JP2008067978A - In vivo implantation electrode lead - Google Patents

In vivo implantation electrode lead Download PDF

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JP2008067978A
JP2008067978A JP2006250745A JP2006250745A JP2008067978A JP 2008067978 A JP2008067978 A JP 2008067978A JP 2006250745 A JP2006250745 A JP 2006250745A JP 2006250745 A JP2006250745 A JP 2006250745A JP 2008067978 A JP2008067978 A JP 2008067978A
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electrode
electrode support
arm
electrode lead
lead
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JP4955353B2 (en
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Takuya Uno
拓也 宇野
Tetsuo Tanaka
哲夫 田中
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Terumo Corp
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Abstract

<P>PROBLEM TO BE SOLVED: To provide an in vivo implantation electrode lead capable of facilitating the mounting of an electrode on body tissue such as the heart, nervous tissues and muscles, reducing inappropriate fixing and mounting dispersion of the electrode on the body tissue, and minimizing the peeling of a connective tissue around the body tissue when mounting the electrode. <P>SOLUTION: This in vivo implantation electrode lead is provided with: a distal end having at least one electrode 6 or 7; a proximal end having a connection means to a stimulus generator provided with an electrode driving power supply; a conductor connected to the distal end and the proximal end and consisting of electric conductors 8 and 9 for transmitting electric signals and a tubular body 2 for storing the electric conductors; and an electrode support body 1 having at least one arm part 1a, 1b or 1c formed with the electrode; wherein the lead is characterized in that at least one arm part of the electrode support body is connected with an electrode support body introduction part 4. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

本発明は、生体内に植え込まれて電気刺激を与えるための電極リードに関し、より具体的には、心臓ペースメーカー、除細動装置、神経刺激装置、筋肉刺激装置、疼痛緩和装置、てんかん治療装置、筋肉電子刺激装置などと接続するとともに、心臓、神経組織、筋肉等の生体組織に装着・固定し、当該組織を刺激するための電極リードに関する。   The present invention relates to an electrode lead that is implanted in a living body and applies electrical stimulation, and more specifically, a cardiac pacemaker, a defibrillator, a nerve stimulator, a muscle stimulator, a pain relieving device, and an epilepsy treatment device. The present invention also relates to an electrode lead that is connected to a muscle electronic stimulator and attached to a biological tissue such as a heart, a nerve tissue, and a muscle to stimulate the tissue.

従来より、心臓ペースメーカー、埋込型除細動装置、神経刺激装置、疼痛緩和装置、てんかん治療装置、筋肉刺激装置等の電気刺激を直接または間接的に心臓、神経組織、筋肉等の生体組織に与え、治療を行う装置がある。これらの装置は、内部電源を有し電気的刺激を作り出す刺激発生装置を有しており、使用時に生体内に植え込まれる刺激発生装置と共に使用するための生体内植え込み可能な電極リードが付属していることが知られている。一般に、電極リードは、心臓、神経組織、筋肉等の生体組織に電気的刺激を与え、もしくはこれらの電気的興奮を感知するための少なくとも一つの電極と、心臓ペースメーカー、埋込型除細動装置、神経刺激装置、疼痛緩和装置、てんかん治療装置、筋肉刺激装置等の刺激発生装置に電気的接続を成すための電気コネクタ、および電極と電気コネクタの間に設けられ、電極と、心臓ペースメーカー、埋込型除細動装置、神経刺激装置、疼痛緩和装置、てんかん治療装置、筋肉刺激装置等の刺激発生装置と、の間で電気信号を伝えるための電気導体および生体適合性の絶縁被覆からなるリードボディから構成されている。   Conventionally, electrical stimulation from cardiac pacemakers, implantable defibrillators, nerve stimulators, pain relief devices, epilepsy treatment devices, muscle stimulators, etc., directly or indirectly to living tissues such as the heart, nerve tissue, muscles, etc. There are devices that give and treat. These devices have a stimulus generator that has an internal power source and produces electrical stimulation, and comes with an in vivo implantable electrode lead for use with the stimulus generator that is implanted in the body when in use. It is known that In general, an electrode lead provides at least one electrode for applying electrical stimulation to a living tissue such as the heart, nerve tissue, muscle, etc., or sensing these electrical excitations, a cardiac pacemaker, and an implantable defibrillator. An electrical connector for making an electrical connection to a stimulation generating device such as a nerve stimulating device, a pain relieving device, an epilepsy treatment device, a muscle stimulating device, and an electrode, a cardiac pacemaker, Lead comprising an electrical conductor and a biocompatible insulation coating for transmitting electrical signals to and from a stimulus generator such as a built-in defibrillator, nerve stimulator, pain relieving device, epilepsy treatment device, muscle stimulator, etc. It consists of a body.

特許文献1に記載の神経刺激用の生体内植え込み可能な電極アセンブリは、反対方向に向かう一対の螺旋状部分を持つ電極を有しており、この螺旋部分が神経に巻きつくように装着される。特許文献2に記載の神経組織に電気回路を接続するための電極システムは、電極の長軸方向に渡る中央の背骨構造とそこから左右に延びる肋骨状の電極支持部からなる構造であり、この肋骨状の電極支持部が神経に巻きつくように装着される。特許文献3に記載の生体植え込み用電極リードでは、上記した絶縁被覆の表面の一部に潤滑コート層が設けられている。   The in vivo implantable electrode assembly for nerve stimulation described in Patent Document 1 includes an electrode having a pair of spiral portions facing in opposite directions, and is mounted so that the spiral portions wrap around the nerve. . The electrode system for connecting an electric circuit to the nerve tissue described in Patent Document 2 is a structure comprising a central spine structure extending in the longitudinal direction of the electrode and a rib-like electrode support portion extending left and right therefrom. A rib-shaped electrode support is attached to the nerve. In the living body implanting electrode lead described in Patent Document 3, a lubricating coat layer is provided on a part of the surface of the insulating coating described above.

