Abstract: A system and process for providing safety limits on the delivery of an infusion formulation by an infusion pump system in response to a sensed biological state. The safety limits may comprise user-initiated event signals corresponding to events that may significantly affect the biological state. The safety limits may further comprise user-initiated event ranking signals for respective events which specify a degree, quantity, or measure for the respective event. The user-initiated event and event ranking signals may be communicated to a computing element associated with the infusion pump by an associated communication device having a user interface which comprises a plurality of user-selectable operators for entering information about the events and event rankings.

Abstract: Apparatus is provided for implanting a prosthetic device (108) in a patient, the apparatus includes a trocar tube (101), a first portion of which is configured to be placed in a left ventricle (12) of the patient during a procedure for implantation of the prosthetic device (108), and a second portion of which is configured to be placed in an extracardiac location during the procedure. The first portion is shaped so as to define at least one opening to an interior thereof. One or more flexible bypass tubes (103, 104, 106), each of which is coupled to the second portion, and each of which is configured to be coupled to at least one artery (20, 21, 30) of the patient, so as to create a blood flow bypass path during the procedure, from the left ventricle (12), via the opening and the bypass tubes (103, 105, 106), to the at least one artery (20, 21, 30). Other embodiments are also described.

Abstract: A lithium-ion battery includes a positive electrode having a first active material and a second active material and a negative electrode including a third active material. The second active material includes a lithiated form of a material that does not include electrochemically cyclable lithium in the as-provided state.

Abstract: Electrochemical device and method for assembling an electrochemical device. The electrochemical device has an electrochemical module and an enclosure configured to enclose the electrochemical module. The enclosure has a first housing portion forming a first rim and being an insulative material and a second housing portion forming a second rim and being the insulative material, the first housing portion and the second housing portion at least partially forming, when the first rim substantially abuts the second rim, a volume configured to enclose the electrochemical device. The enclosure further has a crimp ring engaging the first rim and the second rim, the crimp ring securing the first housing portion with respect to the second housing portion and a grommet positioned between and contacting the first rim and the second rim. The enclosure is substantially sealed.

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: Methods and apparatus are provided, for selective destruction or temporary disruption of nerves and/or conduction pathways in a mammalian body for the treatment of pain and other disorders. Apparatus comprises catheters having electrodes for targeting and affecting nerve tissue at a cellular level to reversible and irreversible nerve portion and incapacitation.

Abstract: A stimulation lead is configured to be implanted into a patient's body and includes at least one distal stimulation electrode and at least one conductive filer electrically coupled to the distal stimulation electrode. A jacket is provided for housing the conductive filer and providing a path distributed along at least a portion of the length of the lead for conducting induced RF energy from the filer to the patient's body.

Abstract: Systems and processes for managing data relating to one or more medical or biological conditions of a plurality of subjects (such as patients) over a wide area network, such as the Internet, may be employed for diabetes subjects or subjects with other medical conditions requiring monitoring and/or treatment over time. Such systems and processes provide various functions for several types of users, including patients or subject-users, healthcare provider-users and payor entity-users and combinations thereof, which allow for improved treatment and medical data management of individual subjects and groups of subjects and which allow collection and analysis of aggregate data from many subject sources, for improving overall healthcare practices of providers and subjects (e.g., patients).

Abstract: The disclosure herein relates generally to methods for treating heart conditions using vagal stimulation, and further to systems and devices for performing such treatment. Such methods may include monitoring physiological parameters of a patient, detecting cardiac conditions, and delivering vagal stimulation (e.g., electrical stimulation to the vagus nerve or neurons having parasympathetic function) to the patient to treat the detected cardiac conditions.

Abstract: A variable hemostasis valve is disclosed that may be used during medical procedures to prevent blood loss while permitting the percutaneous introduction, operation, and removal of medical instruments. A flexible tubular seal element is disclosed that is disposed within the variable hemostasis valve to provide a fluid-tight, adjustable seal. After insertion of a medical instrument into the valve through at least a portion of the flexible tubular seal element, a proximal portion of the valve housing may be rotated to cause the tension of the flexible tubular seal element to increase over the inserted medical instrument and engage the valve in a closed position. The proximal portion of the valve housing may then be rotated in an opposite direction to release the seal and return the tubular seal element to a relaxed lumen open position.

Abstract: An infusion system, which may be a closed loop, or “semi-closed-loop”, infusion system, uses state variable feedback to control the rate at which fluid is infused into a user's body. The closed loop system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user and produces a sensor signal which is representative of the user's condition. The delivery system infuses a fluid into the user at a rate dictated by the commands from the controller. The system may use three state variables, e.g., subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused with a bolus and to be removed from the basal delivery of the fluid.

