Methods and apparatus for electrode placement and tracking

Abstract

The present application relates to methods and apparatus for electrode placement and tracking. An electrode carrier system includes one or more electrode assemblies having an electrode body. One or more tubular members extend from the electrode body and define a lumen terminating in a distal opening. The electrode assembly carries a reservoir containing a conductive fluid or gel. The reservoir is in fluid communication with the lumen in the tubular member, and the electrode assembly is typically supported on a backing that can optionally be configured as a headband. A system for tracking patient movement can be used in conjunction with the electrode carrier system.

Description

[0001] This application is a divisional application of an application filed on March 28, 2017, with application number 201780033456.X and invention name “Method and device for electrode placement and tracking”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of provisional application 62 / 314,873, filed March 29, 2016, and utility application 15 / 387,381, filed December 21, 2016, the entire disclosures of which are incorporated herein by reference. Background of the Invention

[0004] 1. Field of the invention. The present invention relates to methods and apparatus for facilitating the placement of one or more electrodes against a patient's skin surface and monitoring the patient's condition. More particularly, the present invention relates to methods and apparatus for facilitating the speed and efficiency of placing one or more electroencephalogram (EEG) electrodes against a patient's scalp, optionally in combination with tracking the patient's movement.

[0005] Electrodes commonly used in electrocardiography and electroencephalography typically provide uniform contact between the metal electrode and the skin to prevent electrical noise caused by the interface between the electrode and the skin surface. To provide uniform contact across an area of ​​skin, a conductive gel can be applied to the skin surface to facilitate electrical conduction with the electrode. However, applying the gel and determining electrode placement requires specialized training and skills and is also time-consuming when electrodes are placed at multiple locations on a patient's scalp.

[0006] Some electrodes utilize a conductive gel interface that is pre-formed for contacting the electrode, but this gel interface becomes ineffective when hair is present and may sometimes require removal of the underlying hair.

[0007] It has been suggested that EEG electrodes could be formed with an onboard conductive gel dispenser for delivering the gel immediately after the helmet is placed on the patient. See U.S. Patent No. 6,640,122. However, the device of the '122 patent does not provide for the preservation of the gel as an electrode component over an extended period of time.

[0008] Therefore, there is a need for a method and apparatus that facilitates the speed of electrode placement and facilitates contact between the electrode and the skin surface, even in the presence of hair, without the need to manually prepare the hair and scalp for each electrode contact. It would be particularly desirable to have such a method and apparatus provide for the incorporation of a conductive fluid or gel as part of the electrode assembly and for the preservation of such a conductive fluid or gel over an extended period of time. The invention described and claimed herein will satisfy at least some of these needs.

[0009] 2. Description of Background Art . EEG electrodes with plungers and / or capsules for dispensing conductive gel are described in U.S. Patent Nos. 9,408,575; 8,805,470; 6,640,122 and U.S. Patent Publication No. 2007 / 0255127. U.S. Patent No. 6,381,481 describes an EEG electrode with fingers for parting hair. Other patents of interest include U.S. Patent Nos. 7,841,301; 4,709,702; 5,273,037; and 5,357,957; 4,166,457; 4,079,731; 4,033,334; 3,830,229; and U.S. Patent Publication No. 2007 / 0272313. Helmets including integrated EEG electrodes are available from Advanced Brain Monitoring, Inc. of Carlsbad, California under the trade name Mobile EEG is commercially available (http: / / www.advancedbrainmonitoring.com) and from Hydrodot, Inc. of Westford, Massachusetts under the trade name StatNet TM An EEG helmet (http: / / www.hydrodot.net) was purchased commercially. Summary of the Invention

[0010] Generally, while facilitating placement and contact of an electrode on a selected area of ​​a skin surface, an electrode carrier system can generally include an at least partially conductive electrode body; one or more tubular members extending from the electrode body, each of the one or more tubular members defining a lumen therethrough and a distal opening; a reservoir having a compressible structure and containing a conductive fluid or gel in fluid communication with the one or more tubular members; and a backing supporting the electrode body and the reservoir.

[0011] In other variations, the electrode carrier system may generally include an electrode body having one or more tubular members extending therefrom, each of the tubular members defining a lumen therethrough and a distal opening; a reservoir having a compressible structure defining an internal volume and in fluid communication with the one or more tubular members; and a controller and / or output device electrically connected to the electrode body, wherein the controller and / or output device is configured to receive electrical signals from the electrode assembly and record and / or output a corresponding response.

[0012] The electrode carrier system can typically include a backing that is fixed around the patient's head. The backing can be configured as a headband, but the carrier system can be incorporated into any number of other platforms or positioning mechanisms for holding the electrodes against the patient's body. The individual electrodes are spaced apart from each other so that when the headband is positioned on the patient's head, the electrodes are optimally aligned on the head for receiving EEG signals. The carrier system can electrically couple each of the electrodes via corresponding wires extending from the backing and, for example, to a controller and / or output device. However, in other variations, the electrodes can be wirelessly coupled to the controller and / or output device.

[0013] The controller and / or output device may generally include any number of devices for receiving the electrical signal, such as an electrophysiological monitoring device, and may also be used in combination with any number of brain imaging devices, such as fMRI, PET, NIRS, etc.

[0014] As described herein, the electrodes can be positioned on the backing to quickly achieve conductive contact with the underlying skin while providing comfort to the patient, such as when the patient is reclining with the back or side of their head resting on the surface without discomfort from the electrodes.

[0015] In one variation of the electrode carrier system, each of the electrodes can be configured to include a visual or tactile indicator to provide feedback to the user that sufficient electrode connection with the skin surface has been achieved. For example, each electrode can incorporate an impedance sensor and indicator such that when the controller and / or output device detects a relatively low impedance in a particular electrode, e.g., 5-50 kΩ, that electrode can activate its indicator (such as an LED) to indicate that sufficient electrical contact has been achieved between the electrode and the underlying skin.

[0016] Turning now to the electrode configuration, one variation of the electrode carrier system may include each electrode enclosed within a reservoir pre-filled with a conductive gel or fluid. Each electrode may be configured to be contained within a flat or atraumatic configuration within its own reservoir, and each reservoir may be formed from any number of flexible materials that can be easily collapsed, such as silicone, polyurethane, rubber, and the like. The electrodes may be coupled via wires that pass through a lumen defined by a backing separated from the electrode by a substrate. Each reservoir may further define one or more openings through which the conductive gel or fluid may be discharged.

[0017] Once the platform is positioned over the patient's head, the user can depress each reservoir, causing the conductive fluid or gel to flow through the openings and onto the patient's skin. The conductive fluid or gel discharged through the openings can maintain fluid communication between the skin surface and the corresponding electrodes, allowing the detected electrical signals to be transmitted from the skin to the electrodes. Furthermore, due to the flexibility of the reservoirs, once the conductive fluid or gel is discharged into contact with the skin surface, the backing can lie flat against the skin surface, allowing the patient to comfortably rest their head on the surface while still maintaining electrical contact with the electrodes.

[0018] Another electrode variation may consist of one or more loops of wire or conductive strip that can be easily bent or flexed against the skin surface. The electrode carrier system may include a pressure relief container for containing a conductive fluid or gel as described above surrounding each of the electrodes, such that the conductive fluid or gel can be expelled around and within the one or more loops to ensure a conductive path.

[0019] Another variation can be configured as one or more tubular members extending laterally from the backing. For each electrode, the tubular members can each be arranged in a circular pattern and can further define a lumen extending therethrough having an opening at each distal end. Each of the tubular members can be made of a conductive metal that can maintain its tubular shape during use, or can be thin and flexible enough to bend or flex when placed on the patient's skin surface. Alternatively, the tubular member can be made of a flexible material coated or laminated with a conductive material so that the member maintains its flexibility. In either case, the conductive fluid or gel can be contained within the tubular member, or it can be retained in a pressure relief reservoir as described above surrounding or near each electrode. Due to the tubular shape of the electrodes, they can easily pass through the patient's hair (if present) and make contact against the skin surface while maintaining electrical contact.

