Abstract: A thrombectomy removal system includes a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion, a vacuum source, a vent liquid source, and a vacuum and vent control system configured to cyclically connect or disconnect the vacuum source and the vent liquid source to change a level of vacuum at the distal end and substantially prevent forward flow. The vacuum source and the vent source are respectively fluidically connected to the vacuum and vent valves. A manifold connects the proximal portion to the vacuum and vent sources through the valves. Control of the valves prevents forward flow of the distal portion out from the distal end during each cycle. Each cycle can have states including vacuum-only, first double-closed, vent-only, and second double-closed. A time of the double-closed states can be no greater than 30 ms.

Abstract: A method for operating a catheter provides a mechanical stiffener to a catheter shaft portion, the shaft comprising an inner sheath having a distal end and an outer surface and defining an access lumen extending distally to the distal end and an outer sheath having an inner surface surrounding the inner sheath distally to the distal end, defining an annulus between the outer and inner surfaces, the annulus having a connection at which vacuum applies to the annulus, and having a substantially constant outer diameter over the portion to the distal end. A tool is shaped and sized to pass through the access lumen and past the distal end. The portion is placed in an increased stiffened state by applying vacuum to create a stable base with at least a shaft segment within the anatomy that atraumatically resists reaction forces applied to the shaft by the tool.

Abstract: A thrombectomy removal system includes a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion, a vacuum source, a vent liquid source, and a vacuum and vent control system configured to cyclically connect or disconnect the vacuum source and the vent liquid source to change a level of vacuum at the distal end and substantially prevent forward flow. The vacuum source and the vent source are respectively fluidically connected to the vacuum and vent valves. A manifold connects the proximal portion to the vacuum and vent sources through the valves. Control of the valves prevents forward flow of the distal portion out from the distal end during each cycle. Each cycle can have states including vacuum-only, first double-closed, vent-only, and second double-closed. A time of the double-closed states can be no greater than 30 ms.

Abstract: A multiple-firing clip device includes a hollow shaft defining a lateral opening communicating with an environment and a distal shaft portion between the lateral opening and a distal end opening. A shuttle longitudinally moves on the shaft and comprises a shuttle body defining a lumen surrounding the shaft, a snare, and a snare-extender slide defining a snare track to form a snare travel path in which the snare is disposed from the body and through the track and a portion of the body. The slide moves along a given extent defining a slide distance and a distal end and movement of the slide to the distal end shortens the snare travel path to extend the snare portion through the lateral opening, through the distal shaft portion, and distally out from a distal side of the body longer than the given extent to secure a suture with the snare.

Abstract: A multiple-firing clip device comprises a shaft comprising an exterior surface, an interior receiving therein suture fixation clips, and a distal end opening shaped to eject a suture fixation clip therefrom. The shaft defines a lateral opening and a distal shaft portion between the lateral opening and the distal end opening. A shuttle moves on the shaft and comprises a shuttle body, a snare having a distal snare portion, and a snare extension slide movable from the shuttle body along a given extent defining a slide distance and a distal end. The shuttle extends at least the distal snare portion distally through the lateral opening from the environment into the interior, through the distal shaft portion, and through the distal end opening along a length that is at least equal to the slide distance when the snare extension slide moves to the distal end of the given extent.

Abstract: A controllable stiffness catheter comprising a shaft comprising an inner sheath defining an access lumen, an outer sheath surrounding the inner sheath and defining an annulus therebetween, the annulus having a vacuum connection at which a vacuum is applied to the annulus, and a mechanical stiffener disposed at least at a portion of the annulus.

Abstract: An external LAA exclusion clip comprises a clipping assembly comprising first and second opposing clip struts each of the clip struts having a tissue-contacting surface and first and second bias surfaces, a bias assembly connecting the first clip strut to the second clip strut to align the first and second clip struts in a strut plane passing through the tissue-contacting surface. The bias assembly comprises at least one first bias spring connected to the first bias surface of the first clip strut and to the first bias surface of the second clip strut and at least one second bias spring connected to the second bias surface of the first clip strut and the second bias surface of the second clip strut. The first bias spring and the second bias spring are configured to permit movement of the first and second clip struts in the strut plane.

