JP7410206B2 - メディカルデバイス及びそのアンカー - Google Patents
メディカルデバイス及びそのアンカー Download PDFInfo
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- JP7410206B2 JP7410206B2 JP2022063881A JP2022063881A JP7410206B2 JP 7410206 B2 JP7410206 B2 JP 7410206B2 JP 2022063881 A JP2022063881 A JP 2022063881A JP 2022063881 A JP2022063881 A JP 2022063881A JP 7410206 B2 JP7410206 B2 JP 7410206B2
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Description
本出願は、2017年10月16日に出願された米国仮出願第62/572,763号の優先権を主張する、2018年10月15日に出願された米国出願第16/160,966号の優先権を主張し、すべての目的のためにそれらの両方の全体を参照により本明細書に取り込む。
本開示は、患者内のアパチャ、導管、空間、器官及び他の構造及び/又は開口部を閉塞し、ろ過し及び/又は支持するために使用することができる、可動固定手段を有するインプラント可能メディカルデバイスに関する。
様々なメディカルデバイスは、標的部位への何らかの形の固定又はアンカリングを必要とする。一般的なアンカリングとしては、棘、フック、縫合糸又はデバイスを周囲の解剖学的構造に取り付けるために使用されるその他の特徴が挙げられる。固定が必要なデバイスの例としては、血管閉塞器/プラグ、血管フィルタ、閉塞器、大静脈フィルタ、ステント、ステントグラフト、胆管/尿路ステント、消化管ステント及びライナー、様々な監視又は診断デバイス、中心静脈カテーテル及びその他のデバイスが挙げられる。経カテーテルデリバリーでは、これらのデバイスは事前装填され、小さなプロファイルに拘束されて、部位への侵襲性の低いデリバリーを可能にする。所望の部位に配置されると、拘束要素は除去され、デバイスが自己拡張するか又はバルーン拡張され、周囲の解剖学的構造に係合することが可能になる。
本開示の様々な態様は、心臓内の構造を含む、患者内のアパチャ、導管、空間、器官及び他の構造又は開口部を閉塞、ろ過及び/又は支持するために使用することができるインプラント可能メディカルデバイスを提供する。本開示は、カテーテルの装填及び展開にそれぞれ応答して格納及び展開するアンカーを備えた、患者に経カテーテル技術(様々な展開技術が考えられるが)を使用して展開できるメディカルデバイスを提供する。本開示の様々な実施形態は、カテーテルにデバイスを装填する間又は展開後にデバイスをカテーテルに再装填する間にカテーテルの中心軸に向かって変位されるアンカーを対象とする。アンカーの先端は十分に変位し、装填時にカテーテルとの接触/相互作用を無くす。これは、デバイス本体の設計、ウエスト、及びアンカー基部をウエストの遠位に配置することで実現される。
本開示の様々な態様は、アンカーを備えたインプラント可能メディカルデバイスを対象とする。アンカーは、デリバリーカテーテル中への装填及び患者におけるデリバリーカテーテルからの展開中のデリバリーカテーテルの損傷を回避するように構成されうる。メディカルデバイスは、装填のために拘束されているときに及びカテーテルなどの拘束要素からの取り出しのために拘束解除されるときに、メディカルデバイスの長手方向軸に対して半径方向に動くアンカーを有する。特定の実施形態において、アンカーは、インプラント可能メディカルデバイスの実施形態の長手方向軸又はインプラント可能メディカルデバイスの外周に向かって又はそれから離れるように変位し、後退し、回転し及び/又は折り畳むことができる。アンカーは、展開中又は展開後に、(例えば、インプラント可能メディカルデバイスの本体から離れるように突出することにより)組織と係合するように構成されている。このようなアンカーの展開/係合と一貫して、アンカーの一部(例えば、アンカーの先端)は、高負荷力、デバイス損傷又はカテーテル損傷の原因となる、デリバリーカテーテルの先端又はカテーテルの内側での捕捉を回避する。アンカーは、デリバリーカテーテルとの接触/相互作用を回避する。幾つかの実施形態は、カテーテル装填中にカテーテルから離れるように変位されるアンカーを有する。アンカーの先端は十分に変位し、装填時にカテーテルとの接触/相互作用を排除する。これは、デバイス本体の設計、ウエスト及びウエストの遠位でのアンカー基部の配置を利用することによって実現される。
