One aspect of the present disclosure includes a delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa of a subject. The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes. The delivery tool can comprise a handle, an elongated shaft extending from the handle, a hub portion, and a double barrel sheath. The hub portion can be located between the shaft and a spine member that extends axially away from the hub portion. The hub portion can be sized and dimensioned to releasably mate with the neurostimulator. The double barrel sheath can be connected to the spine member. A central lumen can extend through at least a portion of the shaft and the hub portion. The central lumen can be adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.

The present disclosure relates to methods, devices and systems used for the treatment of neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotermporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

An implant unit configured for implantation into a body of a subject is provided. The implant unit may include a flexible carrier unit including a central portion and two elongated arms extending from the central portion, an antenna, located on the central portion, configured to receive a signal, at least one pair of electrodes arranged on a first elongated arm of the two elongated arms. The at least one pair of electrodes may be adapted to modulate a first nerve. The elongated arms of the flexible carrier may be configured to form an open ended curvature around a muscle with the nerve to be stimulated within an arc of the curvature.

A medical apparatus configured to neuromodulate tissue and/or record patient information is provided. The apparatus includes an external system to transmit transmission signal(s), each signal having at least power or data, and an implantable system to receive the transmission signal(s). The data transfer between the external and implantable systems is asynchronous. The external system includes external antenna(s) to transmit a transmission signal. The transmission signal is an amplitude modulated signal modulated by varying a load on the external antenna(s) that causes an impedance mismatch prior to amplifying the signal for transmission. An implantable device includes implantable antenna(s) to receive the transmission signal. The implantable system comprises a receiver to receive the transmission signal from the implantable antenna(s), implantable transmission module(s) to transmit data to the external system, and a variable load connected to the implantable antenna(s). Data is transmitted by varying the load.

This disclosure relates to a device for applying a neural stimulus. A battery supplies electrical energy at a battery voltage and an electrode applies the electrical energy to neural tissue. A circuit measures the nervous response of the tissue and a voltage converter receives the electrical energy from the battery and controls a voltage applied to the electrode based on the measured nervous response of the tissue. This direct voltage control is energy efficient because losses across a typical current mirror are avoided. Further, the control based on the measured nervous response leads to automatic compensation of impedance variation due to in-growth or change in posture. As a result, the stimulation results in a desired neural response.

The present disclosure relates to subcutaneous direct current (DC) nerve conduction block. A subcutaneous electrode can be implanted under a subject's skin between the subject's skin and a neural structure within the subject's body. The subcutaneous electrode can be coupled to a current generator. A DC can be configured by the current generator and delivered through the subcutaneous electrode to block conduction in the neural structure. The subcutaneous electrode eliminates an effect of an impedance of the subject's skin on the DC. The DC can be returned to the current generator by a return electrode.

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.

One aspect of the present disclosure includes a delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa of a subject. The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes. The delivery tool can comprise a handle, an elongated shaft extending from the handle, a hub portion, and a double barrel sheath. The hub portion can be located between the shaft and a spine member that extends axially away from the hub portion. The hub portion can be sized and dimensioned to releasably mate with the neurostimulator. The double barrel sheath can be connected to the spine member. A central lumen can extend through at least a portion of the shaft and the hub portion. The central lumen can be adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.

A method for subcutaneously treating pain in a patient includes first providing a neurostimulator with an IPG body and at least a primary, a secondary, and a tertiary integral lead with electrodes disposed thereon. A primary incision is opened to expose the subcutaneous region below the dermis in a selected portion of the body. A pocket is then opened for the IPG through the primary incision and the integral leads are inserted through the primary incision and routed subcutaneously to desired nerve regions along desired paths. The IPG is disposed in the pocket through the primary incision. The primary incision is then closed and the IPG and the electrodes activated to provide localized stimulation to the desired nerve regions and at least three of the nerves associated therewith to achieve a desired pain reduction response from the patient.

Vagal nerve stimulation devices and methods are provided for treating medical conditions, such as conditions associated with insufficient dopamine and/or endogenous opioids in the brain. A device includes one or more electrodes having a contact surface for contacting an outer skin surface of a patient and an energy source coupled to the electrodes. The energy source generates one or more electrical impulses and transmits the electrical impulses to the electrodes and transcutaneously through the outer skin surface of the patient at or near a vagus nerve. The one or more electrical impulses is sufficient to modulate the vagus nerve and release dopamine and/or endogenous opioids in a brain of the patient.