electrode catheter 1 satisfies both the conditions (1) and (2), the protective member 40 covering a part 20x of the distal edge of the electrode 20 and the part of the proximal edge covering the part 20x of the electrode 20 are provided. The protective material 40 may be a separate protective material 40, but the protective material 40 covers a portion 20x of the distal edge of the electrode 20 and the protective material 40 covers a portion of the proximal edge. It is preferable that the protection object 40 is integral with the protection object 40. That is, it is preferable that one protective object 40 covers both the portion 20x of the distal edge portion of the electrode 20 and the portion of the proximal edge portion. The protection 40 covering the portion 20x of the distal edge of the electrode 20 and the protection 40 covering the portion of the proximal edge are integrated, so that the protection 40 is provided outside the electrode 20. Is easily provided, and the manufacture of the electrode catheter 1 is facilitated.

It is preferable that the protective object 40 extends from the distal side of the distal end 20a of the electrode 20 and extends from the proximal side of the proximal end 20b of the electrode 20. Since the protective object 40 extends from the distal end of the electrode 20 farther than the distal end 20a and extends from the proximal end 20b of the electrode 20 more proximally, the distal end 20a of the electrode 20 And the effect that the proximal end 20b is less likely to be caught by another object can be further enhanced.

It is preferable that the protection object 40 is long and extends in the distance direction of the catheter shaft 10. Since the protective object 40 extends in the near-far direction of the catheter shaft 10, the protective object 40 covers at least one of the portion 20 x of the distal edge of the electrode 20 and at least one of the portion of the proximal edge. It becomes easy to arrange the protective object 40 outside the electrode 20, and it is easy to prevent the end of the electrode 20 from contacting another object and damaging the other object.

遠 It is preferable that the length of the protection object 40 in the perspective direction is longer than the length of the electrode 20 in the perspective direction. Since the length of the protective object 40 in the perspective direction is longer than the length of the electrode 20 in the perspective direction, both the distal end 20a and the proximal end 20b of the electrode 20 are covered by the protective object 40, and Can prevent the distal end 20a and the proximal end 20b from being caught on another object.

It is preferable that the length of the protection object 40 in the distance direction is longer than the electrode length or the electrode group length which is the length of the electrode 20 in the distance direction. The electrode group length refers to a plurality of electrodes 20 protected by the protection object 40, from the distal end 20a of the most distal electrode 20 to the proximal end 20b of the most proximal electrode 20. Means the length of The length of the protection object 40 in the distance direction is preferably at least 1.1 times the electrode length or the electrode group length, more preferably at least 1.3 times, and more preferably at least 1.5 times. More preferred. By setting the lower limit value of the length of the protective object 40 in the distance direction in the above-described range, the effect of making it difficult for the end portion of the electrode 20 to be caught by another object can be further improved. The upper limit of the length of the protection object 40 in the perspective direction is not particularly limited, but is, for example, 2 times or less, 1.8 times or less, 1.6 times or less the length of the electrode 20 or the electrode group in the perspective direction. be able to.

The protector 40 preferably covers a range of 1/20 or more of the circumferential length of the catheter shaft 10 in the circumferential direction of the catheter shaft 10, and more preferably covers a range of 1/18 or more. , 1/15 or more. By setting the lower limit of the range in which the protector 40 covers in the circumferential direction of the catheter shaft 10 to the above range, the protector 40 can sufficiently protect the end of the electrode 20, and the end of the electrode 20 can be protected. It becomes easier to prevent the part from being caught and damaged by another object. In addition, the protective object 40 preferably covers a range of 1/2 or less of the circumference of the catheter shaft 10 in the circumferential direction of the catheter shaft 10, and preferably covers a range of 1/3 or less. More preferably, it covers the range of 1/4 or less. By setting the upper limit of the range in which the protective object 40 covers the catheter shaft 10 in the circumferential direction to the above range, the electrode 20 is brought into contact with the inner wall of the heart at the time of examination or treatment using the electrode catheter 1. In this case, the protection object 40 is hardly hindered, and the electrode 20 can sufficiently contact the inner wall of the heart.

The number of the electrodes 20 may be one, but it is preferable that the number is two or more. By having a plurality of electrodes 20, it is possible to perform examinations and treatments at a plurality of locations on the inner wall of the heart at one time, and it is possible to shorten the procedure time. When there are a plurality of electrodes 20, the shape and material of each electrode 20 and the interval between adjacent electrodes 20 may be the same or different. For example, if the shape, material, and interval of each electrode 20 are the same, the conditions for measuring the intracardiac potential of each electrode 20 and the conditions for ablation surgery in the examination and treatment using the electrode catheter 1 are the same, and the electrode catheter 1 becomes easy to handle.

