Abstract: An insertion catheter for a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft. The insertion catheter comprises a tubular body with a distal portion configured to axially movably receive the circulatory support device. A diameter of the distal portion is greater than a diameter of a mid portion of the tubular body. The insertion catheter may be inserted into an introducer sheath for delivery of the MCS device. A distal end of the insertion catheter may be located distally of a distal end of the introducer sheath and distally of the arterial bifurcation. The distal portion of the insertion catheter containing the MCS device may be located distally of the bifurcation, with a distal end of the MCS device slightly offset from the distal end of the tubular body.

Abstract: A radially expandable prosthetic valve can include an annular frame, at least one expansion mechanism, and a biasing member. The annular frame can be radially collapsible and expandable between a radially compressed configuration and a radially expanded configuration. The at least one expansion mechanism can include a first member attached to the frame at a first location and a second member attached to the frame at a second location axially spaced from the first location. Movement of the first member relative to the second member in a first direction can cause the frame to radially expand, and movement of the first member relative to the second member in a second direction, opposite the first direction, causes the frame to radially compress. The biasing member can exert a biasing force against the first member in the first direction, to cause the first member to move relative to the second member, which can further expand the frame as the native annulus enlarges over time.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: A medical device delivery system can comprise a delivery catheter and an in-line sheath, the delivery catheter being preloaded within the in-line sheath. The delivery catheter can comprise a catheter hub and a catheter shaft. The catheter shaft can comprise a proximal portion extending distally from the hub and slidably receiving a proximal narrow portion of a medical device, and a distal portion slidably receiving a distal wide portion of a medical device. The in-line sheath can comprise a sheath hub and a sheath shaft. The sheath shaft can comprise a proximal portion extending distally from the sheath hub and slidably receiving at least a portion of the proximal portion of the catheter shaft, and an expandable distal portion slidably receiving the distal portion of the catheter shaft.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A leaflet structure is situated at least partially within the frame, the leaflet structure including a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion being paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure, the commissure tab portions of each leaflet being folded such that each commissure tab portion forms a plurality of layers. A reinforcement member of a plurality of reinforcement members is positioned between the layers of each commissure tab portion. Each commissure tab portion of each leaflet is positioned entirely within the frame.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: An assembly can comprise a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, where the screw comprises a screw head having an annular bore with internal threads, and where the screw is rotatable to radially expand the frame. The assembly further comprises a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft. The second head is configured to releasably engage with an exterior surface of the screw head and rotate the screw.

Abstract: A prosthetic valve has an annular frame including a plurality of strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A leaflet structure is situated at least partially within the frame. The leaflet structure includes a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure. The commissure tab portions of each leaflet are folded to form a plurality of layers positioned on the inside of the frame. A reinforcement member is positioned between the layers of each commissure tab portion.

Abstract: A method can comprise deploying a prosthetic valve with a delivery apparatus, where the prosthetic valve comprises a frame and a rotatable screw connected to the frame, and where the screw comprises a screw head having an annular bore with internal threads. The delivery apparatus is releasably coupled to the screw and can comprise a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads releasably engaged with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft, the second head releasably engaged with an exterior surface of the screw head. Deploying the valve includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

Abstract: A delivery apparatus for a medical device can include a handle, a shaft, a plurality of sleeves, and a suture. The shaft includes a proximal end portion coupled to the handle and is configured to be disposed outside of a patient's body during an implantation procedure and a distal end portion configured to be disposed inside a patient's body during the implantation procedure. Each of the sleeves includes a connection portion coupled to the distal end portion of the shaft and a receiving portion configured to receive an apex of a stent or a prosthetic heart valve. The suture extends through the shaft and the sleeves and is configured for releasably securing the stent or the prosthetic heart valve to the receiving portions of the sleeves.

Abstract: A method for delivering a prosthetic valve to a native annulus of a heart can include inserting a delivery apparatus into a patient's body, advancing the delivery apparatus to an implantation location within the native annulus, retracting a delivery sheath of the delivery apparatus relative to the prosthetic valve to expose the prosthetic valve from a distal end of the delivery sheath, and after the prosthetic valve is exposed from the delivery sheath, expanding the prosthetic valve from a radially compressed state to a radially expanded state by reducing axial tension on a first end and a second end of the prosthetic valve.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: An introducer sheath can be used to safely introduce a delivery apparatus into a patient’s vasculature (e.g., via the femoral artery). It is advantageous to visualize the placement of an introducer sheath within the vasculature using an imaging system. The sheaths disclosed herein include radiopaque features that assist with imaging without sacrificing the low profile, expandability, and other advantageous aspects of the introducer sheath.

Abstract: A prosthetic valve delivery apparatus can comprise a handle, an outer shaft extending distally from the handle, a gear mechanism arranged distal to the outer shaft, an input torque shaft extending distally from the handle through the outer shaft and having a distal end portion operatively connected to the gear mechanism, and a plurality of output torque shafts operatively connected to and extending distally from the gear mechanism. The gear mechanism is configured to transfer rotational motion from the input torque shaft to the plurality of output torque shafts.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: Expandable sheaths and introducers are disclosed herein. In some examples, the expandable introducer includes an elongated body member, an inflatable balloon disposed between a proximal and distal end of the elongated body member, and an inflation lumen in fluid communication with the inflatable balloon. A portion of the balloon is sized and configured to pass through a distal opening of an expandable introducer sheath when in the deflated condition, and to dilate the distal end of the introducer sheath as the balloon expands from the deflated configuration to the inflated configuration. Methods of making and using the devices disclosed herein are also disclosed.

Abstract: A prosthetic valve delivery apparatus can comprise a handle, a gearbox, an input torque shaft and a plurality of output torque shafts. The input torque shaft can extend distally from the handle and can have a distal end portion operatively connected to the gearbox. The output torque shafts can be operatively connected to and extend distally from the gearbox. Rotation of the input torque shaft can cause rotation of the output torque shafts via the gear box.

Abstract: A transcatheter delivery system including an expandable transition element is disclosed. As one example, an assembly may comprise a prosthetic valve and a delivery device. The delivery device may comprise an outer shaft with a distal end portion forming a sheath adapted to enclose the prosthetic valve therein in a radially compressed configuration; an inner shaft arranged within the outer shaft and including a nosecone arranged at a distal end of the inner shaft, the nosecone arranged outside of the outer shaft, at the distal end portion of the outer shaft; and an expandable transition element adapted to expand from a non-expanded state within the outer shaft to an expanded state outside the outer shaft, wherein, in the expanded state, the transition element forms a continuous transition from the nosecone to the prosthetic valve when the sheath is moved away from the nosecone to uncover the prosthetic valve.