Abstract: In some examples, this disclosure describes techniques for assessing hemodynamic intolerance of ventricular pacing. A method comprises sensing a parameter indicative of autonomic tone during a first period in which a medical device delivers ventricular pacing to a patient, sensing the parameter indicative of autonomic tone during a second period in which the medical device does not deliver ventricular pacing to the patient, and assessing a level of change in autonomic tone in the patient induced by ventricular pacing based on values of the sensed parameter during the first and second periods.

Abstract: Systems for less invasive medical procedures comprise a filter device mounted on an integrated guiding structure and an aspiration catheter. These components can be used together or separately, and the system can be used with other medical devices that are designed for less invasive procedures, such as procedures in a patient's vasculature. The catheter can have a radiopaque band that is held in place under metal wire embedded within the polymer forming the tube of the catheter. In some embodiments, the aspiration catheter has a small diameter distal portion that can access into small diameter vessels in which the distal portion has a smaller average diameter than the remaining tube of the catheter.

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.

Abstract: A medical device performs a method for computing an estimate of a physiological variable. The method includes sensing a physiological signal and measuring an event of the physiological signal. The device initializes a value of a long-term metric of the event measurement, wherein the long-term metric corresponds to a time interval correlated to a response time of the physiological variable to changes in the event. The estimate of the long-term metric is updated in a memory of the medical device using a previous long-term metric and a current measurement of the event. The device detects a need for computing the physiological variable and computes an estimate of the physiological variable using the updated long-term metric.

Abstract: Recent advancements in power electronics technology have provided opportunities for enhancements to circuits of implantable medical devices. The enhancements have contributed to increasing circuit miniaturization and an increased efficiency in the operation of the implantable medical devices. The therapy delivery circuits and techniques of the disclosure facilitate generation of a therapy stimulation waveform that may be shaped based on the patient's physiological response to the stimulation waveform. The generated therapy stimulation waveforms include a stepped leading-edge that may be shaped having a varying slope and varying amplitudes associated with each of the segments of the slope. Unlike the truncated exponential waveform delivered by the conventional therapy delivery circuit which is based on the behavior of the output capacitors (i.e., i=C(dV/dt)), the stimulation waveform of the present disclosure may be dynamically shaped as a function of an individual patient's response.

Abstract: Techniques are disclosed for generating a plurality of output voltages from a single input power source. The techniques include implementing a switched capacitor voltage converter to provide at least two output voltages having different supply ratios. The supply ratio is defined as a function of the input voltage provided to the switched capacitor voltage converter by the power source. The switched capacitor voltage converter includes a plurality of capacitors selectively coupled to a plurality of switches to define at least a first and a second mode with each of the modes having a plurality of configurations. In accordance with aspects of the disclosure, the techniques include coupling the plurality of capacitors to define the first or second mode based on predetermined criteria.

Abstract: Systems and methods for using a sodium chloride source and a buffer source such as sodium bicarbonate in a controlled compliant flow path to generate from water a physiologically compatible fluid having a suitable level of a sodium ion and/or a buffer for use in hemodialysis, hemodiafiltration and hemofiltration. The system has a conditioning flow path that has at least a salination valve or salination pump, and at least one container has at least one solute in excess of the solubility of that solute. At least one of the solutes is a buffer source or sodium chloride. The conditioning flow path is in fluid communication with a controlled compliant flow path. The conditioning flow path can selectively meter fluid into and out of the controlled compliant flow path.

Abstract: Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains a current insulin on board (IOB) value that estimates active insulin in the user, and compensates a calculated insulin infusion rate in response to the obtained IOB value. A second method supervises the operation of a glucose sensor by obtaining and processing insulin-delivered data and glucose sensor data for the user. An alert is generated if the second method determines that a current glucose sensor value has deviated from a predicted sensor glucose value by at least a threshold amount.

Abstract: A method and system for determining activation times for electric potentials from complex electrograms to identify the location of arrhythmic sources or drivers. The method includes counting a number deflections in a recorded cardiac electrogram signal from at least one electrode for a predetermined amount of time. A deflection time is identified for each of the counted number of deflections. A most negative slope is identified between each of the identified deflections times. Each of the identified most negative slopes is correlated to a possible activation time. Each possible activation time is associated with a corresponding electrode from the at least one electrode. A spatial voltage gradient at each corresponding electrode is calculated for each possible activation time. The greatest spatial voltage gradient is identified. The greatest spatial voltage gradient is correlated to an activation time.

