JP6962994B2 - 下肢血管系を処置する装置及び方法 - Google Patents
下肢血管系を処置する装置及び方法 Download PDFInfo
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- 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
- A61F2/02—Prostheses implantable into the body
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Description
本願は、2015年5月21日に出願された米国特許出願第14/718427号、2015年3月23日に出願された米国仮特許出願第62/136755号、2014年9月8日に出願された米国仮特許出願第62/047558号、及び2014年6月19日に出願された米国仮特許出願第62/014554号の優先権の利益を主張する。これらの出願のそれぞれは、引用することによりその全体が本明細書の一部をなす。2014年2月28日に出願された国際出願PCT/US2014/019607号、2008年1月3日に出願された米国特許出願第11/662128号、2009年2月25日に出願され、2013年5月14日に米国特許第8,439,963号として発行された米国特許出願第12/297498号、及び2013年3月8日に出願された米国特許出願第13/791185号もそれぞれ、引用することによりその全体が本明細書の一部をなす。
本明細書に記載される方法及びシステムは、いくつかの実施形態に従って心臓血管手術において特定の有用性を示す。いくつかの態様が以下の非限定的な例によって更に示され、そこでは、システムは、冠動脈の閉塞後の心臓組織の逆行性灌流を可能にするように動脈と静脈との接続処置(PICVA)を行う臨床医によって用いられる。
米国合衆国における肢喪失者は200万人近くである。
肢喪失者のうち、主な原因は以下である:
血管疾患(54%)(糖尿病及び末梢動脈疾患(PAD))、
外傷(45%)、及び、
癌(2%未満)。
毎年、合衆国において約185000件の切断が行われている。
肢切断に伴う入院費は2007年において総計65億ドルを超えた。
切断後の生存率は多様な要因に基づき様々である。血管疾患(PAD及び糖尿病を含む)に起因する切断を受けた者は、30日での死亡率が9%〜15%と報告されており、長期生存率は1年が60%、3年が42%及び5年が35%〜45%である。
血行障害(dysvascular disease)で肢を喪失した者の半数近くが5年以内に死亡する。これは、結腸直腸癌、乳癌及び前立腺癌を患った者が被る5年死亡率よりも高い。 糖尿病を患った者のうち下肢切断を受けた者は、最大55%まで、2年〜3年以内にもう一本の脚の切断が必要となる。
結果:
包括的な検討のために総計56の試験が選択された。特定されたランダム化比較試験(RCT)はなかった。228人の患者を含む7つの患者群が選択基準と合致した。1年全体の肢温存は71%(95% CI:64%〜77%)であり、1年の二次開存率は46%(95% CI:39%〜53%)であった。大切断術を回避した患者の大部分は首尾よく創傷治癒し、休息痛が現れず、深刻な合併症がなかった。
結論:
限定された証拠に基づき、静脈の動脈化は、「手術不能な」慢性重症虚血肢を患った患者に大切断術を行う前の実行可能な代案とみなすことができる。
Claims (22)
- 静脈内で逆行する流体の流れを促し、血流を動脈から前記静脈へと逸らすことにより、前記動脈の閉塞を処置するためのシステムであって、
前記動脈と前記静脈との間の瘻孔に埋め込み可能に構成された瘻孔ステントであって、
第1の端部直径を有し、前記動脈の側壁を並置するように構成された第1の長手方向セクションと、
前記第1の長手方向セクションから長手方向に存在し、前記動脈と前記静脈との間の間質組織にまたがるように構成された第2の長手方向セクションと、
前記第2の長手方向セクションに連結された第1のグラフト材料とを含む、瘻孔ステントと、
前記静脈内に配置されるように構成された血管内プロテーゼであって、
前記第1の端部直径とは異なる第2の端部直径を有し、前記静脈の側壁を並置するように構成されたステントと、
前記ステントの側壁を通過する流体の流れを阻害するために前記ステントに連結され、前記第1のグラフト材料とは分離した第2のグラフト材料であって、前記血管内プロテーゼの内腔を通る逆行性の血流を誘導するように構成されるとともに、前記静脈を裏打ちし、前記静脈の側副血管からの血流が前記内腔に進入するのを阻害するように前記側副血管を覆うように構成された第2のグラフト材料とを含む、血管内プロテーゼと、
を備え、
前記血管内プロテーゼは前記瘻孔ステントとは分離して構成されており、前記血管内プロテーゼと前記瘻孔ステントとは、当接するか、少なくとも部分的に重なり合っている、
