JP6529770B2 - Electrode catheter, manufacturing method of electrode catheter - Google Patents

Description

  The present invention relates to an electrode catheter used for measuring the potential of internal organs, mainly the heart and ablating internal tissue, and a method of manufacturing the electrode catheter.

  The electrode catheter is used as a medical instrument for diagnosing arrhythmias mainly by measuring the potential of the heart, or actuating radio-frequency current to ablate internal tissue to treat the arrhythmia. Generally, in the electrode catheter, a plurality of ring electrodes are disposed outside a cylinder having a lumen. A lead connected to the inside of the ring electrode extends through the lumen of the barrel to the electrocardiograph. A connector is used to connect the lead to the electrocardiograph. Therefore, for example, by inserting an electrode catheter into a patient's heart and connecting a connector to an electrocardiograph, it is possible to measure the electrocardiogram in the vicinity of the ring electrode and accurately grasp the condition of the myocardium which is the cause of arrhythmia. It is possible.

  In order to perform accurate potential measurement and cauterization with an electrode catheter, it is necessary to suppress the occurrence of a drift phenomenon in which the baseline potential of the electrocardiogram becomes unstable due to the inflow of water such as blood into the lumen of the cylinder. For this reason, a method of connecting a ring electrode, a cylinder, and a lead wire suitable for suppressing the inflow of water into the cylinder has been considered.

  For example, in Patent Document 1, when welding and connecting a lead wire (conductor wire) formed by resin-coating a metal core wire with a ring electrode, a metal core wire (including a weld portion) exposed by peeling off the coating resin. The formation of an insulating resin thin film on the surface is described. In the electrode catheter of Patent Document 1, a ring electrode is fixed to the outer peripheral surface of a catheter (cylindrical body) using an adhesive, and the catheter and the ring are further crimped by caulking the ring electrode on the outer peripheral surface of the catheter. Electrodes are connected.

  Also, according to Patent Document 2, the conductive connection between the electrical conductor (lead wire) of the electrode catheter and the ring electrode is provided by welding, soldering or any other suitable method, among which induction welding is preferred Have been described. Further, in the electrode catheter of Patent Document 2, each edge of the ring electrode is thermally treated by induction heating so that the tubular member (cylindrical body) melts locally around at least one ring electrode. Are configured to form a seal along.

JP, 2009-268696, A Japanese Patent Publication No. 2013-533065 gazette

  The electrode catheters of Patent Documents 1 and 2 use welding to connect the ring electrode and the lead wire, but since the width of the ring electrode is as narrow as 1 to 4 mm, for example, the weld does not protrude outside the ring electrode The technology of connecting the ring electrode and the lead is difficult and can not be easily manufactured. For this reason, when the connection between the ring electrode and the conducting wire is insufficient, there is a possibility that moisture such as blood comes into contact with the welding portion to cause a drift phenomenon.

  In addition, the electrode catheter of Patent Document 1 needs to form an insulating resin thin film when connecting a metal core wire and a ring electrode, and when connecting the catheter and the electrode, it is fixed by an adhesive other than caulking. You need to On the other hand, the electrode catheter of Patent Document 2 also needs to form a seal along each edge of the ring electrode. Therefore, since the electrode catheters of Patent Documents 1 and 2 require time to manufacture, there is also a concern about a decrease in productivity.

  Therefore, it is an object of the present invention to provide an electrode catheter and a method of manufacturing the electrode catheter which can easily conduct the ring electrode and the lead wire and can suppress the inflow of water such as blood into the cylinder.

  The electrode catheter of the present invention, which achieves the above object, is connected to a cylindrical body having an opening formed on the side surface, a ring electrode covering the opening of the cylindrical body from the outside, and the ring electrode. A gist of the present invention is that it has a conductive member closing at least a part of the above and a conductive wire connected to the conductive member and disposed in a cylinder. The electrode catheter of the present invention can be easily manufactured because the ring electrode and the conducting wire can be conducted by closing the opening with the conductive member. For this reason, the process of welding, adhesion | attachment, and welding is unnecessary for the connection of a ring electrode and an electrically-conductive member. Even if a gap is generated between the ring electrode and the cylinder, the conductive member closes the opening, so that water such as blood flows into the cylinder and prevents contact with the connecting portion between the lead wire and the conductive member. it can.

  The conductive member according to the present invention is also preferably made of a metal or a mixture containing a resin and a metal. Since the metal or the mixture containing the resin and the metal is susceptible to plastic deformation, the conductive member can reliably close the opening. This can suppress the inflow of water such as blood into the cylinder.

  It is also preferable that the conductive member according to the present invention is connected to one end of the conducting wire. When arrange | positioning several lead wires in a cylinder, it can suppress that lead wires tangle.

  In the electrode catheter of the present invention, it is also preferable that the opening area of the opening becomes smaller toward the axial center of the cylinder. It is possible to prevent the conductive member from falling into the cylinder and blocking the opening.

