ADDRESSABLE ELECTRODE ARRAY SYSTEMS, DEVICES AND METHODS

FIELD OF THE DISCLOSURE

The present invention relates to addressing electrodes within a body-worn electrode array and, in particular, in relation to functional electrical stimulation (FES) devices.

BACKGROUND

Functional electrical stimulation (FES) is a popular technique for delivering electrical pulses to generate muscle contractions. FES is used for a number of different indications related to muscular atrophy and motor disorders.

Pathologies of the neuromuscular system due to disease or trauma to the central nervous system, such as stroke, spinal cord injury, head injury, cerebral palsy, and multiple sclerosis, can impede proper functioning of the upper and lower limbs.

Typical FES systems use self-adhering surface electrodes to deliver the pulses and some devices are garment-based where the electrodes are embedded in clothing or in wearable fabric pieces like sleeves or cuffs. Such systems typically provide the wearable component with a receptacle element into which a plug is connected for delivering electrical pulses to the electrodes within the wearable component. The pulse generator includes components that allow for modulation of the pulses as well as switching to address specific electrodes within the wearable component which includes multiple electrodes. Some systems include no switching mechanism and simply provide for statically addressed electrodes, each electrode being wired to a single output channel of the pulse generator.

Although growing clinical evidence shows that FES, and in particular home-based, patient- directed FES, is effective for motor rehabilitation of stroke or brain injury patients, much room remains for the wide adoption of FES as a patient-directed therapy. Prior art FES devices require knowledge of where to place the electrodes and bimanual dexterity for their operation, which are limited in most neurological patients. Moreover, the complexity of use of existing systems deters physical therapists and physicians from using and prescribing FES for home-use.

Stroke or traumatic brain injury often result in arm and hand impairment on one side of the body, on which the patient-directed FES is applied. In the context of a wearable electrode system for patient-directed motor rehabilitation, it is crucial for a patient to be able to don the system with the contralateral, unaffected hand. In addition, it is important for the therapist to position the electrodes based on the morphology and physiologic condition of each patient, to stimulate the correct muscles or nerves involved in therapy. Prior art wearable FES devices failed to deliver high usability for both donning with one hand by the patient and precise positioning of electrodes by the therapist. In the context of home use, the position of the electrodes with respect to anatomical landmarks should be retained for the duration of the therapy, typically several weeks.

For example, the Innovo® from Atlantic Therapeutics™ provides a lower- trunk garment with an array of electrodes, each electrode having a lead wire to a connector built into the waist of the garment. The pulse generator is then plugged into the connector. Upon activation, the pulse generator addresses pulses to individual electrodes. The Innovo® is a single-purpose device for treating incontinence. The static addressing of electrodes at the pulse generator is highly efficient for that purpose. The Innovo® is not useful, however, for other treatments. The position and the size of the electrodes is fixed by design, i.e., the electrodes are screen-printed onto the inner surface of the garment. Given the targeted muscles and the large size of the electrodes, the stimulation efficacy of the device is not sensitive to slight movements of the electrodes compared to anatomic landmarks.

The Fesia Grasp® from Fesia Technology™ described in European patent publication 3650077A1 provides a stimulation device for the forearm with an array of electrodes, each electrode having a lead wire to a receptacle built into the garment. This arrangement limits the available density of electrodes. The pulse generator is then plugged into the receptacle. Upon activation, the pulse generator addresses pulses to individual electrodes and then delivers the addressed pulses to the electrodes in sequence. The Fesia Grasp® is designed to provide flexion and extension of the wrist and fingers. The therapist can select which electrode to activate using a tablet computer program. However, the therapist setting up the device does not have direct visual cues of the activated stimulation areas and needs to monitor both the screen of the tablet computer and the movements of the patient to adjust the position of stimulation areas through trial and error. This can be especially challenging for therapists that are not familiar with technology and may also require a significant amount of time to setup the device even for therapists that are familiar with technology.

The FES garment described in Moineau, et al., Garments for functional electrical stimulation: Design and proofs of concept; J. of Rehab, and Assistive Tech. Eng., 6, 1-15 (2019) (available at https://d0i.0rg/l 0.1177/2055668319854340) includes conductive textile electrodes for stimulating the forearm, upper arm, and shoulder. However, the shape and relative position of each stimulation area is fixed by design and cannot be adjusted once the garment has been donned. This and other similar prior art devices present would require different sizes, versions, etc. for different patients. Accordingly, the manufacturing process is more costly due to the numerous various versions required for virtually custom fitting for a patient of the device, including different combinations of wearable’s size, electrodes placement within the wearable, electrodes’ sizes each depending on the patient size and condition. Moreover, the selected electrode lead wires make it impractical for use outside of a laboratory proof- of- concept.

U.S. Patent 4,239,046 to Ong describes an electrode arrangement that uses hook-and-loop fasteners to attach lead wires to a conductive substrate. However, the arrangement is limited to a single electrode and lead wire. The arrangement must be placed at the area of stimulation and, if misplaced, the entire electrode must be displaced to stimulate another area on the skin of a patient.

SUMMARY OF SOME OF THE EMBODIMENTS

The background art does not teach or suggest an addressable body-worn electrode array that supports easy and consistent positioning of the array portion selected (i.e., electrode array active area) by the therapist. The background art also does not teach or suggest an addressable body-worn electrode array in which the electrode array active area retains its positioning during therapy. The background art also does not teach or suggest a device, such as a garment for example, comprising the addressable body-worn electrode array which is easy for a patient to don, preferably by using a single hand. The background art also does not teach or suggest such a device in which the electrode array active area retains its positioning during multiple therapeutic sessions over a period of time.

