Abstract: Methods for determining if a nerve is nearby a device. The neural stimulation tools described herein are configured to be flexible and low-profile, so that they can be used within body regions that may be tortuous or difficult to reach, such as within a compressed or partially occluded neural foramen. In most cases, these tools described herein are ribbon-shaped and adapted to be manipulated bimanually, applying force to the ends of the devices from separate locations outside of the patient's body. Thus, the distal end region of the device may be configured to couple to the proximal end of a guidewire. One or more surfaces of the devices may include an electrode or multi-polar network of electrodes configured to stimulate only nerves within a predetermined distance of a particular face of the device. Methods of using these devices are described.

Abstract: A pedicle access system including a cannula, a stylet, and a removable T-handle. The pedicle access system may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during the pilot hole formation. To do this, the cannula and stylet are locked in combination and inserted through an operating corridor to the pedicle target site, using the T-handle to facilitate easy movement and positioning of the cannula/stylet combination. A stimulation signal may be applied during pilot hole formation to conduct the pedicle integrity assessment. In a significant aspect, the T-handle may be detached from the cannula/stylet combination to facilitate the use of various surgical tools as necessary.

Abstract: A device for measuring a neural response evoked by a stimulus. First and second sense electrodes are positioned at distinct locations along a neural pathway. A neural stimulus is applied and first and second recordings of a neural response evoked by the stimulus are obtained from the respective sense electrodes. The first recording and the second recording are compared to determine propagation properties of the evoked neural response.

Abstract: An implantable device for estimating neural recruitment arising from a stimulus, has a plurality of electrodes. A stimulus source provides stimuli to be delivered from the electrodes to neural tissue. Measurement circuitry obtains a measurement of a neural signal sensed at the electrodes. A control unit is configured to control application of a selected stimulus to neural tissue using the stimulus electrodes; and after the selected neural stimulus, apply a probe stimulus having a short pulse width. A remnant neural response evoked by the probe stimulus is measured; and the control unit estimates from the remnant neural response a neural recruitment caused by the selected neural stimulus.

Abstract: The invention relates to systems and methods for estimating a response of at least a part of a physiological system to a first deterministic stimulus signal. The methods include separating a measured first signal into a plurality of segments, each segment representing a response of the physiological system to a corresponding portion of the first stimulus signal and generating a template signal representing the plurality of segments. The methods further include calculating a measure of similarity of each segment in the plurality of segments to the template signal to provide a set of scalar quantities, and determining a metric representing a characteristic of the response of at least a part of the physiological system to the first stimulus signal.

Abstract: The present invention involves systems and related methods for performing surgical procedures and assessments, including the use of neurophysiology-based monitoring to: (a) determine nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site; (b) assess the pathology (health or status) of a nerve or nerve root before, during, or after a surgical procedure; and/or (c) assess pedicle integrity before, during or after pedicle screw placement, all in an automated, easy to use, and easy to interpret fashion so as to provide a surgeon-driven system.

Abstract: A method of monitoring relative nerve health and the presence of neuropraxia is described. The methods utilize the integration of a waveform function of an elicited or monitored nerve response to provide an indication of the strength of a detected signal from a nerve and thus the relative health and integrity of the nerve. In some embodiments motor nerve stimulation innervates muscle and an EMG waveform is obtained in response thereto. The integration under the waveform is expressed and an indexed value indicating a percentage of a certain threshold value. Methods set forth provide a more reliable status of a nerve in real-time and allow action to be taken to reduce neuropraxia or prevent permanent nerve damage.

Abstract: Systems and methods for performing neurophysiologic assessments of neural tissue including nerve pathology monitoring which may or may not be augmented by adding the ability to assess or monitor the pressure being exerted upon a nerve or nerve root before, during and/or after retraction.

Abstract: The present invention involves systems and related methods for performing surgical procedures and assessments, including the use of neurophysiology-based monitoring to: (a) determine nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site; (b) assess the pathology (health or status) of a nerve or nerve root before, during, or after a surgical procedure; and/or (c) assess pedicle integrity before, during or after pedicle screw placement, all in an automated, easy to use, and easy to interpret fashion so as to provide a surgeon-driven system.

