Ultrasonic irrigator device for in-body cleaning and disinfection
Patent Information
- Application Number
- EP2023818548
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-11-08
- Filing Date
- 2023-11-07
- Publication Date
- 2025-09-17
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Current medical devices and procedures for treating joint infections, particularly in arthroscopic knee surgery, face challenges in effectively cleaning and disinfecting joint areas, leading to complications such as bacterial biofilm formation and infection recurrence.
An ultrasonic irrigator device that uses nanoparticles suspended in a fluid medium, activated by an ultrasonic transducer, to generate cavitation and deliver antimicrobial agents directly to the infected area, enhancing cleaning and disinfection efficacy while minimizing tissue damage.
The device effectively removes bacterial biofilms and reduces bacterial loads on implanted devices, demonstrating superior efficacy compared to standard care methods, with no adverse effects on tissue and potential for reducing surgical site infections.
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Figure 1.1
Abstract
Description
[0001]ULTRASONIC IRRIGATOR DEVICE FOR IN-BODY CLEANING AND DISINFECTION TECHNICAL FIELD OF THE INVENTION The disclosure generally relates to ultrasonic medical devices and particularly to an ultrasonic medical device which uses nanoparticles for cleaning and disinfecting areas of the subject’s body. BACKGROUND OF THE INVENTION The approaches described in this section are approaches that could be pursued, but are not necessarily approaches that have been previously conceived or pursued. Therefore, unless otherwise indicated, it should not be assumed that any of the approaches described in this section qualify as prior art merely by virtue of their inclusion in this section. Similarly, issues identified with respect to one or more approaches should not be assumed to have been recognized in any prior art on the basis of this section, unless otherwise indicated. Arthroscopy (or arthroscopic or keyhole surgery) is a minimally invasive surgical procedure on a joint in which examination and sometimes treatment of damage is performed using an arthroscope. An arthroscope is an endoscope that is inserted into the joint through a small incision. The most common cause of joint infection is septic arthritis which can develop when an infection, such as a skin infection or urinary tract infection, spreads through the bloodstream to a joint. Less frequently, a puncture wound, drug injection, or surgery in or near a joint can give pathogenic germs entry into the joint space. In all these cases there is a need to treat joint infection to prevent further infection in the body. Irrigation and suction of the joint may be performed before, during or after arthroscopy in order to clean out the area, remove debris, and / or increase visibility of the field. Indeed, they are used as part of treatment of bacterial arthritis. According to the American Academy of Orthopedic Surgeons, one in every 100 people who have a hip or knee replacement will develop an infection. The treatment for knee replacement infection includes both nonsurgical and surgical procedures. Some knee replacement infections are superficial, which means that the infection has reached the skin and tissue around the joint but does not affect the artificial joint itself and may be treated with oral or intravenous antibiotics. Surgical treatment, if a knee replacement infection goes deeper than the skin and tissue around a joint, include debridement and a surgical washout of the joint. Any contaminated soft tissue is removed surgically, and the artificial joint is cleaned and disinfected. Staged surgery, another option, involves a series of surgeries to remove and replace the artificial joint. This may be necessary if the infection has developed months or years after the original knee replacement. After removal of the artificial joint, joint washout is performed, which helps get rid of infected soft tissue in the joint. The antimicrobial, bactericidal and disinfecting effects of various metallic particles such as silver, copper, zinc, and titanium are well known in the art and have been well documented. Nanoparticle carriers may use ultrasonically generated microbubbles, as described by Mullin et al., 2013 (“Nanoparticle delivery enhancement with acoustically activated microbubbles.” IEEE transactions on ultrasonics, ferroelectrics, and frequency control, 60, 1.,), as a means of drug delivery which improves their efficacy and increases cellular and vascular permeability. The sonication of metallic particles has been documented in the art. Pradhan et al., 2016 (“Effect of sonication on particle dispersion, administered dose and metal release of non- functionalized, non-inert metal nanoparticles”) describes probe sonication of metallic nanoparticles and shows that probe sonication is the preferred method for dispersion and metal release. Similarly, infections of other permanent or temporary implanted devices such as pacemakers, valves, grafts, etc. pose a problem for the healthcare system. It is therefore evident that improvements in medical devices and procedures may increase the level of patient care and be beneficial both medically and financially. SUMMARY OF THE INVENTION Certain embodiments disclosed herein include a method for ultrasonically cleaning an internal body part by providing into a cavity of a living body a liquid; providing into the cavity nanoparticles; generating ultrasonic waves in the liquid with the nanoparticles suspended therein for a defined period of time; and removing from the cavity the liquid with the nanoparticles suspended therein, after the defined period of time has lapsed. Certain embodiments disclosed herein also include an irrigation system for ultrasonic cleansing of an internal body part, which include an irrigator having an ultrasonic transducer, an inlet and an outlet; at least one control unit comprising at least one power supply configured for supplying power at least to the control unit; a liquid supply configured for storing liquid; a nanoparticles supply configured for storing one or more nanoparticle powders; a pump configured for supplying liquid from the liquid supply to a body cavity via the irrigator inlet and / or for extracting liquid from the body cavity; and a control circuitry configured for coupling to one or more of the power supply, the liquid supply, the nanoparticles supply and the pump; wherein the control circuitry and the at least one power supply are further configured for coupling to the ultrasonic transducer, the ultrasonic transducer being configured to contact the liquid. Non-limiting aspects of the invention include: A method for ultrasonically cleaning and disinfecting internal element in a body cavity, comprising steps of: providing at least one device, comprising: at least one ultrasound transducer in communication with at least one container, said container is in communication with at least one adhesive element, adapted to ensure a reversible seal-tight coupling between said container and said body cavity; reversibly coupling, in a seal-tight manner, said container to said body cavity; providing into said container at least one liquid and at least one type of nanoparticles; generating ultrasonic waves by means of said at least one ultrasound transducer in the liquid with the nanoparticles suspended therein for a defined period of time; and removing from said at least one container said liquid with the nanoparticles suspended, after the defined period of time has lapsed. In some embodiments, the element is selected from a group consisting of an implant, a soft tissue, a hard tissue and any combination thereof. In some embodiments, the container is either flexible or rigid. In some embodiments, the container comprises a lid, said lid comprising at least one opening throughout which said at least one ultrasound transducer is inserted. In some embodiments, the step of generating ultrasonic waves by means of said at least one ultrasound transducer in the liquid with the nanoparticles suspended therein is applied simultaneously with said step of providing into said container at least one liquid and at least one type of nanoparticles and step of removing from the cavity the liquid with the nanoparticles suspended therein. In some embodiments, the cavity is a joint cavity. In some embodiments, the at least one ultrasound transducer comprises at least one coil at least partially circulating the same. In some embodiments, the method additionally comprises the step of providing electromagnetic field by means of said at least one coil. In some embodiments, the step of removing from the cavity the liquid with the nanoparticles suspended therein, after the defined period of time has lapsed, is provided by generating a magnetic field in said body cavity by said at least one ultrasound transducer and collecting said at least one type of nanoparticles. In some embodiments, the step of providing into said container at least one liquid and at least one type of nanoparticles, additionally comprising step of pre-mixing at least one liquid and at least one type of nanoparticles. In some embodiments, the pre-mixing is provided by means selected from said at least one ultrasonic transducer, a mechanical mixer, a magnetic mixer and any combination thereof. In some embodiments, the step of providing into said container at least one liquid and at least one type of nanoparticles is performed sequentially by: (a) providing into said container at least one liquid and, then (b) providing at least one type of nanoparticles. In some embodiments, the step of providing into said container at least one liquid and at least one type of nanoparticles is performed after mixing said at least one liquid and at least one type of nanoparticles. In some embodiments, the irrigation device comprises at least one control unit adapted to regulate said step of providing into said container at least one liquid and at least one type of nanoparticles. In some embodiments, the said control unit is adapted to regulate at least one parameter selected from a group consisting of rate, flow, pressure, timing, the