Abstract: A delivery device for a prosthetic heart valve includes a shaft, a sheath, and a pull wire. The shaft has a proximal end, a distal end, and a longitudinal axis. The sheath is attached to the shaft and is rotatable about an axis transverse to the longitudinal axis of the shaft. The pull wire is mechanically coupled to the sheath such that movement of the pull wire rotates the sheath relative to the shaft. The sheath may be in a first position relative to the shaft when a distal end of the pull wire is in a first position and may be in a second position when the distal end of the pull wire is in a second position. Deflection of the sheath relative to the shaft enables a prosthetic valve to be axially aligned with the native valve annulus for deployment.

Abstract: A delivery device for a prosthetic heart valve includes a shaft, a sheath, and a pull wire. The shaft has a proximal end, a distal end, and a longitudinal axis. The sheath is attached to the shaft and is rotatable about an axis transverse to the longitudinal axis of the shaft. The pull wire is mechanically coupled to the sheath such that movement of the pull wire rotates the sheath relative to the shaft. The sheath may be in a first position relative to the shaft when a distal end of the pull wire is in a first position and may be in a second position when the distal end of the pull wire is in a second position. Deflection of the sheath relative to the shaft enables a prosthetic valve to be axially aligned with the native valve annulus for deployment.

Abstract: Devices, systems and methods for improving the function of a valve of a heart by implanting the device adjacent the valve such that the device indirectly applies a force to the valve and increases coaptation of the leaflets, or otherwise improves valve function. The device may be implanted in a position that does not directly contact the valve structures. The force may be applied to a wall of the heart, and the force may be an inward force applied to two walls of the heart, such as the left ventricular free wall and the ventricular septum, or the left ventricular free wall and the right ventricular free wall, to improve mitral valve function.

Abstract: According to the present invention, an alignment device for marking and aligning selected positions on a heart's surface is provided. The device includes a handle assembly having upper and lower handle portions which are detachable from one another. Each handle portion is connected to a tissue engaging member which may be secured to the surface of the heart via a vacuum. The tissue engaging members are articulatable with respect to the handle portions, such that movement of the handle portions after the tissue engaging members are secured to the heart's surface will not dislodge or displace the tissue engaging members. The tissue engaging members may be permanently or detachably connected to the handle portions. The tissue engaging members may also be used to locate and mark desired positions on the heart. In use, after the tissue engaging members are secured to the surface of the heart, the handle portions are manipulated to connect to one another.

Abstract: A splint assembly for placement transverse a heart chamber to reduce the heart chamber radius and improve cardiac function has a tension member formed of a braided cable with a covering. A fixed anchor assembly is attached to one end of the tension member and a leader for penetrating a heart wall and guiding the tension member through the heart is attached to the other end. An adjustable anchor assembly can be secured onto the tension member opposite to the side on which the fixed pad assembly is attached. The adjustable anchor assembly can be positioned along the tension member so as to adjust the length of the tension member extending between the fixed and adjustable anchor assemblies. The pad assemblies engage with the outside of the heart wall to hold the tension member in place transverse the heart chamber. A probe and marker delivery device is used to identify locations on the heart wall to place the splint assembly such that it will not interfere with internal heart structures.

Abstract: According to the present invention, an alignment device for marking and aligning selected positions on a heart's surface is provided. The device includes a handle assembly having upper and lower handle portions which are detachable from one another. Each handle portion is connected to a tissue engaging member which may be secured to the surface of the heart via a vacuum. The tissue engaging members are articulatable with respect to the handle portions, such that movement of the handle portions after the tissue engaging members are secured to the heart's surface will not dislodge or displace the tissue engaging members. The tissue engaging members may be permanently or detachably connected to the handle portions. The tissue engaging members may also be used to locate and mark desired positions on the heart. In use, after the tissue engaging members are secured to the surface of the heart, the handle portions are manipulated to connect to one another.

Abstract: A urethral occlusion device having a very malleable, flexible, deformable polymer occlusion band which may be easily wrapped about the exterior of the penis to provide sufficient pressure to prevent urine flow, but without restricting blood circulation. The occlusion band includes a silicone rubber shell with silicone gel liner surfaces which provide a washable, reusable, skin-sensitive bond when wrapped, and allow the band to be tightened to the patient's desired degree of compression. A plurality of pliant, deformable ribs are positioned on the occlusion band and oriented along the underside of the penis to mildly stretch the urethra to an occluded position.