Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The preferred embodiment of the catheter includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The preferred embodiment of the catheter includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through guide tubes which may be supported by an expandable balloon. The guide tubes expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The diameter of the inflated balloon is less than the inside diameter of the vessel, allowing perfusion across the inflated balloon and guide tubes.

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: 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: 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 system for the detection of cardiac events occurring in a human patient is provided. At least two electrodes are included in the system for obtaining an electrical signal from a patient's heart. An electrical signal processor is electrically coupled to the electrodes for processing the electrical signal and a patient alarm means is further provided and electrically coupled to the electrical signal processor. The electrical signal is acquired in the form of electrogram segments, which are categorized according to heart rate, ST segment shift and type heart rhythm (normal or abnormal). Baseline electrogram segments are tracked over time.

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 catheter-based/intravascular ablation system includes needles which expand around a central axis to engage a blood vessel or left atrium wall, allowing the injection of an ablative solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein or around the renal artery. The system includes means to adjust the depth of penetration into the tissue of the targeted blood vessel wall. The catheter can include expandable guide tubes that engage the blood vessel wall. Injection needles having injection egress at or near their sharpened distal end are then advanced through the guide tubes to penetrate the blood vessel wall to a prescribed depth. The ability to provide PeriVascular injection only affecting the outer layer(s) of a blood vessel without affecting the media has particular application for PeriVascular Renal Denervation (PVRD) of the sympathetic nerves which lie in or outside the adventitia of the renal artery.

Abstract: A catheter-based/intravascular ablation system includes needles which expand around a central axis to engage a blood vessel or left atrium wall, allowing the injection of an ablative solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein or around the renal artery. The system includes means to adjust the depth of penetration into the tissue of the targeted blood vessel wall. The catheter can include expandable guide tubes that engage the blood vessel wall. Injection needles having injection egress at or near their sharpened distal end are then advanced through the guide tubes to penetrate the blood vessel wall to a prescribed depth. The ability to provide PeriVascular injection only affecting the outer layer(s) of a blood vessel without affecting the media has particular application for PeriVascular Renal Denervation (PVRD) of the sympathetic nerves which lie in or outside the adventitia of the renal artery.

Abstract: The present invention is a carotid sheath that has a proximal portion that is stiffer than the distal portion of the sheath as a result of the proximal portion having a higher durometer of the outer plastic coating of the sheath's proximal portion with a lower durometer for the plastic coating on the more flexible distal portion of the sheath. Another means to increase the flexibility of the sheath's distal portion compared to a stiffer proximal portion is by having a slightly smaller outside diameter for the outer plastic coating of the distal portion of the sheath. A more flexible distal portion of the sheath allows easier access for angiography, angioplasty or stenting when the sheath is used to access the tortuous path encountered when entering the carotid arteries.

Abstract: Dilators and sheaths for use in minimally invasive vascular therapy are disclosed. In some embodiments, the dilators include a slot that accesses a guidewire lumen within the dilator. These slots facilitate rapid exchange of one dilator for another. In another embodiment, a dilator is sufficiently stiff to facilitate entry, but also designed to facilitate placement of the dilator along a tortuous path.

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: 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 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: 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: 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: The present invention is a carotid sheath that has a proximal portion that is stiffer than the distal portion of the sheath as a result of the proximal portion having a higher durometer of the outer plastic coating of the sheath's proximal portion with a lower durometer for the plastic coating on the more flexible distal portion of the sheath. Another means to increase the flexibility of the sheath's distal portion compared to a stiffer proximal portion is by having a slightly smaller outside diameter for the outer plastic coating of the distal portion of the sheath. A more flexible distal portion of the sheath allows easier access for angiography, angioplasty or stenting when the sheath is used to access the tortuous path encountered when entering the carotid arteries.

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.