JP2007504915A - 可撓性血栓形成性継手を有し、外れにくさが改善されたpfo閉鎖デバイス - Google Patents
可撓性血栓形成性継手を有し、外れにくさが改善されたpfo閉鎖デバイス Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
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Abstract
Description
本出願は、2001年12月19日に提出された米国仮出願第60/340,858号の利益を請求する、2002年12月19日に提出された米国特許出願第10/326,535号の一部継続出願である。
本発明は、全般に、卵円孔開存などの身体の異常を閉鎖するための閉塞デバイスに関する。
図1に示す卵円孔開存(PFO)は、心臓の右心房10と左心房12の間の壁に遺残する一方向の、通常はフラップ状の開口部である。左心房(LA)圧は、通常、右心房(RA)圧よりも高いため、フラップは、通常、閉鎖したままである。しかし、ある一定の条件では、右心房圧は左心房圧を超える可能性があり、血液が右心房10から左心房12に流れ、血餅が体循環に入り得る可能性が生じる。このような状況は起こらないことが望ましい。
本発明の様々な実施形態は、PFOなどの中隔欠損を閉鎖するためのデバイスに関する。閉鎖デバイスは、一般に、近位アンカー部材、遠位アンカー部材、および2つのアンカー部材を接続する可撓性中心継手を具備する。中心継手は、1つ以上の縫合糸であってもよい。或いは、中心継手は、組織の内方成長(ingrowth)を促進し得る又は薬物を送達し得る可撓性エラストマー層であってもよい。また、可撓性材料は、組織への接着を促進する生体適合性材料、又は組織の内方成長を加速する成長因子で被覆されてもよい。
本発明の様々な実施形態は、主に、欠損における治癒反応を誘発することによってPFOなどの中隔欠損を閉鎖する方法およびデバイスに関する。デバイスは、一般に、中隔欠損の各側のアンカー部材と、そのアンカー部材間にアンカー部材を接合する少なくとも1つの接続部材を具備する、様々な形状を有してもよい。少なくとも1つの接続部材は、欠損における治癒反応を促進する幾つかの形状の1つを有してもよい。
Claims (38)
- 中隔組織の欠損を閉鎖するためのデバイスであって、
前記中隔組織の一方側に配置されるように構成されている第1の側と、
前記中隔組織の反対側に配置されるように構成されている第2の側と、を備え、
前記第1の側と前記第2の側とは、少なくとも1つの中心継手によって接続され、
前記第1の側と前記第2の側とのそれぞれは、アンカー部材を具備し、
前記第1の側及び前記第2の側の少なくとも一方の前記アンカー部材は、長さの中心部分に沿って分割され、細長い楕円形を形成する略円筒状の部材を備える、デバイス。 - 前記デバイスが意図される送達位置に配備されているとき、前記少なくとも1つの中心継手が前記中隔組織の欠損を通って延在する、請求項1に記載のデバイス。
- 前記第1の側と前記第2の側が協働して、前記欠損を取囲む中隔組織に圧縮力を提供する、請求項2に記載のデバイス。
- 前記第1の側と前記第2の側のそれぞれが、長さの中心部分に沿って分割され、細長い楕円形を形成する略円筒状の部材を備える、請求項1に記載のデバイス。
- 前記第1および第2のアンカー部材が三次元である、請求項4に記載のデバイス。
- 前記アンカー部材が、金属、ポリマー、形状記憶材料、生体吸収性材料、薬物滲出材料、およびこれらの材料の組合せからなる群から選択される材料を含む、請求項1に記載のデバイス。
- 前記少なくとも1つの中心継手が、延伸性エラストマー性材料を含む、請求項1に記載のデバイス。
- 前記少なくとも1つの中心継手が、形状記憶材料を含む、請求項7に記載のデバイス。
- 前記少なくとも1つの中心継手が、ニチノールを含む、請求項8に記載のデバイス。
- 前記少なくとも1つの中心継手が、ニチノールフィルムを備える、請求項9に記載のデバイス。
- 前記ニチノールフィルムが、スリットおよび穴からなる群から選択される開口部を具備する、請求項10に記載のデバイス。
- 前記少なくとも1つの中心継手が、前記中隔組織の欠損の閉鎖を促進する材料を含む、請求項7に記載のデバイス。
- 前記少なくとも1つの中心継手が、血栓形成性材料、炎症性材料、薬物滲出材料、および、これらの材料の組合せからなる群から選択される材料を含む、請求項12に記載のデバイス。
- 前記少なくとも1つの中心継手が多孔質である、請求項7に記載のデバイス。
- 前記第1および第2のアンカー部材の少なくとも1つが、組織スキャフォールドを具備する、請求項1に記載のデバイス。
- 前記組織スキャフォールドが、ポリエステル布帛、テフロン(登録商標)ベースの材料、ePTFE、ポリウレタン、金属材料、ポリビニルアルコール(PVA)、細胞外基質(ECM)、合成生体吸収性ポリマースキャフォールド、コラーゲン、薬物滲出材料、および、これらの材料の組合せからなる群から選択される材料を含む、請求項15に記載のデバイス。
- 前記第1および第2のアンカー部材のそれぞれが、組織スキャフォールドを具備する、請求項15に記載のデバイス。
- 前記少なくとも1つの中心継手が、前記組織スキャフォールドに接続されている、請求項17に記載のデバイス。
- 前記デバイスが回収可能である、請求項1に記載のデバイス。
- 中隔組織の欠損を閉鎖するためのデバイスであって、
前記中隔組織の一方側に配置されるように構成されている第1の側と、
前記中隔組織の反対側に配置されるように構成されている第2の側と、を備え、
前記第1の側と前記第2の側とは、少なくとも1つの中心継手によって接続され、
前記第1の側と前記第2との側のそれぞれが、長さの中心部分に沿って分割され、細長い楕円形を形成する略円筒状の部材を備えるアンカー部材を具備し、
当該デバイスが意図される送達位置に配備されているとき、前記第1の側と前記第2の側とが協働して、前記欠損を取囲む中隔組織に圧縮力を提供する、デバイス。 - 前記アンカー部材が、金属、ポリマー、形状記憶材料、生体吸収性材料、薬物滲出材料、および、これらの材料の組合せからなる群から選択される材料を含む、請求項20に記載のデバイス。
- 前記細長い楕円形のアンカー部材のそれぞれが三次元である、請求項21に記載のデバイス。
- 前記細長い楕円形のアンカー部材のそれぞれが、当該デバイスの中隔プロファイルを最小限にするような形状に作られている、請求項22に記載のデバイス。
- 前記細長い楕円形のアンカー部材の弧が、当該デバイスの面から角度θに位置決めされる、請求項23に記載のデバイス。
