JP5290763B2 - 間接的解放の電解的インプラント送達システム - Google Patents
間接的解放の電解的インプラント送達システム Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0071—Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible
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Description
1)開いた/開いているステントと血管壁とを通る/それらの間の解放されたテザーまたはバンドを引くことによる組織の損傷または傷つきやすいプラクの移動のリスク
2)腐食可能なハンダ接合部のステントへの直接接続による、ステントの上に薬物溶出マトリックスを使用することができないこと
3)接合部または解放セグメントの腐食の予測不能性
4)インプラントの解放をもたらすために溶出する材料が多量であることの結果としての長い配備時間、および/または
5)システム設計の大きさ
を含む。他の課題が、提示され、かつ、当業者によって理解され得る。従って、ステントおよび/または他のインプラントに対する電解的解放の潜在的な利益を最大化するために、改良されたシステムに対する必要性が存在する。
本明細書において使用される場合、用語「ステント」は、任意のステント、例えば、冠状動脈ステント、他の脈管の補綴物、または記述された治療などに適した半径方向に拡張するまたは拡張可能な他の補綴物またはスキャフォルドタイプのインプラントを含む。例示的な構造は、ワイヤメッシュまたは格子パターンおよびコイルを含むが、他のものも本発明において使用され得る。本明細書に使用される場合、「自己拡張」ステントは、(円形であれ何であれ)減少した直径構造から増加した直径構造に拡張する(多くの目的のうちの任意のものに役立つ)スキャフォルドタイプの構造である。形状回復のためのメカニズムは、弾性があるか、または擬似的に弾性があり得る。超弾性体の合金としての使用に設定された合金(例えば、ニッケル−チタン、またはニチノール合金)を使用することが一般的に望ましいが、あるいは解放と同時に拡張を駆動するために、熱形状記憶特性を使用し得る。
このフレームワークに照らして、図1は、その血管が1つ以上の血管形成および/またはステンティング処置の対象であり得る心臓2を示す。しかしながら、今日まで、より小さな冠状動脈4に達する際に、大きな困難性または不可能性に直面する。ステントおよび送達システムが、そのような小さな血管および他の難しい解剖学的構造にアクセスするために提供され得る場合、さらに、冠状経皮的処置のうちの20〜25%が、そのようなシステムを用いて実行され得る。そのような可能性は、人の医療における莫大な利益に対する機会、および付随的な市場への機会、さらには、治療される人々の収入および生産性の損失を避けるさらなる利益を提供する。
「管腔の使用を介する」ために任意的に構成されるような本発明のシステムを使用する態様に関して、図4A〜図4Lは、例示的な血管形成処置を例示する。さらに、本明細書に記述された送達システムおよびステントまたはインプラントは、特に本明細書に明確に参照されたように、他の方法で使用され得る。
(ステントおよび送達システムの概観)
図4Lに戻ると、主題の送達システムに使用されるステント82は、近い端すなわち近位端84、遠い端すなわち遠位端86、およびその間を延びる主要本体または支持構造88を備えている。ステント82はさらに突起90を備え得る。突起90は、近くの嵌合部分90と遠くの嵌合部分94とを備え、該近くの嵌合部分90と遠くの嵌合部分94とは、送達システムにおける補綴物82の保持を可能にする。1つの動作モードにおいて、かかる保持は、端が互いに対して回転させられたときに、ステントを縮小されたプロフィールに捻ることによるものである。本発明の一部の変形例において、突起は提供される必要がない。他の変形例においては、突起はステント本体88の片側にのみ必要とされる。
本発明の特定の変形例において、ステントは、捻られた構成において送達ガイドに装填される。本質的に、ケージまたは格子/メッシュのタイプのステントが、直径を横切ってステントの本体の各部分を引っ張り、本体を内側に圧縮することによる捻りを介した減少された直径をとる。ステントと送達システムとが、連結インターフェースまたはキー付きインターフェースを提供するとき、ステントの装填はインターフェースを係合し、次いで送達ガイドのコア部材の周りでステントの嵌合部分の受け取りの際に、シート部材を回転させることによって圧縮されたプロフィールにステントを引っ張る(それによりステントを「ネック」ダウンさせる)こと、および/または捻ることによって容易に達成される。
図5は、フルサイズの送達システムを例示するが、多数の続く図面は、かかるシステムの遠い端すなわち遠位端108の詳細な図を例示する。示された送達ガイドの遠位部分は、本発明に従った、送達のためのステントまたは他のインプラントを解放可能に固定するための多数の手法を描く。デバイスの特徴は、一般的に、完全なシステムに組み込まれ、記述されたように使用され得、他の特徴は、当業者には明らかであり得る。
上で様々なシステムを記述する際、一部の記述は、要素が互いから絶縁されるか、または貴金属によって腐食から保護されることに関して提供された。それに関する特定の詳細は、当業者には容易に理解される。しかしながら、概して、上記のシステムのうちの多くのシステムは、電解的に腐食可能な解放手段を作動する別個のリードワイヤを例示する。同様に、システムのうちの多くが、近位の電解的に腐食可能な解放手段を作動する別個のリードワイヤを含む。特に、デバイスの本体が戻りの経路として働く例において、別個の回路を提供することによって、ラッチは独立して作動され得る。ラッチの作用は、モニタリングされ得る。所与の回路において電流がもはや流れていないとき、対象のラッチが既に解放されていることの明確な表示が提供される。さらに、腐食される材料の量に単に依存することがシステムにおいて可能であるので、他方のラッチに対する一方のラッチの意図しない早い解放をもたらすことなく、ラッチが解放され得る。別の有益な要素は、一度に1つのラッチを腐食させることによって、材料の複数の区間が一度に腐食されるシステムに対して、電流が制限されることである。
