JP7410034B2 - 血管内血液ポンプならびに使用および製造の方法 - Google Patents
血管内血液ポンプならびに使用および製造の方法 Download PDFInfo
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Description
[0001]本出願は、あらゆる目的のために参照によりその開示が本明細書に完全に組み込まれる以下の米国仮特許出願:2018年2月1日に出願された出願第62/625,312号の優先権を主張するものである。
参照による組み込み
[0002]本明細書で言及されるすべての刊行物および特許出願は、各々の個別の刊行物または特許出願が参照により組み込まれることを具体的にかつ個別に示されるような場合と同様の程度で、参照により本明細書に組み込まれる。
[0010]本開示の一態様は、血管内血液ポンプであり、この血管内血液ポンプが、流体ルーメンを備える折り畳み可能なハウジングであって、流体ルーメンが遠位端、近位端、および近位端を有する略一定の直径部分を有し、流体ルーメン近位端が略一定の直径部分の近位端の近位にある、折り畳み可能なハウジングと、折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、遠位側羽根車が拡大構成を有し、近位側羽根車が拡大構成を有する、折り畳み可能な遠位側羽根車と、を備え、近位側羽根車が、拡大構成における軸方向長さを有し、軸方向長さに沿って測定される近位側羽根車の少なくとも一部分が、略一定の直径部分の近位端の近位に配設される。
[0025]流体ルーメンは、略一定の直径部分の近位に配設される近位側部分をさらに備え得、この近位側部分は、流体ディフューザとして働くように適合および構成される少なくとも1つの表面を含む。近位側部分は、フレア状の構成を備え得る。近位側部分は、略一定の直径部分の近位端から流体ルーメン近位端への連続的および段階的なフレアを有し得る。近位側部分は、本明細書に開示される任意の他の近位側部分構成を有し得る。
[0027]本開示の一態様は、血管内血液ポンプであり、この血管内血液ポンプが、流体ルーメンを備える折り畳み可能なハウジングであって、流体ルーメンが、遠位端、および流体ルーメン遠位端に近位である遠位端を有するフレア状の近位側領域を有し、フレア状の近位側領域が、流体ディフューザとして働くように適合および構成される少なくとも1つの表面を備える、折り畳み可能なハウジングと、折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、遠位側羽根車が拡大構成を有し、近位側羽根車が拡大構成を有し、近位側羽根車の少なくとも一部分が、フレア状の近位側領域の遠位端の遠位に配設される、折り畳み可能な遠位側羽根車と、を備え、近位側羽根車が、拡大構成における軸方向長さを有し、軸方向長さに沿って測定される近位側羽根車の少なくとも一部分が、フレア状の近位側領域の遠位端の近位に配設される。
[0042]流体ルーメンは、フレア状の近位側領域の遠位にある略一定の直径部分をさらに備え得る。
[0044]本開示の一態様は、血管内血液ポンプであり、この血管内血液ポンプが、流体ルーメンを備える折り畳み可能なハウジングであって、流体ルーメンが遠位端、近位端、および近位端を有する略一定の直径部分を有する、折り畳み可能なハウジングと、折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、遠位側羽根車が拡大構成を有し、近位側羽根車が拡大構成を有し、近位側羽根車の少なくとも一部分が略一定の直径部分の中に配設される、折り畳み可能な遠位側羽根車と、を備え、近位側羽根車が、拡大構成における軸方向長さ、および軸方向長さの途中に中点を有し、中点が、略一定の直径部分の近位端の近位にある。
[0047]血液ポンプは、近位側羽根車と遠位側羽根車との間に軸方向に配設されるベーンを含まなくてもよい。
[0049]軸方向長さに沿って測定される近位側羽根車の少なくとも半分は、流体ルーメンの略一定の直径部分の近位端の近位に配設され得る。
