Abstract: An electrical interferential device comprises a circuit for delivering electrical interferential energy into the body of a patient. A sensor detects a function of the autonomic nervous system of the patient and provides an output indicative of the response of the autonomic nervous system to the electrical interferential energy. A treatment regimen is selected which uses a combination of carrier and beat frequencies and electrode placement pattern that produce a desired response in the autonomic nervous system of the patient. In one embodiment of the invention, a diagnostic tool is used to determine which combination of carrier and beat frequencies are desirable and treatment is provided by a second electrical interferential device. In another embodiment of the invention, the same diagnostic tool or a portion of the same diagnostic tool may be used to treat the patient.

Abstract: Embodiments are disclosed relating to classification of sematosensory evoked potential waveforms.

Abstract: A system for accessing a surgical target site and related methods, involving an initial distraction system for creating an initial distraction corridor, and an assembly capable of distracting from the initial distraction corridor to a secondary distraction corridor and thereafter sequentially receiving a plurality of retractor blades for retracting from the secondary distraction corridor to thereby create an operative corridor to the surgical target site, 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.

Abstract: A target nerve or nerve plexus registration point is located utilizing a nerve stimulator needle positioned in a bore of a carrier. The carrier is configured with an electrically nonconductive smooth curved surface at a distal end of the bore. The needle tip is fixed in an operative cutaneous electrode position and the smooth curved surface of the carrier is forced against and compresses the epidermis, corium and subcutaneous tissue and traverses cutaneous surfaces to locate a target nerve or nerve plexus without physical penetration by the needle tip. The needle is then inserted at the located point, with or without the needle path being guided by the bore. In another embodiment, a subcutaneous portion of carrier is introduced and is pivoted about its introduction point to locate the target nerve.

Abstract: A method of determining the total body fat of a person comprising measuring a subcutaneous fat thickness at four points on the person's body, located in the right anterior part of the left mid-thigh, in the left anterior part of the right mid-thigh, in the right dorsal part navel level and in the left dorsal part at navel level, respectively, and determining a first estimate of the person's total body fat as a function of these measurements.

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: In one form of the present invention, there is provided a method for detecting an A-wave, the method comprising: applying a series of stimuli to a nerve; recording a series of late responses; creation of a feature space map from an ensemble of late responses; identification of clusters within the feature space that represent A-wave components; consolidation of A-wave components into a discrete collection of A-waves; removal of false positive A-waves; and extraction of A-wave characteristics.

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: Systems and methods according to the present invention provide a means for determining, as an example, the health or location of nerves. Generally, embodiments according to the present invention may be used to verify the absence of nerve tissue along a prospective incision location to avoid damage caused by such incision. Alternatively or additionally, embodiments according to the present invention may be used to locate and/or hone in on a more precise location of one or more nerves. Electrical stimulation may be applied to tissue in an iterative fashion in one or more desired patterns and at one or more stimulation intensities to determine one or more regional neural responses and one or more focused neural responses.

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. Such improved assemblies may be utilized in embodiments of methods according to the present invention allowing, preferably by a single hand, manipulation, carrying, parameter adjustment and/or informational feedback generation from within a surgical field. Single-handed operation and easily identifiable feedback generation is desirable especially where focused attention is required, such as during surgery observed through a microscope.

Abstract: Systems and methods according to the present invention provide a means for determining, as an example, the health or location of nerves. A determination according to the present invention may include semi-quantitative threshold testing using intra-operative electrical stimulation to determine whether one or more nerves are functioning as expected. A determination according to the present invention may also be utilized to determine or predict the success of a surgical procedure that may affect the functioning of one or more nerves. Semi-quantitative analysis may be performed by comparing electrical stimulation intensity, or an approximation thereof, at which a threshold neural response is observed to an expected or previously applied electrical stimulation intensity, or an approximation thereof.

Abstract: Improved assemblies, systems, and methods provide safeguarding against nerve 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.

Abstract: A surgical apparatus for facilitating testing nerves during HF surgery. The surgical apparatus comprises a converter for converting a high-frequency treatment current into a nerve stimulating current. A controllable selector switch optionally feeds either the treatment current or the nerve stimulating current to the electrosurgical instrument.

Abstract: A method and apparatus is provided that allow the surgeon and the IONM specialist to continuously get feedback on the relative proximity of instrumentation to a nerve and the health of this nerve. By using a coupling device that allows every instrument to be electrically stimulated, the surgeon, through the instruments, continuously sends a small electrical input into the patient's body. Depending on the relative proximity between this electrical stimulation and a nerve, a neuromonitoring modality is recorded through electrodes placed on the patient. This modality is read and analyzed by the IONM specialist. The characteristics of this response allow the IONM specialist to determine the health status and or location of the nerves.

