Abstract: 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 transcatheter interatrial septum excision device assembly 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 first catheter having a central lumen and a penetrating tip that permits passage of a guidewire, and a cutter attached to a second catheter having a central lumen that permits passage of the first catheter. Alternative configurations comprise a (third) catheter having a central lumen that permits passage of the aforementioned components to and from the right atrium, a tissue retention mechanism and an optional coaxial alignment mechanism.

Abstract: 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.

Abstract: A introducer is disclosed that includes an introducer sheath for introducing a catheter into a blood vessel at an insertion point, a plurality of electrodes on the introducer sheath, a flush line coupled to the introducer sheath including a proximal end and a distal end. In addition, the introducer includes an impedance assessment unit coupled to the flush line between the proximal end and the distal end and electrically coupled to the electrodes. The impedance assessment unit is configured to inject a predetermined current or voltage into a first of the plurality of electrodes and measure a resulting voltage or current, respectively, from a second of the plurality of electrodes.

Abstract: An introducer includes a sheath for introducing a catheter into a blood vessel at an insertion site and a plurality of electrodes on the sheath. The introducer also includes an impedance assessment unit connected to the electrodes. The impedance assessment unit includes a power source and a wireless transceiver and is configured to inject one of a predetermined current or voltage across a first pair of electrodes and to measure the other of the current or voltage across a second pair of electrodes. The impedance assessment unit also is configured to perform at least one: wirelessly transmit current and voltage values to an external apparatus for detection of a bleed, and compute an impedance based on the current and voltage and wirelessly transmit the computed impedance to the external apparatus for detection of the bleed.

Abstract: A system including a stent further including a plurality of conductive struts disposed within a non-conductive body. The stent is configured to exclude an aneurysm within a blood vessel of a person. In addition, the system includes a first electrode and a second electrode. Further, the system includes a controller coupled to the first electrode and second electrode. The controller is configured to measure an impedance between the first electrode and the second electrode and across tissue surrounding the stent to determine if a leak has occurred between the stent and the aneurysm.

Abstract: A introducer is disclosed that includes an introducer sheath for introducing a catheter into a blood vessel at an insertion point, a plurality of electrodes on the introducer sheath, a flush line coupled to the introducer sheath including a proximal end and a distal end. In addition, the introducer includes an impedance assessment unit coupled to the flush line between the proximal end and the distal end and electrically coupled to the electrodes. The impedance assessment unit is configured to inject a predetermined current or voltage into a first of the plurality of electrodes and measure a resulting voltage or current, respectively, from a second of the plurality of electrodes.

Abstract: An introducer comprise a sheath for introducing a catheter into a blood vessel, a plurality of electrodes on the sheath, and an impedance assessment unit provided on the sheath and connected to the electrodes. The impedance assessment unit fixes one of a current or voltage across a first pair of the electrodes and measures the other of the current or voltage across a second pair of electrodes.

Abstract: A method to detect internal bleeding complications. The method includes determining, by an impedance assessment unit, a bioimpedance value at each of a plurality of frequencies. The method further includes normalizing, by the impedance assessment unit, each bioimpedance value at each frequency to a calibration bioimpedance value at that same frequency to produce a set of normalized bioimpedance values at the plurality of frequencies. The method also includes computing a bleed indication value based on the set of normalized bioimpedance values; and generating an alarm indicative of a bleed complication based on a comparison of the bleed indication value to a threshold.

Abstract: An embodiment of a system is disclosed including an introducer usable to insert a catheter into a blood vessel of a patient. The introducer further includes a hollow sheath to receive the catheter when inserting the catheter into the blood vessel. In addition, the system includes a hollow sleeve to be disposed around the sheath. Further, the system includes a first electrode provided on the sleeve. Still further, the system includes a measuring device to be coupled to the first electrode and to a second electrode to be coupled to the first electrode through the patient's tissue. The measuring device is configured to detect a bleed in the patient's tissue by computing an impedance or a conduction velocity between the first electrode on the sleeve and the second electrode.

Abstract: An introducer comprise a sheath for introducing a catheter into a blood vessel, a plurality of electrodes on the sheath, and an impedance assessment unit provided on the sheath and connected to the electrodes. The impedance assessment unit fixes one of a current or voltage across a first pair of the electrodes and measures the other of the current or voltage across a second pair of electrodes.