JP6424410B2 - 脊髄刺激装置システム - Google Patents
脊髄刺激装置システム Download PDFInfo
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- JP6424410B2 JP6424410B2 JP2016501754A JP2016501754A JP6424410B2 JP 6424410 B2 JP6424410 B2 JP 6424410B2 JP 2016501754 A JP2016501754 A JP 2016501754A JP 2016501754 A JP2016501754 A JP 2016501754A JP 6424410 B2 JP6424410 B2 JP 6424410B2
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- Biomedical Technology (AREA)
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- Radiology & Medical Imaging (AREA)
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- Acoustics & Sound (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Electromagnetism (AREA)
- Pain & Pain Management (AREA)
- Electrotherapy Devices (AREA)
Description
本出願は、2013年3月15日に出願された仮出願第61/792,654号に対する優先権を主張する非仮出願であり、これは、その全体が本明細書に組み込まれる。
図1は、試験的及び永久取り付け期間中のSCSシステムに含まれ得る様々なコンポーネントを図解する。脊髄刺激装置(SCS)100は、慢性的な痛みを治療するために脊髄に電気パルス療法を提供するために使用される埋込み型デバイスである。このシステムの埋込み型コンポーネントは、埋込み型パルス発生器(IPG)102と、多数の刺激電極130とからなる。IPG102は、患者に苦痛のない部位で深さ30mm以下の皮下に移植されるが、刺激電極130は、硬膜外腔内に直接移植される。刺激電極130は、リード140、141を介してIPG102に配線され、これらのリードは、各個々の電極130に正しい療法を提供するために、刺激パルスを互いに分離したままにする。
経皮刺激リード140は、図8に示されるように、埋込み型SCS100と併用して使用される完全埋込み型電気医療用装身具である。リードの主要機能は、IPG102から脊髄上の目標刺激部位に電気信号を運ぶことである。経皮刺激リード140は、周辺刺激をもたらす。経皮刺激リード140は、IPG102と刺激部位との間にロバストな可撓性かつ生体適合性電気接続を提供しなければならない。リード140は、脊椎穿刺針または硬膜外針によって外科的に埋め込まれ、リード140の中心を通す操縦スタイレットを用いて脊柱管に貫通される。リード140は、組織を通したアンカーまたは縫合糸のいずれを用いて患者に機械的に固定され、リード140の本体に巻き付けられる。リード140は、近位接点の遠位端上のブランク接点に半径方向圧力をかけるIPG102上の止めねじ119で近位端に固定される。
リードアンカー170は、図12及び13に示されるように、経皮刺激リード140及びパドル刺激リード141の両方と併用して使用される完全埋込み型電気医療用装身具である。リードアンカー170の主要機能は、リード140、141を組織に機械的にロックすることによってリード140、141の遠位先端の移動を防ぐことである。現在、図12に示される2種類のアンカー170、単純なスリーブ171、及び図13に示されるロッキング機構172があり、各々がわずかに異なる界面を有する。単純なスリーブ型のアンカー171では、リード140、141は、アンカー171の中央貫通孔174に通され、次に、縫合糸がアンカー171の外側の周囲に通され、アンカー171内のリード140、141を固定するように締め付けられる。次に、アンカー171は、筋膜に縫合され得る。ロッキングアンカー172は、ロッキング目的のために止めねじ176を、ロッキング及びロッキング解除のために双方向の使い捨てトルクレンチを使用する。ロッキング及びロッキング解除の両方のために触覚及び可聴フィードバックが提供される。