自体が網羅的であることを意図していない。特に、構造、材料、要素、構成要素、形状、サイズ及び本明細書に記載された原理内の組み合わせを含む部品の配置の問題に関して、添付の特許請求の範囲が表現される用語の広く一般的な意味によって示されている範囲全体にわたって様々な変更を加えることができることは当業者に明らかであろう。これらの様々な変更が添付の特許請求の範囲の主旨及び範囲から逸脱する範囲まで、前記変更はその範囲内に含まれることが意図されている。本明細書で参照されるすべての参考文献、刊行物及び特許の全体を、それらに含まれる図及び図面を含めて、参照により本明細書に取り込む。
(態様)
(態様1)
近位端、遠位端及び長手方向軸を有するフレームを含む、体内の導管、付属器官及び開口部に配置するためのデバイスであって、前記デバイスは、
第一の本体部分、
前記長手方向軸に対して角度を付けたウエスト部分、及び、
前記ウエスト部分に沿って配置されており、前記フレームがデリバリー構成に配置されるのに応答して、前記長手方向軸に対してそして前記長手方向軸に向かって回転して、アンカー先端とデリバリーシースとの間の接触を回避するように構成された1つ以上のアンカー、
を含む、デバイス。
(態様2)
前記遠位端に向かって前記長手方向軸に対して内向きにテーパ型になっている第二の本体部分をさらに含み、前記ウエスト部分は前記第一の本体部分と前記第二の本体部分との間に配置され、そして前記1つ以上のアンカーのそれぞれは、前記ウエスト部分に配置された根元を含み、前記1つ以上のアンカーは、前記フレームがデリバリー構成に配置されることに応答して、前記根元で前記長手方向軸に向かって回転するように構成されている、態様1記載のデバイス。
(態様3)
前記第一の本体部分又は前記第二の本体部分は、周方向に延在するストラット対の列を含み、隣接するストラット対は互いに接合し、前記1つ以上のアンカーのそれぞれは遠位端で先端を含み、前記1つ以上のアンカーは、前記フレームがデリバリー構成に配置されることに応答して、内向きに移動しそして前記隣接するストラット対の間に前記先端を配置するように構成されている、態様2記載のデバイス。
(態様4)
前記根元は、デリバリー構成において、前記長手方向軸に対して約-10°~0°の角度、及び、展開構成において、前記長手方向軸に対して約10°~55°の角度の曲率を備える、態様2~3のいずれか1項記載のデバイス。
(態様5)
前記1つ以上のアンカーは、前記フレームがデリバリー構成に配置されることに応答して、前記ウエスト部分で前記長手方向軸に向かって回転するように構成されている、態様1~4のいずれか1項記載のデバイス。
(態様6)
前記ウエスト部分は、前記第一の本体部分及び前記第二の本体部分に対する本体角を備え、前記本体角は、前記フレームがデリバリー構成に配置されることに応答して、前記1つ以上のアンカーの回転を促進する、態様5記載のデバイス。
(態様7)
前記本体角は、展開構成において180°未満である、態様6記載のデバイス。
(態様8)
前記1つ以上のアンカーは、展開構成において、前記本体角以下である半径を備える、態様7記載のデバイス。
(態様9)
第二の本体部分をさらに含み、前記第二の本体部分の可撓性は前記ウエスト部分の可撓性よりも低い、態様1~8のいずれか1項記載のデバイス。
(態様10)
デリバリー構成及び展開構成を有する、体内の導管、付属器官及び開口部に配置するためのデバイスであって、前記デバイスは、
近位端、遠位端及び長手方向軸を有するフレームを含み、前記フレームは、
複数のセルを含む第一の本体部分、
第二の本体部分、
前記第一の本体部分と前記第二の本体部分との間に配置されており、前記第一の本体部分と前記第二の本体部分との間に約20°~90°の角度を形成するウエスト部分、及び、
前記ウエスト部分の遠位端に配置された根元と、近位端に向かって延びる先端とを有する少なくとも1つのアンカーを含み、
前記少なくとも1つのアンカーは、展開構成において、前記ウエスト部分から前記長手方向軸に対して外向きに突出し、そしてデリバリー構成において、複数のセルのうちの1つ以上の中に入れ子になっている、デバイス。
(態様11)
前記少なくとも1つのアンカーは、前記フレームが展開構成からデリバリー構成に配置されることに応答して、前記長手方向軸に向かって回転するように構成されている、態様10記載のデバイス。
(態様12)
前記少なくとも1つのアンカーは、前記フレームがデリバリー構成から展開構成に配置されることに応答して、前記長手方向軸に対して回転し、そしてアンカー先端を内向きに移動させるように構成されている、態様10~11のいずれか1項記載のデバイス。
(態様13)
