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: The present invention relates to a shaft for a catheter which may be usable having a tubular core which may be usable with a minimally invasive procedure such as intravascular medical treatment system. It also relates to a method of fabricating such shaft.

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: 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 conduit for creating a passage from a right atrium to a left atrium, through a mitral valve into the left ventricle, and to provide a passage from the left ventricle into the aortic valve. The conduit includes an elongate tubular member having a shaft with a proximal section and a distal loop section at a distal end of the proximal section. The distal loop section includes a proximal curve, a distal curve, a generally straight segment extending between the curves, and a distal tip. The shaft in the distal loop section curves back on itself so that proximal curve is formed by a part of the shaft that is closer along the length of the shaft to the distal tip.

Abstract: A conduit for creating a passage from a right atrium to a left atrium, through a mitral valve into the left ventricle, and to provide a passage from the left ventricle into the aortic valve. The conduit includes an elongate tubular member having a shaft with a proximal section and a distal loop section at a distal end of the proximal section. The distal loop section includes a proximal curve, a distal curve, a generally straight segment extending between the curves, and a distal tip. The shaft in the distal loop section curves back on itself so that proximal curve is formed by a part of the shaft that is closer along the length of the shaft to the distal tip.

Abstract: A conduit for creating a passage from a right atrium to a left atrium, through a mitral valve into the left ventricle, and to provide a passage from the left ventricle into the aortic valve. The conduit includes an elongate tubular member having a shaft with a proximal section and a distal loop section at a distal end of the proximal section. The distal loop section includes a passive proximal curve, a steerable distal curve, a generally straight segment extending between the curves, and a distal tip. The shaft in the distal loop section is steerable to cause it to curve back on itself so that proximal curve is formed by a part of the shaft that is closer along the length of the shaft to the distal tip.

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: 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: The present invention relates to a shaft for a catheter which may be usable having a tubular core which may be usable with a minimally invasive procedure such as intravascular medical treatment system. It also relates to a method of fabricating such 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 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 conduit for creating a passage from a right atrium to a left atrium, through a mitral valve into the left ventricle, and to provide a passage from the left ventricle into the aortic valve. The conduit includes an elongate tubular member having a shaft with a proximal section and a distal loop section at a distal end of the proximal section. The distal loop section includes a proximal curve, a distal curve, a generally straight segment extending between the curves, and a distal tip. The shaft in the distal loop section curves back on itself so that proximal curve is formed by a part of the shaft that is closer along the length of the shaft to the distal tip.

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: A system for use in transseptally delivering a cardiac therapeutic device (“CTD”) to a target site in the heart, includes a CTD having an elongate flexible advancer on its distal end, and a flexible member proportioned for introduction into a vasculature and having a length to extend from the right subclavian vein, through the heart via a transseptal puncture, and to a femoral artery such that a first end of the flexible member is external to the patient at the right subclavian vein or other venous access site and a second end of the flexible member is external to the patient at the femoral artery. The flexible member has a grasper releasably engageable with the advancer.