  It is also preferable that the conductive member according to the present invention has a conical portion tapered toward the axial center of the cylinder. Accordingly, when the conductive member is inserted into the opening, the positional relationship between the conductive member and the opening can be easily confirmed.

  It is also preferable that the conductive member according to the present invention is made of the same material as the ring electrode. Even if water such as blood reaches the connection portion between the ring electrode and the conductive member, the battery does not function as a battery, so that the occurrence of the drift phenomenon can be suppressed.

  It is also preferable that the conductive member according to the present invention is made of a material different from that of the ring electrode. In the electrode catheter of the present invention, since the opening is closed by the conductive member, even if the conductive member is formed of a material different from that of the ring electrode, the mixing of water such as blood into the cylinder can be suppressed.

  In the method of manufacturing an electrode catheter according to the present invention, the step A of preparing a cylinder having an opening on the side, the step B of connecting the conductive member and the conducting wire, and the conducting wire disposed in the tubular body The method includes the step C of disposing in the opening, the step D of disposing the ring electrode outside the opening, and the step E of caulking the ring electrode and closing at least a part of the opening by the conductive member. The manufacturing method of the electrode catheter of the present invention facilitates the manufacture of the electrode catheter because the ring electrode and the conducting wire can be conducted by caulking the ring electrode and closing the opening with the conductive member. Also, in order to close the opening by the conductive member, even if a gap is generated between the ring electrode and the cylinder, water such as blood flows into the cylinder and contacts the connecting portion of the conducting wire and the conductive member. It can be suppressed.

  It is also preferable that the conductive member is plastically deformed in step E of the method for producing an electrode catheter of the present invention. As a result, when the ring electrode is crimped, the conductive member tends to close the opening.

  In step C of the method of manufacturing an electrode catheter of the present invention, it is also preferable that the conductive member has a shape that does not pass through the opening. When the ring electrode is crimped, the conductive member can be prevented from being contained in the cylinder.

The electrode catheter of the present invention can be easily manufactured because the ring electrode and the conducting wire can be conducted by closing the opening with the conductive member. For this reason, the process of a welding, adhesion | attachment, and welding is unnecessary for the connection of a ring electrode and a conductive member. Even if a gap is generated between the ring electrode and the cylinder, the conductive member closes the opening, so that water such as blood flows into the cylinder and prevents contact with the connecting portion between the lead wire and the conductive member. it can.
Further, the method of manufacturing the electrode catheter according to the present invention facilitates the manufacture of the electrode catheter because the ring electrode and the conducting wire can be conducted by caulking the ring electrode and closing the opening with the conductive member. . Also, in order to close the opening by the conductive member, even if a gap is generated between the ring electrode and the cylinder, water such as blood flows into the cylinder and contacts the connecting portion of the conducting wire and the conductive member. It can be suppressed.

FIG. 1 is a cross-sectional view (partially side view) along the axial direction of an electrode catheter according to an embodiment of the present invention. Fig.2 (a) is a front view of the cylinder which concerns on embodiment of this invention, FIG.2 (b) is sectional drawing along the axial direction of the cylinder which concerns on embodiment of this invention. Fig.3 (a) and FIG.3 (b) are sectional drawings (one part side view) along the axial direction of the electrode catheter which concerns on embodiment of this invention. FIG. 4 is a side view of the conductive member according to the embodiment of the present invention. FIG. 5 is a cross-sectional view along the axial direction of the electrode catheter according to the embodiment of the present invention. FIG. 6 is a sectional view (partially side view) along the axial direction of the electrode catheter according to the embodiment of the present invention. FIG. 7 is a cross-sectional view (partially side view) along the axial direction of the electrode catheter according to the embodiment of the present invention. FIG. 8 is a cross-sectional view (partially side view) along the axial direction of the electrode catheter according to the embodiment of the present invention.

  Hereinafter, the present invention will be more specifically described based on the following embodiments, but the present invention is not limited by the following embodiments as a matter of course, and modifications can be appropriately made within the scope which can conform to the above and below. In addition, it is of course possible to carry out, and all of them are included in the technical scope of the present invention. In addition, in each drawing, although hatching, a member code | symbol, etc. may be abbreviate | omitted for convenience, in this case, a specification and other drawings shall be referred to. Further, the dimensions of various members in the drawings may differ from the actual dimensions, as priority is given to helping to understand the features of the present invention.

  In the present invention, the axial direction refers to the longitudinal direction of the cylinder unless otherwise specified, and in the axial direction, the proximal side refers to the proximal direction of the operator, and the distal side is the proximal side. Point in the opposite direction of Further, the radial direction refers to the radial direction of the cylinder, the inward refers to the direction toward the axial center of the cylinder, and the outward refers to the radial direction of the cylinder.

