This invention is directed to electrophysiological testing, specifically, to electrode configuration and electrical connection of one or more electrophysiological testing wires between a subject and an electrophysiological device with user interface.
A multitude of electrophysiological tests are currently available for medical professionals to perform on subjects in order to analyze the electrical processes of the body, including electroencephalography (EEG), electromyography (EMG), nerve conduction studies (NCS), evoked potentials (EP), electrocardiography (ECG/EKG), and Holter monitoring. Electrophysiological tests detect electrical activity transduced to the skin's surface via an electrode frequently attached by a substance such as colloidal gel or paste. This information is currently transmitted through individual cables to a computer interface that amplifies the signal and may filter the signal which has been transmitted for analysis by a trained medical professional.
Specifically, EEG is a non-invasive test which is widely used to study electrical activity of the brain. EEG has been used to assess many different medical issues, including but not limited to epileptic seizures, locating areas of damage following head injury or stroke, and investigate sleep disorders. EEG utilizes a number of electrodes that measure electrical activity in multiple areas of the brain, including frontal, central, posterior, temporal and occipital regions. There are several electrode configurations currently used by medical professionals for EEG, including the 10/20 and 10/10 electrode systems. To determine the placement of electrodes, measurements must be taken between cranial structures including the nasion, preauricular points, and inion. From these points measurements of 10% and 20% must be determined for electrode placement. This typically produces between 21 and 329 points of connection which must be individually connected to a Brain Computer Interface (BCI) or electrophysiological testing device for amplification and analysis by medical professionals. During or just prior to EEG testing there are occasions that may require the subject to be disconnected from the BCI. By utilizing multiple cables individually attached to a BCI the mobility of a subject is limited and the ability of a medical professional to perform tests, such as MRI, is hindered at the expense of set up time.
EEG readings are highly sensitive and subject to artifacts due to movement and broken wire contacts. These artifacts are amplified upon transmission to an electrophysiological testing device. It becomes imperative to limit such incidents during subject testing to appropriately analyze data. Currently the process involves attaching individual cables to a BCI which can increase the potential for cable movement or broken wire contacts, which must be replaced. Furthermore, troubleshooting bad electrical connections is complex and hindered by the lack of intuitive links between the software user interface and the actual electrode connections on the patient's scalp.
Methods to combat the difficulties associated with EEG cable organization and simplify the connections have been pursued. Methods have been produced to simplify the disconnection process without simplifying the initial system connection scheme. Other methods have been produced which facilitate the ease and placement of electrodes on the head of a patient which may sacrifice specificity and test viability. Others methods of electrode placement facilitate the ease of connection to a BCI but maintain the number of lead contacts or lead connections requiring a technician for junction to head boxes. All of these techniques provide benefits which sacrifice either ease of test performance or accuracy of electrophysiological tests.
A system must be provided which will allow a medical professional to simply and freely attach and detach these cables from the patient for specific situations which require such an application. This system must be associated with a user interface scheme that is easily interpreted for troubleshooting electrode problems to facilitate better workflow of placing and verifying electrodes. A system must be provided which allows medical professionals to perform electrophysiological testing which limits the production of unintended abnormalities during testing without affecting the sensitivity of the device. This system should not affect the viability of test results.
One object of the present disclosure is to provide a device and system for simplified connection, disconnection, and mitigation of signal interference for an electrophysiological testing device. One or more electrophysiological electrodes and leads may be attached to the patient. The electrode leads may be bundled based on anatomical regions and may terminate at a single connector, which may be individually keyed and/or colored for ease of connection and disconnection to a junction box. Electrode bundles may be connected to a single junction box within proximity to the patient. A single cable may connect the junction box to an electrophysiological testing and monitoring interface, such as a BCI. The associated user interface may maintain the correlation between color code, anatomical placement, and the acquired signal as part of a referential montage to facilitate rapid user interpretation. Together this device and system may generate a means to perform electrophysiological testing that easily connects and disconnects from a medical testing device and promotes faster detection and location of electrode signal abnormalities, all while maintaining the viability of the test results.
