JPWO2020131978A5 - - Google Patents

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JPWO2020131978A5
JPWO2020131978A5 JP2021535023A JP2021535023A JPWO2020131978A5 JP WO2020131978 A5 JPWO2020131978 A5 JP WO2020131978A5 JP 2021535023 A JP2021535023 A JP 2021535023A JP 2021535023 A JP2021535023 A JP 2021535023A JP WO2020131978 A5 JPWO2020131978 A5 JP WO2020131978A5
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heart valve
valve
fixation element
configuration
prosthetic heart
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JP2022514008A (en
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Priority claimed from US16/455,417 external-priority patent/US10653522B1/en
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Claims (27)

人工心臓弁であって、
中心軸を有し、前記中心軸に沿って延びる開口を画定する弁フレームであって、遠位固定要素及び近位固定要素を含む、前記弁フレームと、
前記開口内に装着され、流れ制御構成要素の流入端から流出端まで前記中心軸にほぼ平行な第１の方向の血流を可能にし、前記第１の方向とは反対の第２の方向の血流を遮断するように構成された前記流れ制御構成要素と、を含み、
前記弁フレームが、前記人工心臓弁が送達カテーテルを介して患者の心臓に送達されることを可能にする圧縮構成を有し、前記弁フレームが、前記人工心臓弁が前記送達カテーテルから解放されるときに前記圧縮構成から拡張構成に移行するように構成され、
前記人工心臓弁が、前記拡張構成のときに前記心臓の自己弁の弁輪に着座するように構成され、前記遠位固定要素及び前記近位固定要素が、前記人工心臓弁が前記弁輪に着座する前に前記自己弁の前記弁輪を通って挿入されるように構成され、前記近位固定要素が、前記人工心臓弁が前記自己弁の前記弁輪に着座した後に第１の構成から第２の構成に移行するように構成されている、前記人工心臓弁。 A prosthetic heart valve,
a valve frame having a central axis and defining an opening extending along the central axis, the valve frame including a distal fixation element and a proximal fixation element;
mounted within the opening to permit blood flow in a first direction substantially parallel to the central axis from the inflow end to the outflow end of the flow control component, and in a second direction opposite the first direction; said flow control component configured to block blood flow;
The valve frame has a compressed configuration that allows the prosthetic heart valve to be delivered to the patient's heart via a delivery catheter, the valve frame allowing the prosthetic heart valve to be released from the delivery catheter. configured to transition from said compressed configuration to an expanded configuration at times;
The prosthetic heart valve is configured to seat against an annulus of the heart's native valve when in the expanded configuration, and the distal fixation element and the proximal fixation element support the prosthetic heart valve against the annulus. configured to be inserted through the annulus of the native valve prior to seating, wherein the proximal fixation element is removed from the first configuration after the prosthetic heart valve is seated in the annulus of the native valve; The prosthetic heart valve configured to transition to a second configuration. 前記弁フレームが、前記拡張構成にあるとき、前記中心軸に沿った第１の高さと、前記中心軸に垂直な横方向軸に沿った第１の横方向幅と、前記中心軸及び前記横方向軸に垂直な長手方向軸に沿った長手方向長さと、を有し、
前記圧縮構成にあるとき、前記弁フレームが、前記第１の高さ未満の前記中心軸に沿った第２の高さと、前記第１の横方向幅未満の前記横方向軸に沿った第２の横方向幅と、を有する、請求項１に記載の人工心臓弁。 When the valve frame is in the expanded configuration, it has a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, the central axis and the lateral axis. a longitudinal length along a longitudinal axis perpendicular to the directional axis;
