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Publication number
JPWO2020159783A5
JPWO2020159783A5 JP2021543425A JP2021543425A JPWO2020159783A5 JP WO2020159783 A5 JPWO2020159783 A5 JP WO2020159783A5 JP 2021543425 A JP2021543425 A JP 2021543425A JP 2021543425 A JP2021543425 A JP 2021543425A JP WO2020159783 A5 JPWO2020159783 A5 JP WO2020159783A5
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JP
Japan
Prior art keywords
frame
prosthetic valve
skirt
tether
outer portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP2021543425A
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Japanese (ja)
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JP7662526B2 (en
JP2022518919A (en
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Priority claimed from PCT/US2020/014701 external-priority patent/WO2020159783A1/en
Publication of JP2022518919A publication Critical patent/JP2022518919A/en
Publication of JPWO2020159783A5 publication Critical patent/JPWO2020159783A5/ja
Priority to JP2025061263A priority Critical patent/JP2025096362A/en
Application granted granted Critical
Publication of JP7662526B2 publication Critical patent/JP7662526B2/en
Active legal-status Critical Current
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Claims (25)

流入端および流出端を有する環状フレームと、
前記フレームに搭載される少なくとも1つのアクチュエータであって、前記フレームを径方向圧縮構成と径方向拡張構成との間で径方向に拡張または圧縮するように構成されるアクチュエータと、
前記フレームの外面の少なくとも一部分、および前記フレームの内面の少なくとも一部分を覆うように、前記フレームの前記流入端の周りで延びる折りを有する環状スカートと
を備え、
前記フレームが前記径方向拡張構成にあるとき、前記スカートの外側部分は前記フレームの前記外面にきつく適合し、前記フレームの前記流入端は、前記フレームと前記折りとの間で軸方向に延びる隙間を形成するために、前記折りから軸方向で離間され、前記フレームが前記径方向圧縮構成にあるとき、前記フレームの前記流入端は、前記軸方向に延びる隙間を少なくとも部分的に満たすように軸方向に延びる、補綴弁。
an annular frame having an inflow end and an outflow end;
at least one actuator mounted to the frame, the actuator configured to radially expand or compress the frame between a radially compressed configuration and a radially expanded configuration;
an annular skirt having a fold extending around the inflow end of the frame to cover at least a portion of the outer surface of the frame and at least a portion of the inner surface of the frame;
When the frame is in the radially expanded configuration, the outer portion of the skirt fits tightly against the outer surface of the frame, and the inflow end of the frame defines an axially extending gap between the frame and the fold. axially spaced from the fold, and the inflow end of the frame is axially spaced so as to at least partially fill the axially extending gap when the frame is in the radially compressed configuration. A prosthetic valve extending in a direction.
前記少なくとも1つのアクチュエータは、前記フレームの前記内面に搭載され、前記フレームの前記内面の周りに等しく離間される複数のアクチュエータのうちの1つである、請求項1に記載の補綴弁。 2. The prosthetic valve of claim 1 , wherein the at least one actuator is one of a plurality of actuators mounted on the inner surface of the frame and equally spaced around the inner surface of the frame. 前記少なくとも1つのアクチュエータは、前記フレームの第1の場所に取り付けられる第1の係留部と、前記フレームの第2の場所に固定される第2の係留部と、前記第1の係留部および前記第2の係留部を貫いて延びる棒材とを備え、前記第2の場所は前記第1の場所より前記フレームの前記流入端の近くにあり、前記棒材は、前記フレームを径方向に圧縮または拡張するように、前記第1の場所と前記第2の場所との間の距離をそれぞれ増加または低下させるように構成される、請求項1または2に記載の補綴弁。 The at least one actuator includes a first tether attached to the frame at a first location, a second tether secured to the frame at a second location, the first tether and the and a bar extending through a second anchorage, the second location being closer to the inflow end of the frame than the first location, the bar radially compressing the frame. 