In one embodiment, an apparatus is provided for use in association with a plurality of electrodes and an electrophysiological testing device for supporting a plurality of electrode configurations on a patient. The apparatus may comprise a plurality of bundles, each of the bundles comprising a plurality of electrode leads, each of the electrode leads being adapted to transmit electrophysiological signals from one of the plurality of electrodes, wherein each of the plurality of bundles terminates at a single keyed connector. The apparatus may further comprise a junction box including a plurality of keyed receivers, each of the keyed receivers adapted to pair with and receive a corresponding keyed connector and a cable adapted to connect the junction box to the electrophysiological testing device. Each of the keyed receivers of the junction box may be adapted to receive the electrophysiological signals from the corresponding keyed connector, and the cable may be adapted to transmit the electrophysiological signals received at the junction box from each of the plurality of bundles to the electrophysiological testing device.
Each of the plurality of bundles may be identified by a different color. In another aspect, each of the plurality of bundles may be adapted for connection to a specific anatomical region on the patient. Each of the keyed receivers may be color coded to a respective one of the plurality of bundles, the color code comprising a different color corresponding to each pair of bundle and keyed receiver.
The plurality of electrode leads within at least one of the plurality of bundles may be of different lengths. The different lengths of the plurality of electrode leads within the at least one of the plurality of bundles may comprise at least one shorter length for a first electrode lead adapted for attachment to a back of a head of the patient and at least one longer length for a second electrode lead adapted for attachment to a front of the head of the patient. In another aspect, the different lengths of the plurality of electrode leads within the at least one of the plurality of bundles may comprise at least one shorter length for a first electrode lead adapted for attachment to a front of a head of the patient and at least one longer length for a second electrode lead adapted for attachment to a back of the head of the patient. In a further aspect, the plurality of electrodes within at least one of the plurality of bundles may all be the same length.
In another aspect, at least one retainer may be provided, said retainer connecting the plurality of electrode leads within at least one of the bundles at a longitudinal location between the electrodes and the keyed connector. The retainer may be adapted to slide longitudinally along the at least one bundle. In one aspect, a plurality of retainer may be provided, each of the plurality of retainers being attached to one of the plurality of bundles, wherein each of the plurality of bundles along with its corresponding retainer is identified by a different color.
In another embodiment, an apparatus is provided for use in association with a plurality of electrodes and an electrophysiological testing device for supporting a plurality of electrode configurations on a patient. The apparatus may comprise a plurality of electrode leads grouped into a plurality of bundles, wherein each of the plurality of bundles corresponds to a different anatomical region on the patient, wherein each of the plurality of bundles includes at least two of the electrode leads that terminate at a single connector, and wherein each of the electrode leads is adapted to transmit electrophysiological signals from one of the plurality of electrodes to a corresponding single connector. In addition, the apparatus may comprise a junction box including a plurality of receivers, each of the receivers adapted to be paired with the connector of one of the bundles and a cable adapted to connect the junction box to the electrophysiological testing device. Each of the receivers of the junction box may include an identifier that is coded to only one of the plurality of bundles. Each of the receivers of the junction boxy may be adapted to receive the electrophysiological signals from the corresponding paired connector. In another aspect, the cable may be adapted to transmit the electrophysiological signals received at the junction box from each of the plurality of bundles to the electrophysiological testing device.
The identifier may comprise a color, such that each of the receivers is color coded to only one of the bundles.
In another aspect, each connector of each bundle may be a different shape, and the identifier may comprise a shape, such that each of the receivers is shaped to correspond to the shape of only connector of only one of the bundles.
A plurality of retainers may be provided, each retainer adapted to receive and maintain relative position of the electrode leads within a given bundle. In a further aspect, the identifier may comprise color, such that each of the retainers includes a color that matches a color of its corresponding bundle, and each of the receivers may be color coded to only one of the bundles.
