Abstract: A cardiac valve prosthesis for implantation at a native valve having leaflets includes a distal fixation member configured to be implanted downstream of a native valve and includes engagement arms configured to apply, to a native valve's downstream side, a first force directed upstream, when the distal fixation member is implanted. The number of engagement arms matches the number of native valve leaflets. The prosthesis also includes a proximal fixation member configured to be implanted at least partially upstream of the native valve such that the proximal fixation member applies, to a native valve's upstream side, a second force directed downstream when the proximal fixation member is implanted. The application of the first and second forces is configured to couple the prosthesis to the native valve. The engagement arms and the proximal fixation member are configured to capture the leaflets of the native valve therebetween.

Abstract: An implantable medical system may include an implantable medical lead including at least one electrode and an implantable medical device. The implantable medical device comprises an electromagnetic interference (EMI) detection module that monitors for one or more particular characteristics of EMI. A control module is configured to control a therapy module to generate monophasic stimulation pulses while operating the IMD in a first operating mode. In response to detecting the condition indicative of the presence of EMI, the control module switches the IMD from the first operating mode to a second operating mode and generates at least one multiphasic stimulation pulses while operating the IMD in the second operating mode.

Abstract: Endovascular catheters and control wires for operating the catheters and associated systems, apparatuses, and methods are disclosed include a catheter apparatus having an elongated shaft, a therapeutic assembly at a distal portion of the shaft, and a handle at a proximal portion of the shaft. An actuator is located at the handle and operably coupled to the therapeutic assembly via a tuned control member extending through the shaft. The tuned control member includes a control wire and a tuning component attached to one another within the shaft. The tuned control member is configured to achieve a desired tuned force-displacement response by modifying the stress-strain response that a non-tuned control wire would ordinarily provide without the intervening tuning component.

Abstract: A tool for deploying an anchor sleeve onto one or more implantable medical device bodies includes a holding element, on which the sleeve is mounted, and a base member having a channel, which receives the element in sliding engagement. A conduit of the holding element receives the one or more elongate bodies in sliding engagement. A deployment tip forms an opening of the channel, through which the holding element extends in sliding engagement, and which engages the mounted anchor sleeve for deployment thereof. The deployment tip may be provided as a separate component, wherein a distal segment of the base member is configured for attachment therewith; as such, the tip may be part of a deployment assembly that also includes the holding element. The deployment assembly may be selected from a plurality thereof included in a kit along with the base member.

Abstract: The present disclosure relates to acquiring image data of a subject with an imaging system that has been calibrated. The imaging system can include an ultrasound imaging system that collects one of more images based on a plane of image acquisition. The plane of image acquisition can be calibrated to a tracking device associated with the ultrasound transducer.

Abstract: A lead pin fixture is used to align and hold lead pins in place for brazing lead pins to metal contact pads of a ceramic insulator and brazing a ferrule to the ceramic insulator in a single step.

Abstract: Methods and apparatus are provided for bilateral renal neuromodulation, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Abstract: A method for determining the status of a catheter of an implanted infusion system, where the catheter is intended to deliver a fluid composition to CSF of a patient, includes monitoring catheter pressure, developing a pressure modulation profile based on the monitored pressure, and comparing the developed pressure modulation profile to a predetermined pressure profile. The predetermined pressure profile may be a profile of cerebrospinal fluid or a bolus infusion or withdrawal profile for the catheter. A determination of catheter status, such as properly functioning, occluded or leaky, can be made based on the comparison.

Abstract: A method and medical device for monitoring cardiac function in a patient that includes a plurality of electrodes to deliver cardiac pacing therapy, and a processor configured to determine a pacing threshold in response to initial delivery of the pacing therapy, determine whether there is a change in the pacing threshold during initial delivery of the pacing therapy, adjust a delivery parameter of the pacing therapy in response to determining the change in the pacing threshold during initial delivery of the pacing therapy, determine whether there is an increase in the pacing threshold during delivery of the adjusted pacing therapy, and determine hypokalemia in response to the increase in the pacing threshold during delivery of the adjusted pacing therapy being present.

Abstract: Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally spiral/helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., spiral/helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function.

Abstract: Catheters including elements configured to deliver energy to nerves at or near a treatment location within a body lumen. A treatment assembly is transformable between a low-profile delivery configuration wherein a pair of electrodes are in a staggered arrangement relative to each other along the longitudinal axis, and an expanded deployed configuration wherein the pair of electrodes is aligned along an electrode axis that is orthogonal relative to the longitudinal axis.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element operably connected to the shaft. The neuromodulation element includes an elongate support member and a plurality of bow springs operably connected to the support member. The individual bow springs are configured to independently expand radially outward from the support member when the neuromodulation element transitions from a low-profile delivery state to a deployed state at a treatment location within a body lumen. The individual bow springs include a distal leg and a proximal leg and carry an electrode and/or a transducer between their respective distal and proximal legs. The distal and proximal legs of the plurality of bow springs are longitudinally interdigitated. The plurality of bow springs is configured to urge the electrodes and/or the transducers into contact with an inner surface of a wall of the body lumen at a series of contact regions.

