U.S. patent application number 14/591629 was filed with the patent office on 2015-07-09 for systems and methods for the treatment of oral and systemic maladies in animals using electrical current.
This patent application is currently assigned to ANIMAL ORALECTRICS LLC. The applicant listed for this patent is ANIMAL ORALECTRICS LLC. Invention is credited to Robert Armstrong, Michael V Kaminski, Michael J. Keller, Scott Mizer, Paul L Ruflin.
Application Number | 20150190631 14/591629 |
Document ID | / |
Family ID | 53494434 |
Filed Date | 2015-07-09 |
United States Patent
Application |
20150190631 |
Kind Code |
A1 |
Ruflin; Paul L ; et
al. |
July 9, 2015 |
SYSTEMS AND METHODS FOR THE TREATMENT OF ORAL AND SYSTEMIC MALADIES
IN ANIMALS USING ELECTRICAL CURRENT
Abstract
Systems and methods for the concurrent treatment of multiple
oral diseases and defects while promoting general oral hygiene
utilizing electricity are provided for non-human animals.
Electrodes are used to deliver an electrical current to the
gingival tissues of a mouth in order to achieve a number of
therapeutic, prophylactic, and regenerative benefits. These
benefits include killing oral microbes, increasing oral
vasodilation, reducing oral biofilm, improving oral blood
circulation, reversing oral bone resorption, promoting oral
osteogenesis, treating gum recession, and fostering gingival
regeneration. Other benefits include the treatment of gingivitis,
periodontitis, and oral malodor, and other systemic diseases
correlated with oral pathogens.
Inventors: |
Ruflin; Paul L; (Gates
Mills, OH) ; Keller; Michael J.; (Tallmadge, OH)
; Kaminski; Michael V; (Elyria, OH) ; Mizer;
Scott; (Lakewood, OH) ; Armstrong; Robert;
(Solon, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ANIMAL ORALECTRICS LLC |
Cleveland |
OH |
US |
|
|
Assignee: |
ANIMAL ORALECTRICS LLC
Cleveland
OH
|
Family ID: |
53494434 |
Appl. No.: |
14/591629 |
Filed: |
January 7, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61924381 |
Jan 7, 2014 |
|
|
|
Current U.S.
Class: |
607/134 |
Current CPC
Class: |
A61D 5/00 20130101; A61N
1/36014 20130101; A61N 1/205 20130101; A61N 1/0548 20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05 |
Claims
1. A device comprising: a body having an external surface, the body
at least partially surrounding a first cavity; a first electrically
conductive surface forming a first portion of the external surface;
a second electrically conductive surface forming a second portion
of the external surface; and a power source disposed in the first
internal cavity, wherein the first electrically conductive surface
is in electrical communication with a first pole of the power
source and the second electrically conductive surface is in
electrical communication with a second pole of the power
source.
2. A device according to claim 1, wherein the body at least
partially comprises an hourglass shape.
3. A device according to claim 2, wherein the body extends between
a first end and a second end and the external surface comprises at
least one circumferential ridge located between the first end and
the second end.
4. A device according to claim 3, wherein the first electrically
conductive surface and the second electrically conductive surface
are disposed on a single ridge of the at least one circumferential
ridge.
5. A device according to claim 3, comprising a plurality of
circumferential ridges located between the first end and the second
end.
6. A device according to claim 5, wherein the first electrically
conductive surface is disposed on a first plurality of the
plurality of circumferential ridges.
7. A device according to claim 6, wherein the second electrically
conductive surface is disposed on a second plurality of the
plurality of circumferential ridges.
8. A device according to claim 7, wherein the first plurality of
circumferential ridges is the same as the second plurality of
circumferential ridges.
9. A device according to claim 8, wherein the external surface
comprises an electrically insulative portion disposed between the
first electrically conductive surface and the second electrically
conductive surface.
10. A device according to claim 9, wherein the electrically
insulative portion is formed from an elastomeric material having a
first durometer hardness and the first and second electrically
conductive surfaces having a second durometer hardness.
11. A device according to claim 10, wherein the first durometer
hardness is substantially the same as the second durometer
hardness.
12. A device according to claim 1, the body extending
longitudinally along a length between a first end and an opposed
second end, wherein the first cavity extends through the first end
and towards the second end, the device further comprising a second
cavity extending through the second end towards the first end.
13. A device according to claim 12, wherein one of the first cavity
and the second cavity is longer than one half of the length.
14. A device according to claim 1, wherein when the first
conductive surface and the second conductive surface are
electrically coupled through a load resistance of up to about 70
kilo-ohms, an electrical current of between 50 microamps and 500
microamps will flow through the load resistance.
15. A device according to claim 14, wherein the electrical current
is about 50 microamps to about 250 microamps.
16. A device according to claim 15, wherein the electrical current
is about 100 microamps.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of co-pending U.S.
Provisional Patent Application Ser. No. 61/924,381, filed 7 Jan.
2014, and entitled "Systems and Methods for the Treatment of Oral
and Systemic Maladies in Animals Using Electrical Current," which
is incorporated herein by reference in its entirety.
