Abstract: 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.

Abstract: Approaches to addressing asymmetric loads at the distal end of a flexible elongate device are disclosed herein. In some embodiments, symmetry is recovered by mechanically redesigning the flexible elongate device to counter the asymmetric load. In other embodiments, symmetry is recovered by altering the controls scheme for managing the control elements in a flexible elongate device. Generally, a flexible elongate device includes a plurality of control elements able to actuate the distal section. The amount of force applied to each control element can be changed so that the plurality of control elements is able to collectively apply a bending moment that counters the asymmetric load.

Abstract: 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.

Abstract: 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.

Abstract: An apparatus of the present technology generally includes an elongated shaft having a proximal portion and a distal portion, a first elongated channel extending from the proximal portion to the distal portion, a second channel extending from the proximal portion to the distal portion, and a slidable imaging probe disposed within the first elongated channel. The apparatus can be manually, robotically, and/or teleoperably steerable and is configured for delivery to a subject and/or positioning within a subject near or at a target location. Once the steerable apparatus has been successfully positioned at the target location, the imaging probe can be repositioned relative to the first elongated channel, thereby opening a working lumen. The working lumen and second channel are configured for removal of material from the target location within the subject by applying simultaneous activities including suction, irrigation, and/or deliver a tool to the target location.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A containment vessel for storing and rinsing a medical implant coupled to a delivery system having an outer sheath may include a hollow element having a wall, a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the lumen of the hollow element being configured and adapted to contain a medical implant in a partially-deployed configuration during storage and rinsing of the medical implant and a proximal end cap including a secondary proximal end cap removably secured to the proximal end cap and configured to reversibly seal the proximal end cap to the outer sheath, thereby establishing a closed fluid connection between the lumen of the hollow element and a lumen of the outer sheath. The proximal end cap may include a sheathing guide configured and adapted to direct the medical implant into the lumen of the outer sheath.

Abstract: A medical device delivery system includes an outer shaft having an outer shaft lumen extending therethrough and an inner shaft that is slidingly disposable within the outer shaft lumen. A coupler assembly is secured to a distal end region of the inner shaft and includes an elongate tubular member including a proximal region and a distal region, the proximal region of the elongate tubular member secured to the distal end region of the inner shaft, a plurality of fingers extending distally from the distal region of the elongate tubular member that are adapted to releasably engage an implantable medical device and a plurality of sheathing aids extending distally from the distal region of the elongate tubular member that are adapted to guide the medical device back into the outer shaft lumen.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example system medical device delivery system includes an outer shaft having a proximal end region, a distal end region and a lumen extending therein. The delivery system also includes an inner shaft having a proximal end region, a distal end region and a lumen extending therein, wherein the inner shaft extends within at least a portion of the lumen of the outer shaft. The delivery system also includes a tip member disposed the along the distal end region of the outer shaft, the tip member including a proximal end region and a distal end region; wherein the outer shaft and the inner shaft are configured to position an implantable medical device therebetween and wherein the tip member includes an annular groove positioned adjacent the proximal end region of the tip member.

Abstract: 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.

Abstract: An example implant delivery system is disclosed. The example implant delivery system includes a catheter shaft having a distal end region and proximal end region, an implant coupled to the distal end region of the catheter shaft, a handle coupled to the proximal end region of the catheter shaft and an introducer sheath disposed along the catheter shaft. The introducer sheath includes an inner liner including a lumen and an expandable support member. The support member includes a plurality of ribs extending along a length of the support member. The introducer sheath further includes a sheath attached to at least a portion of the support member, wherein the support member is designed to shift from a first position to an expanded position.

Abstract: 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.