Systems and methods for the delivery of electrical current to an oral cavity

Abstract

Systems and methods according to the present invention include a device for delivering non-invasive direct current electricity to the oral cavity of a non-human animal. The device generally comprises layers, wherein an electronic circuit assembly is protected within an enclosure, which itself is protected within a frame. Surrounding the frame, an electrically conductive elastomer is overmolded, wherein a conductive outer layer comprises nubs acting as anodic and cathodic electrodes. Surrounding those electrically conductive layers, an electrically insulative elastomer is overmolded, wherein the nubs reach through the insulative outer layer. When masticated, the non-human animal's mouth (teeth and / or gums) closes the circuit between the anodic and cathodic electrodes, delivering relatively weak direct current electricity to the animal's oral health benefit.

Description

[0001] Atty. Docket No.: 829-11294-PCT

[0002] - 1 -

[0003] Patent

[0004] SYSTEMS AND METHODS FOR THE DELIVERY OF ELECTRICAL CURRENT TO AN ORAL CAVITY

[0005] Background

[0006] This invention relates generally to the upkeep of oral hygiene in non-human animals. Animals, like humans, experience a variety of oral maladies, including cavity-causing oral microbes, biofilms, gingivitis and periodontitis. It is a goal of the present invention to reduce the occurrences of these maladies, as well as to promote oral health in non-human animals through increasing salivation, promoting gingival tissue regeneration, increasing blood flow in oral tissues, treating systemic oral bacterial diseases, fostering osteogenesis in the bones of the mouth and jaw, and treating other periodontal and oral maladies through non-invasive applications of weak direct current electricity.

[0007] Poor oral health, including periodontal diseases, have been shown to correlate with other health problems by doctors and veterinarians. For example, oral health directly has been shown to be an indicator of poor or failing health due to cardiovascular diseases, diabetes, pancreatic diseases, arthritis, and adverse pregnancy outcomes. Thus, methods and devices for improvement of oral health non-human animals are continually sought.

[0008] Summary of the Invention

[0009] The present invention relates to an apparatus for improving the oral health of a non-human animal. More particularly, embodiments of the present invention provide a non-invasive application of relatively weak direct current electricity to the oral cavity of a non-human animal to aid in treating periodontal diseases, killing bacteria, reducing biofilms, increasing salivation,Atty. Docket No.: 829-11294-PCT

[0010] -2 -fostering osteogenesis of bones, promoting gingival tissue regeneration, and treating other periodontal and systemic diseases and maladies.

[0011] According to an aspect of an embodiment of a system according to the present invention, the system includes an electrical circuit comprising an electrical power source. The system also includes a first frame supporting a first electrically conductive assembly overlayed by a first electrically insulative assembly, the first frame defining passage therethrough to enable a first electrical coupling to the power source. The system further includes a second frame supporting a second electrically conductive assembly overlayed by a second electrically insulative assembly, the second frame defining passage therethrough to enable a second electrical coupling to the power source. The first electrically conductive assembly comprises a first trace coupled with the first electrical coupling and also also electrically coupled with a first electrically conductive surface extending through the first electrically insulative assembly. The second electrically conductive assembly comprises a second trace coupled with the second electrical coupling and also coupled with a second electrically conductive surface extending through the second electrically insulative assembly. The first frame is preferably nondestructively removably (preferably manually removably, such as by mating structure such as threads, male / female snaps, or twist and lock pegs and slots) securable or secured to the second frame. The first and / or second electrically insulative assembly may further include a palatant.

[0012] According to another aspect of an embodiment of a system according to the present invention, the first and / or second frame(s) is / are hemispherical, and the electrical circuit is contained or enclosed between the first and second frames.

[0013] According to still another aspect of an embodiment of a system according to the present invention, the first electrically conductive surface comprises a first plurality of surfaces (e.g, nubs or pads) at least one of extending through, disposed on, or accessible through the first electrically insulative surface and the second electrically conductive surface comprises a second plurality of surfaces (e.g, nubs or pads) at least one of extending through, disposed on, or accessible through the second electrically insulative surface. The first plurality of surfaces is preferably polarized to a first electrical polarity (e.g., cathodic or anodic) and the second plurality of surfaces is preferablyAtty. Docket No.: 829-11294-PCT

[0014] - 3 -polarized to a second, opposite polarity (e.g., anodic or cathodic). The first and / or second plurality of surfaces may be substantially evenly spaced or dispersed about its respective frame.

[0015] According to an aspect of a second embodiment of a system according to the present invention, the system includes an electrical circuit comprising an electrical power source, and a first and second frame like the first embodiment. The first frame supports a first electrically conductive assembly overlayed by a first electrically insulative assembly, the first frame defining passage therethrough to enable a first and a third electrical coupling to the power source. The second frame supports a second electrically conductive assembly overlayed by a second electrically insulative assembly, the second frame defining passage therethrough to enable a second and a fourth electrical coupling to the power source. The first electrically conductive assembly comprises a first trace coupled with the first electrical coupling, the first trace also electrically coupled with a first electrically conductive surface extending through the first electrically insulative assembly. The second electrically conductive assembly comprises a second trace coupled with the second electrical coupling, the second trace also electrically coupled with a second electrically conductive surface extending through the second electrically insulative assembly. The first electrically conductive assembly further comprises a third trace coupled with the third electrical coupling, the third trace further coupled to the first electrically conductive assembly. The second electrically conductive assembly further comprises a fourth trace coupled with the fourth electrical coupling, the fourth trace further coupled to the second electrically conductive assembly. The first frame is preferably nondestructively removably (preferably manually removably, such as by mating structure such as threads, male / female snaps, or twist and lock pegs and slots) securable or secured to the second frame.

[0016] According to another aspect of the second embodiment of a system according to the present invention, the first electrically conductive surface comprises a first plurality of surfaces (e.g, nubs or pads) at least one of extending through, disposed on, or accessible through the first electrically insulative surface and the second electrically conductive surface comprises a second plurality of surfaces (e.g, nubs or pads) at least one of extending through, disposed on, or accessible through the second electrically insulative surface. The first plurality of surfaces preferably includesAtty. Docket No.: 829-11294-PCT

[0017] -4 -surfaces polarized to a first electrical polarity (e.g., cathodic or anodic) and surfaces preferably polarized to a second, opposite polarity (e.g., anodic or cathodic). The second plurality of surfaces preferably includes surfaces polarized to a first electrical polarity (e.g., cathodic or anodic) and surfaces preferably polarized to a second, opposite polarity (e.g., anodic or cathodic). The anodic and cathodic surfaces are preferably electrically insulated from each other by a respective electrically insulative assembly

[0018] According to still another aspect of the second embodiment of a system according to the present invention, the first plurality of surfaces is split into a first zone and a second zone, the first zone having a first electrical polarization and the second zone having second, opposite electrical polarization. The second plurality of surfaces is split into a third zone and a fourth zone, the third zone having a first electrical polarization and the fourth zone having a second, opposite polarization.

