U.S. patent application number 17/485608 was filed with the patent office on 2022-03-17 for electrical discharge irrigator apparatus and method.
The applicant listed for this patent is G&H Technologies, LLC. Invention is credited to Yuval Charles Avniel, Gilbert Fregoso, Brad Heckerman, Dennis Meuchel.
Application Number | 20220079732 17/485608 |
Document ID | / |
Family ID | 1000005990521 |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220079732 |
Kind Code |
A1 |
Fregoso; Gilbert ; et
al. |
March 17, 2022 |
ELECTRICAL DISCHARGE IRRIGATOR APPARATUS AND METHOD
Abstract
An electrical discharge irrigation device and method is
described. An electrical discharge irrigation device includes a
power source, a circuit coupled to the power source, and an output
tip coupled to the circuit. The output tip includes a first end and
a second end and a longitudinal axis extending between them, an
electrode located in an interior space of the output tip configured
to receive an electrical charge from the circuit and to release an
electric discharge, and a ground return including an inner surface
of the output tip, wherein a space between the electrode and the
ground return comprises a conductive medium, the conductive medium
being in contact with the electrode and the ground return to
produce the electric discharge.
Inventors: |
Fregoso; Gilbert; (Missoula,
MT) ; Heckerman; Brad; (Kalispell, MT) ;
Avniel; Yuval Charles; (Missoula, MT) ; Meuchel;
Dennis; (Missoula, MT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
G&H Technologies, LLC |
Kalispell |
MT |
US |
|
|
Family ID: |
1000005990521 |
Appl. No.: |
17/485608 |
Filed: |
September 27, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15022353 |
Mar 16, 2016 |
11129698 |
|
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PCT/US2014/019474 |
Feb 28, 2014 |
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17485608 |
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PCT/US2013/060943 |
Sep 20, 2013 |
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15022353 |
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61699568 |
Sep 11, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L 2/10 20130101; A61L
2/00 20130101; A61N 1/04 20130101; A61C 1/07 20130101; A61C 5/40
20170201; A61C 17/0202 20130101; A61C 3/00 20130101; A61B 2217/007
20130101; A61C 17/16 20130101; A61N 2005/0606 20130101; A61N 1/0548
20130101; A61C 19/063 20130101; A61C 17/20 20130101; A61C 5/50
20170201; A61L 2/0088 20130101; A61L 2/22 20130101; A61N 1/325
20130101; A61L 2/14 20130101; A61N 1/0448 20130101; A61L 2/18
20130101; A61L 2/025 20130101; A61N 2005/0661 20130101; A61L
2202/25 20130101; A61B 18/042 20130101; F04C 2270/0421 20130101;
A61C 1/06 20130101; A61N 1/306 20130101; A61N 5/0603 20130101; A61N
1/44 20130101 |
International
Class: |
A61C 17/20 20060101
A61C017/20; A61N 1/32 20060101 A61N001/32; A61B 18/04 20060101
A61B018/04; A61N 1/04 20060101 A61N001/04; A61C 5/40 20060101
A61C005/40; A61C 1/06 20060101 A61C001/06; A61C 3/00 20060101
A61C003/00; A61C 17/02 20060101 A61C017/02; A61C 19/06 20060101
A61C019/06; A61C 1/07 20060101 A61C001/07; A61L 2/025 20060101
A61L002/025; A61L 2/10 20060101 A61L002/10; A61L 2/14 20060101
A61L002/14; A61L 2/18 20060101 A61L002/18; A61N 1/05 20060101
A61N001/05; A61N 1/44 20060101 A61N001/44; A61N 5/06 20060101
A61N005/06; A61C 17/16 20060101 A61C017/16; A61N 1/30 20060101
A61N001/30; A61C 5/50 20060101 A61C005/50 |
Claims
1. An electrical discharge irrigation device, comprising: a power
source; a circuit coupled to the power source; and an output tip
coupled to the circuit, the output tip comprising: a first end and
a second end and a longitudinal axis extending between them; an
electrode located in an interior space of the output tip configured
to receive an electrical charge from the circuit and to release an
electric discharge; and a ground return comprising an inside
surface of the output tip, wherein a space between the electrode
and the ground return comprises a conductive medium, the conductive
medium being in contact with the electrode and the ground return to
produce the electric discharge.
2. The device of claim 1, further comprising at least one opening
on an outside surface of the output tip, wherein the electrical
discharge creates cavitation within the conductive medium.
3. The device of claim 2, wherein sonoluminescence occurs
responsive to the cavitation and wherein light is visible to an
operator of the device during operation of the device.
4. The device of claims 1, wherein the conductive medium exits the
output tip through the at least one opening in the tip.
5. The device of claim 2, wherein the output tip can be utilized to
create an incision in tissue when at least one of the output tip or
the conductive medium is positioned adjacent to the tissue.
6. The device of claim 1, the output tip further comprising a
pressure control mechanism.
7. The device of claim 1, wherein the output tip is comprised of a
malleable material.
8. The device of claim 1, wherein the electrode opposes the inner
surface at a distance, wherein the electrode is cylindrical,
wherein the inner surface is cylindrical, and wherein the distance
is equal between the electrode and the inner surface when measured
from the electrode to the inner surface around the circumference of
the electrode.
