Wound debridement device

Abstract

The present disclosure concerns a wound debridement device, comprising scraping means, wherein at least a portion of the scraping means is configured to act as a first electrode; and a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the scraping means is ionised. The scraping means may be a blade, a brush, a mesh, a perforated disc or a wire loop.

Description

[0001] Wound Debridement Device

[0002] Technical Field

[0003] The present invention relates, in general terms, to a wound debridement device.

[0004] Background

[0005] Wound debridement refers to the removal of unwanted tissues like dead tissue, injured non-viable tissue and contaminated or infected tissue. A wound that is debrided well may expedite healing. Wound debridement is useful for facilitating healing of ulcers and removal of tumours.

[0006] Removal of the unwanted tissue may be via surgery or involves the use of organisms to digest the unwanted tissue. For example, surgical removal uses sharp instruments, high-speed liquid jets or ultrasonic probes to remove the tissue from the wound. Such surgeries require trained professionals, may not be suitable for wounds of different topography and can generate fine aerosols from the wound that may carry infective pathogens. The use of organisms, such as enzymes and maggots, to remove unwanted tissue is a slow process and may require repeated examinations of the wound site to rule out infection. It cannot be used for the removal of thick layer of unwanted tissue, contaminated or infected tissue and may cause allergic or immunologic reactions against some of the organisms used.

[0007] It would be desirable to overcome or ameliorate at least one of the abovedescribed problems.

[0008] Summary

[0009] The present disclosure concerns a wound debridement device, comprising: a) scraping means, wherein at least a portion of the scraping means is configured to act as a first electrode; and b) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the scraping means is ionised.

[0010] In some embodiments, the scraping means forms a wall of the reservoir.

[0011] In some embodiments, the scraping means comprises at least one through-hole for eluting the electrolyte.

[0012] In some embodiments, the scraping means is a blade, a brush, a mesh, a perforated disc or a wire loop.

[0013] In some embodiments, the scraping means is a circular blade, an electrically conductive brush, a metal mesh or a metal perforated disc.

[0014] In some embodiments, the portion of the scraping means is an outward facing side of the scraping means, configured to contact the wound.

[0015] In some embodiments, the portion of the scraping means is a blunt edge of the scraping means.

[0016] In some embodiments, the portion of the scraping means is a cutting edge of the scraping means.

[0017] In some embodiments, the portion of the scraping means is adjacent to an insulated and inward facing side of the scraping means.

[0018] In some embodiments, the first electrode is a cathode. In some embodiments, when in use, the second electrode is electrically connected to the eluted electrolyte.

[0019] In some embodiments, when in use, the second electrode electrolyses the electrolyte in order to generate bubbles, increase a pressure within the reservoir and elute the electrolyte onto a wound.

[0020] In some embodiments, the device further comprises a third electrode.

[0021] In some embodiments, when in use, the third electrode is configured to electrically connect the first electrode and a peripheral region of the wound. In some embodiments, the body electrode (third electrode) is electrically connected to the scraping means when in use and external to the reservoir.

[0022] In some embodiments, the first electrode, the second electrode and the third electrode are independently selected from graphite electrode, platinum electrode, gold electrode, steel electrode, alloy electrode and their coated form thereof. In some embodiments, the electrode is a stainless steel electrode. In some embodiments, the second electrode is a graphite electrode. In some embodiments, the third electrode is a graphite electrode. In some embodiments, the third electrode is a steel electrode.

[0023] In some embodiments, the device comprises a first switchable circuit electrically connecting the first electrode and the second electrode, and a second non- switchable circuit in parallel with the first switchable circuit, wherein the second non-switchable circuit is configured to electrically connect the first electrode and a resistor of about 1 K to about 100 K .

[0024] In some embodiments, the device comprises a switch selected from a single pole single throw switch (SPST), a single pole double throw switch (SPDT), a double pole single throw switch (DPST) and a double pole double throw switch (DPDT). In some embodiments, the switch is a single pole single throw switch (SPST). In some embodiments, the switch is a double pole double throw switch (DPDT).

[0025] In some embodiments, the reservoir comprises a tubing.

[0026] In some embodiments, the reservoir comprises a flexible body configured to elute the electrolyte onto a wound when squeezed.

[0027] In some embodiments, the reservoir is a sponge.

[0028] In some embodiments, the reservoir is electrically connected to the second electrode.

[0029] In some embodiments, the electrolyte comprises water, organic salt, inorganic salt, metal ion chelating compound, high pH buffer solution or a combination thereof.

[0030] In some embodiments, the electrolyte is characterised by a pH value of about 6 to about 14.

[0031] In some embodiments, the electrolyte further comprises a thickener.

[0032] In some embodiments, the thickener is selected from polyethylene glycol, Xanthan gum, sodium alginate, hydrocellulose, Povidone, poly vinyl alcohol, pectin, guar gum, dextran, starch, carboxy methyl cellulose, and a combination thereof.

[0033] In some embodiments, the electrolyte is characterised by a wt% of about 0.1 wt% to about 20 wt% of thickener relative to the electrolyte.

[0034] In some embodiments, the electrolyte is characterised by a viscosity of about 1 Pa-s to about 100 Pa-s. In some embodiments, the electrolyte is eluted at a rate of about 1 pL / s to about 10 uL / s.

[0035] In some embodiments, the eluted electrolyte when ionised forms an acidic or alkaline region adjacent to the portion of the scraping means.

[0036] In some embodiments, the acidic region is characterised by a pH of less than 0.

[0037] In some embodiments, the alkaline region is characterised by a pH of more than about 14.

[0038] In some embodiments, the acidic or alkaline region is about 1 pm to about 300 pm relative to the portion of the scraping means.

[0039] In some embodiments, the acidic or alkaline region is formed in about 10 seconds to about 20 seconds after switching on the device. In some embodiments, the acidic or alkaline region is formed in about 15 seconds.

[0040] In some embodiments, the acidic or alkaline region increases or decreases to a pH of about 6 to about 8 in about 25 seconds to about 40 seconds after switching off the device. In some embodiments, the acidic or alkaline region increases or decreases to a pH of about 6 to about 8 in about 25 seconds to about 40 seconds when a polarity of the first electrode and second electrode is reversed. In some embodiments, the acidic or alkaline region increases or decreases to a pH of about 6 to about 8 in about 30 seconds.

[0041] In some embodiments, the device is characterised by a direct current or an alternating current.

[0042] In some embodiments, the device is characterised by a potential of about 1 V to about 50 V across the first and second electrodes. In some embodiments, the device is characterised by a power of about 1 W to about 5 W.

[0043] In some embodiments, the device further comprises suction means.

[0044] The present disclosure also concerns a wound debridement device, comprising: a) a housing having an open end; b) a metal mesh or a perforated metal disc positioned at the open end, wherein at least a portion of the metal mesh or metal disc is configured to act as a first electrode; and c) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the metal mesh or metal disc is ionised.

[0045] The present disclosure also concerns a method of debriding wound using a wound debridement device as disclosed herein, the method comprising: a) contacting the wound with the wound debridement device; b) eluting the electrolyte from the reservoir; c) passing a current between the first and second electrodes and the eluted electrolyte; and d) scraping the wound with the scraping means.

[0046] In some embodiments, the method further comprises a step of removing debrided tissue.

[0047] In some embodiments, the step of removing debrided tissue comprises removing the debrided tissue using a suction means.

[0048] Brief description of the drawings Embodiments of the present invention will now be described, by way of nonlimiting example, with reference to the drawings in which:

[0049] Figure 1 shows the different waveforms of voltage fluctuation.

[0050] Figure 2 illustrates the electrolysis of water.

[0051] Figure 3 shows an embodiment of the debridement device.

[0052] Figure 4 shows animal trials using the debridement device.

[0053] Figure 5 shows histopathological evaluation of a wound after debridement.

[0054] Figure 6 shows another embodiment of the debridement device.

