Edwards Lifesciences Corporation

Adagio Medical, Inc.

Other

Kevin D Rupp

Son V Nguyen

Jeff Lindstrom

Elena Sherman

Ajay Chadha

Alexei V Babkin

Tamir S Levi

Kim D Nguyen

Diana Nguyen-Thien-Nhon

Thanh Huy Le

Tung Thanh Le

Noam Nir

Itai Pelled

Ron Sharoni

Russell Thomas Joseph

Eran Goldberg

Sonny Tran

Steven W Kovalcheck

Dinesh L Sirimanne

Brian C Gray

Vivian Tran

Hien Tran Ngo

Alejandro J Froimovich Rosenberg

Oren H Wintner

Lien Huong Thi Hoang

Pedram Nourian

Thomas Chien

Jun Liu

Hamid Rafi

Uy D Trinh

Chambory Chhe

Faysal S Ahmed

Alyssa Joy Gross

Shirzad Shahriari

Hou Man Chong

Cuong Pham

Duc Hong Nguyen

Thu Tran

Tung T Le

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and a balloon catheter assembly comprising an elongated balloon catheter shaft extending from the handle portion. The balloon catheter shaft includes a proximal end portion coupled to the handle portion and a distal end portion. The balloon catheter assembly further includes a balloon coupled to the distal end portion and configured to mount a prosthetic heart valve in a radially compressed state. A protective cover encapsulates the balloon, the cover defining a cavity shaped to accommodate the balloon.

Delivery system for prosthetic heart valve

A prosthetic heart valve has a radially expandable and collapsible annular frame, the frame having an inflow end and an outflow end and defining a longitudinal axis along a lumen of the prosthetic heart valve when it is in the expanded configuration. A leaflet structure is positioned within the frame and secured thereto. The prosthetic heart valve also has a laminate sealing member including a plurality of layers heat-bonded together to encapsulate at least a portion of the frame. The laminate sealing member extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the laminate sealing member is secured to a main portion of the laminate sealing member downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.

Laminated sealing member for prosthetic heart valve

A multimodality or hybrid ablation system includes an ablation apparatus for creating a lesion in target tissue. The ablation apparatus has an ablation shaft including a handle, a first portion, an ablation portion, distal tip, at least one ablation energy delivery lumen, at least one ablation energy return lumen, and a stylet lumen that extends substantially along a length of the ablation shaft from the handle to at least the ablation portion. The ablation apparatus also includes a stylet that is capable of being inserted into the stylet lumen where the stylet is made of a shape-memory material. A plurality of electrodes are arranged on the ablation portion for measuring or verifying tissue contact with the tissue and applying a pulsed electric field. Optionally, the pulsed electric field may be applied after, contemporaneously, or for only a portion that the cryo-modality is applied to the target tissue.

Multi-modality ablation catheter having a shape memory stylet

A delivery assembly comprises a delivery apparatus and a prosthetic valve releasably connected to a cord-retaining device of the delivery apparatus by a plurality of cords or tethers. The cords desirably have a multi-stranded construction formed from a plurality of strands of material. The multi-stranded construction can be, for example, a braided construction, a twisted construction, or a whip-stitch construction. The multi-stranded construction can include integral openings along opposing end portions of each cord. Each cord can extend through an aperture in an apex of the frame of the prosthetic valve or around an apex with one end portion of the cord being retained on the cord-retaining device and another end portion of the cord being retained on a slideable release member of the delivery apparatus.

Delivery apparatus for a prosthetic valve

An ablation apparatus for creating a lesion in target tissue, the ablation apparatus including a handle, an elongate shaft extending from the handle to a distal tip, where the shaft includes a first portion, an ablation portion distal to the first portion and having an outer sheath, and at least one ablation energy element disposed within the outer sheath, where a space is formed between the at least one ablation energy element and the outer sheath. The ablation apparatus further includes a thermally conductive liner disposed within the space.

Cryoablation element with conductive liner

A prosthetic heart valve includes an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The frame has a plurality of circumferentially extending rows of angled struts, each row of angled struts comprising angled struts arranged in a zig-zag pattern. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame. The sealing member has an undulating outflow edge portion forming a plurality of triangular projections that are connected to and shaped to correspond to the zig-zag pattern of one of the rows of angled struts. The outer sealing member is sized to fit snugly against the outer surface of the frame when the frame is in the expanded configuration.

Sealing member for prosthetic heart valve

An ablation apparatus for creating a lesion in target tissue has a handle, an elongate shaft extending from the handle and a distal ablation portion. The distal ablation portion includes a cryogen flow manifold defining a plurality of fluid pathways between an insert body and a sleeve. Cryogen is circulated through the plurality of fluid pathways to create the lesion in the target tissue.

Flow manifold for cryoablation catheter

Embodiments of a radially collapsible and expandable prosthetic heart valve and method for crimping the prosthetic heart valve are disclosed. A method of radially compressing a prosthetic valve can include partially inserting the valve while in a radially expanded configuration into a crimping device comprising crimper jaws, wherein a portion of the valve comprising an outer skirt extends outside of the crimper jaws. The method can further include crimping the valve to a first partially collapsed configuration, further inserting the valve into the crimping device, such that the outer skirt is between the crimper jaws, and crimping the valve to a second partially collapsed configuration, wherein a diameter of the valve is smaller in the second partially collapsed configuration than in the first partially collapsed configuration.

Prosthetic heart valve

A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

A docking device includes a hollow cylindrical body portion having an internal surface and an outer surface. The hollow cylindrical body portion is formed of a three-dimensional (3D) woven fabric comprising a plurality of different types of fibers.

Three-dimensional woven fabric implant devices

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end and an outflow end, a leaflet structure positioned within the frame and secured thereto, and a laminate sealing member comprising an encapsulating material. The laminate sealing member has a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame, and the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.

Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. The prosthetic valve can comprise an annular frame, leaflets, an inner skirt, and an outer skirt. The outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack that buckles outward radially when the valve is in the expanded configuration and which lies flat when the valve is in the collapsed configuration. In some embodiments, the outer skirt is stiffer in the axial direction of the valve than in the circumferential direction of the valve. In additional embodiments, the outer skirt comprises a self-expandable fabric comprising fibers made of a shape memory material having a shape memory set to enhance the radially outward buckling of the outer skirt. Methods of crimping such valves to a collapsed or partially collapsed configuration are also disclosed.

Growing community of inventors

Irvine, CA, United States of America

Kevin D Rupp