BACKGROUND
[0002] This invention relates to a method of concurrently promoting
general oral hygiene in non-human animals, treating periodontal
diseases such as gingivitis and periodontitis, killing oral
microbes including cavity-causing bacteria, reducing oral biofilms,
increasing blood flow in oral tissues, increasing salivation,
promoting gingival tissue regeneration, fostering osteogenesis in
the boney structures of the teeth, mouth and related areas,
treating systemic diseases associated with oral bacteria, and
treating other periodontal and oral maladies through the
non-invasive application of weak direct current electricity to the
surfaces in the oral cavity, and it also relates to an apparatus
suitable for providing direct current electricity for these
therapeutic, prophylactic, and regenerative effects.
[0003] Periodontal disease has been identified as a risk factor for
various systemic diseases by dentists, physicians, and
veterinarians. Included in these diseases are cardiovascular
disease, adverse pregnancy outcomes, and diabetes with newfound
evidence supporting its association with pancreatic diseases and
arthritis. While many of the studies establish correlation between
the presence of periodontal disease and these systemic conditions,
causation, with most of these conditions, is still a subject of
ongoing research. A few of the biological mechanisms which have
been proposed as to how oral bacteria stemming from periodontal
disease can cause systemic disease are as followed:
[0004] 1. Direct effect of oral infections: Oral microbes and their
byproducts can gain systemic access via the circulatory system
through traveling through compromised tissue and inflamed
periodontium in the oral cavity. In gaining systemic access, oral
microbes have the potential to directly influence subclinical
mediators of various systemic diseases.
[0005] 2. Inflammation: People with periodontal disease have
elevated levels of systemic inflammatory markers due to the burden
of increased levels of oral bacteria. Treatment for periodontal
disease has been reported to decrease systemic inflammation
levels.
[0006] 3. Cross-reactivity: The progression of systemic diseases
can be accelerated by the immune response to bacterial heat-shock
proteins creating antibodies that cross-react with innate heat
shock proteins expressed on cells of the damaged tissues.
SUMMARY OF THE INVENTION
[0007] The present invention relates to an apparatus for aiding
overall oral health of a non-human animal, and more particularly to
treating periodontal diseases such as gingivitis and periodontitis,
killing oral microbes including cavity-causing bacteria, reducing
oral biofilms, increasing blood flow in oral tissues, increasing
salivation, promoting gingival tissue regeneration, fostering
osteogenesis in the boney structures of the teeth, mouth and
related areas, treating systemic diseases associated with oral
bacteria, and treating other periodontal and oral maladies through
the non-invasive application of weak direct current electricity to
the surfaces in the oral cavity.
[0008] One aspect of the present invention includes a device
including an electrical power source and a plurality of
electrically conductive surfaces (which may include an electrically
conductive polymer and/or fabric) on an external surface of the
device. The treatment device may be provided to the animal to be
drawn at least partially into its mouth and in contact with an oral
secretion or tissue, such as at least one of saliva, lingual
tissue, dental tissue, gingival tissue, periodontal tissue, and
oral mucosa tissue. The oral secretion and/or tissue provides an
electrically conductive path between at least two of the conductive
surfaces and electrical current is delivered to the electrically
conductive path by at least one of the conductive surfaces.
[0009] According to another aspect of a device according to the
present invention, the treatment device may regulate the current
that is delivered, such as from about 50 microamps to about 500
microamps, with about 50 microamps to about 250 microamps being
preferred, and about 100 microamps being still further
preferred.
[0010] According to yet another aspect of a device according to the
present invention, the device may further include the step of
activating the treatment apparatus an on/off switch, which may be a
motion-activated switch (such as a reed switch in combination with
a magnet), an accelerometer, or a moisture-activated switch.
[0011] According to a further aspect of a device according to the
present invention, the treatment device may include a timer, which
may cease delivery of electrical current or potential to the
conductive surfaces, such as by disconnecting the power source from
the conductive surfaces, after a predetermined time.
[0012] According to yet a further aspect of a system or method
according to the present invention, the electrical current
delivered by the treatment apparatus may be direct current, which
may be pulsed direct current. Additionally or alternatively, the
treatment apparatus may be capable of delivering alternating
current, which may be pulsed, and delivered at a constant or
variable frequency.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a first embodiment of a
device according to the present invention.
[0014] FIG. 2 is a front elevation view of the embodiment shown in
FIG. 1.
[0015] FIG. 3 is a right side elevation view of the embodiment of
FIG. 1.
[0016] FIG. 4 is a top plan view of the embodiment of FIG. 1.
[0017] FIG. 5 is a bottom plan view of the embodiment of FIG.
1.
[0018] FIG. 6 is a cross-sectional view taken along line 6-6 of
FIG. 2.
[0019] FIG. 7 is a cross-sectional view taken along line 7-7 of
FIG. 3.
[0020] FIG. 8 is a cross-sectional view taken along line 8-8 of
FIG. 4.
[0021] FIG. 9 is a schematic view of an embodiment of an electrical
circuit according to the present invention.
[0022] FIG. 10 is a front elevation view of a second embodiment of
a device according to the present invention.