従来の電極は、植込み後に発生する生体組織(心臓、神経組織、筋肉等)と電極または電極リードにおいて電極を支持する構造との異物反応や、線維性被膜形成による生体インピーダンス上昇、ならびに刺激エネルギーの増大もしくは、電極装着部位での物理的応力に起因した虚血による生体組織構成細胞の死滅などの問題があった。これらの原因の1つとして、生体組織への電極の固定が不適切であることや、生体組織への電極の装着にばらつきがあることが挙げられる。
また、電極を生体組織に装着するのは技術的に容易ではなく、特別なトレーニングを必要としていた。電極を装着する生体組織として、神経組織を例に挙げると、電極を装着する神経組織周辺では、一般に、神経と血管が併走している。神経組織に電極を取り付ける際には、神経と血管を結合する結合織を部分的に剥離して、電極の長さ分だけ神経組織を露出させる必要がある。しかしながら、神経組織への影響を少なくするためには、結合織の剥離は最低限に留めるべきである。このように相反する結合織の剥離量の調整は術者の主観によるところで、技術を習得するためのトレーニングが必要であった。
Conventional electrodes have a foreign body reaction between living tissue (heart, nerve tissue, muscle, etc.) generated after implantation and a structure that supports the electrode in the electrode or electrode lead, an increase in bioimpedance due to the formation of a fibrous coating, and stimulation energy. There have been problems such as increase or death of cells constituting the body tissue due to ischemia due to physical stress at the electrode mounting site. One of these causes is improper fixation of the electrode to the living tissue and variations in the mounting of the electrode on the living tissue.
In addition, it is not technically easy to attach electrodes to living tissue, and special training is required. Taking a nerve tissue as an example of a living tissue to which an electrode is attached, generally, nerves and blood vessels run in parallel around the nerve tissue to which the electrode is attached. When attaching an electrode to the nerve tissue, it is necessary to partially peel away the connective tissue that connects the nerve and the blood vessel to expose the nerve tissue by the length of the electrode. However, connective tissue detachment should be kept to a minimum in order to reduce the impact on nerve tissue. In this way, the adjustment of the peeling amount of the opposite connective weave is based on the subjectivity of the surgeon, and training for learning the technique is necessary.

米国特許第4,920,979号明細書US Pat. No. 4,920,979 米国特許第5,095,905号明細書US Pat. No. 5,095,905 特開2005−58456号公報JP 2005-58456 A

本発明は、上記した従来技術の問題点を解決するため、心臓、神経組織、筋肉等の生体組織に電極を容易に装着することができ、生体組織への電極の不適切な固定や装着のばらつきを少なくすることができ、かつ電極を装着する際の生体組織周辺の結合織の剥離を最低限に抑えることができる生体植え込み用電極リードを提供することを目的とする。   In order to solve the above-described problems of the prior art, the present invention can easily attach an electrode to a living tissue such as heart, nerve tissue, muscle, etc., and improper fixing or attaching of the electrode to the living tissue. It is an object of the present invention to provide an electrode lead for implanting a living body that can reduce variation and can minimize the peeling of the connective tissue around the living tissue when the electrode is mounted.

上記の目的を達成するため、本発明は、少なくとも1つの電極を有する遠位端と、
電極駆動電源を有する刺激発生装置との接続手段を有する近位端と、
前記遠位端と前記近位端に接続され電気信号を伝達する電気導体および該電気導体を収容する管状体からなる導体部と、
前記電極が形成された少なくとも1つの腕部を有する電極支持体と、を有する生体植え込み用電極リードであって、前記電極支持体の少なくとも1つの前記腕部に電極支持体導入部が接続されていることを特徴とする生体植え込み用電極リードを提供する。
To achieve the above objective, the present invention comprises a distal end having at least one electrode;
A proximal end having means for connecting to a stimulus generator having an electrode drive power supply;
An electric conductor connected to the distal end and the proximal end for transmitting an electric signal, and a conductor portion made of a tubular body that accommodates the electric conductor;
An electrode support having at least one arm portion on which the electrode is formed, and an electrode lead for implanting a living body, wherein an electrode support introduction portion is connected to at least one arm portion of the electrode support. An electrode lead for living body implantation is provided.

本発明の生体植え込み用電極リードにおいて、前記電極支持体導入部が、前記電極支持体導入部本体と、前記腕部と前記電極支持体導入部本体とを接続する接続部と、を有しており、
前記接続部が、前記電極支持体導入部本体および前記腕部よりも幅が小さいことが好ましい。
In the electrode lead for living body implantation according to the present invention, the electrode support introduction portion includes the electrode support introduction portion main body, and a connection portion that connects the arm portion and the electrode support introduction portion main body. And
The connection part preferably has a width smaller than that of the electrode support body introduction part main body and the arm part.

本発明の生体植え込み用電極リードにおいて、前記電極支持体導入部と接続される前記腕部が湾曲形状を有しており、前記電極支持体導入部本体が前記湾曲形状よりも曲率が小さい面を有することが好ましい。   In the electrode lead for living body implantation according to the present invention, the arm portion connected to the electrode support introduction portion has a curved shape, and the electrode support introduction portion main body has a surface with a smaller curvature than the curved shape. It is preferable to have.

本発明の生体植え込み用電極リードにおいて、前記電極支持体導入部本体が、前記電極支持体導入部と接続される前記腕部よりも硬度が高いことが好ましい。   In the electrode lead for living body implantation according to the present invention, it is preferable that the electrode support body introduction portion main body has higher hardness than the arm portion connected to the electrode support body introduction portion.

本発明の生体植え込み用電極リードにおいて、前記電極支持体導入部と接続される前記腕部が、該腕部の残りの部位よりも幅が大きい部位を有することが好ましい。   In the living body implantable electrode lead of the present invention, it is preferable that the arm part connected to the electrode support body introducing part has a part having a width larger than the remaining part of the arm part.

本発明の生体植え込み用電極リードにおいて、前記幅が大きい部位が、前記電極支持体導入部の前記接続部から離間する方向に向かって、テーパー状に幅が大きくなっていることが好ましい。   In the electrode lead for implanting a living body according to the present invention, it is preferable that the portion having the large width is tapered in the direction of separating from the connection portion of the electrode support body introduction portion.

本発明は、心臓、神経組織、筋肉等の生体組織に電極を容易に装着することができるため、術者の習熟度の差による装着のばらつきを低減することができる。
また、心臓、神経組織、筋肉等の生体組織への電極の不適切な固定を少なくすることにより、植込み後に発生する生体組織と電極または電極支持部との異物反応、線維性被膜形成による生体インピーダンス上昇、ならびに刺激エネルギーの増大、もしくは、電極装着部位での物理的応力に起因した虚血による生体組織構成細胞の死滅を軽減することができる。
According to the present invention, since electrodes can be easily attached to biological tissues such as the heart, nerve tissue, and muscles, it is possible to reduce the variation in wearing due to differences in the skill level of the operator.
In addition, by reducing improper fixation of electrodes to living tissue such as heart, nerve tissue, muscle, etc., bioimpedance due to foreign body reaction between the living tissue and the electrode or electrode support generated after implantation, and formation of a fibrous coating It is possible to reduce the rise and increase of stimulation energy, or the death of living tissue constituent cells due to ischemia due to physical stress at the electrode mounting site.