The present invention solves several issues of prior art devices and provides: i) configuration of the active electrodes position and size by a therapist, with the configuration being retained for the duration of the therapy; ii) ease of electrode configuration by the therapist, enabled to relocate multiple times the electrode array active area while the garment is worn by the patient; iii) high usability when a patient dons the system with a single hand; iv) high density electrode array, where the size of the electrode array active area can be easily modified to address very fine to very large muscle groups.

Without wishing to be limited to a closed list, the electrode array active area retains its positioning during multiple therapeutic sessions over a period of time, which may comprise, for example and without limitation, a period of minutes, hours, days, weeks and/or months, or any value in between.

The present invention allows for the addressing of electrodes by way of a movable conductive addressing pad. A single lead wire runs from the pulse generator to the addressing pad which conducts the stimulation pulse to the electrodes to which it is applied within an array of electrodes. The addressing pad is optionally reversibly connected to the lead wire, for example through a snap connector.

The addressing pad is shaped according to the needs of the user. Interchangeable addressing pads of differing shapes can be used to address a variety of electrode patterns within the array and a variety of electrodes. The addressing pad can include a fastening element so that its placement over the electrode array is secured. In some cases, the fastening element can be integral to the addressing pad. For example, the addressing pad can include one or more conductive hook-and- loop fastening elements.

According to at least some embodiments, there is provided a system for an addressable body-worn electrode array, comprising a plurality of electrodes in the array, adapted to support easy electrical therapy through a consistent positioning of the electrodes by the therapist that is retained during therapy. Optionally the system further comprises an apparel device for being worn on the body, wherein the apparel device comprises the electrode array and a plurality of addressing pads, wherein placement of the addressing pads determines positioning of active electrodes.

Optionally the electrode array further comprises a substrate that is at least one of flexible and stretchable for attaching, embedding or integrally forming the electrodes. Optionally the electrodes comprise a plurality of electrically conductive patches, wherein the electrically conductive patches are arranged along one side of the substrate. Optionally the system further comprises a plurality of selection patches, wherein the selection patches are arranged along an opposing side of the substrate from the electrodes. Optionally the electrode array features a single array with a plurality of addressing pads. Optionally the electrode array comprises a plurality of electrode arrays, each array having at least one addressing pad. Optionally the electrode array further comprises a lead junction for enabling electrical flow.

Optionally the electrode array further comprises a movable addressing pad for positioning a stimulation area comprising the active electrodes. Optionally the movable addressing pad comprises a conductive pad head connected to a first end of an electrically conductive wire, and a snap connector connected to a second end of the wire. Optionally the snap connector is in electrical contact with the lead junction. Optionally the apparel device further comprises a flexible outer material. Optionally the apparel device further comprises an insulating cover for insulating an external side of the apparel device.

Optionally the apparel device further comprises a frame for supporting placement of the electrode array against a portion of the body. Optionally the frame supports placement of the electrode array against a portion of an arm. Optionally the electrodes comprise a printable conductive material. Optionally the printable conductive material comprises a silver material in an appropriate solvent. Optionally the electrodes comprise an elastomer loaded with conductive particles.

Optionally the elastomer is selected from the group consisting of polyurethane, silicone, butyl rubber, neoprene, nitrile rubber or similar polymer. Optionally the conductive particles comprise a material selected from the group consisting of carbon, silver, copper, gold, platinum, platinumiridium alloy, indium tin oxide, carbon nanotubes, graphene, and the like. Optionally the electrodes comprise a conductive textile. Optionally the conductive textile comprises one or more of silver- coated fabric, copper-coated fabric, stainless-steel fabric, of hydrogels, or of multilayer materials made of hydrogel layers and conductive composite or conductive textile layers. Optionally the electrodes have a square surface area.

Optionally the electrodes have a surface area selected from the group consisting of triangular, circular, rectangular and ovular. Optionally the electrically conductive electrodes retain their positioning during multiple therapeutic sessions over a period of time, comprising a period of minutes, hours, days, weeks and/or months, or any value in between. Optionally a position of the electrode array and the addressing pads is retained. Optionally the position is fixedly retained.

According to at least some embodiments, there is provided a method for manufacturing a device as described herein, comprising providing electrodes and electrically conductive tracks on one side of a flexible substrate and providing selection patches on another side of the substrate; and electrically connecting the surface area of each pair of an electrode and a selection patch with a connective material. Optionally the providing the electrodes and the electrically conductive tracks comprises printing a conductive material on the substrate. Optionally providing the selection patches comprises printing a conductive material on the substrate. Optionally the electrically connecting the pair comprises sewing through the surface area of each pair of an electrode and a selection patch with conductive thread, and through the substrate, such that the conductive thread conductively connects the pair.

Optionally the electrically connecting the pair comprises applying a metallic staple to each pair of an electrode and a selection patch. According to at least some embodiments, the method further comprises applying insulating portions to define a surface area of the electrodes and the selection patches.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting.

Various embodiments of the methods, systems and apparatuses of the present disclosure can be implemented by hardware and/or by software or a combination thereof. For example, as hardware, selected steps of methodology according to some embodiments can be implemented as a chip and/or a circuit. As software, selected steps of the methodology (e.g., according to some embodiments of the disclosure) can be implemented as a plurality of software instructions being executed by a computer (e.g., using any suitable operating system). Accordingly, in some embodiments, selected steps of methods, systems and/or apparatuses of the present disclosure can be performed by a processor (e.g., executing an application and/or a plurality of instructions).

Although embodiments of the present disclosure are described with regard to a “computer,” and/or with respect to a “computer network,” it should be noted that optionally any device featuring a processor and the ability to execute one or more instructions is within the scope of the disclosure, such as may be referred to herein as simply a computer or a computational device and which includes (but not limited to) any type of personal computer (PC), a server, a cellular telephone, an IP telephone, a smartphone or other type of mobile computational device, a PDA (personal digital assistant), a thin client, a smartwatch, head mounted display or other wearable that is able to communicate wired or wirelessly with a local or remote device. To this end, any two or more of such devices in communication with each other may comprise a “computer network.”

