Abstract: A band-shaped annuloplasty device (e.g., C- or D-shaped ring) that is relatively rigid during handling and implantation and becomes relatively complaint after implantation. Preferably, the device includes a core material that softens after implantation.

Abstract: An implantable medical device such as a defibrillator is described. The device includes an hermetically sealed housing containing a flat electrolytic capacitor and an energy source such as a battery. The battery is connected to the capacitor and provides charge thereto. The capacitor stores the charge at a relatively high voltage. The charge stored in the capacitor is discharged through a defibrillation lead to a site on or in the heart when fibrillation of the heart is detected by the implantable medical device. Methods of making and using the implantable medical device, the capacitor, and their various components are disclosed.

Abstract: An implantable medical device monitoring method and system monitors chronic data representative of at least one physiological parameter. The chronic data is monitored to detect changes in state of the at least one physiological parameter. Data associated with detected changes in state is stored within the implantable medical device. The detection of changes in state of the at least one physiological parameter is performed by establishing a baseline (e.g., a center reference line and upper and lower control limits), and then determining if the chronic data being monitored satisfies predetermined conditions (e.g., conditions based on the center reference line and the upper and lower control limits) indicative of a change in state of the at least one physiological parameter. The data stored in memory associated with the detected change in state of the at least one physiological parameter may, for example, include data representative of the center reference line and/or upper and lower control limits.

Abstract: Mulifunction and radial deflection wires (66, 64) extend from a catheter shaft (8) and into a handle (4). The multifunction wire is pulled and pushed longitudinally and is rotated about its axis to change the stiffness of and to laterally deflect the tip portion (12). A curve size manipulator (32) on the handle body (24) moves the multifunction wire longitudinally but does not hinder its rotational movement. Rotation of a lateral deflection manipulator (38) on the handle causes the proximal end (70) of the multifunction wire to rotate about its own axis; the free longitudinal movement of the proximal end is unhindered. Any initial corkscrewing or other deflection of the tip portion can be removed at assembly by rotating the proximal end (68) of the radial deflection wire. The longitudinal movement of the manipulators can be limited by movable stops (120). The longitudinal positions of the abutment faces (126, 128) of the stops preferably change according to their longitudinal (distal or proximal) orientation.

Abstract: A barometric pressure sensor for deriving reference pressure data for use in combination with absolute pressure data derived by an implantable medical device (IMD) is disclosed. The barometric pressure sensor is located in a sensing module adapted to be located with the patient's body having a module housing enclosing an air chamber which encloses the barometric pressure sensor. An air vent extends through the module housing for venting the air chamber to atmospheric pressure outside the module housing. A protective vent cover extends across the air vent formed of a material capable of air passage and capable of inhibiting passage of moisture, liquids, and particulate contaminants through the air vent and into the air chamber. In one embodiment, the sensing module is adapted to be worn or carried by the patient and includes operating circuitry and a power supply for powering the barometric pressure sensor and periodically storing sensed atmospheric pressure values as reference pressure data.

Abstract: An automatic, body-implantable medical device having at least two modes of operation is disclosed. The device is provided with circuitry for automatically detecting when the device has been implanted in a patient, so that the device can automatically switch from a first mode to a second mode of operation upon implantation. In one embodiment, the first mode is a power conserving mode in which one or more non-essential sub-systems of the device are disabled. Prior to detection of implant, at least two conditions of the device known to reflect whether the device has been implanted are monitored. After implant has been detected, situations in which power to the device is disrupted and then restored will cause the device to enter a predefined "power-on-reset" mode of operation. Prior to detection of implant, however, such conditions do not result in the device entering the power-on-reset mode, or this mode is reset.

Abstract: An implantable system is provided that includes: a cell repopulation source comprising genetic material, undifferentiated contractile cells, or a combination thereof capable of forming new contractile tissue in and/or near an infarct zone of a patient's myocardium; and an electrical stimulation device for electrically stimulating the new contractile tissue in and/or near the infarct zone of the patient's myocardium.

Abstract: A medical device comprising a biomaterial formed from a polymer comprising urethane groups, urea groups, or combinations thereof, and sacrificial moieties that preferentially oxidize relative to other moieties in the polymer.

Abstract: The present invention relates to multi-layer ceramic packaging of hybrid micro-electronic devices, including those for implantable medical devices. The invention permits size reduction and design simplification in such packaging by eliminating the need for electrolytic or electroless plating, and by eliminating or substantially eliminating the shrinkage variation typically associated with surface metallization techniques.

Abstract: A deflectable stylet or guidewire formed of an elongated tube having a coil mounted to its distal end and a movable tension or push wire mounted within the coil and the tube, mechanically coupled to the distal end of the coil. A backbone is located within the coil, mechanically coupled to the proximal and distal ends of the coil and extending along one side of the coil. The backbone may be provided with projections extending laterally between adjacent turns of the coil and may have a generally arcuate cross section having a width greater than its arc height. In some embodiments the backbone may be formed from a tube having a slot extending longitudinally along one side thereof. In some embodiments the backbone may be attached to the coil at points between the proximal and distal ends of the coil.