frequency of said at least one ultrasonic transducer and any combination thereof, of said step of providing into said container at least one liquid and at least one type of nanoparticles. In some embodiments, the method additionally comprises the step of providing at least one antibiotic composition. In some embodiments, the antibiotic composition comprises one or more of: vancomycin, gentamycin or ciprofloxacin. In some embodiments, the method for ultrasonically cleaning and disinfecting is performed in minimally-invasive arthroscopic knee surgery. In some embodiments, the method additionally comprises the step of providing into said body cavity at least one colored reagent being selected from crystal violet stain. In some embodiments, the step of generating ultrasonic waves by means of said at least one ultrasound transducer in the liquid with the nanoparticles suspended therein for a defined period of time is continued until all colored reagent is removed. In some embodiments, there is provided an irrigation device for ultrasonic cleaning and disinfecting an internal element in a body cavity, comprising: at least one container sized and shaped to hold at least one liquid and at least one type of nanomaterials; at least one ultrasonic transducer in fluid communication with said container in said container; said at least one container is in communication with at least one adhesive element; wherein said at least one adhesive element is adapted to ensure a reversible seal-tight coupling between said at least one container and said body cavity. In some embodiments, the internal element is selected from a group consisting of an implant, a soft tissue, a hard tissue and any combination thereof. In some embodiments, the container is either flexible or rigid. In some embodiments, the container comprises a lid, said lid comprising at least one opening throughout which said at least one ultrasound transducer is inserted. In some embodiments, the body cavity is a joint cavity. In some embodiments, the at least one ultrasound transducer comprises at least one coil at least partially circulating the same. In some embodiments, the electromagnetic field is provided by means of said at least one coil. In some embodiments, the irrigation device is in communication with at least one pre-mixing device, adapted to mix said at least one liquid and at least one type of nanoparticles. In some embodiments, the pre-mixing is provided by means selected from said at least one ultrasonic transducer, a mechanical mixer, a magnetic mixer and any combination thereof. In some embodiments, the irrigation device additionally comprises a control unit adapted to regulate at least one parameter selected from a group consisting of rate, flow, pressure, timing, the frequency of said at least one ultrasonic transducer and any combination thereof. In some embodiments, the irrigation device is used for arthroscopic knee surgery. In some embodiments, the irrigation device is in communication with at least one liquid supply configured for storing liquid. In some embodiments, the irrigation device is in communication with at least one nanoparticles supply configured for storing one or more nanoparticle powders. In some embodiments, the irrigation device is in communication with at least one pump configured for supplying said at least one liquid to said body cavity. In some embodiments, the pump is adapted for extracting said at least one liquid from said at least one container. In some embodiments, the irrigation device additionally comprises a waste unit configured for storing liquid extracted from said body cavity. In some embodiments, at least one of said liquids comprises an antibiotic composition. In some embodiments, the antibiotic composition comprises one or more of: vancomycin, gentamycin, ciprofloxacin and any combination thereof. In some embodiments, the at least one container comprises at least one inlet port for introducing said at least one liquid into said at least one container. In some embodiments, the at least one container comprises at least one outlet port for withdrawing said at least one liquid from said at least one container. In some embodiments, there is provided a method for ultrasonically cleaning and disinfecting internal element in a body cavity, comprising steps of: providing into said body cavity at least one liquid and at least one type of nanoparticles; generating ultrasonic waves by means of at least one ultrasound transducer, being in fluid contact with said at least one liquid and said at least one type of nanoparticles suspended therein for a defined period of time; wherein said at least one ultrasound transducer comprising at least one coil at least partially circulating the same; and removing from the cavity the liquid with the nanoparticles suspended therein, after the defined period of time has lapsed; wherein said step (c) of removing from said body cavity said liquid with said nanoparticles suspended therein, after the defined period of time has lapsed is provided by generating a magnetic field in said body cavity by said at least one ultrasound transducer and collecting said at least one type of nanoparticles. In some embodiments, the internal element is selected from a group consisting of an implant, a soft tissue, a hard tissue and any combination thereof. In some embodiments, the step of generating ultrasonic waves by means of said at least one ultrasound transducer in the liquid with the nanoparticles suspended therein is applied simultaneously with said step of providing into said container at least one liquid and at least one type of nanoparticles and said step of removing from the cavity the liquid with the nanoparticles suspended therein. In some embodiments, the method additionally comprises the step of communicating said at least one ultrasound transducer with at least one container. In some embodiments, the container is either flexible or rigid. In some embodiments, the container is in communication with at least one adhesive element, adapted to ensure a reversible seal-tight coupling between said container and said body cavity. In some embodiments, the method additionally comprises the step of reversibly coupling, in a seal-tight manner, said container and said body cavity. In some embodiments, the method additionally comprises the step of providing into said container at least one liquid and at least one type of nanoparticles. In some embodiments, the container comprises a lid, said lid comprising at least one opening throughout which said at least one ultrasound transducer is inserted. In some embodiments, the cavity is a joint cavity. In some embodiments, the step of providing said at least one liquid and at least one type of nanoparticles, additionally comprises the step of pre-mixing at least one liquid and at least one type of nanoparticles. In some embodiments, the pre-mixing is provided by means selected from said at least one ultrasonic transducer, a mechanical mixer, a magnetic mixer and any combination thereof. In some embodiments, the step of providing said at least one liquid and at least one type of nanoparticles is performed sequentially by: (a) providing said at least one liquid and, then (b) providing at least one type of nanoparticles. In some embodiments, the step of providing said at least one liquid and at least one type of nanoparticles is performed after mixing said at least one liquid and at least one type of nanoparticles. In some embodiments, the method additionally comprises the step of providing at least one control unit adapted to regulate said step of providing said at least one liquid and at least one type of nanoparticles. In some embodiments, the control unit is adapted to regulate at least one parameter selected from a group consisting of rate, flow, pressure, timing, the frequency of said at least one ultrasonic transducer and any combination thereof, of said step of providing into said container at least one liquid and at least one type of nanoparticles. In some embodiments, the method additionally comprises the step of providing at least one antibiotic composition. In some embodiments, the antibiotic composition comprises one or more of: vancomycin, gentamycin or ciprofloxacin. In some embodiments, the method for ultrasonically cleaning and disinfecting is performed in minimally-invasive arthroscopic knee surgery. In some embodiments, the method additionally comprises the step of providing into said body cavity at least one colored reagent being selected from crystal violet stain. In some embodiments, the step of generating ultrasonic waves by means of said at least one ultrasound transducer in the liquid with the nanoparticles suspended therein for a defined period of time is continued until all colored reagent is removed. Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other objects, features and advantages will become apparent and more readily appreciated from the following detailed description taken in conjunction with the accompanying drawings, in which: Figure 1 illustrates an exemplary and non-limiting schematic illustration of an ultrasonic in- body cleansing and disinfecting device, in accordance with an embodiment of the present invention. Figure 2 illustrates a schematic illustration of said device for use to disinfect a body cavity via irrigation with ultrasonically transduced nanoparticles, in accordance with one embodiment of the present invention. Figures 3a-3b and 4a-4f illustrate another embodiment of the irrigation device, in accordance with one embodiment of the present invention. Figures 5a-5b illustrate an embodiment of an ultrasound transducer having a magnetic tip. Figures 6a-6b illustrate a dedicated device for pre-mixing the irrigation liquid and the nanoparticles, in accordance with one embodiment of the present invention. Figure 7 illustrates a method for providing ultrasonic cleansing and disinfection to a part of the body, implemented in accordance with an embodiment of the present invention. Figures 8-18 illustrate the results of experiments executed to investigate the ability of the nanoparticles of the present invention to remove bacterial attachment and biofilm formation in comparison to the current standard of care. DETAILED DESCRIPTION OF THE INVENTION Below, exemplary embodiments will be described in detail with reference to accompanying drawings so as to be easily realized by a person having ordinary knowledge in the art. The exemplary embodiments may be embodied in various forms without being limited to the exemplary embodiments set forth herein. Descriptions of well-known parts are omitted for clarity, and like reference numerals refer to like elements throughout. It is important to note that the embodiments disclosed herein are only examples of the many advantageous uses of the innovative teachings herein. In general, statements made in the specification of the present application do not necessarily limit any of the various claims. Moreover, some statements may apply to some features but not to others. In general, unless otherwise indicated, singular elements may be in plural and vice versa with no loss of generality. Nanoparticles are suspended in a fluid medium which is activated using an ultrasonic transducer in contact with the fluid medium. The fluid medium may include but is not limited to at least one of saline, water, chlorhexidine or any suitable liquid having a pH level substantially at the pH level of the area being treated, so as not to cause a damaging reaction. In an embodiment the fluid medium may be introduced into a body cavity or be directed at a body part at or over a pressure level which is sufficient to remove debris, biofilm, and the like. The fluid composition may also contain other ingredients that can support the cleaning and disinfection action. The body cavity may contain a hard surface such as a bone, joint, an artificial device or naturally occurring buildup of organic material. In an embodiment, an irrigation device may be used before, during or after a procedure such as a minimally invasive or open surgery to clean, clear or disinfect a body area via irrigation with ultrasonically transduced fluid having nanoparticles suspended therein. The irrigation device may supply the cavity with the fluid and include therein an ultrasonic transducer or be applied using separate devices. In other embodiments, the cleaning and disinfecting process may be performed as treatment of infection in absence of another surgical procedure. In an embodiment, the ultrasonic transducer may be a unidirectional acoustic power source which is redirected to become a semispherical source of acoustic waves. For the purpose of clearing, cleaning, disinfection and sterilization of a part of the body before, during and / or after surgery, nanoparticles are suspended in a fluid medium which is activated using an ultrasonic transducer in contact with the fluid medium. The fluid is for treating a part of the body, an implanted device or naturally occurring buildup of organic material such as calcified tissue and thrombosis. In some embodiments, the body part is a joint, for example a knee joint, a shoulder joint or a hip joint. In another embodiment, the treated area is a cavity, such as a subcutaneous cavity, in which an implanted device is placed. In certain embodiments, the surgery is a minimally invasive surgery, such as knee arthroscopy. In certain embodiments, the cleaning process itself is carried out as treatment of infection in absence of another surgical procedure. In another embodiment, the process is used in an open surgery to clean and disinfect an inner part of the body. In yet another embodiment, the disclosed process may be used to clean the lumen of vessels or heart valves from thrombosis or calcified lesions by inserting a small ultrasonic transducer, for example via catheterization, in order to generate cavitation in the vicinity of the source. In some embodiments, the fluid may additionally contain antibiotic compositions to aid in disinfection. While references are made to human bodies occasionally throughout this disclosure, this is not intended to be in any way read as a limitation. Similar procedures using the devices disclosed herein can be performed, mutatis mutandis, on other animal life as well. Likewise, it would be evident that the disclosed methods and devices can be used in an open surgery, not only a closed off body cavity. Fig. 1 is a cross-sectional schematic illustration of an ultrasonic cleaning and disinfecting irrigator 100 used in a knee joint arthroscopic procedure, implemented in accordance with an embodiment. The irrigator 100 includes a surgical probe 110 for insertion into the cavity of a joint 130. In an embodiment the irrigator 100 may be rigid; in other embodiments the irrigator 100 may be flexible. Irrigator flexibility may be achieved by material choice, or a mechanical design which allows flexibility. The joint cavity may be a knee or hip, or any substantially enclosed structure. A multi-channel conduit 170 may couple the irrigator 100 with one or more controllers 240. The conduit 170 may include, for example, a first channel (not shown) for an electric cable and a second channel (not shown) to allow liquid flow. Alternatively, at least two conduits may be used. For example, one conduit may be used for passage of an electric cable and another conduit may be used for fluid / liquid supply. The one or more controllers 240 may include a nanoparticle supply 242, a power supply 244, a liquid supply 246, a control circuitry 248, a pump 250 and a waste unit 252. In some embodiment the nanoparticle supply 242 and liquid supply 246 may be a single supply, such that the nanoparticles are already suspended in the liquid which is delivered into the irrigator device 100 via the conduit 170. Likewise, the liquid may further contain antibiotics therein. In some embodiments, a plurality of liquid supplies and / or nanoparticle supplies may be utilized in any combination, to create different effects. For example, a first liquid may have a first nanoparticle solution, and a second liquid may have an antibiotic solution. The liquids may be supplied alternatively, successively or in combination, to achieve the desired effects. A valve 178 may be opened to allow flow of the liquid from the control unit 240 to the conduit 170. In certain embodiments, the valve may be uni-directional, or bi-directional. The liquid may hold therein a suspension of insoluble nanoparticles. A nanoparticle may be between 1 and 900 nanometers in size. For the purpose of this disclosure, in certain embodiments micron-sized particles may also be used, however they may not have an optimal effect. Exemplary nanoparticles may be metal oxides, metal nitrides and metal carbides, metal oxides such as silicon dioxide, aluminum dioxide, magnesium oxide, samarium oxide, titanium dioxide, and zinc oxide, metal nitrides such as silicon nitride and titanium nitride, metal carbides, such as silicon carbide, titanium carbide, and tungsten carbide. In certain embodiments, diamond nanoparticles may be used. In certain embodiments, the ratio between liquid and nanoparticles held in a suspension therein is between 10,000 and 100,000 parts liquid medium to 1 part nanoparticles. In another embodiment, the ratio may be between 1,000-1,000,000 parts fluid medium to 1 part nanoparticles. In some embodiments, the nanoparticles may have a morphology which includes one or more sharp shapes. A sharp shape for the purpose of this disclosure is a shape which includes a surface feature that is capable of piercing or otherwise destroying infectious agents (pathogens), such as membrane (cell wall) of a bacterium, or virions. For example, rods (fiber like), or stars are such shapes. The power supply 244 supplies power to various electronic and mechanical elements of the controller 240, such as the pump 250 which is used to regulate flow from the liquid supply 246 through the conduit 170 to the irrigator 100, and an ultrasonic transducer 125 of the irrigator device 100. Control circuitry 248 may be used to regulate the power supply 244, or the nanoparticle supply 242 and liquid supply 246 to change the type of nanoparticles (if various particles are used), the ratio between the liquid and nanoparticles, etc. The control circuitry 248 may be coupled with actuators (not shown), sensors (not shown), and the like. The controller 240 may supply a stream of liquid with suspended nanoparticles via use of a pump 250 to the irrigator 100. The controller 240 may be configured to then initiate the ultrasonic transducer that generates imploding cavitation bubbles creating micro-jets in the liquid which carry the nanoparticles, resulting in bombarding surfaces of the joint cavity with the nanoparticles. This may result in cleaning and disinfection of the cavity and structures within the cavity by destroying the pathogens by way of membrane disruption. Biofilms can develop and grow on implanted medical devices such as pacemakers, prosthetic heart valves, prosthetic joints and catheters and cause infection. The micro-jets inject the nanoparticles through the surface of the film which may destroy the microorganisms inside. Biofilm disruption also allows further penetration of additional antibiotics if necessary. The irrigator 100 may be used before, after, and during surgical procedures where disinfection is required or may aid in the procedure. Once the treatment is complete, the liquid and any debris may be suctioned back up via the conduit 170 and stored in the waste unit 252. Position and location of the probe 110 in the body cavity (for example joint cavity), can be visualized by the image generated by an endoscope 120. In some embodiments, the liquid may be kept in the body cavity (for example joint cavity) during the surgery to distend the cavity and create a surgical space which is more maneuverable for surgical tools, such as surgical tool 140. In another embodiment, the ultrasonic transduction of the suspended nanoparticles may be carried out via a separate transducer device once the liquid has gathered in the cavity. In some embodiments the fluid may contain one or more additional antibiotic compositions such as vancomycin, gentamycin or fluoroquinolones such as ciprofloxacin in a concentration range of 10mg-50mg per liter, and any combination thereof. It should be noted that the device and method of the present invention could also be utilized to cleaning and disinfecting