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that particulars shown are by way of example and for purposes of illustrative discussion of the various embodiments of the present disclosure only and are presented in order to provide what is believed to be a useful and readily understood description of the principles and conceptual aspects of the various embodiments of inventions disclosed therein.

Figure 1 illustrates a schematic for an addressable electrode array as viewed from the skin side in accordance with embodiments.

Figure 2 illustrates a schematic for an addressable electrode array as viewed from the top in accordance with embodiments.

Figure 3 illustrates a side-view schematic of an addressable electrode array in accordance with embodiments. Figure 4A and Figure 4B illustrate side-view schematics of a portion of an addressable electrode array in accordance with embodiments.

Figure 5 illustrates an arrangement of sleeves in accordance with embodiments.

Figure 6A illustrates a method for manufacturing.

Figures 6B-6E illustrate side-view schematics of an addressable electrode array during manufacturing steps in accordance with embodiments.

Figure 7 illustrates a schematic for a 6x5 addressable electrode array as viewed from the bottom in accordance with embodiments.

Figure 8 illustrates a schematic for a pseudo-circular addressable electrode array as viewed from the bottom in accordance with embodiments.

Figure 9 illustrates a schematic for an addressable electrode array having varying sizes of electrodes as viewed from the bottom in accordance with embodiments.

Figure 10 illustrates a schematic for an addressable electrode array and replaceable addressing pads as viewed from the top in accordance with embodiments.

Figures 11A-11E illustrate various addressing pads patterns in accordance with embodiments.

Figure 12 illustrates an exemplary, non-limiting method for use of an exemplary device as described herein for therapy.

Figure 13 shows manufacturing steps for manufacturing an addressable electrode array in accordance with embodiments.

Figures 14A-14E relate to a device manufactured according to the method in Figure 13, assembled in stages.

Figure 15 shows a non-limiting, exemplary method for applying the device to a subject. DETAILED DESCRIPTION OF SOME OF THE EMBODIMENTS

Figure 1 illustrates a schematic for an addressable electrode array as viewed from the bottom, or the side to be in contact with the skin, in accordance with embodiments. Figure 2 illustrates a schematic for an addressable electrode array as viewed from the opposite side in accordance with embodiments. Figure 3, meanwhile, illustrates a side-view schematic of an addressable electrode array device in accordance with embodiments. The Figure 1 schematic corresponds to the bottom plane of the schematic in Figure 3 while the Figure 2 schematic corresponds to the top plane of the schematic in Figure 3. Returning now to Figure 1, a substrate 102 is included which in preferred embodiments is made of a flexible or stretchable fabric. An insulation 106 is layered above the substrate 102 and in which electrodes 108 are embedded. In some preferred embodiments, the insulation 106 is composed primarily or entirely of polyurethane. The insulation 106 can be composed of or include other materials including silicone, butyl rubber, neoprene, nitrile rubber and the like. The thickness of the insulation 106 is preferably between 1 pm and 1mm. In preferred embodiments, the insulation 106 has substantially the same conformability and stretchability as the substrate 102. The electrode 108 and insulation 106 stack are preferably less stiff than the substrate to keep at least the same range of flexibility as the substrate 102. The distance between electrodes is preferably between 0.1 mm and 10 mm.

Surrounding the insulation 106 is a nonconductive threading 104 that is sewn through to the opposing side, as further illustrated in Figure 3. The nonconductive threading 104, as will be discussed further in connection with Figure 2, attaches a hook-and-loop face, a zipper, a series of snaps or buttons or any other type of fastening mechanism known in the art to the opposing side. A conductive threading 110 is sewn through each electrode 108 to the opposing side, as further illustrated in Figure 3. The conductive threading 110 can be of silver-coated polyamide or polyester, copper-coated polyamide or polyester, gold-coated polyamide or polyester, stainless steel, or other appropriate fabric or threading. Conductive threading 110 preferably has a linear resistance between 1 and 1000 Q/m. The array shown includes nine electrodes 108. An electrode 108 may comprise an elastomer loaded with conductive particles. The elastomer can be polyurethane, silicone, butyl rubber, neoprene, nitrile rubber or similar polymer. The conductive particles can include carbon, silver, copper, gold, platinum, platinum-iridium alloy, indium tin oxide, carbon nanotubes, graphene, and the like. An electrode 108 may also be made of conductive textile including silver-coated fabric, copper- coated fabric, stainless-steel fabric, of hydrogels, or of multilayer materials made of hydrogel layers and conductive composite or conductive textile layers. Electrode 108 may comprise a silver ink or other conductive ink, for example a silver ink comprising silver and acetate as solvent.

Electrodes 108 can be of various shapes such as circular, ovular, polygonal with three or more sides, e.g., triangles, rectangles, hexagon, etc., and can be arranged in various patterns to form an array (e.g., matrix, honeycomb, etc.). Preferably, where the array includes multiple electrodes, the pattern arrangement is dense. This can allow for more precise activation of electrodes within the array. Each array or group of electrodes can include two or more electrodes. The area of an individual electrode is preferably between at least 5 mm ² and 100 mm ² . The area of an electrode array active area (i.e., the area that encompasses the electrodes that are selected or addressed via the addressing pad) thus preferably has an area lower bound of at least about one 5 mm ² area and, similarly, preferably has an area upper bound of the complete electrode array. The area of an addressing pad likewise preferably has the same or similar bounds. In some embodiments the array of electrodes in the device can be of different sizes and dimensions and, thus, the bounds of the electrode array active area can be smaller.

