Abstract: An expandable introducer includes a hub and a tubular sheath (121) coupled thereto. The tubular sheath (121) defines a central lumen (103). A circumference of the tubular sheath includes a full thickness region (162) having a first wall thickness (T2) and a reduced thickness region (161) having a second wall thickness (T1) smaller than the first wall thickness (T2). The reduced thickness region (162) is configured to be folded such that the tubular sheath includes an unexpanded, folded state and is configured to expand to an expanded, unfolded state in response to a device passing though the central lumen (103). A first outer diameter of the tubular sheath in the unexpanded, folded state is smaller than a second outer diameter of the tubular sheath in the expanded, unfolded state.

Abstract: An expandable introducer device includes an introducer hub and an introducer sheath coupled to the hub and extending distally therefrom. The introducer sheath includes a mesh tube, a liner disposed within the mesh tube, and an axial strip disposed between the mesh tube and the liner. The introducer sheath is radially-expandable from a first diameter to a second diameter larger than the first diameter in response to a device being advanced through the introducer sheath.

Abstract: A delivery system includes an elongated shaft component, a self-expanding valve prosthesis, at least one cinching suture, and a radially-expandable sleeve. The valve prosthesis is disposed over a distal portion of the elongated shaft component and includes a compressed configuration for delivery and an expanded configuration for deployment. The at least one cinching suture removably couples the valve prosthesis to the elongated shaft component and radially compresses the valve prosthesis into the compressed configuration for delivery. The sleeve is secured to and encircles an outer surface of the valve prosthesis. The sleeve has a delivery state with a first diameter extending over a full length of the valve prosthesis in the compressed configuration and a deployed state with a greater second diameter extending over the full length of the valve prosthesis in the expanded configuration. The sleeve is configured to prevent paravalvular leakage in situ in the deployed state.

Abstract: A QR code proxy system allows digital dispenser assets associated with QR codes on a plurality of dispensers to be externally controlled. The specific digital dispenser assets associated with static QR codes can be changed without needing to change the QR codes themselves by editing a routing map. In some embodiments, the system may include a content/media routing map and a proxy engine. The content/media routing map establishes an association between a plurality of dispensers each with a respective QR code and a plurality of digital dispenser assets. The proxy engine determines an identity of a dispenser based on its QR code and responds with one or more digital dispenser assets based on the association established by the content/media routing map.

Abstract: A transcatheter heart valve delivery assembly includes a first shaft portion including a first wall surrounding a first chamber. A second shaft portion is attached to a distal end of the first shaft portion and includes a second wall surrounding a second chamber. A funnel portion is attached to a distal end of the second shaft portion and includes a funnel wall surrounding a funnel chamber. The funnel portion moves between a radially-compressed position, in which the funnel chamber includes a first diameter that is less than or equal to a diameter of the second chamber, and a radially-expanded position, in which the funnel chamber includes a second diameter that is greater than the first diameter. The funnel portion is biased into the radially-compressed position. Methods of recapturing a heart valve prosthesis are provided.

Abstract: A system includes an inflow loading assembly configured to compress an inflow portion of the implantable medical device as the implantable medical device is advanced through the inflow loading assembly. The system also includes an outflow loading assembly removably coupled to the inflow loading assembly. The outflow loading assembly is configured to partially compress an outflow portion of the implantable medical device during coupling to the inflow loading assembly. The inflow loading assembly includes one or more biasing features that are configured to asymmetrically compress the inflow portion of the implantable medical device.