[0023] FIG. 11 is a cross-sectional view taken through the center
of the embodiment of FIG. 10, parallel to the elevation view of
FIG. 10.
DETAILED DESCRIPTION
[0024] 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.
[0025] It is known in the art that oral bacteria cannot survive
when exposed 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. 4,244,373 of Jan. 13, 1981 and in Detsch, U.S. Pat.
No. 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.
[0026] It has been discovered that by delivering a current level in
the approximate range of 50 to 250 microamperes, a direct current
electrical treatment is able to deliver new and unexpected
therapeutic, prophylactic, and regenerative benefits previously
unknown in the art.
[0027] 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.
[0028] In addition, clinical research has demonstrated that a
direct current in the approximate range of 50 to 250 microamperes
was able to regenerate gingival tissues, providing a non-surgical
treatment alternative for those with recessed gums. While the
osteogenic properties of electricity have been known in the art,
the connection between nonosseous tissue regeneration and
electricity were not well known in the art prior to these
experiments. The unique current range associated with the method
and apparatus of this invention is one of a few effective methods
in animal the dental field to accomplish effective gingival tissue
regeneration in a non-surgical manner.
[0029] In further research, testing has examined the effects of
direct current stimulation on three different oral bacteria (F.
nucleatum, S. oralis, P. gingivalis) in both saline and saliva
solutions. This testing varied the current levels, inoculum size of
bacteria, solution medium, and treatment time to develop an optimal
treatment to reduce these three bacteria species associated with
both periodontal and systemic diseases.
[0030] The results of this testing showed that each different
bacterium had a different dose response to DC stimulation. Through
this testing, treatment parameters have been identified that were
able to kill up to 100% of S. oralis, 99.1% of F. nucleatum, and
52.3% of P. gingivalis in a single treatment lasting thirty minutes
or less. This research yielded specifications for DC-based
treatments of targeted pathogens that was previously unknown in the
art. The optimal treatment parameters discovered in this research
and described in this method can provide an innovative way to
reduce these three species of bacteria, in both supra- and
sub-gingival environments, and thus prevent and/or treat their
associated complications including periodontal disease, biofilm
formation, as well as the systemic diseases correlated to these
oral pathogens.
[0031] In addition, scanning electron microscopy (SEM) has been
conducted on F. nucleatum colonies before and after a 30 minute
treatment to better understand the mechanism by which the method
according to this invention is able to reduce bacterial levels. The
SEM imagery suggested that the method according to this invention
interferes with bacterial cellular division and can weaken the
outer envelope (cell membrane) resulting in fragile cellular
structures that can easily break. It is contemplated that this is
phenomenon is an example of electroporation, where the permeability
of cellular membranes may be affected by electrical stimulation
either temporarily or permanently. It is further contemplated that
the electroporation caused by the method according to this
invention could play a role in developing new therapies in
molecular biology which would take advantage of this cellular
permeability and introduce new material into the cells of oral
pathogens or oral tissues through mechanisms including, but not
limited to genetic material (transfection) such as DNA, RNA, sRNA,
siRNA, plasmids, etc. These effects would prove a new tool in
targeted gene therapies for oral applications.
[0032] Specifically, devices according to the present invention may
be used to reduce viable colony forming units (CFU) in various oral
bacteria.
[0033] An embodiment 100 of an animal treatment apparatus is shown
in FIGS. 1-8. The treatment apparatus 100 generally includes a body
110 extending longitudinally between and including a first end 112
and a second end 114 opposite the first end 112. The body 110 is
preferably a general hourglass shape. While the hourglass shape
could be provided in a variety of fashions, a preferred structure
includes the outward appearance of a plurality (e.g., at least
three) of circumferential ridges 116 defined by a plurality of
stacked toroids. While the term "toroid" is utilized to describe
the general outward appearance of portions of the body 110, it is
understood that the internal construction of the body 110 may not
include corresponding toroidal configurations. With reference
momentarily to FIG. 7, it should be appreciated that the "toroid"
language generally describes a ridge 116 having a continuous curved
outer surface of a preferred radius R, wherein such radius R
extends from a centerpoint C that resides on a circle which extends
about a central longitudinal axis A of the body 110. A first
circumferential ridge 116a is preferably disposed at or near a
longitudinal midpoint of the body 110. This circumferential ridge
116a has a first ridge diameter (118a in FIG. 7), which may be the
smallest of any of the ridges 116. A second circumferential ridge
116b is preferably disposed at the second end 114 of the body 110.
This circumferential ridge 116b has a second ridge diameter (118b
in FIG. 8), which is larger than the first ridge diameter 118a, and
it further may be the largest diameter of any of the ridges 116. A
third circumferential ridge 116c is preferably disposed at the
first end 112 of the body 110. This circumferential ridge 116c has
a third ridge diameter (118c in FIG. 7), which is larger than the
first ridge diameter 118a, and it may be the same as or smaller
than the second ridge diameter 118b.