Without wishing to be limited by a closed list, important determining factors for the area of the electrode include the size of the muscle group targeted and also the desired accuracy. Smaller electrode sizes may provide greater density and hence an increased potential accuracy. In cases where a larger muscle area is targeted there may be larger electrodes toward the center of the electrode array and smaller electrodes away from the center for example. Smaller electrodes and addressing pads/el ectrode array active areas are preferably used in devices targeting smaller areas, e.g., the hand, while the larger electrodes and addressing pads/el ectrode array active areas are preferably used in devices targeting larger muscle areas, e.g., upper arm, upper leg.

The above dimension bounds apply regardless of shape of the electrode. That is, whether square or non-square, an electrode preferably has at least a 5 mm central line (i.e., line through the center point) at its narrowest. For example, circular electrodes preferably have a diameter of at least 5 mm, ovular electrodes preferably have a minor axis of 5 mm, and hexagons preferably have a central line of 5 mm at its narrowest. The above dimensions are preferable in most embodiments but dimensions outside the discussed ranges can be used depending on the circumstances in accordance with embodiments of the invention, including electrodes having dimensions smaller than 5 mm x 5 mm. In prior art devices, smaller electrodes are impractical and, in some cases, dangerous because current would be directed to such a small area. For example, a user may experience burning with small electrodes. In some embodiments of the present invention, however, addressing pads can be larger than individual electrodes so that larger areas are targeted and, thus, those limitations in the prior art are obviated. Examples of such larger addressing pads is discussed further in connection with Figure 9. It should also be understood that in some embodiments the area covered by the electrode array active area is only substantially equal to the area covered by the addressing pad and in some embodiments it can differ significantly. In some cases, the addressing pad can be larger, for example to allow for a fastener on the addressing pad that extends beyond the electrode array active area, or smaller. Preferably, the addressing pad shape and area are substantially similar to the electrodes array active array to assist the user in addressing the proper electrodes.

The total size of the electrode array in the device and the size of the electrode array active area in each instance will depend on the use case. That is, the size of the user and the treatment to be performed, among other factors, will determine the most appropriate electrode active area size, dimensions and shape. For example, an electrode array to be used on large muscles of the upper arm or upper leg typically will be larger than arrays and electrode array active areas intended for use on the lower arm or lower leg, respectively. As noted above, a wearable electrode array device for a small muscle group (e.g., hand muscles) can use a smaller electrode and smaller electrode array active area such as 2 x 2 electrode array active area having 5 mm x 5 mm electrodes. Optionally an addressing pad of about 19x19mm ² may be used to active one electrode, for example to electrically treat a single finger extension. An addressing pad of 50x85mm ² , for example, may be used to cover an array of 3x5 electrodes, for electrically treating triceps or biceps in larger subjects.

Also optionally, as described with regard to Figures 13-15 below, an electrode array may comprise a plurality of fixed electrodes, which are activated upon electrical contact with a movable, removable, addressable pad. The addressable pad may be in contact with one electrode or a plurality of electrodes. Any of the materials, components and/or embodiments described herein may be applied to the device as described with regard to Figures 13-16 below.

Regardless of the size of the electrode array active area (i.e., the area that encompasses the electrodes that are selected or addressed via the addressing pad) or the number of electrodes within it, the electrode array active area includes only some of the electrodes that that could be addressed by changing the location of the addressing pad. For example, in a wearable electrode array device for the hand, the number of electrodes in the device may comprise a plurality of electrodes, preferably ranging from 2 x 2 electrodes to the number of electrodes required to encompass the surface area of the device plus spacing between the electrodes. For larger muscle areas, such as the upper arm or upper leg, preferred embodiments include a larger electrode array active area, or addressing pad, for example, 3 cm x 4 cm or 5 cm x 5 cm active area with larger electrodes and/or a larger addressing pad, for example, 2.5 cm x 2.5 cm. A 4-electrode array of this size would be preferable for large muscle groups for most users in most cases. In some embodiments, the total area of an electrode array can be up to the total surface area of the targeted muscles. For example, the electrode array of a device targeting the upper arm typically would have a surface area around 450 cm ² with an electrode array active area surface area around 225 cm ² (about 15 cm x 15 cm for a square-shaped electrode array active area). However, again, the size of the respective surface areas depends on the size of user and the use case. Similarly, the pattern of the electrode array and the electrode array active area/addressing pad preferably are suited to the intended use of that electrode array.

Returning to Figure 1, a skin-side lead junction 120 is insulated by way of insulation 106 from the electrodes in the substrate. Unlike in much of the prior art, each electrode is insulated and unconnected to any lead wiring through the substrate. Lead junction 120 is enclosed by an insulation patch 114 to protect it from exposure because the lead junction is conductive. From lead junction 120 is an insulated lead wire 116 to a pulse generator which is not shown in the figure. The lead wire 116 is enclosed in wire insulation 118. Wire insulation 118 may be of the same materials as the insulation 106, for example by being screen-printed together with the other materials. The pulse generator can be any known pulse generator. In preferred embodiments, however, the pulse generator is a transcutaneous electrical stimulation device, such as the Intento PRO pulse generator or RehaStim 2® (Hasomed™), Rehab X2® (Cefar™), or AvivaStim® (Saebo™).