9. The device of claim 1, wherein the output tip further comprises
an insulating layer in contact with one of the electrode and the
ground return, the insulating layer comprising at least one
perforation, the at least one perforation defining an area for
electrical coupling between the electrode and the ground
return.
10. A method of producing at least one of cavitation and/or plasma
discharge, comprising: obtaining an electrical discharge irrigation
device, comprising: a trigger to engage the device; a power source;
a circuit coupled to the power source; and an output tip coupled to
the circuit, the output tip comprising: a first end and a second
end and a longitudinal axis extending between them; an electrode
located in an interior space of the output tip configured to
receive an electrical charge from the circuit and to release an
electric discharge; and a ground return comprising an inside
surface of the output tip, wherein a space between the electrode
and the ground return comprises a first conductive medium, the
first conductive medium being in contact with the electrode and the
ground return to produce the electric discharge, positioning the
output tip of the device adjacent to a target; engaging the trigger
on the device to control the electric discharge; and utilizing the
electrical discharge to create compression waves within the first
conductive medium, causing the first conductive medium to exit the
output tip through the at least one opening in the output tip.
11. The method of claim 10, further comprising at least one opening
on an outside surface of the output tip, wherein the electrical
discharge creates cavitation within the first conductive
medium.
12. The method of claim 11, wherein sonoluminescence occurs
responsive to the cavitation and wherein light is visible to an
operator of the device during operation of the device.
13. The method of claim 10, further comprising: positioning the
output tip adjacent to an object; and making an incision in the
object.
14. The method of claim 10, wherein the output tip further
comprises a pressure control mechanism.
15. The method of claim 10, wherein the output tip is comprised of
a malleable material.
16. The method of claim 10, wherein the electrode opposes the inner
surface at a distance, wherein the electrode is cylindrical,
wherein the inner surface is cylindrical, and wherein the distance
is equal between the electrode and the inner surface when measured
from the electrode to the inner surface around the circumference of
the electrode.
17. An output tip comprising: a first end and a second end and a
longitudinal axis extending between them; an electrode located in
an interior space of the output tip configured to receive an
electrical charge from the circuit and to release an electric
discharge; and a ground return comprising an inner surface of the
output tip, wherein a space between the electrode and the ground
return comprises a first conductive medium, the first conductive
medium being in contact with the electrode and the ground return to
produce an environment for the electric discharge; and at least one
aperture extending through the outside surface of the output tip,
wherein the outside surface of the tip is cylindrical
18. The output tip of claim 17, wherein the electrode opposes the
inner surface at a distance, wherein the electrode is cylindrical,
wherein the inner surface is cylindrical, and wherein the distance
is equal between the electrode and the inner surface when measured
from the electrode to the inner surface around the circumference of
the electrode.
19. The output tip of claim 17, further comprising a pressure
control mechanism.
20. The output tip of claim 17, further comprising: an insulating
layer adjacent to the outside surface of the tip; and an insulating
layer between the inner surface and the electrode, wherein the
electrode comprises an array of individual electrodes.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of PCT
Application No. PCT/US13/60943, entitled "ELECTRICAL DISCHARGE
IRRIGATOR APPARATUS AND METHOD," filed Sep. 20, 2013, which claims
the benefit of PCT/US12/70080, entitled "ELECTRICAL DISCHARGE
IRRIGATOR APPARATUS AND METHOD," filed Dec. 17, 2012, which claims
the benefit of U.S. Provisional Application No. 61/699,568, filed
Sep. 11, 2012. This application claims priority to both filed PCT
applications, and all listed applications are incorporated herein,
by reference, in their entirety. This application is related to
commonly owned, co-pending design patent application Ser. No.
29/483,570, entitled "TISSUE BORING DRILL TIP," filed on Feb. 28,
2014, co-pending design patent application Ser. No. 29/483,572,
entitled "FOCUSED TISSUE BORING TIP WITH WATER VENT," filed on Feb.
28, 2014, co-pending design patent application Ser. No. 29/483,574,
entitled "MULTI-DIRECTIONAL TISSUE REAMER," filed on Feb. 28, 2014,
co-pending design patent application Ser. No. 29/483,576, entitled
"SINGLE VENT DIRECTIONAL REAMER TIP," filed on Feb. 28, 2014,
co-pending design patent application Ser. No. 29/483,581, entitled
"IRRIGATION TIP filed on Feb. 28, 2014, co-pending design patent
application Ser. No. 29/483,582, entitled "MODIFIED IRRIGATION TIP"
filed on Feb. 28, 2014, which are hereby incorporated herein by
reference in their entirety.
FIELD OF INVENTION
[0002] The present invention relates to an apparatus and method of
utilizing acoustic waves created by an electrical discharge for
irrigation and disinfection.
BACKGROUND OF INVENTION
[0003] Foreign bodies, such as bacteria and microbes pose a risk to
dental health. These foreign bodies can invade canals and other
hard to reach areas in dental structures and compromise dental
health. It is the infections that are caused by the persistence of
these foreign bodies that pose one of the greatest risks to the
endodontic health of a patient.
