JPH0810338A - Electrode lead for heart pacemaker - Google Patents

Electrode lead for heart pacemaker

Info

Publication number
JPH0810338A
JPH0810338A JP14605594A JP14605594A JPH0810338A JP H0810338 A JPH0810338 A JP H0810338A JP 14605594 A JP14605594 A JP 14605594A JP 14605594 A JP14605594 A JP 14605594A JP H0810338 A JPH0810338 A JP H0810338A
Authority
JP
Japan
Prior art keywords
electrode
electrode lead
coating film
polymer
lead
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP14605594A
Other languages
Japanese (ja)
Inventor
Katsuhiro Shirakawa
勝啓 白川
Kenichi Shimura
賢一 志村
Naoki Ishii
直樹 石井
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KAAGEO P SHINGU RES LAB KK
KAAGEO P-SHINGU RES LAB KK
Terumo Corp
Original Assignee
KAAGEO P SHINGU RES LAB KK
KAAGEO P-SHINGU RES LAB KK
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by KAAGEO P SHINGU RES LAB KK, KAAGEO P-SHINGU RES LAB KK, Terumo Corp filed Critical KAAGEO P SHINGU RES LAB KK
Priority to JP14605594A priority Critical patent/JPH0810338A/en
Publication of JPH0810338A publication Critical patent/JPH0810338A/en
Pending legal-status Critical Current

Links

Abstract

PURPOSE:To enhance the slidability or the like of a silicone insulation coating film, in an electrode lead for a heart pacemaker consisting of an end electrode part, a conductor part, and a base end connector part, by coating a hydrophilic polymer on the surface of the polymer insulation coating film in the conductor part. CONSTITUTION:An electrode lead for a heart pacemaker is made up of an end electrode part 1, a conductor part 2, and a base end connector part 3. To the end electrode 1, for instance, a different electrode 4 and an indifferent electrode 5 are used. Further, to the conductor part 2 such as an enlarged part 6, both lead wires of the different electrode and the indifferent electrode are arranged. In this case, a hydrophilic polymer is applied on the surface of the polymer insulation coating film in the conductor part 2. Thus, the slidability of the silicone insulation coating film can be enhanced, and the inserting operation of the electrode lead into a heart cavity through a blood vessel can be facilitated. On the other hand, the separation of the coating film during a long period of embedded use can be prevented.

Description

【発明の詳細な説明】Detailed Description of the Invention

【0001】[0001]

【産業上の利用分野】本発明は、血管への挿入性を改良
した心臓ペースメーカ用の電極リードに関するものであ
る。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an electrode lead for a cardiac pacemaker, which has improved insertability into blood vessels.

【0002】[0002]

【従来の技術】従来、代表的な心臓ペースメーカ用の電
極リードはリード本体を形成するシリコーンゴムあるい
はポリウレタン製の高分子絶縁材料によって被覆される
コバルト、クロムおよびモリブデン等の合金からなる1
つ以上の導体ワイヤコイルで形成され、ペースメーカ本
体に接続されるコネクタを有する基端部と心臓組織を刺
激し、かつ心臓活動の電気信号を検出するための末端電
極部を有しているのが知られている。
2. Description of the Related Art Conventionally, a typical electrode lead for a cardiac pacemaker is made of an alloy such as cobalt, chromium and molybdenum coated with a polymer insulating material made of silicone rubber or polyurethane which forms the lead body.
A proximal end formed of one or more conductor wire coils and having a connector connected to the pacemaker body and a distal electrode portion for stimulating cardiac tissue and detecting electrical signals of cardiac activity. Are known.

【0003】[0003]

【発明が解決しようとする課題】しかしながら、このよ
うな従来の心臓ペースメーカ用の電極リードにあって
は、前述のように高分子絶縁材料にポリウレタンを使用
した場合、シリコーンゴムと比較して機械的強度に優れ
るためリードの細径化が可能であり、また、血管内での
摺動性が良好である。しかし、ポリウレタンは導体ワイ
ヤコイルに用いられているコバルト、クロムおよびモリ
ブデンとの接触により酸化性劣化を生じることが経験よ
り分かっており、生体内での数年の使用期間中に受ける
繰り返しの屈曲ストレス等によって亀裂の発生や体液の
浸入が起こる。
However, in such a conventional electrode lead for a cardiac pacemaker, when polyurethane is used as the polymer insulating material as described above, it is more mechanical than silicone rubber. Since the strength is excellent, the diameter of the lead can be reduced, and the slidability in the blood vessel is good. However, experience has shown that polyurethane is oxidatively deteriorated by contact with cobalt, chromium and molybdenum used in conductor wire coils, and the repeated bending stress received during several years of in vivo use. As a result, cracks and body fluid infiltration occur.