[0019] According to still another aspect of the second embodiment of a system according to the present invention, the electrical circuit is selectively programmable or configurable to change the polarity of each zone independently from the other zones.

[0020] According to an aspect of a third embodiment of a system according to the present invention, the system includes a body having an outwardly facing, at least substantially spherical electrically insulative surface and a plurality of electrically conductive surfaces at least one of extending through, disposed on, or accessible through, the electrically insulative surface. An electrical circuit operatively electrically coupled to the plurality of electrically conductive surfaces.

[0021] According to another aspect of a third embodiment of a system according to the present invention, the electrically insulative surface is preferably defined by a first set of opposing top and bottom hemispheres, a second set of opposing left and right hemispheres, and a third set of opposing front and back hemispheres, the first, second and third sets each being orthogonal to the others, wherein at least one of the plurality of electrically conductive surfaces is at least one of extending through, disposed on, or accessible through, each of at least one opposing set of hemispheres.

[0022] According to still another aspect of a third embodiment of a system according to the presentAtty. Docket No.: 829-11294-PCT

[0023] -5 -invention, the plurality of electrically conductive surfaces includes a top plurality and a bottom plurality. The top plurality is at least one of extending through, disposed on, or accessible through, the top hemisphere. The bottom plurality being at least one of extending through, disposed on, or accessible through, the bottom hemisphere. At least some of the top plurality are polarized to a first electrical polarity and at least some of the bottom plurality are polarized to a second electrical polarity, which is opposite the first electrical polarity. In a preferred implementation, all of the top plurality are polarized to the first electrical polarity and all of the bottom plurality are polarized to the second electrical polarity.

[0024] According to yet another aspect of a third embodiment of a system according to the present invention, the top plurality of electrically conductive surfaces includes a top-left subset and a topright subset. The top-left subset is at least one of extending through, disposed on, or accessible through, the left hemisphere (in addition to the top hemisphere). The top-right subset being at least one of extending through, disposed on, or accessible through, the right hemisphere (in addition to the top hemisphere). The bottom plurality of electrically conductive surfaces includes a bottomleft subset and a bottom-right subset. The bottom-left subset is at least one of extending through, disposed on, or accessible through, the left hemisphere (in addition to the bottom hemisphere). The bottom-right subset being at least one of extending through, disposed on, or accessible through, the right hemisphere (in addition to the bottom hemisphere). The top-left subset and the bottom-right subset are preferably polarized to a first electrical polarity and the top-right subset and the bottom-left subset are polarized to a second electrical polarity, which is opposite the first electrical polarity.

[0025] According to a further another aspect of a third embodiment of a system according to the present invention, the top-left, top-right, bottom-left, and bottom-right subsets each further include respective front and back subsets. The top-left-front subset is at least one of extending through, disposed on, or accessible through, the front hemisphere (in addition to the top hemisphere and the left hemisphere). The top-left-back subset is at least one of extending through, disposed on, or accessible through, the back hemisphere (in addition to the top hemisphere and the left hemisphere). The top-right-front subset is at least one of extending through, disposed on, orAtty. Docket No.: 829-11294-PCT

[0026] - 6 -accessible through, the front hemisphere (in addition to the top hemisphere and the left hemisphere). The top-right-back subset being at least one of extending through, disposed on, or accessible through, the back hemisphere (in addition to the top hemisphere and the left hemisphere). The bottom-left-front subset is at least one of extending through, disposed on, or accessible through, the front hemisphere (in addition to the bottom hemisphere and the left hemisphere). The bottom-left-back subset is at least one of extending through, disposed on, or accessible through, the back hemisphere (in addition to the bottom hemisphere and the left hemisphere). The bottom-right-front subset is at least one of extending through, disposed on, or accessible through, the front hemisphere (in addition to the bottom hemisphere and the left hemisphere). The bottom-right-back subset being at least one of extending through, disposed on, or accessible through, the back hemisphere (in addition to the bottom hemisphere and the left hemisphere). The top-left-front subset, the top-right-back subset, the bottom-left-back subset and the bottom-right-front subset are preferably polarized to a first electrical polarity and top-left-back subset, the top-right-front subset, the bottom -left-front subset and the bottom-right-back subset are preferably polarized to a second electrical polarity, which is opposite the first electrical polarity.

[0027] Brief Description of the Drawings

[0028] Figure 1A is a perspective view of a device according to the present invention. Figure IB is a front view of the device of Figure 1 A.

[0029] Figure 1C is atop elevated view of the device of Figure 1A.

[0030] Figure ID is a bottom elevated view of the device of Figure 1 A.

[0031] Figure 2A is a perspective view of a top section according to the present invention. Figure 2B is a front view of the top section of Figure 2A.

[0032] Figure 2C is a bottom elevated view of the top section of Figure 2A.

[0033] Figure 3A is a perspective view of a top frame according to the present invention. Figure 3B is a bottom elevated view of the top frame of Figure 3 A.

[0034] Figure 4A is a perspective view of a top conductive assembly according to the present invention.

[0035] Figure 4B is a bottom elevated view of the top conductive assembly of Figure 4A.Atty. Docket No.: 829-11294-PCT

[0036] - 7 - Figure 5A is a perspective view of a top insulative assembly according to the present invention.

[0037] Figure 5B is a bottom elevated view of the top insulative assembly of Figure 5 A. Figure 6 is a cross-sectional view of the top section of Figure 2A, taken along the 6-6 line of Figure 2C.

[0038] Figure 7A is a perspective view of a bottom section according to the present invention.

[0039] Figure 7B is a front view of the bottom section of Figure 7A.

[0040] Figure 7C is an elevated top view of the bottom section of Figure 7A. Figure 8A is a perspective view of a bottom frame according to the present invention.

[0041] Figure 8B is an elevated top view of the bottom frame of Figure 8A.

[0042] Figure 9A is a perspective view of a bottom conductive assembly according to the present invention.

[0043] Figure 9B is an elevated top view of the bottom conductive assembly of Figure 9A. Figure 10A is a perspective view of a bottom insulative assembly according to the present invention.

[0044] Figure 10B is an elevated top view of the bottom insulative assembly of Figure 10 A.

[0045] Figure 11 is a cross-sectional view of the bottom section of Figure 7A, taken along the 11-11 line of Figure 7C.

[0046] Figure 12A is a perspective view of an electronics assembly according to the present invention.

[0047] Figure 12B is an elevated side view of the electronics assembly of Figure 12A. Figure 13 A is a perspective view of an electronics module according to the present invention.

[0048] Figure 13B is an elevated side view of the electronics module of Figure 13A. Figure 14 is a cross-sectional view of the electronics assembly of Figure 12A, takenAtty. Docket No.: 829-11294-PCT

[0049] - 8 -along the 14-14 line of Figure 12B.