以下、本発明の生体植え込み用電極リードについて図面を用いて説明する。
図1(a)〜(c)および図2(d)〜(e)は、本発明の生体植え込み用電極リード(以下、「電極リード」という。)の1実施形態を示した側面図である。図1(a)〜(c)および図2(d)〜(e)において、電極リードはその長軸を中心に回転させた状態(表示角度を変えた状態)で示されている。図1(b)は、図1(a)に対して、図面下側を手前側に向けて約90度回転させた状態、すなわち、図1(a)を下側から見た状態を示している。図1(c)は、図1(b)に対して、図面下側を手前側に向けて約60度回転させた状態を示している。なお、図1(c)は、電極リードの遠位端側の構造についての理解を容易にするため、わずかに斜視図となっている。図2(d)は、図1(b)に対して、図面下側を手前側に向けて約90度回転させた状態を示している。図2(e)は、図2(d)に対して、図面下側を手前側に向けて約90度回転させた状態を示している。図1および図2において、図面左側が電極リードの遠位端側であり、図面右側が近位端側である。図3は、図1(b)に示す電極リードを近位端側から見た端面図である。図4(a)は、図1(b)に示す電極リードを線A−Aに沿って切断した断面図であり、図4(b)はその部分拡大図である。図5(a)は、図1(b)に示す電極リードを線B−Bに沿って切断した断面図であり、図5(b)はその部分拡大図である。
Hereinafter, the electrode lead for living body implantation of the present invention is explained using a drawing.
FIGS. 1A to 1C and 2D to 2E are side views showing an embodiment of an electrode lead for living body implantation (hereinafter referred to as “electrode lead”) according to the present invention. . In FIGS. 1A to 1C and FIGS. 2D to 2E, the electrode lead is shown in a state of rotating about its major axis (a state in which the display angle is changed). FIG. 1 (b) shows a state in which the lower side of the drawing is rotated about 90 degrees with respect to FIG. 1 (a), that is, a state of FIG. 1 (a) viewed from the lower side. Yes. FIG.1 (c) has shown the state rotated about 60 degree | times with the lower side of drawing toward the near side with respect to FIG.1 (b). Note that FIG. 1C is a slightly perspective view in order to facilitate understanding of the structure of the distal end side of the electrode lead. FIG. 2D shows a state in which the lower side of the drawing is rotated about 90 degrees with respect to FIG. FIG. 2E shows a state in which the lower side of the drawing is rotated about 90 degrees with respect to FIG. 1 and 2, the left side of the drawing is the distal end side of the electrode lead, and the right side of the drawing is the proximal end side. FIG. 3 is an end view of the electrode lead shown in FIG. 1B as seen from the proximal end side. 4A is a cross-sectional view of the electrode lead shown in FIG. 1B cut along line AA, and FIG. 4B is a partially enlarged view thereof. Fig.5 (a) is sectional drawing which cut | disconnected the electrode lead shown in FIG.1 (b) along line BB, FIG.5 (b) is the elements on larger scale.

図1および図2において、長尺な中空の管状体からなるシース2は、電気導体8,9を収容する。電気導体8,9と、シース2と、で、本発明の電極リードの導体部が構成される。
シース2の材料としては、柔軟性及び電気的絶縁性を有し、かつ長期間にわたる生体への埋め込みが可能な生体適合性の高い材料が好ましく、具体的には、シリコーン樹脂、ポリウレタン樹脂等が挙げられる。
シース2の外表面には、特許文献3に記載の生体植込み用電極リードのように、潤滑コート層を形成してもよい。
1 and 2, a sheath 2 made of a long hollow tubular body accommodates electrical conductors 8 and 9. The electric conductors 8 and 9 and the sheath 2 constitute a conductor portion of the electrode lead of the present invention.
The material of the sheath 2 is preferably a highly biocompatible material that has flexibility and electrical insulation and can be implanted into a living body over a long period of time, and specifically, silicone resin, polyurethane resin, and the like. Can be mentioned.
A lubricant coat layer may be formed on the outer surface of the sheath 2 like the living body implanting electrode lead described in Patent Document 3.

シース2の遠位端には、電極支持体1が取り付けられている。電極支持体1は、3本の湾曲形状をした(カールした)腕1a,1b,1cを有している。
図4(a)および図5(a)に示すように、3本の腕1a,1b,1cのうち、最も遠位端側の腕1aと最も近位端側の腕1cは、シース2の長軸と平行する軸を包み込むように同一方向にカールしており、中央の腕1bは、他の2本の腕1a,1cに対して反対方向にカールしている。本発明の電極リードの電極支持体1を心臓、神経組織、筋肉等の生体組織に固定する際、これらカールした腕1a,1b,1cが、巻きつくように装着される。
An electrode support 1 is attached to the distal end of the sheath 2. The electrode support 1 has three curved (curled) arms 1a, 1b, and 1c.
As shown in FIGS. 4A and 5A, of the three arms 1a, 1b, and 1c, the arm 1a on the most distal end side and the arm 1c on the most proximal end side of the sheath 2 are The arm 1b is curled in the same direction so as to wrap around an axis parallel to the long axis, and the central arm 1b is curled in the opposite direction with respect to the other two arms 1a and 1c. When the electrode support 1 of the electrode lead of the present invention is fixed to a biological tissue such as the heart, nerve tissue, muscle, etc., these curled arms 1a, 1b, 1c are mounted so as to wrap around.

最も遠位端側の腕1aと中央の腕1bには、それぞれカールした腕1a,1bの内側に、それぞれ電極6,7が形成されている。このように、電極支持体1の長軸方向に離間して複数の電極を設けることにより、電極支持体1を心臓、神経組織、筋肉等の生体組織に固定した際、電極6,7が該生体組織に密着する。
図4(b)に示すように、シース2内を伸びる電極導体9は、電極支持体1との接続部から電極支持体1の壁内および腕1bの壁内を通過してから、カールした腕1bの外側で該腕1bの表面に露出し、電極7の延長部分(腕1bの外側に折り返した部分)と接続している。同様に、図5(b)に示すように、シース2内を伸びる電極導体8は、電極支持体1との接続部から電極支持体1の壁内および腕1aの壁内を通過してから、カールした腕1aの外側で該腕1aの表面に露出し、電極6の延長部分(腕1aの外側に折り返した部分)と接続している。なお、電極6,7の延長部分(腕1a,1bの外側に折り返した部分)は、電極リードを生体内に植え込んだ際、電極支持体1の外側に位置する生体組織と接触しないように、絶縁部材6a,7aによって被覆されている。絶縁部材6a,7aに好適な材料としては、生体適合性に優れた絶縁材料、例えば、シリコーン樹脂が挙げられる。
Electrodes 6 and 7 are formed on the innermost side of the curled arms 1a and 1b, respectively, on the most distal arm 1a and the central arm 1b. As described above, when the electrode support 1 is fixed to a biological tissue such as a heart, a nerve tissue, or a muscle by providing a plurality of electrodes spaced apart in the major axis direction of the electrode support 1, the electrodes 6 and 7 Adheres to living tissue.
As shown in FIG. 4B, the electrode conductor 9 extending in the sheath 2 was curled after passing through the wall of the electrode support 1 and the wall of the arm 1b from the connection portion with the electrode support 1. It is exposed on the surface of the arm 1b outside the arm 1b, and is connected to an extended portion of the electrode 7 (a portion folded back to the outside of the arm 1b). Similarly, as shown in FIG. 5B, the electrode conductor 8 extending in the sheath 2 passes through the wall of the electrode support 1 and the wall of the arm 1a from the connection portion with the electrode support 1. The outer surface of the curled arm 1a is exposed on the surface of the arm 1a, and is connected to the extended portion of the electrode 6 (the portion folded back to the outer side of the arm 1a). In addition, when the electrode lead is implanted in the living body, the extended portions of the electrodes 6 and 7 (the portions folded back on the arms 1a and 1b) do not come into contact with the living tissue located outside the electrode support 1. It is covered with insulating members 6a and 7a. As a material suitable for the insulating members 6a and 7a, an insulating material excellent in biocompatibility, for example, a silicone resin can be used.

