Boston Scientific Scimed, Inc.

Medtronic, Inc.

Takashi Harry Ino

Randy S Gamarra

Floriza Q Escalona

Mimi Trinh Fitterer

Michael P Calomeni

Crissly Valdez Crisostomo

Benjamin Sutton

Andrew J H Backus

Donnell William Gurskis

Brian D Brandt

James M Anderson

Michael J Drews

David J Paul

Joshua K Wallin

Adam David Grovender

Dwight John Knab, Jr

Frederick J Serrahsu

David S Tung

Ali Salahieh

Kenneth M Martin

Jasper Ellington Adamek-Bowers

Anh Thu Pham

Leticia Marquez Zuniga

Owen Raybould

Crissly V Crisostomo

John Jianhua Chen

Steven Robert Bacich

James P Rohl

Robert T Chang

Daniel J Foster

Tim O'Connor

Ernest Lane

James K Hong

Christopher William Ledesma

Sumit Agrawal

Patricia McAfee

Dongming Hou

Jarad S Waisblatt

Noel Boyhan

Richard O'Sullivan

Marc Feeley

Art Flannery

John Darst

Mimi Nguyen Fitterer

Mimi Nguyen-Fitterer

Andrew James Harlan Backus

Ted Feldman

Jonathan M Tanaka

Mark W McElligott

Andrew D Whelton

Benjamin T Sutton

Andrew JH Backus

Floriza Q Escanola

Dwight J Knab

An expandable sheath may include an inelastic compliant membrane having a lumen therethrough, and a discontinuous outer member bonded to the membrane. The membrane may include one or more folds formed therein. At least a portion of the outer member may extend continuously around a circumference of the membrane in a first configuration. The outer member may be configured to separate to a second configuration when subjected to a radially outward force from within the membrane. The outer member may taper from a first diameter adjacent a proximal hub to a second smaller diameter at a distal end. A method of manufacturing an expandable sheath may include forming one or more folds in a compliant membrane, cutting a plurality of apertures through a wall of an outer covering; and laminating the outer covering onto the membrane, wherein the plurality of apertures is disposed over the one or more folds.

Fully compliant large bore expandable sheath

An example introducer is disclosed. An example introducer includes an inner liner including a lumen, a distal region and at least one folded portion extending along the distal region. The introducer also includes a reinforcing member having a length and including at least one spine extending along the length of the reinforcing member. The introducer also includes a sheath disposed along at least a portion of the introducer, wherein the sheath includes at least one perforation, wherein material adjacent to the at least one folded portion is removed from a distal portion of the introducer to form a tip region. The introducer also includes a tip member disposed along the tip region.

Introducer with expandable capabilities

A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

Embedded radiopaque marker in adaptive seal

A medical device handle may include a handle housing including a cavity disposed within the handle housing. The medical device handle may include a carriage assembly disposed within the cavity and operatively connected to the tubular member and the medical implant, the carriage assembly being longitudinally movable between a distal position and a proximal position by rotation of a control knob with respect to the handle housing, the control knob being disposed around a proximal end of the handle housing. The carriage assembly may include a carriage member, a first sliding member, a second sliding member, and a locking element configured to releasably fix the first sliding member and the second sliding member relative to the carriage member. The locking element may be rotatable relative to the handle housing.

Medical device handle

A delivery system for delivering an implantable heart valve includes an outer shaft and an inner shaft that is slidingly disposable within an outer shaft lumen, the inner shaft including a distal end region. A plurality of fingers extend distally relative to the distal end region of the inner shaft and are adapted to releasably engage an implantable heart valve. A plurality of looped sheathing aids extend distally from the distal region of an inner shaft lumen and are adapted to guide the implantable heart valve back into the outer shaft lumen when the implantable heart valve is pulled back into the outer shaft lumen. Each of the plurality of looped sheathing aids include a distal petal adapted to engage tissue adjacent a native valve annulus in order to limit distal advancement of the implantable heart valve during deployment of the implantable heart valve.