Abstract: In general, the disclosure is directed to techniques for identification and remediation of oversensed cardiac events using far-field electrograms (FFEGMs). Identification of oversensed cardiac events can be used in an ICD to prevent ventricular fibrillation (VF) detection, and thereby avoid delivery of an unnecessary defibrillation shock. Alternatively, or additionally, identification of oversensed cardiac events can be used in an ICD to support delivery of bradycardia pacing during an oversensing condition. In some cases, bradycardia pacing delivered in response to detection of oversensed cardiac events may include pacing pulses from multiple vectors to provide redundancy in the event the oversensing may be due to a lead-related condition.

Abstract: An implantable medical device system and method provide physiological variable monitoring for use in patient management. A target value for a physiological variable and formulations for computing metrics of the physiological variable are stored. Values of the physiological variable are determined from a sensed physiological signal and are used to compute a selected metric. The metric is compared to the stored target value.

Abstract: An implanted device-implemented method of detecting and monitoring congestive heart failure in a patient includes performing ongoing measurements of changes in local impedance of a portion of the patient's body between at least two electrodes on the exterior of the implanted device, the changes representing ventilation of the patient, and including measuring the patient's respiratory rate and respiratory amplitude. A body-implantable device is adapted to detect and monitor congestive heart failure in a patient, and includes a circuit module coupled to plural surface electrodes of the device arranged and adapted, when the device is implanted, for contacting tissue in a portion of the patient's body generally occupied by the lungs, to monitor changes in local impedance of said body portion, and to detect the patient's EKG.

Abstract: The disclosures made herein relate to an infusion device specifically adapted for syringe injections. In one embodiment of the disclosures made herein, an infusion device comprises a body including an accessible surface having a single inlet port therein, an engagement surface having a single outlet port therein, a medication delivery channel extending between the single inlet port and the single outlet port, and an identification feature on the accessible surface of the body adjacent to the single inlet port. The single inlet port of the medication delivery channel is tapered thereby forming a funnel-shaped entry into the medication delivery channel. A cannula is coupled to the body at the single outlet port and is adapted for receiving medication from the single outlet port and transmitting the medication therethrough.

Abstract: This disclosure describes a chopper mixer telemetry circuit for use in a wireless receiver. The receiver may be located in an implantable medical device (IMD) or external programmer. The chopper mixer telemetry circuit may include a mixer amplifier that operates as a synchronous demodulator to provide selective extraction of wireless signals received from a transmitter while suppressing out-of-band noise that can undermine the reliability of the telemetry link between an IMD or programmer and another device. The mixer amplifier may utilize parallel signal paths to convert the received telemetry signal into an in-phase (I) signal component and a quadrature (Q) signal component and recombine the I and Q signal components to reconstruct the total signal independently of the phase mismatch between the transmitter and receiver. Each signal path may include a chopper-stabilized mixer amplifier that amplifies telemetry signals within a desired band while suppressing out-of-band noise.

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 endoluminal prosthesis comprises a tubular body which can be expanded about a longitudinal axis. A plurality of serpentines extend in a substantially circumferential direction. Each comprises arm portions and bend portions which join two subsequent arms. The bends facing an adjacent serpentine are circumferentially offset relative to the respective opposite bends of the contiguous serpentine, both when the prosthesis is collapsed and when the prosthesis is expanded. A first portion comprises at least two adjacent serpentines interconnected by at least one bridge, and at least two bends situated at the shortest longitudinal distance between the two serpentines is not connected by a bridge. A second portion comprises at least two adjacent serpentines interconnected by a number of bridges equal to the number of pairs of bends of the two serpentines, at the shortest longitudinal distance between the two serpentines.

Abstract: The disclosure herein relates generally to methods for treating heart conditions using vagal stimulation, and further to systems and devices for performing such treatment. Such methods may include monitoring physiological parameters of a patient, detecting cardiac conditions, and delivering vagal stimulation (e.g., electrical stimulation to the vagus nerve or neurons having parasympathetic function) to the patient to treat the detected cardiac conditions.

Abstract: The present disclosure is directed to the detection of coughs and coughing episodes using acoustic signals. In various examples, an implantable medical device processes an acoustic signal obtained from an acoustic sensor to determine whether a patient has coughed. In some examples, the implantable medical device also performs a cough severity assessment. In some examples, the cough severity assessment may include a determination of the depth of the cough, the duration of the coughing episode, or whether the cough was wet or dry.