an internal element within a body cavity. Such element could be an implant, soft tissue, hard tissue (e.g., bones) and any combination thereof. Fig. 2 is a schematic illustration of the irrigator device 100, implemented in accordance with an embodiment. The device 100 includes a surgical probe 110, a transducer 125, a handle 116, and a valve 115. The transducer 125 is attached to a multi-channel conduit 170 which holds, for example, at least one electrical cable 176 and at least one liquid-carrying tube 177. While this example discussed a multi-channel conduit it would be readily apparent to one skilled in the art that one or more conduits may be utilized to conduct one or more liquid supplies, nanoparticle supplies, or power supplies without departing from the scope of this disclosure. Power to the transducer 125 may be supplied by the controller (discussed in more detail with respect to Fig. 1 above) or by a separate power supply. The valve 115 may allow manual control of the flow of fluid from the device 100 to the probe 110 and into the body cavity (for example, joint cavity), such that an operator of the device 100 can manually control the pressure of fluid expelled from the device. The mechanical handle 116 allows manual control of the device. Using the internal visual image obtained, for example, by way of an endoscope, the probe 110 can be directed to the correct location within the cavity. In some embodiments the transducer 125 may have a portion extending through at least a portion of the probe 110 to activate the nanoparticles closer to the cavity. In some embodiments, the irrigator device 100 may be operative to release fluid from the probe 110 at a high pressure, creating a fluid jet having kinetic energy which may assist in removing debris by transferring kinetic energy from the fluid jet to a treated surface upon impact. For example, the probe 110 may taper towards an outlet from which fluid is ejected, such that the taper would create a pressure difference. Such an irrigator device is discussed in more detail in PCT application Publication No. WO 2020 / 141,533, having at least one joint inventor, the contents of which are incorporated by reference herein. Reference is now made to Figs. 3a-3b and 4a-4b, illustrating another embodiment of the irrigator device 300 of the present invention. According to this embodiment, the device is reversibly attachable to the body cavity (e.g., the knee, as illustrated in Figs. 4a-4b) and functions as both an ultrasound transducer holder and a container to hold the irrigation liquid and the nanoparticles. It should be noted that the body cavity may be any cavity selected from a knee joint, shoulder joint, elbow joint, wrist joint, ankle joint, or hip joint. According to this embodiment, the irrigator device 300 comprises at least one ultrasound transducer 301 and a flexible container 302 having a lid 303. Said lid 303 comprises at least one opening through which the at least one ultrasound transducer 301 can pass. As disclosed above, the at least one ultrasound transducer 301 is adapted to produce acoustic waves in flexible container 302 which, as will be described hereinafter, contains the irrigation liquid and the nanoparticles to disinfect the implant by providing the nanoparticles with kinetic energy, which assists in removing debris of the treated surface (e.g., implants) upon impact. The flexible container 302 is designed to hold within it a sufficient amount of liquid with nanoparticle suspension. It should be noted that the liquid medium is mixed with the nanoparticles within the flexible container 302, for example by manipulating one or more of the ultrasound transducers 301. In another embodiment, as illustrated in Figs. 6a-6b below, the liquid and the nanoparticles are pre-mixed in a separate device. Once mixed, the liquid and nanoparticles are supplied into the treated area. In a further embodiment, the liquid and the nanoparticles are supplied separately into the cavity, such that the combining occurs only within the cavity. As disclosed above, the ultrasound transducer generates ultrasonic waves, generating imploding cavities in the fluid which cause the nanoparticles to bombard surfaces within the treated body cavity and disinfect the same as the bacteria and pathogens that come into contact with the nanoparticles in the liquid will experience disruption of the membrane of the pathogen thus inhibiting function. It is within the scope of the present invention where the irrigation fluid may contain one or more additional antibiotic compositions such as vancomycin, gentamycin or fluoroquinolones such as ciprofloxacin. According to one embodiment, the irrigation device 300 may contain a valve which allows control of flow of ultrasonically transduced nanoparticles suspended in liquid to the cavity. According to another embodiment, the irrigation device 300 additionally comprises at least one adhesive element 304 in communication with the bottom part of the flexible container 302. The adhesive element 304 is adapted to provide a sealed tight connection with the body cavity (e.g., as seen in Figs. 4a-4b, the knee 305), such that a tight fit connection between the flexible container 302 and the body cavity is provided (i.e., without leakage of fluids outside). According to one embodiment, the adhesive element 304 is coupled to several locations in the bottom part of the flexible container 302. According to another embodiment, the adhesive element 304 is coupled to the entire periphery of the bottom part of the flexible container 302. Reference is now made to Figs. 4a-4b illustrating the irrigation device 300 and the adhesive element 304 in a seal tight connection with the knee when the knee is held in a bent position (Fig. 4a) and in a straight position (Fig. 4b). Reference is now made to Figs. 4c-4e illustrating another embodiment of the present invention, in which the transducers are perpendicular to the flexible container 302. Adhesive element 304 is in communication with the bottom part of the flexible container 302. The adhesive element 304 is adapted to provide a sealed tight connection with the body cavity (e.g., as seen in Figs. 4a-4b, the knee 305), such that a tight fit connection between the flexible container 302 and the body cavity is provided (i.e., without leakage of fluids outside). Also seen in this embodiment is the irrigation inlet port 306a and the irrigation outlet port 306b, throughout which irrigation fluids are introduced into the container 302 and drawn out thereof, respectively. According to another embodiment, the ultrasound transducer 301 may be rigid. Alternatively, the ultrasound transducer 301 may be flexible, as illustrated in Fig. 4f, for example. Reference is now made to Figs. 5a-5b illustrating another optional embodiment of the ultrasound transducer 301. At the end of the procedure (post the disinfection), suction of the liquid medium is performed, and extraction of the nanoparticles and any debris is required. According to this embodiment, at least one of the ultrasound transducers 301 comprises at least one magnetic coil 401 at least partially coiled around the body 402 of the ultrasound transducer 301. Thus, producing an electromagnetic field, by means of said at least one coil 401, results in the ultrasound transducer 301 having a magnetic tip. Such magnetic tip is used to collect the nanoparticles from within the body cavity. The remaining liquid and any debris may be suctioned back up into a waste unit by e.g., a pump. It is noted that the time frame for such extraction may be dependent on considerations such as the location of the cavity, the type of infection and / or the level of infection. Instead of the magnetic application, suction of the irrigation liquid may be applied similarly to the nanoparticles. Reference is now made to Figs. 6a-6b, illustrating a dedicated device for pre-mixing the irrigation liquid and the nanoparticles to provide a liquid medium with nanoparticles suspension therewithin. According to this embodiment, the dedicated device 500 comprises: at least one ultrasound transducer 503, coupled via at least one electronics cable 502 to an electronic connector 501. Such ultrasound transducer 503 is in liquid communication with a container 504 for holding the nanoparticles and the irrigation liquid. Upon operation thereof, the irrigation liquid is provided through at least one inlet 505. Once the nanoparticles are provided to the container 504, the ultrasound transducer 503 is operated to produce ultrasonic waves; thereby providing kinetic energy to said nanoparticles. Such kinetic energy results in mixture thereof and a liquid medium having said nanoparticles as suspensions. In some embodiments, the dedicated pre-mixing device 500 may mix the nanoparticles in several different liquids; or alternatively, the dedicated pre-mixing device 500 may mix several different nanoparticles in one liquid. In some embodiments, the dedicated pre-mixing device 500 may supply a first liquid with a first nanoparticle suspension, and then supply a second liquid with a second nanoparticle suspension. The first and second suspensions may differ in nanoparticle type, nanoparticle size, ratio of nanoparticles to liquid, liquid type, liquid viscosity, combinations thereof, and the like. Fig. 7 is flowchart of an exemplary method for providing ultrasonic cleansing and disinfection to an internal part of the body using an ultrasonic irrigator device, implemented in accordance with an embodiment. At step S310, a surgical probe of an irrigator device is inserted into a specific cavity via a key-hole incision. The cavity may be of a knee joint, shoulder joint, elbow joint, wrist joint, ankle joint, or hip joint. While other joints are certainly possible, these are listed here as the most common types to undergo an arthroscopic procedure. In certain embodiments, other body cavities or organs may be treated, such as arteries. The cavity should be able to hold within an amount of liquid with nanoparticle suspension. It can be appreciated that the insertion via a keyhole incision of step S310 is unnecessary when the ultrasonic cleansing method is executed during open surgery. At optional step S320, a controller coupled with the