阅读说明：本技术 可调节形状的可穿戴电极 (Shape-adjustable wearable electrode ) 是由 布拉德利·G·巴赫尔德 潮兴娟 于 2019-05-28 设计创作，主要内容包括：本公开内容提供用于使用可穿戴电极组装件的系统、装置和方法。所述电极组装件通过提供增加的其底表面的总表面积来提高舒适度,该底表面与患者的头皮和毛发接触。底表面的坍缩、压缩或伸缩将因此减小底表面的一个或多个远侧构件施加到皮肤的直接力和/或压力。这对于在电极接触区域几乎没有毛发的患者、对皮肤特别敏感的患者人群和/或必须长时间穿戴电极组装件的患者可能是有利的。电极组装件还包括用于分配和/或保持放置在患者皮肤上的导电凝胶的结构,从而保持电连接质量,和/或在建立电连接之前促进清除皮肤和/或毛发。(The present disclosure provides systems, devices, and methods for using a wearable electrode assembly. The electrode assembly improves comfort by providing an increased total surface area of its bottom surface that is in contact with the scalp and hair of the patient. The collapsing, compressing, or telescoping of the bottom surface will thus reduce the direct force and/or pressure applied to the skin by the one or more distal members of the bottom surface. This may be advantageous for patients with little hair at the electrode contact area, patient populations that are particularly sensitive to skin, and/or patients who must wear the electrode assembly for extended periods of time. The electrode assembly also includes structure for dispensing and/or retaining a conductive gel placed on the patient's skin, thereby maintaining the quality of the electrical connection, and/or facilitating the removal of skin and/or hair prior to establishing the electrical connection.)

1. An electrode assembly, comprising:

an electrode body defining an internal reservoir for storing a tissue conductive fluid or gel and having a bottom opening to dispense the tissue conductive fluid or gel,

wherein the electrode body is at least partially adjustable, collapsible or compressible in a direction toward the skin.

2. The electrode assembly of claim 1, wherein the electrode body is at least partially collapsible or compressible in response to an increase in a force exerted on the electrode body in the skin-facing direction.

3. The electrode assembly of claim 1, wherein the electrode body comprises a first body member and a second body member operably coupled to each other.

4. The electrode assembly of claim 3, wherein one or more of the first body member or the second body member is electrically conductive.

5. The electrode assembly of claim 3, wherein the first body member and the second body member are coaxial.

6. The electrode assembly of claim 3, wherein the first body member and the second body member are configured to telescope relative to each other in response to an increase in force.

7. The electrode assembly of claim 6, wherein the second body member is spring loaded within the first body member.

8. The electrode assembly of claim 3, wherein the first body member is rigid and the second body member is flexible and resiliently collapsible in response to an increase in force.

9. The electrode assembly of claim 8, wherein the second body member is elastic.

10. The electrode assembly of claim 3, wherein the first body member has a cylindrical shape and the second body member has a conical shape.

11. The electrode assembly of claim 3, wherein the bottom opening is disposed on the second body member.

12. The electrode assembly of claim 11, wherein the electrode body has a central axis and the bottom opening is offset from the central axis.

13. The electrode assembly of claim 1, wherein the electrode body is at least partially depressible to dispense the tissue conductive fluid or gel through the bottom opening.

14. The electrode assembly of claim 13, wherein the electrode body comprises a depressible top surface or button.

15. The electrode assembly of claim 13, wherein the electrode body comprises a depressible side surface or button.

16. The electrode assembly of claim 1, wherein the electrode body includes an adapter for an external dispenser of the tissue conductive fluid or gel.

17. The electrode assembly of claim 16, wherein the electrode body has an upper surface and the adapter is located at the upper surface.

18. The electrode assembly of claim 16, wherein the external dispenser comprises one or more of a syringe, a manually-extruded tube, or a roll-extruded tube.

19. The electrode assembly of claim 16, wherein the adapter is configured to be removably coupled to the external dispenser such that the external dispenser is movable relative to the electrode body.

20. The electrode assembly of claim 19, wherein the external dispenser includes a skin preparation surface, and wherein movement of the external dispenser relative to the electrode body clears one or more of a subject's skin or hair when the external dispenser is removably coupled to the adapter and moved.

21. An electrode assembly according to claim 20 wherein the skin preparation surface is one or more of rigid or abrasive.

22. The electrode assembly of claim 19, wherein the outer dispenser is movable relative to the electrode body by one or more of translation, rotation, or pivoting.

23. The electrode assembly of claim 19, wherein the electrode body comprises one or more template elements having one or more slots through which the skin preparation surface of the external dispenser guides movement of the external dispenser relative to the electrode body.

24. The electrode assembly of claim 16, wherein the adapter further comprises a valve to prevent backflow of the tissue conductive fluid or gel.

25. The electrode assembly of claim 1, wherein the electrode body comprises a skin preparation surface adjacent to the bottom opening, and wherein the electrode body is movable relative to a body of the wearable sensor device to cleanse the subject of one or more of skin or hair.

26. The electrode assembly of claim 25, wherein the skin preparation surface adjacent the electrode body is one or more of rigid or abrasive.

27. The electrode assembly of claim 25, wherein the electrode body is movable relative to the body of the wearable sensor by one or more of translation, rotation, or pivoting.

28. The electrode assembly of claim 1, further comprising a protective skirt configured to be coupled to the electrode body, the protective skirt having a base with an increased surface area to minimize exposure of skin adjacent to a distal opening of the electrode body to an external environment.

29. The electrode assembly of claim 28, wherein the protective skirt is configured to be removably coupled to the electrode body.

30. The electrode assembly of claim 28, wherein the protective skirt is spring loaded onto the electrode body.

Background

The present disclosure relates to methods and devices for placing one or more electrodes against a skin surface of a patient and monitoring the status of the patient. More particularly, the present disclosure relates to methods and devices for facilitating the speed and efficiency of placement of one or more electrodes against the scalp of a patient, optionally in combination with tracking the patient's motion. The present disclosure also relates to methods and devices for comfortably and chronically wearing one or more electrodes against a patient's scalp in various patient settings.

Uniform contact between the metal electrodes and the skin may be beneficial for electrodes used in electrocardiography and electroencephalography to prevent electrical noise due to the interface between the electrodes and the skin surface. To provide uniform contact with an area of skin, a conductive gel may be applied to the skin surface to facilitate electrical conduction with the electrodes. However, when placing electrodes at multiple locations on a patient's scalp, the application of the gel and the determination of electrode placement may require specialized training and skill, and may also be very time consuming.

Some electrodes utilize a conductive gel interface that is pre-formed for contacting the electrode, but when hair is present, the gel interface may become ineffective and sometimes it may be desirable to remove the underlying hair.

Specialized electrode assemblies have been developed that dispense gel when worn and in contact with the scalp of a patient. However, these electrode assemblies may be uncomfortable to wear for extended periods of time, such as when a patient is lying on a pillow or other platform during sleep. Furthermore, these electrode assemblies may suffer gel loss over time, and the connection quality may degrade during extended wear.

Accordingly, there is a need for a method and apparatus that facilitates the speed of electrode placement. Even if hair is present, it is desirable to promote contact between the electrodes and the skin surface. It would be preferable to provide methods and devices that simplify or reduce the necessity of preparing the hair and scalp for each electrode contact. It is particularly desirable that such methods and devices can provide for the incorporation of conductive fluids or gels as part of an electrode assembly and provide for the preservation of such conductive fluids or gels over extended periods of time. It would be desirable if such methods and devices facilitated comfortable long-term wear by the patient.

Disclosure of Invention

The present disclosure provides systems, devices, and methods for using an electrode assembly that may be worn by a user or patient. The electrode assemblies provided herein can improve comfort by increasing the total surface area of the electrode assembly bottom surface, which can be in contact with the patient's skin (e.g., scalp) and hair. The collapsing, compressing, or telescoping of the bottom surface may thus reduce direct forces and/or pressure applied to the skin by the distal member of the bottom surface of the electrode assembly. This may be advantageous for patients with little hair at the electrode contact area, patients with particular sensitivity to skin, and/or patients who have to wear the electrode assembly for a long time. The electrode assembly may include structure for dispensing and/or retaining a conductive gel placed on the patient's skin, thereby maintaining the quality of the electrical connection. The electrode assemblies described herein can also facilitate the removal of skin and/or hair prior to establishing an electrical connection with the skin.

Disclosure of Invention

The present disclosure provides systems, devices, and methods for using an electrode assembly that may be worn by a user or patient. The electrode assemblies provided herein can improve comfort by increasing the total surface area of the electrode assembly bottom surface, which can be in contact with the patient's skin (e.g., scalp) and hair. The collapsing, compressing, or telescoping of the bottom surface may thus reduce direct forces and/or pressure applied to the skin by the distal member of the bottom surface of the electrode assembly. This may be advantageous for patients with little hair at the electrode contact area, patients with particular sensitivity to skin, and/or patients who have to wear the electrode assembly for a long time. The electrode assembly may include structure for dispensing and/or retaining a conductive gel placed on the patient's skin, thereby maintaining the quality of the electrical connection. The electrode assemblies described herein can also facilitate the removal of skin and/or hair prior to establishing an electrical connection with the skin.

