JP2016137020A - Electrode catheter and manufacturing method of electrode catheter - Google Patents
Electrode catheter and manufacturing method of electrode catheter Download PDFInfo
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Abstract
Description
本発明は、体内臓器、主に心臓の電位測定や体内組織の焼灼に用いる電極カテーテルと、この電極カテーテルの製造方法に関するものである。 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.
電極カテーテルは、主に心臓の電位測定を行うことで不整脈を診断したり、不整脈を治療するために高周波電流を流して体内組織を焼灼する医療器具として用いられている。一般に、電極カテーテルは、内腔を有する筒体の外側に複数のリング電極が配置される。リング電極の内側に接続される導線は筒体の内腔を通って心電図計まで延びている。導線と心電図計との接続にはコネクターが用いられる。したがって、例えば、電極カテーテルを患者の心臓内に挿入してコネクターを心電図計に接続することにより、リング電極部近傍の心電図を測定して不整脈の原因となる心筋の様子を正確に把握することが可能である。 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.
電極カテーテルで正確な電位測定や焼灼を行うためには筒体の内腔への血液等の水分流入によって、心電図のベースライン電位が不安定になるドリフト現象の発生を抑制する必要がある。このため、筒体内への水分の流入を抑制するのに適したリング電極、筒体、導線の接続方法が検討されている。 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.
例えば特許文献１には、金属芯線を樹脂被覆してなるリード線（導線）とリング電極を溶接して接続する際に、被覆樹脂を剥離して露出させた金属芯線（溶接部を含む）の表面に絶縁性樹脂薄膜を形成することが記載されている。なお、特許文献１の電極カテーテルは、カテーテル（筒体）の外周面にリング状電極が接着剤を用いて固定されて、さらにカテーテルの外周面にリング状電極をかしめることにより、カテーテルとリング状電極が接続されている。 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.
また特許文献２には、電極カテーテルの電気伝導体（導線）とリング電極との導電性接続は、溶接、はんだ付けまたは他のあらゆる好適な方法によって提供されるが、中でも誘導溶接が好ましいことが記載されている。また、特許文献２の電極カテーテルは、管状部材（筒体）が、少なくとも１つのリング電極の周囲において局所的に溶融するように、誘導加熱によって管状部材を熱処理することにより、リング電極の各縁に沿ってシールを形成するように構成されている。 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.
特許文献１、２の電極カテーテルは、リング電極と導線の接続に溶接を用いているが、リング電極の幅は例えば１〜４ｍｍと狭いため、リング電極の外に溶接部がはみ出さないようにリング電極と導線を接続する技術は難易度が高く、容易に製造できるものではない。このため、リング電極と導線の接続が不十分な場合には、溶接部に血液等の水分が接触してドリフト現象が発生するおそれがある。 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.
また、特許文献１の電極カテーテルは、金属芯線とリング状電極を接続する際に、絶縁性樹脂薄膜を形成する必要があるほか、カテーテルと電極を接続する際にはかしめ以外に接着剤による固定をする必要がある。他方、特許文献２の電極カテーテルも、リング電極の各縁に沿ってシールを形成する必要がある。したがって特許文献１および２の電極カテーテルは製造に時間を要するため、生産性の低下も懸念される。 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.
そこで本発明は、リング電極と導線の導通が容易に行えるとともに、筒体内への血液等の水分の流入を抑制可能な電極カテーテルおよび電極カテーテルの製造方法を提供することを目的とする。 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.
上記目的を達成し得た本発明の電極カテーテルとは、筒体と、第１区間、第２区間、第３区間を順に有する導線と、筒体の外側に配されているリング電極と、を有し、導線の第１区間および第３区間は、筒体内に配され、導線の第２区間は、筒体の側面に露出しており、導線の第２区間の少なくとも一部は、リング電極に接続されている点に要旨を有するものである。
本発明の電極カテーテルでは、導線の第２区間が筒体の側面に露出する一方で第２区間の両側の第１区間、第３区間は筒体内に収められることから、第２区間が変位しにくくなる（ずれにくくなる）。すると、この第２区間の少なくとも一部を、例えば溶接を用いることなく、リング電極に接続することによって、このリング電極と導線とを導通することができる。すなわち、溶接等の工程数を削減させて、電極カテーテルを容易に製造できる。
その上、導線の第２区間が変位しにくい状態においてリング電極が接続されるため、確実に第２区間をリング電極で覆うこともできる。そのため、リング電極と導線の溶接部が、血液等の水分に接触することがなくなり、ドリフト現象の発生を抑制できる。
The electrode catheter of the present invention that has achieved the above object comprises a cylinder, a conducting wire having a first section, a second section, and a third section in order, and a ring electrode disposed on the outside of the cylinder. A first section and a third section of the conducting wire are arranged in the cylindrical body, a second section of the conducting wire is exposed on a side surface of the cylindrical body, and at least a part of the second section of the conducting wire is a ring electrode It has a gist in that it is connected to.
In the electrode catheter of the present invention, the second section is displaced because the second section of the conducting wire is exposed on the side surface of the cylinder while the first section and the third section on both sides of the second section are stored in the cylinder. It becomes difficult (it becomes difficult to shift). Then, by connecting at least a part of the second section to the ring electrode without using, for example, welding, the ring electrode and the conducting wire can be conducted. That is, the electrode catheter can be easily manufactured by reducing the number of processes such as welding.
In addition, since the ring electrode is connected in a state where the second section of the conducting wire is not easily displaced, the second section can be reliably covered with the ring electrode. Therefore, the welded portion between the ring electrode and the conductive wire is not in contact with moisture such as blood, and the occurrence of the drift phenomenon can be suppressed.
筒体の側面に開口部が形成されており、導線が開口部に挿通されていることも好ましい。筒体の側面に形成された開口部を用いて、導線を筒体内外に配置することができる。 It is also preferable that an opening is formed on the side surface of the cylindrical body, and the conducting wire is inserted through the opening. Using the opening formed on the side surface of the cylindrical body, the conducting wire can be arranged inside and outside the cylindrical body.
リング電極を軸方向に遠位部、中央部、近位部に三分割したときに、開口部がリング電極の中央部に覆われていることも好ましい。これにより、導線の第２区間はリング電極の少なくとも中央部、中央部に収まりきれない場合には遠位部および近位部にも覆われるため、導線の第２区間とリング電極の接続を確実にすることができる。また、リング電極の遠位部および近位部では筒体との段差が生じにくいため、血液等の水分の筒体内への混入を防ぐこともできる。 It is also preferable that the opening is covered by the center of the ring electrode when the ring electrode is divided into a distal part, a center part, and a proximal part in the axial direction. As a result, the second section of the conducting wire is covered at least at the central portion of the ring electrode and also at the distal and proximal portions if it cannot fit in the central portion, so that the connection between the second section of the conducting wire and the ring electrode is ensured. Can be. In addition, since a step difference from the cylindrical body is unlikely to occur at the distal and proximal portions of the ring electrode, it is possible to prevent moisture such as blood from being mixed into the cylindrical body.
本発明の電極カテーテルは、開口部が複数形成されていることも好ましい。導線の第１区間と第３区間をそれぞれ異なる開口部から筒体内に挿入することができる。また、複数の開口部から導線を出入りさせることで、意図せずに筒体から導線が抜けることを防止できる。 The electrode catheter of the present invention preferably has a plurality of openings. The first section and the third section of the conducting wire can be inserted into the cylinder from different openings. Moreover, it can prevent that a conducting wire pulls out from a cylinder unintentionally by making a conducting wire enter / exit from a some opening part.
一の開口部がリング電極の遠位部に覆われており、他の開口部がリング電極の近位部に覆われていることも好ましい。開口部間の距離を長くすることができるため、導線の第２区間とリング電極との接触距離および接触面積を大きくすることができる。 It is also preferred that one opening is covered by the distal part of the ring electrode and the other opening is covered by the proximal part of the ring electrode. Since the distance between the openings can be increased, the contact distance and the contact area between the second section of the conducting wire and the ring electrode can be increased.
複数の開口部が、筒体の周方向に沿って配置されていることも好ましい。容易に開口部を形成することができる。また、導線の第２区間とリング電極の接続を確実にすることができる。 It is also preferable that the plurality of openings are arranged along the circumferential direction of the cylindrical body. An opening can be easily formed. Further, the connection between the second section of the conducting wire and the ring electrode can be ensured.
複数の開口部が、筒体の軸方向に沿って配置されていることも好ましい。容易に開口部を形成することができる。また、筒体内への導線の挿入を容易にする。 It is also preferable that the plurality of openings are arranged along the axial direction of the cylindrical body. An opening can be easily formed. In addition, it facilitates the insertion of the conducting wire into the cylinder.
筒体の側面には開口部に連通するスリットが形成されており、スリットの幅は導線の外径よりも大きいことも好ましい。開口部だけでなく、スリットから導線の第１区間または第３区間を筒体内に挿入したり、導線の第２区間を筒体外に露出させることができる。 A slit communicating with the opening is formed on the side surface of the cylindrical body, and the width of the slit is preferably larger than the outer diameter of the conducting wire. Not only the opening but also the first section or the third section of the conducting wire can be inserted into the cylinder from the slit, or the second section of the conducting wire can be exposed outside the cylinder.
導線の第１区間は、開口部を通過するが、スリットを通過できない形状の係止部材を有していることも好ましい。これにより、係止部材がスリットに係止されるため、導線の第１区間が筒体外に露出するのを抑制できる。 It is also preferable that the first section of the conducting wire has a locking member having a shape that passes through the opening but cannot pass through the slit. Thereby, since a locking member is locked by a slit, it can suppress that the 1st area of conducting wire is exposed outside a cylinder.