irrigator causes the liquid medium to mix with the nanoparticles, for example by manipulating one or more actuators. In another embodiment, the liquid and the nanoparticles are pre-mixed in a prepared solution. In yet another embodiment, the liquid and nanoparticles are supplied into the treated area. At step S330, the liquid medium with suspended nanoparticles is supplied to the irrigator via a conduit by way of a pump. In one embodiment, the liquid and the nanoparticles are supplied to the irrigator separately and are mixed in the irrigator. In a further embodiment, the liquid and the nanoparticles are supplied separately into the cavity, such that the combining occurs only within the cavity. The pump may be switched on manually via the controller. In an embodiment, the liquid medium can only travel through the conduit when a valve of the controller is in an open state. At step S340, power is supplied to the ultrasonic transducer by way of the controller or a separate power supply. In some embodiments, the ultrasonic transducer is contained within the irrigator. The transducer generates ultrasonic waves, generating imploding cavities in the fluid which cause the nanoparticles to bombard surfaces within the treated body cavity. The irrigator may contain a valve which allows control of flow of ultrasonically transduced nanoparticles suspended in liquid to the cavity. In another embodiment, the transducer may be a separate device which is inserted through a separate surgical incision (unless the surgery is open surgery) and generates ultrasonic waves from within the body cavity. Surfaces of the cavity are bombarded with nanoparticles suspended in the liquid. In certain embodiments, the liquid medium may be provided at a regulated flow and pressure. In some embodiments, the irrigator may supply a first liquid with a first nanoparticle suspension, and then supply a second liquid with a second nanoparticle suspension. The first and second suspensions may differ in nanoparticle type, nanoparticle size, ratio of nanoparticles to liquid, liquid type, liquid viscosity, combinations thereof, and the like. The imploding cavities and resulting bombarding nanoparticles will clean and disinfect the joint as the bacteria and pathogens that come into contact with the nanoparticles in the liquid will experience disruption of the membrane of the pathogen thus inhibiting its function. In some embodiments, the fluid may contain one or more additional antibiotic compositions, such as vancomycin, gentamycin or fluoroquinolones such as ciprofloxacin, in a concentration range of 10mg - 50mg per liter, or any combination thereof. At step S350, suction of the liquid medium is performed, once it has been in contact with the cavity for a set amount of time. The time frame may be dependent on considerations such as the location of the cavity, the type of infection and / or the level of infection. On conclusion of cleaning, the remaining liquid and any debris is suctioned back up through the probe, into the irrigator and into a waste unit by way of the pump and power supply. In another embodiment, the waste unit is separate from the control unit. In another embodiment, suction may be performed by a separate suction device, which is distinct from the irrigator device. In some embodiments, the liquid may remain in the joint for the duration of the surgery, to provide joint distention. In other embodiments, suction may be performed after cleaning / disinfecting, then a second liquid may be supplied, with or without nanoparticles to distend the joint. Surgery is then performed, after which an additional activation may be performed, and finally a suction to remove all nanoparticle suspended liquid from the joint. At optional step S360, a fluid medium containing one or more antibiotic compositions, such as vancomycin, gentamycin or fluoroquinolones such as ciprofloxacin in a concentration range of 10mg - 50mg per liter, or any combination thereof, is supplied to the irrigator via a conduit by way of a pump. The pump may be switched on manually via the controller. In some embodiments, steps S320 through S350 may be performed multiple times. In certain embodiments, steps S320 through S360 may be performed multiple times, so that a first set of steps S320 through S350 are performed, with step S360 being performed before or after each set of steps. According to another embodiment, the ultrasound is provided simultaneously with the irrigation. In contrary to other methods, according to this embodiment, the fluid medium and the nanoparticles suspended therewithin are provided to the body cavity (e.g., the knee 305) and at the same time are withdrawn therefrom, whilst simultaneously ultrasound is applied to treat the body cavity (e.g., the knee 305). According to another embodiment, a colored reagent that adheres to biofilm is added to the treated body cavity. The procedure is continued until the color (of the reagent) disappears. Such use of a colorful reagent could be utilized to ensure all the biofilm is removed and, thus, the procedure is completed. An example of such reagent could be crystal violet stain. Example 1 The incidence of surgical site infection following knee replacement has been reported between 1%-20%. These infections result in increased patient morbidity and decreased hospital reimbursements. Hardware implanted at the time of surgery is vulnerable to colonization by bacterial biofilms, resulting in hardware loosening and infection. The source of colonization is still an area of intense investigation and is likely to include a combination of systemic infection(s) from bacteria normally colonizing the oral cavity and / or the gut, as well as entry from the skin during the initial surgery. Once seeded, bacterial biofilms are recalcitrant to therapy and are clinically treated by physical removal during additional surgeries (Ehrlich et al., 2012; Stoodley et al., 2011; Stoodley et al., 2013). The inventors of the present invention expanded the successful in vitro research and evaluated nanoparticle ultra-sonication against bacterial attachment and biofilm formation in a total joint infection model. During the course of the study, the orthopedic implant and surrounding host tissue 21 days post implantation / inoculation was studied. The objective was to investigate the ability of the nanoparticles of the present invention to remove bacterial attachment and biofilm formation in comparison to the current standard of care. Methods Animal Study: The animal study was approved by the Institutional Animal Care and Use Committee (IACUC) of the Allegheny Health Network Research Institute (AHNRI) under animal research protocol # 1096. Animals were housed at the AHNRI animal care facility. Animal Model: Adult male Sprague-Dawley rats (~350g) Incubation length: 21 Days Bacterial Inoculum: A clinical strain of methicillin resistant Staphylococcus aureus was streaked on a blood agar plate and incubated overnight at 370C with 5% CO2. A single colony was picked from the plate and incubated in 10ml of Brain Heart Infusion for 2 hours until log phase was reached. At this time, the culture was diluted to a concentration of ~1x10^6 CFU / 2.5 uL. The broth culture was dispensed into single use 1ml aliquots and transported to the animal facility on ice. Surgical Procedure: On the day before surgery, preoperative baseline measurements were performed, including weight and local temperatures. On the day of surgery, the rats were anesthetized with 1-3% isoflurane in 1L of O2 / min. Buprenorphine at 0.05mg / kg IP were administered 30 minutes before surgery. A 3-4cm skin incision was created on the craniolateral on the surface of the right femur from the supracondylar region to the tibia of the right leg. An intercondylar canal was drilled into the tibia and 10μl containing 2 x 107 S. aureus was injected after which a 1.5mm in diameter and 5.0mm in length titanium maxillofacial screw was implanted. Control animals received saline instead of the inoculum. The wounds were closed using 5-0 Vicryl deep dermal sutures. The rats received one dose of post-operative buprenorphine-SR and 3 doses of meloxicam at 24 hours intervals. After surgery on POD 1, 3, 7, 14, and 21 the animals were monitored for weight changes, incisional integrity, gait changes, and static weight bearing abilities. On Day 21, the animals were anesthetized and an incision on the native joint (left knee) was created as previously described. Animals then underwent the nanoparticle treatment, as disclosed in the present invention, on the native knee while under anesthesia (namely, Ag nanoparticles solution at a concentration of 12mg nanoparticles / 300mL saline for a duration of 15 minutes).Explanted Screw: The implanted screw was removed and the assigned treatment, nanoparticles or standard of care, was performed. Treatment in accordance with the present invention: The screw was placed in the silicon container (as disclosed in the present invention) and 20ml of HBSS were added containing 12mg / 300mL of nanoparticles. The sample was sonicated for 15 minutes. At the end of sonication, the magnetic beads were removed from the solution. Samples were then serially diluted and plated onto BHI (Brain Heart Infusion) plates. After 24-h incubation at 37ºC, the colony-forming units (CFU) were counted for the appropriate dilution and the CFUs calculated. In addition, crystal violet staining was performed. SOC treatment: The screw was placed into a sterile polystyrene centrifuge tube containing 1mL of HBSS. The sample underwent 3 cycles of vortexing for a period of 10 seconds. The samples were then serially diluted and plated onto BHI (Brain Heart Infusion) plates. After 24-h incubation at 37ºC, the colony-forming units (CFU) were counted for the appropriate dilution and the CFUs calculated. In addition, crystal violet staining was performed. Crystal Violet Staining: After treatment, the screw was placed into 1mL of crystal violet solution and incubated at room temp for 15 minutes. After incubation, the crystal violet was removed and the screw was transferred to a fresh tube containing 1mL of DI water. After 1 minute, the screw was transferred to a new tube containing 1mL of water. This process was repeated 3 times. The