In general, implantation of neurostimulation systems or device includes subcutaneous or percutaneous placement of at least the electrodes. Preferred are minimally invasive implantation procedures, systems and devices that can reliably operate for extended periods, and systems and devices providing a high degree of comfort for the subject. The implantation specialist may need to address adequate placement of the electrodes with respect to the nerve tissue to be stimulated, and to choose between one or more convenient locations for the elements of the system or device. Methods are provided comprising forming a first 1250 and second 1260 incision on opposite sides of a target location, and introducing a first introducer sheath 3050a under the skin with a maximum internal transverse cross-section less than the further maximum transverse cross-section 710 of an implantable stimulator. Such a method is advantageous if the maximum transverse cross-section 710 of the further portion is at least 1.2 times greater than the maximum transverse cross-section 730 of the first portion—the dimensions of the implantation tools may be reduced. A further method is provided wherein the first portion 630 with at least two electrodes 200, 400 is introduced in the skin layers between the nerve tissue 2003 to be stimulated and above or in the aponeurosis layer 2009. By being implanted deeper and/or more accurately, comfort and/or reliability for the subject may be improved. In addition, the chance that the stimulator is implanted under the nerve tissue is greatly increased.

Disclosed is a device for modulating a nerve of a patient by applying electrical stimulation to the nerve of the patient. The device includes a stimulation module that applies a signal to the nerve of the patient, and a controller that controls a signal to be applied to the stimulation module, wherein the signal to be applied to the stimulation module includes pulse bursts and a direct current (DC) waveform.

The use of neurostimulation leads in the craniofacial region is associated with skin erosion and lead migration. The cylindrical shape and associated thickness of state-of-the-art leads results in the lead eroding through the skin or results in the lead being displaced so that the electrodes no longer cover the targeted nerves.

An implantable stimulator 100,1110 is provided having a substrate 300, 1400 comprising a conformable portion with an electrode array, and a pulse generator 500. A plurality of electrical interconnections 250, 1210 are positioned between the surfaces of the substrate The conformable portion has a thickness equal to or less than 0.5 millimeters. Optionally, one or more encapsulation layers 1300 may be provided. Optionally, one or adhesion layers 1500 may also be provided comprising a ceramic material.

By providing a more easily patternable substrate, more complicated electrode array configurations may be supported, allowing a higher degree of flexibility to address transverse and/or longitudinal misalignment. By providing a relatively thin implantable electrode array, user comfort may be increased. The one or more adhesion layers improve the performance of the encapsulation.

An implantable stimulator is provided having a conformable foil-like substrate, having a longitudinal axis extending from a pulse generator to a distal end of the substrate. The substrate comprising one or more adjacent polymeric substrate layers and an electrode array. The electrode array having a first and second electrode where one or more electrical interconnections are comprised in the substrate. The conformable foil-like substrate has a maximum thickness of 0.5 millimeter or less, proximate the electrodes. By providing a more easily pattemable multilayer substrate, more complicated electrode array configurations may be supported, allowing a higher degree of flexibility to address transverse and/or longitudinal misalignment. By providing a relatively thin implantable electrode array user comfort may be increased through application of energy to tissue by the implantable stimulator.

An implantable head-mounted unibody peripheral neurostimulation system is provided for implantation in the head for the purpose of treating chronic head pain, including migraine. The system may include an implantable pulse generator (IPG) from which multiple stimulating leads may extend sufficient to allow for adequate stimulation over multple regions of the head, preferably including the frontal, parietal and occipital regions. A lead may include an extended body, along which may be disposed a plurality of surface metal electrodes, which may be sub-divided into a plurality of electrode arrays. A plurality of internal metal wires may run a portion of its length and connect the IPG's internal circuit to the surface metal electrodes. The IPG may include a rechargeable battery, an antenna, and an application specific integrated circuit. The IPG may be capable of functional connection with an external radiofrequency unit for purposes that may include recharging, diagnostic evaluation, and programming.

Estimating a nerve-to-electrode distance involves applying a stimulus from a stimulus electrode to a nerve. Neural measurements of at least one evoked compound action potential are obtained, and processed in order to estimate an originating state of stimulation exhibiting at least one characteristic defined by a single fibre size. A single fibre model is then applied to produce a measure of the nerve-to-electrode distance. Also provided for is estimation of a distribution of recruited fibres. Measurements of a compound action potential are obtained from sense electrodes spaced apart along a neural pathway. A conduction velocity of the compound action potential is determined from the latency between the measurements. From the conduction velocity a dominant recruited fibre diameter is determined. A rate of dispersion of the compound action potential between the sense electrodes is determined. From the rate of dispersion a distribution of diameters of the recruited fibre population is determined.

Devices and methods for manipulating devices such as micro-scale devices are provided. The devices can include a tether of various materials surrounded by a stiff body. The tether interfaces with microscale devices to draw them against the stiff body, holding the microscale devices in a locked position for insertion into or extraction out of tissue. The tensional hook and stiff body are configurable in a multitude of positions and geometries to provide increased engagement. Such configurations allow for a range of implantation and extraction surgical procedures for the device within research and clinical settings.

A device and method is provided for stimulation of neurons. The device includes a stimulation unit that can be implanted into a body of a patient and has stimulation elements that apply a stimulation signal to tissue of the patient to stimulate neurons in the brain and/or the spinal cord of the patient. Moreover, a measuring unit receive a measurement signal that reflects a neuronal activity of the stimulated neurons. Further, a control unit generate a modulation signal from the measurement signal, and modulates an amplitude of a pulse train with the modulation signal. Individual pulses of the pulse train include a first and second pulse portions that introduce and remove charge from the tissue. Moreover, the control unit varies a pause between the pulse portions until the synchronization of the stimulated neurons is minimized or falls below a predetermined threshold.

An ear-piece assembly includes (i) an antenna portion enclosing a transmitting antenna configured to send one or more input signals containing electrical energy to a passive implantable neural stimulator device such that the passive implantable neural stimulator generates one or more stimulation pulses suitable for stimulating a neural structure in the craniofacial region solely using the electrical energy in the input signals; and (ii) an enclosure coupled to the antenna portion, wherein enclosure is sized and shaped to be mounted on a helix portion of an ear such that, when worn by a patient, weight from the enclosure is distributed over the helix portion of the ear for the enclosure to rest thereon, wherein the enclosure comprises (i) a controller module configured to provide the one or more input signals to the transmitting antenna, and (ii) a battery adapted to provide energy to the ear-piece assembly.

The present invention relates to methods that enable one to design temporal patterns for the optimal stimulation of a nervous system, one or more nerve cells, or nervous tissue. In one embodiment, the present invention relates to methods to design improved stimulation patterns and/or genetic algorithms for the optimal stimulation of a nervous system, one or more nerve cells, or nervous tissue. In one embodiment, the present invention utilizes a model-based design to achieve a more optimal stimulation pattern for use in connection with a nervous system, one or more nerve cells, or nervous tissue (e.g., a human nervous system). In another embodiment, the model-based design of the present invention utilizes a systematic search method to identify parameters (e.g., design variables) that minimize a cost function (e.g., optimize the fitness of a particular design). In one instance, the system and method of the present invention is demonstrated via optimal temporal patterns of electrical stimulation for a nervous system, one or more nerve cells, or nervous tissue.