JP5341240B2 - 心臓弁の機能を改善するためのデバイスおよび方法 - Google Patents
心臓弁の機能を改善するためのデバイスおよび方法 Download PDFInfo
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Description
本発明は、一般に、種々の奇形および機能不全を有する心臓弁の修復の分野に関する。より具体的には、本発明は、心臓弁修復技術および輪状形成術デバイスに関する処置に関する。
罹患した僧帽弁および三尖弁は、置換または修復を必要とすることが多い。僧帽弁および三尖弁の弁膜または支持腱索が変性もしくは弱化しているか、または、弁輪が拡張して、弁の漏れ、すなわち、不十分な弁機能に繋がっている可能性がある。弁膜および腱索は、石灰化および肥厚化して、これらを狭窄状態にし得、これは、弁を通る前進性の流れの妨害を伴う。最終的には、弁は、心室の内側の腱索の挿入に頼る。心室の形状が変化する場合、弁の支持は機能不全となり、そして、弁が漏れ得る。
本発明の目的は、弁修復および弁置換のための改善された医療用デバイスおよび方法を提供することである。本発明の別の目的は、弁の弁輪への容易かつ耐久性のある固定を可能にする、輪状形成術用デバイスを提供することであり得る。
(項目1)
弁輪(20)と複数の弁膜(22、24)とを含む弁組織から構成される心臓弁の機能を改善するための医療用デバイス(40)であって、該医療用デバイスは、以下:
該心臓弁の第一の側と接するように構成される、第一のループ形状の支持体(42)と、
該第一のループ形状の支持体に接続され、かつ、該第一のループ形状の支持体が該心臓弁と接しているときに、該弁輪に抗して配置されるように構成される、第一のフランジユニット(50)と
を備える、デバイス。
(項目2)
項目1に記載のデバイスであって、前記第一の側の反対側にある前記心臓弁の第二の側と接するように構成される、第二のループ形状の支持体(44)をさらに備え、該第二の支持体は、前記第一の側の反対にある該心臓弁の第二の側と接し、それにより、前記弁組織の一部が、前記第一の支持体(42)と該第二の支持体(44)との間に捕捉される、デバイス。
(項目3)
前記第一のループ形状の支持体(42)が、前記第二のループ形状の支持体(44)と連続しており、コイル形状の本体(41)を形成している、項目2に記載のデバイス。
(項目4)
前記第一のフランジユニット(50)が、前記第一のループ形状の支持体(42)から前記第二のループ形状の支持体(44)まで延び、それによって、該フランジユニット(50)が、該第一の支持体と該第二の支持体との間に捕捉された前記弁組織の反対側で弁輪に抗して配置されるように構成される、項目2または3に記載のデバイス。
(項目5)
項目2または3に記載のデバイスであって、前記第二のループ形状の支持体(44)が、該第二の支持体に接続された第二のフランジユニット(50)を備え、該フランジユニット(50)が、該第二のループ形状の支持体が前記心臓弁と接しているときに、前記第一のループ形状の支持体の反対側にある側で前記弁輪(20)に抗して配置されるように構成される、デバイス。
(項目6)
項目1〜5のいずれかに記載のデバイスであって、前記第一および第二のフランジユニット(50)のうち少なくとも一方が、前記弁輪(20)に対し、前記ループ形状の支持体(42、44)および補綴弁(64)のうち少なくとも一方の接続部を形成するように適合される、デバイス。
(項目7)
前記第一および第二のフランジユニット(50)のうち少なくとも一方が、その対応するループ形状の支持体(42、44)の周縁に沿って断続的な伸長部を有する、項目1〜6に記載のデバイス。
(項目8)
前記第一および第二のフランジユニット(50)のうち少なくとも一方が、その対応するループ形状の支持体(42、44)の周縁に沿って連続した伸長部を有する、項目1〜6のいずれかに記載のデバイス。
(項目9)
前記第一および第二のフランジユニット(50)のうち少なくとも一方が、織布素材のものである、項目1〜8に記載のデバイス。
(項目10)
前記第一および第二のフランジユニット(50)のうち少なくとも一方が、補強要素を備える、項目1〜9のいずれかに記載のデバイス。
(項目11)
項目2〜10のいずれかに記載のデバイスであって、少なくともその使用もしくは移植の前に、前記第一および第二のフランジユニットのうち少なくとも一方が、前記ループ形状の支持体(42、44)のうちの一方によって形成される直径に沿った平面から外に延び、かつ、該平面の下に、30〜60°、より好ましくは40〜50°の角度を成す、デバイス。