Aspects of the present disclosure provide an electrode assembly. An exemplary electrode assembly may include an electrode body defining an internal reservoir for storing a tissue conductive fluid or gel and having a bottom opening to dispense the tissue conductive fluid or gel. The electrode body may be at least partially adjustable, collapsible or compressible in a direction towards the skin.

The electrode body may be at least partially collapsible or compressible in response to an increase in force exerted on the electrode body in a direction toward the skin.

The electrode body may include a first body member and a second body member operatively coupled to each other. One or more of the first body member or the second body member may be electrically conductive. The first body member and the second body member may be coaxial. The first body member and the second body member may be configured to telescope relative to each other in response to an increase in force. For example, the second body member may be spring loaded within the first body member. The first body member may be rigid and the second body member may be flexible and resiliently collapsible in response to an increase in force. The second body member may be elastic (elastomeric). The first body member may have a cylindrical shape and the second body member may have a conical shape. The bottom opening may be provided on the second body member. The electrode body may have a central axis, and the bottom opening may be offset from the central axis.

The electrode body may be at least partially depressible to dispense the tissue conductive fluid or gel through the bottom opening. The electrode body may include a depressible top surface or button. The electrode body may include depressible sides or buttons.

The electrode body may include an adapter for an external dispenser of tissue conductive fluid or gel. The electrode body may have an upper surface, and the adapter may be located on the upper surface. The external dispenser may include one or more of a syringe, a manually extruded tube, or a roll-extruded tube. The adapter may be configured to be removably coupled to the external distributor such that the external distributor is movable relative to the electrode body. The external dispenser may comprise a skin preparation surface. When the external dispenser is removably coupled to the adapter and moved, movement of the external dispenser relative to the electrode body may clean one or more of the subject's skin or hair. The skin preparation surface may be one or more of rigid or abrasive. The outer dispenser may be movable relative to the electrode body by one or more of translation, rotation, or pivoting. The electrode body may include one or more stencil elements (slots) having one or more slots through which a skin preparation surface of the external dispenser guides movement of the external dispenser relative to the electrode body. The adapter may further include a valve to prevent backflow of the tissue conductive fluid or gel.

The electrode body may include a skin preparation surface adjacent the bottom opening. The electrode body is movable relative to the body of the wearable sensor device to remove one or more of the subject's skin or hair. The skin preparation surface adjacent to the electrode body may be one or more of rigid or abrasive. The electrode body can move relative to the body of the wearable sensor by one or more of translation, rotation, or pivoting.

The electrode assembly may further include a protective skirt configured to be coupled to the electrode body. The protective skirt may have a base with an increased surface area to minimize exposure of skin adjacent to the distal opening of the electrode body to the external environment. The protective skirt may be configured to be removably coupled to the electrode body. The skirt may be spring loaded onto the electrode body. The skirt may be resiliently compressible relative to the electrode body. The skirt and the electrode body may be coaxial when coupled to each other.

The electrode body may include a bottom surface. The bottom surface may have one or more receiving features for receiving tissue conductive gel or fluid that has been dispensed through the bottom opening. The one or more receiving features may include a plurality of protrusions or fingers.

Aspects of the present disclosure provide methods of continuously monitoring a subject. In an example method, the wearable sensor device can be configured to be placed on the skin of a subject such that the at least one electrode assembly of the wearable sensor device is adjacent to the skin. Movement of the at least one electrode assembly relative to the body of the wearable sensor device can be accommodated to clean one or more of skin particles or hair from the skin. A tissue conductive fluid or gel may be dispensed from the at least one electrode assembly in response to the compressive force. The electrode body of the at least one electrode assembly may be at least partially adjusted, collapsed, or compressed in a direction toward the skin.

The at least one electrode assembly may be at least partially collapsed or compressed in response to an increase in force exerted on the electrode body in a direction toward the skin. The movement of the at least one electrode assembly relative to the body of the wearable sensor device can include one or more of translation, rotation, or pivoting. Movement of the at least one electrode assembly relative to the body of the wearable sensor device can move the skin preparation surface of the electrode body to clean one or more of skin particles or hair from the skin.

The conductive fluid or gel may be dispensed in response to a compressive force applied to a top surface of the electrode body or button of the at least one electrode assembly. The conductive fluid or gel may be dispensed in response to a compressive force applied to a side surface of the electrode body or button of the at least one electrode assembly. The tissue conductive fluid or gel may be dispensed by coupling an external dispenser to the electrode body of the at least one electrode assembly and actuating the external dispenser.

To at least partially collapse or compress the electrode body, the second body member of the electrode body may be telescoped relative to the first body member of the electrode body. Alternatively or in combination, the flexible body member of the electrode body may be compressed or collapsed in order to at least partially collapse or compress the electrode body. The flexible body member may be resilient.

The electrode body of the at least one electrode assembly may be coupled with a skirt. The protective skirt may have a base with an increased surface area to minimize exposure of skin adjacent to the distal opening of the electrode body to the external environment.

The skin of the subject may include the scalp.

The wearable sensor device may include one or more of an EEG sensor, an EKG sensor, or an EMG sensor.

The wearable sensor device can include a wearable headband. The increase in force exerted on the electrode body in the direction towards the skin may be from resting the subject's head against the surface. The surface may comprise one or more of a pillow, a bed, a headrest, or a platform.

Aspects of the present disclosure may provide an electrode assembly. An exemplary electrode assembly may include an electrode body defining an internal reservoir for storing a tissue conductive fluid or gel, and having a bottom opening to dispense the tissue conductive fluid or gel. The electrode body may include an adapter for an external dispenser of tissue conductive fluid or gel. The internal reservoir of the electrode body may receive the tissue conductive fluid or gel dispensed by the external dispenser and then dispense through the bottom opening of the electrode body.

The external dispenser may include one or more of a syringe, a manually extruded tube, or a roll-extruded tube.

The adapter may be configured to be removably coupled to the external distributor such that the external distributor is movable relative to the electrode body. The external dispenser may comprise a skin preparation surface. When the external dispenser is removably coupled to the adapter and moved, movement of the external dispenser relative to the electrode body may clean one or more of the subject's skin or hair. The skin preparation surface may be one or more of rigid or abrasive. The outer dispenser may be movable relative to the electrode body by one or more of translation, rotation, or pivoting. The electrode body may include one or more template elements having one or more slots through which a skin preparation surface of the external dispenser guides movement of the external dispenser relative to the electrode body.

The adapter may further include a valve to prevent backflow of the tissue conductive fluid or gel.

At least a portion of the electrode body may be collapsible or compressible. At least a portion of the electrode body may be elastically collapsible or compressible. Alternatively or in combination, at least a portion of the electrode body may be telescopic. At least a portion of the electrode body may be collapsible or compressible in response to an increase in force exerted on the electrode body in a direction toward the skin.

The electrode assembly may further include a protective skirt configured to be coupled to the electrode body. The protective skirt may have a base with an increased surface area to minimize exposure of skin adjacent to the distal opening of the electrode body to the external environment. The protective skirt may be configured to be removably coupled to the electrode body. The skirt may be spring loaded onto the electrode body. The skirt may be resiliently compressible relative to the electrode body. The protective skirt and the electrode body may be coaxial when coupled to each other.

The electrode body may include a bottom surface. The bottom surface may have one or more receiving features for receiving tissue conductive gel or fluid that has been dispensed through the bottom opening. The one or more receiving features may include a plurality of protrusions or fingers.

Aspects of the present disclosure may further provide an electrode assembly system comprising any of the electrode assemblies disclosed herein and any of the external dispensers disclosed herein.

Aspects of the present disclosure may provide methods of continuously monitoring a subject. The wearable sensor device can be configured to be placed on the skin of a subject such that the at least one electrode assembly of the wearable sensor device is adjacent to the skin. An external dispenser may be coupled to the electrode body of the at least one electrode assembly. The external dispenser may be actuated to dispense the tissue conductive fluid or gel from the external dispenser into the internal reservoir of the electrode body.

Movement of the at least one electrode assembly relative to the body of the wearable sensor device can be accommodated to clean one or more of skin particles or hair from the skin. The movement of the at least one electrode assembly relative to the body of the wearable sensor device can include one or more of translation, rotation, or pivoting.

Movement of the external dispenser relative to the at least one electrode assembly coupled thereto may be accommodated to clean one or more of skin particles or hair from the skin. The movement of the at least one electrode assembly relative to the body of the wearable sensor device can include one or more of translation, rotation, or pivoting.

Movement of the at least one electrode assembly relative to the body of the wearable sensor device can move the skin preparation surface of the electrode body to clean one or more of skin particles or hair from the skin.

The external distributor may be coupled to the electrode body by an adapter that removably couples the external distributor to the electrode body. The adapter may be located on an upper surface of the electrode body. The adapter may be located on a side surface of the electrode body. The adapter may further include a valve to prevent backflow of the tissue conductive fluid or gel.

The external dispenser may include one or more of a syringe, a manually extruded tube, or a roll-extruded tube.