Abstract: Methods and systems are provided for the noninvasive measurement of the subepithelial impedance of the breast and for assessing the risk that a substantially asymptomatic female patient will develop or be at substantially increased risk of developing proliferative or pre-cancerous changes in the breast, or may be at subsequent risk for the development of pre-cancerous or cancerous changes. A plurality of electrodes are used to measure subepithelial impedance of parenchymal breast tissue of a patient at one or more locations and at least one frequency, particularly moderately high frequencies. The risk of developing breast cancer is assessed according to measured and expected or estimated values of subepithelial impedance for the patient and according to one or more experienced-based algorithms. Devices for practicing the disclosed methods are also provided.

Abstract: An automated system, method, apparatus, device and/or computer program product for detecting positioning effect is set forth, the apparatus according to an exemplary embodiment may include an output operable to couple to one or more stimulating electrodes to stimulate one or more peripheral nerves of the patient, an input operable to couple to one or more recording electrodes to record resultant electrical waveforms generated by a nervous system of a patient in response to the stimulating module, and one or more processors operable to identify the positioning effect based on the resultant electrical waveforms.

Abstract: The present invention relates to methods and devices for determining the state of a neural system. In one embodiment, a plurality of stimuli to the system can be delivered to the system, and then the resulting respective responses can be analyzed to determine whether the system state is static, or whether it is undergoing dynamic changes. In another aspect of the invention, a single stimulus having a plurality of components can be administered, and the responses to each component can be contrasted and compared to determine the state of the neural system. In each case, this information can be used to predict the occurrence of neural perturbations or episodes associated with a change in the state of the neural system.

Abstract: This invention provides methods for mapping and ablating renal nerves to treat disease caused by systemic renal nerve hyperactivity, e.g. hypertension, heart failure, renal failure and diabetes. Also provided are catheters for performing the mapping and ablating functions.

Abstract: Disclosed herein is a system for displaying a degree of neuromuscular block in a patient. An example system can include: a display unit having a graphical user interface (GUI); a processor; and a memory. The system can be configured to: receive data in response to a pattern of stimuli applied to the patient according to a stimulation protocol; determine the degree of neuromuscular block based on the received data; display a numerical representation corresponding to the degree of neuromuscular block; display a graphical representation corresponding to the degree of neuromuscular block and display a timer related to the stimulation protocol. The numerical and graphical representations can be displayed in first and second regions of the GUI, respectively. Additionally, a display color of at least a portion of the first region, the numerical and graphical representations can be configured to dynamically change based on the degree of neuromuscular block.

Abstract: A stimulation device includes an adapter component to increase the usability of the stimulation device. The adapter may be a bipolar adapter arranged to connect to the housing of the stimulation device. The adapter may include a clip having a first channel configured to receive an operative element therein and a second channel having a return operative element therein. The return operative element is in electrical communication with an electrical circuit of said stimulation control device. Alternatively, the adapter may be a percutaneous adapter comprising a connector configured to connect to an operative element of a stimulation device and a lead wire connected to the connector. A needle may be connected to the lead wire to deliver a electrical stimulation signal to a target tissue located beneath the skin of a subject patient.

Abstract: A method of identifying a change in the health of a nerve during a surgical procedure includes determining a sensitivity of the nerve at a first time, determining a sensitivity of the nerve at a second time, and providing an indication to a user corresponding to a change in the sensitivity of the nerve from the first time to the second time. In each instance, the sensitivity of the nerve is determined by providing an electrical stimulus via an electrode disposed on a distal end portion of an elongate medical instrument, and monitoring a magnitude of a mechanical response of a muscle innervated by the nerve.

Abstract: A system and method for applying stimulation to a target stimulation site within a patient, while avoiding undesirable eye movement side effects of the stimulation, are provided. The method includes determining whether eye movement, sensed by internal or external electrodes, is a side effect of a conveyed electrical stimulus. If the eye movement is a side effect, the electrical current distribution of the stimulus is modified in order to steer a locus of the electrical stimulus from one tissue region of the patient to another different tissue region of the patient, thereby mitigating the eye movement side effects. For example, the locus of the electrical stimulus may be steered away from the oculomotor nerve. Eye movement side effects of DBS treatment may include apraxia of lid opening, downward movement and adduction of only one eyeball, and/or continuous deviation of both eyeballs.