Abstract: A delivery apparatus can include a handle portion and at least one rotatable drive shaft. The handle portion has an actuation mechanism. The actuation mechanism includes a motor and one or more actuators. The rotatable drive shaft has a proximal end portion and a distal end portion. The proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve. The handle is configured for actuating the actuation mechanism, tracking a response of native tissue when the prosthetic heart valve is in contact with the native tissue, and stopping expansion of the prosthetic heart valve once a rate of change of expansion of the prosthetic heart valve declines below a threshold.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A method for delivering RF energy to living tissue includes the steps of extending a guidewire to a tissue treatment site in a body. A controllable stiffness catheter is provided with a stiffness device having non-metallic properties and a temperature-changing device. The stiffness device is in a stiff state below a given temperature and in a soft state above the given temperature. While supplying power to the temperature-changing device, the catheter is threaded along the guidewire up to the treatment site in the soft state. Power is removed from the temperature-changing device to alter the non-metallic properties of the stiffness device and directly result in a change of the stiffness device to the stiff state without straightening the catheter. The RF energy supply device is physically contacted with the treatment site and RF energy is delivered to the treatment site from the RF energy supply device.

Abstract: A controllable stiffness catheter comprises a shaft comprising an inner sheath defining an access lumen, an outer sheath surrounding the inner sheath and defining an annulus therebetween, the annulus having a vacuum connection at which a vacuum is applied to the annulus, and a mechanical stiffener disposed at least at a portion of the annulus and free to move relatively in the annulus with respect to at least one of the inner sheath and the outer sheath.

Abstract: A controllable stiffness catheter comprising a shaft comprising an inner sheath defining an access lumen, an outer sheath surrounding the inner sheath and defining an annulus therebetween, the annulus having a vacuum connection at which a vacuum is applied to the annulus, and a mechanical stiffener disposed at least at a portion of the annulus.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A method for implanting a stent includes contracting a self-expanding/forcibly-expanding stent of a shape-memory material set to a given shape to a reduced implantation size with a delivery system having drive wires. The stent has a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the self-expanding stent occurs. The contracted stent is inserted into a native annulus in which the stent is to be implanted. The drive wires are rotated with the delivery system to forcibly expand the stent into the native annulus. While rotating the drive wires, a torque applied to the drive wires is determined with the delivery system. Rotation of the drive wires is stopped based upon a value of the determined torque.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A method for delivering RF energy to living tissue includes the steps of extending a guidewire to a tissue treatment site in a body. A controllable stiffness catheter is provided with a stiffness device having non-metallic properties and a temperature-changing device. The stiffness device is in a stiff state below a given temperature and in a soft state above the given temperature. While supplying power to the temperature-changing device, the catheter is threaded along the guidewire up to the treatment site in the soft state. Power is removed from the temperature-changing device to alter the non-metallic properties of the stiffness device and directly result in a change of the stiffness device to the stiff state without straightening the catheter. The RF energy supply device is physically contacted with the treatment site and RF energy is delivered to the treatment site from the RF energy supply device.

Abstract: A multiple-fire securing device includes a hollow outer shaft, a reloader, a reloader movement assembly, a rail, and securing structures each defining an inner securing orifice. The reloader longitudinally moves within the outer shaft and has a distal end shaped to temporarily contact one of the securing structures. The rail is disposed within the reloader and has an installing location. The securing structures are disposed on the rail. The reloader movement assembly moves the reloader longitudinally in a distal direction to deliver a first securing structure to the installing location from a first proximal position and moves the reloader proximally away from the installing location without the first securing structure to a position in which the distal end of the reloader temporarily contacts a second one of the securing structures. The second and successive securing structures are moved one at a time to the installing location.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.

Abstract: A multiple-firing crimp device comprises crimps, a shaft, a crimp movement assembly, and a snare. Each crimp has an internal hollow. The shaft has a distal crimping location, an exterior surface, and an interior with the clips stacked therein, the crimps moving therein along a longitudinal axis. The shaft defines a lateral opening proximal to the crimping location and communicates the interior to the environment outside the exterior surface. The crimp movement assembly within the shaft delivers the first crimp to the distal crimping location by moving the first crimp longitudinally from a first proximal position into the distal crimping location and returning to a second proximal position without the first crimp. The snare pulls at least one cord from distal of the first crimp through the first crimp and through a portion of the shaft and out the side of the shaft through the lateral opening.