The electrode body of the at least one electrode assembly may be coupled with a skirt. The protective skirt may have a base with an increased surface area to minimize exposure of skin adjacent to the distal opening of the electrode body to the external environment.

The skin of the subject may include the scalp.

The wearable sensor device may include one or more of an EEG sensor, an EKG sensor, or an EMG sensor.

The wearable sensor device can include a wearable headband. The increase in force exerted on the electrode body in the direction towards the skin may be due to the head of the subject being pressed against the surface. The surface may comprise one or more of a pillow, a bed, a headrest, or a platform.

Aspects of the present disclosure provide an electrode assembly for use with a wearable sensor device that is placed on the skin of a subject. An exemplary electrode assembly may include an electrode body and a protective skirt. The electrode body may define an internal reservoir for storing a tissue conductive fluid or gel, and the electrode body has a bottom opening to dispense the tissue conductive fluid or gel. The protective skirt may be configured to couple to the electrode body. The protective skirt may have a base with an increased surface area to minimize exposure of skin adjacent to the distal opening of the electrode body to the external environment.

The protective skirt may be configured to be removably coupled to the electrode body.

The skirt may be spring loaded onto the electrode body.

The skirt may be resiliently compressible relative to the electrode body.

The protective skirt and the electrode body may be coaxial when coupled to each other.

The electrode body may include an adapter for an external dispenser of tissue conductive fluid or gel. The internal reservoir of the electrode body may receive the tissue conductive fluid or gel dispensed by the external dispenser and then dispense through the bottom opening of the electrode body. The external dispenser may include one or more of a syringe, a manually extruded tube, or a roll-extruded tube. The adapter may be configured to be removably coupled to the external distributor such that the external distributor is movable relative to the electrode body. The external dispenser may comprise a skin preparation surface. When the external dispenser is removably coupled to the adapter and moved, movement of the external dispenser relative to the electrode body may clean one or more of the subject's skin or hair. The skin preparation surface may be one or more of rigid or abrasive. The outer dispenser may be movable relative to the electrode body by one or more of translation, rotation, or pivoting. The electrode body may include one or more template elements having one or more slots through which a skin preparation surface of the external dispenser guides movement of the external dispenser relative to the electrode body. The adapter may further include a valve to prevent backflow of the tissue conductive fluid or gel.

At least a portion of the electrode body may be collapsible or compressible, for example elastically collapsible or compressible. Alternatively or in combination, at least a portion of the electrode body may be telescopic. The portion of the electrode body may be collapsible or compressible in response to an increase in force exerted on the electrode body in a direction toward the skin.

The electrode body may include a bottom surface. The bottom surface may have one or more receiving features for receiving tissue conductive gel or fluid that has been dispensed through the bottom opening. The one or more receiving features may include a plurality of protrusions or fingers.

Is incorporated by reference

All publications, patents and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

fig. 1 illustrates a side view of a patient having an electrode carrier system configured as a headband.

Fig. 2 illustrates a perspective view of a variation of an electrode carrier system in which individual electrodes may be configured to indicate whether sufficient contact is made with the underlying skin surface.

Fig. 3A illustrates a detailed cross-sectional side view of another variation of an electrode carrier system, in which each electrode may be surrounded or surrounded by a pressure-relief reservoir.

Fig. 3B illustrates a detailed cross-sectional side view of another variation, where the electrodes may be formed from one or more loops of wire or ribbon.

Fig. 3C illustrates a detailed cross-sectional side view of another variation, in which each electrode may be formed from one or more conductive tubes defining a conduit.

Fig. 4A, 4B, and 4C illustrate cross-sectional side views of another variation, in which each electrode may include a compressible reservoir having one or more openings.

Fig. 5A, 5B, and 5C illustrate cross-sectional side views of another variation, in which each electrode may include a compressible reservoir having a conical shape.

Fig. 6A, 6B, and 6C illustrate cross-sectional side views of another variation, in which each electrode may include a telescopically compressible reservoir.

Fig. 7 illustrates an electrode carrier system of the present disclosure including a headband having a plurality of electrode assemblies distributed over its perimeter.

Fig. 8A, 8B, and 8C illustrate perspective, cross-sectional, and bottom views, respectively, of an electrode assembly that may include a plunger to activate the dispensing of a conductive fluid or gel.

Fig. 9A, 9B, and 9C show perspective, cross-sectional, and bottom views, respectively, of an electrode assembly that may include a depressible top surface or button to activate dispensing of a conductive fluid or gel.

Fig. 10A shows a perspective view of an electrode assembly that may include a screw interface with an external dispenser of a conductive fluid or gel.

Fig. 10B, 10C and 10D show perspective, cross-sectional and bottom views of the electrode assembly of fig. 10A.

Fig. 10E and 10F show side and enlarged cross-sectional views of the electrode assembly of fig. 10A in use with an external dispenser.

Figures 11A, 11B, and 11C show cross-sectional, perspective, and bottom views, respectively, of an electrode assembly that may include a duckbill valve to interface with an external dispenser of an electrically conductive fluid or gel.

Fig. 12A, 12B and 12C show a perspective view, a cross-sectional view and a bottom perspective view, respectively, of an electrode assembly for use with an external gel dispenser having a scalp preparation element disposed thereon.

Fig. 13A and 13B illustrate perspective and exploded views, respectively, of an electrode assembly including a scalp preparer that can be docked with an external dispenser.

Fig. 14 illustrates an exploded view of an electrode assembly including a scalp preparer that can interface with an external dispenser having a skin preparation surface.

Fig. 15 illustrates an exploded view of an electrode assembly including a scalp preparer that can interface with an external abrasive element.

Fig. 16A, 16B, and 16C illustrate perspective views of an electrode assembly including an adjustable structure that may additionally include a scalp preparation element.

Fig. 17 schematically illustrates an example of optically tracking patient motion in conjunction with an electrode carrier system.

Fig. 18 schematically illustrates another example of using one or more accelerometers in conjunction with an electrode carrier system to detect motion of a patient.

Detailed Description

The present disclosure relates to systems, devices, and methods for using an electrode assembly that is wearable by a user. The electrode assembly of the present disclosure may improve comfort by increasing the total surface area of the bottom surface of the electrode assembly, which may be in contact with the scalp and hair of a patient. For example, when a force and/or pressure is applied to the skin from the electrode assembly, the electrode assembly may be configured to increase the surface area of contact. The collapsing, compressing, or telescoping of the bottom surface may thus reduce the direct force exerted by the one or more distal members of the bottom surface of the electrode assembly. This may be advantageous for patients with little hair at the electrode contact area, patients with particular sensitivity to skin, and/or patients who have to wear the electrode assembly for a long time.

Embodiments of the present disclosure include devices having structures for dispensing a conductive fluid or gel to improve contact between an electrode assembly and a patient's skin. Embodiments of the present invention may improve upon existing electrode assemblies by providing a valve that allows for repeated filling of the electrode with a conductive gel to counteract evaporation or drying of the gel. These embodiments may be beneficial for long wear and continuous signal collection and use of the electrodes.

Embodiments of the present disclosure may facilitate the speed of placing electrodes by integrating the electrodes into a wearable electrode assembly. Additionally or alternatively, embodiments of the present disclosure may facilitate the refilling of the conductive fluid or gel in order to improve electrical contact over a longer measurement period (e.g., when the gel may have dried). Optionally, in any embodiment, the electrode assemblies disclosed herein may be combined with a system for tracking patient motion (e.g., with accelerometer and/or optical tracking).

Embodiments of the present disclosure may include embodiments, variations, and examples of electrode carriers, commonly assigned U.S. patent application No. 15/387,381, filed on 13.10.2017 (which was published on 21.11.2017 as U.S. patent No. 9,820,670 (attorney docket No. 49938-703.201), U.S. patent application No. 15/783,346 filed on 13.10.2017 (attorney docket No. 49938-703.301), and PCT application No. PCT/US2017/024505 filed on 28.3.2017 (attorney docket No. 49938-703.601), the entire contents of which are incorporated herein by reference.

The electrode carrier system 10 may generally include a backing 12 shown in a side view in fig. 1, with fig. 1 illustrating the carrier system 10 secured around the head H of a patient P. In this variation, the backing 12 is shown configured as a headband, although the carrier system 10 may be incorporated into any number of other platforms or positioning mechanisms for holding the electrodes against the 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 such 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. Electrode carrier system 10 may electrically couple each electrode assembly 14 via a respective lead extending from backing 12 and, for example, to a controller and/or output device 18. In other variations, however, the electrode assembly 14 may be wirelessly coupled to the controller and/or output device 18.

The controller and/or output device 18 may generally include any number of devices for receiving the electrical signals, 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. 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.

As described herein, the electrode assembly 4 may be positioned on the backing 12 to quickly achieve conductive contact with the underlying skin while providing comfort to the patient, e.g., when the patient P is lying on his back or side of his head H on the surface without discomfort from the electrodes 14 as shown.

One challenge in ensuring that the individual electrodes 14 are in sufficient contact with the underlying skin is the presence of hair HR on the scalp S of the patient P. The electrode-carrier assemblies of the present disclosure as described herein achieve rapid and reliable electrical contact with the scalp surface through the hair HR on each electrode assembly without having to remove the hair.