(項目12)
前記第一および第二のフランジユニット(50)のうち少なくとも一方が、その対応するループ形状の支持体(42、44)から内向きもしくは外向きに放射状に延びる、項目1〜11のいずれかに記載のデバイス。
(項目13)
前記心臓弁の前記第一の側が心房側であり、前記第二の側が心室側である、項目1〜12のいずれかに記載のデバイス。
(項目14)
前記デバイス(40)が、人工補綴心臓弁を運ぶように適合される、項目1〜13のいずれかに記載のデバイス。
(項目15)
前記フランジユニット(50)が、その弾性の配置によって、挿入の間に形状を変化させるように配置される、項目1〜14のいずれかに記載のデバイス。
(項目16)
前記フランジユニット(50)が、形状記憶素材を含み、かつ、前記医療用デバイス(40)の挿入の間に予め画定された形状に戻るように配置される、項目1〜15のいずれかに記載のデバイス。
(項目17)
前記フランジユニット(50)が、前記第一の支持体(42)および/または第二の支持体(44)の少なくとも一部分と一体である、項目1〜16のいずれかに記載のデバイス。
(項目18)
前記フランジユニット(50)が、実質的に同軸性の接続部として配置されるように、前記第一の支持体(42)および/または第二の支持体(44)上を通される管形状の可撓性素材(52)から作製される、項目1〜16のいずれかに記載のデバイス。
(項目19)
心臓弁の機能を改善するための、項目1〜18のいずれかに記載の医療用デバイス、および該医療用デバイスに着脱可能もしくは取り付けられる人工補綴心臓弁のキット。
(項目20)
前記人工補綴心臓弁が、前記医療用デバイスのループ形状の支持体またはフランジユニット上に配置される、項目19に記載のキット。
(項目21)
前記人工補綴心臓弁が、前記心臓弁の弁輪の心房側に位置決めされることが意図される前記医療用デバイスの前記ループ形状の支持体もしくはフランジユニット上に配置され得る、項目19に記載のキット。
(項目22)
血液の流れを与えたり妨げたりするために、弁輪(20)と複数の弁膜(22、24)とを含む弁組織から構成される心臓弁を修復するための方法であって、該方法は、以下:
少なくとも1つのループ形状の支持体(42、44)と、該ループ形状の支持体に接続されている少なくとも1つのフランジユニット(50)とを備える医療用デバイス(40)を、心臓弁に挿入する工程と、
該心臓弁の第一の側と接するように該ループ形状の支持体を位置決めする工程と、
該弁輪と接するように該フランジユニットを位置決めする工程と、
該フランジユニットを該弁輪に取り付けることによって、該デバイスを固定する工程とを包含する、方法。
(項目23)
前記フランジユニット(50)が、縫合糸もしくはクリップ(62)によって前記弁輪(20)に取り付けられる、項目22に記載の方法。
(項目24)
前記フランジユニット(50)が、前記デバイス(40)を固定する前に、前記弁輪(20)に合わされる、項目22〜23のいずれかに記載の方法。
(項目25)
前記デバイス(40)が、カテーテルを使用することにより前記心臓弁に挿入され、該カテーテルが引き抜かれると、該デバイスが残される、項目22〜24のいずれかに記載の方法。
(項目26)
前記心臓弁の前記第一の側が心房側である、項目22〜25のいずれかに記載の方法。
(項目27)
血液の流れを与えたり妨げたりするために、弁輪と複数の弁膜とを含む弁組織から構成される心臓弁を置換するための方法であって、該方法は、以下:
人工弁と、少なくとも1つのループ形状の支持体と、該ループ形状の支持体に接続されている少なくとも1つのフランジユニットとを備える医療用デバイスを、心臓弁に挿入する工程と、
該心臓弁の第一の側と接するように該ループ形状の支持体を位置決めする工程と、
該弁輪と接するように該フランジユニットを位置決めする工程と、
該フランジユニットを該弁輪に取り付けることによって、該デバイスを固定する工程とを包含する、方法。
本発明の特定の実施形態が、ここで、添付の図面を参照して記載される。しかし、本発明は、多くの異なる形態で実施され得、そして、本明細書中に示される実施形態に限定されるものとしてみなされるべきではない;むしろ、これらの実施形態は、本開示が、徹底的かつ完全であり、そして、当業者に本発明の範囲を完全に伝えるように提供される。添付の図面に示される実施形態の詳細な説明において使用される専門用語は、本発明を限定するものであることは意図されない。図面において、同様の参照番号は同様の要素を指す。