1. Electrode Catheter FIG. 1 is a cross-sectional view (partially side view) of an electrode catheter 10 according to an embodiment of the present invention. The electrode catheter 10 of the present invention is connected to the cylindrical body 20 having the opening 25 formed on the side, the ring electrode 30 covering the opening 25 of the cylindrical body 20 from the outside, and the ring electrode 30. And at least a part of the conductive member 40 closing the conductive member 40, and a conductive wire 50 connected to the conductive member 40 and disposed in the cylindrical body 20. The electrode catheter 10 of the present invention can be easily manufactured since the ring electrode 30 and the conducting wire 50 can be conducted by closing the opening 25 with the conductive member 40. For this reason, the process of welding, adhesion | attachment, and welding is unnecessary for the connection of the ring electrode 30 and the electrically-conductive member 40. FIG. Even if a gap is generated between the ring electrode 30 and the cylindrical body 20, the conductive member 40 closes the opening 25. Therefore, water such as blood flows into the cylindrical body 20, and the conducting wire 50 and the conductive member 40 It can control that it contacts the connection part of.

  The electrode catheter 10 is used for diagnosis and treatment of arrhythmia. For example, in the diagnosis of arrhythmia, an electrocardiogram can be obtained by inserting the electrode catheter 10 into the body of a patient, placing the ring electrode 30 near the tissue to be diagnosed in the heart, and measuring the potential of the tissue. In the treatment of arrhythmia, for example, if a high frequency current is applied to the electrode of the electrode catheter 10, internal tissue can be ablated.

  The cylindrical body 20 is a portion inserted into the patient's body from the distal side. The cylindrical body 20 is a cylindrical body having a lumen, and has a good balance of both flexibility to be bent along the shape of the body cavity and rigidity to reliably reach the internal tissue to be treated desirable. The cylindrical body 20 may have, for example, a single cylindrical structure, or may have a multiple cylindrical structure formed of a plurality of concentric circular cylinders having different diameters.

  As the cylinder 20, a cylinder formed of a polyurethane resin, an olefin resin, a fluorine resin, a polyamide resin, a polyimide resin or the like can be used. The cylinder 20 is a cylinder formed by laminating synthetic resins different in rigidity, or a cylinder formed of a resin layer and a coil or braid reinforcement layer formed using metal and / or resin strands. May be

  An opening 25 is formed on the side surface of the cylindrical body 20. For forming the opening 25, a method such as needle puncturing, laser cauterization, or opening by punch can be used. When forming the opening 25 by laser ablation, for example, by inserting a rod made of a synthetic resin into the cylindrical body 20, it is possible to suppress the formation of an unintended opening in the cylindrical body 20.

  The shape of the opening 25 is not particularly limited. For example, the shape of the opening 25 as viewed from above may be circular, elliptical, polygonal, or a combination thereof.

  It is also preferable that the opening area of the opening 25 be smaller toward the axial center 21 of the cylindrical body 20 (that is, the inner side of the cylindrical body 20). When the ring electrode 30 of the opening 25 is crimped, it is possible to suppress that the conductive member 40 falls into the cylindrical body 20 and the opening 25 is not closed.

  Fig.2 (a) is a front view of the cylinder 20 which concerns on embodiment of this invention, FIG.2 (b) is sectional drawing along the axial direction of the cylinder 20 which concerns on embodiment of this invention . Fig.2 (a) and FIG.2 (b) have shown the example which formed the shape of the opening part 25 when the cylinder 20 is seen from the front in circular shape. When the opening 25 has a circular shape as shown in FIG. 2B, it is also preferable that the inner diameter D of the opening 25 becomes smaller toward the axial center 21 of the cylindrical body 20. When the ring electrode 30 of the opening 25 is crimped, it is possible to suppress that the conductive member 40 falls into the cylindrical body 20 and the opening 25 is not closed.

  When the opening area of the opening 25 is large, a large conductive member 40 for covering the opening 25 and a wide ring electrode 30 covering the opening 25 are required. In this case, since the conductive member 40 is large, handling in manufacture is facilitated, but the number of ring electrodes 30 that can be disposed on the cylindrical body 20 is limited.

  On the other hand, when the opening area of the opening 25 is small, the number of ring electrodes 30 that can be disposed in the cylindrical body 20 can be increased, but the conductive member 40 becomes smaller, which may make handling difficult in manufacturing. There is.

  From the above, the opening range of the opening 25 in the circumferential direction of the cylindrical body 20 is preferably 20 degrees or more and 60 degrees or less with respect to the circumferential direction of the cylindrical body 20. In addition, the opening range of the opening 25 in the axial direction of the cylindrical body 20 is covered by the central portion of the ring electrode 30 when the ring electrode 30 is divided into three in the distal portion, the central portion, and the proximal portion in the axial direction. Is preferred.