[0020] Yet another variation of the electrode embodiment may also utilize a pressure relief reservoir filled with the conductive fluid or gel. The reservoir may be formed of a flexible material, such as silicone, polyurethane, rubber, etc., which extends from the backing to form a curved or arched structure having one or more openings defined above the reservoir. These openings may remain closed until a force is applied to the reservoir and / or backing that causes the fluid or gel contained therein to escape through the openings and contact the outer surface of the reservoir and the underlying skin surface. The outer surface of the reservoir may have a layer of conductive material that is in electrical contact with the wire, such that electrical contact can be achieved once the fluid or gel has been expelled from the reservoir and reaches the conductive material on the outer surface of the reservoir and the skin surface.

[0021] In yet another variation, an electrode carrier system having an electrode body can define one or more tubular members extending from the body such that the members protrude laterally away from the backing. The electrode body can be constructed of a conductive material that can be rigid, such as a metal. However, in other variations, the body can be made of a conductive material that is also flexible (e.g., conductive silicone) and / or can be made of a flexible material (e.g., silicone, polyurethane, rubber, etc.) coated or laminated with a conductive material such that the underlying tubular member maintains its flexibility.

[0022] In either case, the body can be secured to the backing so that the one or more openings are defined along the body and extend through the member in fluid communication with a reservoir having a compressible housing. The reservoir can also be secured to the backing and contain a volume of conductive fluid or gel located locally on the electrode body. The tubular members can be arranged in a uniform pattern or in an arbitrary pattern, and although the members are shown arranged in a circular configuration, other patterns can be implemented. After the backing is secured to the patient, the reservoir can be pressed or pushed so that the fluid or gel contained therein is discharged through each of the tubular members and contacts the underlying skin surface through the corresponding distal opening. The slender nature of the members can allow them to easily pass through the patient's hair (if present) and contact directly against the skin surface.

[0023] In another variation, an electrode carrier system having a tubular body may define one or more openings above its surface. The tubular body may have one or more tubular members extending away from the backing in a coiled or spiral pattern. The tubular member may define a lumen therethrough, the lumen extending from the tubular body and extending to a distal opening at its end. The backing may further define a reservoir containing a volume of conductive fluid or gel such that the body is in fluid communication with the reservoir. Additionally and / or alternatively, the distal end of the member may present a rough surface for contacting the skin. Optionally, the rough end may be rotated or otherwise translated or moved by the user above the skin surface to at least partially exfoliate the skin surface to facilitate electrical contact.

[0024] In particular, the distal skin-contacting surface of the electrode assembly can be modified to prepare the skin surface to enhance the conductivity (i.e., reduce the resistance) between the conductive portion of the electrode assembly and the skin when the conductive portion is in physical contact with the skin. For example, the tissue-contacting surface of the electrode assembly can be modified to have an abrasive surface, for example, by coating with abrasive particles; can be formed or molded to have prominent rigid features, such as bumps, ridges, etc.; and / or can be coated with a material that reduces the impedance of the electrode connection. Such sweeping and / or chemical coating of the tissue-contacting surface of the electrode assembly over the target tissue location can scrape, dissolve and / or otherwise disrupt dead tissue and degrade scalp oil. In a specific example, at least a portion of the distal tissue-contacting surface of the electrode assembly, such as the distal surface of at least some of the tubular members, includes such surface features, surface coatings, surface treatments, or combinations thereof for improving the quality of the electrode connection.

[0025] In another variation, the electrode carrier system can also be used for other applications, such as patient motion tracking using visual motion tracking or accelerometers. The motion tracking can be coupled with an EEG device to reject EEG data during periods of intense exercise. The visual motion tracking allows the camera to automatically track the patient wearing the headband, providing recording accuracy and greater mobility for the patient.

[0026] In another specific aspect of the invention, an electrode assembly comprises an electrode body and one or more tubular members extending from the electrode body, typically from the bottom surface of the electrode body. Each tubular member has a distal end, and at least some of the tubular members have a lumen having a distal opening in the distal end. A reservoir containing a conductive fluid or gel is optionally disposed in the electrode body, and the electrode body is configured to dispense the conductive fluid or gel from the reservoir through the lumen and out of the distal opening of the tubular member. Alternatively, in some embodiments, a syringe or other separate delivery device can be used to dispense the conductive fluid or gel onto or through the lumen of the tubular member.

[0027] As used herein, the term "conductive" shall mean electrically conductive, ie, having very low electrical resistance and the ability to carry low current biosignals such as EEG signals.

[0028] As further used herein, the term "tubular member" shall mean a generally elongated structure, i.e., a length extending away from the bottom of the electrode body that is greater than its width parallel to the bottom of the electrode body, wherein the width is measured at its narrowest point. Typically, the length will be at least twice the width, and often at least three times the width. An exemplary tubular member may have a generally circular horizontal perimeter (in a plane parallel to the bottom of the electrode body) such that it is generally cylindrical along a vertical axis. Other exemplary tubular members may have a crescent-shaped horizontal perimeter.

[0029] In specific embodiments, the electrode assembly will typically include at least two tubular members, and may include three tubular members, four tubular members, or even more. The tubular members will typically depend vertically downward from the bottom surface of the electrode body and will be specifically configured to penetrate the patient's hair so that the distal tips of the tubular members can engage the patient's scalp and provide reliable electrical contact with the patient's scalp. The tissue-engaging area of ​​the tubular members on the bottom surface of the electrode body will typically be 50% or less of the area of ​​the bottom surface, often 30% or less of the area of ​​the electrode body, and typically at least 5% of the area of ​​the bottom surface. Thus, the tissue-engaging area of ​​the tubular members on the bottom surface of the electrode body will typically be in the range of 5% to 50% of the area of ​​the bottom surface, and often in the range of 5% to 30% of the area of ​​the bottom surface.

[0030] In most cases, the tubular member will extend at a vertical angle from the bottom of the generally flat surface of the electrode body. However, in other cases, the tubular member may extend at any angle in the range of 30° to 150° relative to the plane, typically 60° to 120° relative to the plane. However, in other cases, the tubular member may have other configurations, such as being configured in a spiral shape so that they can penetrate the hair to reach the patient's scalp by rotating the electrode assembly about a vertical axis.

[0031] In other embodiments of the present invention, the distal tips of at least some of the tubular members will have a skin preparation surface, such as a tissue roughening surface. For example, the tissue roughening surface may include an abrasive material, such as grit or other abrasive particles, formed on at least a portion of the distal tip of the tubular member. In other cases, the surface roughening may include surface features, such as ridges, protrusions, grooves, etc., formed on at least a portion of the distal tip that contacts the patient's skin.

[0032] The electrode body, and in particular the tubular member connected to the electrode body, can be at least partially formed from a conductive material, such as a metal, a conductive coating, an embedded wire, or a conductive polymer. In such a case, the electrode body and / or the tubular member will provide at least a portion of the electrical path required to conduct the bioelectrical current from the end of the tubular member to the electrical terminal or other conductive connector on the electrode body, as described below. However, in other cases, the electrode body and / or the tubular member can be primarily or even entirely formed from a non-conductive material. In such a case, the conductive fluid or gel will provide most or all of the conductive path required to transfer the bioelectrical current from the distal end of the tubular member to the electrical terminal after such conductive fluid or gel is distributed throughout the electrode and tubular member, as described in more detail below.

[0033] The tubular member can include a variety of geometric shapes. Typically, the tubular member will be generally cylindrical with a lumen extending therein. However, in other cases, the tubular member can be formed as a "prong" having a relatively wide tissue contact area along a curved "axis" at its distal end. In many cases, the tissue contact area of ​​the prongs will be generally crescent-shaped so that they will follow a generally circular path when rotated relative to the patient's tissue, as described in more detail below.

[0034] The forks or other tubular members of the present invention will preferably have a port in their tissue-contacting surface for delivering the conductive fluid or gel to the patient's skin. In some cases, the port can be formed in the generally flat bottom surface of the tubular member or fork. In other cases, the port can be connected to a channel or other distributed feature on the tissue-contacting surface of the fork or other tubular member. In further embodiments, the port for delivering the conductive fluid or gel can be located in a recessed surface of the fork, which can be adjacent to the lower tissue-contacting surface of the fork or other tubular member.

