JP2016137019A - Electrode catheter and manufacturing method of electrode catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an electrode catheter capable of achieving easily conduction between a ring electrode and a conductor wire, and suppressing inflow of moisture such as blood into a cylinder; and to provide a manufacturing method of the electrode catheter.SOLUTION: An electrode catheter 10 has: a cylinder 20 having an opening part 25 formed on the side face; a ring electrode 30 for covering the opening part 25 of the cylinder 20 from the outside; a conductive member 40 connected to the ring electrode 30, for blocking at least a part of the opening part 25; and a conductor wire 50 connected to the conductive member 40, and arranged in the cylinder 20.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an electrode catheter used for measuring the potential of a body organ, mainly the heart, or cauterizing a body tissue, and a method for manufacturing the electrode catheter.

  Electrode catheters are used as medical instruments that mainly diagnose cardiac arrhythmias by measuring the potential of the heart, or cause high-frequency currents to cauterize internal tissues in order to treat arrhythmias. Generally, in an electrode catheter, a plurality of ring electrodes are arranged outside a cylindrical body having a lumen. A conducting wire connected to the inside of the ring electrode extends to the electrocardiograph through the lumen of the cylinder. A connector is used to connect the lead wire and the electrocardiograph. Therefore, for example, by inserting an electrode catheter into the patient's heart and connecting the connector to an electrocardiograph, the electrocardiogram near the ring electrode can be measured to accurately grasp the state of the myocardium that causes arrhythmia Is possible.

  In order to perform accurate potential measurement or 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, the connection method of the ring electrode, cylinder, and conducting wire suitable for suppressing the inflow of moisture into the cylinder is being studied.

  For example, Patent Document 1 discloses a metal core wire (including a welded portion) that is exposed by peeling off a coating resin when a lead wire (conductive wire) formed by resin coating of a metal core wire and a ring electrode are connected by welding. It describes that an insulating resin thin film is formed on the surface. In the electrode catheter of Patent Document 1, the ring-shaped electrode is fixed to the outer peripheral surface of the catheter (tubular body) using an adhesive, and the ring-shaped electrode is caulked to the outer peripheral surface of the catheter. The electrode is connected.

  Further, in Patent Document 2, the conductive connection between the electric conductor (conductor) of the electrode catheter and the ring electrode is provided by welding, soldering, or any other suitable method, among which induction welding is preferable. Have been described. In addition, the electrode catheter of Patent Document 2 heats the tubular member by induction heating so that the tubular member (tubular body) locally melts around the at least one ring electrode. Is configured to form a seal along the line.

JP 2009-268696A Special table 2013-533065 gazette

  The electrode catheters of Patent Documents 1 and 2 use welding to connect the ring electrode and the conductive wire, but the width of the ring electrode is as narrow as 1 to 4 mm, for example, so that the welded portion does not protrude from the ring electrode. The technology for connecting the ring electrode and the conductive wire is difficult and cannot be easily manufactured. For this reason, when the connection between the ring electrode and the conductive wire is insufficient, moisture such as blood may come into contact with the welded portion and a drift phenomenon may occur.

  In addition, the electrode catheter of Patent Document 1 needs to form an insulating resin thin film when connecting the metal core wire and the ring-shaped electrode, and is fixed by an adhesive other than caulking when connecting the catheter and the electrode. It is necessary to do. 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 a concern about a decrease in productivity.

  Accordingly, an object of the present invention is to provide an electrode catheter capable of easily conducting a ring electrode and a conducting wire and suppressing inflow of moisture such as blood into the cylinder, and a method for manufacturing the electrode catheter.

  The electrode catheter of the present invention that has achieved the above-mentioned object includes a cylindrical body having an opening formed on a side surface, a ring electrode that covers the opening of the cylindrical body from the outside, and an opening connected to the ring electrode. The present invention has a gist in that it has a conductive member that closes at least a part of the conductive member, and a conductive wire that is connected to the conductive member and disposed 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 welding, adhesion | attachment, and welding is unnecessary for the connection of a ring electrode and an electrically-conductive member. Even if there is a gap between the ring electrode and the cylinder, the opening is closed by the conductive member, so that water such as blood flows into the cylinder and prevents contact between the conductor and the conductive member. it can.