[0004] Treatments to eliminate harmful canal contents, and
therefore reduce the risk of infections, range from invasive
treatments, such as extraction, to the far less invasive, yet not
always effective, irrigation. Irrigation involves the use of an
anti-bacterial solution to flush the canals. Today's irrigation
solutions include utilizing direct lift, displacement and/or
gravity pumps to move a fluid into canals, utilizing ultrasonic
tips at varying rates, utilizing mechanical instruments, such as
files, using positive pressure to inject fluid (for example, using
a hypodermic needle) and negative pressure to remove it, and
combinations of these techniques.
[0005] Studies have demonstrated that mechanical instruments alone
cannot disinfect root canals. This is because large areas of canal
walls, including apical, ribbon-shaped, and oval canals, cannot be
cleaned mechanically because mechanical means cannot reach and come
into physical contact with all surfaces within the tooth, so
microorganisms in these areas can survive. Irrigation solutions are
generally required to eradicate these microorganisms and various
chemicals have been used for this purpose.
[0006] Ideally, an irrigant kills bacteria, dissolves necrotic
tissue, lubricates the canal, removes the smear layer, and does not
irritate healthy tissue. Presently, solutions that include sodium
hypochlorite (NaOCl) and ethylenemide tetra-acetic acid (EDTA) are
favored by dentists. The NaOCl solution, usually at a concentration
between 1%-3% is used to dissolve tissue and disinfect (remove
bacteria), while EDTA removes the smear layer. During an irrigation
procedure, NaOCl is used initially to dissolve tissue and disinfect
and EDTA is introduced at the end of the procedure to remove the
smear layer. The EDTA application is followed by another flush of
NaOCl or another inert solution.
[0007] Although certainly less invasive than extraction, irrigation
has its shortcomings. First, NaOCl, EDTA, and other solutions found
effective in irrigation are caustic solutions, including other
bleaches, which when applied can badly irritate the mouth and
surrounding structures. During an application, there is a risk that
these solutions will perforate the apex of the canal, the end of
the canal where the nerve meets the bone. If this happens, the
results are so painful for a patient that the patient will end up
on significant pain management, i.e., prescription pain killers,
for at least two days, but sometimes, as long as two months.
Second, current irrigation techniques carry a failure rate of up to
5% because often, the procedure fails to remove all the nerve
tissue that is infected in the root canal system, so residual
bacteria remains. Third, irrigation solutions are only effective at
the time that they are applied. After a patient is treated with
NaOCl and/or EDTA, the solutions are flushed out and there is no
positive residual effect after the treatment is complete. Thus, any
bacteria remaining in hard to reach canals will remain indefinitely
and can lead to infection.
[0008] A need exists for a method and apparatus for effectively
irrigating even hard to reach dental canals in a manner that
produces residual benefits without causing damage and/or pain in
the mouth and surrounding structures.
SUMMARY OF INVENTION
[0009] Shortcomings of the prior art are overcome and additional
advantages are provided through the provision of an electrical
discharge irrigation device that includes a power source, a circuit
coupled to the power source; and an output tip coupled to the
circuit. The output tip includes a first end and a second end and a
longitudinal axis extending between them, an electrode located in
an interior space of the output tip configured to receive an
electrical charge from the circuit and to release an electric
discharge, and a ground return that includes an outside surface of
the output tip, where a space between the electrode and the ground
return includes a conductive medium, the conductive medium being in
contact with the electrode and the ground return to produce the
electric discharge.
[0010] Shortcomings of the prior art are overcome and additional
advantages are provided through the provision of a method of
producing at least one of cavitation or plasma discharge the
includes obtaining an embodiment of the earlier described
electrical discharge irrigation device, which includes a trigger to
engage the device, positioning the output tip adjacent to a target,
engaging the trigger on the device to control the electric
discharge, and utilizing the electrical discharge to create
compression waves within the conductive medium inside the output
tip, causing the conductive medium in the tip to exit the output
tip through the at least one opening in the output tip.
[0011] Shortcomings of the prior art are overcome and additional
advantages are provided through the provision of an output tip
which includes a first end and a second end and a longitudinal axis
extending between them, an electrode located in an interior space
of the output tip configured to receive an electrical charge from
the circuit and to release an electric discharge; and a ground
return which includes an outside surface of the output tip, wherein
a space between the electrode and the ground return comprises a
first conductive medium, the first conductive medium being in
contact with the electrode and the ground return to produce an
environment for the electric discharge; and at least one aperture
extending through the outside surface of the output tip, where the
outside surface of the output tip is cylindrical.
[0012] In a further aspect of an embodiment of the present
invention, the output tip includes at least one opening on the
outside surface of the output tip, and the electrical discharge
creates cavitation within the conductive medium.
[0013] In a further aspect of an embodiment of the present
invention, sonoluminescence may occur in response to the cavitation
and light is visible to an operator of the device during operation
of the device.
[0014] In a further aspect of an embodiment of the present
invention, a conductive medium exits the output tip through the at
least one opening in the tip.
[0015] In a further aspect of an embodiment of the present
invention, the output tip can be utilized to create an incision in
tissue when at least one of the output tip or the conductive medium
is positioned adjacent to the tissue.
[0016] In a further aspect of an embodiment of the present
invention, the output tip further includes a pressure control
mechanism.
[0017] In a further aspect of an embodiment of the present
invention, the output tip includes a malleable material.