[0035] While the electrode assembly will typically include one or more tubular members as just discussed, in some alternative embodiments, the electrode body may have a generally flat bottom, devoid of tubular members and other protruding members. The flat bottom will be configured to engage the skin and have an opening for releasing a conductive fluid or gel in any manner described elsewhere herein for delivering the conductive fluid or gel through the tubular member. The tissue-contacting surface of such a flat bottom may be modified in any manner discussed herein to provide electrical conductivity to the target tissue surface.

[0036] The reservoir in the electrode body containing the conductive fluid or gel will preferably be sealed to preserve the fluid or gel and allow long-term storage of the electrode assembly pre-filled with the conductive fluid or gel. In a specific embodiment, the interior of the reservoir will have a sealed dispensing container that can be incorporated into the electrode assembly during its initial manufacturing. For example, the sealed dispensing container may include a sealed dispensing container, such as a bag, constrained within a chamber of the electrode body, wherein the electrode body includes a plunger configured to be manually pressed against the sealed dispensing container to deliver the conductive fluid or gel from the sealed dispensing container through the lumen and out of the distal opening of the tubular body. In a specific case, the sealed dispensing container and the plunger will be located on the upper portion of the electrode body, and the tubular member will extend from the lower surface of the electrode body. In such a specific case, the electrode body will be configured to define a flow path for delivering the conductive fluid or gel from the sealed dispensing container, through the lumen in the tubular member, and out of the distal opening of the tubular member.

[0037] The electrode assembly of the present invention can be provided with various mechanisms for releasing the conductive fluid or gel from such a sealed dispensing container. For example, the reservoir can have a dispensing orifice configured to define a rupture zone on the sealed dispensing container when the sealed dispensing container is pressurized by the plunger. However, in other cases, the sealed dispensing container can include any of a syringe, a manually squeezed tube, a roller squeezed tube, etc., which is incorporated into the electrode body or otherwise combined with the electrode body.

[0038] The electrode assembly of the present invention will typically have a conductive tip that is mounted on the electrode body and is configured to allow the electrode assembly to be attached to a controller or other instrument to measure EEG or other electrical biosignals. The conductive tip will be configured to be electrically coupled to a wire or other conventional electrical conductor to provide a connection to a control system. In disclosed embodiments, the conductive tip will have an internal portion that is located in the flow path for the conductive fluid or gel within the electrode body and is exposed to the flow path. In some cases, the conductive tip will be the only solid conductive component that is part of the electrode assembly. After such a conductive fluid or gel has been distributed throughout the electrode body, the electrical conduction of the biosignal to the conductive tip can be provided entirely by the conductive fluid or gel. However, in other cases, additional conductive components, coatings, wires, etc. can be provided within the electrode body of the electrode assembly to provide or enhance conductivity.

[0039] In a further aspect of the present invention, an electrode carrier system includes an elongated backing, generally depicted as a headband or helmet, for placement on a patient's head. As described above, a plurality of electrode assemblies are mounted and distributed along the length of the elongated backing, and at least one electrical lead or other conductor is connected to each of the electrode assemblies to deliver a low-current biosignal from the electrode assembly to a separate controller and / or output device.

[0040] The system of the present invention may also include a controller and / or output device configured to receive the low current biosignal from the electrode assembly. In addition, the controller can be configured to output a response corresponding to the electrical signal from the electrode assembly. In a preferred embodiment, the distal ends of at least some of the tubular members will define a tissue roughening surface or other skin preparation surface, and at least some of the electrode assemblies will be movably, for example, rotatably mounted on the elongated backing to allow a user to sweep or scrape the tissue engaging surface of the assembly over the target tissue surface to abrade the tissue surface to enhance electrical contact. In particular, after the elongated backing of the electrode carrier system has been mounted on the patient's head, the electrode assembly can be rotated or alternatively translated (pushed back and forth) on the contacting tissue surface.

[0041] In another specific aspect of the present invention, a plurality of electrodes may be placed on the patient's scalp by placing a headband or other headgear around the patient's scalp. The headband carries a plurality of electrode assemblies, such as those described above, and the distal ends of one or more tubular members extending from at least some of the electrode assemblies engage the scalp tissue. A conductive fluid or gel is then extruded from a reservoir disposed in at least some of the electrode assemblies such that the fluid or gel passes through the tubular members to form a conductive path to the patient's scalp tissue. The plurality of electrode assemblies are connected to a controller and / or output device configured to receive a low-power biocurrent from the electrode assemblies. In a specific aspect of the method of the present invention, the distal ends of at least some of the tubular members will be positioned through hair on the patient's scalp. At least some of the plurality of electrode assemblies may be rotated so as to rub the scalp tissue adjacent the distal ends of the one or more tubular members to reduce the contact resistance between the electrode assemblies and the scalp tissue. Typically, at least some of the tubular member defines the skin preparation surface, e.g., a tissue roughening surface, and the conductive fluid or gel is extruded from the reservoir through the lumen into the tubular member and out of a distal opening in the distal tip of the tubular member onto the scalp tissue. In particular cases, the conductive fluid or gel can be extruded from or through a groove in the distal tip of the tubular member. Such extrusion typically involves manually applying external pressure to a sealed dispensing container that holds the conductive fluid or gel, or the sealed dispensing container is incorporated into the electrode assembly, typically within a chamber within the electrode body. In particular cases, applying external pressure to the sealed dispensing container can include depressing a plunger to engage a rupturably sealed dispensing container carrying the conductive fluid or gel. Alternatively, applying external pressure to the sealed dispensing container can include manually squeezing the tube, manually depressing a syringe plunger, rolling the tube, etc. In many cases, the conductive path to the patient's scalp tissue is formed solely by the conductive fluid or gel. However, in other cases, the conductive path to the patient's scalp may be formed at least by conductive structures on the tubular member or elsewhere within the electrode assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 A side view of a patient with an electrode carrier system configured as a headband is illustrated.

[0043] Figure 2 Illustrated is a perspective view of a variation of an electrode carrier system in which individual electrodes may be configured to indicate whether sufficient contact is achieved with the underlying skin surface.

[0044] Figure 3A detailed cross-sectional side view of another variation of an electrode carrier system is shown, in which each electrode may be surrounded or enclosed by a pressure relief reservoir.

[0045] Figure 4 A detailed cross-sectional side view of another variation is shown, in which the electrodes may be formed from one or more loops of wire or conductive strip.

[0046] Figure 5 A detailed cross-sectional side view of another variation is shown in which each electrode may be formed from one or more conductive tubes defining a conduit.

[0047] Figures 6A to 6C A cross-sectional side view of yet another variation is illustrated, in which each electrode may contain a compressible reservoir having one or more openings.

[0048] Figure 7A and Figure 7B Illustrated are top and partial cross-sectional perspective views of another variation in which each electrode is formed with one or more electrically conductive tubes in fluid communication with a compressible reservoir.

[0049] Figure 8 A partial cross-sectional side view of another variation is shown in which each electrode is configured in a helical configuration that is rotatable relative to a support platform.

[0050] Figure 9 An example of optically tracking a patient's motion in conjunction with an electrode carrier system is illustrated.

[0051] Figure 10 Another example of detecting patient motion using one or more accelerometers in conjunction with an electrode carrier system is illustrated.

[0052] Figure 11 An electrode carrier system of the present invention is illustrated, comprising a headband having a plurality of electrode assemblies distributed along its length.

[0053] Figure 12 An exemplary electrode assembly constructed in accordance with the principles of the present invention is illustrated.

[0054] Figure 13 Exploded diagram showing Figure 12 electrode assembly.

[0055] Figure 14 A cross-sectional view is shown Figure 12 electrode assembly.

[0056] Figure 15 Shown along Figure 14 The line 15-15 is intercepted Figure 12-14 A cross-sectional view of the lower portion of the electrode assembly.

[0057] Figure 16 for Figure 12-15 Simplified illustration of the conductive fluid or gel flow path within an electrode assembly, wherein specific components and flow path segments are used Figure 12-15 The number used in .

[0058] Figure 17 and Figure 18 yes Figure 12-15 Detail view of the bottom portion of the electrode assembly.

