Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The shunt may include an anchor having a first flared region, a second flared region, and a neck region disposed between the first flared region and the second flared region, and a biocompatible covering disposed on the anchor to form a lumen. The one or more sensors may be pivotally coupled to the first flared region such that the one or more sensors may transition between a delivery configuration and a deployed configuration where the sensing surface of the one or more sensors is in fluid communication with the lumen.

Abstract: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

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: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Abstract: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Abstract: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures are 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: Techniques are provided for detecting a clinically-significant pulmonary fluid accumulation within a patient using a pacemaker or other implantable medical device. Briefly, the device detects left atrial pressure (LAP) within the patient and tracks changes in the LAP values over time that are indicative of possible pulmonary fluid accumulation within the patient. The device determines whether the changes in LAP values are sufficiently elevated and prolonged to warrant clinical intervention using, e.g., a predictor model-based technique. If the fluid accumulation is clinically significant, the device then generates warning signals, records diagnostics, controls therapy and/or titrates diuretics. False positive detections of pulmonary edema due to transients in LAP are avoided with this technique. Pulmonary artery pressure (PAP)-based techniques are also described.

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: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Abstract: A device and method for hermetically sealing a medical device is provided. In one aspect, a silicon device is coupled to a sensor, such as a pressure transducer, which benefits from having direct contact with its environment, which in many cases, is the human body. Thus, a method to hermetically seal the non-sensing portion of a silicon device while allowing the sensing portion (e.g. the pressure transducer) to have direct contact with the body is provided. In one aspect, a silicon chip, a gold preform and a metallic housing are each primed for sealing and are assembled. The assembly is then heated to react the gold preform to the silicon chip and to form a molten gold-silicon alloy in-situ to bind the metallic housing to the non-sensing portion of the silicon chip. In this way, the non-sensing portion of the silicon chip is hermetically sealed and protected from exposure, while still permitting exposure of the sensing portion to the environment.

Abstract: An implantable cardiac stimulation device applies pacing stimulation pulses to a heart and senses evoked responses to the pacing stimulation pulses. A pulse generator applies the stimulation pacing pulses to the heart in accordance with a pacing configuration. A sensor control selects an evoked response sensing electrode configuration from among a plurality of evoked response sensing electrode configurations in response to the pacing configuration. A sensor is then programmed to sense the evoked responses with the selected evoked response sensing electrode configuration. In accordance with a preferred embodiment, signal-to-noise ratios obtained with the various electrode configurations are used to select a best electrode configuration for sensing evoked responses.

Abstract: An external programmer is provided with the capability of automatically resetting the programming state of an implantable medical device to a previous programming state. To this end, the pacemaker maintains parameters representative of current and past programming states. In response to a physician-initiated reset function using an external programmer, the pacemaker transfers information pertaining to the programming states to the external programmer along with a pointer identifying the current state. The physician selects one of the previous programming states and the external programmer then updates the pointer to identify the selected state and transmits the pointer back to the pacemaker. The pacemaker accesses the programming parameters stored therein corresponding to the programming state identified by the new pointer and is reprogrammed. Accordingly, the programming state of the pacemaker is reset to the previous programming state without requiring manual reentry of the parameters.

Abstract: An implantable cardiac stimulation device applies pacing stimulation pulses to a heart and senses evoked responses to the pacing stimulation pulses. A pulse generator applies the stimulation pacing pulses to the heart in accordance with a pacing configuration. A sensor control selects an evoked response sensing electrode configuration from among a plurality of evoked response sensing electrode configurations in response to the pacing configuration. A sensor is then programmed to sense the evoked responses with the selected evoked response sensing electrode configuration. In accordance with a preferred embodiment, signal-to-noise ratios obtained with the various electrode configurations are used to select a best electrode configuration for sensing evoked responses.

Abstract: A system and method for identifying and displaying safety alert advisories. The system of the present invention automatically performs a comparison of identification data with a safety alert advisory. The system stores identification data in a plurality of dedicated fields. Each of the dedicated fields contains information related to the patient. Upon the telemetric retrieval of the data by an external programmer, the external programmer automatically cross-correlates the data in the dedicated fields with the safety alert advisories. Upon identification of a match between the data and one of the safety alert advisories, the identified safety alert advisory is displayed to a medical practitioner. In addition, the system provides a dedicated memory to store an advisory flag. The advisory flag is marked when the programmer identifies a safety alert condition that is relevant to one of the dedicated fields.

Abstract: A pacemaker programmer and diagnostic system retrieves information stored within a pacemaker and analyzes the retrieved data in real time. The stored information can be retrieved by means of a telemetry communication link. The pacemaker automatically lengthens an AV delay. The pacemaker determines atrial capture by generating atrial stimulation pulses while maintaining the ventricular stimulation pulse amplitude at a level known to ensure ventricular capture, and by detecting loss of atrial capture. In response to the loss of atrial capture, a processor automatically records the atrial capture threshold, and restores the AV delay to its pre-test value. The pulse generator also delivers a backup atrial stimulation pulse concurrent with a ventricular stimulation pulse to reduce the possibility of a retrograde P-wave initiating a pacemaker-mediated tachycardia (PMT).

Abstract: A pacemaker programmer and diagnostic system retrieves information stored within a pacemaker and analyzes the retrieved data in real time. The stored information can be retrieved by means of a telemetry communication link. The pacemaker automatically lengthens a post-ventricular atrial refractory period (PVARP). The pacemaker determines atrial capture threshold by generating atrial stimulation pulses while maintaining the ventricular stimulation pulse amplitude at a level known to ensure ventricular capture, and by detecting loss of atrial capture. In response to loss of atrial capture, a processor automatically triggers a premature ventricular contraction (PVC) response to prevent a retrograde P-wave from initiating a pacemaker-mediated tachycardia. Also in response to loss of atrial capture, the processor sets the atrial stimulation pulse amplitude to a value above the atrial capture threshold in a subsequent cardiac cycle, and restores the PVARP to its pre-test value.