JP2017523870A - 膀胱機能不全およびその他の症状を緩和するための神経刺激のための埋込可能導線添着構造 - Google Patents
膀胱機能不全およびその他の症状を緩和するための神経刺激のための埋込可能導線添着構造 Download PDFInfo
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Abstract
Description
本願は、米国仮出願第62/038,122号、出願日2014年8月15日;第62/110,274号、出願日2015年1月30日の非仮出願であり、これらの米国仮出願の優先権の利益を主張するものであり、これらの全体の内容は、あらゆる目的のために、本明細書中に参照により援用される。
本明細書に説明されるもののいずれか等の神経刺激治療システムは、急性疼痛障害、運動障害、情動障害、ならびに膀胱関連機能不全および大腸ならびに排便機能不全等の種々の病気および関連付けられた症状を治療するために使用されることができる。神経刺激によって治療され得る疼痛障害の実施例は、脊椎手術後疼痛症候群、反射性交感神経性ジストロフィまたは複合性局所疼痛症候群、灼熱痛、クモ膜炎、および末梢神経障害を含む。運動障害は、筋麻痺、振戦、ジストニア、およびパーキンソン病を含む。情動障害は、うつ病、強迫性障害、群発頭痛、トゥレット障害、およびあるタイプの慢性疼痛を含む。膀胱関連機能不全は、限定ではないが、OAB、切迫尿失禁、尿意切迫−頻尿、および尿閉を含む。OABは、単独で、または組み合わせて、切迫尿失禁および尿意切迫−頻尿を含むことができる。切迫尿失禁は、突然の強い尿意(切迫性)と関連付けられた失禁である。尿意切迫−頻尿は、頻繁な、多くの場合、制御不能な尿意切迫感(切迫性)であって、多くの場合、非常に少量の排尿をもたらす(頻尿)。尿閉は、膀胱を空にすることができない状態である。神経刺激治療は、その状態もしくは関連付けられた症状と関連付けられた感覚および/または運動制御に関連する標的神経組織の神経刺激をもたらすことによって、特定の状態に対処するように構成されることができる。
SNMは、切迫尿失禁、尿意切迫−頻尿、および非閉塞性尿閉の管理のための安全、効果的、可逆的、かつ長期的に継続する治療選択肢を提供する、確立された療法である。SNM療法は、下背に位置する仙骨神経を刺激するために、弱電気パルスの使用を伴う。電極は、電極導線を仙骨の対応する孔の中に挿入することによって、仙骨神経に隣接して、通常、S3レベルに留置される。電極は、皮下に挿入され、続いて、埋込可能パルス発生器(IPG)に取り付けられる。切迫尿失禁および尿意切迫−頻尿の両方の患者のために、5年の耐久性を含む、OABの治療のためのSNMの安全性および有効性が、複数の研究において支持されており、十分に証明されている。SNMはまた、より保守的治療に失敗した、またはその候補ではない患者における慢性便失禁を治療するためにも承認されている。
現在、SNMの資格として、試験段階を設けており、成功する場合、恒久的埋込が続く。試験段階は、試験刺激周期であって、患者は、療法が効果的であるかどうか評価される。典型的には、試験刺激を行うために利用される、2つの技法がある。1つは、経皮的神経評価(PNE)と称される通院ベースの手技であって、もう1つは、段階的試験である。
従来の仙骨神経刺激アプローチは、膀胱および大腸関連機能不全の治療において有効性を示しているが、神経刺激導線の位置付けおよび導線の試験的ならびに恒久的埋込位置間の一貫性を改良し、かつプログラム方法を改良する必要性がある。神経刺激は、治療用刺激をパルス発生器から1つまたはそれを上回る神経刺激電極を介して特定の神経もしくは標的領域に一貫して送達することに依拠する。神経刺激電極は、患者組織内に形成されるトンネルを通して前進されることができる、埋込可能導線の遠位端上に提供される。埋込可能神経刺激システムは、患者に大幅な自由度および移動性を提供するが、外科手術で埋め込まれる前に、そのようなシステムの神経刺激電極を調節することがより容易であり得る。医師は、IPGを埋め込む前に、患者が所望の運動および/または感覚反応を有することを確認することが望ましい。少なくともいくつかの治療(少なくともいくつかの形態の排尿および/または排便機能不全の治療を含む)に関して、適切な運動反応の実証は、感覚反応が要求されない、または利用不可能であり得る(例えば、患者が全身麻酔下にある)間、正確かつ客観的導線留置のために非常に有益であり得る。
