A method and system for monitoring an electrotherapy treatment applied to a subject in need of such therapy. An ultrasound transducer array is positioned adjacent a tissue of the subject to which the electrotherapy treatment is to be applied. The electrotherapy treatment is administered to the tissue as a plurality of ultra-short electric pulses which generate an electric field in the vicinity of the tissue. The ultrasound transducer array detects acoustic signals which are induced by the electric field. The detected acoustic signals are then used to construct tomographic images which represent the electric field generated by the electrotherapy treatment during real-time.

Nanosecond pulsed electric field (nsPEF) treatments of a tumor are adjusted based on a size and type of the tumor to stimulate an immune response against the tumor and other tumors in the subject. Calreticulin expression on tumor cells can be detected to confirm treatment. An immune response biomarker can be measured, and further nsPEF treatments can be performed if needed to stimulate or further stimulate the immune response. Cancers that have metastasized may be treated by directly treating a tumor that is most accessible. The treatment can be combined with CD47-blocking antibodies, doxorubicin, CTLA-4-blocking antibodies, and/or PD-1-blocking antibodies. Electrical characteristics of nsPEF treatments can be based on the size, type, and/or strength of tumors and/or a quantity of tumors in the subject.

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.

The present application relates to a device for the electroporation of bacterial cells in or on a surface of the Stratum corneum layer of a person's skin. It comprises electrodes positionable in the vicinity of said surface; a generator to supply a voltage to the electrodes to generate an electrical field having a strength in the order of 25 to 35 KV/cm at said surface of the Stratum corneum layer to inactivate bacterial cells in or on said surface. The electrodes are configured so that the strength of the electrical field reduces as a function of the depth of penetration into the skin from 25 to 35 KV/cm at said surface to 3 KV/cm or less at a depth of penetration that does not exceed 15 microns. The electrical field generated by the device will have sufficient strength to inactivate bacteria cells present on the stratum corneum while at the same time this electrical field is not strong enough to appreciable effect living skin cells in the epidermis below the stratum corneum or at the interface between the stratum corneum and the epidermis.

A device for vacuum-assisted in vivo delivery of an agent into cells of tissue includes a housing that defines a chamber and at least one opening into the chamber. A port extends through the housing, is remote from the at least one opening, and is connectable to a vacuum source. The port is configured to communicate vacuum pressure from the vacuum source to the chamber for drawing tissue through the opening and into the chamber.

Methods for electrical modulation of inflammation or serum TNF levels in a subject.

In alternative embodiments, provided are products of manufacture and kits, and methods, for delivering macromolecules, including nucleic acids such as DNA and RNA, including genes and protein-encoding nucleic acids, to the skin, or the dermis or epidermis, and mucosa. In alternative embodiments, provided are products of manufacture and kits, and methods, for detecting macromolecules, including nucleic acids such as DNA and RNA, including genes and protein-encoding nucleic acids, in skin, epidermal or mucosal cells. In alternative embodiments, exemplary products of manufacture are physically flexible nanodelivery devices that are wearable, e.g., they can be worn as patches on the skin or mucosa. In alternative embodiments, nanodelivery devices provided herein are fabricated in a microelectrodemicrofluidicnanochannel configuration which can precisely deliver cargo into the touched cells upon localized and safe-voltage electroporation. The on-skin electroporation can be wirelessly powered and controlled via on-chip near field communication (NFC) module. An accessory skin sensor can be simultaneously implemented on the same chip for skin impedance detection at the same time.

A patch for a therapeutic electrical stimulation device includes a shoe connected to the first side of the patch, the shoe including a body extending in a longitudinal direction from a first end to a second end, and having first and second surfaces, the first end of the shoe defining at least two ports, and the first surface of the shoe defining a connection member. The patch also includes at least one conductor positioned in the ports of the first end of the shoe. The shoe is configured for sliding insertion into a receptacle defined by a controller so that the conductor is connected to the controller to deliver electrical current from the controller, through the conductor, and to the electrodes, and the connection member is at least partially captured by a detent defined by the controller in the receptacle to retain the shoe within the receptacle.

The invention relates generally to systems and devices for material delivery, energy delivery, and/or monitoring electrophysiological activity, and method of use thereof. In particular, the present invention provides devices and systems, and methods of use thereof, configured to deliver therapeutic compositions, to provide electroporation and/or sonoporation to increase therapeutic efficiency, and to monitor electrophysiological activity, for example, before and after treatment.

Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.