Abstract: An implantable medical device that is adapted to be implanted at an implantation site includes an expandable frame that is adapted to expand from a collapsed configuration to an expanded configuration. The expandable frame includes an upper crown portion, a lower crown portion, commissural posts that extend proximally from the upper crown portion, and stabilization arches that extend proximally from the commissural posts. One or more valve cusps are secured relative to the expandable frame. An inner skirt is disposed along an inner portion of the lower crown portion and an outer skirt is disposed along an outer portion of the lower crown portion of the expandable frame. An expandable member is secured to the outer skirt.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for driving a needle to facilitate suturing, such as may be performed in a surgical anastomosis procedure. In an illustrative embodiment, an apparatus includes a frame. First and second rollers are rotatably mounted parallel with each other in the frame and are configured to engage therebetween a shaft of a needle formed in a helical shape. The first and second rollers are configured to counter-rotate. The needle is revolvable eccentrically around the first roller responsive to counter-rotation of the first and second rollers. A drive mechanism is secured to the frame and is configured to move the frame.

Abstract: A replacement heart valve system includes a replacement heart valve implant including an expandable framework and a plurality of leaflets, wherein the framework includes an attachment tab extending upstream from an inflow end, and an implant delivery system including an implant holding portion including a stent holder configured to engage the attachment tab to axially secure the implant relative to the delivery system. The stent holder includes a first radiopaque marker, and the attachment tab includes a second radiopaque marker, the first and second markers may collectively indicate a rotational orientation of the framework relative to a native heart valve under fluoroscopy. The first radiopaque marker may indicate when a middle commissure post of the framework is disposed in a posterior position and an anterior position relative to a native heart valve under fluoroscopy in a 3-cusp view.

Abstract: A replacement heart valve implant includes an expandable framework including a tubular wall comprising a plurality of interconnected struts and defining a central lumen, wherein the wall includes inflow and outflow ends, and a plurality of commissure posts. A plurality of valve leaflets is secured to the commissure posts. The framework may include a plurality of native leaflet clamps extending upstream from the outflow end, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall. The framework may include a plurality of native commissure clamps extending upstream from the commissure posts, wherein the commissure clamps are configured to pinch native commissures of the native heart valve. The framework may include a plurality of native leaflet clamps extending upstream from the commissure posts, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall.

Abstract: A replacement heart valve system includes an implant delivery subassembly couplable to an implant delivery system. The subassembly includes a first elongate shaft and a stent holder fixedly attached at a distal end of the first elongate shaft, a replacement heart valve implant, and a distal sheath disposed over a distal portion of the implant with a proximal portion of the implant disposed outside of the distal sheath in a pre-loaded configuration. The subassembly is initially physically separate from the delivery system in the pre-loaded configuration. A method of loading the implant into the replacement heart valve system includes positioning the subassembly adjacent to the delivery system, coupling the subassembly to the delivery system in the pre-loaded configuration, and thereafter shifting a proximal sheath of the delivery system over the proximal portion of the implant.

Abstract: An implant delivery system includes an elongate shaft assembly including an implant holding portion configured to constrain the implant in a collapsed configuration. The shaft assembly includes a stent holder configured to engage the implant and a plurality of longitudinal marker elements. The marker elements are spaced distally from stent holder and configured to align commissure posts of the implant with native commissures under fluoroscopy. The shaft assembly may include a distal cap extending distal of the marker elements. The marker elements are disposed inward of the cap. Each marker element may include a non-longitudinal directional marker element. A method of delivering the implant includes configuring an imaging device to produce a 3-cusp view, advancing the delivery system adjacent the native valve, imaging to determine an initial orientation, rotating the delivery system to position a middle marker element in a posterior position; and deploying the implant.

Abstract: A delivery system for delivering, adjusting, and/or recapturing a stent-valve includes an inner shaft and an expandable stent-valve coupled to the inner shaft. The stent-valve has an upper portion, a lower portion, and a valve. The delivery system also includes a distal sheath disposed over at least the lower portion, a proximal sheath disposed over at least the upper portion, and at least one cinching member coupled to the stent-valve and extending through one of the inner shaft, the distal sheath, or the proximal sheath. The upper and lower portions of the stent-valve are configured to move to an expanded configuration when the proximal and distal sheaths are withdrawn, respectively. After at least a portion of the stent-valve has been moved to the expanded configuration, the at least one cinching member is configured to at least partially radially compress at least a portion of the stent-valve.

