JP5619899B2 - ポリイソブチレン系ポリマー及びその誘導体を含んだ植え込み型医療用リード - Google Patents
ポリイソブチレン系ポリマー及びその誘導体を含んだ植え込み型医療用リード Download PDFInfo
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Description
第7の実施形態は、上記の実施形態のいずれかに記載の植え込み型医療用リードであって、リード本体が内部ルーメンを有し、内部ルーメンの内面がポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体のいずれかを含む。
第13の実施形態は、上記の実施形態のいずれかに記載の植え込み型医療用リードであって、中間領域のショア硬度が60A〜85Aである。
第15の実施形態は、上記の実施形態のいずれかに記載の植え込み型医療用リードであって、基端側領域、中間領域、及び先端領域の追加的ポリマーセグメントがポリテトラメチレンオキシドジオールの残留物を含む。
第26の実施形態は、上記の実施形態のいずれかに記載の植え込み型医療用リードであって、ポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体が不飽和ポリイソブチレンセグメントを含む。
第31の実施形態は、上記の実施形態のいずれかに記載の植え込み型医療用リードであって、リード本体を形成する工程が、第1のショア硬度を有する基端側領域、第2のショア硬度を有する中間領域、及び第3のショア硬度を有する先端側領域を形成する工程を含み、同基端側領域、中間領域、及び先端側領域のそれぞれがポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体のいずれかを含む。
本発明のいくつかの実施形態による植え込み型又は挿入型医療器具は、ポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体のいずれかもしくは複数(以下、集合的に「ポリイソブチレンウレタン共重合体」と呼ぶ)を含んだ1つ以上のポリマー領域を有する。ポリマー領域は、例えば50重量%以下から、75重量%、90重量%、95重量%、97.5重量%、99重量%、又はそれ以上のポリマーを含んだ領域(例えば、器具全体、絶縁層、器具部品、及び器具のコーティング層)を指す。
ポリウレタンは、多官能性イソシアネート(脂肪族ジイソシアナート及び芳香族ジイソシアナートの両方を含んだジイソシアナート等)、及びポリオール(マクログリコール等)から合成される共重合体の族のひとつである。一般的なマクログリコールは、ポリウレタンのポリマーセグメントを形成するポリエステルジオール、ポリエーテルジオール、及びポリカーボネートジオールを含む。一般的に脂肪族又は芳香族のジオール又はジアミンも鎖延長剤として用いられ、その結果、例えばポリウレタンの物理特性を向上される。鎖延長剤としてジアミンを用いる場合、尿素結合が形成され、得られるポリマーはポリウレタン/ポリ尿素と呼ばれる。
図7Bは、図7Aに示す器具のB−B線における断面図である。この図には、2つのルーメンを有する内部長尺状部材140及び外側管状絶縁層120が示されている。内部長尺状部材140のルーメンは、例えばガイドワイヤ、1つの導体、及び2つの導体等を収容する。内部長尺状部材は、1つ、4つ、5つ、6つ、7つ、又は8つ等のルーメンを備えた部材等、他の構成を有する部材であってもよい。
例えば本発明の一実施形態によるポリイソブチレンウレタン共重合体が熱可塑性を有する場合、様々な熱可塑性処理方法によりポリマー領域を形成できる。このような方法においては、ポリマーがケイ酸塩や治療薬等の任意の追加的物質とともに溶解され、その後冷却される。熱可塑性処理方法の例としては、圧縮成形、射出成形、ブロー成形、スプレー法、真空成形、カレンダー法、押出成形、及びこれらの方法の組み合わせが挙げられる。押出成形においては、シート状、糸状、棒状、管状、及び他の断面形状を有する形成物を様々な長さに形成することができる。上記の方法及び他の熱可塑性処理方法により、器具(器具部品等)の一部又は全体を形成することができる。
実施例
実験
材料
PTMO(TERATHANE(登録商標)1000ポリエーテルグリコール)、4,40−メチレンビス(イソシアン酸フェニル)(98%)、トルエン(99%)、1,4−ブタネジオール(99%)、過酸化水素溶液(30%)、塩化コバルト六水和物(98%)、及びTriton(登録商標)X−100をSigma−Aldrich社(米国ミズーリ州セントルイス)より入手して使用した。Sn(Oct)2(米国イリノイ州ナイルスPolyscience社の第一スズオクトアート)、及びテトラ−n−ブチルーアンモニウムブロミド(TBAB)(98+%、米国マサチューセッツ州ワードヒルAlfa Aesar社)を使用した。本実験に用いた対照試料はDow Chemical社のPELLETHANE(登録商標)2363−55D及びPELLETHANE(登録商標)2363−80Aである。硬度及びPIB対PTMOの配合がそれぞれ異なるポリウレタンが前述のように合成された。これらのポリウレタンを下記の表1に示す。
