Patent Description:
An orthosis, such as a splint, cuff or garment, can be used in conjunction with an electrode to provide electrical stimulation of, for example, paralyzed limbs in therapeutic exercises and for generating limb function during functional electrical stimulation (FES). An electrode kit for such use can include, for example, a base portion that can be attached to an interior surface of an orthosis and an electrode assembly including an electrode and a pad that contacts the surface of the patient's skin. In such FES devices, the contact with the pad can cause irritation to the patient's skin. For example, many known FES devices include the use of hydro-gel electrodes that can cause skin irritation to the patient over prolonged use.

FES is a means to communicate with the neuromuscular system for producing contraction in muscles or sensory input to the body. FES can be used in neuroprostheses for restoring active function to paralyzed or plegic body limbs in patients suffering disease or trauma to the central nervous system, in neurological conditions such as stroke, spinal cord injury, head injury, cerebral palsy and multiple sclerosis. Surface FES systems use controlled electrical currents through electrodes placed on the surface of the body, in order to trigger contraction from muscles underlying the electrode or to input sensory stimulus. Surface neuroprostheses can coordinate the FES-activation of several muscles of the limb alone, or in coordination with voluntary activation of muscles under natural neurological control. Surface neuroprostheses are in use today for functional activities such as walking, standing, gripping/releasing objects, etc..

Activation of selected muscles of a limb by FES to generate controlled movements has been used, both as a therapeutic modality and for the improvement or restoration of activities of daily living (ADL) or functional restoration. Devices based on surface electrical stimulation which have been developed for activating specific body sites include, for example, the dropfoot system, which activates the ankle joint, modifying hemiplegic gait; hybrid FES-orthosis systems for restoring gait in spinal cord-injured patients, and systems for therapeutic activation and functional restoration of the hand.

In many of the known FES devices, replacement of dried-out pads and/or electrodes can be complex, making it difficult for a patient to perform without assistance. In addition, the location of the pad relative to the electrode is not always well-defined, producing a possible misalignment between the electrode and the motor point of the muscle, which can cause an undesirable overflow of the electrical stimulus. Thus, electrode placement is an important issue for surface neuroprostheses and involves accurately positioning the electrodes over the motor points of the muscles to be activated. Accurate electrode positioning can ensure activation of the correct muscle without overflow to unwanted muscles, sensory tolerance of the stimulation current intensity needed to produce the desired response, and the quality of the muscle contraction.

Thus, there is a need for an electrode and/or electrode kit for use in conjunction with an orthosis that can be easily and accurately attached to and removed from the orthosis by the clinician or by the patient. There is also a need for an electrode that provides patient comfort and reduces or eliminates skin reactions to the electrode. <CIT> discloses a perforated sized adjustable biomedical electrode. <CIT> discloses a skin conducting electrode and electrode assembly. <CIT> discloses an improved biomedical electrode for extended patient wear featuring a tap, or snap, which is isolated from the retention seal. <CIT> discloses a surface neuroprosthetic device having an internal cushion interface system. <CIT> discloses an electrode for muscle stimulation.

In a first aspect of the present invention there is provided an apparatus according to independent claim <NUM>.

In the following, each of the described methods, apparatuses, examples and aspects, which do not fully correspond to the invention as defined in the claims is thus not according to the invention and is, as well as the whole following description, present for illustration purposes only or to highlight specific aspects or features of the claims.

Systems, devices and methods for treating a targeted body tissue (e.g., bone, soft tissue, muscle, ligaments, etc.) by stimulating the body tissue with an electric current are described herein. In one embodiment, an apparatus, comprising an electrode base, a first conductor member coupled to the electrode base, a second conductor member coupled to the electrode base, a pad coupled to the electrode base such that the first conductor member is disposed between the electrode base and the first pad, the first pad and the first conductor member collectively forming a first electrode, a portion of the first pad configured to contact a skin surface, a second pad coupled to the electrode base such that the second conductor member is disposed between the electrode base and the second pad, the second pad and the second conductor collectively forming a second electrode,_a portion of the second pad configured to contact the skin surface, the second electrode differing from the first electrode in size; the electrode base configured to be releasably couplable to an orthosis by one of hook and pile fasteners, press-studs, magnetic couplers or specialized holders that press the conductive back of the electrode assembly against a conductive stud or panel inside the orthosis, or a combination thereof such that the first conductor member and the second conductor member are each electrically coupled to the orthosis and not electrically coupled to each other.

Devices, kits and methods are described herein that include an electrode kit and/or electrode device that can be used in conjunction with a surface neuroprosthesis device or orthosis for functional electrical stimulation (FES) and/or neuromuscular electrical stimulation (NMES) of a targeted body tissue (e.g., muscle, ligament), such as an impaired limb. For example, in some embodiments, such treatment includes the functional electrical stimulation of intact nerves of limbs to trigger a muscle contraction or response. In some embodiments, such treatment includes the functional stimulation of a targeted body tissue to provide sensory stimulation. A surface neuroprosthesis device or orthosis, can be for example, a cast, splint, cuff, wristlet, gauntlet, strap or other garment that can be worn by a patient and that has one or more electrodes coupled to the orthosis and is in contact with the skin of the patient.