また、本発明の電極カテーテルの製造方法とは、筒体と、第１区間、第２区間、第３区間を順に有する導線を準備するステップＡと、筒体内に導線の第１区間および第３区間を配置して、筒体の外側に導線の第２区間を配置するステップＢと、筒体の外側にリング電極を配置するステップＣと、リング電極をかしめて、導線の第２区間とリング電極を接続するステップＤと、を含む点に要旨を有するものである。本発明の電極カテーテルの製造方法では、導線の第２区間が筒体の側面に露出する一方で第２区間の両側の第１区間、第３区間は筒体内に収められることから、第２区間が変位しにくくなる（ずれにくくなる）。そこで、この第２区間の少なくとも一部を、例えば溶接を用いることなく電極をかしめることにより、リング電極に接続することによって、このリング電極と導線とを導通することができる。すなわち、溶接等の工程数を削減させて、電極カテーテルを容易に製造できる。
その上、導線の第２区間が変位しにくい状態においてリング電極が接続されるため、確実に第２区間をリング電極で覆うこともできる。そのため、リング電極と導線の溶接部が、血液等の水分に接触することがなくなり、ドリフト現象の発生を抑制できる。
The electrode catheter manufacturing method of the present invention includes a step of preparing a cylindrical body and a conducting wire having a first section, a second section, and a third section in order, a first section of the conducting wire and a third section in the tubular body. Step B for arranging the section and arranging the second section of the conductor outside the cylinder, Step C for arranging the ring electrode outside the cylinder, and caulking the ring electrode, the second section of the conductor and the ring And a step D of connecting the electrodes. In the electrode catheter manufacturing method of the present invention, since the second section of the conducting wire is exposed on the side surface of the cylindrical body, the first section and the third section on both sides of the second section are accommodated in the cylindrical body. Becomes difficult to be displaced (difficult to shift). Therefore, by connecting at least a part of the second section to the ring electrode by caulking the electrode without using, for example, welding, the ring electrode and the conducting wire can be conducted. That is, the electrode catheter can be easily manufactured by reducing the number of processes such as welding.
In addition, since the ring electrode is connected in a state where the second section of the conducting wire is not easily displaced, the second section can be reliably covered with the ring electrode. Therefore, the welded portion between the ring electrode and the conductive wire is not in contact with moisture such as blood, and the occurrence of the drift phenomenon can be suppressed.
筒体の側面に複数の開口部が形成されており、ステップＢは、導線の第１区間を一の開口部から筒体内に挿入するステップＢ１１と、導線の第３区間を他の開口部から筒体内に挿入するステップＢ１２と、を含むことも好ましい。開口部から導線を筒体内に挿入することによって、筒体の外側に導線の第２区間を配置することができる。 A plurality of openings are formed in the side surface of the cylindrical body, and step B includes step B11 for inserting the first section of the conductive wire into the cylindrical body from one opening section, and the third section of the conductive wire from the other opening section. It is also preferable to include step B12 inserted into the cylinder. By inserting the conducting wire into the cylinder from the opening, the second section of the conducting wire can be arranged outside the cylinder.
筒体の側面に、開口部と、開口部に連通して導線の外径よりも大きい幅を有するスリットとが形成されて、導線の第１区間は、開口部を通過するが、スリットを通過できない形状の係止部材を有しており、ステップＢは係止部材を開口部から筒体内に挿入するステップＢ２１と、スリットに沿って、導線を開口部から離れる方向に移動させるステップＢ２２と、導線の第３区間を開口部から筒体内に挿入するステップＢ２３と、を含むことも好ましい。係止部材がスリットに係止されるため、導線の第１区間が筒体の外側に露出するのを抑制できる。 An opening and a slit that communicates with the opening and has a width larger than the outer diameter of the conducting wire are formed on the side surface of the cylindrical body, and the first section of the conducting wire passes through the opening but passes through the slit. Step B includes a step B21 of inserting the locking member into the cylinder from the opening, and a step B22 of moving the lead wire in the direction away from the opening along the slit. It is also preferable that step B23 which inserts the 3rd area of conducting wire in a cylinder from an opening part is included. Since the locking member is locked by the slit, it is possible to suppress the first section of the conducting wire from being exposed to the outside of the cylindrical body.
本発明の電極カテーテルおよび本発明の電極カテーテルの製造方法では、導線の第２区間が筒体の側面に露出する一方で第２区間の両側の第１区間、第３区間は筒体内に収められることから、第２区間が変位しにくくなる（ずれにくくなる）。すると、この第２区間の少なくとも一部を、例えば溶接を用いることなく、リング電極に接続することによって、このリング電極と導線とを導通することができる。すなわち、溶接等の工程数を削減させて、電極カテーテルを容易に製造できる。その上、導線の第２区間が変位しにくい状態においてリング電極が接続されるため、確実に第２区間をリング電極で覆うこともできる。そのため、リング電極と導線の溶接部が、血液等の水分に接触することがなくなり、ドリフト現象の発生を抑制できる。 In the electrode catheter of the present invention and the electrode catheter manufacturing method of the present invention, the second section of the conducting wire is exposed on the side surface of the cylindrical body, while the first section and the third section on both sides of the second section are stored in the cylindrical body. For this reason, the second section is less likely to be displaced (difficult to be displaced). Then, by connecting at least a part of the second section to the ring electrode without using, for example, welding, the ring electrode and the conducting wire can be conducted. That is, the electrode catheter can be easily manufactured by reducing the number of processes such as welding. In addition, since the ring electrode is connected in a state where the second section of the conducting wire is not easily displaced, the second section can be reliably covered with the ring electrode. Therefore, the welded portion between the ring electrode and the conductive wire is not in contact with moisture such as blood, and the occurrence of the drift phenomenon can be suppressed.
以下、下記実施の形態に基づき本発明をより具体的に説明するが、本発明はもとより下記実施の形態によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、ハッチングや部材符号等を省略する場合もあるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々部材の寸法は、本発明の特徴を理解に資することを優先しているため、実際の寸法とは異なる場合がある。 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.
本発明において軸方向とは、特記されていない場合には筒体の長軸方向を指し、軸方向において近位側とは術者の手元側の方向を指し、遠位側とは近位側の反対方向を指す。また径方向とは、筒体の径方向を指し、径方向において内方とは筒体の軸心に向かう方向を指し、外方とは筒体の放射方向を指す。 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．電極カテーテル
図１は本発明の実施の形態に係る電極カテーテル１０の断面図（一部側面図）であり、図２は本発明の実施の形態に係る電極カテーテル１０の軸方向に沿った断面の拡大図（一部側面図）である。本発明の電極カテーテル１０は、筒体２０と、第１区間Ｓ１、第２区間Ｓ２、第３区間Ｓ３を順に有する導線３０と、筒体２０の外側に配されているリング電極４０と、を有し、導線３０の第１区間Ｓ１および第３区間Ｓ３は、筒体２０内に配され、導線３０の第２区間Ｓ２は、筒体２０の側面に露出しており、導線３０の第２区間Ｓ２の少なくとも一部は、リング電極４０に接続されている。本発明の電極カテーテル１０では、導線３０の第２区間Ｓ２が筒体２０の側面に露出する一方で第２区間Ｓ２の両側の第１区間Ｓ１および第３区間Ｓ３は筒体２０内に収められることから、第２区間Ｓ２が変位しにくくなる（ずれにくくなる）。すると、この第２区間Ｓ２の少なくとも一部を、例えば溶接を用いることなく、リング電極４０に接続することによって、このリング電極４０と導線３０とを導通することができる。すなわち、溶接等の工程数を削減させて、電極カテーテル１０を容易に製造できる。
その上、導線３０の第２区間Ｓ２が変位しにくい状態においてリング電極４０が接続されるため、確実に第２区間Ｓ２をリング電極４０で覆うこともできる。そのため、リング電極４０と導線３０の溶接部が、血液等の水分に接触することがなくなり、ドリフト現象の発生を抑制できる。
また、例えば、溶接によってリング電極４０に接続された導線３０を、開口部２５から筒体２０内に挿入する作業においては、意図せずに溶接部に溶接強度以上の力が掛かってリング電極４０から導線３０が外れてしまわないように注意することが求められる。さらに、リング電極４０が複数ある場合は近位側に配置されるリング電極４０から順に筒体２０の外側に配置していく必要があり、作業に制約がある。しかしながら、本発明の実施の形態に係る電極カテーテル１０は、このような制約を受けることなく、製造工程の簡略化および削減を達成しつつ、品質の安定化を図ることができる。
1. 1 is a cross-sectional view (partial side view) of an electrode catheter 10 according to an embodiment of the present invention, and FIG. 2 is a cross-sectional view along the axial direction of the electrode catheter 10 according to an embodiment of the present invention. It is an enlarged view (partial side view). The electrode catheter 10 of the present invention includes a tubular body 20, a conducting wire 30 having a first section S1, a second section S2, and a third section S3 in this order, and a ring electrode 40 disposed outside the tubular body 20. And the first section S1 and the third section S3 of the conducting wire 30 are arranged in the cylindrical body 20, and the second section S2 of the conducting wire 30 is exposed on the side surface of the cylindrical body 20, and the second section of the conducting wire 30 is provided. At least a part of the section S2 is connected to the ring electrode 40. In the electrode catheter 10 of the present invention, the second section S2 of the conducting wire 30 is exposed on the side surface of the cylindrical body 20, while the first section S1 and the third section S3 on both sides of the second section S2 are accommodated in the cylindrical body 20. For this reason, the second section S2 is less likely to be displaced (difficult to be displaced). Then, by connecting at least a part of the second section S2 to the ring electrode 40 without using, for example, welding, the ring electrode 40 and the conducting wire 30 can be electrically connected. That is, the electrode catheter 10 can be easily manufactured by reducing the number of processes such as welding.
In addition, since the ring electrode 40 is connected in a state in which the second section S2 of the conducting wire 30 is not easily displaced, the second section S2 can be reliably covered with the ring electrode 40. Therefore, the welded portion between the ring electrode 40 and the conducting wire 30 is not in contact with moisture such as blood, and the occurrence of the drift phenomenon can be suppressed.
Further, for example, in the operation of inserting the conductive wire 30 connected to the ring electrode 40 by welding into the cylindrical body 20 from the opening 25, a force higher than the welding strength is applied to the welded portion unintentionally, and the ring electrode 40 is applied. Therefore, care must be taken so that the lead wire 30 does not come off. Furthermore, when there are a plurality of ring electrodes 40, it is necessary to dispose them sequentially from the ring electrode 40 disposed on the proximal side to the outside of the cylindrical body 20, and there is a restriction in work. However, the electrode catheter 10 according to the embodiment of the present invention can stabilize the quality while achieving simplification and reduction of the manufacturing process without being subjected to such restrictions.
電極カテーテル１０は、例えば、不整脈の診断や治療に利用される。不整脈の診断では、電極カテーテル１０を患者の体内に挿入し、リング電極４０を心臓の診断対象組織近傍に配置して、当該組織の電位を測定することにより心電図を得ることができる。また、不整脈の治療では、例えば、電極カテーテル１０の電極に高周波電流を流せば、体内組織を焼灼（アブレーション）することができる。 The electrode catheter 10 is used for, for example, diagnosis and treatment of arrhythmia. 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 40 near the tissue to be diagnosed on 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).