[0018] In a further aspect of an embodiment of the present
invention, the output tip also includes an inner surface and where
the electrode opposes the inner surface at a distance. The
electrode is cylindrical, the inner surface is cylindrical, and the
distance is equal between the electrode and the inner surface when
measured from the electrode to the inner surface around the
circumference of the electrode.
[0019] In a further aspect of an embodiment of the present
invention, the output tip also includes an insulating layer in
contact with one of the electrode and the ground return, the
insulating layer includes at least one perforation, the at least
one perforation defining an area for electrical coupling between
the electrode and the ground return.
[0020] In a further aspect of an embodiment of the present
invention, the method includes positioning the output tip adjacent
to an object, and making an incision in the object.
[0021] In a further aspect of the present invention, the output tip
also includes an insulating layer adjacent to the outside surface
of the tip; and an insulating layer between the inner surface and
the electrode. In this embodiment, the electrode comprises an array
of individual electrodes and this tip is adapted for making the
aforementioned incisions.
[0022] Additional features are realized through the devices and
techniques of the present invention. Other embodiments and aspects
of the invention are described in detail herein and are considered
a part of the claimed invention.
BRIEF DESCRIPTION OF DRAWINGS
[0023] The foregoing and objects, features, and advantages of one
or more aspects of the invention are apparent from the following
detailed description taken in conjunction with the accompanying
drawings in which:
[0024] FIG. 1 depicts an aspect of embodiment of the present
invention;
[0025] FIG. 2 depicts an aspect of an embodiment of the present
invention;
[0026] FIG. 3 depicts an aspect of an embodiment of the present
invention;
[0027] FIG. 4 depicts an oscilloscope trace associated with a
degraded electrode utilized in an embodiment of the present
invention;
[0028] FIG. 5 depicts an oscilloscope trace associated with a
degraded electrode utilized in an embodiment of the present
invention;
[0029] FIG. 6 depicts an exemplary method performed utilizing an
embodiment of the present invention;
[0030] FIG. 7 depicts an aspect of embodiment of the present
invention;
[0031] FIG. 8 depicts an aspect of an embodiment of the present
invention;
[0032] FIG. 9 depicts various aspect of some embodiments of the
present invention; and
[0033] FIG. 10 depicts various aspects of some embodiments of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0034] The apparatus and method of the present invention utilize an
electric discharge and creates oscillating pressure to eradicate
unwanted matter from a medium. Embodiments of the present invention
are used as irrigation systems in endodontic procedures as well as
in periodontal procedures, including treatments for periodontal
disease and peri-implantitis. These dental irrigation systems
include, but are not limited to, an irrigation system for
Piezoelectric/Magnetostrictive scalars, irrigation system for
cleaning the teeth pockets (e.g., root canals or periodontal or
endodontic regions), and removing biofilm, a water pick irrigation
system for cleaning the teeth, an irrigation system for flushing
the periodontal pocket, and/or an irrigation system for surgery for
disinfecting wounds. While some embodiments of the present
invention pulse liquid that is external to the device directly, for
example, in dental canals in endodontic uses, some embodiments of
the present invention contain one or more internal reservoir(s)
where the liquid and/or water used is pre-treated (pre-pulsed)
before it is released into the treatment area, for example, in
Piezoelectric/Magnetostrictive scalars and/or water picks.
[0035] An embodiment of the present invention utilized for
endodontic procedures comprises a tube with electrodes to deliver
an electrical discharge which creates the desired acoustical waves,
cavitation related byproducts, and/or plasma, in many of these
procedures, the embodiment utilized emit electrical pulses through
a tip of an embodiment of the apparatus as spark discharges.
[0036] Throughout this application, the terms "tip" and "output
tip" are used interchangeably to describe and aspect of embodiments
of the present invention.
[0037] The electrical pulses agitate the liquid into which the tip
is immersed and create acoustic waves, shock waves, cavitation,
plasma, sonoluminsence, microjets and additional discharges that
kill foreign agents, including toxins, bacteria, and microbes,
dissolve necrotic tissue, lubricate the canal, and remove the smear
layer while providing anti-bacterial and anti-microbial benefits
both during and after treatment. Thus, an embodiment of the present
invention can be utilized to irradiate bacteria and other
infectious agents while providing cleaning and irrigation of the
tooth canals for proper Root Canal Procedures in accordance with
ADA guidelines.
[0038] An embodiment of the apparatus is used as a
Piezoelectric/Magnetostrictive scalar. As discussed later in
greater detail, an embodiment of the present invention utilized for
as a Piezoelectric/Magnetostrictive scalar utilizes an ultrasonic
tip that disrupts biofilm (bacteria colonies) by using ultrasonic
energy to remove the biofilm, and disrupt the bacteria. In an
embodiment of this invention, the ultrasonic pulse is provided in a
target area at a rate of about 1-99 Hz-with a pulse duration of
100-500 microseconds at power settings ranging from milli-joules to
micro-joules to mechanically remove the biofilm, and disrupt the
bacteria. Tips utilized in this application comprise an exterior
and/or interior water line system that delivers water to cool the
tips, provide a medium for the electrical discharge and to flush
the periodontic pocket with water. The flushing action cleanses the
area of the bacteria that the mechanical action of the tip has
disrupted in and/or fractured off the tooth structure.