  Further, from the results of the test described later in the “Example”, in the case where the circular opening portion 25 is provided in the cylindrical body 20 and the spherical conductive member 40 is used, the diameter and the electric conductivity of the opening portion 25 of the cylindrical body 20 Preferably, the diameters of the members 40 are approximately the same size. Thereby, while making the ring electrode 30 and the conducting wire 50 into a conduction | electrical_connection state, mixing of the water | moisture content in the cylinder 20 can be suppressed.

  The electrode catheter 10 is inserted into the heart from, for example, a vein or artery in the thigh of a patient, a vein or artery under the clavicle, or the like. Therefore, the lower limit of the outer diameter of the cylindrical body 20 is preferably 0.5 mm, more preferably 0.8 mm, and still more preferably 1.0 mm. The upper limit of the outer diameter of the cylindrical body 20 is, for example, preferably 3.0 mm, more preferably 2.7 mm, and still more preferably 2.4 mm.

  A conducting wire 50 is disposed in the cylinder 20. Therefore, in order to secure the flexibility and rigidity of the cylindrical body 20 and the space in which the conducting wire 50 is disposed in the cylindrical body 20, the lower limit of the inner diameter of the cylindrical body 20 is preferably 0.3 mm, for example. It is more preferable that it is 0.7 mm, and it is further more preferable that it is 1.5 mm. The upper limit of the inner diameter of the cylindrical body 20 is preferably 2.2 mm, more preferably 2.0 mm, and still more preferably 1.7 mm.

  The ring electrode 30 plays a role of a probe at the time of potential measurement. The ring electrode 30 covers the opening 25 of the cylindrical body 20 from the outside. It is preferable to use a caulking method for the arrangement of the ring electrode 30 outside the opening 25 of the cylindrical body 20.

  The number of ring electrodes 30 is not particularly limited, and may be singular or plural. As will be described later, the ring electrode 30 is placed in electrical communication with the conducting wire 50 disposed in the cylinder 20. Therefore, the number of ring electrodes 30 depends on the number of the conductive wires 50 disposed in the cylindrical body 20 and the outer diameter of the conductive wires 50. When the electrode catheter 10 has a plurality of ring electrodes 30, in order to measure the potential of each ring electrode 30 individually, the number of the leads 50 conducted with one ring electrode 30 is one. preferable.

  The ring electrode 30 only needs to have conductivity, and can be made of metal, or a mixture containing resin and metal. Among them, it is preferable to use a conductive resin, platinum, a platinum iridium alloy, stainless steel, or tungsten as a material of the ring electrode 30, but in the case of using a conductive resin, barium sulfate or It is preferred to mix contrast agents such as bismuth oxide.

  Since the ring electrode 30 is disposed outside the cylindrical body 20, the inner diameter of the ring electrode 30 before caulking is preferably larger than the outer diameter of the cylindrical body 20, and the outer diameter of the ring electrode 30 before caulking is the patient's Preferably it is smaller than the internal diameter of the vein or artery.

  The width of the ring electrode 30 can be, for example, 1 mm or more and 4 mm or less. The thickness of the ring electrode 30 can be, for example, 0.3 mm or more and 0.7 mm or less.

  The conductive member 40 is connected to the ring electrode 30 so as to close at least a part of the opening 25. In connection between the conductive member 40 and the ring electrode 30, it is sufficient that a part of the conductive member 40 is in contact with the ring electrode 30, and the conductive member 40 and the ring electrode 30 are connected by caulking the ring electrode 30, for example. . That is, in the present invention, the arrangement of the ring electrode 30 on the outside of the cylindrical body 20 can be combined with the connection between the conductive member 40 and the ring electrode 30.

  When the conductive member 40 closes at least a part of the opening 25, at least one of the opening 25 in the thickness direction of the opening 20 of the cylinder 20 is in a state where the ring electrode 30 is disposed outside the cylinder 20 by caulking or the like. It means closing the part. In the electrode catheter 10 of the present invention, since at least a part of the opening 25 is closed by the conductive member 40, even if a gap is generated between the ring electrode 30 and the cylindrical body 20, water such as blood is contained in the cylindrical body 20. Can be prevented from coming into contact with the connecting portion between the conducting wire 50 and the conductive member 40.

  FIG. 3A is a cross-sectional view (partially side view) along the axial direction of the electrode catheter 10 in a state in which a part of the opening 25 is closed by the conductive member 40. After disposing the ring electrode 30 on the outside of the cylindrical body 20 by the caulking method or the like, the height in the radial direction of the conductive member 40 is greater than the thickness of the cylindrical body 20 at the opening 25 as shown in FIG. It may also be small. Since the conductive member 40 is not disposed in the lumen of the cylindrical body 20, it is suitable when a large number of ring electrodes 30 are disposed (ie, the number of the leads 50 is increased).