図1は、本発明の側面による、試験的神経刺激システム200において使用するための設定と、恒久的埋込式神経刺激システム100において使用するための設定とを含む、例示的神経刺激システム設定を図式的に図示する。EPG80およびIPG50はそれぞれ、試験的神経刺激システム200および/または試験成功後の恒久的埋込式システム100を位置付けるおよび/またはプログラムする際に使用される、臨床医用プログラム装置(CP)60および患者遠隔装置70と互換性があって、無線で通信する。前述のように、システムは、ケーブルセットおよびEMGセンサパッチを試験的システム設定100内で利用し、導線留置および神経刺激プログラミングを促進する。CPは、特殊ソフトウェア、特殊ハードウェア、および/または両方を含み、導線留置、プログラミング、再プログラミング、刺激制御、および/またはパラメータ設定を支援することができる。加えて、IPGおよびEPGはそれぞれ、患者が、患者遠隔装置を用いて、刺激の少なくとも一部を制御し(例えば、事前に設定されたプログラムを開始する、刺激を増減させる)、および/またはバッテリステータスを監視することを可能にする。本アプローチはまた、試験的システムと恒久的システムとの間のほぼシームレスな遷移を可能にする。
図7は、展開構成に示される、導線の係留部分22上に搭載される係留本体10を伴う、図4におけるものと類似する神経刺激導線20の詳細図を図示する。図から分かるように、螺旋本体12は、導線本体上への留置のために、中心縦軸を中心として螺旋状に掃引され、複数の尖叉14は、螺旋本体12に沿って分布され、中心軸から側方外向きに延在し、近位方向に角度付けられる。図8の10の詳細図に示されるように、係留本体の複数の尖叉14は、複数の尖叉が中心軸を中心として円周方向に異なる方向に外向きに延在するように、10°〜90°等の間隔の範囲内において、規則的間隔(例えば、30°、45°、90°)で相互から半径方向にオフセットされるように分布される。これは、導線の係留を改善するように、任意の係留力を導線本体を中心として分布させる。
本発明は、例えば、以下を提供する。
(項目1)
埋込可能神経刺激システムであって、
導線本体内に配置される1つまたはそれを上回る導体を有する、埋込可能導線であって、上記1つまたはそれを上回る導体は、上記導線の近位端から、上記導線の遠位端またはその近傍に配置される1つまたはそれを上回る神経刺激電極まで延在する、埋込可能導線と、
上記埋込可能導線の近位端に結合可能なパルス発生器であって、上記パルス発生器は、上記埋込可能導線に結合されると、上記1つまたはそれを上回る神経刺激電極と電気的に結合され、標的場所に埋め込まれると、上記1つまたはそれを上回る神経刺激電極を通して神経刺激治療を患者に送達するための複数の電気インパルスを発生させるように構成される、パルス発生器と、
上記導線本体と結合されるアンカであって、
縦軸に沿って上記導線本体の外側上に螺旋状に延在する、螺旋本体と、
上記螺旋本体から延在する複数の尖叉であって、上記複数の尖叉のそれぞれは、展開構成に向かって付勢され、上記展開構成では、上記複数の尖叉は、上記縦軸から離れるように側方に延在し、上記複数の尖叉は、上記複数の尖叉が、上記縦軸に向かって内向きに折畳され、埋込の間、上記神経刺激導線の送達を促進する、送達構成に向かって弾性的に偏向可能である、複数の尖叉と、
を備える、アンカと、
を備える、システム。
(項目2)
上記アンカは、上記送達構成では、上記複数の尖叉がそれぞれ上記導線本体に対して折畳されるように構成される、項目1に記載のシステム。
(項目3)
上記アンカは、上記送達構成では、上記アンカが、5フレンチまたはそれを上回る直径を有するシースと互換性がある断面外形を有するように定寸される、項目1に記載のシステム。
(項目4)
上記螺旋本体および上記複数の尖叉は、一体的に形成される、項目1に記載のシステム。
(項目5)