Abstract: A method for analyzing nerve fibers distribution is provided, including inputting a stimulation signal into a nerve tissue through at least two sensing and conducting electrodes, applying a stimulation signal ratio to control the stimulation signal using an electric current steering technique to electrically stimulate a plurality of nerve fibers within a plurality of stimulations areas of the nerve tissue; receiving a plurality of evoked compound action potentials (ECAP) using at least two sensing and conducting electrodes due to the nerve fibers electrically stimulated and computing a distance between the nerve fiber and the conducting electrodes including eliminating non-ideal effect caused by an electric potential attenuation factor, wherein the electric potential attenuation factor is a function of the distance between each of the conducting electrodes and the nerve tissue; and integrating and comparing the received ECAPs and analyzing the nerve fibers distribution of the nerve tissue.

Abstract: The present disclosure involves an electronic device. The electronic device is configured to perform evaluations on a patient user for medical purposes. The electronic device includes a touchscreen display configured to receive input from the user. The electronic device includes a memory storage component configured to store programming code. The electronic device includes a computer processor configured to execute the programming code to perform an evaluation of the user's mental and physical abilities. The evaluation includes prompting the user to perform a plurality of tasks. At least one of the tasks prompts the user to manipulate one or more graphical models shown on the touchscreen display according to predefined instructions. The evaluation includes detecting, via the touchscreen display, responses from the user for the tasks. The evaluation includes determining, based on the detected responses, whether the user is mentally and physically fit to provide reliable feedback to medical personnel.

Abstract: A method of detecting the presence of a sacral nerve in a human subject includes providing an electrical stimulus within an intracorporeal treatment area of the human subject; detecting a physical response of at least one of an external sphincter of the bladder and an external sphincter of the anus; and providing an indication to a user if the detected physical response corresponds to the provided electrical stimulus.

Abstract: Methods and devices for treatment to at least interfere with the function of a muscle are described herein. These methods and devices may have application in cosmetic and plastic surgery, dermatology, suppression of tension and/or migraine-type headaches, pain management, one particular application of the subject matter deals primarily with reducing wrinkles caused by ongoing muscular activation. The devices and methods described herein allow medical practitioners to effectively identify selective nerves for paralyzing muscles, without the need for injections of agents such as botulism toxin. Moreover, the devices and methods herein, may allow for artificial generation of signals in nerves that were otherwise damaged by stimulating transmission of nerve signals across damaged nerves.

Abstract: A neural monitoring system includes a stimulator configured to provide an electrical stimulus within an intracorporeal treatment area of a subject, an elongate sphincter contraction sensor, and a receiver in communication with the sphincter contraction sensor. The elongate sphincter contraction sensor includes an elongate device body configured to be inserted within a sphincter of the subject and a force sensor in mechanical communication with the elongate device body. The force sensor is configured to provide a mechanomyography output signal in response to a contact force applied against the elongate device body by the sphincter. The receiver is configured to receive the mechanomyography output signal from the elongate sphincter contraction sensor and provide an indicator to a user based on at least a portion of the output of the sphincter contraction sensor.

Abstract: Methods for determining structural integrity of a bone within the spine of a patient, the bone having a first aspect and a second aspect, wherein the second aspect separated from the first aspect by a width and located adjacent to a spinal nerve. The methods involve (a) applying an electrical stimulus to the first aspect of the bone; (b) electrically monitoring a muscle myotome associated with the spinal nerve to detect if an onset neuro-muscular response occurs in response to the application of the electrical stimulus to the first aspect of the bone; (c) automatically increasing the magnitude of the electrical stimulus to until the onset neuro-muscular response is detected; and (d) communicating to a user via at least one of visual and audible means information representing the magnitude of the electrical stimulus which caused the onset neuro-muscular response.