[0055] Figure 7 shows a photo and a cross section schematic drawing of an embodiment of the wound debridement device.

[0056] Figure 8 shows a photo and a cross section schematic drawing of another embodiment of the wound debridement device.

[0057] Figure 9 shows a schematic drawing of another embodiment of the wound debridement device.

[0058] Figure 10 shows a battery powered embodiment of the wound debridement device.

[0059] Figure 11 shows a DC powered or console powered embodiment of the wound debridement device.

[0060] Figure 12 shows another embodiment of the wound debridement device with fine steel mesh electrode insulated on the inner surface, maintaining the perforations.

[0061] Figure 13 shows the production of high pH in the electrolyte at the cathode by electrode induced chemical reaction.

[0062] Figure 14 shows partially burned pig dermis before and after debridement.

[0063] Figure 15 shows a 4 mm thick porcine dermis being punctured by a wound debridement device to create a hole in two minutes.

[0064] Figure 16 shows different types of tissues being digested by a wound debridement device.

[0065] Figure 17 shows the experimental setup for experimental testing on safety of the wound debridement device. Detailed description

[0066] The present disclosure concerns a device which is easy to use, cost effective for clinicians and allied health staff. The device allows for wound debridement. Wound debridement refers to the removal of unwanted tissue like dead tissue, injured non-viable tissue and contaminated or infected tissue.

[0067] The wound debridement device removes unwanted tissue and may remove tissue layer by layer to minimise healthy tissue loss. The scraping of the tissue is augmented with the ionisation of the electrolyte. A current passing through the electrodes and the electrolyte ionises the electrolyte. The ionisation of the electrolyte alters the pH of the electrolyte adjacent to the electrodes, which improves the effect of wound debridement. A suction force may be applied to remove the debrided tissue from the wound. The device allows for easier and faster tissue debridement and may be used on wounds of different topography.

[0068] Accordingly, the present disclosure concerns a wound debridement device, comprising : a) scraping means, wherein at least a portion of the scraping means is configured to act as a first electrode; and b) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the scraping means is ionised.

[0069] The eluted electrolyte thus contacts the wound and the first electrode, and through electrolysis of the electrolyte at the first electrode, the portion of the scraping means is "activated" to debride the wound.

[0070] It was found that with an eluted electrolyte, the wound site may be kept clean as the constant flow of fluids helps washes the impurities away. Additionally, as the debrided tissue does not enter the device, the device may be more easily cleaned.

[0071] As shown in Figure 3, 6, 7 and 8, the wound debridement device comprises scraping means. The scraping means is configured to have at least a portion acting as a first electrode. The wound debridement device also comprises a reservoir for containing an electrolyte. The reservoir is configured to elute the electrolyte onto a wound. In use, the scraping means is in contact with the wound. When an electric current is made to flow between the first electrode and the eluted electrolyte on the wound, the eluted electrolyte adjacent to the portion of the scraping means is ionised. The wound debridement device may be pressed in contact with the wound and the scraping means is moved almost parallel (substantially perpendicular to the longitudinal axis of the wound debridement device) to the tissue surface to remove the superficial unwanted tissue layer by layer until the deeper healthy tissue is exposed. The scraping means may also be moved almost perpendicular to the tissue surface in a sweeping motion to remove the superficial unwanted tissue layer by layer until the deeper healthy tissue is exposed. The wound may be debrided in a layer- by-layer manner which minimises removal of healthy tissue. This is in contrast to other wound debridement device, where much healthy tissue is also removed during debridement.

[0072] In some embodiments, the scraping means forms a wall of the reservoir. The scraping means may help to contain the electrolyte within the reservoir.

[0073] In some embodiments, the scraping means comprises at least one through-hole for eluting the electrolyte. This may allow the scraping means to aid in the controlled elution of the electrolyte to the wound and may limit the spread or spillage of the electrolyte beyond the wound. This may allow for a more targeted and focused delivery of the electrolyte, improving the effectiveness of the wound debridement process. As shown in Figure 3, the scraping means is a blade, or in particular a circular blade. The scraping means may also be a brush, as shown in Figure 6, a mesh, a perforated disc, as shown in Figure 9, or a wire loop. The brush may be an electrically conductive brush, such as a metal brush. The metal brush may have a hardness of about 350 MPa to about 1500 MPa. The mesh may be a wire mesh with multiple metallic wires interconnected through different methods, forming either two-dimensional or three-dimensional grids. The wire mesh may be a metal mesh, with a mesh size openings of about 5 pm to about 500 pm. The perforated disc may be a solid, flat surface with a series of perforations throughout its structure. The perforated disc may be a metal perforated disc, with a perforation size of about 150 pm to about 300 pm in diameter. The perforated disc may have about 100 to about 300 perforations. The wire loop may have a thickness of about 0.1 mm to about 1 mm.

[0074] In some embodiments, the perforated disc is characterised by a perforation size of about 200 pm in diameter.

[0075] In some embodiments, the portion of the scraping means is an outward facing side of the scraping means, configured to contact the wound in use. When in use, the portion of the scraping means acting as the first electrode is in contact with the eluted electrolyte and aids in the debridement process through the ionisation of the eluted electrolyte adjacent to the first electrode. When a sweeping motion is applied, the portion of the scraping means may contribute to the mechanical debridement of the wound by physically removing and dislodging necrotic tissue and other debris. This action is improved by the ionisation of the eluted electrolyte, which lyse the cells before the scraping means contacts the wound, thus allowing for a smoother debriding action.

[0076] In some embodiments, the portion of the scraping means is a blunt edge of the scraping means. The mesh and / or the perforated disc may have a flat surface, providing a blunt edge for the portion of the scraping means. A blunt edge may be less likely to cause accidental punctures or lacerations to the wound or surrounding tissues during the debridement process, reducing the risk of infections or further tissue damage as compared to a scraping means with sharper edges. It may also allow a more controlled and targeted application of pressure during debridement with a reduced risk of the device slipping or cutting accidentally. This may enhance the efficiency of the debridement, allowing the procedure to be completed in less time. A blunt edge may also be less abrasive and traumatic to the wound as compared to a sharper edge and by avoiding a brushing or rubbing motion on the wound surface, patient comfort may be improved, and the wound debridement process may be less labour-intensive.

[0077] The portion of the scraping means may also be a cutting edge. In this sense, when in use, the first electrode may also be in contact with the wound and used to debride the wound. The cutting edge may be oriented parallel to the longitudinal axis of the wound debridement device. Alternatively, the cutting edge may be oriented parallel to a longitudinal plane of the wound debridement device. The cutting edge is used to debride tissue from the wound. For example, the wound debridement device may be pressed in contact with the wound and the cutting edge of the blade is moved almost parallel (substantially perpendicular to the longitudinal axis of the wound debridement device) to the tissue surface to remove the superficial unwanted tissue layer by layer until the deeper healthy tissue is exposed. In this way, a tangential force is applied to the wound such that greater control over the debridement process may be obtained; i.e. the wound may be debrided in a layer-by-layer manner which minimises removal of healthy tissue. This is in contrast to other wound debridement device, where much healthy tissue is also removed during debridement.

[0078] In some embodiments, the portion of the scraping means is adjacent to an insulated and inward facing side of the scraping means. For example, as shown in Figure 9, the mesh and / or the perforated disc may be insulated on an inner surface, wherein the insulated surface is in contact with the electrolyte. The insulated surface may help to isolate the electrical current within the device, preventing the current from directly contacting a subject, reducing the risk of electrical shocks or burns to the subject. When the scraping means has no insulated surface, during electrolysis, an electrical current may flow between the inward facing side and the second electrode (anode) which may be immersed in the electrolyte. This prevents the formation of an acidic or alkaline region in the eluted electrolyte adjacent to the portion of the scraping means in contact with the wound, wherein the acidic or alkaline region aids in tissue disintegration and sterilisation of the wound. Thus, the inward facing side may be insulated with a stable insulation. The insulation may be corrosion-resistant. The first electrode may be a cathode (negatively-charged electrode). The cathode may be exposed to the eluted electrolyte and the wound. Accordingly, in use, the eluted electrolyte is ionised such that the alkaline region generated from the ionisation of the electrolyte near the cathode aids in tissue disintegration and sterilisation of the wound. In particular, a high pH zone is created at the cathode due to the removal of H+as hydrogen gas and accumulation of anions.