[0039] An advantage of the present invention over ultrasonic based
techniques is that embodiments of the present invention do not
vibrate, while ultrasonic technologies do vibrate. A vibrating tip,
such as that incorporated into ultrasonic devices, causes damage to
the structural integrity of a tooth and a reduction in the original
tooth structure. In fact, vibration itself can also cause cracks
etc. in dental structures. One benefit of embodiments of the
present invention is that because they do not vibrate, they do not
cause the types of changes to the original tooth structure,
including damage, that are associated with ultrasonic based
technologies.
[0040] By utilizing cavitation to create sonoluminsence,
embodiments of the present invention create a light discharge from
the tip, which provides an operator of the device with a light
guide that indicates that the device is in operation and can assist
the operator in targeting the discharge at biological structures
that are being targeted by the device and the output tip.
[0041] In an aspect of a Piezoelectric/Magnetostrictive embodiment,
the water and/or fluid that is pulsed is essentially pre-treated in
one or more "holding chambers" internal to the apparatus before it
passes into the water lines feeding the tips. Then, as the tip is,
used it is this treated water that flushes the pockets and provides
better pathogen kill, and long term protection in contrast to
current methods of just using water, or a mild chemical agent and
water. The current industry-standard treatment, as opposed to
embodiment of the present method, has an anti microbial effect, but
only while it is actually flushing the pocket. This effect does not
continue. In an aspect of a Piezoelectric/Magnetostrictive
embodiment, this anti microbial effect will continue after flushing
the pocket. Liquids utilized in this application include, but are
not limited to, a 2% glutaraldehyde solution. In embodiments of the
present invention, liquids used in this application may or may not
be generally known anti-microbial solutions like gluteraldehyde,
hydrogen peroxide, etc. Pre-treating the water/liquid in internal
reservoirs is also utilized in embodiments used to clean
periodontic wound sites.
[0042] Returning to endodontic uses, an embodiment of the present
invention is a hand held irrigation device that generates an
electrical discharge, creating acoustical shock waves in an
irrigant and UV radiation that irrigate dental canals and other
structures during an irrigation treatment, and also introduce one
or more of the following: UV light, hydrated electrons, OH
radicals, H.sub.2O.sub.2, H.sub.3O, O.sub.2, MnO.sub.2, O.sub.3
(ozone), O, HO.sub.2, electrons, positive or negative ions,
reactive chemical radicals, hydroxyl radicals, super oxides,
nanoparticles, and/or any other known anti-pathogen, anti-chemical
pollution, chemical reactions, which act to combat foreign agents
after use of the device has ceased. Further embodiments of the
present invention are mounted or table top models, as opposed to
hand held.
[0043] An embodiment of the hand-held version of the present
apparatus, which is utilized, for example, for endodontic
treatments, is comprised of a handle, which is used to grip and
manipulate the apparatus, a body, where various electrical
components are housed, and a tip, which contains one or more
electrodes and a ground return, which is inserted into a conductive
liquid in the mouth of a patient in order to irrigate a selected
area using acoustic waves generated by one or more circuits in the
apparatus. An embodiment of the tip of the apparatus is comprised
of flexible material such that it can be positioned deep within
dental canals.
[0044] An embodiment of the apparatus contains a low voltage power
source and the internal circuitry of the apparatus, discussed later
in greater detail, converts the initial low voltage power, to high
voltage power, which pulses the liquid into which the tip is
immersed. The tip of an embodiment of the present method and
apparatus utilizes electrodes comprised of biologically inert
materials, including but not limited to, silver, copper, stainless
steel, and/or iron (ferrite) which have a toxicity to bacteria and
act as an anti-pathogen. Electrodes in further embodiments of the
present invention may include ceramic-based electrode, carbon-based
electrodes, and other conductive materials. The nanoparticles
created by the electrodes, and/or working surface, combat the
bacteria and other foreign particles in the canals.
[0045] In an embodiment of the present invention, because the
electrical discharge itself destroys foreign agents both during and
after an irrigation treatment, the irrigant utilized needn't
possess antiseptic or anti-bacterial qualities on its own. For
example, although NaOCl and EDTA can be used in conjunction with
this method, saline and water solutions are also effectively used
with this method. In general, any anti-bacterial and/or
anti-microbial fluids utilized in irrigation protocols are
compatible with this apparatus and method as dielectric liquids
transmit the electrical discharge and they may improve its
effectiveness in use. Thus, because water is conductive, it works
well with the present method and apparatus.
[0046] The utilization of the electrical discharge from one or more
electrodes in the tip of an embodiment of the present apparatus
create(s) "shock waves" in the irrigation fluid which have a high
gradient at their front, so the difference in pressure created in
the irrigation fluid damages bacterial membranes and/or destroys
them. The waves are effective in a given radius and therefore
penetrate canals and dental structures that are difficult to reach
and thus effectively irrigating them.
[0047] The electrical discharges produce the pulsed shock waves,
which damage pollutants on a cellular level. The pulses may
mechanically destroy bacteria and microbial cells, chemically and
permanently change the cells so they cease regular biochemical
activity, and/or irreversibly change the genetic system of the
cells. Cellular damage sustained by the pollutants includes, but is
not limited to, cracking the cell walls without releasing the
contents of the cells, and dispersing the cell wall and contents of
the cells, DNA disruption.