Abstract: Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Abstract: A method and medical device for detecting a cardiac event that includes sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector, determining, in response to the cardiac event being identified as a shockable event, a first R-wave morphology corresponding to R-waves of a next interval subsequently sensed along the first sensing vector during the predetermined sensing window and a second R-wave morphology corresponding to R-waves of a next interval subsequently sensed along the second sensing vector, determining whether the next interval subsequently sensed along the first sensing vector and the next interval subsequently sensed along the second sensing vector satisfy a morphology metric, and identifying the cardiac event as one of a monomorphic ventricular tachycardia and a polymorphic ventricular tachycardia in response to the determined first R-wave morphology, second R-wave morphology, and the next interval subsequently se

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: An implantable pacemaker system includes a housing having a proximal end and a distal end. A control electronics subassembly defines the housing proximal end, and a battery subassembly defines the housing distal end. A distal fixation member extends from the housing distal end for fixing the housing distal end at an implant site. A pacing extension extends from the housing proximal end and carries a pacing cathode electrode. The pacing extension extends the pacing cathode electrode to a pacing site that is spaced apart from the implant site when the pacemaker is deployed in a patient's body.

Abstract: A surgical instrument including a tool, a handpiece, and a locking member. The handpiece includes both a coupling member configured to cooperate with the tool, and a driver for rotating the tool. The locking member is movable from an unlocked position to a locked position in response to centrifugal force generated during rotation of the locking member. The locking member is configured to secure the tool to the handpiece when in the locked position.

Abstract: A tether holder has a locking portion, for securing a proximal end of a tether, and a pin portion that may fit within a receptacle of a handle assembly of a tool. A distal member of an inner assembly of the tool engages an implantable medical device, from which the tether extends, through at least one lumen of the inner assembly and out through a proximal port of the handle assembly, which is located in proximity to the receptacle. An enlarged distal-most portion of a deployment tube of the tool contains the distal member and the device, and is moveable, relatively to the inner assembly and the device, to deploy the device out through a distal opening of the tool. The handle assembly may also include a flush lumen and a tether engaging conduit, both in fluid communication with the at least one lumen of the inner assembly.

Abstract: An indication that a patient event occurred may be used to evaluate the efficacy of at least one therapy program and/or adjust therapy delivery to the patient. In some examples, the patient event indication includes patient input that may be received via an event indication button of a programming device. In addition to or instead of the patient input, the patient event indication may be generated based on a physiological parameter of the patient. In some examples, therapy delivery may be adjusted by adjusting at least one therapy parameter value, switching therapy programs or therapy program groups or restarting a therapy cycle of a medical device. The patient input via an event indication button may also help evaluate whether a therapy system is useful for the patient.

Abstract: Systems, devices and methods transmit data from a patient device to a location, for example a remote location, where the patient is monitored. The system may comprise a server system, for example a backend server system, a gateway and the patient worn device. The gateway can be configured to communicate with the patient worn device in response to a list transmitted from the server, for example an approved patient device list transmitted from the server to the gateway. The gateway may exclude communication with patient worn devices that are not on the list. This use of the list can control data throughput from the patient device to the gateway and also from the gateway to the server, such that the communication from the device on the list to the server is maintained and appropriate information can be reliably sent from the patient device to the server.

Abstract: A delivery system for percutaneously deploying a prosthetic heart valve. The system includes an inner shaft assembly, a delivery sheath capsule and a handle maintaining a first actuator and a second actuator. The capsule is configured to compressively retain the prosthetic heart valve over the inner shaft assembly. The first actuator is operated to proximally retract the delivery sheath capsule and expose the prosthetic heart valve relative to the capsule. The second actuator is operated to proximally retract the prosthetic heart valve by transmitting forces to the inner shaft assembly.

Abstract: A medical device and associated method determine a signal amplitude of a sensor signal produced by a MEMS sensor, compare the signal amplitude to a stiction detection condition, detect stiction of the MEMS sensor in response to the signal amplitude meeting the stiction detection condition, and automatically provide a corrective action in response to detecting the stiction.