Abstract: The present disclosure is directed to embodiments and methods of reducing or eliminating erosion resulting from the use of an occluder, as well as reducing or eliminating other interference with cardiac tissue by an occluder, including reducing pressure on cardiac tissue, minimizing micro-perforations, and/or minimizing residual leak by improving sealing around the occluder. In particular, the present disclosure is directed to providing an external skirt on an occluder that improves sealing of the occluder while reducing interference with the cardiac tissue by the occluder.

Abstract: The present disclosure is directed to embodiments and methods of reducing or eliminating erosion resulting from the use of an occluder. In particular, the present disclosure is directed to reducing or eliminating erosion resulting from the use of an occluder while maintaining the fundamental function and effectiveness of the occluder with an improved occluder braid pattern. The embodiments and methods disclosed herein reduce or eliminate erosion, for example, by reducing the friction and force of an occluder on cardiac tissue and/or by increasing occluder disc compliance to cardiac structures and movement.

Abstract: In specific embodiments, a method to monitor left atrial pressure and/or intra-thoracic fluid volume of a patient, comprises (a) monitoring posture of the patient using a posture sensor implanted within the patient, and (b) using portions of an impedance signal, obtained using implanted electrodes, to monitor the left atrial pressure and/or intra-thoracic fluid volume of the patient. Each portion of the impedance signal used to monitor the left atrial pressure and/or intra-thoracic fluid volume of the patient corresponds to a period after which the patient has maintained a predetermined posture for at least a predetermined period of time, and during which the patient has remained in the predetermined posture.

Abstract: Systems, devices and methods of monitoring blood flow velocity are disclosed herein. For example, one method of monitoring blood flow velocity includes: locating a blood flow velocity sensor near the ostium in the coronary sinus; and sensing towards a portion of the aorta. A second example method includes: locating a blood flow velocity sensor in a vein; and sensing towards an adjacent artery. A third example method includes: locating a blood flow velocity sensor near the tricuspid valve; and sensing towards a tricuspid valve annulus. A fourth example method includes: locating a blood flow velocity sensor right ventricular outflow tract; and sensing towards a portion of the aorta. A fifth example method includes: locating a blood flow velocity sensor in the great cardiac vein; and sensing towards a left anterior descending artery. A sixth example method includes: locating a blood flow velocity sensor in the right atrial appendage; and sensing towards a portion of the aorta.

Abstract: Techniques are provided for estimating left atrial pressure (LAP) or other cardiac performance parameters based on measured conduction delays. In particular, LAP is estimated based interventricular conduction delays. Predetermined conversion factors stored within the device are used to convert the various the conduction delays into LAP values or other appropriate cardiac performance parameters. The conversion factors may be, for example, slope and baseline values derived during an initial calibration procedure performed by an external system, such as an external programmer. In some examples, the slope and baseline values may be periodically re-calibrated by the implantable device itself. Techniques are also described for adaptively adjusting pacing parameters based on estimated LAP or other cardiac performance parameters. Still further, techniques are described for estimating conduction delays based on impedance or admittance values and for tracking heart failure therefrom.

Abstract: Techniques are provided for estimating left atrial pressure (LAP) or other cardiac performance parameters based on measured conduction delays. In particular, LAP is estimated based interventricular conduction delays. Predetermined conversion factors stored within the device are used to convert the various the conduction delays into LAP values or other appropriate cardiac performance parameters. The conversion factors may be, for example, slope and baseline values derived during an initial calibration procedure performed by an external system, such as an external programmer. In some examples, the slope and baseline values may be periodically re-calibrated by the implantable device itself. Techniques are also described for adaptively adjusting pacing parameters based on estimated LAP or other cardiac performance parameters. Still further, techniques are described for estimating conduction delays based on impedance or admittance values and for tracking heart failure therefrom.

Abstract: Various techniques are provided for use with an implantable medical device for exploiting near-field impedance/admittance. Examples include techniques for assessing heart chamber disequilibrium, detecting chamber volumes and pressures, calibrating near-field-based left atrial pressure (LAP) estimation procedures and for assessing the recovery from injury at the electrode-tissue interface. In one particular example, the implantable device assesses the degree of concordance between the left ventricle (LV) and the right ventricle (RV) by quantifying a degree of scatter between LV and RV near-field admittance values. An increase in RV admittance is indicative of RV failure, an increase in LV admittance is indicative of LV failure, and an increase in both LV and RV admittance is indicative of biventricular failure.