Turning now to Figure 2, an illustrative schematic of the opposing side of the addressable electrode array in accordance with embodiments is shown. Surrounding the electrode array is a fastening perimeter 216. Fastening perimeter 216 allows a cover flap (not shown) to be placed over the electrode array to protect and insulate any of the exposed conductive elements while in use. Fastening perimeter 216 can be hook-and-loop, zipper, a series of snaps or buttons or any other type of fastening mechanism known in the art. In the embodiment illustrated, a hook-and-loop fastener is used and is sewn around the perimeter of the electrode array with nonconductive threading 104. In the embodiments shown in Figure 3, nonconductive threading 104 penetrates the entire thickness of the conductive and insulating layers. Conductive selection patches 206 are conductively connected to the electrodes 108 on the opposing side via conductive threading 110. In preferred embodiments, addressing pad 204 use a reversible fastening technology to attach to the conductive selection patches 206 so that detachment is made simple and the conductive addressing pad 204 can be repeatedly attached and detached. The preferred fastening technology is hook-and-loop but could also include magnet, reusable adhesives, zipper, snap, through- fastener (e.g., button, lacing, or other fastening device that fastens through the material). The fastening component provides the conductivity in preferred embodiments. In some cases, however, the conductive selection patch 206 can include a non- conductive fastener and a separate conductive component or material attached to or integral with the conductive selection patch 206 and that maintains contact with the electrode array during use. A combination of conductive and nonconductive fastening components can be used as well. An example of a preferred conductive selection patch 206 is Conductive Hooks and Loops from Kitronik Ltd.

Conductive selection patches 206 preferably have a linear resistance of 1 Q/cm for a 2.5 cm wide strip and are preferably made of silver-coated plastic and/or of a printable material, such as silver in a suitable solvent for example. A linear resistance of less than 5 Q/cm for a 2.5 cm wide strip would be acceptable. A lead junction 210 is conductively connected to skin-side lead junction 120 via conductive threading 112. As described in embodiments herein, in addition to, or as a replacement for, such conductive threading, optionally another conductive means through the fabric thickness may be employed, including but not limited to a metallic snap connector, as described with regard to Figures 13-15 for example.

A lead wire 214 is run from the lead junction 210 to an addressing pad 204 which is applied to one or multiple conductive selection patches 206. In addition to, or in replacement for, such a lead wire, optionally a screen-printed conductive track may be employed, including but not limited to such a screen-printed conductive track featuring an insulating layer on one side and bonded on fabric on the other side, as described with regard to Figures 13-15 for example. Furthermore, such a lead wire may be permanently or temporarily connected to the junction. For a temporary, removable connection, a snap connector or other conductive fastener may be employed, as described with regard to Figures 13-15 for example.

The conductive fastener 302 of the addressing pad 204 shown in Figure 3 that is applied to conductive selection patches 206 is made from an electrically conductive material which is connected to lead wire 214, preferably electrically and mechanically. In some embodiments, the entirety of the addressing pad 204 can be a single layer of conductive material. As noted above and discussed further below, an insulating cover is applied to the top of the array of conductive selection patches 206 to protect any exposed conductive elements while in use. In some embodiments, the addressing pad 204 can include an insulating layer for further protection at the side that may be exposed to being touched by the subject. In the embodiment shown, the conductive selection patches 206 and addressing pad 204 use a conductive hook-and-loop fastener for applying and securing the addressing pad 204. Some embodiments may use other conductive fasteners such as snaps, magnets, and the like.

In operation, the stimulation pulse from the pulse generator is delivered to the addressed electrodes 108, on the opposing side from the addressing pad 204 through conductive path described above: insulated lead wire 116, skin-side lead junction 120, conductive threading 112, lead junction 210, lead wire 214, addressing pad 204, addressed conductive selection patches 206, conductive thread 110, addressed electrode 108. Prior art devices include switches at the pulse generator to activate lead wires permanently connected to specific electrodes. For garment-based electrodes however the problem of electrode placement to generate contraction of a specific muscle or muscle group remains. Thus, prior art devices are left with either providing large electrodes to account for inaccurate placement and movement but that cannot target a specific muscle group or providing complex switching mechanisms at the pulse generator. In contrast with the prior art, electrodes are addressed here by way of placing the addressing pad 204 on the conductive selection patches in correspondence of the electrodes to be activated. This allows for users to easily switch the set of active electrodes within the array, optionally and preferably without doffing (removing) the body- worn device featuring the electrode array, which may then remain in contact with the skin.

Prior art devices and systems suffer from the following complications which are alleviated by embodiments described. In prior art devices, visualizing the stimulated area requires a screen or other representation. On the contrary, with embodiments described herein, the addressing pad is placed in visual and physical correspondence with the stimulated area. Many prior art devices can stimulate some areas inadvertently (e.g., because of incorrect manipulation, software bugs, and the like) without a therapist or patient realizing. On the contrary, with embodiments described herein, the addressing pads are physically displaced by a user as they would do with standard self-adhering electrodes, limiting the risk of incorrect manipulation. Furthermore, many prior art devices require the user (e.g., therapist) to learn a new procedure to select the correct active electrode site. Embodiments described herein solve this problem by allowing the user to place the addressing pads in a trial-and- error procedure that is very similar to the procedure they have been trained for with standard self-adhering electrodes.

Figure 3 illustrates a side-view schematic of an addressable electrode array in accordance with embodiments. Conductive threading 110 and 112 and nonconductive threading 104 are shown passing through from the base side to the opposing side of the device. As can be seen in Figures 4A and 4B, nonconductive threading need not pass through the entire depth of the device. For example, as illustrated in Figure 4A, nonconductive threading 402 can pass through at least partially each layer. In another example, as illustrated in Figure 4B, nonconductive threading 404 can partially pass through a single layer. Nonconductive threading should pass deep enough into the material so that fastener 216 can remain attached to the opposing side through repeated use. It should be understood that nonconductive threading may not be required. For example, an adhesive, heat transfer, or ultrasonic welding may be used. Additionally, in some embodiments, a type of fastener can be used that does not require threading. Returning to Figure 3, conductive fastener 302 is shown. Additionally, protective insulating cover 304 with nonconductive fastener 306 is shown. In the embodiment illustrated in Figure 3, nonconductive fastener components 216 and 306 are hook-and-loop. In some embodiments, as explained above in relation to conductive fasteners, other types of fastening components can be used. Layers 102 and 202 are shown. It should be understood that other layers may be included.

