Abstract: An oxygenator apparatus for use in an extracorporeal circuit. The apparatus includes a housing and a membrane assembly disposed within the housing. The membrane assembly includes a first plurality of gas exchange elements disposed in a first zone and a second plurality of gas exchange elements disposed in a second zone. The second zone is arranged concentrically around the first zone. The first and second plurality of gas exchange elements are fluidly open along a body and fluidly separated along a distal end. The first zone is configured to be fluidly coupled to an oxygen source and the second zone is configured to be fluidly coupled to a negative pressure source. A blood flow path includes a generally radial flow through the first zone to add oxygen to the blood and the second zone to separate gaseous micro emboli from the blood through the plurality of gas exchange elements.

Abstract: An extra-cardiovascular implantable cardioverter defibrillator 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 ICD determines intervals between successively sensed R-waves and, in response to at least a predetermined number of the intervals being less than a tachyarrhythmia detection interval, analyzes at least a portion of the time segment of the second cardiac electrical signal corresponding to a most recent one of the sensed R-waves to confirm the most recent one of the R-waves. The ICD updates an unconfirmed beat count in response to the most recent one of the R-waves not being confirmed and withholds detection of a tachyarrhythmia episode in response to the unconfirmed beat count being equal to or greater than a rejection threshold.

Abstract: A medical device, 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 acquired by a second sensing channel in response to each sensed R-wave. The ICD determines morphology match scores from the stored time segments of the second cardiac electrical signal and, based on the morphology match scores, withholds detection of a tachyarrhythmia episode. In some examples, the ICD detects T-wave oversensing based on the morphology match scores and withholds detection of a tachyarrhythmia episode in response to detecting the T-wave oversensing.

Abstract: A medical device is configured to receive sensed cardiac event data including a value of a feature determined from each one of a plurality of cardiac events sensed from a cardiac signal according to a first setting of a sensing control parameter. The medical device is configured to classify each value of the feature of each one of the sensed cardiac events as either a predicted sensed event or a predicted undersensed event according to a second setting of the sensing control parameter that is less sensitive to sensing cardiac events than the first setting. The medical device is configured to determine a predicted sensed event interval between each consecutive pair of the predicted sensed events and predict that an arrhythmia is detected or not detected based on the predicted sensed event intervals.

Abstract: A medical system for treating incontinence includes an implantable medical device (IMD) implantable proximate to a tibial nerve of a patient comprising therapy delivery circuitry configured to provide electrical stimulation therapy proximate the tibial nerve of the patient for treating incontinence, and processing circuitry configured to: during an implant period, determine a set of stimulation parameters to control the therapy delivery circuitry, during an induction period after the implant period, initiate electrical stimulation therapy according to the set of stimulation parameters, during a first maintenance period, determine an adjustment to the set of stimulation parameters as first maintenance period stimulation parameters to reduce the electrical stimulation therapy from the induction period, and during a second maintenance period, determine an adjustment to the set of stimulation parameters as second maintenance period stimulation parameters to reduce the electrical stimulation therapy from the first

Abstract: An implantable medical device (IMD) automatically determines at least a portion of the parameters and, in some instances all of the parameters, of an exposure operating mode based on stored information regarding sensed physiological events or therapy provided over a predetermined period of time. The IMD may configure itself to operate in accordance with the automatically determined parameters of the exposure operating mode in response to detecting a disruptive energy field. Alternatively, the IMD may provide the automatically determined parameters of the exposure operating mode to a physician as suggested or recommended parameters for the exposure operating mode. In other instances, the automatically determined parameters may be compared to parameters received manually via telemetry and, if differences exist or occur, a physician or patient may be notified and/or the manual parameters may be overridden by the automatically determined parameters.

Abstract: Distal tips for use with delivery catheters are disclosed that are configured to facilitate deflection of the catheters as they are advanced through the vasculature to a desired treatment site. Distal tips so configured realize one or more of the objectives of safer, more accurate steering of the catheter through the vasculature.

Abstract: This disclosure relates to devices, systems, and methods for autotitrating stimulation parameters.

Abstract: Various fixation techniques for implantable medical device (IMDs) are described. In one example, an assembly comprises an IMD; and a set of active fixation tines attached to the IMD. The active fixation tines in the set are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from the IMD to a hooked position in which the active fixation tines bend back towards the IMD. The active fixation tines are configured to secure the IMD to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue.

Abstract: Disclosed is a localizer system. The localizer system may be incorporated into a navigation system for tracking a tracking device. Generally, the localizer may include a transmitting coil array and a field shaping assembly.