[0050] Figure 15A is a front side elevation view showing a first alternate division of nub polarity, where the rear side elevation view is identical and the left and right side elevation views are mirror images.

[0051] Figure 15B is a top plan view of the embodiment of Figure 15A.

[0052] Figure 16A is a perspective view of a second embodiment of a device according to the present invention.

[0053] Figure 16B is a front view of the device of Figure 16A.

[0054] Figure 16C is a left elevated view of the device of Figure 16A.

[0055] Figure 16D is a top elevated view of the device of Figure 16A.

[0056] Figure 16E is a bottom elevated view of the device of Figure 16A.

[0057] Figure 17A is a perspective view of a top section of the embodiment of Figure 16A. Figure 17B is a front view of the top section of Figure 17A.

[0058] Figure 17C is a bottom elevated view of the top section of Figure 17A.

[0059] Figure 18A is a perspective view of a top frame of the embodiment of Figure 16A. Figure 18B is a bottom elevated view of the top frame of Figure 18A. Figure 19A is a perspective view of a top conductive assembly of the embodiment of Figure 16 A.

[0060] Figure 19B is a bottom elevated view of the top conductive assembly of Figure 19A.

[0061] Figure 20A is a perspective view of a top insulative assembly of the embodiment of Figure 16 A.

[0062] Figure 20B is a bottom elevated view of the top insulative assembly of Figure 20A. Figure 21 is a cross-sectional view of the top section of Figure 17A, taken along the 21-21 line of Figure 17C.

[0063] Figure 22A is a perspective view of a bottom section of the embodiment of Figure 16 A.

[0064] Figure 22B is a front view of the bottom section of Figure 22A.Atty. Docket No.: 829-11294-PCT

[0065] - 9 - Figure 22C is an elevated top view of the bottom section of Figure 22A.

[0066] Figure 23 A is a perspective view of a bottom frame of the embodiment of Figure 16 A.

[0067] Figure 23B is an elevated top view of the bottom frame of Figure 23 A.

[0068] Figure 24A is a perspective view of a bottom conductive assembly of the embodiment of Figure 16A.

[0069] Figure 24B is an elevated top view of the bottom conductive assembly of Figure 24A.

[0070] Figure 25A is a perspective view of a bottom insulative assembly according to the present invention.

[0071] Figure 25B is an elevated top view of the bottom insulative assembly of Figure 25A.

[0072] Figure 26 is a cross-sectional view of the bottom section of Figure 22A, taken along the 26-26 line of Figure 22C.

[0073] Figure 27A is a perspective view of an electronics assembly of the embodiment of Figure 16A.

[0074] Figure 27B is an elevated side view of the electronics assembly of Figure 27A. Figure 28A is a perspective view of an electronics module of the embodiment of Figure 16A.

[0075] Figure 28B is an elevated side view of the electronics module of Figure 13 A. Figure 29 is a cross-sectional view of the electronics assembly of Figure 27A, taken along the 29-29 line of Figure 27A.

[0076] Detailed Description

[0077] Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention.

[0078] It is known in the art that some human oral bacteria cannot survive when exposedAtty. Docket No.: 829-11294-PCT

[0079] - 10 -to low-microampere direct current electricity. This method of killing oral bacteria and treating bacteria-caused conditions such as gingivitis has been demonstrated in Nachman, U.S. Pat. No.

[0080] 4,244,373 of Jan. 13, 1981 and in Detsch, U.S. Patent 4,509,519 of Apr. 9, 1985. Killing oral bacteria has the added benefit of preventing tooth decay and dental caries, or cavities. Generally, tooth decay is attributed to aerobic acid-producing bacteria whose acid causes uncompensated demineralization of the teeth. However, Nachman does not instruct optimal approaches to reducing oral bacteria including aerobic and anaerobic bacteria on a species-by-species level and instead teaches a generic, untargeted treatment.

[0081] It has been discovered that by delivering a current level preferably in the approximate range of 50 to 500 microamps, with ranges of 100 to 400 microamps, 110-200 microamps, 120-170 microamps, or 140-160 microamps being more preferable, a direct current electrical treatment is able to deliver new and unexpected therapeutic, prophylactic, and regenerative benefits previously unknown in the art. In a specific embodiment, the current is delivered at a generally constant 150 microamps.

[0082] Specifically, by utilizing a direct current in the aforementioned range, not only can such a treatment kill bacteria, but it can also kill or disable viruses and fungus as well. Studies from the podiatric field have shown that higher current levels than those used in existing oral electrical treatments are necessary to effectively treat fungal infections ("Low-Voltage Direct Current as a Fungicidal Agent for Treating Onychomycosis", Kalinowski, et al., Journal of the American Podiatric Medical Association Vol. 94 No.6: 565-572,2004). Thus, fungicidal and viricidal benefits have been additionally provided in conjunction with a method already known to be bactericidal. Studies have shown that these microbicidal properties begin to take effect within approximately 5 and 15 minutes of treatment, reducing both supra- and sub-gingival microbes.

[0083] A first embodiment 100 of a non-human animal treatment device is shown in Figures 1A-15B, most wholly in Figures 1A-D. The treatment device 100 generally includes an electronics assembly 180 comprising a power source 189 and situated within a top section 110 removably coupled to a bottom section 150, forming a substantially spherical device 100. Materials used for the top and bottom sections 110,150, respectively, preferably have sufficient mechanicalAtty. Docket No.: 829-11294-PCT

[0084] - 11 -resistance to not be chewed through immediately by a non-human animal (e.g., a dog), while also having sufficient elasticity to not be a danger to the non-human animal’s dental health, such as through tooth chipping and / or breaking. Materials such as silicone or thermoplastic elastomer (TPE) (preferably having a hardness measurable on the Shore A scale, such as having a Shore A hardness of less than 90) may be suitable to be used in creating the sections 110,150. The sections 110,150 are preferably manually removable from each other, as explained further below.

[0085] As seen most clearly in Figures 2A-C, the top section 110 of the device 100 generally comprises a top electrically conductive assembly 120, portions of which are exposed through a top electrically insulative assembly 130, both of which are supported by a top frame 112. The top section 110 also preferably optionally includes a depression or pit (or reentrant bore) 140, within which food or other items may be placed to encourage mastication of the device by a non-human animal. As shown in Figures 3A-B, the top frame 112 is preferably substantially hemispherical in shape and hollow, preferably having an open top cavity 114 within the top frame 112. Further, the top frame 112 most preferably comprises a mechanical coupling mechanism, such as one or more threads 116 provided about a free edge of the hemisphere, which allows the top section 110 to removably mate to the bottom section 150 as will be discussed further below. Finally, the top frame 112 preferably comprises a plurality of holes 118 extending through the top frame 112, as will also be discussed further below.

