JP2009240540A - Electrode lead and manufacturing method of electrode lead - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an electrode lead which arrives at an appropriate position to perform heart stimulation without using a guide wire. <P>SOLUTION: The electrode lead 101 includes: a core metal 301 comprising an elastic material; a first coil conductor 302 whose one end is a distal end electrode and which is covered around the core metal 301 along the whole length; a first insulation cover 303 covered around the first coil conductor 302 except the distal end electrode part of the first coil conductor 302; and a second coil conductor 304 whose prescribed area is a proximal electrode and which is covered around the first insulation cover 303. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an electrode lead and a method for manufacturing the electrode lead, and more particularly to an electrode lead for defibrillation used by being inserted into a coronary sinus and a method for manufacturing the electrode lead.

  Conventionally, a device that performs treatment by directly or indirectly applying an electrical stimulus to an affected part such as a heart or nerve, such as a cardiac pacemaker, an implantable cardioverter defibrillator, a nerve stimulation device, a pain relief device, an epilepsy treatment device, or a muscle stimulation device. There is. These devices employ implantable electrode leads for use with living implant stimulators that have a power source and produce electrical stimulation.

  In general, an electrode lead comprises at least one electrode for applying electrical stimulation to the heart, nerves, etc. or sensing electrical excitation of the heart. The electrode lead also includes a connector for electrical connection with the above-described cardiac pacemaker, defibrillator, or the like. Between the electrode of the electrode lead and the connector, there is an electric conductor for transmitting an electric signal from a device such as a cardiac pacemaker to the electrode from the connector, and a lead body made of an insulating coating for insulating the electric conductor. Is provided.

  In general, a cardiac pacemaker or an implantable cardioverter defibrillator (ICD) has a lead implanted so as to reach the heart from a vein that does not affect the living body. As is well known, blood flow in the heart circulates from the vena cava ⇒ right atrium ⇒ right ventricle ⇒ pulmonary artery ⇒ lung ⇒ pulmonary vein ⇒ left atrium ⇒ left ventricle ⇒ aorta. Therefore, for the convenience of inserting a lead from the vena cava, a technique in which stimulation electrodes are installed in the right atrium and the right ventricle has been performed for many years.

On the other hand, in recent years, it is effective to perform left ventricular stimulation in a pacemaker, and it is inserted into a coronary sinus (CS) as an electrode lead for performing left ventricular stimulation, and stimulation is performed from the outside of the left ventricle. Things have also been proposed.
The electrode lead described in Patent Document 1 shown as a prior art document has a structure (lumen structure) having a lumen for passing a guide wire, and by inserting the electrode lead into a vein through the guide wire, The electrode is guided to an appropriate position for cardiac stimulation.

US Pat. No. 6,408,213

  However, the conventional electrode lead as shown in Patent Document 1 does not independently reach the electrode to an appropriate position in the vein, and guides the guide wire to the appropriate position through the guide wire through the guide wire. The structure was a pull-out structure. For this reason, when the guide wire passed through the electrode lead is pulled out from the blood vessel, the electrode of the electrode lead may be displaced from an appropriate position, or the blood vessel near the heart may be damaged.

  The present invention has been made in view of such points, and an electrode lead that can reach a position suitable for cardiac stimulation alone, that is, does not require a guide wire, and a method of manufacturing the electrode lead. The purpose is to provide.

  In order to solve the above-described problems, an electrode lead of the present invention includes a cored bar made of an elastic material, a multi-coil that has one end serving as a tip electrode and covers the entire length of the cored bar, the cored bar, and the first coil Except for the conductor and the tip electrode portion of the first coil conductor, a first insulating coating that covers the first coil conductor, and a second coil conductor that covers the first insulating coating with a predetermined region serving as a proximal electrode And.

  According to the above configuration, force and rotational force (torque) in various directions can be reliably transmitted to the tip portion of the electrode lead by the thin elastic wire and the two coil conductors wound around the wire. .

