Abstract: An introducer sheath assembly comprises a tubular sheath member having a deflectable distal end portion and a sheath member lumen, a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member, and a hemostasis valve assembly. The hemostasis valve assembly includes a side port member configured to be connected to a fluid source for introducing fluid into the sheath member lumen. The side port member is axially rotatable relative to the handle assembly and the sheath member such that the side port member can remain rotationally fixed relative to the fluid source as the handle assembly and the sheath member are rotated relative to the fluid source. The side port member may also be made transparent to allow for easy visualization of air bubbles, and is also configured to allow for evacuation of any visualized air bubbles.

Abstract: Various embodiments concern an introducer sheath assembly comprising a tubular sheath member having a deflectable distal end portion and a sheath member lumen, and a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member. The distal end portion of the sheath member can deflect in different directions along a plane by selective tension in one of two pull wires. The selective tension can be caused by selective proximal or distal axial translation of a shuttle assembly relative to the tubular sheath member. The selective proximal or distal axial translation can be controlled by selective clockwise or counterclockwise rotation of a control knob.

Abstract: Various embodiments concern sensing a first signal indicative of a plurality of different phases of a cardiac cycle with a sensor and sensing a second signal with an ultrasound sensor within the heart over different phases, the second signal indicative of the density of a section of cardiac tissue. Each phase can be associated with an indication of the density of the section of cardiac tissue during the phase based on the second signal. It can be determined whether the section of cardiac tissue compressed during the cardiac cycle based on a change in the indication of density of the cardiac tissue over the plurality of different phases. The efficacy of ablation therapy can be evaluated based on the compressibility of the section of cardiac tissue.

Abstract: Various embodiments concern an introducer sheath assembly comprising a tubular sheath member having a deflectable distal end portion and a sheath member lumen, and a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member. The distal end portion of the sheath member can deflect in different directions along a plane by selective tension in one of two pull wires. The selective tension can be caused by selective proximal or distal axial translation of a shuttle assembly relative to the tubular sheath member. The selective proximal or distal axial translation can be controlled by selective clockwise or counterclockwise rotation of a control knob.

Abstract: An introducer sheath assembly comprises a tubular sheath member having a deflectable distal end portion and a sheath member lumen, a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member, and a hemostasis valve assembly. The hemostasis valve assembly includes a side port member configured to be connected to a fluid source for introducing fluid into the sheath member lumen. The side port member is axially rotatable relative to the handle assembly and the sheath member such that the side port member can remain rotationally fixed relative to the fluid source as the handle assembly and the sheath member are rotated relative to the fluid source. The side port member may also be made transparent to allow for easy visualization of air bubbles, and is also configured to allow for evacuation of any visualized air bubbles.

Abstract: Apparatus and methods for retracting a balloon back into a delivery sheath following a medical procedure using the balloon. A handle on the device includes a balloon folding mechanism coupled to a proximal end of a guide wire shaft so that actuating the balloon folding mechanism causes rotation of the guide wire shaft within a catheter body. A distal end of the balloon is attached to a distal end of the guide wire shaft, which extends beyond the distal end of the catheter body, and a proximal end of the balloon is attached to the distal end of the catheter body so that actuating the folding mechanism causes the balloon to wrap around the guide wire shaft. The folding mechanism may also be configured for elongating the balloon. Rotating, or rotating and elongating, the deflated balloon results in a balloon with a smaller profile that may easily be retracted into a delivery sheath.