[0086] Preferably overlayed (e.g., over molded) onto the top frame 112 is the top conductive assembly 120, seen in Figures 4A-B, which preferably comprises a top conductive outer layer 122 overlayed onto the outside (convex) surface of the top frame 112 and a top conductive inner layer 128 overlayed onto the inner (concave) surface of the top frame 112. At least one of the outer conductive layer 122 and the inner conductive layer 128 receive electrical current from the power source 189. Preferably, the top conductive inner layer 128 first receives the electrical current through mechanical interface (touching) with one or more top section contacts 188, such as one or more leaf spring contacts, discussed further below in relation to the electronics assembly 180, at one or more respective contact points 128a. The top conductive outer layer 122 is most preferably in electronic communication with the top conductive inner layer 128 through aAtty. Docket No.: 829-11294-PCT

[0087] - 12 -series of top electrical conductors 129 (e.g., wires or stems), which are preferably at least contacting, but most preferably formed integrally with, each top conductive layer 122,128, thereby allowing the electric current to pass between the top conductive layers 122,128. The top conductive connectors 129 are disposed within and / or molded through one or more of the plurality of holes 118 in the top frame 112.

[0088] Protruding from the top conductive outer layer 122 are preferably a series of nubs consisting of two subsets, a first plurality of nubs 124 (preferably all of the same polarity when activated). As used herein, the term “nub” refers to a structure that includes a domed top extending about an axis 124a that is perpendicular to a tangent of the respective hemisphere. Each nub may include generally frustoconical side portion extending radially outward to the domed top. Each nub 124 preferably has a nub diameter 125 (measured perpendicular to the axis 124a). During use, the nubs 124 are preferably electrically coupled to one pole or the other of the power source 189, creating a plurality of anodic nubs or a plurality of cathodic nubs. Each nub 124 is also preferably substantially similar (if not identical, within manufacturing tolerances) to each other nub 124 in form factor. The nubs 124 are preferably substantially evenly dispersed about the top conductive outer layer 122, except in or around the pit 140.

[0089] Overlayed onto the top conductive assembly 120 is preferably a top insulative assembly 130, comprising a top insulative outer layer 132 and a top insulative inner layer 134 as seen in Figures 5A-B. The top insulative outer layer 132 preferably covers the entirety of top section 110 outer surface, except for the plurality of nubs 124 that remain exposed to ambient environment. The top insulative assembly 130 also has an accompanying top insulative inner layer 134, which is overlayed (inwardly) onto the top conductive inner layer 128 in the top frame cavity 114. The top insulative inner layer 134 is also mechanically coupled to and supported by the top conductive inner layer 128, or the top insulative outer layer 132 through connectors 136 that extend through one or more holes 118 in the top frame 112. The top electrically insulative layers 132,134 prevent electrical contact with the top conductive layers 122,128, except for the nubs 124 and the contact points 128a.

[0090] When manufactured, the various top conductive layers 122,128 and top insulativeAtty. Docket No.: 829-11294-PCT

[0091] - 13 -layers 132,134 are preferably affixed to and supported by the top frame 112, as seen in Figure 6. As also seen in Figure 6, the conductive nubs extend radially from the outwardly facing electrically insulative layer 132 along the nub axis 124a to a preferred nub height 127. Thus, as shown, the electrically conductive nubs 124 extend radially outwardly through the insulative layer 132. Alternative orientations are also contemplated. Rather than extending through the insulative layer 132 and protruding outwardly therefrom, the conductive layer 122 may be slightly recessed inwardly from the spherical outward layer 132, being accessible therethrough. Alternatively or additionally, the electrically conductive layer 122 may be disposed on the outer layer 132.

[0092] Similar to the top section 110, the bottom section 150 of the device 100, shown in Figures 7A-C, preferably generally comprises a bottom electrically conductive assembly 160, portions of which are exposed through a bottom electrically insulative assembly 170, both of which are supported by a bottom frame 152. The bottom frame 152, shown in Figures 8A-B, is preferably substantially hemispherical in shape and hollow, preferably having an open bottom cavity 154 within the bottom frame 152. Further, the bottom frame 152 most preferably comprises a mechanical coupling mechanism to mate with the top section 110, such as one or more threads 156 provided about a free edge of the hemisphere, which allows the bottom section 150 to selectively mate with the top section thread 116, allowing the sections 110,150 to be selectively secured together.

[0093] As seen in Figures 9A-B, the bottom conductive assembly 160 preferably comprises a bottom conductive outer layer 162 overlayed onto the outside (convex) surface of the bottom frame 152 and a bottom conductive inner layer 164 overlayed onto the inside (convex) surface of the bottom frame 152 within the bottom cavity 154, both the bottom conductive layers 162,164 being electrically conductive. In use, at least one of the bottom conductive outer layer 162 and inner layer 164 receives electrical current from the power source 189 through one or more electrical contacts, such as a bottom section leaf spring contact 194, discussed further in relation to the electronics assembly 180 below, which mechanically contacts one or more contact points 164a on the bottom conductive inner layer 164. The bottom conductive inner layer 164 then passes the electrical current to the bottom conductive outer layer 162 through a series of bottom electricalAtty. Docket No.: 829-11294-PCT

[0094] - 14 -conductors 166 (e g., wires or stems), which are preferably formed integrally with, or at least contacting, each of the bottom conductive layers 162, 164, thereby allowing electric current to pass therebetween. These conductors 166 are disposed within and / or molded through the bottom frame holes 158 in the bottom frame 152.

[0095] Protruding from the bottom conductive outer layer 162 is a first plurality of nubs 126 (preferably all of the same polarity when activated). Similar to the nubs 124 on the top assembly 110, the term “nub” refers to a structure that is generally frustoconical radially outward extension to a domed top extending about an axis 126a that is perpendicular to a tangent of the respective hemisphere. Each nub 126 preferably has a nub diameter 125 (measured perpendicular to the axis 126a). During use, the nubs 126 are preferably electrically coupled to one pole or the other of the power source 189 (the opposite pole from that electrically coupled to the top nubs 124), creating a plurality of cathodic nubs or a plurality of anodic nubs. Each nub 126 is also preferably substantially similar (if not identical, within manufacturing tolerances) to each other nub 126 in form factor. The nubs 126 are preferably substantially evenly dispersed about the bottom conductive outer layer 162.

[0096] Over! ay ed onto the top conductive assembly 160 is preferably a bottom insulative assembly 170, comprising a top insulative outer layer 172 and a bottom insulative inner layer 174 as seen in Figures 10A-B. The bottom insulative outer layer 172 preferably covers the entirety of bottom section 150 outer surface, except for the plurality of nubs 126 that remain exposed to ambient environment. The bottom insulative assembly 170 also has an accompanying bottom insulative inner layer 174, which is overlay ed (inwardly) onto the bottom conductive inner layer 164 in the top frame cavity 154. The bottom insulative inner layer 174 is also mechanically coupled to and supported by the bottom conductive inner layer 164, or the bottom insulative outer layer 172 through connectors 176 that extend through one or more holes 158 in the bottom frame 152. The bottom electrically insulative layers 172,174 prevent electrical contact with the bottom conductive layers 162,164, except for the nubs 126 and the contact point(s) 164a.