シース2の近位端において、電極導体8はピンコネクタ3aに接続しており、電極導体9はリングコネクタ3bに接続している。ピンコネクタ3aと、リングコネクタ3bとは、絶縁部材3cにより電気的に絶縁されている。絶縁部材3cに好適な材料としては、生体適合性に優れた絶縁材料、例えば、シリコーン樹脂が挙げられる。
ピンコネクタ3aおよびリングコネクタ3bは、電極リードの使用時、刺激発生装置に設けられたコネクタと電気的および機械的に接続される接続手段である。刺激発生装置としては、心臓ペースメーカー、除細動装置、神経刺激装置、疼痛緩和装置、てんかん治療装置、または筋肉刺激装置等で従来から用いられているものを使用できる。刺激発生装置には、生体に植え込まれるものや、体外に装着されるものがあるが、いずれの場合も、電極駆動用電源(バッテリー)、治療用の刺激信号を発生するための電気回路、および電極リードのピンコネクタ3aおよびリングコネクタ3bと電気的および機械的に接続するためのコネクタを有している。
生体に植え込まれる刺激発生装置は、一般に円形、楕円形、または長方形であり、植込みに適した寸法である。生体植込みの刺激発生装置は一般に医師によって形成された患者の左胸部の皮膚の直ぐ下のポケット内に植込まれ、該生体植込み刺激発生装置の裏(または表)の面は胸筋に接しているが、必ずしも左胸部に植込まれる必要は無い。
At the proximal end of the sheath 2, the electrode conductor 8 is connected to the pin connector 3a, and the electrode conductor 9 is connected to the ring connector 3b. The pin connector 3a and the ring connector 3b are electrically insulated by an insulating member 3c. As a material suitable for the insulating member 3c, an insulating material excellent in biocompatibility, for example, a silicone resin can be used.
The pin connector 3a and the ring connector 3b are connection means that are electrically and mechanically connected to a connector provided in the stimulus generator when the electrode lead is used. As the stimulus generation device, those conventionally used for cardiac pacemakers, defibrillation devices, nerve stimulation devices, pain relief devices, epilepsy treatment devices, muscle stimulation devices, and the like can be used. Stimulation generators include those that are implanted in the living body and those that are worn outside the body. In any case, an electrode driving power source (battery), an electrical circuit for generating a stimulation signal for treatment, And a connector for electrically and mechanically connecting the electrode lead pin connector 3a and the ring connector 3b.
A stimulus generator implanted in a living body is generally circular, elliptical, or rectangular, and has dimensions suitable for implantation. A living body stimulation generator is generally implanted in a pocket formed by a doctor in a pocket just below the skin of a patient's left chest, and the back (or front) surface of the living body stimulation generator is in contact with the pectoral muscle. However, it does not have to be implanted in the left chest.

図6は、図1に示す電極支持体1の展開図である。図6に示すように、電極支持体1の中央の腕部1bには、電極支持体導入部4が接続されている。電極支持体導入部4は、環状の電極支持体導入部本体4aと、腕部1bと電極支持体本体4aとを接続する接続部4bと、で構成される。該接続部4bは、柔軟かつ細い糸状体からなる。
糸状体からなる接続部4bは、電極支持体導入部本体4aおよび腕部1bに比べて幅が小さくなっている。このように構成することで、後述する手順で、腕部1bを心臓、神経組織、筋肉等の生体組織に巻きつくように装着し、該生体組織に電極支持体1を固定した後、不要となった電極支持体導入部4を、接続部4bを切断することで容易に除去できる。図7は、図6と同様の図であり、電極支持体1を心臓、神経組織、筋肉等の生体組織に装着した後、接続部4bを切断して電極支持体導入部4を除去した後の状態を示している。
FIG. 6 is a development view of the electrode support 1 shown in FIG. As shown in FIG. 6, an electrode support introducing portion 4 is connected to the central arm portion 1 b of the electrode support 1. The electrode support body introduction part 4 includes an annular electrode support body introduction part body 4a and a connection part 4b that connects the arm part 1b and the electrode support body body 4a. The connecting portion 4b is made of a flexible and thin thread-like body.
The connecting portion 4b made of a filament has a smaller width than the electrode support body introducing portion main body 4a and the arm portion 1b. With this configuration, it is unnecessary to attach the arm 1b so as to wrap around a biological tissue such as the heart, nerve tissue, muscle, etc., and fix the electrode support 1 to the biological tissue in the procedure described later. The formed electrode support body introduction part 4 can be easily removed by cutting the connection part 4b. FIG. 7 is a view similar to FIG. 6, after the electrode support 1 is attached to a biological tissue such as the heart, nerve tissue, muscle, etc., and after the connection portion 4 b is cut and the electrode support introduction portion 4 is removed. Shows the state.

図4(a)に示すように、電極支持体導入部本体4aは、環形状を側面視すると平板状であり、湾曲形状をした(カールした)腕部1bよりも曲率が小さい面(図4(a)では平面)を有している。このように構成することで、後述する手順で電極支持体1を心臓、神経組織、筋肉等の生体組織に装着する際に、結合織に形成した穴に電極支持体導入部本体4aを通過させる操作が容易になる。
また、結合織に形成した穴に電極支持体導入部本体4aを通過させる操作を容易にするという観点から、電極支持体導入部本体4aは比較的硬度が高い材料、具体的には、腕部1bよりも硬度が高い材料で作成されていることが好ましい。一方、腕部1bは、結合織に形成した穴に通過させ、その後、腕部1bを、心臓、神経組織、筋肉等の生体組織に巻きつくように装着させる操作を容易にするため、柔軟性及び電気的絶縁性を有する材料で作成されていることが好ましい。
As shown in FIG. 4 (a), the electrode support body introduction portion main body 4a has a flat plate shape when the ring shape is viewed from the side, and has a smaller curvature than the curved (curled) arm portion 1b (FIG. 4). (A) has a flat surface). With this configuration, when the electrode support 1 is attached to a biological tissue such as a heart, nerve tissue, muscle, or the like according to the procedure described later, the electrode support introduction body 4a is passed through a hole formed in the connective tissue. Easy to operate.
Further, from the viewpoint of facilitating the operation of passing the electrode support body introduction portion main body 4a through the hole formed in the connective weave, the electrode support body introduction portion main body 4a is made of a material having a relatively high hardness, specifically, an arm portion. It is preferably made of a material having a hardness higher than 1b. On the other hand, the arm portion 1b is passed through a hole formed in the connective weave, and then the arm portion 1b is flexible so as to facilitate the operation of attaching the arm portion 1b around a living tissue such as the heart, nerve tissue, muscle, etc. And preferably made of a material having electrical insulation.