3. The prosthetic valve of claim 1 or 2 , configured to increase or decrease the distance between the first location and the second location, respectively, to expand or expand. 前記棒材は、前記第2の係留部の雌ネジと嵌まり合って係合するように構成される雄ネジを備える、請求項3に記載の補綴弁。 4. The prosthetic valve of claim 3 , wherein the bar comprises external threads configured to matingly engage internal threads of the second anchor. 前記第1の場所は、前記フレームの2つの重なる支柱の間の接合部であり、前記第1の係留部は留め具によって前記接合部にヒンジで連結される、請求項3または4に記載の補綴弁。 5. The claim 3 or 4 , wherein the first location is a joint between two overlapping struts of the frame, and the first anchoring portion is hinged to the joint by a fastener. prosthetic valve. 前記少なくとも1つのアクチュエータは、スリーブの中に少なくとも部分的に受け入れられる棒材を備え、前記スリーブに対する前記棒材の軸方向の移動が前記フレームの径方向の拡張または圧縮を引き起こす、請求項1または2に記載の補綴弁。 10. The at least one actuator comprises a bar at least partially received within a sleeve, wherein axial movement of the bar relative to the sleeve causes radial expansion or compression of the frame or 2. The prosthetic valve according to 2. 前記少なくとも1つのアクチュエータは、前記フレームを前記径方向拡張構成において係止するように構成される係止機構を備える、請求項6に記載の補綴弁。 7. The prosthetic valve of Claim 6 , wherein the at least one actuator comprises a locking mechanism configured to lock the frame in the radially expanded configuration. 前記少なくとも1つのアクチュエータは、送達装置の作動部材が前記フレームを径方向に圧縮または拡張するために力を前記少なくとも1つのアクチュエータに加えることができるように、前記送達装置の対応する前記作動部材と解放可能な連結を形成するように構成される取付部材を備える、請求項1から7のいずれか一項に記載の補綴弁。 The at least one actuator is aligned with the corresponding actuating member of the delivery device such that the actuating member of the delivery device can exert a force on the at least one actuator to radially compress or expand the frame. 8. The prosthetic valve of any one of claims 1-7 , comprising an attachment member configured to form a releasable connection. 前記フレームの中に位置決めされ、一方向において前記補綴弁を通る血液の流れを許容し、反対方向において血液の流れを阻止するように構成される弁構造をさらに備える、請求項1から8のいずれか一項に記載の補綴弁。 9. Any of claims 1-8 , further comprising a valve structure positioned within the frame and configured to allow blood flow through the prosthetic valve in one direction and block blood flow in an opposite direction. or the prosthetic valve according to item 1. 前記弁構造は、流入縁部分を各々が有する複数の弁尖を備え、前記弁尖の前記流入縁部分は、前記フレームが前記径方向拡張構成にあるとき、周方向に沿って前記フレームの相互連結された複数の支柱区分に従う起伏して湾曲した波形を定める、請求項9に記載の補綴弁。 The valve structure comprises a plurality of leaflets each having an inflow edge portion, the inflow edge portions of the leaflets extending circumferentially relative to each other of the frame when the frame is in the radially expanded configuration. 10. The prosthetic valve of claim 9 , defining an undulating curved corrugation that follows a plurality of connected strut segments. 前記スカートの前記外側部分は前記スカートの内側部分より軸方向で長い、請求項1から10のいずれか一項に記載の補綴弁。 11. The prosthetic valve of any one of claims 1-10 , wherein the outer portion of the skirt is axially longer than the inner portion of the skirt. 前記スカートの前記外側部分は前記スカートの内側部分とほぼ同じ軸方向長さを有する、請求項1から10のいずれか一項に記載の補綴弁。 11. The prosthetic valve of any one of claims 1-10 , wherein the outer portion of the skirt has approximately the same axial length as the inner portion of the skirt. 前記スカートの前記外側部分は前記スカートの内側部分より軸方向で短い、請求項1から10のいずれか一項に記載の補綴弁。 11. The prosthetic valve of any one of claims 1-10 , wherein the outer portion of the skirt is axially shorter than the inner portion of the skirt. 