[0079] The device also comprises a second electrode. The second electrode is the anode (positively-charged electrode). In particular, a low pH zone is created at the anode due to the accumulation of cations.

[0080] The cathode and the anode may be separated by a spacer. The two electrodes may be separated by a material to prevent unintentional short of the electrical circuit. The material may be sandwiched between the electrodes. The spacer may be a non-conductive material. For example, cellulose may be used. The spacer may be a foam or sponge material. The material may comprise a material selected from materials consisting of glass, ceramics or plastics.

[0081] In some embodiments, when in use, the second electrode is electrically connected to the eluted electrolyte for the ionisation of the electrolyte adjacent to the first and second electrodes when a current is passed through the electrodes and the electrolyte.

[0082] In some embodiments, when in use, the second electrode electrolyses the electrolyte in order to generate bubbles, increase a pressure within the reservoir and elute the electrolyte onto a wound. For example, water in the electrolyte may be oxidised at the anode to give oxygen gas. When there is an increase in pressure in the reservoir, the electrolyte may be forced through the at least one through-hole of the scraping means. The first electrode may be a mesh or a perforated disc. When a current is passed through the first electrode, the second electrode and the electrolyte, bubbles may be formed at the second electrode (anode), building pressure inside the reservoir. The bubbles may be formed as the water molecules in the electrolyte are oxidised, producing oxygen gas and releasing hydrogen ions. The built-up pressure from the oxygen bubbles may slowly and continuously push the electrolyte through the pores in the mesh or the perforated disc, maintaining connectivity between the cathode and the anode. An electrolyte with high viscosity may allow for a small volume of electrolyte to be dispensed from the reservoir at a slow rate without excessive spillage.

[0083] In some embodiments, the second electrode extends out from the reservoir such that a portion thereof is exposed. The second electrode may extend in the same direction as the scraping means (Figure 7). The exposed portion of the second electrode may be of a length which is shorter than the scrapping means. Thus, when the device is used, the second electrode is not directly in contact with the wound. The electrolyte within the reservoir may be eluted via the second electrode. For example, the second electrode may be porous, or may comprise at least one through-hole. The second electrode may be configured such that it is adjacent to the scraping means. For example, the second electrode may be a pair of electrodes positioned at opposite ends of the scrapping means. Alternatively, the second electrode may be a ring electrode configured to surround the scrapping means. In some embodiments, the device further comprises a third electrode. The third electrode may be an anode. The third electrode may be electrically connected to the first electrode. The third embodiment may be connected to the first electrode through a lead wire. The third electrode may be electrically connected to a member of a subject. The third electrode may be connected in parallel to the second electrode through a lead wire. The current may flow through a body between the first electrode and the third electrode. The third electrode may be electrically connected to a peripheral region of the wound. The surface area of the third electrode may be larger than the surface area of the first electrode and hence the current density is low at the third electrode, preventing burns on the skin next to the wound. An electrolyte gel may be used to improve the contact between the third electrode and the peripheral region of the wound. The third electrode may be an electrically conductive plate. Reduction reactions may occur during the electrolysis process at the first electrode. The electrical potential applied across the first and second electrodes may result in the formation of extreme concentrations of H+and OH- ions at the surface layer of the portion of the scraping means configured to act as the first electrode. The accumulation of H+and OH' ions at the region adjacent to the portion of the scraping means may result in the formation of an acidic or alkaline region. The electrons generated from the reduction reaction may flow from the cathode through the reservoir to the second electrode and from the cathode through the reservoir to the third electrode, passing through a body. The third electrode, being in a parallel circuit to the second electrode, may increase the flow of electrons in the body of the patient and at the wound, thus increasing the size of the acidic or alkaline region formed. This may increase the efficiency and rate of tissue digestion and may shorten the duration required for tissue lysis of larger wounds. By adjusting the positioning and size of the third electrode, the distribution and flow of the electrons between the first electrode and the third electrode may be optimised for different wounds.

[0084] In some embodiments, when in use, the third electrode is configured to electrically connect the first electrode and a peripheral region of the wound. In some embodiments, the body electrode (third electrode) is electrically connected to the scraping means when in use and external to the reservoir.

[0085] The electrodes may be independently selected from graphite electrode, platinum electrode, gold electrode, steel electrode, alloy electrode and their coated form thereof. In some embodiments, the first electrode is a steel electrode. In some embodiments, the first electrode is a stainless steel electrode. In some embodiments, the first electrode is a stainless steel 304 electrode. In some embodiments, the second electrode is a graphite electrode. In some embodiments, the third electrode is a graphite electrode. In some embodiments, the third electrode is a steel electrode.

[0086] The first electrode may be protected against corrosion by galvanic protection. Galvanic protection is a corrosion prevention method that uses electrochemical means to protect a base material from corrosion. It requires a sacrificial anode that is more electrochemically reactive than the material to be protected. Since the sacrificial anode is more electrochemically reactive, it will corrode before the protected material, so long as they are electrically connected. In some embodiments, the first electrode is protected by a sacrificial electrode. In some embodiments, the first electrode is galvanised. The galvanised coating acts as a sacrificial electrode and may be zinc, magnesium or aluminium.

[0087] The first electrode may be protected against corrosion by coating with corrosion resistant metals. In some embodiments, the first electrode is electroplated with corrosion resistant metals. The first electrode may be electroplated with silver, gold, platinum or graphite.

[0088] In some embodiments, the third electrode may be protected against corrosion by coating with corrosion resistant metals. In some embodiments, the third electrode may be coated with silver, gold, platinum or graphite.

[0089] In some embodiments, the device comprises a first switchable circuit electrically connecting the first electrode and the second electrode. In some embodiments, the device comprises a second non-switchable circuit in parallel with the first switchable circuit, wherein the second non-switchable circuit is configured to electrically connect the first electrode and a resistor of about 1 KQ to about 100 KQ. The first switchable circuit may be powered by multiple coin cells connected in series and may be regulated by a variable resistor of about 1 KQ to about 100 KQ. The first switchable circuit may comprise a switch, which is switched on during debridement, biasing the electrode immersed in the electrolyte as an anode and the mesh or perforated disc as the cathode. The eluted electrolyte is ionised and a high pH may develop and aids in the debridement of the wound. The coin cells in the first circuit may be replaced by a DC power supply, as shown in Figure 11. The second non-switchable circuit, powered by a coin cell, may connect to the first electrode, thus biasing it as the cathode. This circuit may provide galvanic protection to the first electrode, preventing corrosion.

[0090] In other embodiments, the resistor has a resistance of about 1 KQ to about 80 KQ, about 1 KQ to about 60 KQ, about 1 KQ to about 40 KQ, about 1 KQ to about 20 KQ, about 20 KQ to about 100 KQ, about 20 KQ to about 80 KQ, about 20 KQ to about 60 KQ, about 20 KQ to about 40 KQ, about 40 KQ to about 100 KQ, about 40 K to about 80 K , about 40 KQ to about 60 KQ, about 60 KQ to about 100 KQ, or about 60 KQ to about 80 KQ.