In a further embodiment, a method is disclosed for evaluating electrophysiological signals from a patient. The method may comprise attaching a plurality of electrodes to the patient, the plurality of electrodes being grouped according to a plurality of anatomical regions and adapted to transmit the electrophysiological signals from the patient. The method may further include providing a plurality of bundles of electrode leads, wherein each bundle comprises at least two electrode leads that terminate at a single connector, and wherein each bundle corresponds to a single one of the anatomical regions. In addition, the method may include connecting each of the electrode leads of a first bundle to electrodes of a first of the anatomical regions, and each of the electrode leads of a second bundle to electrodes of a second of the anatomical regions. A junction box may be provided, the junction box including a plurality of receivers color coded to correspond to a single one of the plurality of bundles and further including a cable adapted for pairing with an electrophysiological testing device. The method may include connecting the single connector of each of the plurality of bundles to a corresponding color coded receiver, pairing the cable of the junction box with the electrophysiological testing device, and displaying on the electrophysiological testing device the electrophysiological signals of the patient.
In one aspect, the electrophysiological signals may be displayed in groups according to anatomical regions. In another aspect, the electrophysiological signals may be displayed in groups according to bundle. In a further aspect, the electrophysiological signals may be displayed in groups according to the color coding of the bundles and receivers.
These connectors may interact with individually keyed receivers 110 of a junction box 104, with each keyed connector 103 corresponding to a particular keyed receiver 110. For example, each keyed connector 103 may correspond in shape to an individual keyed receiver 110, but not to other keyed receivers. The junction box 104 may relay individual signals through a single cable 105 and connector 106 to an electrophysiological device with user interface 107. This user interface 107 may organize and display electrophysiological data based on lead groupings for ease in identifying specific electrophysiological signal. One skilled in the art will appreciate the disclosed material is illustrative and should not be construed as limited to an individual electrophysiological test or electrode configuration. Modifications to embodiments described in this document, and other embodiments, will be evident to those of ordinary skill in the art after review of information provided. The described embodiments provided in this document are not to be considered limiting.
The one or more electrophysiological electrodes 201 may attach to patients using an adhesive or other form of releasable connection. These electrodes 201 may be attached to or detachable from the individual leads 202. In some embodiments, the electrodes 201 may be permanently affixed to respective lead wires 202. One or more electrodes 201 may be attached to patient through mechanisms comprising but not limited to colloidal gel or paste and/or reusable or electrode heads such as disposable electrode cups or ear clips.
Leads 202 may comprise an individual conductive wire or cable. The location of these electrodes 201 and leads 202 attached to a specifically keyed connector 203 is dependent on the type of electrophysiological monitoring desired.
A length of each of the individual leads 302 may correspond to a respective location or placement of one or more electrodes 301 upon the patient in a given test. For example, a shorter lead 302a may be adapted for electrodes placed toward the inion and a longer lead 302b may be adapted for electrodes placed towards the nasion. Alternatively, lead length may correspond to probe placement with shorter lead lengths associated with electrodes placed toward the nasion and longer lead lengths correspond to electrodes placed near the inion. The number of electrodes 301 and leads 302 attached to each specifically keyed connector 303 is dependent on the type of electrophysiological electrode configuration to be used.
With reference to
In one aspect, electrode leads 402 may be grouped into specific bundles, such as bundles 402a, 402b, 402c of
For example, a first bundle 402a of a 10/20 EEG configuration may be a first color, such as blue, and its corresponding first keyed connector 403a may also be blue. Blue may represent a first anatomical placement corresponding to a first brain region. A second bundle 402b may be a second color, such as red, and its corresponding second keyed connector 403b, which may be different in shape from the first keyed connector 403a, may also be red. Red may represent a second anatomical placement corresponding to a second brain region. Similarly, a third bundle 402c may be a third color, such as yellow, and its corresponding third keyed connector 403c, which may be different in shape from both the first and second keyed connectors 403a, 403b, may also be yellow. Yellow may represent a third anatomical placement corresponding to a third brain region.
In a further aspect, the length of leads 402, 502 of a given bundle may correspond to an anatomical placement of the electrodes 401,501 associated with the leads of said bundle. For example, a first bundle adapted for and keyed for placement on a left temporal region may be longer than a second bundle adapted for and keyed for placement on a brain midline region, or vice versa.