上記アンカは、上記標的場所において上記患者の組織内に埋め込まれると、組織と上記複数の尖叉の係合が上記導線の軸方向移動を阻止するように、十分な剛度を伴う材料から形成される、項目1に記載のシステム。
(項目6)
上記アンカは、50A〜80Dの範囲内のショア硬さを有するポリウレタン系材料から成形される、項目5に記載のシステム。
(項目7)
上記アンカは、上記螺旋本体が、その上に結合されると、上記導線本体の遠位部分に沿って10mm〜30mmの長さに延在するように定寸される、項目1に記載のシステム。
(項目8)
上記アンカは、上記螺旋本体が約20mmの長さに延在するように定寸される、項目7に記載のシステム。
(項目9)
上記展開位置では、上記複数の尖叉はそれぞれ、上記縦軸から側方外向きに1mm〜4mmの距離に延在する、項目1に記載のシステム。
(項目10)
上記複数の尖叉はそれぞれ、1.5mm〜3mmの長さである、項目1に記載のシステム。
(項目11)
上記複数の尖叉はそれぞれ、0.5mm〜2.0mmの幅である、項目10に記載のシステム。
(項目12)
上記複数の尖叉は、可変長さまたは幅の尖叉を含む、項目10に記載のシステム。
(項目13)
上記複数の尖叉はそれぞれ、長方形または伸長タブ形状を有する、項目10に記載のシステム。
(項目14)
上記複数の尖叉はそれぞれ、上記角および/または縁における組織損傷を阻止するように、丸みを帯びたもしくは面取りされた角および/または縁を伴う長方形形状を有する、項目13に記載のシステム。
(項目15)
上記展開位置では、上記複数の尖叉はそれぞれ、上記縦軸から30〜80度の角度において上記縦軸から側方外向きに延在する、項目1に記載のシステム。
(項目16)
上記展開位置では、上記複数の尖叉はそれぞれ、近位方向に角度付けられる、項目1に記載のシステム。
(項目17)
上記展開位置では、上記複数の尖叉は、近位方向および遠位方向の両方に角度付けられる、項目1に記載のシステム。
(項目18)
上記螺旋本体は、上記送達構成にあるとき、上記アンカが、2mmまたはそれ未満の断面外形を有するように、陥凹部分内において上記導線本体に取り付けられる、項目1に記載のシステム。
(項目19)
上記アンカは、複数の区分を備える、項目1に記載のシステム。
(項目20)
上記アンカはさらに、可視化技法を使用して上記導線の位置付けを促進するように、上記螺旋本体の実質的長さに沿って延在する放射線不透過性要素またはマーカを備える、項目1に記載のシステム。
(項目21)
上記アンカは、磁気共鳴画像診断誘発加熱を遮蔽するために好適な埋設された遮蔽材料を備える、項目1に記載のシステム。
(項目22)
上記複数の尖叉は、生体分解性である、項目1に記載のシステム。
(項目23)
上記複数の尖叉は、薬物溶出材料を含む、項目1に記載のシステム。
(項目24)
上記螺旋本体は、連続螺旋フラップであって、上記複数の尖叉は、上記連続螺旋フラップの複数の区分を含む、上記複数の区分は、上記複数の区分が相互に重複せずに内向きに折畳することを可能にするように、上記連続螺旋フラップの長さに沿って、複数の切り込みによって画定される、項目1に記載のシステム。
(項目25)
上記導線は、上記1つまたはそれを上回る電極の近位にある、縮小直径を有する係留部分を含み、上記係留部分は、上記アンカをぴったりと受容するように定寸される、項目1に記載のシステム。
(項目26)
上記係留部分の縮小直径および長さは、上記アンカが上記拘束構成で上記係留部分内に配置されると、上記アンカは、上記アンカの近位および遠位の上記導線の外側表面と実質的に同一平面となるように構成される、項目25に記載のシステム。
(項目27)
上記導線と上記パルス発生器の接合部に隣接する上記導線の近位部分に沿って延在する、歪み緩和部材をさらに備える、項目1に記載のシステム。
(項目28)
上記歪み緩和部材は、上記接合部に隣接する上記導線の近位部分を中心として巻着された螺旋部分を含み、上記螺旋部分は、上記導線の近位部分と比較して増加した剛度の材料を含む、項目27に記載のシステム。
(項目29)
上記歪み緩和部材は、上記螺旋部分の可変厚さおよび/または可変ピッチの一方もしくは両方によって、上記導線の近位部分に沿って可変剛度を提供するように構成される、項目28に記載のシステム。
(項目30)