腕部1bを含む電極支持体1の材料としては、柔軟性を有し、かつ長期間にわたる生体への埋め込みが可能な生体適合性の高いものが好ましい。このような材料としては、具体的には、シリコーン樹脂、ポリウレタン樹脂等が例示される。一方、電極支持体導入部本体4aの材料としては、生体適合性が高く、結合織に形成した穴を通過できる程度に硬度が高い材料であればよい。このような材料としては、ステンレスなどの金属材料や、ポリエチレン樹脂などの硬質樹脂材料が挙げられる。
接続部4bをなす糸状体の材料としては、生体適合性が高い材料であることが好ましい。このような材料としては、縫合糸などで実績のあるポリアミド(特にナイロン6やナイロン66)、ポリエステル、ポリプロピレン、シルクが好ましく挙げられる。
なお、接続部4bをなす糸状体は、後述する手順で電極リードの電極支持体1を心臓、神経組織、筋肉等の生体組織に巻きつくように装着させる際に、意図しない場面で切断しない程度の引っ張り強度を有していることが好ましい。
As a material of the electrode support 1 including the arm portion 1b, a material having flexibility and high biocompatibility that can be embedded in a living body for a long period of time is preferable. Specific examples of such materials include silicone resins and polyurethane resins. On the other hand, the material of the electrode support body introduction portion main body 4a may be any material that has high biocompatibility and high hardness to the extent that it can pass through the holes formed in the connective weave. Examples of such materials include metal materials such as stainless steel and hard resin materials such as polyethylene resin.
It is preferable that the material of the filaments forming the connection portion 4b is a material having high biocompatibility. Preferred examples of such a material include polyamides (especially nylon 6 and nylon 66), polyester, polypropylene, and silk that have a proven record in sutures.
In addition, the filamentous body forming the connection portion 4b is not cut in an unintended scene when the electrode support 1 of the electrode lead is attached so as to be wound around a biological tissue such as a heart, nerve tissue, muscle, or the like in the procedure described later. It is preferable to have a tensile strength of

図6に示すように、電極支持体導入部4と接続する腕部1bは、該腕部1bの残りの部位よりも幅が大きい部位(幅広部位)1dを有している。図6において、幅広部位1dは、電極支持体導入部4の接続部4bから離間する方向に向かってテーパー状に幅が大きくなっており、腕部1b全体としてやじり状の形状をしている。腕部1bが幅広部位1dを有していれば、腕部1bを結合織に形成した穴に通過させてから、心臓、神経組織、筋肉等の生体組織に巻きつくように装着させ、電極支持体1を生体組織に固定した際、該幅広部位1dが穴の縁に係止するため、腕部1bが結合織に形成した穴から抜けて、電極支持体1が生体組織から脱落することが防止される。図6に示すように、幅広部位1dが電極支持体導入部4の接続部4bから離間する方向に向かってテーパー状に幅が大きくなっていれば、腕部1bを結合織に形成した穴に通過させるのが容易であり、かつ、結合織に形成した穴に腕部1bを通過させた後、幅広部位1dが穴の縁に係止するので好ましい。   As shown in FIG. 6, the arm part 1b connected to the electrode support body introduction part 4 has a part (wide part) 1d having a larger width than the remaining part of the arm part 1b. In FIG. 6, the wide portion 1 d has a taper-like width increasing in a direction away from the connection portion 4 b of the electrode support introducing portion 4, and the arm portion 1 b as a whole has a twisted shape. If the arm portion 1b has a wide portion 1d, the arm portion 1b is passed through a hole formed in the connective tissue, and then attached to be wound around a biological tissue such as the heart, nerve tissue, muscle, and the like. When the body 1 is fixed to the living tissue, the wide portion 1d is locked to the edge of the hole, so that the arm 1b can come out of the hole formed in the connective weave, and the electrode support 1 can fall out of the living tissue. Is prevented. As shown in FIG. 6, if the width of the wide portion 1d increases in a tapered shape toward the direction away from the connection portion 4b of the electrode support body introduction portion 4, the arm portion 1b is formed in the hole formed in the connective weave. This is preferable because it is easy to pass through and the wide portion 1d is locked to the edge of the hole after passing the arm portion 1b through the hole formed in the connective weave.

以下、本発明の電極リードを心臓、神経組織、筋肉等の生体組織に装着する手順、より具体的には、電極リードの電極支持体を生体組織に装着する手順を、電極リードの電極支持体を神経組織(頚部迷走神経)に装着する場合を例に説明する。図8(a)〜(c)および図9(d)〜(e)は、図1(a)〜(c)および図2(d)〜(e)に示す電極リードの電極支持体1を神経100に装着した状態を示した図であり、図1(a)〜(c)および図2(d)〜(e)と同様に、電極リードをその長軸を中心に回転させた状態(表示角度を変えた状態)で示されている。図8(b)は、図8(a)に対して、図面下側を手前側に向けて約90度回転させた状態、すなわち、図8(a)の下側から見た状態を示している。図8(c)は、図8(b)に対して、図面下側を手前側に向けて約60度回転させた状態を示している。なお、図8(c)は、神経100への電極支持体1の装着状態の理解を容易にするため、わずかに斜視図となっている。図9(d)は、図8(b)に対して、図面下側を手前側に向けて約90度回転させた状態を示している。図9(e)は、図9(d)に対して、図面下側を手前側に向けて約90度回転させた状態を示している。図10は、図8(b)に示す電極リードを近位端側から見た端面図である。
図8および図9において、神経100と、それに並走する血管200と、は結合織(図示していない)により結合している。
Hereinafter, the procedure for attaching the electrode lead of the present invention to a living tissue such as the heart, nerve tissue, muscle, etc., more specifically, the procedure for attaching the electrode support of the electrode lead to the living tissue, the electrode support of the electrode lead Is described as an example in which is attached to nerve tissue (cervical vagus nerve). FIGS. 8A to 8C and FIGS. 9D to 9E show the electrode support 1 of the electrode lead shown in FIGS. 1A to 1C and FIGS. 2D to 2E. It is the figure which showed the state with which the nerve 100 was mounted | worn, and is the state which rotated the electrode lead centering on the major axis like FIG.1 (a)-(c) and FIG.2 (d)-(e) ( The display angle is changed). FIG. 8 (b) shows a state in which the lower side of the drawing is rotated about 90 degrees with respect to FIG. 8 (a), that is, a state seen from the lower side of FIG. 8 (a). Yes. FIG. 8C shows a state in which the lower side of the drawing is rotated about 60 degrees with respect to FIG. FIG. 8C is a slightly perspective view in order to facilitate understanding of the mounting state of the electrode support 1 to the nerve 100. FIG. 9D shows a state in which the lower side of the drawing is rotated about 90 degrees with respect to FIG. FIG. 9E shows a state in which the lower side of the drawing is rotated about 90 degrees with respect to FIG. FIG. 10 is an end view of the electrode lead shown in FIG. 8B as seen from the proximal end side.
8 and 9, the nerve 100 and the blood vessel 200 parallel to the nerve 100 are connected by a connective tissue (not shown).