[0048] The embodiment of the tip additionally discharges UV
radiation, which when absorbed in different degrees by water
molecules, hydrogen peroxide, the other mediums discussed, and/or
in the irrigating fluid, produces ozone, H.sub.2O.sub.2 and OH
radicals, which destroy microbes and also some organic compounds.
The electrical discharge of an embodiment of the invention
additionally disseminates hydrated electrons, nanoparticles, and
positive and/or negative ions (from metal electrodes utilized in
various embodiments) which continue anti-microbial and
anti-bacterial action against foreign agents after the irrigation
procedure has terminated. Embodiments of tips may discharge one or
more of the following: UV light, hydrated electrons, OH radicals,
H.sub.2O.sub.2, H.sub.3O, O.sub.2, MnO.sub.2, O.sub.3 (ozone), O,
HO.sub.2, electrons, positive or negative ions, reactive chemical
radicals, hydroxyl radicals, super oxides, nanoparticles, and/or
any other known anti-pathogen, anti-chemical pollution, chemical
reactions.
[0049] One advantage of embodiments of the present invention is
that they are effective against pollutants yet are able to utilize
relatively low power settings over relatively short periods of time
and achieve high levels of efficiency. Embodiments of the present
invention that use particularly low power settings enable the
miniaturization and the simplification of the driving circuit and
power requirements. For example, an embodiment of the present
invention eradicates foreign agents from a selected medium in 25
seconds-5 minutes at between 20 Hz, the energy in 26 microjoules-4
joules. Some embodiments of the present invention utilize power
requirements at least three magnitudes lower than the previous
example, i.e., microjoules in place of joules. These settings are
exemplary as dependent upon the use of the apparatus and the
embodiment of the apparatus, the power settings and the duration of
a treatment will vary.
[0050] In an embodiment of the present invention, an output tip can
be adapted to cut tissue and/or other biological structures when
positioned in proximity to the structure. The applications of this
cutting functionality are not limited to dental applications. In
addition to their endodontic and periodontal applications, one of
skill in the art will recognize that embodiments of the present
invention can be adapted for additional specific uses. These uses
include, but are not limited to, bladder surgery, sinus surgery,
cardiovascular surgery, various cancer surgeries, and prostate
surgery. In these surgeries, the ability to utilize embodiments of
the device and output tips to cut biological structures is of
particular use.
[0051] In embodiments of the present invention, sonoluminescence
may occur during treatment utilizing embodiments of the present
device and techniques, which provides light at the working surface
which assists an operator in confirming the actuation of the device
as well as providing UV light which is known to further remediate
microbial/biologic species. However, in further embodiments of the
present invention, cavitation can occur without
sonoluminescence.
[0052] In addition to its aforementioned surgical uses, embodiments
of the present invention can also be utilized to assist in
sterilization of environments and parts of the body upon which a
treatment is being performed. Embodiments of the present invention
can be integrated into humidifiers, as well as into neti pots, to
name just a few integrations.
[0053] Embodiments of the present invention can also be utilized in
the remediation of biotica species. For example, microorganisms
related to fecal matter can be remediated in a targeted area by
applying the discharge from the present invention. Use of
embodiments the present invention to remediate microorganisms is
not limited to remediating those associated with fecal matter as
this is offered only as an example. As a further example,
embodiments of the present invention can be effective in
remediating tetanus and E. coli.
[0054] Embodiments of the present invention can also be utilized to
activate materials in situ, activating these materials to provide
remediation of pollutants, including but not limited to, bacteria
and microorganisms.
[0055] Aforementioned PCT Application No. PCT/US13/60943 and
PCT/US12/70080, which are incorporated herein in their entirety,
include descriptions and figures that describe various embodiments
of the present invention, including some examples of circuits that
can be utilized in embodiments of the present invention to assist
in creating the electrical charges, including the cavitation and
plasma discharges.
[0056] In an embodiment of the present invention, output tips can
be used to cut targeted areas and the cutting functionality is
enabled by the use of embodiments of the output tip specifically
adapted for this purpose. Embodiments capable of cutting
functionality include a center electrode that is comprised of an
array of electrodes. In one embodiment, the outside of the tip is
comprised of an insulating material, which is in contact with a
ground return. Between the ground return and the center conductor,
as it can be referred to in conjunction with this embodiment for
ease of understanding, is additional insulation. The center
conductor is an array. Thus, when the circuit, which is part of
embodiment of the device is loaded, in can deliver to individual
electrode in the array. FIG. 1 depicts the structure of an
embodiment of a cutting tip utilized in an embodiment of the
present invention and FIG. 2 depicts an exemplary configuration for
the described array.
[0057] Referring to FIG. 1, an embodiment of an output to 100 is
depicted. This tip includes insulation of the outer surface 110,
adjacent to a ground return 120. An insulating layer 130 is
positioned between the ground return 120 and center conductor 130.
In an embodiment of the present invention, this insulating layer is
perforated to allow electrical coupling between the ground and the
center conductor 130.
[0058] The center conductor 130 is comprised of more than one
electrode oriented in an array. Referring to FIG. 2, the central
conductor 130 of FIG. 1, which is an array, can be understood as a
cluster array 200 and when a circuit used in the present device
and/or technique is loaded, the circuit is capable of delivering to
the individual electrodes that comprise the cluster array 200. This
cluster array 200 enables the output tip 100 to produce multiple
discharges as one time.
