Abstract: The disclosure describes methods and devices for providing early indicators of a lead-related condition in a medical electrical lead. Among other things, the methods and devices will detect, obtain, or provide indicators of static or intermittent disruptions in a conductive pathway of the lead based on changes in conductive continuity properties of a medical electrical lead. The conductive behaviors and properties will be managed to facilitate signal stability and fidelity. In some embodiments, the methods and devices may include functions to enable one or more of monitoring a lead's conductive pathway, detecting static and transient behaviors of the conductive pathway, stabilizing the monitored pathway, reconfiguring the pathway, and providing lead-related condition data to an associated implantable medical device. The early indicators may be generated in a real-time, continuous manner to provide early detection and notification of lead degradation.

Abstract: In general, the disclosure describes techniques for detecting lead related conditions, such as lead fractures or other lead integrity issues. As described herein, delivering an electrical signal through selected electrodes may result in, reveal, or amplify noise if a lead related condition is present. A processor may detect electrical noise indicative of the lead related condition subsequent to the delivery of the electrical signal, and identify a lead related condition in response to detecting the noise.

Abstract: An expiration time of a therapeutic fluid delivered by an implantable fluid delivery device is employed to calculate a fill volume and determine a refill interval for the fluid. The expiration time of the therapeutic fluid may be based on or dictated by a stability time set by the manufacturer of the therapeutic fluid, a clinician treating a patient to whom the fluid is to be delivered, the manufacturer of the device delivering the fluid, or combinations thereof.

Abstract: The present invention is directed to an automated high voltage (HV) defibrillator tester system that is able to asynchronously test a plurality of devices (e.g. defibrillators etc.). The HV defibrillator tester system includes a first field programmable gate array (FPGA) connected to a set of tester modules. Each tester module of tester modules is individually associated with a single communication port of the first FPGA.

Abstract: The present invention is a packaged system that includes a housing to protect a treatment device mounted on a distal portion of a catheter. The housing holds the device suspended such that there is little or no contact between the housing and the device, protecting the device from physical damage and also from exchange of chemical components between the device and the packaging materials, which can occur when a device remains in contact with packaging materials over an extended period of time. A port in the housing allows a controlled environment, for example a vacuum, to be maintained within the housing. A hollow stylet inserted into the distal end of the catheter before the catheter is placed in the housing precludes compression of the catheter and provides an injection port through which the catheter may be flushed with a fluid prior to use, eliminating the need for a separate flushing cannula.

Abstract: An apparatus for oxygenating blood including a housing and an oxygenator bundle. The housing defines a primary chamber, a blood inlet port open to the primary chamber, and a blood outlet region. The outlet region includes a blood outlet port, an outlet chamber open to the outlet port, and a partition. The partition establishes spaced apart, first and second passageways from the primary chamber to the outlet chamber. The oxygenator bundle is disposed within the primary chamber. A blood flow path is formed from the blood inlet port, through the oxygenator bundle and to the blood outlet port, and includes first and second outlet flow paths within the outlet chamber via the first and second passageways, respectively. The first and second outlet blood flow paths merge at the blood outlet port. A dual port blood outlet is created, increasing mixing of blood immediately upstream of the outlet port.

Abstract: A system for treating mitral valve regurgitation includes a tensioning device having a plurality of helical anchors and a tensioning filament. One embodiment of the invention includes a method for attaching a tensioning device to the annulus of a mitral valve in a trans-leaflet configuration, and applying a tension force to the tension filament in order to exert force vectors on the annulus, thereby reshaping the mitral valve annulus so that the coaption of the anterior and posterior leaflets of the mitral is improved during ventricular contraction.

Abstract: Methods and apparatus for storing data records associated with a medical monitoring event in a data structure. These include initiating loop recording in an implantable medical device upon determination of a neurological event, wherein loop recording comprises storing a data record of a plurality of data records in a data structure, the plurality of data records representing information about determined neurological events. Methods and apparatus can further include determining a priority index for the plurality of data records based on severity levels of the determined neurological events and replacing older data records of the plurality of data records on the data structure with new data records according to the priority index, wherein the new data records selectively replace those data records in the data structure having the lowest associated priority index.

Abstract: A method includes depositing a thin film on a first surface of a first substrate and moving a second surface of a second substrate into contact with the thin film such that the thin film is located between the first and second surfaces. The method further includes generating electromagnetic (EM) radiation of a first wavelength, the first wavelength selected such that the thin film absorbs EM radiation at the first wavelength. Additionally, the method includes directing the EM radiation through one of the first and second substrates and onto a region of the thin film until the first and second substrates are fused in the region.