Figure 5 illustrates an arrangement of sleeves in accordance with embodiments. Shown are sleeves 502 and 504. Embodiments can include one or more sleeves. In the embodiment shown, sleeves 502 and 504 attach to the upper and lower arm, respectively, by wrapping around the arm 508 at least partially. Embodiments can include fasteners on the sleeves to attach one end to the other to maintain compression on the limb and thereby maintain position on the limb. Fastener components to connect sleeve ends can include fasteners as discussed elsewhere herein. Embodiments can include electrode arrays in a pad format in which the pad itself does not wrap around at least partially to maintain position but adheres to a limb or body part with an adhesive, strap or other attached fastener component. Embodiments can include alignment marks to align the sleeves with anatomical landmarks to maintain precise positioning of the electrode arrays with respect to the user’s muscle across multiple donning and doffing. At the top end of the electrode array device is a connector housing 506 that allows connection to the pulse generator. The connector 506 may be placed anywhere on the sleeves and several connectors may be distributed on the sleeves. Each sleeve may optionally comprise a frame, separately or in a connected manner for both sleeves (not shown). The frame may comprise rigid and/or moldable material, to enable each sleeve to be molded around or otherwise feature a tight, well-adjusted placement against a portion of the subject’s arm.

Figure 6A illustrates a method for manufacturing, and Figures 6B-6E illustrate side-view schematics of an addressable electrode array during manufacturing steps in accordance with embodiments. Figure 6A shows the overall process as a method, while Figures 6B-6E illustrates each stage schematically in more detail. At 602 (of Figure 6A) and Figure 6B, the electrodes 108 and conductive traces 116 are transferred onto layer 202. Preferably, this is done using heat transfer. Insulation 106 is preferably also transferred onto layer 202. Optionally and preferably, each of electrodes 108 and conductive traces 116 comprise a plurality of layers. Conductive traces 116 are preferably implemented in place of the previously described conductive lead wire. Conductive traces 116 are preferably implemented with an insulating layer on the exposed side (the side not bonded to the fabric), shown as insulation 106.

At 604 (of Figure 6A) and Figure 6C (partially), conductive threading 110 and 112 are sewn into the electrode array layers. At 606 (of Figure 6A) and further in Figure 6C (partially) the conductive fasteners 206 and lead junction 210 are attached to the opposing side material, thereby providing a conductive trace to the electrode 108 and lead junction 120. At 608 (of Figure 6A) and Figure 6D, nonconductive elements such as nonconductive threading 104 and nonconductive fasteners 216 are added. At 610 (of Figure 6A) and Figure 6E, insulation patch 114 and insulation cover 218 are added to cover and protect conductive material, such as lead junctions 120 and 210. Insulation cover 218 may comprise a plastic cover of the snap fastener button (connector) for an exemplary implementation.

Figure 7 illustrates a schematic of a 6x5 electrode array as viewed from the bottom, or the side to be in contact with the skin, in accordance with embodiments. One or more of the electrodes 108 can be activated using addressing pads discussed herein and, in particular, below in connection with Figures 11 A- HE. Arrays of varying dimensions and resolution, and with varying electrode sizes can be used in accordance with embodiments. Figure 8 illustrates a schematic of an array in a pseudo-circular format in accordance with embodiments. Figure 9 illustrates a schematic of an electrode array in accordance with embodiments having varying sizes of electrodes. As discussed herein, variable sized addressing pads or addressing pads with different geometries can be used to select the active electrodes.

Figure 10 illustrates a schematic of an electrode array and replaceable addressing pads for use thereon and having different geometries to actively select various electrodes for stimulation, as seen from the top, or the side opposing to the skin, in accordance with embodiments. In the schematic shown, addressing pad 1002 can be used to select four electrodes in a 2x2 subarray of the array. Addressing pad 1004 can be used to select two electrodes in a 1x2 subarray, either along the x axis or the y axis. And addressing pad 1006 can be used to select two catercorner electrodes. Each addressing pad includes a lead wire 1008 with a detachable connector 1010 to connect to connector 1012 and lead wire 1014 to provide a conductive path from the pulse generator to the electrodes 108. Optionally and alternatively, connector 1012 may be placed in correspondence to the junction (as shown for example with regard to Figures 13-15), such that lead wire 1014 may not be required.

In some embodiments, multiple addressing pads can be used to address electrodes in an array in lieu of relying on specific shapes of addressing pads. For example, a first and a second addressing pads can be combined to address electrodes in the way one of addressing pads 1002, 1004, 1006 addresses electrodes. In some instances, additional addressing pads beyond a second can be combined. In such cases, each of the addressing pads preferably include lead wires to provide a conductive path. In some instances, the lead wires can connect to the connector 1012 or the lead wires can be connected to similar connectors on other addressing pads to create a conductive path.

Figures 11 A-l IE illustrate various addressing pads patterns in accordance with embodiments. The geometries of addressing pads can correspond to the electrode array size, dimension, and geometry. The addressing pad 1102 of Figure 11 A is circular. As noted, any geometry is possible based on the electrode array. Addressing pad 1102 includes an offset connection to lead wire junction 1104 which can allow for easier removal of the addressing pad and lead to less wear in the area of the lead wire junction.