  The conductive member according to the present invention is also preferably composed of a metal or a mixture containing a resin and a metal. Since a metal or a mixture containing a resin and a metal is easily plastically deformed, the opening can be reliably closed by the conductive member. Thereby, it can control that moisture, such as blood, flows into a cylinder.

  It is also preferable that the conductive member according to the present invention is connected to one end of the conducting wire. When arranging several conducting wires in a cylinder, it can control that conducting wires get entangled.

  As for the electrode catheter of this invention, it is also preferable that the opening area of an opening part becomes small toward the axial center of a cylinder. It can be suppressed that the conductive member falls into the cylinder and the opening is not blocked.

  It is also preferable that the conductive member according to the present invention has a cone-shaped portion that tapers toward the axial center of the cylindrical body. This makes it easy to confirm the positional relationship between the conductive member and the opening when the conductive member is inserted into the opening.

  It is also preferable that the conductive member according to the present invention is made of the same material as the ring electrode. Even when moisture such as blood reaches the connection portion between the ring electrode and the conductive member, it does not function as a battery, and thus the occurrence of a 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 moisture such as blood into the cylinder can be suppressed.

  The electrode catheter manufacturing method of the present invention includes a step A for preparing a cylindrical body having an opening on a side surface, a step B for connecting the conductive member and the conductive wire, the conductive wire is disposed in the cylindrical body, Step C is arranged in the opening, Step D is in which the ring electrode is arranged outside the opening, and Step E is in which the ring electrode is caulked and at least a part of the opening is closed by the conductive member. The electrode catheter manufacturing method 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. Further, since the opening is closed by the conductive member, even if a gap is generated between the ring electrode and the cylinder, moisture such as blood flows into the cylinder and contacts the connecting portion of the conductive wire and the conductive member. Can be suppressed.

  In step E of the electrode catheter manufacturing method of the present invention, it is also preferable that the conductive member be plastically deformed. Thereby, when the ring electrode is caulked, the conductive member easily closes the opening.

  In Step C of the electrode catheter manufacturing method 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 caulked, the conductive member can be prevented from being stored 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 welding, adhesion | attachment, and welding is unnecessary for the connection of a ring electrode and an electrically-conductive member. Even if there is a gap between the ring electrode and the cylinder, the opening is closed by the conductive member, so that water such as blood flows into the cylinder and prevents contact between the conductor and the conductive member. it can.
Further, the electrode catheter manufacturing method 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. . Further, since the opening is closed by the conductive member, even if a gap is generated between the ring electrode and the cylinder, moisture such as blood flows into the cylinder and contacts the connecting portion of the conductive wire and the conductive member. Can be suppressed.

FIG. 1 is a cross-sectional view (partial side view) along the axial direction of an electrode catheter according to an embodiment of the present invention. FIG. 2A is a front view of a cylinder according to the embodiment of the present invention, and FIG. 2B is a cross-sectional view along the axial direction of the cylinder according to the embodiment of the present invention. FIGS. 3A and 3B are cross-sectional views (partial side views) along the axial direction of the electrode catheter according to the embodiment of the present 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 cross-sectional view (partial 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 (partial 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 (partial side view) along the axial direction of the electrode catheter according to the embodiment of the present invention.

  Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments as a matter of course, and appropriate modifications are made within a range that can meet the purpose described above and below. In addition, it is of course possible to carry out them, all of which 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 description and another drawing shall be referred. In addition, the dimensions of the various members in the drawings are given priority to contribute to the understanding of the features of the present invention, and may be different from the actual dimensions.

  In the present invention, the axial direction refers to the long axis direction of the cylinder unless otherwise specified, the proximal side refers to the direction of the operator's hand side in the axial direction, and the distal side refers to the proximal side Point in the opposite direction. In addition, the radial direction refers to the radial direction of the cylindrical body, the inner side in the radial direction refers to the direction toward the axial center of the cylindrical body, and the outer direction refers to the radial direction of the cylindrical body.