管内酸化処理
試料をガラス瓶に入れ、20%のH2O2を含んだ0.1MのCoCI2 水系溶液に浸し、50度にて保管した。ラジカル濃度を一定にするために、溶液は1日おきに交換した。1週間、2週間、4週間、6週間、及び12週間を経た時点で酸化環境から試料を取り出し、水系の1%TRITON(登録商標)X−100界面活性剤溶液により7回洗浄した。その後、エタノールにより5回洗浄し、精製水により5回洗浄してから、恒量が得られるまで真空状態にて80度で乾燥させた。
特性検査
乾燥された試料の特性を、重量損失測定、ATR−FTIR分光法、最大引張強度測定、破断点伸び測定、走査型電子顕微鏡(SEM)、GPC分析により検査した。検査結果は、n=3を用いて表す。
実施例1
重量損失測定
乾燥したポリウレタンフィルムの重量を、Sartorius社(米国イリノイ州エルクグローブ)のMC1分析用はかりAC 210OSを用いて酸化処理の前後に測定した。図14に、経過時間に対する重量損失を示す。PIB−PTMOポリイソブチレンウレタン共重合体の12週間経過後の重量損失は非常に少なく、組成に応じて6〜15%であった。60Aの組においては、90:10の組成物の重量損失は6%であり、80:20の組成物の8%よりも低かった。60A 91 SATと不飽和60A 91の重量損失は同程度であった。同様に、80Aの組においてもPTMO含有量の低い方が重量損失も低く、PTMO30%で15%、PTMO20%で10%、及びPTMO10%で6%であった。つまり、重量損失は、ポリウレタン中のPTMO含有量と相関していた。
実施例2
ATR−FTIR分光法
Thermo Electron Corporation(米国マサチューセッツ州ウォルサム)のNicolet(登録商標)4700FT−IR装置と、Thermo Electron Corporationのダイヤモンド結晶を備えたSmart Orbit(登録商標)ATRアクセサリとを用いてATR−FTIR分光法による分析を行った。各試料の1つのスペクトルを取得するために平均32回スキャンした。洗浄及び乾燥されたポリイソブチレンウレタン共重合体片をクリスタルの上に置き、支持取付具によりしっかりと固定して分析のためにスキャンを行った。分析の対象となるのは〜1700cm−1及び〜1100cm−1の範囲であり、この範囲には、硬質セグメント劣化生成物(〜1650cm−1)、軟質セグメントの劣化部分(〜1110cm−1)、生成物(〜1170cm−1)、及び正規化された参照ピーク(〜1410cm−1)が含まれる。
実施例3
GPC分析
分子量及び分子量分布をWaters社のHPCLシステムを用いて計測した。このHPCLシステムは、HPLCポンプ510モデル、示差屈折計410モデル、吸光度検出器441モデル、多角度光散乱(MALLS)検出器(米国カルフォルニア州サンタバーバラ所在のWyatt Technology社のMini−Dawn(登録商標))、試料プロセッサ712モデル、500、103、104、105及び100Åと連続して連結された5つのUltrastyragel(登録商標)GPCコラム(マサチューセッツ州ミルフォード所在のWaters社)を備えていた。水素結合撹乱物質であるテトラ−n−ブチルアンモニウムブロミド(TBAB)をテトラヒドロフラン(THF)(2重量%)に溶かし、ポリイソブチレンウレタン共重合体の溶解に用いた。THF:TBABが98:2(重量:重量)である溶液を、1mL min−1の流速にてキャリヤ溶液として用いた。
実施例4
機械的試験
引張強度試験は、室温及び大気圧環境にてInstro社(米国マサチューセッツ州ノーウッド)の引張試験機と約23kg(50lb)のロードセルを用い、破断まで50mm min−1の伸張速度にて行った。最大引張強度及び破断点伸びを記録した。
実施例5
SEM(走査型電子顕微鏡)
乾燥した処理済みのフィルムの一部を切り離してSEM分析を行った。Denton社(ニュージャージー州ムーアズタウン)のVacuum Desk IV冷陰極スパッタコータを用いて金のスパッタ膜を施した試料の表面の形態を観察した。試料には出力25%にて1.5分間スパッタ処理を施し、厚さ75Å以下の金膜を形成した。被覆された試料は日本電子株式会社(米国マサチューセッツ州ピーボディ)の電界放出形走査電子顕微鏡JSM−7401Fを用いて検査した。様々な写真が倍率30倍及び300倍にて撮影された。
実施例6
劣化試験
PELLETHANE(登録商標)80A、PELLETHANE(登録商標)55D、Elast−Eon(登録商標)E2A、及びPIB−PU 80A等の様々な試料の生体安定性を、負荷をかけた状態にて試験した。本試験で用いたPIB−PU 80Aの組成を以下の表3に示す。
