Abstract: A capacitor for an implantable medical device is presented. The capacitor includes an anode, a cathode, a separator therebetween, and an electrolyte over the anode, cathode, and separator. The electrolyte includes ingredients comprising acetic acid, ammonium acetate, phosphoric acid, and tetraethylene glycol dimethyl ether. The capacitor has an operating voltage ninety percent or greater of its formation voltage.

Abstract: A sinus dilation instrument useful with a navigation system and including a handle, a rigid probe, a balloon, and an identifier device. The probe extends from the handle, forms a curved segment, and carries the balloon. The identifier device is programmed to generate a signal indicative of an instrument identification assigned to the instrument, and is a frontal, maxillary or sphenoid sinus instrument. The signal is formatted to be recognized by an IGS. Once connected, the IGS recognizes the instrument and can retrieve information indicative of a spatial location of the balloon, for example via an instrument tracking device. A surgeon can “plug and play” the sinus dilation instrument with the IGS to perform a procedure.

Abstract: The present disclosure describes an implantable medical device utilizing an event-triggered prognostic indicator. The disclosure describes techniques for prognostics and management of implantable medical systems to facilitate continuity of performance of sensing and therapy delivery functions by providing adequate response time to handle emerging issues prior to adverse clinical impacts. In accordance with the present disclosure, event-triggered prognostic indicators facilitate the identification of potential device conditions.

Abstract: An injectable device for use in a subcutaneous physiological monitoring of a patient includes a body, a plurality of sensors, and a monitoring unit. The plurality of sensors provide an indication of at least one physiological event of a patient, wherein the plurality of sensors includes two or more electrodes in contact with tissue of the patient. The monitoring unit is located within the body and is coupled to the plurality of sensors and configured to monitor a physiologic signal of the patient using the electrodes, wherein the physiologic signal includes an impedance signal related to hydration of tissue of the patient and wherein the monitoring unit is further configured to, based at least in part on the impedance signal measured from the patient, detect an impending cardiac decompensation of the patient.

Abstract: A fixation band for affixing a prosthetic heart valve to tissue having proximal and distal annular portions positionable relative to one another, the proximal and distal annular portions each having a proximal and distal sides, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and a prosthetic heart valve being attachable to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device operative between the proximal and distal annular portions for selectively positioning the proximal and distal annular members toward one another for compressing the staples therebetween and deploying the staples into tissue so as to affix the prosthetic heart valve to tissue.

Abstract: A medical device and method are provided for mapping and therapeutic treatment, which may include a source of cryogenic fluid, a balloon or other expandable member in fluid communication with the source of cryogenic fluid, and a plurality of electrodes on the expandable member. The medical device may include a catheter or elongate body, and the electrodes may take the form of longitudinal strips. The expandable member may take the form of an inner and outer balloon, and the electrodes may be on the outer balloon. The electrodes may be on a proximal or distal conical portion of the expandable member, or both. An electrical insulator may be provided covering a portion of the electrodes.

Abstract: A stepped catheter comprising a distal portion of smaller diameter than a proximal portion, wherein the distal portion defines a flow aperture configured to deliver fluid passing through the catheter from the proximal portion to the flow aperture. The catheter may include a flow restrictor located within a lumen of the catheter at or near the flow aperture. A filter element may also be included and located within the lumen of the catheter at a location upstream of the flow restrictor.

Abstract: Systems and methods for providing a cardiac stimulus device lead having fault tolerance and fault isolation are disclosed. A medical electrical lead is provided according to one aspect. According to one embodiment, the lead includes a first conductor and a second conductor for transmitting an electrical pulse from a pulse generator. The lead further includes a switching mechanism, a first electrode, and a lead assessment circuit. The switching mechanism selectively couples the first conductor to the first electrode. The first electrode is decoupled during a test phase and the switching mechanism directly couples the first conductor to the second conductor. The lead assessment circuit processes a signal associated with the electrical properties of the lead to determine whether the lead is exhibiting a lead related condition.

Abstract: Aspects of this disclosure describe measuring intervals within a cardiac cycle to, for example, determine whether a patient is a candidate for cardiac therapy initiation or modification. The intervals may be measured in response to a trigger identifying a physiological event. The intervals and an identification of the physiological event may be stored. A physician or clinician may determine whether the patient is a candidate for cardiac therapy modification based on the measured intervals.