1. Electrode Catheter FIG. 1 is a cross-sectional view (partial 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 an opening 25 formed on the side surface, the ring electrode 30 that covers the opening 25 of the cylindrical body 20 from the outside, and the ring electrode 30. The conductive member 40 that closes at least a part of the conductive member 40, and the conductive wire 50 that is connected to the conductive member 40 and is disposed in the cylindrical body 20. The electrode catheter 10 of the present invention can be easily manufactured because the ring electrode 30 and the conductor 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 there is a gap between the ring electrode 30 and the cylinder 20, the opening 25 is closed by the conductive member 40, so that moisture such as blood flows into the cylinder 20, and the lead wire 50 and the conductive member 40. It can suppress contacting the connecting part.

  The electrode catheter 10 is used for arrhythmia diagnosis and treatment. 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, the body tissue can be cauterized (ablated).

  The cylinder 20 is a portion that is inserted into the patient's body from the distal side. The cylindrical body 20 is a cylindrical body having a lumen, and has both a flexibility that bends along the shape in the body cavity and a rigidity that reliably reaches the body tissue to be treated in a well-balanced manner. desirable. The cylinder 20 may have, for example, a single cylinder structure or a multiple cylinder structure formed from a plurality of concentric cylinders having different diameters.

  The cylinder 20 can be a cylinder formed of polyurethane resin, olefin resin, fluororesin, polyamide resin, polyimide resin or the like. The cylindrical body 20 is a cylindrical body formed of a laminated body of synthetic resins having different rigidity, or a reinforcing layer of a coil or a braid formed by using a resin layer and a metal and / or resin strand. May be.

  The cylindrical body 20 has an opening 25 formed on the side surface. For the formation of the opening 25, methods such as puncture with a needle, cauterization with a laser, and opening with a punch can be used. When the opening 25 is formed by cauterization with a laser, if a rod-shaped body made of, for example, a synthetic resin is inserted into the cylinder 20, it is possible to prevent an unintended opening from being formed in the cylinder 20.

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

  It is also preferable that the opening area of the opening 25 decreases toward the axis 21 of the cylinder 20 (that is, the inner side of the cylinder 20). When the ring electrode 30 of the opening 25 is caulked, it can be suppressed that the conductive member 40 falls into the cylindrical body 20 and the opening 25 is not blocked.

  FIG. 2A is a front view of the cylindrical body 20 according to the embodiment of the present invention, and FIG. 2B is a sectional view along the axial direction of the cylindrical body 20 according to the embodiment of the present invention. . 2A and 2B show an example in which the shape of the opening 25 when the cylinder 20 is viewed from the front is formed in a circular shape. When the opening 25 is circular as shown in FIG. 2B, it is also preferable that the inner diameter D of the opening 25 decreases toward the axis 21 of the cylindrical body 20. When the ring electrode 30 of the opening 25 is caulked, it can be suppressed that the conductive member 40 falls into the cylindrical body 20 and the opening 25 is not blocked.

  When the opening area of the opening 25 is large, a large conductive member 40 and a wide ring electrode 30 that covers the opening 25 are required to close the opening 25. In this case, since the conductive member 40 is large, handling at the time of manufacture becomes easy, but the number of ring electrodes 30 that can be arranged 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 arranged on the cylindrical body 20 can be increased. However, since the conductive member 40 becomes small, handling during manufacturing may be difficult. There is.

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

  Further, from the result of the test described later in “Example”, when the circular opening 25 is provided in the cylinder 20 and the spherical conductive member 40 is used, the diameter and the conductivity of the opening 25 of the cylinder 20 are determined. It is preferable to make the diameter of the member 40 substantially 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 patient's thigh, a vein or artery under the clavicle. For this reason, the lower limit of the outer diameter of the cylindrical body 20 is preferably 0.5 mm, more preferably 0.8 mm, and even more preferably 1.0 mm. Moreover, it is preferable that it is 3.0 mm, for example, the upper limit of the outer diameter of the cylinder 20 is more preferable, it is 2.7 mm, and it is further more preferable that it is 2.4 mm.