[0034] On the body 110, preferably extending radially outward from
the second circumferential ridge 116b may be one or more handle
anchors 120. The anchors 120 preferably provide a location at which
to, for example, dock a flexible handle 122, such as a rope. The
rope 122 may be inserted through the anchor 120, such as through an
aperture (124 in FIG. 7) formed at least partially in the anchor
120, and possibly partially into the second circumferential ridge
116b. The rope 122 could then be provided with a slip-stop 126,
such as a knot or aglet. Where more than one anchor 120 is
provided, the plurality of anchors 120 is preferably equally spaced
about a circumference of the body 110 extending about the
longitudinal axis A.
[0035] One or more cavities may extend inwardly from an exterior
surface of the body 110. A first cavity 128 extends into the body
110 from the first end 112. The cavity 128 is preferably formed
symmetrically about the longitudinal body axis A, extending into
the body 110 for a preferred depth, which may be less than half of
the longitudinal length of the body 110, which extends between and
includes the first end 112 and the second end 114. The cavity 128
extends from an aperture 130 formed in the first end 112 to a
closed end 132 disposed within the body 110. The aperture 130
extends about a diameter 134 defined by an annular ridge 136, and
the cavity 128 expands outwardly to a second, larger diameter 138
on the inside of the ridge 136. Extending further inward, the
cavity 128 is defined by a substantially frustoconical wall 140,
ending with a terminal diameter 142, which is preferably smaller
than both the aperture diameter 134 and the larger diameter 138. A
second cavity 144 may also be provided in the body 110. The second
cavity 144 may extend into the body 110 from the second end 114,
and may be provided as a cylindrical or a stepped reentrant bore.
The second cavity 144 extends into the body 110 for a preferred
depth, but preferably does not extend so far as to intersect the
first cavity 128. If the body 110 is provided with a first cavity
128 and a second cavity 144 as described, they are preferably
separated by a divider 146, which is preferably a solid,
non-conductive divider formed of the same nonconductive material as
a majority of the body 110.
[0036] At least two electrodes, one cathode 150 and one anode 160,
are provided and electrically accessible on the material forming
the outer surface of the device 100. On an external surface of at
least one of the ridges 116, a cathodic electrode element 150 is
provided. On an external surface of at least one of the ridges 116,
an anodic electrode element 160 is provided. The body 110 is
generally formed from a first, electrically insulative material 170
and a second, electrically conductive material 180. The insulative
material 170 may be injection molded from a desirable material in a
first mold, which may include a removable insert defining wells 172
to receive the conductive material 180 after the insulative
material 170 is cured. The conductive material 180 is placed into
electrical communication with the electronics module 148 through
one or more connection passages 174. The wells 172 preferably have
a radial surface area that is larger than the longitudinal
cross-sectional area of the connection passage 174. The conductive
material 180 is preferably exposed within the second cavity 144
through the connection passage 174. Alternatively, a wire (not
shown) or other electrical connection could be used. Preferably,
the conductive material 180 comprises a resilient material
(preferably durometer Shore A range of about 25 to about 80, or
even up to about 90-95) to encourage chewing of the treatment
apparatus 100. As non-limiting examples, a conductive silicone,
urethane, fluorosilicone, or other conductive polymer or a
conductive fabric (e.g. silver-plated nylon, or non-woven
conductive or conductive-through-adhesive fabric tape) may be used
as, or as a part of, the covering material. Regardless of the
covering material used, it is preferred that at least a portion of
the material forming the outer surface of the apparatus conducts
electricity from the power supply, or regulated amount thereof, to
the animal's mouth. The conductive material portions 180 are
preferably separated by non-conductive material 170, such as an
insulative polymer (e.g. non-conductive silicone) or fabric,
preferably having approximately the same durometer Shore A hardness
as the conductive material, or a similar tooth feel thereto.
Alternatively, in another preferred embodiment, the hardness of the
non-conductive material 170 is less than that of the conductive
material 180, such as about half. While the conductive material 180
may be disposed in the wells 172, the device 100 is preferably
provided with a substantially or completely imperforate radial
outer surface.
[0037] The cathodic electrode 150 may be formed into a variety of
configurations, but a preferred configuration includes a cathodic
stem portion 152, from which one or more cathodic branches 154
extend. The cathodic stem 152 preferably extends along a majority
of the length of the body, generally parallel to the longitudinal
axis A. The cathodic branches 154 are preferably formed integrally
with the stem 152, but preferably extend annularly from the stem
152, more preferably being disposed on the radially outermost
surface of respective ridges 116 of the body 110. As indicated,
separated from the cathodic electrode 150 by insulative material
170 is an anodic electrode 160. A preferred anodic electrode
configuration includes an anodic stem portion 162, from which one
or more anodic branches 164 extend. The anodic stem 162 preferably
extends along a majority of the length of the body, generally
parallel to the longitudinal axis A. The anodic stem 162 may be
diametrically opposed from the cathodic stem 152. The anodic
branches 164 are preferably formed integrally with the anodic stem
162, but preferably extend annularly from the anodic stem 162, more
preferably being disposed on the radially outermost surface of
respective ridges 116 of the body 110. A plurality of ridges 116
preferably includes a cathodic branch 154 and an anodic branch 164
on each ridge 116. It should be noted that alternative shapes and
configurations that maintain a spaced cathodic electrode 150 and
anodic electrode 160 configuration are within the scope of the
present invention. For instance, if the device 100 is provided with
two anchors 120, which are diametrically opposed from one another,
while the electrode stems 152, 162 may be disposed longitudinally
in line therewith, it is preferred to have the stems 152, 162
longitudinally offset by some predetermined number of degrees, such
as about 90 degrees, as shown.