Abstract: Methods, systems and devices for monitoring a target in a neural system involve delivering inputs to and recording output responses from the neural system and obtaining I/O characterizations of the neural system both before and during or after a change is introduced to the system, for example, a change associated with a stem cell therapy. Baseline and therapeutic I/O characterizations are compared, and interpretations of the results of the comparison may be used to adjust some aspect of the therapy to facilitate it or control it. An implantable neurostimulator with the capability of delivering electrical stimulation to an electrode and of measuring and recording responses sensed from electrodes, where the electrodes are strategically positioned at or near the target, can be used to deliver an electrical stimulation input and record the output responses for the I/O characterizations.

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 an operative element adjustment portion and a visual indication to provide feedback or status to the user.

Abstract: A device to stimulate and measure a response from the ulnar dorsal cutaneous nerve of a patient may include a first surface electrode to apply a stimulating signal to the ulnar dorsal cutaneous nerve, a second surface electrode to record the response from the stimulating signal after applying the stimulating signal to the ulnar dorsal cutaneous nerve, and a third surface electrode to reference the stimulating signal. The second surface electrode may be placed over the fifth metacarpal joint, and the device may include a ground electrode positioned over the dorsal surface of the hand. The device may include a inactive stimulating electrode positioned near to the first surface electrode. The inactive stimulating electrode may be positioned within 3 cm of the first surface electrode, and the first electrode may be placed substantially above the tendon the flexor carpi ulnaris muscle.

Abstract: A manual neurological testing device for measuring a subject's reaction time comprising: a releasable holding member operable to be grasped by the subject; a stimulus device coupled with the releasable holding member, the stimulus device outputting a perceivable stimulus; and a measurement device coupled with the releasable holding member, the measurement device measuring the subject's reaction time for grasping the releasable holding member relative to the perceivable stimulus.

Abstract: This invention relates to a sensor assembly and a method for measuring characteristics of a surface, preferably skin, comprising a first pair of current supply electrodes coupled to a current source, providing an electrical current to the skin, at least one pickup electrodes at chosen positions relative to the current supply electrodes, at least a first of said pickup electrodes being coupled to an instrument for measuring the voltage between said first pickup electrode and at least one of the pickup or current supply electrodes.

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 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 disclosure provides systems and methods for screening vagus nerve stimulation to determine the potential efficacy of permanent stimulation systems. In one aspect, the system includes temporary electrode assemblies adapted for temporary placement on or in the body adjacent the vagus nerve. In another aspect, a method is provided to place a stimulating electrode adjacent the posterior of the carotid sheath.

Abstract: A method, system, and products that allow for accurate localization, virtual depiction, and testing of nerve(s) or neural structures that course through or around a proposed surgical site are described. The method and system employs a variety of types of neurodiagnostic tests that incorporate sensory, motor, and mixed nerve conduction studies in an orthodromic and antidromic fashion as well as utilizing triggered electromyography. This method, system, and products allow for a much more specific and sensitive method to assess the baseline function and continued integrity of nerves and neural structures prior to, during, and after a surgical procedure.

Abstract: Non-invasive device for locating a structure (N2), such as a nerve, in a region of a body having an external surface (Se), the device comprising: a focused ultrasonic transducer (1), advantageously of the HIFU type, designed to produce an ultrasound beam (Fu) through the external surface (Se) in the region, the beam (Fu) having a focal point that can be positioned on the structure (N2); monitoring means (3) for detecting a response of the structure when this is subjected to a stimulation; and stimulation means (1; 4) for stimulating the structure (N2), which delivers a response detected by the monitoring means (3), the stimulation means comprising the ultrasonic transducer (1) capable of delivering an ultrasound beam (Fu) to said structure (N2), so as to disturb it, characterized in that the device includes: an imager (2, 21, 22) mechanically coupled to the ultrasonic transducer (1) so that the imager follows the focal point of the transducer so as to display, on an image, the position of the focal point of t

Abstract: A consideration of electromagnetic energy transfer following from Poynting's theorem leads to a power signal that facilitates the detection of biomedical pulses. This power signal is derived from and is complementary to the measured biomedical voltage signals. The method may be applied to F-wave signals obtained from nerve conduction studies as well as other biomedical signals. Among other things, this power signal is useful in latency determination.