Claims (4)
- ルーメンを有する長尺状のリード本体を備え、同ルーメン内には少なくとも1つの導体が配置され、少なくとも1つの電極が同導体に動作可能に接続されるとともにリード本体に沿って配置され、前記リード本体のショア硬度は30A〜75Dであり、リード本体は軟質ポリマーセグメントと硬質ポリマーセグメントとを含んだポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体のいずれかを含み、
前記軟質ポリマーセグメントはポリイソブチレンセグメントと、ポリエーテルジオール、フッ素化ポリエーテルジオール、フッ素ポリマージオール、ポリエステルジオール、ポリアクリレートジオール、ポリメタクリレートジオール、ポリシロキサンジオール、フッ化ポリシロキサンジオール、及びポリカーボネートジオールのいずれかの残留物を含む少なくとも1つの追加的ポリマーセグメントとを含み、
前記ポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体内の軟質セグメント対硬質セグメントの重量比が50:50乃至90:10であり、かつ
前記ポリイソブチレンセグメント対前記追加的ポリマーセグメントの重量比が70:30乃至90:10である植え込み型医療用リード。 - 前記軟質ポリマーセグメントがポリイソブチレンセグメント、及びポリテトラメチレンオキシドジオールの残留物を含み、
前記ポリイソブチレンセグメント対前記ポリテトラメチレンオキシドジオールの重量比が70:30乃至90:10である請求項1に記載の植え込み型医療用リード。 - 前記ポリイソブチレンセグメントが飽和ポリイソブチレンジオールの残留物を含む請求項1に記載の植え込み型医療用リード。
- 前記リード本体が内部ルーメンを有し、同内部ルーメンの内面がポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体のいずれかを含む請求項1に記載の植え込み型医療用リード。
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Application Number | Priority Date | Filing Date | Title |
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US23911509P | 2009-09-02 | 2009-09-02 | |
US61/239,115 | 2009-09-02 | ||
US12/784,559 | 2010-05-21 | ||
US12/784,559 US8374704B2 (en) | 2009-09-02 | 2010-05-21 | Polyisobutylene urethane, urea and urethane/urea copolymers and medical leads containing the same |
PCT/US2010/047703 WO2011028920A2 (en) | 2009-09-02 | 2010-09-02 | Medical devices including polyisobutylene based polymers and derivatives thereof |
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JP2013503711A JP2013503711A (ja) | 2013-02-04 |
JP5619899B2 true JP5619899B2 (ja) | 2014-11-05 |
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JP2012528051A Active JP5619899B2 (ja) | 2009-09-02 | 2010-09-02 | ポリイソブチレン系ポリマー及びその誘導体を含んだ植え込み型医療用リード |
JP2012528036A Active JP5657003B2 (ja) | 2009-09-02 | 2010-09-02 | ポリイソブチレンウレタン共重合体、ポリイソブチレン尿素共重合体、及びポリイソブチレンウレタン/尿素共重合体、ならびにこれらを含んだ医療用リード及びその形成方法 |
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EP (3) | EP3170516B1 (ja) |
JP (2) | JP5619899B2 (ja) |
AU (1) | AU2010289506B2 (ja) |
WO (2) | WO2011028873A2 (ja) |
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