  According to the present invention, the electrode lead itself has a function as a guide wire, and it is possible to obtain a small-diameter electrode lead that does not require the formation of a guide wire lumen.

Hereinafter, exemplary embodiments of the present invention will be described with reference to FIGS.
FIGS. 1 and 2 are an external view and a perspective view showing the entire electrode lead 101 and an implantable defibrillator (ICD) 103 according to an embodiment of the present invention.

  The electrode lead 101 includes a distal end 102 to be inserted into a thin and bifurcated vessel such as a coronary sinus, a connector portion 104 connected to the ICD 103, and an intermediate portion 105 connecting the distal end 102 and the connector portion 104. Consists of. The electrode lead 101 is formed in a so-called taper shape that becomes thinner as it approaches the tip of the distal end 102.

  The distal end 102 is provided with two electrode portions. One is a tip electrode 106 provided at the tip of the distal end 102, and the other is a proximal electrode 107 serving as an electrode on the near side when viewed from the connector portion 104.

  In the present embodiment, the tip electrode 106 is an electrode for performing defibrillation of the heart. More specifically, when the ICD 103 detects ventricular fibrillation, a predetermined electrical signal generated from the ICD 103 is transmitted to the outer surface of the heart, and a relatively strong stimulus (electric shock) is applied to the myocardium to thereby cause the heart to ventricular fibrillation. It is an electrode for recovering from movement.

  The proximal electrode 107 is an electrode for pacing the heart. Specifically, when the ICD 103 detects an arrhythmia, a predetermined electrical signal generated from the ICD 103 is transmitted to the heart (myocardium), and a relatively weak electric shock is applied to the heart muscle to normalize the heart motion (heart rate). It is an electrode for returning to.

  The connector unit 104 is provided with two connectors. One connector is a connector pin 108 farther from the distal end 102, and the other connector is a connector ring 109 closer to the distal end 102. These connector pin 108 and connector ring 109 are mechanically and electrically detachably connected to the ICD 103 and a connector cavity 110 of a cardiac pacemaker main body (not shown).

  The connector ring 109 is electrically connected to the proximal electrode 107 via the intermediate portion 105, and the connector pin 108 is also electrically connected to the tip electrode 106 via the intermediate portion 105. In either case, a predetermined electrical signal generated from the ICD 103 is transmitted to the proximal electrode 107 or the tip electrode 106 to which each is connected.

  As described above, the intermediate portion 105 electrically connects the tip electrode 106 to the connector pin 108 and electrically connects the proximal electrode 107 to the connector ring 109. Further, during the treatment, the intermediate portion 105 transmits a force applied by a surgeon or other practitioner to the tip of the distal end 102 and moves the tip electrode 106 to a deep portion of the vascular vessel. It also has the role of The detailed internal structure of the electrode lead 101 will be described later with reference to FIGS.

FIG. 3 is a cross-sectional view showing a detailed internal structure of a distal end of an electrode lead according to an embodiment of the present invention.
FIG. 3A is a cross-sectional view showing a detailed internal structure near the tip electrode.
The tip electrode 106 is composed of a triple coil 302 that is a conductor wound around the cored bar 301.
The metal core 301 is made of a so-called superelastic alloy, which is a shape memory alloy having a transformation temperature of room temperature or lower. The total length of the core metal 301 is desirably equal to the length of the distal end of the electrode lead 101 inserted into the vein during the treatment, and is preferably about 200 to 400 mm. Moreover, the outer diameter of the cored bar 301 is about 0.1 to 1 mm. In order to make it easy to select one of a plurality of vessels extending from a vein such as a coronary sinus during the operation, a portion about 2 mm from the tip of the cored bar 301 is selected. It has a bend that is bent at ˜60 °, preferably about 45 °.
In the following description, a direction where the core metal 301 is bent at about 45 ° is defined as the tip of the core metal 301, and a direction where the core metal 301 is not bent is defined as the base of the core metal 301.