The addressing pad 1106 of Figure 1 IB includes a concentric square design having an outer square 1108 and inner square 1110. The inner square 1110 and the area of the outer square 1108 outside of the area of the inner square can be covered by an insulating layer. On use, one or both insulating layers can be removed to expose only those areas to be used to select electrodes. In preferred embodiments, the insulating layer is a thin shielded layer attached to the conductive fastener 302 of the addressing pad 204 using either the same fastener component used for the conductive selection patch or a different fastener appropriate for the material of the face of the addressing pad. For example, if the addressing pad uses a magnetic layer conductivity, an adhesive or magnetic material can be used to attach the insulating layer. Lead wire junction 1104 is shown as it would attach to the opposing side in a way that it connects to both sections of the addressing pad. In some embodiments, each section can have its own lead wire junction. Addressing pads 1112 and 1114 of Figures 11C and 11D, respectively, illustrate schematics of addressing pads similar to that of Figure 11B although with a circular geometry. Preferably only the inner circle (Figure 11C) or only the annulus (Figure 1 ID) are exposed and thus used to select electrodes. The lead wire junctions and lead wires are not shown but can be configured as described in connection with Figure 11B.

The addressing pad 1116 of Figure HE illustrates a foldable addressing pad. Fold lines 1118 indicate where the conductive material can be folded away from the electrodes or unfolded to deselect or select electrodes. As shown, lead wire junction 1104 is in the center of the addressing pad 1116. In preferred embodiments, a hook-and-loop or other fastener can be used to fold a foldable section 1120 onto the base section 1122 to maintain the addressing pad in a given shape and prevent connection with adjacent selection patches. To accommodate attachment and the lead wire 1008, a notch can be made in the edge of the foldable section 1120. In some embodiments, the protective cover (not shown) as described above can hold foldable sections 1120 in place to prevent inadvertent selection of an adjacent electrode.

Figure 12 illustrates an exemplary, non-limiting method for use of an exemplary device as described herein for therapy. As shown in a method 1200, the method begins by selecting at least two electrodes for delivering electrical therapy at 1202, for example with a plurality of electrode array portions. At least two electrodes are needed for electrical current to pass through the tissue. A therapist may perform such a selection, for example according to which muscle is to receive electrical therapy. At 1204, at least one addressing pad per array is placed on the device to deliver the electrical therapy, in which the position of the addressing pad corresponds to the electrode array portion selected (i.e., electrode array active area) in the correct position to deliver therapy. Optionally exactly one addressing pad per array is placed on the device. Adding the addressing pad to permit electrical therapy to be delivered is a safer option, in that the default is that therapy is not delivered at a particular position without such an addressing pad.

At 1206, the device is placed on the body of the subject. For example, the device may be incorporated to a garment that is worn by the subject, in such a manner that the electrode array portion that is able to deliver electrical therapy is in the correct position. An outer fabric cover is preferably present to prevent unwanted electrical contact between the subject and the electrode array.

At 1208, power is supplied to the device to begin therapy; however, electrical therapy is only delivered to the position or positions of electrodes at which an addressing pad was placed. Without wishing to be limited by a single hypothesis, the addressing pads allow for addressing certain electrodes at the wearable instead of at the generator (power supply). They are easier for users, including less skilled users, than addressing using the pulse generator interface (e.g., the addressing pads are a visual and manual addressing device and, thus, intuitive whereas using an interface at the generator requires some special knowledge of how the generator and addressing work).

If the desired electrode placement has not been achieved, the process may return to 1202.

Figure 13 shows manufacturing steps for manufacturing an addressable electrode array in accordance with embodiments. As shown in a method 1300, the method begins at 1302 with heat transfer of screen-printed electrodes and tracks on one side of the fabric. At 1304, the screen- printed conductive patches are heat pressed on the other side of the fabric, placed so that each selection patch on one side of the fabric corresponds to an electrode on the other side of the fabric. At 1306, the conductive selection patches and electrodes are sewn and therefore electrically connected using conductive thread. The process of sewing with conductive thread supports conduction of electricity from the electrode to the subject when the device is worn during therapy. At 1308, the Lead Junction snap connector, which supports conduction of electrical signals from a power supply to an addressing pad, when the latter is “snapped” to the snap connector at the appropriate end.

At 1310, insulation patches are added so that electricity flows to the addressable patches. At 1312, addressing pads are added, so that electricity may be conducted to the appropriate electrodes. As noted above, the addressing pads feature one end with an appropriate snap connector, to supporting snapping that connector to the snap connector of the electrical junction.

Figures 14A-14E relate to a device manufactured according to the method in Figure 13, assembled in stages. Some reference numbers may be omitted for the sake of clarity; however, the components themselves are shown unless otherwise noted. Reference is made to a “device” with the understanding that a cut-away of a portion of the device is shown.

Figure 14A shows heat transfer of a plurality of electrically conductive patches that, on the skin side, play the role of Electrodes and, on the opposite side, play the role of Selection Patches, for a device 1400. Electrically conductive patches (both Electrodes and Selection Patches) feature a conductive material, such as a material comprising silver, including without limitation as an alloy or composite. Selection patches 1402 are present at a suitable density at the side of device 1400 that does not directly contact the skin. Electrically conductive patches 1420 are present at a suitable density at the side of device 1400 that contacts the skin. Figures 14A-14E feature selection patches 1402A and 1402, and electrically conductive patches 1420A and 1420B for the sake of illustration and without any intention of being limiting.

As shown electrically conductive patches (electrodes) 1420 are disposed on one side of a flexible layer and selection patches 1402 are disposed on another side of the flexible layer as shown. The flexible layer in this non-limiting example features a first fabric layer 1404 and a second fabric layer 1406. First fabric layer 1404 may comprise a Velcro or other fastening or adhesive fabric, while second fabric layer 1406 may comprise any suitable fabric. The flexible layer is preferably sufficiently flexible to permit device 1400 to be molded or otherwise fitted closely against an area of skin to be treated, such as a lower arm and/or an upper arm, or shoulder.