When in the compressed configuration, the valve frame has a second height along the central axis that is less than the first height and a second height along the lateral axis that is less than the first lateral width. The prosthetic heart valve of claim 1, having a lateral width of . 前記人工心臓弁を前記自己弁の前記弁輪に着座させることが、前記人工心臓弁が前記自己弁の前記弁輪に着座する前に前記遠位固定要素を心室流出管内に位置決めすることを含む、請求項１または２に記載の人工心臓弁。 Seating the prosthetic heart valve against the annulus of the native valve includes positioning the distal fixation element within a ventricular outflow tract before seating the prosthetic heart valve against the annulus of the native valve. 3. The heart valve prosthesis of claim 1 or 2. 前記遠位固定要素が、ワイヤループ、ワイヤフレーム、一体型フレーム部分、またはステントのうちの少なくとも１つである、請求項１から３のいずれか１項に記載の人工心臓弁。 4. The heart valve prosthesis of any one of claims 1-3, wherein the distal fixation element is at least one of a wire loop, a wire frame, an integral frame portion, or a stent. 前記近位固定要素が、ワイヤループ、ワイヤフレーム、一体型フレーム部分、またはステントのうちの少なくとも１つである、請求項１から４のいずれか１項に記載の人工心臓弁。 5. The heart valve prosthesis of any one of claims 1-4, wherein the proximal fixation element is at least one of a wire loop, a wire frame, an integral frame portion, or a stent. 前記近位固定要素が、前記人工心臓弁が前記自己弁の前記弁輪に着座するときに前記第１の構成にある、請求項１から５のいずれか１項に記載の人工心臓弁。 6. The prosthetic heart valve of any one of claims 1-5, wherein the proximal fixation element is in the first configuration when the prosthetic heart valve seats in the annulus of the native valve. 前記遠位固定要素が、ガイドワイヤに一時的に結合されるように構成されている、請求項１から６のいずれか１項に記載の人工心臓弁。 7. The heart valve prosthesis of any one of claims 1-6, wherein the distal fixation element is configured to be temporarily coupled to a guidewire. 前記弁フレームに結合された引張部材をさらに含み、前記引張部材は、前記引張部材が前記近位固定要素と係合されて前記近位固定要素を第１の構成に維持する前記第１の構成と、前記引張部材が前記近位固定要素から係脱されて前記近位固定要素が第２の構成に移行することを可能にする前記第２の構成と、を有する、請求項１から７のいずれか１項に記載の人工心臓弁。 Further comprising a tensioning member coupled to the valve frame, the tensioning member being in the first configuration, the tensioning member being engaged with the proximal fixation element to maintain the proximal fixation element in the first configuration. and said second configuration wherein said tensioning member is disengaged from said proximal fixation element to allow said proximal fixation element to transition to a second configuration. The prosthetic heart valve according to any one of claims 1 to 3. 前記引張部材の少なくとも一部分が、前記弁フレームによって画定される中間点を通って延びる、請求項８に記載の人工心臓弁。 9. The prosthetic heart valve of claim 8, wherein at least a portion of the tension member extends through a midpoint defined by the valve frame. 前記引張部材が、前記近位固定要素に取り外し可能に結合している、請求項８または９に記載の人工心臓弁。 10. The heart valve prosthesis of claim 8 or 9, wherein the tension member is removably coupled to the proximal fixation element. 前記引張部材が、縫合糸、ケーブル、ワイヤのうちの１つである、請求項８から１０のいずれか１項に記載の人工心臓弁。 11. The heart valve prosthesis of any one of claims 8-10, wherein the tension member is one of a suture, cable, wire. 前記引張部材が、前記引張部材の少なくとも一部分を前記近位固定要素に動作可能に結合するように構成されたコネクタを有する、請求項８から１１のいずれか１項に記載の人工心臓弁。 12. The heart valve prosthesis of any one of claims 8-11, wherein the tension member has a connector configured to operably couple at least a portion of the tension member to the proximal fixation element. 前記コネクタが、前記引張部材が前記近位固定要素内で係合されるときに第１の構成にあり、前記コネクタが、前記引張部材の少なくとも前記一部分が前記近位固定要素から係脱されることを可能にする第２の構成に移行するように構成されている、請求項１２に記載の人工心臓弁。 The connector is in a first configuration when the tension member is engaged within the proximal fixation element, the connector disengaging at least the portion of the tension member from the proximal fixation element. 13. The heart valve prosthesis of claim 12, wherein the prosthetic heart valve is configured to transition to a second configuration that allows for. 前記コネクタが、ねじ山付きコネクタまたはボール及びカップコネクタのうちの少なくとも１つである、請求項１２または１３に記載の人工心臓弁。 14. The heart valve prosthesis of claim 12 or 13, wherein the connector is at least one of a threaded connector or a ball and cup connector. 人工心臓弁であって、