  The entire outer surface of the cored bar 301 is covered with a triple coil 302 as a first coil conductor serving as an electrical conductor. The triple coil 302 is a platinum iridium alloy, and the triple coil 302 has an outer diameter of 0.6 mm. Note that the material of the triple coil 302 need not be made of platinum iridium alloy as long as it is an electrical conductor that does not corrode or electrolyze in the body.

  The triple coil 302 is formed by winding a conductor wire having a single wire diameter of 0.05 mm in three layers without a gap. The conductor wire of the layer closest to the cored bar 301 is spirally wound counterclockwise, the conductor wire of the layer closest to the cored bar 301 is spirally wound clockwise, and the conductor wire farthest from the cored bar 301 is spirally wound counterclockwise. Thus, the multiple coils are alternately wound in different directions. The reason why the triple coil 302 has such a structure is that torque and force applied to the intermediate portion 105 of the electrode lead 101 during the treatment are more efficiently transmitted to the tip of the distal end 102. Note that the conductor wire of each layer of the triple coil 302 may be wound in a manner opposite to the winding method described above.

  Further, a caulking pipe, which will be described later with reference to FIG. The caulking pipe is a caulking for crimping so that the triple coil 302 placed on the core 301 is not detached, and stainless steel is preferable as an example.

FIG. 3B is a cross-sectional view showing a detailed internal structure in the vicinity of the proximal electrode.
The outside of the triple coil 302 is covered with a first insulating coating 303. The first insulating coating 303 is formed from a position 5 mm from the tip of the cored bar 301 to the base of the cored bar 301. The outer diameter of the first insulating coating 303 is 0.7 mm. The first insulating coating 303 is particularly preferably an ethylene-tetrafluoroethylene copolymer (ETFE). This is because it has excellent chemical stability with respect to long-term in vivo implantation and has a very low coefficient of friction. The bare triple coil 302 and the cored bar 301 that are between the tip of the cored bar 301 and 5 mm from the leading end serve as the tip electrode 106.

  Further, the surface of the first insulating coating 303 is covered with a parallel two-winding coil 304 serving as a second coil conductor. The parallel two-winding coil 304 is composed of two conductor wires, and each conductor wire is spirally wound on the first insulating coating 303 in a parallel two-winding manner. The single wire diameter of each conductor wire is 0.05 mm.

  Such a parallel double winding coil 304 is covered on the surface of the first insulating coating 303 from a position 7 mm from the tip of the core metal 301 to the base of the core metal 301. However, each of the conductor wires of the parallel double-wound coil 304 from 38 mm from the tip of the core metal 301 to the base of the core metal 301 is covered with an ETFE coating 310 for insulation. Note that the distal end portion of the parallel double-wound coil 304 without the ETFE coating 310 (removed) serves as the proximal electrode 107.

  The parallel double winding coil 304 is a platinum iridium alloy, and the parallel double winding coil 304 has an outer diameter of 0.9 mm. Moreover, the outer diameter of the part covered with ETFE of the parallel double winding coil 304 is 1.0 mm. In addition, the material of the parallel double winding coil 304 may not be a platinum iridium alloy as long as it is an electrical conductor that does not corrode or electrolyze in the body.

  A first insulating coating tapered portion 305 is provided at the boundary between the first insulating coating 303 that is not covered with anything and the parallel double-wound coil 304 that is covered on the surface of the first insulating coating 303. The first insulating coating taper portion 305 is formed in a taper shape so as to reduce a step generated at the boundary between the first insulating coating 303 and the parallel double winding coil 304, and becomes thinner toward the tip end of the cored bar 301. It has a shape. As the first insulating coating tapered portion 305, polytetrafluoroethylene (Poly Tetra Fluoro Ethylene: PTFE) is particularly preferable. This is because it has excellent chemical stability with respect to long-term in vivo implantation and has a very low coefficient of friction.