[0059] Figure 19 and Figure 20 An alternative bottom portion is shown, which may replace Figure 12-15 The bottom portion shown in .

[0060] Figure 21-Figure 27 Each illustrates another alternative configuration of the bottom portion of an electrode assembly constructed in accordance with the principles of the present invention.

[0061] Figures 28A-28C Yet another alternative configuration of a bottom portion of an electrode assembly is illustrated having a flat surface that is free of tubular members and other similar structures.

[0062] Figures 29A-29C Another exemplary electrode assembly constructed in accordance with the principles of the present invention is illustrated having one or two grommets for attaching the electrode assembly to a headband and also having a vertical passageway for introducing electrode gel using the assembly or other delivery device.

[0063] Figures 30A-30C Yet another exemplary embodiment of an electrode assembly is illustrated that has a single cylindrical tubular member on a bottom surface of a lower portion thereof and is received within the buckle assembly to allow rotation when the buckle is attached to the headband.

[0064] Figure 31A and Figure 31B Yet another exemplary embodiment of an electrode assembly constructed in accordance with the principles of the present invention is illustrated, wherein the electrode assembly is configured to translate axially within a slot of a buckle assembly. Detailed Description of the Invention

[0065] The electrode carrier system 10 may generally include Figure 1 The backing 12 is shown in a side view, Figure 1The illustration shows a carrier system 10 secured around a head H of a patient P. In this variation, the illustrated backing 12 is configured as a headband, although the carrier system 10 can be incorporated into any number of other platforms or positioning mechanisms for holding electrodes against a patient's body. In this variation, the illustrated backing 12 is configured as a headband, and the individual electrode assemblies 14 are spaced apart from one another so that when the headband is positioned on the patient's head H, the electrode assemblies 14 are optimally aligned on the head H for receiving EEG signals. The electrode carrier system 10 can electrically couple each electrode assembly 14 via a respective wire 16 extending from the backing 12 and, for example, to a controller and / or output device 18. However, in other variations, the electrode assemblies 14 can be wirelessly coupled to the controller and / or output device 18.

[0066] The controller and / or output device 18 may generally include any number of devices for receiving electrical signals, such as electrophysiological monitoring devices, and may also be used in combination with any number of brain imaging devices, e.g., fMRI, PET, NIRS, etc. In one particular variation, the electrode embodiments described herein may be used in combination with devices such as those configured to receive and process electrical signals from the electrodes.

[0067] As described herein, the electrode assembly 4 can be positioned on the backing 12 to quickly achieve conductive contact with the underlying skin while providing comfort to the patient, such as when the patient P is reclining as shown, with the back or side of their head H resting on the surface without discomfort from the electrodes 14.

[0068] One challenge in ensuring that each electrode 14 makes adequate contact with the underlying skin is the presence of hair HR on the scalp S of the patient P. Prior to the present invention, the area on the scalp S where the electrode assembly 14 is placed was typically shaved to remove excess hair, if present, which interferes with and hinders electrical contact between the electrode assembly 14 and the scalp surface. In contrast, the inventive electrode carrier assembly as described herein enables fast, reliable electrical contact with the scalp surface through the hair HR on each electrode assembly without having to remove the hair.

[0069] In one variation of the electrode carrier system 10, Figure 2 A perspective view is shown in which each electrode 14 can be configured to include a visual indicator or a tactile indicator to provide feedback to the user that sufficient electrode connection with the skin surface has been achieved. For example, each electrode 14 can include an impedance sensor and an indicator such that when the controller and / or output device 18 detects a relatively low impedance (e.g., 5 kΩ) in a particular electrode 14, that electrode can be actuated to indicate that sufficient electrical contact has been achieved between the electrode 14 and the underlying skin.

[0070] Figure 2An example is shown in which each electrode 14 may also incorporate a visual indicator, such as one or more light emitting diodes (LEDs). The LED on a particular electrode 14 may emit light 20 of a first color (e.g., green) when sufficient electrical contact is achieved, but may emit light 22 of a second color (red) if the electrode 14 does not achieve sufficient electrical contact. Alternatively, a single-color LED may be used, where sufficient contact may be indicated by a steady on of the LED, while insufficient contact may be indicated by a flashing LED. In other variations, the electrodes may include, for example, piezoelectric sensors, eccentric load weights coupled to motors, etc., to provide a vibration or other tactile response to indicate whether the electrode 14 is in sufficient electrical contact with the underlying skin. In this way, the electrodes 14 may effectively provide a direct indication of electrical contact, rather than having to check a separate controller or indicator.

[0071] Now turning to electrode configuration, Figure 3 A cross-sectional detail side view of a variation of an electrode carrier system 35 is illustrated in which electrodes 32A and 32B can be enclosed in reservoirs pre-filled with a conductive gel or fluid. Each electrode 38A, 38B can be configured in a flat or atraumatic configuration contained within a respective reservoir 30A, 30B, and each reservoir 30A, 30B can be formed from any number of flexible materials that can be easily collapsed, such as silicone, polyurethane, rubber, etc. The electrodes 38A, 38B can be coupled via a wire 16 that passes through a lumen 34 defined by a backing 12 separated from the electrodes by a substrate 36. Each reservoir 30A, 30B can also define one or more openings 32A, 32B, respectively, through which the conductive gel or fluid can be discharged.

[0072] Once the platform 12 is positioned over the patient's head H, the user can depress each reservoir 30A, 30B, causing the conductive fluid or gel 40A, 40B to flow through the openings 32A, 32B and onto the skin of the patient P. The conductive fluid or gel 40A, 40B discharged through the openings can maintain fluid communication between the skin surface and the corresponding electrodes 38A, 38B, allowing detected electrical signals to be transmitted from the skin to the electrodes 38A, 38B. Furthermore, due to the flexibility of the reservoirs 30A, 30B, once the conductive fluid or gel 40A, 40B is discharged into contact with the skin surface, the backing 12 can lie flat against the skin surface, allowing the patient P to comfortably place their head on the surface while still maintaining electrical contact with the electrodes 38A, 38B.

[0073] Figure 4A side view of another electrode carrier system 35 is shown, in which paired electrode assemblies 50A, 50B may include one or more loops of wire or conductive strips 51A, 51B that can be easily bent or flexed against the skin surface. Some or all of the electrode assemblies 50A, 50B may include a pressure relief reservoir (shown as dashed lines 53A and 53B) for containing a conductive fluid or gel 52A, 52B as described above around each wire or strip electrode 51A, 51B, such that the conductive fluid or gel 52A, 52B can be discharged around and within the one or more loops to ensure a conductive path between the loops and the scalp. Alternatively, a quantity of conductive fluid or gel may be simply placed on the electrode assemblies 50A, 50B prior to placement against the patient's skin surface, without using a pressure relief reservoir. Each wire or strip electrode 51A, 51B may be electrically connected via a wire 16, and since the wire or strip electrodes 51A, 51B will preferably have a thin diameter or thin width, they may easily pass through the patient's hair and contact the scalp surface even if they are bent or flexed.

[0074] Figure 5 A side view of another variation of an electrode carrier system 56 is shown having a plurality of electrode assemblies 58A and 58B, each of which may include one or more tubular members 60A, 60B that may extend perpendicularly or at an angle from the inner surface of the backing 12 (the surface that contacts the patient's scalp). The tubular members 60A, 60B may define a lumen therethrough having an opening 62A, 62B defined at each distal end. Each tubular member 60A, 60B may be made of a conductive metal that may maintain its tubular shape when in use, or may be sufficiently thin and flexible so as to bend or flex when placed against the patient's skin surface. Alternatively, the tubular members 60A, 60B may be made of a flexible material coated or laminated with a conductive material so that the members maintain their flexibility. In either case, a conductive fluid or gel 64A, 64B may be contained within the tubular members 60A, 60B, or it may be retained within the tubular members 60A, 60B as described above but not within the tubular members 60A, 60B. Figure 5 58A, 58B.

