Abstract: The present disclosure provides apparatuses and methods for navigating a medical device into the body of a patient during an intracoronary or other medical procedure. In many embodiments, the present disclosure includes the use of a guidewire managing assembly that may be used in combination with a guidewire that includes a medical positioning system sensor. This guidewire managing assembly and sensor enabled guidewire are used in combination with a medical positioning system to determine the position of a medical device, such as a catheter or catheter sheath, and specifically the tip of the catheter or catheter sheath, that is threaded over the guidewire during a procedure. The present disclosure further relates to methods of tracking a medical device, such as a catheter tip, inside the body of a subject during a procedure.

Abstract: The present disclosure may take the form of a method of optimizing CRT wherein candidate pacing settings are administered at a candidate lead implantation site. Such a method may comprise: determining a navigation sensor path at a measurement site for each candidate pacing setting at the candidate lead implantation site; and identifying which navigation sensor path corresponds to a most efficient cardiac tissue displacement.

Abstract: The present disclosure may take the form of a method of optimizing CRT wherein candidate pacing settings are administered at a candidate lead implantation site. Such a method may comprise: determining a navigation sensor path at a measurement site for each candidate pacing setting at the candidate lead implantation site; and identifying which navigation sensor path corresponds to a most efficient cardiac tissue displacement.

Abstract: The present disclosure provides a spinal cord stimulation (SCS) trial system. The SCS trial system includes at least one rigid needle lead including a biocompatible conductor extending from a proximal end to a distal end, and insulation surrounding at least a portion of the biocompatible conductor, wherein the at least one rigid needle lead is configured to pierce the skin of a patient and be percutaneously implanted in the patient such that the distal end is proximate to at least one of a dorsal column, a dorsal root, dorsal root ganglia, and a peripheral nerve of the patient. The system further includes an external pulse generator (EPG) coupled to the at least one rigid needle lead and configured to apply electrical stimulation to the patient via the at least one rigid needle lead.

Abstract: Described herein are methods, devices, and systems for treating human anemia. The methods, devices, and systems generally include monitoring a patient's hemoglobin level and at least one of autonomic balance and inflammatory state to determine the etiology of the anemic state, modulating at least one of a sympathetic or parasympathetic nerve based on the cause of the anemia, monitoring for changes in the patient's cardiac activity and state of inflammation, and hemoglobin level. An external neurostimulation system is describes, and well as a chronic implantable system. A method for treating a patient for anemia in conjunction with a renal denervation ablation catheter is also disclosed.

Abstract: A system and method for treating an arrhythmia in a heart are provided. The system includes an electronic control unit configured to monitor movement of one or more position sensor over a period of time. The position sensors may, for example, comprise electrodes or coils configured to generate induced voltages and currents in the presence of electromagnetic fields, The positions sensors are in contact with portions of heart tissue and changes in position are representative of motion of that tissue. The electronic control unit is further configured to generate an indicator, responsive to the movements of the sensors over the period of time, of a characteristic of the heart affected by delivery of ablation energy to heart tissue. In this manner, the effectiveness and safety of cardiac tissue ablation for treatment of the arrhythmia can be assessed and a post-ablation therapy regimen determined.

Abstract: Described herein are methods, devices, and systems for treating human anemia. The methods, devices, and systems generally include monitoring a patients hemoglobin level and at least one of autonomic balance and inflammatory state to determine the etiology of the anemic state, modulating at least one of a sympathetic or parasympathetic nerve based on the cause of the anemia, monitoring for changes in the patients cardiac activity and state of inflammation, and hemoglobin level. An external neurostimulation system is describes, and well as a chronic implantable system. A method for treating a patient for anemia in conjunction with a renal denervation ablation catheter is also disclosed.

Abstract: A system and method for treating an arrhythmia in a heart are provided. The system includes an electronic control unit configured to monitor movement of one or more position sensor over a period of time. The position sensors may, for example, comprise electrodes or coils configured to generate induced voltages and currents in the presence of electromagnetic fields. The positions sensors are in contact with portions of heart tissue and changes in position are representative of motion of that tissue. The electronic control unit is further configured to generate an indicator, responsive to the movements of the sensors over the period of time, of a characteristic of the heart affected by delivery of ablation energy to heart tissue. In this manner, the effectiveness and safety of cardiac tissue ablation for treatment of the arrhythmia can be assessed and a post-ablation therapy regimen determined.

Abstract: A system and method for delivering coupled burst and tonic stimulation of nervous tissue is provided. The system and method includes providing a lead with at least one stimulation electrode configured to be implanted at a target position proximate to nervous tissue of interest. The system and method further includes coupling the lead to an implantable pulse generator (IPG). The method delivers a first current pulse configured as a tonic stimulation waveform to the at least one electrode. The tonic stimulation waveform is configured to excite A-beta fibers of the nervous tissue. After a tonic-burst delay, the IPG delivers second current pulses configured as a burst stimulation waveform to at least one electrode. The burst stimulation waveform is configured to excite C-fibers of the nervous tissue.

Abstract: Described herein are implantable systems and devices, and methods for use therewith, that can be used to monitor and treat heart failure (HF). Such implantable systems preferably includes a lead having at least two electrodes implantable in a patient's left ventricular (LV) chamber. A plurality of different sensing vectors are used to obtain a plurality of IEGMs each of which is indicative of an evoked response at a corresponding different region of the LV chamber. For each of the IEGMs, there is a determination of one or more evoked response metrics indicative of a localized cardiac function at the corresponding region of the LV chamber. The evoke response metrics can be, e.g., paced depolarization integral (PDI) and/or maximum upward slope of an R-wave, but are not limited thereto.