間隔 The distance between two adjacent electrodes 20 is preferably longer than the length of the electrode 20 in the distance direction. Since the interval between two adjacent electrodes 20 is arranged to be longer than the length of the electrodes 20 in the perspective direction, sufficient insulation between the electrodes 20 on the outer surface of the catheter shaft 10 can be ensured. Test and treatment can be performed efficiently.

The electrode 20 has a first electrode 21 and a second electrode 22. The first electrode 21 is disposed more distally than the second electrode 22. It is preferable that the second electrode 22 and at least a part of the first electrode 21 are provided. That is, the protection object 40 is preferably provided continuously over the first electrode 21 and the second electrode 22. Since the protection object 40 is provided over at least a part of the first electrode 21 and at least a part of the second electrode 22, even if there are a plurality of electrodes 20, the first protection object 40 allows the first protection object 40 to perform the first protection. Since both ends of the electrode 21 and the second electrode 22 can be hardly caught by other objects, the trouble in providing the protective object 40 is reduced, and the manufacture of the electrode catheter 1 is facilitated.

When the electrode 20 has an electrode 20 other than the first electrode 21 and the second electrode 22, the first electrode 21 and the second electrode 22 may be arranged so as to be adjacent to each other. Between the first electrode 21 and the second electrode 22 so that another electrode 20 is disposed on the proximal side of the first electrode 21 and on the distal side of the second electrode 22. Another electrode 20 may be disposed on the first electrode, and the first electrode 21 and the second electrode 22 may not be adjacent to each other.

Among the electrodes 20 arranged on the catheter shaft 10, the first electrode 21 is arranged on the most distal side, the second electrode 22 is arranged on the most proximal side, and 40 is preferably provided from the distal edge of the first electrode 21 to the proximal edge of the second electrode 22. That is, it is preferable that the protectors 40 are continuously provided over all the electrodes 20 arranged on the catheter shaft 10, and the ends of all the electrodes 20 are covered with one protector 40. The first electrode 21 is disposed on the most distal side, and the second electrode 22 is disposed on the most proximal side, respectively, and the protective object 40 is disposed between the distal edge of the first electrode 21 and the second electrode 22. By being provided over the proximal edge, it is possible to cover all the ends of the electrodes 20 by providing only one protective object 40, thereby reducing the manufacturing cost and making the ends of the electrodes 20 protect other objects. The electrode catheter 1 that is hard to be damaged can be efficiently manufactured.

It is preferable that the catheter shaft 10 has a bent portion 12 at a distal portion. Specific shapes of the bent portion 12 include, for example, a loop shape, a curved shape, a spiral shape, and the like. Further, it is preferable that at least one electrode 20 is arranged on the bent portion 12. Since the electrode catheter 1 has a bent portion 12 at a distal portion, and at least one electrode 20 is disposed at the bent portion 12, the distal portion of the catheter shaft 10 can be brought into contact with the inner wall of the heart. The electrode 20 has a suitable shape, so that the electrode 20 disposed in the bent portion 12 can be easily brought into contact with the inner wall of the heart, and the examination and treatment using the electrode catheter 1 can be easily performed.

It is preferable that at least one electrode 20 is disposed on the bent portion 12, but more than half of all the electrodes 20 provided on the catheter shaft 10 is more preferably disposed on the bent portion 12, More preferably, all the electrodes 20 are arranged on the bent portion 12. In the electrode catheter 1, more than half of all the electrodes 20 provided on the catheter shaft 10 are arranged in the bent portion 12, so that the efficiency of examination and treatment using the electrode catheter 1 can be improved. .

屈曲 As shown in FIG. 2, the bent portion 12 preferably has a loop shape. Since the bent portion 12 has a loop shape, it is easy to fit the pulmonary vein opening in the left atrium, which often has an abnormal portion of the heart that causes arrhythmia, and the examination and treatment using the electrode catheter 1 can be performed. It is easier to perform and the procedure time can be reduced.

It is preferable that the protective object 40 is disposed outside the catheter shaft 10 and inside the bent portion 12. When the catheter shaft 10 has the bent portion 12, when the electrode catheter 1 is inserted through the introducer or the sheath, particularly, the inside of the bent portion 12 is easily pressed against the introducer or the sheath, and the introducer or the sheath may be damaged. The electrode 20 was sometimes damaged or dropped. Therefore, by arranging the protection object 40 outside the catheter shaft 10 and inside the bending part 12, the inside of the bending part 12 that is easily caught by another object is protected by the protection object 40, and the end of the electrode 20 is It is possible to enhance the effect of preventing catching.

