WO2023064459A1 - Integrated electrochemical treatment system for removal of biofilm from implanted devices - Google Patents

Abstract

A modular system for treatment of a percutaneous implant includes a working electrode, at least one counter electrode and a stimulating device electrically coupled to the at least one counter electrode and the working electrode, the stimulating device being capable of providing a current. The working electrode is the percutaneous implant and in which each of the at least one counter electrode, stimulating device and optionally at least one reference electrode are integrally disposed on an anchoring unit that is releasably securable in relation to the percutaneous implant. Alternatively, the stimulating device can be integrally disposed on the counter electrode, enabling treatment while a prosthetic remains attached to the patient.

Description

Integrated Electrochemical Treatment System for Removal of Biofilm from Implanted Devices

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority under relevant portions of 35 USC §119 and 35 USC §120 to United States Patent Application Serial No. 63/255,081, filed October 13, 2021 and entitled: Integrated Electrochemical Treatment System for Removal of Biofilm from Implanted Devices. The entire contents of this document is herein incorporated by reference.

TECHNICAL FIELD

[0002] This application is generally directed to the field of medical devices and more specifically to a modular treatment system including a support which is configured for integrally maintaining a plurality of electrodes and a stimulating device, the treatment system being used for removing or cleaning biofilm deposits from surgically implanted devices.

BACKGROUND

[0003] Metal implants are commonly used in the medical field for patients afflicted with many different injuries or medical problems. For example, metal implants may be used as stabilization mechanisms for prosthetic limb attachment. These known percutaneous (transcutaneous) metal implants use components that are embedded deep within the intramedullary cavity of certain bones, such as the femur or humerus, in order to achieve a stabilized mount for the prosthetic limb. Portions of the metal implants may protrude through the skin of an amputee patient with a portion of the implant extending external to the limb. This external portion is typically what the prosthetic limb can attach to and is usually in the form of a rod, post, pin or similar structure. Dental implants are another example of a percutaneous implant. Typically, a portion of the dental implant is embedded within the jaw bone of the patient with the remaining portion of the dental implant protruding outwardly into the oral cavity. The outwardly protruding portion of the dental implant is configured for enabling the attachment of a prosthetic (crown) component. [0004] A long term problem with metal implants is that they tend to allow for the growth of bacteria on the surface. This growth may increase the patient’ s risk for an infection. To decrease the risk of infection, electrochemically based treatment systems have been developed that incorporate electrodes, which can provide electrical stimulation to disrupt the growth of bacteria or prevent bacterial attachment in the first place. It has been shown in scientific literature that the application of cathodic current to metal samples create chemical reactions at that surface that can disrupt and kill bacterial biofilms existing on the metal sample.

[0005] For electrochemical processes to occur in these treatment systems, there must be an anode and a cathode within an electrolyte solution. The anode is a metallic surface where oxidative reactions occur, and the cathode is another metallic surface where reduction reactions occur. A reduction reaction is essentially when the material of interest gains electrons and thereby decreases the oxidation state of the molecules. Local water molecules at the surface of the cathode are dissociated into different reactive oxygen species that can increase the local pH. The electrolyte in which the cathode and anode each reside provides an electrical connection by facilitating the flow of electrons shuttled by ion carriers, such as sodium or potassium ions. Electrons are driven from the anode to the cathode through an electrical path via a stimulating device, such as a potentiostat or galvanostat that is used to drive current from a counter electrode (anode) to a working electrode (cathode) to keep the voltage or current on the working electrode at a constant value compared to a stable reference electrode.

[0006] Cathodic Voltage Controlled Electrical Stimulation (CVCES) is a treatment technique in an in-vivo setting that has been proven effective in fighting and preventing bacterial biofilm infections on metallic implants in a very minimally invasive way. According to this technique, the patients’ bodies act as an electrochemical cell by using the metal implant as the cathode and the counter electrode as the anode, wherein the anode represents the counter electrode, and the cathode represents the working electrode. Using a potentiostat or similar stimulating device, a user can dictate which electrochemical process is occurring on the working electrode and at what rate the process occurs simply by adjusting the applied voltage parameters. The counter electrode has specific physical, electrical, and chemical requirements that the electrode must meet to sufficiently facilitate CVCES, especially in a clinical environment in which the patient’s health is concerned.