図11(a)〜(d)は、電極リードの電極支持体1を神経100に装着する手順を示している。図11(a)に示すように、神経100と、血管200と、を結合する結合織を部分的に切開して、電極支持体導入部本体4aおよび腕部1bをさせるための穴300を形成する。穴300の大きさは、腕部1b、より具体的には、幅広部位1dを通過させるのに必要十分な大きさであればよい。なお、結合織の伸縮により、穴300は拡げることができるので、幅広部位1dよりわずかに小さい程度の寸法が好適である。
次に、図11(b)に示すように、上記手順で形成した穴300に電極支持体導入部本体4aを通過させる。電極支持体導入部本体4aは、硬く(腕部1bよりも硬度が高い材料で作成されている)、平板状である(腕部1bよりも曲率が小さい面を有する)ので、結合織に形成した穴300に、電極支持体導入部本体4aを通過させるのは比較的容易である。次に、電極支持体導入部本体4aを手で保持し、該導入部本体4aを上側に引き上げて穴300に腕部1bを通過させる。電極支持体導入部本体4aは環状であるため、該導入部本体4aを手で保持して上側に引き上げる操作が容易である。腕部1bは柔軟性を有する材料で作成されているため、該導入部本体4aを上側に引き上げた際、腕部1bは、図11(b)に示すように、真っ直ぐに伸ばされた状態となるので、穴300に該腕部1bを容易に通過させることができる。ここで、腕部1bのうち幅広部位1dが穴300を通過すればよく、腕部1b全体が穴300を通過することは必ずしも必要ではない。該導入部本体4aを上側に引き上げた際、腕1aおよび1cは穴300を通過せず、神経100の外側面(すなわち、結合織に対して裏面側の側面)に沿って引き上げられる。腕部1bが穴300を通過した後、該導入部本体4aを引き上げる力を弱めると、腕部1bが元のカールした形状に戻り、図11(c)に示すように、カールした腕1a,1b,1cが神経100に巻きつくように装着されて、電極支持体1が神経100に固定される。図11(c)に示す状態において、幅広部位1dが穴300の縁に係止するため、腕部1bが穴300から抜けて、電極支持体1が神経100から脱落するおそれがない。
次に、図11(d)に示すように、接続部4bの根元をはさみ等で切断して、不要となった電極支持体導入部4を除去する。糸状体からなる接続部4bは、はさみ等で容易に切断することができる。
FIGS. 11A to 11D show a procedure for attaching the electrode support 1 of the electrode lead to the nerve 100. FIG. As shown in FIG. 11A, the connective tissue connecting the nerve 100 and the blood vessel 200 is partially incised to form a hole 300 for causing the electrode support body main body 4a and the arm 1b. To do. The size of the hole 300 may be as large as necessary to allow the arm portion 1b, more specifically, the wide portion 1d to pass therethrough. In addition, since the hole 300 can be expanded by expansion and contraction of the connective weave, a dimension slightly smaller than the wide portion 1d is preferable.
Next, as shown in FIG. 11B, the electrode support body main body 4a is passed through the hole 300 formed by the above procedure. Since the electrode support body introduction portion main body 4a is hard (made of a material having a higher hardness than the arm portion 1b) and has a flat plate shape (having a surface with a smaller curvature than the arm portion 1b), it is formed in a bonded weave. It is relatively easy to pass the electrode support body introducing portion main body 4a through the hole 300 formed. Next, the electrode support body introducing portion main body 4a is held by hand, and the introducing portion main body 4a is pulled upward to pass the arm portion 1b through the hole 300. Since the electrode support body introduction portion main body 4a is annular, it is easy to hold the introduction portion main body 4a by hand and pull it upward. Since the arm portion 1b is made of a flexible material, when the introduction portion main body 4a is pulled upward, the arm portion 1b is straightened as shown in FIG. 11 (b). Therefore, the arm 1b can be easily passed through the hole 300. Here, it is only necessary that the wide portion 1d of the arm portion 1b passes through the hole 300, and it is not always necessary that the entire arm portion 1b passes through the hole 300. When the introduction portion main body 4a is pulled up, the arms 1a and 1c do not pass through the hole 300, but are pulled up along the outer surface of the nerve 100 (that is, the side surface on the back side with respect to the connective tissue). After the arm portion 1b passes through the hole 300, when the force for pulling up the introduction portion main body 4a is weakened, the arm portion 1b returns to the original curled shape, and as shown in FIG. The electrode support 1 is fixed to the nerve 100 by attaching 1b and 1c so as to wrap around the nerve 100. In the state shown in FIG. 11C, since the wide portion 1d is locked to the edge of the hole 300, there is no possibility that the arm 1b comes out of the hole 300 and the electrode support 1 falls off the nerve 100.
Next, as shown in FIG. 11D, the base of the connecting portion 4b is cut with scissors or the like to remove the electrode support introducing portion 4 that is no longer needed. The connecting portion 4b made of a filament can be easily cut with scissors or the like.

本発明の電極リードの各部の寸法は、必要に応じて適宜選択することができる。図示した電極リードの場合、各部の寸法は以下の通りである。
電極支持体1
長さ:12mm
腕部1a
長さ:5mm
幅(最広部):4.6mm
(最狭部):2mm
図4(a)に示す湾曲形状のφ:2.4mm
腕部1b
長さ:5mm
幅(最広部):6mm
(最狭部):4mm
図4(b)に示す湾曲形状のφ:2.4mm
腕部1c
長さ:5mm
幅:2mm
電極6
長さ:5mm(折り返し部分を含む)
幅:1mm
図4(a)において、腕部1bがなす湾曲形状の中心と、電極7の両端部と、がなす扇形の角度:120度
電極7
長さ:5mm(折り返し部分を含む)
幅:1mm
図5(a)において、腕部1aがなす湾曲形状の中心と、電極6の両端部と、がなす扇形の角度:120度
シース2
長さ:400〜500mm
電極支持体導入部本体4a
φ:3.3mm
接続部4b
長さ:7mm
The dimension of each part of the electrode lead of this invention can be suitably selected as needed. In the case of the illustrated electrode lead, the dimensions of each part are as follows.
Electrode support 1
Length: 12mm
Arm 1a
Length: 5mm
Width (widest part): 4.6 mm
(Narrowest part): 2 mm
Curved shape φ shown in FIG. 4A: 2.4 mm
Arm 1b
Length: 5mm
Width (widest part): 6mm
(Narrowest part): 4 mm
Curved shape φ shown in FIG. 4B: 2.4 mm
Arm 1c
Length: 5mm
Width: 2mm
Electrode 6
Length: 5mm (including folded part)
Width: 1mm
In FIG. 4A, a fan-shaped angle formed by the center of the curved shape formed by the arm 1b and both ends of the electrode 7 is 120 degrees.
Electrode 7
Length: 5mm (including folded part)
Width: 1mm
In FIG. 5A, a fan-shaped angle formed by the center of the curved shape formed by the arm 1a and both ends of the electrode 6 is 120 degrees.
Sheath 2
Length: 400-500mm
Electrode support body introduction body 4a
φ: 3.3 mm
Connection part 4b
Length: 7mm