無線ドングル200は、スマートフォン/携帯電話202またはタブレット204へのハードウェア接続であり、この接続は、図14に図解されるように、試験的発生器107またはIPG102と、スマートフォン/携帯デバイス202またはタブレット204との間の通信を可能にする。試験的または永久移植段階時に、無線ドングル200は、タブレット204の特定の接続ピンによってタブレット204に接続され、タブレット204上の臨床医プログラマソフトウェアは、刺激パラメータを制御するために使用される。臨床医プログラマソフトウェアからのコマンドは、無線ドングル200に転送され、これは次に、試験的発生器107またはIPG102へのRF信号を用いて無線ドングル200から転送される。臨床医プログラマのパラメータが設定されると、パラメータは、タブレット204に保存され、スマートフォン/携帯デバイス202上の患者プログラマソフトウェアに転送される。無線ドングル200は、アンテナ、マイクロコントローラ(IPG102及び試験的発生器107と同じ仕様を有する)、ならびにスマートフォン/携帯デバイス202及びタブレット204と接続するピンコネクタからなる。
IPG102は、その活動に電力を供給する充電式リチウムイオンバッテリ108を有する。外部誘導型の充電器210(図1)は、無線でIPG102の内側の包含バッテリ108を再充電することが必要である。充電器210は、充電式バッテリ、ワイヤの一次コイル、及び電子機器のためのプリント回路基板(PCB)からなり、すべてが筐体に詰められる。スイッチ入れると、この充電器210は、磁場を作り、電圧をインプラント内の二次コイル109に誘導する。次に、誘導電圧は整流され、その後IPG102の内側のバッテリ108を充電するために使用される。コイル間の結合を最大化するために、内部及び外部コイルの両方は、特定の共通の周波数でコンデンサを共振させるようにそのコンデンサと組み合わせられる。インダクタLとして機能を果たすコイルは、LC共振タンクを形成する。充電器は、E級増幅器トポロジを使用して、共振周波数の周囲の一次コイル内に交流電流を生成する。以下が充電器210の特徴である。
・無線でIPG102を充電する
・30mmの最大深度まで充電する
・より高い電力転送効率のために集積された整列センサが充電器をIPG102と整列させることを支援する
・整列センサが可聴及び視覚フィードバックをユーザに与える
・小型かつ携帯型
保護型の円筒形Liイオンバッテリが充電器210のバッテリとして使用される。電力増幅器のE級のトポロジは、誘導充電器、特に埋込み型電子医療用デバイスのための最も好ましい種類の増幅器であった。これは、高効率電力転送が必要であるデバイスにとって最も有利な選択にした比較的高い理論効率である。この回路を通る電流を検知する0.1オームの高ワット数のレジスタが直列に使用される。
C1=nC2;n=4の値が上記の実施例で使用[[される]]された;多くの場合、3<n<10。
外部充電器210と内部IPG102との間の電力転送の効率は、それらが適切に整列するときのみ最大である。整列センサは、適切な整列を確保するために不可欠である。これは、外部回路設計の一部である。第1の設計は、反射インピーダンスと呼ばれる原理に基づいている。外部が内部により近づくと、両回路のインピーダンスが変化する。検知は、反射インピーダンスを測定すること、及びそれが閾値を超えるかの試用に基づいている。可聴フィードバックを患者に与えるためにポケットベルが使用され、視覚フィードバックのためにLEDが使用される。
プログラマ
臨床医プログラマは、タブレット204にインストールされるアプリケーションである。これは、手術室で試験的及び永久移植中、臨床医によって試験的発生器107またはIPG102の刺激パラメータを設定するために使用される。臨床医プログラマは、多数の患者の多数の設定を保存することができ、手術室の外で刺激パラメータを調整するために使用され得る。これは、患者の中の[[試験的]]試験的発生器107またはIPG102がRF範囲内であるとき、RF無線ドングル200によって刺激パラメータを変化させることができる。加えて、これはまた、タブレット204及びスマートフォン/携帯デバイス202の上の患者プログラマの両方がともに、インターネットにアクセスすることができるとき、インターネットを通じて試験的発生器107及び/またはIPG102の刺激パラメータを設定または変更することができる。
チューヒー針240は、図15に示されるように、抵抗消失針配置のための塩水負荷シリンジ、及び脊柱管へのリード140の配置のための経皮刺激リード140と併用して使用される。チューヒー硬膜外針240は、針240の深さを測定する抵抗消失技術を用いて脊柱管の中にゆっくりと挿入される。適切な深さに挿入されると、経皮刺激リード140は、針240を通じて、脊柱管の中に通される。