[0007] The CVCES treatment technique has been shown to be compatible with certain implants. An example of a known CVCES treatment system is schematically shown in FIG. 1 with regard to a limb 10 of a patient, including a metal post 14 that is inserted into a bone 12 of the limb 10. An exposed portion of the metal post 14 forms the working electrode of the treatment system having a conductive surface 22 and forms a support for a prosthetic component (not shown). The treatment system further includes a counter electrode 16 and a reference electrode 18 in addition to the working electrode (implant), wherein each of the counter and reference electrodes 16, 18 are locally attached to the skin of the patient as shown. Each of the electrodes 14, 16 and 18 are further coupled mechanically and electrically to the stimulating device, such as a potentiostat 20, through a series of associated lead wires, each having suitable electrical contacts.

[0008] For the most part, all known treatment systems, such as those shown in FIG. 1, include a plurality of disparate components. There is a prevailing need in the field for an improved design that combines all or substantially all of the components for electrochemical treatment of biofilms of a percutaneous metal implant, such as a dental implant, an orthopedic implant or other similar device.

BRIEF DESCRIPTION

[0009] Therefore and according to at least one aspect of the present invention, there is provided a treatment system for removing biofilm from a percutaneous implant, the treatment system comprising a working electrode, at least one counter electrode, and a stimulating device electrically coupled to the at least one counter electrode and the working electrode. The stimulating device is capable of providing a cathodic current wherein the working electrode is the percutaneous implant. The treatment system further comprises an anchoring unit upon which the at least one counter electrode is disposed, the anchoring unit being connectable to the percutaneous implant and wherein the stimulating device is integrally disposed on at least one of the counter electrode and the anchoring unit. [0010] Preferably, the treatment system further comprises a tightening mechanism configured for securing the anchoring unit to an exposed metal portion of the percutaneous implant. According to at least one version, the at least one counter electrode comprises a plurality of counter electrode pads each made from a conductive material, and in which the counter electrode pads are each coupled to the anchoring unit. In at least one version, the counter electrode pads are configured and arranged on the anchoring unit in order to peripherally surround the exposed portion of the percutaneous metal implant. In at least one version, the counter electrode pads are shaped and sized to configure with the exposed portion of the percutaneous implant. In one version, for example, the counter electrode pads can be defined by a trapezoidal shape or configuration. According to one embodiment, a total of four (4) counter electrode pads are disposed coupled to the anchoring unit.

[0011] Electrical contacts are provided between the stimulating device and the counter electrode pads, wherein the electrical contacts are disposed within an interior of the anchoring unit. In at least one version, the stimulating device can be snap-fitted directly to the anchoring unit wherein the stimulating device can be a potentiostat, galvanostat or similar device. In at least one version, the stimulating device is attached at a distal end of the anchoring unit in order to effectively cap the exposed portion of the percutaneous implant. In another version, the stimulating device can be anchored to the at least one counter electrode, enabling treatment while a prosthetic is attached to the exposed metal portion of the implant.

[0012] In at least one version, the treatment system further comprises at least one stable sensing or reference electrode. Preferably, the at least one sensing electrode is electrically coupled to the at least one counter electrode and more preferably to at least one of the counter electrode pads.

[0013] According to another aspect, there is provided a method for manufacturing an integrated system for treatment of a percutaneous implant for removal of biofilm deposits, the method comprising the steps of providing an anchoring unit having a mechanism that is configured to secure to an exposed metal portion of the percutaneous implant, integrally attaching at least one counter electrode to the anchoring unit, integrally attaching a stimulating device to at least one of the anchoring unit and the at least one counter electrode; and electrically coupling the at least one counter electrode and the exposed metal portion of the percutaneous implant to the stimulating device, wherein a working electrode for treatment is the percutaneous implant.

[0014] According to yet another aspect, there is provided a method for biofilm removal or biofilm cleaning of a percutaneous metal implant, the method comprising attaching an anchoring unit to an exposed metal portion of the percutaneous metal implant, and attaching at least one counter electrode integrated to the anchoring unit onto the limb of a patient surrounding the percutaneous metal implant. A cathodic current is applied to the at least one counter electrode and the working electrode using a stimulating device, the stimulating device being capable of providing a current wherein the working electrode is the percutaneous implant and in which the at least one counter electrode is integrally disposed on an anchoring unit that is connectable to the percutaneous implant, and the stimulating device is integrally attached to at least one of the counter electrode and the anchoring unit.

