Abstract: A medical device includes telemetry circuitry configured to receive programming instructions. The medical device also includes stimulation circuitry configured to generate a plurality of electrical pulses in response to the programming instructions to provide an electrical stimulation therapy for a patient. The stimulation circuitry includes a voltage converter, a multiplexor, and a stimulation driver. At least one of the voltage converter, the multiplexer, or the stimulation driver is selectively enabled and disabled during or between the electrical pulses to reduce power consumption of the medical device.

Abstract: Devices, systems and methods are disclosed for electrical stimulation of the vagus nerve to treat or prevent disorders in a patient. The methods comprise transmitting impulses of energy to the vagus nerve according to a treatment paradigm that includes single doses of 30 seconds to 5 minutes of continuous stimulation. The treatment paradigm further comprises one or more daily treatment sessions that each include one or more doses for prophylactic or acute treatment of the patient's condition. Vagus nerve stimulation is used to modulate the release of inhibitory neurotransmitters in the brain, such as GABA, norepinephrine, and/or serotonin.

Abstract: The present specification discloses devices and methodologies for the treatment of transient lower esophageal sphincter relaxations (tLESRs). Individuals with tLESRs may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow and have improved energy storage requirements.

Abstract: A multi-lead multi-electrode system and method of manufacturing the multi-lead multi-electrode system includes a multi-electrode lead that may be used to deploy multiple separable electrodes to different spaced apart contact sites, such as nerve or muscle tissues, for example, that are spatially distributed over a large area.

Abstract: A system for functional electrical stimulation can include a cuff and a stimulation device. The cuff can be attachable to a nerve or a muscle filament. The cuff can include an elastic collar configured to exert a force on the nerve or the muscle filament to reshape the nerve or the muscle filament to the internal configuration of an opening in the elastic collar. The stimulation device can be coupled to the cuff and configured to provide a stimulation waveform to the cuff.

Abstract: The present invention is related to an implantable medical device for treating breathing disorders and cardiac disorders by delivering stimulation energy to the phrenic nerve, hypoglossal nerves and cardiac muscle tissues.

Abstract: Variable amplitude signals for neurological therapy, and associated systems and methods are disclosed. A representative method includes activating automatic delivery of an electrical therapy signal to a patient's spinal cord region at a frequency in a frequency range between 1.5 kHz and 100 kHz, via at least one signal delivery contact carried by an implanted signal delivery device. The delivery can include repeatedly and automatically delivering the electrical therapy signal at each of multiple therapy signal amplitudes to the at least one signal delivery contact, without the therapy signal generating paresthesia in the patient. The foregoing process can be used as a screening tool to screen responders from non-responders in the context of a non-paresthesia-generating therapy, and/or can be used during long-term treatment, for example, for chronic pain.

Abstract: A leadless intra-cardiac medical device is configured to be implanted entirely within a heart of a patient. The device includes an intra-cardiac extension and a housing. The intra-cardiac extension includes a loop body having at least one loop segment retaining at least one coil group that is configured to one or both of receive and transmit radio frequency (RF) energy, wherein the loop body is configured to extend into a first chamber of the heart. The housing is in electrical communication within the loop body, and includes a transceiver, control logic and an energy source. The housing is configured to be securely attached to an interior wall portion of a second chamber of the heart, wherein the transceiver is configured to communicate with an external device through the RF energy.

Abstract: A system for controlled sympathectomy procedures is disclosed. A system for controlled micro ablation procedures is disclosed. Methods for performing a controlled surgical procedure are disclosed. A system for performing controlled surgical procedures in a minimally invasive manner is disclosed. An implantable device for monitoring and/or performing a neuromodulation procedure is disclosed.

Abstract: A nerve probe array has a connector made of a flexible material; and a plurality of probes coupled to the connector, each of the plurality of probe having an electrode formed at a body thereof. The plurality of probes are arranged with intervals in a length direction of the connector, and the connector surrounds an outer circumference of a nerve, and the plurality of probes pierce the outer circumference of the nerve and are inserted into the nerve.

Abstract: Disclosed herein is a device, and method for treating heart failure by electrically modulating a splanchnic nerve with an implantable device.

Abstract: An implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials.