[0097] When manufactured, the various bottom conductive layers 162,164 and bottom insulative layers 172,174 are preferably affixed to and supported by the top frame 152, as seen inAtty. Docket No.: 829-11294-PCT

[0098] - 15 - Figure 11.

[0099] In manufacturing, the layers of the top section 110 and bottom section 150 are configured to be fixed (immovable with respect to each other), meaning that, once manufactured, the layers of the top section 110 do not come apart from one another, nor do the layers of the bottom section 150 come apart from one another. However, the top section 110 and bottom section 150 are selectively manually coupleable to each other, wherein the connection mechanisms, such as the thread(s) 116 of the top section 110 and the thread(s) 156 of the bottom section 150, are removably mated together. In embodiments featuring the threads 116,156, the sections 110,150 may be removably screwed together for use with the non-human animal, then unscrewed to access the electronics assembly 180 disposed within, explained further below.

[0100] As seen in Figures 12A-14, the electronics assembly 180 most preferably comprises an electronics module 182 disposed within a housing 190. The electronics module 182 most preferably further comprises a printed circuit board (PCB) 184 including electrical circuitry configured to control the device 100. Basic circuitry for electrical current delivery is known, and exemplary circuitry can be found in U.S. Patent No. 10,617,502, to Nemeh, et al., entitled “Concurrent treatment of oral and systemic maladies using direct current electricity,” which is incorporated herein by reference in its entirety. The circuitry in the module 182 preferably includes a power switch 185, one or more visual indicators (e.g., lights) 186, a charging port 187, and the one or more top section contacts 188. Also fully contemplated in the purview of the present invention to be included in the circuitry are timers, audile (e.g., sounds representative or imitative of a mouse squeak or bird chirp), tactile / haptic (e.g. vibrations provided by a vibratory motor such as a coin or pancake vibration motor), and / or visible prompts or feedback, or usage, activity and / or other power indicators (e.g. beeper, buzzer), motion activation (e.g. using an accelerometer), moisture activation, pressure activation, electrical current intensity adjustment (e.g. based on sensed impedance between a cathode and an anode), and / or the power switch 185 to control the possible current deliver to the power source 189. The module 182 is preferably in the form of a removable module 182 that may be reused with one or each of a second top assembly 110 and bottom assembly 150, such as if a first top assembly 110 and / or bottom assembly 150 becomeAtty. Docket No.: 829-11294-PCT

[0101] - 16 -destroyed through intended use (e.g., chewing) or accidentally broken or lost.

[0102] As shown in Figures 13A-B, the power switch 185 may take the form of a push button, which may be pressed to activate or deactivate the electronics module 182, but other types of switches (e.g. binary switches such as rocker, toggle, or rotary switches) are also contemplated. The visual indicators 186 may preferably be light-emitting diodes (LEDs) which are visible through the housing 190. The visual indicators 186 may provide a plurality of visual indications (e.g., colors and / or flash patterns) of device status and operating parameters, such as remaining battery capacity, battery charging status, on / off status, and / or error status. The charging port 187 is most preferably a USB-C charging port, but other types of ports are also contemplated, including USB types A, B, micro, mini, 8 pin, or Thunderbolt®.

[0103] Preferably in electrical connection with the PCB 184 (and more specifically electrical current regulators for current delivery) are one or more top section contacts 188, which are preferably spring contacts. In use, these top section contacts 188 extend from the electronics module 182 (through the housing 190) and most preferably contact against the top conductive inner layer 128 to facilitate the transfer of electric current from the electronics module 182 to the top conductive layers 122,128. The top section contacts 188 may all comprise a single polarity, delivering only one polarity of current to the nubs, or may comprise a mix of positive and negative polarities, as discussed further below.

[0104] Preferably disposed on the opposite side of the PCB 184 from the top section contacts 188 is the power source 189. The PCB 184 is most preferably in electrical communication at all times with the power source 189, which is preferably a dry-cell battery and even more preferably a rechargeable battery, such as a rechargeable lithium-ion or NiCad battery. Alternatively, the power source 189 could be a capacitor, a kinetic energy generator, a piezoelectric generator, a microcontrolled DC or AC power source, or other form of power source known in the art. Regardless of the type of power source 189 used, it is most preferable to control the amount of electrical current delivered by the device 100 to provide a relatively constant current power source to provide at least up to about 200 microamps, and preferably up to 500 microamps, of direct or alternating current. While 50 microamps to about 500 microamps may be a desired range,Atty. Docket No.: 829-11294-PCT

[0105] - 17 -about 50 microamps to about 250 microamps is preferred, and about 150 microamps is still further preferred.

[0106] In embodiments wherein the power source 189 is a rechargeable battery, a power cord may be plugged into the charging port 187 (and through any operative biasing circuitry), allowing the battery to recharge as needed. Similarly, the light indicators 186 most preferably indicate the amount of charge left in the power source 189, preferably using a color code. For example, when the device 100 is powered on and the power source 189 is at or near full, the light sources 186 may preferably emit a green light, in a steady pattern. When the power source 189 is below half of the charge it can hold, the light indicator 186 may preferably emit a yellow light and at low or near zero charge, the light indicator 186 preferably emit a red light. The power switch 185 is preferably configured to activate or deactivate connection of current regulation circuitry to the nubs 124, and may further facilitate the flow of power to the rest of the electronics module 182. Finally, the power source 189 is most preferably held static in relation to the PCB 184 by a first bracket 189a. The power source 189 may further rest on an optional foam bias or shockabsorbing member 192, which protects the power source 189 from being jostled or harmed from below, as seen in Figures 13A-14.

[0107] At the opposite end of the electronics module 182 from the top section contacts 188 is one or more bottom section contact 194. Like the top section contacts 188, the bottom section contact 194 is preferably a spring contact in electronic communication with the power source 189 and / or PCB 184. In the embodiment seen in the Figures 1-15B, there is only one bottom section contact 194, a single polarity (positive or negative) is established at the bottom section 150. However, alternate embodiments comprising multiple bottom section contacts 194 are also contemplated, comprising combination of polarities. The bottom section contact 194 may be held static with reference to the rest of the electronics module 182 through the use of a second bracket 194a. In use, the bottom section contact 194 contacts against the bottom conductive inner layer 164, facilitating current flow from the electronics module 182 the bottom conductive layers 162,164. The bottom section contact 194 is preferably aligned with and intersects a central axis 194b of the device 100.Atty. Docket No.: 829-11294-PCT

[0108] - 18 - Both the top section and bottom section contacts 188, 194, respectively, as described herein are preferably metal (e.g. bronze or steel alloy) spring contacts as known in the art, as shown in Figures 13A-14. However, other types of connectors are also contemplated, such as wires or cables. The coupling of the contacts 188,194 to the power source 189 is not required to be a direct coupling, but rather may be indirect coupling through a variety of other electrical passive or active electrical components, such as one or more voltage regulators, operational amplifiers, transistors, microcontrollers, voltage converters, inverters, etc. Regardless of the specific circuit design, it is preferable that the electronics module 182 be able to supply a stimulation (pulsed or steady) current of about 50 microamps to about 500 microamps to a load of up to about 70 kilo-ohms. More preferably, to such load, a stimulation current of about 50-250 microamps, and still more preferably, a current of about 150 microamps has been shown to be effective. A circuit will be completed by an animal’s mouth when the device 100 is masticated.