[0015] The above needs for a modular solution are satisfied by allowing the at least one counter electrode and other auxiliary electrodes to be coupled mechanically and electrically to an anchoring unit, the latter having a gripping or securement mechanism that locks onto a post or other protruding metal portion of a percutaneous metal implant. The anchoring unit simultaneously electrically connects the post/implant itself to the stimulating device for use as the working electrode. On the proximal end of the anchoring unit, a stimulation device (potentiostat or galvanostat) is integrally disposed that may cap the post while the post is electrified. By attaching the stimulation device and all skin-based electrodes integrally to the anchoring unit, traditional lead wires and communication cables are effectively eliminated. This advantageously creates a much more user friendly and organized system to use. In addition, multiple connection points on the anchoring post to the counter and other auxiliary electrodes may allow for these electrodes to be applied and detached in sections that optimally surround the limb for improved treatment. [0016] Advantageously, a novel design is described to apply a multiple electrode system specifically to a percutaneous metal implant that improves device usability for purposes of biofilm treatment, as compared to previously known treatment systems of this type.

[0017] An advantage of the herein described apparatus is in increasing the overall efficiency of attachment of electrodes to a percutaneous implant such as a prosthetic, dental implant, or fixation pin or post. The herein described apparatus is configured to consolidate multiple electrode components and a stimulating device, each into a single integrated system that can be anchored or is otherwise secured to the percutaneous metal implant.

[0018] Another advantage realized is that the herein described system is configured to support modular and circumferentially disposed electrodes for use with a percutaneous implant, in order to more uniformly and efficiently remove biofilm deposits. The herein described treatment system also simplifies electrode application to the patient.

[0019] Yet another advantage is that the integrality of the herein described system and apparatus virtually eliminates the need for lead wires and cabling, as is required in known biofilm removal or treatment systems.

[0020] These and other features and advantages will be readily apparent from the following Detailed Description, which should be read in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and together with the general description given above and the detailed description given below, serve to explain features of the invention (in which like numerals represent like elements), of which:

[0022] FIG. 1 is a perspective schematic view of an implant biofilm treatment system in accordance with the prior art; [0023] FIG. 2 is a side elevational view, in section of an integrated biofilm treatment system made in accordance with an embodiment of the present invention;

[0024] FIG. 3 is a top view of the integrated biofilm treatment system of FIG. 2 prior to attachment to a percutaneous implant;

[0025] FIG. 4 is a comparative view of an electrode pad of an exemplary treatment system with another electrode pad additionally having a sensing or reference electrode; and

[0026] FIG. 5 is a side elevational view of an integrated biofilm treatment system made in accordance with another exemplary embodiment of the present invention.

DETAILED DESCRIPTION

[0027] The following Detailed Description should be read in reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not limited to the scope of the invention. The detailed description illustrates, by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is believed to be the best mode of carrying out the invention.

[0028] As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for the intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values + 10 percent of the recited value, e.g., “about 90%” may refer to the range of values from 81% to 99%. The terms “distal” and “proximal” as well as a number of other terms are also used in order to adequately define a suitable frame of reference with regard to the accompanying drawings. These latter terms are not intended to limit the intended scope of the invention, except where so specifically indicated. [0029] The following describes an exemplary embodiment of an integrated electrochemically-based biofilm treatment system (CVCES) 100 with regard to a percutaneous implant of interest. It will be understood that the herein described embodiments have applicability to literally any current-based treatment system. In this embodiment, the percutaneous implant 110 is directed to a specific area (leg) of a patient although the system is configurable with other forms of limb implants, as well as dental implants.