[0091] In some embodiments, the device comprises a switch. In some embodiments, the device comprises a switch selected from a single pole single throw switch (SPST), a single pole double throw switch (SPDT), a double pole single throw switch (DPST) and a double pole double throw switch (DPDT). A switch pole refers to the number of circuits controlled by the switch, for example single pole switches control only one electrical circuit and double pole switches control two independent circuits (and act like two identical switches that are mechanically linked). A switch throw refers to the number of output connections each pole of the switch may have, for example, a double throw has two different switch output option. Single throw switches may close a circuit at only one position and the other position of the handle is "Off". Double throw switches may close a circuit in the "Up" position, as well as the "Down" position. A double throw switch may also have a centre position, which may open the circuit.

[0092] In some embodiments, the switch is a single pole single throw switch (SPST). A SPST switch may provide an on / off control for the overall operation of the device where the switch opens and closes a single contact for a single circuit.

[0093] In some embodiments, the switch is a double pole double throw switch (DPDT). A DPDT switch may independently control two separate circuits, and each pole may have two possible positions which it may be switched between. One pole of the DPDT switch may be used to switch between different electrode setups, such as changing the anode and the cathode connections, reversing the polarity of the circuit. The circuit may be programmed to reverse the polarity for a duration of about 5 seconds to about 5 minutes.

[0094] The device further comprises a reservoir for containing an electrolyte. The reservoir may be attached or coupled to the wound debridement device, or may be an isolated chamber in fluid communication with the wound debridement device. The reservoir may comprise a tubing that elutes the electrolyte onto the wound. The tubing may be connected to a container containing electrolyte. The eluted electrolyte may connect the first electrode on the scraping means and the second electrode. This creates a closed circuit. When a current passes through the circuit, an acidic or alkaline region is generated adjacent to the electrodes. The acidic or alkaline region was found to provide an advantage in improving the sharpness of the cutting edge of the scraping means and in tissue disintegration and sterilisation of the wound. Biological macromolecules acting as the matrix for tissue or cell structures may be denatured and digested. It allows for effective and faster tissue debridement in combination with scraping and is able to remove hard tissues such as eschar.

[0095] In some embodiments, the reservoir comprises a flexible body configured to elute the electrolyte onto a wound when squeezed. The eluted electrolyte may connect the first electrode on the scraping means and the second electrode, creating a closed circuit for a current to pass through. The acidic or alkaline region generated from the ionisation of the electrolyte near the first electrode aids in tissue disintegration and sterilisation of the wound. The flexible body may be squeezed when needed during the wound debridement process, controlling the amount and location of the eluted electrolyte, allowing delivery of the electrolyte to specific areas of the wound that require debridement. The flexible body may reduce the amount of electrolyte used, minimising waste and potential spillage of the electrolyte.

[0096] In some embodiments, as shown in Figure 6, 7 and 8, the reservoir may be or may comprise a sponge. The sponge may be soaked with the electrolyte or connected to a tubing which transports the electrolyte to the sponge. The first and second electrodes may be electrically connected via electrical wires. As shown in Figure 6, the electrolyte is eluted from the sponge onto the wound, connecting the brush and the second electrode when the brush is in contact with the wound. This creates a closed circuit for a current to pass through. The acidic or alkaline region generated from the ionisation of the electrolyte near the brush and the sponge aids in tissue disintegration and sterilisation of the wound. The sweeping motion of the brush on the wound surface removes the unwanted tissue from the tissue disintegration process.

[0097] In some embodiments, the sponge is electrically connected to the second electrode. The second electrode may be connected via electrical wires.

[0098] In some embodiments, the second electrode may be immersed in the reservoir containing the electrolyte.

[0099] The electrolyte may be a neutral pH electrolyte or a high pH electrolyte. A neutral pH electrolyte may be inorganic or organic salts that easily ionise in water. A high pH electrolyte may be alkaline compounds soluble in water. In some embodiments, the electrolyte comprises water, organic salt, inorganic salt, metal ion chelating compound, high pH buffer solution or a combination thereof. Organic salts may comprise calcium lactate, potassium lactate, calcium gluconate, magnesium gluconate, magnesium aspartate, zinc gluconate or a combination thereof. Inorganic salts may comprise sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, magnesium hydroxide, calcium hydroxide, aluminium hydroxide, ferric hydroxide, or a combination thereof. Metal ion chelating compounds may comprise sodium EDTA, potassium EDTA, sodium EGTA, potassium EGTA, sodium citrate, potassium citrate or a combination thereof.

[0100] In some embodiments, the electrolyte is characterised by a pH value of about 6 to about 14. In other embodiments, the pH value is about 6 to about 14, about 6 to about 12, about 6 to about 10, about 6 to about 8, about 7 to about 14, about 7 to about 12, about 7 to about 10, about 7 to about 8, about 8 to about 14, about 8 to about 12, about 8 to about 10, about 10 to about 14, or about 10 to about 12.

[0101] In some embodiments, the electrolyte further comprises a thickener. The thickener increases the viscosity of the electrolyte, making the electrolyte more gel-like. This may make the device spill-proof as the electrolyte may drip or flow less easily from the reservoir to the first and / or second electrode, improving the handling and application of the electrolyte to the wound. The thickener may be hydrophilic polymers such as polyacrylic acid and polyvinylpyrrolidone, natural gums such as xanthan gum and guar gum, and silicates such as bentonite and kaolin.

[0102] In some embodiments, the thickener is selected from polyethylene glycol, Xanthan gum, sodium alginate, hydrocellulose, povidone, poly vinyl alcohol, pectin, guar gum, dextran, starch, carboxy methyl cellulose, and a combination thereof. In some embodiments, the electrolyte is a gel. An electrolyte gel may allow for a more controlled and targeted application of the electrolyte onto the wound and / or onto a peripheral region of the wound.

[0103] In some embodiments, the electrolyte is characterised by a wt% of about 0.1 wt% to about 20 wt% of thickener relative to the electrolyte. In other embodiments, the wt% is about 0.1 wt% to about 15 wt%, about 0.1 wt% to about 10 wt%, about 0.1 wt% to about 5 wt%, about 0.1 wt% to about 1 wt%, about 1 wt% to about 20 wt%, about 1 wt% to about 15 wt%, about 1 wt% to about 10 wt%, about 1 wt% to about 5 wt%, about 5 wt% to about 20 wt%, about 5 wt% to about 15 wt%, or about 5 wt% to about 10 wt%.

[0104] In some embodiments, the electrolyte is characterised by a viscosity of about 1 Pa-s to about 100 Pa-s. In other embodiments, the viscosity is about 1 Pa-s to about 80 Pa-s, about 1 Pa-s to about 60 Pa-s, about 1 Pa-s to about 40 Pa-s, about 1 Pa-s to about 20 Pa-s, about 1 Pa-s to about 10 Pa-s, about 10 Pa-s to about 100 Pa-s, about 10 Pa-s to about 80 Pa-s, about 10 Pa-s to about 60 Pa-s, about 10 Pa-s to about 40 Pa-s, about 10 Pa-s to about 20 Pa-s, about 20 Pa-s to about 100 Pa-s, about 20 Pa-s to about 80 Pa-s, about 20 Pa-s to about 60 Pa-s, or about 20 Pa-s to about 40 Pa-s.

[0105] In some embodiments, the device is characterised by an elution rate of the electrolyte of about 1 p L / s to about 10 pL / s. In other embodiments, the elution rate is about 1 pL / s to about 8 pL / s, about 1 pL / s to about 6 pL / s, about 1 pL / s to about 4 pL / s, about 1 pL / s to about 2 pL / s, about 2 pL / s to about 10 p pL / s, about 2 pL / s to about 8 pL / s, about 2 pL / s to about 6 pL / s, about 2 pL / s to about 4 pL / s, about 4 pL / s to about 10 pL / s, about 4 pL / s to about 8 pL / s, or about 4 pL / s to about 6 pL / s.