[0109] Surrounding, and preferably substantially encasing, the electronics module 182 is the electronics housing 190, most preferably comprising a cover 190a, side wall 190b, and base portion 190c. The housing 190 preferably protects the various parts within the electronics module 182 from damage, both during use within the device 100 and when or if the module 182 is taken out of the device 100, such as for charging. The cover 190a most preferably substantially shields the PCB 184 and power supply 189. However, various components preferably extend through the cover 190a. For example, the top section contacts 188 preferably extend through the cover 190a, allowing the electronics module 182 to provide power to the top section conductive layers 122,128. Further, the charging port 187 and power switch 185 are preferably accessible through the cover 190a, such as by being disposed substantially flush with the surface of the cover 190a as shown in Figures 13A-B. Finally, the one or more light sources 186 on the PCB 184 are most preferably viewable through the cover 190a, such as through a hole in the cover 190a.

[0110] The housing side wall 190b and base 190c preferably cooperate with the cover 190a to substantially encase the electronics module 182. Further, like the top section contacts 188 extending through the cover 190a, the bottom section contact 194 preferably extends through the base 190c to allow electronic connection between the electronics module 182 and the bottomAtty. Docket No.: 829-11294-PCT

[0111] - 19 -section conductive layers 162,164. The various components of the housing 190 are most preferably removably secured to each other, allowing access to the electronics module 182 within. In other embodiments, the housing 190 may be relatively permanently closed, such as by adhesive or ultrasonic welding.

[0112] In use, the electronics assembly 180 is most preferably placed into the bottom section 150 of the device 100, with the bottom section contact 194 abutted against the bottom section conductive inner layer 164. An advantage of the arrangement(s) of contacts 188,194 discussed herein is that placement of the electronics assembly 180 may not require horizontal (left to right in Fig. lb) rotational registration in a particular position to ensure proper electrical contact between those contacts 188,194 and respective conductive nubs 124,126. That is, as long as the bottom contact 194 is inserted into the bottom assembly 150, the rotational alignment of the contacts 188,194, no matter the left-right rotational angle of insertion, are aligned properly. Further embodiments may alternatively include inner electrical layers 122, 162 patterned to provide electrical contacts that allow for either vertical (top to bottom in Fig. lb) rotational registration. If the electronics module 182 is powered (i.e. the power source battery is charged), a user may engage the power switch 185 (e.g. press the power button) to turn on the device 100 and allow a flow of electric current during mastication.

[0113] The user may view the charge level of the device 100 by observing the color and / or pattern shown from the light indicators 186 through the electronic assembly cover 190a, as explained above. If the light indicator 186 demonstrates a dead battery, the user can plug a power cord into the charging port 187 on the electronics module 182 to recharge the power source 189. If the light source 186 indicates some level of battery charge, the user can choose to charge (or replace, if a nonrechargeable source is used) the power source 189 further or begin use of the device 100 with a non-human animal. The user may then connect the top section 110 of the device 100 to the bottom section 150 by mating the threads 116,156, such as by mating and rotating the sections 110,150 together. In doing so, the top section contacts 188 abut the top section conductive inner layer 128.

[0114] When a non-human animal licks or bits down on the device 100, at least one of theAtty. Docket No.: 829-11294-PCT

[0115] -20 -first plurality of first polarity nubs 124 and at least one of the second plurality of second polarity nubs 126 contact the teeth, oral tissue, and / or saliva of the non-human animal, closing the circuit between the anodic and cathodic portions and allowing delivery of electric current, preferably between 50 and 250 microamps and most preferably approximately 150 microamps, through to the saliva and / or across teeth and / or along the oral tissue of the animal. As discussed above, this electrical charge has numerous health benefits, including therapeutic, prophylactic, and regenerative benefits previously unknown in the art. It is further contemplated by the present invention that the treatment apparatus 100 is preferably used by non-human animals, such as felines, bovines, ovines, canines, equines, porcines, etc.

[0116] To make the device 100, the frames 112,152 are molded, machined, or otherwise formed, preferably of plastic, and in a general form capable of supporting elastomer overmolding. The frames 112,152 may be individually placed in a first respective mold providing a void to be filled with an electrically conductive elastomer to form the conductive surface(s) (e.g. nubs 124,126 and conductive layers 122,128,162,164). The conductive elastomer is injected into the first mold and the conductive elastomer is allowed to sufficiently cure. A second mold is used to provide a void to be filled with an electrically insulative elastomer to form the insulative surface(s) (e.g. insulative layers 132,134,172,174). The insulative elastomer is injected into the second mold (which already contains the one of the frames 112,152 and its respective conductive layers 122,128,162,164) and the insulative elastomer is allowed to sufficiently cure.

[0117] After the elastomers have sufficiently cured, the electronic assembly 180 is placed into the bottom section cavity 154 such that the bottom section contact 194 abuts the bottom section contact point 164a, establishing the electrical connection between the electronic assembly 180 and the bottom section conductive assembly 160 when the electronic assembly 180 is activated. The top section 110 may then be attached (i.e. screwed) to the bottom section 150, causing the top section contacts 188 to abut the top section contact point(s) 128a, establishing the electrical connection between the electronic assembly 180 and the top section conductive assembly 120 when the electronic assembly 180 is activated. Components of the device 100 may be packaged for delivery in various configurations. In a first sealed package, only a top section 110 (without aAtty. Docket No.: 829-11294-PCT

[0118] -21 -bottom section 150 and without an electronic assembly 180) may be provided. In a second sealed package configuration, only a bottom section 150 (without a top section 110 and without an electronic assembly 180) may be provided. In a third sealed package configuration, a top section 110 and a bottom section 150 coupled or uncoupled (without an electronic assembly 180) may be provided. In a fourth sealed package configuration, only an electronic assembly 180 (without a top section 110 and without a bottom section 150) may be provided. In a fifth sealed package configuration, a top section 110 and a bottom section 150 coupled or uncoupled, and an electronic assembly 180, may be provided