以上、図面を用いて説明したが、本発明の電極リードは図示した態様に限定されない。例えば、図示した電極リードでは、電極支持体1が複数(3本)の腕部1a,1b,1cを有しているが、本発明の電極リードにおいて、電極支持体は少なくとも1つの腕部を有していればよい。また、図示した電極リードでは、腕部1a,1bに電極6,7が形成されているが、腕部1a,1cまたは腕部1b,1cに電極6,7が形成されていてもよい。また、腕部1a,1b,1cのうち、いずれか1つのみに電極が形成されていてもよい。この場合、電極に接続する電気導体は1つであってもよいし、複数であってもよい。また、腕部1a,1b,1cの全てに電極が形成されていてもよい。この場合、各電極に1つ電気導体が接続してもよいし、複数の電気導体が接続してもよい。
また、図示した電極リードでは、腕部1bに電極支持体導入部4が接続しているが、腕部1aまたは1cに電極支持体導入部4が接続していてもよい。また、本発明の電極リードにおいて、電極支持体が有する腕部の少なくとも1つに電極支持体導入部が接続されていればよいため、電極支持体導入部が複数あってもよく、腕部1a,1b,1cのうち、いずれか2つに電極支持体導入部が接続していてもよく、腕部1a,1b,1cの全てに電極支持体導入部が接続していてもよい。
また、電極支持体導入部4は、環状の電極支持体導入部本体4aと、糸状体からなる接続部4bと、で構成されるものに限定されず、他の形態であってもよい。具体的には、電極支持体導入部は、電極支持体の腕部よりも硬度が高く単体で結合織内の通過が容易な電極支持体導入部本体と、該導入部本体および電極支持体の腕部よりも幅が狭く切断が容易な接続部と、を有していればよい。したがって、例えば、電極支持体と一体成型で同じ材料から作ることも出来る。この場合、電極支持体本体は、電極支持体の腕部よりも厚みを設けるなどして、該腕部よりも硬度を高くすればよい。電極支持体導入部本体の形状も環状に限定されず、該導入部本体を手で保持して操作するのに好ましい限り他の形状、例えば、取っ手状やフック状の形状であってもよい。
また、刺激発生装置と電気的および機械的に接続するために、管状体(シース)の近位端に形成するコネクタ類もピンコネクタおよびリングコネクタに限定されず、各種コネクタを使用可能である。
以上、頚部迷走神経刺激用リードに最も適した形態を用いて、本発明の電極リードについて説明した。但し、本発明は、これに限定されるものではなく、刺激対象となる生体組織が、他の組織と結合または癒着している場合に、当該生体組織に巻きつけて装着・固定する電気刺激用のリードとして、頚部迷走神経刺激用以外にも様々な用途に適用することができる。
As mentioned above, although demonstrated using drawing, the electrode lead of this invention is not limited to the aspect shown in figure. For example, in the illustrated electrode lead, the electrode support 1 has a plurality (three) of arm portions 1a, 1b, and 1c. In the electrode lead of the present invention, the electrode support has at least one arm portion. It only has to have. In the illustrated electrode lead, the electrodes 6 and 7 are formed on the arm portions 1a and 1b, but the electrodes 6 and 7 may be formed on the arm portions 1a and 1c or the arm portions 1b and 1c. Moreover, the electrode may be formed only in any one among the arm parts 1a, 1b, and 1c. In this case, the electric conductor connected to the electrode may be one or plural. Moreover, the electrode may be formed in all the arm parts 1a, 1b, and 1c. In this case, one electrical conductor may be connected to each electrode, or a plurality of electrical conductors may be connected.
In the illustrated electrode lead, the electrode support introducing portion 4 is connected to the arm portion 1b, but the electrode support introducing portion 4 may be connected to the arm portion 1a or 1c. Further, in the electrode lead of the present invention, since the electrode support introducing portion may be connected to at least one of the arm portions of the electrode support, there may be a plurality of electrode support introducing portions, and the arm portion 1a. , 1b, 1c, the electrode support introduction part may be connected to any two of them, or the electrode support introduction part may be connected to all of the arms 1a, 1b, 1c.
Moreover, the electrode support body introduction part 4 is not limited to what is comprised by the cyclic | annular electrode support body introduction part main body 4a and the connection part 4b which consists of a thread-like body, Other forms may be sufficient. Specifically, the electrode support body introduction part has a higher hardness than the arm part of the electrode support body and is easy to pass through the connective woven alone, and the introduction part body and the electrode support body. It is only necessary to have a connection part that is narrower than the arm part and easy to cut. Therefore, for example, it can be made from the same material by integral molding with the electrode support. In this case, the electrode support body may be thicker than the arm portion of the electrode support body so that the hardness is higher than that of the arm portion. The shape of the electrode support body introduction portion main body is not limited to an annular shape, and may be other shapes, for example, a handle shape or a hook shape, as long as it is preferable to hold and operate the introduction portion main body by hand.
Further, the connectors formed at the proximal end of the tubular body (sheath) for electrical and mechanical connection with the stimulus generator are not limited to the pin connector and the ring connector, and various connectors can be used.
As described above, the electrode lead of the present invention has been described using the most suitable form for the cervical vagus nerve stimulation lead. However, the present invention is not limited to this, and when the biological tissue to be stimulated is bonded or adhered to another tissue, it is wound around the biological tissue and attached / fixed. As a lead, it can be applied to various uses other than cervical vagus nerve stimulation.