Fig. 2 shows an example 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 made, but may emit light 22 of a second color (red) if the electrode 14 does not make sufficient electrical contact. Alternatively, a single color LED may be used, where sufficient contact may be indicated by steady illumination of the LED, while insufficient contact may be indicated by a blinking LED. In other variations, the electrodes may include, for example, piezoelectric sensors, eccentric load weights coupled to a motor, or the like to provide a vibratory or other tactile response to indicate whether the electrodes 14 have sufficient electrical contact with the underlying skin. In this manner, the electrodes 14 may effectively provide a direct indication of electrical contact, rather than having to check a separate controller or indicator.

Turning now to the electrode configuration, fig. 3A illustrates a cross-sectional detail side view of a variation of electrode carrier system 35, wherein electrodes 32A and 32B may be enclosed within a reservoir that is pre-filled with a conductive gel or fluid. Each electrode 38A, 38B may be configured in a flat or atraumatic configuration contained within a respective reservoir 30A, 30B, and each reservoir 30A, 30B may be formed from any number of flexible materials that may be readily collapsed, e.g., silicone, polyurethane, rubber, etc. The electrodes 38A, 38B may be coupled via a lead 16, the lead 16 passing through a lumen 34 defined by the backing 12 separated from the electrodes by a substrate 36. Each reservoir 30A, 30B may also define one or more openings 32A, 32B, respectively, through which the conductive gel or fluid may be expelled.

Once the platform 12 is positioned over the patient's head H, the user may depress each reservoir 30A, 30B such that the conductive fluid or gel 40A, 40B flows through the openings 32A, 32B and onto the skin of the patient P. The conductive fluid or gel 40A, 40B expelled through the openings can maintain fluid communication between the skin surface and the respective electrodes 38A, 38B so that the detected electrical signals can 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 expelled into contact with the skin surface, the backing 12 may lie flat against the skin surface so that the patient P may comfortably place their head on the surface while still maintaining electrical contact with the electrodes 38A, 38B.

Fig. 3B shows a side view of another electrode carrier system 35, wherein the pair of electrode assemblies 50A, 50B may comprise one or more loops of wire or conductive strips 51A, 51B that can easily bend or flex against the skin surface. Some or all of the electrode assemblies 50A, 50B may include a pressure relief reservoir (shown in phantom at 53A and 53B) for containing a conductive fluid or gel 52A, 52B as described above around each wire or strip electrode 51A, 51B so that the conductive fluid or gel 52A, 52B may be expelled around and inside one or more rings to ensure a conductive path between the rings and the scalp. Alternatively, a quantity of conductive fluid or gel may simply be placed over electrode assemblies 50A, 50B prior to placement against the skin surface of the patient, without the use of a pressure relief reservoir. Each wire or strip electrode 51A, 51B may be electrically connected via the lead 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 bent.

Fig. 3C shows a side view of another variation of an electrode carrier system 56 having a plurality of electrode assemblies 58A and 58B, each electrode assembly 58A and 58B may include one or more tubular members 60A, 60B, and the tubular members 60A, 60B may extend perpendicularly or at an angle from the inner surface of the backing 12 (the surface in contact with the patient's scalp). The tubular members 60A, 60B may define a lumen therethrough having an opening 62A, 62B defined at each distal side. Each tubular member 60A, 60B may be made of a conductive metal that may retain its tubular shape when in use, or may be sufficiently thin and flexible to bend or flex when placed against the skin surface of a patient. Alternatively, the tubular members 60A, 60B may be made of a flexible material coated or laminated with an electrically conductive material such that the members retain their flexibility. In either case, the conductive fluid or gel 64A, 64B may be contained within the tubular member 60A, 60B, or it may be held within a pressure relief reservoir surrounding or proximate to each electrode as described above but not shown in fig. 3C. 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. The tubular members 60A, 60B may be arranged in serial pairs as shown, or may be arranged in a triangular, rectangular or circular pattern when there are three, four or more tubular members in a single electrode assembly 58A, 58B.

Referring to fig. 4A-4C, yet 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 may be formed of a flexible material, such as silicone, polyurethane, rubber, hydrogel, elastomeric polymer, and the like. The walls of the reservoir may be made of a conductive elastomer, for example, rubber or silicone mixed with portions of graphite, graphene, carbon nanotubes, and the like. In embodiments where the walls of the reservoir are flexible, the reservoir may be resiliently collapsible such that the reservoir returns to its previous shape after application of a force. The reservoir extends from the backing 12 to form a curved or arcuate structure having one or more openings 72 defined over the interior of the reservoir 70. These openings 72 are normally maintained in a closed state until a force F is applied to the reservoir 70 and/or backing 12 to cause the conductive fluid or gel 74 contained within the reservoir to escape through the openings 72 (as shown in fig. 4B) and contact the outer surface of the reservoir 70 and form a conductive path to the underlying skin surface. A layer of conductive material 76 is electrically coupled to the leads 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 reservoir 76 (as shown in fig. 4B) to squeeze or otherwise release the fluid or gel 74 from the interior of the reservoir 70 and onto the conductive material 76 and skin, as shown in fig. 4C, wherein the opening 72 returns to its closed state after the force F is removed.

Fig. 5A-5C illustrate embodiments of pressure relief reservoirs having conical reservoirs. The pressure relief reservoir system 500 may include an internal reservoir 570 filled with a conductive fluid or gel 574. The reservoir 570 may be formed of a flexible material, such as silicone, polyurethane, rubber, hydrogel, elastomeric polymer, or the like. The walls of the reservoir may be made of a conductive elastomer, for example, rubber or silicone mixed with portions of graphite, graphene, carbon nanotubes, and the like. In embodiments where the walls of the reservoir are flexible, the reservoir may be resiliently collapsible such that the reservoir returns to its previous shape after application of a force. The reservoir extends from the backing 12 to form a conical structure having a single opening 572 at the distal tip of the reservoir 570. The opening 572 is normally maintained in a closed state until a force F is applied to the reservoir 570 and/or backing 12 to cause the conductive fluid or gel 574 contained within the reservoir to escape through the opening 572 (as shown in fig. 5B) and contact the outer surface of the reservoir 570 and form a conductive path to the underlying skin surface. In embodiments where the reservoir may be made of an insulating material, a layer of conductive material 576 is electrically coupled to the leads 16 and may be formed on a portion or the entire outer surface of the reservoir 570. Electrical contact with the skin surface may be achieved by applying a force F to the backing 12 or reservoir 570 (as shown in fig. 5B) to squeeze or otherwise release a fluid or gel 574 from the interior of the reservoir 570 and onto the skin, as shown in fig. 5C, wherein the opening 572 returns to its closed state after the force F is removed.

Fig. 6A-6C illustrate an embodiment of a pressure relief reservoir, wherein the reservoir may be telescopically compressible. The pressure release reservoir system 600 may include an internal reservoir 670 filled with a conductive fluid or gel 674. The reservoir 670 may be formed of a flexible material, such as silicone, polyurethane, rubber, hydrogel, elastomeric polymer, and the like. The walls of the reservoir may be made of a conductive elastomer, for example, rubber or silicone mixed with portions of graphite, graphene, carbon nanotubes, and the like. In embodiments where the walls of the reservoir are flexible, the reservoir may be resiliently collapsible such that the reservoir returns to its previous shape after application of a force. The reservoir extends from the backing 12 to form two coaxial telescoping cylinders with a single opening 672 distal to the reservoir 670. In the illustrated embodiment, the telescoping elements of the reservoir 670 may be actuated by pressure changes in the chamber. Alternatively, the inner telescoping member may be spring loaded or otherwise resiliently compressible relative to the outer telescoping member to provide the restoring force after compression of the reservoir. For example, one or more spring elements 676 may be positioned internally between the telescoping elements of the reservoir 670 to bias the telescoping elements apart a desired distance; alternatively or in combination, a resiliently compressible material may be positioned between the telescoping elements of the reservoir 670 for the same purpose, and may include thermoplastic elastomers, rubber materials, compressible foams, compressible open-cell foams, silicone-based materials, to name a few. The openings 672 generally remain in a closed state until a force F is applied to the reservoir 670 and/or backing 12 to cause the conductive fluid or gel 674 contained within the reservoir to escape through the openings 672 (as shown in fig. 6B) and come into contact with the outer surface of the reservoir 670 and form a conductive path to the underlying skin surface. Electrical contact to the skin surface may be achieved by applying a force F to the backing 12 or reservoir 670 (as shown in fig. 6B) to squeeze or otherwise release the fluid or gel 674 from the interior of the reservoir 670 and onto the conductive material 676 and the skin, as shown in fig. 6C, where the openings 672 return to their closed state after the force F is removed.

Referring now to fig. 7, an electrode carrier system 700 constructed in accordance with the principles of the present disclosure includes an elongated backing 704, typically in the form of a headband or other helmet, having a plurality of electrodes distributed along its perimeter. The elongated backing 704 will typically have overlapping ends 706, and when the elongated backing is placed over the head of a patient, the overlapping ends 706 may be adjustably attached, as generally shown in fig. 1 above, so that the electrode carrier system 700 may be worn by patients with a wide range of head sizes. Any conventional method may be used, for example usingHook and loop fasteners attach the overlapping ends.