[0075] Reference Figures 6A-6CYet another embodiment of the electrode carrier system 68 includes a pressure relief reservoir 70 filled with a conductive fluid or gel 74. The reservoir 70 can be formed of a flexible material, such as silicone, polyurethane, rubber, etc., and extends from the backing 12 to form a curved or arcuate structure having one or more openings 72 defined above the interior of the reservoir 70. These openings 72 are typically maintained in a closed state until a force F is applied to the reservoir 70 and / or the backing 12 to cause the conductive fluid or gel 74 contained within the reservoir to escape through the openings 72 (e.g., Figure 6B ) and contacts the outer surface of the reservoir 70 and forms a conductive path to the underlying skin surface. A layer of conductive material 76 is electrically coupled to the lead 16 and may be formed on a portion or the entire outer surface of the reservoir 70. Electrical contact with the skin surface may be achieved by applying a force F to the backing 12 or the reservoir 76 (e.g., Figure 6B ), to squeeze or otherwise release the fluid or gel 74 from the interior of the reservoir 70 and onto the conductive material 76 and the skin, as shown Figure 6C , where the opening 72 returns to its closed state after the force F is removed.

[0076] Reference Figure 7A-7B , yet another embodiment of the electrode carrier system 78 includes an electrode assembly 79 having an electrode body 80 carrying one or more tubular members 84 extending from its lower surface. The tubular members 84 protrude vertically away from the plane of the backing 12. In some embodiments, the electrode body 80 will be at least partially formed from a conductive material, such as a rigid or flexible metal and / or a conductive polymer, such as a conductive silicone. In other embodiments, the electrode body 80 will be at least partially formed from a non-conductive flexible material, for example, silicone, polyurethane, rubber, etc., which can be coated or laminated with a conductive material so that at least the tubular member 84 is conductive while maintaining its flexibility. Due to the conductivity, the electrode body 80 and the tubular member 84 can be directly electrically coupled to a wire or conductive strip.

[0077] In both cases, the electrode body 80 can be secured to the backing 12 so that the tubular member 84 extends through an opening in the backing so that the tubular member 84 can contact the patient's scalp when the backing is placed on the head, e.g., as Figure 1 The conductive fluid or gel 88 is contained in an internal reservoir 86 of the electrode body 80 and can be opened by pressing the flexible top of the electrode body (eg Figure 7B ) is delivered through a passage in the tubular member.

[0078] like Figure 7A and 7BAs shown, the tubular members 84 can be arranged in a uniform or random pattern and in a generally circular pattern. After the backing 12 is secured to the patient, the reservoir 86 can be pressed or pushed so that the fluid or gel 88 contained therein is discharged through the central passage along the length of each tubular member 84 and contacts the skin surface below through the corresponding distal opening. The members 84 will typically be elongated, for example, having a length in the range of 1-2 cm, and can easily pass through the patient's hair (if present) and directly contact the skin surface. Moreover, even if the tubular members 84 are in a collapsed or deformed configuration, for example, when the patient lies down with their head, the tubular members 84 and the body 80 can continue to conduct electrical signals from the skin surface below.

[0079] Now refer to Figure 8 , yet another embodiment of the electrode carrier system 89 includes a tubular body 90 that can define one or more openings 96 above its surface. The tubular body 90 can have one or more tubular members 92 extending away from the backing 12 in a coiled or spiral pattern. The one or more tubular members 92 can each define a lumen therethrough that extends from the bottom of the tubular body 90 and extends to a distal opening 94 at a tip thereof. The backing 12 can further define a reservoir 100 containing a volume of a conductive fluid or gel 102 such that the body 90 is in fluid communication with the reservoir 100. Opposing walls 104A, 104B can surround the reservoir and one or both of the walls 104A, 104B can be squeezed or otherwise translationally movable toward the tubular body 90. Alternatively or additionally, the body 90 can be rotatably secured to the backing 12 such that the body 90 and member 92 can be rotated about their longitudinal axes, as shown at 98, to distribute the conductive fluid or gel 102 and exfoliate the skin to promote electrical contact between the conductive tubular member 92 and the scalp.

[0080] Additionally and / or alternatively, the distal tip 94 of the member 92 can present a rough surface for contacting the skin. The optionally roughened tip can be rotated by the user on the skin surface to at least partially exfoliate the skin surface to facilitate electrical contact.

[0081] In use, once the backing 12 has been secured to the patient's head, the tubular body 90 can be manually rotated by the user so that the member 92 is advanced into and through any hair that may be present on the patient's scalp. Once the opening 94 of the distal tip is positioned in contact with or proximate to the skin surface, one or both walls 104A, 104B can be actuated, for example by the user squeezing, so that the conductive fluid or gel 102 is introduced into the interior of the tubular body 90 via the opening 96. The conductive fluid or gel 102 can flow into the tubular body 90 and into the member 92 and out through the opening 94 into contact with the skin surface.

[0082] As described above, the tubular body 90 and / or member 92 can be made of a conductive material that is also flexible (e.g., conductive silicone), and / or a flexible material that can be coated or laminated with a conductive material (e.g., silicone, polyurethane, rubber, etc.), such that the tubular body 90 and / or member 92 below maintains its flexibility. Due to its electrical conductivity, the tubular body 90 can be directly electrically coupled to a wire or conductive strip. Furthermore, in the case where the tubular body 90 and / or member 92 have an optionally flexible configuration, the member 92 can collapse on itself while maintaining electrical conductivity to the underlying skin surface.

[0083] Turning now to other aspects of the present invention, the electrode carrier system may also be used in other applications, such as patient motion tracking using visual motion tracking or accelerometers.

[0084] In further embodiments, the electrode carrier system may be configured as a headband, such as Figure 9 As shown, and mounted on a patient P. The electrode carrier system is in electrical communication with a controller and / or output device 112 via a wire 114. In other variations, the device 112 may also be wirelessly coupled. If desired, the electrode assembly 14 may include any of the electrode assembly variations described herein and any number of combinations. Figure 9 In the illustrated embodiment, the headband backing 12 may also incorporate one or more fiducial markers 110A, 110B that allow for visual tracking of these markers 110A, 110B within the field of view of a camera or other optical imager 116. The markers 110A, 110B may include any visual indicator, shown in this variation as a high-contrast printed pattern having a specific shape, as shown. In other variations, the fiducial markers 110A, 110B may include lights, such as an arrangement of LEDs.

[0085] While two markers are shown as an example, additional markers may be further distributed around the circumference of the backing 12 to allow for more precise tracking, for example, to allow for tracking when the patient's head H may rotate in a manner that obscures one of the markers. As described, during use of the electrode carrier system 10, a camera or other optical imager 116, such as a digital camera, may be positioned near the patient P so that the electrode carrier system 10 and the markers 110A, 110B remain within the field of view 118 of the imager 116. While a single imager 116 is shown in this example, additional imagers located at different locations may also be used in combination to help ensure that the electrode carrier system 10 and the markers 110A, 110B always remain within the field of view 118. Additionally, the imager 116 may optionally be motorized with pan and tilt capabilities to ensure that the patient P remains within the field of view 118 of the imager 116.

[0086] In the case where the electrode carrier system 10 is electrically coupled to the controller and / or output device 112, the imager 116 can also be connected to the controller and / or output device 112 by a wire or another communication link 120 or to a second controller and / or output device by wired or wireless communication. In this way, the controller 120 can be further programmed with a computer vision algorithm to identify the position and orientation of the patient's head H so that the controller can receive marker information from the imager 116 to determine the patient's movement in real time. This information can then be used for artifact exclusion and diagnostic purposes. For example, visual tracking of the markers 110A, 110B can be used to determine or confirm whether the patient P is experiencing a seizure, and in particular to determine or confirm whether the detected patient brain signals are sonified.

[0087] In yet another variation, as an alternative to visual markers, the electrode carrier system 10 may incorporate one or more accelerometers 130 attached within or along the backing 12, such as Figure 10 As shown. One or more accelerometers 130 may include a triaxial accelerometer device sensitive enough to detect movement of the patient's head. This data may be transmitted via wires 134 to a controller and / or output device 132 for processing to determine patient movement and motion artifact rejection. If the detected acceleration exceeds a predetermined threshold, this may be an indicator to the controller that these motion artifacts can be excluded from consideration to prevent artifact noise from being included in other detected data.