In another aspect, the length of leads 402, 502 within a given bundle may vary such that the lengths of the leads correspond to an anatomical placement of the electrodes 401, 501 associated within said leads within said bundle. For example, a first lead within a first bundle 502a which corresponds to an electrode adapted for placement in a left temporal region nearer the nasion may be longer than a second lead within the first bundle which corresponds to an electrode adapted for placement in the left temporal region nearer the inion.
With further reference to
With reference to
The anatomical regions may correspond to alphanumeric coordinates, such as nomenclature understood to correspond to standard 10/10 electrode configurations. For instance, the regions may correspond to regions including but not limited to frontotemporal, frontocentral, temporal-posterior temporal, centroparietal, posterior temporo-occipital, parieto-occipital, anterior frontal, occipital, and temporal, and numerical designations correspond to standardized 10/10 nomenclature. As illustrated in
With further reference to
One or more of the leads of bundle 502a, the keyed connector 503a, and the corresponding electrodes 501 of
In a further aspect, a retainer 204, 304 may be provided for organizing, separating, managing and retaining electrode lead bundles, such as is illustrated in
Movement of the retainer along the longitudinal axis of the bundle may allow the retainer to help reform or modify a condition of the bundle. For example, the retainer 204, 304 may be mobile along the leads of the bundles 202, 302, thereby limiting loose cable length. In another aspect, the retainer may be colored corresponding to color of its corresponding bundle 202, 302.
In one embodiment, the retainer 204, 304 may be a notched clip. The notched clip may include notches or channels adapted to retain one or more leads of a given bundle to keep them arrayed in a specific form such that the wires are not twisted or tangled. The retainer 204, 304 may be configurable for any number of leads within or between bundles 202, 302.
In one aspect, a plurality of retainers 204, 304 may be placed along the length of a given bundle 202, 302. The retainers 204, 304 may be permanent or removable. It should be appreciated by one skilled in the art that the retainer 204, 304 may be made of any number of flexible or rigid materials.
With further reference to
In one aspect, the receivers 906 may be adapted to form an interference fit with the electrode leads 902. Accordingly, the receivers 906 may comprise an enlarged recess 908 in which the electrode leads 902 may be placed. In another aspect, the receivers 906 may comprise a mouth 910 which is smaller than the enlarged recess 908. The mouth 910 and enlarged recess 908 may be sized such that a diameter of the electrode lead 902 is larger in diameter than, or no smaller than, the mouth 910, such that the electrode leads 902 may be snapped into and the enlarged recess 908 through the mouth 910, and retained therein by the mouth, which is no greater than the diameter of the electrode lead 902. The enlarged recess 908 may be at least as large in diameter as the diameter of the electrode lead 902, such that the retainer 904 may be allowed longitudinal movement along the electrode leads 902 when said leads are retained within the recesses 908. In one aspect, the diameters of the recesses 908 may be approximately equal to the diameters of the electrode leads 902. Accordingly, friction may hold the retainer 904 at a given longitudinal position along the electrode leads 902. Said friction may be overcome by applying a force to the retainer 904 in a direction along the longitudinal axis of the electrode leads, so that the retainer 904 may be moved along said electrode leads.
As shown in
As illustrated, the plurality of arms 1008 may extend radially outward from a central body. In one aspect, the arms may form a floriform configuration. The receivers 1006 may include a narrowed mouth 1010, which may allow for the interference fit with the electrode leads. In a further aspect, the arms 1008 may be adapted to wrap around a given electrode lead 1002, with the narrowed mouth 1010 adapted to hold the electrode lead within the receiver 1006. Such a configuration may require a force to be applied to open the receiver 1006 of each arm to insert or remove an electrode lead from the receiver. The retainer 1004 may be adapted to recoil and wrap around the electrode lead upon removal of said force. For example, the retainer 1004 may comprise a resilient material that may temporarily be deformed by a force for insertion or removal of the electrode lead 1002, and then retake its original shape upon removal of the force. Similarly to the embodiment of
With reference to
The keyed receivers 610, 710 may correspond to specific electrode lead bundles 402, 502. For example, the keyed receivers 610, 710 may be colored so as to correspond to a specific color of a given bundle 402, 502, as outlined above. The keyed receivers 610, 710 may be placed on the front or sides or on top of a housing of the junction box 601, 701. Keyed receivers 610, 710 may be located on the junction box such that their location may correspond to the anatomical location of electrodes of the corresponding bundles 402, 502.
