Abstract: Devices, systems and methods are provided for treating a variety of conditions with PEF energy. PEF energy is typically characterized as high voltage pulsed energy that is configured to be delivered in one or more doses. The one or more doses create a lesion in the tissue. Lesion dimensions vary depending on the parameters of the PEF waveform and the dose, among other influences such as tissue type, etc. Therefore, different waveforms of PEF energy and different doses of PEF energy provide different results, particularly different lesion sizes and types. Systems, devices, and methods are provided that allow a physician or user to control the PEF energy delivered to provide a desired result and/or provide predictive information with which the user can utilize to generate a desired result.

Abstract: Devices, systems and methods are provided for treating conditions of the heart, particularly the occurrence of arrhythmias, more particularly atrial fibrillation. Therapeutic pulsed electric field energy is delivered to portions the heart to provide tissue modification, particularly to the entrances to the pulmonary veins in the treatment of atrial fibrillation. Such tissue modification creates a lesion or series of lesions which act as a conduction block within the tissue to prevent the transmission of aberrant electrical signals. Cardiovascular lesion analysis systems and methods provide information related to the effectiveness of the treatment during the procedure so as to create an electrical blockade within the heart that will remain durable and effective long-term.

Abstract: Devices, systems and methods are provided to treat damaged, diseased, abnormal, obstructive, undesired or potentially undesired tissue by delivering specialized pulsed electric field (PEF) energy and optionally therapeutic agents to target tissue areas, particularly within the vasculature. The therapy may be used to treat a variety of conditions, particularly conditions of the vascular system such as atherosclerosis and angina. Once a target tissue area has been identified as associated with vascular spasm, the target tissue areas are treated with PEF energy. Optionally, one or more agents can be delivered as well in conjunction with the treatment. Although the primary focus is on treating the coronary arteries, such treatment may be applicable to other portions of the vasculature, including the peripheral vasculature. Likewise, such treatment may be applicable to other body lumens.

Abstract: Devices, systems and methods are provided for treating conditions of the heart, particularly the occurrence of arrhythmias. The devices, systems and methods deliver therapeutic energy to portions the heart to provide tissue modification, such as to the entrances to the pulmonary veins in the treatment of atrial fibrillation. Generally, the tissue modification systems include a specialized catheter, a high voltage waveform generator and at least one distinct energy delivery algorithm. Other embodiments include conventional ablation catheters and system components to enable use with a high voltage waveform generator. Example catheter designs include a variety of delivery types including focal delivery, “one-shot” delivery and various possible combinations. In some embodiments, energy is delivered in a monopolar fashion. However, it may be appreciated that a variety of other embodiments are also provided.

Abstract: A system that produces temperature estimations of a tissue surface comprises a base, a probe assembly having a proximal end and a distal end, a fiber assembly extending through the probe assembly, a motion unit at the base constructed and arranged to at least one of rotate at least one fiber relative to the base about the longitudinal axis and translate the at least one fiber relative to the base in a linear direction along the longitudinal axis, a first coupling mechanism coupled to the base, wherein the handle is removably coupled to the first coupling mechanism, and a second coupling mechanism at the motion unit, wherein the probe connector is removably coupled to the second coupling mechanism.

Abstract: A system is provided for stimulating one or more cells, wherein the stimulation is sub-threshold and may alter a transmembrane potential of the one or more cells. For some populations of cells it may be possible to affect the transmembrane potential to gain a therapeutic benefit. Cells of the sino-atrial node spontaneously depolarize predominantly due to the slow depolarization of transmembrane potential. The present system may provide sino-atrial cells with a local field stimulation that while not eliciting an action potential may nonetheless alter local transmembrane potential. Such alteration of transmembrane potential may permit an increase or decrease in a rate of depolarization, and hence modify heart rate.

Abstract: A system and device are provided which include a gene regulatory system controlling expression of one or more expression cassettes present in or released by the device, by emitting one or more stimulations. An expression cassette includes a regulatable transcription control element that is responsive to the emitted stimulations linked to an open reading frame of interest. The system optionally includes a sensor to sense a parameter indicative of a need, a telemetry module to receive an external command, or a programmable device, for regulating gene expression of the open reading frame.

Abstract: A catheter with a tissue property sensor provides for localization of myocardial infarction (MI) by utilizing one or more differences between properties of infarcted myocardial tissue and properties of normal myocardial tissue. The tissue property sensor is to be placed on endocardial wall or epicardial wall during catheterization to sense at least one tissue property allowing for detection of MI. In one embodiment, the tissue property sensor includes a contractility sensor and senses a tissue property in various locations on endocardial wall or epicardial wall and detects substantial changes in the tissue property that indicate a boundary between infarcted tissue and normal tissue.

Abstract: A method for monitoring a biological cardiac pacemaker is provided. The method may include stimulating a heart at a region selected for implantation of a biological pacemaker and sensing at least one electrical signal indicative of a cardiac depolarization originating in the region selected for implantation of the biological pacemaker. The method may further include sensing at least one subsequent electrical signal produced by the heart and determining if the subsequent electrical signal originated in the region selected for the biological pacemaker or another region of the heart. In an alternative embodiment, the method may include determining a template time difference between two points on cardiac complexes sensed in two or more different cardiac locations during normal sinus rhythm. The method may further include determining a time difference between two points on a subsequent cardiac complex sensed in two or more different cardiac locations.