  3B is a cross-sectional view (partially side view) along the axial direction of the electrode catheter 10 in a state in which the opening 25 is closed by the conductive member 40. As shown in FIG. As shown in FIG. 3B, a part of the conductive member 40 may be accommodated in the cylindrical body 20 in a state where the ring electrode 30 is disposed on the outside of the cylindrical body 20 by a caulking method or the like. That is, the height of the conductive member 40 in the radial direction may be larger than the thickness of the cylindrical body 20 at the opening 25 after the ring electrode 30 is disposed outside the cylindrical body 20 by a caulking method or the like. Since the contact area of the cylindrical body 20 and the conductive member 40 is increased, the opening 25 can be reliably closed by the conductive member 40.

  The shape of the conductive member 40 is not particularly limited as long as it is a shape suitable for closing the opening 25. For example, it may be a sphere, an ellipsoid, a polyhedron, a cone, or a combination thereof.

  Moreover, it is also preferable that the conductive member 40 has a shape in which the conductive member 40 does not pass through the opening 25. It can be suppressed that the conductive member 40 falls into the cylinder 20 and the opening 25 is not closed.

  FIG. 4 is a side view showing the shape of the conductive member 40 according to the embodiment of the present invention. 4 (a), 4 (b), 4 (c), 4 (d), 4 (e) and 4 (f) respectively show the case where the conductive member 40 is a sphere and the case of an ellipsoid. , In the case of a rectangular parallelepiped, in the case of a cone, in the case of cutting off the tip of the cone, and in the case of a rectangular parallelepiped provided with a ridge.

  In order to facilitate the manufacture of the conductive member 40, as shown in FIGS. 4A to 4C, the conductive member 40 may be formed into a sphere, an ellipsoid or a rectangular solid.

  As shown in FIG. 4 (d), it is also preferable that the conductive member 40 have a conical portion 41 which is tapered toward the axial center 21 of the cylindrical body 20. Thus, when the conductive member 40 is inserted into the opening 25, the position in the thickness direction of the conductive member 40 in the opening 25 of the cylindrical body 20 (that is, the insertion depth of the conductive member 40 with respect to the cylindrical body 20) is confirmed It becomes easy to do. In addition, since the conductive member 40 having the conical portion 41 contacts and fits the inner wall surface of the cylindrical body 20 when inserted into the opening 25, the conductive member 40 can be easily pushed inward of the cylindrical body 20.

  As shown in FIG. 4E, the conductive member 40 may have a shape obtained by cutting out the tip (axial center 21 side) of the conical portion 41. Since it becomes difficult to arrange the conductive member 40 in the cylindrical body 20, it is suitable when arranging a large number of ring electrodes 30 (that is, the number of the conducting wires 50 is increased).

  As shown in FIG. 4 (f), the conductive member 40 may have a collar 42 not inserted into the opening 25 on the outer side of the cylindrical body 20. Even if the ring electrode 30 is crimped, the collar 42 is retained on the cylindrical body 20, so that the conductive member 40 can be prevented from falling into the cylindrical body 20 and the opening 25 will not be closed.

  When the cylinder 20 is viewed from above, the collar portion 42 may have a shape that does not pass through the opening 25, and may be formed to cover a part of the opening 25.

  It is preferable that the height of the ridge portion 42, that is, the radial length of the ridge portion 42 be smaller than the thickness of the ring electrode 30. Thereby, even if the ring electrode 30 is disposed outside the cylindrical body 20 by a caulking method or the like, the difference in level between the surface of the cylindrical body 20 and the ring electrode 30 can be reduced.

  The conductive member 40 only needs to have conductivity, and can preferably be made of a metal or a mixture containing a resin and a metal. Thereby, when connecting the ring electrode 30 and the conductive member 40 by a caulking method etc., since the conductive member 40 is plastically deformed, the opening 25 of the cylindrical body 20 is easily closed by the conductive member 40. This is because the conductive member 40 is plastically deformed and the contact area between the conductive member 40 and the ring electrode 30 is increased. Among them, it is preferable to use a conductive resin, platinum, a platinum iridium alloy, stainless steel, or tungsten as a material of the conductive member 40, but in the case of using a conductive resin, barium sulfate or It is preferred to mix contrast agents such as bismuth oxide.

  It is also preferable that the conductive member 40 be made of the same material as the ring electrode 30. Even if water such as blood reaches the connection between the ring electrode 30 and the conductive member 40, the battery does not function as a battery, so that the occurrence of the drift phenomenon can be suppressed.

  Since the ring electrode 30 has a larger volume than the conductive member 40, if the ring electrode 30 and the conductive member 40 are made of the same material, the material cost of the ring electrode 30 is high. Therefore, it is also preferable that the conductive member 40 according to the present invention is made of a material different from that of the ring electrode 30. Thereby, the materials of the conductive member 40 and the ring electrode 30 can be appropriately selected in consideration of the cost and the like. For example, if platinum which is easily deformed but relatively expensive is used as the material of the conductive member 40 and stainless steel cheaper than platinum is used as the material of the ring electrode 30, the ring electrode 30 and the conductive member 40 are made of platinum. The cost of materials can be reduced compared to the case.