埋込式神経刺激導線を患者の身体内の標的組織場所に係留するためのアンカであって、
その縦軸に沿って螺旋状に延在する螺旋本体と、
上記螺旋本体から延在する複数の尖叉であって、上記複数の尖叉はそれぞれ、展開構成に向かって付勢され、かつ送達構成のために弾性的に偏向可能である、複数の尖叉と、
を備え、
上記展開構成では、上記複数の尖叉は、上記螺旋本体の縦軸から離れるように側方に延在し、上記送達構成では、上記複数の尖叉は、上記螺旋本体の上記縦軸に向かって内向きに折畳され、埋込の間、上記神経刺激導線の送達を促進する、アンカ。
(項目31)
上記アンカは、上記送達構成において導線本体に取り付けられると、上記複数の尖叉がそれぞれ、上記導線本体に対して折畳されるように構成される、項目30に記載のアンカ。
(項目32)
上記アンカは、導線本体に取り付けられ、上記送達構成にあるとき、上記アンカが、5フレンチシースを通して送達を促進するために十分に小さい断面外形を有するように定寸される、項目30に記載のアンカ。
(項目33)
上記螺旋本体および上記複数の尖叉は、共通材料から一体的に形成される、項目30に記載のアンカ。
(項目34)
上記アンカは、埋込式導線に取り付けられ、上記展開構成にあるとき、上記標的場所において上記患者の組織内に埋め込まれると、組織と上記複数の尖叉の係合が上記導線の軸方向移動を阻止するように、十分な剛度を伴う材料から形成される、項目30に記載のアンカ。
(項目35)
上記アンカは、50A〜80Dの範囲内のショア硬さを有するポリウレタン系材料から成形される、項目30に記載のアンカ。
(項目36)
埋込式神経刺激導線を患者の身体内の標的組織場所に係留するためのアンカを形成する方法であって、
螺旋パターンを材料の管状区分にレーザ切断するステップであって、上記パターンは、拘束構成における複数の尖叉を有する螺旋本体を伴う神経刺激導線アンカに対応する、ステップと、
上記管状区分の尖叉を上記アンカの展開構成に対応する外向きに突出する位置に支持するステップと、
上記尖叉が支持されている間に上記管状区分を熱硬化させ、それによって、上記アンカが上記展開構成にある間に、上記材料を硬化させるステップと、
を含む、方法。
(項目37)
上記材料は、埋込後、上記本体の加熱に応じて、上記金属合金が上記展開構成に弾性的に戻るように、形状記憶金属合金である、項目36に記載の方法。
(項目38)
上記材料は、リフローによって硬化され、上記複数の尖叉が、シース内に拘束されると、導線に対して内向きに折畳し、上記導線上に添着されるときに上記アンカの埋込を促進し得るように、硬化されても十分に可撓性のままである、ポリマー系材料である、項目36に記載の方法。
(項目39)
上記螺旋本体を上記導線の係留部分を中心として巻着することによって、上記アンカを神経刺激導線の係留部分に添着するステップをさらに含む、項目36に記載の方法。
(項目40)
埋込式神経刺激導線を患者の身体内の標的組織場所に係留するためのアンカを形成する方法であって、
複数の外向きに延在する尖叉を伴う螺旋本体を含むアンカの外側表面を画定するマルチ部品金型を、上記螺旋本体の中心管腔を画定する中心コアピンとともに組み立てるステップと、
流動性材料を上記組み立てられた金型の中に注入し、上記材料を少なくとも部分的に硬化させるステップと、
上記金型を除去し、上記アンカを離型させるステップと、
を含む、方法。
(項目41)
組立の間、放射線不透過性リボンを上記金型内に追加する、および/または上記組み立てられた金型の中に注入する前に、放射線不透過性材料を上記流動性材料に追加するステップをさらに含む、項目40に記載の方法。
(項目42)
上記マルチ部品金型を除去するステップは、上記尖叉が延在する1つまたはそれを上回る軸に沿って、上記マルチ部品金型の外側部品を抜去するステップを含む、項目40に記載の方法。
(項目43)
上記螺旋本体を導線の係留部分を中心として巻着することによって、上記アンカを神経刺激導線の係留部分に添着するステップをさらに含む、項目40に記載の方法。
(項目44)
神経刺激システムの埋込式神経刺激導線を患者内に係留する方法であって、