【0004】また、高分子絶縁材料にシリコーンゴムを
用いた場合は、十年以上の長期の生体内植え込みに対し
ても化学的に安定なため、機械的強度を補うよう被覆に
肉厚を厚くしてやればポリウレタンのような致命的なト
ラブルの発生確率は低いが、素材そのものの動摩擦係数
が比較的高いため、植え込み時の血管壁との摩擦により
摺動抵抗が大きく、電極リードの血管から心腔内へのア
プローチに手間取ることがある。
Further, when silicone rubber is used as the polymer insulating material, it is chemically stable even when it is implanted in a living body for a long period of ten years or more. Therefore, the thickness of the coating is increased so as to supplement the mechanical strength. Although the probability of fatal trouble such as polyurethane is low, the sliding coefficient is large due to the friction with the blood vessel wall at the time of implantation because the material itself has a relatively high coefficient of dynamic friction, and the blood vessels from the electrode leads to the heart chamber. It may take some time to approach inside.

【0005】[0005]

【課題を解決するための手段】本発明は、上述したよう
な問題を解消するため、発明者らは鋭意開発を進めた結
果、徐脈性不整脈等の疾患を有する患者の心臓の心房ま
たは心室、もしくはこれらの両者にタイミングの良い電
気的刺激信号を与えることによって性状な心拍活動を喚
起するために、通常患者の胸部皮下に植え込まれるパル
ス発生器としてのペースメーカ本体と電気的に接続さ
れ、経静脈的にペースメーカ本体からの電気的刺激信号
を心臓の前記所定部位に導くための電極リードを提供す
ることにある。その発明の要旨とするところは、先端電
極部と導体部および基端コネクタ部からなる心臓ペース
メーカ用電極リードにおいて、該導体部の高分子絶縁被
膜の表面に親水性高分子をコーティングしたものであ
る。また、特に高分子絶縁被膜が加硫ゴム、好ましくは
シリコーンゴムであり、さらには親水性高分子が化学的
結合により高分子絶縁被膜表面にコーティングされた心
臓ペースメーカ用の電極リードである。
In order to solve the above-mentioned problems, the present invention has been intensively developed by the present inventors, and as a result, the atrium or ventricle of the heart of a patient having a disease such as bradyarrhythmia. Or, in order to arouse the characteristic heartbeat activity by applying a timely electrical stimulation signal to both of them, it is electrically connected to the pacemaker body as a pulse generator that is usually implanted in the chest of the patient. An object is to provide an electrode lead for guiding an electrical stimulation signal from the pacemaker body to the predetermined part of the heart transvenously. The gist of the invention is an electrode lead for a cardiac pacemaker comprising a tip electrode part, a conductor part, and a base end connector part, in which a hydrophilic polymer is coated on the surface of the polymer insulating coating of the conductor part. . In particular, the polymer insulating coating is a vulcanized rubber, preferably a silicone rubber, and further, a hydrophilic polymer is an electrode lead for a cardiac pacemaker in which the surface of the polymer insulating coating is coated by chemical bonding.

【0006】以下、本発明について図面に従って詳細に
説明する。図1は本発明に係る心臓ペースメーカ用電極
リードの概略図である。この図に示すように、先端電極
部1と導体部2及び基端コネクタ部3より構成され、先
端電極部1には、例えば関電極4及び不関電極5の2つ
の電極が使用され、従って拡大部6のように導体部2に
は、この関電極リードと不関電極リードの2つのリード
線を通し、このリード線を絶縁材料による被膜によって
絶縁された構成からなっている。この導体部の高分子絶
縁被膜としては加硫ゴムが使用される。特に、本発明に
使用されるものとしてはシリコーン、フルオロシリコー
ン及びフッ素系エラストマー等を掲げることが出来る。
The present invention will be described in detail below with reference to the drawings. FIG. 1 is a schematic view of an electrode lead for a cardiac pacemaker according to the present invention. As shown in this figure, it is composed of a tip electrode portion 1, a conductor portion 2 and a base end connector portion 3. For the tip electrode portion 1, for example, two electrodes, a common electrode 4 and an indifferent electrode 5, are used. Like the enlarged portion 6, the conductor portion 2 is configured such that two lead wires, that is, the related electrode lead and the indifferent electrode lead, are passed through, and the lead wires are insulated by a film made of an insulating material. Vulcanized rubber is used as the polymer insulating coating of the conductor portion. In particular, silicones, fluorosilicones, fluoroelastomers and the like can be cited as those used in the present invention.

