Abstract: The invention describes fluid-based lead systems. The fluid-based leads may be used for sensing from, and stimulating of, human tissue. The fluid-based leads can be used to transfer signals between two locations. The fluid-based leads offer advantages when communicating signals along their length since the leads may be safely used in magnetic environments and offer increased elastic characteristics which are less prone to breakage. The leads can be used externally or with implantable devices, such as those used to monitor, and deliver therapy during the treatment of medical disorders such as cardiac and neurological disorders.

Abstract: A medical alarm communications system comprises a pager like device to be kept near a patient. The pager like device communicates medical alerts regarding the patient to a remote central station, which can provide therapeutic and/or diagnostic assistance by communicating to the pager like device. When the pager like device determines that an alert should be sent to the central station, it attempts to establish communication with the central station according to a primary communication protocol. If this attempt is unsuccessful according to some predetermined criteria (e.g. too much time has elapsed before communication is established), then the pager like device generates a message to the patient indicative of the failure, and The attempts to establish communication with the central station according to a secondary communication protocol.

Abstract: Disclosed is a system for the detection of cardiac events (a guardian system) that includes an implanted device called a cardiosaver, a physician's programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using one or more detection algorithms, the cardiosaver can detect a change in the patient's electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the guardian system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means).

Abstract: Disclosed are methods for detecting an acute myocardial infarction (i.e., a heart attack) at the earliest possible time and promptly warning the patient that he should immediately seek medical care. The present invention includes an implantable electronic system that can sense a change in the patient's electrogram that is indicative of a heart attack. If a heart attack is sensed, the device would then cause an implantable and/or externally located alarm to be actuated to warn the patient of his condition and a medical practitioner at a remote diagnostic center would receive the patient's electrogram for analysis. The patient or a caretaker would then be informed to self-inject medication through a subcutaneous, pass-through drug port that can be a separate device or integrated into the implanted device that is designed for the early detection of a heart attack.

Abstract: An implanted device which includes a vibrator having a drive motor and a drive circuit. An accelerometer is connected to the vibrator and senses alarm test data related to the displacement of the vibrator. A power source provides electricity to the implanted device and a processor is configured for bi-directional wireless communication. The processor is configured for receiving a command from an external device for performance of an alarm test and the processor analyzes the alarm test data for generating test results.

Abstract: A stent in the form of a thin-walled, multi-cellular tubular structure is provided. The tubular structure has a longitudinal axis and the stent includes a plurality of circumferential sets of strut members. Each set of the strut members is longitudinally displaced from each other and connected to each other by longitudinally extending links. Each set of the strut members forms a closed and cylindrical portion of the stent. Further, each set of the strut members includes a plurality of connected curve sections and diagonal sections. The sets of the strut members further include end sets of strut members located at each end of the stent and central sets of strut members located between the end sets of the strut members. The diagonal sections of the end sets of the strut members have a center portion and two ends.

Abstract: A device for detecting cardiac ischemia is disclosed. The device includes a processor that is configured to operate in three different modes according to relative frequency of different beat types. If beats of a first beat type, such as ventricularly paced beats, are predominant, the processor ignores other beat types and performs ischemia detection only on ventricularly paced beats. Conversely, if beats of a second beat type, such as sinus or atrially paced beats, are predominant, the processor ignores ventricularly paced beats and performs ischemia detection only on sinus or atrially paced beats. If there is a mixture of beat types such that neither predominates, the processor performs ischemia detection on both beat types.

Abstract: A thin-walled introducer sheath is described. In some embodiments, the introducer sheath includes structural support components, such as wires, used in connection with a polymeric inner coating, a polymeric outer coating, or both. Further, in some embodiments, the wire components are annealed to reduce cold-work-related stresses and hardness. Use of annealed components may enable a reduction in the thickness of the polymeric outer coating in some applications.

