Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: An improved user interface system for an irreversible electroporation (IRE) system is provided. User interfaces are provided that dynamically display information provided by an operator or provided by the IRE system during setup, planning, and implementation stages of an IRE procedure in a more intuitive and efficient manner. As a result of being provided the user interfaces described herein, operators can plan and implement more effective IRE procedures to the benefit of a patient.

Abstract: The present invention relates to medical devices and methods for treating a lesion such as a vascular stenosis using non-thermal irreversible electroporation (NTIRE). Embodiments of the present invention provide a balloon catheter type NTIRE device for treating a target lesion comprising a plurality of electrodes positioned along the balloon that are electrically independent from each other so as to be individually selectable in order to more precisely treat an asymmetrical lesion in which the lesion extends only partially around the vessel.

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: Methods, systems and devices are provided which transmit energy to a body lumen or passageway in the form of pulsed electric fields (PEFs) and in a manner which provides focal therapy. In some embodiments, PEFs are delivered through independent electrically active electrodes of an energy delivery body, typically in a monopolar fashion. Such delivery concentrates the electrical energy over a smaller surface area, resulting in stronger effects than delivery through an electrode extending circumferentially around the lumen or passageway. It also forces the electrical energy to be delivered in a staged regional approach, mitigating the effect of preferential current pathways through the surrounding tissue. Focal delivery of PEFs can provide increased tissue lethality by employing precise timing and sequencing of energy delivery to the electrodes.

Abstract: The present invention provides methods, devices, and systems for in vivo treatment of cell proliferative disorders. Included is a method of treating tissue with electrical energy, the method comprising: delivering electrical energy to tissue using one or more electroporation devices comprising one or more electrodes; and cooling the tissue, surrounding tissue, one or more of the electrodes, or one or more of the electroporation devices to minimize heating. In embodiments, the invention can be used to treat solid tumors, such as brain tumors, and in some embodiments, exemplary methods rely on non-thermal irreversible electroporation (IRE) to cause cell death in treated tumors.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

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, cancerous or undesired tissue (e.g. a tumor, a benign tumor, a malignant tumor, a cyst, or an area of diseased tissue, etc) by delivering specialized pulsed electric field (PEF) energy to target tissue areas. The energy is delivered in a manner so as to be non-thermal (i.e. below a threshold for causing thermal ablation). Consequently, when extracellular matrices present, the extracellular matrices are preserved, and the targeted tissue maintains its structural architecture including blood vessels and lymphatics. Thus, sensitive structures, such as biological lumens, blood vessels, nerves, etc, are preserved which are critical to maintaining the integrity and functionality of the tissue. The energy is delivered with the use of systems and devices advantageously designed for superior access to target tissue throughout the body, particularly in locations previously considered inaccessible to percutaneous approaches.

Abstract: A medical system and method for estimating a treatment region for a medical treatment device is provided. The system includes a memory; a processor coupled to the memory; and a treatment control module stored in the memory and executable by the processor. The treatment control module generates an estimated treatment region which is an estimate of a treatment region which would have been derived as a result of a numerical model analysis such as a finite element analysis. Advantageously, the estimated treatment region is generated using a fraction of the time it takes to generate the region using the numerical model analysis.

Abstract: Apparatuses, systems and methods are provided for treating pulmonary tissues via delivery of energy, generally characterized by high voltage pulses, to target tissue using a pulmonary tissue modification system (e.g., an energy delivery catheter system). Example pulmonary tissues include, without limitation, the epithelium (the goblet cells, ciliated pseudostratified columnar epithelial cells, and basal cells), lamina propria, submucosa, submucosal glands, basement membrane, smooth muscle, cartilage, nerves, pathogens resident near or within the tissue, or a combination of any of these. The system may be used to treat a variety of pulmonary diseases or disorders such as or associated with COPD (e.g., chronic bronchitis, emphysema), asthma, interstitial pulmonary fibrosis, cystic fibrosis, bronchiectasis, primary ciliary dyskinesia (PCD), acute bronchitis and/or other pulmonary diseases or disorders.