スタイレット250は、図16に示されるように、剛性及び操縦性を加えることによって経皮刺激リード140の先端を所望の刺激区域に駆動するために使用される。スタイレット250のワイヤ252は、経皮リード140の中央ルーメン142を通過し、リード140の遠位先端でのブロッキングプラグで停止する。スタイレット250の先端は、真っすぐな先端及び湾曲した先端の両方を伴う。小さいハンドル254は、駆動することを支援する中央ルーメン142内でスタイレット250を回転するためにスタイレット250の近位端で使用される。このハンドル254は、取り外され、再び取り付けられることができ、スタイレット250が依然として適所である間、アンカー170がリード140を通過することを可能にする。スタイレット250のワイヤ252は、PTFEコーティングされたステンレス鋼ワイヤであり、ハンドル254は、プラスチックである。
通過エレベータ260は、図17に示されるように、脊柱管内の組織を取り除き、かつ外科医がリードを生体構造に寸法決めすることを支援するためにパドルリード141より前に使用される。通過エレベータ260は、閉塞の脊柱管を取り除くように可撓性のパドル形状の先端262を提供する。可撓性の先端は、外科用ハンドル264に取り付けられる。
トンネル工具270は、図18に示されるように、侵入点から脊柱管の中に入りIPG移植部位に刺激リード140を通すように皮下管を提供するために使用される。トンネル工具270は、近位端274にリグレットハンドル272を備えた長い串形状の工具である。工具270は、先細の先端278を備えたプラスチックシース276によって覆われ、これは、工具270が組織を容易に通過することを可能にする。IPG102移植区域が脊柱管へのリード140の侵入点へのブリッジであると、内部コア275は取り除かれ、シース276を残す。次に、リード140は、シース276を通じてIPG102の移植部位まで通され得る。トンネル工具270は、組織を通じて操縦することを支援するように曲げられることが多い。
トルクレンチ280は、図19に示されるように、内部止めねじ119を締め付けるためにIPG102、リード拡張部150及びリードスプリッタ160と併用して使用され、刺激リード140、141の固着接点に対する半径方向力を提供し、リード140、141が取り外すのを防ぐ。トルクレンチ280はまた、アンカー170をロック及びロック解除するために使用される。トルクレンチ280は、あらゆるSCS100のケースで使用される小さい使い捨ての医療器具である。トルクレンチ280は、リード140、141がIPG102、拡張部150、もしくはスプリッタ160に固定されるか、またはアンカー170がロック位置またはロック解除位置にあることを外科医に可聴及び触覚フィードバックを提供する。
試験的パッチは、脊柱管内の刺激リード140、141の侵入点の清潔な人間工学的保護カバーを提供するために試験的パルス発生器107と併用して使用される。パッチはまた、試験的発生器107を覆い、含むことを意図される。パッチは試用段階時に手術後に患者に適用される大きい接着性の包帯である。パッチは、リード140、141、及び発生器107を完全に覆い、抗菌接着で患者に固着する。
磁気磁気スイッチは、IPG102の近くに配置されるとき、そのスイッチをオンまたはオフすることができるコインの大きさの磁石である。磁石の方向は、IPG102に向いていて、磁気スイッチがIPG102のスイッチをオンまたはオフしているかを決定する。
Claims (15)
- 埋込み型パルス発生器(102)と、
複数の埋込み型刺激電極(130)と、
前記埋込み型パルス発生器(102)及び試験的埋込み型パルス発生器(107)を前記複数の刺激電極(130)に電気的に接続する複数の埋込み型リード(140、141)と、
一次充電コイルを有する外部充電器(210)と、
コンピューティングデバイス(204)上に提供された臨床医プログラマアプリケーションと、
携帯デバイス(202)上に提供された患者プログラマアプリケーションと、
前記コンピューティングデバイス(204)及び前記携帯デバイス(202)と、前記埋込み型パルス発生器(102)及び前記試験的埋込み型パルス発生器(107)との間の通信を可能にする通信デバイス(200)と、を備え、
前記埋込み型パルス発生器(102)は、
エポキシヘッダ(114)を有するケーシング(120)と、
リード接触アセンブリ(116)と、