システム。 - 前記血管内プロテーゼの前記ステントは、前記第1の長手方向セクション及び前記瘻孔ステントの前記第2の長手方向セクションのうち少なくとも一方とは異なるパラメータを有し、前記パラメータは、長さ、径方向のストラット厚さ、周方向のストラット幅、ストラットの形状、セルの形状、カットパターン、カットタイプ、材料、形状設定のうち少なくとも1つを含む、
請求項1に記載のシステム。 - 前記第1のグラフト材料は、前記第2の長手方向セクションの側壁を通過する流れを妨げるように構成されている、
請求項1または2に記載のシステム。 - 前記第1のグラフト材料はPTFEを含む、
請求項1から3のいずれかに記載のシステム。 - 前記第2のグラフト材料はPTFEを含む、
請求項1から4のいずれかに記載のシステム。 - 前記第2の長手方向セクションは、拡張状態で円錐台形である、
請求項1から5のいずれかに記載のシステム。 - 前記第1の長手方向セクションは、拡張状態で円筒形である、
請求項1から6のいずれかに記載のシステム。 - 前記第1の端部直径は、2mmから4mmの間である、
請求項1から7のいずれかに記載のシステム。 - 前記第2の長手方向セクションは、4mmから6mmの間の第3の端部直径を有する、
請求項1から8のいずれかに記載のシステム。 - 前記第2の端部直径は5mmから7mmの間である、
請求項1から9のいずれかに記載のシステム。 - 前記第1の長手方向セクションは20mmから40mmの間の長さを有する、
請求項1から10のいずれかに記載のシステム。 - 前記瘻孔ステントは、自己拡張し、ニチノールの支柱を含む、
請求項1から11のいずれかに記載のシステム。 - 弁無機能化装置、
をさらに備える、請求項1から12のいずれかに記載のシステム。 - 前記弁無機能化装置は、逆行の弁膜切開刀を含む、
請求項13に記載のシステム。 - 前記弁無機能化装置は、バルーンを含む、
請求項13又は14に記載のシステム。 - 前記ステントの導入前の瘻孔及び導入後の前記ステントの少なくとも一方を拡張するように構成された拡張バルーン、
をさらに備える、請求項1から12のいずれかに記載のシステム。 - 静脈内で逆行する流体の流れを促し、血流を動脈から前記静脈へと逸らすことにより、前記動脈の閉塞を処置するためのシステムであって、
前記動脈と前記静脈との間の瘻孔に埋め込み可能に構成される瘻孔ステントと、
前記静脈内に配置されるように構成された血管内プロテーゼであって、
前記静脈内に配置され、かつ前記静脈内の1つまたは複数の静脈弁を横切るように配置されるとともに、前記1つまたは複数の静脈弁に径方向の力を加えることにより前記1つまたは複数の静脈弁を開いた状態に維持し、前記静脈内を逆行する血流が阻害されないように前記1つまたは複数の静脈弁を無機能化するように構成されるステントを含む血管内プロテーゼと、
を備え、
前記血管内プロテーゼは、前記瘻孔ステントとは分離して構成され、前記血管内プロテーゼと前記瘻孔ステントとは、当接するか、少なくとも部分的に重なり合っている、
システム。 - 静脈内で逆行する流体の流れを促し、血流を動脈から前記静脈へと逸らすことにより、前記動脈の閉塞を処置するためのシステムであって、
前記動脈と前記静脈との間の瘻孔に埋め込み可能に構成される瘻孔ステントと、
前記静脈内に配置されるように構成された血管内プロテーゼであって、
前記静脈内に配置され、前記流体の通過を阻止するように構成される側壁を有し、前記側壁は前記静脈を裏打ちするとともに、前記静脈の側副血管からの血流が前記血管内プロテーゼの内腔に進入するのを阻害するように前記側副血管を覆うように構成されたステントを含む、血管内プロテーゼと、
を備え、
前記血管内プロテーゼは、前記瘻孔ステントとは分離して構成され、前記血管内プロテーゼと前記瘻孔ステントとは、当接するか、少なくとも部分的に重なり合っている、
システム。 - 前記静脈は、下肢静脈を含む、
請求項17または18に記載のシステム。 - 前記血管内プロテーゼを複数備え、前記血管内プロテーゼの各々は、第1端部と第2端部とを有し、
第1の血管内プロテーゼの第2端部は、第2の血管内プロテーゼの第1端部と重なり、
前記第2の血管内プロテーゼの第2端部は、第3の血管内プロテーゼの第1端部と重なり、
前記血管内プロテーゼの各々は、1つまたは複数の静脈弁に径方向の力を加えることにより、前記1つまたは複数の静脈弁を開いた状態に維持するように構成される、
請求項17または18に記載のシステム。 - 前記血管内プロテーゼの各々は、前記瘻孔ステントとは異なるパラメータを有する、
請求項17から19のいずれかに記載のシステム。 - 前記パラメータは、長さ、径方向のストラット厚さ、周方向のストラット幅、ストラットの形状、セルの形状、カットパターン、カットタイプ、材料、形状設定のうち少なくとも1つを含む、
請求項21に記載のシステム。
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