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

  The ring electrode 30 serves as a probe during 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 conduction with a conducting wire 50 disposed in the cylinder 20. For this reason, the number of ring electrodes 30 depends on the number of conducting wires 50 arranged in the cylinder 20 and the outer diameter of the conducting wires 50. When the electrode catheter 10 has a plurality of ring electrodes 30, the number of the conductive wires 50 connected to one ring electrode 30 may be one in order to measure the potential of each ring electrode 30 individually. preferable.

  The ring electrode 30 only needs to have conductivity, and can be composed of a metal or a mixture containing a resin and a metal. Among these, it is preferable to use a conductive resin, platinum, a platinum iridium alloy, stainless steel, or tungsten as the material of the ring electrode 30, but when using a conductive resin, in order to make it visible under X-ray fluoroscopy, It is preferable to mix a contrast agent 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 outer diameter. It is preferably smaller than the inner diameter of the vein or artery.

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

  The conductive member 40 is connected to the ring electrode 30 and closes 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. For example, the conductive member 40 and the ring electrode 30 are connected by caulking the ring electrode 30. . That is, in the present invention, the arrangement of the ring electrode 30 on the outside of the cylindrical body 20 and the connection between the conductive member 40 and the ring electrode 30 can be combined.

  That the conductive member 40 closes at least a part of the opening 25 means that the ring electrode 30 is disposed on the outside of the cylinder 20 by a caulking method or the like and at least one in the thickness direction in the opening 25 of the cylinder 20. It means that the part is blocked. In the electrode catheter 10 of the present invention, since at least a part of the opening 25 is blocked by the conductive member 40, even if a gap is generated between the ring electrode 30 and the cylinder 20, moisture such as blood is contained in the cylinder 20. Can be prevented from flowing in and coming into contact with the connecting portion between the conductive wire 50 and the conductive member 40.

  FIG. 3A is a cross-sectional view (partial side view) along the axial direction of the electrode catheter 10 in a state where a part of the opening 25 is closed by the conductive member 40. After the ring electrode 30 is arranged outside the cylinder 20 by caulking or the like, the radial height of the conductive member 40 is larger than the thickness of the cylinder 20 in the opening 25 as shown in FIG. May be small. Since the conductive member 40 is not disposed in the lumen of the cylindrical body 20, this is suitable when a large number of ring electrodes 30 are disposed (that is, the number of the conductive wires 50 increases).

  On the other hand, FIG. 3B is a cross-sectional view (partial side view) along the axial direction of the electrode catheter 10 in a state where the opening 25 is closed by the conductive member 40. As shown in FIG. 3B, a part of the conductive member 40 may be accommodated in the cylindrical body 20 with the ring electrode 30 disposed outside the cylindrical body 20 by a caulking method or the like. That is, after the ring electrode 30 is disposed outside the cylinder 20 by a caulking method or the like, the radial height of the conductive member 40 may be larger than the thickness of the cylinder 20 in the opening 25. Since the contact area between the cylinder 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 the shape is suitable for closing the opening 25, and may be, for example, 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 suppress that the electrically-conductive member 40 falls in the cylinder 20, and the opening part 25 is no longer obstruct | occluded.

  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) show the case where the conductive member 40 is a sphere or an ellipsoid, respectively. In the case of a rectangular parallelepiped, the case of a cone, the case where the tip of the cone is cut out, and the case of a rectangular parallelepiped provided with a collar portion are shown.

  In order to facilitate the manufacture of the conductive member 40, the conductive member 40 may be formed in a sphere, an ellipsoid, or a rectangular parallelepiped as shown in FIGS. 4 (a) to 4 (c).

  As shown in FIG. 4D, it is also preferable that the conductive member 40 has a cone-shaped portion 41 that tapers toward the axis 21 of the cylindrical body 20. Accordingly, 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. Moreover, since the conductive member 40 having the conical portion 41 contacts and fits to the inner wall surface of the cylindrical body 20 when inserted into the opening 25, the conductive member 40 is easily pushed into the cylindrical body 20 inward.

  As shown in FIG. 4E, the conductive member 40 may have a shape in which the tip (axis 21 side) of the cone-shaped portion 41 is cut out. Since it becomes difficult to arrange the conductive member 40 in the cylindrical body 20, it is suitable for a case where a large number of ring electrodes 30 are arranged (that is, the number of the conductive wires 50 is increased).