As shown in FIG. 2, the catheter shaft 10 has a straight section 13 on the proximal side of the bent section 12, and the bent section 12 is a first section 12 a that is 1 cm from the distal end of the bent section 12. And a second section 12b that is a section 1 cm from the boundary between the bent section 12 and the straight section 13. The position of the protective object 40 in the circumferential direction of the catheter shaft 10 is determined by the first section 12a and the second section 12b. Are preferably different. When the electrode catheter 1 having the bent portion 12 at the distal portion of the catheter shaft 10 and having the linear portion 13 on the proximal side of the bent portion 12 is inserted into the introducer or the sheath, in the circumferential direction of the catheter shaft 10 The location where the load is applied may be different between the vicinity of the boundary between the bent portion 12 and the straight portion 13 and the distal end of the bent portion 12. In such an electrode catheter 1, in order to enhance the effect of preventing the end of the electrode 20 from being caught by the introducer or the sheath, the vicinity of the boundary between the bent portion 12 and the straight portion 13 and the distal end of the bent portion 12 It is preferable to dispose the protector 40 at a position where a load is applied in the circumferential direction of the catheter shaft 10 with respect to each part. In the first section 12a and the second section 12b, the protector 40 is arranged at a place where a load is easily applied, and the position of the protector 40 in the circumferential direction of the catheter shaft 10 is different between the first section 12a and the second section 12b. With such a configuration, it is possible to prevent the end of the electrode 20 of the electrode catheter 1 having the bent portion 12 and the straight portion 13 from being caught by another object and damaged.

The angle between the position of the protective object 40 in the first section 12a and the position of the protective object 40 in the second section 12b in the circumferential direction of the catheter shaft 10 is preferably 30 degrees or more, and more preferably 45 degrees or more. , More preferably 60 ° or more. The angle formed by the position of the protection object 40 in the first section 12a and the position of the protection object 40 in the second section 12b is determined by the protection of the first section 12a in a section perpendicular to the perspective direction of the catheter shaft 10 in the first section 12a. A straight line connecting the center of the object 40 in the width direction and the center of the catheter shaft 10, and a cross section of the second section 12 b perpendicular to the perspective direction of the catheter shaft 10 in the width direction of the protective object 40 in the second section 12 b. It can be obtained by measuring the angle between a straight line connecting the center of the catheter shaft 10 and the center. By setting the lower limit of the angle formed by the position of the protective object 40 in the first section 12a and the position of the protective object 40 in the second section 12b within the above range, the load applied to each of the first section 12a and the second section 12b Are different from each other, the effect of preventing the end of the electrode 20 from being caught on another object can be made sufficient. The upper limit value of the angle formed between the position of the protection object 40 in the first section 12a and the position of the protection object 40 in the second section 12b in the circumferential direction of the catheter shaft 10 is not particularly limited, but is, for example, 180 degrees or less, 150 degrees or less. , 120 degrees or less, and 100 degrees or less.

As shown in FIG. 1, the electrode catheter 1 has a connector 4 connected to a catheter shaft 10. As shown in FIGS. 4 and 6, the catheter shaft 10 is connected to the outside of the catheter shaft 10 and a lumen 11. The conductor 30 extends through the hole 14 from the electrode 20 to the connector 4, and the hole 14 and the protective object 40 are opposite to the axial center L1 of the catheter shaft 10. Is preferred. When the electrode catheter 1 is pulled into the introducer, the protector 40 comes into contact with the distal end of the introducer, so that the end of the electrode 20 does not come into contact with the introducer, and the breakage of the introducer or the detachment of the electrode 20 occurs. Has been prevented. When the electrode catheter 1 is retracted while the protector 40 is in contact with the introducer, vibration or impact may be generated near the protector 40, and the connection portion between the electrode 20 and the conductive wire 30 is disposed near the protector 40. If so, the conducting wire 30 may come off the electrode 20 in some cases. The conducting wire 30 extends from the electrode 20 to the connector 4 through the hole 14, and the hole 14 and the protective object 40 are opposite to the axial center L1 of the catheter shaft 10, so that the electrode catheter 1 can be used as an introducer. Since the distance between the protector 40, which generates vibration and impact when the wire is pulled in, and the connection portion between the electrode 20 and the conductor 30 can be increased, the conductor 30 can be prevented from coming off the electrode 20.

