公开(公告)号：US11806234B2

公开(公告)日：2023-11-07

申请号：US17659169

申请日：2022-04-13

Applicant: Edwards Lifesciences Corporation

Inventor： Nikolai Gurovich ,  Michael Bukin ,  Elena Sherman ,  Tamir S. Levi ,  Ziv Yohanan ,  Gil Senesh ,  Dikla Kersh ,  Alexey Tsypenyuk ,  Waina Michelle Chu ,  Alexander Barash

IPC: A61F2/24 ,  A61F2/90

CPC classification number: A61F2/2418 ,  A61F2/2409 ,  A61F2/2433 ,  A61F2/2412 ,  A61F2/90 ,  A61F2220/0075 ,  A61F2230/0023 ,  A61F2230/0052 ,  A61F2250/0003 ,  A61F2250/0039 ,  A61F2250/0069 ,  A61F2310/00017 ,  A61F2310/00029 ,  A61F2310/00059

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.

公开(公告)号：US11666434B2

公开(公告)日：2023-06-06

申请号：US17658584

申请日：2022-04-08

Applicant: Edwards Lifesciences Corporation

Inventor： Ziv Yohanan ,  Tamir S. Levi ,  Netanel Benichou ,  Michael Bukin ,  Nikolai Gurovich ,  Elena Sherman

IPC: A61F2/24

CPC classification number: A61F2/2409 ,  A61F2/2412 ,  A61F2/2418 ,  A61F2/2433 ,  A61F2220/0075 ,  A61F2230/0013 ,  A61F2230/0054 ,  A61F2250/0036 ,  A61F2250/0039

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

公开(公告)号：US20230113498A1

公开(公告)日：2023-04-13

申请号：US18065257

申请日：2022-12-13

Applicant: Edwards Lifesciences Corporation

Inventor： Noam Nir ,  Michael Bukin

IPC: A61F2/24

Abstract: Prosthetic implant systems for diameter adaptation may be provided. The systems may provide for increased flexibility of providing implants having various diameters, and reducing expense associated with keeping a stock of implants at various sizes. Embodiments as disclosed herein may utilize a prosthetic implant having a docking frame that may be configured to expand to a range of working diameters. The docking frame may dock with a valve frame that may be configured to expand to a working diameter that is more closely tailored to the diameter of the implantation site. The valve frame may have a lesser range of expansion of working diameters than the docking frame.

公开(公告)号：US20230080070A1

公开(公告)日：2023-03-16

申请号：US18056486

申请日：2022-11-17

Applicant: Edwards Lifesciences Corporation

Inventor： Michael Bukin ,  Nikolai Gurovich

IPC: A61F2/24

Abstract: A prosthetic valve has a radially expandable and compressible frame including a plurality of interconnected struts and a valvular structure including a plurality of leaflets configured to regulate the flow of blood through the prosthetic valve. The leaflets can have undulating cusp edge portions. The prosthetic valve further includes at least one connecting skirt having a shape that corresponds to the cusp edge portion of at least one leaflet. The connecting skirt can connect the cusp edge portion of the leaflet to at least one of the struts of the frame. The connecting skirt can include a first set of yarns intersecting with a second set of yarns. The first and second sets of yarns can extend at oblique angles relative to a longitudinal axis of the at least one strut.

公开(公告)号：US20220346949A1

公开(公告)日：2022-11-03

申请号：US17863195

申请日：2022-07-12

Applicant: Edwards Lifesciences Corporation

Inventor： Dikla Kersh ,  Michael Bukin ,  Tamir S. Levi ,  Noam Nir

IPC: A61F2/24

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

公开(公告)号：US20220331096A1

公开(公告)日：2022-10-20

申请号：US17660394

申请日：2022-04-22

Applicant: Edwards Lifesciences Corporation

Inventor： Ziv Yohanan ,  Tamir S. Levi ,  Netanel Benichou ,  Michael Bukin ,  Nikolay Gurovich ,  Elena Sherman