  The conducting wire 50 is connected to the conductive member 40 and disposed in the cylindrical body 20. The conducting wire 50 electrically connects the ring electrode 30 and an external device of the electrode catheter 10, for example, an electrocardiograph.

  As the conducting wire 50, it is preferable to use a wire which is covered with a covering material such as a covering tube so as to prevent a short circuit with an adjacent member. The material of the core of the conducting wire 50 may be any conductive material, but copper wire, iron wire, stainless steel wire, piano wire, tungsten wire, nickel titanium wire, etc. may be used as an example. it can. For example, copper wire is easy to use because its material cost is low compared to other materials. The stainless steel wire is particularly preferable in that it is flexible, can disperse stress applied when the lead wire 50 is passed through the cylindrical body 20, and does not easily cause disconnection of the connection portion between the lead wire 50 and the conductive member 40. In addition, the connection portion between the conducting wire 50 and the conductive member 40 is covered with a resin or the like in order to prevent oxidation deterioration when water contained in the atmosphere or the like and water such as blood temporarily enter the cylinder 20. Preferably. Examples of the resin used for covering the connection portion between the conducting wire 50 and the conductive member 40 include a urethane resin and an epoxy resin.

  The connection between the conductive member 40 and the conducting wire 50 can be performed by using, for example, a welding method, a soldering method, a caulking method, a brazing method, or the like. Among them, the welding method is particularly preferable because the inner diameter of the ring electrode 30 can be secured most widely and the manufacture is easy.

  The position of the conductive member 40 in the axial direction of the conductive wire 50 is not particularly limited, but it is also preferable that the conductive member 40 be connected to one end of the conductive wire 50. When arrange | positioning the several conducting wire 50 in the cylinder 20, it can suppress that conducting wire 50 comrades tangle.

  The other end of the lead 50 is connected to a connector 64 for connecting to a power supply device or the like of the electrode catheter 10 through an intermediate shaft 60 and a shaft 62 described later. The shape of the connector 64 may be monopolar or bipolar.

  As shown in FIG. 1, an intermediate shaft 60 is connected to the proximal side of the cylindrical body 20. Although there is no restriction | limiting in particular in the connection form of the cylindrical body 20 and the intermediate shaft 60, For example, the proximal side of the cylindrical body 20 can be pinched and fixed by the fixing member 60a. The proximal end of the intermediate shaft 60 is connected to a shaft 62 gripped by the user of the electrode catheter 10.

  As shown in FIG. 1, a distal end 35 of the cylindrical body 20 may be provided with a tip 35 serving as a guide for the tip of the electrode catheter 10. One end of a pull wire 61 is connected to the distal end tip 35, and the other end of the pull wire 61 is connected to a handle 63 provided on the shaft 62. With such a structure, the handle 63 can be operated at hand to control the degree of bending of the distal end of the cylinder 20. If the distal end tip 35 is made of a conductive material and the distal end tip 35 is also connected to the conducting wire 50 (not shown), the distal end tip 35 can also function as an electrode like the ring electrode 30. Therefore, similarly to the lead 50 connected to the conductive member 40, the other end of the lead 50 connected to the distal end tip 35 passes through the intermediate shaft 60 and the shaft 62 to connect to the power supply device or the like of the electrode catheter 10. Is connected with the connector 64.

2. Method of Manufacturing Electrode Catheter The method of manufacturing the electrode catheter 10 of the present invention will be described in detail with reference to FIGS. FIG. 5 is a sectional view along the axial direction of the electrode catheter 10 according to the embodiment of the present invention, and FIGS. 6 to 8 are a sectional view along the axial direction of the electrode catheter 10 according to the embodiment of the present invention (Partial side view). In addition, about each member which comprises the electrode catheter 10, it is as having described in "1. electrode catheter" of this specification.

  In the method of manufacturing the electrode catheter 10 of the present invention, the step A of preparing the cylindrical body 20 having the opening 25 on the side, the step B of connecting the conductive member 40 and the conducting wire 50, and the conducting wire 50 in the tubular body 20. Placing the conductive member 40 in the opening 25; placing the ring electrode 30 outside the opening 25; caulking the ring electrode 30; And a step E of closing the part. In the method of manufacturing the electrode catheter 10 of the present invention, since the ring electrode 30 and the conducting wire 50 can be conducted by caulking the ring electrode 30 and closing the opening 25 with the conductive member 40, the manufacturing of the electrode catheter 10 is easy. It is to Further, since the opening 25 is closed by the conductive member 40, even if a gap is generated between the ring electrode 30 and the cylindrical body 20, water such as blood flows into the cylindrical body 20, and the conducting wire 50 and the conductive member 40 It can control that it contacts the connection part of.