[0038] Turning now to FIGS. 6-9, disposed within the second cavity
144 may be an electronics module 148, which is preferably sealed
water-tight, and houses a circuit 200 shown in FIG. 9. The circuit
200 generally includes a control board 210 and a power supply 230.
The control board 210 and power supply 230 may be of any types
known to provide an ability to transfer the power of the power
supply 230 to the electrodes 150 and 160, which were previously
described. Fully contemplated within the purview of the present
invention to be included in the circuit 200 are timers, audible
(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 power indicators
(e.g. beeper, buzzer, light-emitting diodes), motion activation
(e.g. using an accelerometer), moisture activation, pressure
activation, electrical current intensity adjustment (e.g., based on
sensed impedance between a cathode 150 and an anode 160), and/or an
on/off switch 232 to control the possible current delivery by the
power supply 230. Optionally, a programmable microcontroller (or a
pre-programmed ASIC) could be used, as previously described, to
control the various functions prompts/feedback and could record
various treatment parameters and/or treatment history in
non-volatile memory to be analyzed in real-time or post-treatment.
If a programmable microcontroller is utilized, a programming
interface may be provided, such as a wired (e.g., Universal Serial
Bus) or a wireless (e.g., Bluetooth.RTM., WiFi (e.g., IEEE 802.11),
infrared, etc.) interface to allow programming of the
microcontroller, thereby enabling it to control the operation of
the device. Parameters that may be desirably programmed may be
electrical stimulation intensity (e.g. current level) and/or the
frequency and type of prompts and/or feedback. The power supply 230
may be a simple dry-cell battery, a rechargeable battery, a
capacitor, a kinetic energy generator, a piezoelectric generator, a
microcontrolled DC power supply, or other power supply (such as a
microcontrolled AC power supply). Regardless of the power supply
230 used, it is most preferable to control the amount of electrical
current delivered by the treatment device to provide a relatively
constant current power source to provide up to about 500 microamps
of direct or alternating current. While 50 microamps to about 500
microamps may be a desired range, about 50 microamps to about 250
microamps is preferred, and about 100 microamps is still further
preferred. Such control may be provided by a microcontroller or
discrete monitoring circuitry (such as through current and/or
impedance sensing), or optimal dry-cell design if expected
impedances are generally known. 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. Power supplies and other circuit
components may be found in published U.S. patent application Ser.
No. 13/839,513, which is incorporated herein by reference in its
entirety.
[0039] A circuit will be completed by an animal's mouth when the
device 100 is masticated. This is schematically represented in FIG.
9 by impedances Ro, provided by the animal's mouth (e.g. saliva
and/or oral tissues), extending between two or more electrodes. The
circuit 200 contained within the electronics module 148 may be
coupled to the conductive material 180 forming the electrodes 150,
160 by exposed electrical conductors supported by the module 148
which are placed in frictional contact with the conductive material
180 when the module 148 is inserted into and supported within the
second cavity 144. Preferably, electrical conductors that interface
between the power supply 230 and the electrodes 150, 160 extend
from the power supply 230 in the same direction. That is, a first
electrical conductor that couples the cathodic electrode 150 to the
positive pole of the power supply 230 preferably extends from the
positive pole in a first longitudinal or radial direction. A second
electrical conductor that couples the anodic electrode 160 to the
negative pole of the power supply 230 preferably extends from the
negative pole in the same longitudinal or radial direction as the
first electrical conductor. Of course, the coupling of the
electrodes 150, 160 to the power supply 230 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 circuit 200 be able to supply a
stimulation (pulsed or steady) current of about 50 microamps to
about 500 microamps to a load (Ro) 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 100
microamps has been shown to be effective.
[0040] FIGS. 10 and 11 depict features of a second embodiment 200
of a device according to the present invention, where similar
reference numerals refer to substantially similar or identical
structure as described with respect to the first embodiment 100.
Like the first embodiment one or more cavities may extend inwardly
from an exterior surface of the body 210. A first cavity 228
extends into the body 110 from the first end 212. The cavity 228 is
preferably formed symmetrically about the longitudinal body axis A,
extending into the body 210 for a preferred depth, which may be
less than half of the longitudinal length of the body 210, which
extends between and includes the first end 212 and the second end
214. The cavity 228 extends from an aperture 230 formed in the
first end 212 to a closed end 232 disposed within the body 210. The
aperture 230 extends about a diameter 234 defined by an annular
ridge 236, and the cavity 228 expands outwardly to a second, larger
diameter 238 on the inside of the ridge 236. Extending further
inward, the cavity 228 is defined by a substantially frustoconical
wall 240, which may be ribbed or textured, ending with a terminal
diameter 242, which is preferably smaller than both the aperture
diameter 234 and the larger diameter 238. A second cavity 244 may
also be provided in the body 210. The second cavity 244 may extend
into the body 210 from the second end 214, and may be provided as a
cylindrical or a stepped reentrant bore. The cavity 244 may include
a retaining lip 245 adapted to maintain the electronics module 248
generally securely within the cavity 244. The second cavity 244
extends into the body 210 for a preferred depth, which may be
greater than half of the length of the body 210 along the axis A,
but preferably does not extend so far as to intersect the first
cavity 228. If the body 210 is provided with a first cavity 228 and
a second cavity 244 as described, they are preferably separated by
a divider 246, which is preferably a solid, non-conductive divider
formed of the same nonconductive material as a majority of the body
210.