The electrode assemblies 702 are preferably rotatably mounted so that a user can manually rotate them back and forth as indicated by arrow 708 so that the patient's skin can be gently rubbed after placing the elongated backing on the scalp and placing the select electrode assembly 702. In particular, it may be desirable to perform such manual rubbing immediately prior to dispensing the conductive fluid or gel, as will be described in greater detail herein and below. In other cases, the rubbing may be performed while the conductive fluid or gel is dispensed and/or after the conductive fluid or gel is dispensed. Alternatively or in combination, the conductive fluid or gel itself may be at least partially abrasive and/or include an abrasive component to facilitate rubbing of the skin by movement of the electrode assembly 702 and/or other elements. Examples of abrasive ingredients included in the conductive fluid or gel may include particles of silica or silica, alumina, pumice, clay, lanolin, jojoba oil, to name a few. Commercially available abrasive conductive fluids or gels may include those available from Weaver corporation of Aurora, CO, coloradoSkin Prep Gel。

The electrode assembly 702 may include embodiments of the electrode assemblies 800, 900, 1000, 1100 presented in fig. 8A-12C, and may be incorporated into the electrode carrier system 700 according to aspects of the present disclosure. Electrode carrier system 700 may be used with a single embodiment of an electrode assembly (e.g., all electrode assemblies may comprise assembly 800). Alternatively, multiple embodiments of the electrode assembly may be used at various locations on the scalp. For example, an electrode assembly including a flat contact surface may be used on a patient's forehead (e.g., assembly 1200), while another assembly may be more suitable for use in a location overlying hair, such as assembly 800. Electrode carrier system 700 may include embodiments 1300, 1400, 1500, and 1600 electrode assemblies that comprise a scalp preparation. In embodiments where the scalp preparation is an auxiliary tool, the scalp preparation can be rotatably mounted in place of the electrode assembly 702 and can be removed after the scalp is prepared. After preparation, the electrode assembly 702 may be installed.

Fig. 8A-8C illustrate an electrode assembly 800 according to some embodiments, which may include a plunger to activate the dispensing of a conductive fluid or gel. As shown in fig. 8A, electrode assembly 800 will generally include a lower body portion or base 810, an upper body portion or cover 812, and one or more at least partially collapsible or compressible body portions 814. The upper body portion 812 and the lower body portion 810 may be rigid. The plunger 816 is configured to enter the chamber 824 within the upper body portion 812 through the opening 822. A sealed dispensing container (e.g., a cartridge) or sealed dispensing container 820 contains a conductive fluid or gel and is configured to be contained within the chamber 824, while the plunger 816 readily extends outwardly from the upper body portion 812, i.e., in its non-depressed configuration.

Once the sealed dispensing container 820 is placed in the chamber 824, the plunger 816 can be positioned such that the leading edge is adjacent to one side of the sealed dispensing container. By pressing the plunger 816 in the direction of arrow 817, the conductive fluid or gel within the sealed dispensing container 820 may be pressurized to cause a portion of the container to pass through the dispensing orifice 826. When additional pressure is applied with the plunger 816, a portion of the chamber within the dispensing orifice 826 may rupture and cause the conductive fluid or gel to flow into the vertical passageways 832 within the upper body portion 812, as shown in FIG. 8B. The conductive fluid or gel may then be brought into contact with the conductive tip 818 and the conductive fluid or gel may continue to flow through the horizontal passage 834 and onto the internal reservoir 830 of the compressible body portion 814, as shown in fig. 8B. In some embodiments, when pressure or force is applied along arrows 842 (e.g., from a patient's head pressing against a hard surface or by tightening electrode carrier 700), compressible body portion 814 may collapse, thereby reducing the volume of internal reservoir 830. An increase in pressure or force may cause the fluid or gel to flow along the flow path. The fluid or gel may flow outwardly from the internal reservoir 830 through a channel or aperture formed in the bottom of the compressible body 814 so that it may flow onto the patient's tissue in contact with the lower surface 844 of the compressible body portion 814.

Once the entire flow path from the vertical channel 832 to the channel 840 in the lower surface of the compressible body portion 814 is filled with the conductive fluid or gel, it will be appreciated that the bioelectrical current present in the fluid or gel region will be conducted to the conductive tip 818, which in turn is connected to the wire or other conductor present in the backing 704 of the electrical carrier system 700. Attachment of the wire or other conductor to the conductive tip 818 may be performed in a manner that accommodates rotation of the electrode assembly relative to the elongate backing 704, as indicated by arrow 708 and in fig. 7.

Fig. 8C illustrates a view of the bottom of electrode assembly 800 according to some embodiments. The center 856 of the channel or hole 840 may be disposed at an offset distance from the center of the lower body portion 810. Arrows 852 and 854 together make up the diameter of circular upper body portion 810 through center 856 of passageway or bore 840. In the illustrated embodiment, arrow 852 may be shorter than arrow 854. The channel 840 may be offset from the center of the upper body portion such that when the electrode assembly 800 is rotated, the distal tip of the channel may span a circle on the patient's skin, providing an enlarged area for rubbing against the skin as compared to the channel or aperture 840 that is concentric with the lower body portion 810. The distal tip of the compressible body portion may prepare the surface of the patient's skin.

Fig. 9A-9C illustrate an electrode assembly 900 according to some embodiments, which may include a depressible top surface or button to activate dispensing of a conductive fluid or gel. As shown in fig. 9A, electrode assembly 900 will generally include a lower body portion or base 910, an upper body portion or depressible top surface 912, and one or more at least partially collapsible or compressible body portions 914. The lower body portion 910 may be rigid. The dome of the depressible top surface 912 may be resilient. As shown in fig. 9B, the conductive fluid or gel within the internal reservoir 930 may be pressurized by pressing the depressible top surface 912 in the direction of arrow 917. The internal reservoir 930 may be a resiliently compressible reservoir, optionally having a conical shape, as described above and herein. In some embodiments, when pressure or force is applied along arrows 942 (e.g., from a patient's head pressing against a hard surface or by tightening electrode carrier 700), compressible body portion 914 may collapse, thereby reducing the volume of internal reservoir 930. An increase in pressure or force may cause the fluid or gel to flow along the flow path. When additional pressure is applied to the depressible top surface, the conductive fluid or gel flows outwardly through a channel or aperture 940 formed in the bottom of the compressible body portion 914 so that it can flow onto the patient tissue in contact with the lower surface 944 of the compressible body portion 914.

Once the entire flow path through the channel 940 in the lower surface of the compressible body portion 914 is filled with the conductive fluid or gel, it should be understood that bioelectrical current present in the region of the fluid or gel may be conducted to the conductive tip 918 within the groove, which in turn may be connected to a wire or other conductor present in the backing 704 of the electrical carrier system 700. Attachment of the wire or other conductor to the conductive tip 918 within the slot may be made in a manner that accommodates rotation of the electrode assembly relative to the elongate backing 704, as shown by arrow 708 and fig. 7.

Fig. 9C illustrates a view of the bottom of electrode assembly 900 according to some embodiments. The center 956 of the channel or aperture 940 may be disposed at a distance offset from the center of the lower body portion 910. Arrows 952 and 954 collectively make up the diameter of circular upper body portion 910 through center 956 of channel or bore 940. In the illustrated embodiment, arrow 952 may be shorter than arrow 954. The channel 940 may be offset from the center of the upper body portion such that when the electrode assembly 900 is rotated, the distal tip of the channel may span a circle on the patient's skin, providing an enlarged area for rubbing the skin compared to the channel or hole 940, which is concentric with the lower body portion 910. The distal tip of the compressible body portion may prepare the surface of the patient's skin.

Embodiments of the electrode assemblies 1000, 1100, and 1200 that may be incorporated into the electrode carrier system 700 according to aspects of the present disclosure may include an adapter for an external dispenser of a conductive fluid or gel. The external dispenser may include a syringe, a manually extruded tube, a roll-extruded tube, or the like.

Fig. 10A-10F illustrate an electrode assembly 1000 that may include a threaded interface with an external dispenser of a conductive fluid or gel. Fig. 10A shows an electrode assembly coupled to an external dispenser. Figure 10B shows the electrode assembly decoupled from the external dispenser and the threaded adapter. The electrode assembly 1000 may be removably coupled to an external dispenser 1070, such as a syringe. Electrode assembly 1000 generally includes a lower body portion or base 1010, an upper body portion or cover 1012, and one or more at least partially collapsible or compressible body portions 1014. In the illustrated embodiment, electrode assembly 1000 includes skirt elements 1005 and 1007. The skirt element can distribute forces from the compressible body portion to a wider surface area, which can increase patient comfort. Skirt elements 1005 and 1007 may be coaxial with body portion 1010 of electrode assembly 1000. Skirt elements 1005 and 1007 may constitute a large surface area. Such a surface area may increase contact between the patient's skin and the electrode assembly 1000. Additionally, such a surface area may provide an increased contact area between the conductive fluid or gel and the electrode assembly and/or between the conductive fluid or gel and the patient's skin. In addition, a smaller electrode assembly 1000 profile may reduce acute direct pressure that may be directed from the pillow or bed through, for example, the electrode assembly to the patient's scalp, and may increase patient comfort during use. The skirt element may comprise a flexible material. Additionally or alternatively, a skirt element may secure the electrode assembly 1000 to the electrode carrier system 700. In other embodiments, the skirt element may be removably coupled to the electrode body. In some embodiments, the skirt element may be spring loaded or loaded with a resiliently compressible material relative to the electrode body such that the skirt element may telescope relative to the electrode body. The resiliently compressible material may include thermoplastic elastomers, rubber materials, compressible foams, compressible open-cell foams, silicone-based materials, to name a few.