Abstract: A regional anesthesia system and a cart for aiding in the placement of a regional anesthesia block without the need of ancillary assistance. The invention includes equipment for use in the performance of a regional anesthesia block which is carried on a cart for transporting and providing a stable foundation for the equipment. The equipment includes a nerve localization means such as ultrasound or a peripheral nerve stimulator for locating a target nerve of a patient, a position assist arm for maintaining the position of the localization means over the target nerve while the operator inserts an anesthetic needle over the target nerve, and an anesthetic infusion device for infusing or aspirating through the anesthesia needle. The infusion device includes an infusion pump controlled by a foot pedal. The system may be easily transported to a patient requiring a regional anesthesia block, and allows the regional anesthesia block to be performed with minimal ancillary assistance.

Abstract: An apparatus for determining body impedance comprising: first and second electrodes suitable for being electrically coupled to the body; and a variable frequency relaxation oscillator coupled to the electrodes; wherein, the period of oscillation is indicative of the body impedance.

Abstract: An apparatus and method for detecting physiological function, for example, nerve conduction, is described. In one embodiment the apparatus includes a housing including a stimulator shaped to fit a first anatomical site and a detector shaped to fit a second anatomical site. The housing automatically positions the detector substantially adjacent to the second anatomical site when the stimulator is positioned substantially adjacent to the first anatomical site. The detector contains a plurality of individual detection elements, whereby the response evoked by stimulation at the first anatomical site is measured using one or more of these detection elements at the second anatomical location.

Abstract: The present invention involves systems and related methods for performing dynamic pedicle integrity assessments involving the use of neurophysiology.

Abstract: An integrated ultrasound and nerve stimulation system, ultrasound probe and method are provided. The system may include a transcutaneous electrode adapted for external placement on a patient, a percutaneous electrode having an electrically-conducting tip adapted for percutaneous placement proximate a nerve in the patient and a control for causing a current to flow between the electrodes. The system may also include a probe having an ultrasound transducer that transmits ultrasound waves into the patient and receives reflected ultrasound waves from the patient. The probe also has a communication interface for transmitting a signal representative of the received reflected ultrasound waves to a main unit. The main unit is in operative communication with the communication interface and includes a display and a processor, which receives the signal from the probe and causes the display to display an image in accordance with the received signal.

Abstract: A multi-electrode assembly for use in neuromuscular testing, the multi-electrode assembly comprising: a substrate; at least one stimulation electrode carried by the substrate; at least one detection electrode carried by the substrate; a connector carried by the substrate, the connector being configured for connection with testing electronics; and a plurality of traces for electrically connecting the at least one stimulation electrode and the at least one detection electrode to the connector; wherein the substrate is flexible so that the at least one stimulation electrode and the at least one detection electrode are independently positionable on a patient.

Abstract: A neural probe array is provided for subdural implantation to record intracranial field potentials in the brain. The neural probe array includes a base having first and second sides and a plurality of apertures therebetween. A plurality of contacts are spaced along the first side of the base for recording the field potentials. It is contemplated to provide drug delivery through the apertures in the base in order to enhance the biocompatibility of the neural probe array and to utilize the field potentials recorded by the contacts to drive an external device.

Abstract: A method and device for reducing muscle tension through electrical manipulation applies a low level current to muscles of a user. Each muscle has two electrodes applied thereto, one for passing the current from the device to the muscle, and the other for receiving the current from the muscle to complete the circuit. The device has several channels, one for each pair of electrodes, and current is passed through a muscle at a level below the threshold required to cause the muscle to contract. The device is programmed to automatically apply an alternating current at predetermined frequencies for predetermined time periods to each muscle of the user that is being treated. A method of diagnosing an ailment using the device is provided.

Abstract: A system and method of neural stimulation is disclosed, comprising the steps of electrically connecting at least one electrode to a first tissue, applying a stimulus to the at least one electrode, observing a response of a second tissue, identifying an electrode position on the first tissue wherein a desired response occurs on the second tissue when the stimulus is applied to the at least one electrode, and fixing the at least one electrode in place at the identified electrode position.

Abstract: An apparatus and method for simultaneously measuring at least two different bio signals without interference are provided. The apparatus includes a stimulus signal generating unit generating the stimulus signal to be applied to a human body, a sensing unit contacting the human body, including a plurality of electrodes to which the stimulus signal is applied and from which at least one intermediate signal containing the first and second bio signals is detected, configured to share at least one of the plurality of electrodes to apply the stimulus signal or to detect each intermediate signal, and a signal acquisition unit separating and acquiring the first and second bio signals from each intermediate signal detected from the sensing unit.

Abstract: In one form of the present invention, there is provided a method for detecting an A-wave, the method comprising: applying a series of stimuli to a nerve; recording a series of late responses; creation of a feature space map from an ensemble of late responses; identification of clusters within the feature space that represent A-wave components; consolidation of A-wave components into a discrete collection of A-waves; removal of false positive A-waves; and extraction of A-wave characteristics.