前記少なくとも1つのアンカーのそれぞれの根元は、前記フレームの遠位端からのデバイスの全長の約40%である、態様10~12のいずれか1項記載のデバイス。
(態様14)
前記第一の本体部分の可撓性及び前記第二の本体部分の可撓性のうちの少なくとも1つは前記ウエスト部分の可撓性よりも低い、態様10~13のいずれか1項記載のデバイス。
(態様15)
隣接するストラット対の幅は少なくとも1つのアンカーに隣接して減少している、態様10~14のいずれか1項記載のデバイス。
(態様16)
体内の導管、付属器官及び開口部においてデバイスを展開するためのシステムであって、前記システムは、
管腔及び実質的に円形の本体部分を有するデリバリーカテーテル、ならびに、近位端、遠位端及び長手方向軸を有するフレームを含み、前記フレームは、
第一の本体部分、
遠位端に向かって長手方向軸に対して内向きにテーパ型になっている第二の本体部分、
前記第一の本体部分と前記第二の本体部分との間に配置されたウエスト部分、及び、
前記ウエスト部分に沿って配置された1つ以上のアンカーであって、前記フレームがデリバリーカテーテル内に配置されることに応答して、前記長手方向軸に対して内向きにそして前記長手方向軸に向かって移動して、アンカー先端と前記デリバリーカテーテルとの接触を回避するように構成されている1つ以上のアンカーを含む、システム。
(態様17)
前記1つ以上のアンカーは、前記デリバリーカテーテル内に配置されることに応答して、前記実質的に円形の本体部分に接触することなく前記長手方向軸に向かって回転するように構成されている、態様16記載のシステム。
(態様18)
前記1つ以上のアンカーは、前記デリバリーカテーテルからの前記フレームの展開に応答して前記長手方向軸に対して外向きに移動するように構成されている、態様16~17のいずれか1項記載のシステム。
(態様19)
前記デリバリーカテーテルは、前記フレームの近位端の前に前記フレームの遠位端を展開するように構成され、そして前記1つ以上のアンカーは、展開構成における前記デリバリーカテーテルからの前記フレームの展開に応答して、前記ウエスト部分から外向きに突
出し、近位端に向かって上向きに湾曲する、態様16~18のいずれか1項記載のシステム。
(態様20)
前記デリバリーカテーテルは、前記フレームを前記デリバリーカテーテルに引き込むことに応答して、展開構成から前記フレームを再捕捉し、そして前記1つ以上のアンカーを前記長手方向軸に向かって回転させるように構成されている、態様16~19のいずれか1項記載のシステム。
(態様21)
デバイスを体内の導管、付属器官及び開口部に展開する方法であって、前記方法は、
インプラント可能メディカルデバイスをデリバリーを行うように配置することであって、前記インプラント可能メディカルデバイスは第一の本体部分、遠位端に向かって長手方向軸に対して内向きにテーパ型になっている第二の本体部分、前記第一の本体部分と前記第二の本体部分との間に配置されたウエスト部分、及び、前記ウエスト部分に沿って配置された1つ以上のアンカーを含む、配置することと、
前記フレームがデリバリーカテーテル内に配置されることに応答して、デバイスをデリバリーカテーテル中に装填することによってデバイスを折り畳み、それにより、1つ以上のアンカーを長手方向軸に向かって内向きに移動させることと、
前記デリバリーカテーテルから前記デバイスを展開し、前記1つ以上のアンカーが前記長手方向軸から半径方向外向きに移動し、体内の組織に係合するように構成されている展開構成に前記フレームを拡張することにより、体内に前記デバイスをインプラントすることと、を含む、方法。
(態様22)
前記デバイスをインプラントした後に、前記1つ以上のアンカーを前記組織から外して、前記1つ以上のアンカーを前記長手方向軸に向かって回転させるために、前記デバイスを前記デリバリーカテーテル中に再装填することをさらに含む、態様21記載の方法。
(態様23)
前記デバイスを前記デリバリーカテーテルに再装填した後に、体内に前記デバイスを再度インプラントすることをさらに含み、前記1つ以上のアンカーは前記長手方向軸から半径方向外向きに回転し、体内の組織に係合するように構成されている、態様22記載の方法。
Claims (14)
- デリバリー構成から展開構成に拡張可能でありおよび近位端、遠位端、長手方向軸を有する、患者の体内にインプラント可能なデバイスであって、前記デバイスは、
複数のストラットから形成された本体と、
1つ以上の接合部にまたは前記1つ以上の接合部に隣接して配置された1つ以上のアンカーと、
を含み、前記本体は、
前記1つ以上の接合部で収束する周方向に拡がるストラット対の列を含む第一の本体部分と、