The external dispenser may include a means to dispense the fluid or gel, such as a plunger 1074, which may be depressed along arrow 1076. In alternative embodiments, other actuation means such as folding, twisting, or squeezing may be utilized to dispense the fluid or gel from the dispenser 1070. In the illustrated embodiment, the dispenser 1070 includes a first surface of the threaded interface 1072 (e.g., a luer fitting) that may be twisted together with a corresponding second surface 1066. The first and second surfaces may include embodiments of adapters that may couple the external dispenser 1070 to the electrode assembly 1000. Other embodiments may include compression fittings, snap fittings, retaining rings, and the like. A second surface of the threaded interface 1066 may be removably coupled to the upper body portion 1012 of the electrode assembly 1000. In an alternative embodiment, the second surface of the threaded interface may be fixed relative to the upper body portion. In some embodiments, the upper body portion 1012 and the nipple 1066 may be separated during manufacture and secured after initial assembly. In an alternative embodiment, the threaded interface 1066 may be removable between uses to enable cleaning of the electrode assembly 1000 via the access aperture 1024, as shown in fig. 10B.

As shown in fig. 10E, the second surface of the threaded interface 1066 may include keying or other mating-type features that facilitate scalp preparation, which may require increased mechanical transmission force directly to the scalp, such as using rotation-based actuation during scalp preparation. Increasing the force directed toward the scalp during scalp preparation may be beneficial when using electrode assemblies having electrode assembly designs with collapsible, compressible or telescoping bottom surfaces that do not typically exert too much force on the scalp of a patient. As shown in fig. 10B, the upper body portion 1012 may include a ridged or textured surface. In some embodiments, the electrode assembly may be used as a knob to allow additional skin preparation actuation and application of force, even when the electrode assembly tool is not being used to collect electrical data.

Fig. 10C illustrates a cut through the electrode assembly 1000 according to some embodiments. As shown in the illustrated embodiment, the upper body portion 1012 and the lower body portion 1010 may be rigid. In the illustrated embodiment, the compressible body portion 1014 can be resilient. The electrode assembly 1000 may include an inner container 1030. The internal reservoir 1030 may comprise a conductive fluid or gel. Optionally, the upper body portion 1012 may include a valve 1020 to allow for external filling and/or refilling of the conductive fluid or gel. The valve 1020 may be integrated with an adapter 1060 that may be coupled with a threaded interface 1066. In some embodiments, the adapter 1060 may be flexible. In an alternative embodiment, the upper body portion may include a restrictor in place of the valve. Additionally or alternatively, the valve 1020 may prevent backflow of the gel when the pressure inside the internal reservoir increases. Valve 1020 may include a duckbill valve, a cross-slot valve, a ball valve, a pinch valve, or the like. The outlet holes 1022 may be open during filling and closed when the external dispenser is removed. The inlet aperture 1024 may be sized and shaped to interface with various external dispensers (e.g., syringes, squeeze tubes, etc.) known to those skilled in the art. In some embodiments, the inlet aperture 1024 may be spring loaded or otherwise provided with a resiliently compressible material such that the outer dispenser needs to be pushed towards the inlet aperture 1024 prior to dispensing the conductive fluid or gel, thereby minimizing the risk of inadvertent dispensing.

The internal reservoir 1030 may be a resiliently compressible reservoir, optionally having a conical shape, as described above and herein. When pressure or force is applied along arrow 1042 (e.g., from the patient's head against a hard surface or by tightening electrode carrier 700), compressible body portion 1014 may collapse, thereby reducing the volume of internal reservoir 1030. When additional pressure is applied, the electrically conductive fluid or gel flows outwardly through the channel or bore 1040 formed in the bottom of the compressible body portion 1014 so that it can flow onto the patient's tissue in contact with the lower surface 1044 of the compressible body portion 1014.

Once the entire flow path through the channel 1040 in the lower surface of the compressible body portion 1014 is filled with an electrically conductive fluid or gel, it should be understood that bioelectrical current present in the region of the fluid or gel may be conducted to the electrically conductive tip 1018 within the groove, which in turn is connected to a wire or other conductor present in the backing 704 of the electrical carrier system 700. Attachment of the wire or other conductor to the conductive tip may be made in a manner that accommodates rotation of the electrode assembly relative to the elongate backing 704, as shown by arrow 708 and fig. 7.

Fig. 10D illustrates a view of the bottom of an electrode assembly 1000 according to some embodiments. The center 1056 of the channel or bore 1040 can be disposed at a distance offset from the center of the lower body portion 1010. Arrows 1052 and 1054 together make up the diameter of circular upper body portion 1012 passing through center 1056 of channel or bore 1040. In the illustrated embodiment, arrow 1052 may be shorter than arrow 1054. The channel 1040 may be offset from the center of the upper body portion such that when the electrode assembly 1000 is rotated, the distal tip of the channel may span a circle on the patient's skin, providing an enlarged area for rubbing against the skin as compared to the channel or aperture 1040, which is concentric with the lower body portion 1010. The distal tip of the compressible body portion may prepare the surface of the patient's skin, for example, by mechanical abrasion.

Fig. 10E illustrates a cut through the electrode assembly 1000 coupled to the outer dispenser 1070 of fig. 10A, according to some embodiments. The external dispenser 1070 may include a reservoir for storing a conductive fluid or gel. The external dispenser 1070 may include an actuator 1074, such as a plunger, which when depressed along arrow 1076, the actuator 1074 may cause a fluid or gel to be dispensed into the reservoir of the electrode assembly 1030.

Fig. 10F illustrates a cut-out of a feedthrough electrode assembly 1000 including an adapter having a threaded interface 1066 according to some embodiments. In some embodiments, the adapter 1060 and the threaded interface 1066 may be integrated into a single component; for example, the adapter 1060 and the threaded interface 1066 may be integrated into a single component; alternatively, adapter 1060 and threaded interface 1066 may be separate components that may be press-fit, glued, or otherwise removably or permanently secured. The outer dispenser 1070 may be removably coupled to the electrode assembly 1000 by rotating about the axis of the threads as shown by arrow 1078. In some embodiments, the electrode assembly 1000 may include an internal separator 1028, which internal separator 1028 may include an open channel 1026 that may more evenly direct the conductive fluid or gel into the reservoir 1030.

Fig. 11A-11C illustrate an electrode assembly 1100 according to some embodiments, which may include a duckbill valve to interface with an external dispenser of an electrically conductive fluid or gel. As shown in fig. 11A, electrode assembly 1100 will generally include a lower body portion or base 1110, an upper body portion or cover 1112, and one or more at least partially collapsible or compressible body portions 1114. The upper body portion 1112 and the lower body portion 1110 may be rigid. In the illustrated embodiment, the compressible body portion 1114 can be resilient. Valve 1120 may allow for repeated filling of the electrode with the conductive gel to counteract evaporation or drying of the gel. In addition, the valve may allow for additional skin preparation after dispensing the gel, which may be beneficial for extended collection and use.

As shown in fig. 11A, the internal reservoir 1130 contains a conductive fluid or gel. Upper body portion 1112 may include a valve 1120 to prevent external filling and/or refilling of the conductive fluid or gel. Additionally or alternatively, the valve 1120 may prevent backflow of the gel when the pressure inside the internal reservoir increases. Valve 1120 may include a duckbill valve, a cross-slit valve, a ball valve, a pinch valve, etc. The outlet aperture 1122 may be open during filling and closed when the external dispenser is removed. The inlet aperture 1124 may be sized and shaped to interface with various external dispensers (e.g., syringes, squeeze tubes, etc.) known to those skilled in the art. In some embodiments, the inlet aperture 1124 may be spring loaded or otherwise provided with a resiliently compressible material such that an outer dispenser needs to be urged towards the inlet aperture 1124 prior to dispensing the conductive fluid or gel, thereby minimizing the risk of inadvertent dispensing.

The internal reservoir 1130 may be a resiliently compressible reservoir, optionally having a conical shape, as described above and herein. When pressure or force is applied along arrow 1142 (e.g., from the patient's head against a hard surface or by tightening the electrode carrier 700), the compressible body portion 1114 may collapse, thereby reducing the volume of the internal reservoir 1130. When additional pressure is applied, the conductive fluid or gel flows outwardly through the channel or hole 1140 formed in the bottom of the compressible body portion 1114 so that it can flow onto the patient's tissue in contact with the lower surface 1144 of the compressible body portion 1114.