[0059] When placed in a conductive solution, the output tip 100 of
FIG. 1, with the center electrode array 200 in FIG. 2 will churn
this liquid. When voltage is applied to the device comprising this
tip from a power source, the output tip enables precise utilization
of the multiple discharges, for example, to cut biological
material, such as tissue. In this way, and embodiment of the
present invention can be utilized to blast anisotropic
structures.
[0060] Returning to FIG. 2, the individual electrodes in the array
can be comprised of a variety of conductive materials, including
but not limited to, silver. An advantage of utilizing silver in the
electrodes is that because water treated with silver electrodes has
the highest bactericidal activity because ions of silver have the
highest toxicity to bacteria, it is an anti-pathogen. Thus, the
nanoparticles created by the silver electrodes also combat the
bacteria and foreign particles. Further embodiments of the present
invention utilize electrodes comprised from additional materials
that are biologically inert. Materials used to comprise the
electrodes include but are not limited to silver, copper, stainless
steel, ceramic, carbon-based material, iron, and/or other
conductive materials. The suspensions utilized with an embodiment
of the present invention can also contain nanoparticles, which
further aid in the efficacy of embodiments of the device in
combating bacteria and foreign particles. The use of silver
electrodes is not confined to the embodiment of FIG. 2, which is
used as an illustrative example. This array of electrodes is just
offered as an example.
[0061] Referring the FIG. 3, an embodiment of the present invention
may include an output tip with a pressure control portion 310. The
pressure control portion of the output tip 300 is utilized during
operation of an embodiment of the device in order to control the
pressure within the output tip 300 to avoid blowing out the apex
320 of the tip.
[0062] Tips utilized in the present technique are most effective in
some embodiments of the present invention when the electrode in the
tip is centered relative to the ground, which is included in the
outer surface of the tip. This geometry is most easily achieved by
providing a cylindrical electrode and a cylindrical ground. The
efficacy of the tip increases with the geometry and the tip may
degrade at a slower rate.
[0063] FIGS. 4-5 are captures of oscilloscope graphs associated
with tip performance and tip degradation. These graphs record the
dielectric behavior of the embodiment of the present system as it
changes in reference to ground. The curve can also be described as
the discharge curve as a function of time. The "tighter" the curve,
the more effective the discharge.
[0064] FIG. 4 depicts an embodiment of an output tip starting to
show the very first signs of degradation. This figure shows an
oscilloscope trace with very little area under the recorded curve.
The graph shows a highly vertical trace, i.e., straight up and
almost straight down. This graph captured the initial degradation
of the tip. The graph shows two discharge rates. The very tight
curve depicts the fastest discharge rate, and the second curve
(more area under the curve and angled so that it intersects farther
down the X-axis) shows slightly slower discharge rate. As the
electrode wears, the dielectric behavior degrades, as does the
cavitation behavior.
[0065] FIG. 5 depicts an oscilloscope trace associated with a
degraded electrode. The change in the shape of the curve is
noticeable in this figure. The expansion horizontally (expansion
into the time domain), relates a degradation of dielectric behavior
in the system, which also means a degradation of the discharge
characteristics (longer time to discharge). These degradations in
turn result in decreased cavitation.
[0066] Embodiments of the present invention include features that
an operator can utilize to observe whether the tip attached to the
device is degrading. The characteristics used to define the usable
life of a tip are electrical characteristics and are therefore
measurable and recordable. This measurement (or feedback) can be
integrated into embodiments of the present invention that include a
display, such as an LCD display to both stop the operation of the
system upon degradation and apprise the operator to change the
tip.
[0067] Embodiments of the present invention can be utilized with
established protocols in the dental applications previously
discussed. However, the unique advantages of the device allow it to
be operated with newly established protocols as well. The method
that follows is a proposed standard operating procedure (SOP) for
the use of an embodiment of the present invention in a root canal
procedure. This SOP is offered as an example and one of skill in
the art will recognize that variations of this SOP can be performed
utilizing embodiments of the present invention and achieve the
advantages through the use of embodiments of the present invention.
This SOP is depicted by the workflow in FIG. 6.
[0068] In this method, before utilizing the present invention, the
tooth crown and the root canal are opened. To open the tooth crown
(S605), first, a dental drill to open crown of tooth to gain access
to pulp and top of canal. Then, the crown opening is rinsed with a
solution, for example, a saline solution (e.g. 5 mL). To open the
root canal (S610), the following series of endodontic files are
used to open the root canal and to remove the majority of necrotic
tissue and pulp within the root canal (e.g., red pulp in the case
of true teeth): #15 endo file, #20 endo file, #30 endo file. In the
case that the #30 endo file is sticky or does not enter, the #25
endo file can be used after the #20 file and prior to the #30
file.
[0069] When utilized in this SOP, files should be rotated (or spun)
back and forth between the thumb and a finger to gain access
towards the apex of the canal. It is recommended that an individual
performing the SOP use a rotation and an ingress/egress motion, to
both open the canal and remove necrotic tissue and pulp within said
canal. It is important to remove pulp/necrotic tissue from the
opening in the crown during this process and particular between
different files, thereby insuring that the removed tissue is not
re-introduced during the filing process. Files should not be forced
into the canal, rather an individual performing the protocol should
use the cutting ability of the file in conjunction with rotation
and ingress/egress motion to gain access and remove tissue.