FIG.3 (c) is sectional drawing which shows the detailed internal structure of the AA arrow part of a distal end.
A joint tube 306 is provided on the surface of the parallel two-winding coil 304 that is 58 mm from the tip of the cored bar 301 and 62 mm from the tip to eliminate a step generated between the conductor wires of the parallel two-winding coil 304. ing. The joint tube 306 is made of polyimide and has an outer diameter of 1.4 mm.

  A second insulating coating taper portion 307 is provided on the surface of the joint tube 306 that is 58 mm from the tip of the cored bar 301 and 60 mm from the tip. The second insulating coating tapered portion 307 is preferably a polyurethane coating. The second insulating coating taper portion 307 has a truncated cone shape and is a cavity having the same size as the outer diameter of the joint tube 306 from the center of the upper base portion to the center of the lower base portion. The outer diameter of the upper bottom portion of the second insulating coating tapered portion 307 is 1.2 mm, and the outer diameter of the lower bottom portion of the second insulating coating tapered portion 307 is 2.0 mm.

  The surface of the joint tube 306 that is 60 mm from the tip of the core metal 301 to 62 mm from the tip is covered with a second insulating coating 308, and a lead body 309 is formed. The second insulating coating 308 is preferably a polyurethane coating.

  The outer diameter of the second insulating coating 308 (the outer diameter of the lead body 309) is equal to the outer diameter of the lower bottom portion of the second insulating coating tapered portion 307, and is 2.0 mm. Note that the surface of each polyurethane coating of the second insulating coating tapered portion 307 and the second insulating coating 308 has a hydrophilic lubricating coating (hydrophilic coating) for improving slippage when the electrode lead 101 is inserted into the blood vessel. Coating).

  The polyurethane coating is preferable as the second insulating coating tapered portion 307 and the second insulating coating 308 because it is excellent in chemical stability against long-term in vivo implantation, and is provided with a hydrophilic / lubricating coat on the surface. Because it is suitable.

FIG. 4 is a cross-sectional view showing a detailed internal structure of the connector portion 104 at the proximal end of the electrode lead 101 according to an embodiment of the present invention. Note that description of portions not directly related to the present invention is omitted.
As shown in FIG. 4, the connector section 104 shown in FIG. 1 includes a connector ring 109, a connector pin 108, a connector ring coil conductor 402, and a connector pin coil conductor 403. The connector portion 104 has a lumen structure, that is, a cylindrical shape, and a gap 405 passes through the center thereof.

  An insulating member 404A is provided between the connector ring 109 and the connector pin 108, and the connector ring 109 and the connector pin 108 are electrically insulated from each other. A connector ring coil conductor 402 is connected to the connector ring 109, and a connector pin coil conductor 403 is connected to the connector pin 108. Similarly, the connector ring coil conductor 402 and the connector pin coil conductor 403 are insulated by an insulating member 404A. Further, an insulating member 404 </ b> B is covered on the surface of the connector ring coil conductor 402.

FIG. 5 is a cross-sectional view showing a detailed internal structure of an intermediate portion of an electrode lead according to an embodiment of the present invention.
FIG. 5A is a cross-sectional view of the intermediate portion 105 shown in FIG.
The intermediate portion 105 electrically connects the triple coil 302 and the parallel double winding coil 304 extending from the distal end 102 to the connector pin coil conductor 403 and the connector ring coil conductor 402 extending from the connector portion 104. The proximal end side insulating members 404A and 404B and the gap 405 are the same as those in FIG.

FIG. 5B is a perspective view showing the triple coil 302, the caulking pipe 503, and the cored bar 301 in the vicinity of the connection portion.
In the vicinity of the connecting portion, the first caulking pipe 503A completely fixes the triple coil 302 on the surface of the cored bar. The first caulking pipe 503A can also be said to be a fixed portion. The first caulking pipe 503 </ b> A is fixed at a position slightly closer to the tip than the base end of the triple coil 302. This is to leave a margin for electrically connecting the triple coil 302 to the connector pin coil conductor 402 at the base end portion.