本発明のさらに別の局面において、バイポーラシステムが提供され、該バイポーラシステムにおいて、参照された「電流が流れている」区間とグランド区間とは、互いに近接している。電荷移動/電流通過するためにイオンの移動が生じなければならない距離を制限することによって、電気線の広がりが最小化される。図25の図は、この効果を例示する。概して、本発明の一局面は、電解的に腐食可能区間184と戻りの経路302との間の分離を最小化することを含む。分離「S」は、1cmの距離の範囲内であることが望ましい。さらに好適には、分離「S」は、5mmから1mm以下の距離である。このように、2mm〜3mmの血管における潜在的な電気透過の量が最小化される。
インプラントを解放するための、送達システムの要素の金属の区間の電解的腐食が、要素における正の電荷を発達させるために電圧を印加することによって駆動され、負に帯電された本体に対して電流を流れさせる強い推進力をもたらす。電流が流れるメカニズムは、腐食される区間からのイオン移動である。このプロセスに関するさらなる記述は、Guglielmiに対する米国特許第5,122,136号、Elliotに対する米国特許第6,716,238号、Kupieckiらに対する米国特許第6,168,592号、Frantzenに対する米国特許第5,873,907号、およびこれらの特許に関連する複数の継続出願、部分継続出願、および分割出願を含む様々な特許に記述され、および/またはこれらの特許における解放の様式に関する。
張力が加えられた0.002インチのステンレス鋼のワイヤのベンチテストの間の、実際の侵食/腐食速度におけるAC電圧の影響に関するテストが行われた。絶縁されたワイヤが均等に張力が加えられた、0.020インチの長さの部分にそって露出されたセットアップが提供された。ワイヤは、38°の豚の血液の中に配置され、電力が印加された。2VのDCを印加したとき、ワイヤを破壊するのに3〜4分かかった。2VのDCと10VppのACとを印加すると、分離までの時間は、20〜30秒の範囲だった。DCだけの条件でテストされたセットアップは、腐食された区間の反対側のワイヤの端に電解凝集の約0.040インチのボールを生成することを観察された。好対照に、AC/DC電力駆動のセットアップは、目に見える電解凝集を示さなかった。
実施例1に記述された同じテストピースのセットアップが、より低いDC電圧を用いて使用された。1VのDCだけを用いると、ワイヤは、電流を加えた15分後になっても破壊しなかった。10VppのAC信号が、1VのDC信号に加えられたときには、サンプルテストの区間は、約1分で破壊した。
GDC(登録商標)コイルを脱着するために、Target Therapeuticsによって提供された電源に対して示された改善を測定するために、テストが行われた。最初に、比較モデルが開発された。GDCシステムにおける電解的「接合部」が、長さ約0.005インチ、直径0.003インチのステンレス鋼のワイヤであるように決定された。38°の豚の血液において、約1mAの電流送達設定に設定されたTarget Therapeutics電源を用いて、電源によって計測された電圧は、最初に、3Vを示し、配備時間の大部分の間、6.5Vに上がり、その後に8Vに上がった。40秒において測定された配備時間にわたって、観察された平均電圧は、約6.5Vだった。さらに、約1/32インチの直径を有する血液凝固のボールが観察された。
本発明は、主題のデバイスを使用してまたは他の手段によって実行され得る方法を含む。方法はすべて、適切なデバイスを提供する作用を含み得る。そのような提供はエンドユーザによって実行され得る。換言すれば、(例えば、送達システムを)「提供すること」は、エンドユーザが、主題の方法において、必要なデバイスを提供するために、獲得すること、アクセスすること、アプローチすること、配置すること、設置すること、動作させること、パワーアップすること、または他の行動をすることを必要とするだけである。本明細書に列挙された方法は、論理的に可能である列挙されたイベントの任意の順序で、ならびにイベントの列挙された順序で実行され得る。
Claims (12)
- ステント送達システムであって、
近いシート(200)と遠いシート(202)とを備える遠位インプラント担持区間(108)と、電解的に腐食可能区間(184)を含むワイヤ(252/254)、リボン(206)、およびバンド(256)を備える、ステントの解放を引き起こすための細長い部材(106)(ここで、リボン(206)は、ワイヤ(252/254)によって回転に抵抗して固定された、バンド(256)およびシート(200)に接続する)とを有する送達ガイド本体(102)と、
近い端(84)と、遠い端(86)と、その間に延びている構造とを有する円筒形本体(88)を備え、該近い端(84)と該遠い端(86)はそれぞれ近い嵌合部分(92)と遠い嵌合部分(94)とを備えている閉じたステント(82)であって、該構造は閉じたセル(16)の格子を備え、該円筒形本体(88)は、該ステント(82)の一端が他端に対して回転して該ステント(82)の直径を減少させ、かつ該送達ガイド本体(102)と接触して保持される該ステント(82)の該近い端(84)と該遠い端(86)を保持するように、捻られた構成にある、閉じたステント(82)と
を備え、