[0041] Also like the first embodiment 100, this embodiment 200
includes at least two electrodes, one cathode 250 and one anode
260, provided and electrically accessible on the material forming
the outer surface of the device 200. The stem portions 252, (262
not shown) of this embodiment 200 are serpentine, rather than being
substantially linear like the stem portions 152, 162 on the first
embodiment 100. Additionally, this embodiment 200 includes one or
more ruts 290 adapted to receive an edible substance (e.g. canned
dog food or nutrient gel) or a dentifrice. The ruts 290 preferably
extend radially about the body 210 for a predetermined length or
about a predetermined angle (e.g. 30-60 degrees) about the axis
A.
Treatment of Non-Human Animals
[0042] A method according to the present invention may be used for
promoting oral hygiene in non-human animals, such as felines,
bovines, ovines, canines, porcines, and/or equines. The method
comprises the steps of providing a treatment apparatus comprising a
power source and a plurality of electrodes electrically coupled to
the power source. The power source may be an internal direct
current power source, or other power source as described above. The
plurality of electrodes includes at least one, but preferably a
plurality of cathodic electrodes and at least one, but preferably a
plurality of anodic electrodes. The electrodes may be positioned in
a spaced arrangement about, and preferably conductive through, the
exterior of the treatment apparatus by a conductive material. The
electrodes may be arranged in an alternating cathodic/anodic
fashion about the device. The method further comprises the step of
providing such device to a non-human animal, thereby allowing
delivery of electrical current from the power source, through the
electrodes and to at least one of the animal's oral secretions
(e.g., saliva) and oral tissue (e.g., lingual tissue, dental
tissue, gingival tissue, periodontal tissue, and oral mucosa
tissue).
[0043] Systems and methods according to the present invention may
be used to reduce oral bacteria and/or biofilm, as well as to treat
systemic diseases that may be associated with oral bacteria, in
non-human animals, such as dogs, cats, sheep, horses, cows, pigs,
etc.
[0044] For instance, periodontal disease is one of the most common
health problems affecting dogs (>75%). The prevalence of
periodontal disease has been found to increase age but decrease
with body weight. Various systemic diseases have been suggested as
a strong co-factor for periodontal disease in animals, just as in
humans. It has been suggested that periodontal disease could have a
causal relationship with systemic diseases in both humans and
animals. For dogs, and animals in general, periodontitis is a
recurrent and persistent disease and exposes the host to negative
systemic effects over an extended period of time, e.g. several
years.
[0045] It has been observed that, over the course of several years,
frequent exposure of bacteremia as a result of minor trauma at
sites of periodontal inflammation may cause infection or induce
inflammation at distant sites with the body. The pathogenesis of
periodontal disease in dogs has been linked with gram-negative
anaerobic bacteria upon accumulation within the gingival sulcus
causing inflammation and the formation of periodontal pockets. The
inflammatory response to periodontal pathogens promotes the
formation and release of endotoxins and inflammatory cytokines that
can decrease functions of vital organs over time. It has been
suggested that systemic diseases may be associated with periodontal
disease in dogs, including chronic bronchitis, pulmonary fibrosis,
endocarditis, interstitial nephritis, glomerulonephritis, and
hepatitis.
[0046] Periodontal organisms present in dogs with periodontitis
have been isolated and identified previously. For instance, the
following periodontal pathogens have been found to be associated
with periodontal disease in dogs: P. gingivalis (64% of
periodontitis-positive dogs), C. rectus, A. actinomycetemcomitans,
P. intermedia, T. forsythensis, F. nucleatum (4% of
periodontitis-positive dogs), E. corrodens, P. denticanis, P.
gulae, P. salivosa. Recommended treatments using systems and/or
methods according to the present invention to treat and/or prevent
periodontal disease by reducing or controlling such types of
bacteria, may include a predetermined time, such as 20 minutes, of
oral secretions and/or tissue (i.e., saliva, lingual tissue, dental
tissue, gingival tissue, periodontal tissue, and/or oral mucosa
tissue) exposure to an electrical current (alternating or direct
current, constant or pulsed) level of between about 50 microamps
(.mu.A) and about 500 microamps (.mu.A), with about 50 microamps to
about 250 microamps being preferred, and about 100 microamps being
still further preferred. Devices according to the present invention
have been shown to be effective at reducing the count of bacterial
species in this current range.