The triple coil 302 and the connector pin coil conductor 402 are electrically connected by covering the outer surface of the base end of the triple coil 302 with the connector pin coil conductor 402 and caulking with the second caulking pipe 503B. The outer surfaces of the first caulking pipe 503A and the second caulking pipe 503B are covered with an insulating member 404C for insulation. The insulating member 404C overlaps the first insulating coating 303 and the insulating member 404A and forms a continuous insulating coating.
The electrical connection between the parallel double winding coil 304 and the connector ring coil conductor 403 is performed by caulking the base end portion of the parallel double winding coil 304 and the distal end portion of the connector ring coil conductor 403 with a third caulking pipe 503C. .
A reinforcing member 502 for reinforcing and insulating the connecting portion is put on the surface of the connecting portion, that is, the surface of the lead body 309 (see FIG. 3C) and the insulating member 404B. As the reinforcing member 502, silicon is particularly preferable. This is because, as described above, the practitioner applies the force to the intermediate portion to perform the treatment.

Next, the operation of the electrode lead 101 of the present invention will be described with reference to FIG. As details of the operation, an example in which pacing of the left atrium and defibrillation of the left ventricle are performed is shown.
FIG. 6 is a schematic view of the human body as viewed from the front side.
A heart 611 shown in FIG. 6 is a human body viewed from the front side. Therefore, the entire appearance of the distal end 102 of the electrode lead 101 cannot be shown only by FIG. Therefore, the back side of the heart 611 is shown in FIG.

  When the electrode lead is used, an insertion opening in which the tip portion (tip electrode 106, proximal electrode 107 and lead body 309) is artificially opened in the subclavian vein 609 rather than the intermediate portion 105 of the electrode lead 101. 610 is placed in the vessel. For example, when stimulating the left atrium 603 and the left ventricle 604, the vessel in which the electrode lead is disposed branches from the subclavian vein 609, the superior vena cava 609, the right atrium 607, the coronary sinus 605, and the coronary sinus 605. It is a vascular vessel (left ventricular vein described later in FIG. 7). Note that the vascular branching from the coronary vein 605 and the coronary artery 605 on the back side of the heart will be described later with reference to FIG.

  The intermediate part 105, the connector part 104, and the ICD 103 are fixed to a living body tissue in the vicinity of the insertion port 610. Specifically, it is implanted directly under the skin of the heart 611.

FIG. 7 is an enlarged view of the human body 611 and the heart 602.
FIG. 7A is a diagram showing the right shoulder vessel in a state where the human body 611 is viewed from the front.
FIG. 7B is a diagram showing the heart 602 viewed from the back side of the human body 611.
Since the distal electrode 106 of the electrode lead 101 is an electrode for defibrillation, it is arranged so as to be aligned with the left ventricle 604 of the heart 602. That is, the tip electrode 106 is disposed in the left ventricular vein 702 on the surface of the left ventricle 604. Further, since the proximal electrode 107 of the electrode lead 101 is an electrode for pacing, it is disposed near the left atrium 603 of the heart 602. That is, the proximal electrode 107 is placed in the coronary sinus 605 on the surface of the left atrium 603.

  In order to place the tip electrode 106 in the left retroventricular vein 702 and the proximal electrode 107 in the coronary sinus 605, the practitioner places the electrode lead 101 into the insertion port 610 based on the structure of the vascular structure of the human body. I have to insert it. That is, the electrode lead 101 is moved so that the distal electrode 106 of the electrode lead 101 passes through each vessel in the order of the subclavian vein 609, the superior vena cava 608, the right atrium 607, the coronary sinus 605, and the left retroventricular vein 702. It is necessary to operate.