Abstract: A vascular nerve ablation (denervation) system includes a multiplicity of expandable needles which open around a central axis to engage the wall of a blood vessel allowing the injection of a cytotoxic or neurotoxic solution for ablating conducting tissue in and near the vessel wall of a renal artery or pulmonary vein. The expandable needles are formed of self-expanding materials and include structures which limit the distance of penetration of the injection needles into the tissue of the wall of the blood vessel.

Abstract: A catheter-based/intravascular fluid injection system with application to renal denervation includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic and/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable delivery system includes expandable components that facilitate positioning of a multiplicity of injection needles against the inside wall of a blood vessel from where they can be advanced. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel.

Abstract: A catheter-based/intravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic or/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel.

Abstract: An introducer sheath for placement into the vascular system of a human subject. The introducer sheath has a tubular shaft, a side arm, and a hemostasis valve with an integrated attachment mechanism for attaching and detaching a proximal end of the introducer sheath to and from the skin of the human subject.

Abstract: Alarm tests are disclosed which use alarm test signals to assess alarms provided by medical devices. Especially relevant are implanted devices that monitor cardiac activity and provide notification in response to medically relevant events. Alarm tests can occur periodically, or in response to a patient, doctor, or remote party initiating the alarm test. Alarm tests can also occur during the actual alarms issued to detected medical events. Alarm tests lead to pass or fail results, which in turn may cause operations to contingently occur. Alarm test failure in the auditory, visual, or tactile modality, may cause an alternatively defined alarm signal to be used as back-up. Alarm test logs can store alarm test results, including quantification of the measured alarm signal. Rapid alarm tests are described, as are various methods of accurately measuring characteristics of the test signal in ambulatory patients, which are especially relevant to a vibration alarm.

Abstract: At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium, or the aortic wall.

Abstract: At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium.

Abstract: A device for detecting cardiac ischemia is disclosed. The device includes a processor that is configured to distinguish between two different heart beats types such as ventricularly paced beats and supraventricular beats. The processor applies different ischemia tests to the two different beat types, and generates alert when it detects ischemia.

Abstract: Alarm tests are disclosed which use alarm test signals to assess alarms provided by medical devices. Especially relevant are implanted devices that monitor cardiac activity and provide notification in response to medically relevant events. Alarm tests can occur periodically, or in response to a patient, doctor, or remote party initiating the alarm test. Alarm tests can also occur during the actual alarms issued to detected medical events. Alarm tests lead to pass or fail results, which in turn may cause operations to contingently occur. Alarm test failure in the auditory, visual, or tactile modality, may cause an alternatively defined alarm signal to be used as back-up. Alarm test logs can store alarm test results, including quantification of the measured alarm signal. Rapid alarm tests are described, as are various methods of accurately measuring characteristics of the test signal in ambulatory patients, which are especially relevant to a vibration alarm.

Abstract: Disclosed is a system for the detection of cardiac events that includes an implanted device called a cardiosaver, a physician's programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using different algorithms, the cardiosaver can detect a change in the patient's electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means) which are activated after the ST segment of the electrogram exceeds a preset threshold.

Abstract: Disclosed is a means and method for the treatment of migraine headaches and other disorders of the human body by the application of one or more intense magnetic pulses. By placing an intense magnetic field pulse(s) onto a certain region of the brain, an electrical current can be generated in the cerebral cortex that can stop a migraine headache in some patients or at least decrease its severity. The device to perform this function can be called a “magnetic pulser system.” This system can be made in one piece and powered by plugging into a household or automobile receptacle or from a battery. The pulser system uses capacitors that are first charged to a high voltage and then discharged into a coil that creates the intense magnetic pulse. Both visual and auditory signals can be provided by the pulser system to assist the patient in using the device.

Abstract: A physician's programmer for an implantable device is disclosed. The programmer includes a receiver for receiving wireless transmission data from the implantable heart monitor. A processor is configured to extract from the wireless transmission data ST-deviation histogram data as a function of heart rate. The histogram data for a particular heart rate range is shown on a display in the form of a bar chart. The histogram data for a plurality of heart rate ranges is shown in the form of a chart with multiple line plots.