[0106] In some embodiments, the eluted electrolyte when ionised forms an acidic or alkaline region adjacent to the portion of the scraping means. The acidic region may have a pH value of about 0 to about 4 and the alkaline region may have a pH value of about 10 to about 14. The electrical potential applied across the first and second electrodes may result in the formation of extreme concentrations of H+and OH' ions at the surface layer of the portion of the scraping means. The pH in those regions may drop below 0 or may exceed 14. The pH effect produced adjacent to the portion of the scraping means may be enhanced when a high pH electrolyte is used. In some embodiments, the eluted electrolyte forms an alkaline region adjacent to the portion of the scraping means. The alkaline region may promote dissolution and removal of necrotic tissue and debris from the wound.

[0107] As shown in Figure 13, when the electrolyte comprises insoluble or less soluble metal hydroxide (such as magnesium hydroxide and calcium hydroxide), a metal ion chelating compound (such as sodium EDTA or potassium EDTA) and a thickener, there may be a low spontaneous reaction rate between the metal hydroxide and the metal ion chelating compound as the electrolyte is viscous due to the thickener. The electrolyte may be at a near neutral pH or a slightly alkaline pH as the hydroxide salts are insoluble. When a current is passed through the first electrode (cathode) and the electrolyte, the electrolyte may become less viscous at the cathode due to repulsion of the thickener at the cathode. This may increase the reaction rate between the metal hydroxides (magnesium hydroxide and calcium hydroxide) and the metal ion chelating compound (sodium EDTA) to form magnesium EDTA and calcium EDTA and sodium hydroxide. This may increase the pH of the electrolyte due to the formation of sodium hydroxide solution which is highly alkaline.

[0108] In some embodiments, the acidic region is characterised by a pH of less than 0.

[0109] In some embodiments, the alkaline region is characterised by a pH of more than about 14.

[0110] In some embodiments, the acidic or alkaline region is about 1 m to about

[0111] 300 pm relative to the portion of the scraping means. The acidic or alkaline region aids in tissue disintegration and sterilisation of the wound. In other embodiments, the acidic or alkaline region is about 1 |jm to about 200 pm, about 1 pm to about 100 pm, about 10 pm to about 300 pm, about 10 pm to about 200 pm, about 10 pm to about 100 pm, about 20 pm to about 300 pm, about 20 pm to about 200 pm, about 20 pm to about 100 pm, about 50 pm to about 300 pm , about 50 pm to about 200 pm, or about 50 pm to about 100 pm.

[0112] The relatively thin and confined region of the acidic or alkaline region may be controlled by switching the wound debridement device on and off. This may aid the clinician in controlling the duration and intensity of the wound debridement process, allowing a targeted and controlled approach and reducing the risk of over-debridement or damage to health tissue. Intermittently turning the wound debridement device off may provide opportunities for the clinician to visually assess the wound and make necessary adjustments to the debridement process. It may also help manage a patient's pain and discomfort during the debridement process by cycling the wound debridement device on and off. The clinician may optimise the safety and effectiveness of the wound debridement process, tailoring the process to a patient's needs and wound characteristics.

[0113] The relatively thin and confined region of the acidic or alkaline region may also be controlled by reversing the polarity of the first electrode and the second electrode. Reversing the polarity may result in a swap in the anode and the cathode. An alkaline region may form around the new cathode and an acidic region may form around the new anode. This may result in a neutralisation of the original acidic or alkaline region formed adjacent to the portion of the scraping means when the eluted electrolyte is ionised. When a DPDT switch is actuated, the polarity of the circuit and the electrodes may be reversed, neutralising the pH at the acidic or alkaline region.

[0114] In some embodiments, the acidic or alkaline region is formed in about 10 seconds to about 20 seconds after switching on the device. In other embodiments, the acidic or alkaline region is formed in about 10 seconds to about 18 seconds, about 10 seconds to about 15 seconds, about 12 seconds to about 20 seconds, about 12 seconds to about 18 seconds, about 12 seconds to about 15 seconds, about 15 seconds to about 20 seconds, or about 15 seconds to about 18 seconds. In some embodiments, the acidic or alkaline region is formed in about 15 seconds.

[0115] In some embodiments, the acidic or alkaline region increases or decreases to physiological pH in about 25 seconds to about 40 seconds after switching off the device. In some embodiments, the acidic or alkaline region increases or decreases to physiological pH in about 25 seconds to about 40 seconds when a polarity of the first electrode and second electrode is reversed. Physiological pH refers to the normal pH range found in various fluids and tissues of the human body. The physiological pH range may be about pH 6 to about pH 8. In some embodiments, the acidic or alkaline region increases or decreases to a pH of about 6 to about 8. In other embodiments, the acidic or alkaline region increases or decreases to a pH of about 6 to about 8 in about 25 seconds to about 35 seconds, about 25 seconds to about 30 seconds, about 30 seconds to about 40 seconds, or about 30 seconds to about 35 seconds. In some embodiments, the acidic or alkaline region increases or decreases to a pH of about 6 to about 8 in about 30 seconds.

[0116] In some embodiments, the device is characterised by a direct current or an alternating current. The current may be of any waveform. The electrical current or potential can take any waveform or frequency in both direct and alternative nature of currents.

[0117] In general, when electrical energy is used by the device, it is either Direct Current (DC) or Alternating Current (AC). Both DC and AC can take different wave forms (Figure 1). These waveforms can have different frequencies. If the voltage fluctuation keeps entirely on one side (either negative or positive side) of the zero line, it is a DC wave form. If the voltage fluctuation goes up and down across the zero line, it is an AC wave form. Both waveforms and steady DC current can power the devices. DC wave forms and steady DC provides the first electrode either acidic or alkaline pH based on the biasing potential relative to the second electrode.

[0118] DC may be used to cause electrolysis - the ionisation of the molecules, shifting of the pH around the first and second electrodes to acidic or alkaline depending on the potential difference between the first electrode and the second electrode, heat, and micro-bubbling of gas molecules. The DC induced pH shift to extreme acidic or alkaline nature around the first electrode may be exploited to augment the sharpness of the blade as well as the power of tissue disintegration and / or sterilisation of the wound by the dynamically induced pH zone (Figure 2).

[0119] When a DC power source is connected to electrodes immersed in water with a salt, electrolysis occurs, producing an oxidising and acidic environment around the positive electrode (anode) and a reducing and alkaline environment around the negative electrode (cathode). Water ionises into H+and OH- ions at both electrodes. At the anode, the OH- ions lose electrons, get oxidised and form oxygen which bubbles out. The remaining H~ ions formed are repelled away from the positively charged anode, creating an acidic environment around this electrode. As a result, at the anode, OH' ions are removed and H~ ions are produced proportional to the current flowing through the electrode. At the cathode, the H+ions receive electrons, get reduced and form hydrogen which bubbles out. The remaining OH' ions formed are repelled away from the negatively charged cathode, creating an alkaline environment around this electrode. As a result, at the cathode, the H+ions are removed and OH- ions are produced proportional to the current flowing through the electrode. Hence, acidic and alkaline environments are created around the anode and the cathode respectively, proportional to the current flowing through the electrodes and the electrolyte.

[0120] Electrode corrosion, especially at the anode, may occur with DC. Hence, special electrode materials or special coating needed to be used on the electrode. A graphite electrode, graphite coated electrode, platinum electrode, and platinum coated electrode, gold electrode or gold coated electrode, and special alloy electrodes, such as stainless steel electrodes, are resistant to corrosion at variable degrees. Alternatively, the anode may be isolated within the device and hence, seldom comes into contact with the tissue. For example, the anode may be in contact with a portion of the sponge which does not contact the wound. The anode may be immersed in the electrolyte in the reservoir and does not contact the wound. The cathode may be protected from corrosion by galvanic protection. When sacrificial electrode is used, the electrolyte may contain metal ion chelating compounds.

[0121] When AC is used, it may help in developing heat, ionisation and vibration of small electrolyte ions around the first and second electrodes activated by the current. AC may lead to less issues with corrosion of the electrodes.