1つまたはそれを上回る神経刺激電極と、上記1つまたはそれを上回る電極の近位のアンカとを有する、神経刺激導線を提供するステップであって、上記アンカは、上記導線の長さに沿って巻着される螺旋本体と、導線本体に対して内向きに折畳されて上記螺旋本体に取り付けられる複数の尖叉とを含み、上記螺旋本体は、シースによって拘束される、ステップと、
上記複数の尖叉が上記シースによって拘束されて上記導線本体に対して内向きに折畳されている間、上記導線を患者の組織を通して標的場所に前進させるステップと、
上記シースを抜去することによって、上記1つまたはそれを上回る尖叉を上記螺旋本体から側方外向きに延在された展開構成に弾性的に展開するステップと、
上記展開構成における上記複数の尖叉を隣接する組織に対して係合させ、それによって、上記埋込式導線の軸方向移動を阻止することによって、上記神経刺激導線を上記標的場所に係留するステップと、
を含む、方法。
(項目45)
上記標的場所は、上記導線を上記組織を通して前進させることが、上記1つまたはそれを上回る神経刺激電極が仙骨神経に位置付けられるまで、上記導線をS3孔を通して前進させるステップを含むようなOABの神経刺激治療のための仙骨神経を含む、項目44に記載の方法。
(項目46)
複数回、隣接する組織に対して係合させることによって、上記神経刺激導線を係留するステップは、組織を上記S3孔内および/またはそれに隣接して係合させるステップを含む、項目45に記載の方法。
Claims (46)
- 埋込可能神経刺激システムであって、
導線本体内に配置される1つまたはそれを上回る導体を有する、埋込可能導線であって、前記1つまたはそれを上回る導体は、前記導線の近位端から、前記導線の遠位端またはその近傍に配置される1つまたはそれを上回る神経刺激電極まで延在する、埋込可能導線と、
前記埋込可能導線の近位端に結合可能なパルス発生器であって、前記パルス発生器は、前記埋込可能導線に結合されると、前記1つまたはそれを上回る神経刺激電極と電気的に結合され、標的場所に埋め込まれると、前記1つまたはそれを上回る神経刺激電極を通して神経刺激治療を患者に送達するための複数の電気インパルスを発生させるように構成される、パルス発生器と、
前記導線本体と結合されるアンカであって、
縦軸に沿って前記導線本体の外側上に螺旋状に延在する、螺旋本体と、
前記螺旋本体から延在する複数の尖叉であって、前記複数の尖叉のそれぞれは、展開構成に向かって付勢され、前記展開構成では、前記複数の尖叉は、前記縦軸から離れるように側方に延在し、前記複数の尖叉は、前記複数の尖叉が、前記縦軸に向かって内向きに折畳され、埋込の間、前記神経刺激導線の送達を促進する、送達構成に向かって弾性的に偏向可能である、複数の尖叉と、
を備える、アンカと、
を備える、システム。 - 前記アンカは、前記送達構成では、前記複数の尖叉がそれぞれ前記導線本体に対して折畳されるように構成される、請求項1に記載のシステム。
- 前記アンカは、前記送達構成では、前記アンカが、5フレンチまたはそれを上回る直径を有するシースと互換性がある断面外形を有するように定寸される、請求項1に記載のシステム。
- 前記螺旋本体および前記複数の尖叉は、一体的に形成される、請求項1に記載のシステム。
- 前記アンカは、前記標的場所において前記患者の組織内に埋め込まれると、組織と前記複数の尖叉の係合が前記導線の軸方向移動を阻止するように、十分な剛度を伴う材料から形成される、請求項1に記載のシステム。
- 前記アンカは、50A〜80Dの範囲内のショア硬さを有するポリウレタン系材料から成形される、請求項5に記載のシステム。
- 前記アンカは、前記螺旋本体が、その上に結合されると、前記導線本体の遠位部分に沿って10mm〜30mmの長さに延在するように定寸される、請求項1に記載のシステム。
- 前記アンカは、前記螺旋本体が約20mmの長さに延在するように定寸される、請求項7に記載のシステム。
- 前記展開位置では、前記複数の尖叉はそれぞれ、前記縦軸から側方外向きに1mm〜4mmの距離に延在する、請求項1に記載のシステム。
- 前記複数の尖叉はそれぞれ、1.5mm〜3mmの長さである、請求項1に記載のシステム。
- 前記複数の尖叉はそれぞれ、0.5mm〜2.0mmの幅である、請求項10に記載のシステム。
- 前記複数の尖叉は、可変長さまたは幅の尖叉を含む、請求項10に記載のシステム。