In a further aspect, keyed receivers 610, 710 for left and right corresponding regions, such as parasagittal regions, may have the same identifiers or keying. For example, the electrodes 401, 501, the lead bundles 402, 502, the keyed connectors 403, 503, the corresponding keyed receivers (or any combination thereof) which correspond to the left temporal region may have the same identifier (e.g. color) and keyed configuration as those of the right temporal region. In another example, the identifier, such as color, of the electrodes, bundles, keyed connectors, keyed receivers (or any combination thereof) of the left and right similar anatomical regions may be the same, but the keyed configurations of left and right elements may be different. Alternately, both the identifier, such as color, and the keyed configurations of the electrodes, bundles, keyed connectors, keyed receivers (or any combination thereof) of the left and right similar anatomical regions may both be different from one another.
In use, the junction box 601, 701 may be placed within close proximity to the patient to eliminate length of electrode lead bundle length. One skilled in the art will appreciate that the junction box 601, 701 may be constructed of any one of a variety of materials such as molded plastic and/or metal, and may be configured according to various shapes or geometries.
As illustrated,
Similarly,
The cable 603, 703 associated with the junction box 601, 701 may include one or more individual conductive signal wires or cables originating at the junction box 601, 701 and terminating at the connector 704 specific for relaying electrode signal to an electrophysiological monitoring interface including but not limited to a BCI, a computer terminal, and a display screen. The cable 603, 703 may be shielded with strip or braided conductive material and may be surrounded in protective material.
For example, a strip chart graph may be displayed in which data from bundles 803 are depicted and organized together and may be given specific identifiers 804 which contrast for ease of visualization. Color coding or other identifiers 804, such as shape, may coordinate with a coding which is also applied to electrodes 401, 501, bundles 402, 502, keyed connectors 403, 503, and/or keyed receivers 610, 710. Graphic depiction of text for data associated with specific lead bundles, such as identifiers 804, may also be associated with colored shapes for ease of visualization. Color coding or shape display may also change to indicate detection of specific signal patterns occurring in a data channel, such as change in impedance or other signal abnormality. The data channels corresponding to specific bundles 803 may be grouped with the electrode nearest the nasion represented as the first data channel while the electrode nearest the inion may be visualized as the last data channel. Accordingly, a workflow allowing for rapid and simple channel identification corresponding to specific electrode anatomical regions 805 may be facilitated.
With respect to the disclosed subject matter, the preferred patient is a warm-blooded mammal, with the most preferable being a human. As used herein the term “patient” is reflective of such preference.
With further respect to the disclosed subject matter, electrophysiological tests include any test which measures electrical potential of a patient utilizing electrodes specific for such assessment. Examples of electrophysiological tests include electroencephalography (EEG), electromyography (EMG), nerve conduction studies (NCS), evoked potentials (EP), electrocardiography (ECG/EKG), and Holter monitoring. The most preferred electrophysiological test is EEG. In other embodiments, however, one or more of these tests may be used in parallel and transmitted along with patient EEG data.
It will be understood that various details of the presently disclosed subject matter can be changed without departing from the scope of the subject matter disclosed herein. Furthermore, the foregoing description is for the purpose of illustration only, and not for the purpose of limitation. As such, total embodiments which may be utilized should not be limited by expressed embodiments of 10/10 and 10/20 electrode configurations.
This application claims priority to U.S. Provisional Patent Application Ser. No. 62/542,999, filed Aug. 9, 2017, the disclosure of which is incorporated herein by reference.
Number | Date | Country | |
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62542999 | Aug 2017 | US |