[0088] The electrode carrier system 10 can be used with any combination of electrodes described herein and can also be used in any combination with optical motion detection or accelerometer monitoring. In other variations, optical motion detection and accelerometer monitoring can be used in combination if desired.

[0089] Now refer to Figure 11 , an electrode carrier system 200 constructed in accordance with the principles of the present invention includes an elongated backing 204, typically in the form of a headband or other helmet, having a plurality of electrode assemblies 202 distributed along its length. The elongated backing 204 will typically have overlapping ends 206 that can be adjustably attached when the elongated backing is placed on the patient's head, typically as described above. Figure 1 The overlapping ends may be attached using any conventional method, such as using Hook and loop fastener.

[0090] The electrode assembly 202 is preferably rotatably mounted so that the user can manually rotate it back and forth as indicated by arrow 208 to gently abrade the patient's skin after the elongated backing is placed on the scalp. In particular, it will be desirable to perform such manual abrasion immediately prior to dispensing a conductive fluid or gel, as described in greater detail herein and below. In other cases, abrasion may be performed while dispensing a conductive fluid or gel and / or after dispensing the conductive fluid or gel.

[0091] Now refer to Figure 12-15 , the electrode assembly 202 will generally include a lower body portion or base 210, an upper body portion or cover 212, and one or more tubular members 214 depending downwardly from a bottom surface 244 of the lower body portion. A plunger 216 is configured to enter a chamber 224 within the upper body portion 212 through an opening 222. A sealed dispensing container, such as a cartridge or sealed dispensing container 220, holds a conductive fluid or gel and is configured to be constrained within the chamber 224 while the plunger 216 readily extends outwardly from the upper body portion 212, i.e., it is in an undepressed configuration.

[0092] Once the sealed dispensing container 220 is placed in the chamber 224, the plunger 216 can be positioned so that the leading edge 228 is adjacent to one side of the sealed dispensing container. By pressing the plunger 216 in the direction of arrow 217, the conductive fluid or gel within the sealed dispensing container 220 will be pressurized, causing a portion of the container to pass through the dispensing aperture 226. When additional pressure is applied with the plunger 216, the portion of the chamber within the dispensing aperture 226 will rupture and allow the conductive fluid or gel to flow into the vertical passage 232 within the upper body portion 212, as shown. Figure 14 and Figure 16 Then, the conductive fluid or gel will contact the conductive end 218, and the conductive fluid or gel will continue to flow through the horizontal passage 234 and flow into the vertical lumen 238 in the fork 214, as shown. Figure 15 and Figure 16 shown.

[0093] After flowing through the vertical lumens 238, the liquid or gel will flow outwardly through channels 240 formed in the bottom of the prongs 214 so that it can flow onto the patient's tissue in contact with the prongs' lower surfaces 240. For the sake of completeness, it should be noted that the lower body portion or base 210 has a hollow interior 242, which is an artifact of manufacturing and does not directly contribute to the flow of fluid within the device.

[0094] Once the entire flow path from the vertical passage 232 through the channel 238 in the lower surface of the prong 214 is filled with the conductive fluid or gel, it will be understood that the bioelectric current present in the liquid or gel region will be conducted to the conductive tip 218, which in turn is connected to the wire or other conductor 230 present in the backing 204 of the electrocarrier system 200. For the sake of completeness, it should be noted that the attachment of the wire 230 or other conductor to the conductive tip 218 will be done in such a manner as to accommodate rotation of the electrode assembly relative to the elongated backing 204, as shown by arrows 208 and Figure 11 shown.

[0095] Now refer to Figures 17-27 , various configurations of the lower body portion of the electrode assembly for use with the present invention will be described. Figure 17 and Figure 18 The lower body portion 210 is shown, which has been combined with the upper Figure 12-15 Shown. Figure 17 and Figure 18 The detailed view of FIG. 2 shows a pair of prongs 214 formed on the lower surface 244 of the lower body portion 210. Figure 18 As best shown in FIG, the prongs 214 have a generally crescent or arcuate shape with a curved channel formed on their lower surface 240. However, the curve or arc of the prongs 214 is not concentric with the circular perimeter of the lower body portion 210. Instead, the arc of the prongs 214 is non-concentrically positioned on the bottom 244 of the lower body portion 210. In this manner, gel entering through the vertical lumen 236 of the prongs will be distributed relative to the tissue such that when the electrode assembly 202 is rotated back and forth as previously discussed, the gel will be distributed from the prongs' lower surface 240. Thus, this asymmetry of the prongs will help facilitate the distribution of the conductive fluid or gel as it is dispensed through the vertical lumen 236 and the arcuate channel 238.

[0096] In an alternative embodiment, if Figure 19 and 20 As shown, the lower body portion or base 260 has three prongs 262 concentrically and evenly spaced about a bottom 268. Thus, the conductive fluid gel delivered through the vertical lumen 264 and distributed through the channels 266 formed in the lower surface 270 of each prong will not be further distributed by the lower surface passing over the gel. However, the presence of the three prongs will further promote reliable electrical connection.

[0097] Now refer to Figure 21, other embodiments of the lower body portion 280 include two symmetrical prongs 286 having a single irrigation port 282 in their lower surface 284. However, a similar lower body portion 290, in which three prongs 296 each have a lower surface 294 with an irrigation port 98, also includes a plurality of surface features 292, generally in the form of small protrusions, that aid in the distribution of the conductive fluid or gel (distributed through the port 298).

[0098] Another embodiment of a lower body portion or base 300 is shown having three symmetrical prongs 306. Each prong 306 has a lower surface 304 formed thereon with a plurality of surface features 302. As with the previous embodiment, each prong has a respective vertical lumen 308 leading to a channel 310 formed in the lower surface for delivering and distributing a conductive fluid or gel.

[0099] exist Figures 24 to 27 . Instead of having a single lower surface with a port channel formed therein on each prong, these lower body portions have a lower surface with recesses for delivering a conductive fluid or gel. Figure 24 As shown, the bottom portion 320 includes three symmetrically placed prongs 322 extending from its bottom. The prongs each have a lower surface 224, but the fluid or gel delivery port 328 is formed in a recessed surface of the prong.

[0100] Figure 25 A similar bottom portion 340 is shown having three asymmetric prongs 342 , wherein a lower surface 344 of each prong includes a plurality of surface features 342 .

[0101] like Figure 26 As shown, an alternative lower body portion 360 includes a prong 362 with an adjacent gel or fluid delivery tube 364 having a port 366 therein. The prong 362 has a generally flat lower surface without surface features.

[0102] exist Figure 27 , a lower body portion 380 similar to the lower body portion 360 includes three prongs 386 with adjacent fluid delivery tubes. The lower surface 384 of each prong 386 includes a surface feature 382.

[0103] Now refer to Figures 28A-28C , the electrode assembly 400 includes an upper portion or cover 402 and a lower portion or base 404. Generally as described with respect to the previous embodiments, the plunger 406 is reciprocally received by the wall of the cover 402 and extends into the reservoir 412. However, in contrast to the previous embodiments, the lower portion or base 404 of the electrode assembly 400 has a flat bottom surface 408, as shown in FIG. Figure 28B and Figure 28C The electrode assembly 400 is free of tubular elements and other protruding elements on its lower bottom surface and is particularly useful for engaging against hairless tissue surfaces, such as a patient's forehead. It should be understood that, as described above, the tubular member of the present invention is particularly intended to allow electrical contact to be made through the patient's hair present on the scalp. As a headband around the patient's skull, for example Figure 11 In the embodiment of the headband 206, at least some of the electrode assemblies 202 will engage against the patient's forehead, which is almost hairless. In this case, those electrode assemblies that engage the forehead can be made without the tubular member, such as Figures 28A-28C shown.