[0047] As with dogs, periodontal disease in cats is associated with
local inflammation and is purported to influence and induce
systemic responses and organ function in distal sites. One of the
common oral pathogens found in the oral cavity of cats is P.
gingivalis. Studies have demonstrated that indeed measurable
systemic changes arise during the progression of periodontal
disease, such as increased levels of serum IgG. Further, these
levels could be altered with periodontal treatment. Recommended
treatments using systems and/or methods according to the present
invention to treat and/or prevent periodontal disease in cats by
reducing or controlling such types of bacteria, may include a
predetermined time, such as 20 minutes, of oral tissue exposure to
an electrical current (alternating or direct current, constant or
pulsed) level of between about 50 microamps (.mu.A) and about 500
microamps (.mu.A), with about 50 microamps to about 250 microamps
being preferred, and about 100 microamps being still further
preferred. Devices according to the present invention have been
shown to be effective at reducing the count of such bacterial
species in this current range.
[0048] Periodontitis may also be found in sheep and cattle, also
referred to as "broken mouth", and is associated with severe
degradation of periodontal collagen, loss of alveolar bone,
appearance of periodontal pockets and premature tooth loss.
Although morphological and histological differences exist between
the periodontium of sheep, cattle, and humans, the
histopathological appearance is similar in periodontal disease,
including the role that P. gingivalis plays in the progression of
the disease. Recommended treatments using systems and/or methods
according to the present invention to treat and/or prevent
periodontal disease in sheep and/or cattle by reducing or
controlling such types of bacteria, may include a predetermined
time, such as 20 minutes, of oral tissue exposure to an electrical
current (alternating or direct current, constant or pulsed) level
of between about 50 microamps (.mu.A) and about 500 microamps
(.mu.A), with about 50 microamps to about 250 microamps being
preferred, and about 100 microamps being still further preferred.
Devices according to the present invention have been shown to be
effective at reducing the count of such bacterial species in this
current range.
[0049] Cardiovascular-related conditions may also exist in
non-human animals. For instance, there has in dogs been revealed an
association between periodontal disease severity and risk of
cardiovascular-related conditions, such as endocarditis and
cardiomyopathy. Endocarditis is a result of infection and
inflammation of the heart endothelium, or tissue lining the inner
surface of the heart valves and can be caused by various
microorganisms. Cardiomyopathy is characterized by an enlarged
heart that does not function properly. Both diseases carry a poor
prognosis based on the severity of the case. For dogs, it has been
found that the risk of endocarditis was 6-fold higher in dogs with
stage 3 periodontal disease than it was for healthy dogs and for
cardiomyopathy it was about 4-fold. Cardiac disease progression may
be affected by the presence and/or prevalence of certain oral
bacteria, including S. oralis, F. nucleatum, and P. gingivalis.
Recommended treatments using systems and/or methods according to
the present invention to treat and/or prevent cardiac disease by
reducing or controlling such types of bacteria, may include a
predetermined time, such as 20 minutes, of oral tissue exposure to
an electrical current (alternating or direct current, constant or
pulsed) level of between about 50 microamps (.mu.A) and about 500
microamps (.mu.A), with about 50 microamps to about 250 microamps
being preferred, and about 100 microamps being still further
preferred. Devices according to the present invention have been
shown to be effective at reducing bacterial burden of all three
species in this current range.
[0050] In addition to cardiac disease, a prior retrospective
longitudinal study has established a relationship between
periodontal disease and chronic kidney disease (CKD). The hazard
ratio of CKD in dogs, in conjunction with increased serum
creatinine and blood urea nitrogen concentrations, has been shown
to increase, with increasing severity of periodontal disease, from
stage 1 to stage 4, thereby establishing a significant positive
association between periodontal disease and CKD.
[0051] Both F. nucleatum and P. gingivalis are common oral
pathogens presented in dogs, and may be linked to kidney disease.
Accordingly, reduction of such pathogens may be used as a treatment
or prevention thereof. Recommended treatments using systems and/or
methods according to the present invention to treat and/or prevent
kidney disease by reducing or controlling such types of bacteria,
may include a predetermined time, such as 20 minutes, of oral
tissue exposure to an electrical current (alternating or direct
current, constant or pulsed) level of between about 50 microamps
(.mu.A) and about 500 microamps (.mu.A), with about 50 microamps to
about 250 microamps being preferred, and about 100 microamps being
still further preferred. Devices according to the present invention
have been shown to be effective at reducing the count of such
bacterial species in this current range.
[0052] Non-human animal diabetes may also be treated and/or
prevented using systems and methods according to the present
invention. In humans, as stated, there is an established link
between diabetes mellitus and periodontal disease, and such a
relationship has been suspected in veterinary medicine. One prior
study has demonstrated that blood glucose concentrations are
increased in relation to attachment loss and periodontal disease
state in dogs. Additionally, these levels decreased following
periodontal disease treatment.