[0051]近位側羽根車および遠位側羽根車は各々、それらの拡大構成にあるとき、近位側羽根車が血液ポンプの作用の55%以上を実施しており、遠位側羽根車が血液ポンプの作用の45%未満を実施しているように、流体ルーメンに対して配置され得る。
[0063]血液ポンプは、近位側羽根車と遠位側羽根車との間に軸方向に配設される静翼を含まなくてもよい。
[0070]本開示の一態様は、血管内血液ポンプであり、この血管内血液ポンプが、流体ルーメンを備える折り畳み可能なハウジングであって、流体ルーメンが、遠位端、近位端、およびルーメン壁構成を有する近位側領域を有し、近位側領域が近位端を含む、折り畳み可能なハウジングと、折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、遠位側羽根車が拡大構成を有し、近位側羽根車が拡大を有し、近位側羽根車の少なくとも一部分が、流体ルーメンの近位側領域の遠位に配設される、折り畳み可能な遠位側羽根車と、を備え、近位側羽根車が、表面を有する少なくとも1つの翼を有し、少なくとも1つの翼表面およびルーメン壁が、近位側羽根車が初期位置に対して少なくとも2mm近位側に移動され、その結果、近位側羽根車がより少なく流体ルーメンの近位側領域の遠位に配設される場合、近位側羽根車の軸方向位置における変化が、流れにおいて少なくとも10%を結果としてもたらすように構成される。
[0072]本開示は、本明細書内のありとあらゆる血液ポンプを使用する方法を含み、その例は、いくつかの例示的な解剖学的場所において本明細書では提供される。
[0097]医療デバイスを折り畳んだり拡大したりするための、例示の、被覆物の中に収容する(sheathing)および被覆物から出す(unsheathing)手法および概念は、例えば、その開示が参照により本明細書に組み込まれる米国特許第7,841,976号または米国特許第8,052,749号で説明されて示される手法および概念などから、知られている。
[0202]いくつかの実施形態において、近位側羽根車は、血液ポンプによって生成される圧力の55%以上を生成し、遠位側羽根車は、血液ポンプによって生成される圧力の45%未満を生成する。いくつかの実施形態において、近位側羽根車は、血液ポンプの圧力の60%以上を生成し、遠位側羽根車は、血液ポンプの圧力の40%未満を生成する。いくつかの実施形態において、近位側羽根車は、血液ポンプの圧力の70%以上を生成し、遠位側羽根車は、血液ポンプの圧力の30%未満を生成する。いくつかの実施形態において、近位側羽根車は、血液ポンプの圧力の約80%を生成し、遠位側羽根車は、血液ポンプの圧力の約20%を生成する。
Claims (15)
- 血管内血液ポンプであって、
流体ルーメンを備える折り畳み可能なハウジングであって、前記流体ルーメンが遠位端、近位端、および近位端を有する略一定の直径部分を有し、前記流体ルーメン近位端が前記略一定の直径部分の前記近位端の近位にある、折り畳み可能なハウジングと、
折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、前記遠位側羽根車が拡大構成を有し、前記近位側羽根車が拡大構成を有し、前記近位側羽根車の少なくとも一部分が前記略一定の直径部分の中に配設される、折り畳み可能な遠位側羽根車と、を備え、
前記近位側羽根車が、前記拡大構成における軸方向長さを有し、前記軸方向長さに沿って測定される前記近位側羽根車の20%~50%が、前記略一定の直径部分の前記近位端の近位に配設される、血管内血液ポンプ。 - 前記近位側羽根車の20%~45%が、前記略一定の直径部分の前記近位端の近位に配設される、請求項1に記載の血液ポンプ。
- 前記近位側羽根車の20%~40%が、前記略一定の直径部分の前記近位端の近位に配設される、請求項1に記載の血液ポンプ。
- 血管内血液ポンプであって、
流体ルーメンを備える折り畳み可能なハウジングであって、前記流体ルーメンが遠位端および近位端を有する、折り畳み可能なハウジングと、
