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: An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being joined together by ductile hinges to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. The plurality of struts and ductile hinges are arranged to improve the spatial distribution of the struts which is particularly important when delivering beneficial agents with the struts. The improved strut arrangement expands to a substantially parallelogram shape for improved beneficial agent distribution to the surrounding tissue. A beneficial agent may be loaded into openings within the struts or coated onto the struts for delivery to the tissue.

Abstract: An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. Alternatively, the beneficial agent is loaded in a shape which is configured to achieve the desired agent delivery profile. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Abstract: Methods and devices are disclosed for minimally invasive procedures in the heart. In one application, a catheter is advanced from the left atrium through the mitral valve and along the left ventricular outflow tract to orient and stabilize the catheter and enable a procedure such as a “bow tie” repair of the mitral valve. Right heart procedures are also disclosed.

Abstract: A cardiac rhythm management apparatus includes a proximal housing, a distal housing and a lead. The proximal housing includes a first energy storage device. The distal module is implantable within a patient's heart, and includes a second energy storage device, at least one electrode, and a control module. The control module controls the delivery of at least one electrical stimulus from the second energy storage device to a location in communication with the patient's heart. The lead connects the proximal housing to the distal module and is configured to communicate one or more digital signals between the proximal housing and the distal module.

Abstract: Embodiments include a cardiac rhythm management system having a lead that includes an omni-directional pressure sensor that is configured to resist tissue in-growth and provide reliable and consistent pressure readings from within a patient's vasculature. Embodiments of the cardiac rhythm management lead may also include a variety of pacing and shocking electrodes.

Abstract: A system for detecting and treating congestive heart failure includes an implantable module, such as a pacemaker, and a patient advisory module. The system is configured to measure thoracic impedance and to provide the patient with instructions in order to improve the accuracy of the thoracic impedance measurement as well as treating symptoms of congestive heart failure.

Abstract: A method for accessing a target site in the body by transferring a guidewire from an initial insertion site on the body to a different insertion site on the body is provided. In one aspect, a method for transferring a medical device or component, such as a sensor lead, from an initial insertion site to another insertion site is also provided. A guidewire of sufficient length, pliancy and deformability to perform a transfer from one insertion site to another insertion site is provided. In one aspect, the guidewire comprises a removable core mandrel to increase rigidity, facilitate insertion and/or improve steerability. A kit or system, comprising introducers, guidewires and catheters for performing a guidewire or device transfer is also provided.

Abstract: A method for accessing a target site in the body by transferring a guidewire from an initial insertion site on the body to a different insertion site on the body is provided. In one aspect, a method for transferring a medical device or component, such as a sensor lead, from an initial insertion site to another insertion site is also provided. A guidewire of sufficient length, pliancy and deformability to perform a transfer from one insertion site to another insertion site is provided. In one aspect, the guidewire comprises a removable core mandrel to increase rigidity, facilitate insertion and/or improve steerability. A kit or system, comprising introducers, guidewires and catheters for performing a guidewire or device transfer is also provided.

Abstract: A method of monitoring pressure within a medical patient, includes measuring an actual pressure in a medical patient in a first time period; measuring an indicator of the actual pressure in the first time period, wherein the indicator is derived from an electrical signal of the patient's heart; determining a correlative relationship between the actual pressure and the indicator, wherein both the actual pressure and the indicator are obtained in the first time period; measuring the indicator in a second time period; and determining the actual pressure in the second time period based on the correlative relationship obtained in the first time period and the indicator obtained in the second time period.

Abstract: Systems and methods for penetrating a tissue membrane to gain access to a target site are disclosed. In some examples, systems and methods for accessing the left atrium from the right atrium of a patient's heart are carried out by puncturing the intra-atrial septal wall. One embodiment provides a system for transseptal cardiac access that includes a stabilizer sheath having a side port, a shaped guiding catheter configured to exit the side port and a tissue penetration member disposed within and extendable from the distal end of the guide catheter. The tissue penetration member may be configured to penetrate tissue upon rotation and may be coupled to a distal portion of a torqueable shaft. In some embodiments, the stabilizer sheath and shaped guiding catheter may be moved relative to the patient's body structure and relative to each other so that a desired approach angle may be obtained for the tissue penetration member with respect to the target tissue.