【0007】これらの材料は従来のポリウレタン等に比
較して耐久性や安定性が高いことで優れているが、潤滑
性が従来のポリウレタン等に比較して劣ることから、本
発明においては、この絶縁被膜の表面に親水性高分子を
コーティングすることによって血管への挿入性を改善し
たものである。すなわち、親水性高分子として、例えば
アクリル酸系ポリマーを使用することにより、シリコー
ンとの相互作用によってシリコーン表面に潤滑性を付与
するものである。その手段としては、 (1)基材であるシリコーンにプラズマ開始グラフト重
合法により潤滑性を有するポリマーを固定化させる。 (2)基材であるシリコーンにプラズマ開始グラフト重
合法により反応性基を有するポリマーを導入し、該反応
性基と潤滑性を有するポリマーとを反応させ潤滑性を発
現させる、のいずれかによって行われる。 このようにして潤滑性を有するポリマーが固定化されれ
ば、アクリル酸系ポリマーに拘らず、いかなるポリマー
であっても、特に限定されるものではない。ただし、基
材との相溶性及び操作性の観点からはアクリル酸系ポリ
マーが好ましい。
These materials are superior in durability and stability as compared with conventional polyurethanes and the like, but are inferior in lubricity as compared with conventional polyurethanes and the like. By inserting a hydrophilic polymer on the surface of the insulating film, the insertability into a blood vessel is improved. That is, by using, for example, an acrylic acid-based polymer as the hydrophilic polymer, lubricity is imparted to the silicone surface by interaction with silicone. As the means, (1) a polymer having lubricity is immobilized on silicone as a base material by a plasma-initiated graft polymerization method. (2) A polymer having a reactive group is introduced into a silicone as a base material by a plasma-initiated graft polymerization method, and the reactive group is reacted with a polymer having a lubricity to develop lubricity. Be seen. As long as the polymer having lubricity is fixed in this manner, any polymer is not particularly limited regardless of the acrylic acid-based polymer. However, an acrylic acid-based polymer is preferable from the viewpoint of compatibility with the substrate and operability.

【0008】図2はシャフトの潤滑性を評価するための
実験装置の概念図である。すなわち、図2は本発明の実
施例と比較例におけるシャフトの潤滑性を評価するため
の実験装置であって、オートグラフ7を用いシャフト8
をチャック9で吊り下げた状態において、このシャフト
8をパイプ10内で繰り返し水槽11中を上下に移動さ
せたときの抵抗値を記録するものである。
FIG. 2 is a conceptual diagram of an experimental device for evaluating the lubricity of a shaft. That is, FIG. 2 shows an experimental apparatus for evaluating the lubricity of the shaft in the example of the present invention and the comparative example.
The resistance value when the shaft 8 is repeatedly moved up and down in the water tank 11 in the pipe 10 in a state where the shaft 8 is suspended by the chuck 9 is recorded.

【0009】[0009]

【作用】上述したような構成によれば、生体内における
十年以上の長期間の植え込み使用に耐久性を有し、かつ
経血管的な心腔内への挿入操作が容易な心臓ペースメー
カ用の電極リードの実現が可能となった。
According to the above-described structure, it is suitable for a cardiac pacemaker that has durability for a long-term implantation of 10 years or more in a living body and is easily transvascularly inserted into a heart chamber. It has become possible to realize electrode leads.

【0010】[0010]