An electrode kit or device as described herein can include, for example, a base and an electrode assembly couplable to the base. As described herein, the base of an electrode device can be coupled to the interior surface of an orthosis with, for example, VELCRO patches, press-studs, magnetic couplers, or specialized holders that press the conductive back of the electrode assembly against a conductive stud or panel inside the orthosis, or a combination thereof. The electrode devices described herein can be used in conjunction with a variety of different types of orthoses configured for various body limbs, such as, for example, devices used in functional electrical stimulation of a muscle of an upper limb, such as various locations on an arm, and for lower limbs, such as various locations on a leg.

As described herein, an electrode assembly that is configured to make electrical contact with the skin can include a conductive electrode assembly that is held onto a part of the body with the orthosis. In some embodiments, the electrode assembly includes a metal mesh conductor and an absorbent pad, all of which can be soaked in water. The electrode assembly can be releasably coupled to the electrode base of the electrode kit such that it can be easily removed and replaced as needed. The electrode assembly can be, for example, disposable.

<FIG> is a schematic illustration of an embodiment of an electrode kit or device that can be used in conjunction with an orthosis to provide functional electrical stimulation to a target body tissue. An electrode device <NUM>, includes a base <NUM> and an electrode assembly <NUM>. The electrode device <NUM> is configured to be coupled to an orthosis <NUM>, such as, for example, a cast, splint, cuff, wristlet, gauntlet, strap or other garment that can be worn by a patient. The orthosis <NUM>, can be configured for use in electrical stimulation treatment at various locations on a patient's body, such as for example, a leg, foot, arm or hand. In some embodiments, multiple electrode devices are configured to be coupled to an orthosis <NUM>. Various example embodiments of an orthosis and/or stimulation control systems that can be used in conjunction with an electrode device <NUM> as described herein are described in <CIT>,<CIT>,<CIT>,<CIT> and <CIT>, and International Patent Publication No. <CIT>. Other example embodiments of orthosis devices and a stimulation control system that can be used in conjunction with the electrode devices described herein are described in co-pending <CIT>.

The base <NUM> includes an electrode carrier <NUM> coupled to a connection member <NUM>. The connection member <NUM> can be releasably coupled to the orthosis <NUM> at a desired location on an interior surface of the orthosis <NUM>. The connection member <NUM> can include a base member (not shown in <FIG>) and a coupling portion (not shown in <FIG>). The coupling portion can be configured to be coupled to a mating coupling member disposed on the orthosis <NUM>. In some embodiments, the coupling portion can also serve as the connecting terminal for the stimulating current. In some embodiments, the coupling portion of the connection member <NUM> includes a protrusion configured to be received within a recess defined in the orthosis <NUM> to form a snap-fit connection. In such an embodiment, although the connection member <NUM> is releasably coupled to the orthosis <NUM>, it is stationary or fixed to the orthosis <NUM> during the electrical stimulation treatment.

In some embodiments, the base <NUM> can be coupled to a panel (not shown in <FIG>) that can be releasably coupled to the orthosis <NUM>. The panel can be provided as a layer between the inner surface of the orthosis <NUM> and the skin of the user/patient. The panel can include openings through which a coupling portion of the base <NUM> can be disposed such that it can be coupled to mating coupling member on the inner surface of the orthosis <NUM>. The panel can be configured for a particular user/patient and can allow for a common orthosis <NUM> to be used on a variety of different users/patients. In some embodiments, the panel can be disposable. An embodiment of such a panel and electrode assembly are described in more detail below.

The electrode carrier <NUM> can be electrically coupled to the connection member <NUM> with an electrical lead or cable (not shown in <FIG>). The electrode carrier <NUM> is also configured to be removably coupled to an interior surface of the orthosis <NUM> such that it can be repositioned at various locations on the orthosis <NUM> as needed during treatment. For example, the electrical lead can be flexible allowing the electrode carrier <NUM> to be moved relative to the connection member <NUM>. The connection member <NUM> can be fixedly or releasably coupled to the orthosis <NUM> at a designated location, and the electrode carrier <NUM> can be coupled to the orthosis <NUM> at a different location than the connection member <NUM> such that it is at a spaced distance from the connection member <NUM>. The electrode carrier <NUM> can be moved to different locations relative to the connection member <NUM> as needed. Through its electrical coupling to the connection member <NUM>, the electrode carrier <NUM> is also electrically coupled to the orthosis <NUM> when coupled thereto.

In some embodiments, the electrode carrier <NUM> can be removably coupled to the orthosis <NUM> with a VELCRO attachment. For example, the electrode carrier <NUM> can include a first part of a VELCRO attachment member and a second mating part can be attached to the orthosis <NUM>. Such an attachment method is described in more detail below with reference to specific embodiments.

In some embodiments, the electrode carrier <NUM> can be coupled to the orthosis <NUM> with, for example, a snap fit coupling. In some such embodiments, the snap-fit coupling can also provide an electrical connection to the orthosis <NUM>. In some embodiments, the base <NUM> does not include a connection member <NUM>. In some such embodiments, the electrode carrier <NUM> can include two coupling portions to couple the electrode carrier <NUM> to the orthosis <NUM>.

