Abstract: The present disclosure pertains to cardiac pacing methods and systems, and, more particularly, to cardiac resynchronization therapy (CRT). In particular, the present disclosure pertains to determining the efficacy of CRT through use of an effective capture test (ECT). One or more embodiments comprises sensing a signal in response to a ventricular pacing stimulus. Through signal processing, a number of features are parsed from the signal. Exemplary features parsed from the signal include a maximum amplitude, a maximum time associated with the maximum amplitude, a minimum amplitude, and a minimum time associated with the minimum amplitude. The data is evaluated through use of the ECT. By employing the ECT, efficacy of CRT is easily and automatically evaluated.

Abstract: Various embodiments of a bioelectric sensor device for sensing bioelectric data from a human body are disclosed. The device can include a flexible substrate, a plurality of sensors arranged in a sensor array on a sensor array portion of the substrate, an electrically conductive network located on the substrate, and a plurality of lines of weakness formed in the sensor array portion of the substrate. In one or more embodiments, each line of weakness is configured to enhance separation of the sensor array portion of the substrate along a separation line that extends between at least two sensors of the plurality of sensors. The device can also include a left reference electrode proximate a distal end of a left reference electrode arm of the substrate and a right reference electrode proximate a distal end of a right reference electrode arm of the substrate.

Abstract: A delivery system for percutaneously deploying a stented prosthetic heart valve. The system includes a delivery capsule and a recapture assembly. The capsule is configured to compressively retain the prosthesis. The recapture assembly includes a frame and sleeve attached to the frame. The recapture assembly is transitionable from a compressed arrangement to an expanded arrangement with a distally increasing diameter.

Abstract: A system for detecting impending acute cardiac decompensation of a patient includes impedance circuitry, an activity sensor, and a processor system. The impedance circuitry measures a hydration signal of the patient, wherein the hydration signal corresponds to a tissue hydration of the patient. The activity sensor to measure an activity level of the patient, and the processor system includes a computer readable memory in communication with the impedance circuitry and the activity sensor, wherein the computer readable memory of the processor system embodies instructions to combine the hydration signal and the activity level of the patient to detect the impending acute cardiac decompensation.

Abstract: This disclosure describes techniques that support delivering electrical stimulation current via at least two user-selected electrodes of an implantable medical device (IMD) and automatically delivering balancing current below via at least one non-selected electrode. Balancing currents delivered via the at least one non-selected electrode may be configured with an amplitude below a perception threshold of a patient. Delivery of balancing current via the at least one third electrode may allow an implantable medical device to automatically balance the total current delivered to a patient.

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: 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: The invention provides an inclusion body fusion partner to increase peptide and polypeptide production in a cell.

Abstract: An inflation device useful for inflating a balloon provided with a surgical instrument, such as a balloon sinus dilation instrument. The inflation device includes a syringe, a connector, and mechanical pressure indicator. The syringe includes a plunger slidably disposed within a barrel. The connector is configured to fluidly connect an outlet of the syringe with a surgical instrument balloon in establishing a closed inflation system between the syringe and an interior of the balloon. The pressure indicator is associated with the syringe and is configured to transition from a non-alert state to an alert state when a pressure of the inflation system has reached a predetermined level. In some embodiments, the inflation device is characterized by the absence of a pressure gauge.

Abstract: The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart.

Abstract: A method and apparatus for treatment of heart failure, hypertension and renal failure by stimulating the renal nerve. The goal of therapy is to reduce sympathetic activity of the renal nerve. Therapy is accomplished by at least partially blocking the nerve with drug infusion or electrostimulation. Apparatus can be permanently implanted or catheter based.

