Abstract: An apparatus for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon.

Abstract: Embodiments of the present disclosure provide an introducer device and method for introducing a delivery apparatus into a patient's vasculature. Disclosed methods can include positioning a sleeve of an introducer sheath in a blood vessel of a patient, the sleeve having a lattice layer with a lumen therethrough, inserting a distal end portion of the delivery apparatus and a prosthetic heart valve into the lumen, and advancing the distal end portion of the delivery apparatus through the lumen from the proximal end to the distal end. The method can then include expanding the lumen from a first diameter smaller to a second diameter at least equal to the diameter of the prosthetic heart valve to allow passage of the prosthetic heart valve through the lumen, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic heart valve through the lumen.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a housing, a steerable shaft, a slide nut, and a threaded shaft disposed over the slide nut. The slide nut can have an external threaded surface and an internal surface comprising a slot. The threaded shaft can have an internal threaded surface engaging the external threaded surface of the slide nut. The delivery apparatus can further include an elongated nut guide extending into the slot of the nut to restrain the slide nut against rotation relative to the housing, and a pull wire having a proximal end portion extending into the housing and coupled to the slide nut, and a distal end portion coupled to a distal end portion of the steerable shaft. The threaded shaft can be rotatable relative to the housing to produce axial movement of the slide nut within the threaded shaft.

Abstract: Embodiments of the present disclosure provide an introducer device and methods for introducing a medical device into a patient's vasculature. In one embodiment, a method of using an introducer device including a housing, a hemostatic seal mounted within the housing, and a tube extending into the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position, includes moving the tube to the distal position such that the distal end of the tube extends through the hemostatic seal. The method further includes inserting a distal end portion of the medical device through the tube and into the patient's vasculature without contacting the hemostatic seal.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed steerable catheters can include a handle, a steerable shaft extending from the handle, and a pull wire. The shaft can include a main lumen, an inner polymeric layer surrounding the main lumen, a braided layer surrounding the inner polymeric layer, and an outer polymeric layer surrounding the braided layer, the outer polymeric layer defining a pull wire lumen. The pull wire can extend from the handle and through the pull wire lumen and can have a distal end portion coupled to a distal end portion of the shaft.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a handle, a first shaft extending from the handle, a second shaft disposed around the first shaft, and a valve cover. The valve cover can be coupled to a distal end portion of the first shaft and can be configured to house a prosthetic heart valve in a radially compressed state. The valve cover can have an outer diameter greater than an outer diameter of the second shaft, and the first shaft and valve cover can be movable together in an axial direction relative to the second shaft.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: An apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Abstract: Embodiments of the present disclosure provide an introducer device for introducing a medical device into a patient's vasculature. In one embodiment, the introducer device comprises a housing, a distal sheath adapted to be inserted into a patient's vasculature with the housing positioned outside of the patient's vasculature, a hemostatic seal mounted within the housing, and a tube positioned within the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the hemostatic seal with the hemostatic seal closed. In the distal position, the distal end of the tube extends through the hemostatic seal and permits the medical device to be inserted through the housing and into the patient's vasculature without contacting the hemostatic seal.

Abstract: Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: An apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Abstract: An apparatus for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon.

Abstract: Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.