Abstract: A flat optogenetic cuff interface (FOCI) is configured for functional optical stimulation of axons in a single fascicle of a peripheral nerve bundle in which the axons have been genetically modified to express light sensitive proteins for excitation or inhibition of the nerves. The FOCI is configured to gradually reshape the single fascicle to a final height between 0.2 mm and 0.5 mm by reorganizing the individual axons within the fascicle without reshaping (and damaging) the individual axons. The FOCI facilitates stimulation of axons over the entire cross-section of the reshaped fascicle within the power limitations for pulsed laser energy. An electrical interface may be included to sense nerve activity of either the stimulated axons to provide closed-loop feedback to control the optical sources or stimulated axons of a different modality to record the response.

Abstract: A device includes a handle, an expandable structure including a plurality of splines extending from a proximal hub to a distal hub, a first electrode on a first spline of the plurality of splines, an outer tube extending from the handle to the proximal hub, and a shaft extending through the outer tube from the handle to the distal hub. The expandable structure has a collapsed state and a self-expanded state. The handle is configured to retract the shaft. Retracting the shaft may expand the expandable structure outward of the self-expanded state.

Abstract: A method of inhibiting the release of a proinflammatory cytokine in a cell is disclosed. The method comprises treating the cell with a cholinergic agonist. The method is useful in patients at risk for, or suffering from, a condition mediated by an inflammatory cytokine cascade, for example endotoxic shock. The cholinergic agonist treatment can be effected by stimulation of an efferent vagus nerve fiber, or the entire vagus nerve.

Abstract: An electrode assembly includes a retainer, a flexible sheath, and an electrode. The retainer may include a plurality of clasping arms. The retainer is movable to an open position and a closed position. The flexible sheath is positioned below a lower surface of the retainer. The flexible sheath is at least partially surrounded by the clasping arms of the retainer. The retainer is able to hold the flexible sheath around a target tissue when the retainer is in the closed position. The electrode is configured for conducting electrical signals to or from the target tissue. The electrode is connected to at least one of the retainer and the flexible sheath. The retainer is able to hold the electrode in electrical communication with the target tissue when the retainer is disposed around the target tissue in the closed position.

Abstract: A wearable, percutaneous device for suppressing appetite or hunger in a patient includes a microprocessor, electrical stimulator and at least one percutaneous electrode implanted and configured to deliver electrical stimulation through the patient's skin. The percutaneous device includes a pad and at least one needle, in which the electrode is disposed, for secure placement of the device within the skin of a patient. The percutaneous device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

Abstract: The present invention consists of an implantable device with at least one package that houses electronics that sends and receives data or signals, and optionally power, from an external system through at least one coil attached to the at least one package and processes the data, including recordings of neural activity, and delivers electrical pulses to neural tissue through at least one array of multiple electrodes that is/are attached to the at least one package. The device is adapted to electrocorticographic (ECoG) and local field potential (LFP) signals. The output signals provide control for a motor prosthesis and the inputs signals provide sensory feedback for the motor prosthesis. The invention, or components thereof, is/are intended to be installed in the head, or on or in the cranium or on the dura, or on or in the brain.

Abstract: Conductors within an implantable medical lead that carry stimulation signal signals are at least partially embedded within a lead body of the medical lead over at least a portion of the length of the conductors while being surrounded by a radio frequency (RF) shield. A space between the shield and the conductors is filled by the presence of the lead body material such that body fluids that infiltrate the lead over time cannot pool in the space between the shield and the conductors. The dielectric properties of the lead body are retained and the capacitive coupling between the shield and the conductors continues to be inhibited such that current induced on the shield is inhibited from being channeled onto the conductors. Heating at the electrodes of the medical lead is prevented from becoming excessive.

Abstract: A medical device including an elongate member having a proximal end configured to be electrically coupled to an energy source, and a distal member disposed at a distal end of the elongate member. The distal member may include a plurality of contact elements configured to deliver stimulating energy to innervated tissue, detect a response from the innervated tissue to the stimulating energy, and deliver therapeutic energy to the innervated tissue based on the response from the innervated tissue.

Abstract: A biocompatible, micro-fabricated ribbon cable is described in which at least one set of conductors diverges laterally into a bypass wing that forms an aperture through the ribbon cable. The bypass wing is folded in a line through the aperture and over a central portion of the ribbon cable, resulting in a ribbon cable with a narrow, stacked region. The narrow region can fit through small incisions in membranes, such as through an incision in a sclera of an eyeball. The ribbon cable can have an integrally-formed electrode array for attaching to a retina of an eyeball and other electronics for sending signals to the electrode array.