筒体２０は遠位側から患者の体内に挿入される部分である。筒体２０は内腔を有する筒状体であり、体腔内の形状に沿って屈曲する可撓性と、処置対象となる体内組織まで確実に到達する剛性の両方をバランス良く兼ね備えていることが望ましい。筒体２０は、例えば単筒構造でもよいし、直径の異なる複数の同心円状の筒体から形成される多重筒構造であってもよい。 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.
図３（ａ）および図３（ｂ）は本発明の実施の形態に係る筒体２０の一例を示す斜視図である。図３（ａ）に示すように、筒体２０は、後述するように側面に開口部２５ａ，２５ｂが形成された単筒構造の筒体でもよい。構造が単純であるため、筒体２０を容易に製造可能である。図３（ｂ）に示すように、コイル状に形成された筒体を筒体２０として用いてもよい。筒体２０を形成する材料は、例えば、ポリウレタン樹脂、オレフィン樹脂、フッ素樹脂、ポリアミド樹脂、ポリイミド樹脂等を用いることができる。さらに強度を高める観点から、筒体２０は、剛性の異なる合成樹脂を積層した筒体や、樹脂層と金属および／または樹脂製の素線を用いて形成されたコイルや編組の補強層とからなる筒体であってもよい。 FIG. 3A and FIG. 3B are perspective views showing an example of the cylinder 20 according to the embodiment of the present invention. As shown in FIG. 3A, the cylinder 20 may be a cylinder having a single cylinder structure in which openings 25a and 25b are formed on the side surfaces as will be described later. Since the structure is simple, the cylindrical body 20 can be easily manufactured. As shown in FIG. 3B, a cylindrical body formed in a coil shape may be used as the cylindrical body 20. For example, a polyurethane resin, an olefin resin, a fluororesin, a polyamide resin, a polyimide resin, or the like can be used as a material for forming the cylindrical body 20. From the viewpoint of further increasing the strength, the cylindrical body 20 includes a cylindrical body in which synthetic resins having different rigidity are laminated, a coil formed using a resin layer and a metal and / or resin strand, and a reinforcing layer of a braid. It may be a cylindrical body.
電極カテーテル１０は、例えば、患者の大腿部の静脈または動脈、鎖骨下の静脈または動脈から心臓内に挿入される。このため、筒体２０の外径の下限は１．０ｍｍであることが好ましく、０．８ｍｍであることがより好ましく、０．５ｍｍであることがさらに好ましい。また、筒体２０の外径の上限は、例えば３．０ｍｍであることが好ましく、２．７ｍｍであることがより好ましく、２．４ｍｍであることがさらに好ましい。 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 1.0 mm, more preferably 0.8 mm, and even more preferably 0.5 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.
筒体２０内には導線３０が配される。したがって、筒体２０の可撓性および剛性と、筒体２０内における導線３０が配される空間を確保するために、筒体２０の内径の下限は、例えば０．３ｍｍであることが好ましく、０．７ｍｍであることがより好ましく、１．５ｍｍであることがさらに好ましい。また、筒体２０の内径の上限は、２．２ｍｍであることが好ましく、２．０ｍｍであることがより好ましく、１．７ｍｍであることがさらに好ましい。 A conducting wire 30 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 30 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.
導線３０は、リング電極４０と電極カテーテル１０の外部機器、例えば、心電図計とを電気的に接続するものである。図２において、導線３０は、第１区間Ｓ１、第２区間Ｓ２、第３区間Ｓ３を順に有している。 The conducting wire 30 electrically connects the ring electrode 40 and an external device of the electrode catheter 10, for example, an electrocardiograph. In FIG. 2, the conducting wire 30 has a first section S1, a second section S2, and a third section S3 in this order.
導線３０の第１区間Ｓ１および第３区間Ｓ３は筒体２０内に配されている。すなわち、筒体２０の内腔に導線３０の第１区間Ｓ１および第３区間Ｓ３が存在している。 The first section S <b> 1 and the third section S <b> 3 of the conducting wire 30 are arranged in the cylindrical body 20. That is, the first section S1 and the third section S3 of the conducting wire 30 exist in the lumen of the cylindrical body 20.
導線３０の第２区間Ｓ２は筒体２０の側面に露出している。電極カテーテル１０の製造が完了してリング電極４０によって導線３０の第２区間Ｓ２が覆われていても、筒体２０の側面よりも外方に導線３０の第２区間Ｓ２が位置している場合には、導線３０の第２区間Ｓ２は筒体２０の側面に露出しているとみなす。 The second section S2 of the conducting wire 30 is exposed on the side surface of the cylindrical body 20. Even if the manufacturing of the electrode catheter 10 is completed and the second section S2 of the conducting wire 30 is covered by the ring electrode 40, the second section S2 of the conducting wire 30 is located outward from the side surface of the cylindrical body 20. The second section S2 of the conducting wire 30 is considered to be exposed on the side surface of the cylindrical body 20.
導線３０の第２区間Ｓ２の少なくとも一部は、リング電極４０に接続されている。導線３０の第２区間Ｓ２と、リング電極４０との接続方法は特に限定されないが、リング電極４０をかしめることにより、導線３０の第２区間Ｓ２の少なくとも一部とリング電極４０は接触させることが好ましい。 At least a part of the second section S <b> 2 of the conducting wire 30 is connected to the ring electrode 40. The connection method between the second section S2 of the conducting wire 30 and the ring electrode 40 is not particularly limited, but the ring electrode 40 is brought into contact with at least a part of the second section S2 of the conducting wire 30 by caulking the ring electrode 40. Is preferred.
電極カテーテル１０を軸方向からみたときに、導線３０の第２区間Ｓ２が筒体２０の全周の１／２の区間内に存在することが好ましく、導線３０の第２区間Ｓ２が筒体２０の全周の１／４の区間内に存在することがより好ましい。これにより、導線３０の第２区間Ｓ２とリング電極４０とを確実に接続することができる。 When the electrode catheter 10 is viewed from the axial direction, it is preferable that the second section S2 of the conducting wire 30 is present in a half of the entire circumference of the cylindrical body 20, and the second section S2 of the conducting wire 30 is the cylindrical body 20. More preferably, it exists in a quarter of the entire circumference. Thereby, 2nd area S2 of the conducting wire 30 and the ring electrode 40 can be connected reliably.
導線３０の第１区間Ｓ１の第２区間Ｓ２と反対側の端部が、導線３０の第１区間Ｓ１が通る開口部２５よりも近位側に配されていることも好ましい。これにより、導線３０は開口部２５に掛止されるため、導線３０の第１区間Ｓ１の筒体２０外への露出を抑制できる。 It is also preferable that the end of the first wire S1 opposite to the second zone S2 is disposed on the proximal side of the opening 25 through which the first wire S1 passes. Thereby, since the conducting wire 30 is latched by the opening part 25, exposure to the cylinder 20 outside the 1st area S1 of the conducting wire 30 can be suppressed.
一のリング電極４０に接続される一の導線３０の第１区間Ｓ１が、一のリング電極４０よりも近位側に位置する他のリング電極４０と接続される他の導線３０の第１区間Ｓ１よりも近位側に配されていることも好ましい。一の導線３０の第１区間Ｓ１と、他の導線３０の第１区間Ｓ１が接触しにくいため、導線３０間の短絡や絡まりの発生を抑制できる。 A first section S1 of one conductor 30 connected to one ring electrode 40 is a first section of another conductor 30 connected to another ring electrode 40 located on the proximal side of the one ring electrode 40. It is also preferable that it is arranged closer to S1 than S1. Since the first section S1 of one conducting wire 30 and the first section S1 of another conducting wire 30 are difficult to contact, the occurrence of a short circuit or entanglement between the conducting wires 30 can be suppressed.
導線３０としては、両端部以外の部分が被覆チューブ等の被覆材で覆われていて、隣接する部材と短絡しないものを用いることが好ましい。導線３０のコアの材料は導電性材料であればどのようなものでも用いることができるが、例として、銅線、鉄線、ステンレス鋼線、ピアノ線、タングステン線、ニッケルチタン線等を用いることができる。例えば、銅線は材料費が他の材料と比べると安価であることから利用しやすい。また、ステンレス鋼線は柔軟性があり、導線３０を筒体２０内に通す際にかかる応力を分散でき、導線３０とリング電極４０の断線が生じにくい点で特に好ましい。 As the lead wire 30, it is preferable to use a wire that is covered with a covering material such as a covering tube at portions other than both end portions and does not short-circuit with an adjacent member. Any material can be used as the core material of the conductive wire 30 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, etc. 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 30 is passed through the cylindrical body 20, and does not easily break the conducting wire 30 and the ring electrode 40.
導線３０の両端部以外の部分が被覆チューブ等の被覆材で覆われている場合には、導線３０の第２区間Ｓ２とリング電極４０の接続前に、導線３０の第２区間Ｓ２の一部の被覆を除去しておくことが好ましい。これにより、導線３０とリング電極４０の導通を確保することができる。なお、導線３０の被覆には、例えばウレタン樹脂やエポキシ樹脂等を用いればよい。 When a portion other than both ends of the conducting wire 30 is covered with a covering material such as a covering tube, a part of the second section S2 of the conducting wire 30 is connected before the second section S2 of the conducting wire 30 and the ring electrode 40 are connected. It is preferable to remove the coating. Thereby, the conduction | electrical_connection of the conducting wire 30 and the ring electrode 40 is securable. In addition, what is necessary is just to use a urethane resin, an epoxy resin, etc. for the covering of the conducting wire 30, for example.
導線３０は、導線３０の第１区間Ｓ１および第３区間Ｓ３を筒体２０内に挿入可能な径を有していればよく、例えば０．０５ｍｍ以上、０．２ｍｍ以下にすることができる。また、後述するように筒体２０の側面に開口部２５が形成される場合には、開口部２５の最小径が導線３０の外径よりも大きいことがより好ましい。 The conducting wire 30 only needs to have a diameter that allows the first section S1 and the third section S3 of the conducting wire 30 to be inserted into the cylindrical body 20, and can be, for example, 0.05 mm or more and 0.2 mm or less. Moreover, when the opening part 25 is formed in the side surface of the cylinder 20 so that it may mention later, it is more preferable that the minimum diameter of the opening part 25 is larger than the outer diameter of the conducting wire 30.