Abstract: A system and method are provided for the detection of a heart-related condition by obtaining information in real-time when a condition is initially identified as potentially occurring. A physical exercise and recovery episode is initially detected from physiological signals sensed in a patient. Once detected, a HR-ST segment deviation hysteresis analysis is performed in an implantable medical device (IMD) from certain physiological signals over portions of the exercise and recovery episode to identify the probability that a certain condition is occurring. Once a desired level of probability that the heart-related condition has been detected exists, data utilized in the analysis can be transmitted remotely for clinical review and confirmation of the device's detection of the condition. The patient may be prompted to answer questions related to symptoms that patient is experiencing through an input device in order further confirm the probability that the condition is occurring in the patient.

Abstract: An implantable medical device includes a low-power circuit, a high-power circuit, and a multi-cell power source. The implantable medical device delivers stimulation therapy to cardiac tissue. The cardioversion energy is delivered across through electrodes that are coupled to terminals of the high-power circuit. A protection circuit for protecting the low-voltage circuit components from high voltage pulses includes a first segment coupled to a first of the electrodes and a second segment coupled to a second of the electrodes, the components of the low-voltage circuit being coupled to the transthoracic protection circuit portion, and a reference potential corresponding to a ground potential, wherein the first and second segments of the transthoracic protection circuit portion are coupled to the reference potential in a parallel configuration.

Abstract: Delivery tools of interventional medical systems facilitate deployment of relatively compact implantable medical devices that include extensions, for example, cardiac pacing devices that include an extension for atrial sensing, wherein an entirety of the device is contained within the delivery tool while a distal-most portion of the tool is navigated to a target implant site. Once at the implant site, a device fixation member may be exposed out from a distal opening of the tool, for initial deployment, while the extension remains contained within the delivery tool. The tool includes a grasping mechanism, operable, within and without a lumen of the tool, to alternately grip and release the device extension, for example, to position a distal end of the extension after the tool has been withdrawn from over an entirety of the initially deployed device.

Abstract: Methods and apparatus for anchoring an elongate medical device within a body portal, for example, a stimulation lead in a cranial burr hole, employ a securing element attached to a plate member, which may be held over a body portal by a base ring. The securing element includes a spring member and an engagement surface; a retaining member holds the engagement surface, spaced apart from a side of a slot of the plate member, in an open position, against a bias of the spring member. In the open position, the device may be received between the engagement surface and the side of the slot, through an opening of the slot. Disengaging the retaining member releases a moveable portion of the spring member to move the engagement surface toward the side of the slot and into a closed position, at which the inserted device is anchored. The anchored device may be routed through one of a plurality of base ring channels.

Abstract: Embodiments of the invention provide electrochemical analyte sensors having elements designed to modulate their electrochemical reactions as well as methods for making and using such sensors.

Abstract: Miniature electrodes and electrochemical cells are disclosed. Such electrodes are made from forming an electrode mixture onto a current collector and distal end of a feedthrough pin such that the current collector and distal end of the feedthrough pin is encapsulated. The methods and electrode assemblies disclosed herein allow such electrode assemblies to be made free from the step of directly attaching a formed electrode to a feedthrough pin and thus simplifying assembly and decreasing size.

Abstract: A medical monitoring device for monitoring electrical signals from the body of a subject is described. The medical monitoring device monitors electrical signals originating from a cardiac cycle of the subject and associates each cardiac cycle with a time index. The medical monitoring device applies a forward computational procedure to generate a risk score indicative of hyperkalemia, hypokalemia or arrhythmia of the subject. The medical monitoring device can adjust the forward computational procedure based upon clinical data obtained from the subject.

Abstract: An implantable medical device is configured to detect saturation events from a cardiac electrical signal, detect a tachyarrhythmia based at least in part on the cardiac electrical signal, responsive to detecting the tachyarrhythmia, and compare the detected saturation events to lead issue criteria. If the detected saturation events satisfy lead issue criteria, a therapy for treating the tachyarrhythmia is withheld by the implantable medical device.

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

Abstract: A medical method, device, and system are provided, including advancing an ablation element of a medical device into contact with tissue to be treated, selecting a power level of energy to ablate the tissue, delivering energy at the selected power level to the ablation element, determining whether the ablation element is in continuous contact with the tissue, and reducing the selected power level when the ablation element ceases to be in continuous contact with the tissue.