Device 1400 also preferably features a plurality of insulating portions 1408, which as shown are disposed between electrodes 1420. Two such insulating portions 1408 are shown as insulating portions 1408A and 1408B, for the sake of illustration and without any intention of being limiting. Electrodes 1420 and selection patches 1402 may be screen-printed, for example as silver or other conductive material in a suitable solvent. The screen-printed layers may be considered as multiple layers of a structure, which are added as separate layers on top of each other and then heat transferred at the same time on the fabric. In such an implementation, one layer may extend completely along the length of the array, while a second layer may be added in portions, such that the size of the portions of the second layer (such as insulating portions 1408 in this example) determine the available area of the first layer (such as electrodes 1420 in this example).

Figure 14B shows that the conductive selection patches and electrodes are sewn using electrically conductive thread to electrically connect the two sides of the fabric The lines of the sewn thread are shown as 1410A and 1410B, again for the purpose of illustration only. Thread is preferably sewn between electrodes 1420 and selection patches 1402 on opposing sides of the flexible layer as shown, between 1420A and 1402A, and then between 1420B and 1402B. A “W” or other pattern may be applied, as appropriate. In Figure 14C a lead junction snap connector 1412 has been added through the flexible layer. Lead junction snap connector 1412 is conductive and is preferably positioned such that one end is in conductive communication with electrically conductive material 1422, while the other end protrudes through the flexible layer. An additional insulation portion 1424 is present to further insulate electrically conductive material 1422.

Figure 14D shows the addition of another insulating portion 1414, which may comprise similar or different material to insulating portions 1408 and 1424. Insulating portion 1414 is added to one end of lead junction snap connector 1412 as shown, while still enabling lead junction snap connector 1412 to remain in electrical communication with electrically conductive material 1422.

Figure 14E shows the addition of a removable addressable pad 1416. Addressable pad 1416 preferably features an electrically conductive connector 1418, which as shown is able to “snap onto” the protruding end of lead junction snap connector 1412. Connector 1418 is connected to an electrically conductive wire 1426. Connector 1418 comprises a material which enables electricity to flow from lead junction snap connector 1412 to wire 1426. Electricity then flows to a pad head 1428, which features at least one electrically conductive point, and preferably a plurality of such points. For example, and without limitation, pad head 1422 may comprise electrically conductive Velcro.

An adhesive layer (not shown) preferably adheres the various selection patches 1402, insulation patches 1408 and electrically conductive patches 1402 to the flexible layer. Preferably the adhesive is included into the heat transferred layered screen-printed structure.

Figure 15 shows a non-limiting, exemplary method for applying the device to a subject. As shown, a method 1500 begins at 1502, when the device is placed on the subject. For example, if the device comprising the electrode array arrangement of Figure is incorporated into the sleeve or sleeves of Figure 5, then an arm of the subject may be placed onto or within the sleeve. The sleeve may then be adjusted to fit securely against the arm of the subject. At 1504, at least one electrode array is selected, corresponding to the area of the arm to be treated. At 1506, at least two addressing pads are placed, with the pad head against a selected electrode array, and the pad connector connected to the lead junction snap connector. An outer fabric layer is preferably present to prevent unwanted electrical contact between the subject and the electrode array. At 1508, the device is powered to initiate therapy. The process may return to 1502 and may then be repeated if the fit was not sufficient.

Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented in the present application, are herein incorporated by reference in their entirety.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

Example embodiments of the devices, systems and methods have been described herein. As noted elsewhere, these embodiments have been described for illustrative purposes only and are not limiting. Other embodiments are possible and are covered by the disclosure, which will be apparent from the teachings contained herein. Thus, the breadth and scope of the disclosure should not be limited by any of the above-described embodiments but should be defined only in accordance with claims supported by the present disclosure and their equivalents. Moreover, embodiments of the subject disclosure may include methods, systems and apparatuses which may further include any and all elements from any other disclosed methods, systems, and apparatuses, including any and all elements corresponding to target particle separation, focusing/concentration. In other words, elements from one or another disclosed embodiment may be interchangeable with elements from other disclosed embodiments. In addition, one or more features/elements of disclosed embodiments may be removed and still result in patentable subject matter (and thus, resulting in yet more embodiments of the subject disclosure). Correspondingly, some embodiments of the present disclosure may be patentably distinct from one and/or another reference by specifically lacking one or more elements/features. In other words, claims to certain embodiments may contain negative limitation to specifically exclude one or more elements/features resulting in embodiments which are patentably distinct from the prior art which include such features/elements. WHAT IS CLAIMED IS: A system for an addressable body-worn electrode array, comprising a plurality of electrodes in the array, adapted to support easy electrical therapy through a consistent positioning of the electrodes by the therapist that is retained during therapy. The system of claim 1, further comprising an apparel device for being worn on the body, wherein the apparel device comprises the electrode array and a plurality of addressing pads, wherein placement of the addressing pads determines positioning of active electrodes. The system of claims 1 or 2, wherein the electrode array further comprises a substrate that is at least one of flexible and stretchable for attaching, embedding or integrally forming the electrodes. The system of claim 3, wherein the electrodes comprise a plurality of electrically conductive patches, wherein said electrically conductive patches are arranged along one side of said substrate. The system of claim 4, further comprising a plurality of selection patches, wherein said selection patches are arranged along an opposing side of said substrate from said electrodes. The system of any of the above claims, wherein said electrode array features a single array with a plurality of addressing pads. The system of any of the above claims, wherein said electrode array comprises a plurality of electrode arrays, each array having at least one addressing pad. The system of any of the above claims, wherein said electrode array further comprises a lead junction for enabling electrical flow. The system of any of the above claims, wherein the electrode array further comprises a movable addressing pad for positioning a stimulation area comprising the active electrodes.