The electrode assembly <NUM> is configured to be coupled to the electrode carrier <NUM>. In some embodiments, the electrode assembly <NUM> is removably coupled to the electrode carrier <NUM>. For example, in some embodiments, the electrode carrier <NUM> defines a recess configured to matingly receive a portion of the electrode assembly <NUM> forming a snap-fit coupling. The removable coupling of the electrode assembly <NUM> to the electrode carrier <NUM> allows for the electrode assembly <NUM> to be easily removed and/or replaced as needed. The electrode assembly <NUM> can also be disposable. Because the electrode assembly <NUM> is easily removable, the user (e.g., patient) can remove and replace the electrode assembly <NUM>, for example, after two weeks, rather than requiring a clinician or specialist. In some embodiments, the user can remove the electrode assembly <NUM> more frequently, such as for example, on a daily basis to wet the electrode assembly <NUM>. The removability and disposability of the electrode assembly <NUM> also helps reduce or eliminate "scale" build up on the electrode that can occur after prolonged use.

The electrode assembly <NUM> can include a support frame <NUM>, a conductor member <NUM> and a pad <NUM>. The support frame <NUM> can be formed in part with a substantially rigid material, such as a suitable plastic material, and include a coupling portion that can be releasably and electrically coupled to the electrode carrier <NUM>. For example, the support frame <NUM> can include a protrusion (not shown in <FIG>) configured to be matingly received within a recess of the electrode carrier <NUM> to form a snap-fit connection. The protrusion can be formed integrally with the support frame <NUM> or be provided as a separate component. The support frame <NUM> can be formed, for example, with a polypropylene, a polyvinyl or a mixture thereof.

The pad <NUM> can be coupled to a surface of the support frame <NUM>. The conductor member <NUM> can also be coupled to the same surface of the support frame <NUM> such that it is disposed between the support frame <NUM> and the pad <NUM>. For example, the pad <NUM> can be ultrasonically welded around a perimeter portion of the surface of the support frame <NUM>, sandwiching the conductor member <NUM> therebetween. With the conductor member <NUM> disposed below the pad <NUM>, the electrical stimulation can be more evenly spread across the pad <NUM> during FES or NMES treatment. The conductor member <NUM> can be formed with, for example, a stainless steel material. The conductor member <NUM> can be shaped substantially similar to the shape of the pad <NUM>. In some embodiments, the conductor member <NUM> is circular or disc shaped.

The pad <NUM> can include at least a portion that includes an absorptive material, such as, for example, a cloth, felt, velvet, a non-woven viscose, or other suitable material that is absorptive of liquids, gels, etc. The absorptive material of the pad <NUM> allows the pad <NUM> to be soaked with liquid (e.g., water) in preparation for use, as described in more detail below. In some embodiments, the pad <NUM> can be porous and/or include holes to enable faster absorption of the liquid. In some embodiments, the pad <NUM> can include a thin membrane that can reduce and/or prevent the liquid from evaporating quickly. The pad <NUM> is configured to contact the skin of the patient during treatment, and therefore, it is desirable to be formed with a material that will provide comfort to the patient and reduce the possibility of irritation to the patient's skin. The conductor member <NUM> can be, for example, formed with a fine metallic wire mesh.

In use, the connection member <NUM> can be releasably or fixedly coupled to the orthosis <NUM> such that it is stationary during the electrical stimulation treatment. For example, the connection member <NUM> can be snapped into the orthosis <NUM> providing an electrical connection to the orthosis <NUM> for the electrical stimulation. The electrode assembly <NUM> is soaked with water until it is saturated and the excess water is wiped or blotted off the support frame side of the electrode assembly <NUM> where the coupling portion of the electrode assembly <NUM> is disposed. The electrode assembly <NUM> is then coupled to the electrode carrier <NUM>. The electrode carrier <NUM> can be coupled to the orthosis <NUM> before or after the electrode assembly <NUM> is coupled to the electrode carrier <NUM>. The electrode carrier <NUM> is coupled to the orthosis <NUM> at a desired location such that the electrode assembly <NUM> is positioned at the targeted treatment site when the orthosis <NUM> is placed on the patient's body. For example, as described above, the electrode carrier <NUM> can be coupled to the orthosis <NUM> with a VELCRO attachment. The above procedure can be performed to couple a second (or more) electrode kit to the orthosis <NUM>.

With the electrode device <NUM> in place on the orthosis <NUM>, the orthosis <NUM> can be placed on the user to provide FES treatment or NMES treatment to the targeted treatment site. Examples of a stimulation system that can be used to activate the functional electrical stimulation of the orthosis <NUM> are described, for example, in International Patent Publication No. <CIT>, and the <CIT>.

If at a subsequent time the desired treatment site has changed, the patient and/or clinician can decouple the electrode carrier <NUM> from the orthosis <NUM> and reposition it at a different location. Thus, the movability of the electrode carrier <NUM> allows for easy repositioning of the electrode assembly <NUM> to a desired target treatment site. In addition, the releasable attachment of the electrode assembly <NUM> to the electrode carrier <NUM> allows for the patient and/or clinician to easily remove the electrode assembly <NUM> from the electrode carrier <NUM> as needed. Thus, the electrode assembly <NUM> can be disposable and as the pad <NUM> becomes dried out or worn, it can be easily discarded and replaced.

To replace the electrode base <NUM>, the user turns off the system and then disconnects the connection member <NUM> from the orthosis <NUM>, terminating the electrical connection. The electrode carrier <NUM> can be removed as described above. A new electrode base <NUM> can then be coupled to the orthosis <NUM>. The same or new electrode assembly <NUM> can be coupled to the new electrode base <NUM> as described above. Prior to removing the electrode base <NUM>, the position of the electrode base <NUM> on the orthosis <NUM> can be marked, using for example, a marking tool such as a pen, pencil, etc., such that the new electrode base <NUM> can be positioned on the orthosis <NUM> at the same location.