【実施例】以下、本発明について実施例に従って具体的
に説明する。 実施例1 外径2mmのシリコーンシャフト(Silastic
Q7−4750:Dow Corning社製)の表面
に低温プラズマ(Ar:0.1torr)を10秒間照
射した後、ジメチルアクリルアミドモノマーを気相にて
供給し、288Kの温度で表面グラフト重合を行なっ
た。該シャフトはジメチルアクリルアミドモノマー及び
ポリジメチルアクリルアミドの良溶媒にて1日間洗浄し
た後乾燥させた。得られたシャフトは生理食塩水または
水で湿潤させると優れた潤滑性を示した。潤滑性判定の
指標として、図2に示すような実験装置で摺動抵抗の評
価を行った。具体的には、オートグラフAGS−100
A(島津製作所製)を用い、水中において内径2.2m
mのパイプ内で該シャフトを繰り返し上下に移動(10
0回程度)させたときの抵抗値を記録した。その結果を
表1に示す。
EXAMPLES The present invention will be specifically described below with reference to examples. Example 1 Silicone shaft having an outer diameter of 2 mm (Silastic
After irradiating the surface of Q7-4750: Dow Corning) with low temperature plasma (Ar: 0.1 torr) for 10 seconds, dimethyl acrylamide monomer was supplied in a gas phase to carry out surface graft polymerization at a temperature of 288K. The shaft was washed with a good solvent of dimethylacrylamide monomer and polydimethylacrylamide for 1 day and then dried. The resulting shaft showed excellent lubricity when wetted with physiological saline or water. As an index for determining the lubricity, the sliding resistance was evaluated with an experimental device as shown in FIG. Specifically, Autograph AGS-100
A (manufactured by Shimadzu Corporation) is used, and the inside diameter is 2.2 m in water.
Repeatedly move the shaft up and down in the m pipe (10
The resistance value was recorded when the resistance was set to 0 times. Table 1 shows the results.

【0011】実施例2〜4 実施例1と同様のシリコーンシャフトの表面に低温プラ
ズマ(Ar:0.1torr)を10秒間照射した後、
表1に示すモノマーを気相にて供給し、288Kの温度
で表面グラフト重合を行なった。該シャフトは良溶媒に
て1日間洗浄した後乾燥させ、5%、1,4−ジアミノ
ブタンアセトン溶液中で40℃、6時間反応させた(基
材表面へのアミノ基の導入)、乾燥後無水マレイン酸2
%アセトン溶液(触媒ピリジン1%を含む)中に浸し、
40℃、2時間反応させ、更に炭酸水素ナトリウムによ
り中和し、潤滑性を有するシャフトを得た。潤滑性判定
の指標として、実施例1と同様の試験を行った。そのと
きの抵抗値を表1に示す。
Examples 2 to 4 After irradiating the surface of the same silicone shaft as in Example 1 with low temperature plasma (Ar: 0.1 torr) for 10 seconds,
The monomers shown in Table 1 were supplied in the gas phase, and surface graft polymerization was carried out at a temperature of 288K. The shaft was washed with a good solvent for 1 day, dried, and allowed to react in a 5% 1,4-diaminobutaneacetone solution at 40 ° C. for 6 hours (introduction of an amino group to the surface of the base material), and after drying. Maleic anhydride 2
% Acetone solution (containing 1% catalyst pyridine),
The mixture was reacted at 40 ° C. for 2 hours and further neutralized with sodium hydrogen carbonate to obtain a shaft having lubricity. The same test as in Example 1 was conducted as an index for determining the lubricity. The resistance value at that time is shown in Table 1.

【0012】比較例1 未処理のシリコーンシャフトにて、実施例1と同様の試
験を行った。そのときの抵抗値を表1に示す。 比較例2 外径2mmのポリウレタンシャフト(Pelletha
ne 80AE:Daw Chemical社製)に
て、実施例1と同様の試験を行った。そのときの抵抗値
を表1に示す。
Comparative Example 1 The same test as in Example 1 was carried out on an untreated silicone shaft. The resistance value at that time is shown in Table 1. Comparative Example 2 Polyurethane shaft with an outer diameter of 2 mm (Pelletha
ne 80AE: manufactured by Daw Chemical), the same test as in Example 1 was performed. The resistance value at that time is shown in Table 1.

【0013】[0013]

【表1】 [Table 1]

【0014】[0014]

【発明の効果】以上述べたように本発明によれば、心臓
ペースメーカ用の電極リードの絶縁被膜表面に親水性高
分子膜をコーティングすることにより、シリコーン絶縁
被膜の摺動性が向上するため、電極リードの経血管的な
心腔内への挿入操作が容易になる。さらに、絶縁被膜表
面への親水性高分子膜のコーティングが化学的結合によ
り得られることにより、絶縁被膜と親水性高分子膜の結
合が強固であるため、挿入操作時間や長期間の植え込み
使用中にコーティング膜が剥がれて肺塞栓症の要因とな
ることもない優れた効果を奏するものである。
As described above, according to the present invention, by coating the surface of the insulating coating of the electrode lead for a cardiac pacemaker with the hydrophilic polymer film, the sliding property of the silicone insulating coating is improved. The operation of inserting the electrode lead into the heart chamber in a transvascular manner becomes easy. Furthermore, since the hydrophilic polymer film coating on the surface of the insulation film is obtained by chemical bonding, the bond between the insulation film and the hydrophilic polymer film is strong. In addition, the coating film is not peeled off to cause pulmonary embolism, which is an excellent effect.

