Abstract: Substernal implantable cardioveter-defibrillator (ICD) systems and methods for providing substernal electrical stimulation therapy to treat malignant tachyarrhythmia, e.g., ventricular tachycardia (VT) and ventricular fibrillation (VF) are described. In one example, an implantable cardioveter-defibrillator (ICD) system includes an ICD implanted in a patient and an implantable medical electrical lead. The lead includes an elongated lead body having a proximal end and a distal portion, a connector at the proximal end of the lead body configured to couple to the ICD, and one or more electrodes along the distal portion of the elongated lead body. The distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the ICD is configured to deliver electrical stimulation to a heart of the patient using the one or more electrodes.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining a current amount of active fluid in the body of the user, determining a threshold amount of active fluid in the body of the user, and automatically altering operation of the infusion device to modify delivery of the fluid to the user based on a relationship between the current amount and the threshold amount.

Abstract: Implantable cardiac pacing systems and methods for providing substernal pacing are described. In one example, a cardiac pacing system includes a pacemaker implanted in a patient and an implantable medical electrical lead. The implantable medical electrical lead includes an elongated lead body having a proximal end and a distal portion, a connector configured to couple to the pacemaker at the proximal end of the elongated lead body, and one or more electrodes along the distal portion of the elongated lead body, wherein the distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the pacemaker is configured to deliver pacing pulses to a heart of the patient.

Abstract: An introducer sheath system including an outer layer, an inner layer, and a dilator is disclosed. The outer layer is circumferentially extending between a first longitudinal edge and a second longitudinal edge. An expandable gap is defined between the first and second longitudinal edges. The inner layer is disposed within the outer layer. The inner layer is configured to be continuously circumferentially expandable. The inner layer includes a non-extended state having a circumferential portion extending circumferentially inside the outer layer and a fold portion extending into an interior cavity of the inner layer. The inner layer includes an extended state wherein the fold portion extends at least partially circumferentially between the first and second longitudinal edges. The dilator is extendable longitudinally within the inner layer. The dilator includes a recess configured to accommodate the fold portion of the inner layer.

Abstract: The disclosure is directed to rendering visual representations of VOAs by manipulating vertices of a three-dimensional (3-D) mesh structure. In one example, a processing circuitry of a computing device may receive a 3-D mesh structure having adjustable vertices. The processing circuitry may adjust the vertices to generate an adjusted shape of the 3-D mesh structure according to an intersection between activated tissue and non-activated tissue defined by one or more stimulation parameter values.

Abstract: Various embodiments of a sealed package and a method of forming such package are disclosed. The package includes a housing, a substrate hermetically sealed to the housing, and a light source disposed on a first major surface of the substrate. The package further includes a detector disposed on the first major surface of the substrate and having a detecting surface. The package also includes a masking layer disposed on at least one of the first major surface and a second major surface of the substrate, where the masking layer includes a first aperture aligned with an emission axis of the light source in a direction orthogonal to the first major surface of the substrate. The masking layer further includes a second aperture aligned with a detection axis of the detector in a direction orthogonal to the first major surface of the substrate.

Abstract: A medical device system, such as an extra-cardiovascular implantable cardioverter defibrillator ICD, senses R-waves from a first cardiac electrical signal by a first sensing channel and stores a time segment of a second cardiac electrical signal in response to each sensed R-wave. The medical device system determines a morphology parameter correlated to signal noise from time segments of the second cardiac electrical signal, detects a noisy signal segment based on the signal morphology parameter; and withholds detection of a tachyarrhythmia episode in response to detecting a threshold number of noisy signal segments.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver a bolus amount of fluid influencing a physiological condition in a body of a user involves identifying, based on measurement values for the physiological condition, a residual value for the physiological condition resulting from the bolus amount of the fluid and determining an updated ratio for a subsequent bolus by adjusting an initial ratio influencing the bolus amount to compensate for the residual value. The updated ratio may be stored in a data storage element for use in determining a subsequent bolus amount in lieu of the initial ratio value.

Abstract: Disclosed is a method and system for navigating an instrument relative to a patient that can be near a field distorting feature. A localizer can generate an electromagnetic field that is sensed by a tracking device to determine a location of the tracking device with the sensed electromagnetic field. The system and related method can assist in determining whether a navigation field is distorted near a tracking device of the instrument.