Abstract: In specific embodiments, a method to monitor pulmonary edema of a patient, comprises (a) detecting, using an implanted posture sensor, when a posture of the patient changes from a first predetermined posture to a second predetermined posture, (b) determining an amount of time it takes an impedance signal to achieve a steady state after the posture of the patient changes from the first predetermined posture to the second predetermined posture, where the impedance signal is obtained using implanted electrodes and is indicative of left atrial pressure and/or intra-thoracic fluid volume of the patient, and (c) monitoring the pulmonary edema of the patient based on the determined amount of time it takes the impedance signal to achieve the steady state after the posture of the patient changes from the first predetermined posture to the second pre-determined posture.

Abstract: A new model is provided for understanding and exploiting impedance or admittance values measured by implantable medical devices, such as pacemakers or cardiac resynchronization devices (CRTs.) The device measures impedance along vectors extending through tissues of the patient between various pairs of electrodes. The device then converts the vector-based impedance measurements into near-field individual electrode-based impedance values. This is accomplished, in at least some examples, by converting the vector-based impedance measurements into a set of linear equations to be solved while ignoring far-field contributions to the impedance measurements. The device solves the linear equations to determine the near-field impedance values for the individual electrodes, which are representative of the impedance of tissues in the vicinity of the electrodes.

Abstract: Techniques are provided for estimating left atrial pressure (LAP) or other cardiac performance parameters based on measured conduction delays. In particular, LAP is estimated based interventricular conduction delays. Predetermined conversion factors stored within the device are used to convert the various the conduction delays into LAP values or other appropriate cardiac performance parameters. The conversion factors may be, for example, slope and baseline values derived during an initial calibration procedure performed by an external system, such as an external programmer. In some examples, the slope and baseline values may be periodically re-calibrated by the implantable device itself. Techniques are also described for adaptively adjusting pacing parameters based on estimated LAP or other cardiac performance parameters. Still further, techniques are described for estimating conduction delays based on impedance or admittance values and for tracking heart failure therefrom.

Abstract: Techniques are provided for estimating left atrial pressure (LAP) or other cardiac performance parameters based on measured conduction delays. In particular, LAP is estimated based interventricular conduction delays. Predetermined conversion factors stored within the device are used to convert the various the conduction delays into LAP values or other appropriate cardiac performance parameters. The conversion factors may be, for example, slope and baseline values derived during an initial calibration procedure performed by an external system, such as an external programmer. In some examples, the slope and baseline values may be periodically re-calibrated by the implantable device itself. Techniques are also described for adaptively adjusting pacing parameters based on estimated LAP or other cardiac performance parameters. Still further, techniques are described for estimating conduction delays based on impedance or admittance values and for tracking heart failure therefrom.

Abstract: Systems, devices and methods of monitoring blood flow velocity are disclosed herein. For example, one method of monitoring blood flow velocity includes: locating a blood flow velocity sensor near the ostium in the coronary sinus; and sensing towards a portion of the aorta. A second example method includes: locating a blood flow velocity sensor in a vein; and sensing towards an adjacent artery. A third example method includes: locating a blood flow velocity sensor near the tricuspid valve; and sensing towards a tricuspid valve annulus. A fourth example method includes: locating a blood flow velocity sensor right ventricular outflow tract; and sensing towards a portion of the aorta. A fifth example method includes: locating a blood flow velocity sensor in the great cardiac vein; and sensing towards a left anterior descending artery. A sixth example method includes: locating a blood flow velocity sensor in the right atrial appendage; and sensing towards a portion of the aorta.

Abstract: Various techniques are provided for assessing the reliability of left atrial pressure (LAP) estimates made by an implantable medical device based on impedance values or related electrical values. In one example, various cardioelectric and cardiomechanical parameters are used to corroborate LAP estimation in circumstances where the LAP estimates deviate from an acceptable, satisfactory or otherwise healthy range. The cardioelectric parameters include, e.g.: ST elevation; heart rate (HR); heart rate variability (HRV); T-wave alternans (TWA); QRS waveform parameters; P-wave duration; evoked response (ER) parameters; and intrinsic PV/AV/VV conduction delays. The cardiomechanical parameters include, e.g.: heart rate turbulence (HRT); cardiogenic impedance signals; heart sounds; and non-LAP blood pressure measurements, such as aortic pressure measurements.