導線３０は開口部２５への係止を容易にするために、導線３０は係止部材３１を有していてもよい。導線３０の軸方向のどの位置に係止部材３１を有しているかは特に限定されないが、導線３０の第１区間Ｓ１が係止部材３１を有していることが好ましい。 The conducting wire 30 may have a locking member 31 in order to facilitate the locking of the conducting wire 30 to the opening 25. Although it is not particularly limited at which position in the axial direction of the conducting wire 30 the locking member 31 is provided, the first section S1 of the conducting wire 30 preferably has the locking member 31.
係止部材３１は、例えば、導線３０の一方端部３０ａを結んだものでもよいし、導線３０の一方端部３０ａをかしめ法等により偏平させたものでもよいし、レーザー溶接等により導線３０の一方端部３０ａに形成される球体でもよい。あるいは、金属部材をレーザー溶接等により所望の形状に成形したものを係止部材３１として、導線３０に接続してもよい。 For example, the locking member 31 may be formed by connecting one end portion 30a of the conducting wire 30, or may be obtained by flattening the one end portion 30a of the conducting wire 30 by a caulking method or the like, or by the laser welding or the like. A sphere formed on one end 30a may be used. Alternatively, a metal member formed into a desired shape by laser welding or the like may be connected to the conductive wire 30 as the locking member 31.
係止部材３１は、導電性であっても非導電性であってもよいが、好ましくは、金属や、樹脂と金属を含む混合物から構成することができる。中でも、導電性樹脂、白金、白金イリジウム合金、ステンレス、タングステン等を用いることが好ましいが、導電性樹脂を用いる場合にはＸ線透視下で目視可能とするために硫酸バリウムや酸化ビスマス等の造影剤を混合することが好ましい。 The locking member 31 may be conductive or non-conductive, but can preferably be composed of a metal or a mixture containing a resin and a metal. Among them, it is preferable to use conductive resin, platinum, platinum iridium alloy, stainless steel, tungsten, etc., but when using conductive resin, contrast such as barium sulfate or bismuth oxide is used to make it visible under X-ray fluoroscopy. It is preferable to mix the agent.
係止部材３１と導線３０の接合を容易にするために、係止部材３１が導線３０と同じ材料から構成されていることが好ましい。また、電極カテーテル１０の製造に必要なコスト等を勘案して、係止部材３１と導線３０が異なる材料から構成されていることも好ましい。 In order to facilitate the joining of the locking member 31 and the conductive wire 30, the locking member 31 is preferably made of the same material as the conductive wire 30. It is also preferable that the locking member 31 and the conductive wire 30 are made of different materials in consideration of the cost required for manufacturing the electrode catheter 10.
導線３０と係止部材３１の接合には、例えばレーザー溶接、抵抗溶接、かしめ、接着剤による接合等を用いることができる。 For joining the conducting wire 30 and the locking member 31, for example, laser welding, resistance welding, caulking, joining with an adhesive, or the like can be used.
リング電極４０は、電位測定時にプローブの役割を果たす。リング電極４０は、筒体２０の外側に配されている。筒体２０の開口部２５の外側へのリング電極４０の配置には、かしめ法を用いることが好ましい。 The ring electrode 40 serves as a probe during potential measurement. The ring electrode 40 is disposed on the outside of the cylindrical body 20. It is preferable to use a caulking method for disposing the ring electrode 40 outside the opening 25 of the cylindrical body 20.
リング電極４０の個数は特に限定されず、単数であってもよく、複数でもよい。後述するように、リング電極４０は導線３０と接続されるが、導線３０の第１区間Ｓ１および第３区間Ｓ３は筒体２０内に配されるため、リング電極４０の個数は筒体２０内に配される導線３０の本数と、導線３０の外径に依る。電極カテーテル１０が複数のリング電極４０を有する場合には、各リング電極４０の電位を個別に測定するために、１つのリング電極４０と導通される導線３０の本数は、１本であることが好ましい。 The number of ring electrodes 40 is not particularly limited, and may be singular or plural. As will be described later, the ring electrode 40 is connected to the conducting wire 30, but the first section S <b> 1 and the third section S <b> 3 of the conducting wire 30 are arranged in the cylindrical body 20, so the number of the ring electrodes 40 is within the cylindrical body 20. Depends on the number of conducting wires 30 disposed on the outer circumference and the outer diameter of the conducting wire 30. When the electrode catheter 10 has a plurality of ring electrodes 40, the number of the conductive wires 30 that are electrically connected to one ring electrode 40 may be one in order to measure the potential of each ring electrode 40 individually. preferable.
リング電極４０は、導電性を有していればよく、好ましくは、金属や、樹脂と金属を含む混合物から構成することができる。中でも、リング電極４０の材料として導電性樹脂、白金、白金イリジウム合金、ステンレス、タングステンを用いることが好ましいが、導電性樹脂を用いる場合にはＸ線透視下で目視可能とするために硫酸バリウムや酸化ビスマス等の造影剤を混合することが好ましい。 The ring electrode 40 only needs to have conductivity, and can be preferably composed of a metal or a mixture containing a resin and a metal. Among them, it is preferable to use conductive resin, platinum, platinum iridium alloy, stainless steel, and tungsten as the material of the ring electrode 40. However, when 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.
導線の第２区間Ｓ２とリング電極４０の接触距離および接触面積を大きくするために、リング電極４０の幅は、好ましくは１ｍｍ以上、より好ましくは１．５ｍｍ以上、さらに好ましくは２．０ｍｍ以上とすることができる。また、電極カテーテル１０の可撓性を確保するために、リング電極４０の幅は好ましくは４ｍｍ以下、より好ましくは３．５ｍｍ以下、さらに好ましくは３ｍｍ以下とすることができる。 In order to increase the contact distance and the contact area between the second section S2 of the conducting wire and the ring electrode 40, the width of the ring electrode 40 is preferably 1 mm or more, more preferably 1.5 mm or more, and further preferably 2.0 mm or more. can do. Further, in order to ensure the flexibility of the electrode catheter 10, the width of the ring electrode 40 is preferably 4 mm or less, more preferably 3.5 mm or less, and even more preferably 3 mm or less.
筒体２０の側面とリング電極４０の段差を小さくして、この段差に隙間が生じるのを抑制したり、リング電極４０と導線３０の接触面積を大きくしてリング電極４０と導線３０を確実に接続するためには、リング電極４０は変形しやすいことが好ましい。したがって、リング電極４０の厚みは、好ましくは０．１ｍｍ以上、より好ましくは０．０５ｍｍ以上、さらに好ましくは０．０３ｍｍ以上とすることができる。 The step between the side surface of the cylindrical body 20 and the ring electrode 40 is reduced to prevent the gap from being generated, or the contact area between the ring electrode 40 and the conducting wire 30 is increased so that the ring electrode 40 and the conducting wire 30 are securely connected. In order to connect, it is preferable that the ring electrode 40 is easily deformed. Therefore, the thickness of the ring electrode 40 can be preferably 0.1 mm or more, more preferably 0.05 mm or more, and still more preferably 0.03 mm or more.
リング電極４０の剛性が高すぎると、かしめ法等によるリング電極４０の筒体２０への配置が困難になるおそれがある。したがって、リング電極４０の厚みは、好ましくは０．７ｍｍ以下、より好ましくは０．６ｍｍ以下、さらに好ましくは０．５ｍｍ以下とすることができる。 If the rigidity of the ring electrode 40 is too high, it may be difficult to arrange the ring electrode 40 on the cylindrical body 20 by a caulking method or the like. Therefore, the thickness of the ring electrode 40 is preferably 0.7 mm or less, more preferably 0.6 mm or less, and even more preferably 0.5 mm or less.
導線３０とリング電極４０の接続は、例えば、かしめ法、溶接固定法、半田法、ろう固定法等を用いることができるが、中でもかしめ法は製造が容易であることから特に好ましい。 For example, a caulking method, a welding fixing method, a soldering method, a brazing fixing method, or the like can be used for the connection between the conducting wire 30 and the ring electrode 40. Among these, the caulking method is particularly preferable because it is easy to manufacture.
筒体２０の外側にリング電極４０が配置されるため、かしめ前のリング電極４０の内径は、筒体２０の外径よりも大きいことが好ましい。 Since the ring electrode 40 is disposed outside the cylindrical body 20, the inner diameter of the ring electrode 40 before caulking is preferably larger than the outer diameter of the cylindrical body 20.
筒体２０の側面に開口部２５が形成されて、導線３０が開口部２５に挿通されていることも好ましい。開口部２５の形成には、針による穿刺、レーザーによる焼灼、ポンチによる開口等の方法を用いることができる。レーザーによる焼灼で開口部２５を形成する場合、筒体２０内に例えば合成樹脂からなる棒状体を挿入すれば、筒体２０に意図しない開口部２５が形成されることを抑止できる。 It is also preferable that an opening 25 is formed on the side surface of the cylindrical body 20 and the conducting wire 30 is inserted through the opening 25. 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 the opening 25 from being unintentionally formed in the cylinder 20.
図３（ａ）の筒体２０では、側面に円形状の開口部２５ａ，２５ｂが形成されており、導線３０は、開口部２５ａ，２５ｂに挿通されている。このように筒体２０に開口部２５ａ，２５ｂが形成されていれば、導線３０を筒体２０外から筒体２０内に挿入したり、導線３０を筒体２０内から筒体２０外に露出させることができる。 In the cylindrical body 20 of FIG. 3A, circular openings 25a and 25b are formed on the side surfaces, and the conducting wire 30 is inserted through the openings 25a and 25b. If the openings 25a and 25b are formed in the cylindrical body 20 as described above, the conductive wire 30 is inserted into the cylindrical body 20 from the outside of the cylindrical body 20, or the conductive wire 30 is exposed from the cylindrical body 20 to the outside of the cylindrical body 20. Can be made.
図３（ｂ）のようにコイル状に形成された筒体２０の場合には、隣り合う筒体２０の間に生じる隙間を開口部２５とみなして、導線３０が開口部２５に挿通されていると考えることができる。コイル状に形成された筒体２０の場合には、開口部２５を別途形成する必要がない。 In the case of the cylindrical body 20 formed in a coil shape as shown in FIG. 3B, the gap formed between the adjacent cylindrical bodies 20 is regarded as the opening 25, and the conducting wire 30 is inserted into the opening 25. Can be considered. In the case of the cylindrical body 20 formed in a coil shape, it is not necessary to form the opening 25 separately.
