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.

A subcutaneously implantable device is implantable into a body of a patient, and includes a prong and an electrode. The prong has a contact portion at or adjacent to a distal end thereof that is configured to contact an organ, a nerve, and/or a tissue of the patient. The prong is constructed to apply pressure to the organ, the nerve, and/or the tissue so as to maintain contact between the contact portion and the organ, the nerve, and/or the tissue without fixing the contact portion to the organ, the nerve, and/or the tissue. The electrode is provided at the contact portion of the prong, is configured to contact the organ, the nerve, and/or the tissue, and is electrically coupled or couplable with circuitry that is configured to provide monitoring, therapeutic, and/or diagnostic capabilities with respect to the organ, the nerve, and/or the tissue.

The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead. A stimulation-induced EMG motor response is recorded with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one pair of EMG sensing electrodes so as to facilitate initial positioning of the implantable lead at a target stimulation region.

Disclosed are various examples and embodiments of systems, devices, components and methods configured to treat mood disorders in a patient using a compact implantable neurostimulator and corresponding lead(s) that are shaped, sized and configured to be implanted beneath a patient's skin in the head or neck, and to stimulate one or more target cranial nerves. The one or more medical electrical leads comprising electrode(s) are positioned adjacent to, in contact with, or in operative positional relationship to, the one or more target cranial nerves of the patient. In some embodiments, electrical stimulation is provided to the one or more target cranial nerve(s) of the patient for periods of time ranging between 30 and 60 minutes, once or twice per day. In some embodiments, power is provided to the implantable neurostimulator transcutaneously by inductive, wireless, RF, acoustic, microwave, or other suitable non-invasive means.

An integrated functional electrical stimulation (FES) system includes a component of a mobility assistance device, and an FES system mounted within the component. The FES system includes an FES stimulator that is embedded within the component, and a plurality of FES jacks that are electrically connected to the FES stimulator and are located on the component. The FES jacks are configured to receive a plurality of FES electrodes, and an electrical stimulation output from the FES stimulator is conducted through the FES jacks to the FES electrodes. In a wireless embodiment, the FES stimulator is configured to wirelessly transmit a control signal for applying an electrical stimulation output to the plurality of FES electrodes, and the FES jacks are eliminated. The FES stimulator may be embedded within a back portion of the hip component of an exoskeleton device, and in the wired embodiment the FES jacks are located on wing portions of the hip component.

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.

An integrated functional electrical stimulation (FES) system includes a component of a mobility assistance device, and an FES system mounted within the component. The FES system includes an FES stimulator that is embedded within the component, and a plurality of FES jacks that are electrically connected to the FES stimulator and are located on the component. The FES jacks are configured to receive a plurality of FES electrodes, and an electrical stimulation output from the FES stimulator is conducted through the FES jacks to the FES electrodes. In a wireless embodiment, the FES stimulator is configured to wirelessly transmit a control signal for applying an electrical stimulation output to the plurality of FES electrodes, and the FES jacks are eliminated. The FES stimulator may be embedded within a back portion of the hip component of an exoskeleton device, and in the wired embodiment the FES jacks are located on wing portions of the hip component.

Apparatus is provided that includes a two-dimensional arrangement (70) of extracranial electrodes (30), configured to be placed outside and in electrical contact with a skull of a subject identified as at risk of or suffering from a disease; and a cerebrospinal fluid (CSF) electrode (32), configured to be implanted in a ventricular system of a brain of the subject. Control circuitry is configured to drive the extracranial and the CSF electrodes (30, 32) to clear a substance from brain parenchyma of the subject into at least one region of the brain selected from the group consisting of: a subarachnoid space of the brain and dural sinuses of the brain. Other embodiments are also described.

Implantable medical electrical leads having electrodes arranged such that a defibrillation coil electrode and a pace/sense electrode(s) are concurrently positioned substantially over the ventricle when implanted as described. The leads include an elongated lead body having a distal portion and a proximal end, a connector at the proximal end of the lead body, a defibrillation electrode located along the distal portion of the lead body, wherein the defibrillation electrode includes a first electrode segment and a second electrode segment proximal to the first electrode segment by a distance. The leads may include at least one pace/sense electrode, which in some instances, is located between the first defibrillation electrode segment and the second defibrillation electrode segment.

A medical device is configured to sense an electrical signal and determine that signal to noise criteria are met based on electrical signal segments stored in response to sensed electrophysiological events. The medical device is configured to determine an increased gain signal segment from one of the stored electrical signal segments in response to determining that the signal to noise criteria are met. The medical device determines a noise metric from the increased gain signal segment. The stored electrical signal segment associated with the increased gain signal segment may be classified as a noise segment in response to the noise metric meeting noise detection criteria.