  First, as shown in FIG. 5, a cylindrical body 20 having an opening 25 on the side surface, which is necessary for manufacturing the electrode catheter 10, is prepared (step A).

  In step A, the cylinder 20 may use the cylinder 20 in which the opening 25 is formed on the side in advance. Alternatively, the opening 25 may be formed on the side surface of the cylindrical body 20 using a method such as puncture with a needle, cauterization with laser irradiation, or opening with a punch.

  Next, the conductive member 40 and the conducting wire 50 are prepared, and the conducting member 40 and the conducting wire 50 are connected (step B). Preferably, one end of the conducting wire 50 is connected to the conductive member 40. The connection between the conductive member 40 and the conducting wire 50 can be performed by using, for example, a welding method, a soldering method, a caulking method, a brazing method, or the like. Among them, the welding method is particularly preferable because the inner diameter of the ring electrode 30 can be secured most widely and the manufacture is easy.

  As shown in FIG. 6, the conducting wire 50 is arrange | positioned in the cylinder 20, and the electrically-conductive member 40 is arrange | positioned to the opening part 25 (step C). For example, the other end of the conducting wire 50 (the end not connected to the conductive member 40) is inserted from the opening 25 of the cylindrical body 20, and the other end of the conducting wire 50 is drawn to the proximal side of the cylindrical body 20. The conductive member 40 is engaged with the opening 25, and the conductive member 40 is disposed in the opening 25. At this time, at least a part of the conductive member 40 may be accommodated in the opening 25. That is, it is preferable that at least a part of the conductive member 40 be exposed to the outside of the cylindrical body 20. This is because the conductive member 40 is deformed when the ring electrode 30 is crimped in step E described later, so that the opening 25 can be easily closed by the conductive member 40.

  Moreover, in the step C, it is preferable that the conductive member 40 have a shape that does not pass through the opening 25. When the ring electrode 30 is crimped, the conductive member 40 can be prevented from falling into the cylindrical body 20 and the opening 25 will not be closed.

  As shown in FIG. 7, the ring electrode 30 is disposed outside the opening 25 (step D). One end or the other end of the cylindrical body 20 is inserted into the ring electrode 30, and the axial position of the opening 25 and the ring electrode 30 are aligned so that the ring electrode 30 is disposed on the opening 25.

  In the step D, the ring electrode 30 is preferably disposed outside the opening 25 so that the opening 25 is not covered by the ring electrode 30 and seen.

  As shown in FIG. 8, the ring electrode 30 is crimped, and at least a part of the opening 25 is closed by the conductive member 40 (step E). In the method of manufacturing the electrode catheter 10 of the present invention, since the ring electrode 30 and the conducting wire 50 can be conducted by caulking the ring electrode 30 and closing the opening 25 with the conductive member 40, the electrode catheter 10 is easily manufactured. can do.

  It is also preferable that the conductive member 40 be plastically deformed in the step E. Thereby, when the ring electrode 30 is crimped, the conductive member 40 easily closes the opening 25.

  It is also preferable that the conductive member 40 be made of a metal or a mixture containing a resin and a metal in order to easily deform the conductive member 40 plastically. Thereby, since the opening 25 can be reliably closed by the conductive member 40, it is possible to suppress the inflow of water such as blood into the cylindrical body 20.

  EXAMPLES Hereinafter, the present invention will be more specifically described by way of examples. However, the present invention is of course not limited by the following examples, and appropriate modifications may be made as long as the present invention can be applied to the purpose. Of course, implementation is also possible, and all of them are included in the technical scope of the present invention.

  Below, the test result which measured the conduction | electrical_connection state of the ring electrode and conducting wire in, when the diameter of the spherical electrically-conductive member used for an electrode catheter is changed, and the state in the cylinder after leaving still under water is demonstrated. First, an electrode catheter having a cylinder necessary for measurement, a ring electrode, a conductive member, and a conducting wire was manufactured. An opening was formed on the side surface of the cylinder, and the cylinder had an outer diameter of 2.00 mm and an inner diameter of 1.60 mm. The outer diameter of the ring electrode was 2.20 mm and the inner diameter was 2.10 mm. The diameters of the spherical conductive members were changed to 0.10 mm, 0.20 mm, and 0.30 mm. In this test, after the electrode catheter is manufactured, first, the conduction state of the ring electrode and the lead is confirmed. As a result, only with respect to the electrode catheter confirmed to be in the conductive state, the state in the cylinder after being left in water for a predetermined time was observed.

  Outer diameter (mm), inner diameter (mm), diameter of the opening (mm) of the cylinder in this test; outer diameter (mm) of the ring electrode, inner diameter (mm); diameter of the conducting wire (mm); shape of the conductive member Diameter (mm); bending radius (mm) when placed in water; settling time in water (minutes); conduction between the lead wire and the electrode; and the state of the cylinder after being placed in water is shown in Table 1.