Abstract: An implantable system for the defibrillation of the atria of a patient's heart comprises (a) a first catheter configured for insertion into the right atrium of the heart, preferably without extending into the right ventricle of the heart; a first atrial defibrillation electrode carried by the first catheter and positioned at the atrial septum of the heart (i.e., an atrial septum electrode); (b) a second atrial defibrillation electrode which together with the first atrial defibrillation electrode provides a pair of atrial defibrillation electrodes that are configured for orientation in or about the patient's heart to effect atrial defibrillation, and (c) a pulse generator operatively associated with the pair of atrial defibrillation electrodes for delivering a first atrial defibrillation pulse to the heart of the patient. The second electrode may be configured for positioning through the coronary sinus ostium and in the coronary sinus or a vein on the surface of the left ventricle, such as the great vein.

Abstract: A method for monitoring a biological cardiac pacemaker is provided. The method may include stimulating a heart at a region selected for implantation of a biological pacemaker and sensing at least one electrical signal indicative of a cardiac depolarization originating in the region selected for implantation of the biological pacemaker. The method may further include sensing at least one subsequent electrical signal produced by the heart and determining if the subsequent electrical signal originated in the region selected for the biological pacemaker or another region of the heart. In an alternative embodiment, the method may include determining a template time difference between two points on cardiac complexes sensed in two or more different cardiac locations during normal sinus rhythm. The method may further include determining a time difference between two points on a subsequent cardiac complex sensed in two or more different cardiac locations.

Abstract: A method for monitoring a biological cardiac pacemaker. The method may include stimulating a heart at a region selected for implantation of a biological pacemaker and sensing at least one electrical signal indicative of a cardiac depolarization originating in the region selected for implantation of the biological pacemaker. The method may further include sensing at least one subsequent electrical signal produced by the heart and determining if the subsequent electrical signal originated in the region selected for the biological pacemaker or another region of the heart.

Abstract: An implantable system which includes a gene/protein delivery device and a pulse generator, as well as method of preparing the gene/protein delivery device and using the system, are provided. In one embodiment, the implantable system detects a predetermined condition or event and, in response, delivers gene(s) and/or protein(s) in conjunction with delivering pacing and/or defibrillation pulses.

Abstract: An implantable medical device in which an electrogram is recorded and analyzed in order to detect changes indicative of cardiac ischemia. Cardiac ischemia may be detected by recording an electrogram from a sensing channel of the device and comparing the recorded electrogram with a reference electrogram. If cardiac ischemia is detected, a cardiac drug such as a thrombolytic agent is delivered.

Abstract: The present invention includes a method for controlling pacemaker therapy in a patient with an implanted biological pacemaker. The method may include pacing a heart at a predetermined rate using an electronic pacemaker and configuring the pacemaker to periodically enter a biological pacemaker weaning mode. The weaning mode may include ceasing pacing for at least a predetermined length of time and monitoring the heart to detect electrical depolarizations of a ventricle of the heart during the predetermined length of time. The weaning mode may further include determining the length of time between the cessation of pacing and the detected electrical depolarization and determining if the length of time between the cessation of pacing and the detected electrical depolarization is less than a maximum predetermined interval. The pacemaker therapy may be withheld as long as the length of time is less than the maximum predetermined interval.

Abstract: The invention provides a composition for cold storage of cells which includes a population of isolated stem cells, a cell medium, and isolated trophic factors, as well as devices having a plurality of the trophic factors.

Abstract: An implantable system for the defibrillation of the atria of a patient's heart comprises (a) a first catheter configured for insertion into the right atrium of the heart; a first atrial defibrillation electrode carried by the first catheter and positioned to stimulate Bachmann's bundle, or positioned at the atrial septum of the heart (i.e., an atrial septum electrode); (b) a second atrial defibrillation electrode which together with the first atrial defibrillation electrode provides a pair of atrial defibrillation electrodes that are configured for orientation in or about the patient's heart to effect atrial defibrillation, and (c) a pulse generator operatively associated with the pair of atrial defibrillation electrodes for delivering a first atrial defibrillation pulse to the heart of the patient. The second electrode may be configured for positioning through the coronary sinus ostium and in the coronary sinus or a vein on the surface of the left ventricle, such as the great vein.

Abstract: A cardiac rhythm management system includes a lead assembly for intracardiac mapping, pacing, and drug delivery. The lead assembly includes an implantable endocardial lead having a proximal end for connection to an implantable cardiac rhythm management device and a distal end for disposal in an intracardiac region. The lead includes a pacing-sensing electrode and a drug delivery device, both located at or near the distal end. A lumen is within and extends throughout the lead, with an opening at or near the proximal end and another opening at or near the distal end. The lumen provides for access to the intracardiac region by a steerable stylet and a hollow needle, one at a time. The steerable stylet allows for electrophysiological mapping of the intracardiac region. The hollow needle allows for delivery of chemical, biochemical, and/or biological substance to the intracardiac region.

Abstract: A method and device for delivering defibrillation shock therapy in patients having an inter-ventricular conduction disorder is presented. Ventricular resynchronization therapy is employed to reduce the dispersion of ventricular depolarization which takes place due to the conduction disorder and reduces the safety margin of shocks delivered synchronously with ventricular beats. The method may be employed in the treatment of atrial or ventricular tachyarrhythmias.

Abstract: A cardiac rhythm management device is configured to detect oscillations in cardiac rhythm by comparing electrogram signals during successive heart beats. Upon detection of electrical alternans, the device may adjust its operating behavior to compensate for the deleterious effects of the condition.