Having described above various general principles, several examples of various embodiments of these concepts are now described. These embodiments are only examples, and many other configurations of an electrode kit and/or the various components of am electrode kit are contemplated.

<FIG> illustrates an electrode kit according to an embodiment. An electrode kit or device <NUM> includes an electrode base <NUM> and an electrode assembly portion <NUM> releasably coupled thereto. As described above, one or more electrode devices <NUM> can be coupled to an orthosis and used to provide functional electrical stimulation to a targeted treatment site on a patient.

The electrode base <NUM> includes an electrode carrier <NUM>, a connection member <NUM>, and an electrical lead or cable <NUM> (as best shown in <FIG>). As shown in <FIG>, the connection member <NUM> includes a coupling portion <NUM> coupled to a frame assembly <NUM>. In this embodiment, the coupling portion <NUM> is a protrusion configured to be received within an opening defined in an orthosis (not shown) to releasably couple the base <NUM> to the orthosis with a snap-fit connection. The frame assembly <NUM> includes a first member <NUM>, a second member <NUM>, a third member <NUM> and a pronged connector <NUM>. The components of the frame assembly <NUM> can be coupled together with, for example, adhesive, ultrasonic welding, over-molding, or other known methods. The first member <NUM> defines an opening <NUM> configured to receive an end portion of the electrical lead <NUM> to couple the lead <NUM> to the connection member <NUM>.

The electrode carrier <NUM> includes a carrier base assembly <NUM> (see e.g., <FIG>) and an orthosis attachment member <NUM> (shown in <FIG>). In this embodiment, the orthosis attachment member <NUM> is a VELCRO disc coupled to a first surface <NUM> (see e.g., <FIG>) of the carrier base assembly <NUM>. <FIG> illustrates the electrode base <NUM> with the orthosis attachment member <NUM> removed for illustrative purposes. The orthosis attachment member <NUM> can be, for example, sewn around a perimeter portion of the first surface <NUM> of the carrier base assembly <NUM>. In some embodiments, the orthosis attachment member <NUM> can be adhesively coupled to the first surface <NUM>. The orthosis attachment member <NUM> also defines an opening <NUM> configured to receive the electrical lead <NUM> therethrough, as shown in <FIG>. The orthosis attachment member <NUM> can be used to removably couple the electrode carrier <NUM> to the orthosis at one or more locations. For example, the orthosis can include one or more discrete mating VELCRO attachment portions configured to matingly couple to the VELCRO orthosis attachment member <NUM>. In some embodiments, the orthosis can include a continuous mating VELCRO attachment portion disposed on a surface of the orthosis such that the orthosis attachment member <NUM> can be moved to different locations on the orthosis as needed or desired. The removable coupling of the electrode carrier <NUM> to an orthosis is described in more detail below.

The carrier base assembly <NUM> includes a coupling member <NUM>, a first member <NUM> and a second o member <NUM> (see e.g., <FIG>, which illustrates an exploded perspective view of each of the components of the carrier base assembly <NUM>). The coupling member <NUM> defines an opening or recess <NUM> configured to receive a protrusion defined by the electrode assembly <NUM> and provide a releasable snap-fit coupling (the electrode assembly <NUM> is described in more detail below). As shown, for example, in <FIG>, the carrier base assembly <NUM> has a second surface <NUM> on which the electrode assembly <NUM> is disposed when coupled to the carrier base assembly <NUM>. The coupling member <NUM> also defines a groove <NUM> on the first surface <NUM> configured to receive an end portion of the electrical lead <NUM> to electrically couple the electrode carrier <NUM> to the connection member <NUM>.

The coupling member <NUM>, the first member <NUM> and the second member <NUM> can be coupled together, for example, with an over-mold process. <FIG> illustrate the coupling member <NUM> and <FIG> illustrate the first member <NUM> coupled to the coupling member <NUM> (prior to the second member <NUM> being coupled thereto). The coupling member <NUM> includes a support plate <NUM> and spring <NUM> that can be, for example, welded together.

<NUM>-<NUM>(c) illustrate the electrode assembly <NUM>. The electrode assembly <NUM> includes a frame assembly <NUM> and an electrode pad <NUM>. The electrode pad <NUM> can be formed at least in part with an absorptive material, such as, for example, felt. The pad <NUM> can be, for example, coupled to the frame assembly <NUM> with ultrasonic welding, described in more detail below.

As shown in <FIG>, the frame assembly <NUM> includes a support frame <NUM>, a conductor member <NUM>, and a coupling member <NUM> that includes a snap stud <NUM> and a snap post <NUM>. The snap stud <NUM> defines an opening configured to receive the snap post <NUM> in a snap fit connection. The snap stud <NUM> and the snap post <NUM> are configured to be coupled together such that the support frame <NUM> and the conductor member <NUM> are sandwiched together as shown in <FIG>. When assembled, the coupling member <NUM> provides a protrusion to be received in a mating recess or opening (e.g., opening <NUM>) of the electrode carrier <NUM> as described in more detail below. The conductor member <NUM> can be formed with, for example, with a stainless steel metallic mesh and the support frame <NUM> can be formed with, for example, a suitable plastic material, such as polypropylene or polyvinyl or a mixture thereof. In one example, the support frame <NUM> can have, for example, a diameter Ds of <NUM> and the conductor member <NUM> can have a diameter Dc of for example <NUM>, as shown in <FIG>.