screw was then placed in an empty tube and dried overnight. The next day, 100uL of 100% ethanol was added to the tube containing the screw and incubated for 10 minutes. Following incubation, the crystal violet-ethanol solution was transferred to a 96 well plate. The absorbance of the solution was measured using a Tecan plate reader at 570nm. Screw Cavity: Upon the removal of the implanted screw, the screw cavity was filled with 20uL of HBSS and then recovered. The recovered fluid was then serially diluted and plated onto BHI (Brain Heart Infusion) plates. After 24-h incubation at 37ºC, the colony-forming units (CFU) were counted for the appropriate dilution and the CFUs / mL was calculated. Tissue CFUs: At the time of retrieval, the samples were submerged in HBSS in a sterile 1mL polystyrene centrifuge tube. A section of tissue was used for CFU calculations. To calculate bacteria removed using the technology of the present invention: the sample was weighed and then placed in the silicon container and 25ml of HBSS were added containing 12 mg / 300mL of nanoparticles. The sample was sonicated, using the device of the present invention for 15 minutes. At the end of sonication, the magnetic beads were removed from the solution. Samples were then serially diluted and plated onto BHI (Brain Heart Infusion) plates. After 24-h incubation at 37ºC, the colony-forming units (CFU) were counted for the appropriate dilution and the CFUs / mg of tissue calculated. To calculate bacteria remaining after the use of the technology of the present invention: The tissue was then placed in a new tube with 1mL of HBSS. The same was sonicated for 5 minutes, vortexed for 10 seconds, sonicated for 5 minutes, and then vortexed for 10 seconds. Samples were then serially diluted and plated onto BHI (Brain Heart Infusion) plates. After 24-h incubation at 37ºC, the colony-forming units (CFU) were counted for the appropriate dilution and the CFUs / mL calculated. Tissue Histology: At the time of retrieval, the samples were placed in a sterile 1mL polystyrene centrifuge tube. Tissue was fixed in FFPE, paraffin embedded and 10µm sections were sliced using a microtome and attached to microscope slides. Tissue was stained using Hematoxylin and Eosin and imaged on an EVOS FL. Tissue sections underwent histopathology to identify signs of local cellular damage and presence of nanoparticles, by a board-certified clinical pathologist. Results: Summary of visual inspection: All animals at 21 days showed various signs of inflammation, including redness, tenderness, and increased temperature at the implanted joint. When the joint capsule was opened, many animals displayed a cloudy serous fluid within the space and evidence of scar tissue within the knee joint. When the screw was explanted, bone loss could be seen in a majority of animals around the implanted screw, indicating an indolent infection was present within the tissue. Joint Capsule Swabs: A total of 25 pockets were tested for the presence of planktonic bacteria. A positive result equals one or more colonies present on the blood agar plate. Summary of joint capsule swab testing: Mannitol salt is selective for Staphylococcus aureus and a color change is observed from red to yellow when it grows on the media. The joint capsule swab was positive for planktonic S. aureus in all 20 joint capsules (Table 1) at various levels of bacterial growth. This is reflective of the visual inspection of the pockets at the time of material retrieval in which cloudy fluid was visible in the joint capsule space. Summary of CFU testing: Overall, the nanoparticles removed more bacteria when compared to SOC with less bacteria remaining after nanoparticle treatment. Reference is now made to Fig. 8, which illustrates the screw CFUs compared between the two treatments. The nanoparticle bar represents the median CFUs of 15 screws. The SOC bar represents the median CFUs of 10 screws. A total of 25 screws were analyzed. The nanoparticle treatment (denoted in the figure as ‘nanoparticles’) removed more bacteria compared to the SOC treatment. Additionally, the nanoparticles removed on average 1x104 S. aureus per gram of tissue. Reference is now made to Fig. 9, illustrating the tissue CFUs calculated after nanoparticle treatment. The CFU / ml bar represents the average CFUs of the fluid after the tissue underwent the treatment of the present invention (denoted in the figure as ‘nanoparticles’). The CFU / gram tissue bar represents the removed bacteria per gram of tissue after treatment of the present invention. A total of 25 tissue samples were analyzed. Crystal Violet Staining Overall, the Crystal violet readings for the use of the technology of the present invention was 5 times lower than the Standard of Care treatment. While Fig. 10 illustrates the lower trends of the individual screws treated with the nanoparticles of the present invention, Fig. 11 demonstrates the statistical significance between the two treatment groups. It is noted that in Fig. 10, each bar represents the crystal violet absorbance reading from each individual screw after the assigned treatment, and in Fig. 11, the nanoparticle bar represents the median of the crystal violet results for the 15 screws assigned the treatment of the present invention. The Standard of Care bar represents the median of the crystal violet results for the 10 screws assigned the SOC treatment. Statistical analysis of the CV absorbance reading demonstrates the p-value of <0.5 which is significant: Safety Results All animals’ sonication with the device of the present invention showed no signs of visual tissue damage. Animals tolerated sonication under anesthesia without any signs of pain, distress or adverse events reported. Summary of Histology: The results of the histology staining do not suggest any damage to the host tissue. Intact cellular structures were observed without any evidence of the nanoparticles of the present invention. These findings were verified by a board-certified clinical pathologist. Discussion The results of this study further validate in vitro studies which demonstrated the efficacy of the present invention’s technology against methicillin resistant Staphylococcus aureus (MRSA) biofilms on titanium screws and coupons. The rat total joint infection model was successfully conducted with all study animals making it to the 21-day endpoint without any adverse events reported. At 21 days, all animals showed various signs of inflammation, including redness, tenderness, and increased temperature at the implanted joint. When the screw was explanted, bone loss could be seen in a majority of animals around the implanted screw and swabs of the joint capsule space were positive for S. aureus, indicating an indolent infection was present within the tissue, demonstrating the efficacy of the model to produce a chronic total joint infection. The technology of the present invention demonstrated efficacy to remove bacteria biofilms from the implanted titanium screws. Evaluation of the nanoparticle of the present invention’s ultra-sonication process demonstrated the ability of the technology to remove more bacteria than the SOC process with the nanoparticles removing ~ 1x104 S. aureus per gram of tissue. Crystal violet readings for the nanoparticle of the present invention treatment were 5 times lower than the Standard of Care treatment, with a statistical significance between the two treatment groups with a p-value of 0.002335 based on Mann-Whitney analysis. In addition, the nanoparticle sonication process of the present invention was shown to be safe in an in-vivo model. No adverse events were reported or evidence of pain or distress observed among the study animals when the sonication was performed under anesthesia. No damage was observed upon visual inspection of the host tissue after sonication. Furthermore, pathology results verified the presence of intact host tissues without any evidence of nanoparticles reported. In conclusion, these results support our hypothesis that the nanoparticle sonication technology of the present invention can remove attached bacteria biofilms from implanted orthopedic hardware and the joint capsule without destroying native tissue. Thus, the technology of the present invention has the potential to provide a novel solution for patients with suspected infection after joint replacement. Example 2 As disclosed above, the incidence of surgical site infection following knee replacement has been reported to be around 1.5%. These infections result in increased patient morbidity and decreased hospital reimbursements. Hardware implanted at the time of surgery is vulnerable to colonization by bacterial biofilms, resulting in hardware loosening and infection. The source of colonization is still an area of intense investigation and likely to include a combination of systemic infection(s) from bacteria normally colonizing the oral cavity and / or the gut, as well as entry from the skin during the initial surgery. Once seeded, bacterial biofilms are recalcitrant to therapy and are clinically treated by physical removal during additional surgeries. In the following example, optimization of the nanoparticles concentration used is illustrated. As will be demonstrated, a statistically significance of 1.45x-2.36x superiority of USN (ultrasound with nanoparticles) over US (ultrasound alone) in both bacteria biofilm and artificial biofilm. Study outline Titanium elements (discs and Screws) were: 1. Infected with Methicillin resistant Staphylococcus aureus bacterial biofilms commonly isolated from orthopedic infections. 