Pacesetter, Inc.

St. Jude Medical, Cardiology Division, Inc.

Dan E Gutfinger

Dorin Panescu

Yelena Nabutovsky

Fujian Qu

Alex C Soriano

Xiaoyi Min

Brian Jeffrey Wenzel

Anders Bjorling

Riddhi Shah

Mihir Naware

Ryan Rooke

Jeffery Siou

Steve Koh

Neal L Eigler

James S Whiting

Phong D Doan

Paul Hindrichs

Andreas Blomqvist

Pankaj Gupta

Yongning Zou

Yang Zhang

Jeffrey Siou

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.

Occluder including external skirt

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.

Methods and systems that use implanted posture sensor to monitor left atrial pressure and/or inter-thoracic fluid volume

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.

System and method for estimating cardiac pressure based on cardiac electrical conduction delays using an implantable medical device

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.

Systems and methods for exploiting near-field impedance and admittance for use with implantable medical devices

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.

Methods and systems that use implanted posture sensor to monitor pulmonary edema

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. The device then performs or controls various device functions based on the near-field values, such as analyzing selected near-field values to detect heart failure or pulmonary edema.

Near field-based systems and methods for assessing impedance and admittance for use with an implantable medical device

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.

System and method for calibrating cardiac pressure measurements derived from signals detected by an implantable medical device

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.

Systems and methods for estimating left atrial pressure (LAP) in patients with acute mitral valve regurgitation for use by an implantable medical device

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.

Transseptal delivery instrument

Techniques are provided for estimating left atrial pressure (LAP) or other cardiac pressure parameters based on various parameters derived from impedance signals. In particular, effective LAP is estimated based on one or more of: electrical conductance values, cardiogenic pulse amplitudes, circadian rhythm pulse amplitudes, or signal morphology fractionation values, each derived from the impedance signals detected by the implantable device. Predetermined conversion factors stored within the device are used to convert the various parameters derived from the electrical impedance signal into LAP values or other appropriate cardiac pressure values. 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.

System and method for estimating cardiac pressure using parameters derived from impedance signals detected by an implantable medical device

An economical, repeatable, and non-invasive method and apparatus for the calibration of implantable pressure sensors that can minimize patient discomfort and risk of infection. In one embodiment, a calibration system for calibrating a first pressure sensor coupled to a management device and implanted into a human patient is provided. The calibration system includes a mouthpiece, a pump, a second pressure sensor, and a computer. The pump provides a positive pressure into an airway of the human patient via the mouthpiece. The second pressure sensor measures the airway pressure of the human patient, and the computer is coupled to the pump and monitors pressures measured by the first and second pressure sensors. Here, the computer also calculates one or more calibration constants based on the pressures measured by the first and second pressure sensors and provides the calibration constants to the management device to calibrate the first pressure sensor.

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Agoura Hills, CA, United States of America

Dan E Gutfinger