[0104] As with the previous embodiments, the reservoir 412 of the electrode assembly 400 can have a capsule or other sealed container that holds a conductive gel or other fluid therein. Alternatively, the gel can be unconfined within the reservoir 412, for example, by being introduced into the reservoir by injection through a passage 422 having a port 424 in the plunger 406. When the plunger 406 is depressed, the pressure on the gel (encapsulated or unconfined) within the reservoir 412 will cause the gel to flow downward through the vertical passage 414 and out through the bottom port 416 into the groove 410 formed in the bottom surface 408. The gel or other conductive fluid will be able to distribute within the groove and form a conductive path with the conductive tip 420, which passes through the hole 418 in the wall of the lower portion or base 404. Thus, bioelectrical signals can be coupled through the patient's skin to the conductive gel in the groove 410, so that current can be transferred to the conductive tip 420. Optionally, the bottom surface 408 can be modified to enhance conductivity in any manner described elsewhere herein in conjunction with other embodiments of the electrode assembly.

[0105] Now refer to Figures 29A-29C , an electrode assembly 430 constructed in accordance with the principles of the present invention includes an upper portion or cover 432 and a lower portion or base 434. A tubular member or probe 436 projects downwardly from the bottom surface of the lower portion or base 434, and a chamber 440 is formed in the lower portion or base to receive a conductive gel or other fluid through a vertical passage 438 in the upper portion or cover 432. It should be understood that the electrode assembly 430 does not include a plunger for delivering the conductive gel as with other embodiments described herein.

[0106] Conductive gel or other fluid can be injected through vertical passageway 438 so that the gel first flows into chamber 44 and then flows through vertical delivery passageway 442 formed through tubular member or stylet 436. Thus, the conductive gel or other fluid will be able to flow onto the patient's skin so that it can form an electrical path from the skin to the conductive tip or pin 452, which passes through the wall of lower portion or base 434 and into chamber 440.

[0107] The electrode assembly 430 is mounted in the lower grommet 444 and optionally in the upper grommet 446. Figure 29B As shown, a single grommet 444 can be connected to the headband 445 using adhesive, staples, pins, etc. Alternatively, the headband 445 can be sandwiched between an upper grommet 444 and a lower grommet 446, as shown. Figure 29C In such a case, at least one of the grommets will include a slot 448 to receive the conductive tip 452 and allow the electrode assembly to rotate within the grommets 444 and 446. As described elsewhere herein, the slot allows the conductive tip 452 to move while the electrode assembly rotates to enhance electrical contact with the skin.

[0108] In yet another embodiment, an electrode assembly 460 constructed in accordance with the principles of the present invention includes an upper portion or cover 462 secured to a lower portion or base 464, as shown. Figures 30A-30C 4. A single tubular member 466 projects downwardly from a bottom surface 465 of the lower portion or base 464. A vertical passageway or port 468 extends from an upper portion or guide port 470 through the upper and lower portions to allow for the introduction of a conductive gel or other fluid. The lower surface of the single tubular member 466 includes a plurality of surface features 472, generally as described elsewhere herein, to allow for surface treatment or abrasion of tissue before, during, or after the introduction of the conductive gel or other fluid through the vertical passageway 468.

[0109] The electrode assembly 460 can be placed in the plate or buckle 474, generally through the opening, so that the channel 467 formed between the lower surface of the upper portion or cover 462 and the flange 469 on the lower portion or base 464 receives the wall of the plate 474 to allow the electrode assembly to rotate relative to the plate. The conductive tip 476 passes through the wall of the lower portion or base 464 so that it makes electrical contact with the conductive gel or other fluid passing through the vertical passage 468 to form a conductive path with the tissue contacted by the lower surface of the single tubular member 466. The conductive tip 476 is free to move within the cutout area 478 on the lower surface of the buckle or plate 474, as indicated by the arrows on either side of the tip. The buckle 474 includes side loops or cutouts 480 that allow the buckle to be attached to a strap to form a headband by connecting the buckle to other similar structures.

[0110] Now refer to Figure 31A and Figure 31B Yet another electrode assembly 482 constructed in accordance with the principles of the present invention includes an upper portion 484 and a lower portion 486. The electrode assembly 482 is received within a buckle or plate structure 492 so that it can be positioned along the Figure 31AThe electrodes 482 slide freely within the slots 494 in the direction of the arrow shown. The electrode assembly 482 has a port 498 for receiving a conductive gel or other fluid and distributing the fluid through the lower port 488, which is located in an array of surface features 490 on the lower surface of the lower portion 486. In this way, after the electrode assembly 482 is engaged against the patient's skin (typically as part of a headband), the electrodes can be translated back and forth relative to the buckle 492 and headband to treat the skin surface and enhance conductivity, as described in more detail elsewhere herein. The buckle or plate 492 includes slots 496 on either side to facilitate attachment to the headband assembly.

[0111] The following numbered paragraphs further describe the invention:

[0112] 1. An electrode assembly comprising:

[0113] Electrode body;

[0114] one or more tubular members extending from the electrode body and having a distal tip, at least some of the one or more tubular members having a lumen with a distal opening in the distal tip; and

[0115] A device structure on the electrode body is provided for dispensing a conductive fluid or gel from a reservoir through the lumen and out of the distal opening of the tubular member.

[0116] 2. The assembly according to 1, comprising at least two tubular members.

[0117] 3. The assembly of 2, wherein the at least two tubular members are generally straight.

[0118] 4. The assembly of claim 3, wherein the at least two tubular members are configured to extend from a bottom portion of the electrode body.

[0119] 5. An assembly according to claim 4, wherein the at least two tubular members are configured to extend from a generally planar bottom of the electrode body at an angle in the range of 30° to 150° relative to the plane.

[0120] 6. The assembly of claim 5, wherein the at least two tubular members are configured to extend from a generally planar bottom portion of the electrode body at an angle range that is generally perpendicular to the plane.

[0121] 7. The assembly of claim 2, wherein the at least two tubular members are configured in a spiral shape.

[0122] 8. The assembly of claim 1 , wherein the distal tips of at least some of the tubular members define a skin preparation surface.

[0123] 9. The assembly of 8, wherein the skin preparation surface comprises at least one of (a) an abrasive and (b) a surface feature on the distal tip.

[0124] 10. The assembly of claim 1, wherein the tubular member is at least partially formed of an electrically conductive material.

[0125] 11. The assembly of claim 1 , wherein the tubular member is at least partially formed from a non-conductive material.

[0126] 12. The assembly of claim 1, wherein the tubular member comprises a prong formed on a lower base of the electrode body.

[0127] 13. The assembly of claim 1 , wherein the distal opening is located on a lower surface of the prong.

[0128] 14. The assembly of claim 13, wherein the lower surface has at least one skin preparation surface area adjacent the distal opening.

[0129] 15. The assembly of claim 13, wherein the lower surface has a crescent shape and the distal opening comprises an arcuate gel delivery channel.

[0130] 16. The assembly of claim 15, wherein the lower surface of the crescent has at least one skin preparation surface area adjacent to the arcuate gel delivery channel.

[0131] 17. The assembly of claim 13, wherein the prong has a lower surface with a convex portion and a concave portion, wherein the distal opening is located in the concave portion.

[0132] 18. The assembly of claim 1, further comprising a reservoir in the electrode body, the reservoir containing a conductive fluid or gel.

[0133] 19. The assembly of claim 18, wherein the reservoir comprises a sealed dispensing container confined within a cavity in the electrode body.

[0134] 20. An assembly according to claim 18, wherein the device structure on the electrode body for dispensing the conductive fluid or gel from the reservoir includes a plunger, which is configured to be manually pressed against the conductive fluid to deliver the conductive fluid or gel from the reservoir through the tubular cavity and out of the distal opening of the tubular member.

[0135] 21. An assembly according to claim 19, wherein the sealed dispensing container and the plunger are located on the upper portion of the electrode body and the tubular member extends from the lower surface of the electrode body, wherein the electrode body defines a flow path for delivering the conductive fluid or gel from the sealed dispensing container through the tubular cavity and out of the distal opening of the tubular member.

[0136] 22. The assembly of claim 21, wherein the flow path has a dispensing aperture in the upper portion of the electrode body, wherein the dispensing aperture is configured to define a rupture zone on the sealed dispensing container when the sealed dispensing container is pressurized by the plunger.

[0137] 23. The assembly of claim 18, wherein the sealed dispensing container comprises any one of a syringe, a hand squeeze tube, and a roller squeeze tube.