Medical device delivery system with alignment feature

A medical device apparatus may include a medical implant including a braided anchor member configured to actuate between a delivery configuration and a deployed configuration operatively connected to a delivery system. The delivery system may include a handle, an outer sheath extending distally from the handle, and an inner catheter disposed within the outer sheath. A sheathing aid may connect the delivery system to the medical implant, the sheathing aid being configured to guide the medical implant into the outer sheath upon relative closing movement therebetween. The sheathing aid may include a plurality of arms extending from the inner catheter to a proximal end of the braided anchor member. At least one arm of the plurality of arms may comprise a core member having a width and a flexible member positioned about the core member.

Sheathing aid

An example introducer is disclosed. An example introducer includes an inner liner including a lumen, a proximal region, and at least one folded portion extending longitudinally along the proximal region. The introducer further includes an expandable support member. The support member includes a plurality of ribs extending along a length of the support member. The introducer further includes a sheath attached to at least a portion of the support member and the support member is designed to shift from a first position to an expanded position.

A replacement heart valve commissure assembly may include a locking mechanism including a first locking portion spaced apart from a second locking portion in a delivery configuration and configured to engage with the second locking portion in a deployed configuration, wherein the first locking portion is longitudinally actuatable relative to the second locking portion between the delivery and deployed configurations. The commissure assembly may include a first valve leaflet and a second valve leaflet each secured to the first locking portion. A first sleeve portion of the first valve leaflet may be fixedly attached to a first fabric sleeve wrapped around a first leg of the first locking portion by a first filament, and a second sleeve portion of the second valve leaflet may be fixedly attached to a second fabric sleeve wrapped around a second leg of the first locking portion by a second filament.

Replacement heart valve commissure assembly

A replacement heart valve may comprise a tubular anchor member actuatable between an elongated delivery configuration and an expanded deployed configuration, a buckle member fixedly attached to the anchor member, a post member axially translatable relative to the buckle member, an actuator member including a suture member forming a loop unreleasably attached to a distal end thereof, the actuator member being releasably connected to a proximal end of the post member by the loop, a release pin extending axially along the actuator member and through the loop in a first position, wherein axial translation of the release pin to a second position proximal the first position disconnects the actuator member from the post member, and a valve leaflet attached to the post member.

Everting leaflet delivery system with pivoting

A medical device system may include a replacement heart valve implant including an expandable anchor member reversibly actuatable between a delivery configuration and a deployed configuration, wherein the replacement heart valve implant includes at least one locking mechanism configured to lock the expandable anchor member in the deployed configuration, and at least one actuator element configured to releasably engage the at least one locking mechanism and actuate the expandable anchor member between the delivery configuration and the deployed configuration. The at least one actuator element may include external threads on a distal portion of each actuator element and a ramp disposed proximal of the external threads.

Medical implant locking mechanism

A replacement heart valve implant defining a central longitudinal axis extending from an upstream end to a downstream end may include an expandable anchor member configured to shift between a delivery configuration and a deployed configuration, a circumferential support member distinct from and attached to the expandable anchor member, at least a portion of the circumferential support member extending downstream of the expandable anchor member, and a plurality of valve leaflets secured to the expandable anchor member. The plurality of valve leaflets may include a valve leaflet commissure movable from a first longitudinal position relative to the downstream end in the delivery configuration to a second longitudinal position relative to the downstream end in the deployed configuration.

Heart valve implant commissure support structure

A medical device handle for percutaneous delivery of a medical device implant may include an elongated handle housing having a proximal end, a distal end, and a longitudinal axis extending from the proximal end to the distal end; a rotatable collar disposed about the proximal end of the handle housing; and a rotatable control knob disposed about a proximal portion of the rotatable collar. The rotatable collar may include a first internally-facing longitudinal slot extending less than a full length of the rotatable collar and terminating proximally at a distally-facing wall of an internally-facing circumferentially-oriented slot. The rotatable control knob may be configured to actuate the medical device implant between a delivery configuration, a deployed configuration, and a released configuration.

Growing community of inventors

San Jose, CA, United States of America

Takashi Harry Ino