[0119] In some embodiments of the present invention, the pluralities of nubs 124,126 of each respective section 110,150 may comprise alternative arrangements to those described above. For example, in some embodiments, the top section 110 may have all nubs of the same first polarity 124, while the bottom section 150 may have all nubs of the same second polarity 126, or vice versa, as described above. Other arrangements and electrical connectivity are thought to be evident from the instant disclosure as long as at least one nub of each polarity 124,126 is in contact with the mouth or oral tissue of the animal causing electrical current conduction therebetween. As seen in Figures 15A-B, some embodiments of the device 100 according to the present invention may be split into polarity zones, which may generally be defined by orthogonal hemispheres (sets of opposite top / bottom, left / right, and front / back) of the at least substantially spherical outwardly facing electrically insulative surface layer 132. For instance, in embodiments wherein the top section contacts 188 and bottom section contacts 194 comprise a combination of positive and negative polarities, the device 100 may have areas of positive polarity nubs and negative polarity nubs, rather than hemispherical sections 110,150 of a single polarity or alternating polarity with each nub. Such embodiments require that the conductive assemblies 120,160 not be formed integrally, rather the polarity zones are preferably insulated from zones of opposite polarity (i.e. all positive zones insulated from all negative zones). Alternative polarity zones are also contemplated, such as having one side / hemi sphere of the device 100 comprise one polarity and the other side the other polarity. These polarity zones increase the likelihood that the non-human animal will make oral contact with at least one zone of each polarity at once, completing the circuitAtty. Docket No.: 829-11294-PCT

[0120] -22 -and delivering current to the non-human animal’s oral tissues. While polarity zones are shown as bifurcating nubs 124,126, it is to be understood that such display is a theoretical display, and each nub would be one of two polarities.

[0121] In some embodiments of the present invention, one or more of the various non-conductive portions of the device 100, such as the top insulative outer layer 132 and bottom insulative outer layer 172, may further comprise palatants and / or other flavorings added during the manufacturing process. Such palatants may be known in the art, such as meat or non-meat-based palatants that encourage the non-human animal to chew on the device 100, which increases the chances that the circuit is completed and current is delivered to the non-human animal’ s oral tissue. Such palatants may include proteins, yeasts, phosphates, antioxidants, antimicrobials, processing agents, and / or other ingredients to enhance flavor and / or smell.

[0122] A second embodiment 200 of the non-human animal treatment device can be seen in Figures 16A-29. System 200 shares most of the properties and operations of the first embodiment system 100, such that like numbers (110 and 210, 112 and 212, etc.) refer to the structures having substantially the same form and / or function. However, as can be seen most clearly in Figures 16A-E, second embodiment 200 preferably comprises smaller nubs 224, 226, such that the nubs 224, 226 barely rise above the insulative outer layers 232, 274. Additionally or alternatively, the pit 240 of the second embodiment 200 is much more shallow than the pit 140 described before, but still substantially serves to hold an attractant or treat (such as a palatant). Additionally or alternatively, the pit 240 may be entirely absent from the second embodiment 200 and / or additionally include, or is replaced by, embossed letters (not shown).

[0123] As seen in Figures 16A-E, the nubs 224, 226 are not dispersed uniformly around the top and bottom sections 210, 250 as they were in the first embodiment 100. This is because the second embodiment 200 preferably comprises the polarized quadrants discussed previously with relation to Figure 15 A. That is, the nubs 224, 226 on each section 210, 250 are clumped together according to their polarity, with a clear division between the two polarized groups. Most preferably, and as seen in the Figures, the placement of the nubs 224, 226 are offset between the top section 210 and bottom section 250, wherein the groups of nubs 224, 226 on the top sectionAtty. Docket No.: 829-11294-PCT

[0124] -23 - 210 are vertically aligned with the open space on the bottom section 250 created by the division of the polarized nub groups. The same is true for the bottom section 250, wherein the nub groups 224, 226 are vertically aligned with the open space on the top section 210. This placement scheme increases the chances that the non-human animal, when chewing on the device 200, will contact at least one nub in each of the nub groups 224, 226, which completes the circuit to deliver electric current to the teeth and gingival tissue of the non-human animal.

[0125] To accomplish the separation of the nub groups 224, 226 on each of the top section 210 and bottom section 250, some of the internal structures of the second embodiment 200 are slightly different than the first embodiment 100. For example, the top frame 212 (seen in Figures 18A-B) preferably includes a protruding divider 213 that divides the top conductive assembly 220 into to sections (seen in Figures 19A-B). The top conductive assembly 220 is thus in two parts, with a gap 223 between them into which the divider 213 slots. This division creates the two polarized groups of nubs 224, 226, such that all nubs in one group maintain the same polarity without risk of crossing with the other group. Similarly, the bottom frame 252 also comprises a divider 253 which slots into a gap 268 in the bottom conductive assembly 260 to divide the two polarized nub groups 224, 226 as seen in Figures 23A-24B. The electronics module housing 290 may further comprise a gap 291 in the base section 290c where the divider 253 in the bottom frame may slot.

[0126] Finally, the electronics module 280 may have some slight differences from the electronic module 180 of the first embodiment 100. For example, there are preferably only two top sections contacts 288 protruding from opposite ends of the housing cover 290a as seen in Figures 27A-28B. Each top section contact 288 preferably transfers electrical current to one group of polarized nubs 224, 226 in the top section 210. Similarly, there are preferably two bottom section contacts 294 protruding from the housing base 290c, one for each of the polarized nub groups 224, 226, as seen in Figures 27B-29. Otherwise, the electronics module 280 contains substantially the same components as the electronics module 181 of the first embodiment 100.

[0127] The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in theAtty. Docket No.: 829-11294-PCT

[0128] -24 -art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention.

Claims

Atty. Docket No.: 829-11294-PCT-25 - We claim:

1. A system comprising:an electrical circuit comprising an electrical power source;a first frame supporting a first electrically conductive assembly overlayed by a first electrically insulative assembly, the first frame defining passage therethrough to enable a first electrical coupling to the power source; anda second frame supporting a second electrically conductive assembly overlayed by a second electrically insulative assembly, the second frame defining passage therethrough to enable a second electrical coupling to the power source,wherein the first electrically conductive assembly comprises a first trace coupled with the first electrical coupling, the first trace also electrically coupled with a first electrically conductive surface extending through the first electrically insulative assembly,wherein the second electrically conductive assembly comprises a second trace coupled with the second electrical coupling, the second trace also electrically coupled with a second electrically conductive surface extending through the second electrically insulative assembly, andwherein the first frame is removably securable to the second frame.

2. The system according to claim 1, wherein at least one of the first frame and the second frame is shaped as a hemisphere.

3. The system of claim 2, wherein the first frame is removably secured to the second frame, and the electrical circuit is enclosed between the first and second frames.

4. The system of claim 1, wherein the first electrically conductive surface comprises a first plurality of nubs extending through the first electrically insulative surface and the second electrically conductive surface comprises a second plurality of nubs extending through the second electrically insulative surface.

5. The system of claim 4, wherein the first plurality of nubs have a first electrical polarization and the second plurality of nubs have a second, opposite polarization.