Next, an operation method of the electrode lead 101 when placing the electrode lead 101 in the target vessel will be described.
8 and 9 are diagrams showing a method for operating an electrode lead according to an embodiment of the present invention.
First, the practitioner cuts a predetermined position of the subclavian vein 609 with a scalpel to create an insertion opening for the electrode lead 101 (see FIG. 8A). Then, the practitioner inserts the tip electrode 106 of the electrode lead 101 into the insertion port 610 (see FIG. 8B). Then, the practitioner applies a force in a direction parallel to the cored bar 301 (the direction in which the distal end 102 is present) to the intermediate portion 105 of the electrode lead 101, and the tip electrode 106 is brought deep into the subclavian vein 609. Push in. This is because the force applied to the intermediate portion 105 in the direction parallel to the core metal 301 (in the direction of the distal end 102) is reliably transferred to the tip electrode 106 by the structure including the core metal 301, the triple coil 302, and the double winding coil 304. This is because it is transmitted.

  Here, when the practitioner turns the intermediate portion 105 in the direction of the arrow, the torque is transmitted to the distal end 102, and the entire distal end 102 turns in the direction of the arrow (see FIG. 8C). This is because the torque applied to the intermediate portion 105 is reliably transmitted to the distal end 102 by the structure composed of the cored bar 301, the triple coil 302, the double winding coil 304, and the like.

  At this time, the practitioner turns the intermediate portion 105 to point the distal electrode 106 in the direction of the superior vena cava 608 branched from the subclavian vein 609.

  Then, the tip electrode 106 is made to reach the superior vena cava 608 by applying a force in a direction parallel to the cored bar 301 (in the direction of the distal end 102) to the intermediate part 105. Further, a force parallel to the cored bar 301 is applied, and the tip electrode 106 is placed in the right ventricle 607.

  Here, the practitioner turns the intermediate portion 105 to point the tip electrode 106 in the direction of the coronary sinus 605 opening the tip electrode into the right ventricle 607. Then, a force in a direction parallel to the cored bar 301 is applied to the intermediate portion 105 to push the tip electrode 106 into the coronary sinus 605.

  The practitioner turns the intermediate portion 105 and directs the distal electrode toward the left retroventricular vein 702 branched from the coronary sinus 602 (see FIG. 9A). Then, a force in a direction parallel to the cored bar 301 is applied to the intermediate portion 105, and the distal electrode 106 is inserted into a deep portion of the left ventricular vein 702 (see FIG. 9B). Then, when the distal electrode 106 and the proximal electrode 107 are disposed at the target positions, the practitioner sutures the intermediate portion 105 and the connector portion 104 to the living tissue, and fixes the electrode lead 101.

  As described above, since the tip electrode 103 of the electrode lead 101 has a curved portion, the practitioner selects a target vessel from a plurality of vessels branching from a predetermined vessel, The electrode lead 101 can be placed in the intended vessel. In FIG. 6, only one lead is shown for explanation, but another lead placed in the right atrium or right ventricle may be additionally connected to the ICD 103.

Next, a method for manufacturing the electrode lead 101 will be described.
10, FIG. 11 and FIG. 12 are a flowchart showing a manufacturing method of an electrode lead and a diagram showing each manufacturing process in one embodiment of the present invention.
First, a superelastic alloy cored bar 301 having a straight shape is prepared (step S1001). Then, the core metal 301 is bent by a predetermined heat treatment so that a portion of 0.6 mm from the tip of the core metal 301 is 45 ° (step S1002). A triple coil 302 is placed on the surface of the bent cored bar 301 (see step S1003, FIG. 111 (a)). Then, in order to fix the triple coil 302 to the cored bar 301, the caulking pipe 503 is put on the base of the cored bar 301 and crimped (see step S1004, FIG. 11B).

  After covering from 5 mm from the tip of the cored bar 301 to the base of the cored bar 301 with ETFE, the ETFE coating is shrunk by a predetermined heat treatment until there is no gap between the ETFE coated and the triple coil 302 (step S1005). FIG. 11 (c)). In the procedure of step S1005, ETFE contracted by heat treatment is the first insulating coating 303.