Claims (21)
- 弁輪と複数の弁膜とを含む弁組織から構成される心臓弁の機能を改善するための医療用デバイスであって、該医療用デバイスは、以下:
該心臓弁の第一の側と接するように構成される、第一のループ形状の支持体と、
該第一のループ形状の支持体に接続される、第一のフランジユニットと
を備え、該第一のフランジユニットは、第一の補強要素を備える、デバイス。 - 前記第一のフランジユニットは、前記第一のループ形状の支持体が前記心臓弁と接して配置されているときに、前記弁輪に抗するシーリング表面を提供するように構成されている、請求項1に記載のデバイス。
- 前記第一の補強要素は、ビーズまたはねじである、請求項1に記載のデバイス。
- 前記第一のフランジユニットが、固定要素または組織接着剤、あるいはその両方を備える、請求項1に記載のデバイス。
- 前記第一のフランジユニットが、補綴弁の固定のために適合されている、請求項1に記載のデバイス。
- 請求項1に記載のデバイスであって、前記第一の側の反対側にある前記心臓弁の第二の側と接するように構成される、第二のループ形状の支持体をさらに備え、それにより、前記弁組織の一部が、前記第一の支持体と該第二の支持体との間に捕捉される、デバイス。
- 前記第一のループ形状の支持体が、前記第二のループ形状の支持体と連続しており、コイル形状の本体を形成している、請求項6に記載のデバイス。
- 前記第一のフランジユニットが、前記第一のループ形状の支持体から前記第二のループ形状の支持体まで延び、それによって、該第一のフランジユニットが、該第一の支持体と該第二の支持体との間に捕捉された前記弁組織の反対側で弁輪に抗して配置されるように構成される、請求項7に記載のデバイス。
- 請求項6に記載のデバイスであって、前記第二のループ形状の支持体が、該第二の支持体に接続された第二のフランジユニットを備え、該第二のフランジユニットが、該第二のループ形状の支持体が前記心臓弁と接しているときに、前記第一のループ形状の支持体の反対側にある側で前記弁輪に抗して配置されるように構成される、デバイス。
- 前記第二のフランジユニットが、第二の補強要素を備える、請求項9に記載のデバイス。
- 前記第二の補強要素は、ビーズまたはねじである、請求項10に記載のデバイス。
- 前記第二のフランジユニットが、固定要素または組織接着剤、あるいはその両方を備える、請求項9に記載のデバイス。
- 前記第一および第二のフランジユニットのうち少なくとも一方が、その対応するループ形状の支持体の周縁に沿って断続的な伸長部を有する、請求項9に記載のデバイス。
- 前記第一および第二のフランジユニットのうち少なくとも一方が、その対応するループ形状の支持体の周縁に沿って連続した伸長部を有する、請求項9に記載のデバイス。
- 前記第一および第二のフランジユニットのうち少なくとも一方が、織布素材、ポリエチレン、ポリテトラフルオロエチレン、および形状記憶素材からなる群より選択される素材から作製されている、請求項9に記載のデバイス。
- 請求項9に記載のデバイスであって、少なくとも前記デバイスの移植の前に、前記第一または第二のフランジユニットが、前記第一または第二のループ形状の支持体によって形成される直径に沿った平面から外に延び、かつ、該平面の下に、30〜60°の角度(α)を成す、デバイス。
- 前記第一および第二のフランジユニットのうち少なくとも一方が、その対応するループ形状の支持体から内向きもしくは外向きに放射状に延びる、請求項9に記載のデバイス。
- 前記心臓弁の前記第一の側が心房側であり、前記第二の側が心室側である、請求項9に記載のデバイス。
- 請求項9に記載のデバイスであって、前記第一および第二のフランジユニットのうち少なくとも一方が、前記弁輪に対し、前記第一および第二のループ形状の支持体のうち少なくとも一方と補綴弁との接続部を形成するように適合される、デバイス。
- 請求項1に記載の医療用デバイス、および前記第一のフランジユニットに固定されたかまたは固定可能である人工補綴心臓弁を備える、キット。
- 請求項9に記載の医療用デバイス、ならびに前記第一および第二のフランジユニットのうちの少なくとも一方に固定されたかまたは固定可能である人工補綴心臓弁を備える、キット。
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