The pad <NUM> is formed with an absorptive material, such as felt, cloth, velvet, viscose, etc., such that the pad <NUM> can be saturated with liquid (e.g., water) prior to use. The pad <NUM> can be coupled to the support frame <NUM> about a perimeter portion, as shown for example at location <NUM> in <FIG>. For example, the pad <NUM> can be ultrasonically welded to the plastic support frame <NUM> such that a perimeter portion of the pad <NUM> overhangs the support frame <NUM> as shown, for example, in <FIG>. The conductor member <NUM> will then be disposed between the pad <NUM> and the support frame <NUM>. The location of the conductor member <NUM> below the pad <NUM> allows for the electrical stimulation during the FES treatment to be distributed evenly across the pad <NUM> and to the target treatment site.

The coupling member <NUM> of the electrode assembly <NUM> is used to releasably couple the electrode assembly <NUM> to the electrode carrier <NUM> of the base assembly <NUM>. Specifically, the snap post <NUM> of the coupling member <NUM> is configured to be received within the opening <NUM> of the electrode carrier <NUM> to releasably couple the electrode assembly <NUM> to the electrode carrier <NUM> with a snap-fit connection. As described previously, the electrode assembly <NUM> is soaked in water prior to being coupled to the electrode carrier <NUM> such that the absorptive material of the pad <NUM> is saturated with water.

In alternative embodiments, the coupling member <NUM> can include a magnet element (not shown). For example, the magnet element can be disposed adjacent to the snap stud <NUM> and can be used to help locate and/or align the coupling member <NUM> to the mating opening of the electrode carrier <NUM> of the electrode carrier <NUM>. In some embodiments, magnetic coupler can be used in place of the snap-fit coupling member <NUM>. For example, a magnetic coupling member can be disposed on the electrode assembly <NUM> or the electrode carrier <NUM> that can be magnetically coupled to a magnetically attracted coupling member (e.g., a metallic member) on the other of the electrode assembly <NUM> or the electrode carrier <NUM>. In some embodiments, the magnetic coupler can provide the conductive medium of the electrode assembly. In some embodiments, and electrode assembly <NUM> can include one or more snap-fit coupling members and one or more magnetic coupling members.

<FIG> illustrate a portion of an orthosis <NUM> that can be used in conjunction with one or more electrode devices <NUM>. The orthosis <NUM> is a cuff style orthosis that can be used, for example, for functional electrical stimulation treatment of an arm or leg. The orthosis <NUM> includes an interior surface <NUM> on which the electrode device <NUM> (or multiple devices <NUM>) can be coupled. The orthosis <NUM> defines recesses <NUM> configured to matingly receive the coupling member <NUM> (i.e., protrusion) of the connection member <NUM>. As described above, the coupling member <NUM> can be snap-fit into the recess <NUM> to provide a releasable snap-fit coupling of the connection member <NUM> to the orthosis <NUM> and provide an electrical connection to the orthosis <NUM> for the electrical stimulation. The orthosis <NUM> also includes at least one VELCRO attachment portion <NUM> configured to matingly couple to the VELCRO orthosis attachment member <NUM> of the electrode carrier <NUM>.

In use, the electrode assembly <NUM> is soaked with water until it is saturated and the excess water is wiped or blotted off the support frame <NUM> of the electrode assembly <NUM>. The electrode assembly <NUM> is then coupled to the electrode carrier <NUM> of the electrode base assembly <NUM> either before or after the electrode carrier <NUM> is coupled to the orthosis <NUM>. With the electrode device <NUM> in place on the orthosis <NUM>, the orthosis <NUM> can be placed on the user to provide FES treatment to the targeted treatment site.

If needed, the patient and/or clinician can decouple and reposition the electrode carrier <NUM> on the orthosis <NUM> as illustrated in <FIG> by the dashed-line version of the electrode device <NUM>. In addition, the releasable attachment of the electrode assembly <NUM> to the electrode carrier <NUM> allows for the patient and/or clinician to easily remove the electrode assembly <NUM> from the electrode carrier <NUM> as needed. The entire base <NUM> can also be removed and replaced as needed as described previously.

<FIG> illustrates a portion of another embodiment of an orthosis that can be used in conjunction with the electrode device <NUM>. In this embodiment, an orthosis <NUM>' defines a recess (not shown) configured to matingly receive the coupling member <NUM> as described above for orthosis <NUM>. In this embodiment, the orthosis <NUM>' includes a mating VELCRO attachment <NUM>' in the form of a continuous sheet that allows for the electrode carrier <NUM> to be removably coupled to a variety different locations on the VELCRO attachment <NUM>'. The dash-line version of the electrode device <NUM>' illustrates the electrode carrier <NUM> being moved to different locations on the orthosis <NUM>' while the connection member <NUM> remains stationary.

<FIG> illustrates an embodiment of a panel that can optionally be used in conjunction with an electrode device, such as, electrode device <NUM>. A panel <NUM> includes a panel member <NUM> that defines two openings <NUM>. The panel member <NUM> can be formed with a flexible material that can conform to the inner surface of an orthosis. The panel member <NUM> can be formed, for example, with a fabric, cloth, felt, velvet, or other suitable material. Each of the openings <NUM> can receive a coupling member <NUM> (i.e., protrusion) of a connection member <NUM> of an electrode device <NUM>, as shown in <FIG>. Thus, in this example embodiment, two electrode devices <NUM> can be coupled to the panel <NUM>. Although <FIG> and <FIG> illustrate the panel member <NUM> defining two openings <NUM>, it should be understood that in other embodiments a panel member <NUM> can include less or more openings configured to receive a coupling member of an electrode assembly.