Abstract: A cuff for use in nerve stimulation includes a sheet of elastomer having at least one electrode and being pre-stressed so as to allow its spiral self-winding to form a cuff around the nerve. The sheet is delimited by a first width defining an outer edge of the cuff after winding, a second width defining an opposite inner edge, a first length and a second opposite length. The first width is at both ends connected to the two lengths by a respective bevel edge forming an oblique angle relative to the direction of greatest dimension of the sheet.

Abstract: A stimulation electrode assembly configured to be positioned relative to a patient for an operative procedure is disclosed. The stimulation electrode may be a connection or self-contained component to contact a portion of a nerve. The stimulation electrode may provide or receive a signal to and/or from the nerve to assist in testing integrity of the nerve.

Abstract: Devices, systems and methods are provided for stimulation of tissues and structures within a body of a patient. In particular, implantable leads are provided which are comprised of a flexible circuit. Typically, the flexible circuit includes an array of conductors bonded to a thin dielectric film. Example dielectric films include polyimide, polyvinylidene fluoride (PVDF) or other biocompatible materials to name a few. Such leads are particularly suitable for stimulation of the spinal anatomy, more particularly suitable for stimulation of specific nerve anatomies, such as the dorsal root (optionally including the dorsal root ganglion).

Abstract: Some implementations provide a method for modulating excitable tissue in a body of a patient, the method including: placing a wireless implantable stimulator device at a target site in the patient's body, the stimulator device including one or more electrodes; reconfiguring the wireless implantable stimulator device to form an enclosure that substantially surrounds the excitable tissue at the target site with the electrodes on the inside of the enclosure and facing the nerve; and causing electrical impulses to be delivered to the electrodes on the wireless implantable stimulator device such that neural modulation is applied to the excitable tissue substantially surrounded by the enclosure.

Abstract: A method of blocking signal transmission through a nerve with reduced onset activity includes applying an HFAC to an axon of a nerve to block the transmission of signals through the axon. The method may also include applying a direct current (DC) to the axon, increasing the amplitude of the DC over time to a predetermined amplitude, applying the HFAC, and then decreasing the DC. The method may also include temporarily reducing the amplitude of the HFAC to permit the transmission of signals through the axon and subsequently increasing the amplitude to block transmission without triggering an onset response. The method may also include temporarily applying an unbalanced charge to the nerve and then balancing the charge over time.

Abstract: The disclosure relates to a flexible circuit electrode array comprising: a polymer base layer; metal traces deposited on said polymer base layer, including electrodes suitable to stimulate neural tissue; a polymer top layer deposited on said polymer base layer and said metal traces; and at least one support embedded in said array. The disclosure further relates to a flexible circuit electrode array comprising: a polymer base layer; metal traces deposited on said polymer base layer, including electrodes suitable to stimulate neural tissue; a polymer top layer deposited on said polymer base layer and said metal traces; and a folded flexible circuit cable connecting the electrode array with an interconnection pad.

Abstract: In one embodiment of the present invention, an implantable blood pump includes a housing defining a flow path, a rotor positioned within the flow path, and a motor including a stator, positioned outside of said housing, the stator including a length of silver wire, wherein the silver wire is not positioned within a hermetically sealed compartment once the blood pump is ready for implantation into a patient in need thereof. The present invention may also include a method of implanting the implantable blood pump including the step of implanting the blood pump within the patient and within or adjacent to the vasculature.

Abstract: An external medical device generates a drive signal inductively coupled to an implantable coil from an external coil. A regulator module coupled to the implantable coil generates an output signal in response to the inductively coupled signal and a feedback signal correlated to an amplitude of the inductively coupled signal. A signal generator receives the output signal for generating a therapeutic electrical stimulation signal. The control module adjusts the drive signal in response to the feedback signal to control the electrical stimulation signal.

Abstract: Apparatus comprising (1) a breathing sensor, configured to detect a breathing-related factor of a subject; (2) at least a first electrode configured to be placed in a vicinity of a respective first hypoglossal nerve, and to be driven, in response to the detected breathing-related factor, to apply a first electrical current to the first hypoglossal nerve; (3) at least a second electrode configured to be placed in a vicinity of a respective second hypoglossal nerve, and to be driven, in response to the detected breathing-related factor, to apply a second electrical current to the second hypoglossal nerve; and (4) circuitry configured to, in response to a detected symmetry-related factor indicative of a degree of symmetry of the subject, configure at least one current selected from the group consisting of: the first current and the second current. Other embodiments are also described.

