Abstract: A method for loading a prosthesis onto a delivery system includes passing a distal end of a delivery system through a first open end and a second open end of a reducing member. The method includes seating the prosthesis in a piston member of a cap by contacting a first end of the prosthesis with a first surface of the piston member and by contacting a portion of a side of the prosthesis with at least one side wall extending from the periphery of the first surface. Additionally, the method includes inserting the distal end of the delivery system into a center of the prosthesis and an opening defined by the piston member. And the method includes advancing the cap towards a reducing member such that a portion of the prosthesis seated in the piston member advances along an inner surface of the conical wall of the reducing member.

Abstract: A valve prosthesis comprises a valve fixation device that comprises a plurality of struts that run in a direction substantially parallel to the longitudinal axis; a first circumferential row of cells coupled to the plurality of struts; and a second circumferential row of cells coupled to the plurality of struts. The valve fixation device is compressible to a compressed state for delivery to an implantation site, and expandable to an expanded state for deployment at the implantation site. The plurality of struts are substantially rigid such that the plurality of struts do not change dimensions between the compressed state and the expanded state. The valve prosthesis also comprises a valve comprising a plurality of leaflets and a plurality of commissures. The valve is coupled to the valve fixation device such that the plurality of commissures are radially aligned with respective struts of the plurality of struts.

Abstract: Nasal or sinus site may be treated with a ready-to-use paste having a high concentration of a water-soluble chitosan, an osmolality reducing agent in a phosphate-containing solution. The paste forms at room temperature, has a pH of at least 4 and the osmolality reducing agent does not crosslink with the water-soluble chitosan. The paste provides stenting and adheres to the nasal or sinus site and has a residence time of at least 1 day.

Abstract: This disclosure describes a chopper stabilized instrumentation amplifier. The amplifier is configured to achieve stable measurements at low frequency with very low power consumption. The instrumentation amplifier uses a differential architecture and a mixer amplifier to substantially eliminate noise and offset from an output signal produced by the amplifier. Dynamic limitations, i.e., glitching, that result from chopper stabilization at low power are substantially eliminated through a combination of chopping at low impedance nodes within the mixer amplifier and feedback. The signal path of the amplifier operates as a continuous time system, providing minimal aliasing of noise or external signals entering the signal pathway at the chop frequency or its harmonics. The amplifier can be used in a low power system, such as an implantable medical device, to provide a stable, low-noise output signal.

Abstract: A heart valve prosthesis configured for placement at a mitral valve in the heart is disclosed that includes a stent-like support structure for supporting a prosthetic mitral valve. The support structure is configured to have a low ventricular profile with only a short length thereof protruding into the left ventricle when deployed in vivo. The support structure includes an upstream section that is outwardly expandable to sit against the atrial wall so as to at least partially anchor the prosthesis therein and a downstream section to which the prosthetic mitral valve is coupled that extends between the left atria and ventricle through the native mitral valve. The low-ventricular profile of the prosthesis is achieved by shaping the support structure such that the downstream section extends within and overlaps with the upstream section at given regions around the circumference of the support structure in an expanded configuration.

Abstract: An attachment mechanism for coupling a stent to a delivery system is disclosed. The delivery system includes an inner shaft assembly. The attachment mechanism is configured to pivot relative to the inner shaft assembly of the delivery system in order to release the stent from the delivery system upon retraction of a delivery sheath capsule compressively containing the stent.

Abstract: A method of detecting a fault condition within an implantable medical pump comprises delivering therapeutic fluid using a medical pump comprising an actuation mechanism configured to be energized to provide a pump stroke, detecting a property associated with energizing the actuation mechanism, and determining whether the property associated with energizing the actuation mechanism indicates that a fault condition exists with the medical pump.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous wire structure, a liner, and a jacket.

Abstract: Methods for treating polycystic kidney disease with therapeutic renal neuromodulation and associated systems and methods are disclosed herein. One aspect of the present technology is directed to methods that at least partially inhibit sympathetic neural activity in nerves proximate a renal artery of a kidney of a patient. One or more measurable physiological parameter corresponding to the polycystic kidney disease can thereby be reduced. Moreover, central sympathetic drive in the patient can be reduced in a manner that treats the patient for the polycystic kidney disease. Renal sympathetic nerve activity can be modulated along the afferent and/or efferent pathway. The modulation can be achieved, for example, using an intravascularly positioned catheter carrying a neuromodulation assembly, e.g., a neuromodulation assembly configured to cryotherapeutically cool the renal nerve or to deliver an energy field to the renal nerve.

Abstract: The disclosure relates generally to wireless communication with an implantable medical device. An implantable medical device (IMD) may initiate the establishment of a communication session by sending a wakeup communication to an external device with which the IMD desires to communicate. The external device may operate in low power state (sometimes referred to as a sleep state or a low current state) in which the external device occasionally powers up telemetry circuitry to monitor for the wakeup communication from the IMD. Upon receiving the wakeup communication, the external device transitions from the low power state to a high power state to establish the communication session with the IMD. Operating the external device in the low power state when no communication session is established reduces the amount of power consumed by the external device when no telemetry is occurring, thus enabling the external device to be powered by a battery.