Abstract: A minimally invasive dilation device includes a stylus, a plurality of rigid arms radially arrayed about the stylus, and a dilating member positioned between the stylus and the arms. An outer flexible sleeve may be circumferentially secured to the arms, lying within or without the plurality of arms. An inner mesh may surround the stylus and dilating member. The device may be introduced into tissue toward a targeted area, while in a closed configuration. The dilating member may be a balloon, wherein upon inflation of the balloon, the arms are pushed radially outward, expanding the device and dilating the surrounding tissue. A cannula may be inserted inside the plurality of arms to keep the arms in an open configuration, and the stylus, balloon and inner mesh may be withdrawn, providing an open passageway through the device to the targeted area. The device may be used with a neural monitoring system.

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: Methods and apparatus are provided for selective surgical removal of tissue. In one variation, tissue may be ablated, resected, removed, or otherwise remodeled by standard small endoscopic tools delivered into the epidural space through an epidural needle. The sharp tip of the needle in the epidural space, can be converted to a blunt tipped instrument for further safe advancement. The current invention includes specific tools that enable safe tissue modification in the epidural space, including a barrier that separates the area where tissue modification will take place from adjacent vulnerable neural and vascular structures. A nerve stimulator may be provided to reduce a risk of inadvertent neural abrasion.

Abstract: Methods and apparatus are provided for selective surgical removal of tissue. In one variation, tissue may be ablated, resected, removed, or otherwise remodeled by standard small endoscopic tools delivered into the epidural space through an epidural needle. The sharp tip of the needle in the epidural space, can be converted to a blunt tipped instrument for further safe advancement. The current invention includes specific tools that enable safe tissue modification in the epidural space, including a barrier that separates the area where tissue modification will take place from adjacent vulnerable neural and vascular structures. A nerve stimulator may be provided to reduce a risk of inadvertent neural abrasion.

Abstract: A nerve monitoring system facilitates monitoring an integrity of a nerve.

Abstract: A nerve monitoring system facilitates monitoring an integrity of a nerve.

Abstract: According to certain examples, an implanted medical device is used to determine a mass attribute of a patient. The patient's phrenic nerve is stimulated, and the diaphragmatic response is measured by an accelerometer. The measured response is analyzed in certain embodiments to determine a mass attribute. This information can help in the diagnosis of, and efficient response to, edema.

Abstract: Techniques for adjusting stimulation are disclosed. A medical device measures an impedance associated with one or more electrodes, e.g., the impedance presented to the medical device by a total electrical circuit that includes the one or more electrodes, the conductors associated with the electrodes, and tissue proximate to the electrodes. The medical device stores at least one patient-specific relationship between impedance and a stimulation parameter, and adjusts the value of the stimulation parameter based on the measured impedance according to the relationship. The medical device may store multiple relationships, and select one the relationships based on, for example, an activity level of the patient, posture of the patient, or a current stimulation program or electrode combination used to deliver stimulation. By adjusting a stimulation parameter, such as amplitude, according to such a relationship, the stimulation intensity as perceived by the patient may be kept substantially constant.

Abstract: A method and system for atrial fibrillation analysis, characterization, and mapping is disclosed. A finite element model (FEM) representing a physical structure of a heart is generated. Electrogram data can be sensed at various locations in the heart using an electrophysiology catheter, and the electrogram data is mapped to the elements of the FEM. Function parameters, which measure some characteristics of AF arrhythmia, are then simultaneously calculated for all of the elements of the FEM based on the electrogram data mapped to the elements of the FEM. An artificial neural network (ANN) can be used to calculate the function parameters.

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 operational status display for a nerve stimulator is located remote from the nerve stimulator. In one embodiment the display comprises a stand-alone discrete component that can be placed as desired by the nerve stimulator needle. In another embodiment, the display comprises an integral part of the nerve stimulator needle. The display can be alphanumeric or can comprise one or more discrete signal lights or other visual indicia. Color can be used to provide information regarding levels (intensity) of current, or the energy being provided to the needle and/or being delivered to the patient. In some embodiments these displays also provide information regarding the presence or absence of current and/or the polarity of the electricity then being provided to the nerve stimulator needle.

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 surgical access system including a tissue distraction assembly and a tissue refraction 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.

Abstract: A process is described for non-invasively screening a patient to select a stimulation site for treatment of head, neck or facial pain and tension symptoms caused by disorders such as occipital neuralgia. The screening process involves application of a transcutaneous stimulation screening device, a percutaneous micro-electrode screening device, and a temporary implantable screening device to the patient to select a site for chronic implantation.