[0122] In some embodiments, the device is characterised by a potential of about 1 V to about 50 V across the first and second electrodes. In other embodiments, the potential is about 1 V to about 40 V, about 1 V to about 30 V, about 1 V to about 20 V, about 1 V to about 10 V, about 10 V to about 50 V, about 10 V to about

[0123] 40 V, about 10 V to about 30 V, about 10 V to about 20 V, about 20 V to about

[0124] 50 V, about 20 V to about 40 V, about 20 V to about 30 V, about 30 V to about

[0125] 50 V, about 30 V to about 40 V, or about 40 V to about 50 V.

[0126] In some embodiments, the device is characterised by a power of about 1 W to about 5 W. In other embodiments, the power is about 1 W to about 4 W, about 1 W to about 3 W, about 1 W to about 2 W, about 2 W to about 5 W, about 2 W to about 4 W, about 2 W to about 3 W, about 3 W to about 5 W, or about 3 W to about 4 W.

[0127] In some embodiments, the device comprises suction means. The suction means removes the debrided tissue and keeps the wound site clean and visible. The suction means may be a suction tube, housed together with the two electrodes and the separating material between the two electrodes.

[0128] The present disclosure also concerns a wound debridement device, comprising: a) a housing having a curved open end; b) a circular blade positioned at the curved open end, wherein at least a portion of the circular blade is configured to act as a first electrode; and c) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the circular blade is ionised.

[0129] It was found that this wound debridement device is especially useful for debriding eschar.

[0130] An embodiment is shown in Figure 8. In this example, the housing having a curved open end is shaped as a L or J shaped housing. The open end comprises a circular blade, which is electrically connected to a battery source as a cathode. The reservoir comprises a tubing which flows electrolyte to a sponge positioned adjacent to the open end of the housing and spaced apart from the circular blade. The sponge may be a graphite sponge, and hence may act as the anode. When in use, the electrolyte may be caused to be eluted from the sponge through positive pressure on the reservoir, or when the sponge is compressed. The wound may be positioned between the circular blade and the sponge. As the sponge (anode) and circular blade (cathode) are electrically connected via the eluted electrolyte, the eluted electrolyte is ionised and aids in the debridement of the wound.

[0131] The device may further comprise suction means to remove the debrided tissue from the wound site. The suction means may remove the debrided tissue via the orifice within the circular blade and the hollow of the housing. The present disclosure also concerns a wound debridement device, comprising: a) an electrically conductive brush or a wire loop, wherein at least a portion of the electrically conductive brush or wire loop is configured to act as a first electrode; and b) a sponge for containing an electrolyte, wherein the sponge is configured to act as a second electrode and to elute the electrolyte onto a wound; wherein when in use, the electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the electrically conductive brush or wire loop is ionised.

[0132] It was found that this wound debridement device is especially useful for removing superficially dead tissue layers in a layer-by-layer manner.

[0133] An embodiment is shown in Figure 7. In this example, the reservoir comprises a sponge. The sponge is also the anode, and in particular the sponge is a graphite sponge electrically connected to a battery source. The other end of the battery source is electrically connected to an electrically conductive brush, and hence acts as the cathode. The electrically conductive brush is configured to be longer than the anode, and hence extends a substantial distance away from the ends of the sponge. This allows the debridement to be performed without disturbance and / or damage to the sponge. In use, electrolyte flows from the chamber into the sponge and is eluted onto the wound. The eluted electrolyte bridges the contact between the anode and the cathode, causing the eluted electrolyte to be ionised and thus assist in the debridement.

[0134] The present disclosure also concerns a wound debridement device, comprising: a) a housing having an open end; b) a metal mesh or a perforated metal disc positioned at the open end, wherein at least a portion of the metal mesh or metal disc is configured to act as a first electrode; and b) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the metal mesh or metal disc is ionised.

[0135] It was found that this wound debridement device is especially useful for improving patient comfort during the debridement process.

[0136] An embodiment is shown in Figure 9. In this example, the housing having an open end is a housing with a conical bottom. The open end comprises a mesh or a perforated disc. The mesh or perforated disc may be insulated on the inner surface which is in contact with the electrolyte. The mesh or perforated disc may act as a blunt electrode, which is electrically connected to a battery source as a cathode. The battery source may be a coin cell. The reservoir, and thus the electrolyte, is contained within the housing with an electrode immersed in the electrolyte. The electrode may be biased as an anode. The open end may be immersed in saline prior to use to ensure good connectivity between the cathode and the electrolyte. When in use, bubbles may be released from the anode, causing pressure inside the housing to build up slowly. This may result in an elution of the electrolyte through the pores of the mesh or perforated disc continuously, thereby maintaining the electrolyte bridge and / or connectivity between the anode and the cathode. The device may further comprise a third electrode, which may be electrically connected to the anode and a subject.

[0137] The present disclosure also concerns a method of debriding wound using a wound debridement device as disclosed herein, the method comprising: a) contacting the wound with the wound debridement device; b) eluting the electrolyte from the reservoir; c) passing a current between the first and second electrodes and the eluted electrolyte; and d) scraping the wound with the scraping means.

[0138] In some embodiments, the method further comprises a step of removing debrided tissue. In some embodiments, the step of removing debrided tissue comprises removing the debrided tissue using a suction means.

[0139] The wound debridement device may debride the wound at a rate of about 5 pm / min to about 200 pm / min. In other embodiments, the rate is about 5 pm / min to about 150 pm / min, 5 pm / min to about 100 pm / min, 10 pm / min to about 200 pm / min, 10 pm / min to about 150 pm / min, 10 pm / min to about 100 pm / min, 25 pm / min to about 200 pm / min, 25 pm / min to about 150 pm / min, 25 pm / min to about 100 pm / min, 50 pm / min to about 200 pm / min, 50 pm / min to about 150 pm / min, 50 pm / min to about 100 pm / min, 75 pm / min to about 200 pm / min, 75 pm / min to about 150 pm / min, or 75 pm / min to about 100 pm / min. In other embodiments, the rate is about 100 pm / min.

[0140] The present disclosure also concerns a wound debridement device, comprising: a) scraping means, wherein at least a portion of the scraping means is configured to act as a first electrode; b) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; and c) a third electrode external to the reservoir and configured to contact a peripheral region of the wound; and wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the scraping means is ionised.

[0141] Examples

[0142] Example 1 - A wound debridement device - J shaped suction tube with a circular metallic blade

[0143] The debridement device is a J shaped suction tube with a circular metallic blade at the lower end (Figure 3). The upper end of the tube is connected to the suction line through an adapter. The electric plug to the power supply and the inlet of the electrolyte infusion line to the electrolyte reservoir line also emerge out towards the upper end of the device. The lower end has the circular sharp cathode blade (1), an insulation Teflon layer (2) sandwiched between the anodic graphite (3), an inner metallic tube (4) and the external anodic platinum wires in (b). A fluidic outlet in (b) brings the electrolyte to bridge the anodes and cathode, (d) Once activated, electrolysis sets at the cutting face of the assembly generating bubbles here, (e) A pH paper placed at the cutting edge turns orange once the device is activated (f). (g) The surgeon grips the vertical middle portion of the J shaped device and sweeps the lower electrode assembly through the wound bed to remove the dead debris on the wound surface. Once activated with electric flow of low DC voltage and current, and electrolyte flow, the sweeping movement of the device on the wound removes the dead tissues layer by layer (h), and the removed debris is carried away from the wound surface continuously up through the suction line. The process of removing the debris is continued till the healthy wound bed is exposed.

[0144] The user moves the cutting blade edge almost parallel to the tissue surface to remove the unwanted tissue layer by layer until the healthy tissue plane is exposed. This way, the process minimises excessive tissue removal and guarantees almost complete removal of the unwanted tissue. The tissue cut off is removed away by the suction line away from the surgical field keep it clean and visible. The device may be used with or without electrical energy. For example, the electrical energy may be used to augment the sharpness of the blade. This allows removal of tough dead tissue like eschar. Without electrical energy, the device may be used as a mechanical device with a cutting blade and suction.