Abstract: Various fixation techniques for implantable medical device (IMDs) are described. In one example, an assembly comprises an IMD; and a set of active fixation tines attached to the IMD. The active fixation tines in the set are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from the IMD to a hooked position in which the active fixation tines bend back towards the IMD. The active fixation tines are configured to secure the IMD to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue.

Abstract: This disclosure is directed to devices, systems, and techniques for wirelessly charging a medical device. A charging device may receive a request to wirelessly charge a medical device. The charging device may, in response to receiving the request, physically move within wireless charging range of the medical device. The charging device may, in response to determining that the charging device is within the wireless charging range of the medical device, wirelessly transmit power to the medical device to wirelessly charge the medical device.

Abstract: A system and method for a procedure that can be performed on an appropriate subject. Procedures can include assembling any appropriate work piece or installing members into a work piece, such as an airframe, autoframe, etc. Regardless of the subject, generally the procedure can have a selected result that is efficacious. The efficacious result may be the desired placement of a device. The system and method can be used in confirming an efficacious result.

Abstract: An implantable medical device system delivers a pacing pulse to a patient's heart and starts a first pacing interval corresponding to a pacing rate in response to the delivered pacing pulse. The system charges a holding capacitor to a pacing voltage amplitude during the first pacing interval. The system detects an increased intrinsic heart rate that is at least a threshold rate faster than the current pacing rate from a cardiac electrical signal received by a sensing circuit of the implantable medical device. The system starts a second pacing interval in response to an intrinsic cardiac event sensed from the cardiac electrical signal and withholds charging of the holding capacitor for at least a portion of the second pacing interval in response to detecting the increased intrinsic heart rate.

Abstract: Some examples include a lithium-ion battery including an electrode assembly, a battery case, and an insulator. The electrode assembly includes a plurality of stacked electrodes. The battery case includes a cover and a housing. The housing includes a bottom, a perimeter side, and an open top. The cover is configured to extend across the open top. The cover and the housing form an interior enclosure to house the electrode assemble with the cover and the housing sealingly coupled at the lip. The insulator includes a body and a profiled portion. The body being generally planar and the profiled portion extending from the body at an angle. The body is disposed between the electrode assembly and the cover of the battery case. The profiled portion extends between the electrode assembly and the lip of the housing. The insulator is to provide a barrier between the electrode assembly and the sealed lip.

Abstract: A surgical alignment device including a base, a guide, and a plurality of linear actuators each extending between the base and the guide. The plurality of linear actuators include first ends connected to the base at base joints and second ends connected to the guide at guide joints. A locking arrangement is configured to simultaneously lock all of the base joints or simultaneously lock all of the guide joints.

Abstract: A medical device comprises therapy delivery circuitry and processing circuitry. The therapy delivery circuitry is configured to deliver anti-tachycardia pacing (ATP) therapy to a heart of a patient. The ATP therapy includes one or more pulse trains and each of the one or more pulse trains includes a plurality of pacing pulses. The processing circuitry is configured to, for at least one of the plurality of pacing pulses of at least one of the one or more pulse trains, determine at least one latency metric of an evoked response of the heart to the pacing pulse. The processing circuitry is further configured to modify the ATP therapy based on the at least one latency metric.

Abstract: Aspects of the disclosure provide a cardiac implant delivery device including catheter having a distal end and a telescoping capsule assembly secured to the distal end. The capsule assembly can include a distal capsule and a proximal capsule. Other embodiments include additional capsules positioned between the proximal and distal capsules. The capsule assembly has a loaded arrangement and a deployed arrangement. As the capsule assembly transitions from the loaded arrangement fully covering the implant to the deployed arrangement, the proximal capsule and any intermediate capsules move distally in the direction of the distal capsule to unsheathe the implant. In various embodiments, the cardiac implant is a prosthetic heart valve. Methods of delivering a cardiac implant are also disclosed. Various methods include methods of delivering a replacement tricuspid heart valve.

Abstract: A medical device includes a sensor to observe a characteristic of an anatomy, and a sensor base coupled to the sensor. The medical device includes a coupling system to couple the sensor base to the anatomy. The coupling system includes a first adhesive member and a second adhesive member. The first adhesive member is coupled to the sensor base and the second adhesive member is to couple to the anatomy. The second adhesive member includes at least one cut-out to direct moisture to an ambient environment surrounding the medical device.

Abstract: A method of non-invasively monitoring hematocrit levels includes monitoring a first emission response to the light provided at the first excitation wavelength, wherein the first emission response is monitored at a first wavelength and monitoring a second emission response to the light provided at the first excitation wavelength, wherein the second emission response is monitored at a second wavelength. A ratiometric value is calculated based on a ratio of the first emission response to the second emission response, wherein the ratiometric value corresponds with hematocrit level of the patient.