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: 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 delivering molecules, particularly small molecules and/or macromolecules, to cells within the body, particularly to target cells which directly therapeutically benefit from the functionality of the molecules. Example molecules include DNA plasmids, RNAs (e.g. messenger RNA (mRNA), small interfering RNA (siRNA), micro RNA), oligonucleotides, antisense oligonucleotides (ASO), proteins and/or materials which invoke genetic or epigenetic changes in the cellular behavior, to name a few. In such instances, the molecules are driven into the target cells with the use of pulsed electric fields (PEFs) which deliver the molecules through the cell wall of the target cells so that the desired genes are able to carry out the desired effect within the cells. Thus, the molecules are to be delivered to the desired location within the body at a desired time and in a desired concentration relative to the delivery of the pulsed electric fields for optimal outcomes.

Abstract: Devices, systems and methods are provided for delivering pulsed electric field (PEF) energy to tissue through one or more energy delivery bodies, each having one or more electrodes. The PEF energy is generated from a waveform having a variety of features. Waveform delays, such as inter-pulse delays, inter-cycle delays, inter-phase delays, inter-packet delays, inter-bundle delays, may be utilized within a treatment to obtain a desired outcome. In particular, these delays may be specifically manipulated to obtain particular desired outcomes. For example, one, some or all of these delays may be manipulated to control various aspects of PEF therapy so as to mitigate any associated risks, such as gas formation, electrical discharge, cavity formation, muscle contraction, and temperature rise, to name a few. In some embodiments, the delays distribute the period over which PEF energy is delivered, resulting in marked changes and optimization to the treatment delivery outcomes.

Abstract: Damaged, diseased, abnormal, obstructive, cancerous or undesired neural tissue treated by delivering specialized pulsed electric field (PEF) energy to target tissue areas. In some instances, the target tissue includes a tumor, a benign tumor, a malignant tumor, a cyst, or an area of diseased tissue. Most brain and spinal cord tumors develop from glial cells. These tumors are sometimes referred to as a group called gliomas. They arise from the supporting cells of the brain, called the glia. These cells are subdivided into astrocytes, ependymal cells and oligodendroglial cells (or oligos). One difficulty in the treatment of gliomas is that they are behind the blood-brain barrier (BBB) and blood-tumor barrier (BTB) which leads to poor delivery of anti-cancer drugs or immune agents to the tumor-infiltrated brain.

Abstract: Devices, systems and methods are provided for treating conditions of the reproductive tract. A number of conditions can afflict the lining and cell layers deeper within the anatomical structures. For example, cervical intraepithelial neoplasia (CIN), also known as cervical dysplasia, is a condition involving abnormal growth of cells on the surface of the cervix that could potentially lead to cervical cancer in situ (CIS). Other conditions include human papillomavirus (HPV)-related cervical disease, various endometrial diseases, acute and chronic cervicitis, and various infections (e.g. trichomoniasis) to name a few. In some embodiments, treatments eliminate diseased, damaged, abnormal or otherwise undesired cells leaving the tissue framework intact. This allows the tissue to regenerate in a normal fashion, avoiding the formation of scar tissue.

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: 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: 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, those within the respiratory tract, particularly 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 systems may be used to treat pathogens, such as bacteria and viruses, particularly coronaviruses.