[0145] The device used with electrical energy was tested in animal experiments. Multiple deep burns induced on the pig's skin were allowed to mature and mummify into a dry thick tough woody layer like eschar. The eschars were debrided using the device and the conventional surgical blade. The results were compared and showed that the debridement using the device was superior to the conventional process (Figure 4). Eschar burn wound model in a pig was used for testing the debridement device. Multiple deep burns induced on the pig's skin were allowed to mature and dry for 10 days. The burned and dead skin layer turned into a dry thick tough woody layer. This specific wound model was chosen because eschar is one of the toughest dead tissue to be debrided. The debridement device successfully removed the tough eschar in a precise and controlled manner to expose the healthy healing tissue underneath with minimal injury to the wound bed. The process efficiency was tested in comparison to a control debridement process with conventional surgical blade / knife. It was difficult to remove the eschar layer with the surgical knife. A compelled attempt to penetrate the blade through the eschar caused heavy bleeding from the injury to the wound bed. Removing the eschar layer with surgical knife was found to be impractical.

[0146] Excision biopsy from the wound margin and histopathological evaluation showed that the present device produces an efficient debridement of the eschar (Figure 5). Histopathological assessment of the wounds was carried out after debridement of the eschar. Encircled areas (arrows) indicate the dead skin tissue (eschar) adherent to the surface of the wounds in the studied biopsy samples. The study showed that (a) conventional surgical knife debridement (control) had a significant amount of eschar still adherent on the wound surface, compared to (b) the wound debrided with the present device, where most of it was removed.

[0147] As shown in Figure 8, the debridement device may be modified to have a larger steel / metallic L or J shaped tube. The lower end of the L shaped tube is fitted with a circular sharp blade. The circular blade is biased negative through a DC power source. A smaller flexible tube carries the electrolyte through the L shaped tube to the lower end of the device. A graphite sponge electrode covers this end of the electrolyte infusion tube. The electrolyte infuses the graphite sponge electrode and drains down to the tissue surface through the graphite electrode. The graphite electrode is biased positive through the DC power source. The electrolyte layer formed on the tissue surface bridges between the opposite electrodes and establish electrolysis and the pH zones. The high pH zone around the circular blade electrode helps to cut and lyse the tissue tangentially. The dislodged tissue fragments are sucked out through the larger L shaped steel / metallic tube which is connected to the suction line on its upper end.

[0148] Example 2 - A wound debridement brush device

[0149] The debridement device has a brush and a sponge (Figure 6). The brush acts as an electrode and the sponge elutes an electrolyte onto the wound. A second electrode is in electrical connection with the sponge. When a current passes through the electrodes and the electrolyte, the sweeping movement of the brush on the wound surface removes the dead tissue, layer-by-layer, and the dislodged debris may be sucked away, through the suction line. This suction line may be integrated with the debriding brush or may be a stand-alone suction in the surgical procedure room. The process of removing the debris continues until the healthy living wound bed is exposed deep to the superficial dead tissue layers. The device is a fast and convenient debridement device, intended to reduce the process time of wound debridement.

[0150] As shown in Figure 7, the device may be modified to be held in one hand. The device has an electrolyte chamber that opens below through to the electrodes assembled at the lower end of the device. The middle electrode has multiple steel loop bristles that forms a brush. This steel brush electrode is Teflon sleeved for insulation except for the tip. The steel brush electrode is biased as negative electrode through a DC power source. Two graphite sponge electrodes sandwich the Teflon sleeved part of the steel brush electrode. The graphite sponge electrode is biased as positive electrode through a DC power source. The graphite sponge electrode extends into the electrolyte chamber and drains the electrolyte through its pores downward towards the steel brush electrode. This layer of electrolyte that bridges the opposite electrodes, establish electrolysis and pH zones around the electrodes. As the steel brush bristles are the longer electrode, it meets the tissue surface and cause tissue lysis with the high pH developed on its surface. Example 3 - A wound debridement device with a blunt end

[0151] The wound debridement brush device may be modified with inputs from multiple clinicians experienced in wound debridement. The modifications may result in an enhancement of the efficiency of debridement to complete the procedure in less time, and to avoid brushing or rubbing motions on the wound surface to improve patient comfort and make the wound debridement process less labour- intensive.

[0152] In the modified design of the wound debridement device as shown in Figure 9, a 15-50 ml plastic container with a conical bottom is open at the lower end. This opening is covered by a metal disc with perforations, with the inner side of the disc insulated and the perforations aligned with those in the metal disc. The perforations are as small as 200 microns in diameter, and the metal disc may have hundreds of them. In some embodiments, the metal disc may be replaced by a fine metallic mesh, similarly insulated on the inner surface. This metal disc or mesh serves as the cathode, a blunt electrode that debrides unwanted tissue upon contact. The plastic container is filled with an electrolyte, and the anode is placed inside the container, immersed in the electrolyte. The mesh or perforated disc may act as a blunt end for the debridement process, which may enhance the comfort of the patient as compared to a sharp end in contact with the wound.

[0153] As shown in Figures 9 and 10, the device features two battery-powered circuits: a small power circuit and a large power circuit. The small power circuit, powered by a small coin cell, connects to the metal disc, biasing it as the cathode. This circuit has a high resistance, on the order of several kilo-ohms, and lacks a switch, so it is always active, providing galvanic protection to prevent corrosion of the metal disc.

[0154] The large power circuit, on the other hand, consists of multiple coin cells with higher ampere-hours connected in series. The DC battery power can be regulated by a variable resistor. In some embodiments, the batteries may be replaced by a DC power supply or console. In this case as shown in Figure 11, the pen like debridement device is connected to the power supply via wires ending in a DC plug. It has a switch and is only activated during debridement, biasing the graphite electrode as the anode and the metal disc as the cathode. When activated, a high pH develops on the outer surface of the metal disc, which is used to debride tissue.

[0155] Initially, the tip of the assembly may be immersed in saline to ensure good connectivity between the cathode and the electrolyte inside. Once activated, bubbles released from the anode build pressure inside the container, very slowly and continuously driving the electrolyte through the pores, thereby maintaining the electrolyte bridge or connectivity between the anode and cathode.

[0156] The device may comprise a body electrode connected to the anode of the circuit as shown in Figure 9.

[0157] The results of debridement of different tissues using the wound debridement device are shown in Figures 14 to 16.

[0158] Electrodes

[0159] For the wound debridement device with a blunt end, the anode used is graphite electrode that is very resistant to corrosion. The cathode disc / mesh is stainless steel 304 that is resistant to corrosion. The cathode may be protected by galvanic protection. In addition, the cathode may be electroplated with corrosion resistance metals like silver, gold, platinum or graphite coated.

[0160] Electrolyte

[0161] For the wound debridement device with a blunt end, the electrolyte used may be either neutral or high pH. When using a high pH electrolyte, it may have a higher viscosity, making the device spill-proof. A small volume of high pH electrolyte may be dispensed at a slow rate (microlitre or microliters per second) through the gradual buildup of gas bubbles inside the closed container. This controlled pressure increase may allow the electrolyte to be dispensed at a very precise rate without excessive spillage through the pores of the cathode. When high pH electrolyte is used, it may enhance the high pH effect produced at the cathode, resulting in an additive effect.

[0162] Neutral pH electrolytes may be inorganic or organic salts that easily ionise in water. High pH electrolytes may be sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, high pH buffer solutions, sodium hydroxide solution, potassium hydroxide solution, or any other alkaline compounds soluble in water.

[0163] Electrolyte that produces high pH at the cathode by electrode induced chemical reaction

[0164] The electrolyte may be a viscous solution of an insoluble / less soluble metal hydroxide like magnesium hydroxide, calcium hydroxide, aluminium hydroxide, ferric hydroxide & a chelating agent for the metal like sodium EDTA, potassium EDTA, sodium EGTA, potassium EGTA, sodium citrate, potassium citrate etc.

