FIELD OF INVENTION

[0001] The present invention relates to an apparatus and method of utilizing acoustic waves created by an electrical discharge for irrigation and disinfection.

CROSS-REFERENCE TO RELATED APPLICATION

[0002] This application is a continuation-in-part of PCT Application No.

PCT/US13/60943, entitled "ELECTRICAL DISCHARGE IRRIGATOR APPARATUS AND METHOD," filed September 20, 2013, which claims the benefit of PCT/US12/70080, entitled

"ELECTRICAL DISCHARGE IRRIGATOR APPARATUS AND METHOD," filed December 17, 2012, which claims the benefit of U.S. Provisional Application No. 61/699,568, filed September 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 serial number

, entitled "TISSUE BORING DRILL TIP," filed on February 28, 2014, attorney docket no. 3600.021, co-pending design patent application serial number , entitled "FOCUSED TISSUE BORING TIP WITH WATER VENT," filed on February 28, 2014, attorney docket no. 3600.022, co-pending design patent application serial number

, entitled "MULTI-DIRECTIONAL TISSUE REAMER," filed on February 28,

2014, attorney docket no. 3600.023, co-pending design patent application serial number

, entitled "SINGLE VENT DIRECTIONAL REAMER TIP," filed on February 28,

2014, attorney dock no. 3600.024, co-pending design patent application serial number

, entitled "IRRIGATION TIP filed on February 28, 2014, attorney docket no.

3600.025, co-pending design patent application serial number , entitled

"MODIFIED IRRIGATION TIP" filed on February 28, 2014, attorney dock no. 3600.026, which are hereby incorporated herein by reference in their entirety.

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 (NaOCI) and ethylenemide tetra-acetic acid (EDTA) are favored by dentists. The NaOCI solution, usually at a concentration between l%-3% is used to dissolve tissue and disinfect (remove bacteria), while EDTA removes the smear layer. During an irrigation procedure, NaOCI 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 NaOCI or another inert solution.

[0007] Although certainly less invasive than extraction, irrigation has its

shortcomings. First, NaOCI, 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 a re only effective at the time that they are applied. After a patient is treated with NaOCI 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; and

[0031] FIG 8 depicts an aspect of an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0032] 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.

[0033] 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.

[0034] Throughout this application, the terms "tip" and "output tip" are used interchangeably to describe and aspect of embodiments of the present invention.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] I n 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. I n 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. I n 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.

[0040] 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 ₂ 0 ₂ , H ₃ 0, 0 ₂ , Mn0 ₂ , 0 ₃ (ozone), O, H0 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.

[0041] 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.

[0042] 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. [0043] 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 NaOCI 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.

[0044] 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.

[0045] 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.

[0046] 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 ₂ 0 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 ₂ 0 ₂ , H ₃ 0, 0 ₂ , Mn0 ₂ , 0 ₃ (ozone), O, H0 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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 a nisotropic structures.

[0058] 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.

[0059] 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 t he output tip 300 to avoid blowing out the apex 320 of the tip. [0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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. [0065] Em bodiments 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 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.

[0066] I n 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. 5mL). 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. I n 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.

[0067] 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 reintroduced 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.

[0068] 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). M ultiple root canals may require individual irrigation cycles. [0069] 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, NaOCI, and EDTA. Thus, this protocol employs these solutions as well.

[0070] 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 operators evaluation of the procedure and what is needed for a successful outcome.

[0071] 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% NaOCI passively into canal and at the same time, the operator actuates the embodiment of the present device and initiates NaOCI irrigation (S635).

[0072] 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 NaOCI, 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.

[0073] After using the NaOCI, 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.

[0074] 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).

[0075] 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].

[0076] 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 noteably, 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 vl 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 cl to the transformer Tl to create a high voltage pulse.

[0077] 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.

[0078] 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, un less 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.