開口部２５の形状は特に限定されないが、例えば開口部２５を筒体２０の外方から内方に見たときの形状が、円形状、楕円形状、多角形状、弧状、またはこれらの組み合わせ等でもよい。 The shape of the opening 25 is not particularly limited. For example, the shape when the opening 25 is viewed from the outside of the cylindrical body 20 to the inside may be a circular shape, an elliptical shape, a polygonal shape, an arc shape, or a combination thereof. Good.
開口部２５から筒体２０内に血液等の水分が流入することを防ぐために、開口部２５はリング電極４０に覆われていることも好ましい。 In order to prevent moisture such as blood from flowing into the cylindrical body 20 from the opening 25, it is also preferable that the opening 25 is covered with the ring electrode 40.
開口部２５の開口面積が大きい場合、筒体２０内外への導線３０の配置は容易になるが、開口部２５を覆うために幅広のリング電極４０が必要となるため、筒体２０に配置可能なリング電極４０の個数が限定されてしまう。 When the opening area of the opening 25 is large, the arrangement of the conducting wire 30 inside and outside the cylinder 20 is facilitated, but a wide ring electrode 40 is required to cover the opening 25, so that it can be arranged on the cylinder 20. The number of such ring electrodes 40 is limited.
他方、開口部２５の開口面積が小さい場合、筒体２０に配置可能なリング電極４０の個数を増やすことができるが、開口部２５に導線３０を通す作業などが困難になる。 On the other hand, when the opening area of the opening 25 is small, the number of ring electrodes 40 that can be arranged on the cylinder 20 can be increased, but the operation of passing the lead wire 30 through the opening 25 becomes difficult.
以上のことから、筒体２０の周方向における開口部２５の開口範囲は、筒体２０の周方向に対して２０度以上、６０度以下であることが好ましい。 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.
図４（ａ）〜図４（ｇ）は、本発明の実施の形態に係る電極カテーテル１０の斜視図である。以下では、図４（ａ）〜図４（ｇ）を用いて、筒体２０の側面に開口部２５が形成される場合の筒体２０の開口部２５、導線３０、リング電極４０の配置について説明する。 4 (a) to 4 (g) are perspective views of the electrode catheter 10 according to the embodiment of the present invention. Below, arrangement | positioning of the opening part 25 of the cylinder 20, the conducting wire 30, and the ring electrode 40 in case the opening part 25 is formed in the side surface of the cylinder 20 using FIG. 4 (a)-FIG.4 (g). explain.
開口部２５の数は１つでもよいが、図４（ａ）〜図４（ｅ）のように、開口部２５が複数形成されていることも好ましい。導線３０の第１区間Ｓ１と第３区間Ｓ３をそれぞれ異なる開口部２５から筒体２０内に挿入することができる。例えば、図４（ａ）では、導線３０の第１区間Ｓ１を開口部２５ａから筒体２０内に挿入しており、導線３０の第３区間Ｓ３を開口部２５ｂから筒体２０内に挿入している。導線３０を２つの開口部２５ａ，２５ｂから筒体２０内に挿入することで、意図せずに筒体２０から導線３０が抜けることを防止できる。 The number of openings 25 may be one, but it is also preferable that a plurality of openings 25 be formed as shown in FIGS. 4 (a) to 4 (e). The first section S1 and the third section S3 of the conducting wire 30 can be inserted into the cylindrical body 20 from different openings 25, respectively. For example, in FIG. 4A, the first section S1 of the conducting wire 30 is inserted into the cylinder 20 through the opening 25a, and the third section S3 of the conducting wire 30 is inserted into the cylinder 20 through the opening 25b. ing. By inserting the conducting wire 30 into the cylindrical body 20 through the two openings 25a and 25b, it is possible to prevent the conducting wire 30 from being unintentionally removed from the cylindrical body 20.
図４（ａ）に示すように、複数の開口部２５ａ，２５ｂが、筒体２０の周方向（矢印Ａ方向）に沿って配置されていることも好ましい。開口部２５ａ，２５ｂを形成するためのレーザー溶接装置等に対して、筒体２０を周方向に回転させることによって、容易に開口部２５ａ，２５ｂを形成できるからである。また、導線３０の第２区間Ｓ２とリング電極４０の接続を確実にすることができる。 As shown to Fig.4 (a), it is also preferable that several opening part 25a, 25b is arrange | positioned along the circumferential direction (arrow A direction) of the cylinder 20. As shown in FIG. This is because the openings 25a and 25b can be easily formed by rotating the cylindrical body 20 in the circumferential direction with respect to a laser welding apparatus or the like for forming the openings 25a and 25b. Further, the connection between the second section S2 of the conducting wire 30 and the ring electrode 40 can be ensured.
図４（ｂ）に示すように、複数の開口部２５ａ，２５ｂが、筒体２０の軸方向（矢印Ｂ方向）に沿って配置されていることも好ましい。開口部２５ａ，２５ｂを形成するためのレーザー溶接装置等に対して筒体２０を軸方向に移動させることによって、容易に開口部２５ａ，２５ｂを形成できるからである。また、開口部２５ａ，２５ｂは比較的狭いリング電極４０の幅に収まるように軸方向に配置されるため、導線３０の挿入を容易に行うことができる。図４（ｂ）では、導線３０の第１区間Ｓ１を開口部２５ａから筒体２０内に挿入しており、導線３０の第３区間Ｓ３を開口部２５ｂから筒体２０内に挿入している。 As shown in FIG.4 (b), it is also preferable that several opening part 25a, 25b is arrange | positioned along the axial direction (arrow B direction) of the cylinder 20. As shown in FIG. This is because the openings 25a and 25b can be easily formed by moving the cylindrical body 20 in the axial direction with respect to a laser welding apparatus or the like for forming the openings 25a and 25b. Further, since the openings 25a and 25b are arranged in the axial direction so as to be within the width of the relatively narrow ring electrode 40, the conducting wire 30 can be easily inserted. In FIG.4 (b), 1st area S1 of the conducting wire 30 is inserted in the cylinder 20 from the opening part 25a, and 3rd area S3 of the conducting wire 30 is inserted in the cylinder body 20 from the opening part 25b. .
図４（ｃ）に示すように、複数の開口部２５ａ，２５ｂが筒体２０の周方向（矢印Ａ方向）および軸方向（矢印Ｂ方向）の重ならない位置にそれぞれ設けられていてもよい。筒体２０の限られた範囲内で開口部２５ａ，２５ｂ間の距離を長くすることができるため、導線３０の第２区間Ｓ２とリング電極４０との接触距離および接触面積を大きくすることができる。 As shown in FIG.4 (c), the some opening part 25a, 25b may be provided in the position where the circumferential direction (arrow A direction) and axial direction (arrow B direction) of the cylinder 20 do not overlap, respectively. Since the distance between the openings 25a and 25b can be increased within a limited range of the cylindrical body 20, the contact distance and the contact area between the second section S2 of the conducting wire 30 and the ring electrode 40 can be increased. .
図４（ｄ）に示すように、リング電極４０を軸方向（矢印Ｂ方向）に遠位部４０ａ、中央部４０ｂ、近位部４０ｃに三分割したときに、開口部２５がリング電極４０の中央部４０ｂに覆われていることも好ましい。これにより、導線３０の第２区間Ｓ２はリング電極４０の少なくとも中央部４０ｂ、さらには遠位部４０ａおよび近位部４０ｃに覆われるため、導線３０とリング電極４０の接続を確実にすることができる。また、リング電極４０の遠位部４０ａおよび近位部４０ｃでは筒体２０との段差が生じにくいため、血液等の水分の筒体２０内への混入を防ぐこともできる。
なお、リング電極４０の遠位部４０ａと近位部４０ｃはそれぞれリング電極４０の全体幅の１５％〜４５％の範囲を指し、リング電極４０の中央部４０ｂは遠位部４０ａおよび近位部４０ｃ以外の残りの７０〜１０％の範囲を指す。
As shown in FIG. 4D, when the ring electrode 40 is divided into the distal part 40a, the central part 40b, and the proximal part 40c in the axial direction (the direction of the arrow B), the opening 25 is formed on the ring electrode 40. It is also preferable that the central portion 40b is covered. As a result, the second section S2 of the conducting wire 30 is covered by at least the central portion 40b of the ring electrode 40, and further the distal portion 40a and the proximal portion 40c, so that the connection between the conducting wire 30 and the ring electrode 40 can be ensured. it can. In addition, since a step difference from the cylindrical body 20 is unlikely to occur at the distal portion 40a and the proximal portion 40c of the ring electrode 40, it is possible to prevent moisture such as blood from being mixed into the cylindrical body 20.
The distal portion 40a and the proximal portion 40c of the ring electrode 40 refer to a range of 15% to 45% of the entire width of the ring electrode 40, and the central portion 40b of the ring electrode 40 is the distal portion 40a and the proximal portion. It refers to the remaining 70 to 10% range other than 40c.
図４（ｅ）に示すように、筒体２０の側面に複数の開口部２５ａ，２５ｂが形成されている場合、一の開口部２５ａがリング電極４０の遠位部４０ａに覆われており、他の開口部２５ｂがリング電極４０の近位部４０ｃに覆われていることも好ましい。開口部２５ａ，２５ｂ間の距離を長くすることができるため、導線３０の第２区間Ｓ２とリング電極４０との接触距離および接触面積を大きくすることができる。 As shown in FIG. 4E, when a plurality of openings 25a and 25b are formed on the side surface of the cylindrical body 20, one opening 25a is covered with the distal portion 40a of the ring electrode 40, It is also preferable that the other opening 25 b is covered with the proximal portion 40 c of the ring electrode 40. Since the distance between the openings 25a and 25b can be increased, the contact distance and the contact area between the second section S2 of the conducting wire 30 and the ring electrode 40 can be increased.
図４（ｆ）に示すように、開口部２５ｃが弧状であることも好ましい。より好ましくは、筒体２０の側面に遠位側に凸となる弧状の開口部２５ｃが形成される。これにより、弧状の開口部２５ｃから離れて導線３０の第２区間Ｓ２を配置することができるため、導線３０の第２区間Ｓ２が筒体２０内に没落することを抑止できる。 As shown in FIG.4 (f), it is also preferable that the opening part 25c is arc shape. More preferably, an arcuate opening 25 c that protrudes distally is formed on the side surface of the cylindrical body 20. Thereby, since 2nd area S2 of conducting wire 30 can be arrange | positioned away from the arc-shaped opening part 25c, it can suppress that 2nd area S2 of conducting wire 30 falls in the cylindrical body 20. FIG.