折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、前記遠位側羽根車が拡大構成を有し、前記近位側羽根車が拡大構成を有し、前記遠位側および近位側羽根車の各々の少なくとも一部分が、前記流体ルーメンの前記遠位端と前記近位端との間に配設される、折り畳み可能な遠位側羽根車と、を備え、
前記近位側羽根車および前記遠位側羽根車が各々、それらの拡大構成にあるとき、および回転するとき、前記近位側羽根車が前記血液ポンプの作用の50%以上を実施しており、前記遠位側羽根車が前記血液ポンプの作用の50%未満を実施しているように、前記流体ルーメンに対して配置される、血管内血液ポンプ。 - 前記血液ポンプが、前記近位側羽根車と前記遠位側羽根車との間に軸方向に配設されるベーンを含まない、請求項4に記載の血液ポンプ。
- 前記血液ポンプが、前記近位側羽根車と前記遠位側羽根車との間に軸方向に配設される静翼を含まない、請求項4に記載の血液ポンプ。
- 軸方向長さに沿って測定される前記近位側羽根車の少なくとも半分が、前記流体ルーメンの略一定の直径部分の近位端の近位に配設される、請求項4に記載の血液ポンプ。
- 軸方向長さに沿って測定される前記近位側羽根車の最大90%が、前記流体ルーメンの略一定の直径部分の近位端の近位に配設される、請求項7に記載の血液ポンプ。
- 前記近位側羽根車および前記遠位側羽根車が各々、それらの拡大構成にあるとき、前記近位側羽根車が前記血液ポンプの作用の55%以上を実施しており、前記遠位側羽根車が前記血液ポンプの作用の45%未満を実施しているように、前記流体ルーメンに対して配置される、請求項4に記載の血液ポンプ。
- 前記近位側羽根車および前記遠位側羽根車が各々、それらの拡大構成にあるとき、前記近位側羽根車が前記血液ポンプの作用の60%以上を実施しており、前記遠位側羽根車が前記血液ポンプの作用の40%未満を実施しているように、前記流体ルーメンに対して配置される、請求項9に記載の血液ポンプ。
- 前記近位側羽根車および前記遠位側羽根車が各々、それらの拡大構成にあるとき、前記近位側羽根車が前記血液ポンプの作用の70%以上を実施しており、前記遠位側羽根車が前記血液ポンプの作用の30%未満を実施しているように、前記流体ルーメンに対して配置される、請求項10に記載の血液ポンプ。
- 前記近位側羽根車および前記遠位側羽根車が各々、それらの拡大構成にあるとき、前記近位側羽根車が前記血液ポンプの作用の約80%を実施しており、前記遠位側羽根車が前記血液ポンプの作用の約20%を実施しているように、前記流体ルーメンに対して配置される、請求項11に記載の血液ポンプ。
- 血管内血液ポンプであって、
流体ルーメンを備える折り畳み可能なハウジングであって、前記流体ルーメンが遠位端および近位端を有する、折り畳み可能なハウジングと、
折り畳み可能な近位側羽根車から軸方向に離間する折り畳み可能な遠位側羽根車であって、前記遠位側羽根車が拡大構成を有し、前記近位側羽根車が拡大構成を有し、前記遠位側および近位側羽根車の各々の少なくとも一部分が、前記流体ルーメンの前記遠位端と前記近位端との間に配設される、折り畳み可能な遠位側羽根車と、を備え、
前記近位側羽根車および前記遠位側羽根車が各々、それらの拡大構成にあるとき、および回転するとき、前記近位側羽根車が前記血液ポンプによって生成される圧力の50%以上を生成しており、前記遠位側羽根車が前記血液ポンプによって生成される圧力の50%未満を生成しているように、前記流体ルーメンに対して配置される、血管内血液ポンプ。 - 軸方向長さに沿って測定される前記近位側羽根車の少なくとも半分が、前記流体ルーメンの略一定の直径部分の近位端の近位に配設される、請求項13に記載の血液ポンプ。
- 軸方向長さに沿って測定される前記近位側羽根車の最大90%が、前記流体ルーメンの略一定の直径部分の近位端の近位に配設される、請求項14に記載の血液ポンプ。
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