Abstract: We report a method of determining an occurrence of an epileptic convulsive seizure in a patient, comprising: receiving body data from a patient during a first time period, determining a work level relating to said first time period at least based partially upon said body data; determining whether said work level exceeds an extreme work level threshold; performing a responsive action, in response to a determination that said work level exceeds said extreme work level threshold. We also report a medical device system configured to implement the method. We also report a non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform the method.

Abstract: One aspect of the present disclosure relates to a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

Abstract: A method of treating a subject in need thereof, is carried out by (a) administering said subject a therapeutic intervention (e.g., an active agent) in a treatment effective amount; and concurrently (b) administering said subject caloric vestibular stimulation in a treatment effective amount, said caloric vestibular stimulation administered so as to enhance the efficacy of said active agent. In some embodiments, the caloric vestibular stimulation is administered as an actively controlled time varying waveform.

Abstract: A therapy assembly configured for at least partial insertion in a living body. At least one fixation structure is attached to the therapy delivery element proximate the electrodes. The fixation structure is configured to collapse radially inward and wrap circumferentially around the therapy delivery element to a collapsed configuration when inserted into a lumen of an introducer. The fixation structures deploy to a deployed configuration when the introducer is retracted. The fixation structure includes major surfaces generally parallel with, and extending radially outward from, a central axis of the therapy delivery element, proximal edge surface oriented toward the proximal end, and a distal edge surface oriented toward the distal end. The proximal and distal edge surfaces provide generally symmetrical resistance to displacement of the therapy delivery element within the living body in either a proximal direction or a distal direction along the central axis.

Abstract: To achieve, an in vivo repair of injured mammalian nerve tissue, an effective amount of a biomembrane fusion agent is administered to the injured nerve tissue. The application of the biomembrane fusion agent may be performed by directly contacting the agent with the nerve tissue at the site of the injury. Alternatively, the biomembrane fusion agent is delivered to the site of the injury through the blood supply after administration of the biomembrane fusion agent to the patient. The administration is preferably by parenteral administration including including intravascular, intramuscular, subcutaneous, or intraperitoneal injection of an effective quantity of the biomembrane fusion agent so that an effective amount is delivered to the site of the nerve tissue injury.

Abstract: A nerve cuff stimulation electrode for cervical VNS is provided and configured to be arranged so as to at least partially surround or enclose one of the vagus nerves. The cuff stimulation electrode has at least two contacts configured to deliver electric stimulation pulses to a vagus nerve. The cuff stimulation electrode further has or may be attached or connected to a tilt sensor, a kinematic sensor, and/or a pulsation sensor configured to generate a signal representative of arterial and venous pressures. The implantable tilt sensor is configured to output a posture signal indicating a patient's posture, thus allowing discrimination between supine and semi-recumbent or erect postures.

Abstract: A method of neural stimulation is described for maintaining the responsiveness of electrically excitable cells to repeated electrical stimulation. A stimulating signal (23) is applied to the electrically excitable cells. The stimulating signal is repeatedly applied (26, 29, 32, 35) with a progressively increasing signal strength. A quiescent period (44) may be interleaved between bursts (43, 45) of stimulation. The electrically excitable cells may be retinal cells.

Abstract: An example of a method embodiment may place a set of stimulation electrodes on tissue containing the baroreceptor region, and may test bipolar configurations of the electrodes. Each of the bipolar configurations of the electrodes includes at least one of the electrodes configured to function as an anode and at least one other of the electrodes configured to function as a cathode. Testing the bipolar configurations may include stimulating the tissue using each of the bipolar configurations. For each of the tested bipolar configurations at least one physiological parameter may be monitored for a baroreflex response to stimulation of the tissue, and the baroreflex response may be recorded for each of the tested bipolar configurations.

Abstract: An implantable cuff includes an elastic collar, at least one conductive segment disposed on or within the elastic collar, and at least one conductor in electrical communication with the at least one conductive segment. The elastic collar defines an internal opening configured to receive an internal body tissue. At least a portion of the elastic collar includes a stiffening region having a stiffness greater than a second region of the elastic collar. The at least one conductor is configured to operably mate with an apparatus capable of delivering electrical stimulation to, and/or recording an electrical activity of, the internal body tissue.

Abstract: In order to treat hypertension, an implantable receiving device is connected to implantable leads, which are adapted to deliver electrical energy to the carotid body or bodies of the patient. The receiving device is arranged to receive electrical energy from an external generator. The device thus enables the delivery of electrical currents, which modify the function of neural tissue, particularly where repeated treatments are needed or where positioning of a percutaneous needle is difficult.