[0030] First and with reference to FIG. 2, there is depicted a side elevational view, taken in section, of a metal percutaneous implant 110 in the distal end of a thigh 120 of a subject, in which the thigh 120 has been amputated above the knee (not shown). For purposes of this discussion, it is assumed for purposes of this discussion that the percutaneous implant 110 is embedded to a predetermined distance within the intramedulary cavity of the femur bone 124 that is inside of the thigh 120. A metal portion, and more specifically a metal post 114 of the percutaneous implant 110, is exposed wherein an anchoring unit 160 has been mounted onto the implant 110, which is locked into position. The anchoring unit 160 according to this embodiment is defined by a unit body 164 having an interior, as well as a distal end and an opposing proximal end. The anchoring unit 160 is preferably equipped with a tightening mechanism 150, preferably located within the defined interior of the anchoring unit 160, which is responsible for engaging and tightening the exposed metal post 114 of the percutaneous implant 110 for securement thereto. More specifically, the tightening mechanism 150 may include at least one of a chuck, cam, springs, pads, or similar device that is configured to engage an exterior surface of the exposed metal post 114 and mechanically couple and secure the anchoring unit 160 thereto. According to this exemplary embodiment, at least one point of contact 154 of the tightening mechanism 150 is made from of a suitably electrically conductive material such as stainless steel, cobalt-chrome, titanium or other suitable material that can provide electrical conduction to the exposed metal post 114 of the percutaneous implant 110. In one version, shown most clearly in FIG. 3, a plurality of points of contact 154 are provided on respective sides of a collet 166. [0031] The tightening mechanism 150 is configured in order to selectively loosen and tighten such that the anchoring unit 160 can be disposed around the exposed metal post 114 and engaged to secure the anchoring unit 160 prior to treatment and then be subsequently released by a user following a prescribed treatment. Once the tightening mechanism 150 is loosely applied onto the exposed metal post 114, the anchoring unit 160 is configured to tighten, preferably using an external user engageable locking member (not shown) in order to secure the tightening mechanism 150 into the exterior surface of the exposed metal post 114 of the percutaneous implant 110. According to another version, the tightening mechanism 150 can be secured or loosened by twisting (rotating) the anchoring unit 160 relative to the exposed metal post 114.

[0032] The anchoring unit 160 according to this exemplary embodiment also integrally retains two (2) other forms of electrically connecting contacts, and more specifically at least one counter electrode contact 130 and at least one stimulation device contact 170. According to one configuration, the at least one counter electrode contact 130 may be a snap connector, but may alternatively be a screw, eyelet, pin, plug, or other suitable form of connection. In a preferable configuration, as illustrated in FIG. 3, there may be four (4) equally spaced counter electrode contacts 130 evenly disposed around the collet 166 of the anchoring unit 160. These contacts 130 are configured to allow for retention of four (4) separate counter electrode pads 190, each of which can be applied in order to fully surround the thigh 120 of the patient in order to provide uniform treatment using cathodic voltage. It will be understood that the actual number of counter electrode pads 190 and electrode contacts 130 can be suitably varied. For example, there may be anywhere from 1 to 20 counter electrode contacts in less preferred embodiments. The cross section view in FIG. 2 depicts two (2) counter electrode pads 190 adhered up the medial and lateral sides of the leg.

[0033] After a complete application of the electrodes via the anchoring unit 160 via the electrode contacts 130, the counter electrode pads 190 preferably completely surround the limb of the patient, as well as the percutaneous implant 110, in order to provide an equally distributed electrical treatment to the embedded implant 110. The length and width dimensions of the counter electrode pads 190 are preferably configured and sized to provide optimal coverage upon the percutaneous implant 110 and limb (e.g., the thigh 120), wherein the counter electrode pads 190 may be selected before treatment and attached to the anchoring unit 160 for deployment, thereby making the treatment system 100 modular to patient needs. Each counter electrode pad 190 is defined at least in part by an anodic surface, as further described below, as well as a hydrogel that interfaces with the skin of the patient in addition to an adhesive backing. Preferably, the overall length of each of the counter electrode pads 190 should ideally match or exceed the length of the percutaneous implant 110 into the femur, according to this example. Despite being physically separate electrodes, the counter electrode pads 190 may all be electrically connected to the anchoring unit 160 via a corresponding number of the electrode contacts 130 and wiring that is internal to the anchoring unit 160 that connects them all. Once connected, each of the separately disposed electrode pads 190 will act in unison with respect to the stimulation of the metal implant 110.