  Then, the parallel double-wound coil 304 is placed on the surface of the ETFE coating from 7 mm from the tip of the cored bar 301 to the base of the cored bar 301 (see step S1006, FIG. 11 (d)). However, when the parallel two-wound coil 304 is covered on the surface of the first insulating coating 303, which is an ETFE coating, in the procedure of step S1006, the parallel two-strands are so insulated that the parts other than the proximal electrode 107 of the parallel two-wound coil 304 are insulated. Each conductor wire of the winding coil 304 is covered with an ETFE coating 310 in advance except for the tip.

  After covering the surface of the first insulating coating 303 and the surface of the tip of the parallel double winding coil 304 with PTFE, the PTFE coating is shrunk by a predetermined heat treatment (see step S1007, FIG. 12A). In the procedure of step S1007, the PTFE coating contracted by the heat treatment is the first insulating coating tapered portion 305.

  Next, the surface of the base end side of the parallel double winding coil 304 is covered with polyimide, that is, the joint tube 306 is covered (see step S1008, FIG. 12B). Then, the surface of the joint tube 306 is covered with a polyurethane coating formed in a tapered shape (step S1009). The polyurethane coating formed in this taper shape is the second insulating coating taper portion 307.

  Then, the surface of the joint tube 306 and the parallel two-winding coil 304 is covered with a polyurethane coating (see step S1010, FIG. 12C), and a second insulating coating 308 is formed. This polyurethane coating is then coated with a hydrophilic and lubricating coating.

  Further, at the base of the cored bar 301, the parallel two-winding coil 304 and the connector ring coil conductor 402 in the connector part 104 are connected to the triple coil 302 and the connector pin coil conductor 403 to form a connection part. (Step S1011). Then, the reinforcing member 502 is placed on the connection portion between the connector portion 104 and the distal end 102, that is, the surfaces of the lead body 309 and the connector ring coil conductor 402 to form the intermediate portion 105 (step S1012), and the process ends (step S1013). ).

  As described above, in the electrode lead of the present embodiment, the triple coil is completely fixed to the core metal by crimping the crimp coil on the surface of the triple coil applied to the core metal. In addition to this, the electrode wire of each layer of the triple coil having a three-layer structure was spirally wound, and the electrode wire of the adjacent layer was wound reversely. As a result, the electrode wires of the triple coil are not loosened regardless of the direction of force and torque applied to the intermediate portion.

  In the above embodiment, the angle of the curved portion of the tip electrode 106 is 45 °. However, the angle may be any number as long as the vessel can be selected. Furthermore, it goes without saying that the tip electrode 106 need not be provided with a curved portion.

  In the above embodiment, since the triple coil 302 is passed through the surface of the cored bar 301, the first caulking pipe 503 </ b> A is used to fix the triple coil 302 to the cored bar 301. However, it is also possible to fix the triple coil 302 to the metal core 301 by forming the triple coil 302 by winding the electrode wire tightly on the surface of the metal core 301 and utilizing the elastic force of the triple coil 302 itself. Good.

  In the above embodiment, the tip electrode 106 is a defibrillation electrode, and the proximal electrode 107 is a pacing electrode. However, the tip electrode 106 may be a pacing electrode, the proximal electrode 107 may be a defibrillation electrode, and both electrodes may be pacing electrodes.

  In the above embodiment, the number of electrodes provided on the distal end 102 is two. However, the number of electrodes provided on the distal end 102 may be increased as long as the outer diameter of the thickest portion of the distal end 102 does not exceed the vessel to be inserted.

  As described above, the present invention covers the triple coil on the metal core, and uses the triple coil as the tip electrode, thereby transmitting the force applied to the intermediate portion to the entire distal end without using a guide wire. be able to. This eliminates the need to form a guide wire lumen in the electrode lead. Therefore, it is possible to obtain an electrode lead in which the outer diameter of the lead body, which is the thickest part of the distal end inserted into the vessel during the treatment, is sufficiently narrower than the outer diameter of the vessel. Since it is no longer necessary to remove the guide wire from the vein, safety can be improved.