Abstract: Disclosed are apparatus and methods that provide the ability to electrical stimulate a physical system, and actively eliminate interference with signal acquisition (artifacts) that arises from the stimulation. The technique implemented in the circuits and methods for eliminating interference connects a discharge path to a physical interface to the system to remove charge that is built-up during stimulation. By placing the discharge path in a feedback loop that includes a recording preamplifier and AC-coupling circuitry, the physical interface is brought back to its pre-stimulation offset voltage. The disclosed apparatus and methods may be used with piezoelectric transducers, ultrasound devices, optical diodes, and polarizable and non-polarizable electrodes. The disclosed apparatus can be employed in implantable devices, in vitro or in vivo setups with vertebrate and invertebrate neural tissue, muscle fibers, pancreatic islet cells, osteoblasts, osteoclasts, bacteria, algae, fungi, protists, and plants.

Abstract: An expandable tip cannula system, comprising: a hollow cannula shaft having a proximal end and a distal end; and an expandable tip mounted at the distal end of the hollow cannula shaft, the expandable tip comprising a plurality of generally-triangular shaped petals held together in a radially-inwardly tapered arrangement between adjacent petals, each petal comprising a nerve sensing electrode disposed therein.

Abstract: An automated EP analysis apparatus for monitoring, detecting and identifying changes (adverse or recovering) to a physiological system generating the analyzed EPs, wherein the apparatus is adapted to characterize and classify EPs and create alerts of changes (adverse or recovering) to the physiological systems generating the EPs if the acquired EP waveforms change significantly in latency, amplitude or morphology.

Abstract: Improved sensors and sensing methods for detection of Neuromuscular Blockade (NMB), for example to improve monitoring generally, as well as facilitate automated NMB drug administration. The methods, systems, devices, etc., herein can increase the quantity and quality of data available. The methods, etc., include translation between commonly available sensing types, use of partially saturated sensor measurements, use of a model of neurotransmitter storage and release and sophisticated use of more than one sensor simultaneously. These methods are aided by new sensors and methods of decreasing electrical noise. An implementation of the methods, systems, devices, etc., herein is automated drug delivery for NMB, whether through an advisor system or through with full computer control.

Abstract: An object of the present invention is to provide a microelectrode capable of recording action potentials of nerve cellsneurons as large-amplitude waveforms and being appropriate for multi-channeling. The electrode 1 of the present invention comprises a conductive linear core material 2, an insulating coating layer 3a with which the outer circumference of the linear core material is coated, and an extending part 3b formed by extending the end part of the coating layer on one tip side of the linear core material beyond the tip in the longitudinal direction of the linear core material, in which a cavity that opens in the extending direction is formed within the extending part.

Abstract: A surgical access system including a tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures before, during, and after the establishment of an operative corridor to a surgical target site. Some embodiments of the surgical access system may be particularly suited for establishing an operative corridor to a surgical target site in the spine. Such an operative corridor may be established through the retroperitoneal space and the psoas muscle during a direct lateral, retroperitoneal approach to the spine.

Abstract: The present invention includes a system and methods aimed at surgery, and more particularly to a system and methods for monitoring nervous tissue to assess the integrity of a pedicle wall during or after pilot hole formation and before, during, or after screw implantation, particularly in the thoracic spine. The system also performs other neurophysiologic assessments including, but not necessarily limited to, neuromuscular pathway status, nerve proximity detection, nerve pathology monitoring, and spinal cord health monitoring.

Abstract: Assessment of neuron excitation is implemented by quantifying the interaction between focused and unfocused stimulation applied to a cochlear array. By applying focused and unfocused stimulation to the electrode array and comparing the difference in the responses to the two types of stimulation the interaction may be determined. The magnitude of the interaction may be related to neural excitation and using this data a neural excitation profile may be determined.

Abstract: Improved assemblies, systems, and methods provide safeguarding against tissue injury during surgical procedures and/or identify nerve damage occurring prior to surgery and/or verify range of motion or attributes of muscle contraction during reconstructive surgery. A stimulation control device may incorporate a range of low and high intensity stimulation to provide a stimulation and evaluation of both nerves and muscles. A stimulation control device is removably coupled to a surgical device or is imbedded within the medical device to provide a stimulation and treatment medical device. A disposable hand held stimulation system includes an operative element extending from the housing, the housing includes a visual indication to provide feedback or status to the user.