図４（ｇ）に示すように、筒体２０の側面には開口部２５ａに連通するスリット２６が形成されており、スリット２６の幅は導線３０の外径よりも大きいことも好ましい。開口部２５ａだけでなく、スリット２６から導線３０の第１区間Ｓ１または第３区間Ｓ３を筒体２０内に挿入したり、導線３０の第２区間Ｓ２を筒体２０外に露出させることができる。 As shown in FIG. 4G, a slit 26 communicating with the opening 25 a is formed on the side surface of the cylindrical body 20, and the width of the slit 26 is preferably larger than the outer diameter of the conducting wire 30. The first section S1 or the third section S3 of the conducting wire 30 can be inserted into the cylindrical body 20 from the slit 26 as well as the opening 25a, or the second section S2 of the conducting wire 30 can be exposed outside the cylindrical body 20. .
また、図４（ｇ）に示すように、導線３０の第１区間Ｓ１は、開口部２５ａを通過するが、スリット２６を通過できない形状の係止部材３１を有していることも好ましい。すなわち、係止部材３１の最大外径がスリット２６の幅よりも大きいことも好ましい。係止部材３１がスリット２６に係止されるため、導線３０の第１区間Ｓ１が筒体２０外に露出するのを抑制できる。 As shown in FIG. 4G, it is also preferable that the first section S1 of the conducting wire 30 has a locking member 31 having a shape that passes through the opening 25a but cannot pass through the slit 26. That is, it is also preferable that the maximum outer diameter of the locking member 31 is larger than the width of the slit 26. Since the locking member 31 is locked to the slit 26, it is possible to suppress the first section S1 of the conducting wire 30 from being exposed to the outside of the cylindrical body 20.
導線３０の第３区間Ｓ３の近位側は、後述する中間シャフト６０およびシャフト６２内を通って、電極カテーテル１０の電源機器等に接続するためのコネクター６４と接続されている。コネクター６４の形状はモノポーラ式でもバイポーラ式でもよい。 The proximal side of the third section S3 of the conducting wire 30 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 a monopolar type or a bipolar type.
図１に示すように、筒体２０の近位側には、中間シャフト６０が接続されている。筒体２０と中間シャフト６０との接続形態に特に制限はないが、例えば固定部材６０ａにより筒体２０の近位側を挟んで固定することができる。中間シャフト６０の近位端は電極カテーテル１０の使用者が把持するシャフト６２に接続されている。 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.
図１に示すように、筒体２０の遠位端には、電極カテーテル１０先端の案内役となる先端チップ５０が設けられてもよい。先端チップ５０にはプルワイヤー６１の一方端部が接続されており、プルワイヤー６１の他方端部はシャフト６２に設けられたハンドル６３に接続されている。このような構造により、ハンドル６３を手元で操作して筒体２０の遠位側の曲がり具合をコントロールすることができる。なお、先端チップ５０を導電性材料から構成して、先端チップ５０も導線３０に接続（図示せず）すれば、先端チップ５０をリング電極４０と同様に電極として機能させることもできる。先端チップ５０に接続される導線３０の他方端部は中間シャフト６０およびシャフト６２内を通って、電極カテーテル１０の電源機器等に接続するためのコネクター６４と接続されている。 As shown in FIG. 1, a distal end tip 50 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 50, 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 50 is made of a conductive material and the tip 50 is also connected to the conductive wire 30 (not shown), the tip 50 can function as an electrode in the same manner as the ring electrode 40. The other end of the conductive wire 30 connected to the distal tip 50 is connected to a connector 64 for connecting to the power supply device of the electrode catheter 10 through the intermediate shaft 60 and the shaft 62.
２．電極カテーテルの製造方法
本発明の電極カテーテルの製造方法について、図５〜図１７を用いて詳細に説明する。図５〜図８は本発明の実施の形態に係る電極カテーテル１０の製造方法を示す斜視図であり、図１０、図１６、図１７は本発明の実施の形態に係る電極カテーテル１０の製造方法を示す断面図（一部側面図）であり、図９〜図１５は本発明の実施の形態に係る電極カテーテル１０の他の製造方法を示す斜視図である。なお、電極カテーテル１０を構成する各部材については、本明細書の「１．電極カテーテル」に記載したとおりである。
2. Electrode catheter manufacturing method The electrode catheter manufacturing method of the present invention will be described in detail with reference to FIGS. 5 to 8 are perspective views showing a method of manufacturing the electrode catheter 10 according to the embodiment of the present invention, and FIGS. 10, 16, and 17 are methods of manufacturing the electrode catheter 10 according to the embodiment of the present invention. FIG. 9 to FIG. 15 are perspective views showing another method for manufacturing the electrode catheter 10 according to the embodiment of the present invention. In addition, about each member which comprises the electrode catheter 10, it is as having described in "1. Electrode catheter" of this specification.
本発明の電極カテーテル１０の製造方法は、筒体２０と、第１区間Ｓ１、第２区間Ｓ２、第３区間Ｓ３を順に有する導線３０を準備するステップＡと、筒体２０内に導線３０の第１区間Ｓ１および第３区間Ｓ３を配置して、筒体２０の外側に導線３０の第２区間Ｓ２を配置するステップＢと、筒体２０の外側にリング電極４０を配置するステップＣと、リング電極４０をかしめて、導線３０の第２区間Ｓ２とリング電極４０を接続するステップＤと、を含む。本発明の電極カテーテル１０の製造方法では、導線３０の第２区間Ｓ２が筒体２０の側面に露出する一方で第２区間Ｓ２の両側の第１区間Ｓ１および第３区間Ｓ３は筒体２０内に収められることから、第２区間Ｓ２が変位しにくくなる（ずれにくくなる）。そこで、この第２区間Ｓ２の少なくとも一部を、例えば溶接を用いることなくリング電極４０をかしめることにより、リング電極４０に接続することによって、このリング電極４０と導線３０とを導通することができる。すなわち、溶接等の工程数を削減させて、電極カテーテル１０を容易に製造できる。
その上、導線３０の第２区間Ｓ２が変位しにくい状態においてリング電極４０が接続されるため、確実に第２区間Ｓ２をリング電極４０で覆うこともできる。そのため、リング電極４０と導線３０の溶接部が、血液等の水分に接触することがなくなり、ドリフト現象の発生を抑制できる。
The manufacturing method of the electrode catheter 10 of the present invention includes a step A for preparing a tubular body 20 and a conducting wire 30 having a first section S1, a second section S2, and a third section S3 in order, and the conducting wire 30 in the tubular body 20. Step B in which the first section S1 and the third section S3 are disposed, the second section S2 of the conducting wire 30 is disposed outside the cylinder 20, and the ring electrode 40 is disposed outside the cylinder 20. A step D in which the ring electrode 40 is caulked to connect the second section S2 of the conducting wire 30 to the ring electrode 40. In the method for manufacturing the electrode catheter 10 of the present invention, the second section S2 of the conducting wire 30 is exposed on the side surface of the cylindrical body 20, while the first section S1 and the third section S3 on both sides of the second section S2 are inside the cylindrical body 20. Therefore, the second section S2 is less likely to be displaced (difficult to be displaced). Therefore, by connecting at least a part of the second section S2 to the ring electrode 40 by caulking the ring electrode 40 without using, for example, welding, the ring electrode 40 and the conductive wire 30 can be electrically connected. it can. That is, the electrode catheter 10 can be easily manufactured by reducing the number of processes such as welding.
In addition, since the ring electrode 40 is connected in a state in which the second section S2 of the conducting wire 30 is not easily displaced, the second section S2 can be reliably covered with the ring electrode 40. Therefore, the welded portion between the ring electrode 40 and the conducting wire 30 is not in contact with moisture such as blood, and the occurrence of the drift phenomenon can be suppressed.
まず、電極カテーテル１０の製造に必要な、筒体２０と、第１区間Ｓ１、第２区間Ｓ２、第３区間Ｓ３を順に有する導線３０を準備する（ステップＡ）。 First, a conductor 20 having a cylindrical body 20 and a first section S1, a second section S2, and a third section S3, which are necessary for manufacturing the electrode catheter 10, are prepared (step A).
ステップＡにおいて筒体２０は、予め側面に開口部２５が形成された筒体２０を用いてもよい。また、針による穿刺、レーザー照射による焼灼、ポンチによる開口等の方法を用いて筒体２０の側面に開口部２５を形成してもよい。例えば、図５では筒体２０に２つの開口部２５ａ，２５ｂが形成されている。 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. For example, in FIG. 5, two openings 25 a and 25 b are formed in the cylindrical body 20.
次に、筒体２０内に導線３０の第１区間Ｓ１および第３区間Ｓ３を配置して、筒体２０の外側に導線３０の第２区間Ｓ２を配置する（ステップＢ）。導線３０の第２区間Ｓ２が筒体２０の側面に露出する一方で、第２区間Ｓ２の両側の第１区間Ｓ１および第３区間Ｓ３は筒体２０内に収められることから、第２区間Ｓ２が変位しにくくなる。 Next, the first section S1 and the third section S3 of the conducting wire 30 are arranged in the cylindrical body 20, and the second section S2 of the conducting wire 30 is arranged outside the cylindrical body 20 (Step B). Since the second section S2 of the conducting wire 30 is exposed on the side surface of the cylindrical body 20, the first section S1 and the third section S3 on both sides of the second section S2 are accommodated in the cylindrical body 20, so that the second section S2 Becomes difficult to displace.
側面に複数の開口部２５ａ，２５ｂが形成された筒体２０を用いる場合、上記ステップＢは、導線３０の第１区間Ｓ１を一の開口部２５ａから筒体２０内に挿入するステップＢ１１を含んでもよい。例えば、図６に示すように導線３０の一方端部３０ａを開口部２５ａから筒体２０内に挿入することによって、図７に示すように導線３０の第１区間Ｓ１が開口部２５ａから筒体２０内に配置される。 When the cylindrical body 20 having a plurality of openings 25a and 25b formed on the side surfaces is used, the step B includes a step B11 of inserting the first section S1 of the conducting wire 30 into the cylindrical body 20 from the one opening 25a. But you can. For example, as shown in FIG. 6, by inserting one end 30a of the conducting wire 30 into the cylinder 20 through the opening 25a, the first section S1 of the conducting wire 30 becomes a cylinder from the opening 25a as shown in FIG. 20.