該送達ガイド本体(102)の近いシート(200)と遠いシート(202)は、それぞれ該ステント(82)の近い嵌合部分(92)と遠い嵌合部分(94)を受け入れ、
該腐食可能区間(184)の電気的に開始された腐食が、該ステント(82)の一端を解放して該ステント(82)は捻りを解くことができ、ステント(82)の解放を引き起こし、
リボン(206)は、該近い嵌合部分(92)の上に巻かれる、
ステント送達システム。 - 前記ステント(82)は、前記細長い部材(106)と接触する捻られた構成である、請求項1に記載のシステム。
- 近い嵌合部分(92)と遠い嵌合部分(94)および近いシート(200)と遠いシート(202)のうちの少なくとも一部が、キー付きインターフェースを提供する、請求項1に記載のシステム。
- 近い嵌合部分(92)と遠い嵌合部分(94)および近いシート(200)と遠いシート(202)のうちの少なくとも一部が、スライドアウトインターフェースを提供する、請求項1に記載のシステム。
- 近いシート(200)と遠いシート(202)は、それぞれ近い嵌合部分(92)と遠い嵌合部分(94)を受け入れ、少なくとも1つのシートは、腐食可能な区間の解放の際に回転可能である、請求項1に記載のシステム。
- 前記ステント(82)の一端は、該ステント(82)と前記送達ガイド本体(102)との間の相対的な滑動運動によって解放される、請求項1に記載のシステム。
- 前記滑動解放は、腐食可能な区間(184)の解放の結果として生じる、請求項6に記載のステント送達システム。
- 捻られた構成で前記ステント(82)を拘束しているスリーブ(160)をさらに備えており、該スリーブ(160)は、前記腐食可能区間(184)によって解放可能に固定されている、請求項1に記載のシステム。
- 各閉じたセル(16)は、複数のストラット(14)を備え、該複数のストラット(14)は、隣接し相互接続されたストラットの第1の対と、隣接し相互接続されたストラットの第2の対とを含み、該第1の対のうちの1つのストラットは、該第2の対のうちの1つのストラットと、ストラットのジャンクション(28)を介して直接的に接続される、請求項1に記載のシステム。
- 各閉じたセル(16)は、4つの相互接続されたストラット(14)から構成される、請求項1に記載のシステム。
- 前記ステント(82)は、前記送達ガイド本体(102)から解放され、捻られないことが可能にされると、拡張および短縮するように構成されている、請求項1に記載のシステム。
- 前記ステント(82)は、前記送達ガイド本体(102)に解放可能に連結されている1つ以上の突起(90)を含む、請求項1に記載のシステム。
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US11/265,999 US20070100414A1 (en) | 2005-11-02 | 2005-11-02 | Indirect-release electrolytic implant delivery systems |
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JP2009514593A JP2009514593A (ja) | 2009-04-09 |
JP2009514593A5 JP2009514593A5 (ja) | 2009-10-15 |
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US (7) | US20070100414A1 (ja) |
EP (2) | EP1959862A4 (ja) |
JP (1) | JP5290763B2 (ja) |
CN (1) | CN101365401B (ja) |
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WO (1) | WO2007055780A2 (ja) |
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US20070100418A1 (en) | 2007-05-03 |
EP1959862A2 (en) | 2008-08-27 |
US8579954B2 (en) | 2013-11-12 |
CN101365401B (zh) | 2011-10-05 |
US20070100416A1 (en) | 2007-05-03 |
US20110160835A1 (en) | 2011-06-30 |
US20070100414A1 (en) | 2007-05-03 |
US20070100419A1 (en) | 2007-05-03 |
JP2009514593A (ja) | 2009-04-09 |
US20070100415A1 (en) | 2007-05-03 |
US8273116B2 (en) | 2012-09-25 |
CN101365401A (zh) | 2009-02-11 |
US20070100417A1 (en) | 2007-05-03 |
US8974509B2 (en) | 2015-03-10 |
WO2007055780A3 (en) | 2008-01-17 |
US7862602B2 (en) | 2011-01-04 |
EP2340790B1 (en) | 2016-07-06 |
EP2340790A1 (en) | 2011-07-06 |
US8900285B2 (en) | 2014-12-02 |
ES2600961T3 (es) | 2017-02-13 |
WO2007055780A2 (en) | 2007-05-18 |
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