The panel <NUM> can be releasably coupled to an orthosis device <NUM> (see e.g., <FIG>). For example, one or more electrode devices <NUM> can be coupled to the panel <NUM> and the coupling portion <NUM> of the electrode device <NUM> (extending through the openings <NUM>) can be coupled to a mating snap-fit coupler <NUM> on the orthosis device <NUM>. The panel <NUM> can also include a coupling member (not shown), such as a VELCRO attachment member configured to be coupled to a mating VELCRO attachment (not shown) on the inner surface of the orthosis device <NUM>. In some embodiments, additional snap-fit couplings and/or magnetic couplings can be used to couple the panel <NUM> to the orthosis device <NUM>.

The panel <NUM> can be configured to fit a particular patient/user of the electrode device <NUM> and orthosis device <NUM>. Thus, the orthosis device <NUM> can be a common size and the panel <NUM> can be sized and configured to accommodate the orthosis <NUM> to fit different patients/users. The panel <NUM> (and electrode assemblies coupled thereto) can be removed and re-coupled to the orthosis device <NUM> as needed.

<FIG> illustrate another embodiment of an electrode device. The electrode device <NUM> can include an electrode pad <NUM>, a support frame <NUM>, and a conductor member (not shown) disposed between the electrode pad <NUM> and the support frame <NUM>. The electrode pad <NUM> can be formed at least in part with an absorptive material, such as, for example, felt as described above for electrode assemblies <NUM>, <NUM>. The pad <NUM> can be coupled to the support frame with, for example, ultrasonic welding, thermal coupling, sewing or adhesives.

In some embodiments, the electrode device <NUM> includes two snap-fit couplings configured to be matingly coupled to an inner surface of an orthosis device, as previously described for other embodiments. The electrode device <NUM> also includes a magnet member <NUM> that can help locate and/or align the snap-fit couplings <NUM> with mating snap-fit couplings on an orthosis device. For example, the orthosis device can have a mating magnetically attracted metallic component disposed between its snap-fit couplings in a similar manner as the electrode device <NUM>. When the electrode device <NUM> is being placed on the orthosis device, the magnet member <NUM> will be drawn toward the metallic component, which will in turn align the snap-fit couplings of the electrode device <NUM> to the mating snap-fit couplings on the orthosis device. Alternatively, instead of the snap-fit couplings, the electrode device <NUM> and the orthosis can be magnetically coupled.

In alternative embodiments, the electrode device <NUM> can be coupled to an orthosis device using any of the coupling methods described herein for other embodiments. For example, the electrode device <NUM> can be coupled to an orthosis device using one or more snap-fit couplings and/or one or more magnetic couplings and/or one or more VELCRO couplings as described herein. Additionally, more than one electrode device <NUM> can be coupled to an orthosis device.

<FIG> illustrate an embodiment of an electrode device <NUM> that includes two electrodes that are coupled to a single backing, but that are not electrically coupled directly to one another. The electrode device <NUM> can be used, for example, with a panel (see, e.g., <FIG>), similar to, for example, panel <NUM> described above. The electrode device <NUM> includes a first electrode pad <NUM>, a second electrode pad <NUM>, a first conductor member <NUM> and a second conductor member <NUM>. The first conductor member <NUM> and the second conductor member <NUM> can be formed with, for example, a metallic mesh material. In some embodiments, the first conductor member <NUM> and/or the second conductor member <NUM> can be formed with, for example, stainless steel mesh. The first electrode pad <NUM> and the second electrode pad <NUM> can be, for example, formed with an absorptive material, such as, for example, felt as described above for electrode assemblies <NUM>, <NUM>. As used herein, the first electrode pad <NUM> and the first conductor member <NUM> can also be collectively referred to as a first electrode, and the second electrode pad <NUM> and the second conductor member <NUM> can also be collectively referred to as a second electrode.

The first conductor member <NUM> and the second conductor member <NUM> are each coupled to a base <NUM> as shown in <FIG>. An electrical snap stud member <NUM> is inserted through holes <NUM> in each of the first conductor member <NUM> and the second conductor member <NUM>, and corresponding holes <NUM> in the base <NUM> (see e.g., the exploded view of <FIG>). The electrical snap stud members <NUM> pass through an opening in spacers <NUM> and are inserted into mating snap post members <NUM>. The spacers <NUM> can be used to fill a cavity that may be present between the mating snap connectors inside a functional electrical stimulation (FES) orthosis device and enable the electrode device <NUM> to snap directly to the orthosis. The snap post members <NUM> can be used to mechanically couple the electrode device <NUM> to the orthosis and can also be used to conduct electrical current from the orthosis to the first conductor member <NUM> and the second conductor member <NUM>.

The first electrode pad <NUM> and the second electrode pad <NUM> can each be coupled to the base <NUM> with the first and second conductor members <NUM> and <NUM> disposed between the base <NUM> and the electrode pads <NUM> and <NUM>. The first electrode pad <NUM> and the second electrode pad <NUM> can each be coupled to the base <NUM> with, for example, hook and pile fasteners, an adhesive, or other suitable coupling method. The location of the first and second conductor members <NUM> and <NUM> below the first and second electrode pads <NUM> and <NUM>, respectively, allows for the electrical stimulation during a FES treatment to be distributed evenly across the first and second electrode pads <NUM> and <NUM> and to the target treatment site as discussed above for previous embodiments.