側面に複数の開口部２５ａ，２５ｂが形成された筒体２０を用いる場合、上記ステップＢは、導線３０の第３区間Ｓ３を他の開口部２５ｂから筒体２０内に挿入するステップＢ１２を含んでもよい。例えば、図８に示すように導線３０の他方端部３０ｂを開口部２５ｂから筒体２０内に挿入することによって、図９に示すように導線３０の第３区間Ｓ３が開口部２５ｂから筒体２０内に配置される。 When the cylindrical body 20 having a plurality of openings 25a and 25b formed on the side surfaces is used, the step B includes a step B12 of inserting the third section S3 of the conducting wire 30 into the cylindrical body 20 from the other opening 25b. But you can. For example, as shown in FIG. 8, the other end 30b of the conducting wire 30 is inserted into the cylinder 20 through the opening 25b, so that the third section S3 of the conducting wire 30 is formed from the opening 25b into the cylinder as shown in FIG. 20.
上記ステップＢは、上記ステップＢ１１と、上記ステップＢ１２と、を含むことも好ましい。ステップＢ１１およびステップＢ１２のように、開口部２５ａ，２５ｂから導線３０を筒体２０内に挿入することによって、図９に示すように筒体２０の外側に導線３０の第２区間Ｓ２を配置することができる。図１０は、開口部２５ａ，２５ｂが形成された筒体２０に導線３０を配置したときの軸方向に沿った断面図である。 The step B preferably includes the step B11 and the step B12. As shown in FIG. 9, the second section S <b> 2 of the conducting wire 30 is disposed outside the cylindrical body 20 by inserting the conducting wire 30 into the cylindrical body 20 from the openings 25 a and 25 b as in Step B <b> 11 and Step B <b> 12. be able to. FIG. 10 is a cross-sectional view along the axial direction when the conducting wire 30 is arranged in the cylindrical body 20 in which the openings 25a and 25b are formed.
図１１に示すように、筒体２０の側面に、開口部２５ａと、開口部２５ａに連通して導線３０の外径よりも大きい幅を有するスリット２６とが形成されて、導線３０の第１区間Ｓ１が、開口部２５ａを通過するがスリット２６を通過できない形状の係止部材３１を有している場合、上記ステップＢは、図１２に示すように係止部材３１を開口部２５ａから筒体２０内に挿入するステップＢ２１を含むことも好ましい。 As shown in FIG. 11, an opening 25 a and a slit 26 communicating with the opening 25 a and having a width larger than the outer diameter of the conducting wire 30 are formed on the side surface of the cylindrical body 20. When the section S1 has the locking member 31 having a shape that passes through the opening 25a but cannot pass through the slit 26, the step B is performed by moving the locking member 31 from the opening 25a to the cylinder as shown in FIG. It is also preferable to include step B21 for insertion into the body 20.
図１３に示すように、上記ステップＢは、スリット２６に沿って、導線３０を開口部２５ａから離れる方向に移動させるステップＢ２２を含むことも好ましい。 As shown in FIG. 13, the step B preferably includes a step B22 of moving the conducting wire 30 in the direction away from the opening 25a along the slit 26.
さらに図１４に示すように、上記ステップＢは、導線３０の第３区間Ｓ３を開口部２５ａから筒体２０内に挿入するステップＢ２３を含むことも好ましい。具体的には、導線３０の係止部材３１を有していない区間の他方端部３０ｂを開口部２５ａから筒体２０内に挿入することにより、図１５に示すように導線３０の第３区間Ｓ３を開口部２５ａから筒体２０内に配置させることができる。 Further, as shown in FIG. 14, the step B preferably includes a step B <b> 23 in which the third section S <b> 3 of the conducting wire 30 is inserted into the cylindrical body 20 from the opening 25 a. Specifically, by inserting the other end 30b of the section of the conductor 30 that does not have the locking member 31 into the cylinder 20 from the opening 25a, the third section of the conductor 30 as shown in FIG. S3 can be disposed in the cylindrical body 20 from the opening 25a.
上記ステップＢが、ステップＢ２１、ステップＢ２２、ステップＢ２３を含むものであれば、係止部材３１がスリット２６に係止されるため、導線３０の第３区間Ｓ３が筒体２０の外側に露出するのを抑制できる。 If step B includes step B21, step B22, and step B23, since the locking member 31 is locked to the slit 26, the third section S3 of the conducting wire 30 is exposed to the outside of the cylindrical body 20. Can be suppressed.
ステップＢを終えたら、図１６に示すように、筒体２０の外側にリング電極４０を配置する（ステップＣ）。なお、筒体２０の開口部２５ａ，２５ｂを覆うようにリング電極４０が配置されていることも好ましい。これにより、導線３０とリング電極４０を確実に接続することができる。 When step B is completed, as shown in FIG. 16, the ring electrode 40 is disposed outside the cylindrical body 20 (step C). In addition, it is also preferable that the ring electrode 40 is disposed so as to cover the openings 25a and 25b of the cylindrical body 20. Thereby, the conducting wire 30 and the ring electrode 40 can be reliably connected.
図１７に示すように、リング電極４０をかしめて、導線３０の第２区間Ｓ２とリング電極４０を接続する（ステップＤ）。リング電極４０を筒体２０の内方にかしめると、リング電極４０の径が小さくなるため、リング電極４０と重なる部分での筒体２０の肉厚はリング電極４０が配置されない部分での肉厚よりも小さくなる。これにより、リング電極４０と導線３０の第２区間Ｓ２が接触し、リング電極４０と導線３０の第２区間Ｓ２の少なくとも一部が接続されるため、リング電極４０と導線３０を導通することができる。また、第２区間Ｓ２の少なくとも一部を、例えば溶接を用いることなくリング電極４０をかしめることにより、リング電極４０に接続することによって、このリング電極４０と導線３０とを導通することができる。すなわち、溶接等の工程数を削減させて、電極カテーテル１０を容易に製造できる。
その上、導線３０の第２区間Ｓ２が変位しにくい状態においてリング電極４０が接続されるため、確実に第２区間Ｓ２をリング電極４０で覆うこともできる。そのため、リング電極４０と導線３０の溶接部が、血液等の水分に接触することがなくなり、ドリフト現象の発生を抑制できる。
As shown in FIG. 17, the ring electrode 40 is caulked to connect the second section S2 of the conducting wire 30 and the ring electrode 40 (step D). When the ring electrode 40 is caulked inward of the cylindrical body 20, the diameter of the ring electrode 40 is reduced. Therefore, the thickness of the cylindrical body 20 at the portion overlapping the ring electrode 40 is the thickness at the portion where the ring electrode 40 is not disposed. It becomes smaller than the thickness. Accordingly, the ring electrode 40 and the second section S2 of the conducting wire 30 are in contact with each other, and at least a part of the second section S2 of the ring electrode 40 and the conducting wire 30 is connected, so that the ring electrode 40 and the conducting wire 30 can be electrically connected. it can. Further, by connecting at least a part of the second section S2 to the ring electrode 40 by caulking the ring electrode 40 without using welding, for example, the ring electrode 40 and the conducting wire 30 can be electrically connected. . That is, the electrode catheter 10 can be easily manufactured by reducing the number of processes such as welding.
In addition, since the ring electrode 40 is connected in a state in which the second section S2 of the conducting wire 30 is not easily displaced, the second section S2 can be reliably covered with the ring electrode 40. Therefore, the welded portion between the ring electrode 40 and the conducting wire 30 is not in contact with moisture such as blood, and the occurrence of the drift phenomenon can be suppressed.
以下、実施例を挙げて本発明をより具体的に説明するが、本発明はもとより下記実施例によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。 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.
以下では、筒体に形成する開口部の形状を変えて電極カテーテルを製造して、電極カテーテルを所定の曲げ半径で曲げる前後の導線とリング電極間の通電状態を観察した結果について説明する。はじめに、測定に必要な筒体と、導線と、リング電極とを準備し、「２．電極カテーテルの製造方法」に記載の製造方法で電極カテーテルを製造した。筒体の外側にリング電極の配置する方法としてはかしめ法を用いた。いずれも筒体の外径は２．００ｍｍ、内径は１．６０ｍｍであった。導線の直径は０．１２ｍｍであり、リング電極の外径は、２．２０ｍｍ、内径は２．１０ｍｍであった。筒体には、開口部（実施例１〜３）、または開口部とスリット（実施例４）が形成されている。本試験では、電極カテーテルを製造した後、リング電極と導線の導通状態を確認した。また、電極カテーテルの遠位部を曲げ半径２０ｍｍで曲げた後のリング電極と導線の導通状態も確認した。 Below, the result of observing the energized state between the lead wire and the ring electrode before and after bending the electrode catheter with a predetermined bending radius by manufacturing the electrode catheter by changing the shape of the opening formed in the cylindrical body will be described. First, a cylinder, a conducting wire, and a ring electrode necessary for measurement were prepared, and an electrode catheter was manufactured by the manufacturing method described in “2. Method for manufacturing electrode catheter”. A caulking method was used as a method of arranging the ring electrode on the outside of the cylindrical body. In any case, the outer diameter of the cylinder was 2.00 mm, and the inner diameter was 1.60 mm. The diameter of the conducting wire was 0.12 mm, the outer diameter of the ring electrode was 2.20 mm, and the inner diameter was 2.10 mm. An opening (Examples 1 to 3) or an opening and a slit (Example 4) are formed in the cylindrical body. In this test, after the electrode catheter was manufactured, the conduction state between the ring electrode and the conducting wire was confirmed. Moreover, the conduction | electrical_connection state of the ring electrode and conducting wire after bending the distal part of an electrode catheter with the bending radius of 20 mm was also confirmed.