Abstract: In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

Abstract: Disclosed is a surgical navigation system for tracking an instrument relative to a patient. The system can track a portion of the patient, an instrument, and/or both relative to image data, a coordinate system, an atlas, a morphed atlas, or combinations thereof. The system can include a tracking device on the instrument to provide six degree of freedom information regarding the location of the instrument.

Abstract: An example device for detecting one or more parameters of a cardiac signal is disclosed herein. The device includes one or more electrodes and sensing circuitry configured to sense a cardiac signal via the one or more electrodes. The device further includes processing circuitry configured to determine a representative signal based on the cardiac signal, the representative signal having a single polarity, and determine an end of a T-wave of the cardiac signal based on an area under the representative signal.

Abstract: A catheter includes a proximal shaft, a distal shaft, a pressure sensor, and at least one pressure sensor wire. The proximal shaft is substantially C-shaped such that in cross-section, the proximal shaft includes a first circumferential end, a second circumferential end, and a gap between the first circumferential and circumferential end. The proximal shaft defines a groove configured to receive a guidewire therein. The distal shaft is coupled to the proximal shaft and defines a guidewire lumen therein. The pressure sensor is coupled to the distal shaft. The pressure sensor wire is operably connected to the pressure sensor. A proximal portion of the pressure sensor wire is disposed within a proximal shaft wall of the proximal shaft and a distal portion of the pressure sensor wire is disposed within a distal shaft wall of the distal shaft.

Abstract: A pump for delivering a fluid includes a pump housing that defines at least one reservoir having a circumferentially open first end, a circumferentially closed second end and a chamber to receive the fluid. The pump includes a plunger assembly having at least one plunger arm and a cannula fluidly coupled to the plunger arm to dispense the fluid from the pump. The plunger arm is receivable within the first end of the reservoir, and the at least one plunger arm defining an internal conduit to receive the fluid from the at least one fluid reservoir. The internal conduit is fluidly coupled to the cannula. The plunger assembly is movable in a first direction relative to the pump housing to advance the plunger arm within the fluid reservoir to dispense the fluid from the fluid reservoir out of the pump via the cannula.

Abstract: The techniques of this disclosure generally relate to an assembly including a docking graft. The docking graft includes a main graft defining a main lumen, a first internal lumen within the main lumen, a second internal lumen within the main lumen, and a main docking lumen within the main lumen. The first and second internal lumens are configured to receive first and second bridging stent graft therein. The main docking lumen is configured to receive a tube graft therein. The first internal lumen, the second internal lumen, and the main docking lumen being parallel to one another and extending an entire length of the docking graft when the docking graft is in a relaxed configuration. The docking graft forms the foundation, or anchor device, for attachment of the first bridging stent graft, the second bridging stent graft, and the tube graft within the aorta.

Abstract: The neural interface system of the preferred embodiments includes an electrode array having a plurality of electrode sites and a carrier that supports the electrode array. The electrode array is coupled to the carrier such that the electrode sites are arranged both circumferentially around the carrier and axially along the carrier. A group of the electrode sites may be simultaneously activated to create an activation pattern. The system of the preferred embodiment is preferably designed for deep brain stimulation, and, more specifically, for deep brain stimulation with fine electrode site positioning, selectivity, tunability, and precise activation patterning. The system of the preferred embodiments, however, may be alternatively used in any suitable environment (such as the spinal cord, peripheral nerve, muscle, or any other suitable anatomical location) and for any suitable reason.

Abstract: A method and system is disclosed for acquiring image data of a subject. The image data can be collected with an imaging system with a selected filtering characteristic. The image data can be reconstructed using reconstruction techniques.

Abstract: Embodiments of the invention provide constellations of elements useful in glucose sensors as well as methods for making and using such glucose sensors. In typical embodiments of the invention, the sensor is a glucose sensor for diabetics that comprises an analyte sensing membrane formed from a layered stack of material that includes a cellobiose dehydrogenase enzyme composition disposed over an electrode that is further coated with an analyte modulating layer formed from a cellulose acetate composition.