6. The system of claim 5, wherein the first plurality of nubs are substantially evenlyAtty. Docket No.: 829-11294-PCT-26 -dispersed over a surface of the first frame.

7. The system of claim 6, wherein the second plurality of nubs are substantially evenly dispersed over a surface of the second frame.

8. A system comprising:an electrical circuit comprising an electrical power source;a first frame supporting a first electrically conductive assembly overlayed by a first electrically insulative assembly, the first frame defining passage therethrough to enable a first and a third electrical coupling to the power source; anda second frame supporting a second electrically conductive assembly overlayed by a second electrically insulative assembly, the second frame defining passage therethrough to enable a second and a fourth electrical coupling to the power source,wherein the first electrically conductive assembly comprises a first trace coupled with the first electrical coupling, the first trace also electrically coupled with a first electrically conductive surface extending through the first electrically insulative assembly,wherein the second electrically conductive assembly comprises a second trace coupled with the second electrical coupling, the second trace also electrically coupled with a second electrically conductive surface extending through the second electrically insulative assembly,wherein the first electrically conductive assembly further comprises a third trace coupled with the third electrical coupling, the third trace further coupled to the first electrically conductive assembly,wherein the second electrically conductive assembly further comprises a fourth trace coupled with the fourth electrical coupling, the fourth trace further coupled to the second electrically conductive assembly, andwherein the first frame is removably securable to the second frame.

9. The system of claim 8, wherein the first electrically conductive surface comprises a first plurality of nubs and the second electrically conductive surface comprises a second plurality of nubs.Atty. Docket No.: 829-11294-PCT-27 - 10. The system of claim 9, wherein the first plurality of nubs comprises nubs having anodic polarization and nubs having cathodic polarization.

11. The system of claim 10, wherein the nubs in the first plurality having anodic polarization are insulated from the nubs in the first polarity having cathodic polarization by the first electrically insulative assembly.

12. The system of claim 11, wherein the second plurality of nubs comprises nubs having anodic polarization and nubs having cathodic polarization.

13. The system of claim 12, wherein the nubs in the second polarity having anodic polarization are insulated from the nubs in the second polarity having cathodic polarization by the second electrically insulative assembly.

14. The system of claim 13, wherein the first plurality of nubs is split into a first zone and a second zone, the first zone having anodic polarization and the second zone having cathodic polarization.

15. The system of claim 14, wherein the second plurality of nubs is split into a third zone and a fourth zone, the third zone having anodic polarization and the fourth zone having cathodic polarization.

16. The system of claim 15, wherein the electrical circuit is configurable to change the polarity of each zone independently from the other zones.

17. The system of claim 1, wherein at least one of the first electrically insulative assembly and the second electrically insulative assembly further comprises one or more palatants.

18. A system comprising:a body having an outwardly facing, at least substantially spherical electrically insulative surface;a plurality of electrically conductive surfaces at least one of extending through, disposed on, or accessible through, the electrically insulative surface;an electrical circuit operatively electrically coupled to the plurality of electrically conductive surfaces.

19. The system of claim 18, the electrically insulative surface being defined by a first setAtty. Docket No.: 829-11294-PCT-28 -of opposing top and bottom hemispheres, a second set of opposing left and right hemispheres, and a third set of opposing front and back hemispheres, the first, second and third sets each being orthogonal to the others,wherein at least one of the plurality of electrically conductive surfaces is at least one of extending through, disposed on, or accessible through, each of at least one opposing set of hemispheres.

20. The system of claim 19, further comprising:a top plurality of the plurality of electrically conductive surfaces, the top plurality being at least one of extending through, disposed on, or accessible through, the top hemisphere;a bottom plurality of the plurality of electrically conductive surfaces, the bottom plurality being at least one of extending through, disposed on, or accessible through, the bottom hemisphere, wherein at least some of the top plurality are polarized to a first electrical polarity and at least some of the bottom plurality are polarized to a second electrical polarity, which is opposite the first electrical polarity.

21. The system of claim 20, wherein all of the top plurality are polarized to the first electrical polarity and all of the bottom plurality are polarized to the second electrical polarity.

22. The system of claim 20, further comprising:a top-left subset of the top plurality of the plurality of electrically conductive surfaces, the top-left subset being at least one of extending through, disposed on, or accessible through, the left hemisphere;a top-right subset of the top plurality of the plurality of electrically conductive surfaces, the top-right subset being at least one of extending through, disposed on, or accessible through, the right hemisphere,a bottom-left subset of the bottom plurality of the plurality of electrically conductive surfaces, the bottom-left subset being at least one of extending through, disposed on, or accessible through, the left hemisphere; anda bottom-right subset of the bottom plurality of the plurality of electrically conductive surfaces, the bottom-right subset being at least one of extending through, disposed on, or accessibleAtty. Docket No.: 829-11294-PCT-29 -through, the right hemisphere.

23. The system of claim 22, wherein the top-left subset and the bottom-right subset are polarized to a first electrical polarity and the top-right subset and the bottom-left subset are polarized to a second electrical polarity, which is opposite the first electrical polarity.

24. The system of claim 22, further comprising:a top-left-front subset of the top-left subset of the plurality of electrically conductive surfaces, the top-left-front subset being at least one of extending through, disposed on, or accessible through, the front hemisphere;a top-left-back subset of the top-left subset of the plurality of electrically conductive surfaces, the top-left-back subset being at least one of extending through, disposed on, or accessible through, the back hemisphere;a top-right-front subset of the top-right subset of the plurality of electrically conductive surfaces, the top-right-front subset being at least one of extending through, disposed on, or accessible through, the front hemisphere;a top-right-back subset of the top-right subset of the plurality of electrically conductive surfaces, the top-right-back subset being at least one of extending through, disposed on, or accessible through, the back hemisphere;a bottom-left-front subset of the bottom-left subset of the plurality of electrically conductive surfaces, the bottom-left-front subset being at least one of extending through, disposed on, or accessible through, the front hemisphere;a bottom-left-back subset of the bottom-left subset of the plurality of electrically conductive surfaces, the bottom-left-back subset being at least one of extending through, disposed on, or accessible through, the back hemisphere;a bottom-right-front subset of the bottom-right subset of the plurality of electrically conductive surfaces, the bottom-right-front subset being at least one of extending through, disposed on, or accessible through, the front hemisphere; anda bottom-right-back subset of the bottom-right subset of the plurality of electrically conductive surfaces, the bottom-right-back subset being at least one of extending through,Atty. Docket No.: 829-11294-PCT- 30 -disposed on, or accessible through, the back hemisphere;wherein the top -left-front subset, the top-right-back subset, the bottom-left-back subset and the bottom-right-front subset are polarized to a first electrical polarity and top-left-back subset, the top-right-front subset, the bottom-left-front subset and the bottom-right-back subset are polarized to a second electrical polarity, which is opposite the first electrical polarity.

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