[0053] The S. oralis bacterium has been associated with severe
periodontitis and diabetes. Recommended treatments using systems
and/or methods according to the present invention to treat and/or
diabetes by reducing or controlling such types of bacteria, may
include a predetermined time, such as 20 minutes, of oral tissue
exposure to an electrical current (alternating or direct current,
constant or pulsed) level of between about 50 microamps (.mu.A) and
about 500 microamps (.mu.A), with about 50 microamps to about 250
microamps being preferred, and about 100 microamps being still
further preferred. Devices according to the present invention have
been shown to be effective at reducing the count of such bacterial
species in this current range. Such a reduction may help combat
high levels of blood glucose.
[0054] Furthermore, systems and methods according to the present
invention may be used to affect (preferably reduce and/or
eliminate) the number of oral bacteria transferred between animals
of different species, such as between a pet and its owner. It is
well established that oral bacteria, including periodontal
pathogens, can be transmitted between mothers and their children
simply through everyday close contact. Therefore, it is not
unfounded that transmission of such bacteria may occur between
humans and their companion animals. One study investigated In fact,
the prevalence of periodontal pathogen species in dogs and their
owners to examine the possibility of pet-to-owner transmission has
been studied. P. gulae was detected in 71.2% of dogs in the study
and 16% in the owners. Interestingly, P. gulae is extremely
uncommon in the human oral cavity, and each owner who harbored the
bacteria had a dog that tested positive for the pathogen. Two
additional species, E. corrodens and T. denticola, were found to
correlate between owners and dogs indicating that oral bacteria
species may be transmitted between dogs and their owners.
[0055] The P. gulae bacterium, a member of the Porphyromonas genus
found in the oral cavity of dogs, has been shown to share 60%
homology with P. gingivalis. This suggests that P. gulae would
respond similarly to treatment with the device as does P.
gingivalis. Recommended treatments using systems and/or methods
according to the present invention to remedy and/or prevent the
transfer of oral bacteria between animals of different species by
reducing or controlling such types of bacteria, may include a
predetermined time, such as 20 minutes, of oral tissue exposure to
an electrical current (alternating or direct current, constant or
pulsed) level of between about 50 microamps (.mu.A) and about 500
microamps (.mu.A), with about 50 microamps to about 250 microamps
being preferred, and about 100 microamps being still further
preferred. Either or both animals (e.g. a dog and/or its owner) may
be so treated. Devices according to the present invention have been
shown to be effective at reducing the count of such bacterial
species in this current range. Such treatment should reduce levels
of P. gulae and diminish the possibility of pathogen transmission
to the animal's owner.
[0056] The treatment times may be a constant treatment time (e.g.
20 consecutive minutes) or treatments may be prescribed and/or
delivered for a predetermined period of time (e.g. 1-60 minutes)
within a treatment window (e.g. 24 hours, one week, one month,
etc.) in shorter incremental treatments, such as two minutes, five
times a day (to achieve 10 minutes of stimulation within a
treatment window of 24 hours).
[0057] Thus, embodiments according to the present invention are
able to achieve multiple prophylactic, therapeutic, and
regenerative effects in non-human animals whose combination was not
previously known or available in the art. Namely, these effects
are: promotion of oral osteogenesis, destruction or disabling of
oral microbes, gingival tissue regeneration, reduction and
prevention of the formation of oral biofilms, caries prevention,
increased oral vasodilation and oral blood flow, treatment of
common oral conditions such as gingivitis and periodontitis,
treatment of systemic diseases and conditions correlated with oral
pathogens, and generally improved oral hygiene.
[0058] These effects are accomplished by the delivery of direct
current to the animal's oral secretions and/or tissues through a
plurality of electrodes. The electrodes may be fashioned out of any
electrically-conductive material, including but not limited to
metals such as silver, stainless steel, copper, gold, platinum,
palladium, aluminum, an alloy thereof, electrically-conductive
nanotubes, carbonized rubber, electrically-conductive silicone, or
electrically-conductive polymers. The electrodes may be composed of
the same or of differing materials.
[0059] Electrical conductors then couple these electrodes to an
adjustable power supply. All of the anodic electrodes will
electrically communicate with the positive pole of the power supply
and all of the cathodic electrodes will electrically communicate
with the negative pole of the power supply. The adjustable power
supply is capable of delivering a stable, direct current in the
approximate range of 1 to 500 microamperes. The preferred current
setting for most treatments is in the approximate range of 50 to
250 microamperes, with about 100 microamps being still further
preferred.
[0060] Thus, the reader will see that at least one embodiment
herein addresses a desired need in the non-human animal oral
hygiene and dental fields to treat common oral diseases and
conditions in a more effective, less invasive, and less expensive
manner. These embodiments promote general oral hygiene, reduce oral
biofilm, treat periodontal diseases such as gingivitis and
periodontitis, kill oral microbes including bacteria and thus
preventing cavities and tooth decay, increase vasodilation and
blood flow in oral tissues, promote gingival tissue regeneration,
foster osteogenesis in the boney structures of the teeth, mouth,
and related areas, treat systemic diseases related to oral
pathogens, and treat other periodontal and oral maladies through
the non-invasive application of weak direct current electricity to
the surfaces in the oral cavity.
[0061] 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
the 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, which is defined by the claims.
* * * * *