公开(公告)号：US11883294B2

公开(公告)日：2024-01-30

申请号：US17663626

申请日：2022-05-16

Applicant: Edwards Lifesciences Corporation

Inventor： Arie Tylis ,  Nikolai Gurovich ,  Eran Goldberg ,  Boaz Manash ,  Dan Rottenberg ,  Hagar Adika ,  Tal Regev ,  Dikla Kersh ,  Danny M. Garmahi ,  Hernan Altman ,  Amir Blumenfeld

IPC: A61F2/24 ,  A61B17/04 ,  A61B17/00 ,  A61B8/08 ,  A61B8/12 ,  A61B8/00

CPC classification number: A61F2/2487 ,  A61B8/085 ,  A61B8/0883 ,  A61B8/12 ,  A61B8/42 ,  A61B17/0401 ,  A61F2/2445 ,  A61B2017/00243 ,  A61B2017/00783 ,  A61B2017/042 ,  A61B2017/0409 ,  A61B2017/0419 ,  A61B2017/0464 ,  A61F2/2466

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

公开(公告)号：US11872125B2

公开(公告)日：2024-01-16

申请号：US17659577

申请日：2022-04-18

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 first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, 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 connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

公开(公告)号：US20230277313A1

公开(公告)日：2023-09-07

申请号：US18316942

申请日：2023-05-12

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

CPC classification number: A61F2/2418 ,  A61F2/2433 ,  A61F2/2409 ,  A61F2250/0069 ,  A61F2250/0003 ,  A61F2230/0052 ,  A61F2230/0023 ,  A61F2/2412 ,  A61F2/90

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

公开(公告)号：US12290436B2

公开(公告)日：2025-05-06

申请号：US17316885

申请日：2021-05-11

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

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings between them. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a main body, opposing tabs on opposite sides of the main body, a coaptation edge portion, and a cusp edge portion. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each leaflet can have opposing edge portions between the opposing tabs and the cusp edge portion that are unattached to the frame, each unattached edge portion defining a gap that extends radially into the main body of the leaflet.

公开(公告)号：US20250114189A1

公开(公告)日：2025-04-10

申请号：US18977753

申请日：2024-12-11

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Tamir S. Levi ,  Nikolai Gurovich

IPC: A61F2/24

Abstract: A leaflet subassembly for a prosthetic heart valve can include a leaflet having a cusp edge portion and opposite major surfaces. A reinforcing structure can be attached to the leaflet along the cusp edge portion. The reinforcing structure can include a first reinforcing member and a second reinforcing member arranged on the opposite major surfaces of the leaflet. A prosthetic heart valve can include a frame and a leaflet subassembly. The leaflet subassembly can include a leaflet and a reinforcing structure attached to the leaflet along a cusp edge portion of the leaflet. The cusp edge portion can be coupled to the frame via the reinforcing structure. A method of assembling a prosthetic heart valve can include disposing a leaflet at least partially within a frame and attaching the leaflet to the frame by extending a suture through reinforcing members attached to opposite major surfaces of the leaflet.

公开(公告)号：US20250099233A1

公开(公告)日：2025-03-27

申请号：US18976163

申请日：2024-12-10

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Boaz Manash ,  Khen Perlmutter ,  Adi Carmi ,  Noa Axelrod Manela ,  Nikolai Gurovich

IPC: A61F2/24

Abstract: A prosthetic heart valve has an inner frame and an outer frame that is sutured to the inner frame. The outer frame has an atrial portion and a ventricular portion. The inner frame has a leaflet structure positioned between first and second ends of the metallic inner frame. The prosthetic heart valve has an inflow end and an outflow end, and is radially expandable and collapsible. The prosthetic heart valve has a plurality of tissue-engaging elements positioned along an exterior surface of the outer frame. The outer frame is configured such that in the expanded state the atrial portion of the outer frame extends upwardly beyond an inflow end of the inner frame, and a diameter of the outer frame increases from a first diameter at the outflow end of the prosthetic heart valve to a second diameter moving in an upstream direction toward the inflow end.

公开(公告)号：US20250073027A1

公开(公告)日：2025-03-06

申请号：US18949766

申请日：2024-11-15

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Tamir S. Levi ,  Karin Lavon ,  Nikolai Gurovich

IPC: A61F2/24

Abstract: A prosthetic valve has an annular frame that is radially expandable and a leaflet structure positioned within the frame. The frame has an inflow end, an outflow end, a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts, and a plurality of axial frame members comprising respective first ends and second ends. The first ends are connected to the second row of angled struts and the second ends are connected to the third row of angled struts. The plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial posts located between any two immediately adjacent commissure supports. Each commissure support is configured to support a corresponding commissure of the leaflet structure.

公开(公告)号：US12226312B2

公开(公告)日：2025-02-18

申请号：US18316942

申请日：2023-05-12

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

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

公开(公告)号：US20240382306A1

公开(公告)日：2024-11-21

申请号：US18787184

申请日：2024-07-29

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Diana Nguyen-Thien-Nhon ,  Timothy A. Geiser ,  Larry L. Wood ,  Dinesh L. Sirimanne ,  Son V. Nguyen ,  Tamir S. Levi ,  Nikolai Gurovich ,  Michael Bukin

IPC: A61F2/24 ,  A61F2/07

Abstract: A prosthetic valve includes an annular frame with a plurality of inflow apices and a plurality of outflow apices. Each one of the outflow apices can be circumferentially offset from a respective inflow apex. The prosthetic valve can further include a leaflet structure positioned within the frame and secured thereto. The prosthetic valve can further include an outer skirt secured to the frame. The outer skirt can include an upper edge portion disposed around an outer surface of the frame, a lower edge portion wrapped around the inflow apices, and a plurality of creases. Each crease can be circumferentially aligned with a corresponding outflow apex and can extend from the lower edge portion towards the upper edge portion. The inner skirt can be secured to an inner surface of the frame and can include a lower edge portion attached to the lower edge portion of the outer skirt.

公开(公告)号：US20240285401A1

公开(公告)日：2024-08-29

申请号：US18658051

申请日：2024-05-08

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Tamir S. Levi ,  Elena Sherman ,  Melissa Fusari ,  Nikolai Gurovich

IPC: A61F2/24

CPC classification number: A61F2/2418 ,  A61F2/2412 ,  A61F2/2433 ,  A61F2210/0057 ,  A61F2220/005 ,  A61F2220/0075 ,  A61F2250/0004 ,  A61F2250/0039 ,  A61F2250/006 ,  A61F2250/0097 ,  A61F2250/0098

Abstract: A prosthetic heart valve including an annular frame and one or more detachable outer skirts and methods associated therewith. The frame has one or more outer skirts releasbly attached to an exterior surface of the frame. In some examples, an outer skirt is attached to the frame via at least one retaining suture formed by stitches looped around a pull suture and struts of the frame. Portions of the outer skirt are captured between the pull suture and the exterior surface of the frame along a suture line. Removal of the pull suture from the suture line enables the outer skirt and frame to separate as the stitches are pulled through openings in the outer skirt. In some examples, outer skirts can be releasably attached to the frame via bioresorbable couplers. Removability of the outer skirts can facilitate improvements in implant and explant procedures of the prosthetic valves.