As discussed above, the electrode device <NUM> can optionally be coupled to a panel <NUM> as shown in <FIG>. The panel <NUM> includes a panel member <NUM> that defines two openings <NUM> (see, <FIG>). The panel member <NUM> can be formed with a flexible material that can conform to the inner surface of an orthosis. The panel member <NUM> can be formed, for example, with a fabric, cloth, felt, velvet, or other suitable material. Each of the openings <NUM> can receive an electrical snap stud member <NUM> of the electrode device <NUM>.

The panel <NUM> can be releasably coupled to an orthosis device (not shown) as described above for previous embodiments. For example, the electrode assembly <NUM> can be coupled to the panel <NUM> and the electrical snap stud members <NUM> (extending through the openings <NUM>) can be coupled to a mating snap-fit coupler on the orthosis device. In some embodiments, the panel <NUM> can also include a coupling member (not shown), such as a VELCRO attachment member configured to be coupled to a mating VELCRO attachment (not shown) on the inner surface of the orthosis device. In some embodiments, additional snap-fit couplings and/or magnetic couplings can be used to couple the panel <NUM> to the orthosis device.

<FIG> illustrate another embodiment of an electrode device that includes two electrodes (e.g., a pad and conductor member) that are coupled to a single backing, but that are not electrically coupled directly to one another. The electrode device <NUM> includes a first electrode pad <NUM>, a second electrode pad <NUM>, a first conductor member <NUM> and a second conductor member <NUM> (see e.g., <FIG>). The first conductor member <NUM> and the second conductor member <NUM> can be formed with, for example, a metallic mesh material, such as stainless steel. The first electrode pad <NUM> and the second electrode pad <NUM> can be, for example, formed with an absorptive material, such as, for example, felt as described for previous embodiments. As used herein, the first electrode pad <NUM> and the first conductor member <NUM> can also collectively be referred to as a first electrode, and the second electrode pad <NUM> and the second conductor member <NUM> can also collectively be referred to as a second electrode.

The first conductor member <NUM> and the second conductor member <NUM> are each coupled to a base <NUM> as shown in for example, <FIG> and <FIG>. An electrical snap stud member <NUM> is inserted through holes <NUM> (see e.g., <FIG>) in each of the first conductor member <NUM> and the second conductor member <NUM> and corresponding holes <NUM> in the base <NUM> (see e.g., <FIG>). The electrical snap stud members <NUM> pass through an opening in spacers <NUM> and are inserted into mating snap post members <NUM>. As described above for electrode device <NUM>, the spacers <NUM> can be used to fill a cavity that may be present between the mating snap connectors inside a functional electrical stimulation orthosis and enable the electrode assembly <NUM> to snap directly to the orthosis. The snap post members <NUM> can be used to mechanically couple the electrode assembly <NUM> to the orthosis and can also be used to conduct electrical current from the orthosis to the first conductor member <NUM> and the second conductor member <NUM>.

The first electrode pad <NUM> and the second electrode pad <NUM> can each be coupled to the base <NUM> with the conductor members <NUM> and <NUM> disposed between the base <NUM> and the first and second electrode pads <NUM> and <NUM> (see e.g., <FIG> which shows the first and second electrode pads <NUM> and <NUM> partially transparent). The location of the first and second conductor members <NUM> and <NUM> below the first and second electrode pads <NUM> and <NUM>, respectively, allows for the electrical stimulation during a FES treatment to be distributed evenly across the first and second electrode pads <NUM> and <NUM> and to the target treatment site as discussed above for previous embodiments.

The electrode device <NUM> can optionally be coupled to a panel (not shown), such as, for example, panel <NUM>, as described above for electrode device <NUM>. The panel can be releasably coupled to an orthosis device (not shown) as described above for previous embodiments. The electrode device <NUM> can also be coupled directly to an orthosis device. For example, the electrical snap stud members <NUM> extending from a back side of the electrode device <NUM> (see e.g., <FIG>) can be coupled to a mating snap-fit coupler on the orthosis device.

<FIG> illustrate one example of preparing an electrode device <NUM> for use with an orthosis device <NUM> to be used for electrical stimulation during a FES treatment. As shown in <FIG>, with the orthosis system turned off, the electrode device <NUM> can be removed from the orthosis device <NUM> by detaching the snap stud members <NUM> from the orthosis device <NUM>. The electrode device <NUM> can then be wet with water as shown in <FIG>. Excess water can be removed from the electrode device <NUM> using a cloth or, for example, a paper towel as shown in <FIG>. To place the electrode device <NUM> back onto the orthosis device <NUM>, the snap stud members <NUM> on the electrode device <NUM> can be aligned with mating coupling holes on the orthosis device <NUM> (as shown in <FIG>), and the electrode device <NUM> can be pressed firmly to snap the snap stud members <NUM> thereto (as shown in FIG. In some embodiments, the snap stud members <NUM> are color coded to align with color coded rings or markings around the mating openings on the orthosis device <NUM>.