Abstract: A device includes (i) a housing defining an interior, wherein the interior has a blood compartment, a plasma compartment, and a fluid compartment; (ii) a first filter disposed in the interior of the housing, and (iii) a second filter disposed in the interior of the housing. The first filter separates at least a portion of the blood compartment from at least a portion of the plasma compartment. The first filter is configured to allow plasma components, but not cell components, of blood to pass through the first filter from the blood compartment to the plasma compartment. The second filter separates at least a portion of the plasma compartment from at least a portion of the fluid compartment. The second filter is configured to allow fluid and small molecules, but not larger components, to pass through the second filter from the plasma compartment to the fluid compartment. The device may include a sorbent in the plasma compartment to remove or reduce the concentration of selected components of the plasma.

Abstract: A method for producing a battery includes providing a battery having a positive electrode, a negative electrode, and an electrolyte that includes a solvent and a salt. The capacity of the negative electrode is less than that of the positive electrode and the negative electrode includes an active material having an average potential versus a lithium reference electrode of greater than approximately 0.2 volts. The method also includes applying an initial charge to the battery at a voltage that is greater than a fully charged voltage of the battery for a sufficient amount of time to cause at least a portion of the solvent to undergo a reduction reaction. The step of applying an initial charge to the battery acts to increase the irreversible capacity loss of the battery during the initial charge and provides the battery with enhanced tolerance to deep discharge conditions.

Abstract: Formation of a feedthrough in a substrate for use in an implantable medical device is presented. A substrate includes a first surface and a second surface, and a via that extends through the first and the second surfaces. A dielectric layer is formed over one of a first surface of the substrate. Conductive material is introduced into the via to form a feedthrough.

Abstract: An implantable sensor module includes a housing having an inner shell and an outer layer formed to extend over and enclose the inner shell to form an outer wall of the housing, the inner shell having a thickness extending between an inner wall of the inner shell and an outer wall of the inner shell, the outer layer having an inner side engaged against the outer wall of the inner shell and having a thickness extending between the inner side and the outer wall of the housing, wherein the inner shell and the outer layer form a substantially flat portion. A flexible diaphragm is formed within the inner shell and extends between a first edge and a second edge, and a shoulder extends adjacent to the first edge to extend the outer layer laterally away from a central medial line extending between the first and second edges of the diaphragm.

Abstract: A dialysis device for operation in multiple modes and for maintaining a known gradient of potassium ion or other electrolyte between the blood of a patient and a dialysate fluid is described. The dialysis device is capable of being used for hemodialysis or peritoneal dialysis, and the dialysis device is capable of operation with a dialysate purification unit outside of a clinical setting or with a supply of water that can be supplied in a clinical setting. The dialysis device has a composition sensor containing a potassium-sensitive electrode for measuring a potassium ion concentration in one or more of the patient's blood and the dialysate fluid and an infusate pump operated to adjust a potassium ion concentration in the dialysate fluid based at least in part on data from the composition sensor.

Abstract: A method and medical device for monitoring cardiac function in a patient that includes a plurality of electrodes to deliver cardiac pacing therapy, and a processor configured to determine a pacing threshold in response to initial delivery of the pacing therapy, determine whether there is a change in the pacing threshold during initial delivery of the pacing therapy, adjust a delivery parameter of the pacing therapy in response to determining whether there is a change in the pacing threshold during initial delivery of the pacing therapy, determine whether there is a decrease in the pacing threshold during delivery of the adjusted pacing therapy, and determine hyperkalemia in response to the decrease in the pacing threshold during delivery of the adjusted pacing therapy being present.

Abstract: A delivery device for percutaneously deploying a prosthetic valve includes a sheath, an inner shaft, and a release assembly. The release assembly is disposed between the sheath and the inner shaft, and includes a retraction member, a release member, and a retention member. The retraction member can self-retract in length from an extended condition to a retracted condition. The release member can self-expand from a compressed condition to an expanded condition. The retention member is distal the release member. In a delivery state, the sheath end is distal the retention member, the release member is in the compressed condition and the retraction member in the extended condition to retain the prosthesis. In a deployment state, the sheath end is positioned to permit the release member to self-transition to the expanded condition, allowing the retraction member to self-transition to the retracted condition and release the prosthesis.