(Comparative example 1)
In Comparative Example 1, an electrode catheter was manufactured using a cylindrical body having a circular opening with a diameter of 0.20 mm and a spherical conductive member with a diameter of 0.10 mm. The ring electrode and the conductor did not conduct. This is because the diameter of the conductive member was as small as 0.10 mm with respect to the diameter 0.20 mm of the opening of the cylinder, so the conductive member fell into the cylinder and the opening was not closed by the conductive member. it is conceivable that.

Example 1
In Example 1, an electrode catheter was manufactured using a cylindrical body having a circular opening with a diameter of 0.20 mm and a spherical conductive member with a diameter of 0.20 mm. The ring electrode and the lead were in a conductive state. Thereafter, the electrode catheter was allowed to stand in water for 30 minutes with a bending radius of 20 mm, and the condition inside the cylinder was observed. As a result, no water was mixed in the cylinder. From the above, it was found that the opening was closed by the conductive member, and the ring electrode and the conducting wire were connected via the conductive member.

(Comparative example 2)
In Comparative Example 2, an electrode catheter was manufactured using a cylindrical body having a circular opening with a diameter of 0.20 mm and a spherical conductive member with a diameter of 0.30 mm. Since the ring electrode and the conducting wire were in the conductive state, it was found that the ring electrode and the conducting wire were connected via the conductive member. Thereafter, the electrode catheter was allowed to stand in water for 30 minutes with a bending radius of 20 mm, and the condition inside the cylinder was observed, and water was mixed in the cylinder. This is because the diameter of the conductive member is as large as 0.30 mm with respect to the diameter of 0.20 mm of the opening of the cylindrical body, so the conductive member can not fit into the opening, and a gap between the cylindrical body and the conductive member at the opening It is considered that the cause is that the opening is not closed by the conductive member.

(Example 2)
In Example 2, an electrode catheter was manufactured using a cylindrical body having a tapered opening that is tapered from the outer side to the inner side of the cylindrical body and a spherical conductive member having a diameter of 0.20 mm. . The diameters of the openings on the outer surface side and the inner surface side of the cylinder were 0.30 mm and 0.20 mm, respectively. Since the ring electrode and the conducting wire were in the conductive state, it was found that the ring electrode and the conducting wire were connected via the conductive member. Thereafter, the electrode catheter was allowed to stand in water for 30 minutes with a bending radius of 20 mm, and the condition inside the cylinder was observed. As a result, no water was mixed in the cylinder. From the above, it was found that the opening was closed by the conductive member, and the ring electrode and the conducting wire were connected via the conductive member.

  From the above test results, in the electrode catheter of the present invention, since at least a part of the opening is closed by the conductive member connected to the ring electrode, the ring electrode and the conducting wire can be brought into conduction, and It was concluded that the mixing of water can be suppressed. Furthermore, when providing a circular opening in the cylinder and using a spherical conductive member, it was found that it is preferable to make the diameter of the opening of the cylinder and the diameter of the conductive member substantially the same.

10: electrode catheter 20: cylinder 21: axial center 25: opening 30: ring electrode 35: tip 40: conductive member 50: conducting wire 60: intermediate shaft 60a: fixing member 61: pull wire 62: shaft 63: handle 64 :connector

Claims (10)

A cylinder having an opening formed on the side surface,
A ring electrode covering the opening of the cylinder from the outside;
A conductive member connected to the ring electrode and closing at least a part of the opening;
An electrode catheter comprising: a conductive wire connected to the conductive member, disposed in the cylinder and not radially outward of the outer surface of the cylinder .   The electrode catheter according to claim 1, wherein the conductive member is made of metal or a mixture containing resin and metal.   The electrode catheter according to claim 1, wherein the conductive member is connected to one end of the conducting wire.   The electrode catheter according to any one of claims 1 to 3, wherein the opening area of the opening decreases toward the axial center of the cylinder.   The electrode catheter according to any one of claims 1 to 4, wherein the conductive member has a conical portion tapered toward the axial center of the cylinder.   The electrode catheter according to any one of claims 1 to 5, wherein the conductive member is made of the same material as the ring electrode.   The electrode catheter according to any one of claims 1 to 5, wherein the conductive member is made of a material different from that of the ring electrode. Step A of preparing a cylinder having an opening on the side
Step B of connecting the conductive member and the conducting wire;
Placing the conducting wire in the cylinder and placing the conductive member in the opening C;
Placing a ring electrode on the outside of the opening;
And D. the ring electrode is crimped and at least a part of the opening is closed by the conductive member.   The method according to claim 8, wherein the conductive member is plastically deformed in the step E.   The method according to claim 8 or 9, wherein in the step C, the conductive member has a shape which does not pass through the opening.