い な い Although not shown, it is preferable that a filler filling the gap between the hole 14 and the conductive wire 30 is provided between the hole 14 and the conductive wire 30. When the electrode catheter 1 is inserted into a blood vessel or a heart, water such as blood enters the lumen 11 of the catheter shaft 10 from a gap between the hole 14 and the lead 30, and blood or the like enters a connection portion between the electrode 20 and the lead 30. Contact, a so-called drift phenomenon occurs in which the baseline potential of the electrocardiogram becomes unstable when measuring the intracardiac potential. The presence of the filler inside the hole 14 can prevent blood or the like from entering the lumen 11 of the catheter shaft 10 from the gap between the hole 14 and the conductive wire 30, and can prevent a drift phenomenon from occurring. As the filler, for example, an adhesive such as a fluorine-based resin such as PTFE, PFA, and ETFE, and an epoxy-based resin can be used.

As described above, the electrode catheter of the present invention has a perspective direction, a catheter shaft having a lumen extending in the perspective direction, an electrode disposed on the catheter shaft, and a lead wire connected to the electrode. And a protective member disposed outside the electrode, wherein at least one of the following condition (1) and the following condition (2) is satisfied.
(1) A part of the distal edge portion of the electrode is covered with the protective material, and the remaining portion is not covered with the protective material.
(2) A part of the proximal edge of the electrode is covered with the protective material, and the remaining part is not covered with the protective material.
With the electrode catheter of the present invention having such a configuration, the end of the electrode is hardly caught on the inner wall of the introducer, the sheath, and the blood vessel or the heart. It can be hard to damage. In addition, the protection object can be easily arranged, and the manufacture of the electrode catheter is easy.

This application claims the benefit of priority based on Japanese Patent Application No. 2018-190373 filed on October 5, 2018. The entire contents of the specification of Japanese Patent Application No. 2018-190373 filed on October 5, 2018 are incorporated herein by reference.

1: Electrode catheter 2: Handle 3: Wire 4: Connector 5: Tip 10: Catheter shaft 11: Lumen 12: Bend 12a: First section 12b: Second section 13: Straight section 14: Hole 20: Electrode 20a : The distal end of the electrode 20b: the proximal end of the electrode 20x: a part of the distal edge of the electrode 20y: the remaining part of the distal edge of the electrode 21: the first electrode 22: the second electrode 30: Conductor 40: Protective object L1: Center of axis of catheter shaft

Claims (13)

A catheter shaft having a perspective direction and having a lumen extending in the perspective direction;
An electrode disposed on the catheter shaft;
A conductor connected to the electrode,
Having a protective object disposed outside the electrode,
An electrode catheter which satisfies at least one of the following condition (1) and the following condition (2):
(1) A part of the distal edge of the electrode is covered with the protective object, and the remaining part is not covered with the protective object.
(2) A part of the proximal edge of the electrode is covered with the protective material, and the remaining part is not covered with the protective material. 電極 The electrode catheter according to claim 1, wherein the protective object is in contact with the electrode. The electrode catheter according to claim 1 or 2, wherein the protective object is an insulating material. 電極 The electrode catheter according to any one of claims 1 to 3, which satisfies both the condition (1) and the condition (2). The electrode catheter according to claim 4, wherein the protective material covering a part of the distal edge of the electrode and the protective material covering a part of the proximal edge of the electrode are integrated. The protection device according to any one of claims 1 to 5, wherein the protective object extends from a distal side of a distal end of the electrode, and extends from a proximal side of a proximal end of the electrode. Electrode catheter. The protective object is elongate,
The electrode catheter according to any one of claims 1 to 6, wherein the electrode catheter extends in a distance direction of the catheter shaft. The electrode has a first electrode and a second electrode,
The first electrode is disposed more distally than the second electrode,
The electrode catheter according to any one of claims 1 to 7, wherein the protective object is provided over at least a part of the first electrode and at least a part of the second electrode. Among the electrodes disposed on the catheter shaft, the first electrode is disposed most distally, the second electrode is disposed most proximally,
The electrode catheter according to claim 8, wherein the protective object is provided from a distal edge of the first electrode to a proximal edge of the second electrode. The catheter shaft has a bent portion at a distal portion,
The electrode catheter according to any one of claims 1 to 9, wherein at least one of the electrodes is disposed at the bent portion. The electrode catheter according to claim 10, wherein the protective object is disposed outside the catheter shaft and inside the bent portion. The catheter shaft has a straight portion proximal to the bent portion,
The bent portion has a first section that is a section of 1 cm from the distal end of the bent portion, and a second section that is a section of 1 cm from the boundary between the bent portion and the linear portion,
The electrode catheter according to claim 10, wherein a position of the protective object in a circumferential direction of the catheter shaft is different between the first section and the second section. Having a connector connected to the catheter shaft,
The catheter shaft has a hole that communicates the lumen with the outside of the catheter shaft,
The lead extends from the electrode to the connector through the hole;
The electrode catheter according to any one of claims 1 to 12, wherein the hole and the protector are opposite to an axial center of the catheter shaft.

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