2. Coated with artificial material, gellan-based hydrogel and Methylcellulose simulating the mechanical properties of biofilm. Each of the specimens was treated by either USN (ultrasound with nanoparticles), when two types of nanoparticles were compared: Ti2O3 (30-50Nm) and Ag (30-50Nm), or US (ultrasound alone). Two kinds of Titanium elements were used to best represent the surfaces of the implants used for total knee arthroplasty procedures and the deep grooves created between the implant and bony elements in the knee. Testing using Biofilm-simulating material Background Biofilm-forming microorganisms are ubiquitous, but continuous cultivation of these microorganisms with predictable biofilm growth and structural properties remains challenging. The development of a reliable simulated biofilm has been limited by a lack of information about the microorganism subpopulations and fluid-structure interactions involved in biofilm formation and detachment due to mechanical stress. Presented is a gellan-based hydrogel as an alternative material for a simulated physicochemical biofilm. The mechanical properties of the hydrogel in terms of the storage (G') and loss (G'') moduli can be tuned and adapted to imitate biofilms of different strengths by changing the concentration of gellan and Methylcellulose. The storage modulus of the hydrogel ranges from 2 to 20kPa, and the loss modulus ranges from 0.1 to 2.0kPa. The material constants of the hydrogels and biofilms of Pseudomonas putida KT2440 were experimentally determined by rheometric analysis. A simplified biofilm imitation based on highly hydrolyzed gellan hydrogels and Methylcellulose was established by using experimental design. This model system design was compared to real biofilms and was adapted to mimic the mechanical properties of biofilms, resulting in biofilm-like viscoelastic behavior. The use of a gellan-based hydrogel enables the imitation of biofilm behavior in the absence of growth effects, thus simplifying the system. Biofilm characterization tools can be tested and verified before their application to real biofilm. In general, this method permits faster and more reliable testing of biofilm mechanical properties (Günther s., Kwad A., A Biomimetic Gellan-Based Hydrogel as a Physicochemical Biofilm Model Journal of Biomaterials and Nanobiotechnology 05(02), 2014). The testing was performed using a simulating material that best represents the mechanical properties of the biofilm created naturally with bacteria. The material used was a mix of 3% w / v Hydrogel and 3% w / v Methylcellulose. This mixture enabled creating a substantial enough layer (50-100mg) to simulate the layer of biofilm created in the human body over a long period of at least a few months. This artificial biofilm can be created relatively fast (1 day). Growing the same amount of biofilm in the lab can take months. Method The simulating material (3% w / v Hydrogel and 3% w / v Methylcellulose) was applied to the Titanium sample surfaces in 3 coats using a small brush. The samples were heated in an oven at 100 degrees centigrade for 15 minutes until they were completely dry. The total weight of the coating was 50 to 100mg. Two beakers with 300ml of water in each were inserted into the ultrasonic bath filled with 2400ml of water. That way the total water volume was set to 3 liters. The bath was operated at power of 150 watts– (50 Watts per liter). One beaker held water only and the other one had the nanoparticles added at different concentration. The samples were inserted into the beakers and the ultrasound was activated until full cleaning was reached. The cleaning process was set to be completed once the difference in weight of the samples was less than 5mg between cleaning cycles and the total weight of the cleaned element reached a 5mg difference from the original element weight. Once completed, the samples were fully dried in an oven and weighed. Optimizing Nanoparticles concentration The concentration was determined as milligrams of Ti2O3 nanoparticles (30-50nm) in 300ml of water contained in a 450ml beaker. The ultrasound used was 50 watts per liter. The tested concentrations used were 0 (sonication alone without nanoparticles), 3, 6, 12 and 20mg per 300ml. Test procedure Two beakers containing 300ml of water were put into the ultrasonic bath containing additional 2400ml of water. The bath was set to 150 watts (150 watts for a total of 3000 ml – 50 watts per liter). The bath was not preheated, and the temperature reached during the test was up to 35 deg Centigrade. 15 discs were coated with the simulating material. The cleaning procedure was performed until the discs were clean. The cleaning effect was determined by measuring the weight of the discs and comparing the weight of the cleaned discs to the original weight of the discs. The process was done 3 times for each nanoparticles concentration. The parameter of the cleaning rate was calculated as follows – (contaminated disc weight – final weight post cleaning) / Time needed for cleaning. The efficacy of cleaning was presented as mg per minutes and was calculated for each concentration level tested. Results The following table represents the concentration and the cleaning rate: It is noted that the phrase ‘nano concentration’ refers to mg per 300ml of water; the phrase ‘cleaning rate’ relates to mg per min. Reference is now made to Fig. 12, which illustrates the results of the cleaning rate in different concentrations of Ti2o3 nanoparticles 0,3,6,12 and 20mg per 300ml. The following table summarizes the nanoparticles concentration and the average cleaning rate: As seen, the concentration of 12mg per 300ml gives the best cleaning rate of 3.62 mg per min in average, as compared with 1.94 mg per min for sonication alone (0mg / 300ml) - a ratio of 1.86. Also seen is that the addition of nanoparticles improved the average cleaning rate by 51.3%. Example 3 Testing of titanium discs using Ti2O3 nanoparticles and biofilm simulating material In the following example the superior cleaning effect of adding nanoparticles at the previously determined concentration of 12mg per 300ml to the cleaning liquid is demonstrated. This effect was demonstrated using titanium discs and biofilm simulating material. The concentration was determined as milligrams of Ti2O3 nanoparticles in 300ml of water contained in a 450ml beaker. Test parameters Test items – Discs (20mm diameter) Nanoparticles – Ti2O3 (30 to 50nm) Ultrasound – 50 watts per liter Concentrations – 0, 12, 20 mg per 300ml (0 stands for sonication alone without nanoparticles). Test procedure Two beakers containing 300ml of water were put into the ultrasonic bath containing additional 2400ml of water. The bath was set to 150 watts (150 watts for a total of 3000ml – 50 watts per liter). The bath was not preheated, and the temperature reached during the test was up to 35 deg Centigrade. 12 discs were contaminated using the simulating material. The cleaning procedure was performed until the discs were clean. The cleaning effect was determined by measuring the weight of the discs and comparing the cleaned discs to the original weight of the discs and weight of the contaminated discs. The process was done 4 times for each nanoparticles concentration. The parameter of the cleaning rate was calculated as follows – (contaminated disc weight – final disc weight post cleaning) / Time needed for cleaning. This resulted in the cleaning rate parameter for comparing the cleaning efficiency of sonication with nanoparticles as compared to sonication alone. The cleaning rate was measured in units of mg per minutes. Results The following table summarizes the nanoparticles concentration (mg per 300ml of water) and the cleaning rate (mg per min): Reference is now made to Fig. 14, illustrating the cleaning rate for three concentrations, four times in each concertation. The following table summarizes the average cleaning rate for each nanoparticles concentration: Reference is now made to Fig. 15, illustrating the average cleaning rate for three concentrations, four times in each concertation. As seen in the results, the titanium discs demonstrated that in average the cleaning rate using ultrasound with Ti2O3 nanoparticles in the concentration of 12mg per 300ml on contaminated titanium discs was 1.85 times more efficient than using ultrasound alone (0mg per 300ml). The cleaning results using USN were significantly better than US (this is based on a one-way ANOVA with Bonferroni post-hoc correction for 3 groups p<0.05). Example 4 Testing of titanium Screws using Ti2O3 nanoparticles and biofilm simulating material In the example, the superior cleaning effect of adding nanoparticles at the previously determined concentration of 12mg per 300ml to the cleaning liquid is demonstrated. This effect was demonstrated using titanium screws and biofilm simulating material. The concentration was determined as milligrams of Ti2O3 nanoparticles (30 to 50nm) in 300ml of water contained in a 450ml beaker. Test parameters Test items – Screws (M620mm long) Nanoparticles – Ti2O3 (30 to 50nm) Ultrasound – 50 watts per liter Concentrations – 0, 12, 20mg per 300ml (0 stands for sonication alone without nanoparticles) Test procedure Two beakers containing 300ml of water were put into the ultrasonic bath containing additional 2400ml of water. The bath was set to 150 watts (150 watts for a total of 3000ml – 50 watts per liter). The bath was not preheated, and the temperature reached during the test was up to 35 deg. Centigrade. 