経弁輪部分及び前記経弁輪部分の上端の周囲に取り付けられた心房カラーを有する弁フレームと、
前記弁フレームの前記経弁輪部分に結合された遠位固定要素と、
前記弁フレームの前記経弁輪部分に結合された近位固定要素と、
前記弁フレーム内に装着され、前記人工心臓弁の流入端を通る第１の方向の血流を可能にし、前記第１の方向とは反対の、前記人工心臓弁の流出端を通る第２の方向の血流を遮断するように構成された流れ制御構成要素と、を含み、
前記人工心臓弁が、送達カテーテルを介して患者の心臓に導入するための圧縮構成と、前記人工心臓弁が前記送達カテーテルから前記心臓の心房内に解放されるときの拡張構成とを有し、
前記拡張構成にあるときに前記人工心臓弁が前記心臓の自己弁の弁輪内に着座するように構成され、前記人工心臓弁が前記自己弁の前記弁輪に着座するときに前記遠位固定要素が心室流出管内に配設されるように構成され、前記人工心臓弁が前記自己弁の前記弁輪に着座した後に前記近位固定要素が第１の構成から第２の構成に移行するように構成されている、前記人工心臓弁。 A prosthetic heart valve,
a valve frame having a transvalvular portion and an atrial collar attached around the upper end of the transvalvular portion;
a distal fixation element coupled to the transannular portion of the valve frame;
a proximal fixation element coupled to the transannular portion of the valve frame;
A second flow path mounted within the valve frame for permitting blood flow in a first direction through an inflow end of the prosthetic heart valve and through an outflow end of the prosthetic heart valve opposite the first direction. a flow control component configured to block blood flow in a direction;
said prosthetic heart valve having a compressed configuration for introduction into a patient's heart via a delivery catheter and an expanded configuration when said prosthetic heart valve is released from said delivery catheter into an atrium of said heart;
The prosthetic heart valve is configured to seat within an annulus of the native valve of the heart when in the expanded configuration, and the distal fixation is configured when the prosthetic heart valve seats in the annulus of the native valve. An element is configured to be disposed within a ventricular outflow tract, such that the proximal fixation element transitions from a first configuration to a second configuration after the prosthetic heart valve seats in the annulus of the native valve. The prosthetic heart valve, comprising: 前記自己弁が自己僧帽弁であり、前記心室流出管が左心室流出路（ＬＶＯＴ）である、請求項１５に記載の人工心臓弁。 16. The prosthetic heart valve of claim 15, wherein the native valve is a native mitral valve and the ventricular outflow tract is a left ventricular outflow tract (LVOT). 前記自己弁が自己三尖弁であり、前記心室流出管が右心室流出路（ＲＶＯＴ）である、請求項１５に記載の人工心臓弁。 16. The prosthetic heart valve of claim 15, wherein the native valve is a native tricuspid valve and the ventricular outflow tract is a right ventricular outflow tract (RVOT). 前記近位固定要素が、前記人工心臓弁が前記自己弁の前記弁輪に着座するときに前記第１の構成にある、請求項１５から１７のいずれか１項に記載の人工心臓弁。 18. The prosthetic heart valve of any one of claims 15-17, wherein the proximal fixation element is in the first configuration when the prosthetic heart valve seats in the annulus of the native valve. 前記近位固定要素の近位端部分が、前記第１の構成にあるときに前記経弁輪部分に対して第１の位置に配設され、前記第２の構成にあるときに前記経弁輪部分に対して第２の位置に配設され、前記第２の位置が、前記第１の位置よりも前記経弁輪部分から遠い、請求項１５から１８のいずれか１項に記載の人工心臓弁。 A proximal end portion of the proximal fixation element is disposed at a first position relative to the transvalvular annulus portion when in the first configuration and the transvalvular portion when in the second configuration. 19. The prosthesis of any one of claims 15-18, disposed at a second position relative to the annulus portion, said second position being farther from said transvalvular annulus portion than said first position. heart valve. 前記第２の構成にあるときの前記近位固定要素が、前記自己弁の前記弁輪の近位側の弁輪下組織に接触するように構成されている、請求項１５から１９のいずれか１項に記載の人工心臓弁。 