[0138] 24. The assembly of claim 1 wherein the electrode body defines a flow path for the conductive fluid or gel from the reservoir, through the lumen, and out of the distal opening of the tubular member.

[0139] 25. The assembly of claim 24, further comprising a conductive tip mounted on the electrode body and exposed to the flow path to create a conductive path with the conductive fluid or gel, wherein the conductive tip is configured to attach to external wiring.

[0140] 26. An assembly according to 25, wherein the conductive tip is positioned away from the distal opening in the distal end of the tubular member so that the conductive fluid or gel will provide a unique conductive path between the conductive tip and the distal end of the tubular member.

[0141] 27. An electrode carrier system comprising:

[0142] an elongated backing configured as a headband for placement on a patient's head;

[0143] a plurality of electrode assemblies according to claim 1 distributed along the length of the elongated backing; and

[0144] At least one electrical lead is connected to each electrode assembly to deliver a low current biosignal from the electrode assembly to a controller and / or output device.

[0145] 28. The system according to 27 further includes a controller and / or output device configured to receive the low current biosignal from the electrode assembly.

[0146] 29. The assembly of 28, wherein the controller is further configured to record electrical signals from the electrode assembly.

[0147] 30. A system according to 27, wherein the distal ends of at least some of the tubular members define a skin preparation surface and at least some of the electrode assemblies are movable relative to the slender backing to allow a user to move the assemblies, treat the tissue surface, and enhance electrical contact.

[0148] 31. A method for placing a plurality of electrodes on the scalp of a patient, the method comprising:

[0149] placing a headband around the patient's scalp, the headband carrying a plurality of electrode assemblies;

[0150] engaging distal tips of one or more tubular members extending from at least some of the electrode assemblies against scalp tissue;

[0151] extruding a conductive fluid or gel from a reservoir disposed in at least some of the electrode assemblies through the tubular members of those electrode assemblies to form a conductive path to the patient's scalp tissue; and

[0152] The plurality of electrode assemblies are connected to a controller and / or output device configured to receive a low-power bioelectrical current from the electrode assemblies.

[0153] 32. The method of 31 , wherein the distal tips of at least some of the tubular members are positioned through hair on the patient's scalp.

[0154] 33. The method of claim 31, further comprising moving at least some of the plurality of electrode assemblies to rub scalp tissue adjacent to the distal ends of the one or more tubular members so as to reduce contact resistance between the electrode assemblies and the scalp tissue.

[0155] 34. The method of 33, wherein the distal tips of at least some of the tubular members define a skin preparation surface.

[0156] 35. The method of claim 31, wherein the conductive fluid or gel is extruded from the reservoir through the lumen in the tubular member and out of the distal opening on the distal tip of the tubular member onto the scalp tissue.

[0157] 36. The method of claim 35, wherein the conductive fluid or gel is extruded from a groove on the distal tip of the tubular member.

[0158] 37. The method of claim 31, wherein squeezing the conductive fluid or gel from the reservoir comprises manually applying external pressure to a sealed dispensing container that holds the conductive fluid or gel, wherein the sealed dispensing container is incorporated into the electrode assembly.

[0159] 38. The method of claim 37, wherein applying external pressure to the sealed dispensing container comprises depressing a plunger to engage a rupturably sealed dispensing container carrying the conductive fluid or gel.

[0160] 39. The method of 37, wherein applying external pressure to the sealed dispensing container comprises manually squeezing a tube, manually depressing a syringe plunger, and roll-squeezing the tube.

[0161] 40. The method of 31, wherein the conductive path to the patient's scalp tissue is formed solely by the conductive fluid or gel.

[0162] 41. The method of claim 31, wherein the conductive path to the patient's scalp tissue is formed at least in part by conductive structures on the tubular member.

[0163] 42. A patient monitoring system comprising:

[0164] one or more electrodes configured to contact a skin surface;

[0165] a backing securable to a patient's body and further configured to hold the one or more electrodes against the skin surface;

[0166] at least one motion detection device attached to the backing; and

[0167] A controller for receiving electrical data from the one or more electrodes and motion data associated with the at least one motion detecting device, wherein the controller is programmed to process the electrical data and motion data.

[0168] 43. A system according to claim 42, wherein the one or more electrodes each include an at least partially conductive electrode body, one or more tubular members extending from the electrode body, each of the one or more tubular members defining a lumen therethrough and a distal opening.

[0169] 44. The system of claim 43, further comprising a reservoir having a compressible structure and containing a conductive fluid or gel in fluid communication with the one or more tubular members.

[0170] 45. The system of claim 42, wherein the backing is configured as a headband for placement on a patient's head.

[0171] 46. ​​The system of claim 42, wherein the at least one motion detection device comprises one or more fiducial markers.

[0172] 47. The system of claim 46, further comprising an imaging device configured to image the one or more fiducial markers.

[0173] 49. The system of 47, wherein the imaging device comprises a camera.

[0174] 50. The system of claim 46, wherein the imaging device is in communication with the controller.

[0175] 51. The system of claim 42, wherein the at least one motion detection device comprises one or more accelerometers.

[0176] The applications of the devices and methods discussed above are not limited to electrical sensing on a patient's head, but can include any number of further therapeutic applications. In addition, such devices and methods can be applied to other treatment areas on the body. Modifications of the above-described components and methods for implementing the present invention, combinations of different practical variations, and variations of various aspects of the present invention that are obvious to those skilled in the art are intended to fall within the scope of the appended claims.

Claims

1. An electrode carrier system, comprising: a backing configured to be placed on a patient's head; as well as a plurality of electrode assemblies distributed along the length of the backing, wherein one or more of the plurality of electrode assemblies comprises a reservoir, a horizontal passage, and at least one prong, the at least one prong comprising a vertical lumen directly connected to the horizontal passage, wherein the vertical lumen and the horizontal passage are configured to deliver a conductive fluid or gel from the reservoir to the vertical lumen via the horizontal passage, and Another one or more electrode assemblies among the plurality of electrode assemblies include a base without a prong.

2. The electrode carrier system according to claim 1, wherein: The at least one prong has a length and a width.

3. The electrode carrier system according to claim 2, wherein: The length of the fork is at least twice the width of the fork.

4. The electrode carrier system according to claim 3, wherein: The length of the prong is at least three times the width of the prong.

5. The electrode carrier system according to claim 2, wherein: The length of the prongs is in the range of about 1 cm to about 2 cm.

6. The electrode carrier system according to claim 1, wherein: The at least one prong comprises a rigid material.

7. The electrode carrier system according to claim 6, wherein: The rigid material includes metal or conductive polymer.

8. The electrode carrier system according to claim 1, wherein: The at least one prong has a crescent shape.

9. The electrode carrier system according to claim 1, wherein: The distal tip of the at least one prong includes a skin preparation surface.

10. The electrode carrier system according to claim 9, wherein: The skin preparation surface includes an abrasive material.

11. The electrode carrier system according to claim 10, wherein: The abrasive material includes abrasive particles.

12. The electrode carrier system according to claim 9, wherein: The skin preparation surface includes a plurality of skin roughening features.

13. The electrode carrier system according to claim 12, wherein: The plurality of skin roughening features include ridges, bumps, grooves, or a combination thereof.

14. The electrode carrier system according to claim 1, wherein: The base has a flat bottom surface.

15. The electrode carrier system according to claim 14, wherein: The planar bottom surface includes a plurality of openings.

16. The electrode carrier system of claim 1, further comprising at least one electrical lead connected to each electrode assembly to deliver EEG signals from the plurality of electrode assemblies to a controller and / or output device.

17. The electrode carrier system of claim 16, wherein the controller is further configured to record EEG signals from the electrode assembly.

18. The electrode carrier system according to claim 1, wherein: The backing is elongated and configured to be placed around the patient's head.

19. The electrode carrier system according to claim 18, wherein: The elongated backing is configured as a headband.

20. The electrode carrier system according to claim 1, wherein The backing is configured as a helmet.

21. The electrode carrier system according to claim 9, wherein: The skin preparation surface has a crescent shape.

22. The electrode carrier system according to claim 9, wherein: The distal tip also includes a channel or slot directly connected to the vertical lumen.

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