12 screws were coated using the simulating material. Cleaning procedure was performed until the screws were clean. The cleaning effect was determined by measuring the weight of the screws and comparing the cleaned screws to the original weight of the screws and weight of the contaminated screws. The process was done 4 times for each nanoparticles concentration. The parameter of the cleaning rate was calculated as follows – (contaminated screw weight – final screw weight post cleaning ) / Time needed for cleaning. This resulted in the cleaning rate parameter for comparing the cleaning efficiency of sonication with nanoparticles as compared to sonication alone. The cleaning rate was measured in units of mg per minutes. Results The following table summarizes the nanoparticles concentration (mg per 300ml of water) and the cleaning rates (mg per min) thereof: Reference is now made to Fig. 16, illustrating the cleaning rate for three concentrations, four times in each concertation. The following table summarizes the average cleaning rate for each concentration: Conclusions The above example demonstrates that, in average, the cleaning rate using ultrasound with Ti2O3 nanoparticles in the concentration of 12mg per 300ml on contaminated titanium screws was 2.36 times more efficient than US (0 mg per 300ml). The result is statistically significant based on a one-way ANOVA with Bonferroni correction for 3 groups p<0.05. It can be seen that the effect demonstrated using the screws was far more significant than the one demonstrated using discs. The inventors of the present invention believe this difference is related to the rough surface morphology of the screws compared to the smoothness of the polished discs. It is therefore expected that the advantage of USN over US will be much greater in a real-life situation of a TKA procedure where many cracks and voids can be populated by biofilm. The cleaning results using USN were significantly better. Example 5 Testing of titanium Screws using Ag Silver nanoparticles and biofilm simulating material In this example, the superior cleaning effect of adding nanoparticles of silver at the previously determined concentration of 12mg per 300ml to the cleaning liquid is demonstrated. This effect was demonstrated using titanium screws and biofilm simulating material. The concentration was determined as milligrams of Ag nanoparticles in 300ml of water contained in a 450ml beaker. Test parameters Test items – Screws (M620mm long) Nanoparticles – Ag Silver (30 to 50nm) Ultrasound – 50 watts per liter Concentrations – 0, 12, 20 mg per 300ml (0 stands for sonication alone without nanoparticles) Test procedure Two beakers containing 300ml of water were put into the ultrasonic bath containing additional 2400ml of water. The bath was set to 150 watts (150 watts for a total of 3000ml – 50 watts per liter). The bath was not preheated, and the temperature reached during the test was up to 35 deg. Centigrade. 6 screws were coated using the simulating material. The cleaning procedure was performed until the screws were clean. The cleaning effect was determined by measuring the weight of the screws and comparing the cleaned screws to the original weight of the screws and weight of the contaminated screws. The process was done twice for each nanoparticles concentration. The parameter of the cleaning rate was calculated as follows – (contaminated screw weight – final screw weight post cleaning) / Time needed for cleaning Results The following table summarized the cleaning average rate (mg per min) for each nanoparticle concentration (mg per 300ml of water): Reference is now made to Fig. 17, illustrating the cleaning rate calculated for three concentrations, twice for each concertation. The following table illustrates the average cleaning rate for each nanoparticles concentration: Conclusions The above demonstrates that the average cleaning rate using ultrasound with nanoparticles of AG (Silver) in the concentration of 12mg per 300ml on coated titanium screws was 1.28 times more efficient than using ultrasound alone (0 mg per 300ml). The effect demonstrated using the screws and Ag nanoparticles was less profound than the one demonstrated using screws and TI2O3 nanoparticles. This result was anticipated because of the higher weight of the Ag nanoparticles compared to the Ti2O3 nanoparticles and as the same amount of ultrasound energy (50 watts per liter) was used, the velocity of those particles moving in the liquid was lower. This made the impact velocity of the particles with the surfaces lower and thus made the mechanical effect of the system less significant. An additional mechanical effect is the hardness of the different nanoparticles. As the hardness (shore A) of the Ti2O3 nanoparticles is much higher than the one of the Ag nanoparticles, the mechanical cleaning effect, which is based on the sand blasting effect on a nano scale of the Ti2O3, was much higher, as expected. Both phenomena of the velocity and the hardness of the different nanoparticles demonstrate that the dominant cleaning mechanism using ultrasound enhanced with nanoparticles is mechanical and unrelated to any inherent disinfection property of the titanium. Example 6 Testing using biofilm - bacteria incubation In this example, the superior cleaning effect of adding nanoparticles at the previously determined concentration of 12mg per 300ml to the cleaning liquid is demonstrated. This effect was demonstrated using titanium screws using methicillin resistant Staphylococcus aureus bacteria that was grown to create a biofilm on the screws for 14 days. The concentration was determined as milligrams of Ti2O3 nanoparticles in 300ml of water contained in a 450ml beaker. Test method A clinical isolate of methicillin resistant Staphylococcus aureus was grown and diluted to a concentration of 6 log10 CFU to achieve a robust bacterial biofilm on the titanium screws. 8 screws for each condition (24 screws total) were inoculated with 6 log10 CFU of S. aureus in petri dishes. Bacteria was fed daily to encourage biofilm growth. After 14 days of incubation at 37oC, sonication was performed on the screws. 8 of the screws were cleaned with USN and 8 of the screws were cleaned with US. Additional 8 screws were used as control with no treatment. After 20 minutes of sonication the titanium screws were fixed and submerged in crystal violet stain which stained any bacteria present on the screws. The samples were analyzed using a plate reader and absorbance measured at 550nm. Test parameters Test items – Screws (M620mm long) Sonication time – 20 minutes Sonication power – 50 watts per liter, 300ml volume of liquid Nano Ti2O3 concentration – 0 (sonication alone) and 12mg per 300ml Results The following table illustrates the biofilm growth after 7 / 14 days (weight in grams). Two screws from each group were measured. Remaining biofilm / bacteria on screws post cleaning as it was measured with crystal violet emission measured in Absorbance Units. The results thereof are illustrated in the following table (measured in absorbance units): Reference is now made to Fig. 18, illustrating the crystal violet emission. Cleaning effectiveness was measured on 14 days grown biofilm. For the Crystal Violet staining results after 20 minutes of sonication there is significant difference between sonication with nanoparticles compared to sonication alone P<0.05 (ANOVA + post hoc Bonferroni correction) – showing a better cleaning results (and less crystal violet emission) when nanoparticles were used. The results demonstrate a statistically significant 1.45x - 2.36x superiority of USN over US in both bacteria biofilm and artificial biofilm and highlighted the mechanical mechanism of action of USN. Thus, the technology of the present invention presents a superior biofilm cleaning effect in TKA patients, that warrants continuation of this project to the next level of using USN in pre- clinical total knee arthroplasty model. The following results illustrates the average USN compared to US for examples 2-6: It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such. Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. The methods of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such. The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.
Claims
CLAIMS 1. An irrigation device for ultrasonic cleansing of an internal element in a body cavity, comprising: at least one container sized and shaped to hold at least one liquid and at least one type of nanomaterials; at least one ultrasonic transducer configured to generate ultrasonic waves in said at least one liquid within said container; and at least one adhesive element coupled to said at least one container and configured to ensure a reversible seal-tight coupling between said at least one container and said body cavity.
2. The irrigation device according to claim 1, wherein said at least one ultrasound transducer comprises an electromagnetic element for generating a magnetic field.
3. The irrigation device according to either one of claims 1 or 2, wherein said irrigation device is configured to be in communication with at least one pre-mixing device, said at least one pre-mixing device being configured to mix said at least one liquid and at least one type of nanoparticles.
4. The irrigation device according to any one of claims 1 to 3, further comprising a control unit configured to regulate supply of one or more of said at least one liquid and said at least one type of nanomaterials into said at least one container.
5. The irrigation device according to claim 4, wherein said control unit is further configured to regulate at least one parameter selected from a group consisting of rate, flow, pressure, timing, a frequency of said at least one ultrasonic transducer and any combination thereof.
6. The irrigation device according to any one of claims 1 to 5, wherein said device is configured to be in communication with at least one liquid supply configured for storing said at least one liquid.
7. The irrigation device according to any one of claims 1 to 6, further comprising at least one pump configured for supplying said at least one liquid to said body cavity.
8. The irrigation device according to any one of claims 1 to 7, wherein said at least one container is flexible.
9. The irrigation device according to any one of claims 1 to 8, wherein said at least one type of nanomaterials comprises nanoparticles that have a surface feature capable of piercing or otherwise destroying an infectious agent.
10. The irrigation device according to any one of claims 1 to 9, wherein said at least one container comprises a lid that has at least one opening through which said at least one ultrasound transducer passes.
11. The irrigation device according to any one of claims 1 to 10, wherein said at least one container comprises at least one inlet port configured for introducing said at least one liquid into said at least one container.
12. The irrigation device according to any one of claims 1 to 11, wherein said at least one container comprises at least one outlet port configured for removing said at least one liquid from said at least one container.
13. The irrigation device according to any one of claims 1 to 12, wherein said internal element is selected from a group consisting of: an implant, a soft tissue, a hard tissue and any combination thereof.
14. The irrigation device according to any one of claims 1 to 13, wherein said body cavity comprises a joint.
15. The irrigation device according to any one of claims 1 to 14, wherein said at least one liquid comprises a colored reagent that adheres to biofilm on the internal element.