Abstract: A stimulation probe includes a proximal end connector and a flexible wire coupled to the end connector. A handle is coupled to the wire and a needle extends from the handle and terminates at a conductive tip.

Abstract: The present invention involves a system and methods for nerve testing during anterior surgery, including but not limited to anterior total disc replacement surgery, nucleus replacement, and interbody fusion.

Abstract: A system and methods that can be used to monitor and detect nerve status and/or proximity by determining relative neuro-muscular response onset value thresholds for a nerve. The nerve status and/or proximity may be determined by delivering and increasing a stimulation signal to depolarize the nerve and measuring the current intensity level at which a neuro-muscular response to the depolarization of the nerve is detected.

Abstract: A bio-probe assembly comprises a flexible substrate, a probe array, and an adhesive. The flexible substrate has a surface. The probe array has a plurality of probes, which is disposed on the surface of the flexible substrate. The adhesive is disposed on the surface of the flexible substrate as well. Each probe has a protrusion length in a range from 100 to 300 micrometers.

Abstract: The present invention involves systems and related methods for performing surgical procedures and assessments, including the use of neurophysiology-based monitoring to: (a) determine nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site; (b) assess the pathology (health or status) of a nerve or nerve root before, during, or after a surgical procedure; and/or (c) assess pedicle integrity before, during or after pedicle screw placement, all in an automated, easy to use, and easy to interpret fashion so as to provide a surgeon-driven system.

Abstract: A neural monitoring system for detecting an induced response of a muscle to a stimulus provided within an intracorporeal treatment area of a human subject includes a mechanical sensor configured to be placed in mechanical communication with the muscle and to generate a mechanomyography output signal corresponding to a sensed mechanical movement of the muscle, and a receiver in communication with the mechanical sensor. The receiver is configured to: receive the mechanomyography output signal from the mechanical sensor; compute a time derivative of the sensed muscle movement from the mechanomyography output signal; compare the computed time derivative to a threshold; and indicate that the sensed mechanical movement of the muscle was induced by the provided intracorporeal stimulus if the computed time derivative exceeds the threshold.

Abstract: Provided is a system that may be used in delivering targeted electrical stimulation to tissue, such as animal bodily tissue. A system according to the present invention includes a longitudinal stimulation probe that includes a first electrode disposed at a distal tip and a second electrically conductive surface spaced proximally from the first electrode. Another system according to the present invention may include an improved user interface including an improved probe/handle interface including high visibility indication.

Abstract: A neural monitoring enabled insulating sleeve for use with a surgical instrument during a surgical procedure on a patient in patient body tissue includes a tubular portion having a proximal end, a distal end, and a bore extending therethrough. The bore is configured to receive the surgical instrument. The tubular portion being formed of a material that electrically insulates the surgical instrument from the patient body tissue and having a flexible portion configured to flex between a locked and an unlocked condition. A camming component is configured to interface at the proximal end of the tubular portion. It is configured to cam the flexible portion between the locked and unlocked condition.

Abstract: A neural monitoring system for detecting an induced response of a muscle to a stimulus provided within an intracorporeal treatment area of a human subject includes a mechanical sensor configured to be placed in mechanical communication with the muscle and to generate a mechanomyography output signal corresponding to a sensed mechanical movement of the muscle, and a receiver in communication with the mechanical sensor. The receiver is configured to: receive the mechanomyography output signal from the mechanical sensor; compute a time derivative of an acceleration of the muscle from the mechanomyography output signal; compare the computed time derivative of acceleration to a jerk threshold; and indicate that the sensed mechanical movement of the muscle was induced by the provided intracorporeal stimulus if the computed time derivative of acceleration exceeds the jerk threshold.

Abstract: A system and method is described to map the renal artery prior to an ablation in order to a-priori identify the location of the sympathetic nerves. In specific embodiments, the nerve modulating energy may be electrical or optical.