Abstract: An automated reservoir filling system for a portable medical device is disclosed. The system includes a vial sealed by a septum partially filled with a liquid and a gas occupying a headspace. The system further includes a reservoir with a volume defined between a reservoir septum and a plunger head. The plunger head is coupled to a plunger arm which is further coupled to a drive system. Further included is a transfer system with a vial end that pierces the vial septum and remains in contact with the liquid, and a reservoir end that pierces the reservoir septum and remains in the reservoir volume. A controller coupled to the drive system to actuates the drive system automatically drawing fluid from the vial to the reservoir through the degas system.

Abstract: The disclosure is directed to a user interface with a menu that facilitates stimulation therapy programming. The user interface displays a representation of the electrical leads implanted in the patient and at least one menu with icons that the user can use to adjust the stimulation therapy. The user may drag one or more field shapes from a field shape selection menu onto the desired location relative to the electrical leads. A manipulation tool menu may also allow the user to adjust the field shapes placed on the electrical leads, which represent the stimulation region. The programmer that includes the user interface then generates electrical stimulation parameter values for the stimulator to deliver stimulation according to the field shapes or field shape groups defined/located by the user. The field shapes may represent different types of stimulation representations, such as current density, activation functions, and neuron models.

Abstract: A physiological signal of a patient is sensed with sense electrodes symmetrically arranged relative to a stimulation electrode. In some examples, a member includes a plurality of relatively small electrodes that are configured to function as both sense and stimulation electrodes. One or more of the electrodes may be selected as stimulation electrodes and two or more different electrodes of the member may be selected as sense electrodes that are symmetrically arranged relative to the one or more selected stimulation electrodes. In some examples, a member includes a plurality of levels of segmented sense electrodes and a plurality of levels of stimulation electrodes. The levels of sense electrodes are arranged such that each level of stimulation electrodes is adjacent at least two levels of sense electrodes symmetrically arranged relative to the level of stimulation electrodes.

Abstract: A medical device communication system includes a receiver adapted to receive radio frequency (RF) signals and configured to operate in a first mode to poll for an RF signal for a first time interval to detect an element of a valid input signal during the first time interval. In response to detecting the element of a valid input signal in the first time interval, the receiver operates in a second mode to poll for the RF signal for a second time interval to analyze the RF signal over the second time interval to detect a valid modulation of the RF signal. In response to detecting a valid modulation of the RF signal during the second time interval, the receiver is enabled to establish a communication session with a transmitting device.

Abstract: A sensing apparatus may include a substrate having a first side for a sensing element and a second side for electronics, the substrate may have a at least one via from the first side of the substrate to the second side of the substrate, the at least one via may be hermetically sealed with an optically transmissive material.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: An implantable medical device monitors ST segment data collected from EGM. ST trends are established and monitored over time. The IMD is able to discern whether the data indicate supply ischemia, demand ischemia, or other physiological causes. The IMD is then able to provide appropriate information and alerts.

Abstract: An adjustable annuloplasty device holder has a member having an anterior segment and a posterior segment that are shaped to hold an anterior portion and a posterior portion, respectively, of an annuloplasty device. The anterior segment has a given size and the posterior segment is adjustable in order to change the anterior-posterior ratio of the holder to accommodate annuloplasty devices having a plurality of different anterior-posterior ratios.

Abstract: In some examples, a primary battery comprising a cathode comprising at least one active material and at least one of a metal oxide and metal fluoride, wherein the active material exhibits a first discharge capacity and the at least one of metal oxide and metal fluoride exhibits a second discharge capacity at a voltage lower than the first discharge capacity; an anode comprising a metal as an electron source; and an electrolyte between the cathode and anode. The metal reacts with the electrolyte below a third discharge capacity at a voltage lower than the second discharge capacity to form a gas, where the metal reacts with the active material at the first discharge capacity, and, following the consumption of the active material of the cathode, the metal reacts with the at least one of metal oxide and metal fluoride of the cathode prior to reacting with the electrolyte below the third discharge capacity.

Abstract: Methods for delivering a prosthetic heart valve include advancing a delivery catheter containing the prosthetic heart valve to a deployment location at a native heart valve, advancing an inner core movably coupled to a restraining sheath of the delivery catheter to expose a first end of the prosthetic heart valve, and advancing the inner core and the restraining sheath to expose a second end of the prosthetic heart valve. The delivery catheter can include a distal flange located at a distal end of an outer core of the catheter body, configured to restrict distal longitudinal displacement of the prosthetic heart valve, and a retaining structure located proximally from the distal flange along the outer core of the catheter body, configured to restrict proximal longitudinal displacement of the prosthetic heart valve.

Abstract: Methods for delivering a medical device loaded onto a catheter include positioning a first tube relative to a second concentric tube such that sheathing material having a first end affixed to the first tube and a second end affixed to the second tube forms an inner layer and an outer layer having at least one inversion point, such that no portion of the first tube is between any portion of the inner and outer layers of the sheathing material. Upon positioning the catheter at a desired target site, the first tube can be moved relative to the second tube so that the inversion point moves to expose the medical device, thereby permitting expansion of the medical device at the target site.