  As shown in FIG. 4F, the conductive member 40 may have a flange 42 that is not inserted into the opening 25 on the outer side of the cylindrical body 20. Even if the ring electrode 30 is caulked, since the collar portion 42 is hooked on the cylindrical body 20, the conductive member 40 can be prevented from falling into the cylindrical body 20 and the opening 25 being not blocked.

  When the cylindrical body 20 is viewed from above, the flange portion 42 only needs to have a shape that does not pass through the opening 25 and may be formed so as to cover a part of the opening 25.

  The height of the flange portion 42, that is, the length of the flange portion 42 in the radial direction is preferably 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 step 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 be preferably composed of a metal or a mixture containing a resin and a metal. Thereby, since the conductive member 40 is plastically deformed when the ring electrode 30 and the conductive member 40 are connected by caulking or the like, the conductive member 40 easily closes the opening 25 of the cylindrical body 20. This is because the conductive member 40 is plastically deformed to increase the contact area between the conductive member 40 and the ring electrode 30. Among these, it is preferable to use conductive resin, platinum, platinum iridium alloy, stainless steel, and tungsten as the material of the conductive member 40. However, in the case of using conductive resin, barium sulfate or the like is used to make it visible under X-ray fluoroscopy. It is preferable to mix a contrast agent such as bismuth oxide.

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

  Since the volume of the ring electrode 30 is larger than that of 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 becomes expensive. 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 material of the conductive member 40 and the ring electrode 30 can be appropriately selected in consideration of cost and the like. For example, if platinum that is easily plastically deformed but relatively expensive is used as the material of the conductive member 40 and stainless steel that is 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 material cost can be reduced more than 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 lead wire 50, it is preferable to use a wire that is covered with a covering material such as a covering tube, and that does not short-circuit with an adjacent member. Any material can be used for the core of the conductive wire 50 as long as it is a conductive material. For example, a copper wire, an iron wire, a stainless steel wire, a piano wire, a tungsten wire, a nickel titanium wire, or the like may be used. it can. For example, copper wire is easy to use because the material cost is low compared to other materials. In addition, the stainless steel wire is particularly preferable in that it has flexibility, can disperse stress applied when the conducting wire 50 is passed through the cylindrical body 20, and does not easily cause disconnection of the connecting portion between the conducting wire 50 and the conductive member 40. In addition, the connection portion between the conductive wire 50 and the conductive member 40 is covered with a resin or the like in order to prevent oxidative deterioration when moisture contained in the atmosphere or moisture such as blood is mixed into the cylinder 20. It is preferred that Examples of the resin used for covering the connecting portion between the conductive wire 50 and the conductive member 40 include urethane resin and epoxy resin.

  For example, a welding fixing method, a soldering method, a caulking method, a brazing fixing method, or the like can be used to connect the conductive member 40 and the conductive wire 50. Among these, the welding fixing method is particularly preferable because the inner diameter of the ring electrode 30 can be secured most widely and the manufacturing is easy.

  Although it is not particularly limited to which position in the axial direction of the conductive wire 50 the conductive member 40 is connected, the conductive member 40 is preferably connected to one end of the conductive wire 50. When arrange | positioning the some conducting wire 50 in the cylinder 20, it can suppress that conducting wire 50 entangles.

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

  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 cylinder 20 and the intermediate shaft 60, For example, it can fix by pinching | interposing the proximal side of the cylinder 20 with the fixing member 60a. The proximal end of the intermediate shaft 60 is connected to a shaft 62 held by a user of the electrode catheter 10.

  As shown in FIG. 1, a distal end tip 35 that serves as a guide for the distal end of the electrode catheter 10 may be provided at the distal end of the cylindrical body 20. One end of a pull wire 61 is connected to the distal 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, it is possible to control the degree of bending on the distal side of the cylindrical body 20 by operating the handle 63 at hand. If the tip tip 35 is made of a conductive material and the tip tip 35 is also connected to the lead wire 50 (not shown), the tip tip 35 can function as an electrode in the same manner as the ring electrode 30. Therefore, similarly to the conductive wire 50 connected to the conductive member 40, the other end of the conductive wire 50 connected to the distal tip 35 passes through the intermediate shaft 60 and the shaft 62 and is connected to the power supply device of the electrode catheter 10 and the like. For this purpose.