【図面の簡単な説明】[Brief description of drawings]

【図1】本発明に係る心臓ペースメーカ用の電極リード
の概略図、
FIG. 1 is a schematic view of an electrode lead for a cardiac pacemaker according to the present invention,

【図2】シャフトの潤滑性を評価するための実験装置の
概念図である。
FIG. 2 is a conceptual diagram of an experimental device for evaluating the lubricity of a shaft.

【符号の説明】[Explanation of symbols]

1 先端電極部 2 導体部 3 基端コネクタ部 4 関電極 5 不関電極 6 導体部の拡大部 7 オートグラフ 8 シャフト 9 チャック 10 パイプ 11 水槽 1 tip electrode part 2 conductor part 3 base end connector part 4 related electrode 5 indifferent electrode 6 enlarged part of conductor part 7 autograph 8 shaft 9 chuck 10 pipe 11 water tank

───────────────────────────────────────────────────── フロントページの続き (72)発明者 志村 賢一 神奈川県足柄上郡中井町井ノ口1500番地 テルモ株式会社内 (72)発明者 石井 直樹 神奈川県足柄上郡中井町井ノ口1500番地 テルモ株式会社内 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Kenichi Shimura, Inoguchi 1500, Nakano-cho, Ashigagami-gun, Kanagawa Terumo Corporation (72) Inventor Naoki Ishii, Inoguchi, Nakai-cho, Ashigagami-gun, Kanagawa 1500 Terumo Corporation

Claims (1)

【特許請求の範囲】[Claims] 【請求項1】 先端電極部と導体部および基端コネクタ
部からなる心臓ペースメーカ用電極リードにおいて、該
導体部の高分子絶縁被膜の表面に親水性高分子をコーテ
ィングしたことを特徴とする心臓ペースメーカ用の電極
リード。
1. A cardiac pacemaker, comprising: an electrode lead for a cardiac pacemaker, which comprises a tip electrode portion, a conductor portion, and a proximal end connector portion, wherein a hydrophilic polymer is coated on the surface of a polymer insulating film of the conductor portion. Electrode lead for.
JP14605594A 1994-06-28 1994-06-28 Electrode lead for heart pacemaker Pending JPH0810338A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP14605594A JPH0810338A (en) 1994-06-28 1994-06-28 Electrode lead for heart pacemaker

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP14605594A JPH0810338A (en) 1994-06-28 1994-06-28 Electrode lead for heart pacemaker

Publications (1)

Publication Number Publication Date
JPH0810338A true JPH0810338A (en) 1996-01-16

Family

ID=15399075

Family Applications (1)

Application Number Title Priority Date Filing Date
JP14605594A Pending JPH0810338A (en) 1994-06-28 1994-06-28 Electrode lead for heart pacemaker

Country Status (1)

Country Link
JP (1) JPH0810338A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1314449A2 (en) 2001-11-26 2003-05-28 Terumo Kabushiki Kaisha Implantable electrode lead
US7187981B2 (en) 2003-08-12 2007-03-06 Terumo Kabushiki Kaisha Implantable electrode lead
JP2013500765A (en) * 2009-09-02 2013-01-10 カーディアック ペースメイカーズ, インコーポレイテッド Method of forming a coating on a medical electrical lead body without using a solvent

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1314449A2 (en) 2001-11-26 2003-05-28 Terumo Kabushiki Kaisha Implantable electrode lead
US6985777B2 (en) 2001-11-26 2006-01-10 Terumo Kabushiki Kaisha Implantable electrode lead
US7187981B2 (en) 2003-08-12 2007-03-06 Terumo Kabushiki Kaisha Implantable electrode lead
JP2013500765A (en) * 2009-09-02 2013-01-10 カーディアック ペースメイカーズ, インコーポレイテッド Method of forming a coating on a medical electrical lead body without using a solvent
US8753708B2 (en) 2009-09-02 2014-06-17 Cardiac Pacemakers, Inc. Solventless method for forming a coating on a medical electrical lead body

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