Once the entire flow path through the channel 1140 in the lower surface of the compressible body portion 1114 is filled with the conductive fluid or gel, it will be appreciated that the bioelectric current present in the fluid or gel region may be conducted to the conductive tip 1118 within the groove, which in turn is connected to a wire or other conductor present in the backing 704 of the electrical carrier system 700. Attachment of the wire or other conductor to the conductive tip 1118 within the slot may be in a manner to accommodate rotation of the electrode assembly relative to the elongate backing 704, as indicated by arrow 708 and in fig. 7.

Fig. 11C illustrates a view of the bottom of the electrode assembly 1100 according to some embodiments. The center 1156 of the channel or bore 1140 may be disposed at a distance offset from the center of the lower body portion 1110. Arrows 1152 and 1154 collectively make up the diameter of the circular upper body portion 1110 passing through the center 1156 of the channel or bore 1140. In the illustrated embodiment, arrow 1152 may be shorter than arrow 1154. The channel 1140 may be offset from the center of the upper body portion so that the distal tip of the channel may span a circle on the patient's skin as the electrode assembly 1100 is rotated. The distal tip of the compressible body portion may prepare the surface of the patient's skin.

Fig. 12A-12C illustrate an electrode assembly including a scalp preparation disposed on an external dispenser, according to some embodiments. Electrode assembly 1200 may include an external dispenser that may be in direct contact with the scalp of a patient for direct scalp preparation, having a scalp preparation surface and features and a gel delivery. This may reduce the design requirements of the rest of the electrode assembly, which may primarily serve to maintain contact between the electrodes, conductive gel and the scalp. The dispensed electrode gel may be filled and/or refilled as desired. In addition, the electrode material may be less rigid, for example by using a sponge, foam or soft rubber.

As shown in fig. 12A, the electrode assembly 1200 will generally include a lower body portion 1210 and an upper body portion 1212. The upper body portion may include an upper bore 1224 into which an external dispenser 1270 may be inserted. The external dispenser may include a reservoir for storing the electrically conductive fluid or gel and a means for dispensing the fluid or gel, such as a plunger. In alternative embodiments, other actuation means such as folding, twisting or squeezing may be utilized to dispense the fluid or gel from the dispenser 1270. In the illustrated embodiment, the dispenser 1270 may include a first surface of the threaded interface 1272 (e.g., a luer fitting) that may be coupled to the adapter 1260. Adapter 1260 can be slidably inserted into the upper bore on an axis along arrow 1268. Adapter 1260 can additionally include a hole 1264 on the distal tip of the adapter through which the conductive fluid or gel can be dispensed. The distal tip of the adapter may additionally include a scalp preparation surface. Twisting of the adapter along arrow 1269 may actuate the scalp preparer.

Fig. 12B shows the outer dispenser and adapter of fig. 12A after insertion into upper bore 1224, according to some embodiments. The upper aperture may be in fluid communication with the lower aperture 1222. The reservoir of the dispenser may be coupled to a central channel of adapter 1260, which may allow passage of a fluid or gel through bore 1262 of adapter 1260. The lower body portion 1210 can include a bottom surface 1244 that can be electrically conductive. Additionally, the lower body portion can include a cavity or reservoir 1230 that can receive a fluid or gel dispensed through the lower aperture 1222. The increase in pressure from the dispenser may cause the fluid or gel to flow out of the dispenser along a flow path and fill the reservoir. The fluid or gel can flow from the reservoir 1230 outwardly through the bottom of the body portion and can thus flow onto patient tissue in contact with the lower surface 1244. The electrode assembly 1200 may include an electrical tip that is in turn connected to wires or other conductors present in the backing 704 of the electrode carrier system 700. Fig. 12C shows a view of the distal tip of adapter 1260. The distal tip may include a hole 1262 and a scalp preparation member 1264.

Embodiments of the present disclosure provide a device for preparing patient tissue to improve electrical contact. The elongated elements on the distal tips of various embodiments of the electrode assemblies (e.g., the compressible body portions of electrode assemblies 800, 900, 1000, and 1100) can allow electrical contact through the patient's hair present on the scalp. In some embodiments, the elongated elements may include a plurality of protrusions or fingers. Optionally, the elongated element may include a receiving feature for receiving a conductive gel or fluid that has been disposed through the bottom opening. Fig. 13A-16C illustrate embodiments 1300, 1400, 1500, and 1600 of scalp preparers that may be used as individual preparation tools or as examples, embodiments, and variations of compressible body portions of electrode assemblies 800, 900, 1000, and 1200.

The use of a scalp preparation as an aid may allow for a more comfortable electrode assembly for longer wearing, lying use, or more sensitive patients. The scalp preparer of the present disclosure can move relative to the body of the wearable sensor. In some embodiments, scalp preparation may be one or more of rotation, translation, and pivoting relative to the electrode carrier assembly. The scalp preparer can prepare the scalp by removing skin, hair, etc., which may disrupt scalp conduction. In some embodiments, the scalp preparer may include a flexible element to promote patient comfort. Such flexible elements may improve the comfort of the patient for long-term use. In an alternative embodiment, the scalp preparer may include a rigid element. In embodiments where the scalp preparer includes a rigid element, the scalp preparer may be removably placed within the electrode carrier assembly. The scalp preparer may be used to prepare the scalp and then replace it with a more comfortable electrode assembly for long term use.

Fig. 13A-13B illustrate an electrode assembly including a scalp preparation 1300, which scalp preparation 1300 may interface with an external dispenser, according to some embodiments. Optionally, in some embodiments, scalp preparer 1300 is an embodiment of an electrode assembly, which may be integrated into the electrode carrier assembly of the present disclosure. Fig. 13A shows a bottom view of a scalp preparation apparatus including a body 1312 and an elongate element 1314. The elongate element 1314 may be rigid, abrasive, or both rigid and abrasive. In some embodiments, the elongate element 1314 is electrically conductive. In some embodiments, the elongate member 1314 includes an aperture 1340 that can be fluidly coupled to the reservoir. Although the illustrated example shows a single aperture in each elongate element. In alternative embodiments, the elongate element may comprise a plurality of holes. In some embodiments, the elongate element may comprise a porous material and/or a sponge-like material. In embodiments where the elongate element is electrically conductive or comprises an electrically conductive element, the porous material and/or the sponge-like material may increase the contact surface area between the gel and the electrode to increase electrical contact. The reservoir may contain a conductive fluid or gel. Such a reservoir may be internal to the scalp preparer, however, in alternative embodiments, the conductive fluid or gel may be contained in an external dispenser, such as those described herein with respect to fig. 10A-10E, 11A-11C, 12A-12C, and 13A-13B. As disclosed elsewhere herein, the conductive fluid or gel may be at least partially abrasive and/or include abrasive components.

Fig. 13B shows a top view of an electrode assembly including a scalp preparer 1300. The scalp preparer 1300 may include an inlet aperture 1324. The inlet aperture 1324 may be sized and shaped to interface with a variety of external dispensers known to those skilled in the art, such as syringes, squeeze tubes, and the like. Fig. 13B also shows a carrier 1380 for the assembly 1300. The carrier 1380 may be removably coupled to the electrode carrier assembly and the scalp preparer. The carrier 1380 includes a slot 1382. The elongate element 1314 may be received by a slot or template element 1382. The slots may allow embodiments of the scalp preparer to rotate relative to a carrier, which may optionally be fixed relative to the electrode carrier assembly. In some embodiments, the inlet aperture 1324 may be spring-loaded or otherwise provided with a resiliently compressible material such that the outer dispenser needs to be pushed towards the inlet aperture 1324 prior to dispensing the conductive fluid or gel, thereby minimizing the risk of inadvertent dispensing.

Fig. 14 illustrates an electrode assembly including a scalp preparer 1400 that can interface with an external dispenser having a skin preparation surface, according to some embodiments. Optionally, in some embodiments, scalp preparer 1400 is an embodiment of an electrode assembly, which may be integrated into the electrode carrier assembly of the present disclosure. Fig. 14 shows a bottom view of the scalp preparer including a body 1412 and a distal tip of an external dispenser 1464. The distal tip 1464 may include embodiments, variations, or examples of an external dispenser that includes the scalp preparation surface of fig. 12A-12C. The body 1412 may optionally include a reservoir that may contain a conductive fluid or gel. Such a reservoir may be internal to the scalp preparer, however, in alternative embodiments, the electrically conductive fluid or gel may be contained in an external dispenser, such as those described herein with respect to fig. 10A-10E, 11A-11C, 12A-12C, and 13A-13B.

In some embodiments, scalp preparer 1400 includes a base 1420. The base 1420 may include elongated elements 1414. Elongated elements 1414 may be rigid, abrasive, or both rigid and abrasive. In some embodiments, elongated elements 1414 are electrically conductive. In some embodiments, elongate element 1414 includes a hole 1440, and hole 1440 can be fluidly coupled to a reservoir. Although the illustrated example shows a single aperture in each elongate element. In alternative embodiments, the elongate element may comprise a plurality of holes. In some embodiments, the elongate element may comprise a porous material and/or a sponge-like material. In embodiments where the elongate element is electrically conductive or comprises an electrically conductive element, the porous material and/or the sponge-like material may increase the contact surface area between the gel and the electrode to increase electrical contact. In some embodiments, the body 1412 rotates while the base 1420 moves. In an alternative embodiment, the body 1412 moves while the base 1420 is stationary. In some embodiments, the two elements move together.

