Abstract: The invention disclosed herein includes sensors having three dimensional configurations that allow expansive “360°” sensing (i.e. sensing analyte from multiple directions) in the environments in which such sensors are disposed. Embodiments of the invention provide analyte sensors having foldable substrates adapted to produce optimized configurations of electrode elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: Method of recharging a power source such as a rechargeable lithium ion battery for an implantable medical device. Energy is received within the implantable medical device from an external energy source which energy is used to recharge the power source. At least one recharge parameter associated with recharging of the power source is monitored. Recharging is regulated by increasing a charging rate of the power source in response, at least in part, on the recharge parameter being monitored.

Abstract: A system comprises an implantable medical device and an actively deployable clip attached to the implantable medical device that restricts movement of the implantable medical device once the clip is deployed within a body of a patient. In one embodiment, the implantable medical device is a lead and a clip that includes electrically conductive portion is an electrode of the lead. The implantable medical device may be implanted proximate to any suitable tissue site within the patient, and in one embodiment, the implantable medical device is implanted proximate to an occipital nerve or a trigeminal nerve of the patient.

Abstract: A medical device system is configured to sense a physiological signal by a first device and generate a control signal by the first device in response to the physiological signal. An acoustical emitting device is controlled by the first device to emit an acoustical trigger signal in response to the control signal. A second device detects the acoustical trigger signal and delivers an automatic therapy to a patient in response to detecting the acoustical trigger signal.

Abstract: A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft assembly, a delivery sheath assembly, an outer stability tube, and a handle. The sheath assembly is slidably disposed over the inner shaft, and includes a capsule and a shaft. The capsule compressively contains the prosthesis over the inner shaft. The stability tube is slidably disposed over the delivery sheath, and includes a distal region configured to be radially expandable from a first shape having a first diameter to a second shape having a larger, second diameter. In a first delivery state, the distal region assumes the first shape, providing a low profile appropriate for traversing a patient's vasculature. In a second delivery state, the distal region has the expanded diameter second shape, sized to receive the capsule, such as when retracting the capsule to implant the prosthesis.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Abstract: A hybrid integrated circuit in a wafer level package for an implantable medical device includes one or more passive component windings formed, at least in part, along one or more routing layers of the package. The windings may be primary and secondary windings of a transformer, wherein all or part of a magnetic core thereof is embedded in a component layer of the wafer level package. If the core includes a part bonded to a surface of the package, that part of the core may be E-shaped with legs extending into the routing layers, and, in some cases, through the routing layers. Routing layers may be formed on both sides of the component layer to accommodate the transformer windings, in some instances.

Abstract: In some examples, a leadless pacing device (hereinafter, “LPD”) is configured for implantation in a ventricle of a heart of a patient, and is configured to switch between an atrio-ventricular synchronous pacing mode and an asynchronous ventricular pacing mode in response to detection of one or more sensing events, which may be, for example, undersensing events. In some examples, an LPD is configured to switch from a sensing without pacing mode to an atrio-ventricular synchronous pacing mode in response to determining, for a threshold number of cardiac cycles, a ventricular depolarization was not detected within a ventricular event detection window that begins at an atrial activation event.

Abstract: In some examples, a leadless pacing device (hereinafter, “LPD”) is configured for implantation in a ventricle of a heart of a patient, and is configured to switch between an atrio-ventricular synchronous pacing mode and an asynchronous ventricular pacing mode in response to detection of one or more sensing events, which may be, for example, undersensing events. In some examples, an LPD is configured to switch from a sensing without pacing mode to an atrio-ventricular synchronous pacing mode in response to determining, for a threshold number of cardiac cycles, a ventricular depolarization was not detected within a ventricular event detection window that begins at an atrial activation event.

Abstract: Techniques and systems for monitoring cardiac arrhythmias and delivering electrical stimulation therapy using a subcutaneous implantable cardioverter defibrillator (SICD) and a leadless pacing device (LPD) are described. For example, the SICD may detect a tachyarrhythmia within a first electrical signal from a heart and determine, based on the tachyarrhythmia, to deliver anti-tachyarrhythmia shock therapy to the patient to treat the detected arrhythmia. The LPD may receive communication from the SICD requesting the LPD deliver anti-tachycardia pacing to the heart and determine, based on a second electrical signal from the heart sensed by the LPD, whether to deliver anti-tachycardia pacing (ATP) to the heart. In this manner, the SICD and LPD may communicate to coordinate ATP and/or cardioversion/defibrillation therapy. In another example, the LPD may be configured to deliver post-shock pacing after detecting delivery of anti-tachyarrhythmia shock therapy.