Abstract: Electrical stimulation therapy may be delivered to a patient to selectively and independently address different conditions of a pelvic floor disorder of the patient. The conditions of a pelvic floor disorder may include, for example, a lower urinary tract dysfunction (e.g., urinary or fecal incontinence) and sexual dysfunction (e.g., an impaired sexual reflex response to a sexual stimulus). In some examples, a system is configured to selectively deliver a first electrical stimulation therapy that is configured to elicit an inhibitory physiological response from the patient related to voiding, a second electrical stimulation therapy that is configured to improve a sexual reflex response of the patient to a sexual stimulus, and a third electrical stimulation therapy that is configured to both elicit the inhibitory physiological response from the patient related to voiding and increase a sexual response of the patient to a sexual stimulus.

Abstract: Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for extravascular delivery of pulsed electric fields to achieve such neuromodulation.

Abstract: An implantable cardiac monitoring device includes first and second arms, pivotably attached to one another; electronic circuitry and an associated power source of the device are hermetically sealed in a housing formed by one of the arms. A first electrode is carried by the first arm, a second electrode by the second arm, and a third electrode by one of the two arms. The device further includes a tether element, preferably a strut, pivotably attached between the arms and movable between a folded state and an expanded state. When the strut is in the folded state, the device, in a relatively compact form, can be inserted through a relatively small incision and into subcutaneous tissue, after which, the strut is moved to the expanded state where ends of the arms are spaced apart from one another and supported by the strut, and the three electrodes form dual sensing vectors.

Abstract: A programmer allows a clinician to identify combinations of electrodes from within an electrode set implanted in a patient that enable delivery of desirable neurostimulation therapy by an implantable medical device. The programmer executes an electrode combination search algorithm to select combinations of electrodes to test in a non-random order. According to algorithms consistent with the invention, the programmer may first identify a position of a first cathode for subsequent combinations, and then select electrodes from the set to test with the first cathode as anodes or additional cathodes based on the proximity of the electrodes to the first cathode. The programmer may store information for each combination tested, and the information may facilitate the identification of desirable electrode combinations by the clinician. The clinician may create neurostimulation therapy programs that include identified desirable program combinations.

Abstract: A surgical cutting instrument including an outer tube having a bearing sleeve disposed within a lumen thereof, along with an inner wire assembly extending through the outer tube and the bearing sleeve. A cutting tip is connected to the inner wire assembly distal the outer tube. Conversely, a coupling chuck is connected to a proximal section of the inner wire assembly, with a housing maintaining the outer tube and the coupling chuck. When mounted to a motor, the inner wire assembly is rotated to effectuate a surgical cutting procedure at the cutting tip, with the bearing sleeve supporting the inner wire assembly relative to the outer tube during rotation.

Abstract: The disclosure describes an elongated housing, e.g., a catheter, configured to be inserted into a lumen of a patient to diagnose or treat a patient. The elongated housing includes a scope channel that accepts a cystoscope and a viewing window at the distal end of the elongated housing. The user may use the cystoscope to view tissue adjacent to the viewing window. The viewing window may take up at least 10 percent of the length of the elongated housing to allow the user to identify a large area of tissue in the lumen without moving the elongated housing with respect to the tissue. Once the user identifies the target tissue, the user may position the elongated housing graduations on the viewing window and the proximal end of the elongated housing. An ablation needle electrode may be extended into the target tissue to deliver ablation therapy to the target tissue.

Abstract: Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.

Abstract: Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a direct heating element configured to be delivered to a renal blood vessel. The treatment device is selectively transformable between a delivery or low-profile state and a deployed state. The direct heating element is housed within an occlusion element which is sized and shaped so that the direct heating element contacts an interior wall of the occlusion element, an outer wall of which is simultaneously in contact with the inner wall of a renal blood vessel when the treatment assembly is in the deployed state. The direct heating element is configured to apply thermal energy to heat neural fibers that contribute to renal function.

Abstract: A device that may be used as an automatic voiding diary detects urinary and/or fecal voiding events and records voiding information indicative of the voiding events without the need for significant patient interaction. The device includes a microphone that captures internal and/or external sounds that are associated with voiding events and generates an electrical signal based the sounds. The device processes the electrical signal to determine whether the signal is indicative of the occurrence of a voiding event (i.e., the device detects voiding events) by, for example, comparing the electrical signal to a signal template or comparing an amplitude of the signal to a threshold. The device may be a device implanted within the patient or an external device that can be carried or attached to the body or clothing of the patient.

Abstract: Embodiments include heart monitoring systems, apparatus, and methods adapted to detect myocardial ischemia. An apparatus includes at least one first-tier sensor/analyzer adapted to sense a first input related to cardiac function, and to produce a first-tier trigger signal when the first input indicates myocardial ischemia. In an embodiment, a first-tier sensor/analyzer includes an ECG sensor/analyzer. In another embodiment, a first-tier sensor/analyzer includes a patient activator. An apparatus further includes at least one second-tier sensor/analyzer adapted to sense a second input related to cardiac function, and to produce a second-tier trigger signal when the second input indicates myocardial ischemia. In an embodiment, a second-tier sensor-analyzer includes a heart sound sensor/analyzer. A triggering element is adapted to produce a response-invoking signal in response to the first-tier trigger signal and the second-tier trigger signal.