2. Method for Producing Electrode Catheter The method for producing 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 sectional views 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 for manufacturing the electrode catheter 10 of the present invention, the step A for preparing the cylindrical body 20 having the opening 25 on the side surface, the step B for connecting the conductive member 40 and the conductive wire 50, and the conductive wire 50 in the cylindrical body 20 are provided. Step C for disposing the conductive member 40 in the opening 25, Step D for disposing the ring electrode 30 outside the opening 25, and caulking the ring electrode 30, so that at least one of the openings 25 is formed by the conductive member 40. Step E for closing the part. In the method for manufacturing the electrode catheter 10 according to the present invention, the ring electrode 30 and the conductor 50 can be electrically connected by caulking the ring electrode 30 and closing the opening 25 with the conductive member 40. Therefore, the electrode catheter 10 can be easily manufactured. It is to make. 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 cylinder 20, moisture such as blood flows into the cylinder 20, and the lead wire 50 and the conductive member 40. It can suppress contacting the connecting part.

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

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

  Next, the conductive member 40 and the conductive wire 50 are prepared, and the conductive member 40 and the conductive wire 50 are connected (step B). Preferably, one end of the conducting wire 50 is connected to the conductive member 40. For example, a welding fixing method, a soldering method, a caulking method, a brazing fixing method, or the like can be used to connect the conductive member 40 and the conductive wire 50. Among these, the welding fixing method is particularly preferable because the inner diameter of the ring electrode 30 can be secured most widely and the manufacturing is easy.

  As shown in FIG. 6, the conducting wire 50 is disposed in the cylindrical body 20, and the conductive member 40 is disposed in the opening 25 (step C). For example, the other end portion (the end portion not connected to the conductive member 40) of the conducting wire 50 is inserted from the opening portion 25 of the cylindrical body 20, and the other end portion of the conducting wire 50 is drawn into 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 only needs to be accommodated in the opening 25. That is, it is preferable that at least a part of the conductive member 40 is exposed outside the cylindrical body 20. This is because the conductive member 40 is deformed when the ring electrode 30 is caulked in step E to be described later, so that the opening 25 is easily closed by the conductive member 40.

  In Step C, it is also preferable that the conductive member 40 has a shape that does not pass through the opening 25. It can be suppressed that the conductive member 40 falls into the cylindrical body 20 when the ring electrode 30 is caulked and the opening 25 is not blocked.

  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 positions 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, it is preferable that the ring electrode 30 is disposed outside the opening 25 so that the opening 25 is not covered with the ring electrode 30 and is not visible.

  As shown in FIG. 8, the ring electrode 30 is caulked and at least a part of the opening 25 is closed by the conductive member 40 (step E). In the method for manufacturing the electrode catheter 10 according to the present invention, the ring electrode 30 and the conductor 50 can be electrically connected by caulking the ring electrode 30 and closing the opening 25 with the conductive member 40. Therefore, the electrode catheter 10 is easily manufactured. can do.

  In step E, the conductive member 40 is preferably plastically deformed. Thereby, when the ring electrode 30 is caulked, the conductive member 40 easily closes the opening 25.

  In order to facilitate plastic deformation of the conductive member 40, the conductive member 40 is also preferably composed of a metal or a mixture containing a resin and a metal. Thereby, since the opening part 25 can be reliably obstruct | occluded by the electrically-conductive member 40, it can suppress that water | moisture content, such as blood, flows in into the cylinder 20. FIG.

  EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention is not limited by the following examples, but may be appropriately modified within a range that can meet the purpose described above and below. Of course, it is possible to implement them, and they are all included in the technical scope of the present invention.