Abstract: A method and apparatus for monitoring a cardiovascular pressure signal in a medical device that includes determining whether the sensed pressure signal is greater than a first pressure threshold, determining a first metric of the pressure signal in response to the sensed pressure signal being greater than the first pressure threshold, determining whether the sensed pressure signal is greater than a second pressure threshold not equal to the first pressure threshold, determining a second metric of the pressure signal in response to the sensed pressure signal being greater than the first pressure threshold, and determining at least one of a systolic pressure or a diastolic pressure, wherein the at least one of a systolic pressure or a diastolic pressure is determined based on the first metric in response to the pressure signal not being greater than the second threshold, and based on the second metric in response to the pressure signal being greater than the second threshold.

Abstract: Methods and system are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues. In some embodiments, thermally-induced renal neuromodulation is achieved via delivery of a pulsed thermal therapy.

Abstract: An improved medical electrical lead is disclosed herein. The lead may include a longitudinally extending body having a distal end, a proximal end, a conductive element extending between the distal and proximal ends, and an electrode coupled to the conductive element utilizing a reflow process. The conductive element and electrode may comprise materials that are incompatible.

Abstract: A computer-implemented method of implant detection includes receiving a three-dimensional (3D) image of an anatomy portion of a patient from computed tomography (CT) projections of the patient in an image processing computing system. A cluster of voxels forming an implant candidate is identified on a CT slice of the 3D image and the identified implant candidate is compared with artifacts of implants from an implant database stored in a memory of the computing system. A best-fit implant is selected from the implant database and a graphical image of the best-fit implant is overlaid on the CT slice on a display of the computing system.

Abstract: A fully automated computer controlled system is provided for adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction which includes a patient interactive computer, and a universal transmitter interface integrally embedded in the patient interactive computer or built into the antenna which is capable of stimulating any type of implanted neurostimulation devices by imitating programming codes. The patient interacts with the system through the patient interactive computer. The universal transmitter interface includes a direct digital synthesizer, a transistor circuitry driving the antenna in ON-OFF fashion and a gating unit for driving the transistor circuitry under control of the processing means in the patient-interactive computer. Alternatively, the universal transmitting interface includes a balanced modulator for modulation of the carrier signal generated at the direct digital synthesizer.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: A medical device includes a first substrate, a second substrate, a control module, and an energy storage device. The first substrate includes at least one of a first semiconductor material and a first insulating material. The second substrate includes at least one of a second semiconductor material and a second insulating material. The second substrate is bonded to the first substrate such that the first and second substrates define an enclosed cavity between the first and second substrates. The control module is disposed within the enclosed cavity. The control module is configured to at least one of determine a physiological parameter of a patient and deliver electrical stimulation to the patient. The energy storage device is disposed within the cavity and is configured to supply power to the control module.

Abstract: A suturing device includes a handle, an elongated body, at least one suture snag, at least one pair of needles, and at least one suture pair. The suture snag is moveable between a deployed position in which two distal arm portions thereof radially extend away from the elongated body and a retracted position in which the two distal arm portions are disposed within the elongated body. The suture pair is slidingly disposed through the needle pair. The suturing device deploys the suture snag within a vessel adjacent to an arteriotomy, extends the needle pair through a vessel wall around the arteriotomy and through the deployed suture snag, extends the suture pair beyond the distal ends of the needle pair, and then utilizes the suture snag to capture the extended suture pair by retracting the suture snag to pull first or distal ends of the sutures back into the suturing device.

Abstract: A temporary implantable medical electrical lead includes a conductor extending along a proximal, extracorporeal length and a distal, subcutaneous length of the lead. Electrically isolated first and second wire filars of the conductor are wound to form an elongate lumen of the lead. First and second electrodes are mounted directly onto the conductor, along the subcutaneous length, and each is directly coupled to the corresponding filar. A fixation member is attached to a tubular member, which is conformed to an outer surface of the conductor so as to only cover the conductor along the subcutaneous length, leaving the outer surface exposed along a portion thereof, adjacent to the extracorporeal length. When the lead is implanted, the fixation member holds the subcutaneous length in a relatively fixed location, and fluid communication exists between the outer surface of the conductor and the lumen of the lead.