[0034] Similarly, another plurality of electrical contacts 170 are provided, preferably at the distal end of the unit body 164 for mechanical and electrical attachment of a stimulating device 180, such as a potentiostat, galvanostat or similar device capable of providing a desired cathodic voltage or current. According to this exemplary embodiment, all of the electrical communication from the electrical contacts 130 for the counter electrode pads 190 and the electrical contacts 170 for the stimulating device 180 may be internally transferred to the hardware and software systems of the stimulating device 180. According to this exemplary embodiment, the stimulation unit contacts 170 secure the stimulating device 180 to the anchoring unit 160, as well as provide signal conduit for application of treatment currents. The communication contacts 170 may be in the form of a plug/receptacle, ribbon cable, or other common communication line, and may be housed within a defined recess cavity of the stimulation unit 180 such that the housings of the stimulation device 180 and the anchoring unit 160 can positively mate firmly and securely with one another.

[0035] Another important reason why the stimulation unit 180 is designed to interface with the anchoring unit 160 over the distal end of the implant post 114 is to cover any remaining exposed metal of the percutaneous implant 110. When the percutaneous implant 100 is stimulated by the cathodic voltage of the attached stimulating device 180, only the surface area of the implant 110 surrounded by electrolyte (i.e. tissue) will undergo the therapeutic chemical reaction. However, other sections of the metal exposed outside of the body may still have voltage potentials about their surfaces that could either interrupt the therapy or cause unwanted affects to users that may physically contact the post. By enabling the stimulating unit 180 to be attached directly to the anchoring unit 160, the exposed metal is covered, whereby these noted safety concerns are mitigated.

[0036] FIG. 3 depicts a top view of the integrated system 100, which is configured with four (4) counter electrode pads 190 splayed out horizontally relative to the centrally disposed anchoring unit 160, the counter electrode pads 190 being depicted in a first or undeployed state. This figure helps show how the counter electrode pads 190 can be selected and attached in a modular fashion to meet a patient’s anatomical needs. In one preferred embodiment, each counter electrode pad 190 is formed in a trapezoidal shape or configuration that increases in width as the distance from the anchoring unit 160 increases. It will be understood, however, that the counter electrode pads 190 can assume a number of suitable shapes or configurations and most preferably any shape that allows the electrode pads 190 to preferably substantially conform around the patient’s limb. Typically, the circumference of the limb in close proximity to the exposed metal post 114, FIG. 1, of the percutaneous implant 110 begins at a minimum value that increases further up the limb. Therefore and by increasing the width of the counter electrode on each individual counter electrode pad 190, full coverage can be maintained. The anodic surface of the electrode pads 190 should be made from a stable material that is not prone to corrosive effects, such as, for example carbon vinyl or platinum, among others known in the field. Again, all separated electrode pads 190 may be internally connected to the anchoring unit 160 by the contacts 130 and thus will act as a single integrated unit, but maintaining the ease of application in regard to the multiple electrodes when deployed. The connection to the stimulation device 180 is not shown in FIGS. 2 and 3.

[0037] FIG. 4 shows a more detailed comparison between a counter electrode pad 190 as previously described and an alternative counter electrode pad 210, the latter of which may also further include an isolated auxiliary or reference electrode 218, also referred to herein as a sensing electrode, which has been integrated into the electrode pad 210. The ability for the disclosed invention to include or exclude the need for at least one isolated reference electrode, such as electrode 218, allows the herein described apparatus to be compatible with both two-electrode and three-electrode treatment systems (i.e„ CVCES). In either case and in order to incorporate a sensing electrode on the counter electrode pad 210 according to this exemplary embodiment, it is necessary to insulate the back of the counter electrode pad 210 with a non-woven fiber, foam, or other common electrode backing surface 222 in order to prevent exposed electrified anodic surfaces. Having this backing surface 222 allows a multiple number of electrodes to be built in conjunction with a single electrode pad with the multiple electrodes on the pad 210 being isolated electrically from one another. The reference electrode 218, which is preferably Ag/AgCl, has sufficient conductive separation (i.e., isolation) from the anodic surface of the counter electrode 190 and can therefore function separately yet be applied at the same time, further providing overall system versatility. Alternatively, the reference electrode 218 can be made from any suitable stable metal such as platinum, silver, or gold. In addition, each electrode that is built into an electrode pad 210 (or 190) may contain its own respective communication or electrical contact 130 that can fasten by snap-fitting or other suitable means to the anchoring unit 160 in a manner such as previously described.