Abstract: A hemostasis valve is disclosed herein. The hemostasis valve may include an inner bushing, a rotation sleeve, an elastomeric sleeve, and a biasing element. The rotation sleeve may extend about the inner bushing and be rotationally displaceable relative to the inner bushing. The elastomeric sleeve may include a first end operably coupled to the inner bushing, a second end operably coupled to the rotation sleeve, and an iris valve portion. Rotation of the rotation sleeve relative to the inner bushing may cause the iris valve to transition from an open state to a closed state. The biasing element may act between the rotation sleeve and inner bushing to bias the iris valve towards at least one of a closed state or an open state.

Abstract: A hemostasis valve is disclosed herein. The hemostasis valve may include an inner bushing, a rotation sleeve, an elastomeric sleeve, and a biasing element. The rotation sleeve may extend about the inner bushing and be rotationally displaceable relative to the inner bushing. The elastomeric sleeve may include a first end operably coupled to the inner bushing, a second end operably coupled to the rotation sleeve, and an iris valve portion. Rotation of the rotation sleeve relative to the inner bushing may cause the iris valve to transition from an open state to a closed state. The biasing element may act between the rotation sleeve and inner bushing to bias the iris valve towards at least one of a closed state or an open state.

Abstract: An anchoring device and a delivery method thereof can effectively provide a means for securing an implant to a wall of an internal organ within a patient in a variety of clinical applications. In one embodiment, an anchoring device used to retain a cardiac pressure measurement device is provided. The device is implanted in the body by deforming it to a small cross section profile, sliding it through a low profile delivery device and ejecting from the delivery device at a targeted site. The anchoring mechanism, when ejected from the delivery device, reverts back to pre-formed configuration and engages opposite sides of an organ wall, thereby anchoring the implant in the organ wall.

Abstract: A transfer guidewire assembly configured to manipulate an implanted elongate body includes a flexible elongate portion, such as a guidewire, and coupler. The flexible elongate body has a proximal end and a distal end attached to the coupler. The coupler can include a catheter and/or a handle. The handle can include a screw. The coupler is configured to be removably attached to the end of an implanted elongate body, for example, by forming an interference fit with the outside diameter of the implanted body. A method for transferring an end of an implanted medical component from first site to a second site within a patient, such as a pacemaker, defibrillator, and/or sensor lead, etc., includes inserting a guidewire into the body at the first site and externalizing the guidewire at the second site. A proximal portion of the implanted component near the first site and is attached to the guidewire.

Abstract: An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being joined together by ductile hinges to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. The plurality of struts and ductile hinges are arranged to improve the spatial distribution of the struts which is particularly important when delivering beneficial agents with the struts. The improved strut arrangement expands to a substantially parallelogram shape for improved beneficial agent distribution to the surrounding tissue. A beneficial agent may be loaded into openings within the struts or coated onto the struts for delivery to the tissue.

Abstract: 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.

Abstract: A method of treating cardiovascular disease in a medical patient is provided. The method includes the steps of generating a sensor signal indicative of a fluid pressure within the left atrium of the patient's heart, and delivering an electrical stimulus to a location in the heart. The electrical stimulus is delivered based at least in part on the sensor signal. The method also includes the steps of generating a processor output indicative of a treatment to a signaling device. The processor output is based at least in part on the sensor signal. At least two treatment signals are provided to the medical patient. The treatment signals are distinguishable from one another by the patient, and are indicative of a therapeutic treatment. The treatment signals are based at least in part on the processor output.

Abstract: A cardiac rhythm management apparatus includes a proximal housing, a distal housing and a lead. The proximal housing includes a first energy storage device. The distal module is implantable within a patient's heart, and includes a second energy storage device, at least one electrode, and a control module. The control module controls the delivery of at least one electrical stimulus from the second energy storage device to a location in communication with the patient's heart. The lead connects the proximal housing to the distal module and is configured to communicate one or more digital signals between the proximal housing and the distal module.

Abstract: A cardiac rhythm management apparatus includes a proximal housing, a distal housing and a lead. The proximal housing includes a first energy storage device. The distal module is implantable within a patient's heart, and includes a second energy storage device, at least one electrode, and a control module. The control module controls the delivery of at least one electrical stimulus from the second energy storage device to a location in communication with the patient's heart. The lead connects the proximal housing to the distal module and is configured to communicate one or more digital signals between the proximal housing and the distal module.