Fig. 15 illustrates an electrode assembly including a scalp preparation 1500, according to some embodiments, which scalp preparation 1500 may interface with an external abrasive element. Optionally, in some embodiments, scalp preparer 1500 is an embodiment of an electrode assembly, which may be integrated into an electrode carrier assembly of the present disclosure, such as carrier assembly 700. In some embodiments, scalp preparer 1500 includes a bottom 1520. The bottom 1520 may include an elongate element 1514. The elongate element 1514 may be rigid, abrasive, or both rigid and abrasive. In some embodiments, the elongate element 1514 is electrically conductive. In some embodiments, the elongate member 1514 includes a bore 1540, which bore 1540 can be fluidly coupled to a reservoir. Although the illustrated example shows a single aperture in each elongate element. In alternative embodiments, the elongate element may comprise a plurality of holes. In some embodiments, the elongate element may comprise a porous material and/or a sponge-like material. In embodiments where the elongate element is electrically conductive or comprises an electrically conductive element, the porous material and/or the sponge-like material may increase the contact surface area between the gel and the electrode to increase electrical contact. In some embodiments, the outer abrasive element 1590 rotates while the bottom 1520 moves. The outer abrasive element can move relative to the base as indicated by arrow 1594. In an alternative embodiment, the outer abrasive element 1590 is moved while the bottom 1520 is fixed. In such an embodiment, the base may move as indicated by arrow 1596. In some embodiments, the two elements move together. As disclosed elsewhere herein, the conductive fluid or gel may be at least partially abrasive and/or include abrasive components.

Fig. 16A-16C illustrate an electrode assembly 1600 including an adjustable structure that may additionally include a scalp preparation element, according to some embodiments. Optionally, in some embodiments, electrode assembly 1600 may be integrated into an electrode carrier assembly of the present disclosure. Electrode assembly 1600 may include structures, which may be external or internal, that may reduce direct forces that may be transmitted to the patient's scalp through the electrode body and its distal features. The adjustable structure may increase patient comfort. The adjustable structure may include a configuration that applies a variable or constant force, which may be spring loaded, loaded with a resilient compressible material (e.g., thermoplastic elastomers, rubber materials, compressible foams, compressible open-cell foams, silicone-based materials, to name a few) that may act like a spring, and/or may be mechanically adjustable. The adjustment may accommodate different head and hair types, while allowing for proper skin preparation, fluid or gel application, and signal acquisition.

Fig. 16A illustrates an exterior view electrode assembly 1600 in a raised position according to some embodiments. Electrode assembly 1600 includes an upper body portion 1612, a lower body portion 1620, and a plurality of elongate elements 1614 connected to the lower body portion. Electrode assembly 1600 also includes a housing 1610 that is configured to slidably move from a raised position to a lowered position relative to body portions 1612 and 1620. The electrode assembly may include a locking device (e.g., a latch) to secure the housing relative to the body portion. In the illustrated embodiment, two positions are shown, however, optionally the position of the housing may be continuously adjusted relative to the body. Additionally, in some embodiments, the housing may include a skirt element 1605. The skirt element may distribute forces from the compressible body part to a wider surface area, which may increase patient comfort. The skirt element may comprise a flexible material. Optionally, the skirt element may be removably coupled to the housing of the electrode assembly 1600. In some embodiments, the skirt element may be spring loaded or loaded with a resiliently compressible material relative to the electrode assembly 1600 such that the skirt element may telescope relative to the electrode assembly 1600. The resiliently compressible material may include thermoplastic elastomers, rubber materials, compressible foams, compressible open-cell foams, silicone-based materials, to name a few.

Fig. 16B and 16C illustrate an electrode assembly 1600 in a lowered position and a raised position, respectively, according to some embodiments. In the illustrated embodiment, the upper body portion may include an internal stop to limit the range in which the body portion may be raised and lowered. The body portion and the housing may be secured by a twist lock or may not include a locking feature. The upper body portion 1612 may include an inlet hole 1624 that may be coupled to an external dispenser of the present disclosure to allow for external filling and/or refilling of the conductive fluid or gel. Optionally, the electrode assembly 1600 may include a container that may store a conductive fluid or gel. When pressure is applied, for example from an external dispenser, the electrically conductive fluid may flow outwardly through channels or apertures formed in the bottom of the electrode assembly. In some embodiments, elongate element 1614 includes holes 1640 to allow for conductive fluid, however, holes may be present elsewhere on the bottom surface of electrode assembly 1600. When additional pressure is applied, the conductive fluid or gel may flow onto the patient tissue in contact with the bottom of the electrode assembly. Once the entire flow path is filled with a conductive fluid or gel, the current can be conducted to the end on the electrode assembly, which in turn is connected to a wire or other conductor present at the backing of the electrode carrier system 700.

In a further embodiment, the electrode carrier system may be configured as a headband, as shown in fig. 17, and fitted on the patient P. The electrode carrier system is in electrical communication with a controller and/or output device 1718 via leads 1716. In other variations, the device 1718 may also be wirelessly coupled. Electrode assembly 14 may include any of the electrode assembly variations described herein, as well as any number of combinations, if desired. In the embodiment shown in fig. 17, the headband backing 12 may also incorporate one or more fiducial markers 1710A, 1710B that allow visual tracking of these markers 1710A, 1710B within the field of view of the camera or other optical imager 1716. The markers 1710A, 1710B may include any visual indicator, shown in this variation as a high contrast print pattern having a particular shape, as shown. In other variations, fiducial markers 1710A, 1710B may include an arrangement of lights, such as LEDs.

Although two markers are shown as an example, additional markers may be further distributed around the circumference of the backing 12 to allow more precise tracking, for example, to allow tracking when the patient's head H may be rotated in a manner that obscures one of the markers. As noted, during use of the electrode carrier system 10, a camera or other optical imager 1716, such as a digital camera, may be positioned near the patient P such that the electrode carrier system 10 and the markers 1710A, 1710B remain within the field of view 1718 of the imager 1716. Although a single imager 1716 is shown in this example, additional imagers located at different positions may also be used in combination to help ensure that the electrode carrier system 10 and markers 1710A, 1710B remain in the field of view 1718 at all times. In addition, the imager 116 may optionally be motorized with pan and tilt capabilities to ensure that the patient P remains in the field of view 1718 of the imager 1716.

Where the electrode carrier system 10 is electrically coupled to the controller and/or output device 1718, the imager 1716 may also be connected to the controller and/or output device 1718 by a wire or another communication link 1720 or to a second controller and/or output device by wired or wireless communication. In this manner, the controller 1718 can be further programmed with computer vision algorithms to identify the position and orientation of the patient's head H so that the controller can receive marker information from the imager 1716 to determine patient movement in real time. This information can then be used for artifact rejection and diagnostic purposes. For example, visual tracking of markers 1710A, 1710B may be used to determine or confirm whether patient P is experiencing convulsive episodes, and in particular whether the detected brain signals of the patient are sonicated (sonified).

In yet another variation, instead of visual markers, the electrode carrier system 10 may incorporate one or more accelerometers 1810 attached within or along the backing 12, as shown in fig. 18. The one or more accelerometers 1810 may include a tri-axial accelerometer device that is sensitive enough to detect movement of the patient's head. This data may be transmitted via lead 1816 to a controller and/or output device 1818 for processing to determine patient motion and motion artifact rejection. If the detected acceleration exceeds a predetermined threshold, this may be an indicator to the controller, i.e. these motion artifacts may be excluded from consideration to prevent inclusion of artifact noise from other detected data.

The electrode carrier system 10 may be used with any combination of electrodes described herein, such as described with respect to fig. 8A-13C, and may also be used with any combination of optical motion detection or accelerometer monitoring. In other variations, optical motion detection and accelerometer monitoring may be used in combination, if desired.

The present disclosure provides methods of continuously monitoring a subject using the electrode carrier systems and electrode assemblies described herein. Such methods may include placing an electrode-carrier assembly near the skin of a patient, the electrode-carrier assembly including one or more electrode assemblies and optionally a scalp preparer. The method may include accommodating movement of the electrode assembly relative to the electrode carrier system to remove one or more of hair or skin. Optionally, the method of use can accommodate the movement of a scalp preparation device, which can be an auxiliary tool or integrated into the electrode assembly. The method of use may include dispensing a conductive fluid or gel onto the skin of a patient. Dispensing the electrically conductive fluid or gel may optionally include using an external dispenser. The conductive fluid or gel may further be at least partially abrasive. The method of use may include collecting the electrical signal, for example, as part of one or more of an EEG sensor, an EKG sensor, or an EMG sensor. The method may comprise continuously monitoring the subject for a period of time, which may be 1 second, 10 seconds, 30 seconds, 1 minute, 10 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, 1 day, 3 days, 1 week, 2 weeks, 1 month, 6 months, 1 year, and optionally a period defined by a range between any two of the above values.

While preferred embodiments of the present invention have been shown and described herein, it will be readily understood by those skilled in the art that these embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.