Abstract: Treatment of damaged, diseased, abnormal, obstructive, cancerous or undesired tissue (e.g. a tumor, a benign tumor, a malignant tumor, a cyst, or an area of diseased tissue, etc.) is provided by delivering specialized pulsed electric field (PEF) energy to target tissue areas in a specific dose so as to obtain a superior outcome. The PEF energy and delivery has been optimized to provide advanced treatment of target tissue areas, including destruction of undesired tissue and generation of improved inflammatory and immune responses. These various types of treatment are controlled by a variety of factors including the electrode geometry, the dose of PEF energy delivered, the time the energy is delivered over, and the waveform of the PEF energy itself. The PEF energy is delivered in the form a dose which is considered to be one application of the specialized energy. Each dose creates a lesion in the target tissue area.

Abstract: Methods and systems for distributing electrical energy to tissue which minimize Joule heating, thermal effects, and/or thermal damage, without sacrificing efficacy of treatment, are described. The methods and systems are particularly suitable to electrical energy-based therapies employing multiple electrodes, such as arrays of electrodes.

Abstract: The present invention provides methods, devices, and systems for in vivo treatment of cell proliferative disorders. Included is a method of treating tissue with electrical energy, the method comprising: delivering electrical energy to tissue using one or more electroporation devices comprising one or more electrodes; and cooling the tissue, surrounding tissue, one or more of the electrodes, or one or more of the electroporation devices to minimize heating. In embodiments, the invention can be used to treat solid tumors, such as brain tumors, and in some embodiments, exemplary methods rely on non-thermal irreversible electroporation (IRE) to cause cell death in treated tumors.

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 of target tissue within a body of a patient, particularly tumors. Such systems can include an energy delivery device having at least one energy delivery body configured to be positioned near a target tissue area of the patient, and a generator in electrical communication with the at least one energy body. The generator can include at least one energy delivery algorithm configured to provide an electric signal of pulsed electric field energy deliverable to the at least one energy delivery body so as to induce extravasation within the target tissue area.

Abstract: The present invention relates to the field of medical treatment of diseases and disorders, as well as the field of biomedical engineering. Embodiments of the invention relate to the delivery of Irreversible Electroporation (IRE) through the vasculature of organs to treat tumors embedded deep within the tissue or organ, or to decellularize organs to produce a scaffold from existing animal tissue with the existing vasculature intact. In particular, methods of administering non-thermal irreversible electroporation (IRE) in vivo are provided for the treatment of tumors located in vascularized tissues and organs. Embodiments of the invention further provide scaffolds and tissues from natural sources created using IRE ex vivo to remove cellular debris, maximize recellularization potential, and minimize foreign body immune response. The engineered tissues can be used in methods of treating subjects, such as those in need of tissue replacement or augmentation.

Abstract: Methods and systems for distributing electrical energy to tissue which minimize Joule heating, thermal effects, and/or thermal damage, without sacrificing efficacy of treatment, are described. The methods and systems are particularly suitable to electrical energy-based therapies employing multiple electrodes, such as arrays of electrodes.

Abstract: The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Abstract: Energy is transmitted to a body lumen or passageway in the form of pulsed electric fields (PEFs) and in a manner which provides focal therapy. In some embodiments, PEFs are delivered through independent electrically active electrodes of an energy delivery body, typically in a monopolar fashion. Such delivery concentrates the electrical energy over a smaller surface area, resulting in stronger effects than delivery through an electrode extending circumferentially around the lumen or passageway. It also forces the electrical energy to be delivered in a staged regional approach, mitigating the effect of preferential current pathways through the surrounding tissue. Focal delivery of PEFs can provide increased tissue lethality by employing precise timing and sequencing of energy delivery to the electrodes.