The electrode devices <NUM>, <NUM> and <NUM> described above are examples of large electrode devices that can be used in conjunction with a surface neuroprosthesis device or orthosis for functional electrical stimulation (FES) and/or neuromuscular electrical stimulation (NMES) of a targeted body tissue (e.g., muscle, ligament), such as an impaired limb. The electrode devices <NUM>, <NUM> and <NUM> can have various other shapes and sizes and can be used, for example, within an orthosis of a foot drop system used in the treatment of drop foot. The electrode devices <NUM>, <NUM> and <NUM> can be used for example, in an orthosis device described in the <CIT>. The electrode devices <NUM>, <NUM> and <NUM> can include one or more conductor members and one or more electrode devices <NUM>, <NUM> and <NUM> can be coupled to an orthosis.

The large electrode device (<NUM>, <NUM>, <NUM>) is "large" in the sense that it is not narrowly focused for providing stimulation to a narrowly defined area. The size and shape of the large electrode device allows the large electrode device to be used to stimulate a larger group of muscles and produce a more comfortable stimulation. For example, a large electrode device can be configured to provide electrical stimulation to a substantial portion of a peroneal nerve when used, for example, to treat drop foot.

In one example use of a large electrode device with an orthosis configured to be coupled to a patient's upper leg as disclosed in the <CIT>, the resulting physiological effects achieved during the test include the following:.

The large electrode device is able to produce stimulation sufficient to treat a larger population of patients with a single sized device placed in substantially the same location for each patient. For example, in some embodiments, a large electrode device can have a size and shape configured to be used by <NUM>% of patients. The large electrode devices (<NUM>, <NUM>, <NUM>) can be configured to fit a left side, a right side, and/or both a left side and a right side orthosis, such as an orthosis used in the treatment of drop foot that is placed on the patient's right or left leg.

A large electrode device (e.g., <NUM>, <NUM>, <NUM>) can provide a quick and reproducible means of positioning electrodes inside an orthosis so as to decrease the time of electrode set-up and/or eliminate clinicians having to adjust the electrode position to achieve optimal stimulation results. A large electrode device can also decrease training time of the customer and eliminate the need to mark the precise position of electrodes with a marking pen on the user's body. While smaller electrodes can be effectively placed in one of many possible optimal positions, the use of the large electrode eliminates the need for more precise placement of the electrode and orthosis. The use of the large electrodes makes the orthosis "one size fits all" or "one size fits most.

In some embodiments, a large electrode device is placed at a location on the inside of the orthosis without regard to the particular patient for whom the device is being configured. In some embodiments, multiple large electrode devices are placed at a location on the inside of the orthosis without regard to the particular patient. In some embodiments, the electrode devices cover substantially all of the interior area of the orthosis to which they are coupled. For example, in some embodiments, the electrode devices span the interior area of the orthosis device other than, for example, the gap between the electrode devices and the gap, if any, between the outer edge of the electrode devices and the edge of the orthosis.

The large electrode devices (e.g., <NUM>, <NUM>, <NUM>), can have varied sizes and shapes and can be positioned on an orthosis to achieve various desired treatment results. In some embodiments, a large electrode device can include, for example, a first medial electrode (e.g., collectively the pad and conductor members) and a second lateral electrode (e.g., collectively the pad and conductor members) having sizes as shown in Table <NUM> below. The medial electrode can be positioned on an orthosis, for example, at a distance from the orthosis midline in the range of <NUM> to <NUM>. In some embodiments, the medial electrode and the lateral electrode can be coupled to a base of the large electrode at a non-zero distance from each other (e.g., a gap between the medial and lateral electrodes) of between <NUM> and <NUM>. For example, in some embodiments, the gap between the electrodes is <NUM>, <NUM>, or <NUM>. It should be understood that these are merely example sizes and positions and that the large electrode devices can have other combinations of widths and lengths and other shapes. For example, in some embodiments, a large electrode device (e.g., <NUM>, <NUM>) can include one or more electrodes (e.g., collectively the pad and conductor members) with a width between <NUM> and <NUM> and a length of about <NUM>. For example, a large electrode can have a width of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> and a length of, for example, <NUM>. The electrodes can also be positioned at different distances apart from each other and at different locations on an orthosis.

While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. The embodiments have been particularly shown and described, but it will be understood that various changes in form and details may be made.

For example, although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having any combination or sub-combination of any features and/or components from any of the embodiments described herein. The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different than the embodiments shown, while still providing the functions as described herein.

Claim 1:
An apparatus, comprising:
an electrode base (<NUM>, <NUM>); and
an electrode assembly (<NUM>, <NUM>), including:
a first conductor member (<NUM>, <NUM>) coupled to the electrode base;
a second conductor member (<NUM>, <NUM>) coupled to the electrode base;
a first pad (<NUM>, <NUM>) coupled to the electrode base such that the first conductor member is disposed between the electrode base and the first pad, the first pad and the first conductor member collectively forming a first electrode, a portion of the first pad configured to contact a skin surface; and
a second pad (<NUM>, <NUM>) coupled to the electrode base such that the second conductor member is disposed between the electrode base and the second pad, the second pad having a different shape than the first pad, the second pad and the second conductor collectively forming a second electrode, a portion of the second pad configured to contact the skin surface, the second electrode differing from the first electrode in size;
the electrode base (<NUM>, <NUM>) configured to be releasably couplable to an orthosis by one of hook and pile fasteners, press-studs, magnetic couplers or specialized holders that press a conductive back of the electrode assembly against a conductive stud or panel inside the orthosis, or a combination thereof such that the first conductor member and the second conductor member are each electrically coupled to the orthosis and not electrically coupled to each other.