本試験における筒体の外径（ｍｍ）、内径（ｍｍ）、開口部の個数、スリットの個数、開口部およびスリットの配置、開口部の直径（ｍｍ）、スリット幅（ｍｍ）；導線の直径（ｍｍ）、係止部材の有無；リング電極の外径（ｍｍ）、内径（ｍｍ）；曲げ半径（ｍｍ）；電極カテーテルの遠位部を曲げる前と曲げた後の導線と電極間の通電状態を表１に示す。 In this test, the outer diameter (mm), inner diameter (mm), number of openings, number of slits, arrangement of openings and slits, diameter of openings (mm), slit width (mm); (Mm), presence / absence of locking member; outer diameter (mm), inner diameter (mm) of ring electrode; bending radius (mm); conduction between lead wire and electrode before and after bending distal portion of electrode catheter The state is shown in Table 1.
（実施例１）
実施例１では、図４（ａ）のように直径０．２０ｍｍの２つの円形状の開口部が、筒体の周方向に沿って配置されている電極カテーテルを用いた。なお、実施例１で用いた導線は係止部材を有していなかった。電極カテーテルの遠位部を曲げる前と曲げた後の導線と電極間の通電状態を測定したところ、曲げる前、曲げた後の両方で通電していた。
Example 1
In Example 1, an electrode catheter in which two circular openings having a diameter of 0.20 mm were arranged along the circumferential direction of the cylindrical body as shown in FIG. 4A was used. In addition, the conducting wire used in Example 1 did not have a locking member. When the current-carrying state between the lead wire and the electrode before and after bending the distal portion of the electrode catheter was measured, it was energized both before and after bending.
（実施例２）
実施例２では、図４（ｂ）のように直径０．２０ｍｍの２つの円形状の開口部が筒体の軸方向に沿って配置されている電極カテーテルを用いた。なお、実施例３で用いた導線も係止部材を有していなかった。電極カテーテルの遠位部を曲げる前と曲げた後の導線と電極間の通電状態を測定したところ、いずれも曲げる前、曲げた後の両方で通電していた。
(Example 2)
In Example 2, an electrode catheter in which two circular openings having a diameter of 0.20 mm were arranged along the axial direction of the cylinder as shown in FIG. 4B was used. In addition, the conducting wire used in Example 3 did not have a locking member. When the current-carrying state between the electrode and the electrode before and after bending the distal portion of the electrode catheter was measured, the current was applied both before and after bending.
（実施例３）
実施例３では、図４（ｅ）のように一の円形状の開口部がリング電極の遠位部に、他の円形状の開口部がリング電極の近位部に配置されている電極カテーテルを用いた。なお、実施例３で用いた導線も係止部材を有していなかった。本実施例では、直径０．２０ｍｍの２つの開口部が筒体に形成されていた。電極カテーテルの遠位部を曲げる前と曲げた後の導線と電極間の通電状態を測定したところ、いずれも曲げる前、曲げた後の両方で通電していた。
(Example 3)
In Example 3, as shown in FIG. 4E, an electrode catheter in which one circular opening is disposed at the distal portion of the ring electrode and the other circular opening is disposed at the proximal portion of the ring electrode. Was used. In addition, the conducting wire used in Example 3 did not have a locking member. In this example, two openings having a diameter of 0.20 mm were formed in the cylinder. When the current-carrying state between the electrode and the electrode before and after bending the distal portion of the electrode catheter was measured, the current was applied both before and after bending.
（実施例４）
実施例４では、図４（ｇ）のように直径０．２５ｍｍの円形状の開口部に連通する、幅０．１５ｍｍの弧状のスリットが形成されている電極カテーテルを用いた。なお、実施例４で用いた導線は、スリットを通過できない直径０．２ｍｍの球体の係止部材を有していた。電極カテーテルの遠位部を曲げる前と曲げた後の導線と電極間の通電状態を測定したところ、曲げる前、曲げた後の両方で通電していた。
Example 4
In Example 4, an electrode catheter in which an arc slit having a width of 0.15 mm, which communicates with a circular opening having a diameter of 0.25 mm as shown in FIG. The conducting wire used in Example 4 had a spherical locking member with a diameter of 0.2 mm that could not pass through the slit. When the current-carrying state between the lead wire and the electrode before and after bending the distal portion of the electrode catheter was measured, it was energized both before and after bending.
以上のことから、実施例１〜４では、電極カテーテルの遠位部を曲げる前でも曲げた後でも導線と電極間が通電していたため、導線と電極が確実に接続されていることが分かった。したがって、本発明の電極カテーテルおよび電極カテーテルの製造方法は、導線の第２区間の少なくとも一部がリング電極に接続されていることから、容易な方法で導線とリング電極を導通できることが分かった。 From the above, in Examples 1 to 4, it was found that the conductor and the electrode were securely connected because the conductor and the electrode were energized both before and after the distal portion of the electrode catheter was bent. . Therefore, it has been found that the electrode catheter and the electrode catheter manufacturing method of the present invention can conduct the conducting wire and the ring electrode by an easy method because at least a part of the second section of the conducting wire is connected to the ring electrode.
１０：電極カテーテル
２０：筒体
２５，２５ａ，２５ｂ，２５ｃ：開口部
２６：スリット
３０：導線、Ｓ１：第１区間、Ｓ２：第２区間、Ｓ３：第３区間
３１：係止部材
４０：リング電極
５０：先端チップ
６０：中間シャフト
６０ａ：固定部材
６１：プルワイヤー
６２：シャフト
６３：ハンドル
６４：コネクター
10: Electrode catheter 20: Tubes 25, 25a, 25b, 25c: Opening 26: Slit 30: Conductor, S1: First section, S2: Second section, S3: Third section 31: Locking member 40: Ring Electrode 50: Tip tip 60: Intermediate shaft 60a: Fixing member 61: Pull wire 62: Shaft 63: Handle 64: Connector
Claims (12)
第１区間、第２区間、第３区間を順に有する導線と、
前記筒体の外側に配されているリング電極と、を有し、
前記導線の第１区間および第３区間は、前記筒体内に配され、
前記導線の第２区間は、前記筒体の側面に露出しており、
前記導線の第２区間の少なくとも一部は、前記リング電極に接続されていることを特徴とする電極カテーテル。 A cylinder,
A conductor having a first section, a second section, and a third section in order;
A ring electrode disposed on the outside of the cylindrical body,
The first section and the third section of the conducting wire are arranged in the cylinder,
The second section of the conducting wire is exposed on the side surface of the cylindrical body,
At least a part of the second section of the conducting wire is connected to the ring electrode.
前記導線が、前記開口部に挿通されている請求項１に記載の電極カテーテル。 An opening is formed on the side surface of the cylindrical body,
The electrode catheter according to claim 1, wherein the conducting wire is inserted through the opening.
前記筒体内に前記導線の第１区間および第３区間を配置して、前記筒体の外側に前記導線の第２区間を配置するステップＢと、
前記筒体の外側にリング電極を配置するステップＣと、
前記リング電極をかしめて、前記導線の第２区間と前記リング電極を接続するステップＤと、を含む電極カテーテルの製造方法。 Step A for preparing a cylindrical body and a conducting wire having a first section, a second section, and a third section in order,
Step B in which the first section and the third section of the conducting wire are arranged in the cylinder, and the second section of the conducting wire is arranged outside the cylinder,
Arranging a ring electrode outside the cylindrical body; and
A method of manufacturing an electrode catheter, comprising: step D of caulking the ring electrode to connect the second section of the conducting wire and the ring electrode.
前記ステップＢは、
前記導線の第１区間を一の前記開口部から前記筒体内に挿入するステップＢ１１と、
前記導線の第３区間を他の前記開口部から前記筒体内に挿入するステップＢ１２と、を含む請求項１０に記載の電極カテーテルの製造方法。 A plurality of openings are formed on the side surface of the cylindrical body,
Step B includes
Step B11 for inserting the first section of the conducting wire from the one opening into the cylinder;
The method for manufacturing an electrode catheter according to claim 10, further comprising a step B <b> 12 of inserting the third section of the conducting wire into the cylindrical body from the other opening.
前記導線の第１区間は、前記開口部を通過するが、前記スリットを通過できない形状の係止部材を有しており、
前記ステップＢは
前記係止部材を前記開口部から前記筒体内に挿入するステップＢ２１と、
前記スリットに沿って、前記導線を前記開口部から離れる方向に移動させるステップＢ２２と、
前記導線の第３区間を前記開口部から前記筒体内に挿入するステップＢ２３と、を含む請求項１０に記載の電極カテーテルの製造方法。 On the side surface of the cylindrical body, an opening and a slit having a width larger than the outer diameter of the conducting wire in communication with the opening are formed.
The first section of the conducting wire has a locking member having a shape that passes through the opening but cannot pass through the slit,
The step B includes a step B21 of inserting the locking member into the cylindrical body from the opening,
Step B22 for moving the conducting wire in a direction away from the opening along the slit;
The method for manufacturing an electrode catheter according to claim 10, comprising: inserting a third section of the conducting wire into the cylindrical body from the opening.
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| WO2019156059A1 (en) * | 2018-02-06 | 2019-08-15 | 株式会社カネカ | Catheter and method for producing same |
| EP3603721A1 (en) * | 2018-07-31 | 2020-02-05 | Heraeus Deutschland GmbH & Co KG | Catheter with segmented electrodes and methods of making same |
| JP2021090501A (en) * | 2019-12-06 | 2021-06-17 | 東邦化成株式会社 | Conductor wire for electrode catheter and electrode catheter including the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2019156059A1 (en) * | 2018-02-06 | 2019-08-15 | 株式会社カネカ | Catheter and method for producing same |
| JPWO2019156059A1 (en) * | 2018-02-06 | 2021-01-14 | 株式会社カネカ | Catheter and its manufacturing method |
| JP7261183B2 (en) | 2018-02-06 | 2023-04-19 | 株式会社カネカ | Catheter and manufacturing method thereof |
| EP3603721A1 (en) * | 2018-07-31 | 2020-02-05 | Heraeus Deutschland GmbH & Co KG | Catheter with segmented electrodes and methods of making same |
| CN110772315A (en) * | 2018-07-31 | 2020-02-11 | 贺利氏德国有限两合公司 | Catheter with segmented electrodes and method of making same |
| US11730426B2 (en) | 2018-07-31 | 2023-08-22 | Heraeus Medical Components Llc | Catheter with segmented electrodes and methods of making same |
| JP2021090501A (en) * | 2019-12-06 | 2021-06-17 | 東邦化成株式会社 | Conductor wire for electrode catheter and electrode catheter including the same |
| JP7409850B2 (en) | 2019-12-06 | 2024-01-09 | ダイキンファインテック株式会社 | Lead wire for electrode catheter and electrode catheter including the same |
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