[0070] After opening the canals with the files, an individual can
flush and irrigate opened root canal (e.g., with 5 mL of saline
solution) to remove any loose debris from the root canal and/or
opened crown (S615). Multiple root canals may require individual
irrigation cycles.
[0071] Now that the canals are open, an embodiment of the EDI
device can be utilized to in this process. Please note that
embodiments of the described EDI device can also replace files, but
the purpose of this SOP is to show how the EDI processing
accomplished by an embodiment of the present invention can be
integrated into a familiar protocol. Approved protocols include the
use of saline, NaOCl, and EDTA. Thus, this protocol employs these
solutions as well.
[0072] Process parameters are set on an embodiment of the device
(S620). These parameters include: process time, frequency, and
power setting. Additionally, an output tip is selected for use.
These parameters and the tip selection can change depending upon
the operator's evaluation of the procedure and what is needed for a
successful outcome.
[0073] After establishing the process parameters for the EDI
processing, the individual performing the root canal places a
saline irrigation syringe passively into the canal (S625), as far
as possible up the root canal without binding and irrigate with 5
mL of saline solution. This operator then inserts the output tip
passively into root canal (S630) as far down in the canal as
possible, without binding within the canal. The operator then
places a syringe containing 5 mL of 6% NaOCl passively into canal
and at the same time, the operator actuates the embodiment of the
present device and initiates NaOCl irrigation (S635).
[0074] While the device is actuated, the operator moves the EDI tip
up and down the canal being treated such that the entirety of the
canal "sees" actuation from the EDI tip (S640). In one example,
irrigation, using 5 mL of NaOCl, and EDI actuation should last for
the total time of treatment (60 seconds). That is, use a steady
flow of irrigant for the total EDI treatment time.
[0075] After using the NaOCl, the operator then places saline
irrigation syringe passively into the canal (S645), as far as
possible up the root canal without binding and irrigate with 5 mL
of saline solution. Then, the operator can insert the output tip
passively into root canal (S650) as far down said canal as possible
without binding within the canal. The operator then places a
syringe containing 5 mL of 17% EDTA solution passively into canal
and at the same time, actuate the device and initiate EDTA
irrigation (S655). The operator then moves the tip up and down the
canal being treated (S660) such that the entirety of the canal
"sees" actuation from the tip. In this protocol, irrigation, using
5 mL of EDTA, and EDI actuation should last for the total time of
treatment (60 seconds). That is, use a steady flow of irrigant for
the total EDI treatment time.
[0076] After the EDTA treatment, the user again places saline
irrigation syringe passively into the canal (S665), as far as
possible up the root canal without binding and irrigate with 5 mL
of saline solution and dries the area (e.g., with paper points)
(S670).
[0077] As explained in PCT Application No. PCT/US13/60943 and
PCT/US12/70080, a variety of circuits can be integrated into
embodiments of the present invention, provided that a useable
voltage is supplied to the tip to create the reactions to create
the byproducts discussed. However, FIGS. 7-8 are examples of
additional circuit designed that can be used with embodiments of
the present invention and the specific output tips disclosed
herein, in PCT/US13/60943, and in [ADD REFERENCE TO DESIGN
APPLICATIONS].
[0078] FIG. 7 is an example of a circuit that can be integrated
into embodiments of the invention that is compatible with output
tips utilized in applications discussed herein including irrigation
and cutting. Most notably, this embodiment utilizes a push switch
as a timing circuit. In FIG. 7, LED1 is a visual indicator that
assists an operator in monitoring the operation of the device.
However, further embodiment of this invention may not include this
feature. Battery v1 provides a power source for the embodiment
utilizing this circuit, and the device is actuated with a switch,
the on_off_and_time_switch. When the switch is closed to complete
the circuit, a high voltage pulse travels from the capacitor c1 to
the transformer T1 to create a high voltage pulse.
[0079] FIG. 8 is an example of another circuit utilized in
embodiments of the present invention. Use of this electrical
schematic enables the embodiments of the present invention to
utilize 10 different power settings. Additionally, embodiments with
this component are capable of delivering a precision amount of
power to tips, including the smallest tips utilized in connection
with this device.
[0080] The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the invention. As used herein, the singular forms "a", "an" and
"the" are intended to include the plural forms as well, unless the
context clearly indicates otherwise. It will be further understood
that the terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has" and "having"), "include" (and any form of include, such as
"includes" and "including"), and "contain" (and any form contain,
such as "contains" and "containing") are open-ended linking verbs.
As a result, a method or device that "comprises", "has", "includes"
or "contains" one or more steps or elements possesses those one or
more steps or elements, but is not limited to possessing only those
one or more steps or elements. Likewise, a step of a method or an
element of a device that "comprises", "has", "includes" or
"contains" one or more features possesses those one or more
features, but is not limited to possessing only those one or more
features. Furthermore, a device or structure that is configured in
a certain way is configured in at least that way, but may also be
configured in ways that are not listed.
* * * * *