- 前記複数の尖叉はそれぞれ、長方形または伸長タブ形状を有する、請求項10に記載のシステム。
- 前記複数の尖叉はそれぞれ、前記角および/または縁における組織損傷を阻止するように、丸みを帯びたもしくは面取りされた角および/または縁を伴う長方形形状を有する、請求項13に記載のシステム。
- 前記展開位置では、前記複数の尖叉はそれぞれ、前記縦軸から30〜80度の角度において前記縦軸から側方外向きに延在する、請求項1に記載のシステム。
- 前記展開位置では、前記複数の尖叉はそれぞれ、近位方向に角度付けられる、請求項1に記載のシステム。
- 前記展開位置では、前記複数の尖叉は、近位方向および遠位方向の両方に角度付けられる、請求項1に記載のシステム。
- 前記螺旋本体は、前記送達構成にあるとき、前記アンカが、2mmまたはそれ未満の断面外形を有するように、陥凹部分内において前記導線本体に取り付けられる、請求項1に記載のシステム。
- 前記アンカは、複数の区分を備える、請求項1に記載のシステム。
- 前記アンカはさらに、可視化技法を使用して前記導線の位置付けを促進するように、前記螺旋本体の実質的長さに沿って延在する放射線不透過性要素またはマーカを備える、請求項1に記載のシステム。
- 前記アンカは、磁気共鳴画像診断誘発加熱を遮蔽するために好適な埋設された遮蔽材料を備える、請求項1に記載のシステム。
- 前記複数の尖叉は、生体分解性である、請求項1に記載のシステム。
- 前記複数の尖叉は、薬物溶出材料を含む、請求項1に記載のシステム。
- 前記螺旋本体は、連続螺旋フラップであって、前記複数の尖叉は、前記連続螺旋フラップの複数の区分を含む、前記複数の区分は、前記複数の区分が相互に重複せずに内向きに折畳することを可能にするように、前記連続螺旋フラップの長さに沿って、複数の切り込みによって画定される、請求項1に記載のシステム。
- 前記導線は、前記1つまたはそれを上回る電極の近位にある、縮小直径を有する係留部分を含み、前記係留部分は、前記アンカをぴったりと受容するように定寸される、請求項1に記載のシステム。
- 前記係留部分の縮小直径および長さは、前記アンカが前記拘束構成で前記係留部分内に配置されると、前記アンカは、前記アンカの近位および遠位の前記導線の外側表面と実質的に同一平面となるように構成される、請求項25に記載のシステム。
- 前記導線と前記パルス発生器の接合部に隣接する前記導線の近位部分に沿って延在する、歪み緩和部材をさらに備える、請求項1に記載のシステム。
- 前記歪み緩和部材は、前記接合部に隣接する前記導線の近位部分を中心として巻着された螺旋部分を含み、前記螺旋部分は、前記導線の近位部分と比較して増加した剛度の材料を含む、請求項27に記載のシステム。
- 前記歪み緩和部材は、前記螺旋部分の可変厚さおよび/または可変ピッチの一方もしくは両方によって、前記導線の近位部分に沿って可変剛度を提供するように構成される、請求項28に記載のシステム。
- 埋込式神経刺激導線を患者の身体内の標的組織場所に係留するためのアンカであって、
その縦軸に沿って螺旋状に延在する螺旋本体と、
前記螺旋本体から延在する複数の尖叉であって、前記複数の尖叉はそれぞれ、展開構成に向かって付勢され、かつ送達構成のために弾性的に偏向可能である、複数の尖叉と、
を備え、
前記展開構成では、前記複数の尖叉は、前記螺旋本体の縦軸から離れるように側方に延在し、前記送達構成では、前記複数の尖叉は、前記螺旋本体の前記縦軸に向かって内向きに折畳され、埋込の間、前記神経刺激導線の送達を促進する、アンカ。 - 前記アンカは、前記送達構成において導線本体に取り付けられると、前記複数の尖叉がそれぞれ、前記導線本体に対して折畳されるように構成される、請求項30に記載のアンカ。
- 前記アンカは、導線本体に取り付けられ、前記送達構成にあるとき、前記アンカが、5フレンチシースを通して送達を促進するために十分に小さい断面外形を有するように定寸される、請求項30に記載のアンカ。
- 前記螺旋本体および前記複数の尖叉は、共通材料から一体的に形成される、請求項30に記載のアンカ。
- 前記アンカは、埋込式導線に取り付けられ、前記展開構成にあるとき、前記標的場所において前記患者の組織内に埋め込まれると、組織と前記複数の尖叉の係合が前記導線の軸方向移動を阻止するように、十分な剛度を伴う材料から形成される、請求項30に記載のアンカ。