Abstract: Improved sensors and sensing methods for detection of Neuromuscular Blockade (NMB), for example to improve monitoring generally, as well as facilitate automated NMB drug administration. The methods, systems, devices, etc., herein can increase the quantity and quality of data available. The methods, etc., include translation between commonly available sensing types, use of partially saturated sensor measurements, use of a model of neurotransmitter storage and release and sophisticated use of more than one sensor simultaneously. These methods are aided by new sensors and methods of decreasing electrical noise. An implementation of the methods, systems, devices, etc., herein is automated drug delivery for NMB, whether through an advisor system or through with full computer control.

Abstract: A system and method for identifying a stimulation location on a nerve is disclosed. The system includes an image-based navigation interface used to facilitate advancing a stimulation element within a patient body toward a target nerve stimulation site. Using the system one determines, separately for each potential target nerve stimulation site, a neuromuscular response of muscles produced upon applying a stimulation signal at the respective separate potential target stimulation sites. The image-based navigation interface is configured to display a graphic identification of which muscles were activated for each respective potential target nerve stimulation site upon applying the stimulation signal.

Abstract: The present invention relates generally to systems and algorithms aimed at neurophysiology monitoring, and more particularly to a system capable of quickly finding stimulation thresholds over multiple channels of a neurophysiology monitoring system. For example, the neurophysiology monitoring system may be configured to omit stimulation pulses when the neuromuscular response is predictable.

Abstract: Improved assemblies, systems, and methods provide safeguarding against tissue injury during surgical procedures and/or identify nerve damage occurring prior to surgery and/or verify range of motion or attributes of muscle contraction during reconstructive surgery. A stimulation control device may incorporate a range of low and high intensity stimulation to provide a stimulation and evaluation of both nerves and muscles. A stimulation control device is removably coupled to a surgical device or is imbedded within the medical device to provide a stimulation and treatment medical device. A disposable hand held stimulation system includes an operative element extending from the housing, the housing includes a visual indication to provide feedback or status to the user.

Abstract: Methods for determining structural integrity of a bone within the spine of a patient, the bone having a first aspect and a second aspect, wherein the second aspect separated from the first aspect by a width and located adjacent to a spinal nerve. The methods involve (a) applying an electrical stimulus to the first aspect of the bone; (b) electrically monitoring a muscle myotome associated with the spinal nerve to detect if an onset neuro-muscular response occurs in response to the application of the electrical stimulus to the first aspect of the bone; (c) automatically increasing the magnitude of the electrical stimulus to until the onset neuro-muscular response is detected; and (d) communicating to a user via at least one of visual and audible means information representing the magnitude of the electrical stimulus which caused the onset neuro-muscular response.

Abstract: The present invention involves systems and methods for determining nerve proximity, nerve direction, and pathology relative to a surgical instrument based on an identified relationship between neuromuscular responses and the stimulation signal that caused the neuromuscular responses.

Abstract: The present invention relates to a catheter set for nerve treatment used for delivering a stimulus or a drug to nerves in the human body. According to the present invention, the catheter set for nerve treatment includes: a catheter capable of delivering a drug to a target nerve through a tube line, having a tube shape; a cylindrical cannula for supporting the catheter when inserted into the body tissue while slidably accommodating the catheter inside; a conductive guide wire to be accommodated inside the catheter, having one exposed end; and a conductive first stimulator connector for delivering an electric stimulus to the one exposed end of the guide wire, electrically connected to the other end of the guide wire. Therefore, it is possible to accurately place the end of the catheter at the location of the target nerve, to prevent the end of the catheter from deviating from the target nerve during an operation, and to finely adjust the location of the catheter even after removing the cannula.

Abstract: The invention provides a method of electrical artefact compensation in measurement of a neural response. The neural response is evoked by a first stimulus, after which a compensatory stimulus is applied in order to counteract a stimulus artefact caused by the first stimulus. The invention also provides for short circuiting the stimulating electrode subsequent to the first stimulus. A system for implementing such steps is also provided. The invention may be of application in measurement of physiological responses, including neural responses and in particular a neural response of the auditory nerve.