  Below, the test result which measured the conduction | electrical_connection state of a ring electrode and conducting wire in the case of changing the diameter of the spherical electrically-conductive member used for an electrode catheter, and the state in the cylinder after standing in water is demonstrated. First, an electrode catheter having a cylindrical body necessary for measurement, a ring electrode, a conductive member, and a conductive 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 diameter of the spherical conductive member was changed to 0.10 mm, 0.20 mm, and 0.30 mm. In this test, after the electrode catheter is manufactured, the conduction state between the ring electrode and the conducting wire is first confirmed. As a result, only the electrode catheter that was confirmed to be in a conductive state was observed in the cylinder after being left in water for a predetermined time.

  The outer diameter (mm), inner diameter (mm), and opening diameter (mm) of the cylindrical body in this test; outer diameter (mm) and inner diameter (mm) of the ring electrode; conductive wire diameter (mm); shape of the conductive member , Diameter (mm); Bending radius (mm) when left in water, Time when left underwater (min); Conducted state between conductor and electrode; Table 1 shows the state of the cylinder after standing in water.

(Comparative Example 1)
In Comparative Example 1, an electrode catheter was manufactured using a cylindrical body having a circular opening having a diameter of 0.20 mm and a spherical conductive member having a diameter of 0.10 mm. The ring electrode and the conducting wire did not conduct. This is because the diameter of the conductive member was as small as 0.10 mm with respect to the diameter of the cylindrical opening of 0.20 mm, so that the conductive member dropped into the cylindrical body and the opening was not blocked 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 having a diameter of 0.20 mm and a spherical conductive member having a diameter of 0.20 mm. The ring electrode and the conductive wire were in a conductive state. Thereafter, the electrode catheter was left in water for 30 minutes with a bending radius of 20 mm, and then the state inside the cylinder was observed. As a result, water was not 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 conductor 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 having a diameter of 0.20 mm and a spherical conductive member having a diameter of 0.30 mm. Since the ring electrode and the conducting wire were in a conductive state, it was found that the ring electrode and the conducting wire were connected via a conductive member. Thereafter, the electrode catheter was left in water with a bending radius of 20 mm for 30 minutes, and then the state inside the cylinder was observed. As a result, 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 the cylindrical opening of 0.20 mm, so that the conductive member cannot fit in the opening, and there is a gap between the cylindrical body and the conductive member in the opening. This is considered to be because the opening was not blocked by the conductive member.

(Example 2)
In Example 2, an electrode catheter was manufactured using a cylindrical body in which a tapered opening that narrows inward from the outside 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 a conductive state, it was found that the ring electrode and the conducting wire were connected via a conductive member. Thereafter, the electrode catheter was left in water for 30 minutes with a bending radius of 20 mm, and then the state inside the cylinder was observed. As a result, water was not 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 conductor were connected via the conductive member.

  From the above test results, since the electrode catheter of the present invention has at least a part of the opening portion closed by the conductive member connected to the ring electrode, the ring electrode and the conducting wire can be brought into conduction, and the electrode catheter is introduced into the cylinder. It was concluded that the mixing of moisture can be suppressed. Furthermore, when a circular opening is provided in the cylinder and a spherical conductive member is used, it has been 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: cylindrical body 21: axis 25: opening 30: ring electrode 35: tip tip 40: conductive member 50: conductive 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 a side surface;
A ring electrode that covers the opening of the cylindrical body 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 and disposed in the cylindrical body.   The electrode catheter according to claim 1, wherein the conductive member is made of a metal or a mixture containing a resin and a metal.   The electrode catheter according to claim 1 or 2, 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 an opening area of the opening portion decreases toward an axis of the cylindrical body.   The electrode catheter according to any one of claims 1 to 4, wherein the conductive member has a cone-shaped portion that tapers toward an axis of the cylindrical body.   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 for preparing a cylinder having an opening on the side surface;
Step B connecting the conductive member and the conductive wire;
Placing the conducting wire in the cylinder and placing the conductive member in the opening; and
Disposing a ring electrode outside the opening; and
And a step E of crimping the ring electrode and closing at least a part of the opening with the conductive member.   The method for manufacturing an electrode catheter according to claim 8, wherein in step E, the conductive member is plastically deformed.   The method for manufacturing an electrode catheter according to claim 8 or 9, wherein, in the step C, the conductive member has a shape that does not pass through the opening.