- 前記細長い楕円形のアンカー部材のそれぞれの形状が凹状である、請求項24に記載のデバイス。
- 前記角度θが、0°より大きく、約45°未満である、請求項24に記載のデバイス。
- 前記第1および第2のアンカー部材のそれぞれが、組織スキャフォールドを具備する、請求項20に記載のデバイス。
- 前記組織スキャフォールドが、ポリエステル布帛、テフロン(登録商標)ベースの材料、ePTFE、ポリウレタン、金属材料、ポリビニルアルコール(PVA)、細胞外基質(ECM)、合成生体吸収性ポリマースキャフォールド、コラーゲン、薬物滲出材料、および、これらの材料の組合せからなる群から選択される材料を含む、請求項27に記載のデバイス。
- 前記少なくとも1つの中心継手が、延伸性エラストマー性材料を含む、請求項20に記載のデバイス。
- 前記少なくとも1つの中心継手が、形状記憶材料を含む、請求項29に記載のデバイス。
- 前記少なくとも1つの中心継手が、ニチノールを含む、請求項30に記載のデバイス。
- 前記少なくとも1つの中心継手が、前記中隔組織の欠損の閉鎖を促進する材料を含む、請求項29に記載のデバイス。
- 前記少なくとも1つの中心継手が、血栓形成性材料、炎症性材料、薬物滲出材料、および、これらの材料の組合せからなる群から選択される材料を含む、請求項32に記載のデバイス。
- 前記デバイスを意図される送達位置から回収するための回収機構を更に備える、請求項20に記載のデバイス。
- 前記デバイスをカテーテルに引き入れることができるように、前記回収機構が前記デバイスのプロファイルを低減させる、請求項34に記載のデバイス。
- 前記回収機構は、前記第1のアンカー部材と前記第2のアンカー部材との間の距離を小さくすると共に、前記第1のアンカー部材と前記第2のアンカー部材を縦向きに整列させる、請求項35に記載のデバイス。
- 前記回収機構は、
前記第1のアンカー部材の一端から前記第2のアンカー部材まで達し、前記第2のアンカー部材を貫通して延在するストリングと、
前記第2のアンカー部材内で前記ストリングに拘束されているボールと、
を備える、請求項35に記載のデバイス。 - 前記ストリングが可撓性である、請求項37に記載のデバイス。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/662,000 US7318833B2 (en) | 2001-12-19 | 2003-09-12 | PFO closure device with flexible thrombogenic joint and improved dislodgement resistance |
PCT/US2004/029978 WO2005027752A1 (en) | 2003-09-12 | 2004-09-13 | Pfo closure device with flexible thrombogenic joint and improved dislodgement resistance |
Publications (2)
Publication Number | Publication Date |
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JP2007504915A true JP2007504915A (ja) | 2007-03-08 |
JP4597990B2 JP4597990B2 (ja) | 2010-12-15 |
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JP2006526395A Expired - Fee Related JP4597990B2 (ja) | 2003-09-12 | 2004-09-13 | 可撓性血栓形成性継手を有し、外れにくさが改善されたpfo閉鎖デバイス |
Country Status (5)
Country | Link |
---|---|
US (3) | US7318833B2 (ja) |
EP (1) | EP1680026A1 (ja) |
JP (1) | JP4597990B2 (ja) |
CA (1) | CA2538321A1 (ja) |
WO (1) | WO2005027752A1 (ja) |
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JP2012529310A (ja) * | 2009-06-10 | 2012-11-22 | カラク アーゲー | オクルーダー |
JP2015061608A (ja) * | 2009-06-10 | 2015-04-02 | カラク アーゲー | オクルーダー |
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WO2014185230A1 (ja) * | 2013-05-15 | 2014-11-20 | グンゼ株式会社 | 医療用材料 |
JP6002319B2 (ja) * | 2013-05-15 | 2016-10-05 | グンゼ株式会社 | 医療用材料 |
JPWO2021261279A1 (ja) * | 2020-06-22 | 2021-12-30 | ||
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Also Published As
Publication number | Publication date |
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CA2538321A1 (en) | 2005-03-31 |
EP1680026A1 (en) | 2006-07-19 |
US20040133236A1 (en) | 2004-07-08 |
US7318833B2 (en) | 2008-01-15 |
US20120029560A1 (en) | 2012-02-02 |
US8758403B2 (en) | 2014-06-24 |
US20080228218A1 (en) | 2008-09-18 |
US7967840B2 (en) | 2011-06-28 |
WO2005027752A1 (en) | 2005-03-31 |
JP4597990B2 (ja) | 2010-12-15 |
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