A kit comprises a device (1) for electrotherapy and/or electrophysiology and a delivery system and method for the device. The device (1) includes a lead (2) and a paddle (5) comprising at least one electrode (8), the paddle (5) being reconfigurable between an operative configuration and a transport configuration of smaller transverse extent. The delivery system comprises a flexible, hollow outer sheath (28) and a hollow delivery sheath (100) for receiving at least the paddle (5) of the device (1) in the transport configuration. The delivery sheath (100) may be inserted into a proximal end of the outer sheath (28) and transported through the outer sheath (28) to deliver the paddle (5) of the device (1) to a distal end of the outer sheath (28), which is located at or directed towards an implantation site in the body (11) of a patient. The delivery sheath (100) protects the paddle (5) during transport and permits enhanced control of the position and orientation of the paddle (5) when it is deployed.

The present disclosure relates to a system for neuromodulation and/or neurostimulation, for the treatment of a subject. The system comprises a stimulation controller, a stimulation pattern storage means including stimulation data connected to the stimulation controller, an electrical stimulation device and electrical interface between the electrical stimulation device and the subject, the electrical interface being connectable with a bio-interface of the nervous system of the subject. The stimulation data are pre-programmed patterns comprising spatial and temporal components, The stimulation controller sends configuration signals on the basis of the stimulation data to the electrical stimulation device such that via the electrical interface electrical stimulation is provided to the bio-interface, wherein the electrical stimulation provided is characterized by stimulation parameters that vary over time in a pre-programmed manner.

The present disclosure provides devices, systems, and methods for spinal cord stimulation. In some exemplary embodiments, a lead is provided. In one exemplary embodiment, the lead includes a paddle and an electrode array distributed in the paddle. The electrode array includes a first column of electrodes and a second column of electrodes. The first column of electrodes and the second column of electrodes are symmetric about the midline of the paddle. The first column of electrodes includes a first electrode, a second electrode, and a third electrode. The second column of electrodes includes a fourth electrode corresponding to the first electrode, a fifth electrode corresponding to the second electrode, and a sixth electrode corresponding to the third electrode. A vertical inter-electrode distance between the first electrode and the second electrode is larger than that between the second electrode and the third electrode.

Disclosed is a delivery system for a component, for example, a splitting lead. A splitting lead can have a proximal portion to engage a controller and a distal portion to split apart into sub-portions that travel in multiple directions during implantation into a patient. The delivery system can include a handle and a component advancer to advance and removably engage a portion of the component. The component advancer can be coupled to the handle and advance the component into the patient by applying a force to the portion in response to actuation of the handle by the operator. Also, the delivery system can include an insertion tip with first and second ramps to facilitate advancement of first and second sub-portions into the patient in first and second directions. The leads may have various electrode configurations including, for example, wrapped or embedded electrodes, helical or elliptical coils, thin metallic plates, etc.

Systems are provided for compact implantable multi-site optical stimulation and/or combined electrical and optical stimulation of spinal cord, brain, dorsal root ganglion, peripheral nerve, or other tissue. High-power LEDs or other light-emitting elements are provided at the site of stimulation, avoiding complex fiber optics or other means for coupling light from a distant laser along a stimulator to target tissue. Colocation of electrical stimulation contacts and light emitters allows the same tissue to be stimulated electrically and optically, at the same time or according to an alternating or other pattern of combined electrical and optical stimulation. These stimulators can be used as part of permanently implanted systems and/or as part of temporary, percutaneous stimulator systems. Optical and/or combined electrical and optical stimulation can be provided for pain relief, to encourage wound healing in nervous or non-nervous tissue, or to provide other clinical benefits.

A neurostimulation system is disclosed for providing treatment to a patient during a therapy session. The neurostimulation system includes a neurostimulator for transmitting magnetic or electrical signals based upon a treatment program. A programmer is connected to the neurostimulator to set a treatment session parameter value to calculate a therapy compliance value. A compliance module is connected to the neurostimulator and the programmer to calculate and store a therapy compliance value. A control module is connected to the compliance module, the programmer and the neurostimulator and determines whether the therapy compliance value is within a range of the treatment program. The neurostimulator transmits electrical or magnetic signals to the patient in a treatment session only if the therapy compliance value meets a compliance criteria.

The present disclosure relates to implantable neuromodulation devices and methods of fabrication, and in particular to anatomically contoured spinal cord stimulation leads for high density neural interfaces and methods of microfabricating the stimulation leads. Particularly, aspects are directed to a thin film lead assembly that includes a cable having: a first supporting structure formed of dielectric material, a first set of conductive traces formed on the first supporting structure, a second supporting structure formed of dielectric material, and a second set of conductive traces formed on the second supporting structure. The thin film lead assembly also includes an electrode assembly having: a third supporting structure formed of dielectric material, a first set of electrodes in electrical connection with the first set of conductive traces, and a second set of electrodes in electrical connection with the second set of conductive traces.

Spinal cord stimulation (SCS) system having a recharging system with self alignment, a system for mapping current fields using a completely wireless system, multiple independent electrode stimulation outsource, and control through software on a Smartphone/mobile device and tablet hardware during trial and permanent implants. SCS system can include multiple electrodes, multiple, independently programmable, stimulation channels within an implantable pulse generator (IPG) providing concurrent, but unique stimulation fields. SCS system can include a replenishable power source, rechargeable using transcutaneous power transmissions between antenna coil pairs. An external charger unit, having its own rechargeable battery, can charge the IPG replenishable power source. A real-time clock can provide an auto-run schedule for daily stimulation. A bi-directional telemetry link informs the patient or clinician the status of the system, including the state of charge of the IPG battery. Other processing circuitry in current IPG allows electrode impedance measurements to be made.

An electrical stimulation system includes at least one electrical stimulation lead, each of the at least one electrical stimulation lead including a plurality of stimulation electrodes; and a processor coupled to the lead and configured to perform actions, including: directing delivery of at least one electrical pulse through at least one of the stimulation electrodes of the at least one electrical stimulation lead to tissue of a patient; and directing discrete or intermittent measurement of an electrical characteristic of the tissue using at least one of the stimulation electrodes of the at least one electrical stimulation lead during, and after, delivery of the at least one electrical pulse to the tissue of the patient.

Systems and methods for deploying a paddle neurostimulation lead within a patient. A delivery tool includes a delivery tube including a first linear segment, a second linear segment, and an arcuate segment coupled between the first and second linear segments, the second linear segment defining an elongated opening. The delivery tool further includes a stylet positioned within an interior of the delivery tube, and a handle coupled to the delivery tube and including a stylet actuation mechanism, the stylet actuation mechanism configured to selectively advance and retract the stylet between a deployed position and a retracted position, wherein the stylet extends across the elongated opening in the deployed position to engage an engagement member of the paddle neurostimulation lead.