Abstract: An instrument for facilitating transseptal delivery of a cardiac therapeutic device is positionable in a left ventricle. The instrument includes an elongate shaft having a tubular lumen, the shaft having a proximal portion and a distal portion actively steerable between a generally straight position and a curved position. An external pull wire and an internal pull wire are each actuatable to move the distal portion to the curved position. The external pull wire extends internally through the proximal portion of the shaft and longitudinally along the exterior of the distal portion of the shaft, while the internal pull wire extends internally through the proximal portion of the shaft adjacent to the external pull wire, and extends internally through the distal portion of the shaft.

Abstract: A hemostasis valve assembly includes a hollow body delimiting an inner passage for inserting a medical material, the inner passage extending between a proximal opening and a distal opening of the hollow body, a distal seal arranged at the distal opening, a proximal seal arranged at the proximal opening, a spacer element arranged between the distal seal and the proximal seal, and an end cap. The distal seal is an elastic valve that is sealed when idle. The end cap has a fixing element engaging a support element of the hollow body to fix a stacked assembly including the distal seal, the spacer element, and the proximal seal inside the hollow body.

Abstract: An apparatus for insertion into a body through a working channel of an endoscope includes a catheter including a dilator, a guide tube disposed in a lumen of the catheter, and a handle including a puncturing actuator operatively coupled to the proximal end of the guide tube. The dilator may be a cautery device and/or a balloon. The apparatus may also include a stylet needle that includes a cutting distal end for puncturing tissue and extends through a lumen in the guide tube. The handle may further include a stopper detachably coupled to the puncturing actuator to fix a position of the puncturing actuator on the handle, and moveable on the handle independently of the puncturing actuator when detached from the puncturing actuator. The disclosed embodiments also include a method for forming a passageway in a wall of a hollow body organ using the apparatus.

Abstract: A surgical clip includes an elongated body configured to be detachably coupled to a shaft of a surgical instrument, a pair of jaw members received in the body, and a release feature for selectively unlocking the jaw members.

Abstract: An instrument for facilitating transseptal delivery of a cardiac therapeutic device is positionable in a left ventricle. The instrument includes an elongate shaft having a tubular lumen, the shaft having a proximal portion and a distal portion actively steerable between a generally straight position and a curved position. An external pull wire and an internal pull wire are each actuatable to move the distal portion to the curved position. The external pull wire extends internally through the proximal portion of the shaft and longitudinally along the exterior of the distal portion of the shaft, while the internal pull wire extends internally through the proximal portion of the shaft adjacent to the external pull wire, and extends internally through the distal portion of the shaft.

Abstract: An articulating shaft for a steerable catheter system includes a tubular body having a longitudinal central axis and at least one main lumen with a distal end and a proximal end. The shaft further includes at least one wire support element forming at least one wire lumen for supporting at least one actuating wire, the main lumen and the wire lumen are integrally formed in an extrusion part having a uniform hardness in an axial and a radial direction. A plurality of removed sections or cuts of the shaft extend in a radial direction and are distanced from each other in an axial direction.

Abstract: A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.

Abstract: An articulating shaft for a steerable catheter system includes a tubular body and a plurality of wire support elements integrally formed from a single piece with the tubular body. The tubular body has a longitudinal central axis and a sealed lumen with a distal opening and a proximal opening. The wire support elements support an actuating wire. Each of the wire support elements has a feed-through opening receiving the actuating wire. A pair of adjacent wire support elements are separated from each other in an axial direction by a slot.

Abstract: A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.

Abstract: An apparatus for insertion into a body through a working channel of an endoscope includes a catheter including a dilator, a guide tube disposed in a lumen of the catheter, and a handle including a puncturing actuator operatively coupled to the proximal end of the guide tube. The dilator may be a cautery device and/or a balloon. The apparatus may also include a stylet needle that includes a cutting distal end for puncturing tissue and extends through a lumen in the guide tube. The handle may further include a stopper detachably coupled to the puncturing actuator to fix a position of the puncturing actuator on the handle, and moveable on the handle independently of the puncturing actuator when detached from the puncturing actuator. The disclosed embodiments also include a method for forming a passageway in a wall of a hollow body organ using the apparatus.

Abstract: A medical device handle for articulation of a catheter includes a housing having a cylindrical shape, a control element at least partly encompassed by the housing, the control element having a pair of cross-cut threads cross-cut in opposing directions around a longitudinal axis of the medical device handle, and a pair of pull wire mounting elements each having a mounting thread engaging with one of the cross-cut threads. The control element is mechanically coupled to each of the pull wire mounting elements via the cross-cut threads and the mounting threads without any additional gear in between. A rotation of the control element around the longitudinal axis moves the pull wire mounting elements in opposite linear directions along the longitudinal axis.

Abstract: A hemostasis valve assembly includes a hollow body delimiting an inner passage for inserting a medical material, the inner passage extending between a proximal opening and a distal opening of the hollow body, a distal seal arranged at the distal opening, a proximal seal arranged at the proximal opening, a spacer element arranged between the distal seal and the proximal seal, and an end cap. The distal seal is an elastic valve that is sealed when idle. The end cap has a fixing element engaging a support element of the hollow body to fix a stacked assembly including the distal seal, the spacer element, and the proximal seal inside the hollow body.

Abstract: A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.

Abstract: An instrument for facilitating transseptal delivery of a cardiac therapeutic device is positionable in a left ventricle. The instrument includes an elongate shaft having a tubular lumen, the shaft having a proximal portion and a distal portion actively steerable between a generally straight position and a curved position. An external pull wire and an internal pull wire are each actuatable to move the distal portion to the curved position. The external pull wire extends internally through the proximal portion of the shaft and longitudinally along the exterior of the distal portion of the shaft, while the internal pull wire extends internally through the proximal portion of the shaft adjacent to the external pull wire, and extends internally through the distal portion of the shaft.

Abstract: A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.

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: 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.