図1(a)〜(c)は、本発明の生体植え込み用電極リードの1実施形態を示した側面図である1A to 1C are side views showing an embodiment of an electrode lead for living body implantation according to the present invention. 図2(d)〜(e)は、図1(a)〜(c)と同様の図である。2D to 2E are views similar to FIGS. 1A to 1C. 図3は、図1(b)に示す電極リードを近位端側から見た端面図である。FIG. 3 is an end view of the electrode lead shown in FIG. 1B as seen from the proximal end side. 図4(a)は、図1(b)に示す電極リードを線A−Aに沿って切断した断面図であり、図4(b)はその部分拡大図である。4A is a cross-sectional view of the electrode lead shown in FIG. 1B cut along line AA, and FIG. 4B is a partially enlarged view thereof. 図5(a)は、図1(b)に示す電極リードを線B−Bに沿って切断した断面図であり、図5(b)はその部分拡大図である。Fig.5 (a) is sectional drawing which cut | disconnected the electrode lead shown in FIG.1 (b) along line BB, FIG.5 (b) is the elements on larger scale. 図6は、図1に示す電極リードの電極支持体1の展開図である。FIG. 6 is a development view of the electrode support 1 of the electrode lead shown in FIG. 図7は、図6と同様の図である。但し、電極支持体導入部が除去されている。FIG. 7 is a view similar to FIG. However, the electrode support introduction part is removed. 図8(a)〜(c)は、図1(a)〜(c)示す電極リードの電極支持体を神経組織(頚部迷走神経)に装着した状態を示した図である。FIGS. 8A to 8C are views showing a state in which the electrode support of the electrode lead shown in FIGS. 1A to 1C is attached to a nerve tissue (cervical vagus nerve). 図9(d)〜(e)は、図2(d)〜(e)に示す電極リードの電極支持体を神経組織(頚部迷走神経)に装着した状態を示した図である。FIGS. 9D to 9E are views showing a state in which the electrode support of the electrode lead shown in FIGS. 2D to 2E is attached to the nerve tissue (cervical vagus nerve). 図10は、図8(b)に示す電極リードを近位端側から見た端面図である。FIG. 10 is an end view of the electrode lead shown in FIG. 8B as seen from the proximal end side. 図11(a)〜(d)は、電極リードの電極支持体を神経組織(頚部迷走神経)に装着する手順を示した図である。FIGS. 11A to 11D are views showing a procedure for attaching the electrode support of the electrode lead to the nerve tissue (cervical vagus nerve).

符号の説明Explanation of symbols

1:電極支持体
1a,1b,1c:腕部
1d:幅広部位
2:シース
3a:ピンコネクタ
3b:リングコネクタ
3c:絶縁部材
4:電極支持体導入部
4a:電極支持体導入部本体
4b:接続部
6,7:電極
6a,7a:絶縁部材
8,9:電気導体
100:神経(頚部迷走神経)
200:血管
300:穴
1: Electrode support 1a, 1b, 1c: Arm 1d: Wide part 2: Sheath 3a: Pin connector 3b: Ring connector 3c: Insulating member 4: Electrode support introduction 4a: Electrode support introduction 4b: Connection Part 6, 7: Electrode 6a, 7a: Insulating member 8, 9: Electrical conductor 100: Nerve (cervical vagus nerve)
200: Blood vessel 300: Hole

Claims (6)

少なくとも1つの電極を有する遠位端と、
電極駆動電源を有する刺激発生装置との接続手段を有する近位端と、
前記遠位端と前記近位端に接続され電気信号を伝達する電気導体および該電気導体を収容する管状体からなる導体部と、
前記電極が形成された少なくとも1つの腕部を有する電極支持体と、を有する生体植え込み用電極リードであって、前記電極支持体の少なくとも1つの前記腕部に電極支持体導入部が接続されていることを特徴とする生体植え込み用電極リード。
A distal end having at least one electrode;
A proximal end having means for connecting to a stimulus generator having an electrode drive power supply;
An electric conductor connected to the distal end and the proximal end for transmitting an electric signal, and a conductor portion made of a tubular body that accommodates the electric conductor;
An electrode support having at least one arm portion on which the electrode is formed, and an electrode lead for implanting a living body, wherein an electrode support introduction portion is connected to at least one arm portion of the electrode support. An electrode lead for living body implantation.
前記電極支持体導入部が、前記電極支持体導入部本体と、前記腕部と前記電極支持体導入部本体とを接続する接続部と、を有しており、
前記接続部が、前記電極支持体導入部本体および前記腕部よりも幅が小さいことを特徴とする請求項1に記載の生体植え込み用電極リード。
The electrode support introducing portion has the electrode support introducing portion main body, and a connecting portion connecting the arm portion and the electrode support introducing portion main body,
The living body implantable electrode lead according to claim 1, wherein the connection portion has a width smaller than that of the electrode support body introduction portion main body and the arm portion.
前記電極支持体導入部と接続される前記腕部が湾曲形状を有しており、前記電極支持体導入部本体が、前記湾曲形状よりも曲率が小さい面を有することを特徴とする請求項2に記載の生体植え込み用電極リード。   3. The arm portion connected to the electrode support introducing portion has a curved shape, and the electrode support introducing portion main body has a surface having a smaller curvature than the curved shape. The electrode lead for living body implantation as described in 2. 前記電極支持体導入部本体が、前記電極支持体導入部と接続される前記腕部よりも硬度が高いことを特徴とする請求項2または3に記載の生体植え込み用電極リード。   The living body implantable electrode lead according to claim 2 or 3, wherein the electrode support body introduction part main body has higher hardness than the arm part connected to the electrode support body introduction part. 前記電極支持体導入部と接続される前記腕部が、該腕部の残りの部位よりも幅が大きい部位を有することを特徴とする請求項2ないし4のいずれかに記載の生体植え込み用電極リード。   The living body implanting electrode according to any one of claims 2 to 4, wherein the arm part connected to the electrode support body introducing part has a part having a width larger than the remaining part of the arm part. Lead. 前記幅が大きい部位が、前記電極支持体導入部の前記接続部から離間する方向に向かって、テーパー状に幅が大きくなっていることを特徴とする請求項5に記載の生体植え込み用電極リード。   6. The living body implantable electrode lead according to claim 5, wherein the width of the portion having the large width is increased in a tapered shape in a direction away from the connection portion of the electrode support body introduction portion. .
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JP2011152204A (en) * 2010-01-26 2011-08-11 Olympus Corp Electrode part and electrode system
JP2013042978A (en) * 2011-08-25 2013-03-04 Olympus Corp Electrode indwelling system
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US9050453B2 (en) 2010-03-19 2015-06-09 National Cerebral And Cardiovascular Center Electrostimulation system, and electrostimulation electrode assembly and biological implantable electrode therefore

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JP2011152204A (en) * 2010-01-26 2011-08-11 Olympus Corp Electrode part and electrode system
US8606368B2 (en) 2010-01-26 2013-12-10 Olympus Corporation Electrode unit, electrode system, electrode implanting apparatus, and electrode implanting system
US9050453B2 (en) 2010-03-19 2015-06-09 National Cerebral And Cardiovascular Center Electrostimulation system, and electrostimulation electrode assembly and biological implantable electrode therefore
JP2013042978A (en) * 2011-08-25 2013-03-04 Olympus Corp Electrode indwelling system

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