Abstract: The disclosure provides a sensor including a sensor having an external surface and a cannula. The cannula comprises a substantially cylindrical wall encircling a lumen, at least one aperture and a distal end. The sensor is positioned within the lumen and the distal end of the cannula extends beyond the sensor. This configuration functions for example to stabilize chemical reactions associated with the sensor by creating a buffer zone between the sensor and the surrounding tissues at the site of implantation. In certain embodiments, the sensor can further comprise an accessory material in proximity to the external surface, wherein the accessory material modifies the biological response of a tissue that is in contact with the sensor. The sensor can also comprise anchors that keeps the sensor in contact with subcutaneous tissue of a subject upon insertion of the sensor into the body of the subject.

Abstract: Packaging for a catheter includes coiled tubing for receiving the catheter and a mounting card coupled to the coiled tubing. The windings of the coiled tubing are welded together to maintain the coiled configuration. The mounting card includes an integral support flap for reducing the risk of damage during catheter insertion and removal, an integral luer retainer for securing a catheter luer, and one or more integral tabs for attaching catheter accessories to the packaging. The integral support flap creates a contact zone which discourages grasping the packaging at a location that can potentially damage an object passing through the packaging, such as a balloon and/or stent. The integral luer retainer is configured to selectively alternate between a configuration which secures the catheter luer and configuration which allows releases the luer for easy insertion and removal of the catheter.

Abstract: An apparatus for monitoring EMG signals of a patient's laryngeal muscles includes an endotracheal tube having an exterior surface and a first location configured to be positioned at the patient's vocal folds. A first electrode is formed on the exterior surface of the endotracheal tube substantially below the first location to receive EMG signals primarily from below the vocal folds. A second electrode is formed on the exterior surface of the endotracheal tube substantially above the first location to receive EMG signals primarily from above the vocal folds. The first and second electrodes are configured to receive the EMG signals from the laryngeal muscles when the endotracheal tube is placed in a trachea of the patient.

Abstract: A method for manufacturing a stent includes forming a stent blank from a first material, the stent blank comprising a plurality of struts and a plurality of crowns, each crown connecting at least two struts, and a plurality of slots in at least some of the plurality of struts and/or the plurality of crowns, depositing a second material over outer surfaces of the struts and the crowns and in the slots to encase the stent blank in the second material, creating at least one opening through the second material, and removing the first material to form a stent comprising the second material, the stent having a continuous lumen from one end of the stent to the other end of the stent, the continuous lumen being partitioned in portions corresponding to the locations of the slots in the stent blank. The lumen may then be filled with a therapeutic substance.

Abstract: An embodiment of the invention comprises a method of monitoring cardiac electrical activity with two or more ECG devices and computing an enhanced cardiac electrical signal from the cardiac electrical signals obtained from the two or more ECG devices. Electrodes of the two or more ECG devices are positioned in a manner to provide an electrical potential difference that is large enough to give useful information about a given ECG signal. The method further includes recommending addition of a supplemental ECG device when it is determined that the one or more of the existing ECG devices are inadequate for providing cardiac electrical data that identifies a specific cardiac event.

Abstract: Methods and apparatus are provided for bilateral renal neuromodulation, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Abstract: A delivery system for delivering multiple components that is assembled using snap-fit assembly and threadless engagement of syringes and associated parts.

Abstract: A bifurcation stent system includes a pair of self-expanding stents. Each stent has a C-shaped body section having a generally semicircular cross-section along its length and an O-shaped body section having a circular cross-section along its length. The stents are deployed in vivo such that the edges of the C-shaped body sections abut each other to form a tubular scaffold in a Y-shaped formation that conforms to the bifurcation. In order to connect the stents in vivo, the C-shaped body sections are configured to include a ball and socket connection there between. The C-shaped body sections align and abut to form a tubular scaffold that extends in the main vessel of the bifurcation, while the O-shaped body sections are tubular scaffolds that extend into the respective branch legs of the bifurcation.

Abstract: A delivery system for a stent-graft is disclosed having a tip capture device and a tip release handle mechanism configured to actuate the tip capture device. The tip release handle mechanism includes a rotatable grip component and a tip release actuation component. The grip component may be rotatable in a first direction to transition a proximal stent of the stent-graft from the delivery state to a partially deployed state and rotatable in an opposite, second direction to transition the proximal stent from the partially deployed state to a fully deployed state. The grip component is operably coupled to the tip release actuation component. The delivery system further includes a shaft component operably coupled to the tip release actuation component and the tip capture device.

Abstract: An implantable medical device system includes an implantable cardioverter defibrillator (ICD) for detecting and treating ventricular tachycardia (VT). The ICD includes a sensing module for sensing a cardiac signal from selected cardiac signal sensing vectors. A control module generates morphology templates of the cardiac signals for multiple patient postures for each of the available sensing vectors. A cardiac signal received during an unknown cardiac rhythm is compared to the morphology templates without determining a current posture of the patient. The unknown cardiac rhythm is detected and classified as supraventricular tachycardia in response to the cardiac signal matching at least one of the morphology templates.