Abstract: A device having a sheath, a medical device, a stylet, a handle and a plunger device. The handle includes portions connected proximal ends of the sheath, the medical device and the stylet and a chamber portion connected to the actuator. The chamber portion includes a volume of space configured to volumetrically connect to at a lumen of the medical device, the sheath or the stylet and a plunger device configured to be slidably received within the chamber portion. The plunger device is able to pneumatically isolate a proximal portion of the volume of space from a distal portion of the volume of space. Proximal movement of the stylet and the plunger device cause a suction effect (i.e., reduced pressure) at the distal end of the sheath, the medical device and/or the stylet.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for driving a needle to facilitate suturing, such as may be performed in a surgical anastomosis procedure. In an illustrative embodiment, an apparatus includes a frame. First and second rollers are rotatably mounted parallel with each other in the frame and are configured to engage therebetween a shaft of a needle formed in a helical shape. The first and second rollers are configured to counter-rotate. The needle is revolvable eccentrically around the first roller responsive to counter-rotation of the first and second rollers. A drive mechanism is secured to the frame and is configured to move the frame.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for driving a needle to facilitate suturing, such as may be performed in a surgical anastomosis procedure. In an illustrative embodiment, an apparatus includes a frame. First and second rollers are rotatably mounted parallel with each other in the frame and are configured to engage therebetween a shaft of a needle formed in a helical shape. The first and second rollers are configured to counter-rotate. The needle is revolvable eccentrically around the first roller responsive to counter-rotation of the first and second rollers. A drive mechanism is secured to the frame and is configured to move the frame.

Abstract: A device having a sheath, a medical device, a stylet, a handle and a plunger device. The handle includes portions connected proximal ends of the sheath, the medical device and the stylet and a chamber portion connected to the actuator. The chamber portion includes a volume of space configured to volumetrically connect to at a lumen of the medical device, the sheath or the stylet and a plunger device configured to be slidably received within the chamber portion. The plunger device is able to pneumatically isolate a proximal portion of the volume of space from a distal portion of the volume of space. Proximal movement of the stylet and the plunger device cause a suction effect (i.e., reduced pressure) at the distal end of the sheath, the medical device and/or the stylet.

Abstract: A device having a sheath, a medical device, a stylet, a handle having a chamber portion and a plunger device. The handle connects to proximal ends of the sheath, the medical device, and the stylet. The chamber portion includes a volume of space configured to volumetrically connect to at a lumen of the medical device, the sheath or the stylet. The plunger device slides and moves within the chamber portion. The plunger device is able to pneumatically or hydraulically isolate a proximal portion of the volume of space from a distal portion of the volume of space. Proximal movement of the stylet and the plunger device cause a suction effect (i.e., negative or reduced pressure) at the distal end of the sheath and/or the medical device.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for driving a needle to facilitate suturing, such as may be performed in a surgical anastomosis procedure. In an illustrative embodiment, an apparatus includes a frame. First and second rollers are rotatably mounted parallel with each other in the frame and are configured to engage therebetween a shaft of a needle formed in a helical shape. The first and second rollers are configured to counter-rotate. The needle is revolvable eccentrically around the first roller responsive to counter-rotation of the first and second rollers. A drive mechanism is secured to the frame and is configured to move the frame.

Abstract: A device having a sheath, a medical device, a stylet, a handle having a chamber portion and a plunger device. The handle connects to proximal ends of the sheath, the medical device, and the stylet. The chamber portion includes a volume of space configured to volumetrically connect to at a lumen of the medical device, the sheath or the stylet. The plunger device slides and moves within the chamber portion. The plunger device is able to pneumatically or hydraulically isolate a proximal portion of the volume of space from a distal portion of the volume of space. Proximal movement of the stylet and the plunger device cause a suction effect (i.e., negative or reduced pressure) at the distal end of the sheath and/or the medical device.

Abstract: An electrosurgical instrument includes a needle configured as a first electrode and a coil extending through the needle and configured as a second electrode. The coil movable relative to the needle, and as the needle and the coil are inserted into tissue and energized with an electrical energy source, the needle and the coil apply current to the tissue to coagulate the tissue.