[0038] In summary, the herein described system provides a novel way to achieve the interface between the limb and the percutaneous implant for treatment purposes, particularly as a CVCES electrochemically-based treatment system. A fundamental aspect of the herein described invention is to be able to convert the entire multicomponent stimulation system into a single integrated component that can securely attach to the exposed portion (post or pin) of the percutaneous implant and provide effective treatment. To do this, all of the electrode and stimulation components can be centralized to the anchoring unit, which can slide over the exposed external portion of the percutaneous implant and then be tightened/locked in place onto the exposed implant post in a secure fashion. A primary function of the anchoring unit (once it is tightened/locked onto the exposed implant post) is provide electrical contact to the percutaneous implant itself. Because the exposed protruding portion of the percutaneous implant is continuous with its embedded portion, the connection of the protruding portion with the anchoring unit can evenly electrify the entire embedded portion of the exposed implant post from outside of the tissue. The anchoring unit may have multiple contact points for direct interface with counter electrode pads. Each counter electrode may be composed of a corrosion resistant anode material such as carbon or platinum, and may have a conductive gel or hydrogel that interfaces the anode to the surface of the skin adjacent the percutaneous implant.

[0039] As discussed herein, each counter electrode pad may also contain any convenient number of isolated auxiliary or reference (sensing) electrodes that need to adhere to the skin. The counter electrode may be divided into multiple, electrically connected pads to allow for greater ease of application once the anchoring unit has already been locked onto the exposed portion (metal post) of the percutaneous implant. Each counter electrode pad would have a direct point of contact with the anchoring unit. Additionally, the stimulation unit may be attached to the distal side of the anchoring unit. This latter attachment provides multiple advantages as it both caps the exposed, electrified post from user contact, and also eliminates the need for external cabling for communication, as found in typical stimulation devices and treatment systems.

PARTS LIST FOR FIGS. 1 - 5 limb 10 bone 12 post (working electrode) 14 counter electrode 16 reference electrode 18 stimulating device 20 conductive surface (post) 22 treatment system 100 percutaneous metal implant 110 post (exposed portion) 114 thigh 120 femur 124 counter electrode contact 130 tightening mechanism 150 point(s) of contact 154 anchoring unit 160 unit body 164 collet 166 stimulation unit contact(s) 170 stimulation device 180 counter electrode pads 190 counter/reference electrode pad 210 reference electrode 218 backing surface, electrode pad 222 treatment system 300 prosthetic 310 lead 314 [0040] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the intended scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the following appended claims and their equivalents. For example and referring to FIG. 5, there is shown a treatment system 300. For the sake of clarity, similar components are described using the same reference numerals. In this version, the stimulating device 180 can be mechanically decoupled from the connectors 170 (Fig. 1) of the anchoring unit 160 and mechanically anchored to one of the counter electrode pads 190/thigh 120 in order to create access to the exposed metal post 114 of the percutaneous implant 110 for attachment of the prosthetic 310, the latter being shown in phantom. The stimulating device 180 and the anchoring unit 160 would remain in electrical communication in this mode of operation via lead 314 to produce the cathodic reaction required for treatment of the implant 110. As in the previously described version, a tightening mechanism 150 of the anchoring unit 160 provides mechanical securement to the exposed portion 114 of the implant 110, as shown, with points of contact 154 of the tightening mechanism 150 creating electrical contact therewith. When attached, the attached prosthetic 310 would be electrically insulated from the percutaneous implant 110 or electrically isolated from the environment to satisfy the safety concerns relating to voltage potentials previously discussed. In one version, the treatment system 300 can be manufactured to enable dual operational modes (that is, the modes shown in FIGS. 1 and 5) interchangeably. It will be understood that other modifications and variations will also be readily apparent.