  As mentioned above, although the example of embodiment of this invention was demonstrated, this invention is not limited to the said embodiment example, Unless it deviates from the summary of this invention described in the claim, other modifications Needless to say, application examples are included.

It is an external view which shows the electrode lead which concerns on one Embodiment of this invention. It is a perspective view which shows the electrode lead which concerns on one Embodiment of this invention. It is sectional drawing which shows the distal end of the electrode lead which concerns on one Embodiment of this invention. It is sectional drawing which shows the connector part of the electrode lead which concerns on one Embodiment of this invention. It is sectional drawing which shows the intermediate part of the electrode lead which concerns on one Embodiment of this invention. FIG. 6 is a schematic view of the human body as viewed from the front side. FIG. 7 is an enlarged view of the human body and the heart near the insertion opening of the electrode lead. It is a figure which shows the operating method of the electrode lead which concerns on one Embodiment of this invention. It is a figure which shows the operating method of the electrode lead which concerns on one Embodiment of this invention. It is a flowchart which shows the manufacturing method of the electrode lead which concerns on one Embodiment of this invention. It is a figure which shows each process of the manufacturing method of the electrode lead which concerns on one Embodiment of this invention. It is a figure which shows each process of the manufacturing method of the electrode lead which concerns on one Embodiment of this invention.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 101 ... Electrode lead, 102 ... Distal end, 103 ... Cardiac pacemaker, 104 ... Connector part, 105 ... Middle part, 106 ... Tip electrode, 107 ... Proximal electrode, 108 ... Connector pin, 109 ... Connector ring, 110 ... Connector cavity, 301 ... core metal, 302 ... triple coil, 303 ... first insulation coating, 304 ... parallel square coil, 305 ... first insulation taper part, 306 ... joint tube, 307 ... second insulation coating, 308 ... first Two insulating coating taper portions, 309 ... lead body, 310 ... ETFE coating, 402 ... coil conductor for connector ring, 403 ... coil conductor for connector pin, 404 ... insulating member, 502 ... reinforcing member, 503 ... caulking pipe, 602 ... heart, 603 ... Left atrium, 604 ... Left ventricle, 605 ... Coronary sinus, 607 ... Right atrium, 608 ... Vena cava, 609 ... subclavian vein, 610 ... insertion port, 611 ... the human body, 702 ... the left ventricle after intravenous

Claims (8)

A cored bar made of elastic material,
One end is a tip electrode, the first coil conductor covering the periphery of the entire length of the core,
Except for the tip electrode portion of the first coil conductor, a first insulating coating covering the first coil conductor, and
A predetermined region is a proximal electrode, and the second coil conductor is placed around the first insulating coating;
An electrode lead comprising: The elastic material is a superelastic alloy,
The electrode lead according to claim 1. The tip electrode has a curved portion,
The electrode lead according to claim 1. Except for the proximal electrode portion of the second coil conductor, a second insulating coating with a lubricity coat is provided over the second coil conductor.
The electrode lead according to claim 1. At least one of the tip electrode and the proximal electrode serves as an electrode for defibrillation,
The electrode lead according to claim 1. The electrode lead according to claim 1, wherein an outer diameter of the tip electrode is 0.6 mm or less.   The electrode lead according to any one of claims 1 to 6, wherein the first coil conductor is a multi-turn coil having a forward winding and a reverse winding. Covering the circumference of the first coil conductor, one end of which becomes a tip electrode, over the entire length of the core bar made of an elastic material;
Fixing the cored bar and the multiple coil at the other end opposite to the one end;
Excluding the tip electrode portion of the multiple coil, covering the periphery of the multiple coil with an insulating coating for insulation;
And a step of covering the first insulating coating with a second coil conductor in which a predetermined region serves as a proximal electrode.

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