Abstract: Various techniques are provided for calibrating and estimating left atrial pressure (LAP) using an implantable medical device, based on impedance, admittance or conductance parameters measured within a patient. In one example, default conversion factors are exploited for converting the measured parameters to estimates of LAP. The default conversion factors are derived from populations of patients. In another example, a correlation between individual conversion factors is exploited to allow for more efficient calibration. In yet another example, differences in thoracic fluid states are exploited during calibration. In still yet another example, a multiple stage calibration procedure is described, wherein both invasive and noninvasive calibration techniques are exploited. In a still further example, a therapy control procedure is provided, which exploits day time and night time impedance/admittance measurements.

Abstract: Various techniques are provided for use with an implantable medical device for estimating cardiac pressure within a patient based on admittance (or related electrical values such as impedance or conductance) that takes into account the presence of acute MR within the patient. Briefly, the device detects an indication of acute MR, if occurring within the patient. The device also applies electrical fields to tissues of the patient and measures electrical parameters influenced by the electrical field, such as admittance, impedance or conductance. The device then estimates cardiac pressure within the patient based on the measured electrical parameter and the indication of acute MR. In one example, different linear correlation functions are used to convert admittance values to left atrial pressure (LAP) values depending upon the presence or absence of acute MR within the patient.

Abstract: Various techniques are provided for use with an implantable medical device for exploiting near-field impedance/admittance. Examples include techniques for assessing heart chamber disequilibrium, detecting chamber volumes and pressures, calibrating near-field-based left atrial pressure (LAP) estimation procedures and for assessing the recovery from injury at the electrode-tissue interface. In one particular example, the implantable device assesses the degree of concordance between the left ventricle (LV) and the right ventricle (RV) by quantifying a degree of scatter between LV and RV near-field admittance values. An increase in RV admittance is indicative of RV failure, an increase in LV admittance is indicative of LV failure, and an increase in both LV and RV admittance is indicative of biventricular failure.

Abstract: Various techniques are provided for use with an implantable medical device for estimating cardiac pressure within a patient based on admittance (or related electrical values such as impedance or conductance) that takes into account the presence of acute MR within the patient. Briefly, the device detects an indication of acute MR, if occurring within the patient. The device also applies electrical fields to tissues of the patient and measures electrical parameters influenced by the electrical field, such as admittance, impedance or conductance. The device then estimates cardiac pressure within the patient based on the measured electrical parameter and the indication of acute MR. In one example, different linear correlation functions are used to convert admittance values to left atrial pressure (LAP) values depending upon the presence or absence of acute MR within the patient.

Abstract: A new model is provided for understanding and exploiting impedance or admittance values measured by implantable medical devices, such as pacemakers or cardiac resynchronization devices (CRTs.) The device measures impedance along vectors extending through tissues of the patient between various pairs of electrodes. The device then converts the vector-based impedance measurements into near-field individual electrode-based impedance values. This is accomplished, in at least some examples, by converting the vector-based impedance measurements into a set of linear equations to be solved while ignoring far-field contributions to the impedance measurements. The device solves the linear equations to determine the near-field impedance values for the individual electrodes, which are representative of the impedance of tissues in the vicinity of the electrodes.

Abstract: Access to the left side of the heart is gained through a heart wall. A delivery instrument includes a guide that may include or carry a puncturing instrument that is adapted to be directed toward the heart wall. In some embodiments a distal portion of the delivery instrument may be adapted to be co-located with the coronary sinus. In addition, the guide may be located a known distance from the portion of the delivery instrument that is co-located with the coronary sinus. Access to the left side of the heart may thus be readily gained by positioning the delivery instrument relative to the coronary sinus.

Abstract: An implantable medical device includes electrodes that are configured to be positioned within at least one of a heart and a chest wall of a patient. The device also includes an impedance measurement module, a patient position sensor, and a correction module. The impedance measurement module measures an impedance vector between a predetermined combination of the electrodes. The patient position sensor determines at least one of a posture and an activity level of the patient. The correction module adjusts the impedance vector based on the at least one of the posture and the activity level of the patient.