- 前記アンカは、50A〜80Dの範囲内のショア硬さを有するポリウレタン系材料から成形される、請求項30に記載のアンカ。
- 埋込式神経刺激導線を患者の身体内の標的組織場所に係留するためのアンカを形成する方法であって、
螺旋パターンを材料の管状区分にレーザ切断するステップであって、前記パターンは、拘束構成における複数の尖叉を有する螺旋本体を伴う神経刺激導線アンカに対応する、ステップと、
前記管状区分の尖叉を前記アンカの展開構成に対応する外向きに突出する位置に支持するステップと、
前記尖叉が支持されている間に前記管状区分を熱硬化させ、それによって、前記アンカが前記展開構成にある間に、前記材料を硬化させるステップと、
を含む、方法。 - 前記材料は、埋込後、前記本体の加熱に応じて、前記金属合金が前記展開構成に弾性的に戻るように、形状記憶金属合金である、請求項36に記載の方法。
- 前記材料は、リフローによって硬化され、前記複数の尖叉が、シース内に拘束されると、導線に対して内向きに折畳し、前記導線上に添着されるときに前記アンカの埋込を促進し得るように、硬化されても十分に可撓性のままである、ポリマー系材料である、請求項36に記載の方法。
- 前記螺旋本体を前記導線の係留部分を中心として巻着することによって、前記アンカを神経刺激導線の係留部分に添着するステップをさらに含む、請求項36に記載の方法。
- 埋込式神経刺激導線を患者の身体内の標的組織場所に係留するためのアンカを形成する方法であって、
複数の外向きに延在する尖叉を伴う螺旋本体を含むアンカの外側表面を画定するマルチ部品金型を、前記螺旋本体の中心管腔を画定する中心コアピンとともに組み立てるステップと、
流動性材料を前記組み立てられた金型の中に注入し、前記材料を少なくとも部分的に硬化させるステップと、
前記金型を除去し、前記アンカを離型させるステップと、
を含む、方法。 - 組立の間、放射線不透過性リボンを前記金型内に追加する、および/または前記組み立てられた金型の中に注入する前に、放射線不透過性材料を前記流動性材料に追加するステップをさらに含む、請求項40に記載の方法。
- 前記マルチ部品金型を除去するステップは、前記尖叉が延在する1つまたはそれを上回る軸に沿って、前記マルチ部品金型の外側部品を抜去するステップを含む、請求項40に記載の方法。
- 前記螺旋本体を導線の係留部分を中心として巻着することによって、前記アンカを神経刺激導線の係留部分に添着するステップをさらに含む、請求項40に記載の方法。
- 神経刺激システムの埋込式神経刺激導線を患者内に係留する方法であって、
1つまたはそれを上回る神経刺激電極と、前記1つまたはそれを上回る電極の近位のアンカとを有する、神経刺激導線を提供するステップであって、前記アンカは、前記導線の長さに沿って巻着される螺旋本体と、導線本体に対して内向きに折畳されて前記螺旋本体に取り付けられる複数の尖叉とを含み、前記螺旋本体は、シースによって拘束される、ステップと、
前記複数の尖叉が前記シースによって拘束されて前記導線本体に対して内向きに折畳されている間、前記導線を患者の組織を通して標的場所に前進させるステップと、
前記シースを抜去することによって、前記1つまたはそれを上回る尖叉を前記螺旋本体から側方外向きに延在された展開構成に弾性的に展開するステップと、
前記展開構成における前記複数の尖叉を隣接する組織に対して係合させ、それによって、前記埋込式導線の軸方向移動を阻止することによって、前記神経刺激導線を前記標的場所に係留するステップと、
を含む、方法。 - 前記標的場所は、前記導線を前記組織を通して前進させることが、前記1つまたはそれを上回る神経刺激電極が仙骨神経に位置付けられるまで、前記導線をS3孔を通して前進させるステップを含むようなOABの神経刺激治療のための仙骨神経を含む、請求項44に記載の方法。
- 複数回、隣接する組織に対して係合させることによって、前記神経刺激導線を係留するステップは、組織を前記S3孔内および/またはそれに隣接して係合させるステップを含む、請求項45に記載の方法。
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