A device for precise control of blood flow across an interatrial septum is provided. The device includes a sheath having a first set of openings disposed within a first atrium while a second set of openings is disposed within a second atrium. An actuator may be actuated to move an inner sleeve within the sheath to modify the area of second set of openings to permit blood to flow between the first and second atria responsive to a pressure gradient across the interatrial septum via the first and second openings at a blood flow rate corresponding with the area of the second set of openings of the sheath. In addition, the patient's hemodynamics responsive to the shunting of blood across the interatrial septum at each incremental area of the opening may be monitored for selecting a specific sized implantable interatrial shunt for the patient.

A transseptal punch with a steering mechanism within the punch, such that punch can be steered and deflected within a guide catheter during delivery, to avoid skiving of the guide catheter inner wall by passage of the punch tip through the guide catheter. The punch can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature or to permit optimal approach or access to a puncture site. The punch is able to create holes in the atrial septum of the heart or other structures and is easier to use than punches that are pre-curved near their distal tip since it is easier to advance through accessory catheters.

A transseptal insertion device includes a sheath that defines a lumen and has a distal end that is closest to the cardiac interatrial septum of a patient, at least one balloon connected to the distal end of the sheath, in which the at least one balloon, when inflated, overhangs and extends past the distal end of the sheath, preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum, and a dilator positioned within the lumen. The dilator has a distal end and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument. The at least one balloon is connected to at least one hypotube through which the at least one balloon is inflated or deflated by gas or fluid flowing through the at least one hypotube.

The present disclosure relates to a device assembly and a method for treating heart failure by normalizing elevated blood pressure in the left atrium of a heart of a mammal Disclosed herein is a RF energy-based transcatheter interatrial septum excision device configured to create a sized interatrial aperture between the right and left atria of a heart for the relief of elevated left atrial pressure. The device assembly comprises a delivery catheter, a tissue stabilizer attached to a tissue stabilizer catheter, a tissue cutter attached to a tissue cutter catheter, a remotely located RF generator connected to an RF cathode and anode of the device assembly.

An interatrial shunt device includes an opening main body. The opening main body includes an opening component for penetrating the atrial septum and expanding the atrial septal tissue to form an opening. An ablation mechanism that may damage the tissue activity at the opening of the atrial septum is disposed where the opening component contacts the atrial septal tissue. An interatrial shunt system includes the interatrial shunt device, a control mechanism of the interatrial shunt device, and an ablation power source.

An interatrial shunt device includes an opening main body. The opening main body includes an opening component for penetrating the atrial septum and expanding the atrial septal tissue to form an opening. An ablation mechanism that may damage the tissue activity at the opening of the atrial septum is disposed where the opening component contacts the atrial septal tissue. An interatrial shunt system includes the interatrial shunt device, a control mechanism of the interatrial shunt device, and an ablation power source.

A septostomy device 10 with a cutting structure or means 140 and tissue capture mechanisms 240, 250 is disclosed, along with a medical procedure for using the device. The system 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.

A transseptal needle or punch is described wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle includes a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use with an introducer which can also include side windows.

A medical device that can perform plural actions by a single operation and is excellent in operability includes a catheter that is insertable into a living body, a sandwiching portion and a needle positioning portion that are disposed in the catheter so as to be able to advance and retract. A slide portion is operable such that the sandwiching portion and the needle positioning portion advance and retract simultaneously, and an action switching portion causes the sandwiching portion to advance and retract in tandem with or independently of the slide portion by the advance and retraction of the slide portion.

An electrosurgical device comprises an electrically conductive elongate member for traversing body vasculature defining a hollow lumen with one or more apertures at or near its distal end, wherein electrical energy can flow through the wall of the elongate member; and an energy delivery device in electrical communication with the elongate member is located distal to the end of the elongate member. The energy delivery device includes an electrode for delivering energy. Methods of using the electrosurgical device include cutting through occlusions and creating transseptal punctures.