複数の出力コンデンサ(112)、特定用途向け集積回路(106)及びマイクロコントローラ(104)を備える回路基板(105)であって、前記マイクロコントローラ(104)が、前記通信デバイス(200)及び前記特定用途向け集積回路(106)と通信している、回路基板(105)と、
充電式バッテリ(108)と、
前記回路基板(105)に接続するピン(124)をさらに備えるフィードスルー(122)と、
RFアンテナ(110)と、
二次充電コイル(109)と、を備える、脊髄刺激デバイス(100)。 - 前記通信デバイス(200)は、無線ドングルを備える、請求項1に記載の脊髄刺激デバイス(100)。
- 前記通信デバイス(200)は、テレメトリのために最大10チャネルを利用する402MHz〜405MHzの範囲で動作するように構成される、請求項1に記載の脊髄刺激デバイス(100)。
- 前記充電式バッテリ(108)は、ゼロボルト技術を有する埋込み型グレードのリチウムイオンバッテリからなり、前記バッテリ(108)は、前記外部充電器(210)を介して誘導的に充電するように構成される、請求項1に記載の脊髄刺激デバイス(100)。
- 前記複数の埋込み型刺激電極(130)は、刺激のセットで分類され、各刺激のセットが、異なる刺激パラメータでプログラム可能である、請求項1に記載の脊髄刺激デバイス(100)。
- 前記特定用途向け集積回路(106)は、デジタル区間及びアナログ区間を含み、前記デジタル区間は、デジタル素子、タイミング発生器、複数の比較器、調停制御、パルスバースト調整器、及び電極論理を含み、前記アナログ区間は、電界効果トランジスタ及び複数のデジタルアナログ変換器を含む、請求項1に記載の脊髄刺激デバイス(100)。
- 前記パルスバースト調整器は、バースト二相性パルス列を出力し、前記タイミング発生器は、前記二相性パルスの各位相に対して立ち上がり及び立ち下がりエッジトリガを発生させる、請求項6に記載の脊髄刺激デバイス(100)。
- 前記調停制御は、前記タイミング発生器のエンベロープ信号を分析し、一度に1つの信号のみがアクティブであることを許容する、請求項6に記載の脊髄刺激デバイス(100)。
- 前記アナログ区間は、前記二相性パルスを分析して、それを前記複数の電極(130)のうちの1つに出力されたアナログ信号に変換するように構成される、請求項7に記載の脊髄刺激デバイス(100)。
- コンピューティングデバイス(204)上に提供された前記臨床医プログラマアプリケーションは、すべてのデータ処理機能を果たして、前記マイクロコントローラ(104)にのみ動作データを送信するように構成される、請求項1に記載の脊髄刺激デバイス(100)。
- 倍電圧全波整流器は、誘導AC電圧を使用可能なDC電圧に変換する、請求項4に記載の脊髄刺激デバイス(100)。
- 前記二次充電コイル(109)及び前記一次充電コイルは、前記一次充電コイル及び二次充電コイルが共通の周波数で共振するようにコンデンサと組み合わせられる、請求項4に記載の脊髄刺激デバイス(100)。
- 前記一次充電コイル及び前記二次充電コイル(109)がいつ適切に整列するかを示す整列センサをさらに備え、前記整列センサは、整列を示すフィードバックを提供するように構成される、請求項4に記載の脊髄刺激デバイス(100)。
- 前記リード接触アセンブリ(116)は、
複数のロッキング筐体(118)であって、各ロッキング筐体(118)が、開孔を画定し、前記開孔が、シリコーンチューブ(123)を受容するように構成され、前記シリコーンチューブ(123)が、前記リード(140)を受容するように構成され、前記ロッキング筐体(118)は、圧縮リードロック機構(119)を受容するように構成された第2の開孔をさらに画定する、複数のロッキング筐体(118)と、
複数のリード接点(126)であって、各リード接点(126)が、シリコーンシール(127)によって隣接したリード接点(126)から分離され、前記リード接点(126)は、最大8つのリード接点(126)のスタックで構成され、各スタックが、一端で1つのロッキング筐体(118)に接続され、前記リード接点(126)は、前記フィードスルー(122)に接続する、複数のリード接点(126)と、を備える、請求項1に記載の脊髄刺激デバイス(100)。 - 刺激パラメータは、前記コンピューティングデバイス(204)及び前記携帯デバイス(202)に入力され、前記刺激パラメータは、前記通信デバイス(200)を介して前記IPG(102)に送信される、請求項1に記載の脊髄刺激デバイス(100)。
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