[0165] The electrolyte may produce high pH at the cathode through an electrode induced chemical reaction as shown in Figure 13.

[0166] The viscosity of the electrolyte may be increased with electrolyte compatible pharmaceutical thickeners like polyethylene glycol, Xanthan gum, Sodium Alginate, Hydrocellulose, Povidone, poly vinyl alcohol, pectin, guar gum, dextran, starch, carboxy methyl cellulose etc.

[0167] Experiments on safety

[0168] As shown in Figure 17, the device is mounted on a height-adjustable stand, and a spear pH meter was used to measure the pH. The pH on the electrode's surface exceeded the meter's range, indicating a pH of 15 or higher. Such high pH levels are not typically achievable under normal lab conditions, but in an electrolytic setting, the extreme ionization of salts and water produces these extreme pH values.

[0169] On switching on and off, the peaking of pH happened in 15 seconds and dropping of the pH near physiological pH happened in 30 seconds. Instead of a normal switch, a double pole double throw switch (DPDT switch) may be used to reverse the bias of the electrodes to achieve neutral pH faster.

[0170] As the pH meter was moved away from the electrode, the high pH quickly dropped to around 10 within a few hundred microns. These results suggest that the device may create a thin, confined zone of extreme pH that can be switched on and off as needed.

[0171] It will be appreciated that many further modifications and permutations of various aspects of the described embodiments are possible. Accordingly, the described aspects are intended to embrace all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims.

[0172] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

[0173] Throughout this specification and the claims which follow, unless the context requires otherwise, the phrase "consisting essentially of", and variations such as "consists essentially of" will be understood to indicate that the recited element(s) is / are essential i.e. necessary elements of the invention. The phrase allows for the presence of other non-recited elements which do not materially affect the characteristics of the invention but excludes additional unspecified elements which would affect the basic and novel characteristics of the method defined. The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

Claims

Claims1. A wound debridement device, comprising : a) scraping means, wherein at least a portion of the scraping means is configured to act as a first electrode; and b) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the scraping means is ionised.

2. The device according to claim 1, wherein the scraping means forms a wall of the reservoir.

3. The device according to claims 1 or 2, wherein the scraping means comprises at least one-through-hole for eluting the electrolyte.

4. The device according to any one of claims 1 to 3, wherein the scraping means is a blade, a brush, a mesh, a perforated disc or a wire loop.

5. The device according to any one of claims 1 to 4, wherein the portion of the scraping means is an outward facing side of the scraping means, configured to contact the wound.

6. The device according to any one of claims 1 to 5, wherein the portion of the scraping means is a blunt edge of the scraping means or a cutting edge of the scraping means.

7. The device according to any one of claims 1 to 6, wherein the portion of the scraping means is adjacent to an insulated and inward facing side of the scraping means.

8. The device according to any one of claims 1 to 7, wherein the first electrode is a cathode.

9. The device according to any one of claims 1 to 8, wherein when in use, the second electrode is electrically connected to the eluted electrolyte.

10. The device according to any one of claims 1 to 9, wherein when in use, the second electrode electrolyses the electrolyte in order to generate bubbles, increase a pressure within the reservoir and elute the electrolyte onto a wound.

11. The device according to any one of claims 1 to 10, wherein the device further comprises a third electrode external to the reservoir, the third electrode configured to electrically connect to the first electrode and a peripheral region of the wound when in use.

12. The device according to any one of claims 1 to 11, wherein the first electrode, the second electrode and the third electrode are independently selected from graphite electrode, platinum electrode, gold electrode, steel electrode, alloy electrode and their coated form thereof.

13. The device according to any one of claims 1 to 12, wherein the device comprises a first switchable circuit electrically connecting the first electrode and the second electrode, and a second non-switchable circuit in parallel with the first switchable circuit, wherein the second non-switchable circuit is configured to electrically connect the first electrode and a resistor of about 1 Kfi to about 100 K .

14. The device according to any one of claims 1 to 13, wherein the device comprises a switch selected from a single pole single throw switch (SPST), a single pole double throw switch (SPDT), a double pole single throw switch (DPST) and a double pole double throw switch (DPDT).

15. The device according to any one of claims 1 to 14, wherein the reservoir comprises a tubing and / or a flexible body configured to elute the electrolyte onto a wound when squeezed.

16. The device according to any one of claims 1 to 15, wherein the reservoir is a sponge.

17. The device according to any one of claims 1 to 16, wherein the reservoir is electrically connected to the second electrode.

18. The device according to any one of claims 1 to 17, wherein the electrolyte comprises water, organic salt, inorganic salt, metal ion chelating compound, high pH buffer solution, or a combination thereof.

19. The device according to any one of claims 1 to 18, wherein the electrolyte is characterised by a pH value of about 6 to about 14.

20. The device according to any one of claims 1 to 19, wherein the electrolyte further comprises a thickener selected from polyethylene glycol, Xanthan gum, sodium alginate, hydrocellulose, Povidone, poly vinyl alcohol, pectin, guar gum, dextran, starch, carboxy methyl cellulose, and a combination thereof.

21. The device according to claim 20, wherein the electrolyte is characterised by a wt% of about 0.1 wt% to about 20 wt% of thickener relative to the electrolyte.

22. The device according to any one of claims 1 to 21, wherein the electrolyte is characterised by a viscosity of about 1 Pa-s to about 100 Pa-s.

23. The device according to any one of claims 1 to 22, wherein the electrolyte is eluted at a rate of about 1 ptys to about 10 uL / s.

24. The device according to any one of claims 1 to 23, wherein the eluted electrolyte forms an acidic or alkaline region adjacent to the portion of the scraping means.

25. The device according to claim 24, wherein the acidic region is characterised by a pH of less than 0.

26. The device according to claims 24 or 25, wherein the alkaline region is characterised by a pH of more than about 14.

27. The device according to any one of claims 24 to 26, wherein the acidic or alkaline region is characterised by a distance of about 1 pm to about 300 pm relative to the portion of the scraping means.

28. The device according to any one of claims 24 to 27, wherein the acidic or alkaline region is formed in about 10 seconds to about 20 seconds after switching on the device.

29. The device according to any one of claims 24 to 28, wherein the acidic or alkaline region increases or decreases to a pH of about 6 to about 8 in about 25 seconds to about 40 seconds after switching off the device or when a polarity of the first electrode and the second electrode is reversed.

30. The device according to any one of claims 1 to 29, wherein the wound debridement device is characterised by a direct current or an alternating current.

31. The device according to any one of claims 1 to 30, wherein the wound debridement device is characterised by a potential of about 1 V to about 50 V across the first and second electrodes.

32. The device according to any one of 1 to 31, wherein the wounddebridement device is characterised by a power of about 1 W to about 5 W.

33. The device according to any one of claims 1 to 32, wherein the wound debridement device further comprises suction means.

34. A wound debridement device, comprising: a) a housing having an open end; b) a metal mesh or a perforated metal disc positioned at the open end, wherein at least a portion of the metal mesh or metal disc is configured to act as a first electrode; and c) a reservoir for containing a second electrode and an electrolyte, wherein the reservoir is configured to elute the electrolyte onto a wound; wherein when in use, the first electrode is electrically connected to the eluted electrolyte on the wound, and the eluted electrolyte adjacent to the portion of the metal mesh or metal disc is ionised.

35. A method of debriding a wound using a wound debridement device according to any one of claims 1 to 34, the method comprising: a) contacting the wound with the wound debridement device; b) eluting the electrolyte from the reservoir; c) passing a current between the first and second electrodes and the eluted electrolyte; and d) scraping the wound with the scraping means.

36. The method according to claim 35, wherein the method further comprises a step of removing debrided tissue.

37. The method according to claim 36, wherein the step of removing debrided tissue comprises removing the debrided tissue using a suction means.

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