Abstract: A heart valve therapy system includes a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: An expandable introducer includes a hub having a distal end and a proximal end, and a sheath coupled to the hub and extending distally therefrom, the sheath defining a central lumen. The sheath is configured to radially expand from a radially unexpanded, folded state having a first diameter and to a radially expanded, unfolded state having a second diameter larger than the first diameter in response to a device passing through the central lumen. A wall of the sheath includes a thick wall region having a first wall thickness and a thin wall region having a second wall thickness smaller than the first wall thickness, wherein the thick wall region includes a coil embedded within the wall of the sheath.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: Balloon catheters for delivery of prosthetic hear valves are provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: Balloon catheters for delivery of prosthetic hear valves are provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: An advancer includes an advancer hub and an advancer shaft extending distally from the advancer hub. The advancer shaft includes a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The advancer shaft is configured to be disposed around an outer shaft of a delivery catheter, and includes a split line configured to enable splitting the shaft to enable removal of the shaft from the outer shaft. The advancer hub configured to be mounted on the outer shaft of the delivery catheter, and includes a parting line to enable splitting of the advancer hub.

Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: A method include of delivering a heart valve prosthesis includes loading the heart valve prosthesis in a crimped configuration within a dilator shaft, tracking the dilator shaft within a vasculature of a patient to a desired site with the heart valve prosthesis loaded therewithin, advancing a delivery device through the dilator shaft to the distal end of the dilator shaft, advancing the delivery device through the heart valve prosthesis to load the heart valve prosthesis onto the delivery device, advancing the delivery device with the heart valve prosthesis mounted thereon past the distal end of the dilator shaft to a treatment site within the vasculature of the patient, and deploying the heart valve prosthesis from the delivery device at the treatment site.

Abstract: An injector device is configurable between a safe state and an operable state and comprises a housing having a distal end and a proximal end; a medicament cartridge disposed within the housing; a needle unit comprising a needle and being disposed in the distal end of the housing; a sleeve displaceable along a longitudinal axis of the device between a first position in which the sleeve conceals the needle and a second position in which the needle is exposed from an end of the sleeve; a locking mechanism configured to prevent displacement of the sleeve when the device is in the safe state; and a button disposed in the proximal end of the housing, the button being configured to switch the device between the safe state and the operable state by releasing the locking mechanism when the button is pressed from an initial position into a depressed position during use.

Abstract: Balloon catheters for delivery of prosthetic hear valves is provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: A transcatheter heart valve implant apparatus includes a frame extending along a frame axis and radially expandable between a first position and a second position. The frame includes a wire extending circumferentially around the frame axis to define a lumen. The wire includes a first peak portion including a first amplitude measured from a plane perpendicular to the frame axis, a second peak portion including a second amplitude measured from the plane, and a valley portion attaching the first peak portion and the second peak portion. The first amplitude is different than the second amplitude, and the first peak portion and the second peak portion are positioned on a first side of the plane and the valley portion is positioned on an opposing second side of the plane. A cover extends along the frame axis and covers an outer radial side of the wire opposite the lumen.

Abstract: An introducer sheath system including an outer layer, an inner layer, and a dilator is disclosed. The outer layer is circumferentially extending between a first longitudinal edge and a second longitudinal edge. An expandable gap is defined between the first and second longitudinal edges. The inner layer is disposed within the outer layer. The inner layer is configured to be continuously circumferentially expandable. The inner layer includes a non-extended state having a circumferential portion extending circumferentially inside the outer layer and a fold portion extending into an interior cavity of the inner layer. The inner layer includes an extended state wherein the fold portion extends at least partially circumferentially between the first and second longitudinal edges. The dilator is extendable longitudinally within the inner layer. The dilator includes a recess configured to accommodate the fold portion of the inner layer.

Abstract: Systems and methods may be provided for generating applications that may be agile, personalized, quickly delivered, and capable of being seamlessly integrated across an organization. The behavior and functionality of the applications (e.g., user interfaces therein) may be tailored specifically to individual users in response to learned user preferences. Consequently, these dynamic user experience (UX) applications may be rapidly deployed and capable of providing a satisfactory yet complete user experience across one or more applications. The methods and systems may include receiving a user objective, selecting a path associated with one or more steps, generating a dynamic UX application based on the steps, transmitting the dynamic UX application to the user, and displaying the dynamic UX application.