IPC: A61F2/24

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

公开(公告)号：US20220265445A1

公开(公告)日：2022-08-25

申请号：US17662209

申请日：2022-05-05

Applicant: Edwards Lifesciences Corporation

Inventor： Michael Bukin ,  Tamir S. Levi

IPC: A61F2/90 ,  A61F2/92 ,  A61F2/24

Abstract: An implantable prosthetic valve comprises an annular frame that is radially expandable from a radially compressed state to a radially expanded state. The frame has an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end. The prosthetic valve also comprises a plurality of leaflets positioned to regulate a flow of blood from the inflow end to the outflow end of the frame, and a skirt assembly. The skirt assembly comprises a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers are made of an elastomer and the textile layer comprises a first set of yarns and a second set of yarns interwoven with the first set of yarns, wherein the first and second sets of yarns are non-perpendicular and non-parallel to the longitudinal axis.

公开(公告)号：US20220249227A1

公开(公告)日：2022-08-11

申请号：US17730524

申请日：2022-04-27

Applicant: Edwards Lifesciences Corporation

Inventor： Noam Nir ,  Michael Bukin ,  Elena Sherman

IPC: A61F2/24

Abstract: A leaflet assembly for a prosthetic heart valve is disclosed. As one example, a method includes: forming a plurality of leaflet sub-assemblies, each including a leaflet and a skirt and formed by placing the skirt on one side of the leaflet such that the skirt extends along a curved cusp edge portion and two commissure tabs of the leaflet, folding two end portions of the skirt around corresponding commissures tabs, stitching each folded end portion to a corresponding commissure tab to form a respective half commissure portion, and stitching the skirt to the cusp edge portion and forming the leaflet assembly by pairing each half commissure portion of each leaflet sub-assembly with a half commissure portion of another leaflet sub-assembly to form a plurality of pairs of adjacent half commissure portions, and for each pair, stitching the adjacent half commissure portions to each other to form a commissure.

公开(公告)号：US20220202568A1

公开(公告)日：2022-06-30

申请号：US17694578

申请日：2022-03-14

Applicant: Edwards Lifesciences Corporation

Inventor： Tomer Saar ,  Michael Bukin ,  Elena Sherman ,  Alexander Barash ,  Yana Mayatskaya

IPC: A61F2/24

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, and a skirt member secured to the frame. The skirt member is disposed about an edge portion of a leaflet of the plurality of leaflets, and the skirt member includes a plurality of extension portions wrapped around at least one strut member. A cord member is threaded through at least a portion of the plurality of extension portions in a direction along an axis of the at least one strut member to secure the skirt member to the at least one strut member.

公开(公告)号：US20220110742A1

公开(公告)日：2022-04-14

申请号：US17556739

申请日：2021-12-20

Applicant: Edwards Lifesciences Corporation

Inventor： Tamir S. Levi ,  Michael Bukin ,  Noam Nir ,  Ziv Yohanan ,  Elazar Levi Schwarcz ,  Oren Cohen ,  Ofir Witzman ,  Eitan Atias ,  Noam Miller ,  Khen Perlmutter ,  Boaz Manash ,  Eyal Leiba ,  Eran Goldberg

IPC: A61F2/24

Abstract: Various mechanically expandable prosthetic heart valves, as well as deliver apparatus, delivery assemblies, and methods for implanting such prosthetic heart valves. In one example, a prosthetic heart valve includes a mechanically expandable frame, a valve structure, and an actuator. The frame includes a plurality of struts and is movable between a radially compressed state and a radially expanded state. The valve structure includes a plurality of leaflets. The actuator is coupled to the frame and comprises an actuation lumen, a locking member, and a locking element. The actuation lumen is circumferentially spaced and axially parallel to the locking member. The actuation lumen is configured for receiving an axially movable actuation shaft that can move the frame between the radially compressed state and the radially expanded state. The locking element is rotatably coupled to the locking member and is configured to lock the frame at a desired state.