Abstract: A neurostimulation lead includes a lead body having a proximal portion and a distal portion and a first conductor extending through the lead body. An electrode cuff can be secured relative to the distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.

Abstract: Systems and methods selectively stimulate components of the pudendal nerve away from the sacral root to evoke desired physiologic responses in persons who lack the ability to otherwise produce these responses—e.g., maintain continence and/or produce micturition, and/or provide male/female sexuality responses, and/or provide bowel responses. The systems and methods use a multiple electrode array, or individual electrodes, placed on, in, or near the pudendal nerve. The electrode array, or individual electrodes, in association with a pulse generator, provide selective stimulation of individual fascicles within the pudendal nerve, to achieve different physiologic responses.

Abstract: The present disclosure provides systems and methods utilizing a closed-loop neurostimulation apparatus. The apparatus includes at least one sensing electrode that monitors neurological activity of a subject and at least one stimulating electrode that applies stimulation pulses to the subject. An internal pulse generator is coupled to the at least one sensing electrode and the at least one stimulating electrode. The internal pulse generator causes the at least one stimulating electrode to apply stimulating pulses based at least in part on the monitored neurological activity.

Abstract: A neurostimulation lead includes a lead body having a proximal portion and a distal portion and a first conductor extending through the lead body. An electrode cuff can be secured relative to the distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.

Abstract: A method and apparatus for selecting neural stimulation electrode configuration is provided. One aspect of this disclosure relates to an implantable medical device including a neural stimulator adapted to generate neural stimulation signals and an electrode configuration tester for testing a first electrode configuration for stimulating a desired neural target. The device includes a controller to control the neural stimulator to selectively provide a first neural stimulation signal with appropriate signal characteristics to stimulate the desired neural target using the first electrical configuration and a second neural stimulation signal with appropriate signal characteristics to stimulate the desired neural target using a second electrode configuration, and adapted to communicate with the electrode configuration tester and to respond to an indication that an efficacy of the first electrode configuration is lower than a threshold by providing the neural stimulation using the second neural stimulation signal.

Abstract: Devices, systems and methods are provided for stimulation of tissues and structures within a body of a patient. In particular, implantable leads are provided which are comprised of a flexible circuit. Typically, the flexible circuit includes an array of conductors bonded to a thin dielectric film. Example dielectric films include polyimide, polyvinylidene fluoride (PVDF) or other biocompatible materials to name a few. Such leads are particularly suitable for stimulation of the spinal anatomy, more particularly suitable for stimulation of specific nerve anatomies, such as the dorsal root (optionally including the dorsal root ganglion).

Abstract: A device may include at least one pair of modulation electrodes configured for implantation in the vicinity of a nerve to be modulated such that the electrodes are spaced apart from one another along a longitudinal direction of the nerve to be modulated. The electrodes may be further configured to facilitate an electric field in response to an applied electric signal, the electric field including field lines extending in the longitudinal direction of the nerve to be modulated. The device may further include at least one circuit in electrical communication with the at least one pair of modulation electrodes and being configured to cause application of the electric signal applied at the at least one pair of modulation electrodes.

Abstract: The present invention provides a cuff electrode assembly for implantation on a target nerve. The cuff electrode assembly can include a resilient cuff body configured to be disposed about the target nerve. The cuff body includes a first end portion having a first free end, and a second end portion having a second free end. The cuff electrode assembly further includes a first arm member and a second arm member each projecting radially outward from the cuff body and spaced from one another along the cuff body. The cuff body can be configured such that a force applied to urge the first and second arm members toward one another defines an open configuration of the cuff body configured to allow the cuff body to be positioned around the target nerve. The cuff electrode assembly further includes an electrode oriented to provide electrical stimuli to the target nerve.

Abstract: A facial muscle toner system is provided that includes, in some embodiments, a base unit and a hand piece unit. The base unit optionally includes a display portion at a front face and a command portion including one or more keys. The hand piece unit is operably connected to the base unit and is located remotely from the base unit. The hand piece unit includes a housing having a receptacle portion and a therapy distribution instrument extending from the receptacle portion. The therapy distribution instrument is configured to distribute therapy to sub-dermal facial muscles.

Abstract: A method of treating a metabolic condition in a patient, comprising: determining a target non-immediate effect of a therapy relating to treatment of a metabolic condition; and applying an electric field to an abdominal cavity of the patient in a manner designed to at least approach said target.