前記第一の本体部分より遠位に配置されおよび前記長手方向軸に対して角度を付けたウエスト部分と、
を含み、
前記1つ以上のアンカーは根元の曲率を有し、前記デバイスが展開構成にある場合に、前記1つ以上のアンカーが前記ウエスト部分から前記長手方向軸に対して外向きに突出するようなっている、
デバイス。 - 前記1つ以上のアンカーは、フレームがデリバリー構成に配置されることに応答して、前記長手方向軸に対してそして前記長手方向軸に向かって回転可能である、請求項1記載のデバイス。
- 前記1つ以上のアンカーのそれぞれは根元および先端を有し、さらに前記デバイスがデリバリー構成にある場合に、前記根元の曲率は、-30°~10°の長手方向軸に対する角度を有する前記1つ以上のアンカーの根元を含む、請求項1に記載のデバイス。
- 前記デバイスが展開構成にある場合に、前記根元の曲率は、5°~90°の前記長手方向軸に対する角度を有する前記1つ以上のアンカーの根元を含む、請求項3に記載のデバイス。
- 前記デバイスがデリバリー構成にある場合に、前記ウエスト部分の本体角は、20°~90°である、請求項1記載のデバイス。
- 前記第一の本体部分より遠位に配置されおよび前記ウエスト部分の前記長手方向軸に対する角度より大きい角度で前記遠位端に向かって前記長手方向軸に対して内向きにテーパ型になっている第二の本体部分をさらに含み、前記ウエスト部分は前記第一の本体部分と前記第二の本体部分との間に配置され、前記1つ以上のアンカーは、前記ウエスト部分においておよび前記第二の本体部分の近傍において収束する前記本体の隣接するストラットの間で前記ウエスト部分に沿って配置されている、請求項1に記載のデバイス。
- 前記デバイスは、フレームの近位端に配置された面部分をさらに含み、前記第一の本体部分は周方向に拡がるストラット対の列を含み、前記第一の本体部分は前記面部分の隣にある、請求項1に記載のデバイス。
- 前記第一の本体部分より遠位に配置されおよび前記ウエスト部分の前記長手方向軸に対する角度より大きい角度で前記遠位端に向かって前記長手方向軸に対して内向きにテーパ型になっている第二の本体部分をさらに含み、前記ウエスト部分は前記第一の本体部分と前記第二の本体部分との間に配置され、前記第一の本体部分または前記第二の本体部分は周方向に延在するストラット対の列を含み、隣接するストラット対は互いに接合し、さらに前記1つ以上のアンカーのそれぞれは遠位端で先端を含み、前記1つ以上のアンカーはフレームがデリバリー構成にあることに応答して、内向きに移動しそして前記隣接するストラット対の間に前記先端を配置するように構成されている、請求項1に記載のデバイス。
- 前記1つ以上のアンカーの前記根元の曲率は、前記デバイスの前記デリバリー構成と前記展開構成との遷移間で一定のままである、請求項1に記載のデバイス。
- デリバリー構成から展開構成に拡張可能であり、ならびに近位端、遠位端、前記近位端と前記遠位端との間の長さ、およびデバイスの前記長さに沿って延在する長手方向軸を有する、患者の体内にインプラント可能なデバイスであって、前記デバイスは、
複数のストラットから形成された本体と、
根元および先端を有する1つ以上のアンカーと、
を含み、前記本体は、
1つ以上の接合部で収束する周方向に拡がるストラット対の列を含む第一の本体部分と、
前記第一の本体部分より遠位に配置されおよび前記長手方向軸に対して角度を付けたウエスト部分と、
を含み、
前記根元は前記ウエスト部分の遠位端に配置され、前記先端は前記ウエスト部分の近位端に向かって延びおよび前記1つ以上の接合部にまたは前記1つ以上の接合部に隣接して配置されており、
前記1つ以上のアンカーは根元の曲率を有し、前記デバイスが展開構成にある場合に、前記1つ以上のアンカーが前記ウエスト部分から前記長手方向軸に対して外向きに突出するようになっている、
デバイス。 - 前記デバイスがデリバリー構成にある場合に、前記根元の曲率は、-30°~10°の長手方向軸に対する角度を有する前記1つ以上のアンカーの根元を含む、請求項10に記載のデバイス。
- 前記デバイスが展開構成にある場合に、前記根元の曲率は、5°~90°の前記長手方向軸に対する角度を有する前記1つ以上のアンカーの根元を含む、請求項11に記載のデバイス。
- 前記デバイスは、フレームの前記近位端に配置された面部分をさらに含み、前記第一の本体部分は周方向に拡がるストラット対の列を含み、前記第一の本体部分は前記面部分の隣にある、請求項10に記載のデバイス。
- 前記1つ以上のアンカーはデリバリー構成において複数のセルのうちの1つ以上の中に入れ子になっている。請求項10記載のデバイス。
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