Abstract: A wireless implantable system is provided that is externally powered and comprises of a closed-loop feedback for treating both patients with obstructive and central sleep apnea. A method is provided for treating sleep apnea using an implantable device. The method comprises sensing an inspiration (IN) signal representative of inspiration experienced by a patient from a respiratory surrogate signal and sensing a respiratory effort (RE) signal representative of an amount of effort exerted by the patient during respiration.

Abstract: Diastolic function is monitored within a patient based on dynamic cardiogenic impedance as measured by a pacemaker or other implantable medical device. In one example, the device uses ventricular cardiogenic impedance values to detect E-wave parameters representative of passive filling of the ventricles. Atrial cardiogenic impedance values are used to detect A-wave parameters representative of active filling of the ventricles. Diastolic function is then assessed or evaluated based on the E-wave and A-wave parameters. Various functions of the implantable device are then controlled based on the assessment of diastolic function, such as by adjusting atrioventricular delay parameters to improve diastolic function. In some examples, the detection of E- and A-wave parameters is achieved by aligning impedance signals to atrial activation, and separately to ventricular activation, during asynchronous VOO pacing or while artificially inducing a 2:1 block.

Abstract: Diastolic function is monitored within a patient based on dynamic cardiogenic impedance as measured by a pacemaker or other implantable medical device. In one example, the device uses ventricular cardiogenic impedance values to detect E-wave parameters representative of passive filling of the ventricles. Atrial cardiogenic impedance values are used to detect A-wave parameters representative of active filling of the ventricles. Diastolic function is then assessed or evaluated based on the E-wave and A-wave parameters. Various functions of the implantable device are then controlled based on the assessment of diastolic function, such as by adjusting atrioventricular delay parameters to improve diastolic function. In some examples, the detection of E- and A-wave parameters is achieved by aligning impedance signals to atrial activation, and separately to ventricular activation, during asynchronous VOO pacing or while artificially inducing a 2:1 block.

Abstract: The present disclosure provides systems and methods utilizing a closed-loop neurostimulation apparatus. The apparatus includes at least one sensing electrode that monitors neurological activity of a subject and at least one stimulating electrode that applies stimulation pulses to the subject. An internal pulse generator is coupled to the at least one sensing electrode and the at least one stimulating electrode. The internal pulse generator causes the at least one stimulating electrode to apply stimulating pulses based at least in part on the monitored neurological activity.

Abstract: Techniques are provided for use with an implantable cardiac stimulation device equipped for multi-site left ventricular (MSLV) pacing using a multi-pole LV lead. In one example, MSLV interelectrode conduction delays are determined among the electrodes of the multi-pole LV lead. MSLV interelectrode pacing delays are then set based on the MSLV interelectrode conduction delays for use in delivering MSLV pacing. To this end, various criteria are exploited for determining optimal values for the pacing delays based on the interelectrode conduction delays. MSLV pacing is then controlled using the specified MSLV interelectrode pacing delays. In some examples, the optimization procedure is performed by the implantable device itself. In other examples, the procedure is performed by an external programmer device. In such an embodiment, the external device determines optimal MSLV interelectrode pacing delays and then transmits programming commands to the implantable device to program the device to use the pacing delays.

Abstract: The present disclosure provides systems and methods for providing both neurostimulation and defibrillation therapy. The system includes an implantable pulse generator (IPG), at least one neurostimulation electrode electrically coupled to the IPG and configured to apply neurostimulation pulses to a subject, and at least one defibrillation electrode electrically coupled to the IPG and configured to apply defibrillation pulses to the subject.

Abstract: The present disclosure provides systems and methods for providing both neurostimulation and defibrillation therapy. The system includes an implantable pulse generator (IPG), at least one neurostimulation electrode electrically coupled to the IPG and configured to apply neurostimulation pulses to a subject, and at least one defibrillation electrode electrically coupled to the IPG and configured to apply defibrillation pulses to the subject.

Abstract: Systems and methods are provided for neurostimulation (NS) of peripheral nerves and/or associated ganglion. The systems and methods create a magnetic field from an elongated transmission coil of an external stimulator and expose an elongated receiver coil of a magnetic driver to the magnetic field. The systems and methods generate at the magnetic driver a pulse forming a stimulation waveform in response to the magnetic field. The systems and methods deliver the stimulation waveform to a target peripheral nerve through an electrode from the magnetic driver.

Abstract: A system and method for delivering coupled burst and tonic stimulation of nervous tissue is provided. The system and method includes providing a lead with at least one stimulation electrode configured to be implanted at a target position proximate to nervous tissue of interest. The system and method further includes coupling the lead to an implantable pulse generator (IPG). The method delivers a first current pulse configured as a tonic stimulation waveform to the at least one electrode. The tonic stimulation waveform is configured to excite A-beta fibers of the nervous tissue. After a tonic-burst delay, the IPG delivers second current pulses configured as a burst stimulation waveform to at least one electrode. The burst stimulation waveform is configured to excite C-fibers of the nervous tissue.

Abstract: An apparatus and method for characterizing a region of interest (ROI) including measuring position and orientation data within the ROI; and generating a geometric data set to include one or more of: length, bifurcation location, angle and curvature characteristics of the ROI. Also, sequentially taking an image of a tool within the ROI; comparing tool dimensions with ROI dimensions; and estimating diameter, length, take-off angle, and/or tortuosity characteristics based on the comparisons.