Abstract: The present invention relates to an apparatus for monitoring blood parameters during cardio-pulmonary bypass surgery or during other procedures which utilize an extracorporeal circuit. The apparatus is typically used to monitor the percentage of hemoglobin bound with oxygen (oxygen saturation), the total amount of hemoglobin in the blood, and the percent of blood which is comprised of red blood cells (hematocrit), although the apparatus can be adapted to measure other blood parameters. The apparatus (or monitor) provides real-time results to show immediate changes (trending) in the monitored parameters.

Abstract: A method and apparatus for discriminating between evoked response signals and post-pace polarization signals sensed by a sense amplifier of an implantable medical device. The polarity of the positive or negative change in voltage in respect of time (or dv/dt) of the waveform incident on the lead electrodes is monitored during a short period of time immediately following a paced event. The post-pace polarization signal exhibits a relatively constant polarity during the capture detect window, and the evoked response signal may cause the polarity of post-pace polarization signal to reverse during the capture detect window. The sign of the post-pace polarization polarity, either positive or negative, is determined. The evoked response signal may reverse the polarity of the sensed signal from positive to negative or from negative to positive, during the time window of interest.

Abstract: An implantable sensor assembly for use with an implantable medical device are disclosed. The sensor assembly preferably includes two or more physiologic sensors coupled to the medical device via a pair of lead conductors, or alternatively an oxygen sensor having certain features. The oxygen sensor permits more accurate and reliable measurement of oxygen saturation in blood masses flowing within the human body.

Abstract: A cardiac pacing lead for use in the coronary sinus and coronary veins. The lead is provided with a lead body configured to exhibit a curved configuration along a distal portion thereof, induced to maintain a portion of the curved configuration solely by means of a portion of a polyurethane lead body formed to display the curved configuration and wherein the lead conductor is freely mounted within the segment. The curved configuration includes first and second arcuate segments together providing a single-plane curvature of approximately 180 degrees, separated by a generally straight segment, the first segment having a greater length and greater arc of curvature than the second segment.

Abstract: A method or apparatus for conserving power in an implantable medical device (IMD) of the type having at least one IC powered by a battery wherein, in each such IC, a voltage dependent oscillator for providing oscillator output signals at an oscillation frequency dependent upon applied supply voltage to the IC is incorporated into the IC. The voltage dependent oscillator oscillates at a frequency that is characteristic of the switching speed of all logic circuitry on the IC die that can be attained with the applied supply voltage. The applied supply voltage is regulated so that the oscillation frequency is maintained at no less than a target or desired oscillation frequency or within a desired oscillation frequency range. The power supply voltage that is applied to the IC is based directly on the performance of all logic circuitry of the IC.

Abstract: An implantable medical device such as a defibrillator is described. The device includes an hermetically sealed housing containing a flat electrolytic capacitor and an energy source such as a battery. The battery is connected to the capacitor and provides charge thereto. The capacitor stores the charge at a relatively high voltage. The charge stored in the capacitor is discharged through a defibrillation lead to a site on or in the heart when fibrillation of the heart is detected by the implantable medical device. Methods of making and using the implantable medical device, the capacitor, and their various components are disclosed.

Abstract: A prosthetic mechanical heart valve, and in particular, a bi-leaflet and/or a trileaflet mechanical valve formed with rigid frame and hinge elements for providing a stable reliable hinge mechanism with flexible leaflets formed of a thin elastomeric material adhering to and extending from the valve frame to form leaflet occluding sections bounded by outer peripheral edges for softening the opening and closing action of the valve leaflets. In one embodiment, the valve leaflet is formed of a rigid pyrolytic carbon frame supporting hinge elements and defining a leaflet pivot axis and a flexible leaflet body attached to the frame and defining a leaflet abutting section extending from one side of the valve frame and an occluding section extending from the other side of the valve frame to an arcuate leaflet seat.

Abstract: An implantable antiarrhythmia device which detects and classifies arrhythmias of the human heart, and delivers appropriate therapy. The device employs a method of arrhythmia classification based on a set of prioritized rules, each of the rules defining a plurality of criteria based upon characteristics of sensed depolarizations of heart tissue, each rule being met when the criteria associated with the rule are met. Some rules, when met, trigger delivery of antiarrhythmia therapy. Other rules, when met, inhibit delivery of antiarrhythmia therapy. The rules may be met simultaneously, and if so, the highest priority rule governs the behavior of the device.

Abstract: An implantable sensor assembly for use with an implantable medical device are disclosed. The sensor assembly preferably includes two or more physiologic sensors coupled to the medical device via a pair of lead conductors, or alternatively an oxygen sensor having certain features. The oxygen sensor permits more accurate and reliable measurement of oxygen saturation in blood masses flowing within the human body.

Abstract: An arrangement for transvenously introducing and fixing a cardiac electrode at a cardiac implantation site. The arrangement includes a pusher having an elongated body of flexible material, which may be coupled with a cardiac lead adjacent the distal end of the cardiac lead and may be employed to advance the cardiac lead transvenously. The pusher is provided with an engagement mechanism which engages the distal end of the cardiac lead while the lead extends proximally along side the exterior surface of the pusher and which engages the distal end of the lead body when the pusher body is advanced distally and disengages from the cardiac lead body when the pusher is withdrawn proximally. The pusher body has sufficient column strength to be advanced through a patient's venous system to a desired implantation site within the heart.