Claims

1. A system for treatment of a percutaneous implant, the system comprising: a working electrode; at least one counter electrode; a stimulating device electrically coupled to the at least one counter electrode and the working electrode, the stimulating device being capable of providing a suitable current or voltage wherein the working electrode is the percutaneous implant; and an anchoring unit to which the counter electrode is attached, wherein the stimulating device is attached to one of the anchoring unit or the counter electrode, the anchoring unit being securable to the percutaneous implant.

2. The system according to claim 1, in which the anchoring unit includes a tightening mechanism for securing the anchoring unit to an exposed portion of the percutaneous implant.

3. The system according to claim 1, wherein the at least one counter electrode comprises a plurality of counter electrode pads made from a stable, non-corroding conductive material, each of the counter electrode pads being couplable to the anchoring unit.

4. The system according to claim 3, wherein the plurality of counter electrode pads are each configured on the anchoring unit to surround the exposed portion of the percutaneous implant and a portion of the limb of the patient.

5. The system according to claim 4, wherein the counter electrode pads each have a trapezoidal shape.

6. The system according to claim 4, comprising four of the counter electrode pads which are coupled to the anchoring unit. The system according to claim 1, further comprising electrical contacts between the stimulating device and the at least one counter electrode, said electrical contacts being disposed within an interior of the anchoring unit. The system according to claim 1, wherein the stimulating device is mechanically fitted to the anchoring unit using at least one connector. The system according to claim 8, in which the stimulating device is attached to a distal end of the anchoring unit. The system according to claim 1, in which the stimulating device is anchored to the at least one counter electrode and in which the exposed portion of the percutaneous implant can be attached to a prosthetic during treatment. The system according to claim 1, wherein the stimulating device is a potentiostat or a galvanostat. The system according to claim 1, further comprising at least one sensing electrode which is electrically isolated from the counter electrode. The system according to claim 12, wherein the at least one sensing electrode is a reference electrode coupled to one of the counter electrode pads. A method for manufacturing an integrated system for treatment of a percutaneous implant for removal of biofilm deposits, the method comprising: providing an anchoring unit having a mechanism that is configured for securement to an exposed metal portion of the percutaneous implant; integrally attaching a counter electrode to the anchoring unit; integrally attaching a stimulating device to one of the anchoring unit or the counter electrode; and electrically coupling the counter electrode and the exposed metal portion of the percutaneous implant to the stimulating device wherein a working electrode of the system for treatment is the percutaneous implant. The method according to claim 14, in which the counter electrode comprises a plurality of counter electrode pads attached peripherally to the exterior of the anchoring unit. The method according to claim 15, in which the counter electrode comprises four counter electrode pads. The method according to claim 15, further comprising disposing at least one auxiliary electrode to at least one of the counter electrode pads. The method according to claim 14, further comprising disposing all electrical connections within the interior of the anchoring unit. The method according to claim 14, including the step of providing treatment while a prosthetic is attached to the exposed metal portion of the percutaneous implant. A method for biofilm removal or biofilm cleaning of a percutaneous metal implant, the method comprising: attaching an anchoring unit to a percutaneous metal implant; attaching a counter electrode integrated to the anchoring unit onto the limb of a patient surrounding the percutaneous implant; providing a current to a circuit including a working electrode and counter electrode using a stimulating device capable of applying a cathodic current in which the working electrode is the percutaneous implant and in which the counter electrode is integrally disposed on an anchoring unit connectable to the percutaneous metal implant and the stimulating device is integrally disposed on one of the anchoring unit or the counter electrode.

18 The method according to claim 20, wherein the anchoring unit is secured to the percutaneous metal implant using a tightening mechanism disposed on the anchoring unit. The method according to claim 20, wherein the counter electrode comprises a plurality of counter electrode pads mechanically and electrically connected to the anchoring unit. The method according to claim 22, wherein the counter electrode comprises four (4) said counter electrode pads. The method according to claim 22, further comprising the additional step of attaching at least one auxiliary electrode, such as a reference electrode, to the anchoring unit. The method according to claim 24, further comprising the additional step of disposing the at least one auxiliary electrode on at least one of the counter electrode pads. The method according to claim 20, further comprising the step of connecting each of the counter electrodes and the stimulating device via connectors integral to the anchoring unit. The method according to claim 20, further comprising the step of providing treatment while a prosthetic is attached to an exposed portion of the percutaneous implant.

19