前記スカートの前記外側部分は、前記フレームが前記拡張構成にあるときに周方向に伸ばされる、請求項1から13のいずれか一項に記載の補綴弁。 14. The prosthetic valve of any one of claims 1-13 , wherein the outer portion of the skirt is circumferentially stretched when the frame is in the expanded configuration. 前記スカートの前記外側部分の上縁が、前記フレームに取り付けられる前に概して真っ直ぐである、請求項14に記載の補綴弁。 15. The prosthetic valve of claim 14 , wherein the upper edge of the outer portion of the skirt is generally straight prior to attachment to the frame. 前記スカートの前記外側部分の前記上縁は、前記フレームの重なる支柱によって形成される複数の旋回継手において前記フレームに取り付けられる、請求項15に記載の補綴弁。 16. The prosthetic valve of claim 15 , wherein the upper edge of the outer portion of the skirt is attached to the frame at a plurality of pivot joints formed by overlapping struts of the frame. 前記スカートの前記外側部分の上縁が、起伏した形を有し、前記フレームの支柱区分の列に沿って縫合される、請求項14に記載の補綴弁。 15. The prosthetic valve of claim 14 , wherein the upper edge of the outer portion of the skirt has an undulating shape and is stitched along rows of strut sections of the frame. 前記スカートに結合されるテザーであって、前記フレームが前記圧縮構成から前記拡張構成へと径方向に拡張されるときに前記折りが前記フレームの内側に移動するのを防止するように前記テザーが引っ張りを前記スカートに加えるように前記折りに対して斜めの角度で延びる、テザーをさらに備える、請求項1から17のいずれか一項に記載の補綴弁。 A tether coupled to the skirt such that the tether prevents the fold from moving inwardly of the frame when the frame is radially expanded from the compressed configuration to the expanded configuration. 18. The prosthetic valve of any one of claims 1-17 , further comprising a tether extending at an oblique angle to the fold to apply tension to the skirt. 前記斜めの角度は約10°から約80°までの範囲にある、請求項18に記載の補綴弁。 19. The prosthetic valve of claim 18 , wherein the oblique angle ranges from about 10[deg.] to about 80[deg.]. 前記斜めの角度は約30°から約60°までの範囲にある、請求項19に記載の補綴弁。 20. The prosthetic valve of claim 19 , wherein the oblique angle ranges from about 30[deg.] to about 60[deg.]. 前記斜めの角度は約45°である、請求項20に記載の補綴弁。 21. The prosthetic valve of claim 20 , wherein said oblique angle is about 45[deg.]. 前記テザーの第1の端が前記スカートの前記外側部分の流出縁部分に位置させられ、前記テザーの第2の端が前記折りに隣接して位置させられる、請求項18から21のいずれか一項に記載の補綴弁。 22. Any one of claims 18-21 , wherein a first end of the tether is positioned at an outflow edge portion of the outer portion of the skirt and a second end of the tether is positioned adjacent the fold. A prosthetic valve as described in Section 1. 前記テザーは、串縫いを用いて前記スカートの前記外側部分に縫い付けられる縫合を備える、請求項18から22のいずれか一項に記載の補綴弁。 23. The prosthetic valve of any one of claims 18-22 , wherein the tether comprises sutures sewn to the outer portion of the skirt using skewer stitches. 前記テザーは弾性材料を備える、請求項18から23のいずれか一項に記載の補綴弁。 24. The prosthetic valve of any one of claims 18-23 , wherein the tether comprises an elastic material. 前記テザーは、前記折りに対して斜めの角度を各々が形成する複数のテザーのうちの1つである、請求項18から24のいずれか一項に記載の補綴弁。 25. The prosthetic valve of any one of claims 18-24 , wherein the tether is one of a plurality of tethers each forming an oblique angle with respect to the fold.
JP2021543425A 2019-01-28 2020-01-23 Prosthetic valve Active JP7662526B2 (en)

Priority Applications (1)

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JP2025061263A JP2025096362A (en) 2019-01-28 2025-04-02 Prosthetic valve

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US201962797837P 2019-01-28 2019-01-28
US62/797,837 2019-01-28
PCT/US2020/014701 WO2020159783A1 (en) 2019-01-28 2020-01-23 Prosthetic valve

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JPWO2020159783A5 true JPWO2020159783A5 (en) 2023-02-02
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