20. Any of claims 15-19, wherein the proximal fixation element when in the second configuration is configured to contact subannular tissue on the proximal side of the annulus of the native valve. 2. The prosthetic heart valve according to item 1. 前記弁フレームに結合された引張部材をさらに含み、前記引張部材は、前記引張部材が前記近位固定要素と係合されて前記近位固定要素を前記第１の構成に維持する第１の構成と、前記引張部材が前記近位固定要素から係脱されて前記近位固定要素が前記第２の構成に移行することを可能にする第２の構成と、を有する、請求項１５から２０のいずれか１項に記載の人工心臓弁。 Further comprising a tensioning member coupled to the valve frame, the tensioning member in a first configuration where the tensioning member is engaged with the proximal fixation element to maintain the proximal fixation element in the first configuration. and a second configuration in which the tension member is disengaged from the proximal fixation element to allow the proximal fixation element to transition to the second configuration. The prosthetic heart valve according to any one of claims 1 to 3. 前記引張部材の少なくとも一部分が、前記弁フレームの前記経弁輪部分によって画定される中間点を通って延びる、請求項２１に記載の人工心臓弁。 22. The prosthetic heart valve of claim 21, wherein at least a portion of the tension member extends through a midpoint defined by the transannular portion of the valve frame. 前記引張部材が、前記近位固定要素に取り外し可能に結合している、請求項２１または２２に記載の人工心臓弁。 23. The heart valve prosthesis of claims 21 or 22, wherein the tension member is removably coupled to the proximal fixation element. 前記引張部材が、縫合糸、ケーブル、ワイヤのうちの１つである、請求項２１から２３のいずれか１項に記載の人工心臓弁。 24. The heart valve prosthesis of any one of claims 21-23, wherein the tension member is one of a suture, cable, wire. 前記引張部材が、前記引張部材の少なくとも一部分を前記近位固定要素に動作可能に結合するように構成されたコネクタを有する、請求項２１から２４のいずれか１項に記載の人工心臓弁。 25. The heart valve prosthesis of any one of claims 21-24, wherein the tension member has a connector configured to operably couple at least a portion of the tension member to the proximal fixation element. 前記コネクタが、前記引張部材が前記近位固定要素内で係合されるときに第１の構成にあり、前記コネクタが、前記引張部材の少なくとも前記一部分が前記近位固定要素から係脱することを可能にする第２の構成に移行するように構成されている、請求項２５に記載の人工心臓弁。 said connector being in a first configuration when said tension member is engaged within said proximal fixation element, said connector disengaging at least said portion of said tension member from said proximal fixation element; 26. The heart valve prosthesis of claim 25, wherein the prosthetic heart valve is configured to transition to a second configuration that allows for 前記コネクタが、ねじ山付きコネクタまたはボール及びカップコネクタのうちの少なくとも１つである、請求項２５または２６に記載の人工心臓弁。 27. The heart valve prosthesis of claim 25 or 26, wherein the connector is at least one of a threaded connector or a ball and cup connector.
JP2021535023A 2018-12-20 2019-12-18 Proximal tabs and delivery methods for transcatheter heart valves delivered laterally Pending JP2022514008A (en)

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Application Number Priority Date Filing Date Title
US201862782350P 2018-12-20 2018-12-20
US62/782,350 2018-12-20
US16/455,417 US10653522B1 (en) 2018-12-20 2019-06-27 Proximal tab for side-delivered transcatheter heart valve prosthesis
US16/455,417 2019-06-27
PCT/US2019/067010 WO2020131978A1 (en) 2018-12-20 2019-12-18 Proximal tab for side-delivered for transcatheter heart valves and methods of delivery

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JP2022514008A JP2022514008A (en) 2022-02-09
JPWO2020131978A5 true JPWO2020131978A5 (en) 2022-12-21

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EP (1) EP3897462A4 (en)
JP (1) JP2022514008A (en)
CN (1) CN113382695A (en)
AU (1) AU2019406832A1 (en)
CA (1) CA3124128A1 (en)
WO (1) WO2020131978A1 (en)

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