Abstract: 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.

Abstract: A medical device may include a device handle having a diverter block non-movably disposed within an interior cavity of the handle, the diverter block including at least one lumen extending longitudinally therethrough and a distal mounting portion. A delivery sheath may be coupled to the device handle. A catheter assembly may extend distally from the device handle within the delivery sheath. The catheter assembly may include a multi-lumen polymeric shaft coupled to the diverter block, and a metallic hypotube section disposed about and fixedly attached to a proximal end of the shaft. The hypotube section may releasably lock the shaft to the diverter block in fluid communication with the at least one lumen of the diverter block. The delivery sheath may be axially translatable relative to the device handle and the catheter assembly may be fixed in position relative to the device handle.

Abstract: A handle for a medical device system may include a hollow elongate handle housing, a first lead screw disposed within the hollow elongate handle housing, a deployment mechanism configured to actuate a medical implant positioned at a distal end of the medical device system, the deployment mechanism being operatively engaged with the first lead screw, and a control knob rotatably disposed around a proximal end of the hollow elongate handle housing. The first lead screw may be spaced apart from the control knob. Rotation of the control knob in a first direction may cause rotation of the first lead screw in the first direction.

Abstract: 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.

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 release system may include an elongated rod having an enlarged distal end, a ring element slidingly disposed over the elongated rod, and two or more pins. The ring element may have a center channel sized and shaped to receive the elongated rod, wherein the enlarged distal end of the rod is larger than an inner diameter of the center channel, preventing the ring element from disengaging from the distal end of the rod. The two or more pins may each have a proximal end attached to the ring element and a distal end extending longitudinally and radially away from the ring element, the distal ends configured for releasable connection to a medical device.

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 elongated member and a method of manufacturing an elongated member may include first, second, and third elongated rod mandrels. The first, second, and third elongated rod mandrels may be fixed together at predetermined proximal and distal locations and at a ball tip. The first, second, and third rod mandrels may be disposed within a tubular coupling element and fixed to the tubular coupling element at the ball tip. The tubular coupling element may be placed into abutment with and fixed to the distal end of an elongated shaft.

Abstract: An elongated member and a method of manufacturing an elongated member may include first, second, and third elongated rod mandrels. The first, second, and third elongated rod mandrels may be fixed together at predetermined proximal and distal locations and at a ball tip. The first, second, and third rod mandrels may be disposed within a tubular coupling element and fixed to the tubular coupling element at the ball tip. The tubular coupling element may be placed into abutment with and fixed to the distal end of an elongated shaft.

Abstract: 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.

Abstract: 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.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an inner shaft having a distal end region. A valve implant may be releasably coupled to the distal end region. The valve implant may be capable of shifting between an elongated configuration and an expanded configuration. A post assembly may be disposed along the valve implant. The post assembly may include a release member that is axially slidable along the post assembly. The medical device may also include a rod designed to engage the release member. The rod may be designed to shift the valve implant between the elongated configuration and the expanded configuration. Axially shifting the release member along the post assembly may release the rod from the post assembly and deploy the valve implant.

Abstract: A medical device may include a handle housing having a side wall defining an interior space and proximal and distal apertures extending through the side wall, an elongated outer sheath, an elongated inner member, a proximal flush port disposed within the interior space and in fluid communication with the elongated inner member, and a distal flush port disposed within the interior space and in fluid communication with the elongated outer sheath. A control knob may be rotated to move the distal flush port within the interior space.

Abstract: A percutaneous valve delivery system may include an outer sheath and an inner catheter disposed within the outer sheath. The inner catheter may include a plurality of lumens formed therein. A tubular extension may extend distally from a distal end of the inner catheter, wherein the tubular extension is axially movable relative to the inner catheter. A nose cone may be attached to the tubular extension. A handle may be attached to the outer sheath, wherein the handle is configured to shift the outer sheath between a first position and a second position relative to the inner catheter. A valve replacement implant may be releasably coupled to the inner catheter.

Abstract: A medical device may include a device handle having a diverter block non-movably disposed within an interior cavity of the handle, the diverter block including at least one lumen extending longitudinally therethrough and a distal mounting portion. A delivery sheath may be coupled to the device handle. A catheter assembly may extend distally from the device handle within the delivery sheath. The catheter assembly may include a multi-lumen polymeric shaft coupled to the diverter block, and a metallic hypotube section disposed about and fixedly attached to a proximal end of the shaft. The hypotube section may releasably lock the shaft to the diverter block in fluid communication with the at least one lumen of the diverter block. The delivery sheath may be axially translatable relative to the device handle and the catheter assembly may be fixed in position relative to the device handle.

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: A medical device may include a handle housing having a side wall defining an interior space and proximal and distal apertures extending through the side wall, an elongated outer sheath, an elongated inner member, a proximal flush port disposed within the interior space and in fluid communication with the elongated inner member, and a distal flush port disposed within the interior space and in fluid communication with the elongated outer sheath. A control knob may be rotated to move the distal flush port within the interior space.

Abstract: A medical device may include a handle housing having a side wall defining an interior space and proximal and distal apertures extending through the side wall, an elongated outer sheath, an elongated inner member, a proximal flush port disposed within the interior space and in fluid communication with the elongated inner member, and a distal flush port disposed within the interior space and in fluid communication with the elongated outer sheath. A control knob may be rotated to move the distal flush port within the interior space.

Abstract: An elongated member and a method of manufacturing an elongated member may include first, second, and third elongated rod mandrels. The first, second, and third elongated rod mandrels may be fixed together at predetermined proximal and distal locations and at a ball tip. The first, second, and third rod mandrels may be disposed within a tubular coupling element and fixed to the tubular coupling element at the ball tip. The tubular coupling element may be placed into abutment with and fixed to the distal end of an elongated shaft.

Abstract: An elongated member and a method of manufacturing an elongated member may include first, second, and third elongated rod mandrels. The first, second, and third elongated rod mandrels may be fixed together at predetermined proximal and distal locations and at a ball tip. The first, second, and third rod mandrels may be disposed within a tubular coupling element and fixed to the tubular coupling element at the ball tip. The tubular coupling element may be placed into abutment with and fixed to the distal end of an elongated shaft.